Chest Radiograph Interpretation

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Impact of clinical history on chest radiograph interpretation

The inclusion of clinical information in diagnostic testing may influence the interpretation of the clinical findings. Historical and clinical findings may focus the reader's attention to the relevant details, thereby improving the accuracy of the interpretation. However, such information may cause the reader to have preconceived notions about the results, biasing the overall interpretation.

The impact of clinical information on the interpretation of radiographic studies remains an issue of debate. Previous studies have found that clinical information improves the accuracy of radiographic interpretation for a broad range of diagnoses,[1, 2, 3, 4] whereas others do not show improvement.[5, 6, 7] Additionally, clinical information may serve as a distraction that leads to more false‐positive interpretations.[8] For this reason, many radiologists prefer to review radiographs without knowledge of the clinical scenario prompting the study to avoid focusing on the expected findings and potentially missing other important abnormalities.[9]

The chest radiograph (CXR) is the most commonly used diagnostic imaging modality. Nevertheless, poor agreement exists among radiologists in the interpretation of chest radiographs for the diagnosis of pneumonia in both adults and children.[10, 11, 12, 13, 14, 15] Recent studies have found a high degree of agreement among pediatric radiologists with implementation of the World Health Organization (WHO) criteria for standardized CXR interpretation for diagnosis of bacterial pneumonia in children.[16, 17, 18] In these studies, participants were blinded to the clinical presentation. Data investigating the impact of clinical history on CXR interpretation in the pediatric population are limited.[19]

We conducted this prospective case‐based study to evaluate the impact of clinical information on the reliability of radiographic diagnosis of pneumonia among children presenting to a pediatric emergency department (ED) with clinical suspicion of pneumonia.

METHODS

Study Subjects

Six board‐certified radiologists at 2 academic children's hospitals (Children's Hospital of Philadelphia [n = 3] and Boston Children's Hospital [n = 3]) interpreted the same 110 chest radiographs (100 original and 10 duplicates) on 2 separate occasions. Clinical information was withheld during the first interpretation. The inter‐ and inter‐rater reliability for the interpretation of these 110 radiographs without clinical information have been previously reported.[18] After a period of 6 months, the radiologists reviewed the radiographs with access to clinical information provided by the physician ordering the CXR. This clinical information included age, sex, clinical indication for obtaining the radiograph, relevant history, and physical examination findings. The radiologists did not have access to the patients' medical records. The radiologists varied with respect to the number of years practicing pediatric radiology (median, 8 years; range, 336 years).

Radiographs were selected from children who presented to the ED at Boston Children's Hospital with concern of pneumonia. We selected radiographs with a spectrum of respiratory disease processes encountered in a pediatric population. The final radiographs included 50 radiographs with a final reading in the medical record without suspicion for pneumonia and 50 radiographs with suspicion of pneumonia. In the latter group, 25 radiographs had a final reading suggestive of an alveolar infiltrate, and 25 radiographs had a final reading suggestive of an interstitial infiltrate. Ten duplicate radiographs were included.

Radiograph Interpretation

The radiologists interpreted both anterior‐posterior and lateral views for each subject. Digital Imaging and Communications in Medicine images were downloaded from a registry at Boston Children's Hospital, and were copied to DVDs that were provided to each radiologist. Standardized radiographic imaging software (eFilm Lite; Merge Healthcare, Chicago, Illinois) was used by each radiologist.

Each radiologist completed a study questionnaire for each radiograph (see Supporting Information, Appendix 1, in the online version of this article). The questionnaire utilized radiographic descriptors of primary endpoint pneumonia described by the WHO to standardize the radiographic diagnosis of pneumonia.[20, 21] No additional training was provided to the radiologists. The main outcome of interest was the presence or absence of an infiltrate. Among radiographs in which an infiltrate was identified, radiologists selected whether there was an alveolar infiltrate, interstitial infiltrate, or both. Alveolar infiltrate and interstitial infiltrate are defined on the study questionnaire (Appendix 1). A radiograph classified as having either an alveolar infiltrate or interstitial infiltrate (not atelectasis) was considered to have any infiltrate. Additional findings including air bronchograms, hilar adenopathy, pleural effusion, and location of abnormalities were also recorded.

Statistical Analysis

Inter‐rater reliability was assessed using the kappa statistic to determine the overall agreement among the 6 radiologists for each outcome (eg, presence or absence of alveolar infiltrate). The kappa statistic for more than 2 raters utilizes an analysis of variance approach.[22] To calculate 95% confidence intervals (CI) for kappa statistics with more than 2 raters, we employed a bootstrapping method with 1000 replications of samples equal in size to the study sample. Intra‐rater reliability was evaluated by examining the agreement within each radiologist upon review of 10 duplicate radiographs. We used the following benchmarks to classify the strength of agreement: poor (<0.0), slight (00.20), fair (0.210.40), moderate (0.410.60), substantial (0.610.80), almost perfect (0.811.0).[23] Negative kappa values represent agreement less than would be predicted by chance alone.[24, 25] To calculate the kappa, a value must be recorded in 3 of 4 of the following categories: negative to positive, positive to negative, concordant negative, and concordant positive reporting of pneumonia. If raters did not fulfill 3 categories, the kappa could not be calculated.

The inter‐rater concordance for identification of an alveolar infiltrate was calculated for each radiologist by comparing their reporting of alveolar infiltrate with and without clinical history for each of the 100 radiographs. Radiographs that were identified by an individual rater as no alveolar infiltrate when read without clinical history, but those subsequently identified as alveolar infiltrate with clinical history were categorized as negative to positive reporting of pneumonia with clinical history. Those that were identified as alveolar infiltrate but subsequently identified as no alveolar infiltrate were categorized as positive to negative reporting of pneumonia with clinical history. Those radiographs in which there was no change in identification of alveolar infiltrate with clinical information were categorized as concordant reporting of pneumonia.

The study was approved by the institutional review boards at both children's hospitals.

RESULTS

Patient Sample

The radiographs were from patients ranging in age from 1 week to 19 years (median, 3.5 years; interquartile range, 1.66.0 years). Fifty (50%) patients were male.

Inter‐rater Reliability

The kappa coefficients of inter‐rater reliability between the radiologists across the 6 clinical measures of interest with and without access to clinical history are plotted in Figure 1. Reliability improved from fair (k = 0.32, 95% CI: 0.24 to 0.42) to moderate (k = 0.53, 95% CI: 0.43 to 0.64) for identification of air bronchograms with the addition of clinical history. Although there was an increase in kappa values for identification of any infiltrate, alveolar infiltrate, interstitial infiltrate, and pleural effusion, and a decrease in the kappa value for identification of hilar adenopathy with the addition of clinical information, there was substantial overlap of the 95% CIs, suggesting that inclusion of clinical history did not result in a statistically significant change in the reliability of these findings.

Figure 1
Inter‐rater reliability of radiologists (n = 6) evaluating chest radiographs with and without access to clinical history data in children presenting to the emergency department with suspected pneumonia (n = 100).

Intra‐rater Reliability

The estimates of inter‐rater reliability for the interpretation of the 10 duplicate images with and without clinical history are shown in Table 1. The inter‐rater reliability in the identification of alveolar infiltrate remained substantial to almost perfect for each rater with and without access to clinical history. Rater 1 had a decrease in inter‐rater reliability from almost perfect (k = 1.0, 95% CI: 1.0 to 1.0) to fair (k = 0.21, 95% CI: 0.43 to 0.85) in the identification of interstitial infiltrate with the addition of clinical history. This rater also had a decrease in agreement from almost perfect (k = 1.0, 95% CI: 1.0 to 1.0) to fair (k = 0.4, 95% CI: 0.16 to 0.96) in the identification of any infiltrate.

Intra‐rater Reliability of Radiologists With and Without Access to Clinical History While Evaluating Chest Radiographs (n = 10) for Pneumonia in Children
 Phase 1No Clinical HistoryPhase 2Access to Clinical History
Kappa95% Confidence IntervalKappa95% Confidence Interval
  • NOTE: Abbreviations: N/A, not applicable.
  • Too few categories of agreement to calculate kappa. Both responses are negative for all 10 paired radiographs; kappa cannot be calculated.
Any infiltrate    
Rater 11.001.00 to 1.000.400.16 to 0.96
Rater 20.600.10 to 1.000.580.07 to 1.00
Rater 30.800.44 to 1.000.800.44 to 1.00
Rater 41.001.00 to 1.000.780.39 to 1.00
Rater 5N/Aa 0.110.36 to 0.14
Rater 61.001.00 to 1.001.001.00 to 1.00
Alveolar infiltrate    
Rater 11.001.00 to 1.001.001.00 to 1.00
Rater 21.001.00 to 1.001.001.00 to 1.00
Rater 31.001.00 to 1.001.001.00 to 1.00
Rater 41.001.00 to 1.000.780.39 to 1.00
Rater 50.780.39 to 1.001.001.00 to 1.00
Rater 60.740.27 to 1.000.780.39 to 1.00
Interstitial infiltrate    
Rater 11.001.00 to 1.000.210.43 to 0.85
Rater 20.210.43 to 0.850.110.36 to 0.14
Rater 30.740.27 to 1.000.780.39 to 1.00
Rater 4N/A N/A 
Rater 50.580.07 to 1.000.520.05 to 1.00
Rater 60.620.5 to 1.00N/Aa 

Intra‐rater Concordance

The inter‐rater concordance of the radiologists for the identification of alveolar infiltrate during the interpretation of the 100 chest radiographs with and without access to clinical history is shown in Figure 2. The availability of clinical information impacted physicians differently in the evaluation of alveolar infiltrates. Raters 1, 4, and 6 appeared more likely to identify an alveolar infiltrate with access to the clinical information, whereas raters 3 and 5 appeared less likely to identify an alveolar infiltrate. Of the 100 films that were interpreted with and without clinical information, the mean number of discordant interpretations per rater was 10, with values ranging from 6 to 19 for the individual raters. Radiographs in which more than 3 raters changed their interpretation regarding the presence of an alveolar infiltrate are shown in Figure 3. For Figure 3D, 4 radiologists changed their interpretation from no alveolar infiltrate to alveolar infiltrate, and 1 radiologist changed from alveolar infiltrate to no alveolar infiltrate with the addition of clinical history.

Figure 2
Intra‐rater concordance of radiologists before and after access to clinical history while evaluating chest radiographs (n = 100) for alveolar infiltrate in children.
Figure 3
Chest radiographs of children in which 3 or more radiologists changed their interpretation in regard to the presence or absence of an alveolar infiltrate with the addition of clinical information. (A, B, and C) Three of 6 radiologists changed their interpretation. (D) Five of 6 radiologists changed their interpretation. (A) Female, 2 years old. (B) Male, 9 months old. (C) Male, 3 years old. (D) Male, 3 years old. The clinical history provided for (D) read as follows: “3‐year‐old male with cough and difficulty breathing. Rales at left base.”

Comment

We investigated the impact of the availability of clinical information on the reliability of chest radiographic interpretation in the diagnosis of pneumonia. There was improved inter‐rater reliability in the identification of air bronchograms with the addition of clinical information; however, clinical history did not have a substantial impact on the inter‐rater reliability of other findings. The addition of clinical information did not alter the inter‐rater reliability in the identification of alveolar infiltrate. Clinical history affected individual raters differently in their interpretation of alveolar infiltrate, with 3 raters more likely to identify an alveolar infiltrate and 2 raters less likely to identify an alveolar infiltrate.

Most studies addressing the impact of clinical history on radiographic interpretation evaluated accuracy. In many of these studies, accuracy was defined as the raters' agreement with the final interpretation of each film as documented in the medical record or their agreement with the interpretation of the radiologists selecting the cases.[1, 2, 3, 5, 6, 7] Given the known inter‐rater variability in radiographic interpretation,[10, 11, 12, 13, 14, 15] accuracy of a radiologist's interpretation cannot be appropriately assessed through agreement with their peers. Because a true measure of accuracy in the radiographic diagnosis of pneumonia can only be determined through invasive testing, such as lung biopsy, reliability serves as a more appropriate measure of performance. Inclusion of clinical information in chest radiograph interpretation has been shown to improve reliability in the radiographic diagnosis of a broad range of conditions.[15]

The primary outcome in this study was the identification of an infiltrate. Previous studies have noted consistent identification of the radiographic features that are most suggestive of bacterial pneumonia, such as alveolar infiltrate, and less consistent identification of other radiographic findings, including interstitial infiltrate.[18, 26, 27] Among the radiologists in this study, the addition of clinical information did not have a meaningful impact on the reliability of either of these findings, as there was substantial inter‐rater agreement for the identification of alveolar infiltrate and only slight agreement for the identification of interstitial infiltrate, both with and without clinical history. Additionally, inter‐rater reliability for the identification of alveolar infiltrate remained substantial to almost perfect for all 6 raters with the addition of clinical information.

Clinical information impacted the raters differently in their pattern of alveolar infiltrate identification, suggesting that radiologists may differ in their approach to incorporating clinical history in the interpretation of chest radiographs. The inclusion of clinical information may impact a radiologist's perception, leading to improved identification of abnormalities; however, it may also guide their decision making about the relevance of previously identified abnormalities.[28] Some radiologists may use clinical information to support or suggest possible radiographic findings, whereas others may use the information to challenge potential findings. This study did not address the manner in which the individual raters utilized the clinical history. There were also several radiographs in which the clinical information resulted in a change in the identification of an alveolar infiltrate by 3 or more raters, with as many as 5 of 6 raters changing their interpretation for 1 particular radiograph. These changes in identification of an infiltrate suggest that unidentified aspects of a history may be likely to influence a rater's interpretation of a radiograph. Nevertheless, these changes did not result in improved reliability and it is not possible to determine if these changes resulted in improved accuracy in interpretation.

This study had several limitations. First, radiographs were purposefully selected to encompass a broad spectrum of radiographic findings. Thus, the prevalence of pneumonia and other abnormal findings was artificially higher than typically observed among a cohort of children for whom pneumonia is considered. Second, the radiologists recruited for this study all practice in an academic children's hospital setting. These factors may limit the generalizability of our findings. However, we would expect these results to be generalizable to pediatric radiologists from other academic institutions. Third, this study does not meet the criteria of a balanced study design as defined by Loy and Irwig.[19] A study was characterized as balanced if half of the radiographs were read with and half without clinical information in each of the 2 reading sessions. The proposed benefit of such a design is to control for possible changes in ability or reporting practices of the raters that may have occurred between study periods. The use of a standardized reporting tool likely minimized changes in reporting practices. Also, it is unlikely that the ability or reporting practices of an experienced radiologist would change over the study period. Fourth, the radiologists interpreted the films outside of their standard workflow and utilized a standardized reporting tool that focused on the presence or absence of pneumonia indicators. These factors may have increased the radiologists' suspicion for pneumonia even in the absence of clinical information. This may have biased the results toward finding no difference in the identification of pneumonia with the addition of detailed clinical history. Thus, the inclusion of clinical information in radiograph interpretation in clinical practice may have greater impact on the identification of these pneumonia indicators than was found in this study.[29] Finally, reliability does not imply accuracy, and it is unknown if changes in the identification of pneumonia indicators led to more accurate interpretation with respect to the clinical or pathologic diagnosis of pneumonia.

In conclusion, we observed high intra‐ and inter‐rater reliability among radiologists in the identification of an alveolar infiltrate, the radiographic finding most suggestive of bacterial pneumonia.[16, 17, 18, 30] The addition of clinical information did not have a substantial impact on the reliability of its identification.

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References
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  2. Berbaum KS, Franken EA, Dorfman DD, Barloon TJ. Influence of clinical history upon detection of nodules and other lesions. Invest Radiol. 1988;23(1):4855.
  3. Berbaum KS, Franken EA, Dorfman DD, Lueben KR. Influence of clinical history on perception of abnormalities in pediatric radiographs. Acad Radiol. 1994;1(3):217223.
  4. Song KS, Song HH, Park SH, et al. Impact of clinical history on film interpretation. Yonsei Med J. 1992;33(2):168172.
  5. Cooperstein LA, Good BC, Eelkema EA, et al. The effect of clinical history on chest radiograph interpretations in a PACS environment. Invest Radiol. 1990;25(6):670674.
  6. Good BC, Cooperstein LA, DeMarino GB, et al. Does knowledge of the clinical history affect the accuracy of chest radiograph interpretation?AJR Am J Roentgenol. 1990;154(4):709712.
  7. Quekel LG, Goei R, Kessels AG, Engelshoven JM. Detection of lung cancer on the chest radiograph: impact of previous films, clinical information, double reading, and dual reading. J Clin Epidemiol. 2001;54(11):11461150.
  8. Eldevik OP, Dugstad G, Orrison WW, Haughton VM. The effect of clinical bias on the interpretation of myelography and spinal computed tomography. Radiology. 1982;145(1):8589.
  9. Griscom NT. A suggestion: look at the images first, before you read the history. Radiology. 2002;223(1):910.
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  11. Bloomfield FH, Teele RL, Voss M, Knight DB, Harding JE. Inter‐ and intra‐observer variability in the assessment of atelectasis and consolidation in neonatal chest radiographs. Pediatr Radiol. 1999;29(6):459462.
  12. Gatt ME, Spectre G, Paltiel O, Hiller N, Stalnikowicz R. Chest radiographs in the emergency department: is the radiologist really necessary?Postgrad Med J. 2003;79(930):214217.
  13. Hopstaken RM, Witbraad T, Engelshoven JM, Dinant GJ. Inter‐observer variation in the interpretation of chest radiographs for pneumonia in community‐acquired lower respiratory tract infections. Clin Radiol. 2004;59(8):743752.
  14. Novack V, Avnon LS, Smolyakov A, Barnea R, Jotkowitz A, Schlaeffer F. Disagreement in the interpretation of chest radiographs among specialists and clinical outcomes of patients hospitalized with suspected pneumonia. Eur J Intern Med. 2006;17(1):4347.
  15. Tudor GR, Finlay D, Taub N. An assessment of inter‐observer agreement and accuracy when reporting plain radiographs. Clin Radiol. 1997;52(3):235238.
  16. Shimol BS, Dagan R, Givon‐Lavi N, et al. Evaluation of the World Health Organization criteria for chest radiographs for pneumonia diagnosis in children. Eur J Pediatr. 2011;171(2):369374.
  17. Cherian T, Mulholland EK, Carlin JB, et al. Standardized interpretation of paediatric chest radiographs for the diagnosis of pneumonia in epidemiological studies. Bull World Health Organ. 2005;83(5):353359.
  18. Neuman MI, Lee EY, Bixby S, et al. Variability in the interpretation of chest radiographs for the diagnosis of pneumonia in children. J Hosp Med. 2012;7(4):294298.
  19. Loy CT, Irwig L. Accuracy of diagnostic tests read with and without clinical information: a systematic review. JAMA. 2004;292(13):16021609.
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The inclusion of clinical information in diagnostic testing may influence the interpretation of the clinical findings. Historical and clinical findings may focus the reader's attention to the relevant details, thereby improving the accuracy of the interpretation. However, such information may cause the reader to have preconceived notions about the results, biasing the overall interpretation.

The impact of clinical information on the interpretation of radiographic studies remains an issue of debate. Previous studies have found that clinical information improves the accuracy of radiographic interpretation for a broad range of diagnoses,[1, 2, 3, 4] whereas others do not show improvement.[5, 6, 7] Additionally, clinical information may serve as a distraction that leads to more false‐positive interpretations.[8] For this reason, many radiologists prefer to review radiographs without knowledge of the clinical scenario prompting the study to avoid focusing on the expected findings and potentially missing other important abnormalities.[9]

The chest radiograph (CXR) is the most commonly used diagnostic imaging modality. Nevertheless, poor agreement exists among radiologists in the interpretation of chest radiographs for the diagnosis of pneumonia in both adults and children.[10, 11, 12, 13, 14, 15] Recent studies have found a high degree of agreement among pediatric radiologists with implementation of the World Health Organization (WHO) criteria for standardized CXR interpretation for diagnosis of bacterial pneumonia in children.[16, 17, 18] In these studies, participants were blinded to the clinical presentation. Data investigating the impact of clinical history on CXR interpretation in the pediatric population are limited.[19]

We conducted this prospective case‐based study to evaluate the impact of clinical information on the reliability of radiographic diagnosis of pneumonia among children presenting to a pediatric emergency department (ED) with clinical suspicion of pneumonia.

METHODS

Study Subjects

Six board‐certified radiologists at 2 academic children's hospitals (Children's Hospital of Philadelphia [n = 3] and Boston Children's Hospital [n = 3]) interpreted the same 110 chest radiographs (100 original and 10 duplicates) on 2 separate occasions. Clinical information was withheld during the first interpretation. The inter‐ and inter‐rater reliability for the interpretation of these 110 radiographs without clinical information have been previously reported.[18] After a period of 6 months, the radiologists reviewed the radiographs with access to clinical information provided by the physician ordering the CXR. This clinical information included age, sex, clinical indication for obtaining the radiograph, relevant history, and physical examination findings. The radiologists did not have access to the patients' medical records. The radiologists varied with respect to the number of years practicing pediatric radiology (median, 8 years; range, 336 years).

Radiographs were selected from children who presented to the ED at Boston Children's Hospital with concern of pneumonia. We selected radiographs with a spectrum of respiratory disease processes encountered in a pediatric population. The final radiographs included 50 radiographs with a final reading in the medical record without suspicion for pneumonia and 50 radiographs with suspicion of pneumonia. In the latter group, 25 radiographs had a final reading suggestive of an alveolar infiltrate, and 25 radiographs had a final reading suggestive of an interstitial infiltrate. Ten duplicate radiographs were included.

Radiograph Interpretation

The radiologists interpreted both anterior‐posterior and lateral views for each subject. Digital Imaging and Communications in Medicine images were downloaded from a registry at Boston Children's Hospital, and were copied to DVDs that were provided to each radiologist. Standardized radiographic imaging software (eFilm Lite; Merge Healthcare, Chicago, Illinois) was used by each radiologist.

Each radiologist completed a study questionnaire for each radiograph (see Supporting Information, Appendix 1, in the online version of this article). The questionnaire utilized radiographic descriptors of primary endpoint pneumonia described by the WHO to standardize the radiographic diagnosis of pneumonia.[20, 21] No additional training was provided to the radiologists. The main outcome of interest was the presence or absence of an infiltrate. Among radiographs in which an infiltrate was identified, radiologists selected whether there was an alveolar infiltrate, interstitial infiltrate, or both. Alveolar infiltrate and interstitial infiltrate are defined on the study questionnaire (Appendix 1). A radiograph classified as having either an alveolar infiltrate or interstitial infiltrate (not atelectasis) was considered to have any infiltrate. Additional findings including air bronchograms, hilar adenopathy, pleural effusion, and location of abnormalities were also recorded.

Statistical Analysis

Inter‐rater reliability was assessed using the kappa statistic to determine the overall agreement among the 6 radiologists for each outcome (eg, presence or absence of alveolar infiltrate). The kappa statistic for more than 2 raters utilizes an analysis of variance approach.[22] To calculate 95% confidence intervals (CI) for kappa statistics with more than 2 raters, we employed a bootstrapping method with 1000 replications of samples equal in size to the study sample. Intra‐rater reliability was evaluated by examining the agreement within each radiologist upon review of 10 duplicate radiographs. We used the following benchmarks to classify the strength of agreement: poor (<0.0), slight (00.20), fair (0.210.40), moderate (0.410.60), substantial (0.610.80), almost perfect (0.811.0).[23] Negative kappa values represent agreement less than would be predicted by chance alone.[24, 25] To calculate the kappa, a value must be recorded in 3 of 4 of the following categories: negative to positive, positive to negative, concordant negative, and concordant positive reporting of pneumonia. If raters did not fulfill 3 categories, the kappa could not be calculated.

The inter‐rater concordance for identification of an alveolar infiltrate was calculated for each radiologist by comparing their reporting of alveolar infiltrate with and without clinical history for each of the 100 radiographs. Radiographs that were identified by an individual rater as no alveolar infiltrate when read without clinical history, but those subsequently identified as alveolar infiltrate with clinical history were categorized as negative to positive reporting of pneumonia with clinical history. Those that were identified as alveolar infiltrate but subsequently identified as no alveolar infiltrate were categorized as positive to negative reporting of pneumonia with clinical history. Those radiographs in which there was no change in identification of alveolar infiltrate with clinical information were categorized as concordant reporting of pneumonia.

The study was approved by the institutional review boards at both children's hospitals.

RESULTS

Patient Sample

The radiographs were from patients ranging in age from 1 week to 19 years (median, 3.5 years; interquartile range, 1.66.0 years). Fifty (50%) patients were male.

Inter‐rater Reliability

The kappa coefficients of inter‐rater reliability between the radiologists across the 6 clinical measures of interest with and without access to clinical history are plotted in Figure 1. Reliability improved from fair (k = 0.32, 95% CI: 0.24 to 0.42) to moderate (k = 0.53, 95% CI: 0.43 to 0.64) for identification of air bronchograms with the addition of clinical history. Although there was an increase in kappa values for identification of any infiltrate, alveolar infiltrate, interstitial infiltrate, and pleural effusion, and a decrease in the kappa value for identification of hilar adenopathy with the addition of clinical information, there was substantial overlap of the 95% CIs, suggesting that inclusion of clinical history did not result in a statistically significant change in the reliability of these findings.

Figure 1
Inter‐rater reliability of radiologists (n = 6) evaluating chest radiographs with and without access to clinical history data in children presenting to the emergency department with suspected pneumonia (n = 100).

Intra‐rater Reliability

The estimates of inter‐rater reliability for the interpretation of the 10 duplicate images with and without clinical history are shown in Table 1. The inter‐rater reliability in the identification of alveolar infiltrate remained substantial to almost perfect for each rater with and without access to clinical history. Rater 1 had a decrease in inter‐rater reliability from almost perfect (k = 1.0, 95% CI: 1.0 to 1.0) to fair (k = 0.21, 95% CI: 0.43 to 0.85) in the identification of interstitial infiltrate with the addition of clinical history. This rater also had a decrease in agreement from almost perfect (k = 1.0, 95% CI: 1.0 to 1.0) to fair (k = 0.4, 95% CI: 0.16 to 0.96) in the identification of any infiltrate.

Intra‐rater Reliability of Radiologists With and Without Access to Clinical History While Evaluating Chest Radiographs (n = 10) for Pneumonia in Children
 Phase 1No Clinical HistoryPhase 2Access to Clinical History
Kappa95% Confidence IntervalKappa95% Confidence Interval
  • NOTE: Abbreviations: N/A, not applicable.
  • Too few categories of agreement to calculate kappa. Both responses are negative for all 10 paired radiographs; kappa cannot be calculated.
Any infiltrate    
Rater 11.001.00 to 1.000.400.16 to 0.96
Rater 20.600.10 to 1.000.580.07 to 1.00
Rater 30.800.44 to 1.000.800.44 to 1.00
Rater 41.001.00 to 1.000.780.39 to 1.00
Rater 5N/Aa 0.110.36 to 0.14
Rater 61.001.00 to 1.001.001.00 to 1.00
Alveolar infiltrate    
Rater 11.001.00 to 1.001.001.00 to 1.00
Rater 21.001.00 to 1.001.001.00 to 1.00
Rater 31.001.00 to 1.001.001.00 to 1.00
Rater 41.001.00 to 1.000.780.39 to 1.00
Rater 50.780.39 to 1.001.001.00 to 1.00
Rater 60.740.27 to 1.000.780.39 to 1.00
Interstitial infiltrate    
Rater 11.001.00 to 1.000.210.43 to 0.85
Rater 20.210.43 to 0.850.110.36 to 0.14
Rater 30.740.27 to 1.000.780.39 to 1.00
Rater 4N/A N/A 
Rater 50.580.07 to 1.000.520.05 to 1.00
Rater 60.620.5 to 1.00N/Aa 

Intra‐rater Concordance

The inter‐rater concordance of the radiologists for the identification of alveolar infiltrate during the interpretation of the 100 chest radiographs with and without access to clinical history is shown in Figure 2. The availability of clinical information impacted physicians differently in the evaluation of alveolar infiltrates. Raters 1, 4, and 6 appeared more likely to identify an alveolar infiltrate with access to the clinical information, whereas raters 3 and 5 appeared less likely to identify an alveolar infiltrate. Of the 100 films that were interpreted with and without clinical information, the mean number of discordant interpretations per rater was 10, with values ranging from 6 to 19 for the individual raters. Radiographs in which more than 3 raters changed their interpretation regarding the presence of an alveolar infiltrate are shown in Figure 3. For Figure 3D, 4 radiologists changed their interpretation from no alveolar infiltrate to alveolar infiltrate, and 1 radiologist changed from alveolar infiltrate to no alveolar infiltrate with the addition of clinical history.

Figure 2
Intra‐rater concordance of radiologists before and after access to clinical history while evaluating chest radiographs (n = 100) for alveolar infiltrate in children.
Figure 3
Chest radiographs of children in which 3 or more radiologists changed their interpretation in regard to the presence or absence of an alveolar infiltrate with the addition of clinical information. (A, B, and C) Three of 6 radiologists changed their interpretation. (D) Five of 6 radiologists changed their interpretation. (A) Female, 2 years old. (B) Male, 9 months old. (C) Male, 3 years old. (D) Male, 3 years old. The clinical history provided for (D) read as follows: “3‐year‐old male with cough and difficulty breathing. Rales at left base.”

Comment

We investigated the impact of the availability of clinical information on the reliability of chest radiographic interpretation in the diagnosis of pneumonia. There was improved inter‐rater reliability in the identification of air bronchograms with the addition of clinical information; however, clinical history did not have a substantial impact on the inter‐rater reliability of other findings. The addition of clinical information did not alter the inter‐rater reliability in the identification of alveolar infiltrate. Clinical history affected individual raters differently in their interpretation of alveolar infiltrate, with 3 raters more likely to identify an alveolar infiltrate and 2 raters less likely to identify an alveolar infiltrate.

Most studies addressing the impact of clinical history on radiographic interpretation evaluated accuracy. In many of these studies, accuracy was defined as the raters' agreement with the final interpretation of each film as documented in the medical record or their agreement with the interpretation of the radiologists selecting the cases.[1, 2, 3, 5, 6, 7] Given the known inter‐rater variability in radiographic interpretation,[10, 11, 12, 13, 14, 15] accuracy of a radiologist's interpretation cannot be appropriately assessed through agreement with their peers. Because a true measure of accuracy in the radiographic diagnosis of pneumonia can only be determined through invasive testing, such as lung biopsy, reliability serves as a more appropriate measure of performance. Inclusion of clinical information in chest radiograph interpretation has been shown to improve reliability in the radiographic diagnosis of a broad range of conditions.[15]

The primary outcome in this study was the identification of an infiltrate. Previous studies have noted consistent identification of the radiographic features that are most suggestive of bacterial pneumonia, such as alveolar infiltrate, and less consistent identification of other radiographic findings, including interstitial infiltrate.[18, 26, 27] Among the radiologists in this study, the addition of clinical information did not have a meaningful impact on the reliability of either of these findings, as there was substantial inter‐rater agreement for the identification of alveolar infiltrate and only slight agreement for the identification of interstitial infiltrate, both with and without clinical history. Additionally, inter‐rater reliability for the identification of alveolar infiltrate remained substantial to almost perfect for all 6 raters with the addition of clinical information.

Clinical information impacted the raters differently in their pattern of alveolar infiltrate identification, suggesting that radiologists may differ in their approach to incorporating clinical history in the interpretation of chest radiographs. The inclusion of clinical information may impact a radiologist's perception, leading to improved identification of abnormalities; however, it may also guide their decision making about the relevance of previously identified abnormalities.[28] Some radiologists may use clinical information to support or suggest possible radiographic findings, whereas others may use the information to challenge potential findings. This study did not address the manner in which the individual raters utilized the clinical history. There were also several radiographs in which the clinical information resulted in a change in the identification of an alveolar infiltrate by 3 or more raters, with as many as 5 of 6 raters changing their interpretation for 1 particular radiograph. These changes in identification of an infiltrate suggest that unidentified aspects of a history may be likely to influence a rater's interpretation of a radiograph. Nevertheless, these changes did not result in improved reliability and it is not possible to determine if these changes resulted in improved accuracy in interpretation.

This study had several limitations. First, radiographs were purposefully selected to encompass a broad spectrum of radiographic findings. Thus, the prevalence of pneumonia and other abnormal findings was artificially higher than typically observed among a cohort of children for whom pneumonia is considered. Second, the radiologists recruited for this study all practice in an academic children's hospital setting. These factors may limit the generalizability of our findings. However, we would expect these results to be generalizable to pediatric radiologists from other academic institutions. Third, this study does not meet the criteria of a balanced study design as defined by Loy and Irwig.[19] A study was characterized as balanced if half of the radiographs were read with and half without clinical information in each of the 2 reading sessions. The proposed benefit of such a design is to control for possible changes in ability or reporting practices of the raters that may have occurred between study periods. The use of a standardized reporting tool likely minimized changes in reporting practices. Also, it is unlikely that the ability or reporting practices of an experienced radiologist would change over the study period. Fourth, the radiologists interpreted the films outside of their standard workflow and utilized a standardized reporting tool that focused on the presence or absence of pneumonia indicators. These factors may have increased the radiologists' suspicion for pneumonia even in the absence of clinical information. This may have biased the results toward finding no difference in the identification of pneumonia with the addition of detailed clinical history. Thus, the inclusion of clinical information in radiograph interpretation in clinical practice may have greater impact on the identification of these pneumonia indicators than was found in this study.[29] Finally, reliability does not imply accuracy, and it is unknown if changes in the identification of pneumonia indicators led to more accurate interpretation with respect to the clinical or pathologic diagnosis of pneumonia.

In conclusion, we observed high intra‐ and inter‐rater reliability among radiologists in the identification of an alveolar infiltrate, the radiographic finding most suggestive of bacterial pneumonia.[16, 17, 18, 30] The addition of clinical information did not have a substantial impact on the reliability of its identification.

The inclusion of clinical information in diagnostic testing may influence the interpretation of the clinical findings. Historical and clinical findings may focus the reader's attention to the relevant details, thereby improving the accuracy of the interpretation. However, such information may cause the reader to have preconceived notions about the results, biasing the overall interpretation.

The impact of clinical information on the interpretation of radiographic studies remains an issue of debate. Previous studies have found that clinical information improves the accuracy of radiographic interpretation for a broad range of diagnoses,[1, 2, 3, 4] whereas others do not show improvement.[5, 6, 7] Additionally, clinical information may serve as a distraction that leads to more false‐positive interpretations.[8] For this reason, many radiologists prefer to review radiographs without knowledge of the clinical scenario prompting the study to avoid focusing on the expected findings and potentially missing other important abnormalities.[9]

The chest radiograph (CXR) is the most commonly used diagnostic imaging modality. Nevertheless, poor agreement exists among radiologists in the interpretation of chest radiographs for the diagnosis of pneumonia in both adults and children.[10, 11, 12, 13, 14, 15] Recent studies have found a high degree of agreement among pediatric radiologists with implementation of the World Health Organization (WHO) criteria for standardized CXR interpretation for diagnosis of bacterial pneumonia in children.[16, 17, 18] In these studies, participants were blinded to the clinical presentation. Data investigating the impact of clinical history on CXR interpretation in the pediatric population are limited.[19]

We conducted this prospective case‐based study to evaluate the impact of clinical information on the reliability of radiographic diagnosis of pneumonia among children presenting to a pediatric emergency department (ED) with clinical suspicion of pneumonia.

METHODS

Study Subjects

Six board‐certified radiologists at 2 academic children's hospitals (Children's Hospital of Philadelphia [n = 3] and Boston Children's Hospital [n = 3]) interpreted the same 110 chest radiographs (100 original and 10 duplicates) on 2 separate occasions. Clinical information was withheld during the first interpretation. The inter‐ and inter‐rater reliability for the interpretation of these 110 radiographs without clinical information have been previously reported.[18] After a period of 6 months, the radiologists reviewed the radiographs with access to clinical information provided by the physician ordering the CXR. This clinical information included age, sex, clinical indication for obtaining the radiograph, relevant history, and physical examination findings. The radiologists did not have access to the patients' medical records. The radiologists varied with respect to the number of years practicing pediatric radiology (median, 8 years; range, 336 years).

Radiographs were selected from children who presented to the ED at Boston Children's Hospital with concern of pneumonia. We selected radiographs with a spectrum of respiratory disease processes encountered in a pediatric population. The final radiographs included 50 radiographs with a final reading in the medical record without suspicion for pneumonia and 50 radiographs with suspicion of pneumonia. In the latter group, 25 radiographs had a final reading suggestive of an alveolar infiltrate, and 25 radiographs had a final reading suggestive of an interstitial infiltrate. Ten duplicate radiographs were included.

Radiograph Interpretation

The radiologists interpreted both anterior‐posterior and lateral views for each subject. Digital Imaging and Communications in Medicine images were downloaded from a registry at Boston Children's Hospital, and were copied to DVDs that were provided to each radiologist. Standardized radiographic imaging software (eFilm Lite; Merge Healthcare, Chicago, Illinois) was used by each radiologist.

Each radiologist completed a study questionnaire for each radiograph (see Supporting Information, Appendix 1, in the online version of this article). The questionnaire utilized radiographic descriptors of primary endpoint pneumonia described by the WHO to standardize the radiographic diagnosis of pneumonia.[20, 21] No additional training was provided to the radiologists. The main outcome of interest was the presence or absence of an infiltrate. Among radiographs in which an infiltrate was identified, radiologists selected whether there was an alveolar infiltrate, interstitial infiltrate, or both. Alveolar infiltrate and interstitial infiltrate are defined on the study questionnaire (Appendix 1). A radiograph classified as having either an alveolar infiltrate or interstitial infiltrate (not atelectasis) was considered to have any infiltrate. Additional findings including air bronchograms, hilar adenopathy, pleural effusion, and location of abnormalities were also recorded.

Statistical Analysis

Inter‐rater reliability was assessed using the kappa statistic to determine the overall agreement among the 6 radiologists for each outcome (eg, presence or absence of alveolar infiltrate). The kappa statistic for more than 2 raters utilizes an analysis of variance approach.[22] To calculate 95% confidence intervals (CI) for kappa statistics with more than 2 raters, we employed a bootstrapping method with 1000 replications of samples equal in size to the study sample. Intra‐rater reliability was evaluated by examining the agreement within each radiologist upon review of 10 duplicate radiographs. We used the following benchmarks to classify the strength of agreement: poor (<0.0), slight (00.20), fair (0.210.40), moderate (0.410.60), substantial (0.610.80), almost perfect (0.811.0).[23] Negative kappa values represent agreement less than would be predicted by chance alone.[24, 25] To calculate the kappa, a value must be recorded in 3 of 4 of the following categories: negative to positive, positive to negative, concordant negative, and concordant positive reporting of pneumonia. If raters did not fulfill 3 categories, the kappa could not be calculated.

The inter‐rater concordance for identification of an alveolar infiltrate was calculated for each radiologist by comparing their reporting of alveolar infiltrate with and without clinical history for each of the 100 radiographs. Radiographs that were identified by an individual rater as no alveolar infiltrate when read without clinical history, but those subsequently identified as alveolar infiltrate with clinical history were categorized as negative to positive reporting of pneumonia with clinical history. Those that were identified as alveolar infiltrate but subsequently identified as no alveolar infiltrate were categorized as positive to negative reporting of pneumonia with clinical history. Those radiographs in which there was no change in identification of alveolar infiltrate with clinical information were categorized as concordant reporting of pneumonia.

The study was approved by the institutional review boards at both children's hospitals.

RESULTS

Patient Sample

The radiographs were from patients ranging in age from 1 week to 19 years (median, 3.5 years; interquartile range, 1.66.0 years). Fifty (50%) patients were male.

Inter‐rater Reliability

The kappa coefficients of inter‐rater reliability between the radiologists across the 6 clinical measures of interest with and without access to clinical history are plotted in Figure 1. Reliability improved from fair (k = 0.32, 95% CI: 0.24 to 0.42) to moderate (k = 0.53, 95% CI: 0.43 to 0.64) for identification of air bronchograms with the addition of clinical history. Although there was an increase in kappa values for identification of any infiltrate, alveolar infiltrate, interstitial infiltrate, and pleural effusion, and a decrease in the kappa value for identification of hilar adenopathy with the addition of clinical information, there was substantial overlap of the 95% CIs, suggesting that inclusion of clinical history did not result in a statistically significant change in the reliability of these findings.

Figure 1
Inter‐rater reliability of radiologists (n = 6) evaluating chest radiographs with and without access to clinical history data in children presenting to the emergency department with suspected pneumonia (n = 100).

Intra‐rater Reliability

The estimates of inter‐rater reliability for the interpretation of the 10 duplicate images with and without clinical history are shown in Table 1. The inter‐rater reliability in the identification of alveolar infiltrate remained substantial to almost perfect for each rater with and without access to clinical history. Rater 1 had a decrease in inter‐rater reliability from almost perfect (k = 1.0, 95% CI: 1.0 to 1.0) to fair (k = 0.21, 95% CI: 0.43 to 0.85) in the identification of interstitial infiltrate with the addition of clinical history. This rater also had a decrease in agreement from almost perfect (k = 1.0, 95% CI: 1.0 to 1.0) to fair (k = 0.4, 95% CI: 0.16 to 0.96) in the identification of any infiltrate.

Intra‐rater Reliability of Radiologists With and Without Access to Clinical History While Evaluating Chest Radiographs (n = 10) for Pneumonia in Children
 Phase 1No Clinical HistoryPhase 2Access to Clinical History
Kappa95% Confidence IntervalKappa95% Confidence Interval
  • NOTE: Abbreviations: N/A, not applicable.
  • Too few categories of agreement to calculate kappa. Both responses are negative for all 10 paired radiographs; kappa cannot be calculated.
Any infiltrate    
Rater 11.001.00 to 1.000.400.16 to 0.96
Rater 20.600.10 to 1.000.580.07 to 1.00
Rater 30.800.44 to 1.000.800.44 to 1.00
Rater 41.001.00 to 1.000.780.39 to 1.00
Rater 5N/Aa 0.110.36 to 0.14
Rater 61.001.00 to 1.001.001.00 to 1.00
Alveolar infiltrate    
Rater 11.001.00 to 1.001.001.00 to 1.00
Rater 21.001.00 to 1.001.001.00 to 1.00
Rater 31.001.00 to 1.001.001.00 to 1.00
Rater 41.001.00 to 1.000.780.39 to 1.00
Rater 50.780.39 to 1.001.001.00 to 1.00
Rater 60.740.27 to 1.000.780.39 to 1.00
Interstitial infiltrate    
Rater 11.001.00 to 1.000.210.43 to 0.85
Rater 20.210.43 to 0.850.110.36 to 0.14
Rater 30.740.27 to 1.000.780.39 to 1.00
Rater 4N/A N/A 
Rater 50.580.07 to 1.000.520.05 to 1.00
Rater 60.620.5 to 1.00N/Aa 

Intra‐rater Concordance

The inter‐rater concordance of the radiologists for the identification of alveolar infiltrate during the interpretation of the 100 chest radiographs with and without access to clinical history is shown in Figure 2. The availability of clinical information impacted physicians differently in the evaluation of alveolar infiltrates. Raters 1, 4, and 6 appeared more likely to identify an alveolar infiltrate with access to the clinical information, whereas raters 3 and 5 appeared less likely to identify an alveolar infiltrate. Of the 100 films that were interpreted with and without clinical information, the mean number of discordant interpretations per rater was 10, with values ranging from 6 to 19 for the individual raters. Radiographs in which more than 3 raters changed their interpretation regarding the presence of an alveolar infiltrate are shown in Figure 3. For Figure 3D, 4 radiologists changed their interpretation from no alveolar infiltrate to alveolar infiltrate, and 1 radiologist changed from alveolar infiltrate to no alveolar infiltrate with the addition of clinical history.

Figure 2
Intra‐rater concordance of radiologists before and after access to clinical history while evaluating chest radiographs (n = 100) for alveolar infiltrate in children.
Figure 3
Chest radiographs of children in which 3 or more radiologists changed their interpretation in regard to the presence or absence of an alveolar infiltrate with the addition of clinical information. (A, B, and C) Three of 6 radiologists changed their interpretation. (D) Five of 6 radiologists changed their interpretation. (A) Female, 2 years old. (B) Male, 9 months old. (C) Male, 3 years old. (D) Male, 3 years old. The clinical history provided for (D) read as follows: “3‐year‐old male with cough and difficulty breathing. Rales at left base.”

Comment

We investigated the impact of the availability of clinical information on the reliability of chest radiographic interpretation in the diagnosis of pneumonia. There was improved inter‐rater reliability in the identification of air bronchograms with the addition of clinical information; however, clinical history did not have a substantial impact on the inter‐rater reliability of other findings. The addition of clinical information did not alter the inter‐rater reliability in the identification of alveolar infiltrate. Clinical history affected individual raters differently in their interpretation of alveolar infiltrate, with 3 raters more likely to identify an alveolar infiltrate and 2 raters less likely to identify an alveolar infiltrate.

Most studies addressing the impact of clinical history on radiographic interpretation evaluated accuracy. In many of these studies, accuracy was defined as the raters' agreement with the final interpretation of each film as documented in the medical record or their agreement with the interpretation of the radiologists selecting the cases.[1, 2, 3, 5, 6, 7] Given the known inter‐rater variability in radiographic interpretation,[10, 11, 12, 13, 14, 15] accuracy of a radiologist's interpretation cannot be appropriately assessed through agreement with their peers. Because a true measure of accuracy in the radiographic diagnosis of pneumonia can only be determined through invasive testing, such as lung biopsy, reliability serves as a more appropriate measure of performance. Inclusion of clinical information in chest radiograph interpretation has been shown to improve reliability in the radiographic diagnosis of a broad range of conditions.[15]

The primary outcome in this study was the identification of an infiltrate. Previous studies have noted consistent identification of the radiographic features that are most suggestive of bacterial pneumonia, such as alveolar infiltrate, and less consistent identification of other radiographic findings, including interstitial infiltrate.[18, 26, 27] Among the radiologists in this study, the addition of clinical information did not have a meaningful impact on the reliability of either of these findings, as there was substantial inter‐rater agreement for the identification of alveolar infiltrate and only slight agreement for the identification of interstitial infiltrate, both with and without clinical history. Additionally, inter‐rater reliability for the identification of alveolar infiltrate remained substantial to almost perfect for all 6 raters with the addition of clinical information.

Clinical information impacted the raters differently in their pattern of alveolar infiltrate identification, suggesting that radiologists may differ in their approach to incorporating clinical history in the interpretation of chest radiographs. The inclusion of clinical information may impact a radiologist's perception, leading to improved identification of abnormalities; however, it may also guide their decision making about the relevance of previously identified abnormalities.[28] Some radiologists may use clinical information to support or suggest possible radiographic findings, whereas others may use the information to challenge potential findings. This study did not address the manner in which the individual raters utilized the clinical history. There were also several radiographs in which the clinical information resulted in a change in the identification of an alveolar infiltrate by 3 or more raters, with as many as 5 of 6 raters changing their interpretation for 1 particular radiograph. These changes in identification of an infiltrate suggest that unidentified aspects of a history may be likely to influence a rater's interpretation of a radiograph. Nevertheless, these changes did not result in improved reliability and it is not possible to determine if these changes resulted in improved accuracy in interpretation.

This study had several limitations. First, radiographs were purposefully selected to encompass a broad spectrum of radiographic findings. Thus, the prevalence of pneumonia and other abnormal findings was artificially higher than typically observed among a cohort of children for whom pneumonia is considered. Second, the radiologists recruited for this study all practice in an academic children's hospital setting. These factors may limit the generalizability of our findings. However, we would expect these results to be generalizable to pediatric radiologists from other academic institutions. Third, this study does not meet the criteria of a balanced study design as defined by Loy and Irwig.[19] A study was characterized as balanced if half of the radiographs were read with and half without clinical information in each of the 2 reading sessions. The proposed benefit of such a design is to control for possible changes in ability or reporting practices of the raters that may have occurred between study periods. The use of a standardized reporting tool likely minimized changes in reporting practices. Also, it is unlikely that the ability or reporting practices of an experienced radiologist would change over the study period. Fourth, the radiologists interpreted the films outside of their standard workflow and utilized a standardized reporting tool that focused on the presence or absence of pneumonia indicators. These factors may have increased the radiologists' suspicion for pneumonia even in the absence of clinical information. This may have biased the results toward finding no difference in the identification of pneumonia with the addition of detailed clinical history. Thus, the inclusion of clinical information in radiograph interpretation in clinical practice may have greater impact on the identification of these pneumonia indicators than was found in this study.[29] Finally, reliability does not imply accuracy, and it is unknown if changes in the identification of pneumonia indicators led to more accurate interpretation with respect to the clinical or pathologic diagnosis of pneumonia.

In conclusion, we observed high intra‐ and inter‐rater reliability among radiologists in the identification of an alveolar infiltrate, the radiographic finding most suggestive of bacterial pneumonia.[16, 17, 18, 30] The addition of clinical information did not have a substantial impact on the reliability of its identification.

References
  1. Berbaum KS, Franken EA, Dorfman DD, et al. Tentative diagnoses facilitate the detection of diverse lesions in chest radiographs. Invest Radiol. 1986;21(7):532539.
  2. Berbaum KS, Franken EA, Dorfman DD, Barloon TJ. Influence of clinical history upon detection of nodules and other lesions. Invest Radiol. 1988;23(1):4855.
  3. Berbaum KS, Franken EA, Dorfman DD, Lueben KR. Influence of clinical history on perception of abnormalities in pediatric radiographs. Acad Radiol. 1994;1(3):217223.
  4. Song KS, Song HH, Park SH, et al. Impact of clinical history on film interpretation. Yonsei Med J. 1992;33(2):168172.
  5. Cooperstein LA, Good BC, Eelkema EA, et al. The effect of clinical history on chest radiograph interpretations in a PACS environment. Invest Radiol. 1990;25(6):670674.
  6. Good BC, Cooperstein LA, DeMarino GB, et al. Does knowledge of the clinical history affect the accuracy of chest radiograph interpretation?AJR Am J Roentgenol. 1990;154(4):709712.
  7. Quekel LG, Goei R, Kessels AG, Engelshoven JM. Detection of lung cancer on the chest radiograph: impact of previous films, clinical information, double reading, and dual reading. J Clin Epidemiol. 2001;54(11):11461150.
  8. Eldevik OP, Dugstad G, Orrison WW, Haughton VM. The effect of clinical bias on the interpretation of myelography and spinal computed tomography. Radiology. 1982;145(1):8589.
  9. Griscom NT. A suggestion: look at the images first, before you read the history. Radiology. 2002;223(1):910.
  10. Albaum MN, Hill LC, Murphy M, et al. Interobserver reliability of the chest radiograph in community‐acquired pneumonia. PORT Investigators. Chest. 1996;110(2):343350.
  11. Bloomfield FH, Teele RL, Voss M, Knight DB, Harding JE. Inter‐ and intra‐observer variability in the assessment of atelectasis and consolidation in neonatal chest radiographs. Pediatr Radiol. 1999;29(6):459462.
  12. Gatt ME, Spectre G, Paltiel O, Hiller N, Stalnikowicz R. Chest radiographs in the emergency department: is the radiologist really necessary?Postgrad Med J. 2003;79(930):214217.
  13. Hopstaken RM, Witbraad T, Engelshoven JM, Dinant GJ. Inter‐observer variation in the interpretation of chest radiographs for pneumonia in community‐acquired lower respiratory tract infections. Clin Radiol. 2004;59(8):743752.
  14. Novack V, Avnon LS, Smolyakov A, Barnea R, Jotkowitz A, Schlaeffer F. Disagreement in the interpretation of chest radiographs among specialists and clinical outcomes of patients hospitalized with suspected pneumonia. Eur J Intern Med. 2006;17(1):4347.
  15. Tudor GR, Finlay D, Taub N. An assessment of inter‐observer agreement and accuracy when reporting plain radiographs. Clin Radiol. 1997;52(3):235238.
  16. Shimol BS, Dagan R, Givon‐Lavi N, et al. Evaluation of the World Health Organization criteria for chest radiographs for pneumonia diagnosis in children. Eur J Pediatr. 2011;171(2):369374.
  17. Cherian T, Mulholland EK, Carlin JB, et al. Standardized interpretation of paediatric chest radiographs for the diagnosis of pneumonia in epidemiological studies. Bull World Health Organ. 2005;83(5):353359.
  18. Neuman MI, Lee EY, Bixby S, et al. Variability in the interpretation of chest radiographs for the diagnosis of pneumonia in children. J Hosp Med. 2012;7(4):294298.
  19. Loy CT, Irwig L. Accuracy of diagnostic tests read with and without clinical information: a systematic review. JAMA. 2004;292(13):16021609.
  20. Standardization of interpretation of chest radiographs for the diagnosis of pneumonia in children. In:World Health Organization: Pneumonia Vaccine Trial Investigators' Group.Geneva: Department of Vaccine and Biologics;2001.
  21. Hansen J, Black S, Shinefield H, et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than 5 years of age for prevention of pneumonia: updated analysis using World Health Organization standardized interpretation of chest radiographs. Pediatr Infect Dis J. 2006;25(9):779781.
  22. Landis JR, Koch GG. A one‐way components of variance model for categorical data. Biometrics. 1977;33:671679.
  23. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159174.
  24. Juurlink DN, Detsky AS. Kappa statistic. CMAJ. 2005;173(1):16.
  25. Kramer MS, Feinstein AR. Clinical biostatistics. LIV. The biostatistics of concordance. Clin Pharmacol Ther. 1981;29(1):111123.
  26. Bartlett JG, Dowell SF, Mandell LA, File TM, Musher DM, Fine MJ. Practice guidelines for the management of community‐acquired pneumonia in adults. Infectious Diseases Society of America. Clin Infect Dis. 2000;31(2):347382.
  27. Niederman MS, Mandell LA, Anzueto A, et al. Guidelines for the management of adults with community‐acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Respir Crit Care Med. 2001;163(7):17301754.
  28. Berbaum KS, Franken EA. Commentary does clinical history affect perception?Acad Radiol. 2006;13(3):402403.
  29. Berbaum KS, Franken EA. The effect of clinical history on chest radiograph interpretations in a PACS environment. Invest Radiol. 1991;26(5):512514.
  30. Korppi M, Kiekara O, Heiskanen‐Kosma T, Soimakallio S. Comparison of radiological findings and microbial aetiology of childhood pneumonia. Acta Paediatr. 1993;82(4):360363.
References
  1. Berbaum KS, Franken EA, Dorfman DD, et al. Tentative diagnoses facilitate the detection of diverse lesions in chest radiographs. Invest Radiol. 1986;21(7):532539.
  2. Berbaum KS, Franken EA, Dorfman DD, Barloon TJ. Influence of clinical history upon detection of nodules and other lesions. Invest Radiol. 1988;23(1):4855.
  3. Berbaum KS, Franken EA, Dorfman DD, Lueben KR. Influence of clinical history on perception of abnormalities in pediatric radiographs. Acad Radiol. 1994;1(3):217223.
  4. Song KS, Song HH, Park SH, et al. Impact of clinical history on film interpretation. Yonsei Med J. 1992;33(2):168172.
  5. Cooperstein LA, Good BC, Eelkema EA, et al. The effect of clinical history on chest radiograph interpretations in a PACS environment. Invest Radiol. 1990;25(6):670674.
  6. Good BC, Cooperstein LA, DeMarino GB, et al. Does knowledge of the clinical history affect the accuracy of chest radiograph interpretation?AJR Am J Roentgenol. 1990;154(4):709712.
  7. Quekel LG, Goei R, Kessels AG, Engelshoven JM. Detection of lung cancer on the chest radiograph: impact of previous films, clinical information, double reading, and dual reading. J Clin Epidemiol. 2001;54(11):11461150.
  8. Eldevik OP, Dugstad G, Orrison WW, Haughton VM. The effect of clinical bias on the interpretation of myelography and spinal computed tomography. Radiology. 1982;145(1):8589.
  9. Griscom NT. A suggestion: look at the images first, before you read the history. Radiology. 2002;223(1):910.
  10. Albaum MN, Hill LC, Murphy M, et al. Interobserver reliability of the chest radiograph in community‐acquired pneumonia. PORT Investigators. Chest. 1996;110(2):343350.
  11. Bloomfield FH, Teele RL, Voss M, Knight DB, Harding JE. Inter‐ and intra‐observer variability in the assessment of atelectasis and consolidation in neonatal chest radiographs. Pediatr Radiol. 1999;29(6):459462.
  12. Gatt ME, Spectre G, Paltiel O, Hiller N, Stalnikowicz R. Chest radiographs in the emergency department: is the radiologist really necessary?Postgrad Med J. 2003;79(930):214217.
  13. Hopstaken RM, Witbraad T, Engelshoven JM, Dinant GJ. Inter‐observer variation in the interpretation of chest radiographs for pneumonia in community‐acquired lower respiratory tract infections. Clin Radiol. 2004;59(8):743752.
  14. Novack V, Avnon LS, Smolyakov A, Barnea R, Jotkowitz A, Schlaeffer F. Disagreement in the interpretation of chest radiographs among specialists and clinical outcomes of patients hospitalized with suspected pneumonia. Eur J Intern Med. 2006;17(1):4347.
  15. Tudor GR, Finlay D, Taub N. An assessment of inter‐observer agreement and accuracy when reporting plain radiographs. Clin Radiol. 1997;52(3):235238.
  16. Shimol BS, Dagan R, Givon‐Lavi N, et al. Evaluation of the World Health Organization criteria for chest radiographs for pneumonia diagnosis in children. Eur J Pediatr. 2011;171(2):369374.
  17. Cherian T, Mulholland EK, Carlin JB, et al. Standardized interpretation of paediatric chest radiographs for the diagnosis of pneumonia in epidemiological studies. Bull World Health Organ. 2005;83(5):353359.
  18. Neuman MI, Lee EY, Bixby S, et al. Variability in the interpretation of chest radiographs for the diagnosis of pneumonia in children. J Hosp Med. 2012;7(4):294298.
  19. Loy CT, Irwig L. Accuracy of diagnostic tests read with and without clinical information: a systematic review. JAMA. 2004;292(13):16021609.
  20. Standardization of interpretation of chest radiographs for the diagnosis of pneumonia in children. In:World Health Organization: Pneumonia Vaccine Trial Investigators' Group.Geneva: Department of Vaccine and Biologics;2001.
  21. Hansen J, Black S, Shinefield H, et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than 5 years of age for prevention of pneumonia: updated analysis using World Health Organization standardized interpretation of chest radiographs. Pediatr Infect Dis J. 2006;25(9):779781.
  22. Landis JR, Koch GG. A one‐way components of variance model for categorical data. Biometrics. 1977;33:671679.
  23. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159174.
  24. Juurlink DN, Detsky AS. Kappa statistic. CMAJ. 2005;173(1):16.
  25. Kramer MS, Feinstein AR. Clinical biostatistics. LIV. The biostatistics of concordance. Clin Pharmacol Ther. 1981;29(1):111123.
  26. Bartlett JG, Dowell SF, Mandell LA, File TM, Musher DM, Fine MJ. Practice guidelines for the management of community‐acquired pneumonia in adults. Infectious Diseases Society of America. Clin Infect Dis. 2000;31(2):347382.
  27. Niederman MS, Mandell LA, Anzueto A, et al. Guidelines for the management of adults with community‐acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Respir Crit Care Med. 2001;163(7):17301754.
  28. Berbaum KS, Franken EA. Commentary does clinical history affect perception?Acad Radiol. 2006;13(3):402403.
  29. Berbaum KS, Franken EA. The effect of clinical history on chest radiograph interpretations in a PACS environment. Invest Radiol. 1991;26(5):512514.
  30. Korppi M, Kiekara O, Heiskanen‐Kosma T, Soimakallio S. Comparison of radiological findings and microbial aetiology of childhood pneumonia. Acta Paediatr. 1993;82(4):360363.
Issue
Journal of Hospital Medicine - 8(7)
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Impact of clinical history on chest radiograph interpretation
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© 2012 Society of Hospital Medicine

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Address for correspondence and reprint requests: Samir S. Shah, MD, 3333 Burnet Avenue, ML 9016, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229. E-mail: [email protected]
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Pay-for-Performance Challenged as Best Model for Healthcare

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Pushing healthcare toward pay-for-performance models that provide financial rewards for patient outcomes might not be the best direction for healthcare, according to an article published by a duo of doctors and a behavioral economist.

“Will Pay for Performance Backfire? Insights from Behavioral Economics” posted at Healthaffairs.org, questions the validity of paying for outcomes, particularly as there is no evidence yet that the model improves patient outcomes.

“You’re not actually paying for quality,” says David Himmelstein, MD, a professor at City University of New York School of Public Health at Hunter College, New York. “What you’re paying for is some very gameable measurement that doctors will find a way to cheat.”

The blog post notes that monetary rewards can actually undermine motivation for tasks that are intrinsically interesting or rewarding, a phenomenon known as “motivational crowd-out.” Dr. Himmelstein says it could focus attention on coding, rather than patients, or encourage providers to avoid noncompliant patients who will make their measured performances look bad.

“Injecting different monetary incentives into healthcare can certainly change it,” according to the article, “but not necessarily in the ways that policy makers would plan, much less hope for.”

Dr. Himmelstein says that without evidence for, or against, pay for performance, it’s difficult to say whether it will improve outcomes over the long term. Given the government push toward pay-for-performance programs—such as value-based purchasing (VBP)—he suggests physicians prepare themselves to comply. Accordingly, SHM supports policies that link "quality measurement to performance-based payment” and has created a toolkit to help hospitalists prepare for VBP, one of the most targeted pay-for-performance programs.

Even as HM moves toward adopting pay for performance as a mantra, Dr. Himmelstein believes hospitalists are in a good position to lead discussions on whether pay for performance is the only way to move forward.

“It can feel like a fait d’accompli, but things can change, and they can change rapidly,” Dr. Himmelstein adds. “The first step is to have real discussions about it. Up to now, much of the medical literature is saying, ‘It’s not working. We must have the wrong incentives.’ What if there are no right incentives?”

 

Visit our website for more information about pay-for-performance programs.

 

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Pushing healthcare toward pay-for-performance models that provide financial rewards for patient outcomes might not be the best direction for healthcare, according to an article published by a duo of doctors and a behavioral economist.

“Will Pay for Performance Backfire? Insights from Behavioral Economics” posted at Healthaffairs.org, questions the validity of paying for outcomes, particularly as there is no evidence yet that the model improves patient outcomes.

“You’re not actually paying for quality,” says David Himmelstein, MD, a professor at City University of New York School of Public Health at Hunter College, New York. “What you’re paying for is some very gameable measurement that doctors will find a way to cheat.”

The blog post notes that monetary rewards can actually undermine motivation for tasks that are intrinsically interesting or rewarding, a phenomenon known as “motivational crowd-out.” Dr. Himmelstein says it could focus attention on coding, rather than patients, or encourage providers to avoid noncompliant patients who will make their measured performances look bad.

“Injecting different monetary incentives into healthcare can certainly change it,” according to the article, “but not necessarily in the ways that policy makers would plan, much less hope for.”

Dr. Himmelstein says that without evidence for, or against, pay for performance, it’s difficult to say whether it will improve outcomes over the long term. Given the government push toward pay-for-performance programs—such as value-based purchasing (VBP)—he suggests physicians prepare themselves to comply. Accordingly, SHM supports policies that link "quality measurement to performance-based payment” and has created a toolkit to help hospitalists prepare for VBP, one of the most targeted pay-for-performance programs.

Even as HM moves toward adopting pay for performance as a mantra, Dr. Himmelstein believes hospitalists are in a good position to lead discussions on whether pay for performance is the only way to move forward.

“It can feel like a fait d’accompli, but things can change, and they can change rapidly,” Dr. Himmelstein adds. “The first step is to have real discussions about it. Up to now, much of the medical literature is saying, ‘It’s not working. We must have the wrong incentives.’ What if there are no right incentives?”

 

Visit our website for more information about pay-for-performance programs.

 

Pushing healthcare toward pay-for-performance models that provide financial rewards for patient outcomes might not be the best direction for healthcare, according to an article published by a duo of doctors and a behavioral economist.

“Will Pay for Performance Backfire? Insights from Behavioral Economics” posted at Healthaffairs.org, questions the validity of paying for outcomes, particularly as there is no evidence yet that the model improves patient outcomes.

“You’re not actually paying for quality,” says David Himmelstein, MD, a professor at City University of New York School of Public Health at Hunter College, New York. “What you’re paying for is some very gameable measurement that doctors will find a way to cheat.”

The blog post notes that monetary rewards can actually undermine motivation for tasks that are intrinsically interesting or rewarding, a phenomenon known as “motivational crowd-out.” Dr. Himmelstein says it could focus attention on coding, rather than patients, or encourage providers to avoid noncompliant patients who will make their measured performances look bad.

“Injecting different monetary incentives into healthcare can certainly change it,” according to the article, “but not necessarily in the ways that policy makers would plan, much less hope for.”

Dr. Himmelstein says that without evidence for, or against, pay for performance, it’s difficult to say whether it will improve outcomes over the long term. Given the government push toward pay-for-performance programs—such as value-based purchasing (VBP)—he suggests physicians prepare themselves to comply. Accordingly, SHM supports policies that link "quality measurement to performance-based payment” and has created a toolkit to help hospitalists prepare for VBP, one of the most targeted pay-for-performance programs.

Even as HM moves toward adopting pay for performance as a mantra, Dr. Himmelstein believes hospitalists are in a good position to lead discussions on whether pay for performance is the only way to move forward.

“It can feel like a fait d’accompli, but things can change, and they can change rapidly,” Dr. Himmelstein adds. “The first step is to have real discussions about it. Up to now, much of the medical literature is saying, ‘It’s not working. We must have the wrong incentives.’ What if there are no right incentives?”

 

Visit our website for more information about pay-for-performance programs.

 

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Not Sexy Enough

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The annual meeting of the American College of Rheumatology has just ended. As usual, it was frenetic. So many lectures to choose from, so little time (and, as I age, energy) to get to them all.

The meeting is a great opportunity for the motivated rheumatologist if you know how to use it to your advantage – and that’s a skill that’s learned over a few years of attendance. Apart from catching up with old mentors and friends, you can catch up on the latest and greatest in basic science research. You can find out how experts manage difficult cases. There are sessions on how to manage your practice more efficiently. There are thousands of posters from all over the world to peruse.

Year after year there are several sessions on the autoimmune diseases, covering everything from basic science to bench and clinical research to clinical practice. An ever-growing pool of information about the genetic and molecular bases of disease has led to a rapid expansion of treatment targets – primarily for rheumatoid arthritis but extending to other autoimmune diseases as well.

But there are certain bread-and-butter illnesses that are not as sexy and, as such, do not get as much airtime.

This year, for example, there was only one clinical session on gout, and it was held in one of the smaller rooms. Slated for the same time slot were "Dermatology Topics for Rheumatologists" and "Preclinical Autoimmunity – Potential for Prevention," both much sexier-sounding and held in much larger venues. If my small cohort of friends and colleagues is a microcosm of the attendee population, it made complete sense to do this because I was the only one out of six who was interested in gout.

I understand that "Dermatology Topics for Rheumatologists" – by far the most popular in my small cohort – is indeed interesting, but I do not think it provides terribly useful information. No offense to the ACR or to my friends who picked this topic, but while you may see an interesting rash here and there and maybe remember seeing a similar picture from a lecture that you attended somewhere, I contend that it is more valuable for a clinician to be able to treat challenging gout cases, to learn more postmarketing information about pegloticase, and to understand what asymptomatic hyperuricemia might potentially indicate.

And what of osteoarthritis? There was a popular lecture on back pain, though I heard it was not very good. OA has become one of my biggest frustrations. It is never easy to tell patients that there is not much that can be done for their condition. Thankfully there was a basic science lecture on OA. Hopefully, this means more funding for more research, and ultimately perhaps a disease-modifier as well.

I appreciate that there was a session on paraneoplastic syndromes, one on polymyalgia rheumatica, and one on osteoporosis. I see more of these conditions in my practice than I do systemic lupus erythematosus, scleroderma, or vasculitis.

Without a doubt, ours is a wonderful field to be in. Our diseases have historically been very challenging to define, let alone treat. I feel lucky to be a rheumatologist at such a heady time, when it is now possible to go into drug-free remission if you have rheumatoid arthritis. We understand mechanisms of autoimmune disease better and are making great strides in therapeutics.

But there are other diseases that have been largely ignored, for reasons that are not entirely clear to me (perhaps the unfettered profit motivation that I talked about a few columns ago?), and I think it is about time we had a more equitable distribution of resources for research. Glamorous zebras aside, I will be grateful for the day that I can tell my patients: "yes, there is a nonsurgical option for your osteoarthritis, and no, it is not an antidepressant."

Dr. Chan practices rheumatology in Pawtucket, R.I. E-mail her at [email protected].

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The annual meeting of the American College of Rheumatology has just ended. As usual, it was frenetic. So many lectures to choose from, so little time (and, as I age, energy) to get to them all.

The meeting is a great opportunity for the motivated rheumatologist if you know how to use it to your advantage – and that’s a skill that’s learned over a few years of attendance. Apart from catching up with old mentors and friends, you can catch up on the latest and greatest in basic science research. You can find out how experts manage difficult cases. There are sessions on how to manage your practice more efficiently. There are thousands of posters from all over the world to peruse.

Year after year there are several sessions on the autoimmune diseases, covering everything from basic science to bench and clinical research to clinical practice. An ever-growing pool of information about the genetic and molecular bases of disease has led to a rapid expansion of treatment targets – primarily for rheumatoid arthritis but extending to other autoimmune diseases as well.

But there are certain bread-and-butter illnesses that are not as sexy and, as such, do not get as much airtime.

This year, for example, there was only one clinical session on gout, and it was held in one of the smaller rooms. Slated for the same time slot were "Dermatology Topics for Rheumatologists" and "Preclinical Autoimmunity – Potential for Prevention," both much sexier-sounding and held in much larger venues. If my small cohort of friends and colleagues is a microcosm of the attendee population, it made complete sense to do this because I was the only one out of six who was interested in gout.

I understand that "Dermatology Topics for Rheumatologists" – by far the most popular in my small cohort – is indeed interesting, but I do not think it provides terribly useful information. No offense to the ACR or to my friends who picked this topic, but while you may see an interesting rash here and there and maybe remember seeing a similar picture from a lecture that you attended somewhere, I contend that it is more valuable for a clinician to be able to treat challenging gout cases, to learn more postmarketing information about pegloticase, and to understand what asymptomatic hyperuricemia might potentially indicate.

And what of osteoarthritis? There was a popular lecture on back pain, though I heard it was not very good. OA has become one of my biggest frustrations. It is never easy to tell patients that there is not much that can be done for their condition. Thankfully there was a basic science lecture on OA. Hopefully, this means more funding for more research, and ultimately perhaps a disease-modifier as well.

I appreciate that there was a session on paraneoplastic syndromes, one on polymyalgia rheumatica, and one on osteoporosis. I see more of these conditions in my practice than I do systemic lupus erythematosus, scleroderma, or vasculitis.

Without a doubt, ours is a wonderful field to be in. Our diseases have historically been very challenging to define, let alone treat. I feel lucky to be a rheumatologist at such a heady time, when it is now possible to go into drug-free remission if you have rheumatoid arthritis. We understand mechanisms of autoimmune disease better and are making great strides in therapeutics.

But there are other diseases that have been largely ignored, for reasons that are not entirely clear to me (perhaps the unfettered profit motivation that I talked about a few columns ago?), and I think it is about time we had a more equitable distribution of resources for research. Glamorous zebras aside, I will be grateful for the day that I can tell my patients: "yes, there is a nonsurgical option for your osteoarthritis, and no, it is not an antidepressant."

Dr. Chan practices rheumatology in Pawtucket, R.I. E-mail her at [email protected].

The annual meeting of the American College of Rheumatology has just ended. As usual, it was frenetic. So many lectures to choose from, so little time (and, as I age, energy) to get to them all.

The meeting is a great opportunity for the motivated rheumatologist if you know how to use it to your advantage – and that’s a skill that’s learned over a few years of attendance. Apart from catching up with old mentors and friends, you can catch up on the latest and greatest in basic science research. You can find out how experts manage difficult cases. There are sessions on how to manage your practice more efficiently. There are thousands of posters from all over the world to peruse.

Year after year there are several sessions on the autoimmune diseases, covering everything from basic science to bench and clinical research to clinical practice. An ever-growing pool of information about the genetic and molecular bases of disease has led to a rapid expansion of treatment targets – primarily for rheumatoid arthritis but extending to other autoimmune diseases as well.

But there are certain bread-and-butter illnesses that are not as sexy and, as such, do not get as much airtime.

This year, for example, there was only one clinical session on gout, and it was held in one of the smaller rooms. Slated for the same time slot were "Dermatology Topics for Rheumatologists" and "Preclinical Autoimmunity – Potential for Prevention," both much sexier-sounding and held in much larger venues. If my small cohort of friends and colleagues is a microcosm of the attendee population, it made complete sense to do this because I was the only one out of six who was interested in gout.

I understand that "Dermatology Topics for Rheumatologists" – by far the most popular in my small cohort – is indeed interesting, but I do not think it provides terribly useful information. No offense to the ACR or to my friends who picked this topic, but while you may see an interesting rash here and there and maybe remember seeing a similar picture from a lecture that you attended somewhere, I contend that it is more valuable for a clinician to be able to treat challenging gout cases, to learn more postmarketing information about pegloticase, and to understand what asymptomatic hyperuricemia might potentially indicate.

And what of osteoarthritis? There was a popular lecture on back pain, though I heard it was not very good. OA has become one of my biggest frustrations. It is never easy to tell patients that there is not much that can be done for their condition. Thankfully there was a basic science lecture on OA. Hopefully, this means more funding for more research, and ultimately perhaps a disease-modifier as well.

I appreciate that there was a session on paraneoplastic syndromes, one on polymyalgia rheumatica, and one on osteoporosis. I see more of these conditions in my practice than I do systemic lupus erythematosus, scleroderma, or vasculitis.

Without a doubt, ours is a wonderful field to be in. Our diseases have historically been very challenging to define, let alone treat. I feel lucky to be a rheumatologist at such a heady time, when it is now possible to go into drug-free remission if you have rheumatoid arthritis. We understand mechanisms of autoimmune disease better and are making great strides in therapeutics.

But there are other diseases that have been largely ignored, for reasons that are not entirely clear to me (perhaps the unfettered profit motivation that I talked about a few columns ago?), and I think it is about time we had a more equitable distribution of resources for research. Glamorous zebras aside, I will be grateful for the day that I can tell my patients: "yes, there is a nonsurgical option for your osteoarthritis, and no, it is not an antidepressant."

Dr. Chan practices rheumatology in Pawtucket, R.I. E-mail her at [email protected].

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Triple Therapy Boosts HCV Response After Transplant

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Triple Therapy Boosts HCV Response After Transplant

BOSTON  – Liver transplant recipients with hepatitis C virus infection who underwent triple-drug therapy achieved a high extended rapid virologic response rate but often contended with treatment complications in a retrospective multicenter cohort study.

The extended rapid virologic response (eRVR) rate seen in 57% of patients was "encouraging, given a very difficult-to-cure population," Dr. James R. Burton, Jr., said at the annual meeting of the American Association for the Study of Liver Diseases. He noted, however, that it’s not clear if the encouraging eRVR rate will predict sustained virologic response (SVR) as it does in non-liver transplant patients.

Dr. James R. Burton, Jr.

The use of peginteferon plus ribavirin in liver transplant recipients with hepatitis C virus infection has an SVR of only 30%. While triple therapy with peginterferon, ribavirin, and a protease inhibitor (boceprevir or telaprevir) has significantly improved rates of SVR in patients infected with genotype 1 hepatitis C virus, its safety and efficacy in liver transplant recipients is unknown, said Dr. Burton, medical director of liver transplantation at the University of Colorado Hospital, Aurora.

With 101 patients, the five-center study is the largest involving triple therapy in liver transplant recipients with hepatitis C virus infection.

Telaprevir was the protease inhibitor used most often in patients (90% vs. 10% with boceprevir). Nearly all patients (96%) had a lead-in treatment phase with peginterferon plus ribavirin. A minority of patients (14%) had an extended lead-in phase of at least 90 days (median of 189 days) and were excluded from efficacy, but not safety, analyses. The other patients had a lead-in lasting a median of 29 days. The patients with a long lead-in phase had a median of 398 total treatment days, compared with a median of 154 days for those with a shorter lead-in time.

The efficacy study population involved genotype 1–infected patients (54% genotype 1a, 39% 1b, and 7% mixed) from five medical centers. Most patients were men (76%); they had a median age of 58 years and a median duration of 54 months from their liver transplant to starting a protease inhibitor. An unfavorable IL28B genotype was found in 69% of 45 patients tested. In the 60% of patients who had undergone previous antiviral therapy, 29% had a partial response. On liver biopsy, another 47% of patients had either bridging fibrosis or cirrhosis.

The immunosuppressive agents used by the patients included cyclosporine (66%) and tacrolimus (23%). A small percentage did not receive a calcineurin inhibitor or rapamycin. Another 27% were taking corticosteroids, and 72% were taking mycophenolate mofetil or mycophenolic acid.

On treatment, the percentage of patients who had an HCV RNA level less than the limit of detection increased from 55% at 4 weeks to 63% at 8 weeks. At 12 weeks the percentage was 71%. An eRVR, defined as negative HCV RNA tests at 4 and 12 weeks, occurred in 57%. An eRVR occurred significantly more often among patients who had at least a 1 log drop in HCV RNA levels during the lead-in phase than did those with less than a 1 log drop (76% vs. 35%).

Overall, 12% of patients experienced virologic breakthrough, and treatment was stopped. This occurred more often among those with a long lead-in vs. those with a short lead-in (21% vs. 10%, respectively). Another 14% discontinued treatment early because of an adverse event; discontinuations occurred more often among patients with a long lead-in (40% vs. 11%).

Protease inhibitors are known to inhibit the metabolism of calcineurin inhibitors, which was reflected in the study by the need to reduce the median daily doses of cyclosporine (from 200 mg to 50 mg) and tacrolimus (from 1.0 mg to 0.06 mg) after protease inhibitor therapy began.

Many patients (49%) required blood transfusions during triple therapy. During the first 16 weeks of therapy, these patients used a median of 2.5 units. The majority of patients (86%) used growth factors, including granulocyte-colony stimulating factor in 44% and erythropoietin in 79%. Medication dose reductions were most frequent for ribavirin (in 78%). A total of 7% were hospitalized for anemia, Dr. Burton said.

Renal insufficiency, defined as an increase in creatinine of greater than 0.5 mg/dL from baseline, developed in 32%. Of two rejection episodes in the study, one involved a patient coming off a protease inhibitor.

Dr. Burton suggested that future studies should focus on identifying predictors for nonresponse to avoid unnecessary treatment and associated toxicities such as complications of anemia and adverse events related to significant protease inhibitor–calcineurin inhibitor interactions, such as worsening renal function and graft rejection when transitioning off a protease inhibitor.

 

 

Dr. Burton disclosed that he is an investigator in a clinical trial sponsored by Vertex Pharmaceuticals, which makes telaprevir.☐

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BOSTON  – Liver transplant recipients with hepatitis C virus infection who underwent triple-drug therapy achieved a high extended rapid virologic response rate but often contended with treatment complications in a retrospective multicenter cohort study.

The extended rapid virologic response (eRVR) rate seen in 57% of patients was "encouraging, given a very difficult-to-cure population," Dr. James R. Burton, Jr., said at the annual meeting of the American Association for the Study of Liver Diseases. He noted, however, that it’s not clear if the encouraging eRVR rate will predict sustained virologic response (SVR) as it does in non-liver transplant patients.

Dr. James R. Burton, Jr.

The use of peginteferon plus ribavirin in liver transplant recipients with hepatitis C virus infection has an SVR of only 30%. While triple therapy with peginterferon, ribavirin, and a protease inhibitor (boceprevir or telaprevir) has significantly improved rates of SVR in patients infected with genotype 1 hepatitis C virus, its safety and efficacy in liver transplant recipients is unknown, said Dr. Burton, medical director of liver transplantation at the University of Colorado Hospital, Aurora.

With 101 patients, the five-center study is the largest involving triple therapy in liver transplant recipients with hepatitis C virus infection.

Telaprevir was the protease inhibitor used most often in patients (90% vs. 10% with boceprevir). Nearly all patients (96%) had a lead-in treatment phase with peginterferon plus ribavirin. A minority of patients (14%) had an extended lead-in phase of at least 90 days (median of 189 days) and were excluded from efficacy, but not safety, analyses. The other patients had a lead-in lasting a median of 29 days. The patients with a long lead-in phase had a median of 398 total treatment days, compared with a median of 154 days for those with a shorter lead-in time.

The efficacy study population involved genotype 1–infected patients (54% genotype 1a, 39% 1b, and 7% mixed) from five medical centers. Most patients were men (76%); they had a median age of 58 years and a median duration of 54 months from their liver transplant to starting a protease inhibitor. An unfavorable IL28B genotype was found in 69% of 45 patients tested. In the 60% of patients who had undergone previous antiviral therapy, 29% had a partial response. On liver biopsy, another 47% of patients had either bridging fibrosis or cirrhosis.

The immunosuppressive agents used by the patients included cyclosporine (66%) and tacrolimus (23%). A small percentage did not receive a calcineurin inhibitor or rapamycin. Another 27% were taking corticosteroids, and 72% were taking mycophenolate mofetil or mycophenolic acid.

On treatment, the percentage of patients who had an HCV RNA level less than the limit of detection increased from 55% at 4 weeks to 63% at 8 weeks. At 12 weeks the percentage was 71%. An eRVR, defined as negative HCV RNA tests at 4 and 12 weeks, occurred in 57%. An eRVR occurred significantly more often among patients who had at least a 1 log drop in HCV RNA levels during the lead-in phase than did those with less than a 1 log drop (76% vs. 35%).

Overall, 12% of patients experienced virologic breakthrough, and treatment was stopped. This occurred more often among those with a long lead-in vs. those with a short lead-in (21% vs. 10%, respectively). Another 14% discontinued treatment early because of an adverse event; discontinuations occurred more often among patients with a long lead-in (40% vs. 11%).

Protease inhibitors are known to inhibit the metabolism of calcineurin inhibitors, which was reflected in the study by the need to reduce the median daily doses of cyclosporine (from 200 mg to 50 mg) and tacrolimus (from 1.0 mg to 0.06 mg) after protease inhibitor therapy began.

Many patients (49%) required blood transfusions during triple therapy. During the first 16 weeks of therapy, these patients used a median of 2.5 units. The majority of patients (86%) used growth factors, including granulocyte-colony stimulating factor in 44% and erythropoietin in 79%. Medication dose reductions were most frequent for ribavirin (in 78%). A total of 7% were hospitalized for anemia, Dr. Burton said.

Renal insufficiency, defined as an increase in creatinine of greater than 0.5 mg/dL from baseline, developed in 32%. Of two rejection episodes in the study, one involved a patient coming off a protease inhibitor.

Dr. Burton suggested that future studies should focus on identifying predictors for nonresponse to avoid unnecessary treatment and associated toxicities such as complications of anemia and adverse events related to significant protease inhibitor–calcineurin inhibitor interactions, such as worsening renal function and graft rejection when transitioning off a protease inhibitor.

 

 

Dr. Burton disclosed that he is an investigator in a clinical trial sponsored by Vertex Pharmaceuticals, which makes telaprevir.☐

BOSTON  – Liver transplant recipients with hepatitis C virus infection who underwent triple-drug therapy achieved a high extended rapid virologic response rate but often contended with treatment complications in a retrospective multicenter cohort study.

The extended rapid virologic response (eRVR) rate seen in 57% of patients was "encouraging, given a very difficult-to-cure population," Dr. James R. Burton, Jr., said at the annual meeting of the American Association for the Study of Liver Diseases. He noted, however, that it’s not clear if the encouraging eRVR rate will predict sustained virologic response (SVR) as it does in non-liver transplant patients.

Dr. James R. Burton, Jr.

The use of peginteferon plus ribavirin in liver transplant recipients with hepatitis C virus infection has an SVR of only 30%. While triple therapy with peginterferon, ribavirin, and a protease inhibitor (boceprevir or telaprevir) has significantly improved rates of SVR in patients infected with genotype 1 hepatitis C virus, its safety and efficacy in liver transplant recipients is unknown, said Dr. Burton, medical director of liver transplantation at the University of Colorado Hospital, Aurora.

With 101 patients, the five-center study is the largest involving triple therapy in liver transplant recipients with hepatitis C virus infection.

Telaprevir was the protease inhibitor used most often in patients (90% vs. 10% with boceprevir). Nearly all patients (96%) had a lead-in treatment phase with peginterferon plus ribavirin. A minority of patients (14%) had an extended lead-in phase of at least 90 days (median of 189 days) and were excluded from efficacy, but not safety, analyses. The other patients had a lead-in lasting a median of 29 days. The patients with a long lead-in phase had a median of 398 total treatment days, compared with a median of 154 days for those with a shorter lead-in time.

The efficacy study population involved genotype 1–infected patients (54% genotype 1a, 39% 1b, and 7% mixed) from five medical centers. Most patients were men (76%); they had a median age of 58 years and a median duration of 54 months from their liver transplant to starting a protease inhibitor. An unfavorable IL28B genotype was found in 69% of 45 patients tested. In the 60% of patients who had undergone previous antiviral therapy, 29% had a partial response. On liver biopsy, another 47% of patients had either bridging fibrosis or cirrhosis.

The immunosuppressive agents used by the patients included cyclosporine (66%) and tacrolimus (23%). A small percentage did not receive a calcineurin inhibitor or rapamycin. Another 27% were taking corticosteroids, and 72% were taking mycophenolate mofetil or mycophenolic acid.

On treatment, the percentage of patients who had an HCV RNA level less than the limit of detection increased from 55% at 4 weeks to 63% at 8 weeks. At 12 weeks the percentage was 71%. An eRVR, defined as negative HCV RNA tests at 4 and 12 weeks, occurred in 57%. An eRVR occurred significantly more often among patients who had at least a 1 log drop in HCV RNA levels during the lead-in phase than did those with less than a 1 log drop (76% vs. 35%).

Overall, 12% of patients experienced virologic breakthrough, and treatment was stopped. This occurred more often among those with a long lead-in vs. those with a short lead-in (21% vs. 10%, respectively). Another 14% discontinued treatment early because of an adverse event; discontinuations occurred more often among patients with a long lead-in (40% vs. 11%).

Protease inhibitors are known to inhibit the metabolism of calcineurin inhibitors, which was reflected in the study by the need to reduce the median daily doses of cyclosporine (from 200 mg to 50 mg) and tacrolimus (from 1.0 mg to 0.06 mg) after protease inhibitor therapy began.

Many patients (49%) required blood transfusions during triple therapy. During the first 16 weeks of therapy, these patients used a median of 2.5 units. The majority of patients (86%) used growth factors, including granulocyte-colony stimulating factor in 44% and erythropoietin in 79%. Medication dose reductions were most frequent for ribavirin (in 78%). A total of 7% were hospitalized for anemia, Dr. Burton said.

Renal insufficiency, defined as an increase in creatinine of greater than 0.5 mg/dL from baseline, developed in 32%. Of two rejection episodes in the study, one involved a patient coming off a protease inhibitor.

Dr. Burton suggested that future studies should focus on identifying predictors for nonresponse to avoid unnecessary treatment and associated toxicities such as complications of anemia and adverse events related to significant protease inhibitor–calcineurin inhibitor interactions, such as worsening renal function and graft rejection when transitioning off a protease inhibitor.

 

 

Dr. Burton disclosed that he is an investigator in a clinical trial sponsored by Vertex Pharmaceuticals, which makes telaprevir.☐

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Triple Therapy Boosts HCV Response After Transplant
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Liver transplant, hepatitis C virus, hvc, extended rapid virologic response (eRVR), Dr. James R. Burton, Jr., American Association for the Study of Liver Diseases, sustained virologic response (SVR), peginteferon, ribavirin, protease inhibitor, boceprevir, telaprevir
Legacy Keywords
Liver transplant, hepatitis C virus, hvc, extended rapid virologic response (eRVR), Dr. James R. Burton, Jr., American Association for the Study of Liver Diseases, sustained virologic response (SVR), peginteferon, ribavirin, protease inhibitor, boceprevir, telaprevir
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AT THE ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES

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Major Finding: An extended rapid virologic response occurred significantly more often among patients who had at least a 1 log drop in HCV RNA levels during the lead-in phase than did those with less than a 1 log drop (76% vs. 35%)

Data Source: This was a multicenter retrospective cohort study of triple therapy for hepatitis C virus infection in 101 patients with post liver transplant.

Disclosures: Dr. Burton disclosed that he is an investigator in a clinical trial sponsored by Vertex Pharmaceuticals, which makes telaprevir.

End‐of‐Life Discussions

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Opportunity lost: End‐of‐life discussions in cancer patients who die in the hospital

Most patients prefer to die at home, pain free and without the use of life‐sustaining treatments[1, 2] yet the majority of patients with serious illness die in the hospital.[3, 4, 5] When hospitalized patient die, the care is frequently focused on life‐sustaining treatments[6]; pain, dyspnea, and agitation levels are higher when compared with patients who die in non‐hospital settings.[7, 8, 9] End‐of‐life discussions and their products (ie, advanced directives) can clarify treatment options with patients and family,[10] and help ensure that patients receive care consistent with their beliefs.[11, 12, 13] End‐of‐life discussions are associated with a decrease use of life‐sustaining treatments, improved quality of life, and reduced costs of care.[14, 15] For the majority of patients dying of cancer, the first end‐of‐life discussion takes place in the hospital setting.[16]

Conducting end‐of‐life conversations in the hospital setting can be challenging. Patients are acutely ill and nearly 40% are incapable of making their own medical decisions.[17] In order to participate in an end‐of‐life discussion, a physician must determine that a patient meets the 4 criteria of decisional capacity as outlined by Appelbaum and Grisso:[18] Does the patient (1) communicate a clear and consistent choice; (2) understand the relevant information surrounding that decision; (3) appreciate the consequences of that decision; and (4) communicate reasoning for that decision?[19] In practice, however, clinicians inaccurately assign capacity up to 25% of the time.[17] When a physician determines, accurately or inaccurately, that the patient does not meet this standard for decisional capacity, discussions must be held instead with a surrogate decision‐maker. Surrogate decision‐making can make communication with the physician more difficult,[20] delay important medical decisions,[21] and be stressful on the decision‐maker.[22] To our knowledge, no studies have examined patient and surrogate participation in end‐of‐life discussions at the time of terminal hospitalization and its association with end‐of‐life treatments received.

Our goals were to examine physician assessment of decisional capacity and the prevalence of end‐of‐life discussions during the terminal hospitalization of patients with advanced cancer. Our research questions were: (1) What proportion of patients were assessed to have decisional capacity by the clinical team at the time of their terminal hospital admission? (2) What proportion of these patients had a documented discussion about end‐of‐life care with the clinical team, and for what proportion was the conversation held instead by the patient's surrogate decision‐maker because the patient was considered to have lost decisional capacity? (3) Was patient participation in a discussion about end‐of‐life care associated with life‐sustaining and palliative treatments received?

METHODS

Design

This is a retrospective cohort study of consecutive adult patients with advanced cancer who died at the University of Michigan Hospital, Ann Arbor, MI, from January 1, 2004 through December 31, 2007. This study was exempted from review by the University of Michigan (UM) Institutional Review Board because decedent data were used.

Sample

The UM Cancer Registry is a database of all cancer patients treated at the UM Comprehensive Cancer Center. We used the Registry to identify patients who met the following criteria: (1) age 18 years at time of cancer diagnosis; (2) estimated probability of 5‐year survival 20% at time of diagnosis, as predicted by the SEER Cancer Statistics Review[23]; (3) the entirety of cancer treatment was received at University of Michigan Health System (UMHS); and (4) the patient died while admitted to the University Hospital between January 1, 2004 and December 31, 2007.

UMHS is a healthcare system and academic medical center consisting of hospitals, health centers, and clinics, including the University of Michigan Hospital and Comprehensive Cancer Center. Over 4000 cancer patients are admitted to University Hospital and 80,000 outpatient visits occur to the Cancer Center every year. It serves as a major cancer referral center for the patients of Michigan and the greater Midwest. The University of Michigan implemented a palliative care consult service that was started in 2005, during the time period of our study.

Data Collection

Data were abstracted by review of the medical record by an internist (M.Z.) using a comprehensive chart abstraction instrument based on a previously validated tool.[24] Demographic data abstracted from the medical record included age, religious affiliation, race, ethnicity, and marital status. The original abstraction tool, which included 83 items, was reduced to include 47 items focusing on information related to advanced care planning, hospital course, and end‐of‐life discussions. Specific items included: reasons for admission, primary hospital service, occurrence and timing of end‐of‐life decision‐making, whether patient or family preferences were elicited through an end‐of‐life discussion, clinician's assessment of patient's decisional capacity at time of admission and end‐of‐life conversations, whether a comfort care plan was made, and whether palliative morphine was used.

The chart abstraction tool was pilot tested on the medical records of 10 patients, who were not included in the study, and refined to improve completeness of data collection. A copy of the abstraction tool is available upon request.

Definition of Key Variables

Decisional Capacity Assessment

Decisional capacity assessment is a reflection of the clinical team's assessment of the patient's decisional capacity on admission, and was determined through examination of the medical record in the first 24 hours of admission. Positive decision‐making capacity assessment was assumed if the clinician assessment of decisional capacity was documented in the mental status exam, or if the clinician documented conversations between clinician and patient in the history that suggested intact decision‐making capacity (ie, clinician documented terms such as patient stated or patient described and then described a coherent or sensible statement which implied patient capacity and intact mental status), or if the clinician's documentation of the assessment and plan stated or suggested decisions were being made by the patient. Other supportive information from the record was used to corroborate the evidence used to determine the clinician's assessment of the patient's decisional capacity, including whether the patient signed consent forms.

End‐of‐Life Discussions

The presence of an end‐of‐life discussion was presumed when the clinician documented a discussion with the patient, discussion with family, or family meeting concerning treatment preferences, or when the clinician quoted the patient's preferences in a fashion that documents a face‐to‐face discussion or directly described the elicitation of preferences from the patient or family.

Living Will

A living will was identified as present if the document was scanned into the patient's medical record, or if the chart indicated that the patient or family stated that the patient had completed a living will.

Health Care Proxy

Health Care Proxy or Durable Power of Attorney for Healthcare was identified as present if the document was scanned into the patient's medical record, or if the chart indicated that the patient or family stated that the patient had completed such a document.

Do Not Resuscitate (DNR) on Admission

DNR status was identified as present if the patient had documents with established DNR orders, or if a physician explicitly documented code status as DNR in the admission note or other documents placed in the record within the first 24 hours of admission.

Intensive Care Unit (ICU)Treatment

Patients were defined as having received ICU treatment if they were admitted directly or subsequently transferred to the ICU during the hospital course.

Comfort Care

Comfort care was defined as present only if the phrases comfort care, palliative care, or supportive care, were documented.

Palliative Opioid Therapy

Treatments with morphine or other opioids were recorded as palliative only if it was explicitly stated that these medications were used in the context of palliative or end‐of‐life care.

Data Analysis

We report the proportion of patients who were documented to lack decisional capacity at the time of hospital admission. We compared patient characteristics for those with and without documentation of decisional capacity on admission, and patients with decisional capacity on admission who did and did not participate in discussions about end‐of‐life care using chi‐square tests for categorical data, t tests for normally distributed continuous variables, and MannWhitney U tests for non‐normally distributed continuous variables. We examined whether documentation of a discussion about end‐of‐life care was associated with life‐sustaining and palliative treatments received using chi‐square for categorical treatments, and MannWhitney U tests for days from admission to initiation of comfort care. We used P < 0.05 to signify statistical significance.

RESULTS

Characteristics of Population and Decisional Capacity on Admission

The characteristics of the 145 patients who met entry criteria are summarized in Table 1. The most common types of cancers were lung cancer and leukemia/lymphoma. Of the 145 patients, the medical team's assessment of the patient's decisional capacity on admission could be established for 142 patients. As documented within the first 24 hours of admission, 27 patients (19%) were considered not to have decisional capacity, and 115 patients (79%) were considered to have decisional capacity. Both of these groups had similar age and gender distributions. There were no significant differences in the distribution of cancer type between those with and without decisional capacity. In both groups, the majority of the cancer diagnoses were made prior to admission. There was no difference in DNR orders established prior to or on admission between the groups (Table 1).

Characteristics of Patients With and Without Documented Decision‐Making Capacity
 Decision‐Making Capacity on Admissiona 
No (N = 27)Yes (N = 115) 
N (%)N (%)P Value
  • Abbreviations: DNR, do not resuscitate.
  • Decisional capacity as assessed and documented by the clinician; clinicians assessment of decisional capacity could not be determined in 3 patients.
  • Other cancer types: rectal, stomach, bone sarcoma, renal cell, laryngeal, renal pelvic.
Age >6515 (55.6)60 (52.2)0.75
Gender (male)14 (51.9)68 (59.1)0.46
Cancer type
Lung12 (44.4)42 (36.5)0.67
Bone marrow5 (18.5)35 (30.4)
Liver3 (11.1)6 (5.2)
Pancreas3 (11.1)7 (6.10)
Esophagus1 (3.7)8 (7.0)
Colon1 (3.7)6 (5.2)
Otherb2 (7.4)11 (9.6)
Prior to admission
Cancer diagnosis known23 (85.2)91 (79.1)0.48
Living will completed6 (22.2)26 (22.60.97
Health care proxy established3 (11.1)26 (22.6)0.18
DNR established8 (29.6)27 (23.5)0.79

End‐of‐Life Discussion in Patients With Decisional Capacity on Admission

Of the 115 patients assessed to have intact decisional capacity on admission, 56 (48.7%) participated in an end‐of‐life discussion with the medical team during their terminal hospitalization. For the remaining 59 patients who did not participate in an end‐of‐life discussion during the terminal hospital course, 46 (40.0%) had documentation suggesting they lost decisional capacity prior to a conversation and that the end‐of‐life discussions were held instead with the patient's surrogate decision‐maker, and 13 (11.3%) had no evidence of any end‐of‐life discussion (with the patient or surrogate).

When comparing those patients who participated in an end‐of‐life discussion with those patients whose surrogate participated in the discussion, there were no significant differences in gender and age distributions (Table 2). There was a significant difference in the type of cancers between the 2 groups. Among patients who participated in their end‐of‐life discussions, bone marrow cancer was proportionately more prevalent (17.9% vs 2.2%; P <0.01) and lung cancer was less prevalent (16.1% vs 41.3%; P <0.01), when compared to those who required surrogate participation. Timing of cancer diagnosis and prevalence of advance directives were similar between the 2 groups. The proportion of patients who had an established DNR order prior to admission was higher among those who did participate in end‐of‐life discussions when compared to those who had surrogate participation in these discussions (30.4% vs 17.4%; P < 0.04).

Among Patients With Documented Decision‐Making Capacity on Admission, the Characteristics of Patients by Status of Their Participation in End‐of‐Life Discussions
Patients With Documented Decision‐Making Capacity on Admission (N = 115) 
 N =13N = 102 
 End‐of‐Life discussion not documentedEnd‐of‐Life discussion with surrogate (N = 46)End‐of‐Life discussion with patient (N = 56) 
 N (%)N (%)N (%)P Value
  • Abbreviations: DNR, do not resuscitate.
  • Other cancer types: rectal, stomach, bone sarcoma, renal cell, laryngeal, renal pelvic.
Age 659 (69.2)18 (39.1)27 (48.2)0.36
Gender (male)10 (76.9)27 (60.0)31 (55.4)0.64
Cancer type    
Lung3 (23.1)19 (41.3)9 (16.1) 
Bone marrow7 (53.9)1 (2.2)10 (17.9) 
Liver1 (7.7)3 (6.5)2 (3.6) 
Pancreas1 (7.7)2 (4.4)4 (7.1)<0.01
Esophagus06 (13.0)2 (3.6) 
Colon1 (7.7)1 (2.2)3 (5.4) 
Othera01 (2.2)10 (17.9) 
Prior to Admission
Cancer diagnosis known10 (76.9)37 (80.4)43 (76.8)0.66
Living will completed4 (30.8)10 (21.7)12 (21.4)0.97
Health care proxy established    
 3 (23.1)13 (28.3)10 (17.9)0.21
DNR established2 (15.4)8 (17.4)17 (30.4)0.04

Life‐Prolonging and Palliative Care Treatments Received and Participation in End‐of‐Life Discussions

Life‐prolonging treatments were more likely to be used for patients whose end‐of‐life discussions were held by patient's surrogate decision‐maker, in comparison to those patients who participated in the discussions themselves. Patients who had conversations held by surrogates were more likely to receive ventilator support (56.5% vs 23.2%, P < 0.01), chemotherapy (39.1% vs 5.4%, P < 0.01), artificial nutrition or hydration (45.7% vs 25.0%, P = 0.03), and antibiotics (97.8% vs 78.6%, P < 0.01), when compared to patients who participated in their own end‐of‐life discussion. Intensive care treatment rates also differed significantly between the 2 groups; 56.5% of those who did not participate in end‐of‐life discussions, and only 23.2% of those patients who did participate, were admitted or transferred to the intensive care unit (P < 0.01). There was no significant difference in the proportion of patients who received cardiopulmonary resuscitation (CPR) (15.2% vs 7.1%, P = 0.56) (Table 3). Patients who lost decisional capacity and required a surrogate decision‐maker to participate in their end‐of‐life discussions had longer length of stay (15.8 vs 10.3 days, P = 0.03) and length of time to end‐of‐life discussions (14.0 vs 6.1 days, P < 0.01) (Table 3).

Patient or Surrogate Participation in End‐of‐Life Discussions, Treatments Received, and Timing of Advanced Care Planning Among Patients With Documented Decision‐Making Capacity on Admission
 Patients With Documented Decision‐Making Capacity on Admission (N = 115) 
End‐of‐Life Discussion With Surrogate (N =46)End‐of‐Life Discussion With Patient (N = 56) 
 N (%)N (%)P Value
  • Abbreviations: CI, confidence interval; ICU, intensive care unit. *P value is for comparison of end‐of‐life discussion with surrogate vs end‐of‐life discussion with patient.
Life‐Prolonging Treatment   
Ventilatory support26 (56.5)13 (23.2)<0.01
Chemotherapy18 (39.1)3 (5.4)<0.01
Artificial nutrition or hydration21 (45.7)14 (25.0)0.03
Antibiotics45 (97.8)44 (78.6)<0.01
Cardiopulmonary resuscitation7 (15.2)4 (7.1)0.19
ICU treatment (admit or transfer)26 (56.5)13 (23.2)<0.01
Palliative Treatments   
Comfort care39 (84.8)45 (80.4)0.56
Palliative morphine drip24 (52.2)33 (57.1)0.62
 Mean (95% CI) [Range]Mean (95% CI) [Range] 
Timing of Advanced Care Planning   
Length of hospitalization15.8 d (11.420.2) [157]10.3 d (146) [146]0.03
Time to end‐of‐life discussion14.0 d (9.918.1) [055]6.1 d (3.88.4) [046]<0.01
Time to comfort care23.5 d (4.342.8) [1374]9.2 d (6.312.1) [046]0.12

A comparison of the proportion of patients receiving palliative treatments, such as palliative comfort care orders and morphine infusions, revealed no significant differences between those with and without a discussion about end‐of‐life care (Table 3). Furthermore, while the time interval from hospital admission to initiation of comfort care was shorter for those who did participate in end‐of‐life discussions compared with those had surrogate participation (9.3 vs 23.5 days, P = 0.13 for equality), this difference was not statistically significant (Table 3).

Since a higher proportion of those who participated in end‐of‐life discussions during the hospitalization were admitted with a DNR order established prior to or on admission, we also examined the use of life‐prolonging treatments in the subgroup of patients who did not have a DNR order prior to admission. The difference in life‐prolonging treatments between those who did and did not participate in end‐of‐life discussions was preserved among those patients who did not have DNR status on admission (data not shown).

DISCUSSION

In this retrospective study of 145 terminal cancer patients who died in the hospital, we found that half of the patients had documentation suggesting that they lost decisional capacity during hospitalization and did not participate in end‐of‐life discussion with their healthcare providers. Among cancer patients in our study, 19% were determined not to have decisional capacity on admission, and another 32% were determined to lose decisional capacity during the hospital course. When patients did participate in documented discussions about end‐of‐life care, they were less likely to receive intensive life‐sustaining treatments, less likely to be admitted or transferred to the ICU, and more likely to avoid prolonged hospitalization. The finding that the majority of cancer patients are assessed to have intact decisional capacity upon admission to their terminal hospitalization, but less than half of them participate in their own end‐of‐life conversation, suggests that there is an important lost opportunity to provide quality advanced care planning to hospitalized patients.

Advanced care planning is the act of defining a competent patient's wishes regarding their future healthcare in the event of loss of decisional capacity. For many of the patients who were determined to lose decisional capacity during their hospitalization in our study, a surrogate decision‐maker was involved in a subsequent end‐of‐life discussion. This represents a missed opportunity in 2 ways. First, because surrogates may incorrectly predict patients' end‐of‐life treatment preferences in approximately one‐third of the cases,[25] patients may receive care that is inconsistent with their beliefs. Second, reliance on surrogate decision‐making may result in a greater burden on family members. Surrogate decision‐making places a large burden on surrogates, and can lead to emotional and psychological stress that can last well beyond the death of the loved one.[16, 26]

Our results reinforce the growing body of evidence suggesting that communication with the dying patient, both before and during the terminal hospitalization, promotes end‐of‐life care that involves less invasive life‐prolonging treatments,[10, 11, 12, 13, 14, 15] which is a consistently stated goal of most patients at the end of life.[1, 2] Our findings are consistent with a recent randomized trial of hospitalized patients over the age of 80 which showed that advance care planning discussions were associated with decreased use of intensive life‐sustaining treatments, increased patient and family satisfaction with care, as well as decreased psychological symptoms among family members.[27] In addition, studies examining patients with advanced cancer have shown that discussions about end‐of‐life care in the outpatient setting resulted in less intensive life‐sustaining treatments.[14, 15] Nearly 20% of our cohort was determined by the clinical team to lack decisional capacity at the time of their terminal hospitalization, highlighting the importance of end‐of‐life discussion prior to hospitalization. Our results also extend these recent findings to the inpatient setting. Seventy‐nine percent of patients in our study were determined to have decisional capacity at the time of their terminal hospitalization, and end‐of‐life discussion conducted with these patients was associated with decreased use of life‐sustaining treatments.

Seriously ill patients, particularly in hospital settings, have high symptom burden and subsequent poor quality of life.[6] These patients and families often report inadequate pain and symptom relief.[8, 28, 29] It is therefore reassuring that we found no difference in the proportion of patients who received comfort care and palliative morphine infusions according to whether they or a surrogate participated in the end‐of‐life discussions. In fact, the majority of patients were made DNR and received some form of comfort measure prior to death, although these comfort measures were frequently initiated only hours prior to death.

While our findings are consistent with research that has demonstrated that end‐of‐life discussions with patients are associated with a decrease in life‐prolonging treatments, it is important to note that our observational study cannot establish a causal relationship between the end‐of‐life discussion and the subsequent use of life‐sustaining treatments. It is possible that patients who have discussions about end‐of‐life care inherently prefer to have less intensive life‐sustaining treatment at the end of life. Physicians may be more apt to engage in these types of discussions with patients who express interest in limited intervention. Interestingly, patients with a DNR order at the time of admission were more likely to participate in end‐of‐life care with their provider during their terminal hospitalization, which supports this alternate explanation. However, when we excluded all patients with a DNR on admission, our findings persisted. Regardless of the explanation for the association between end‐of‐life discussions and life‐sustaining treatments, our study identifies a cohort of hospitalized patients who could benefit from improved end‐of‐life communication, and a clinical setting where opportunities remain to improve the quality of advanced care planning.

Discussions about end‐of‐life care with patients result in earlier transition to care focused on palliation.[14] Although we examined the timing to initiation of comfort care between those who participated and those who did not participate in end‐of‐life discussions, we were not able to demonstrate a statistically significant difference. However, our cohort may not be suitable for an examination of this type of intervention, as early discussions about end‐of‐life care may have lead to early referral to hospice, and therefore death outside the hospital setting, making the patients ineligible for our study.

There are several additional limitations to our study. First, our study is subject to the potential biases inherent in retrospective chart review. For example, since we identified patients who died in the hospital, our study does not generalize to patients with advanced cancer who survive the hospitalization or who were discharged to die at home.[30] Furthermore, our use of the medical record to assess documentation of communication about end‐of‐life care and decisional capacity relies on the accuracy of clinician documentation. There may have been communication about end‐of‐life care that was not documented in the medical record, resulting in underestimation of the effects of end‐of‐life discussions. In clinical practice, the assessment of decisional capacity can be challenging.[19, 31, 32] Although clinicians are often accurate in identifying patients with capacity, in nearly one‐quarter of all assessments, they mistakenly assign capacity to patients who lack decision‐making capacity.[17] In our study, we examine clinician assessment of the patient's decisional capacity, but cannot assess either the accuracy of their clinical assessment or the accuracy of their documentation of this assessment. A second limitation is that the chart abstraction was conducted by a single reviewer without inter‐rater assessment, although the abstraction tool was modified from a well‐established tool.[24] A third limitation is that all of the patients were from a single academic center and the results may not generalize to other regions. Fourth, we did not assess for the potential effect of individual clinicians. Since most patients were cared for by multiple physicians, our study is not capable of assessing a clinician‐level effect. Finally, our study was not able to address whether the care received by patients was in accord with their informed preferences.

We have shown that opportunities exist for advanced care planning at the time of the terminal hospitalization of patients with advanced cancer. The majority of these patients have documentation of decisional capacity at the time of admission, suggesting that opportunities exist to conduct end‐of‐life discussion while the patient retains decisional capacity. Furthermore, we found that patients who participate in these discussions about end‐of‐life care with their clinicians have an associated decrease in the use of life‐sustaining treatments, which is consistent with prior studies.[11, 13, 14, 15, 27] Improving communication about end‐of‐life care for patients hospitalized with advanced cancer may represent an important opportunity to improve the concordance between patients' wishes for care at the end‐of‐life and the care that these patients actually receive. Such communication may also decrease the burden on family members who are frequently asked to play the role of surrogate decision‐maker without an opportunity to discuss these issues with the patient.

Acknowledgments

The authors acknowledge Melissa Braxton for her assistance with the preparation of this manuscript.

Disclosures: A portion of this data was presented at the annual meeting of the Society of Hospital Medicine, 2011, in Grapevine, TX. This work was supported by the National Cancer Institute at the National Institutes of Health (KO5 CA 104699 to J.G.E.) and the National Heart, Lung, and Blood Institute (K24HL68593 to J.R.C.). Dr Silveira's salary was supported by core funds from the Ann Arbor VA HSRD Center of Excellence. The authors have no relevant financial interest in the subject matter contained within this manuscript.

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Most patients prefer to die at home, pain free and without the use of life‐sustaining treatments[1, 2] yet the majority of patients with serious illness die in the hospital.[3, 4, 5] When hospitalized patient die, the care is frequently focused on life‐sustaining treatments[6]; pain, dyspnea, and agitation levels are higher when compared with patients who die in non‐hospital settings.[7, 8, 9] End‐of‐life discussions and their products (ie, advanced directives) can clarify treatment options with patients and family,[10] and help ensure that patients receive care consistent with their beliefs.[11, 12, 13] End‐of‐life discussions are associated with a decrease use of life‐sustaining treatments, improved quality of life, and reduced costs of care.[14, 15] For the majority of patients dying of cancer, the first end‐of‐life discussion takes place in the hospital setting.[16]

Conducting end‐of‐life conversations in the hospital setting can be challenging. Patients are acutely ill and nearly 40% are incapable of making their own medical decisions.[17] In order to participate in an end‐of‐life discussion, a physician must determine that a patient meets the 4 criteria of decisional capacity as outlined by Appelbaum and Grisso:[18] Does the patient (1) communicate a clear and consistent choice; (2) understand the relevant information surrounding that decision; (3) appreciate the consequences of that decision; and (4) communicate reasoning for that decision?[19] In practice, however, clinicians inaccurately assign capacity up to 25% of the time.[17] When a physician determines, accurately or inaccurately, that the patient does not meet this standard for decisional capacity, discussions must be held instead with a surrogate decision‐maker. Surrogate decision‐making can make communication with the physician more difficult,[20] delay important medical decisions,[21] and be stressful on the decision‐maker.[22] To our knowledge, no studies have examined patient and surrogate participation in end‐of‐life discussions at the time of terminal hospitalization and its association with end‐of‐life treatments received.

Our goals were to examine physician assessment of decisional capacity and the prevalence of end‐of‐life discussions during the terminal hospitalization of patients with advanced cancer. Our research questions were: (1) What proportion of patients were assessed to have decisional capacity by the clinical team at the time of their terminal hospital admission? (2) What proportion of these patients had a documented discussion about end‐of‐life care with the clinical team, and for what proportion was the conversation held instead by the patient's surrogate decision‐maker because the patient was considered to have lost decisional capacity? (3) Was patient participation in a discussion about end‐of‐life care associated with life‐sustaining and palliative treatments received?

METHODS

Design

This is a retrospective cohort study of consecutive adult patients with advanced cancer who died at the University of Michigan Hospital, Ann Arbor, MI, from January 1, 2004 through December 31, 2007. This study was exempted from review by the University of Michigan (UM) Institutional Review Board because decedent data were used.

Sample

The UM Cancer Registry is a database of all cancer patients treated at the UM Comprehensive Cancer Center. We used the Registry to identify patients who met the following criteria: (1) age 18 years at time of cancer diagnosis; (2) estimated probability of 5‐year survival 20% at time of diagnosis, as predicted by the SEER Cancer Statistics Review[23]; (3) the entirety of cancer treatment was received at University of Michigan Health System (UMHS); and (4) the patient died while admitted to the University Hospital between January 1, 2004 and December 31, 2007.

UMHS is a healthcare system and academic medical center consisting of hospitals, health centers, and clinics, including the University of Michigan Hospital and Comprehensive Cancer Center. Over 4000 cancer patients are admitted to University Hospital and 80,000 outpatient visits occur to the Cancer Center every year. It serves as a major cancer referral center for the patients of Michigan and the greater Midwest. The University of Michigan implemented a palliative care consult service that was started in 2005, during the time period of our study.

Data Collection

Data were abstracted by review of the medical record by an internist (M.Z.) using a comprehensive chart abstraction instrument based on a previously validated tool.[24] Demographic data abstracted from the medical record included age, religious affiliation, race, ethnicity, and marital status. The original abstraction tool, which included 83 items, was reduced to include 47 items focusing on information related to advanced care planning, hospital course, and end‐of‐life discussions. Specific items included: reasons for admission, primary hospital service, occurrence and timing of end‐of‐life decision‐making, whether patient or family preferences were elicited through an end‐of‐life discussion, clinician's assessment of patient's decisional capacity at time of admission and end‐of‐life conversations, whether a comfort care plan was made, and whether palliative morphine was used.

The chart abstraction tool was pilot tested on the medical records of 10 patients, who were not included in the study, and refined to improve completeness of data collection. A copy of the abstraction tool is available upon request.

Definition of Key Variables

Decisional Capacity Assessment

Decisional capacity assessment is a reflection of the clinical team's assessment of the patient's decisional capacity on admission, and was determined through examination of the medical record in the first 24 hours of admission. Positive decision‐making capacity assessment was assumed if the clinician assessment of decisional capacity was documented in the mental status exam, or if the clinician documented conversations between clinician and patient in the history that suggested intact decision‐making capacity (ie, clinician documented terms such as patient stated or patient described and then described a coherent or sensible statement which implied patient capacity and intact mental status), or if the clinician's documentation of the assessment and plan stated or suggested decisions were being made by the patient. Other supportive information from the record was used to corroborate the evidence used to determine the clinician's assessment of the patient's decisional capacity, including whether the patient signed consent forms.

End‐of‐Life Discussions

The presence of an end‐of‐life discussion was presumed when the clinician documented a discussion with the patient, discussion with family, or family meeting concerning treatment preferences, or when the clinician quoted the patient's preferences in a fashion that documents a face‐to‐face discussion or directly described the elicitation of preferences from the patient or family.

Living Will

A living will was identified as present if the document was scanned into the patient's medical record, or if the chart indicated that the patient or family stated that the patient had completed a living will.

Health Care Proxy

Health Care Proxy or Durable Power of Attorney for Healthcare was identified as present if the document was scanned into the patient's medical record, or if the chart indicated that the patient or family stated that the patient had completed such a document.

Do Not Resuscitate (DNR) on Admission

DNR status was identified as present if the patient had documents with established DNR orders, or if a physician explicitly documented code status as DNR in the admission note or other documents placed in the record within the first 24 hours of admission.

Intensive Care Unit (ICU)Treatment

Patients were defined as having received ICU treatment if they were admitted directly or subsequently transferred to the ICU during the hospital course.

Comfort Care

Comfort care was defined as present only if the phrases comfort care, palliative care, or supportive care, were documented.

Palliative Opioid Therapy

Treatments with morphine or other opioids were recorded as palliative only if it was explicitly stated that these medications were used in the context of palliative or end‐of‐life care.

Data Analysis

We report the proportion of patients who were documented to lack decisional capacity at the time of hospital admission. We compared patient characteristics for those with and without documentation of decisional capacity on admission, and patients with decisional capacity on admission who did and did not participate in discussions about end‐of‐life care using chi‐square tests for categorical data, t tests for normally distributed continuous variables, and MannWhitney U tests for non‐normally distributed continuous variables. We examined whether documentation of a discussion about end‐of‐life care was associated with life‐sustaining and palliative treatments received using chi‐square for categorical treatments, and MannWhitney U tests for days from admission to initiation of comfort care. We used P < 0.05 to signify statistical significance.

RESULTS

Characteristics of Population and Decisional Capacity on Admission

The characteristics of the 145 patients who met entry criteria are summarized in Table 1. The most common types of cancers were lung cancer and leukemia/lymphoma. Of the 145 patients, the medical team's assessment of the patient's decisional capacity on admission could be established for 142 patients. As documented within the first 24 hours of admission, 27 patients (19%) were considered not to have decisional capacity, and 115 patients (79%) were considered to have decisional capacity. Both of these groups had similar age and gender distributions. There were no significant differences in the distribution of cancer type between those with and without decisional capacity. In both groups, the majority of the cancer diagnoses were made prior to admission. There was no difference in DNR orders established prior to or on admission between the groups (Table 1).

Characteristics of Patients With and Without Documented Decision‐Making Capacity
 Decision‐Making Capacity on Admissiona 
No (N = 27)Yes (N = 115) 
N (%)N (%)P Value
  • Abbreviations: DNR, do not resuscitate.
  • Decisional capacity as assessed and documented by the clinician; clinicians assessment of decisional capacity could not be determined in 3 patients.
  • Other cancer types: rectal, stomach, bone sarcoma, renal cell, laryngeal, renal pelvic.
Age >6515 (55.6)60 (52.2)0.75
Gender (male)14 (51.9)68 (59.1)0.46
Cancer type
Lung12 (44.4)42 (36.5)0.67
Bone marrow5 (18.5)35 (30.4)
Liver3 (11.1)6 (5.2)
Pancreas3 (11.1)7 (6.10)
Esophagus1 (3.7)8 (7.0)
Colon1 (3.7)6 (5.2)
Otherb2 (7.4)11 (9.6)
Prior to admission
Cancer diagnosis known23 (85.2)91 (79.1)0.48
Living will completed6 (22.2)26 (22.60.97
Health care proxy established3 (11.1)26 (22.6)0.18
DNR established8 (29.6)27 (23.5)0.79

End‐of‐Life Discussion in Patients With Decisional Capacity on Admission

Of the 115 patients assessed to have intact decisional capacity on admission, 56 (48.7%) participated in an end‐of‐life discussion with the medical team during their terminal hospitalization. For the remaining 59 patients who did not participate in an end‐of‐life discussion during the terminal hospital course, 46 (40.0%) had documentation suggesting they lost decisional capacity prior to a conversation and that the end‐of‐life discussions were held instead with the patient's surrogate decision‐maker, and 13 (11.3%) had no evidence of any end‐of‐life discussion (with the patient or surrogate).

When comparing those patients who participated in an end‐of‐life discussion with those patients whose surrogate participated in the discussion, there were no significant differences in gender and age distributions (Table 2). There was a significant difference in the type of cancers between the 2 groups. Among patients who participated in their end‐of‐life discussions, bone marrow cancer was proportionately more prevalent (17.9% vs 2.2%; P <0.01) and lung cancer was less prevalent (16.1% vs 41.3%; P <0.01), when compared to those who required surrogate participation. Timing of cancer diagnosis and prevalence of advance directives were similar between the 2 groups. The proportion of patients who had an established DNR order prior to admission was higher among those who did participate in end‐of‐life discussions when compared to those who had surrogate participation in these discussions (30.4% vs 17.4%; P < 0.04).

Among Patients With Documented Decision‐Making Capacity on Admission, the Characteristics of Patients by Status of Their Participation in End‐of‐Life Discussions
Patients With Documented Decision‐Making Capacity on Admission (N = 115) 
 N =13N = 102 
 End‐of‐Life discussion not documentedEnd‐of‐Life discussion with surrogate (N = 46)End‐of‐Life discussion with patient (N = 56) 
 N (%)N (%)N (%)P Value
  • Abbreviations: DNR, do not resuscitate.
  • Other cancer types: rectal, stomach, bone sarcoma, renal cell, laryngeal, renal pelvic.
Age 659 (69.2)18 (39.1)27 (48.2)0.36
Gender (male)10 (76.9)27 (60.0)31 (55.4)0.64
Cancer type    
Lung3 (23.1)19 (41.3)9 (16.1) 
Bone marrow7 (53.9)1 (2.2)10 (17.9) 
Liver1 (7.7)3 (6.5)2 (3.6) 
Pancreas1 (7.7)2 (4.4)4 (7.1)<0.01
Esophagus06 (13.0)2 (3.6) 
Colon1 (7.7)1 (2.2)3 (5.4) 
Othera01 (2.2)10 (17.9) 
Prior to Admission
Cancer diagnosis known10 (76.9)37 (80.4)43 (76.8)0.66
Living will completed4 (30.8)10 (21.7)12 (21.4)0.97
Health care proxy established    
 3 (23.1)13 (28.3)10 (17.9)0.21
DNR established2 (15.4)8 (17.4)17 (30.4)0.04

Life‐Prolonging and Palliative Care Treatments Received and Participation in End‐of‐Life Discussions

Life‐prolonging treatments were more likely to be used for patients whose end‐of‐life discussions were held by patient's surrogate decision‐maker, in comparison to those patients who participated in the discussions themselves. Patients who had conversations held by surrogates were more likely to receive ventilator support (56.5% vs 23.2%, P < 0.01), chemotherapy (39.1% vs 5.4%, P < 0.01), artificial nutrition or hydration (45.7% vs 25.0%, P = 0.03), and antibiotics (97.8% vs 78.6%, P < 0.01), when compared to patients who participated in their own end‐of‐life discussion. Intensive care treatment rates also differed significantly between the 2 groups; 56.5% of those who did not participate in end‐of‐life discussions, and only 23.2% of those patients who did participate, were admitted or transferred to the intensive care unit (P < 0.01). There was no significant difference in the proportion of patients who received cardiopulmonary resuscitation (CPR) (15.2% vs 7.1%, P = 0.56) (Table 3). Patients who lost decisional capacity and required a surrogate decision‐maker to participate in their end‐of‐life discussions had longer length of stay (15.8 vs 10.3 days, P = 0.03) and length of time to end‐of‐life discussions (14.0 vs 6.1 days, P < 0.01) (Table 3).

Patient or Surrogate Participation in End‐of‐Life Discussions, Treatments Received, and Timing of Advanced Care Planning Among Patients With Documented Decision‐Making Capacity on Admission
 Patients With Documented Decision‐Making Capacity on Admission (N = 115) 
End‐of‐Life Discussion With Surrogate (N =46)End‐of‐Life Discussion With Patient (N = 56) 
 N (%)N (%)P Value
  • Abbreviations: CI, confidence interval; ICU, intensive care unit. *P value is for comparison of end‐of‐life discussion with surrogate vs end‐of‐life discussion with patient.
Life‐Prolonging Treatment   
Ventilatory support26 (56.5)13 (23.2)<0.01
Chemotherapy18 (39.1)3 (5.4)<0.01
Artificial nutrition or hydration21 (45.7)14 (25.0)0.03
Antibiotics45 (97.8)44 (78.6)<0.01
Cardiopulmonary resuscitation7 (15.2)4 (7.1)0.19
ICU treatment (admit or transfer)26 (56.5)13 (23.2)<0.01
Palliative Treatments   
Comfort care39 (84.8)45 (80.4)0.56
Palliative morphine drip24 (52.2)33 (57.1)0.62
 Mean (95% CI) [Range]Mean (95% CI) [Range] 
Timing of Advanced Care Planning   
Length of hospitalization15.8 d (11.420.2) [157]10.3 d (146) [146]0.03
Time to end‐of‐life discussion14.0 d (9.918.1) [055]6.1 d (3.88.4) [046]<0.01
Time to comfort care23.5 d (4.342.8) [1374]9.2 d (6.312.1) [046]0.12

A comparison of the proportion of patients receiving palliative treatments, such as palliative comfort care orders and morphine infusions, revealed no significant differences between those with and without a discussion about end‐of‐life care (Table 3). Furthermore, while the time interval from hospital admission to initiation of comfort care was shorter for those who did participate in end‐of‐life discussions compared with those had surrogate participation (9.3 vs 23.5 days, P = 0.13 for equality), this difference was not statistically significant (Table 3).

Since a higher proportion of those who participated in end‐of‐life discussions during the hospitalization were admitted with a DNR order established prior to or on admission, we also examined the use of life‐prolonging treatments in the subgroup of patients who did not have a DNR order prior to admission. The difference in life‐prolonging treatments between those who did and did not participate in end‐of‐life discussions was preserved among those patients who did not have DNR status on admission (data not shown).

DISCUSSION

In this retrospective study of 145 terminal cancer patients who died in the hospital, we found that half of the patients had documentation suggesting that they lost decisional capacity during hospitalization and did not participate in end‐of‐life discussion with their healthcare providers. Among cancer patients in our study, 19% were determined not to have decisional capacity on admission, and another 32% were determined to lose decisional capacity during the hospital course. When patients did participate in documented discussions about end‐of‐life care, they were less likely to receive intensive life‐sustaining treatments, less likely to be admitted or transferred to the ICU, and more likely to avoid prolonged hospitalization. The finding that the majority of cancer patients are assessed to have intact decisional capacity upon admission to their terminal hospitalization, but less than half of them participate in their own end‐of‐life conversation, suggests that there is an important lost opportunity to provide quality advanced care planning to hospitalized patients.

Advanced care planning is the act of defining a competent patient's wishes regarding their future healthcare in the event of loss of decisional capacity. For many of the patients who were determined to lose decisional capacity during their hospitalization in our study, a surrogate decision‐maker was involved in a subsequent end‐of‐life discussion. This represents a missed opportunity in 2 ways. First, because surrogates may incorrectly predict patients' end‐of‐life treatment preferences in approximately one‐third of the cases,[25] patients may receive care that is inconsistent with their beliefs. Second, reliance on surrogate decision‐making may result in a greater burden on family members. Surrogate decision‐making places a large burden on surrogates, and can lead to emotional and psychological stress that can last well beyond the death of the loved one.[16, 26]

Our results reinforce the growing body of evidence suggesting that communication with the dying patient, both before and during the terminal hospitalization, promotes end‐of‐life care that involves less invasive life‐prolonging treatments,[10, 11, 12, 13, 14, 15] which is a consistently stated goal of most patients at the end of life.[1, 2] Our findings are consistent with a recent randomized trial of hospitalized patients over the age of 80 which showed that advance care planning discussions were associated with decreased use of intensive life‐sustaining treatments, increased patient and family satisfaction with care, as well as decreased psychological symptoms among family members.[27] In addition, studies examining patients with advanced cancer have shown that discussions about end‐of‐life care in the outpatient setting resulted in less intensive life‐sustaining treatments.[14, 15] Nearly 20% of our cohort was determined by the clinical team to lack decisional capacity at the time of their terminal hospitalization, highlighting the importance of end‐of‐life discussion prior to hospitalization. Our results also extend these recent findings to the inpatient setting. Seventy‐nine percent of patients in our study were determined to have decisional capacity at the time of their terminal hospitalization, and end‐of‐life discussion conducted with these patients was associated with decreased use of life‐sustaining treatments.

Seriously ill patients, particularly in hospital settings, have high symptom burden and subsequent poor quality of life.[6] These patients and families often report inadequate pain and symptom relief.[8, 28, 29] It is therefore reassuring that we found no difference in the proportion of patients who received comfort care and palliative morphine infusions according to whether they or a surrogate participated in the end‐of‐life discussions. In fact, the majority of patients were made DNR and received some form of comfort measure prior to death, although these comfort measures were frequently initiated only hours prior to death.

While our findings are consistent with research that has demonstrated that end‐of‐life discussions with patients are associated with a decrease in life‐prolonging treatments, it is important to note that our observational study cannot establish a causal relationship between the end‐of‐life discussion and the subsequent use of life‐sustaining treatments. It is possible that patients who have discussions about end‐of‐life care inherently prefer to have less intensive life‐sustaining treatment at the end of life. Physicians may be more apt to engage in these types of discussions with patients who express interest in limited intervention. Interestingly, patients with a DNR order at the time of admission were more likely to participate in end‐of‐life care with their provider during their terminal hospitalization, which supports this alternate explanation. However, when we excluded all patients with a DNR on admission, our findings persisted. Regardless of the explanation for the association between end‐of‐life discussions and life‐sustaining treatments, our study identifies a cohort of hospitalized patients who could benefit from improved end‐of‐life communication, and a clinical setting where opportunities remain to improve the quality of advanced care planning.

Discussions about end‐of‐life care with patients result in earlier transition to care focused on palliation.[14] Although we examined the timing to initiation of comfort care between those who participated and those who did not participate in end‐of‐life discussions, we were not able to demonstrate a statistically significant difference. However, our cohort may not be suitable for an examination of this type of intervention, as early discussions about end‐of‐life care may have lead to early referral to hospice, and therefore death outside the hospital setting, making the patients ineligible for our study.

There are several additional limitations to our study. First, our study is subject to the potential biases inherent in retrospective chart review. For example, since we identified patients who died in the hospital, our study does not generalize to patients with advanced cancer who survive the hospitalization or who were discharged to die at home.[30] Furthermore, our use of the medical record to assess documentation of communication about end‐of‐life care and decisional capacity relies on the accuracy of clinician documentation. There may have been communication about end‐of‐life care that was not documented in the medical record, resulting in underestimation of the effects of end‐of‐life discussions. In clinical practice, the assessment of decisional capacity can be challenging.[19, 31, 32] Although clinicians are often accurate in identifying patients with capacity, in nearly one‐quarter of all assessments, they mistakenly assign capacity to patients who lack decision‐making capacity.[17] In our study, we examine clinician assessment of the patient's decisional capacity, but cannot assess either the accuracy of their clinical assessment or the accuracy of their documentation of this assessment. A second limitation is that the chart abstraction was conducted by a single reviewer without inter‐rater assessment, although the abstraction tool was modified from a well‐established tool.[24] A third limitation is that all of the patients were from a single academic center and the results may not generalize to other regions. Fourth, we did not assess for the potential effect of individual clinicians. Since most patients were cared for by multiple physicians, our study is not capable of assessing a clinician‐level effect. Finally, our study was not able to address whether the care received by patients was in accord with their informed preferences.

We have shown that opportunities exist for advanced care planning at the time of the terminal hospitalization of patients with advanced cancer. The majority of these patients have documentation of decisional capacity at the time of admission, suggesting that opportunities exist to conduct end‐of‐life discussion while the patient retains decisional capacity. Furthermore, we found that patients who participate in these discussions about end‐of‐life care with their clinicians have an associated decrease in the use of life‐sustaining treatments, which is consistent with prior studies.[11, 13, 14, 15, 27] Improving communication about end‐of‐life care for patients hospitalized with advanced cancer may represent an important opportunity to improve the concordance between patients' wishes for care at the end‐of‐life and the care that these patients actually receive. Such communication may also decrease the burden on family members who are frequently asked to play the role of surrogate decision‐maker without an opportunity to discuss these issues with the patient.

Acknowledgments

The authors acknowledge Melissa Braxton for her assistance with the preparation of this manuscript.

Disclosures: A portion of this data was presented at the annual meeting of the Society of Hospital Medicine, 2011, in Grapevine, TX. This work was supported by the National Cancer Institute at the National Institutes of Health (KO5 CA 104699 to J.G.E.) and the National Heart, Lung, and Blood Institute (K24HL68593 to J.R.C.). Dr Silveira's salary was supported by core funds from the Ann Arbor VA HSRD Center of Excellence. The authors have no relevant financial interest in the subject matter contained within this manuscript.

Most patients prefer to die at home, pain free and without the use of life‐sustaining treatments[1, 2] yet the majority of patients with serious illness die in the hospital.[3, 4, 5] When hospitalized patient die, the care is frequently focused on life‐sustaining treatments[6]; pain, dyspnea, and agitation levels are higher when compared with patients who die in non‐hospital settings.[7, 8, 9] End‐of‐life discussions and their products (ie, advanced directives) can clarify treatment options with patients and family,[10] and help ensure that patients receive care consistent with their beliefs.[11, 12, 13] End‐of‐life discussions are associated with a decrease use of life‐sustaining treatments, improved quality of life, and reduced costs of care.[14, 15] For the majority of patients dying of cancer, the first end‐of‐life discussion takes place in the hospital setting.[16]

Conducting end‐of‐life conversations in the hospital setting can be challenging. Patients are acutely ill and nearly 40% are incapable of making their own medical decisions.[17] In order to participate in an end‐of‐life discussion, a physician must determine that a patient meets the 4 criteria of decisional capacity as outlined by Appelbaum and Grisso:[18] Does the patient (1) communicate a clear and consistent choice; (2) understand the relevant information surrounding that decision; (3) appreciate the consequences of that decision; and (4) communicate reasoning for that decision?[19] In practice, however, clinicians inaccurately assign capacity up to 25% of the time.[17] When a physician determines, accurately or inaccurately, that the patient does not meet this standard for decisional capacity, discussions must be held instead with a surrogate decision‐maker. Surrogate decision‐making can make communication with the physician more difficult,[20] delay important medical decisions,[21] and be stressful on the decision‐maker.[22] To our knowledge, no studies have examined patient and surrogate participation in end‐of‐life discussions at the time of terminal hospitalization and its association with end‐of‐life treatments received.

Our goals were to examine physician assessment of decisional capacity and the prevalence of end‐of‐life discussions during the terminal hospitalization of patients with advanced cancer. Our research questions were: (1) What proportion of patients were assessed to have decisional capacity by the clinical team at the time of their terminal hospital admission? (2) What proportion of these patients had a documented discussion about end‐of‐life care with the clinical team, and for what proportion was the conversation held instead by the patient's surrogate decision‐maker because the patient was considered to have lost decisional capacity? (3) Was patient participation in a discussion about end‐of‐life care associated with life‐sustaining and palliative treatments received?

METHODS

Design

This is a retrospective cohort study of consecutive adult patients with advanced cancer who died at the University of Michigan Hospital, Ann Arbor, MI, from January 1, 2004 through December 31, 2007. This study was exempted from review by the University of Michigan (UM) Institutional Review Board because decedent data were used.

Sample

The UM Cancer Registry is a database of all cancer patients treated at the UM Comprehensive Cancer Center. We used the Registry to identify patients who met the following criteria: (1) age 18 years at time of cancer diagnosis; (2) estimated probability of 5‐year survival 20% at time of diagnosis, as predicted by the SEER Cancer Statistics Review[23]; (3) the entirety of cancer treatment was received at University of Michigan Health System (UMHS); and (4) the patient died while admitted to the University Hospital between January 1, 2004 and December 31, 2007.

UMHS is a healthcare system and academic medical center consisting of hospitals, health centers, and clinics, including the University of Michigan Hospital and Comprehensive Cancer Center. Over 4000 cancer patients are admitted to University Hospital and 80,000 outpatient visits occur to the Cancer Center every year. It serves as a major cancer referral center for the patients of Michigan and the greater Midwest. The University of Michigan implemented a palliative care consult service that was started in 2005, during the time period of our study.

Data Collection

Data were abstracted by review of the medical record by an internist (M.Z.) using a comprehensive chart abstraction instrument based on a previously validated tool.[24] Demographic data abstracted from the medical record included age, religious affiliation, race, ethnicity, and marital status. The original abstraction tool, which included 83 items, was reduced to include 47 items focusing on information related to advanced care planning, hospital course, and end‐of‐life discussions. Specific items included: reasons for admission, primary hospital service, occurrence and timing of end‐of‐life decision‐making, whether patient or family preferences were elicited through an end‐of‐life discussion, clinician's assessment of patient's decisional capacity at time of admission and end‐of‐life conversations, whether a comfort care plan was made, and whether palliative morphine was used.

The chart abstraction tool was pilot tested on the medical records of 10 patients, who were not included in the study, and refined to improve completeness of data collection. A copy of the abstraction tool is available upon request.

Definition of Key Variables

Decisional Capacity Assessment

Decisional capacity assessment is a reflection of the clinical team's assessment of the patient's decisional capacity on admission, and was determined through examination of the medical record in the first 24 hours of admission. Positive decision‐making capacity assessment was assumed if the clinician assessment of decisional capacity was documented in the mental status exam, or if the clinician documented conversations between clinician and patient in the history that suggested intact decision‐making capacity (ie, clinician documented terms such as patient stated or patient described and then described a coherent or sensible statement which implied patient capacity and intact mental status), or if the clinician's documentation of the assessment and plan stated or suggested decisions were being made by the patient. Other supportive information from the record was used to corroborate the evidence used to determine the clinician's assessment of the patient's decisional capacity, including whether the patient signed consent forms.

End‐of‐Life Discussions

The presence of an end‐of‐life discussion was presumed when the clinician documented a discussion with the patient, discussion with family, or family meeting concerning treatment preferences, or when the clinician quoted the patient's preferences in a fashion that documents a face‐to‐face discussion or directly described the elicitation of preferences from the patient or family.

Living Will

A living will was identified as present if the document was scanned into the patient's medical record, or if the chart indicated that the patient or family stated that the patient had completed a living will.

Health Care Proxy

Health Care Proxy or Durable Power of Attorney for Healthcare was identified as present if the document was scanned into the patient's medical record, or if the chart indicated that the patient or family stated that the patient had completed such a document.

Do Not Resuscitate (DNR) on Admission

DNR status was identified as present if the patient had documents with established DNR orders, or if a physician explicitly documented code status as DNR in the admission note or other documents placed in the record within the first 24 hours of admission.

Intensive Care Unit (ICU)Treatment

Patients were defined as having received ICU treatment if they were admitted directly or subsequently transferred to the ICU during the hospital course.

Comfort Care

Comfort care was defined as present only if the phrases comfort care, palliative care, or supportive care, were documented.

Palliative Opioid Therapy

Treatments with morphine or other opioids were recorded as palliative only if it was explicitly stated that these medications were used in the context of palliative or end‐of‐life care.

Data Analysis

We report the proportion of patients who were documented to lack decisional capacity at the time of hospital admission. We compared patient characteristics for those with and without documentation of decisional capacity on admission, and patients with decisional capacity on admission who did and did not participate in discussions about end‐of‐life care using chi‐square tests for categorical data, t tests for normally distributed continuous variables, and MannWhitney U tests for non‐normally distributed continuous variables. We examined whether documentation of a discussion about end‐of‐life care was associated with life‐sustaining and palliative treatments received using chi‐square for categorical treatments, and MannWhitney U tests for days from admission to initiation of comfort care. We used P < 0.05 to signify statistical significance.

RESULTS

Characteristics of Population and Decisional Capacity on Admission

The characteristics of the 145 patients who met entry criteria are summarized in Table 1. The most common types of cancers were lung cancer and leukemia/lymphoma. Of the 145 patients, the medical team's assessment of the patient's decisional capacity on admission could be established for 142 patients. As documented within the first 24 hours of admission, 27 patients (19%) were considered not to have decisional capacity, and 115 patients (79%) were considered to have decisional capacity. Both of these groups had similar age and gender distributions. There were no significant differences in the distribution of cancer type between those with and without decisional capacity. In both groups, the majority of the cancer diagnoses were made prior to admission. There was no difference in DNR orders established prior to or on admission between the groups (Table 1).

Characteristics of Patients With and Without Documented Decision‐Making Capacity
 Decision‐Making Capacity on Admissiona 
No (N = 27)Yes (N = 115) 
N (%)N (%)P Value
  • Abbreviations: DNR, do not resuscitate.
  • Decisional capacity as assessed and documented by the clinician; clinicians assessment of decisional capacity could not be determined in 3 patients.
  • Other cancer types: rectal, stomach, bone sarcoma, renal cell, laryngeal, renal pelvic.
Age >6515 (55.6)60 (52.2)0.75
Gender (male)14 (51.9)68 (59.1)0.46
Cancer type
Lung12 (44.4)42 (36.5)0.67
Bone marrow5 (18.5)35 (30.4)
Liver3 (11.1)6 (5.2)
Pancreas3 (11.1)7 (6.10)
Esophagus1 (3.7)8 (7.0)
Colon1 (3.7)6 (5.2)
Otherb2 (7.4)11 (9.6)
Prior to admission
Cancer diagnosis known23 (85.2)91 (79.1)0.48
Living will completed6 (22.2)26 (22.60.97
Health care proxy established3 (11.1)26 (22.6)0.18
DNR established8 (29.6)27 (23.5)0.79

End‐of‐Life Discussion in Patients With Decisional Capacity on Admission

Of the 115 patients assessed to have intact decisional capacity on admission, 56 (48.7%) participated in an end‐of‐life discussion with the medical team during their terminal hospitalization. For the remaining 59 patients who did not participate in an end‐of‐life discussion during the terminal hospital course, 46 (40.0%) had documentation suggesting they lost decisional capacity prior to a conversation and that the end‐of‐life discussions were held instead with the patient's surrogate decision‐maker, and 13 (11.3%) had no evidence of any end‐of‐life discussion (with the patient or surrogate).

When comparing those patients who participated in an end‐of‐life discussion with those patients whose surrogate participated in the discussion, there were no significant differences in gender and age distributions (Table 2). There was a significant difference in the type of cancers between the 2 groups. Among patients who participated in their end‐of‐life discussions, bone marrow cancer was proportionately more prevalent (17.9% vs 2.2%; P <0.01) and lung cancer was less prevalent (16.1% vs 41.3%; P <0.01), when compared to those who required surrogate participation. Timing of cancer diagnosis and prevalence of advance directives were similar between the 2 groups. The proportion of patients who had an established DNR order prior to admission was higher among those who did participate in end‐of‐life discussions when compared to those who had surrogate participation in these discussions (30.4% vs 17.4%; P < 0.04).

Among Patients With Documented Decision‐Making Capacity on Admission, the Characteristics of Patients by Status of Their Participation in End‐of‐Life Discussions
Patients With Documented Decision‐Making Capacity on Admission (N = 115) 
 N =13N = 102 
 End‐of‐Life discussion not documentedEnd‐of‐Life discussion with surrogate (N = 46)End‐of‐Life discussion with patient (N = 56) 
 N (%)N (%)N (%)P Value
  • Abbreviations: DNR, do not resuscitate.
  • Other cancer types: rectal, stomach, bone sarcoma, renal cell, laryngeal, renal pelvic.
Age 659 (69.2)18 (39.1)27 (48.2)0.36
Gender (male)10 (76.9)27 (60.0)31 (55.4)0.64
Cancer type    
Lung3 (23.1)19 (41.3)9 (16.1) 
Bone marrow7 (53.9)1 (2.2)10 (17.9) 
Liver1 (7.7)3 (6.5)2 (3.6) 
Pancreas1 (7.7)2 (4.4)4 (7.1)<0.01
Esophagus06 (13.0)2 (3.6) 
Colon1 (7.7)1 (2.2)3 (5.4) 
Othera01 (2.2)10 (17.9) 
Prior to Admission
Cancer diagnosis known10 (76.9)37 (80.4)43 (76.8)0.66
Living will completed4 (30.8)10 (21.7)12 (21.4)0.97
Health care proxy established    
 3 (23.1)13 (28.3)10 (17.9)0.21
DNR established2 (15.4)8 (17.4)17 (30.4)0.04

Life‐Prolonging and Palliative Care Treatments Received and Participation in End‐of‐Life Discussions

Life‐prolonging treatments were more likely to be used for patients whose end‐of‐life discussions were held by patient's surrogate decision‐maker, in comparison to those patients who participated in the discussions themselves. Patients who had conversations held by surrogates were more likely to receive ventilator support (56.5% vs 23.2%, P < 0.01), chemotherapy (39.1% vs 5.4%, P < 0.01), artificial nutrition or hydration (45.7% vs 25.0%, P = 0.03), and antibiotics (97.8% vs 78.6%, P < 0.01), when compared to patients who participated in their own end‐of‐life discussion. Intensive care treatment rates also differed significantly between the 2 groups; 56.5% of those who did not participate in end‐of‐life discussions, and only 23.2% of those patients who did participate, were admitted or transferred to the intensive care unit (P < 0.01). There was no significant difference in the proportion of patients who received cardiopulmonary resuscitation (CPR) (15.2% vs 7.1%, P = 0.56) (Table 3). Patients who lost decisional capacity and required a surrogate decision‐maker to participate in their end‐of‐life discussions had longer length of stay (15.8 vs 10.3 days, P = 0.03) and length of time to end‐of‐life discussions (14.0 vs 6.1 days, P < 0.01) (Table 3).

Patient or Surrogate Participation in End‐of‐Life Discussions, Treatments Received, and Timing of Advanced Care Planning Among Patients With Documented Decision‐Making Capacity on Admission
 Patients With Documented Decision‐Making Capacity on Admission (N = 115) 
End‐of‐Life Discussion With Surrogate (N =46)End‐of‐Life Discussion With Patient (N = 56) 
 N (%)N (%)P Value
  • Abbreviations: CI, confidence interval; ICU, intensive care unit. *P value is for comparison of end‐of‐life discussion with surrogate vs end‐of‐life discussion with patient.
Life‐Prolonging Treatment   
Ventilatory support26 (56.5)13 (23.2)<0.01
Chemotherapy18 (39.1)3 (5.4)<0.01
Artificial nutrition or hydration21 (45.7)14 (25.0)0.03
Antibiotics45 (97.8)44 (78.6)<0.01
Cardiopulmonary resuscitation7 (15.2)4 (7.1)0.19
ICU treatment (admit or transfer)26 (56.5)13 (23.2)<0.01
Palliative Treatments   
Comfort care39 (84.8)45 (80.4)0.56
Palliative morphine drip24 (52.2)33 (57.1)0.62
 Mean (95% CI) [Range]Mean (95% CI) [Range] 
Timing of Advanced Care Planning   
Length of hospitalization15.8 d (11.420.2) [157]10.3 d (146) [146]0.03
Time to end‐of‐life discussion14.0 d (9.918.1) [055]6.1 d (3.88.4) [046]<0.01
Time to comfort care23.5 d (4.342.8) [1374]9.2 d (6.312.1) [046]0.12

A comparison of the proportion of patients receiving palliative treatments, such as palliative comfort care orders and morphine infusions, revealed no significant differences between those with and without a discussion about end‐of‐life care (Table 3). Furthermore, while the time interval from hospital admission to initiation of comfort care was shorter for those who did participate in end‐of‐life discussions compared with those had surrogate participation (9.3 vs 23.5 days, P = 0.13 for equality), this difference was not statistically significant (Table 3).

Since a higher proportion of those who participated in end‐of‐life discussions during the hospitalization were admitted with a DNR order established prior to or on admission, we also examined the use of life‐prolonging treatments in the subgroup of patients who did not have a DNR order prior to admission. The difference in life‐prolonging treatments between those who did and did not participate in end‐of‐life discussions was preserved among those patients who did not have DNR status on admission (data not shown).

DISCUSSION

In this retrospective study of 145 terminal cancer patients who died in the hospital, we found that half of the patients had documentation suggesting that they lost decisional capacity during hospitalization and did not participate in end‐of‐life discussion with their healthcare providers. Among cancer patients in our study, 19% were determined not to have decisional capacity on admission, and another 32% were determined to lose decisional capacity during the hospital course. When patients did participate in documented discussions about end‐of‐life care, they were less likely to receive intensive life‐sustaining treatments, less likely to be admitted or transferred to the ICU, and more likely to avoid prolonged hospitalization. The finding that the majority of cancer patients are assessed to have intact decisional capacity upon admission to their terminal hospitalization, but less than half of them participate in their own end‐of‐life conversation, suggests that there is an important lost opportunity to provide quality advanced care planning to hospitalized patients.

Advanced care planning is the act of defining a competent patient's wishes regarding their future healthcare in the event of loss of decisional capacity. For many of the patients who were determined to lose decisional capacity during their hospitalization in our study, a surrogate decision‐maker was involved in a subsequent end‐of‐life discussion. This represents a missed opportunity in 2 ways. First, because surrogates may incorrectly predict patients' end‐of‐life treatment preferences in approximately one‐third of the cases,[25] patients may receive care that is inconsistent with their beliefs. Second, reliance on surrogate decision‐making may result in a greater burden on family members. Surrogate decision‐making places a large burden on surrogates, and can lead to emotional and psychological stress that can last well beyond the death of the loved one.[16, 26]

Our results reinforce the growing body of evidence suggesting that communication with the dying patient, both before and during the terminal hospitalization, promotes end‐of‐life care that involves less invasive life‐prolonging treatments,[10, 11, 12, 13, 14, 15] which is a consistently stated goal of most patients at the end of life.[1, 2] Our findings are consistent with a recent randomized trial of hospitalized patients over the age of 80 which showed that advance care planning discussions were associated with decreased use of intensive life‐sustaining treatments, increased patient and family satisfaction with care, as well as decreased psychological symptoms among family members.[27] In addition, studies examining patients with advanced cancer have shown that discussions about end‐of‐life care in the outpatient setting resulted in less intensive life‐sustaining treatments.[14, 15] Nearly 20% of our cohort was determined by the clinical team to lack decisional capacity at the time of their terminal hospitalization, highlighting the importance of end‐of‐life discussion prior to hospitalization. Our results also extend these recent findings to the inpatient setting. Seventy‐nine percent of patients in our study were determined to have decisional capacity at the time of their terminal hospitalization, and end‐of‐life discussion conducted with these patients was associated with decreased use of life‐sustaining treatments.

Seriously ill patients, particularly in hospital settings, have high symptom burden and subsequent poor quality of life.[6] These patients and families often report inadequate pain and symptom relief.[8, 28, 29] It is therefore reassuring that we found no difference in the proportion of patients who received comfort care and palliative morphine infusions according to whether they or a surrogate participated in the end‐of‐life discussions. In fact, the majority of patients were made DNR and received some form of comfort measure prior to death, although these comfort measures were frequently initiated only hours prior to death.

While our findings are consistent with research that has demonstrated that end‐of‐life discussions with patients are associated with a decrease in life‐prolonging treatments, it is important to note that our observational study cannot establish a causal relationship between the end‐of‐life discussion and the subsequent use of life‐sustaining treatments. It is possible that patients who have discussions about end‐of‐life care inherently prefer to have less intensive life‐sustaining treatment at the end of life. Physicians may be more apt to engage in these types of discussions with patients who express interest in limited intervention. Interestingly, patients with a DNR order at the time of admission were more likely to participate in end‐of‐life care with their provider during their terminal hospitalization, which supports this alternate explanation. However, when we excluded all patients with a DNR on admission, our findings persisted. Regardless of the explanation for the association between end‐of‐life discussions and life‐sustaining treatments, our study identifies a cohort of hospitalized patients who could benefit from improved end‐of‐life communication, and a clinical setting where opportunities remain to improve the quality of advanced care planning.

Discussions about end‐of‐life care with patients result in earlier transition to care focused on palliation.[14] Although we examined the timing to initiation of comfort care between those who participated and those who did not participate in end‐of‐life discussions, we were not able to demonstrate a statistically significant difference. However, our cohort may not be suitable for an examination of this type of intervention, as early discussions about end‐of‐life care may have lead to early referral to hospice, and therefore death outside the hospital setting, making the patients ineligible for our study.

There are several additional limitations to our study. First, our study is subject to the potential biases inherent in retrospective chart review. For example, since we identified patients who died in the hospital, our study does not generalize to patients with advanced cancer who survive the hospitalization or who were discharged to die at home.[30] Furthermore, our use of the medical record to assess documentation of communication about end‐of‐life care and decisional capacity relies on the accuracy of clinician documentation. There may have been communication about end‐of‐life care that was not documented in the medical record, resulting in underestimation of the effects of end‐of‐life discussions. In clinical practice, the assessment of decisional capacity can be challenging.[19, 31, 32] Although clinicians are often accurate in identifying patients with capacity, in nearly one‐quarter of all assessments, they mistakenly assign capacity to patients who lack decision‐making capacity.[17] In our study, we examine clinician assessment of the patient's decisional capacity, but cannot assess either the accuracy of their clinical assessment or the accuracy of their documentation of this assessment. A second limitation is that the chart abstraction was conducted by a single reviewer without inter‐rater assessment, although the abstraction tool was modified from a well‐established tool.[24] A third limitation is that all of the patients were from a single academic center and the results may not generalize to other regions. Fourth, we did not assess for the potential effect of individual clinicians. Since most patients were cared for by multiple physicians, our study is not capable of assessing a clinician‐level effect. Finally, our study was not able to address whether the care received by patients was in accord with their informed preferences.

We have shown that opportunities exist for advanced care planning at the time of the terminal hospitalization of patients with advanced cancer. The majority of these patients have documentation of decisional capacity at the time of admission, suggesting that opportunities exist to conduct end‐of‐life discussion while the patient retains decisional capacity. Furthermore, we found that patients who participate in these discussions about end‐of‐life care with their clinicians have an associated decrease in the use of life‐sustaining treatments, which is consistent with prior studies.[11, 13, 14, 15, 27] Improving communication about end‐of‐life care for patients hospitalized with advanced cancer may represent an important opportunity to improve the concordance between patients' wishes for care at the end‐of‐life and the care that these patients actually receive. Such communication may also decrease the burden on family members who are frequently asked to play the role of surrogate decision‐maker without an opportunity to discuss these issues with the patient.

Acknowledgments

The authors acknowledge Melissa Braxton for her assistance with the preparation of this manuscript.

Disclosures: A portion of this data was presented at the annual meeting of the Society of Hospital Medicine, 2011, in Grapevine, TX. This work was supported by the National Cancer Institute at the National Institutes of Health (KO5 CA 104699 to J.G.E.) and the National Heart, Lung, and Blood Institute (K24HL68593 to J.R.C.). Dr Silveira's salary was supported by core funds from the Ann Arbor VA HSRD Center of Excellence. The authors have no relevant financial interest in the subject matter contained within this manuscript.

References
  1. Bruera E, Willey JS, Palmer JL, Rosales M. Treatment decisions for breast carcinoma: patient preferences and physician perceptions. Cancer. 2002;94(7):20762080.
  2. Teno JM, Weitzen S, Fennell ML, Mor V. Dying trajectory in the last year of life: does cancer trajectory fit other diseases?J Palliat Med. 2001;4(4):457464.
  3. Goodman DC, Etsy AR, Fisher ES, Chang C‐H. Trends and Variation in End‐of‐Life Care for Medicare Beneficiaries with Severe Chronic Illness.The Dartmouth Institute for Health Policy 32(3):638643.
  4. Desbiens NA, Mueller‐Rizner N, Connors AF, Wenger NS, Lynn J. The symptom burden of seriously ill hospitalized patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcome and Risks of Treatment. J Pain Symptom Manage. 1999;17(4):248255.
  5. Tolle SW, Tilden VP, Hickman SE, Rosenfeld AG. Family reports of pain in dying hospitalized patients: a structured telephone survey. West J Med. 2000;172(6):374377.
  6. Lynn J, Teno JM, Phillips RS, et al. Perceptions by family members of the dying experience of older and seriously ill patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. Ann Intern Med. 1997;126(2):97106.
  7. Goodlin SJ, Winzelberg GS, Teno JM, Whedon M, Lynn J. Death in the hospital. Arch Intern Med. 1998;158(14):15701572.
  8. Mack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End‐of‐life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol. 2010;28(7):12031208.
  9. Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate decision making before death. N Engl J Med. 2010;362(13):12111218.
  10. Teno JM, Clarridge BR, Casey V, et al. Family perspectives on end‐of‐life care at the last place of care. JAMA. 2004;291(1):8893.
  11. Teno JM, Gruneir A, Schwartz Z, Nanda A, Wetle T. Association between advance directives and quality of end‐of‐life care: a national study. J Am Geriatr Soc. 2007;55(2):189194.
  12. Wright AA, Zhang B, Ray A, et al. Associations between end‐of‐life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008;300(14):16651673.
  13. Zhang B, Wright AA, Huskamp HA, et al. Health care costs in the last week of life: associations with end‐of‐life conversations. Arch Intern Med. 2009;169(5):480488.
  14. Mack JW, Cronin A, Taback N, et al. End‐of‐life care discussions among patients with advanced cancer: a cohort study. Ann Intern Med. 2012;156(3):204210.
  15. Raymont V, Bingley W, Buchanan A, et al. Prevalence of mental incapacity in medical inpatients and associated risk factors: cross‐sectional study. Lancet. 2004;364(9443):14211427.
  16. Applebaum P, Grisso T. Assessing patients' capacities to consent to treatment. N Engl J Med 1998;319:16351638.
  17. Appelbaum PS. Clinical practice. Assessment of patients' competence to consent to treatment. N Engl J Med. 2007;357(18):18341840.
  18. Torke AM, Alexander GC, Lantos J, Siegler M. The physician‐surrogate relationship. Arch Intern Med. 2007;167(11):11171121.
  19. Torke AM, Siegler M, Abalos A, Moloney RM, Alexander GC. Physicians' experience with surrogate decision making for hospitalized adults. J Gen Intern Med. 2009;24(9):10231028.
  20. Handy CM, Sulmasy DP, Merkel CK, Ury WA. The surrogate's experience in authorizing a do not resuscitate order. Palliat Support Care. 2008;6(1):1319.
  21. Ries LAG, Melbert D, Krapcho M, et al. Surveillance Epidemiology and End Results (SEER) Cancer Statistics Review 1975–2004. Bethesda, MD:National Cancer Institute. Based on November 2006 SEER data submission, posted to the SEER Web site,2007. Available at: http://seer.cancer.gov/csr/1975_2004/. Accessed on November 1, 2007.
  22. Fins JJ, Miller FG, Acres CA, Bacchetta MD, Huzzard LL, Rapkin BD. End‐of‐life decision‐making in the hospital: current practice and future prospects. J Pain Symptom Manage. 1999;17(1):615.
  23. Shalowitz DI, Garrett‐Mayer E, Wendler D. The accuracy of surrogate decision makers: a systematic review. Arch Intern Med. 2006;166(5):493497.
  24. Wendler D, Rid A. Systematic review: the effect on surrogates of making treatment decisions for others. Ann Intern Med. 2011;154(5):336346.
  25. Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010;340:c1345.
  26. Claessens MT, Lynn J, Zhong Z, et al. Dying with lung cancer or chronic obstructive pulmonary disease: insights from SUPPORT. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. J Am Geriatr Soc. 2000;48(5 suppl):S146S153.
  27. Somogyi‐Zalud E, Zhong Z, Hamel MB, Lynn J. The use of life‐sustaining treatments in hospitalized persons aged 80 and older. J Am Geriatr Soc. 2002;50(5):930934.
  28. Bach PB, Schrag D, Begg CB. Resurrecting treatment histories of dead patients: a study design that should be laid to rest. JAMA. 2004;292(22):27652770.
  29. Etchells E, Darzins P, Silberfeld M, et al. Assessment of patient capacity to consent to treatment. J Gen Intern Med. 1999;14(1):2734.
  30. Grisso T, Appelbaum PS, Hill‐Fotouhi C. The MacCAT‐T: a clinical tool to assess patients' capacities to make treatment decisions. Psychiatr Serv. 1997;48(11):14151419.
References
  1. Bruera E, Willey JS, Palmer JL, Rosales M. Treatment decisions for breast carcinoma: patient preferences and physician perceptions. Cancer. 2002;94(7):20762080.
  2. Teno JM, Weitzen S, Fennell ML, Mor V. Dying trajectory in the last year of life: does cancer trajectory fit other diseases?J Palliat Med. 2001;4(4):457464.
  3. Goodman DC, Etsy AR, Fisher ES, Chang C‐H. Trends and Variation in End‐of‐Life Care for Medicare Beneficiaries with Severe Chronic Illness.The Dartmouth Institute for Health Policy 32(3):638643.
  4. Desbiens NA, Mueller‐Rizner N, Connors AF, Wenger NS, Lynn J. The symptom burden of seriously ill hospitalized patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcome and Risks of Treatment. J Pain Symptom Manage. 1999;17(4):248255.
  5. Tolle SW, Tilden VP, Hickman SE, Rosenfeld AG. Family reports of pain in dying hospitalized patients: a structured telephone survey. West J Med. 2000;172(6):374377.
  6. Lynn J, Teno JM, Phillips RS, et al. Perceptions by family members of the dying experience of older and seriously ill patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. Ann Intern Med. 1997;126(2):97106.
  7. Goodlin SJ, Winzelberg GS, Teno JM, Whedon M, Lynn J. Death in the hospital. Arch Intern Med. 1998;158(14):15701572.
  8. Mack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End‐of‐life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol. 2010;28(7):12031208.
  9. Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate decision making before death. N Engl J Med. 2010;362(13):12111218.
  10. Teno JM, Clarridge BR, Casey V, et al. Family perspectives on end‐of‐life care at the last place of care. JAMA. 2004;291(1):8893.
  11. Teno JM, Gruneir A, Schwartz Z, Nanda A, Wetle T. Association between advance directives and quality of end‐of‐life care: a national study. J Am Geriatr Soc. 2007;55(2):189194.
  12. Wright AA, Zhang B, Ray A, et al. Associations between end‐of‐life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008;300(14):16651673.
  13. Zhang B, Wright AA, Huskamp HA, et al. Health care costs in the last week of life: associations with end‐of‐life conversations. Arch Intern Med. 2009;169(5):480488.
  14. Mack JW, Cronin A, Taback N, et al. End‐of‐life care discussions among patients with advanced cancer: a cohort study. Ann Intern Med. 2012;156(3):204210.
  15. Raymont V, Bingley W, Buchanan A, et al. Prevalence of mental incapacity in medical inpatients and associated risk factors: cross‐sectional study. Lancet. 2004;364(9443):14211427.
  16. Applebaum P, Grisso T. Assessing patients' capacities to consent to treatment. N Engl J Med 1998;319:16351638.
  17. Appelbaum PS. Clinical practice. Assessment of patients' competence to consent to treatment. N Engl J Med. 2007;357(18):18341840.
  18. Torke AM, Alexander GC, Lantos J, Siegler M. The physician‐surrogate relationship. Arch Intern Med. 2007;167(11):11171121.
  19. Torke AM, Siegler M, Abalos A, Moloney RM, Alexander GC. Physicians' experience with surrogate decision making for hospitalized adults. J Gen Intern Med. 2009;24(9):10231028.
  20. Handy CM, Sulmasy DP, Merkel CK, Ury WA. The surrogate's experience in authorizing a do not resuscitate order. Palliat Support Care. 2008;6(1):1319.
  21. Ries LAG, Melbert D, Krapcho M, et al. Surveillance Epidemiology and End Results (SEER) Cancer Statistics Review 1975–2004. Bethesda, MD:National Cancer Institute. Based on November 2006 SEER data submission, posted to the SEER Web site,2007. Available at: http://seer.cancer.gov/csr/1975_2004/. Accessed on November 1, 2007.
  22. Fins JJ, Miller FG, Acres CA, Bacchetta MD, Huzzard LL, Rapkin BD. End‐of‐life decision‐making in the hospital: current practice and future prospects. J Pain Symptom Manage. 1999;17(1):615.
  23. Shalowitz DI, Garrett‐Mayer E, Wendler D. The accuracy of surrogate decision makers: a systematic review. Arch Intern Med. 2006;166(5):493497.
  24. Wendler D, Rid A. Systematic review: the effect on surrogates of making treatment decisions for others. Ann Intern Med. 2011;154(5):336346.
  25. Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010;340:c1345.
  26. Claessens MT, Lynn J, Zhong Z, et al. Dying with lung cancer or chronic obstructive pulmonary disease: insights from SUPPORT. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. J Am Geriatr Soc. 2000;48(5 suppl):S146S153.
  27. Somogyi‐Zalud E, Zhong Z, Hamel MB, Lynn J. The use of life‐sustaining treatments in hospitalized persons aged 80 and older. J Am Geriatr Soc. 2002;50(5):930934.
  28. Bach PB, Schrag D, Begg CB. Resurrecting treatment histories of dead patients: a study design that should be laid to rest. JAMA. 2004;292(22):27652770.
  29. Etchells E, Darzins P, Silberfeld M, et al. Assessment of patient capacity to consent to treatment. J Gen Intern Med. 1999;14(1):2734.
  30. Grisso T, Appelbaum PS, Hill‐Fotouhi C. The MacCAT‐T: a clinical tool to assess patients' capacities to make treatment decisions. Psychiatr Serv. 1997;48(11):14151419.
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Journal of Hospital Medicine - 8(6)
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Opportunity lost: End‐of‐life discussions in cancer patients who die in the hospital
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Opportunity lost: End‐of‐life discussions in cancer patients who die in the hospital
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Address for correspondence and reprint requests: Mark C. Zaros, Harborview Medical Center, Mailbox 359780, 325 Ninth Ave, Seattle, WA 98104‐2499. Telephone: 206‐744‐2054; Fax: 206‐744‐6063; E-mail: [email protected]
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Hospitalist‐Job Fit

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Person‐job fit: An exploratory cross‐sectional analysis of hospitalists

Person‐organization fit concerns the conditions and consequences of compatibility between people and the organizations for which they work.[1] Studies of other industries have demonstrated that person‐organization fit informs the way individuals join, perform in, and are retained by organizations.[2] Person‐job fit is a closely related subordinate concept that concerns the alignment of workers and their job in as much as workers have needs that their job supplies, or conversely, jobs have requirements that certain workers' abilities can help meet.[3] Explorations of job fit in physicians and their work have recently emerged in a few investigations published in medical journals.[4, 5, 6, 7, 8] Further expanding the understanding of fit between physicians and their employment is important, because the decline of solo practices and recent emphasis on team‐based care have led to a growing number of US physicians working in organizations.[9]

The movement of physicians into employed situations may continue if certain types of Accountable Care Organizations take root.[10] And physicians may be primed to join employer organizations based on current career priorities of individuals in American society. Surveys of medical residents entering the workforce reveal more physicians preferring the security of being employees than starting their own practices.[11] Given these trends, job fit will inform our understanding of how personal and job characteristics facilitate recruitment, performance, satisfaction, and longevity of physician employees.

BACKGROUND

Virtually all hospitalists work in organizationshospitalsand are employees of hospitals, medical schools, physician group practices, or management companies, and therefore invariably function within organizational structures and systems.[7] In spite of their rapid growth in numbers, many employers have faced difficulties recruiting and retaining enough hospitalists to fill their staffing needs. Consequently, the US hospitalist workforce today is characterized by high salaries, work load, and attrition rates.[12]

In this evolving unsaturated market, the attraction‐selection‐attrition framework[13] provides a theoretical construct that predicts that hospitalists and their employers would seek congruence of goals and values early in their relationship through a process of trial and error. This framework assumes that early interactions between workers and organizations serve as opportunities for them to understand if job fit is poor and dissociate or remain affiliated as long as job fit is mutually acceptable. Therefore, job switching on average is expected to increase job fit because workers and organizations gain a better understanding of their own goals and values and choose more wisely the next time.

Other theoretical frameworks, such as the job characteristic model,[14] suggest that over time as workers stay at the same job, they continue to maintain and improve job fit through various workplace‐ or self‐modification strategies. For example, seniority status may have privileges (eg, less undesirable call), or workers may create privileged niches through the acquisition of new skills and abilities over time. Hospitalists' tendency to diversify their work‐related activities by incorporating administrative and teaching responsibilities[15] may thus contribute to improving job fit. Additionally, as a measure of complementarity among people who work together, job fit may be influenced by the quality of relationships among hospitalists and their coworkers through their reorientation to the prevailing organizational climate[16, 17] and increasing socialization.[18] Finally, given that experiential learning is known to contribute to better hospitalist work performance,[19] job fit may affect productivity and clinical outcomes vis‐‐vis quality of work life.

To test the validity of these assumptions in a sample of hospitalists, we critically appraised the following 4 hypotheses:

  • Hypothesis 1 (H1): Job attrition and reselection improves job fit among hospitalists entering the job market.
  • Hypothesis 2 (H2): Better job fit is achieved through hospitalists engaging a variety of personal skills and abilities.
  • Hypothesis 3 (H3): Job fit increases with hospitalists' job duration together with socialization and internalization of organizational values.
  • Hypothesis 4 (H4): Job fit is correlated with hospitalists' quality of work life.

 

METHODS

Analysis was performed on data from the 2009 to 2010 Hospital Medicine Physician Worklife Survey. The sample frame included nonmembers and members of Society of Hospital Medicine (SHM). Details about sampling strategy, data collection, and data quality are available in previous publications.[7, 20] The 118‐item survey instrument, including 9 demographic items and 24 practice and job characteristic items, was administered by mail. Examples of information solicited through these items included respondents' practice model, the number of hospitalist jobs they have held, and the specific kinds of clinical and nonclinical activities they performed as part of their current job.

We used a reliable but broad and generic measure of self‐perceived person‐job fit.[21] The survey items of the 5‐point Likert‐type scale anchored between strongly disagree and strongly agree were: I feel that my work utilizes my full abilities, I feel competent and fully able to handle my job, my job gives me the chance to do the things I feel I do best, I feel that my job and I are well‐matched, I feel I have adequate preparation for the job I now hold. The quality of hospitalists' relationships with physician colleagues, staff, and patients as well as job satisfaction was measured using scales adapted from the Physician Worklife Study.[22] Organizational climate was measured using an adapted scale from the Minimizing Error, Maximizing Outcome study incorporating 3 items from the cohesiveness subscale, 4 items from the organizational trust subscale, and 1 item from the quality emphasis subscale that were most pertinent to hospitalists' relationship with their organizations.[23] Intent to leave practice or reduce work hours was measured using 5 items from the Multi‐Center Hospitalist Survey Project.[24] Frequency of participation in suboptimal patient care was measured by adapting 3 items from the suboptimal reported practice subscale and 2 items from the suboptimal patient care subscale developed by Shanafelt et al.[25] Stress and job burnout were assessed using validated measures.[26, 27] Detailed descriptions of the response rate calculation and imputation of missing item data are available in previous publications.[7, 20]

Mean, variance, range, and skew were used to characterize the responses to the job fit survey scale. A table of respondent characteristics was constructed. A visual representation of job fit by individual hospitalist year in current practice was created, first, by plotting a locally weighted scatterplot smoothing curve to examine the shape of the general relationship, and second, by fitting a similarly contoured functional polynomial curve with 95% confidence intervals (CI) to a plot of the mean and interquartile range of job fit for each year in current practice. Spearman partial correlations were calculated for job fit and each of the 5 items addressing likelihood of leaving practice or reducing workload adjusted for gender to control for the higher proportion of women who plan to work part time. Median (interquartile range) job fit was calculated for categories defined by the number of job changes and compared with the reference category (no job change) using the nonparametric rank sum test for comparing non‐normally distributed data. Multivariate logistic regression models were used to calculate the odds ratio (OR) of participating in each of several clinical and nonclinical hospitalist activities between respondents whose job fit score was optimal (5 on a 5‐point scale) and less than optimal controlling for covariates that influence the likelihood of participating in these activities (years in current practice, practice model, and specialty training). A Spearman correlation matrix was created to assess interscale correlations among organizational parameters (years in current practice, job fit, organizational climate, and relationship with colleagues, staff, and patients). Finally, a separate Spearman correlation matrix was created to assess the interscale correlations among individual worker parameters (job fit, suboptimal patient care, job burnout, stress, and job satisfaction). Statistical significance was defined as P value <0.05, and all analyses were performed on Stata 11.0 (StataCorp, College Station, TX). The Northwestern University institutional review board approved this study.

RESULTS

Respondents included 816 hospitalists belonging to around 700 unique organizations. The adjusted response rate from the stratified sample was 26%. Respondents and nonrespondents were similar with regard to geographic region and model of practice, but respondents were more likely to be members of the SHM than nonrespondents. Panel A of Table 1 shows the demographic characteristics of the respondents. The mean age was 44.3 years, and about one‐third were women. The average hospitalist had about 7 years of experience in the specialty and about 5 years with their current hospitalist job. The majority were trained in internal medicine or one of its subspecialties, whereas pediatricians, family physicians, and physicians with other training made up the remainder.

Characteristics of Respondent Hospitalists
 Panel APanel B
 TotalAssimilation Period HospitalistsAdvancement Period Hospitalists
  • NOTE: Abbreviations: SD, standard deviation.
Total, n816103713
Female, n (%)284 (35)37 (36)247 (35)
Age, mean (SD)44.3 (9.0)41.9 (9.3)44.7 (8.9)
Years postresidency experience as hospitalist, mean (SD)6.9 (4.5)4.3 (3.1)7.2 (4.6)
Years in current practice, mean (SD)5.1 (3.9)0.9 (0.3)6.7 (3.8)
Specialty training, n (%)   
Internal medicine555 (68)75 (73)480 (67)
Pediatrics117 (14)8 (8)109 (15.3)
Family medicine49 (6)7 (7)42 (6)
Other95 (11)13 (13)82 (12)

Job fit was highly skewed toward optimum fit, with a mean of 4.3 on a scale of 1 to 5, with a narrow standard deviation of 0.7. The poorest job fit was reported by 0.3%, whereas optimal fit was reported by 21% of respondents. Job fit plotted against years in current practice had a logarithmic appearance typical of learning curves (Figure 1). An inflection point was visualized at around 2 years. For the purposes of this article, we refer to hospitalists' experience in the first 2 years of a job as an assimilation period, which is marked by a steep increase in job fit early when rapid learning or attrition took place. The years beyond the inflection point are characterized as an advancement period, when a more attenuated rise in job fit was experienced with time. The Spearman correlation between job fit and years in practice during the advancement period was 0.145 (n = 678, P < 0.001). Panel B of Table 1 displays the characteristics of respondents separately for the assimilation and advancement cohorts. Assimilation hospitalists in our sample had a mean age of 41.9 years and mean on‐the‐job experience of 4.3 years, reflecting that many hospitalists in the first 2 years of a job have made at least 1 job change in the past.

Figure 1
Graph of hospitalist‐job fit (minimum 1, maximum 5) by years of completed practice in current hospitalist job.

To show the effects of attrition and reselection, we first evaluated the proposition that hospitalists experience attrition (ie, intend to leave their jobs) in response to poor fit. Table 2 shows the correlations between job fit and the self‐reported intent to leave practice or reduce workload separately for the assimilation and advancement periods. For hospitalists in the assimilation period, job fit was negatively correlated with intent to leave current practice within 2 years and to leave hospital medicine within 5 years (P = 0.010 and 0.043, respectively). Hospitalists with <2 years in their current job, therefore, tended to consider attrition but not workload reduction to deal with poor job fit. On the other hand, hospitalists in the advancement period considered both attrition and workload reduction strategies in response to poor fit (all P < 0.001).

Spearman Correlations Between Hospitalist‐Job Fit (1 Worst Fit, 5 Best Fit) and Intent to Leave or Reduce Workload (1 Not Likely at All, 4 Very Likely) Adjusted for Gender
 Assimilation Period HospitalistsAdvancement Period Hospitalists
RhoP ValueRhoP Value
Likelihood that a hospitalist will:    
Leave current practice within 2 years0.2530.0100.367<0.001
Decrease total work hours within 5 years0.0600.5480.179<0.001
Decrease clinical work hours within 5 years0.0720.4690.144<0.001
Leave hospital medicine within 5 years0.2000.0430.231<0.001
Leave direct patient care within 5 years0.0400.6910.212<0.001

In Table 3, we further compared the median job fit across categories for the number of job switches. The median job fit during the assimilation period of hospitalists who had made 1 job change was slightly but statistically higher than the job fit of their counterparts who never left their first job (4.4 vs 4.0, P = 0.046). This suggests that job switching by hospitalists early in their jobs is associated with improved job fit (H1). However, the fit during the assimilation period of hospitalists who switched jobs twice or more was statistically no different from the fit of those in their first jobs, suggesting that the effect of the attrition‐reselection strategy is weak or inconsistent. The job fit for advancement period hospitalists was also different across the job change and no‐change categories. However, in the case of hospitalists later in their jobs, the median job fit was slightly but statistically lower among those who made job changes, revealing the potential drop in job fit that occurs when a hospitalist already established in his or her job starts over again in a new setting.

Relative Job Fit During the Assimilation and Advancement Periods Comparing Hospitalists Who Made Job Changes to Those Who Did Not
 nAge, Mean (95% CI), yHospitalist‐Job Fit, Median (IQR)P Valuea
  • NOTE: Abbreviations: CI, confidence interval; IQR, interquartile range.
  • Indicates P value of the deviation from the hospitalist‐job fit reference value
  • Eight item nonrespondents.
  • Forty‐one item nonrespondents.
Assimilation period hospitalistsb
No job change2942.3 (37.347.3)4.0 (3.84.4)Reference
1 job change3940.3 (38.142.5)4.4 (4.04.8)0.046
2 or more job changes2743.8 (41.046.6)4.4 (3.84.8)0.153
Advancement period hospitalistsc
No job change39044.5 (43.645.5)4.6 (4.05.0)Reference
1 job change18345.0 (43.746.3)4.2 (4.04.8)0.002
2 or more job changes9944.9 (43.146.6)4.2 (3.84.8)0.002

We hypothesized that hospitalists who achieved high job fit within a particular job were more likely to have engaged in activities that utilize a wider spectrum of their abilities. As shown in Table 4, hospitalists in the highest quartile of job fit were associated with a general trend toward higher odds of participating in a variety of common clinical and nonclinical hospitalist activities, but only the odds ratio associated with teaching achieved statistical significance (OR: 1.53, 95% CI: 1.01‐2.31) (H2).

Odds Ratio of Indicating Participation in Various Clinical and Nonclinical Activities Between the Highest Quartile and the Lower 3 Quartiles of Hospitalist‐Job Fit Adjusted for Years in Current Practice, Practice Model, and Specialty Training
 Participation, n/N (%)Odds Ratio (95% CI)P Value
  • NOTE: Abbreviations: CI, confidence interval.
Administrative or committee work704/816 (86)0.73 (0.431.26)0.262
Quality improvement or patient safety initiatives678/816 (83)1.13 (0.642.00)0.680
Information technology design or implementation379/816 (46)1.18 (0.801.73)0.408
Any of the above leadership activities758/816 (93)1.31 (0.563.05)0.535
Teaching442/816 (54)1.53 (1.012.31)0.046
Research120/816 (15)1.07 (0.601.92)0.816
Any of the above academic activities457/816 (56)1.50 (0.992.27)0.057
Code team or rapid response team437/816 (54)1.13 (0.771.68)0.533
Intensive care unit254/816 (31)0.84 (0.531.35)0.469
Skilled nursing facility or long‐term acute care facility126/816 (15)1.06 (0.621.81)0.835
Outpatient general medical practice44/816 (5)1.75 (0.813.80)0.157
Any of the above clinical activities681/816 (79)1.02 (0.601.76)0.930

Socialization with peers and the gradual sharing of values within organizations are hypothesized mechanisms for increasing job fit with time. We found that the number of years in current practice was positively correlated with job fit (Spearman coefficient R = 0.149, P < 0.001), organizational climate (R = 0.128, P < 0.001), and relationship with nonphysician staff (R = 0.102, P < 0.01). The association between years in practice and relationship with physician colleagues were weaker (R = 0.079, P < 0.05). Consistent with the episodic nature of patients' encounters with hospitalists, the measure of patient relationships was not significantly associated with length of time in job. In addition, we found substantial correlations among job fit, organizational climate, and all the relational measures (all R > 0.280, P < 0.001), indicating that hospitalists increasingly share the values of their organizations over time (H3).

Finally, we also hypothesized that poor job fit is associated with poor performance and quality of work life. Strong correlations with job fit were noted for stress (R = 0.307, P < 0.001), job burnout (R = 0.360, P < 0.001), and job satisfaction (R = 0.570, P < 0.001). Job fit (R = 0.147, P < 0.001), job burnout (R = 0.236, P < 0.001), stress (R = 0.305, P < 0.001), and job satisfaction (R = 0.224, P < 0.001) were all significantly correlated with the frequency of participating in suboptimal care (H4).

DISCUSSION

In this exploratory analysis, we validated in the hospitalist workforce several assumptions about person‐job fit that have been observed in workers of other industries. We observed attrition‐reselection (ie, job switching) as a strategy used by physicians to achieve better fit early in their job tenure, whereas job modification appeared to be more effective than attrition‐reselection among physicians already established in their jobs. We provided weak but plausible evidence that physicians with optimal job fit had a tendency to participate in activities (eg, teaching) that engage a wider set of interests and abilities. We also demonstrated the growth in hospitalists sharing the values of their organization through the time‐dependent associations among organizational climate, relational measures, and job fit. Finally, we found that physicians with suboptimal job fit were more likely to report poor performance in their work compared to those indicating optimal fit.

Our previous analysis of data from the Hospital Medicine Physician Worklife Survey exposed the widely variable work characteristics of hospitalist jobs in the US market and the equally variable preferences and priorities of individual hospitalists in selecting their work setting.[7] The implication of our present study is that hospitalists achieve the high levels of observed job fit using various strategies that aid their alignment with their employment. One of these strategies involves time, but physician longevity in practice may be both a determinant and product of good job fit. Although early job attrition may be necessary for fitting the right hospitalists to the right jobs, employers may appreciate the importance of retaining experienced hospitalists not only for cost and performance considerations but also for the growth of social capital in organizations consisting of enduring individuals. As our data suggest that hospitalists grow with their jobs, physicians may experience better fit with jobs that flexibly couple their work demands with benefits that address their individual work‐life needs over time. Another implication of this study is that job fit is a useful and predictive measure of job selection, performance, and retention. In light of studies that expose the limitations of job satisfaction as a measure influenced more by workers' dispositional affect (ie, their temperament and outlook) than their compatibility with their jobs,[28] job fit may add a functional dimension to traditional employee feedback measures.

There are limitations to this analysis. The most notable is the low survey response rate. Two reasons contributed to the fairly low rate of return. First, the original sampling frame included many outdated addresses and names of individuals who did not meet inclusion criteria. Although all sampled individuals who would have been excluded from the study could not be identified, we calculated our response rate without accounting for the proportion of potential ineligibles in the denominator population [Response Rate 2 (RR2) according to standards of the American Association of Public Opinion Research].[29] Second, the response rates of physician surveys have seen a steady decline over the years.[30] Respondents to our survey may be older and more experienced than US hospitalists in general. Although concerns about bias from under‐reporting cannot be fully addressed, we believe that the study sample is adequate for this preliminary study intended to translate the evidence of observed phenomena from the nonphysician to the physician workforces. The suboptimal response characteristics (high skew and low variability) of the generic person‐job fit survey scale used in this study indicate that a reliable survey instrument specifically designed to measure physician‐job fit need to be constructed de novo and validated for any future study. Although we performed simple analyses to support our assertions, few of our subanalyses may be underpowered, contributing to overinterpretation of the data. Additional empirical work is also necessary to assess the generalizability of this study's claims in other medical and surgical specialties. Such studies would also allow measurement of the sensitivity and specificity of physicians' self‐identification of poor job fit. Finally, additional investigations of this time‐dependent construct are more appropriately performed using a longitudinal study design to overcome the limitations inherent in this cross‐sectional analysis. Our conclusions about the time‐dependent features of job fit may be explained by other characteristics such as generational and cultural differences among hospitalists with varying experience.

As the US healthcare system reorganizes to bolster accountability,[31] we anticipate increasing interdependence between physicians and their employer organizations. Ultimately, the desired accountability in healthcare is likely to be obtained if physicians function not only as passive and interchangeable employees but as active stakeholders in the achievement of each organization's goals. A methodology for assessing the alignment of physicians and their jobs will continue to be important along the way.

Disclosure

Nothing to report.

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References
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Person‐organization fit concerns the conditions and consequences of compatibility between people and the organizations for which they work.[1] Studies of other industries have demonstrated that person‐organization fit informs the way individuals join, perform in, and are retained by organizations.[2] Person‐job fit is a closely related subordinate concept that concerns the alignment of workers and their job in as much as workers have needs that their job supplies, or conversely, jobs have requirements that certain workers' abilities can help meet.[3] Explorations of job fit in physicians and their work have recently emerged in a few investigations published in medical journals.[4, 5, 6, 7, 8] Further expanding the understanding of fit between physicians and their employment is important, because the decline of solo practices and recent emphasis on team‐based care have led to a growing number of US physicians working in organizations.[9]

The movement of physicians into employed situations may continue if certain types of Accountable Care Organizations take root.[10] And physicians may be primed to join employer organizations based on current career priorities of individuals in American society. Surveys of medical residents entering the workforce reveal more physicians preferring the security of being employees than starting their own practices.[11] Given these trends, job fit will inform our understanding of how personal and job characteristics facilitate recruitment, performance, satisfaction, and longevity of physician employees.

BACKGROUND

Virtually all hospitalists work in organizationshospitalsand are employees of hospitals, medical schools, physician group practices, or management companies, and therefore invariably function within organizational structures and systems.[7] In spite of their rapid growth in numbers, many employers have faced difficulties recruiting and retaining enough hospitalists to fill their staffing needs. Consequently, the US hospitalist workforce today is characterized by high salaries, work load, and attrition rates.[12]

In this evolving unsaturated market, the attraction‐selection‐attrition framework[13] provides a theoretical construct that predicts that hospitalists and their employers would seek congruence of goals and values early in their relationship through a process of trial and error. This framework assumes that early interactions between workers and organizations serve as opportunities for them to understand if job fit is poor and dissociate or remain affiliated as long as job fit is mutually acceptable. Therefore, job switching on average is expected to increase job fit because workers and organizations gain a better understanding of their own goals and values and choose more wisely the next time.

Other theoretical frameworks, such as the job characteristic model,[14] suggest that over time as workers stay at the same job, they continue to maintain and improve job fit through various workplace‐ or self‐modification strategies. For example, seniority status may have privileges (eg, less undesirable call), or workers may create privileged niches through the acquisition of new skills and abilities over time. Hospitalists' tendency to diversify their work‐related activities by incorporating administrative and teaching responsibilities[15] may thus contribute to improving job fit. Additionally, as a measure of complementarity among people who work together, job fit may be influenced by the quality of relationships among hospitalists and their coworkers through their reorientation to the prevailing organizational climate[16, 17] and increasing socialization.[18] Finally, given that experiential learning is known to contribute to better hospitalist work performance,[19] job fit may affect productivity and clinical outcomes vis‐‐vis quality of work life.

To test the validity of these assumptions in a sample of hospitalists, we critically appraised the following 4 hypotheses:

  • Hypothesis 1 (H1): Job attrition and reselection improves job fit among hospitalists entering the job market.
  • Hypothesis 2 (H2): Better job fit is achieved through hospitalists engaging a variety of personal skills and abilities.
  • Hypothesis 3 (H3): Job fit increases with hospitalists' job duration together with socialization and internalization of organizational values.
  • Hypothesis 4 (H4): Job fit is correlated with hospitalists' quality of work life.

 

METHODS

Analysis was performed on data from the 2009 to 2010 Hospital Medicine Physician Worklife Survey. The sample frame included nonmembers and members of Society of Hospital Medicine (SHM). Details about sampling strategy, data collection, and data quality are available in previous publications.[7, 20] The 118‐item survey instrument, including 9 demographic items and 24 practice and job characteristic items, was administered by mail. Examples of information solicited through these items included respondents' practice model, the number of hospitalist jobs they have held, and the specific kinds of clinical and nonclinical activities they performed as part of their current job.

We used a reliable but broad and generic measure of self‐perceived person‐job fit.[21] The survey items of the 5‐point Likert‐type scale anchored between strongly disagree and strongly agree were: I feel that my work utilizes my full abilities, I feel competent and fully able to handle my job, my job gives me the chance to do the things I feel I do best, I feel that my job and I are well‐matched, I feel I have adequate preparation for the job I now hold. The quality of hospitalists' relationships with physician colleagues, staff, and patients as well as job satisfaction was measured using scales adapted from the Physician Worklife Study.[22] Organizational climate was measured using an adapted scale from the Minimizing Error, Maximizing Outcome study incorporating 3 items from the cohesiveness subscale, 4 items from the organizational trust subscale, and 1 item from the quality emphasis subscale that were most pertinent to hospitalists' relationship with their organizations.[23] Intent to leave practice or reduce work hours was measured using 5 items from the Multi‐Center Hospitalist Survey Project.[24] Frequency of participation in suboptimal patient care was measured by adapting 3 items from the suboptimal reported practice subscale and 2 items from the suboptimal patient care subscale developed by Shanafelt et al.[25] Stress and job burnout were assessed using validated measures.[26, 27] Detailed descriptions of the response rate calculation and imputation of missing item data are available in previous publications.[7, 20]

Mean, variance, range, and skew were used to characterize the responses to the job fit survey scale. A table of respondent characteristics was constructed. A visual representation of job fit by individual hospitalist year in current practice was created, first, by plotting a locally weighted scatterplot smoothing curve to examine the shape of the general relationship, and second, by fitting a similarly contoured functional polynomial curve with 95% confidence intervals (CI) to a plot of the mean and interquartile range of job fit for each year in current practice. Spearman partial correlations were calculated for job fit and each of the 5 items addressing likelihood of leaving practice or reducing workload adjusted for gender to control for the higher proportion of women who plan to work part time. Median (interquartile range) job fit was calculated for categories defined by the number of job changes and compared with the reference category (no job change) using the nonparametric rank sum test for comparing non‐normally distributed data. Multivariate logistic regression models were used to calculate the odds ratio (OR) of participating in each of several clinical and nonclinical hospitalist activities between respondents whose job fit score was optimal (5 on a 5‐point scale) and less than optimal controlling for covariates that influence the likelihood of participating in these activities (years in current practice, practice model, and specialty training). A Spearman correlation matrix was created to assess interscale correlations among organizational parameters (years in current practice, job fit, organizational climate, and relationship with colleagues, staff, and patients). Finally, a separate Spearman correlation matrix was created to assess the interscale correlations among individual worker parameters (job fit, suboptimal patient care, job burnout, stress, and job satisfaction). Statistical significance was defined as P value <0.05, and all analyses were performed on Stata 11.0 (StataCorp, College Station, TX). The Northwestern University institutional review board approved this study.

RESULTS

Respondents included 816 hospitalists belonging to around 700 unique organizations. The adjusted response rate from the stratified sample was 26%. Respondents and nonrespondents were similar with regard to geographic region and model of practice, but respondents were more likely to be members of the SHM than nonrespondents. Panel A of Table 1 shows the demographic characteristics of the respondents. The mean age was 44.3 years, and about one‐third were women. The average hospitalist had about 7 years of experience in the specialty and about 5 years with their current hospitalist job. The majority were trained in internal medicine or one of its subspecialties, whereas pediatricians, family physicians, and physicians with other training made up the remainder.

Characteristics of Respondent Hospitalists
 Panel APanel B
 TotalAssimilation Period HospitalistsAdvancement Period Hospitalists
  • NOTE: Abbreviations: SD, standard deviation.
Total, n816103713
Female, n (%)284 (35)37 (36)247 (35)
Age, mean (SD)44.3 (9.0)41.9 (9.3)44.7 (8.9)
Years postresidency experience as hospitalist, mean (SD)6.9 (4.5)4.3 (3.1)7.2 (4.6)
Years in current practice, mean (SD)5.1 (3.9)0.9 (0.3)6.7 (3.8)
Specialty training, n (%)   
Internal medicine555 (68)75 (73)480 (67)
Pediatrics117 (14)8 (8)109 (15.3)
Family medicine49 (6)7 (7)42 (6)
Other95 (11)13 (13)82 (12)

Job fit was highly skewed toward optimum fit, with a mean of 4.3 on a scale of 1 to 5, with a narrow standard deviation of 0.7. The poorest job fit was reported by 0.3%, whereas optimal fit was reported by 21% of respondents. Job fit plotted against years in current practice had a logarithmic appearance typical of learning curves (Figure 1). An inflection point was visualized at around 2 years. For the purposes of this article, we refer to hospitalists' experience in the first 2 years of a job as an assimilation period, which is marked by a steep increase in job fit early when rapid learning or attrition took place. The years beyond the inflection point are characterized as an advancement period, when a more attenuated rise in job fit was experienced with time. The Spearman correlation between job fit and years in practice during the advancement period was 0.145 (n = 678, P < 0.001). Panel B of Table 1 displays the characteristics of respondents separately for the assimilation and advancement cohorts. Assimilation hospitalists in our sample had a mean age of 41.9 years and mean on‐the‐job experience of 4.3 years, reflecting that many hospitalists in the first 2 years of a job have made at least 1 job change in the past.

Figure 1
Graph of hospitalist‐job fit (minimum 1, maximum 5) by years of completed practice in current hospitalist job.

To show the effects of attrition and reselection, we first evaluated the proposition that hospitalists experience attrition (ie, intend to leave their jobs) in response to poor fit. Table 2 shows the correlations between job fit and the self‐reported intent to leave practice or reduce workload separately for the assimilation and advancement periods. For hospitalists in the assimilation period, job fit was negatively correlated with intent to leave current practice within 2 years and to leave hospital medicine within 5 years (P = 0.010 and 0.043, respectively). Hospitalists with <2 years in their current job, therefore, tended to consider attrition but not workload reduction to deal with poor job fit. On the other hand, hospitalists in the advancement period considered both attrition and workload reduction strategies in response to poor fit (all P < 0.001).

Spearman Correlations Between Hospitalist‐Job Fit (1 Worst Fit, 5 Best Fit) and Intent to Leave or Reduce Workload (1 Not Likely at All, 4 Very Likely) Adjusted for Gender
 Assimilation Period HospitalistsAdvancement Period Hospitalists
RhoP ValueRhoP Value
Likelihood that a hospitalist will:    
Leave current practice within 2 years0.2530.0100.367<0.001
Decrease total work hours within 5 years0.0600.5480.179<0.001
Decrease clinical work hours within 5 years0.0720.4690.144<0.001
Leave hospital medicine within 5 years0.2000.0430.231<0.001
Leave direct patient care within 5 years0.0400.6910.212<0.001

In Table 3, we further compared the median job fit across categories for the number of job switches. The median job fit during the assimilation period of hospitalists who had made 1 job change was slightly but statistically higher than the job fit of their counterparts who never left their first job (4.4 vs 4.0, P = 0.046). This suggests that job switching by hospitalists early in their jobs is associated with improved job fit (H1). However, the fit during the assimilation period of hospitalists who switched jobs twice or more was statistically no different from the fit of those in their first jobs, suggesting that the effect of the attrition‐reselection strategy is weak or inconsistent. The job fit for advancement period hospitalists was also different across the job change and no‐change categories. However, in the case of hospitalists later in their jobs, the median job fit was slightly but statistically lower among those who made job changes, revealing the potential drop in job fit that occurs when a hospitalist already established in his or her job starts over again in a new setting.

Relative Job Fit During the Assimilation and Advancement Periods Comparing Hospitalists Who Made Job Changes to Those Who Did Not
 nAge, Mean (95% CI), yHospitalist‐Job Fit, Median (IQR)P Valuea
  • NOTE: Abbreviations: CI, confidence interval; IQR, interquartile range.
  • Indicates P value of the deviation from the hospitalist‐job fit reference value
  • Eight item nonrespondents.
  • Forty‐one item nonrespondents.
Assimilation period hospitalistsb
No job change2942.3 (37.347.3)4.0 (3.84.4)Reference
1 job change3940.3 (38.142.5)4.4 (4.04.8)0.046
2 or more job changes2743.8 (41.046.6)4.4 (3.84.8)0.153
Advancement period hospitalistsc
No job change39044.5 (43.645.5)4.6 (4.05.0)Reference
1 job change18345.0 (43.746.3)4.2 (4.04.8)0.002
2 or more job changes9944.9 (43.146.6)4.2 (3.84.8)0.002

We hypothesized that hospitalists who achieved high job fit within a particular job were more likely to have engaged in activities that utilize a wider spectrum of their abilities. As shown in Table 4, hospitalists in the highest quartile of job fit were associated with a general trend toward higher odds of participating in a variety of common clinical and nonclinical hospitalist activities, but only the odds ratio associated with teaching achieved statistical significance (OR: 1.53, 95% CI: 1.01‐2.31) (H2).

Odds Ratio of Indicating Participation in Various Clinical and Nonclinical Activities Between the Highest Quartile and the Lower 3 Quartiles of Hospitalist‐Job Fit Adjusted for Years in Current Practice, Practice Model, and Specialty Training
 Participation, n/N (%)Odds Ratio (95% CI)P Value
  • NOTE: Abbreviations: CI, confidence interval.
Administrative or committee work704/816 (86)0.73 (0.431.26)0.262
Quality improvement or patient safety initiatives678/816 (83)1.13 (0.642.00)0.680
Information technology design or implementation379/816 (46)1.18 (0.801.73)0.408
Any of the above leadership activities758/816 (93)1.31 (0.563.05)0.535
Teaching442/816 (54)1.53 (1.012.31)0.046
Research120/816 (15)1.07 (0.601.92)0.816
Any of the above academic activities457/816 (56)1.50 (0.992.27)0.057
Code team or rapid response team437/816 (54)1.13 (0.771.68)0.533
Intensive care unit254/816 (31)0.84 (0.531.35)0.469
Skilled nursing facility or long‐term acute care facility126/816 (15)1.06 (0.621.81)0.835
Outpatient general medical practice44/816 (5)1.75 (0.813.80)0.157
Any of the above clinical activities681/816 (79)1.02 (0.601.76)0.930

Socialization with peers and the gradual sharing of values within organizations are hypothesized mechanisms for increasing job fit with time. We found that the number of years in current practice was positively correlated with job fit (Spearman coefficient R = 0.149, P < 0.001), organizational climate (R = 0.128, P < 0.001), and relationship with nonphysician staff (R = 0.102, P < 0.01). The association between years in practice and relationship with physician colleagues were weaker (R = 0.079, P < 0.05). Consistent with the episodic nature of patients' encounters with hospitalists, the measure of patient relationships was not significantly associated with length of time in job. In addition, we found substantial correlations among job fit, organizational climate, and all the relational measures (all R > 0.280, P < 0.001), indicating that hospitalists increasingly share the values of their organizations over time (H3).

Finally, we also hypothesized that poor job fit is associated with poor performance and quality of work life. Strong correlations with job fit were noted for stress (R = 0.307, P < 0.001), job burnout (R = 0.360, P < 0.001), and job satisfaction (R = 0.570, P < 0.001). Job fit (R = 0.147, P < 0.001), job burnout (R = 0.236, P < 0.001), stress (R = 0.305, P < 0.001), and job satisfaction (R = 0.224, P < 0.001) were all significantly correlated with the frequency of participating in suboptimal care (H4).

DISCUSSION

In this exploratory analysis, we validated in the hospitalist workforce several assumptions about person‐job fit that have been observed in workers of other industries. We observed attrition‐reselection (ie, job switching) as a strategy used by physicians to achieve better fit early in their job tenure, whereas job modification appeared to be more effective than attrition‐reselection among physicians already established in their jobs. We provided weak but plausible evidence that physicians with optimal job fit had a tendency to participate in activities (eg, teaching) that engage a wider set of interests and abilities. We also demonstrated the growth in hospitalists sharing the values of their organization through the time‐dependent associations among organizational climate, relational measures, and job fit. Finally, we found that physicians with suboptimal job fit were more likely to report poor performance in their work compared to those indicating optimal fit.

Our previous analysis of data from the Hospital Medicine Physician Worklife Survey exposed the widely variable work characteristics of hospitalist jobs in the US market and the equally variable preferences and priorities of individual hospitalists in selecting their work setting.[7] The implication of our present study is that hospitalists achieve the high levels of observed job fit using various strategies that aid their alignment with their employment. One of these strategies involves time, but physician longevity in practice may be both a determinant and product of good job fit. Although early job attrition may be necessary for fitting the right hospitalists to the right jobs, employers may appreciate the importance of retaining experienced hospitalists not only for cost and performance considerations but also for the growth of social capital in organizations consisting of enduring individuals. As our data suggest that hospitalists grow with their jobs, physicians may experience better fit with jobs that flexibly couple their work demands with benefits that address their individual work‐life needs over time. Another implication of this study is that job fit is a useful and predictive measure of job selection, performance, and retention. In light of studies that expose the limitations of job satisfaction as a measure influenced more by workers' dispositional affect (ie, their temperament and outlook) than their compatibility with their jobs,[28] job fit may add a functional dimension to traditional employee feedback measures.

There are limitations to this analysis. The most notable is the low survey response rate. Two reasons contributed to the fairly low rate of return. First, the original sampling frame included many outdated addresses and names of individuals who did not meet inclusion criteria. Although all sampled individuals who would have been excluded from the study could not be identified, we calculated our response rate without accounting for the proportion of potential ineligibles in the denominator population [Response Rate 2 (RR2) according to standards of the American Association of Public Opinion Research].[29] Second, the response rates of physician surveys have seen a steady decline over the years.[30] Respondents to our survey may be older and more experienced than US hospitalists in general. Although concerns about bias from under‐reporting cannot be fully addressed, we believe that the study sample is adequate for this preliminary study intended to translate the evidence of observed phenomena from the nonphysician to the physician workforces. The suboptimal response characteristics (high skew and low variability) of the generic person‐job fit survey scale used in this study indicate that a reliable survey instrument specifically designed to measure physician‐job fit need to be constructed de novo and validated for any future study. Although we performed simple analyses to support our assertions, few of our subanalyses may be underpowered, contributing to overinterpretation of the data. Additional empirical work is also necessary to assess the generalizability of this study's claims in other medical and surgical specialties. Such studies would also allow measurement of the sensitivity and specificity of physicians' self‐identification of poor job fit. Finally, additional investigations of this time‐dependent construct are more appropriately performed using a longitudinal study design to overcome the limitations inherent in this cross‐sectional analysis. Our conclusions about the time‐dependent features of job fit may be explained by other characteristics such as generational and cultural differences among hospitalists with varying experience.

As the US healthcare system reorganizes to bolster accountability,[31] we anticipate increasing interdependence between physicians and their employer organizations. Ultimately, the desired accountability in healthcare is likely to be obtained if physicians function not only as passive and interchangeable employees but as active stakeholders in the achievement of each organization's goals. A methodology for assessing the alignment of physicians and their jobs will continue to be important along the way.

Disclosure

Nothing to report.

Person‐organization fit concerns the conditions and consequences of compatibility between people and the organizations for which they work.[1] Studies of other industries have demonstrated that person‐organization fit informs the way individuals join, perform in, and are retained by organizations.[2] Person‐job fit is a closely related subordinate concept that concerns the alignment of workers and their job in as much as workers have needs that their job supplies, or conversely, jobs have requirements that certain workers' abilities can help meet.[3] Explorations of job fit in physicians and their work have recently emerged in a few investigations published in medical journals.[4, 5, 6, 7, 8] Further expanding the understanding of fit between physicians and their employment is important, because the decline of solo practices and recent emphasis on team‐based care have led to a growing number of US physicians working in organizations.[9]

The movement of physicians into employed situations may continue if certain types of Accountable Care Organizations take root.[10] And physicians may be primed to join employer organizations based on current career priorities of individuals in American society. Surveys of medical residents entering the workforce reveal more physicians preferring the security of being employees than starting their own practices.[11] Given these trends, job fit will inform our understanding of how personal and job characteristics facilitate recruitment, performance, satisfaction, and longevity of physician employees.

BACKGROUND

Virtually all hospitalists work in organizationshospitalsand are employees of hospitals, medical schools, physician group practices, or management companies, and therefore invariably function within organizational structures and systems.[7] In spite of their rapid growth in numbers, many employers have faced difficulties recruiting and retaining enough hospitalists to fill their staffing needs. Consequently, the US hospitalist workforce today is characterized by high salaries, work load, and attrition rates.[12]

In this evolving unsaturated market, the attraction‐selection‐attrition framework[13] provides a theoretical construct that predicts that hospitalists and their employers would seek congruence of goals and values early in their relationship through a process of trial and error. This framework assumes that early interactions between workers and organizations serve as opportunities for them to understand if job fit is poor and dissociate or remain affiliated as long as job fit is mutually acceptable. Therefore, job switching on average is expected to increase job fit because workers and organizations gain a better understanding of their own goals and values and choose more wisely the next time.

Other theoretical frameworks, such as the job characteristic model,[14] suggest that over time as workers stay at the same job, they continue to maintain and improve job fit through various workplace‐ or self‐modification strategies. For example, seniority status may have privileges (eg, less undesirable call), or workers may create privileged niches through the acquisition of new skills and abilities over time. Hospitalists' tendency to diversify their work‐related activities by incorporating administrative and teaching responsibilities[15] may thus contribute to improving job fit. Additionally, as a measure of complementarity among people who work together, job fit may be influenced by the quality of relationships among hospitalists and their coworkers through their reorientation to the prevailing organizational climate[16, 17] and increasing socialization.[18] Finally, given that experiential learning is known to contribute to better hospitalist work performance,[19] job fit may affect productivity and clinical outcomes vis‐‐vis quality of work life.

To test the validity of these assumptions in a sample of hospitalists, we critically appraised the following 4 hypotheses:

  • Hypothesis 1 (H1): Job attrition and reselection improves job fit among hospitalists entering the job market.
  • Hypothesis 2 (H2): Better job fit is achieved through hospitalists engaging a variety of personal skills and abilities.
  • Hypothesis 3 (H3): Job fit increases with hospitalists' job duration together with socialization and internalization of organizational values.
  • Hypothesis 4 (H4): Job fit is correlated with hospitalists' quality of work life.

 

METHODS

Analysis was performed on data from the 2009 to 2010 Hospital Medicine Physician Worklife Survey. The sample frame included nonmembers and members of Society of Hospital Medicine (SHM). Details about sampling strategy, data collection, and data quality are available in previous publications.[7, 20] The 118‐item survey instrument, including 9 demographic items and 24 practice and job characteristic items, was administered by mail. Examples of information solicited through these items included respondents' practice model, the number of hospitalist jobs they have held, and the specific kinds of clinical and nonclinical activities they performed as part of their current job.

We used a reliable but broad and generic measure of self‐perceived person‐job fit.[21] The survey items of the 5‐point Likert‐type scale anchored between strongly disagree and strongly agree were: I feel that my work utilizes my full abilities, I feel competent and fully able to handle my job, my job gives me the chance to do the things I feel I do best, I feel that my job and I are well‐matched, I feel I have adequate preparation for the job I now hold. The quality of hospitalists' relationships with physician colleagues, staff, and patients as well as job satisfaction was measured using scales adapted from the Physician Worklife Study.[22] Organizational climate was measured using an adapted scale from the Minimizing Error, Maximizing Outcome study incorporating 3 items from the cohesiveness subscale, 4 items from the organizational trust subscale, and 1 item from the quality emphasis subscale that were most pertinent to hospitalists' relationship with their organizations.[23] Intent to leave practice or reduce work hours was measured using 5 items from the Multi‐Center Hospitalist Survey Project.[24] Frequency of participation in suboptimal patient care was measured by adapting 3 items from the suboptimal reported practice subscale and 2 items from the suboptimal patient care subscale developed by Shanafelt et al.[25] Stress and job burnout were assessed using validated measures.[26, 27] Detailed descriptions of the response rate calculation and imputation of missing item data are available in previous publications.[7, 20]

Mean, variance, range, and skew were used to characterize the responses to the job fit survey scale. A table of respondent characteristics was constructed. A visual representation of job fit by individual hospitalist year in current practice was created, first, by plotting a locally weighted scatterplot smoothing curve to examine the shape of the general relationship, and second, by fitting a similarly contoured functional polynomial curve with 95% confidence intervals (CI) to a plot of the mean and interquartile range of job fit for each year in current practice. Spearman partial correlations were calculated for job fit and each of the 5 items addressing likelihood of leaving practice or reducing workload adjusted for gender to control for the higher proportion of women who plan to work part time. Median (interquartile range) job fit was calculated for categories defined by the number of job changes and compared with the reference category (no job change) using the nonparametric rank sum test for comparing non‐normally distributed data. Multivariate logistic regression models were used to calculate the odds ratio (OR) of participating in each of several clinical and nonclinical hospitalist activities between respondents whose job fit score was optimal (5 on a 5‐point scale) and less than optimal controlling for covariates that influence the likelihood of participating in these activities (years in current practice, practice model, and specialty training). A Spearman correlation matrix was created to assess interscale correlations among organizational parameters (years in current practice, job fit, organizational climate, and relationship with colleagues, staff, and patients). Finally, a separate Spearman correlation matrix was created to assess the interscale correlations among individual worker parameters (job fit, suboptimal patient care, job burnout, stress, and job satisfaction). Statistical significance was defined as P value <0.05, and all analyses were performed on Stata 11.0 (StataCorp, College Station, TX). The Northwestern University institutional review board approved this study.

RESULTS

Respondents included 816 hospitalists belonging to around 700 unique organizations. The adjusted response rate from the stratified sample was 26%. Respondents and nonrespondents were similar with regard to geographic region and model of practice, but respondents were more likely to be members of the SHM than nonrespondents. Panel A of Table 1 shows the demographic characteristics of the respondents. The mean age was 44.3 years, and about one‐third were women. The average hospitalist had about 7 years of experience in the specialty and about 5 years with their current hospitalist job. The majority were trained in internal medicine or one of its subspecialties, whereas pediatricians, family physicians, and physicians with other training made up the remainder.

Characteristics of Respondent Hospitalists
 Panel APanel B
 TotalAssimilation Period HospitalistsAdvancement Period Hospitalists
  • NOTE: Abbreviations: SD, standard deviation.
Total, n816103713
Female, n (%)284 (35)37 (36)247 (35)
Age, mean (SD)44.3 (9.0)41.9 (9.3)44.7 (8.9)
Years postresidency experience as hospitalist, mean (SD)6.9 (4.5)4.3 (3.1)7.2 (4.6)
Years in current practice, mean (SD)5.1 (3.9)0.9 (0.3)6.7 (3.8)
Specialty training, n (%)   
Internal medicine555 (68)75 (73)480 (67)
Pediatrics117 (14)8 (8)109 (15.3)
Family medicine49 (6)7 (7)42 (6)
Other95 (11)13 (13)82 (12)

Job fit was highly skewed toward optimum fit, with a mean of 4.3 on a scale of 1 to 5, with a narrow standard deviation of 0.7. The poorest job fit was reported by 0.3%, whereas optimal fit was reported by 21% of respondents. Job fit plotted against years in current practice had a logarithmic appearance typical of learning curves (Figure 1). An inflection point was visualized at around 2 years. For the purposes of this article, we refer to hospitalists' experience in the first 2 years of a job as an assimilation period, which is marked by a steep increase in job fit early when rapid learning or attrition took place. The years beyond the inflection point are characterized as an advancement period, when a more attenuated rise in job fit was experienced with time. The Spearman correlation between job fit and years in practice during the advancement period was 0.145 (n = 678, P < 0.001). Panel B of Table 1 displays the characteristics of respondents separately for the assimilation and advancement cohorts. Assimilation hospitalists in our sample had a mean age of 41.9 years and mean on‐the‐job experience of 4.3 years, reflecting that many hospitalists in the first 2 years of a job have made at least 1 job change in the past.

Figure 1
Graph of hospitalist‐job fit (minimum 1, maximum 5) by years of completed practice in current hospitalist job.

To show the effects of attrition and reselection, we first evaluated the proposition that hospitalists experience attrition (ie, intend to leave their jobs) in response to poor fit. Table 2 shows the correlations between job fit and the self‐reported intent to leave practice or reduce workload separately for the assimilation and advancement periods. For hospitalists in the assimilation period, job fit was negatively correlated with intent to leave current practice within 2 years and to leave hospital medicine within 5 years (P = 0.010 and 0.043, respectively). Hospitalists with <2 years in their current job, therefore, tended to consider attrition but not workload reduction to deal with poor job fit. On the other hand, hospitalists in the advancement period considered both attrition and workload reduction strategies in response to poor fit (all P < 0.001).

Spearman Correlations Between Hospitalist‐Job Fit (1 Worst Fit, 5 Best Fit) and Intent to Leave or Reduce Workload (1 Not Likely at All, 4 Very Likely) Adjusted for Gender
 Assimilation Period HospitalistsAdvancement Period Hospitalists
RhoP ValueRhoP Value
Likelihood that a hospitalist will:    
Leave current practice within 2 years0.2530.0100.367<0.001
Decrease total work hours within 5 years0.0600.5480.179<0.001
Decrease clinical work hours within 5 years0.0720.4690.144<0.001
Leave hospital medicine within 5 years0.2000.0430.231<0.001
Leave direct patient care within 5 years0.0400.6910.212<0.001

In Table 3, we further compared the median job fit across categories for the number of job switches. The median job fit during the assimilation period of hospitalists who had made 1 job change was slightly but statistically higher than the job fit of their counterparts who never left their first job (4.4 vs 4.0, P = 0.046). This suggests that job switching by hospitalists early in their jobs is associated with improved job fit (H1). However, the fit during the assimilation period of hospitalists who switched jobs twice or more was statistically no different from the fit of those in their first jobs, suggesting that the effect of the attrition‐reselection strategy is weak or inconsistent. The job fit for advancement period hospitalists was also different across the job change and no‐change categories. However, in the case of hospitalists later in their jobs, the median job fit was slightly but statistically lower among those who made job changes, revealing the potential drop in job fit that occurs when a hospitalist already established in his or her job starts over again in a new setting.

Relative Job Fit During the Assimilation and Advancement Periods Comparing Hospitalists Who Made Job Changes to Those Who Did Not
 nAge, Mean (95% CI), yHospitalist‐Job Fit, Median (IQR)P Valuea
  • NOTE: Abbreviations: CI, confidence interval; IQR, interquartile range.
  • Indicates P value of the deviation from the hospitalist‐job fit reference value
  • Eight item nonrespondents.
  • Forty‐one item nonrespondents.
Assimilation period hospitalistsb
No job change2942.3 (37.347.3)4.0 (3.84.4)Reference
1 job change3940.3 (38.142.5)4.4 (4.04.8)0.046
2 or more job changes2743.8 (41.046.6)4.4 (3.84.8)0.153
Advancement period hospitalistsc
No job change39044.5 (43.645.5)4.6 (4.05.0)Reference
1 job change18345.0 (43.746.3)4.2 (4.04.8)0.002
2 or more job changes9944.9 (43.146.6)4.2 (3.84.8)0.002

We hypothesized that hospitalists who achieved high job fit within a particular job were more likely to have engaged in activities that utilize a wider spectrum of their abilities. As shown in Table 4, hospitalists in the highest quartile of job fit were associated with a general trend toward higher odds of participating in a variety of common clinical and nonclinical hospitalist activities, but only the odds ratio associated with teaching achieved statistical significance (OR: 1.53, 95% CI: 1.01‐2.31) (H2).

Odds Ratio of Indicating Participation in Various Clinical and Nonclinical Activities Between the Highest Quartile and the Lower 3 Quartiles of Hospitalist‐Job Fit Adjusted for Years in Current Practice, Practice Model, and Specialty Training
 Participation, n/N (%)Odds Ratio (95% CI)P Value
  • NOTE: Abbreviations: CI, confidence interval.
Administrative or committee work704/816 (86)0.73 (0.431.26)0.262
Quality improvement or patient safety initiatives678/816 (83)1.13 (0.642.00)0.680
Information technology design or implementation379/816 (46)1.18 (0.801.73)0.408
Any of the above leadership activities758/816 (93)1.31 (0.563.05)0.535
Teaching442/816 (54)1.53 (1.012.31)0.046
Research120/816 (15)1.07 (0.601.92)0.816
Any of the above academic activities457/816 (56)1.50 (0.992.27)0.057
Code team or rapid response team437/816 (54)1.13 (0.771.68)0.533
Intensive care unit254/816 (31)0.84 (0.531.35)0.469
Skilled nursing facility or long‐term acute care facility126/816 (15)1.06 (0.621.81)0.835
Outpatient general medical practice44/816 (5)1.75 (0.813.80)0.157
Any of the above clinical activities681/816 (79)1.02 (0.601.76)0.930

Socialization with peers and the gradual sharing of values within organizations are hypothesized mechanisms for increasing job fit with time. We found that the number of years in current practice was positively correlated with job fit (Spearman coefficient R = 0.149, P < 0.001), organizational climate (R = 0.128, P < 0.001), and relationship with nonphysician staff (R = 0.102, P < 0.01). The association between years in practice and relationship with physician colleagues were weaker (R = 0.079, P < 0.05). Consistent with the episodic nature of patients' encounters with hospitalists, the measure of patient relationships was not significantly associated with length of time in job. In addition, we found substantial correlations among job fit, organizational climate, and all the relational measures (all R > 0.280, P < 0.001), indicating that hospitalists increasingly share the values of their organizations over time (H3).

Finally, we also hypothesized that poor job fit is associated with poor performance and quality of work life. Strong correlations with job fit were noted for stress (R = 0.307, P < 0.001), job burnout (R = 0.360, P < 0.001), and job satisfaction (R = 0.570, P < 0.001). Job fit (R = 0.147, P < 0.001), job burnout (R = 0.236, P < 0.001), stress (R = 0.305, P < 0.001), and job satisfaction (R = 0.224, P < 0.001) were all significantly correlated with the frequency of participating in suboptimal care (H4).

DISCUSSION

In this exploratory analysis, we validated in the hospitalist workforce several assumptions about person‐job fit that have been observed in workers of other industries. We observed attrition‐reselection (ie, job switching) as a strategy used by physicians to achieve better fit early in their job tenure, whereas job modification appeared to be more effective than attrition‐reselection among physicians already established in their jobs. We provided weak but plausible evidence that physicians with optimal job fit had a tendency to participate in activities (eg, teaching) that engage a wider set of interests and abilities. We also demonstrated the growth in hospitalists sharing the values of their organization through the time‐dependent associations among organizational climate, relational measures, and job fit. Finally, we found that physicians with suboptimal job fit were more likely to report poor performance in their work compared to those indicating optimal fit.

Our previous analysis of data from the Hospital Medicine Physician Worklife Survey exposed the widely variable work characteristics of hospitalist jobs in the US market and the equally variable preferences and priorities of individual hospitalists in selecting their work setting.[7] The implication of our present study is that hospitalists achieve the high levels of observed job fit using various strategies that aid their alignment with their employment. One of these strategies involves time, but physician longevity in practice may be both a determinant and product of good job fit. Although early job attrition may be necessary for fitting the right hospitalists to the right jobs, employers may appreciate the importance of retaining experienced hospitalists not only for cost and performance considerations but also for the growth of social capital in organizations consisting of enduring individuals. As our data suggest that hospitalists grow with their jobs, physicians may experience better fit with jobs that flexibly couple their work demands with benefits that address their individual work‐life needs over time. Another implication of this study is that job fit is a useful and predictive measure of job selection, performance, and retention. In light of studies that expose the limitations of job satisfaction as a measure influenced more by workers' dispositional affect (ie, their temperament and outlook) than their compatibility with their jobs,[28] job fit may add a functional dimension to traditional employee feedback measures.

There are limitations to this analysis. The most notable is the low survey response rate. Two reasons contributed to the fairly low rate of return. First, the original sampling frame included many outdated addresses and names of individuals who did not meet inclusion criteria. Although all sampled individuals who would have been excluded from the study could not be identified, we calculated our response rate without accounting for the proportion of potential ineligibles in the denominator population [Response Rate 2 (RR2) according to standards of the American Association of Public Opinion Research].[29] Second, the response rates of physician surveys have seen a steady decline over the years.[30] Respondents to our survey may be older and more experienced than US hospitalists in general. Although concerns about bias from under‐reporting cannot be fully addressed, we believe that the study sample is adequate for this preliminary study intended to translate the evidence of observed phenomena from the nonphysician to the physician workforces. The suboptimal response characteristics (high skew and low variability) of the generic person‐job fit survey scale used in this study indicate that a reliable survey instrument specifically designed to measure physician‐job fit need to be constructed de novo and validated for any future study. Although we performed simple analyses to support our assertions, few of our subanalyses may be underpowered, contributing to overinterpretation of the data. Additional empirical work is also necessary to assess the generalizability of this study's claims in other medical and surgical specialties. Such studies would also allow measurement of the sensitivity and specificity of physicians' self‐identification of poor job fit. Finally, additional investigations of this time‐dependent construct are more appropriately performed using a longitudinal study design to overcome the limitations inherent in this cross‐sectional analysis. Our conclusions about the time‐dependent features of job fit may be explained by other characteristics such as generational and cultural differences among hospitalists with varying experience.

As the US healthcare system reorganizes to bolster accountability,[31] we anticipate increasing interdependence between physicians and their employer organizations. Ultimately, the desired accountability in healthcare is likely to be obtained if physicians function not only as passive and interchangeable employees but as active stakeholders in the achievement of each organization's goals. A methodology for assessing the alignment of physicians and their jobs will continue to be important along the way.

Disclosure

Nothing to report.

References
  1. Kristof AL. Person‐organization fit: an integrative review of its conceptualizations, measurement, and implications. Personnel Psychol. 1996;49:149.
  2. Kristof‐Brown AL, Zimmerman RD, Johnson EC. Consequences of individuals' fit at work: a meta‐analysis of person‐job, person‐organization, person‐group, and person‐supervisor fit. Personnel Psychol. 2005;58(2):281342.
  3. Edwards JR.Person‐job fit: a conceptual integration, literature review and methodological critique. In: Cooper CL, Robertson IT, eds. International Review of Industrial and Organizational Psychology. Vol.6. New York, NY:John Wiley 1991.
  4. Vandenberghe C. Organizational culture, person‐culture fit, and turnover: a replication in the health care industry. J Organ Behav. 1999;20(2):175184.
  5. Zazzali JL, Alexander JA, Shortell SM, Burns LR. Organizational culture and physician satisfaction with dimensions of group practice. Health Serv Res. 2007;42(3 pt 1):11501176.
  6. Shanafelt TD, West CP, Sloan JA, et al. Career fit and burnout among academic faculty. Arch Intern Med. 2009;169(10):990995.
  7. Hinami K, Whelan CT, Miller JA, Wolosin RJ, Wetterneck TB. Job characteristics, satisfaction, and burnout across hospitalist practice models. J Hosp Med. 2012;7(5):402410.
  8. Huesch MD. Provider‐hospital “fit” and patient outcomes: evidence from Massachusetts cardiac surgeons, 2002–2004. Health Serv Res. 2011;46(1 pt 1):126.
  9. Okie S. The evolving primary care physician. N Engl J Med. 2012;366(20):18491853.
  10. Kocher R, Sahni NR. Hospitals' race to employ physicians—the logic behind a money‐losing proposition. N Engl J Med. 2011;364(19):17901793.
  11. 2011 Survey of Final‐Year Medical Residents. Irving, TX:Merritt Hawkins;2011.
  12. State of Hospital Medicine: 2010 Report Based on 2009 Data. Englewood, CO:Society of Hospital Medicine and the Medical Group Management Association;2010.
  13. Schneider B, Goldstein HW, Smith DB. The ASA framework: an update. Personnel Psychol. 1995;48(4):747773.
  14. Hackman JR, Oldham GR. Work Redesign. Reading. MA:Addison‐Wesley;1980.
  15. Sehgal NL, Wachter RM. The expanding role of hospitalists in the United States. Swiss Med Wkly. 2006;136(37–38):591596.
  16. Ostroff C, Kozlowski SWJ. Organizational socialization as a learning‐process—the role of information acquisition. Personnel Psychol. 1992;45(4):849874.
  17. Ostroff C, Rothausen TJ. The moderating effect of tenure in person‐environment fit: a field study in educational organizations. J Occup Organ Psych. 1997;70:173188.
  18. Chatman JA. Matching people and organizations—selection and socialization in public accounting firms. Admin Sci Quart. 1991;36(3):459484.
  19. Meltzer D, Manning WG, Morrison J, et al. Effects of physician experience on costs and outcomes on an academic general medicine service: results of a trial of hospitalists. Ann Intern Med. 2002;137(11):866874.
  20. Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck TB. Worklife and satisfaction of hospitalists: toward flourishing careers. J Gen Intern Med. 2012;27(1):2836.
  21. Xie JL. Karasek's model in the People's Republic of China: effects of job demands, control, and individual differences. Acad Manage J. 1996;39(6):15941618.
  22. Konrad TR, Williams ES, Linzer M, et al. Measuring physician job satisfaction in a changing workplace and a challenging environment. SGIM Career Satisfaction Study Group. Society of General Internal Medicine. Med Care. 1999;37(11):11741182.
  23. Linzer M, Manwell LB, Mundt M, et al. Organizational climate, stress, and error in primary care: The MEMO Study. Adv Patient Saf. 2005;1:6577.
  24. Meltzer DO, Arora V, Zhang JX, et al. Effects of inpatient experience on outcomes and costs in a multicenter trial of academic hospitalists. J Gen Intern Med. 2005;20(suppl 1):141142.
  25. Shanafelt TD, Bradley KA, Wipf JE, Back AL. Burnout and self‐reported patient care in an internal medicine residency program. Ann Intern Med. 2002;136(5):358367.
  26. Yang CL, Carayon P. Effect of job demands and social support on worker stress—a study of VDT users. Behav Inform Technol. 1995;14(1):3240.
  27. Rohland BM, Kruse GR, Rohrer JE. Validation of a single‐item measure of burnout against the Maslach Burnout Inventory among physicians. Stress Health. 2004;20(2):7579.
  28. Dormann C, Zapf D. Job satisfaction: a meta‐analysis of stabilities. J Organ Behav. 2001;22(5):483504.
  29. The American Association for Public Opinion Research. Standard definitions: final dispositions of case codes and outcome rates for surveys.7th ed. Available at: http://www.aapor.org/Standard_Definitions2.htm. Accessed May 2,2012.
  30. Cull WL, O'Connor KG, Sharp S, Tang SFS. Response rates and response bias for 50 surveys of pediatricians. Health Serv Res. 2005;40(1):213226.
  31. Fisher ES, Shortell SM. Accountable care organizations: accountable for what, to whom, and how. JAMA. 2010;304(15):17156.
References
  1. Kristof AL. Person‐organization fit: an integrative review of its conceptualizations, measurement, and implications. Personnel Psychol. 1996;49:149.
  2. Kristof‐Brown AL, Zimmerman RD, Johnson EC. Consequences of individuals' fit at work: a meta‐analysis of person‐job, person‐organization, person‐group, and person‐supervisor fit. Personnel Psychol. 2005;58(2):281342.
  3. Edwards JR.Person‐job fit: a conceptual integration, literature review and methodological critique. In: Cooper CL, Robertson IT, eds. International Review of Industrial and Organizational Psychology. Vol.6. New York, NY:John Wiley 1991.
  4. Vandenberghe C. Organizational culture, person‐culture fit, and turnover: a replication in the health care industry. J Organ Behav. 1999;20(2):175184.
  5. Zazzali JL, Alexander JA, Shortell SM, Burns LR. Organizational culture and physician satisfaction with dimensions of group practice. Health Serv Res. 2007;42(3 pt 1):11501176.
  6. Shanafelt TD, West CP, Sloan JA, et al. Career fit and burnout among academic faculty. Arch Intern Med. 2009;169(10):990995.
  7. Hinami K, Whelan CT, Miller JA, Wolosin RJ, Wetterneck TB. Job characteristics, satisfaction, and burnout across hospitalist practice models. J Hosp Med. 2012;7(5):402410.
  8. Huesch MD. Provider‐hospital “fit” and patient outcomes: evidence from Massachusetts cardiac surgeons, 2002–2004. Health Serv Res. 2011;46(1 pt 1):126.
  9. Okie S. The evolving primary care physician. N Engl J Med. 2012;366(20):18491853.
  10. Kocher R, Sahni NR. Hospitals' race to employ physicians—the logic behind a money‐losing proposition. N Engl J Med. 2011;364(19):17901793.
  11. 2011 Survey of Final‐Year Medical Residents. Irving, TX:Merritt Hawkins;2011.
  12. State of Hospital Medicine: 2010 Report Based on 2009 Data. Englewood, CO:Society of Hospital Medicine and the Medical Group Management Association;2010.
  13. Schneider B, Goldstein HW, Smith DB. The ASA framework: an update. Personnel Psychol. 1995;48(4):747773.
  14. Hackman JR, Oldham GR. Work Redesign. Reading. MA:Addison‐Wesley;1980.
  15. Sehgal NL, Wachter RM. The expanding role of hospitalists in the United States. Swiss Med Wkly. 2006;136(37–38):591596.
  16. Ostroff C, Kozlowski SWJ. Organizational socialization as a learning‐process—the role of information acquisition. Personnel Psychol. 1992;45(4):849874.
  17. Ostroff C, Rothausen TJ. The moderating effect of tenure in person‐environment fit: a field study in educational organizations. J Occup Organ Psych. 1997;70:173188.
  18. Chatman JA. Matching people and organizations—selection and socialization in public accounting firms. Admin Sci Quart. 1991;36(3):459484.
  19. Meltzer D, Manning WG, Morrison J, et al. Effects of physician experience on costs and outcomes on an academic general medicine service: results of a trial of hospitalists. Ann Intern Med. 2002;137(11):866874.
  20. Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck TB. Worklife and satisfaction of hospitalists: toward flourishing careers. J Gen Intern Med. 2012;27(1):2836.
  21. Xie JL. Karasek's model in the People's Republic of China: effects of job demands, control, and individual differences. Acad Manage J. 1996;39(6):15941618.
  22. Konrad TR, Williams ES, Linzer M, et al. Measuring physician job satisfaction in a changing workplace and a challenging environment. SGIM Career Satisfaction Study Group. Society of General Internal Medicine. Med Care. 1999;37(11):11741182.
  23. Linzer M, Manwell LB, Mundt M, et al. Organizational climate, stress, and error in primary care: The MEMO Study. Adv Patient Saf. 2005;1:6577.
  24. Meltzer DO, Arora V, Zhang JX, et al. Effects of inpatient experience on outcomes and costs in a multicenter trial of academic hospitalists. J Gen Intern Med. 2005;20(suppl 1):141142.
  25. Shanafelt TD, Bradley KA, Wipf JE, Back AL. Burnout and self‐reported patient care in an internal medicine residency program. Ann Intern Med. 2002;136(5):358367.
  26. Yang CL, Carayon P. Effect of job demands and social support on worker stress—a study of VDT users. Behav Inform Technol. 1995;14(1):3240.
  27. Rohland BM, Kruse GR, Rohrer JE. Validation of a single‐item measure of burnout against the Maslach Burnout Inventory among physicians. Stress Health. 2004;20(2):7579.
  28. Dormann C, Zapf D. Job satisfaction: a meta‐analysis of stabilities. J Organ Behav. 2001;22(5):483504.
  29. The American Association for Public Opinion Research. Standard definitions: final dispositions of case codes and outcome rates for surveys.7th ed. Available at: http://www.aapor.org/Standard_Definitions2.htm. Accessed May 2,2012.
  30. Cull WL, O'Connor KG, Sharp S, Tang SFS. Response rates and response bias for 50 surveys of pediatricians. Health Serv Res. 2005;40(1):213226.
  31. Fisher ES, Shortell SM. Accountable care organizations: accountable for what, to whom, and how. JAMA. 2010;304(15):17156.
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Journal of Hospital Medicine - 8(2)
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Journal of Hospital Medicine - 8(2)
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Person‐job fit: An exploratory cross‐sectional analysis of hospitalists
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Person‐job fit: An exploratory cross‐sectional analysis of hospitalists
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Address for correspondence and reprint requests: Keiki Hinami, MD, MS, Northwestern University Feinberg School of Medicine, 211 E. Ontario St, 7‐727, Chicago IL 60611; Telephone: 312‐926‐0050; Fax: 312‐926‐4588; E-mail: [email protected]
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Analysis of Serum Folate Testing

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Utility, charge, and cost of inpatient and emergency department serum folate testing

Folate deficiency has been associated with a number of medical conditions. It is well established that folate deficiency leads to macrocytic anemia,[1, 2] and that supplementation of folic acid during pregnancy leads to decreased rates of neural tube defects.[3] Folate deficiency has also been hypothesized to affect other conditions including dementia, delirium, peripheral neuropathy, depression, cancer, and cardiovascular disease.[4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18] Most of these latter assertions are based on case reports or observational studies, with randomized controlled trials failing to demonstrate benefit of folic acid supplementation.[19, 20, 21]

Prior to mandatory folic acid fortification in the United States, the prevalence of folate deficiency was estimated to be between 3% and 16%.[16, 22, 23] In a study conducted prior to fortification, serum folate levels were evaluated in patients presenting with macrocytosis and anemia.[24] The study found that 2.3% of patients were serum folate deficient, with a change in management occurring in 24% of the deficient patients. The study also found that patients were charged $9979 per result that changed physician management.

In 1998, mandatory folic acid fortification began in the United States, and the prevalence of folate deficiency in the general population decreased to an estimated 0.5%.[23, 25] In a postfortification study, serum folate levels were evaluated in patients with anemia, dementia, or altered mental status.[26] The overall rate of serum folate deficiency was 0.4%, with the authors concluding that there was a lack of utility in serum folate testing. Despite this, algorithms addressing the evaluation of anemia continue to include serum folate levels.[2, 27, 28]

To our knowledge, the use of serum folate testing in the inpatient and emergency department population has never been independently evaluated. In our study, we aimed to characterize the indications, rate of deficiency, charge and cost per deficient result, and change in management per deficient result in inpatient and emergency department serum folate testing. We hypothesized that serum folate testing in these populations would have poor utility and would not be cost‐effective for any indication.

METHODS

We conducted a retrospective review of all serum folate tests ordered in inpatient units and the emergency department at a large academic medical center in Boston, Massachusetts from January 1, 2011 through December 31, 2011. The test was considered to be an inpatient or emergency department test based on the location of the blood draw on which the test was performed. Serum folate values were determined using a chemiluminescent competitive binding protein assay on an E170 analyzer as prescribed by the manufacturer (Roche Diagnostics, Indianapolis, IN). We defined serum folate levels as deficient (3.0 ng/mL), low‐normal (3.0 ng/mL3.9 ng/mL),[26] normal (4.0 ng/mL20.0 ng/mL), and high (>20.0 ng/mL). Erythrocyte folate levels are not routinely ordered at our institution and were not measured in our study.[29] Macrocytosis was defined as mean corpuscular volume of >99 fL. Vitamin B12 deficiency was defined as vitamin B12 level of under 200 pg/mL or vitamin B12 level of 200 to 300 pg/mL, with a methylmalonic acid >270 nmol/L and a normal homocysteine level (514 mol/L).[30, 31]

We evaluated 250 randomly selected serum folate levels and all deficient or low‐normal serum folate levels and recorded indication, comorbidities, age, sex, race or ethnicity, hemoglobin, hematocrit, mean corpuscular volume, vitamin B12 level, folic acid supplement on presentation, and folic acid supplement on discharge. Indications were determined by chart review. If serum folate was checked at the same time as iron studies, it was assumed that the indication was anemia without macrocytosis or anemia with macrocytosis unless otherwise documented. Comorbidities were selected based on historical risk factors and included depression, peripheral neuropathy, intestinal surgery, gastric bypass, cirrhosis, inflammatory bowel disease, celiac disease, delirium, dementia, alcohol abuse, malnutrition, anemia, end‐stage renal disease, vitamin B12 deficiency, or current use of phenytoin, valproic acid, or methotrexate.[32]

A charge analysis was performed using the same methodology as Robinson and Mladenovic.[24] We defined the charge of serum folate testing as our institution's charge to the patient or payer, which was $151.00 per test. Because hospital charges are variable, we also made a second calculation based on the charge per patient or payer from the Robinson and Mladenovic study,[24] which was $71.00. The analytical cost to our hospital of performing each serum folate test was <$2.00. We determined the total charge and cost for all serum folate tests and the charge and cost per deficient result.

The study was reviewed by the institutional review board and determined to be exempt.

RESULTS

In 2011, a total of 2093 serum folate levels were obtained on 1944 inpatients and emergency department patients. Of the total patients, 79.9% were inpatients and 20.1% were emergency department patients. Of the patients with tests performed in the emergency department, 98.1% were admitted to an inpatient unit.

Of the 250 random chart reviews, all had normal or high serum folate levels. The demographics, indications, and comorbidities are listed in Table 1. The most common indications were anemia without macrocytosis (43.2%), anemia with macrocytosis (13.2%; mean corpuscular volume [MCV], 106.8 fL), delirium (12.0%), malnutrition (6.4%), and peripheral neuropathy (6.0%). The other indications included thrombocytopenia, macrocytosis (without anemia), methotrexate use, alcohol abuse, frequent falls, syncope, headache, lethargy, optic nerve neuropathy, paranoia, psychosis, leukopenia, anxiety, and suicidal ideation. All of these individual indications were 2% of total reviewed indications. There were 16 cases (6.4%) without a documented indication.

Demographics, Indications, and Comorbidities
  • NOTE: *Indications total more than 100% as patients may have more than 1 indication.
Age, median, y66.0
Male sex, %50.8
Race or ethnicity, %
White76.0
Black or African American12.0
Asian4.4
Hispanic4.0
Unknown or declined2.0
Other1.6
Indications, %*
Anemia without macrocytosis43.2
Anemia with macrocytosis13.2
Delirium12.0
Malnutrition6.4
Peripheral neuropathy6.0
Depression3.6
Dementia3.2
Pancytopenia2.4
Other10.4
Unknown6.4
Comorbidities, %
Depression23.2
Alcohol abuse18.4
Chronic anemia11.2
Malnutrition9.6
Prior intestinal surgery8.8
Peripheral neuropathy6.0
Dementia5.6
Gastric bypass surgery4.4
End‐stage renal disease4.0
End‐stage liver disease3.6
Use of phenytoin3.2
Inflammatory bowel disease2.4
Use of valproic acid2.0
Celiac disease1.2

Of the 2093 serum folate levels, there were 2 deficient (0.1%), 7 low‐normal (0.3%), 1487 normal (71.1%), and 597 high (28.5%) levels (Table 2). There were 128 patients (6.6%) who had more than 1 serum folate level checked within the prior 12 months, with 1 patient having 5 levels obtained during that time period. All of the deficient and low‐normal serum folate results are listed in Table 3. Of the 9 deficient or low‐normal serum folate levels, 8 had comorbid risk factors for folate deficiency. One of the deficient cases was on folic acid and multivitamin supplementation on presentation, although nonadherence with these supplements was documented in the medical record. The other deficient case was not on folic acid supplementation and did not receive folic acid supplementation for the deficient result. Vitamin B12 levels were checked simultaneously to serum folate levels in 85.2% of cases and within 6 months in 99.2% of cases. Of these patients, 2.0% were found to have vitamin B12 deficiency.

Serum Folate Results
  • NOTE: Abbreviations: MCV, mean corpuscular volume; StDev, standard deviation.
Total tests2093
Total patients1944
Low (%)2 (0.1)
Low‐normal (%)7 (0.3)
Normal (%)1487 (71.0)
High (%)597 (28.5)
MCV (StDev)92.1 (9.2)
Deficient and Low‐Normal Serum Folate Results
 Age, ySexFolate (ng/mL)IndicationComorbiditiesHgb (g/dL)MCV (fL)
  • NOTE: Abbreviations: GI, gastrointestinal; Hgb, hemoglobin; HIV, human immunodeficiency virus; MCV, mean corpuscular volume.
Deficient results
Case 135Male2.6Stroke workupPhenytoin, depression16.091
Case 263Male2.9Macrocytic anemiaAlcohol abuse, acute GI bleed7.7119
Low‐normal results
Case 364Male3.3Macrocytic anemiaCirrhosis, alcohol abuse12.3109
Case 442Male3.4PancytopeniaHIV, B12 deficiency7.593
Case 558Male3.4DepressionDepression, alcohol abuse13.898
Case 656Female3.5DepressionAlcohol abuse  
Case 785Male3.6DeliriumDepression10.591
Case 881Female3.6AnemiaChronic anemia9.195
Case 963Male3.9AnemiaChronic anemia, malnutrition7.688

Based on our institution's charge for serum folate, a total of $316,043 was charged for the 2093 serum folate tests. The amount charged per deficient result was $158,022. Substituting the charge from the Robinson and Mladenovic study,[24] we calculated the corresponding total charge and charge per deficient result as $149,545 and $74,772, respectively. The actual total cost to our hospital was <$4186, with a cost per deficient test of <$2093.

DISCUSSION

Serum folate levels are often obtained when evaluating anemia without macrocytosis and anemia with macrocytosis.[2] They are also frequently obtained in the evaluation of delirium and dementia. A prior study evaluated both inpatient and outpatient serum folate levels in anemia, dementia, and altered mental status and found only 0.4% of serum folate results to be deficient.[26] In their study, the indications for serum folate tests were anemia or macrocytic anemia (60%) and dementia or altered mental status (30%).

We found the indications for serum folate testing in inpatients and emergency department patients to be different than prior studies. The majority of tests were done to evaluate anemia without macrocytosis (43.2%) or anemia with macrocytosis (13.2%). Lower percentages were done for the evaluation of delirium (12.0%) or dementia (3.2%). In addition, there were multiple indications that have not been noted in previous studies, including depression, peripheral neuropathy, malnutrition, pancytopenia, and others. These accounted for 28.0% of all indications. The reason for the difference in indications compared to prior studies is unknown but may be related to our cohort of exclusively inpatients and emergency department patients. Also, we observed a high concurrence of serum folate and vitamin B12 testing, with 85.2% of serum folate levels ordered at the same time as vitamin B12 levels. It appears that the tests are often ordered together even when the indication suggests that vitamin B12 alone may be more appropriate, such as peripheral neuropathy.

We found that serum folate deficiency was rare, occurring in only 2 of 2093 results. Furthermore, the deficient serum folate results may have been checked for inappropriate indications. The first deficient result was noted as part of a stroke workup in a patient not taking folic acid supplementation. Current guidelines do not recommend serum folate testing in patients with new stroke.[33] In the second deficient case, serum folate testing was performed for evaluation of macrocytic anemia with an MCV of 119 fL. Although reasonable, this was an alcoholic patient presenting with acute gastrointestinal bleeding already on folic acid and multivitamin supplementation and known nonadherence with these supplements. In neither case was there a change in management based on the deficient result.

Given the low rate of serum folate deficiency and the lack of change in management based on deficient results, we conclude that there is a low utility of serum folate testing for any indication in inpatients and emergency department patients in folic acid‐fortified countries. Based on prior studies, and supported by our results, there is no evidence for checking serum folate levels in delirium, dementia, peripheral neuropathy, malnutrition, or any of the other indications. In addition, our results demonstrate a low utility even in patients with anemia or macrocytic anemia.

The rate of serum folate deficiency in our study was significantly lower than prior studies.[24, 26] There may have been geographical factors that led to a lower prevalence of folate deficiency in our study population. Our cohort included inpatients and emergency department patients, whereas previous studies had a majority of outpatients. It is known that serum folate levels can rapidly fluctuate with proper nutrition.[34] It may be that our patients received nutrition in the hospital that corrected serum folate levels prior to laboratory testing.

In addition to the low utility of serum folate testing, the charge per deficient result in our study ($158,022) was more than 100‐fold higher than that in the Robinson and Mladenovic study ($1321).[24] Even when correcting for variability in hospital charges by using the charge from the latter study, the charge per deficient serum folate test remained 50‐fold higher ($74,772). This implies that the increase in charge per deficient result was driven in part by a decreased rate of deficient tests. Folic acid fortification is likely responsible for some of the decrease. However, we believe another source is the excessive ordering of serum folate tests in patients without previously accepted indications. Because no change in management was made for the deficient patients in our study, the charge per serum folate deficient result that changed management approached infinity. This compares to $9979 in the Robinson and Mladenovic analysis.[24]

The cost to the hospital of a serum folate test was much lower than the charge, and estimated to be <$2093 per deficient result. Because serum folate tests are performed on a highly automated, random access analyzer that performs thousands of other measurements daily, the capital and labor costs for each test was well below $0.50 combined. With the addition of reagent costs, our total cost for each serum folate measurement was <$2.00. It is somewhat difficult to extrapolate these values to other hospitals, as exact costs and charges are variable. Nonetheless, the exceptionally low utility of serum folate testing makes the costs associated with these tests excessive.

Our study has several limitations. We conducted our study at a single institution in a country with mandatory folic acid fortification. Our results may not be generalizable to other institutions or patient populations, such as those in countries without mandatory folic acid fortification. Only 259 (12.4%) charts were reviewed, and indications were determined in 93.6% of charts, which may have caused our frequency to vary from the true frequency. Additionally, the low rate of deficient serum folate results limited our ability to identify associations with deficiency. Further evaluation for geographic variations of serum folate deficiency may reveal variable rates.

We conclude that in folic acid fortified countries, the rate of serum folate deficiency is increasingly rare, and the charge to patients and payers per deficient result is exceptionally high. In addition, testing in our study did not change clinical management, which makes the costs associated with these test wasteful. Further evaluation of serum folate testing of inpatients and emergency department patients in folic acid fortified countries is warranted; however, based on our results the utility appears poor for all indications.

Disclosure

Nothing to report.

Files
References
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  10. Kim YI, Pogribny IP, Basnakian AG, et al. Folate deficiency in rats induces DNA strand breaks and hypomethylation within the p53 tumor suppressor gene. Am J Clin Nutr. 1997;65(1):4652.
  11. Freudenheim JL, Graham S, Marshall JR, Haughey BP, Cholewinski S, Wilkinson G. Folate intake and carcinogenesis of the colon and rectum. Int J Epidemiol. 1991;20(2):368374.
  12. Kune G, Watson L. Colorectal cancer protective effects and the dietary micronutrients folate, methionine, vitamins B6, B12, C, E, selenium, and lycopene. Nutr Cancer. 2006;56(1):1121.
  13. Giovannucci E, Stampfer MJ, Colditz GA, et al. Multivitamin use, folate, and colon cancer in women in the Nurses' Health Study. Ann Intern Med. 1998;129(7):517524.
  14. Gopinath B, Flood VM, Rochtchina E, Thiagalingam A, Mitchell P. Serum homocysteine and folate but not vitamin B12 are predictors of CHD mortality in older adults [published online ahead of print September 29, 2011]. Eur J Cardiovasc Prev Rehabil. doi: 10.1177/1741826711424568.
  15. Genest JJ, McNamara JR, Salem DN, Wilson PW, Schaefer EJ, Malinow MR. Plasma homocyst(e)ine levels in men with premature coronary artery disease. J Am Coll Cardiol. 1990;16(5):11141119.
  16. Bunout D, Petermann M, Hirsch S, et al. Low serum folate but normal homocysteine levels in patients with atherosclerotic vascular disease and matched healthy controls. Nutrition. 2000;16(6):434438.
  17. Voutilainen S, Lakka TA, Porkkala‐Sarataho E, Rissanen T, Kaplan GA, Salonen JT. Low serum folate concentrations are associated with an excess incidence of acute coronary events: the Kuopio Ischaemic Heart Disease Risk Factor Study. Eur J Clin Nutr. 2000;54(5):424428.
  18. Hernandez‐Diaz S, Martinez‐Losa E, Fernandez‐Jarne E, Serrano‐Martinez M, Martinez‐Gonzalez MA. Dietary folate and the risk of nonfatal myocardial infarction. Epidemiology. 2002;13(6):700706.
  19. Lonn E, Yusuf S, Arnold MJ, et al.;Heart Outcomes Prevention Evaluation (HOPE) 2 Investigators. Homocysteine lowering with folic acid and b vitamins in vascular disease. N Engl J Med. 2006;354(15):15671577.
  20. McMahon JA, Green TJ, Skeaff CM, Knight RG, Mann JI, Williams SM. A controlled trial of homocysteine lowering and cognitive performance. N Engl J Med. 2006;354(26):27642772.
  21. Malouf R, Grimley Evans J. Folic acid with or without vitamin B12 for the prevention and treatment of healthy elderly and demented people. Cochrane Database Syst Rev. 2008;(4):CD004514.
  22. Seward SJ, Safran C, Marton KI, Robinson SH. Does the mean corpuscular volume help physicians evaluate hospitalized patients with anemia?J Gen Intern Med. 1990;5(3):187191.
  23. Pfeiffer CM, Caudill SP, Gunter EW, Osterloh J, Sampson EJ. Biochemical indicators of B vitamin status in the US population after folic acid fortification: results from the National Health and Nutrition Examination Survey 1999–2000. Am J Clin Nutr. 2005;82(2):442450.
  24. Robinson AR, Mladenovic J. Lack of clinical utility of folate levels in the evaluation of macrocytosis or anemia. Am J Med. 2001;110(2):8890.
  25. McDowell MA, Lacher DA, Pfeiffer CM, et al. Blood folate levels: the latest NHANES results. NCHS Data Brief. 2008;(6):18.
  26. Ashraf MJ, Cook JR, Rothberg MB. Clinical utility of folic acid testing for patients with anemia or dementia. J Gen Intern Med. 2008;23(6):824826.
  27. Tefferi A. Anemia in adults: a contemporary approach to diagnosis. Mayo Clin Proc 2003;78(10):12741280.
  28. Smith DL. Anemia in the elderly. Am Fam Physician. 2000;62(7):15651572.
  29. Galloway M, Rushworth L. Red cell or serum folate? Results from the National Pathology Alliance benchmarking review. J Clin Pathol. 2003;56(12):924926.
  30. Hoffman R, Benz E, Silberstein LE, Heslop H, Weitz J, Anastasi J. Hematology. Philadelphia, PA:Churchill Livingstone;2012.
  31. Savage DG, Lindenbaum J, Stabler SP, Allen RH. Sensitivity of serum methylmalonic acid and total homocysteine determinations for diagnosing cobalamin and folate deficiencies. Am J Med. 1994;96(3):239246.
  32. Snow CF. Laboratory diagnosis of vitamin B12 and folate deficiency: a guide for the primary care physician. Arch Intern Med. 1999;159(12):12891298.
  33. Adams HP, del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: the American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Stroke. 2007;38(5):16551711.
  34. Verwei M, Freidig AP, Havenaar R, Groten JP. Predicted serum folate concentrations based on in vitro studies and kinetic modeling are consistent with measured folate concentrations in humans. J Nutr. 2006;136(12):30743078.
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Folate deficiency has been associated with a number of medical conditions. It is well established that folate deficiency leads to macrocytic anemia,[1, 2] and that supplementation of folic acid during pregnancy leads to decreased rates of neural tube defects.[3] Folate deficiency has also been hypothesized to affect other conditions including dementia, delirium, peripheral neuropathy, depression, cancer, and cardiovascular disease.[4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18] Most of these latter assertions are based on case reports or observational studies, with randomized controlled trials failing to demonstrate benefit of folic acid supplementation.[19, 20, 21]

Prior to mandatory folic acid fortification in the United States, the prevalence of folate deficiency was estimated to be between 3% and 16%.[16, 22, 23] In a study conducted prior to fortification, serum folate levels were evaluated in patients presenting with macrocytosis and anemia.[24] The study found that 2.3% of patients were serum folate deficient, with a change in management occurring in 24% of the deficient patients. The study also found that patients were charged $9979 per result that changed physician management.

In 1998, mandatory folic acid fortification began in the United States, and the prevalence of folate deficiency in the general population decreased to an estimated 0.5%.[23, 25] In a postfortification study, serum folate levels were evaluated in patients with anemia, dementia, or altered mental status.[26] The overall rate of serum folate deficiency was 0.4%, with the authors concluding that there was a lack of utility in serum folate testing. Despite this, algorithms addressing the evaluation of anemia continue to include serum folate levels.[2, 27, 28]

To our knowledge, the use of serum folate testing in the inpatient and emergency department population has never been independently evaluated. In our study, we aimed to characterize the indications, rate of deficiency, charge and cost per deficient result, and change in management per deficient result in inpatient and emergency department serum folate testing. We hypothesized that serum folate testing in these populations would have poor utility and would not be cost‐effective for any indication.

METHODS

We conducted a retrospective review of all serum folate tests ordered in inpatient units and the emergency department at a large academic medical center in Boston, Massachusetts from January 1, 2011 through December 31, 2011. The test was considered to be an inpatient or emergency department test based on the location of the blood draw on which the test was performed. Serum folate values were determined using a chemiluminescent competitive binding protein assay on an E170 analyzer as prescribed by the manufacturer (Roche Diagnostics, Indianapolis, IN). We defined serum folate levels as deficient (3.0 ng/mL), low‐normal (3.0 ng/mL3.9 ng/mL),[26] normal (4.0 ng/mL20.0 ng/mL), and high (>20.0 ng/mL). Erythrocyte folate levels are not routinely ordered at our institution and were not measured in our study.[29] Macrocytosis was defined as mean corpuscular volume of >99 fL. Vitamin B12 deficiency was defined as vitamin B12 level of under 200 pg/mL or vitamin B12 level of 200 to 300 pg/mL, with a methylmalonic acid >270 nmol/L and a normal homocysteine level (514 mol/L).[30, 31]

We evaluated 250 randomly selected serum folate levels and all deficient or low‐normal serum folate levels and recorded indication, comorbidities, age, sex, race or ethnicity, hemoglobin, hematocrit, mean corpuscular volume, vitamin B12 level, folic acid supplement on presentation, and folic acid supplement on discharge. Indications were determined by chart review. If serum folate was checked at the same time as iron studies, it was assumed that the indication was anemia without macrocytosis or anemia with macrocytosis unless otherwise documented. Comorbidities were selected based on historical risk factors and included depression, peripheral neuropathy, intestinal surgery, gastric bypass, cirrhosis, inflammatory bowel disease, celiac disease, delirium, dementia, alcohol abuse, malnutrition, anemia, end‐stage renal disease, vitamin B12 deficiency, or current use of phenytoin, valproic acid, or methotrexate.[32]

A charge analysis was performed using the same methodology as Robinson and Mladenovic.[24] We defined the charge of serum folate testing as our institution's charge to the patient or payer, which was $151.00 per test. Because hospital charges are variable, we also made a second calculation based on the charge per patient or payer from the Robinson and Mladenovic study,[24] which was $71.00. The analytical cost to our hospital of performing each serum folate test was <$2.00. We determined the total charge and cost for all serum folate tests and the charge and cost per deficient result.

The study was reviewed by the institutional review board and determined to be exempt.

RESULTS

In 2011, a total of 2093 serum folate levels were obtained on 1944 inpatients and emergency department patients. Of the total patients, 79.9% were inpatients and 20.1% were emergency department patients. Of the patients with tests performed in the emergency department, 98.1% were admitted to an inpatient unit.

Of the 250 random chart reviews, all had normal or high serum folate levels. The demographics, indications, and comorbidities are listed in Table 1. The most common indications were anemia without macrocytosis (43.2%), anemia with macrocytosis (13.2%; mean corpuscular volume [MCV], 106.8 fL), delirium (12.0%), malnutrition (6.4%), and peripheral neuropathy (6.0%). The other indications included thrombocytopenia, macrocytosis (without anemia), methotrexate use, alcohol abuse, frequent falls, syncope, headache, lethargy, optic nerve neuropathy, paranoia, psychosis, leukopenia, anxiety, and suicidal ideation. All of these individual indications were 2% of total reviewed indications. There were 16 cases (6.4%) without a documented indication.

Demographics, Indications, and Comorbidities
  • NOTE: *Indications total more than 100% as patients may have more than 1 indication.
Age, median, y66.0
Male sex, %50.8
Race or ethnicity, %
White76.0
Black or African American12.0
Asian4.4
Hispanic4.0
Unknown or declined2.0
Other1.6
Indications, %*
Anemia without macrocytosis43.2
Anemia with macrocytosis13.2
Delirium12.0
Malnutrition6.4
Peripheral neuropathy6.0
Depression3.6
Dementia3.2
Pancytopenia2.4
Other10.4
Unknown6.4
Comorbidities, %
Depression23.2
Alcohol abuse18.4
Chronic anemia11.2
Malnutrition9.6
Prior intestinal surgery8.8
Peripheral neuropathy6.0
Dementia5.6
Gastric bypass surgery4.4
End‐stage renal disease4.0
End‐stage liver disease3.6
Use of phenytoin3.2
Inflammatory bowel disease2.4
Use of valproic acid2.0
Celiac disease1.2

Of the 2093 serum folate levels, there were 2 deficient (0.1%), 7 low‐normal (0.3%), 1487 normal (71.1%), and 597 high (28.5%) levels (Table 2). There were 128 patients (6.6%) who had more than 1 serum folate level checked within the prior 12 months, with 1 patient having 5 levels obtained during that time period. All of the deficient and low‐normal serum folate results are listed in Table 3. Of the 9 deficient or low‐normal serum folate levels, 8 had comorbid risk factors for folate deficiency. One of the deficient cases was on folic acid and multivitamin supplementation on presentation, although nonadherence with these supplements was documented in the medical record. The other deficient case was not on folic acid supplementation and did not receive folic acid supplementation for the deficient result. Vitamin B12 levels were checked simultaneously to serum folate levels in 85.2% of cases and within 6 months in 99.2% of cases. Of these patients, 2.0% were found to have vitamin B12 deficiency.

Serum Folate Results
  • NOTE: Abbreviations: MCV, mean corpuscular volume; StDev, standard deviation.
Total tests2093
Total patients1944
Low (%)2 (0.1)
Low‐normal (%)7 (0.3)
Normal (%)1487 (71.0)
High (%)597 (28.5)
MCV (StDev)92.1 (9.2)
Deficient and Low‐Normal Serum Folate Results
 Age, ySexFolate (ng/mL)IndicationComorbiditiesHgb (g/dL)MCV (fL)
  • NOTE: Abbreviations: GI, gastrointestinal; Hgb, hemoglobin; HIV, human immunodeficiency virus; MCV, mean corpuscular volume.
Deficient results
Case 135Male2.6Stroke workupPhenytoin, depression16.091
Case 263Male2.9Macrocytic anemiaAlcohol abuse, acute GI bleed7.7119
Low‐normal results
Case 364Male3.3Macrocytic anemiaCirrhosis, alcohol abuse12.3109
Case 442Male3.4PancytopeniaHIV, B12 deficiency7.593
Case 558Male3.4DepressionDepression, alcohol abuse13.898
Case 656Female3.5DepressionAlcohol abuse  
Case 785Male3.6DeliriumDepression10.591
Case 881Female3.6AnemiaChronic anemia9.195
Case 963Male3.9AnemiaChronic anemia, malnutrition7.688

Based on our institution's charge for serum folate, a total of $316,043 was charged for the 2093 serum folate tests. The amount charged per deficient result was $158,022. Substituting the charge from the Robinson and Mladenovic study,[24] we calculated the corresponding total charge and charge per deficient result as $149,545 and $74,772, respectively. The actual total cost to our hospital was <$4186, with a cost per deficient test of <$2093.

DISCUSSION

Serum folate levels are often obtained when evaluating anemia without macrocytosis and anemia with macrocytosis.[2] They are also frequently obtained in the evaluation of delirium and dementia. A prior study evaluated both inpatient and outpatient serum folate levels in anemia, dementia, and altered mental status and found only 0.4% of serum folate results to be deficient.[26] In their study, the indications for serum folate tests were anemia or macrocytic anemia (60%) and dementia or altered mental status (30%).

We found the indications for serum folate testing in inpatients and emergency department patients to be different than prior studies. The majority of tests were done to evaluate anemia without macrocytosis (43.2%) or anemia with macrocytosis (13.2%). Lower percentages were done for the evaluation of delirium (12.0%) or dementia (3.2%). In addition, there were multiple indications that have not been noted in previous studies, including depression, peripheral neuropathy, malnutrition, pancytopenia, and others. These accounted for 28.0% of all indications. The reason for the difference in indications compared to prior studies is unknown but may be related to our cohort of exclusively inpatients and emergency department patients. Also, we observed a high concurrence of serum folate and vitamin B12 testing, with 85.2% of serum folate levels ordered at the same time as vitamin B12 levels. It appears that the tests are often ordered together even when the indication suggests that vitamin B12 alone may be more appropriate, such as peripheral neuropathy.

We found that serum folate deficiency was rare, occurring in only 2 of 2093 results. Furthermore, the deficient serum folate results may have been checked for inappropriate indications. The first deficient result was noted as part of a stroke workup in a patient not taking folic acid supplementation. Current guidelines do not recommend serum folate testing in patients with new stroke.[33] In the second deficient case, serum folate testing was performed for evaluation of macrocytic anemia with an MCV of 119 fL. Although reasonable, this was an alcoholic patient presenting with acute gastrointestinal bleeding already on folic acid and multivitamin supplementation and known nonadherence with these supplements. In neither case was there a change in management based on the deficient result.

Given the low rate of serum folate deficiency and the lack of change in management based on deficient results, we conclude that there is a low utility of serum folate testing for any indication in inpatients and emergency department patients in folic acid‐fortified countries. Based on prior studies, and supported by our results, there is no evidence for checking serum folate levels in delirium, dementia, peripheral neuropathy, malnutrition, or any of the other indications. In addition, our results demonstrate a low utility even in patients with anemia or macrocytic anemia.

The rate of serum folate deficiency in our study was significantly lower than prior studies.[24, 26] There may have been geographical factors that led to a lower prevalence of folate deficiency in our study population. Our cohort included inpatients and emergency department patients, whereas previous studies had a majority of outpatients. It is known that serum folate levels can rapidly fluctuate with proper nutrition.[34] It may be that our patients received nutrition in the hospital that corrected serum folate levels prior to laboratory testing.

In addition to the low utility of serum folate testing, the charge per deficient result in our study ($158,022) was more than 100‐fold higher than that in the Robinson and Mladenovic study ($1321).[24] Even when correcting for variability in hospital charges by using the charge from the latter study, the charge per deficient serum folate test remained 50‐fold higher ($74,772). This implies that the increase in charge per deficient result was driven in part by a decreased rate of deficient tests. Folic acid fortification is likely responsible for some of the decrease. However, we believe another source is the excessive ordering of serum folate tests in patients without previously accepted indications. Because no change in management was made for the deficient patients in our study, the charge per serum folate deficient result that changed management approached infinity. This compares to $9979 in the Robinson and Mladenovic analysis.[24]

The cost to the hospital of a serum folate test was much lower than the charge, and estimated to be <$2093 per deficient result. Because serum folate tests are performed on a highly automated, random access analyzer that performs thousands of other measurements daily, the capital and labor costs for each test was well below $0.50 combined. With the addition of reagent costs, our total cost for each serum folate measurement was <$2.00. It is somewhat difficult to extrapolate these values to other hospitals, as exact costs and charges are variable. Nonetheless, the exceptionally low utility of serum folate testing makes the costs associated with these tests excessive.

Our study has several limitations. We conducted our study at a single institution in a country with mandatory folic acid fortification. Our results may not be generalizable to other institutions or patient populations, such as those in countries without mandatory folic acid fortification. Only 259 (12.4%) charts were reviewed, and indications were determined in 93.6% of charts, which may have caused our frequency to vary from the true frequency. Additionally, the low rate of deficient serum folate results limited our ability to identify associations with deficiency. Further evaluation for geographic variations of serum folate deficiency may reveal variable rates.

We conclude that in folic acid fortified countries, the rate of serum folate deficiency is increasingly rare, and the charge to patients and payers per deficient result is exceptionally high. In addition, testing in our study did not change clinical management, which makes the costs associated with these test wasteful. Further evaluation of serum folate testing of inpatients and emergency department patients in folic acid fortified countries is warranted; however, based on our results the utility appears poor for all indications.

Disclosure

Nothing to report.

Folate deficiency has been associated with a number of medical conditions. It is well established that folate deficiency leads to macrocytic anemia,[1, 2] and that supplementation of folic acid during pregnancy leads to decreased rates of neural tube defects.[3] Folate deficiency has also been hypothesized to affect other conditions including dementia, delirium, peripheral neuropathy, depression, cancer, and cardiovascular disease.[4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18] Most of these latter assertions are based on case reports or observational studies, with randomized controlled trials failing to demonstrate benefit of folic acid supplementation.[19, 20, 21]

Prior to mandatory folic acid fortification in the United States, the prevalence of folate deficiency was estimated to be between 3% and 16%.[16, 22, 23] In a study conducted prior to fortification, serum folate levels were evaluated in patients presenting with macrocytosis and anemia.[24] The study found that 2.3% of patients were serum folate deficient, with a change in management occurring in 24% of the deficient patients. The study also found that patients were charged $9979 per result that changed physician management.

In 1998, mandatory folic acid fortification began in the United States, and the prevalence of folate deficiency in the general population decreased to an estimated 0.5%.[23, 25] In a postfortification study, serum folate levels were evaluated in patients with anemia, dementia, or altered mental status.[26] The overall rate of serum folate deficiency was 0.4%, with the authors concluding that there was a lack of utility in serum folate testing. Despite this, algorithms addressing the evaluation of anemia continue to include serum folate levels.[2, 27, 28]

To our knowledge, the use of serum folate testing in the inpatient and emergency department population has never been independently evaluated. In our study, we aimed to characterize the indications, rate of deficiency, charge and cost per deficient result, and change in management per deficient result in inpatient and emergency department serum folate testing. We hypothesized that serum folate testing in these populations would have poor utility and would not be cost‐effective for any indication.

METHODS

We conducted a retrospective review of all serum folate tests ordered in inpatient units and the emergency department at a large academic medical center in Boston, Massachusetts from January 1, 2011 through December 31, 2011. The test was considered to be an inpatient or emergency department test based on the location of the blood draw on which the test was performed. Serum folate values were determined using a chemiluminescent competitive binding protein assay on an E170 analyzer as prescribed by the manufacturer (Roche Diagnostics, Indianapolis, IN). We defined serum folate levels as deficient (3.0 ng/mL), low‐normal (3.0 ng/mL3.9 ng/mL),[26] normal (4.0 ng/mL20.0 ng/mL), and high (>20.0 ng/mL). Erythrocyte folate levels are not routinely ordered at our institution and were not measured in our study.[29] Macrocytosis was defined as mean corpuscular volume of >99 fL. Vitamin B12 deficiency was defined as vitamin B12 level of under 200 pg/mL or vitamin B12 level of 200 to 300 pg/mL, with a methylmalonic acid >270 nmol/L and a normal homocysteine level (514 mol/L).[30, 31]

We evaluated 250 randomly selected serum folate levels and all deficient or low‐normal serum folate levels and recorded indication, comorbidities, age, sex, race or ethnicity, hemoglobin, hematocrit, mean corpuscular volume, vitamin B12 level, folic acid supplement on presentation, and folic acid supplement on discharge. Indications were determined by chart review. If serum folate was checked at the same time as iron studies, it was assumed that the indication was anemia without macrocytosis or anemia with macrocytosis unless otherwise documented. Comorbidities were selected based on historical risk factors and included depression, peripheral neuropathy, intestinal surgery, gastric bypass, cirrhosis, inflammatory bowel disease, celiac disease, delirium, dementia, alcohol abuse, malnutrition, anemia, end‐stage renal disease, vitamin B12 deficiency, or current use of phenytoin, valproic acid, or methotrexate.[32]

A charge analysis was performed using the same methodology as Robinson and Mladenovic.[24] We defined the charge of serum folate testing as our institution's charge to the patient or payer, which was $151.00 per test. Because hospital charges are variable, we also made a second calculation based on the charge per patient or payer from the Robinson and Mladenovic study,[24] which was $71.00. The analytical cost to our hospital of performing each serum folate test was <$2.00. We determined the total charge and cost for all serum folate tests and the charge and cost per deficient result.

The study was reviewed by the institutional review board and determined to be exempt.

RESULTS

In 2011, a total of 2093 serum folate levels were obtained on 1944 inpatients and emergency department patients. Of the total patients, 79.9% were inpatients and 20.1% were emergency department patients. Of the patients with tests performed in the emergency department, 98.1% were admitted to an inpatient unit.

Of the 250 random chart reviews, all had normal or high serum folate levels. The demographics, indications, and comorbidities are listed in Table 1. The most common indications were anemia without macrocytosis (43.2%), anemia with macrocytosis (13.2%; mean corpuscular volume [MCV], 106.8 fL), delirium (12.0%), malnutrition (6.4%), and peripheral neuropathy (6.0%). The other indications included thrombocytopenia, macrocytosis (without anemia), methotrexate use, alcohol abuse, frequent falls, syncope, headache, lethargy, optic nerve neuropathy, paranoia, psychosis, leukopenia, anxiety, and suicidal ideation. All of these individual indications were 2% of total reviewed indications. There were 16 cases (6.4%) without a documented indication.

Demographics, Indications, and Comorbidities
  • NOTE: *Indications total more than 100% as patients may have more than 1 indication.
Age, median, y66.0
Male sex, %50.8
Race or ethnicity, %
White76.0
Black or African American12.0
Asian4.4
Hispanic4.0
Unknown or declined2.0
Other1.6
Indications, %*
Anemia without macrocytosis43.2
Anemia with macrocytosis13.2
Delirium12.0
Malnutrition6.4
Peripheral neuropathy6.0
Depression3.6
Dementia3.2
Pancytopenia2.4
Other10.4
Unknown6.4
Comorbidities, %
Depression23.2
Alcohol abuse18.4
Chronic anemia11.2
Malnutrition9.6
Prior intestinal surgery8.8
Peripheral neuropathy6.0
Dementia5.6
Gastric bypass surgery4.4
End‐stage renal disease4.0
End‐stage liver disease3.6
Use of phenytoin3.2
Inflammatory bowel disease2.4
Use of valproic acid2.0
Celiac disease1.2

Of the 2093 serum folate levels, there were 2 deficient (0.1%), 7 low‐normal (0.3%), 1487 normal (71.1%), and 597 high (28.5%) levels (Table 2). There were 128 patients (6.6%) who had more than 1 serum folate level checked within the prior 12 months, with 1 patient having 5 levels obtained during that time period. All of the deficient and low‐normal serum folate results are listed in Table 3. Of the 9 deficient or low‐normal serum folate levels, 8 had comorbid risk factors for folate deficiency. One of the deficient cases was on folic acid and multivitamin supplementation on presentation, although nonadherence with these supplements was documented in the medical record. The other deficient case was not on folic acid supplementation and did not receive folic acid supplementation for the deficient result. Vitamin B12 levels were checked simultaneously to serum folate levels in 85.2% of cases and within 6 months in 99.2% of cases. Of these patients, 2.0% were found to have vitamin B12 deficiency.

Serum Folate Results
  • NOTE: Abbreviations: MCV, mean corpuscular volume; StDev, standard deviation.
Total tests2093
Total patients1944
Low (%)2 (0.1)
Low‐normal (%)7 (0.3)
Normal (%)1487 (71.0)
High (%)597 (28.5)
MCV (StDev)92.1 (9.2)
Deficient and Low‐Normal Serum Folate Results
 Age, ySexFolate (ng/mL)IndicationComorbiditiesHgb (g/dL)MCV (fL)
  • NOTE: Abbreviations: GI, gastrointestinal; Hgb, hemoglobin; HIV, human immunodeficiency virus; MCV, mean corpuscular volume.
Deficient results
Case 135Male2.6Stroke workupPhenytoin, depression16.091
Case 263Male2.9Macrocytic anemiaAlcohol abuse, acute GI bleed7.7119
Low‐normal results
Case 364Male3.3Macrocytic anemiaCirrhosis, alcohol abuse12.3109
Case 442Male3.4PancytopeniaHIV, B12 deficiency7.593
Case 558Male3.4DepressionDepression, alcohol abuse13.898
Case 656Female3.5DepressionAlcohol abuse  
Case 785Male3.6DeliriumDepression10.591
Case 881Female3.6AnemiaChronic anemia9.195
Case 963Male3.9AnemiaChronic anemia, malnutrition7.688

Based on our institution's charge for serum folate, a total of $316,043 was charged for the 2093 serum folate tests. The amount charged per deficient result was $158,022. Substituting the charge from the Robinson and Mladenovic study,[24] we calculated the corresponding total charge and charge per deficient result as $149,545 and $74,772, respectively. The actual total cost to our hospital was <$4186, with a cost per deficient test of <$2093.

DISCUSSION

Serum folate levels are often obtained when evaluating anemia without macrocytosis and anemia with macrocytosis.[2] They are also frequently obtained in the evaluation of delirium and dementia. A prior study evaluated both inpatient and outpatient serum folate levels in anemia, dementia, and altered mental status and found only 0.4% of serum folate results to be deficient.[26] In their study, the indications for serum folate tests were anemia or macrocytic anemia (60%) and dementia or altered mental status (30%).

We found the indications for serum folate testing in inpatients and emergency department patients to be different than prior studies. The majority of tests were done to evaluate anemia without macrocytosis (43.2%) or anemia with macrocytosis (13.2%). Lower percentages were done for the evaluation of delirium (12.0%) or dementia (3.2%). In addition, there were multiple indications that have not been noted in previous studies, including depression, peripheral neuropathy, malnutrition, pancytopenia, and others. These accounted for 28.0% of all indications. The reason for the difference in indications compared to prior studies is unknown but may be related to our cohort of exclusively inpatients and emergency department patients. Also, we observed a high concurrence of serum folate and vitamin B12 testing, with 85.2% of serum folate levels ordered at the same time as vitamin B12 levels. It appears that the tests are often ordered together even when the indication suggests that vitamin B12 alone may be more appropriate, such as peripheral neuropathy.

We found that serum folate deficiency was rare, occurring in only 2 of 2093 results. Furthermore, the deficient serum folate results may have been checked for inappropriate indications. The first deficient result was noted as part of a stroke workup in a patient not taking folic acid supplementation. Current guidelines do not recommend serum folate testing in patients with new stroke.[33] In the second deficient case, serum folate testing was performed for evaluation of macrocytic anemia with an MCV of 119 fL. Although reasonable, this was an alcoholic patient presenting with acute gastrointestinal bleeding already on folic acid and multivitamin supplementation and known nonadherence with these supplements. In neither case was there a change in management based on the deficient result.

Given the low rate of serum folate deficiency and the lack of change in management based on deficient results, we conclude that there is a low utility of serum folate testing for any indication in inpatients and emergency department patients in folic acid‐fortified countries. Based on prior studies, and supported by our results, there is no evidence for checking serum folate levels in delirium, dementia, peripheral neuropathy, malnutrition, or any of the other indications. In addition, our results demonstrate a low utility even in patients with anemia or macrocytic anemia.

The rate of serum folate deficiency in our study was significantly lower than prior studies.[24, 26] There may have been geographical factors that led to a lower prevalence of folate deficiency in our study population. Our cohort included inpatients and emergency department patients, whereas previous studies had a majority of outpatients. It is known that serum folate levels can rapidly fluctuate with proper nutrition.[34] It may be that our patients received nutrition in the hospital that corrected serum folate levels prior to laboratory testing.

In addition to the low utility of serum folate testing, the charge per deficient result in our study ($158,022) was more than 100‐fold higher than that in the Robinson and Mladenovic study ($1321).[24] Even when correcting for variability in hospital charges by using the charge from the latter study, the charge per deficient serum folate test remained 50‐fold higher ($74,772). This implies that the increase in charge per deficient result was driven in part by a decreased rate of deficient tests. Folic acid fortification is likely responsible for some of the decrease. However, we believe another source is the excessive ordering of serum folate tests in patients without previously accepted indications. Because no change in management was made for the deficient patients in our study, the charge per serum folate deficient result that changed management approached infinity. This compares to $9979 in the Robinson and Mladenovic analysis.[24]

The cost to the hospital of a serum folate test was much lower than the charge, and estimated to be <$2093 per deficient result. Because serum folate tests are performed on a highly automated, random access analyzer that performs thousands of other measurements daily, the capital and labor costs for each test was well below $0.50 combined. With the addition of reagent costs, our total cost for each serum folate measurement was <$2.00. It is somewhat difficult to extrapolate these values to other hospitals, as exact costs and charges are variable. Nonetheless, the exceptionally low utility of serum folate testing makes the costs associated with these tests excessive.

Our study has several limitations. We conducted our study at a single institution in a country with mandatory folic acid fortification. Our results may not be generalizable to other institutions or patient populations, such as those in countries without mandatory folic acid fortification. Only 259 (12.4%) charts were reviewed, and indications were determined in 93.6% of charts, which may have caused our frequency to vary from the true frequency. Additionally, the low rate of deficient serum folate results limited our ability to identify associations with deficiency. Further evaluation for geographic variations of serum folate deficiency may reveal variable rates.

We conclude that in folic acid fortified countries, the rate of serum folate deficiency is increasingly rare, and the charge to patients and payers per deficient result is exceptionally high. In addition, testing in our study did not change clinical management, which makes the costs associated with these test wasteful. Further evaluation of serum folate testing of inpatients and emergency department patients in folic acid fortified countries is warranted; however, based on our results the utility appears poor for all indications.

Disclosure

Nothing to report.

References
  1. Tefferi A, Pruthi RK. The biochemical basis of cobalamin deficiency. Mayo Clin Proc. 1994;69(2):181186.
  2. Kasper DL, Braunwald E, Longo D, et al. Harrison's Principles of Internal Medicine. New York, NY:McGraw‐Hill Professional;2004.
  3. Wald NJ, Bower C. Folic acid, pernicious anaemia, and prevention of neural tube defects. Lancet. 1994;343(8893):307.
  4. Kado DM, Karlamangla AS, Huang M‐H, et al. Homocysteine versus the vitamins folate, B6, and B12 as predictors of cognitive function and decline in older high‐functioning adults: MacArthur Studies of Successful Aging. Am J Med. 2005;118(2):161167.
  5. D'Anci KE, Rosenberg IH. Folate and brain function in the elderly. Curr Opin Clin Nutr Metab Care. 2004;7(6):659664.
  6. Adunsky A, Arinzon Z, Fidelman Z, Krasniansky I, Arad M, Gepstein R. Plasma homocysteine levels and cognitive status in long‐term stay geriatric patients: a cross‐sectional study. Arch Gerontol Geriatr. 2005;40(2):129138.
  7. Parry TE. Folate responsive neuropathy. Presse Med. 1994;23(3):131137.
  8. Coppen A, Bolander‐Gouaille C. Treatment of depression: time to consider folic acid and vitamin B12. J Psychopharmacol (Oxford). 2005;19(1):5965.
  9. Blount BC, Mack MM, Wehr CM, et al. Folate deficiency causes uracil misincorporation into human DNA and chromosome breakage: implications for cancer and neuronal damage. Proc Natl Acad Sci U S A. 1997;94(7):32903295.
  10. Kim YI, Pogribny IP, Basnakian AG, et al. Folate deficiency in rats induces DNA strand breaks and hypomethylation within the p53 tumor suppressor gene. Am J Clin Nutr. 1997;65(1):4652.
  11. Freudenheim JL, Graham S, Marshall JR, Haughey BP, Cholewinski S, Wilkinson G. Folate intake and carcinogenesis of the colon and rectum. Int J Epidemiol. 1991;20(2):368374.
  12. Kune G, Watson L. Colorectal cancer protective effects and the dietary micronutrients folate, methionine, vitamins B6, B12, C, E, selenium, and lycopene. Nutr Cancer. 2006;56(1):1121.
  13. Giovannucci E, Stampfer MJ, Colditz GA, et al. Multivitamin use, folate, and colon cancer in women in the Nurses' Health Study. Ann Intern Med. 1998;129(7):517524.
  14. Gopinath B, Flood VM, Rochtchina E, Thiagalingam A, Mitchell P. Serum homocysteine and folate but not vitamin B12 are predictors of CHD mortality in older adults [published online ahead of print September 29, 2011]. Eur J Cardiovasc Prev Rehabil. doi: 10.1177/1741826711424568.
  15. Genest JJ, McNamara JR, Salem DN, Wilson PW, Schaefer EJ, Malinow MR. Plasma homocyst(e)ine levels in men with premature coronary artery disease. J Am Coll Cardiol. 1990;16(5):11141119.
  16. Bunout D, Petermann M, Hirsch S, et al. Low serum folate but normal homocysteine levels in patients with atherosclerotic vascular disease and matched healthy controls. Nutrition. 2000;16(6):434438.
  17. Voutilainen S, Lakka TA, Porkkala‐Sarataho E, Rissanen T, Kaplan GA, Salonen JT. Low serum folate concentrations are associated with an excess incidence of acute coronary events: the Kuopio Ischaemic Heart Disease Risk Factor Study. Eur J Clin Nutr. 2000;54(5):424428.
  18. Hernandez‐Diaz S, Martinez‐Losa E, Fernandez‐Jarne E, Serrano‐Martinez M, Martinez‐Gonzalez MA. Dietary folate and the risk of nonfatal myocardial infarction. Epidemiology. 2002;13(6):700706.
  19. Lonn E, Yusuf S, Arnold MJ, et al.;Heart Outcomes Prevention Evaluation (HOPE) 2 Investigators. Homocysteine lowering with folic acid and b vitamins in vascular disease. N Engl J Med. 2006;354(15):15671577.
  20. McMahon JA, Green TJ, Skeaff CM, Knight RG, Mann JI, Williams SM. A controlled trial of homocysteine lowering and cognitive performance. N Engl J Med. 2006;354(26):27642772.
  21. Malouf R, Grimley Evans J. Folic acid with or without vitamin B12 for the prevention and treatment of healthy elderly and demented people. Cochrane Database Syst Rev. 2008;(4):CD004514.
  22. Seward SJ, Safran C, Marton KI, Robinson SH. Does the mean corpuscular volume help physicians evaluate hospitalized patients with anemia?J Gen Intern Med. 1990;5(3):187191.
  23. Pfeiffer CM, Caudill SP, Gunter EW, Osterloh J, Sampson EJ. Biochemical indicators of B vitamin status in the US population after folic acid fortification: results from the National Health and Nutrition Examination Survey 1999–2000. Am J Clin Nutr. 2005;82(2):442450.
  24. Robinson AR, Mladenovic J. Lack of clinical utility of folate levels in the evaluation of macrocytosis or anemia. Am J Med. 2001;110(2):8890.
  25. McDowell MA, Lacher DA, Pfeiffer CM, et al. Blood folate levels: the latest NHANES results. NCHS Data Brief. 2008;(6):18.
  26. Ashraf MJ, Cook JR, Rothberg MB. Clinical utility of folic acid testing for patients with anemia or dementia. J Gen Intern Med. 2008;23(6):824826.
  27. Tefferi A. Anemia in adults: a contemporary approach to diagnosis. Mayo Clin Proc 2003;78(10):12741280.
  28. Smith DL. Anemia in the elderly. Am Fam Physician. 2000;62(7):15651572.
  29. Galloway M, Rushworth L. Red cell or serum folate? Results from the National Pathology Alliance benchmarking review. J Clin Pathol. 2003;56(12):924926.
  30. Hoffman R, Benz E, Silberstein LE, Heslop H, Weitz J, Anastasi J. Hematology. Philadelphia, PA:Churchill Livingstone;2012.
  31. Savage DG, Lindenbaum J, Stabler SP, Allen RH. Sensitivity of serum methylmalonic acid and total homocysteine determinations for diagnosing cobalamin and folate deficiencies. Am J Med. 1994;96(3):239246.
  32. Snow CF. Laboratory diagnosis of vitamin B12 and folate deficiency: a guide for the primary care physician. Arch Intern Med. 1999;159(12):12891298.
  33. Adams HP, del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: the American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Stroke. 2007;38(5):16551711.
  34. Verwei M, Freidig AP, Havenaar R, Groten JP. Predicted serum folate concentrations based on in vitro studies and kinetic modeling are consistent with measured folate concentrations in humans. J Nutr. 2006;136(12):30743078.
References
  1. Tefferi A, Pruthi RK. The biochemical basis of cobalamin deficiency. Mayo Clin Proc. 1994;69(2):181186.
  2. Kasper DL, Braunwald E, Longo D, et al. Harrison's Principles of Internal Medicine. New York, NY:McGraw‐Hill Professional;2004.
  3. Wald NJ, Bower C. Folic acid, pernicious anaemia, and prevention of neural tube defects. Lancet. 1994;343(8893):307.
  4. Kado DM, Karlamangla AS, Huang M‐H, et al. Homocysteine versus the vitamins folate, B6, and B12 as predictors of cognitive function and decline in older high‐functioning adults: MacArthur Studies of Successful Aging. Am J Med. 2005;118(2):161167.
  5. D'Anci KE, Rosenberg IH. Folate and brain function in the elderly. Curr Opin Clin Nutr Metab Care. 2004;7(6):659664.
  6. Adunsky A, Arinzon Z, Fidelman Z, Krasniansky I, Arad M, Gepstein R. Plasma homocysteine levels and cognitive status in long‐term stay geriatric patients: a cross‐sectional study. Arch Gerontol Geriatr. 2005;40(2):129138.
  7. Parry TE. Folate responsive neuropathy. Presse Med. 1994;23(3):131137.
  8. Coppen A, Bolander‐Gouaille C. Treatment of depression: time to consider folic acid and vitamin B12. J Psychopharmacol (Oxford). 2005;19(1):5965.
  9. Blount BC, Mack MM, Wehr CM, et al. Folate deficiency causes uracil misincorporation into human DNA and chromosome breakage: implications for cancer and neuronal damage. Proc Natl Acad Sci U S A. 1997;94(7):32903295.
  10. Kim YI, Pogribny IP, Basnakian AG, et al. Folate deficiency in rats induces DNA strand breaks and hypomethylation within the p53 tumor suppressor gene. Am J Clin Nutr. 1997;65(1):4652.
  11. Freudenheim JL, Graham S, Marshall JR, Haughey BP, Cholewinski S, Wilkinson G. Folate intake and carcinogenesis of the colon and rectum. Int J Epidemiol. 1991;20(2):368374.
  12. Kune G, Watson L. Colorectal cancer protective effects and the dietary micronutrients folate, methionine, vitamins B6, B12, C, E, selenium, and lycopene. Nutr Cancer. 2006;56(1):1121.
  13. Giovannucci E, Stampfer MJ, Colditz GA, et al. Multivitamin use, folate, and colon cancer in women in the Nurses' Health Study. Ann Intern Med. 1998;129(7):517524.
  14. Gopinath B, Flood VM, Rochtchina E, Thiagalingam A, Mitchell P. Serum homocysteine and folate but not vitamin B12 are predictors of CHD mortality in older adults [published online ahead of print September 29, 2011]. Eur J Cardiovasc Prev Rehabil. doi: 10.1177/1741826711424568.
  15. Genest JJ, McNamara JR, Salem DN, Wilson PW, Schaefer EJ, Malinow MR. Plasma homocyst(e)ine levels in men with premature coronary artery disease. J Am Coll Cardiol. 1990;16(5):11141119.
  16. Bunout D, Petermann M, Hirsch S, et al. Low serum folate but normal homocysteine levels in patients with atherosclerotic vascular disease and matched healthy controls. Nutrition. 2000;16(6):434438.
  17. Voutilainen S, Lakka TA, Porkkala‐Sarataho E, Rissanen T, Kaplan GA, Salonen JT. Low serum folate concentrations are associated with an excess incidence of acute coronary events: the Kuopio Ischaemic Heart Disease Risk Factor Study. Eur J Clin Nutr. 2000;54(5):424428.
  18. Hernandez‐Diaz S, Martinez‐Losa E, Fernandez‐Jarne E, Serrano‐Martinez M, Martinez‐Gonzalez MA. Dietary folate and the risk of nonfatal myocardial infarction. Epidemiology. 2002;13(6):700706.
  19. Lonn E, Yusuf S, Arnold MJ, et al.;Heart Outcomes Prevention Evaluation (HOPE) 2 Investigators. Homocysteine lowering with folic acid and b vitamins in vascular disease. N Engl J Med. 2006;354(15):15671577.
  20. McMahon JA, Green TJ, Skeaff CM, Knight RG, Mann JI, Williams SM. A controlled trial of homocysteine lowering and cognitive performance. N Engl J Med. 2006;354(26):27642772.
  21. Malouf R, Grimley Evans J. Folic acid with or without vitamin B12 for the prevention and treatment of healthy elderly and demented people. Cochrane Database Syst Rev. 2008;(4):CD004514.
  22. Seward SJ, Safran C, Marton KI, Robinson SH. Does the mean corpuscular volume help physicians evaluate hospitalized patients with anemia?J Gen Intern Med. 1990;5(3):187191.
  23. Pfeiffer CM, Caudill SP, Gunter EW, Osterloh J, Sampson EJ. Biochemical indicators of B vitamin status in the US population after folic acid fortification: results from the National Health and Nutrition Examination Survey 1999–2000. Am J Clin Nutr. 2005;82(2):442450.
  24. Robinson AR, Mladenovic J. Lack of clinical utility of folate levels in the evaluation of macrocytosis or anemia. Am J Med. 2001;110(2):8890.
  25. McDowell MA, Lacher DA, Pfeiffer CM, et al. Blood folate levels: the latest NHANES results. NCHS Data Brief. 2008;(6):18.
  26. Ashraf MJ, Cook JR, Rothberg MB. Clinical utility of folic acid testing for patients with anemia or dementia. J Gen Intern Med. 2008;23(6):824826.
  27. Tefferi A. Anemia in adults: a contemporary approach to diagnosis. Mayo Clin Proc 2003;78(10):12741280.
  28. Smith DL. Anemia in the elderly. Am Fam Physician. 2000;62(7):15651572.
  29. Galloway M, Rushworth L. Red cell or serum folate? Results from the National Pathology Alliance benchmarking review. J Clin Pathol. 2003;56(12):924926.
  30. Hoffman R, Benz E, Silberstein LE, Heslop H, Weitz J, Anastasi J. Hematology. Philadelphia, PA:Churchill Livingstone;2012.
  31. Savage DG, Lindenbaum J, Stabler SP, Allen RH. Sensitivity of serum methylmalonic acid and total homocysteine determinations for diagnosing cobalamin and folate deficiencies. Am J Med. 1994;96(3):239246.
  32. Snow CF. Laboratory diagnosis of vitamin B12 and folate deficiency: a guide for the primary care physician. Arch Intern Med. 1999;159(12):12891298.
  33. Adams HP, del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: the American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Stroke. 2007;38(5):16551711.
  34. Verwei M, Freidig AP, Havenaar R, Groten JP. Predicted serum folate concentrations based on in vitro studies and kinetic modeling are consistent with measured folate concentrations in humans. J Nutr. 2006;136(12):30743078.
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Utility, charge, and cost of inpatient and emergency department serum folate testing
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Address for correspondence and reprint requests: Jesse Theisen‐Toupal, MD, Instructor in Medicine, Division of General Medicine and Primary Care, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, 330 Brookline Avenue PBS‐2, Boston, MA 02215; Telephone: 617‐754‐4677; Fax: 617‐632‐0215; E‐mail: [email protected]
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“I'm Talking About Pain”

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“I'm Talking About Pain”: Sickle cell disease patients with extremely high hospital use

Sickle cell disease (SCD) accounts for approximately 113,000 hospital admissions annually in the United States, at a cost of approximately $500 million.1 The majority of these hospital admissions are due to painful episodes, vaso‐occlusive crises, often triggered by a psychological or physical stressor.2 Most individuals manage these crises at home,3 with sporadic admissions occurring, on average, 1.5 times per year.4 However, a minority of patients are admitted as often as several times per month, persistent over successive years,5, 6 a phenomenon we call extremely high hospital use (EHHU). These patients account for a disproportionate share of total costs, and may suffer worse health outcomes. Three or more hospital admissions per year has been correlated with a lower 5‐year survival rate,7 and high emergency room utilization was found to be associated with more reported pain, and more opioid use at home.8

To improve patient quality of life and to decrease healthcare costs in the management of SCD, there has been increased focus on predicting high utilization9 and identifying strategies to decrease hospitalization rates, especially among patients with EHHU.10 Although SCD patients with EHHU have been identified as a small group of outliers,5 the psychosocial factors associated with EHHU in adults with SCD have not been investigated. The objective of this qualitative study is to characterize the subjective experience of patients with sickle cell disease and EHHU, and generate hypotheses about its antecedents and consequences.

METHODS

The institutional review board (IRB) of Yale University School of Medicine, New Haven, CT, approved the research protocol.

Participants

We accessed the Yale‐New Haven Hospital administrative database to identify the number of patients with SCD who demonstrated EHHU that did not remit over successive years.5 We identified the 10 highest inpatient utilizing individuals with sickle cell disease over the period January 1, 2008December 31, 2010; 8 individuals consented to participate. We collected the following data on each participant through chart review: hemoglobinopathy, length of stay, primary diagnosis for each admission, and SCD‐related comorbidities (eg, avascular necrosis, leg ulcer, etc). No research team member was involved in the care of any of the participants.

Interviews

Based on literature review of other qualitative research in SCD, we created an interview guide to include the following themes: 1) disease, pain, and medication; 2) hospitalization; 3) support structures; 4) daily life; and 5) personal relationships (see Supporting Information, Appendix I, in the online version of this article). Applying Grounded Theory in qualitative research, the interview guide underwent several minor modifications based on field‐testing interviews with 4 interviews of patients not enrolled in the study and early interviews with study participants.11 Tape‐recorded interviews, each lasting at least an hour,12 were conducted by 1 researcher (D.W.) during inpatient hospitalizations, at least several days after admission to ensure that participants were comfortable enough to participate. When the interview exceeded an hour, it was continued at a later time. Recordings were transcribed by a professional transcription service and verified for accuracy by the interviewer. Participants were compensated $25 for completed interviews.

Narrative Analysis

The analysis team consisted of 2 psychiatrists (1 with additional training in internal medicine), 1 medical student, and 1 internist with additional training in addiction medicine. Analysts read each transcript, became thoroughly familiar with its content, and met to discuss preliminary findings. Then, we created patient experts among the group, assigning each analyst 2 interviews with which s/he prepared a detailed summary in the first person, using the participant's own words, according to an established process in phenomenological research13 (Figure 1). These narrative summaries allowed for the development of a holistic view of the participant, the creation of a narrative structure, and the fostering of an empathic bridge,13 a connection between the experiences of the participant and those of the reviewer. The summaries were read aloud at research meetings allowing for discussion, and the content of the summaries were modified based on the consensus of the group.

Figure 1
Narrative and analysis model.13

Next, we randomly rotated the narrative summaries so that each of the 4 analysts became an expert for 2 additional participants in order to critically evaluate the compiled narratives, and develop a structural summary14a summary of the prevalent themes. We extracted content from the narrative summaries based on these common themes, and returned to the transcripts as needed for relevant quotations. This inductive process allowed unique participant narratives to come through unconstrained by a predetermined coding structure.

The team reached consensus on organizing themes following the chronology of childhood to adulthood. This model was utilized to preserve the narrative basis of the methodology, and to ultimately elucidate the antecedents, subjective experience, and consequences of EHHU. An audit trail was maintained throughout the data analysis process.

RESULTS

Table 1 displays demographic, clinical, and hospitalization data for the 8 participants. These patients represented approximately 8% of the population with sickle cell disease at the study institution, but accounted for 57% of hospital days among sickle cell disease patients over a 3‐year period, with cumulative hospital days near or above 100 days per patient each year. Greater than 90% of admissions were for vaso‐occlusive crises without other SCD‐related complications. However, many participants had complicated medical histories, including avascular necrosis, acute chest syndrome, and leg ulcers.

Demographic and Clinical Data
ParticipantAge at Interview DateGenderHemoglobin Diagnosis*Average Hospital Days per Year 20082010
  • HbSS denotes homozygosity for the sickle cell gene (HBB glu6val), sickle cell anemia. HbS‐B thalassemia denotes heterozygosity for the sickle cell gene (HBB glu6val) and one of the B‐thalassemia gene mutations. HbSC denotes heterozygosity for the sickle cell gene (HBB glu6val) and the hemoglobin C gene (HBB glu6lys), sickle‐hemoglobin C disease.

  • Hospitalization data only applies to hospital days at Yale‐New Haven Hospital.

  • Participant spent 1 y in prisonthis interval was not included in his hospitalization rate.

134FHbSS171
227FHbSS263
326MHbS‐B thalassemia151
434MHbSC111
537FHbSS202
625FHbS‐B thalassemia104
724FHbSS123
1032MHbSS94

Participant interviews presented a common narrative of the evolution of EHHU from a young age, culminating in a universally negative description of hospitalization: It's like jail. (participant 2); It's like a massacre, coming in the hospital; I get tortured. (participant 1). Saturation was reached on major themes, which fit into 3 general categories: pain and opioid medication use, interpersonal relationships, and personal development.

Pain and Opioid Medication Use

Participants reported hospital use dating back to childhood, which was the first exposure to intravenous opioid medications and the beginning of a trajectory of accelerating use, tolerance, and dependence: You know, I came in the hospital when I was two years old I stayed 'til I was like five and a half. I started school here. (participant 1); I started taking that medicine when I was on the pedi side. So my body's already used to it it doesn't really touch me. They're gonna have to up my doses. (participant 7).

As adults, participants expressed awareness of the potential problems of opioids. During interviews, many participants exhibited side effects of these medications, such as itching and somnolence. Moreover, participants expressed awareness of the skepticism and mistrust from providers, and acknowledged that such sentiments may be justified toward certain patients: That's all our body knows, is meds, meds, meds. And because your body is addicted to this level, you gotta go up another level, but some doctors think we're taking too much. How can we be taking too much when we need it? (participant 5); The oxy which I'm on [oxycontin 240 mg per day] when you take that, you going to sleep. And then some of them will say when you go home you're not taking the medicine like you should. (participant 5).

Opioids were taken in and out of the hospital by all participants, and were identified as necessary in combating debilitating pain. Many participants expressed a reluctance to try other forms of therapy, such as hydroxyurea: These new chemicals, you come across doctors who say there's this new medicine out, and it's been out for such and such amount of timeI think it would be good, can we try it with you? No. I'm not a guinea. (participant 2).

While all participants described unpredictable pain crises, some also described an underlying, constant pain syndrome: You know, like, I could be fine right now; the next minute I could be Oh, my God crying, so much pain. You never know when you're gonna have a crisis. (participant 1); There's never no pain. There's always pain. It's just a fact of life. I wake up and I can deal with the pain, it's not that bad today. But then when the crisis hits, that's when it gets unbearable. (participant 10); I'm not in pain every day, every second. To me, I don't think that any sickle cell patient is in pain every day. They make theirselves to [be] it saddens me sometimes. (participant 6).

Interpersonal Relationships

In childhood, participants developed close relationships with the staff of the children's hospital and an attachment to this institution: I loved pediatrics. It's the adult side I can't stand. They treat you better. (participant 7); Some people in the ER, they know us; and I call them my family they already know what I need. (participant 5).

In contrast, the hospital experience during adulthood was often punctuated by bitter relationships with staff, and distrust over possible excessive use of opioids. Moreover, participants raised the possibility of racism in their interactions with hospital staff. Overall, participants highlighted a lack of empathy among caregivers: Some doctors, they're rude, like, they're rough. They'll just pull out the scope bang it onto my back, or just push on my body or areas where it hurts. (participant 6); I'm your doctor. And I say I think you're doing a lot better, how would you feel about going home today? And you can say I don't think I'm ready. And I can say Well, you can't live here in the hospital. Why do you think you're not ready for home yet? You're never, ever going to be pain free, and that's when you turn around to me and say I know that. I've been dealing with this for all my life. I know I'm never gonna be pain free! (participant 2).

Such negative interactions extended to friends and family members, leading to a sense of social isolation and a reluctance to discuss their disease with others: I just don't think people will understand where I'm coming from. So I just don't talk to anybody, I keep it inside. Or I write it in my diary. (participant 5); I don't have any friends. I have associates. I'm always by myself. (participant 1).

Even though participants expressed dismay at dysfunctional relationships within the hospital, they also voiced affection for staff members. Participant 1 described hospital stays that were loving, and participant 3 described his hematologist as his brother from another mother, and a nurse practitioner as his aunt.

Personal Development

Hospitalization in childhood was linked to EHHU as an adult by the derailment that participants described in their personal development. Prolonged hospitalization and illness were barriers to education, interfering with the development of social as well as academic skills: I couldn't spell me being in a hospital for so much I was like, no, I don't want that bookwork like everybody else. (participant 3); I stopped going to school. I told [my mom] that I was not going back to school because the kids made fun of me Oh, she has a disease. Be careful, you might get the cooties. (participant 2).

Participants also described a sense of foreshortened future. Many were told that they would not survive their teens: They told my mother I would die before I was 12 years old. And I would be scared to go to sleep, because I would think I was gonna die in my sleep. (participant 2)

As an adult, numerous and/or prolonged hospitalizations interfered with participants' ability to remain employed, and they experienced strains on fulfilling family roles: I would love to work again, but who gonna hire somebody that's always out, more than you're working. Nobody. (participant 5); Sometimes I feel like I'm neglecting my son, being here. You have to take care of yourself in order for you to be there for him. But it just stresses me out. (participant 6).

The struggles of hospitalization and pain management took their toll on participants' mental health. Participants described difficulty sleeping, depression, and suicidal thoughts: Sorrow. That's what [sickle cell] means to me. Unhappy. Everything's depressing. It takes over your body and your mind and your soul. (participant 5); I really was gonna kill myself cause it's like, sometime, the pain, you be in so much pain, you be like, fuck this, man. My pain was bothering me so much, I laid down on the highway, wishin a car would run me over. (participant 4).

Despite fragile mental and physical health, many participants described feelings of strength and resilience, and some described hope in the future for employment, education, travel, and family: I don't know why God picked me, but for some strange, mysterious reason he picked me. I still don't know what that reason may be, but I ain't gonna give up. Maybe he got some kind of plan in store. (participant 2).

DISCUSSION

Our study population represents a unique and understudied group among patients with SCD. While several themes from prior research on individuals with SCD were presentreciprocal mistrust between patients and providers surrounding opioid analgesics and pain reporting,15, 16 racial and disease‐related bias,17 patient dissatisfaction with clinical services,18the common narrative of thwarted personal development in the setting of a long history of hospitalization and opioid use was striking.

The developmental perspective posits that age‐appropriate tasks govern basic capacities and skills (academic, interpersonal, affective, and cognitive) honed through institutional interactions (family, school, and community), which allow individuals to develop autonomy that guides them into effective participation in social groups and civil society, and eventually to becoming guarantors for the next generation. Our participants described problems such as social isolation, depression, and dependence on medications, all linked to their description of recurrent stays in the hospital during childhood and adolescence, where missed vocational and social opportunities left their indelible mark. Participants expressed an awareness of their inability to lead productive lives, and the perception that they were burdensome to their caregivers and the hospital.

While previous research has correlated high hospital utilization in SCD with factors like poor coping strategies,1921 high levels of stress,22 and inadequate support,17 our interviews suggest that such psychosocial difficulties may be consequences as well as causes of hospitalization, creating an accelerating downward spiral of dysfunction. At the center of this spiral is participants' ongoing experience of pain, which may be related to SCD, medications, or neither.23 Additionally, chronic anemia, opioid exposure, airway disease, and cerebrovascular disease are all implicated in impaired neuropsychological functioning in children and adolescents with sickle cell disease.24, 25

Clinical features of SCD remain relevant to hospitalization in adulthood. Chart review revealed that the vast majority of inpatient admissions were due to vaso‐occlusive crises uncomplicated by SCD‐related pathology, such as aseptic necrosis of bone or acute chest syndrome. This finding is consistent with previous work,9 which correlated new onset of high hospital use with SCD‐related complications, but not reliably with persistent EHHU, our study population.

The double‐edged sword of opioid use26 was starkly evident in participants' narratives. Crippling vaso‐occlusive crises were competently treated with opioids starting in childhood, but then a cycle of increasing outpatient doses of opioids and more frequent and longer courses of inpatient intravenous opioids followed. Participants felt judged and stigmatized for seeking one of the few treatment options they had been offered, resulting in confusion and bitterness at times. Other potential complications of long‐term opioid therapy less well known to patients and providers such as hypogonadism and hyperalgesia27may have played a role in the patient experience and should be examined in future research. In addition, undertreatment of pain may lead to pseudoaddiction,28 underscoring the complexity of delineating the pathologies of dependence, addiction, withdrawal, acute pain, and chronic pain.

Our study is limited primarily by the fact that it was conducted with a small number of participants. It is also possible that institutional variation, especially with regard to pain management, makes it difficult to generalize our hypotheses. Similarly, our participants grew up in similar environments outside the hospital, which may differ significantly from environments of other individuals with EHHU. Lastly, participants were all interviewed as inpatients, and the acuteness of their illness may have influenced responses. Despite these limitations, we achieved saturation on the major themes, and there was substantial agreement in their experiences of their illness.

Breaking the cycle of alienation from the external world and dependence on the hospital necessitates an acknowledgement of the role of the hospital, pain, and opioid use in the long‐term development of individuals with EHHU. Further research should test this developmental hypothesis, and focus on early interventions and the critical transition from pediatric to adult care.25 Longitudinal quantitative analysis could include psychosocial variables in SCD in the attempt to predict EHHU as has been accomplished in the chronic pain literature.29 Additionally, a comprehensive qualitative approach including the perspectives of caregivers, family members, and comparison to low hospital utilizers will better inform interventions aimed at ameliorating EHHU. It is particularly important to understand the similarities and differences in the long‐term development of patients with SCD who demonstrate EHHU versus low hospital use. The optimal strategy for opioid use in the long‐term management of pain in patients with SCD remains to be determined. Alternatives to opioids should be investigated in a controlled trial, and institutional differences should be examined as they relate to EHHU and pain‐management strategies. Lastly, our results suggest that psychosocial and skill rehabilitation may mitigate EHHU, and that multidisciplinary resources proactively directed towards this population will reduce hospitalization.30

Files
References
  1. Brousseau DC,Panepinto JA,Nimmer M,Hoffmann RG.The number of people with sickle‐cell disease in the United States: national and state estimates.Am J Hematol.2009;85:7778.
  2. Ballas SK.Current issues in sickle cell pain and its management.Hematology Am Soc Hematol Educ Program.2007:97105.
  3. Smith WR,Penberthy LT,Bovbjerg VE, et al.Daily assessment of pain in adults with sickle cell disease.Ann Intern Med.2008;148:94101.
  4. Brousseau DC,Owens PL,Mosso AL,Panepinto JA,Steiner CA.Acute care utilization and rehospitalizations for sickle cell disease.JAMA.2010;303:12881294.
  5. Carroll CP,Haywood C,Fagan P,Lanzkron S.The course and correlates of high hospital utilization in sickle cell disease: evidence from a large, urban Medicaid managed care organization.Am J Hematol.2009;84:666670.
  6. Shankar SM,Arbogast PG,Mitchel E,Cooper WO,Wang WC,Griffin MR.Medical care utilization and mortality in sickle cell disease: a population‐based study.Am J Hematol.2005;80:262270.
  7. Platt OS,Thorington BD,Brambilla DJ, et al.Pain in sickle cell disease. Rates and risk factors.N Engl J Med.1991;325:1116.
  8. Aisiku IP,Smith WR,McClish DK, et al.Comparisons of high versus low emergency department utilizers in sickle cell disease.Ann Emerg Med.2009;53:587593.
  9. Carroll CP,Haywood C,Lanzkron S.Prediction of onset and course of high hospital utilization in sickle cell disease.J Hosp Med.2011;6:248255.
  10. Chen E,Cole SW,Kato PM.A review of empirically supported psychosocial interventions for pain and adherence outcomes in sickle cell disease.J Pediatr Psychol.2004;29:197209.
  11. Glaser BG.More Grounded Theory Methodology: A Reader.Mill Valley, CA:Sociology Press;1994.
  12. McCracken GD.The Long Interview.Newbury Park, CA:Sage;1988.
  13. Sells D,Topor A,Davidson L.Generating coherence out of chaos: examples of the utility of empathic bridges in phenomenological research.J Phenomenolog Psychol.2004;35:253271.
  14. Davidson L,Wieland M,Flanagan EH,Sells D.Using qualitative methods in clinical research. In: McKay D, ed.Handbook of Research Methods in Abnormal and Clinical Psychology.Los Angeles, CA:Sage;2008:263269.
  15. Shapiro BS,Benjamin LJ,Payne R,Heidrich G.Sickle cell‐related pain: perceptions of medical practitioners.J Pain Symptom Manage.1997;14:168174.
  16. Booker MJ,Blethyn KL,Wright CJ,Greenfield SM.Pain management in sickle cell disease.Chronic Illn.2006;2:3950.
  17. Maxwell K,Streetly A,Bevan D.Experiences of hospital care and treatment‐seeking behavior for pain from sickle cell disease: qualitative study.West J Med.1999;171:306313.
  18. Brousseau DC,Mukonje T,Brandow AM,Nimmer M,Panepinto JA.Dissatisfaction with hospital care for children with sickle cell disease not due only to race and chronic disease.Pediatr Blood Cancer.2009;53:174178.
  19. Gil KM,Abrams MR,Phillips G,Keefe FJ.Sickle cell disease pain: relation of coping strategies to adjustment.J Consult Clin Psychol.1989;57:725731.
  20. Gil KM,Abrams MR,Phillips G,Williams DA.Sickle cell disease pain: 2. Predicting health care use and activity level at 9‐month follow‐up.J Consult Clin Psychol.1992;60:267273.
  21. Anie KA,Steptoe A,Ball S,Dick M,Smalling BM.Coping and health service utilisation in a UK study of paediatric sickle cell pain.Arch Dis Child.2002;86:325329.
  22. Gil KM,Carson JW,Porter LS,Scipio C,Bediako SM,Orringer E.Daily mood and stress predict pain, health care use, and work activity in African American adults with sickle‐cell disease.Health Psychol.2004;23:267274.
  23. Benjamin L.Pain management in sickle cell disease: palliative care begins at birth?Hematology Am Soc Hematol Educ Program.2008:466474.
  24. Schatz J,Finke RL,Kellett JM,Kramer JH.Cognitive functioning in children with sickle cell disease: a meta‐analysis.J Pediatr Psychol.2002;27:739748.
  25. Wills KE,Nelson SC,Hennessy J, et al.Transition planning for youth with sickle cell disease: embedding neuropsychological assessment into comprehensive care.Pediatrics.2010;126(suppl 3):S151S159.
  26. Simoni‐Wastila L.Increases in opioid medication use: balancing the good with the bad.Pain.2008;138:245246.
  27. Mercadante S,Ferrera P,Villari P,Arcuri E.Hyperalgesia: an emerging iatrogenic syndrome.J Pain Symptom Manage.2003;26:769775.
  28. Elander J,Lusher J,Bevan D,Telfer P,Burton B.Understanding the causes of problematic pain management in sickle cell disease: evidence that pseudoaddiction plays a more important role than genuine analgesic dependence.J Pain Symptom Manage.2004;27:156169.
  29. Walker LS,Sherman AL,Bruehl S,Garber J,Smith CA.Functional abdominal pain patient subtypes in childhood predict functional gastrointestinal disorders with chronic pain and psychiatric comorbidities in adolescence and adulthood.Pain.2012;153:17981806.
  30. Artz N,Whelan C,Feehan S.Caring for the adult with sickle cell disease: results of a multidisciplinary pilot program.J Natl Med Assoc.2010;102:10091016.
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Journal of Hospital Medicine - 8(1)
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Sickle cell disease (SCD) accounts for approximately 113,000 hospital admissions annually in the United States, at a cost of approximately $500 million.1 The majority of these hospital admissions are due to painful episodes, vaso‐occlusive crises, often triggered by a psychological or physical stressor.2 Most individuals manage these crises at home,3 with sporadic admissions occurring, on average, 1.5 times per year.4 However, a minority of patients are admitted as often as several times per month, persistent over successive years,5, 6 a phenomenon we call extremely high hospital use (EHHU). These patients account for a disproportionate share of total costs, and may suffer worse health outcomes. Three or more hospital admissions per year has been correlated with a lower 5‐year survival rate,7 and high emergency room utilization was found to be associated with more reported pain, and more opioid use at home.8

To improve patient quality of life and to decrease healthcare costs in the management of SCD, there has been increased focus on predicting high utilization9 and identifying strategies to decrease hospitalization rates, especially among patients with EHHU.10 Although SCD patients with EHHU have been identified as a small group of outliers,5 the psychosocial factors associated with EHHU in adults with SCD have not been investigated. The objective of this qualitative study is to characterize the subjective experience of patients with sickle cell disease and EHHU, and generate hypotheses about its antecedents and consequences.

METHODS

The institutional review board (IRB) of Yale University School of Medicine, New Haven, CT, approved the research protocol.

Participants

We accessed the Yale‐New Haven Hospital administrative database to identify the number of patients with SCD who demonstrated EHHU that did not remit over successive years.5 We identified the 10 highest inpatient utilizing individuals with sickle cell disease over the period January 1, 2008December 31, 2010; 8 individuals consented to participate. We collected the following data on each participant through chart review: hemoglobinopathy, length of stay, primary diagnosis for each admission, and SCD‐related comorbidities (eg, avascular necrosis, leg ulcer, etc). No research team member was involved in the care of any of the participants.

Interviews

Based on literature review of other qualitative research in SCD, we created an interview guide to include the following themes: 1) disease, pain, and medication; 2) hospitalization; 3) support structures; 4) daily life; and 5) personal relationships (see Supporting Information, Appendix I, in the online version of this article). Applying Grounded Theory in qualitative research, the interview guide underwent several minor modifications based on field‐testing interviews with 4 interviews of patients not enrolled in the study and early interviews with study participants.11 Tape‐recorded interviews, each lasting at least an hour,12 were conducted by 1 researcher (D.W.) during inpatient hospitalizations, at least several days after admission to ensure that participants were comfortable enough to participate. When the interview exceeded an hour, it was continued at a later time. Recordings were transcribed by a professional transcription service and verified for accuracy by the interviewer. Participants were compensated $25 for completed interviews.

Narrative Analysis

The analysis team consisted of 2 psychiatrists (1 with additional training in internal medicine), 1 medical student, and 1 internist with additional training in addiction medicine. Analysts read each transcript, became thoroughly familiar with its content, and met to discuss preliminary findings. Then, we created patient experts among the group, assigning each analyst 2 interviews with which s/he prepared a detailed summary in the first person, using the participant's own words, according to an established process in phenomenological research13 (Figure 1). These narrative summaries allowed for the development of a holistic view of the participant, the creation of a narrative structure, and the fostering of an empathic bridge,13 a connection between the experiences of the participant and those of the reviewer. The summaries were read aloud at research meetings allowing for discussion, and the content of the summaries were modified based on the consensus of the group.

Figure 1
Narrative and analysis model.13

Next, we randomly rotated the narrative summaries so that each of the 4 analysts became an expert for 2 additional participants in order to critically evaluate the compiled narratives, and develop a structural summary14a summary of the prevalent themes. We extracted content from the narrative summaries based on these common themes, and returned to the transcripts as needed for relevant quotations. This inductive process allowed unique participant narratives to come through unconstrained by a predetermined coding structure.

The team reached consensus on organizing themes following the chronology of childhood to adulthood. This model was utilized to preserve the narrative basis of the methodology, and to ultimately elucidate the antecedents, subjective experience, and consequences of EHHU. An audit trail was maintained throughout the data analysis process.

RESULTS

Table 1 displays demographic, clinical, and hospitalization data for the 8 participants. These patients represented approximately 8% of the population with sickle cell disease at the study institution, but accounted for 57% of hospital days among sickle cell disease patients over a 3‐year period, with cumulative hospital days near or above 100 days per patient each year. Greater than 90% of admissions were for vaso‐occlusive crises without other SCD‐related complications. However, many participants had complicated medical histories, including avascular necrosis, acute chest syndrome, and leg ulcers.

Demographic and Clinical Data
ParticipantAge at Interview DateGenderHemoglobin Diagnosis*Average Hospital Days per Year 20082010
  • HbSS denotes homozygosity for the sickle cell gene (HBB glu6val), sickle cell anemia. HbS‐B thalassemia denotes heterozygosity for the sickle cell gene (HBB glu6val) and one of the B‐thalassemia gene mutations. HbSC denotes heterozygosity for the sickle cell gene (HBB glu6val) and the hemoglobin C gene (HBB glu6lys), sickle‐hemoglobin C disease.

  • Hospitalization data only applies to hospital days at Yale‐New Haven Hospital.

  • Participant spent 1 y in prisonthis interval was not included in his hospitalization rate.

134FHbSS171
227FHbSS263
326MHbS‐B thalassemia151
434MHbSC111
537FHbSS202
625FHbS‐B thalassemia104
724FHbSS123
1032MHbSS94

Participant interviews presented a common narrative of the evolution of EHHU from a young age, culminating in a universally negative description of hospitalization: It's like jail. (participant 2); It's like a massacre, coming in the hospital; I get tortured. (participant 1). Saturation was reached on major themes, which fit into 3 general categories: pain and opioid medication use, interpersonal relationships, and personal development.

Pain and Opioid Medication Use

Participants reported hospital use dating back to childhood, which was the first exposure to intravenous opioid medications and the beginning of a trajectory of accelerating use, tolerance, and dependence: You know, I came in the hospital when I was two years old I stayed 'til I was like five and a half. I started school here. (participant 1); I started taking that medicine when I was on the pedi side. So my body's already used to it it doesn't really touch me. They're gonna have to up my doses. (participant 7).

As adults, participants expressed awareness of the potential problems of opioids. During interviews, many participants exhibited side effects of these medications, such as itching and somnolence. Moreover, participants expressed awareness of the skepticism and mistrust from providers, and acknowledged that such sentiments may be justified toward certain patients: That's all our body knows, is meds, meds, meds. And because your body is addicted to this level, you gotta go up another level, but some doctors think we're taking too much. How can we be taking too much when we need it? (participant 5); The oxy which I'm on [oxycontin 240 mg per day] when you take that, you going to sleep. And then some of them will say when you go home you're not taking the medicine like you should. (participant 5).

Opioids were taken in and out of the hospital by all participants, and were identified as necessary in combating debilitating pain. Many participants expressed a reluctance to try other forms of therapy, such as hydroxyurea: These new chemicals, you come across doctors who say there's this new medicine out, and it's been out for such and such amount of timeI think it would be good, can we try it with you? No. I'm not a guinea. (participant 2).

While all participants described unpredictable pain crises, some also described an underlying, constant pain syndrome: You know, like, I could be fine right now; the next minute I could be Oh, my God crying, so much pain. You never know when you're gonna have a crisis. (participant 1); There's never no pain. There's always pain. It's just a fact of life. I wake up and I can deal with the pain, it's not that bad today. But then when the crisis hits, that's when it gets unbearable. (participant 10); I'm not in pain every day, every second. To me, I don't think that any sickle cell patient is in pain every day. They make theirselves to [be] it saddens me sometimes. (participant 6).

Interpersonal Relationships

In childhood, participants developed close relationships with the staff of the children's hospital and an attachment to this institution: I loved pediatrics. It's the adult side I can't stand. They treat you better. (participant 7); Some people in the ER, they know us; and I call them my family they already know what I need. (participant 5).

In contrast, the hospital experience during adulthood was often punctuated by bitter relationships with staff, and distrust over possible excessive use of opioids. Moreover, participants raised the possibility of racism in their interactions with hospital staff. Overall, participants highlighted a lack of empathy among caregivers: Some doctors, they're rude, like, they're rough. They'll just pull out the scope bang it onto my back, or just push on my body or areas where it hurts. (participant 6); I'm your doctor. And I say I think you're doing a lot better, how would you feel about going home today? And you can say I don't think I'm ready. And I can say Well, you can't live here in the hospital. Why do you think you're not ready for home yet? You're never, ever going to be pain free, and that's when you turn around to me and say I know that. I've been dealing with this for all my life. I know I'm never gonna be pain free! (participant 2).

Such negative interactions extended to friends and family members, leading to a sense of social isolation and a reluctance to discuss their disease with others: I just don't think people will understand where I'm coming from. So I just don't talk to anybody, I keep it inside. Or I write it in my diary. (participant 5); I don't have any friends. I have associates. I'm always by myself. (participant 1).

Even though participants expressed dismay at dysfunctional relationships within the hospital, they also voiced affection for staff members. Participant 1 described hospital stays that were loving, and participant 3 described his hematologist as his brother from another mother, and a nurse practitioner as his aunt.

Personal Development

Hospitalization in childhood was linked to EHHU as an adult by the derailment that participants described in their personal development. Prolonged hospitalization and illness were barriers to education, interfering with the development of social as well as academic skills: I couldn't spell me being in a hospital for so much I was like, no, I don't want that bookwork like everybody else. (participant 3); I stopped going to school. I told [my mom] that I was not going back to school because the kids made fun of me Oh, she has a disease. Be careful, you might get the cooties. (participant 2).

Participants also described a sense of foreshortened future. Many were told that they would not survive their teens: They told my mother I would die before I was 12 years old. And I would be scared to go to sleep, because I would think I was gonna die in my sleep. (participant 2)

As an adult, numerous and/or prolonged hospitalizations interfered with participants' ability to remain employed, and they experienced strains on fulfilling family roles: I would love to work again, but who gonna hire somebody that's always out, more than you're working. Nobody. (participant 5); Sometimes I feel like I'm neglecting my son, being here. You have to take care of yourself in order for you to be there for him. But it just stresses me out. (participant 6).

The struggles of hospitalization and pain management took their toll on participants' mental health. Participants described difficulty sleeping, depression, and suicidal thoughts: Sorrow. That's what [sickle cell] means to me. Unhappy. Everything's depressing. It takes over your body and your mind and your soul. (participant 5); I really was gonna kill myself cause it's like, sometime, the pain, you be in so much pain, you be like, fuck this, man. My pain was bothering me so much, I laid down on the highway, wishin a car would run me over. (participant 4).

Despite fragile mental and physical health, many participants described feelings of strength and resilience, and some described hope in the future for employment, education, travel, and family: I don't know why God picked me, but for some strange, mysterious reason he picked me. I still don't know what that reason may be, but I ain't gonna give up. Maybe he got some kind of plan in store. (participant 2).

DISCUSSION

Our study population represents a unique and understudied group among patients with SCD. While several themes from prior research on individuals with SCD were presentreciprocal mistrust between patients and providers surrounding opioid analgesics and pain reporting,15, 16 racial and disease‐related bias,17 patient dissatisfaction with clinical services,18the common narrative of thwarted personal development in the setting of a long history of hospitalization and opioid use was striking.

The developmental perspective posits that age‐appropriate tasks govern basic capacities and skills (academic, interpersonal, affective, and cognitive) honed through institutional interactions (family, school, and community), which allow individuals to develop autonomy that guides them into effective participation in social groups and civil society, and eventually to becoming guarantors for the next generation. Our participants described problems such as social isolation, depression, and dependence on medications, all linked to their description of recurrent stays in the hospital during childhood and adolescence, where missed vocational and social opportunities left their indelible mark. Participants expressed an awareness of their inability to lead productive lives, and the perception that they were burdensome to their caregivers and the hospital.

While previous research has correlated high hospital utilization in SCD with factors like poor coping strategies,1921 high levels of stress,22 and inadequate support,17 our interviews suggest that such psychosocial difficulties may be consequences as well as causes of hospitalization, creating an accelerating downward spiral of dysfunction. At the center of this spiral is participants' ongoing experience of pain, which may be related to SCD, medications, or neither.23 Additionally, chronic anemia, opioid exposure, airway disease, and cerebrovascular disease are all implicated in impaired neuropsychological functioning in children and adolescents with sickle cell disease.24, 25

Clinical features of SCD remain relevant to hospitalization in adulthood. Chart review revealed that the vast majority of inpatient admissions were due to vaso‐occlusive crises uncomplicated by SCD‐related pathology, such as aseptic necrosis of bone or acute chest syndrome. This finding is consistent with previous work,9 which correlated new onset of high hospital use with SCD‐related complications, but not reliably with persistent EHHU, our study population.

The double‐edged sword of opioid use26 was starkly evident in participants' narratives. Crippling vaso‐occlusive crises were competently treated with opioids starting in childhood, but then a cycle of increasing outpatient doses of opioids and more frequent and longer courses of inpatient intravenous opioids followed. Participants felt judged and stigmatized for seeking one of the few treatment options they had been offered, resulting in confusion and bitterness at times. Other potential complications of long‐term opioid therapy less well known to patients and providers such as hypogonadism and hyperalgesia27may have played a role in the patient experience and should be examined in future research. In addition, undertreatment of pain may lead to pseudoaddiction,28 underscoring the complexity of delineating the pathologies of dependence, addiction, withdrawal, acute pain, and chronic pain.

Our study is limited primarily by the fact that it was conducted with a small number of participants. It is also possible that institutional variation, especially with regard to pain management, makes it difficult to generalize our hypotheses. Similarly, our participants grew up in similar environments outside the hospital, which may differ significantly from environments of other individuals with EHHU. Lastly, participants were all interviewed as inpatients, and the acuteness of their illness may have influenced responses. Despite these limitations, we achieved saturation on the major themes, and there was substantial agreement in their experiences of their illness.

Breaking the cycle of alienation from the external world and dependence on the hospital necessitates an acknowledgement of the role of the hospital, pain, and opioid use in the long‐term development of individuals with EHHU. Further research should test this developmental hypothesis, and focus on early interventions and the critical transition from pediatric to adult care.25 Longitudinal quantitative analysis could include psychosocial variables in SCD in the attempt to predict EHHU as has been accomplished in the chronic pain literature.29 Additionally, a comprehensive qualitative approach including the perspectives of caregivers, family members, and comparison to low hospital utilizers will better inform interventions aimed at ameliorating EHHU. It is particularly important to understand the similarities and differences in the long‐term development of patients with SCD who demonstrate EHHU versus low hospital use. The optimal strategy for opioid use in the long‐term management of pain in patients with SCD remains to be determined. Alternatives to opioids should be investigated in a controlled trial, and institutional differences should be examined as they relate to EHHU and pain‐management strategies. Lastly, our results suggest that psychosocial and skill rehabilitation may mitigate EHHU, and that multidisciplinary resources proactively directed towards this population will reduce hospitalization.30

Sickle cell disease (SCD) accounts for approximately 113,000 hospital admissions annually in the United States, at a cost of approximately $500 million.1 The majority of these hospital admissions are due to painful episodes, vaso‐occlusive crises, often triggered by a psychological or physical stressor.2 Most individuals manage these crises at home,3 with sporadic admissions occurring, on average, 1.5 times per year.4 However, a minority of patients are admitted as often as several times per month, persistent over successive years,5, 6 a phenomenon we call extremely high hospital use (EHHU). These patients account for a disproportionate share of total costs, and may suffer worse health outcomes. Three or more hospital admissions per year has been correlated with a lower 5‐year survival rate,7 and high emergency room utilization was found to be associated with more reported pain, and more opioid use at home.8

To improve patient quality of life and to decrease healthcare costs in the management of SCD, there has been increased focus on predicting high utilization9 and identifying strategies to decrease hospitalization rates, especially among patients with EHHU.10 Although SCD patients with EHHU have been identified as a small group of outliers,5 the psychosocial factors associated with EHHU in adults with SCD have not been investigated. The objective of this qualitative study is to characterize the subjective experience of patients with sickle cell disease and EHHU, and generate hypotheses about its antecedents and consequences.

METHODS

The institutional review board (IRB) of Yale University School of Medicine, New Haven, CT, approved the research protocol.

Participants

We accessed the Yale‐New Haven Hospital administrative database to identify the number of patients with SCD who demonstrated EHHU that did not remit over successive years.5 We identified the 10 highest inpatient utilizing individuals with sickle cell disease over the period January 1, 2008December 31, 2010; 8 individuals consented to participate. We collected the following data on each participant through chart review: hemoglobinopathy, length of stay, primary diagnosis for each admission, and SCD‐related comorbidities (eg, avascular necrosis, leg ulcer, etc). No research team member was involved in the care of any of the participants.

Interviews

Based on literature review of other qualitative research in SCD, we created an interview guide to include the following themes: 1) disease, pain, and medication; 2) hospitalization; 3) support structures; 4) daily life; and 5) personal relationships (see Supporting Information, Appendix I, in the online version of this article). Applying Grounded Theory in qualitative research, the interview guide underwent several minor modifications based on field‐testing interviews with 4 interviews of patients not enrolled in the study and early interviews with study participants.11 Tape‐recorded interviews, each lasting at least an hour,12 were conducted by 1 researcher (D.W.) during inpatient hospitalizations, at least several days after admission to ensure that participants were comfortable enough to participate. When the interview exceeded an hour, it was continued at a later time. Recordings were transcribed by a professional transcription service and verified for accuracy by the interviewer. Participants were compensated $25 for completed interviews.

Narrative Analysis

The analysis team consisted of 2 psychiatrists (1 with additional training in internal medicine), 1 medical student, and 1 internist with additional training in addiction medicine. Analysts read each transcript, became thoroughly familiar with its content, and met to discuss preliminary findings. Then, we created patient experts among the group, assigning each analyst 2 interviews with which s/he prepared a detailed summary in the first person, using the participant's own words, according to an established process in phenomenological research13 (Figure 1). These narrative summaries allowed for the development of a holistic view of the participant, the creation of a narrative structure, and the fostering of an empathic bridge,13 a connection between the experiences of the participant and those of the reviewer. The summaries were read aloud at research meetings allowing for discussion, and the content of the summaries were modified based on the consensus of the group.

Figure 1
Narrative and analysis model.13

Next, we randomly rotated the narrative summaries so that each of the 4 analysts became an expert for 2 additional participants in order to critically evaluate the compiled narratives, and develop a structural summary14a summary of the prevalent themes. We extracted content from the narrative summaries based on these common themes, and returned to the transcripts as needed for relevant quotations. This inductive process allowed unique participant narratives to come through unconstrained by a predetermined coding structure.

The team reached consensus on organizing themes following the chronology of childhood to adulthood. This model was utilized to preserve the narrative basis of the methodology, and to ultimately elucidate the antecedents, subjective experience, and consequences of EHHU. An audit trail was maintained throughout the data analysis process.

RESULTS

Table 1 displays demographic, clinical, and hospitalization data for the 8 participants. These patients represented approximately 8% of the population with sickle cell disease at the study institution, but accounted for 57% of hospital days among sickle cell disease patients over a 3‐year period, with cumulative hospital days near or above 100 days per patient each year. Greater than 90% of admissions were for vaso‐occlusive crises without other SCD‐related complications. However, many participants had complicated medical histories, including avascular necrosis, acute chest syndrome, and leg ulcers.

Demographic and Clinical Data
ParticipantAge at Interview DateGenderHemoglobin Diagnosis*Average Hospital Days per Year 20082010
  • HbSS denotes homozygosity for the sickle cell gene (HBB glu6val), sickle cell anemia. HbS‐B thalassemia denotes heterozygosity for the sickle cell gene (HBB glu6val) and one of the B‐thalassemia gene mutations. HbSC denotes heterozygosity for the sickle cell gene (HBB glu6val) and the hemoglobin C gene (HBB glu6lys), sickle‐hemoglobin C disease.

  • Hospitalization data only applies to hospital days at Yale‐New Haven Hospital.

  • Participant spent 1 y in prisonthis interval was not included in his hospitalization rate.

134FHbSS171
227FHbSS263
326MHbS‐B thalassemia151
434MHbSC111
537FHbSS202
625FHbS‐B thalassemia104
724FHbSS123
1032MHbSS94

Participant interviews presented a common narrative of the evolution of EHHU from a young age, culminating in a universally negative description of hospitalization: It's like jail. (participant 2); It's like a massacre, coming in the hospital; I get tortured. (participant 1). Saturation was reached on major themes, which fit into 3 general categories: pain and opioid medication use, interpersonal relationships, and personal development.

Pain and Opioid Medication Use

Participants reported hospital use dating back to childhood, which was the first exposure to intravenous opioid medications and the beginning of a trajectory of accelerating use, tolerance, and dependence: You know, I came in the hospital when I was two years old I stayed 'til I was like five and a half. I started school here. (participant 1); I started taking that medicine when I was on the pedi side. So my body's already used to it it doesn't really touch me. They're gonna have to up my doses. (participant 7).

As adults, participants expressed awareness of the potential problems of opioids. During interviews, many participants exhibited side effects of these medications, such as itching and somnolence. Moreover, participants expressed awareness of the skepticism and mistrust from providers, and acknowledged that such sentiments may be justified toward certain patients: That's all our body knows, is meds, meds, meds. And because your body is addicted to this level, you gotta go up another level, but some doctors think we're taking too much. How can we be taking too much when we need it? (participant 5); The oxy which I'm on [oxycontin 240 mg per day] when you take that, you going to sleep. And then some of them will say when you go home you're not taking the medicine like you should. (participant 5).

Opioids were taken in and out of the hospital by all participants, and were identified as necessary in combating debilitating pain. Many participants expressed a reluctance to try other forms of therapy, such as hydroxyurea: These new chemicals, you come across doctors who say there's this new medicine out, and it's been out for such and such amount of timeI think it would be good, can we try it with you? No. I'm not a guinea. (participant 2).

While all participants described unpredictable pain crises, some also described an underlying, constant pain syndrome: You know, like, I could be fine right now; the next minute I could be Oh, my God crying, so much pain. You never know when you're gonna have a crisis. (participant 1); There's never no pain. There's always pain. It's just a fact of life. I wake up and I can deal with the pain, it's not that bad today. But then when the crisis hits, that's when it gets unbearable. (participant 10); I'm not in pain every day, every second. To me, I don't think that any sickle cell patient is in pain every day. They make theirselves to [be] it saddens me sometimes. (participant 6).

Interpersonal Relationships

In childhood, participants developed close relationships with the staff of the children's hospital and an attachment to this institution: I loved pediatrics. It's the adult side I can't stand. They treat you better. (participant 7); Some people in the ER, they know us; and I call them my family they already know what I need. (participant 5).

In contrast, the hospital experience during adulthood was often punctuated by bitter relationships with staff, and distrust over possible excessive use of opioids. Moreover, participants raised the possibility of racism in their interactions with hospital staff. Overall, participants highlighted a lack of empathy among caregivers: Some doctors, they're rude, like, they're rough. They'll just pull out the scope bang it onto my back, or just push on my body or areas where it hurts. (participant 6); I'm your doctor. And I say I think you're doing a lot better, how would you feel about going home today? And you can say I don't think I'm ready. And I can say Well, you can't live here in the hospital. Why do you think you're not ready for home yet? You're never, ever going to be pain free, and that's when you turn around to me and say I know that. I've been dealing with this for all my life. I know I'm never gonna be pain free! (participant 2).

Such negative interactions extended to friends and family members, leading to a sense of social isolation and a reluctance to discuss their disease with others: I just don't think people will understand where I'm coming from. So I just don't talk to anybody, I keep it inside. Or I write it in my diary. (participant 5); I don't have any friends. I have associates. I'm always by myself. (participant 1).

Even though participants expressed dismay at dysfunctional relationships within the hospital, they also voiced affection for staff members. Participant 1 described hospital stays that were loving, and participant 3 described his hematologist as his brother from another mother, and a nurse practitioner as his aunt.

Personal Development

Hospitalization in childhood was linked to EHHU as an adult by the derailment that participants described in their personal development. Prolonged hospitalization and illness were barriers to education, interfering with the development of social as well as academic skills: I couldn't spell me being in a hospital for so much I was like, no, I don't want that bookwork like everybody else. (participant 3); I stopped going to school. I told [my mom] that I was not going back to school because the kids made fun of me Oh, she has a disease. Be careful, you might get the cooties. (participant 2).

Participants also described a sense of foreshortened future. Many were told that they would not survive their teens: They told my mother I would die before I was 12 years old. And I would be scared to go to sleep, because I would think I was gonna die in my sleep. (participant 2)

As an adult, numerous and/or prolonged hospitalizations interfered with participants' ability to remain employed, and they experienced strains on fulfilling family roles: I would love to work again, but who gonna hire somebody that's always out, more than you're working. Nobody. (participant 5); Sometimes I feel like I'm neglecting my son, being here. You have to take care of yourself in order for you to be there for him. But it just stresses me out. (participant 6).

The struggles of hospitalization and pain management took their toll on participants' mental health. Participants described difficulty sleeping, depression, and suicidal thoughts: Sorrow. That's what [sickle cell] means to me. Unhappy. Everything's depressing. It takes over your body and your mind and your soul. (participant 5); I really was gonna kill myself cause it's like, sometime, the pain, you be in so much pain, you be like, fuck this, man. My pain was bothering me so much, I laid down on the highway, wishin a car would run me over. (participant 4).

Despite fragile mental and physical health, many participants described feelings of strength and resilience, and some described hope in the future for employment, education, travel, and family: I don't know why God picked me, but for some strange, mysterious reason he picked me. I still don't know what that reason may be, but I ain't gonna give up. Maybe he got some kind of plan in store. (participant 2).

DISCUSSION

Our study population represents a unique and understudied group among patients with SCD. While several themes from prior research on individuals with SCD were presentreciprocal mistrust between patients and providers surrounding opioid analgesics and pain reporting,15, 16 racial and disease‐related bias,17 patient dissatisfaction with clinical services,18the common narrative of thwarted personal development in the setting of a long history of hospitalization and opioid use was striking.

The developmental perspective posits that age‐appropriate tasks govern basic capacities and skills (academic, interpersonal, affective, and cognitive) honed through institutional interactions (family, school, and community), which allow individuals to develop autonomy that guides them into effective participation in social groups and civil society, and eventually to becoming guarantors for the next generation. Our participants described problems such as social isolation, depression, and dependence on medications, all linked to their description of recurrent stays in the hospital during childhood and adolescence, where missed vocational and social opportunities left their indelible mark. Participants expressed an awareness of their inability to lead productive lives, and the perception that they were burdensome to their caregivers and the hospital.

While previous research has correlated high hospital utilization in SCD with factors like poor coping strategies,1921 high levels of stress,22 and inadequate support,17 our interviews suggest that such psychosocial difficulties may be consequences as well as causes of hospitalization, creating an accelerating downward spiral of dysfunction. At the center of this spiral is participants' ongoing experience of pain, which may be related to SCD, medications, or neither.23 Additionally, chronic anemia, opioid exposure, airway disease, and cerebrovascular disease are all implicated in impaired neuropsychological functioning in children and adolescents with sickle cell disease.24, 25

Clinical features of SCD remain relevant to hospitalization in adulthood. Chart review revealed that the vast majority of inpatient admissions were due to vaso‐occlusive crises uncomplicated by SCD‐related pathology, such as aseptic necrosis of bone or acute chest syndrome. This finding is consistent with previous work,9 which correlated new onset of high hospital use with SCD‐related complications, but not reliably with persistent EHHU, our study population.

The double‐edged sword of opioid use26 was starkly evident in participants' narratives. Crippling vaso‐occlusive crises were competently treated with opioids starting in childhood, but then a cycle of increasing outpatient doses of opioids and more frequent and longer courses of inpatient intravenous opioids followed. Participants felt judged and stigmatized for seeking one of the few treatment options they had been offered, resulting in confusion and bitterness at times. Other potential complications of long‐term opioid therapy less well known to patients and providers such as hypogonadism and hyperalgesia27may have played a role in the patient experience and should be examined in future research. In addition, undertreatment of pain may lead to pseudoaddiction,28 underscoring the complexity of delineating the pathologies of dependence, addiction, withdrawal, acute pain, and chronic pain.

Our study is limited primarily by the fact that it was conducted with a small number of participants. It is also possible that institutional variation, especially with regard to pain management, makes it difficult to generalize our hypotheses. Similarly, our participants grew up in similar environments outside the hospital, which may differ significantly from environments of other individuals with EHHU. Lastly, participants were all interviewed as inpatients, and the acuteness of their illness may have influenced responses. Despite these limitations, we achieved saturation on the major themes, and there was substantial agreement in their experiences of their illness.

Breaking the cycle of alienation from the external world and dependence on the hospital necessitates an acknowledgement of the role of the hospital, pain, and opioid use in the long‐term development of individuals with EHHU. Further research should test this developmental hypothesis, and focus on early interventions and the critical transition from pediatric to adult care.25 Longitudinal quantitative analysis could include psychosocial variables in SCD in the attempt to predict EHHU as has been accomplished in the chronic pain literature.29 Additionally, a comprehensive qualitative approach including the perspectives of caregivers, family members, and comparison to low hospital utilizers will better inform interventions aimed at ameliorating EHHU. It is particularly important to understand the similarities and differences in the long‐term development of patients with SCD who demonstrate EHHU versus low hospital use. The optimal strategy for opioid use in the long‐term management of pain in patients with SCD remains to be determined. Alternatives to opioids should be investigated in a controlled trial, and institutional differences should be examined as they relate to EHHU and pain‐management strategies. Lastly, our results suggest that psychosocial and skill rehabilitation may mitigate EHHU, and that multidisciplinary resources proactively directed towards this population will reduce hospitalization.30

References
  1. Brousseau DC,Panepinto JA,Nimmer M,Hoffmann RG.The number of people with sickle‐cell disease in the United States: national and state estimates.Am J Hematol.2009;85:7778.
  2. Ballas SK.Current issues in sickle cell pain and its management.Hematology Am Soc Hematol Educ Program.2007:97105.
  3. Smith WR,Penberthy LT,Bovbjerg VE, et al.Daily assessment of pain in adults with sickle cell disease.Ann Intern Med.2008;148:94101.
  4. Brousseau DC,Owens PL,Mosso AL,Panepinto JA,Steiner CA.Acute care utilization and rehospitalizations for sickle cell disease.JAMA.2010;303:12881294.
  5. Carroll CP,Haywood C,Fagan P,Lanzkron S.The course and correlates of high hospital utilization in sickle cell disease: evidence from a large, urban Medicaid managed care organization.Am J Hematol.2009;84:666670.
  6. Shankar SM,Arbogast PG,Mitchel E,Cooper WO,Wang WC,Griffin MR.Medical care utilization and mortality in sickle cell disease: a population‐based study.Am J Hematol.2005;80:262270.
  7. Platt OS,Thorington BD,Brambilla DJ, et al.Pain in sickle cell disease. Rates and risk factors.N Engl J Med.1991;325:1116.
  8. Aisiku IP,Smith WR,McClish DK, et al.Comparisons of high versus low emergency department utilizers in sickle cell disease.Ann Emerg Med.2009;53:587593.
  9. Carroll CP,Haywood C,Lanzkron S.Prediction of onset and course of high hospital utilization in sickle cell disease.J Hosp Med.2011;6:248255.
  10. Chen E,Cole SW,Kato PM.A review of empirically supported psychosocial interventions for pain and adherence outcomes in sickle cell disease.J Pediatr Psychol.2004;29:197209.
  11. Glaser BG.More Grounded Theory Methodology: A Reader.Mill Valley, CA:Sociology Press;1994.
  12. McCracken GD.The Long Interview.Newbury Park, CA:Sage;1988.
  13. Sells D,Topor A,Davidson L.Generating coherence out of chaos: examples of the utility of empathic bridges in phenomenological research.J Phenomenolog Psychol.2004;35:253271.
  14. Davidson L,Wieland M,Flanagan EH,Sells D.Using qualitative methods in clinical research. In: McKay D, ed.Handbook of Research Methods in Abnormal and Clinical Psychology.Los Angeles, CA:Sage;2008:263269.
  15. Shapiro BS,Benjamin LJ,Payne R,Heidrich G.Sickle cell‐related pain: perceptions of medical practitioners.J Pain Symptom Manage.1997;14:168174.
  16. Booker MJ,Blethyn KL,Wright CJ,Greenfield SM.Pain management in sickle cell disease.Chronic Illn.2006;2:3950.
  17. Maxwell K,Streetly A,Bevan D.Experiences of hospital care and treatment‐seeking behavior for pain from sickle cell disease: qualitative study.West J Med.1999;171:306313.
  18. Brousseau DC,Mukonje T,Brandow AM,Nimmer M,Panepinto JA.Dissatisfaction with hospital care for children with sickle cell disease not due only to race and chronic disease.Pediatr Blood Cancer.2009;53:174178.
  19. Gil KM,Abrams MR,Phillips G,Keefe FJ.Sickle cell disease pain: relation of coping strategies to adjustment.J Consult Clin Psychol.1989;57:725731.
  20. Gil KM,Abrams MR,Phillips G,Williams DA.Sickle cell disease pain: 2. Predicting health care use and activity level at 9‐month follow‐up.J Consult Clin Psychol.1992;60:267273.
  21. Anie KA,Steptoe A,Ball S,Dick M,Smalling BM.Coping and health service utilisation in a UK study of paediatric sickle cell pain.Arch Dis Child.2002;86:325329.
  22. Gil KM,Carson JW,Porter LS,Scipio C,Bediako SM,Orringer E.Daily mood and stress predict pain, health care use, and work activity in African American adults with sickle‐cell disease.Health Psychol.2004;23:267274.
  23. Benjamin L.Pain management in sickle cell disease: palliative care begins at birth?Hematology Am Soc Hematol Educ Program.2008:466474.
  24. Schatz J,Finke RL,Kellett JM,Kramer JH.Cognitive functioning in children with sickle cell disease: a meta‐analysis.J Pediatr Psychol.2002;27:739748.
  25. Wills KE,Nelson SC,Hennessy J, et al.Transition planning for youth with sickle cell disease: embedding neuropsychological assessment into comprehensive care.Pediatrics.2010;126(suppl 3):S151S159.
  26. Simoni‐Wastila L.Increases in opioid medication use: balancing the good with the bad.Pain.2008;138:245246.
  27. Mercadante S,Ferrera P,Villari P,Arcuri E.Hyperalgesia: an emerging iatrogenic syndrome.J Pain Symptom Manage.2003;26:769775.
  28. Elander J,Lusher J,Bevan D,Telfer P,Burton B.Understanding the causes of problematic pain management in sickle cell disease: evidence that pseudoaddiction plays a more important role than genuine analgesic dependence.J Pain Symptom Manage.2004;27:156169.
  29. Walker LS,Sherman AL,Bruehl S,Garber J,Smith CA.Functional abdominal pain patient subtypes in childhood predict functional gastrointestinal disorders with chronic pain and psychiatric comorbidities in adolescence and adulthood.Pain.2012;153:17981806.
  30. Artz N,Whelan C,Feehan S.Caring for the adult with sickle cell disease: results of a multidisciplinary pilot program.J Natl Med Assoc.2010;102:10091016.
References
  1. Brousseau DC,Panepinto JA,Nimmer M,Hoffmann RG.The number of people with sickle‐cell disease in the United States: national and state estimates.Am J Hematol.2009;85:7778.
  2. Ballas SK.Current issues in sickle cell pain and its management.Hematology Am Soc Hematol Educ Program.2007:97105.
  3. Smith WR,Penberthy LT,Bovbjerg VE, et al.Daily assessment of pain in adults with sickle cell disease.Ann Intern Med.2008;148:94101.
  4. Brousseau DC,Owens PL,Mosso AL,Panepinto JA,Steiner CA.Acute care utilization and rehospitalizations for sickle cell disease.JAMA.2010;303:12881294.
  5. Carroll CP,Haywood C,Fagan P,Lanzkron S.The course and correlates of high hospital utilization in sickle cell disease: evidence from a large, urban Medicaid managed care organization.Am J Hematol.2009;84:666670.
  6. Shankar SM,Arbogast PG,Mitchel E,Cooper WO,Wang WC,Griffin MR.Medical care utilization and mortality in sickle cell disease: a population‐based study.Am J Hematol.2005;80:262270.
  7. Platt OS,Thorington BD,Brambilla DJ, et al.Pain in sickle cell disease. Rates and risk factors.N Engl J Med.1991;325:1116.
  8. Aisiku IP,Smith WR,McClish DK, et al.Comparisons of high versus low emergency department utilizers in sickle cell disease.Ann Emerg Med.2009;53:587593.
  9. Carroll CP,Haywood C,Lanzkron S.Prediction of onset and course of high hospital utilization in sickle cell disease.J Hosp Med.2011;6:248255.
  10. Chen E,Cole SW,Kato PM.A review of empirically supported psychosocial interventions for pain and adherence outcomes in sickle cell disease.J Pediatr Psychol.2004;29:197209.
  11. Glaser BG.More Grounded Theory Methodology: A Reader.Mill Valley, CA:Sociology Press;1994.
  12. McCracken GD.The Long Interview.Newbury Park, CA:Sage;1988.
  13. Sells D,Topor A,Davidson L.Generating coherence out of chaos: examples of the utility of empathic bridges in phenomenological research.J Phenomenolog Psychol.2004;35:253271.
  14. Davidson L,Wieland M,Flanagan EH,Sells D.Using qualitative methods in clinical research. In: McKay D, ed.Handbook of Research Methods in Abnormal and Clinical Psychology.Los Angeles, CA:Sage;2008:263269.
  15. Shapiro BS,Benjamin LJ,Payne R,Heidrich G.Sickle cell‐related pain: perceptions of medical practitioners.J Pain Symptom Manage.1997;14:168174.
  16. Booker MJ,Blethyn KL,Wright CJ,Greenfield SM.Pain management in sickle cell disease.Chronic Illn.2006;2:3950.
  17. Maxwell K,Streetly A,Bevan D.Experiences of hospital care and treatment‐seeking behavior for pain from sickle cell disease: qualitative study.West J Med.1999;171:306313.
  18. Brousseau DC,Mukonje T,Brandow AM,Nimmer M,Panepinto JA.Dissatisfaction with hospital care for children with sickle cell disease not due only to race and chronic disease.Pediatr Blood Cancer.2009;53:174178.
  19. Gil KM,Abrams MR,Phillips G,Keefe FJ.Sickle cell disease pain: relation of coping strategies to adjustment.J Consult Clin Psychol.1989;57:725731.
  20. Gil KM,Abrams MR,Phillips G,Williams DA.Sickle cell disease pain: 2. Predicting health care use and activity level at 9‐month follow‐up.J Consult Clin Psychol.1992;60:267273.
  21. Anie KA,Steptoe A,Ball S,Dick M,Smalling BM.Coping and health service utilisation in a UK study of paediatric sickle cell pain.Arch Dis Child.2002;86:325329.
  22. Gil KM,Carson JW,Porter LS,Scipio C,Bediako SM,Orringer E.Daily mood and stress predict pain, health care use, and work activity in African American adults with sickle‐cell disease.Health Psychol.2004;23:267274.
  23. Benjamin L.Pain management in sickle cell disease: palliative care begins at birth?Hematology Am Soc Hematol Educ Program.2008:466474.
  24. Schatz J,Finke RL,Kellett JM,Kramer JH.Cognitive functioning in children with sickle cell disease: a meta‐analysis.J Pediatr Psychol.2002;27:739748.
  25. Wills KE,Nelson SC,Hennessy J, et al.Transition planning for youth with sickle cell disease: embedding neuropsychological assessment into comprehensive care.Pediatrics.2010;126(suppl 3):S151S159.
  26. Simoni‐Wastila L.Increases in opioid medication use: balancing the good with the bad.Pain.2008;138:245246.
  27. Mercadante S,Ferrera P,Villari P,Arcuri E.Hyperalgesia: an emerging iatrogenic syndrome.J Pain Symptom Manage.2003;26:769775.
  28. Elander J,Lusher J,Bevan D,Telfer P,Burton B.Understanding the causes of problematic pain management in sickle cell disease: evidence that pseudoaddiction plays a more important role than genuine analgesic dependence.J Pain Symptom Manage.2004;27:156169.
  29. Walker LS,Sherman AL,Bruehl S,Garber J,Smith CA.Functional abdominal pain patient subtypes in childhood predict functional gastrointestinal disorders with chronic pain and psychiatric comorbidities in adolescence and adulthood.Pain.2012;153:17981806.
  30. Artz N,Whelan C,Feehan S.Caring for the adult with sickle cell disease: results of a multidisciplinary pilot program.J Natl Med Assoc.2010;102:10091016.
Issue
Journal of Hospital Medicine - 8(1)
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Journal of Hospital Medicine - 8(1)
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42-46
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42-46
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“I'm Talking About Pain”: Sickle cell disease patients with extremely high hospital use
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“I'm Talking About Pain”: Sickle cell disease patients with extremely high hospital use
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Computerized Physician Handoff Tools

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Review of computerized physician handoff tools for improving the quality of patient care

Physician handoff is a common and essential component of daily patient care that includes transfer of important clinical patient information and accountability of patient care. Thus, high‐quality physician handoffs are crucial to ensure patient safety and continuity of patient care, especially with the new resident work hour restriction in North America.[1, 2] As such, healthcare organizations including the World Health Organization[3] have issued specific goals and organizational challenges to improve the effectiveness and coordination of communication among the care/service providers and with the recipients of care/service across the continuum in healthcare.[4, 5]

It has been well‐documented that physician handoffs in hospital settings are often unstructured and not standardized, which leads to medical errors and jeopardizes patient safety.[2, 6, 7, 8, 9, 10, 11, 12] This lack of standardization of physician handoff for hospitalized patients occurs in every major in‐hospital service and affects trainees and staff.[2, 6, 7, 9, 10, 12, 13] It has been demonstrated in healthcare and in other domains that a standardized handoff protocol that involves both verbal communication and written handoff documents is likely to be an effective method of handoff to decrease miscommunication and associated errors.[14, 15, 16, 17] Computerized physician handoff tools (CHTs) have been increasingly deployed to address these challenges and have quickly gained popularity among physicians for documenting patient information during physician handoff for hospitalized patients.[18] CHTs can be an complementary part of electronic medical record (EMR) systems, but not a substitute since their focus is to deliver concise and essential information vital for patient care during interfaces of patient care.

Two recent systematic reviews have examined information technology (IT) systems to promote the handoff process in healthcare.[17, 19] However, to our knowledge, there has not been a systematic review of the potential role of CHT in physician handoff and quality of patient care for hospitalized patients. We therefore conducted a systematic review to examine the current evidence for CHTs in physician handoff for hospitalized patients, focusing specifically on potential effects on continuity of patient care, physician work efficiency, quality of handoffs, and patient outcomes.

METHODS

Criteria for Considering Eligible Studies

We included randomized controlled trials, controlled clinical trial, quasi‐experimental studies, and controlled beforeafter studies that evaluated CHTs during physician handoff of hospitalized patients. Studies needed to report patient outcomes (adverse events, missing patients at rounds, or in‐hospital mortality), physician work efficiency, quality of handoff (accuracy, consistency, or completeness), continuity of care, or physician satisfaction. Articles that met all these inclusion criteria were considered to be eligible for the review. We excluded review articles, commentaries, case reports, and retrospective studies.

Search Strategy

CHTs were defined as computer‐based platforms, designed specifically for the purpose of physician handoff, to allow distributed access and synchronous archiving of patient information via Internet protocols (ie, electronic tool to allow physician data access and data entry for handoff from different computers at multiple locations within the authorized hospitals or clinics). A search strategy was developed based on a MEDLINE search format combined with our inclusion criteria and with this definition of CHTs. We used search terms related to physician communication and information technology, and relevant Medical Subjects Headings, which include handover, handoff, signoff, sign‐over, off‐duty, post‐call, computerized, Web‐based, communication tool. The databases, including MEDLINE, PUBMED, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane database for systematic reviews, and the Cochrane CENTRAL register of controlled trials, were initially searched from 1985 to December 2011 in all languages. The Cochrane Collaboration filter for controlled interventional studies was used to select the above‐mentioned interventional trial designs. In addition, the first 2 authors hand searched the references of included articles and relevant systematic reviews.

Screening for Eligible Studies

All articles identified in the database searches described above were included for screening in 2 stages. First, 2 reviewers (P.L., S.A.) independently reviewed the title and abstracts of the identified articles for eligibility. The articles selected in the first stage of screening were then further assessed by a full‐text review independently by the 2 reviewers. Any discrepancy was resolved by consensus or by involvement of a third reviewer (C.T.).

Data Abstraction and Analysis

Data abstraction from selected studies was conducted independently by 3 authors based on a predefined template. All discrepancies in this stage were resolved by consensus among the 3 authors. For each study, we analyzed study design, data collection, intervention, main outcomes, and components of physician handoffs in the study. Due to heterogeneity of study outcomes, measures used, and results, a meta‐analysis was not performed. Study outcomes, which included adverse events, missing patients at rounds, time spent on rounding patient, accuracy, consistency or completeness of handoff information, and continuity of care, were summarized.

RESULTS

Study Selection

A total of 1026 citations were identified in the initial search, of which 1006 studies did not evaluate CHT and were excluded by title and abstract screening. Of the 20 studies evaluated further by full‐text review, 5 were selected for the final analysis. One additional study was identified by hand searching references. The kappa score of inter‐reviewer agreement on article selection in the first stage of screening was 0.7, and for the second stage of article selection, kappa was 1.0. The reasons for exclusion in the second selection step are presented in Figure 1.

Figure 1
Flow chart of study inclusion.

Study Characteristics

Of the 6 studies identified, 1 study was a randomized controlled trial[20] and the other 5 were controlled beforeafter studies.[21, 22, 23, 24, 25] All studies were conducted in teaching hospitals in English‐speaking high‐income countries. All were single‐center studies, except the study by Van Eaton et[20] that involved 2 centers. All the studies investigated physician handoffs conducted by trainees. Two studies included staff physicians.[22, 24] Van Eaton et al's study included general medical, general surgical, and subspecialty surgical services.[20] The other 5 studies assessed physician handoffs in family medicine,[25] internal medicine services,[21, 23] a surgical service,[22] and a neonatal intensive care unit.[24] The study by Van Eaton et al[20] enrolled the largest study population. The intervention or observation phase ranged from 1 month[20] to 6 months[24] (Table 1).

Study Characteristics Included in the Review
Study Design Setting Target Services Intervention Group Control Group Data Collection and Validation
  • Abbreviations: CHT, computerized physician handoff tool; EMR, electronic medical record; NICU, neonatal intensive care unit.
Ram and Block[25] (1992) Beforeafter study 150‐bed urban hospital in USA Family Medicine Residents (N = 7) Patient no. not reported 1 mo of intervention No CHT training prior to the intervention reported Patient no. not reported Traditional handoff note (on index card or previous list) Components of handoff note not reported Questionnaire No data validation
Peterson et al[21] (1998) Beforeafter study 720‐bed tertiary care hospital in USA All Internal Medicine Services Residents (N = 99) 3747 patients 4 mo of intervention 8 wk of run‐in period 1874 patients Handwritten handoff Components of handoff note not reported Self‐report using e‐mail, report card, in person chart review for unreported adverse events in 250 samples
Van Eaton et al[20] (2005) Randomized cross‐over trial 450‐bed tertiary care hospital and a 368‐bed trauma center in USA General Medicine, General Surgery, and Subspecialties Trauma Residents (N = 7 teams) 8018 patients 14 wk of randomized crossover period 6 wk of run‐in period 7569 patients Individual written lists, cards, a team‐developed computer‐generated spreadsheet Components of handoff note not reported Telephone interview and anonymous online survey No validation of data
Cheah et al[22] (2005) Beforesfter atudy A 400‐bed regional teaching hospital in Australia General Surgery Registrars and Residents (N = 714) Patient no. not reported 3 mo of observation period (for weekend coverage only) No CHT training prior to the intervention reported Patient no. not reported No description of pre‐intervention handoff method reported In‐person interview and survey No validation of data
Flanagan et al[23] (2009) Beforesfter atudy Tertiary care hospital in USA Internal Medicine, Medical Intensive Care Unit First‐year Residents (N = 35) 1264 patient handoff forms 1 mo of observation Orientation session and 1 cross‐over shift of run‐in period Patient no. not reported No description of pre‐CHT implementation handoff method reported In‐person interview and survey No validation of data
Palma et al[24] (2011) Beforeafter study 304‐bed quaternary care women and children hospital in USA NICU Attendings, Residents, Nursing staffs (N = 4652) Patient no. not reported 6 mo of intervention of NICU handoff tool Instruction document by e‐mail and informal instructional session Patient no. not reported A Microsoft‐based standalone handoff tool or EMR integrated Medical/Surgical handoff tool Components of handoff note not reported Online survey No validation of data

CHT Characteristics

Three CHTs were standalone applications designed specifically for physician handoffs.[20, 22, 25] The other 3 CHTs were add‐on functions to existing hospital Electric Medical Record (EMR) systems.[21, 23, 24] All CHTs except one[25] interfaced with existing EMR systems, allowing for variable degrees of data transfer depending on CHT design and the functionalities of the EMR systems. CHT users were actively involved in designing and modifying the CHTs in most of the studies.[20, 21, 23, 25] The characteristics of the CHTs were summarized in Table 2.

Characteristics of CHTs
Study CHT Design EMR Interface Physician Daily Progress Note Participants' Role in CHT Design Components of CHT Components That Require Manual Input
  • Abbreviations: CHT, computerized physician handoff tool; EMR, electronic medical record; IT, information technology.
Ram and Block[25] (1992) Standalone application No interface Paper‐based Designing Patient demographics Medications Diagnosis Problem lists Comment line All the information
Peterson et al[21] (1998) A part of existing EMR Bi‐directional interface Paper‐based Designing Patient demographics Current medication Allergy Code status Recent lab value A problem list A to do list A problem list A to do list
Van Eaton et al[20] (2005) Standalone application Uni‐directional interface (data input from hospital IT system) Electronic‐based Designing and modifying Patient demographics Diagnosis Medication Allergy Vital signs Lab and investigation A problem list A to do list Diagnosis Medication A problem list A to do list
Cheah et al[22] (2005) Standalone application Uni‐directional interface (data input from hospital IT system) Electronic‐based No Patient demographics Diagnosis Length of stay Recent investigations Free‐text note (Not standardized) Free‐text note
Flanagan et al[23] (2009) A part of existing EMR Uni‐directional interface (data input from hospital IT system) Electronic‐based Evaluating and modifying Patient demographics Medication Allergy Lab and investigation Physician daily note Free‐text note (not standardized) Free‐text note (may contain assessment, a problem list, venous access, short‐term concerns and long‐term plan, and follow‐up tasks)
Palma et al[24] (2011) A part of existing EMR Uni‐directional interface (data input from hospital IT system) Paper‐based No Patient demographics Lab and measurement Free‐text note (not standardized) Free‐text note (including patient description, active medical issues, ongoing care and a to do list)

CHT's Impact on Adverse Events

The impact of CHTs on preventable adverse events was evaluated in a single study by Peterson et al.[21] The authors defined an adverse event as an injury due to medical treatment which prolonged hospital stay or produced disability at discharge in the study. Preventability was determined by using a 6‐point scale and assessed independently by 3 reviewers. Fewer adverse events were found after implementation of CHTs (2.38% vs 3.94%, P < 0.001). They also reported nonsignificant reductions in preventable adverse events (1.23% vs 1.72%, P < 0.1) with implementation of the CHT, and preventable adverse events during cross‐coverage (0.24% vs 0.38%, P > 0.10). The odds ratio for a patient experiencing a preventable adverse event during cross‐coverage compared to noncross‐coverage time was reduced from 5.2 (95% confidence interval [CI], 1.518.2) to 1.5 (95% CI, 0.29.0) following implementation of the CHT (Table 3).

Description of Study Outcomes and Recommendations for CHT
Study Outcomes of Interest Results Implication for CHT Design and Use
  • Abbreviations: CHT, computerized physician handoff tool; IT, information technology.
Ram and Block[25] (1992) Physician satisfaction Importance and accessibility of clinical information Improved physician satisfaction Handoff documentation more legible, more consistent, and more comprehensive Information required to be typed in by residents and not up‐to‐date The most important data for handoff: a to do list and code status A CHT interfaced with hospital IT system, and in a format that can focus on physician needs
Petersen et al[21] (1998) Adverse event rate Preventable adverse events rate Fewer adverse events (2.38% vs 3.94%, P < 0.001) Fewer preventable adverse events (1.23% vs 1.72%, P < 0.1) Few preventable adverse events during cross‐coverage (0.24% vs 0.38%, P > 0.10) Lower OR of preventable adverse events during cross‐coverage (1.5; 95% CI 0.29.0 vs 5.2; 95% CI 1.58.2) Active involvement in the design of CHT by house staff likely contributes to high participation and CHT use rate in the study
Van Eaton et al[20] (2005) No. of patients missed on rounds Perception on continuity of care quality and workflow efficiency Daily self‐reported pre‐rounding and rounding times and tasks Reduced the no. of patients missed on rounds (2.5 patients/team/mo) (P = 0.0001) Spent 40% more time with patients at pre‐rounds Reduced time on team rounds by 1.5 min per patient Reduced time on manual copying at pre‐rounding by 50% Improved handoff quality Improved continuity of care No reduction of overall pre‐rounding time The largest benefit from CHTs varies between clinical services, from more time assessing patients before rounds in Internal Medicine to reduced backtracking and locating patients in Surgery
Cheah et al[22] (2005) Completeness and usefulness of handoff information Desirability of electronic handoff system Identified information set for handoff Free text entry in CHT often deficient in particular patient information Concerns of the completeness and consistency of information delivered in CHT CHT needs to be linked to hospital information system
Flanagan et al[23] (2009) Common data elements of interest extracted during physician handoff Missing data required during handoff Physicians' perception of CHT Additional important information needed that not included during handoff in 25% cases Code status, relevant lab data, short‐term concerns, a problem list, and a if‐then list should be included in CHT template A standard form reduces variability of handoff information
Palma et al[24] (2011) Accuracy of handoff information Healthcare provider satisfaction Improved perceived accuracy of handoff information (91% vs 78%, P <0.01) Improved satisfaction with handoff process (71% vs 35%, P < 0.01) Improved satisfaction with handoff documents (98% vs 91%, P <0.01) More time spent on updating handoff information (1620 min vs 1115 min, P = 0.03) A discipline‐specific handoff tool results in perceived handoff accuracy and satisfaction A more efficient handoff tool can be achieved by more extensive data transfer from hospital IT system

CHT's Impact on Physician Work Efficiency

Van Eaton et al's study examined the effect of CHTs on physician work efficiency.[20] Improved physician work efficiency was found following implementation of CHT. Self‐reported time spent on hand‐copying patient information was reduced by 50%, while the portion of time spent on seeing patients during pre‐rounding increased. Similarly, self‐reported time spent on each patient during rounding (routine patient assessment by the primary team) was decreased by 1.5 minutes. Overall, resident physicians subjectively reported an average time saving of 45 minutes daily for junior residents and 30 minutes for senior residents, and 81% of residents reported finishing their work sooner when using CHTs. Although no data were reported in the pre‐CHT period described in the study by Cheah et al, they indicated that work efficiency was felt to be improved because all physicians could locate their patients quickly and were pleased to be able to check patients' lab results in the CHT.[22] Conversely, Palma et al and Ram and Block reported perceived increased work load with CHTs by users due to time spent updating handoff information.[24, 25]

CHT's Impact on Quality of Physician Handoff

Overall quality of physician handoff and completeness of the handoff document was improved in 3 studies.[20, 24, 25] Flanagan et al reported that patient identifiers and medications were extracted most of the time.[23] However, there were concerns regarding consistency,[22] completeness[22, 23] of information provided during physician handoff using CHTs. Palma et al's and Ram and Block's studies[24, 25] commented on the accuracy of patient information communicated during physician handoff. While Ram and Block's study suggested that it may be poorer during the intervention period,[25] Palma et al's study found improved perceived accuracy of handoff information postimplementation of a CHT (98% vs 91%, P < 0.01).[24]

CHT's Impact on Continuity of Patient Care

Using CHTs was associated with a decreased number of patients missed on rounds after handoff (new admitted patients who were not assessed by the primary team in the morning rounds because cross‐covering physicians did not inform the primary team) in Van Eaton et al's study.[20] On the other hand, Cheah et al[22] reported that documented handoffs after physicians returned to duty occurred on 50% of patients who had experienced important clinical events on weekends.

DISCUSSION

Our systematic review identified 6 controlled studies of CHT. Outcome parameters reported in these studies included quality of the handoff (including completeness, accuracy, and consistency), physician time management, continuity of care, adverse events, and missed patients. Our results suggest that while CHT are a promising tool, further evaluation using rigorous study methodologies is needed. These findings are somewhat surprising given increasing popularity of CHTs in daily patient care.[19, 24, 26, 27, 28] This might be due to the fact that IT adoption and use in healthcare is still in a phase of relative infancy,[29] and that the success of adopting IT systems in healthcare depends on various factors.[30]

Roles of CHT in Physician Handoff for Hospitalized Patients

Our study indicates that CHT can potentially improve continuity of patient care by reducing the number of missing patients during rounds following handoff,[20] and similarly improve patient safety by decreasing adverse events and preventable adverse events.[21] Of note, users reported that they were able to spend more time with patients during pre‐rounding[20] which will likely enhance quality and continuity of patient care. However, it is unclear whether these improvements translate into better patient outcomes. Although Peterson et al attempted to minimize the risk of bias by using anonymous reporting and blinding participants to the timing of data collection,[21] adverse events during the intervention period could have been underestimated due to surveillance bias or decreased self‐reporting. Nevertheless, the results suggest that CHTs may have affected quality of patient care in a positive manner from included studies.

The findings from our review also point to a positive impact of CHT on physician work efficiency. Specifically, residents spent less time rounding on patients after handoff and finished their work sooner after introduction of the intervention.[20] Several other published studies on CHT also indicated potential benefits on work efficiency and/or patient safety,[31, 33, 34, 35] although they did not meet the inclusion criteria for our study (prespecified outcomes not reported,[31, 35] or study design[33, 34, 35]). In the studies in which the majority of handoff information was manually typed in the CHT, the work load was perceived to be increased with CHT implementation.[24, 25] On the other hand, the study conducted by Van Eaton et al demonstrated that a CHT that had broad integration with the hospital main IT system, and could automatically transfer important patient information such as medication, medical problems, recent investigation, and vital signs into CHT, quickly gained popularity among residents and staff due to its user‐friendly features.[20] This integration can also potentially reduce miscommunication and associated medical errors during physician handoff. Palma et al's study reported higher perceived workload due to manual entry of patient data.[24] Although the CHT used in their study was developed within their existing EMR system, large amounts of information needed to be manually imputed, and thus increased time spent on updating handoff information. This information included patient demographics, active medical issues, a to do list, and on‐going issues,[24] some of which could be imputed automatically with better CHT design. It is also possible that users spent more time in updating the handoff because they were able to deliver more information using a CHT.[24] However, this may allow cross‐covering physicians to spend less time on looking for patient information from other sources and thus actually decrease workload during cross‐coverage. Although there are numerous factors that could affect physician work efficiency when using a new IT system,[30] it was felt that a well‐designed and easy‐to‐use CHT that is integrated with the hospital information system can improve physician productivity.

The role of CHT in improving quality of handoff is less clear. Three studies[20, 24, 25] found an overall improvement in the quality of handoff after implementation of CHT, such that the handoff information was more complete and more consistent. On the other hand, physicians were concerned about the comprehensiveness of physician handoff after implementation of CHT in 2 studies.[22, 23] In Ram and Block's study,[25] physicians relied heavily on an unstructured free‐text entry system to deliver the majority of patient information that physicians thought to be important. In Flanagan et al's study,[23] resident physicians had to search for alternative sources, such as patient charts and electronic order systems, to obtain vital information in many cases in spite of a structured CHT. As a result, the information available was often not sufficient to help on‐call physicians make patient care decisions.[23]

Implication of CHT Design and Use

It has been demonstrated in many non‐healthcare domains,[15, 36, 37] as well as nursing care,[38] that a standardized handoff protocol is vital to decrease medical errors and improve patient safety. In our review, we found that physicians generally reported being satisfied with the accuracy of handoff information and the overall handoff when using standardized CHTs interfaced with hospital IT systems. This suggests, as recommended by Flanagan et al,[23] Palma et al,[24] and Ram and Block[25] that CHTs be developed with a standardized protocol and wide integration into hospital IT systems.

In order to achieve this goal, key patient information necessary for patient care need to be communicated during physician handoff. As hospitals consist of a wide range of disciplines and specialties with varying cultures and focuses of patient information, it is likely difficult to develop a single panacea CHT template for all the in‐hospital services.[1] This may be even particularly relevant when developing CHTs for different hospital services. However, some patient information appears to be universally important for physician handoff for inpatient care. Key elements, such as patient demographics, diagnosis, outstanding investigation results, code status, a problem list, and a to do list, were noted to be consistently present in the CHTs that were evaluated in our review (Table 2). Other studies have also demonstrated that information items such as a to do list, outstanding investigation results, and patients' code status were regarded as the most important information during physician handoff.[1, 2, 17, 23, 39, 40] Based on these findings, a potential solution for CHT standardization would be to develop a core CHT which includes the universally important components of physician handoff identified in this review, and provides options for adding well‐categorized service‐specific information as needed (eg, type and date of surgical procedures for surgical patients). It also appears that active involvement of physicians in CHT design and modification facilitates successful implementation of CHT, as demonstrated in Van Eaton et al's and Peterson et al's studies.[20, 21]

It is difficult to recommend metrics for CHT evaluation based on the limited literature identified in our review. However, it appears to be reasonable to consider integration into existing IT system, user friendly features, impact on quality of handoff documents, work efficiency, and processes and outcomes of patient care when assessing CHTs.

Limitations

There are several limitations in the studies included in our review. None of the studies were multi‐centered. The majority of the included studies had a beforeafter design.[21, 22, 23, 24, 25] Some studies did not have user training or a run in period to ensure familiarity of CHTs by users.[22, 24, 25] None of the studies described the key components of handoff in the control groups, or used quality control measurements for user familiarity with the CHTs. Furthermore, outcomes reported by the studies were heterogeneous, subjective, based on participant self‐report, and not independently validated.

Our review also has also several limitations. First, in spite of a comprehensive search effort, it is possible that we failed to identify all relevant articles. However, this is unlikely, given that we searched multiple databases and performed hand searches of all references identified from the included articles, as well as content‐related previously published systematic reviews. Second, we were not able to perform a meta‐analysis, given the heterogeneity seen in outcomes assessed across studies, measures applied, and results presented.

CONCLUSIONS AND IMPLICATIONS FOR PRACTICE

Although the current literature suggests that implementation of CHTs is likely to improve physician work efficiency, satisfaction, and quality of patient care during physician handoff for hospitalized patients, the evidence supporting these potential benefits is limited. Furthermore, it is unknown what impacts CHTs may have on clinical outcomes, such as hospital length of stay and mortality. Further studies with larger sample size, multiple center involvement, and more objective patient outcome measurements are therefore needed to evaluate the roles of CHTs in physician handoff and improving the quality of patient care.

In the absence of larger studies evaluating major clinical outcomes, such as length of stay and mortality, hospitals considering innovations in the domain of computerized platforms for physician handoffs will need to consider the pros and cons of immediate system implementation on the basis of the evidence presented here versus waiting until there is more evidence from more definitive studies. In addition, our study suggests that organizations engage physicians during CHT design and develop a standardized CHT protocol that is interfaced with hospital IT systems and includes key components of handoff information, but provides flexibility to meet service‐specific needs. The evidence summarized here, while far from definitive for major outcomes, is nonetheless rather positive for the general benefits of CHTan impetus for careful design, implementation, and modification, whenever and wherever possible. Any such system implementations should, however, incorporate an evaluative component so that the evidence‐base surrounding CHT can be enhanced.

Acknowledgments

Disclosure: Nothing to report.

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References
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Physician handoff is a common and essential component of daily patient care that includes transfer of important clinical patient information and accountability of patient care. Thus, high‐quality physician handoffs are crucial to ensure patient safety and continuity of patient care, especially with the new resident work hour restriction in North America.[1, 2] As such, healthcare organizations including the World Health Organization[3] have issued specific goals and organizational challenges to improve the effectiveness and coordination of communication among the care/service providers and with the recipients of care/service across the continuum in healthcare.[4, 5]

It has been well‐documented that physician handoffs in hospital settings are often unstructured and not standardized, which leads to medical errors and jeopardizes patient safety.[2, 6, 7, 8, 9, 10, 11, 12] This lack of standardization of physician handoff for hospitalized patients occurs in every major in‐hospital service and affects trainees and staff.[2, 6, 7, 9, 10, 12, 13] It has been demonstrated in healthcare and in other domains that a standardized handoff protocol that involves both verbal communication and written handoff documents is likely to be an effective method of handoff to decrease miscommunication and associated errors.[14, 15, 16, 17] Computerized physician handoff tools (CHTs) have been increasingly deployed to address these challenges and have quickly gained popularity among physicians for documenting patient information during physician handoff for hospitalized patients.[18] CHTs can be an complementary part of electronic medical record (EMR) systems, but not a substitute since their focus is to deliver concise and essential information vital for patient care during interfaces of patient care.

Two recent systematic reviews have examined information technology (IT) systems to promote the handoff process in healthcare.[17, 19] However, to our knowledge, there has not been a systematic review of the potential role of CHT in physician handoff and quality of patient care for hospitalized patients. We therefore conducted a systematic review to examine the current evidence for CHTs in physician handoff for hospitalized patients, focusing specifically on potential effects on continuity of patient care, physician work efficiency, quality of handoffs, and patient outcomes.

METHODS

Criteria for Considering Eligible Studies

We included randomized controlled trials, controlled clinical trial, quasi‐experimental studies, and controlled beforeafter studies that evaluated CHTs during physician handoff of hospitalized patients. Studies needed to report patient outcomes (adverse events, missing patients at rounds, or in‐hospital mortality), physician work efficiency, quality of handoff (accuracy, consistency, or completeness), continuity of care, or physician satisfaction. Articles that met all these inclusion criteria were considered to be eligible for the review. We excluded review articles, commentaries, case reports, and retrospective studies.

Search Strategy

CHTs were defined as computer‐based platforms, designed specifically for the purpose of physician handoff, to allow distributed access and synchronous archiving of patient information via Internet protocols (ie, electronic tool to allow physician data access and data entry for handoff from different computers at multiple locations within the authorized hospitals or clinics). A search strategy was developed based on a MEDLINE search format combined with our inclusion criteria and with this definition of CHTs. We used search terms related to physician communication and information technology, and relevant Medical Subjects Headings, which include handover, handoff, signoff, sign‐over, off‐duty, post‐call, computerized, Web‐based, communication tool. The databases, including MEDLINE, PUBMED, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane database for systematic reviews, and the Cochrane CENTRAL register of controlled trials, were initially searched from 1985 to December 2011 in all languages. The Cochrane Collaboration filter for controlled interventional studies was used to select the above‐mentioned interventional trial designs. In addition, the first 2 authors hand searched the references of included articles and relevant systematic reviews.

Screening for Eligible Studies

All articles identified in the database searches described above were included for screening in 2 stages. First, 2 reviewers (P.L., S.A.) independently reviewed the title and abstracts of the identified articles for eligibility. The articles selected in the first stage of screening were then further assessed by a full‐text review independently by the 2 reviewers. Any discrepancy was resolved by consensus or by involvement of a third reviewer (C.T.).

Data Abstraction and Analysis

Data abstraction from selected studies was conducted independently by 3 authors based on a predefined template. All discrepancies in this stage were resolved by consensus among the 3 authors. For each study, we analyzed study design, data collection, intervention, main outcomes, and components of physician handoffs in the study. Due to heterogeneity of study outcomes, measures used, and results, a meta‐analysis was not performed. Study outcomes, which included adverse events, missing patients at rounds, time spent on rounding patient, accuracy, consistency or completeness of handoff information, and continuity of care, were summarized.

RESULTS

Study Selection

A total of 1026 citations were identified in the initial search, of which 1006 studies did not evaluate CHT and were excluded by title and abstract screening. Of the 20 studies evaluated further by full‐text review, 5 were selected for the final analysis. One additional study was identified by hand searching references. The kappa score of inter‐reviewer agreement on article selection in the first stage of screening was 0.7, and for the second stage of article selection, kappa was 1.0. The reasons for exclusion in the second selection step are presented in Figure 1.

Figure 1
Flow chart of study inclusion.

Study Characteristics

Of the 6 studies identified, 1 study was a randomized controlled trial[20] and the other 5 were controlled beforeafter studies.[21, 22, 23, 24, 25] All studies were conducted in teaching hospitals in English‐speaking high‐income countries. All were single‐center studies, except the study by Van Eaton et[20] that involved 2 centers. All the studies investigated physician handoffs conducted by trainees. Two studies included staff physicians.[22, 24] Van Eaton et al's study included general medical, general surgical, and subspecialty surgical services.[20] The other 5 studies assessed physician handoffs in family medicine,[25] internal medicine services,[21, 23] a surgical service,[22] and a neonatal intensive care unit.[24] The study by Van Eaton et al[20] enrolled the largest study population. The intervention or observation phase ranged from 1 month[20] to 6 months[24] (Table 1).

Study Characteristics Included in the Review
Study Design Setting Target Services Intervention Group Control Group Data Collection and Validation
  • Abbreviations: CHT, computerized physician handoff tool; EMR, electronic medical record; NICU, neonatal intensive care unit.
Ram and Block[25] (1992) Beforeafter study 150‐bed urban hospital in USA Family Medicine Residents (N = 7) Patient no. not reported 1 mo of intervention No CHT training prior to the intervention reported Patient no. not reported Traditional handoff note (on index card or previous list) Components of handoff note not reported Questionnaire No data validation
Peterson et al[21] (1998) Beforeafter study 720‐bed tertiary care hospital in USA All Internal Medicine Services Residents (N = 99) 3747 patients 4 mo of intervention 8 wk of run‐in period 1874 patients Handwritten handoff Components of handoff note not reported Self‐report using e‐mail, report card, in person chart review for unreported adverse events in 250 samples
Van Eaton et al[20] (2005) Randomized cross‐over trial 450‐bed tertiary care hospital and a 368‐bed trauma center in USA General Medicine, General Surgery, and Subspecialties Trauma Residents (N = 7 teams) 8018 patients 14 wk of randomized crossover period 6 wk of run‐in period 7569 patients Individual written lists, cards, a team‐developed computer‐generated spreadsheet Components of handoff note not reported Telephone interview and anonymous online survey No validation of data
Cheah et al[22] (2005) Beforesfter atudy A 400‐bed regional teaching hospital in Australia General Surgery Registrars and Residents (N = 714) Patient no. not reported 3 mo of observation period (for weekend coverage only) No CHT training prior to the intervention reported Patient no. not reported No description of pre‐intervention handoff method reported In‐person interview and survey No validation of data
Flanagan et al[23] (2009) Beforesfter atudy Tertiary care hospital in USA Internal Medicine, Medical Intensive Care Unit First‐year Residents (N = 35) 1264 patient handoff forms 1 mo of observation Orientation session and 1 cross‐over shift of run‐in period Patient no. not reported No description of pre‐CHT implementation handoff method reported In‐person interview and survey No validation of data
Palma et al[24] (2011) Beforeafter study 304‐bed quaternary care women and children hospital in USA NICU Attendings, Residents, Nursing staffs (N = 4652) Patient no. not reported 6 mo of intervention of NICU handoff tool Instruction document by e‐mail and informal instructional session Patient no. not reported A Microsoft‐based standalone handoff tool or EMR integrated Medical/Surgical handoff tool Components of handoff note not reported Online survey No validation of data

CHT Characteristics

Three CHTs were standalone applications designed specifically for physician handoffs.[20, 22, 25] The other 3 CHTs were add‐on functions to existing hospital Electric Medical Record (EMR) systems.[21, 23, 24] All CHTs except one[25] interfaced with existing EMR systems, allowing for variable degrees of data transfer depending on CHT design and the functionalities of the EMR systems. CHT users were actively involved in designing and modifying the CHTs in most of the studies.[20, 21, 23, 25] The characteristics of the CHTs were summarized in Table 2.

Characteristics of CHTs
Study CHT Design EMR Interface Physician Daily Progress Note Participants' Role in CHT Design Components of CHT Components That Require Manual Input
  • Abbreviations: CHT, computerized physician handoff tool; EMR, electronic medical record; IT, information technology.
Ram and Block[25] (1992) Standalone application No interface Paper‐based Designing Patient demographics Medications Diagnosis Problem lists Comment line All the information
Peterson et al[21] (1998) A part of existing EMR Bi‐directional interface Paper‐based Designing Patient demographics Current medication Allergy Code status Recent lab value A problem list A to do list A problem list A to do list
Van Eaton et al[20] (2005) Standalone application Uni‐directional interface (data input from hospital IT system) Electronic‐based Designing and modifying Patient demographics Diagnosis Medication Allergy Vital signs Lab and investigation A problem list A to do list Diagnosis Medication A problem list A to do list
Cheah et al[22] (2005) Standalone application Uni‐directional interface (data input from hospital IT system) Electronic‐based No Patient demographics Diagnosis Length of stay Recent investigations Free‐text note (Not standardized) Free‐text note
Flanagan et al[23] (2009) A part of existing EMR Uni‐directional interface (data input from hospital IT system) Electronic‐based Evaluating and modifying Patient demographics Medication Allergy Lab and investigation Physician daily note Free‐text note (not standardized) Free‐text note (may contain assessment, a problem list, venous access, short‐term concerns and long‐term plan, and follow‐up tasks)
Palma et al[24] (2011) A part of existing EMR Uni‐directional interface (data input from hospital IT system) Paper‐based No Patient demographics Lab and measurement Free‐text note (not standardized) Free‐text note (including patient description, active medical issues, ongoing care and a to do list)

CHT's Impact on Adverse Events

The impact of CHTs on preventable adverse events was evaluated in a single study by Peterson et al.[21] The authors defined an adverse event as an injury due to medical treatment which prolonged hospital stay or produced disability at discharge in the study. Preventability was determined by using a 6‐point scale and assessed independently by 3 reviewers. Fewer adverse events were found after implementation of CHTs (2.38% vs 3.94%, P < 0.001). They also reported nonsignificant reductions in preventable adverse events (1.23% vs 1.72%, P < 0.1) with implementation of the CHT, and preventable adverse events during cross‐coverage (0.24% vs 0.38%, P > 0.10). The odds ratio for a patient experiencing a preventable adverse event during cross‐coverage compared to noncross‐coverage time was reduced from 5.2 (95% confidence interval [CI], 1.518.2) to 1.5 (95% CI, 0.29.0) following implementation of the CHT (Table 3).

Description of Study Outcomes and Recommendations for CHT
Study Outcomes of Interest Results Implication for CHT Design and Use
  • Abbreviations: CHT, computerized physician handoff tool; IT, information technology.
Ram and Block[25] (1992) Physician satisfaction Importance and accessibility of clinical information Improved physician satisfaction Handoff documentation more legible, more consistent, and more comprehensive Information required to be typed in by residents and not up‐to‐date The most important data for handoff: a to do list and code status A CHT interfaced with hospital IT system, and in a format that can focus on physician needs
Petersen et al[21] (1998) Adverse event rate Preventable adverse events rate Fewer adverse events (2.38% vs 3.94%, P < 0.001) Fewer preventable adverse events (1.23% vs 1.72%, P < 0.1) Few preventable adverse events during cross‐coverage (0.24% vs 0.38%, P > 0.10) Lower OR of preventable adverse events during cross‐coverage (1.5; 95% CI 0.29.0 vs 5.2; 95% CI 1.58.2) Active involvement in the design of CHT by house staff likely contributes to high participation and CHT use rate in the study
Van Eaton et al[20] (2005) No. of patients missed on rounds Perception on continuity of care quality and workflow efficiency Daily self‐reported pre‐rounding and rounding times and tasks Reduced the no. of patients missed on rounds (2.5 patients/team/mo) (P = 0.0001) Spent 40% more time with patients at pre‐rounds Reduced time on team rounds by 1.5 min per patient Reduced time on manual copying at pre‐rounding by 50% Improved handoff quality Improved continuity of care No reduction of overall pre‐rounding time The largest benefit from CHTs varies between clinical services, from more time assessing patients before rounds in Internal Medicine to reduced backtracking and locating patients in Surgery
Cheah et al[22] (2005) Completeness and usefulness of handoff information Desirability of electronic handoff system Identified information set for handoff Free text entry in CHT often deficient in particular patient information Concerns of the completeness and consistency of information delivered in CHT CHT needs to be linked to hospital information system
Flanagan et al[23] (2009) Common data elements of interest extracted during physician handoff Missing data required during handoff Physicians' perception of CHT Additional important information needed that not included during handoff in 25% cases Code status, relevant lab data, short‐term concerns, a problem list, and a if‐then list should be included in CHT template A standard form reduces variability of handoff information
Palma et al[24] (2011) Accuracy of handoff information Healthcare provider satisfaction Improved perceived accuracy of handoff information (91% vs 78%, P <0.01) Improved satisfaction with handoff process (71% vs 35%, P < 0.01) Improved satisfaction with handoff documents (98% vs 91%, P <0.01) More time spent on updating handoff information (1620 min vs 1115 min, P = 0.03) A discipline‐specific handoff tool results in perceived handoff accuracy and satisfaction A more efficient handoff tool can be achieved by more extensive data transfer from hospital IT system

CHT's Impact on Physician Work Efficiency

Van Eaton et al's study examined the effect of CHTs on physician work efficiency.[20] Improved physician work efficiency was found following implementation of CHT. Self‐reported time spent on hand‐copying patient information was reduced by 50%, while the portion of time spent on seeing patients during pre‐rounding increased. Similarly, self‐reported time spent on each patient during rounding (routine patient assessment by the primary team) was decreased by 1.5 minutes. Overall, resident physicians subjectively reported an average time saving of 45 minutes daily for junior residents and 30 minutes for senior residents, and 81% of residents reported finishing their work sooner when using CHTs. Although no data were reported in the pre‐CHT period described in the study by Cheah et al, they indicated that work efficiency was felt to be improved because all physicians could locate their patients quickly and were pleased to be able to check patients' lab results in the CHT.[22] Conversely, Palma et al and Ram and Block reported perceived increased work load with CHTs by users due to time spent updating handoff information.[24, 25]

CHT's Impact on Quality of Physician Handoff

Overall quality of physician handoff and completeness of the handoff document was improved in 3 studies.[20, 24, 25] Flanagan et al reported that patient identifiers and medications were extracted most of the time.[23] However, there were concerns regarding consistency,[22] completeness[22, 23] of information provided during physician handoff using CHTs. Palma et al's and Ram and Block's studies[24, 25] commented on the accuracy of patient information communicated during physician handoff. While Ram and Block's study suggested that it may be poorer during the intervention period,[25] Palma et al's study found improved perceived accuracy of handoff information postimplementation of a CHT (98% vs 91%, P < 0.01).[24]

CHT's Impact on Continuity of Patient Care

Using CHTs was associated with a decreased number of patients missed on rounds after handoff (new admitted patients who were not assessed by the primary team in the morning rounds because cross‐covering physicians did not inform the primary team) in Van Eaton et al's study.[20] On the other hand, Cheah et al[22] reported that documented handoffs after physicians returned to duty occurred on 50% of patients who had experienced important clinical events on weekends.

DISCUSSION

Our systematic review identified 6 controlled studies of CHT. Outcome parameters reported in these studies included quality of the handoff (including completeness, accuracy, and consistency), physician time management, continuity of care, adverse events, and missed patients. Our results suggest that while CHT are a promising tool, further evaluation using rigorous study methodologies is needed. These findings are somewhat surprising given increasing popularity of CHTs in daily patient care.[19, 24, 26, 27, 28] This might be due to the fact that IT adoption and use in healthcare is still in a phase of relative infancy,[29] and that the success of adopting IT systems in healthcare depends on various factors.[30]

Roles of CHT in Physician Handoff for Hospitalized Patients

Our study indicates that CHT can potentially improve continuity of patient care by reducing the number of missing patients during rounds following handoff,[20] and similarly improve patient safety by decreasing adverse events and preventable adverse events.[21] Of note, users reported that they were able to spend more time with patients during pre‐rounding[20] which will likely enhance quality and continuity of patient care. However, it is unclear whether these improvements translate into better patient outcomes. Although Peterson et al attempted to minimize the risk of bias by using anonymous reporting and blinding participants to the timing of data collection,[21] adverse events during the intervention period could have been underestimated due to surveillance bias or decreased self‐reporting. Nevertheless, the results suggest that CHTs may have affected quality of patient care in a positive manner from included studies.

The findings from our review also point to a positive impact of CHT on physician work efficiency. Specifically, residents spent less time rounding on patients after handoff and finished their work sooner after introduction of the intervention.[20] Several other published studies on CHT also indicated potential benefits on work efficiency and/or patient safety,[31, 33, 34, 35] although they did not meet the inclusion criteria for our study (prespecified outcomes not reported,[31, 35] or study design[33, 34, 35]). In the studies in which the majority of handoff information was manually typed in the CHT, the work load was perceived to be increased with CHT implementation.[24, 25] On the other hand, the study conducted by Van Eaton et al demonstrated that a CHT that had broad integration with the hospital main IT system, and could automatically transfer important patient information such as medication, medical problems, recent investigation, and vital signs into CHT, quickly gained popularity among residents and staff due to its user‐friendly features.[20] This integration can also potentially reduce miscommunication and associated medical errors during physician handoff. Palma et al's study reported higher perceived workload due to manual entry of patient data.[24] Although the CHT used in their study was developed within their existing EMR system, large amounts of information needed to be manually imputed, and thus increased time spent on updating handoff information. This information included patient demographics, active medical issues, a to do list, and on‐going issues,[24] some of which could be imputed automatically with better CHT design. It is also possible that users spent more time in updating the handoff because they were able to deliver more information using a CHT.[24] However, this may allow cross‐covering physicians to spend less time on looking for patient information from other sources and thus actually decrease workload during cross‐coverage. Although there are numerous factors that could affect physician work efficiency when using a new IT system,[30] it was felt that a well‐designed and easy‐to‐use CHT that is integrated with the hospital information system can improve physician productivity.

The role of CHT in improving quality of handoff is less clear. Three studies[20, 24, 25] found an overall improvement in the quality of handoff after implementation of CHT, such that the handoff information was more complete and more consistent. On the other hand, physicians were concerned about the comprehensiveness of physician handoff after implementation of CHT in 2 studies.[22, 23] In Ram and Block's study,[25] physicians relied heavily on an unstructured free‐text entry system to deliver the majority of patient information that physicians thought to be important. In Flanagan et al's study,[23] resident physicians had to search for alternative sources, such as patient charts and electronic order systems, to obtain vital information in many cases in spite of a structured CHT. As a result, the information available was often not sufficient to help on‐call physicians make patient care decisions.[23]

Implication of CHT Design and Use

It has been demonstrated in many non‐healthcare domains,[15, 36, 37] as well as nursing care,[38] that a standardized handoff protocol is vital to decrease medical errors and improve patient safety. In our review, we found that physicians generally reported being satisfied with the accuracy of handoff information and the overall handoff when using standardized CHTs interfaced with hospital IT systems. This suggests, as recommended by Flanagan et al,[23] Palma et al,[24] and Ram and Block[25] that CHTs be developed with a standardized protocol and wide integration into hospital IT systems.

In order to achieve this goal, key patient information necessary for patient care need to be communicated during physician handoff. As hospitals consist of a wide range of disciplines and specialties with varying cultures and focuses of patient information, it is likely difficult to develop a single panacea CHT template for all the in‐hospital services.[1] This may be even particularly relevant when developing CHTs for different hospital services. However, some patient information appears to be universally important for physician handoff for inpatient care. Key elements, such as patient demographics, diagnosis, outstanding investigation results, code status, a problem list, and a to do list, were noted to be consistently present in the CHTs that were evaluated in our review (Table 2). Other studies have also demonstrated that information items such as a to do list, outstanding investigation results, and patients' code status were regarded as the most important information during physician handoff.[1, 2, 17, 23, 39, 40] Based on these findings, a potential solution for CHT standardization would be to develop a core CHT which includes the universally important components of physician handoff identified in this review, and provides options for adding well‐categorized service‐specific information as needed (eg, type and date of surgical procedures for surgical patients). It also appears that active involvement of physicians in CHT design and modification facilitates successful implementation of CHT, as demonstrated in Van Eaton et al's and Peterson et al's studies.[20, 21]

It is difficult to recommend metrics for CHT evaluation based on the limited literature identified in our review. However, it appears to be reasonable to consider integration into existing IT system, user friendly features, impact on quality of handoff documents, work efficiency, and processes and outcomes of patient care when assessing CHTs.

Limitations

There are several limitations in the studies included in our review. None of the studies were multi‐centered. The majority of the included studies had a beforeafter design.[21, 22, 23, 24, 25] Some studies did not have user training or a run in period to ensure familiarity of CHTs by users.[22, 24, 25] None of the studies described the key components of handoff in the control groups, or used quality control measurements for user familiarity with the CHTs. Furthermore, outcomes reported by the studies were heterogeneous, subjective, based on participant self‐report, and not independently validated.

Our review also has also several limitations. First, in spite of a comprehensive search effort, it is possible that we failed to identify all relevant articles. However, this is unlikely, given that we searched multiple databases and performed hand searches of all references identified from the included articles, as well as content‐related previously published systematic reviews. Second, we were not able to perform a meta‐analysis, given the heterogeneity seen in outcomes assessed across studies, measures applied, and results presented.

CONCLUSIONS AND IMPLICATIONS FOR PRACTICE

Although the current literature suggests that implementation of CHTs is likely to improve physician work efficiency, satisfaction, and quality of patient care during physician handoff for hospitalized patients, the evidence supporting these potential benefits is limited. Furthermore, it is unknown what impacts CHTs may have on clinical outcomes, such as hospital length of stay and mortality. Further studies with larger sample size, multiple center involvement, and more objective patient outcome measurements are therefore needed to evaluate the roles of CHTs in physician handoff and improving the quality of patient care.

In the absence of larger studies evaluating major clinical outcomes, such as length of stay and mortality, hospitals considering innovations in the domain of computerized platforms for physician handoffs will need to consider the pros and cons of immediate system implementation on the basis of the evidence presented here versus waiting until there is more evidence from more definitive studies. In addition, our study suggests that organizations engage physicians during CHT design and develop a standardized CHT protocol that is interfaced with hospital IT systems and includes key components of handoff information, but provides flexibility to meet service‐specific needs. The evidence summarized here, while far from definitive for major outcomes, is nonetheless rather positive for the general benefits of CHTan impetus for careful design, implementation, and modification, whenever and wherever possible. Any such system implementations should, however, incorporate an evaluative component so that the evidence‐base surrounding CHT can be enhanced.

Acknowledgments

Disclosure: Nothing to report.

Physician handoff is a common and essential component of daily patient care that includes transfer of important clinical patient information and accountability of patient care. Thus, high‐quality physician handoffs are crucial to ensure patient safety and continuity of patient care, especially with the new resident work hour restriction in North America.[1, 2] As such, healthcare organizations including the World Health Organization[3] have issued specific goals and organizational challenges to improve the effectiveness and coordination of communication among the care/service providers and with the recipients of care/service across the continuum in healthcare.[4, 5]

It has been well‐documented that physician handoffs in hospital settings are often unstructured and not standardized, which leads to medical errors and jeopardizes patient safety.[2, 6, 7, 8, 9, 10, 11, 12] This lack of standardization of physician handoff for hospitalized patients occurs in every major in‐hospital service and affects trainees and staff.[2, 6, 7, 9, 10, 12, 13] It has been demonstrated in healthcare and in other domains that a standardized handoff protocol that involves both verbal communication and written handoff documents is likely to be an effective method of handoff to decrease miscommunication and associated errors.[14, 15, 16, 17] Computerized physician handoff tools (CHTs) have been increasingly deployed to address these challenges and have quickly gained popularity among physicians for documenting patient information during physician handoff for hospitalized patients.[18] CHTs can be an complementary part of electronic medical record (EMR) systems, but not a substitute since their focus is to deliver concise and essential information vital for patient care during interfaces of patient care.

Two recent systematic reviews have examined information technology (IT) systems to promote the handoff process in healthcare.[17, 19] However, to our knowledge, there has not been a systematic review of the potential role of CHT in physician handoff and quality of patient care for hospitalized patients. We therefore conducted a systematic review to examine the current evidence for CHTs in physician handoff for hospitalized patients, focusing specifically on potential effects on continuity of patient care, physician work efficiency, quality of handoffs, and patient outcomes.

METHODS

Criteria for Considering Eligible Studies

We included randomized controlled trials, controlled clinical trial, quasi‐experimental studies, and controlled beforeafter studies that evaluated CHTs during physician handoff of hospitalized patients. Studies needed to report patient outcomes (adverse events, missing patients at rounds, or in‐hospital mortality), physician work efficiency, quality of handoff (accuracy, consistency, or completeness), continuity of care, or physician satisfaction. Articles that met all these inclusion criteria were considered to be eligible for the review. We excluded review articles, commentaries, case reports, and retrospective studies.

Search Strategy

CHTs were defined as computer‐based platforms, designed specifically for the purpose of physician handoff, to allow distributed access and synchronous archiving of patient information via Internet protocols (ie, electronic tool to allow physician data access and data entry for handoff from different computers at multiple locations within the authorized hospitals or clinics). A search strategy was developed based on a MEDLINE search format combined with our inclusion criteria and with this definition of CHTs. We used search terms related to physician communication and information technology, and relevant Medical Subjects Headings, which include handover, handoff, signoff, sign‐over, off‐duty, post‐call, computerized, Web‐based, communication tool. The databases, including MEDLINE, PUBMED, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane database for systematic reviews, and the Cochrane CENTRAL register of controlled trials, were initially searched from 1985 to December 2011 in all languages. The Cochrane Collaboration filter for controlled interventional studies was used to select the above‐mentioned interventional trial designs. In addition, the first 2 authors hand searched the references of included articles and relevant systematic reviews.

Screening for Eligible Studies

All articles identified in the database searches described above were included for screening in 2 stages. First, 2 reviewers (P.L., S.A.) independently reviewed the title and abstracts of the identified articles for eligibility. The articles selected in the first stage of screening were then further assessed by a full‐text review independently by the 2 reviewers. Any discrepancy was resolved by consensus or by involvement of a third reviewer (C.T.).

Data Abstraction and Analysis

Data abstraction from selected studies was conducted independently by 3 authors based on a predefined template. All discrepancies in this stage were resolved by consensus among the 3 authors. For each study, we analyzed study design, data collection, intervention, main outcomes, and components of physician handoffs in the study. Due to heterogeneity of study outcomes, measures used, and results, a meta‐analysis was not performed. Study outcomes, which included adverse events, missing patients at rounds, time spent on rounding patient, accuracy, consistency or completeness of handoff information, and continuity of care, were summarized.

RESULTS

Study Selection

A total of 1026 citations were identified in the initial search, of which 1006 studies did not evaluate CHT and were excluded by title and abstract screening. Of the 20 studies evaluated further by full‐text review, 5 were selected for the final analysis. One additional study was identified by hand searching references. The kappa score of inter‐reviewer agreement on article selection in the first stage of screening was 0.7, and for the second stage of article selection, kappa was 1.0. The reasons for exclusion in the second selection step are presented in Figure 1.

Figure 1
Flow chart of study inclusion.

Study Characteristics

Of the 6 studies identified, 1 study was a randomized controlled trial[20] and the other 5 were controlled beforeafter studies.[21, 22, 23, 24, 25] All studies were conducted in teaching hospitals in English‐speaking high‐income countries. All were single‐center studies, except the study by Van Eaton et[20] that involved 2 centers. All the studies investigated physician handoffs conducted by trainees. Two studies included staff physicians.[22, 24] Van Eaton et al's study included general medical, general surgical, and subspecialty surgical services.[20] The other 5 studies assessed physician handoffs in family medicine,[25] internal medicine services,[21, 23] a surgical service,[22] and a neonatal intensive care unit.[24] The study by Van Eaton et al[20] enrolled the largest study population. The intervention or observation phase ranged from 1 month[20] to 6 months[24] (Table 1).

Study Characteristics Included in the Review
Study Design Setting Target Services Intervention Group Control Group Data Collection and Validation
  • Abbreviations: CHT, computerized physician handoff tool; EMR, electronic medical record; NICU, neonatal intensive care unit.
Ram and Block[25] (1992) Beforeafter study 150‐bed urban hospital in USA Family Medicine Residents (N = 7) Patient no. not reported 1 mo of intervention No CHT training prior to the intervention reported Patient no. not reported Traditional handoff note (on index card or previous list) Components of handoff note not reported Questionnaire No data validation
Peterson et al[21] (1998) Beforeafter study 720‐bed tertiary care hospital in USA All Internal Medicine Services Residents (N = 99) 3747 patients 4 mo of intervention 8 wk of run‐in period 1874 patients Handwritten handoff Components of handoff note not reported Self‐report using e‐mail, report card, in person chart review for unreported adverse events in 250 samples
Van Eaton et al[20] (2005) Randomized cross‐over trial 450‐bed tertiary care hospital and a 368‐bed trauma center in USA General Medicine, General Surgery, and Subspecialties Trauma Residents (N = 7 teams) 8018 patients 14 wk of randomized crossover period 6 wk of run‐in period 7569 patients Individual written lists, cards, a team‐developed computer‐generated spreadsheet Components of handoff note not reported Telephone interview and anonymous online survey No validation of data
Cheah et al[22] (2005) Beforesfter atudy A 400‐bed regional teaching hospital in Australia General Surgery Registrars and Residents (N = 714) Patient no. not reported 3 mo of observation period (for weekend coverage only) No CHT training prior to the intervention reported Patient no. not reported No description of pre‐intervention handoff method reported In‐person interview and survey No validation of data
Flanagan et al[23] (2009) Beforesfter atudy Tertiary care hospital in USA Internal Medicine, Medical Intensive Care Unit First‐year Residents (N = 35) 1264 patient handoff forms 1 mo of observation Orientation session and 1 cross‐over shift of run‐in period Patient no. not reported No description of pre‐CHT implementation handoff method reported In‐person interview and survey No validation of data
Palma et al[24] (2011) Beforeafter study 304‐bed quaternary care women and children hospital in USA NICU Attendings, Residents, Nursing staffs (N = 4652) Patient no. not reported 6 mo of intervention of NICU handoff tool Instruction document by e‐mail and informal instructional session Patient no. not reported A Microsoft‐based standalone handoff tool or EMR integrated Medical/Surgical handoff tool Components of handoff note not reported Online survey No validation of data

CHT Characteristics

Three CHTs were standalone applications designed specifically for physician handoffs.[20, 22, 25] The other 3 CHTs were add‐on functions to existing hospital Electric Medical Record (EMR) systems.[21, 23, 24] All CHTs except one[25] interfaced with existing EMR systems, allowing for variable degrees of data transfer depending on CHT design and the functionalities of the EMR systems. CHT users were actively involved in designing and modifying the CHTs in most of the studies.[20, 21, 23, 25] The characteristics of the CHTs were summarized in Table 2.

Characteristics of CHTs
Study CHT Design EMR Interface Physician Daily Progress Note Participants' Role in CHT Design Components of CHT Components That Require Manual Input
  • Abbreviations: CHT, computerized physician handoff tool; EMR, electronic medical record; IT, information technology.
Ram and Block[25] (1992) Standalone application No interface Paper‐based Designing Patient demographics Medications Diagnosis Problem lists Comment line All the information
Peterson et al[21] (1998) A part of existing EMR Bi‐directional interface Paper‐based Designing Patient demographics Current medication Allergy Code status Recent lab value A problem list A to do list A problem list A to do list
Van Eaton et al[20] (2005) Standalone application Uni‐directional interface (data input from hospital IT system) Electronic‐based Designing and modifying Patient demographics Diagnosis Medication Allergy Vital signs Lab and investigation A problem list A to do list Diagnosis Medication A problem list A to do list
Cheah et al[22] (2005) Standalone application Uni‐directional interface (data input from hospital IT system) Electronic‐based No Patient demographics Diagnosis Length of stay Recent investigations Free‐text note (Not standardized) Free‐text note
Flanagan et al[23] (2009) A part of existing EMR Uni‐directional interface (data input from hospital IT system) Electronic‐based Evaluating and modifying Patient demographics Medication Allergy Lab and investigation Physician daily note Free‐text note (not standardized) Free‐text note (may contain assessment, a problem list, venous access, short‐term concerns and long‐term plan, and follow‐up tasks)
Palma et al[24] (2011) A part of existing EMR Uni‐directional interface (data input from hospital IT system) Paper‐based No Patient demographics Lab and measurement Free‐text note (not standardized) Free‐text note (including patient description, active medical issues, ongoing care and a to do list)

CHT's Impact on Adverse Events

The impact of CHTs on preventable adverse events was evaluated in a single study by Peterson et al.[21] The authors defined an adverse event as an injury due to medical treatment which prolonged hospital stay or produced disability at discharge in the study. Preventability was determined by using a 6‐point scale and assessed independently by 3 reviewers. Fewer adverse events were found after implementation of CHTs (2.38% vs 3.94%, P < 0.001). They also reported nonsignificant reductions in preventable adverse events (1.23% vs 1.72%, P < 0.1) with implementation of the CHT, and preventable adverse events during cross‐coverage (0.24% vs 0.38%, P > 0.10). The odds ratio for a patient experiencing a preventable adverse event during cross‐coverage compared to noncross‐coverage time was reduced from 5.2 (95% confidence interval [CI], 1.518.2) to 1.5 (95% CI, 0.29.0) following implementation of the CHT (Table 3).

Description of Study Outcomes and Recommendations for CHT
Study Outcomes of Interest Results Implication for CHT Design and Use
  • Abbreviations: CHT, computerized physician handoff tool; IT, information technology.
Ram and Block[25] (1992) Physician satisfaction Importance and accessibility of clinical information Improved physician satisfaction Handoff documentation more legible, more consistent, and more comprehensive Information required to be typed in by residents and not up‐to‐date The most important data for handoff: a to do list and code status A CHT interfaced with hospital IT system, and in a format that can focus on physician needs
Petersen et al[21] (1998) Adverse event rate Preventable adverse events rate Fewer adverse events (2.38% vs 3.94%, P < 0.001) Fewer preventable adverse events (1.23% vs 1.72%, P < 0.1) Few preventable adverse events during cross‐coverage (0.24% vs 0.38%, P > 0.10) Lower OR of preventable adverse events during cross‐coverage (1.5; 95% CI 0.29.0 vs 5.2; 95% CI 1.58.2) Active involvement in the design of CHT by house staff likely contributes to high participation and CHT use rate in the study
Van Eaton et al[20] (2005) No. of patients missed on rounds Perception on continuity of care quality and workflow efficiency Daily self‐reported pre‐rounding and rounding times and tasks Reduced the no. of patients missed on rounds (2.5 patients/team/mo) (P = 0.0001) Spent 40% more time with patients at pre‐rounds Reduced time on team rounds by 1.5 min per patient Reduced time on manual copying at pre‐rounding by 50% Improved handoff quality Improved continuity of care No reduction of overall pre‐rounding time The largest benefit from CHTs varies between clinical services, from more time assessing patients before rounds in Internal Medicine to reduced backtracking and locating patients in Surgery
Cheah et al[22] (2005) Completeness and usefulness of handoff information Desirability of electronic handoff system Identified information set for handoff Free text entry in CHT often deficient in particular patient information Concerns of the completeness and consistency of information delivered in CHT CHT needs to be linked to hospital information system
Flanagan et al[23] (2009) Common data elements of interest extracted during physician handoff Missing data required during handoff Physicians' perception of CHT Additional important information needed that not included during handoff in 25% cases Code status, relevant lab data, short‐term concerns, a problem list, and a if‐then list should be included in CHT template A standard form reduces variability of handoff information
Palma et al[24] (2011) Accuracy of handoff information Healthcare provider satisfaction Improved perceived accuracy of handoff information (91% vs 78%, P <0.01) Improved satisfaction with handoff process (71% vs 35%, P < 0.01) Improved satisfaction with handoff documents (98% vs 91%, P <0.01) More time spent on updating handoff information (1620 min vs 1115 min, P = 0.03) A discipline‐specific handoff tool results in perceived handoff accuracy and satisfaction A more efficient handoff tool can be achieved by more extensive data transfer from hospital IT system

CHT's Impact on Physician Work Efficiency

Van Eaton et al's study examined the effect of CHTs on physician work efficiency.[20] Improved physician work efficiency was found following implementation of CHT. Self‐reported time spent on hand‐copying patient information was reduced by 50%, while the portion of time spent on seeing patients during pre‐rounding increased. Similarly, self‐reported time spent on each patient during rounding (routine patient assessment by the primary team) was decreased by 1.5 minutes. Overall, resident physicians subjectively reported an average time saving of 45 minutes daily for junior residents and 30 minutes for senior residents, and 81% of residents reported finishing their work sooner when using CHTs. Although no data were reported in the pre‐CHT period described in the study by Cheah et al, they indicated that work efficiency was felt to be improved because all physicians could locate their patients quickly and were pleased to be able to check patients' lab results in the CHT.[22] Conversely, Palma et al and Ram and Block reported perceived increased work load with CHTs by users due to time spent updating handoff information.[24, 25]

CHT's Impact on Quality of Physician Handoff

Overall quality of physician handoff and completeness of the handoff document was improved in 3 studies.[20, 24, 25] Flanagan et al reported that patient identifiers and medications were extracted most of the time.[23] However, there were concerns regarding consistency,[22] completeness[22, 23] of information provided during physician handoff using CHTs. Palma et al's and Ram and Block's studies[24, 25] commented on the accuracy of patient information communicated during physician handoff. While Ram and Block's study suggested that it may be poorer during the intervention period,[25] Palma et al's study found improved perceived accuracy of handoff information postimplementation of a CHT (98% vs 91%, P < 0.01).[24]

CHT's Impact on Continuity of Patient Care

Using CHTs was associated with a decreased number of patients missed on rounds after handoff (new admitted patients who were not assessed by the primary team in the morning rounds because cross‐covering physicians did not inform the primary team) in Van Eaton et al's study.[20] On the other hand, Cheah et al[22] reported that documented handoffs after physicians returned to duty occurred on 50% of patients who had experienced important clinical events on weekends.

DISCUSSION

Our systematic review identified 6 controlled studies of CHT. Outcome parameters reported in these studies included quality of the handoff (including completeness, accuracy, and consistency), physician time management, continuity of care, adverse events, and missed patients. Our results suggest that while CHT are a promising tool, further evaluation using rigorous study methodologies is needed. These findings are somewhat surprising given increasing popularity of CHTs in daily patient care.[19, 24, 26, 27, 28] This might be due to the fact that IT adoption and use in healthcare is still in a phase of relative infancy,[29] and that the success of adopting IT systems in healthcare depends on various factors.[30]

Roles of CHT in Physician Handoff for Hospitalized Patients

Our study indicates that CHT can potentially improve continuity of patient care by reducing the number of missing patients during rounds following handoff,[20] and similarly improve patient safety by decreasing adverse events and preventable adverse events.[21] Of note, users reported that they were able to spend more time with patients during pre‐rounding[20] which will likely enhance quality and continuity of patient care. However, it is unclear whether these improvements translate into better patient outcomes. Although Peterson et al attempted to minimize the risk of bias by using anonymous reporting and blinding participants to the timing of data collection,[21] adverse events during the intervention period could have been underestimated due to surveillance bias or decreased self‐reporting. Nevertheless, the results suggest that CHTs may have affected quality of patient care in a positive manner from included studies.

The findings from our review also point to a positive impact of CHT on physician work efficiency. Specifically, residents spent less time rounding on patients after handoff and finished their work sooner after introduction of the intervention.[20] Several other published studies on CHT also indicated potential benefits on work efficiency and/or patient safety,[31, 33, 34, 35] although they did not meet the inclusion criteria for our study (prespecified outcomes not reported,[31, 35] or study design[33, 34, 35]). In the studies in which the majority of handoff information was manually typed in the CHT, the work load was perceived to be increased with CHT implementation.[24, 25] On the other hand, the study conducted by Van Eaton et al demonstrated that a CHT that had broad integration with the hospital main IT system, and could automatically transfer important patient information such as medication, medical problems, recent investigation, and vital signs into CHT, quickly gained popularity among residents and staff due to its user‐friendly features.[20] This integration can also potentially reduce miscommunication and associated medical errors during physician handoff. Palma et al's study reported higher perceived workload due to manual entry of patient data.[24] Although the CHT used in their study was developed within their existing EMR system, large amounts of information needed to be manually imputed, and thus increased time spent on updating handoff information. This information included patient demographics, active medical issues, a to do list, and on‐going issues,[24] some of which could be imputed automatically with better CHT design. It is also possible that users spent more time in updating the handoff because they were able to deliver more information using a CHT.[24] However, this may allow cross‐covering physicians to spend less time on looking for patient information from other sources and thus actually decrease workload during cross‐coverage. Although there are numerous factors that could affect physician work efficiency when using a new IT system,[30] it was felt that a well‐designed and easy‐to‐use CHT that is integrated with the hospital information system can improve physician productivity.

The role of CHT in improving quality of handoff is less clear. Three studies[20, 24, 25] found an overall improvement in the quality of handoff after implementation of CHT, such that the handoff information was more complete and more consistent. On the other hand, physicians were concerned about the comprehensiveness of physician handoff after implementation of CHT in 2 studies.[22, 23] In Ram and Block's study,[25] physicians relied heavily on an unstructured free‐text entry system to deliver the majority of patient information that physicians thought to be important. In Flanagan et al's study,[23] resident physicians had to search for alternative sources, such as patient charts and electronic order systems, to obtain vital information in many cases in spite of a structured CHT. As a result, the information available was often not sufficient to help on‐call physicians make patient care decisions.[23]

Implication of CHT Design and Use

It has been demonstrated in many non‐healthcare domains,[15, 36, 37] as well as nursing care,[38] that a standardized handoff protocol is vital to decrease medical errors and improve patient safety. In our review, we found that physicians generally reported being satisfied with the accuracy of handoff information and the overall handoff when using standardized CHTs interfaced with hospital IT systems. This suggests, as recommended by Flanagan et al,[23] Palma et al,[24] and Ram and Block[25] that CHTs be developed with a standardized protocol and wide integration into hospital IT systems.

In order to achieve this goal, key patient information necessary for patient care need to be communicated during physician handoff. As hospitals consist of a wide range of disciplines and specialties with varying cultures and focuses of patient information, it is likely difficult to develop a single panacea CHT template for all the in‐hospital services.[1] This may be even particularly relevant when developing CHTs for different hospital services. However, some patient information appears to be universally important for physician handoff for inpatient care. Key elements, such as patient demographics, diagnosis, outstanding investigation results, code status, a problem list, and a to do list, were noted to be consistently present in the CHTs that were evaluated in our review (Table 2). Other studies have also demonstrated that information items such as a to do list, outstanding investigation results, and patients' code status were regarded as the most important information during physician handoff.[1, 2, 17, 23, 39, 40] Based on these findings, a potential solution for CHT standardization would be to develop a core CHT which includes the universally important components of physician handoff identified in this review, and provides options for adding well‐categorized service‐specific information as needed (eg, type and date of surgical procedures for surgical patients). It also appears that active involvement of physicians in CHT design and modification facilitates successful implementation of CHT, as demonstrated in Van Eaton et al's and Peterson et al's studies.[20, 21]

It is difficult to recommend metrics for CHT evaluation based on the limited literature identified in our review. However, it appears to be reasonable to consider integration into existing IT system, user friendly features, impact on quality of handoff documents, work efficiency, and processes and outcomes of patient care when assessing CHTs.

Limitations

There are several limitations in the studies included in our review. None of the studies were multi‐centered. The majority of the included studies had a beforeafter design.[21, 22, 23, 24, 25] Some studies did not have user training or a run in period to ensure familiarity of CHTs by users.[22, 24, 25] None of the studies described the key components of handoff in the control groups, or used quality control measurements for user familiarity with the CHTs. Furthermore, outcomes reported by the studies were heterogeneous, subjective, based on participant self‐report, and not independently validated.

Our review also has also several limitations. First, in spite of a comprehensive search effort, it is possible that we failed to identify all relevant articles. However, this is unlikely, given that we searched multiple databases and performed hand searches of all references identified from the included articles, as well as content‐related previously published systematic reviews. Second, we were not able to perform a meta‐analysis, given the heterogeneity seen in outcomes assessed across studies, measures applied, and results presented.

CONCLUSIONS AND IMPLICATIONS FOR PRACTICE

Although the current literature suggests that implementation of CHTs is likely to improve physician work efficiency, satisfaction, and quality of patient care during physician handoff for hospitalized patients, the evidence supporting these potential benefits is limited. Furthermore, it is unknown what impacts CHTs may have on clinical outcomes, such as hospital length of stay and mortality. Further studies with larger sample size, multiple center involvement, and more objective patient outcome measurements are therefore needed to evaluate the roles of CHTs in physician handoff and improving the quality of patient care.

In the absence of larger studies evaluating major clinical outcomes, such as length of stay and mortality, hospitals considering innovations in the domain of computerized platforms for physician handoffs will need to consider the pros and cons of immediate system implementation on the basis of the evidence presented here versus waiting until there is more evidence from more definitive studies. In addition, our study suggests that organizations engage physicians during CHT design and develop a standardized CHT protocol that is interfaced with hospital IT systems and includes key components of handoff information, but provides flexibility to meet service‐specific needs. The evidence summarized here, while far from definitive for major outcomes, is nonetheless rather positive for the general benefits of CHTan impetus for careful design, implementation, and modification, whenever and wherever possible. Any such system implementations should, however, incorporate an evaluative component so that the evidence‐base surrounding CHT can be enhanced.

Acknowledgments

Disclosure: Nothing to report.

References
  1. Arora V, Johnson J, Lovinger D, et al. Communication failures in patient sign‐out and suggestions for improvement: a critical incident analysis. Qual Saf Health Care. 2005;14(6):401407.
  2. Solet DJ, Norvell JM, Rutan GH, Frankel RM. Lost in translation: challenges and opportunities in physician‐to‐physician communication during patient handoffs. Acad Med. 2005;80(12):10941099.
  3. World Health Organization. Patient safety solution: communication during patient handovers. Available at: http://www.who.int/patientsafety/solutions/patientsafety/PS‐Solution3.pdf Accessed January 20, 2011.
  4. Accreditation Canada. Required Organizational Practices: Communication. Available at: http://wwwaccreditationca/uploadedFiles/information%20transferpdf?n=1212. Accessed January 20, 2010.
  5. Joint Commission on Accreditation of Healthcare Organizations National Patient Safety Goals. Available at: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsg_cah.html. Accessed January 20, 2010.
  6. Apker J, Mallak LA, Gibson SC. Communicating in the “gray zone”: perceptions about emergency physician hospitalist handoffs and patient safety. Acad Emerg Med. 2007;14(10):884894.
  7. Gandhi TK. Fumbled handoffs: one dropped ball after another. Ann Intern Med. 2005;142(5):352358.
  8. Horwitz LI, Krumholz HM, Green ML, Huot SJ. Transfers of patient care between house staff on internal medicine wards: a national survey. Arch Intern Med. 2006;166(11):11731177.
  9. Horwitz LI, Moin T, Krumholz HM, et al. Consequences of inadequate sign‐out for patient care. Arch Intern Med. 2008;168(16):17551760.
  10. Horwitz LI, Moin T, Krumholz HM, et al. What are covering doctors told about their patients? Analysis of sign‐out among internal medicine house staff. Qual Saf Health Care. 2009;18(4):248255.
  11. Horwitz LI, Meredith T, Schuur JD, et al. Dropping the baton: a qualitative analysis of failures during the transition from emergency department to inpatient care. Ann Emerg Med. 2009;53(6):701710.
  12. Singh H, Thomas EJ, Petersen LA, Studdert DM. Medical errors involving trainees: a study of closed malpractice claims from 5 insurers. Arch Intern Med. 2007;167(19):20302036.
  13. Arora V, Johnson J, Lovinger D, et al. Communication failures in patient sign‐out and suggestions for improvement: a critical incident analysis. Qual Saf Health Care. 2005;14(6):401407.
  14. Lee LH, Levine JA, Schultz HJ. Utility of a standardized sign‐out card for new medical interns. J Gen Intern Med. 1996;11(12):753755.
  15. Patterson ES, Roth EM, Woods DD, et al. Handoff strategies in settings with high consequences for failure: lessons for health care operations. Int J Qual Health Care. 2004;16(2):125132.
  16. Shendell‐Falik N, Feinson M, Mohr BJ. Enhancing patient safety: improving the patient handoff process through appreciative inquiry. J Nurs Adm. 2007;37(2):95104.
  17. Vidyarthi AR, Arora V, Schnipper JL, et al. Managing discontinuity in academic medical centers: strategies for a safe and effective resident sign‐out. J Hosp Med. 2006;1(4):257266.
  18. Eaton EG, Horvath KD, Lober WB, Pellegrini CA. Organizing the transfer of patient care information: the development of a computerized resident sign‐out system. Surgery. 2004;136(1):513.
  19. Arora VM, Manjarrez E, Dressler DD, et al. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7):433440.
  20. Eaton EG, Horvath KD, Lober WB, et al. A randomized, controlled trial evaluating the impact of a computerized rounding and sign‐out system on continuity of care and resident work hours. J Am Coll Surg. 2005;200(4):538545.
  21. Petersen LA, Orav EJ, Teich JM, et al. Using a computerized sign‐out program to improve continuity of inpatient care and prevent adverse events. Jt Comm J Qual Improve. 1998;24(2):7787.
  22. Cheah LP, Amott DH, Pollard J, Watters DA. Electronic medical handover: towards safer medical care. Med J Aust. 2005;183(7):369372.
  23. Flanagan ME, Patterson ES, Frankel RM, Doebbeling BN. Evaluation of a physician informatics tool to improve patient handoffs. J Am Med Inform Assoc. 2009;16(4):509515.
  24. Palma JP, Sharek PJ, Longhurst CA. Impact of electronic medical record integration of a handoff tool on sign‐out in a newborn intensive care unit. J Perinatol. 2011;31(5):311317.
  25. Ram R, Block B. Signing out patients for off‐hours coverage: comparison of manual and computer‐aided methods. Proceedings—The Annual Symposium on Computer Applications in Medical Care. 1992;114118.
  26. Kannry J, Moore C. MediSign: using a Web‐based SignOut system to improve provider identification. Proc AMIA Symp. 1999:550554.
  27. Ovretveit J, Scott T, Rundall TG, et al. Implementation of electronic medical records in hospitals: two case studies. Health Policy. 2007;84(2–3):181190.
  28. Quan S, Tsai O. Signing on to sign out, part 2: describing the success of a Web‐based patient sign‐out application and how it will serve as a platform for an electronic discharge summary program. Healthc Q. 2007;10(1):120124.
  29. Hillestad R, Bigelow J, Bower A, et al. Can electronic medical record systems transform health care? Potential health benefits, savings, and costs. Health Affairs. 2005;24(5):11031117.
  30. Gagnon MP, Legare F, Labrecque M, et al. Interventions for promoting information and communication technologies adoption in healthcare professionals. Cochrane Database Syst Rev. 2009;Jan21(1):CD006093.
  31. Frank G, Lawless ST, Steinberg TH. Improving physician communication through an automated, integrated sign‐out system. J Healthc Inf Manag. 2005;19(4):6874.
  32. Sarkar U, Carter JT, Omachi TA, et al. SynopSIS: integrating physician sign‐out with the electronic medical record. J Hosp Med. 2007;2(5):336342.
  33. Bernstein JA, Imler DL, Sharek P, Longhurst CA. Improved physician work flow after integrating sign‐out notes into the electronic medical record. Jt Comm J Qual Patient Saf. 2010;36(2):7278.
  34. Wong HJ, Caesar M, Bandali S, et al. Electronic inpatient whiteboards: improving multidisciplinary communication and coordination of care. Int J Med Inform. 2009;78(4):239247.
  35. Zsenits B, Polashenski WA, Sterns RH, et al. Systematically improving physician assignment during in‐hospital transitions of care by enhancing a preexisting hospital electronic health record. J Hosp Med. 2009;4(5):308312.
  36. Helmreich RL. On error management: lessons from aviation. BMJ. 2000;320(7237):781785.
  37. Mumaw RJ, Roth EM, Vicente KJ, Burns CM. There is more to monitoring a nuclear power plant than meets the eye. Hum Factors 2000;42(1):3655.
  38. Streitenberger K, Breen‐Reid K, Harris C. Handoffs in care—can we make them safer?Pediatr Clin North Am. 2006;53(6):11851195.
  39. Kemp CD, Bath JM, Berger J, et al. The top 10 list for a safe and effective sign‐out. Arch Surg. 2008;143(10):10081010.
  40. Riesenberg LA, Leitzsch J, Little BW. Systematic review of handoff mnemonics literature. Am J Med Qual. 2009;24(3):196204.
References
  1. Arora V, Johnson J, Lovinger D, et al. Communication failures in patient sign‐out and suggestions for improvement: a critical incident analysis. Qual Saf Health Care. 2005;14(6):401407.
  2. Solet DJ, Norvell JM, Rutan GH, Frankel RM. Lost in translation: challenges and opportunities in physician‐to‐physician communication during patient handoffs. Acad Med. 2005;80(12):10941099.
  3. World Health Organization. Patient safety solution: communication during patient handovers. Available at: http://www.who.int/patientsafety/solutions/patientsafety/PS‐Solution3.pdf Accessed January 20, 2011.
  4. Accreditation Canada. Required Organizational Practices: Communication. Available at: http://wwwaccreditationca/uploadedFiles/information%20transferpdf?n=1212. Accessed January 20, 2010.
  5. Joint Commission on Accreditation of Healthcare Organizations National Patient Safety Goals. Available at: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsg_cah.html. Accessed January 20, 2010.
  6. Apker J, Mallak LA, Gibson SC. Communicating in the “gray zone”: perceptions about emergency physician hospitalist handoffs and patient safety. Acad Emerg Med. 2007;14(10):884894.
  7. Gandhi TK. Fumbled handoffs: one dropped ball after another. Ann Intern Med. 2005;142(5):352358.
  8. Horwitz LI, Krumholz HM, Green ML, Huot SJ. Transfers of patient care between house staff on internal medicine wards: a national survey. Arch Intern Med. 2006;166(11):11731177.
  9. Horwitz LI, Moin T, Krumholz HM, et al. Consequences of inadequate sign‐out for patient care. Arch Intern Med. 2008;168(16):17551760.
  10. Horwitz LI, Moin T, Krumholz HM, et al. What are covering doctors told about their patients? Analysis of sign‐out among internal medicine house staff. Qual Saf Health Care. 2009;18(4):248255.
  11. Horwitz LI, Meredith T, Schuur JD, et al. Dropping the baton: a qualitative analysis of failures during the transition from emergency department to inpatient care. Ann Emerg Med. 2009;53(6):701710.
  12. Singh H, Thomas EJ, Petersen LA, Studdert DM. Medical errors involving trainees: a study of closed malpractice claims from 5 insurers. Arch Intern Med. 2007;167(19):20302036.
  13. Arora V, Johnson J, Lovinger D, et al. Communication failures in patient sign‐out and suggestions for improvement: a critical incident analysis. Qual Saf Health Care. 2005;14(6):401407.
  14. Lee LH, Levine JA, Schultz HJ. Utility of a standardized sign‐out card for new medical interns. J Gen Intern Med. 1996;11(12):753755.
  15. Patterson ES, Roth EM, Woods DD, et al. Handoff strategies in settings with high consequences for failure: lessons for health care operations. Int J Qual Health Care. 2004;16(2):125132.
  16. Shendell‐Falik N, Feinson M, Mohr BJ. Enhancing patient safety: improving the patient handoff process through appreciative inquiry. J Nurs Adm. 2007;37(2):95104.
  17. Vidyarthi AR, Arora V, Schnipper JL, et al. Managing discontinuity in academic medical centers: strategies for a safe and effective resident sign‐out. J Hosp Med. 2006;1(4):257266.
  18. Eaton EG, Horvath KD, Lober WB, Pellegrini CA. Organizing the transfer of patient care information: the development of a computerized resident sign‐out system. Surgery. 2004;136(1):513.
  19. Arora VM, Manjarrez E, Dressler DD, et al. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7):433440.
  20. Eaton EG, Horvath KD, Lober WB, et al. A randomized, controlled trial evaluating the impact of a computerized rounding and sign‐out system on continuity of care and resident work hours. J Am Coll Surg. 2005;200(4):538545.
  21. Petersen LA, Orav EJ, Teich JM, et al. Using a computerized sign‐out program to improve continuity of inpatient care and prevent adverse events. Jt Comm J Qual Improve. 1998;24(2):7787.
  22. Cheah LP, Amott DH, Pollard J, Watters DA. Electronic medical handover: towards safer medical care. Med J Aust. 2005;183(7):369372.
  23. Flanagan ME, Patterson ES, Frankel RM, Doebbeling BN. Evaluation of a physician informatics tool to improve patient handoffs. J Am Med Inform Assoc. 2009;16(4):509515.
  24. Palma JP, Sharek PJ, Longhurst CA. Impact of electronic medical record integration of a handoff tool on sign‐out in a newborn intensive care unit. J Perinatol. 2011;31(5):311317.
  25. Ram R, Block B. Signing out patients for off‐hours coverage: comparison of manual and computer‐aided methods. Proceedings—The Annual Symposium on Computer Applications in Medical Care. 1992;114118.
  26. Kannry J, Moore C. MediSign: using a Web‐based SignOut system to improve provider identification. Proc AMIA Symp. 1999:550554.
  27. Ovretveit J, Scott T, Rundall TG, et al. Implementation of electronic medical records in hospitals: two case studies. Health Policy. 2007;84(2–3):181190.
  28. Quan S, Tsai O. Signing on to sign out, part 2: describing the success of a Web‐based patient sign‐out application and how it will serve as a platform for an electronic discharge summary program. Healthc Q. 2007;10(1):120124.
  29. Hillestad R, Bigelow J, Bower A, et al. Can electronic medical record systems transform health care? Potential health benefits, savings, and costs. Health Affairs. 2005;24(5):11031117.
  30. Gagnon MP, Legare F, Labrecque M, et al. Interventions for promoting information and communication technologies adoption in healthcare professionals. Cochrane Database Syst Rev. 2009;Jan21(1):CD006093.
  31. Frank G, Lawless ST, Steinberg TH. Improving physician communication through an automated, integrated sign‐out system. J Healthc Inf Manag. 2005;19(4):6874.
  32. Sarkar U, Carter JT, Omachi TA, et al. SynopSIS: integrating physician sign‐out with the electronic medical record. J Hosp Med. 2007;2(5):336342.
  33. Bernstein JA, Imler DL, Sharek P, Longhurst CA. Improved physician work flow after integrating sign‐out notes into the electronic medical record. Jt Comm J Qual Patient Saf. 2010;36(2):7278.
  34. Wong HJ, Caesar M, Bandali S, et al. Electronic inpatient whiteboards: improving multidisciplinary communication and coordination of care. Int J Med Inform. 2009;78(4):239247.
  35. Zsenits B, Polashenski WA, Sterns RH, et al. Systematically improving physician assignment during in‐hospital transitions of care by enhancing a preexisting hospital electronic health record. J Hosp Med. 2009;4(5):308312.
  36. Helmreich RL. On error management: lessons from aviation. BMJ. 2000;320(7237):781785.
  37. Mumaw RJ, Roth EM, Vicente KJ, Burns CM. There is more to monitoring a nuclear power plant than meets the eye. Hum Factors 2000;42(1):3655.
  38. Streitenberger K, Breen‐Reid K, Harris C. Handoffs in care—can we make them safer?Pediatr Clin North Am. 2006;53(6):11851195.
  39. Kemp CD, Bath JM, Berger J, et al. The top 10 list for a safe and effective sign‐out. Arch Surg. 2008;143(10):10081010.
  40. Riesenberg LA, Leitzsch J, Little BW. Systematic review of handoff mnemonics literature. Am J Med Qual. 2009;24(3):196204.
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Increased Falls Associated with Zolpidem

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Zolpidem is independently associated with increased risk of inpatient falls

Hospitalized patients have increased rates of sleep disturbances.1, 2 Sleep disturbances are perceived to be disruptive to both patients and staff, a putative reason for the high rates of hypnotic use in hospitalized patients.3, 4 Zolpidem, a short‐acting, non‐benzodiazepine, benzodiazepine receptor agonist that acts at the ‐aminobutyric acid (GABA)‐A receptor complex, is the most commonly prescribed hypnotic agent in the United States.5, 6 It is also extremely commonly used in inpatient settings. Although zolpidem is thought to have a relatively benign side‐effect profile, it has been found to impair balance in healthy volunteers, even after a single dose.7 Zolpidem use has been found to be higher in community‐dwelling adults who sustained a hip fracture.8, 9

Falls in the inpatient setting are associated with significantly increased morbidity, serious injury, and can result in a prolonged hospital stay and increased healthcare expenditure.10, 11 It is for these reasons that fall reduction is one of the target aims of the Department of Health and Human Services Partnership for Patients.10 While many fall prevention programs have been shown to be effective, they are resource intensive.11 If zolpidem use were associated with increased rates of falls in hospitalized patients, decreasing zolpidem prescription could be an easy and effective intervention in order to reduce fall risk.

A previous case‐control study showed increased zolpidem use in geriatric inpatients who sustained a fall.8 However, the literature linking zolpidem use with an increased fall risk in hospitalized patients is based upon a small sample and does not correct for potential confounders, such as other medication use, delirium, or insomnia.8

We aimed to conduct a cohort study in a large inpatient teaching hospital to ascertain whether zolpidem is associated with increased rates of falls after accounting for age, sex, insomnia, delirium, and use of other medications previously shown to be associated with increased fall risk.

METHODS

All inpatients 18 years or older, admitted in 2010 to hospitals at Mayo Clinic, Rochester, MN, who were prescribed zolpidem were eligible for inclusion in the study. We excluded all patients who were pregnant and those in the intensive care unit (ICU) setting. We compared the group that was prescribed zolpidem and received it, to the group that was prescribed zolpidem but did not receive the medication. We restricted the analysis to patients who were prescribed zolpidem because there may be systematic differences between patients eligible to receive zolpidem and patients in whom zolpidem is not prescribed at all. Our institutional admission order sets provide physicians and other healthcare providers an option of selecting as‐needed zolpidem or trazodone as sleep aids. Zolpidem was the most common sleep aid that was prescribed to inpatients with a ratio of zolpidem to trazodone prescriptions being 2:1.

We used the pharmacy database to identify all eligible inpatients who were prescribed or administered either scheduled or as needed (PRN) zolpidem during the study period. All details regarding zolpidem prescription and administration were obtained from the inpatient pharmacy electronic database. This database includes all zolpidem orders that were placed in the inpatient setting. The database also includes details of dose and time of all zolpidem administrations.

The institution uses electronic medication profiles, and automated dispensing machines with patient profiles and point‐of‐care barcode scan technology, which forces highly accurate electronic documentation of the medication administered. The documentation of medication not given or patient refusal would be documented as not administered.

We reviewed the electronic medical record to ascertain demographics, as well as diagnoses of visual impairment, gait abnormality, cognitive impairment/dementia, insomnia, and delirium, based on International Classification of Diseases, Ninth Revision (ICD‐9) diagnosis codes for these conditions (see Supporting Information, Appendix 1, in the online version of this article). These diagnostic codes were electronically abstracted from the medical record. The diagnosis codes are entered by medical coding specialists based on review of all provider notes. Hospital length of stay, Charlson comorbidity index scores, and Hendrich's fall risk scores from day of admission were abstracted from the individual electronic medical records. The nursing staff at our institution perform all the requisite assessments and electronically input all components required to calculate a Hendrich's fall risk score upon admission.

The Charlson index is a composite score calculated based on a patient's medical comorbidities. Each comorbidity is designated a score of 1, 2, 3, or 6 based on the risk of mortality associated with that condition.12 The Hendrich's fall risk is calculated based on the patient's current medication regimen, level of alertness, current medical condition, and the get up and go test.13A score of 5 or greater indicates increased risk of falling. These scores from the day of admission were available for all patients and were extracted from the nursing flow sheet.

At our institution, all falls are required to be called into a central event reporting system, and each fall receives an analysis regarding risk factors and proximal causes. We obtained details of all inpatient falls from this event system. The medication administration record, a part of the patient's electronic medical record, was accessed to identify all medications administered in the 24 hours prior to the fall. Medications were grouped into their respective pharmacologic classes. Antidepressants, antipsychotics, antihistamines, sedative antidepressants (this class included trazodone and mirtazapine), benzodiazepines, and opioids were included in the analyses. These medications have previously been shown to be associated with increased risk of falls.14

Statistical analyses were performed using JMP (version 9.03, Cary, NC). Univariate analyses were performed to calculate the odds ratio of falling in inpatients who were administered zolpidem, in male patients, those admitted to a surgical floor, and in those that had a diagnosis of insomnia, visual impairment, gait abnormality, cognitive impairment/dementia, or delirium. Hospital length of stay, age, zolpidem dose, Charlson comorbidity index scores, and Hendrich's fall risk scores were treated as continuous variables, and odds ratio of falling per unit increase was calculated for each of these variables.

Multivariable logistic regression analysis was performed to calculate the odds of falling in patients who received zolpidem, after accounting for age, gender, insomnia, visual impairment, gait abnormality, cognitive impairment/dementia, delirium, hospital length of stay, zolpidem dose, Charlson comorbidity index scores, and Hendrich's fall risk scores. Logistic regression analyses was repeated with only those factors that were significantly associated (P < 0.05) with falls or factors where the association was close to statistical significance (P < 0.08).

To account for the presence of other medications that might have increased fall risk, separate analyses using the MannWhitney U test comparing medication use in all hospitalized patients who sustained a fall were performed. We compared the rates of use of antidepressants, antipsychotics, antihistamines, sedative antidepressants (this class included trazodone and mirtazapine), benzodiazepines, and opioid medication in patients who were administered zolpidem to those patients not administered zolpidem in the 24 hours prior to sustaining a fall. This study had the requisite institutional review board approval.

RESULTS

There were 41,947 eligible admissions during the study period. Of these, a total of 16,320 (38.9%; mean age 54.7 18 years) patients were prescribed zolpidem. Among these patients, 4962 (30.4% of those prescribed, or 11.8% of all admissions) were administered zolpidem during the study period (Figure 1). The majority (88%) of zolpidem prescriptions were for PRN or as needed use. Patients who received zolpidem were older than those who were prescribed the medication but did not receive it (56.84 17.2 years vs 53.79 18.31 years; P < 0.001).

Figure 1
Breakdown of patient population and fall risk as it relates to zolpidem order and administration.

Patients who were prescribed and received zolpidem were more likely to be male, or have insomnia or delirium. They had higher Charlson comorbidity index scores and were more likely to be on a surgical floor. There was no statistically significant difference between patients who received zolpidem and patients who were prescribed but did not receive zolpidem in terms of their fall risk scores, length of hospital stay, rates of visual impairment, gait abnormalities, and cognitive impairment/dementia (all P > 0.05) (Table 1).

Demographic Characteristics of All Patients Who Were Prescribed Zolpidem
CharacteristicsZolpidem Administered N = 4962 (%)Zolpidem Not Administered N = 11,358 (%)P Value
  • Abbreviations: SD, standard deviation.

Age56.84 17.24 y53.8 18.30 y<0.0001
Males2442 (49.21)4490 (39.53)<0.0001
Falls151 (3.04)81 (0.71)<0.0001
Insomnia1595 (32.3)1942 (17.1)<0.0001
Delirium411 (8.28)378 (3.33)<0.0001
Cognitive impairment38 (0.77)63 (0.55)0.11
Visual impairment84 (1.69)198 (1.74)0.82
Gait abnormalities814 (16.40)1761 (15.50)0.15
Patients on surgical floors2423 (48.8)5736 (50.50)0.05
Length of hospital stay (mean/SD)4.26 8.03 d4.18 8.07 d0.60
Charlson index (mean/SD)4.07 3.813.76 3.70<0.0001
Hendrich's fall risk score (mean/SD)1.97 1.931.91 1.970.08

During the study period, there were a total of 672 total falls, with 609 unique patients falls (fall rate of 1.45/100 patients). Those who were administered zolpidem had an increased risk of falling compared to patients who were prescribed, but were not administered, zolpidem (fall rate of 3.04/100 patients vs 0.71/100 patients; odds ratio [OR] = 4.37, 95% confidence interval [CI] = 3.335.74; P < 0.001). Additionally, patients who received zolpidem had an increased risk of falling, as opposed to all other adult inpatients who did not receive zolpidemwhether prescribed zolpidem or not (3.04 falls/100 patients vs 1.24 falls/100 patients; OR = 2.50, 95% CI = 2.083.02; P < 0.001). The absolute increase in risk of sustaining a fall after receiving zolpidem as compared to all other adult inpatients was 1.8%, revealing a number needed to harm of 55.

During the study period, a total of 21,354 doses of zolpidem were administered, revealing a fall rate of 0.007 falls per dose of zolpidem administered (151/21,354). This was significantly greater than the baseline fall risk of 0.0028 falls per day of hospitalization (672/240,015 total hospital days) (P < 0.0001).

On univariate analyses, zolpidem use (OR = 4.37; 95% CI = 3.345.76; P < 0.001), male sex (OR = 1.36; 95% CI = 1.051.76; P = 0.02), insomnia (OR = 2.37; 95% CI = 1.813.08; P < 0.01), and delirium (OR = 4.96; 95% CI = 3.526.86; P < 0.001) were significantly associated with increased falls, as were increasing age, Charlson comorbidity index scores, fall risk scores, and dose of zolpidem (Table 2). While the association between the presence of cognitive impairment/dementia and falling was close to significant (OR = 2.89; 95% CI = 0.886.98; P = 0.075), the association between fall risk and the presence of visual impairment, gait abnormalities, and being on a surgical floor was not statistically significant.

Univariate Analysis of Potential Risk Factors for Falling in All Patients Prescribed Zolpidem
Risk FactorOdds Ratio of FallingLower Confidence Interval*Upper Confidence Interval*P Value
  • 95% Confidence intervals;

  • per 1 year increase in age;

  • per 1 day increase in length of hospital stay;

  • per unit increase in Charlson score;

  • per unit increase in Hendrich's fall risk score;

  • per 1 mg increase in dose.

Zolpidem administration4.373.345.76<0.001
Male sex1.361.051.760.02
Insomnia2.371.813.08<0.001
Delirium4.963.526.86<0.001
Cognitive impairment2.890.886.980.075
Visual impairment1.260.442.760.63
Gait abnormalities1.220.861.680.26
Being on a surgical floors0.880.681.150.36
Age1.011.011.02<0.001
Length of hospital stay0.990.981.010.93
Charlson index1.291.261.32<0.001
Hendrich's fall risk score1.361.291.42<0.001
Dose of zolpidem1.211.171.26<0.001

Zolpidem use continued to be significantly associated with increased fall risk (adjusted OR = 6.39; 95% CI = 3.0714.49; P < 0.001) after multivariable logistic regression analyses accounting for all factors where the association with increased fall risk was statistically significant or close to significant on univariate analyses (Table 3). On further analyses, of all adult non‐ICU, non‐pregnant inpatients who sustained a fall, those who sustained a fall after receiving zolpidem did not differ from other inpatients who did not sustain a fall in terms of their age (59.6 17.95 vs 63.2 16.8 years; P = 0.07), antidepressant (42.62% vs 39.70%; P = 0.39), antipsychotic (9.83% vs 13.78%; P = 0.24), antihistamine (6.55% vs 3.49%; P = 0.10), sedative antidepressant (14.75% vs 15.80%; P = 0.31), benzodiazepine (36.06% vs 26.86%; P = 0.83), or opioid use (55.73% vs 43.01%; P = 0.66).

Multivariate Analysis of Potential Risk Factors for Falls
CharacteristicAdjusted Odds Ratio of FallingLower Confidence Interval*Upper Confidence Interval*P Value
  • 95% Confidence intervals;

  • per 1 year increase in age;

  • per unit increase in Hendrich's fall risk score;

  • per unit increase in Charlson index;

  • per 1 mg increase in dose.

Zolpidem administration6.393.0714.49<0.001
Male sex1.240.931.670.14
Insomnia1.601.172.170.003
Delirium2.621.733.88<0.001
Cognitive impairment1.470.334.530.56
Age1.041.031.05<0.001
Hendrich's fall risk score1.301.231.36<0.001
Charlson index1.331.291.36<0.001
Dose0.940.821.060.37

DISCUSSION

In this study, zolpidem use was associated with an increased risk of falling in hospitalized patients. We calculate that for every 55 inpatients administered zolpidem, we might expect one more fall than would otherwise have occurred. To our knowledge, this is the largest study examining the association between zolpidem use and falls in an inpatient setting. Previous literature have not accounted for the presence of several other factors that could increase fall risk in hospitalized patients using zolpidem, such as visual impairment, gait abnormalities, and type of admission. In our study, insomnia and delirium were associated with higher rates of falls, however, the risk of sustaining a fall after receiving zolpidem continued to remain elevated even after accounting for these and multiple other risk factors.

Previous research in healthy volunteers found that subjects who received zolpidem experienced increased difficulty maintaining their balance.15, 16 The subject's ability to correct their balance, with their eyes closed and also with their eyes open, was adversely affected, indicating that both proprioception and visually enabled balance correction were impacted. Navigating obstacles in a hospital setting, where the patient is in a novel environment and on other medications that could impact balance, is potentially made significantly worse by zolpidem, thus resulting in an increased fall risk.

While a previous case‐control study of inpatients, 65 years and older, reported increased rates of zolpidem use among inpatients who sustained a fall, it did not report whether this association continued to remain significant after accounting for potential confounders.9 Another study, in a similar age group and carried out in an ambulatory community setting, found that patients who sustained a hip fracture were more likely to have received zolpidem in the 6 months prior to their fall.8 In this study, zolpidem use continued to be significantly associated with hip fractures after accounting for potential confounders such as the use of other medication, age, comorbidity index score, the number of hospital days, and the number of nursing days. Our study differs from these studies in that it was a cohort study in an inpatient setting, and we included all non‐pregnant adult hospitalized patients outside of the ICU. Also, we examined medication administration in the 24 hours prior to a fall rather than medications simply prescribed in the months prior to a fall.8 In our cohort of adult inpatients, the odds of zolpidem use among patients who fell was greater than those previously reported. This could indicate increased vulnerability in hospitalized patients compared to community‐dwelling elderly.

Insomnia, older age, and delirium have all been shown to be associated with an increased risk of falls in previous research.1517 In one study of community‐dwelling older adults, the authors found a higher risk of falling in subjects with insomnia, but not in those who received a hypnotic agent.15 Delirium increases the likelihood of nocturnal wandering, also associated with increased risk of fall. Our inpatient cohort study confirms these prior findings: insomnia, delirium, and older age were all associated with an increased risk of falling. However, zolpidem use continued to remain a significant risk factor for falls even after accounting for these risk factors.

Hospitalized patients are more likely to be physically compromised and on a greater number of medications compared to community‐dwelling subjects, and hence at increased risk of falling. Multiple classes of medications have been shown to be associated with an increased fall risk in hospitalized patients.14 In our study, the patients who sustained a fall after receiving zolpidem did not differ from other patients who sustained a fall in terms of their medication use. Zolpidem thus appears to increase the risk of falling beyond that attributable to other medications in hospitalized patients.

A recent United States Preventive Services Task Force on Prevention of Falls in Community Dwelling Older Adults recommendation indicates that withdrawal of medication alone does not appear to have a significant impact on fall rates.18 Another study indicates that reduced benozodiazepine use did not significantly reduce the rates of hip fractures in the community.19 While these studies indicate that fall risk is multifactorial and requires a complex set of interventions, our results indicate that there might be an association between zolpidem administration and falls in an inpatient setting. Changing order sets so that zolpidem use is not encouraged could potentially reduce fall rates in hospitalized patients, a step that we have already taken in our institution based upon these findings. Other potential measures to reduce fall risk include the use of fall precautions in patients who are prescribed zolpidem or use of non‐pharmacologic treatments for insomnia. However, these interventions would need to be empirically tested before they could be recommended with confidence.

The results of this study must be viewed in the light of some limitations. Although we included age, sex, zolpidem dose, length of hospital stay, Charlson comorbidity index score, fall risk score, and diagnoses of insomnia, visual impairment, gait abnormality, cognitive impairment/dementia, and delirium in our analyses, we were unable to account for the degree of severity of these conditions. There could also be other possible medical conditions that result in an increased risk of falling that were not accounted for in our analyses. While we did attempt to correct for insomnia and delirium diagnoses, transient complaints of insomnia or altered mental status may have been missed by our retrospective methodology, and perhaps could co‐associate with risk of falling. Furthermore, administration of zolpidem was associated with a higher risk of falls when compared to other patients who were prescribed zolpidem, and also when compared to all other patients regardless of zolpidem prescription. We used ICD‐9 codes to identify patients with insomnia, delirium, visual impairment, and gait abnormalities, and these could be prone to misclassification and possible ascertainment bias. Finally, we were unable to account for use of medications that might potentially increase the risk of falling in the entire cohort. We were, however, able to account for this in the subset of patients who sustained a fall, and did not note a difference between the group that received zolpidem and the group that did not. In these analyses, we were able to account for administration of these other medications, but not the dose or cumulative dose.

CONCLUSIONS

Our study, the largest in an inpatient cohort, reveals that zolpidem administration is associated with increased risk of falling even after accounting for insomnia, delirium, and multiple other risk factors. Patients who sustained a fall after receiving zolpidem did not differ from other patients who sustained a fall, in terms of age or use of other medications conferring increased fall risk. Although insomnia and delirium are also associated with an increased risk of falling, addition of zolpidem in this situation appears to result in a further increase in fall risk. Presently, because there is limited evidence to recommend other hypnotic agents as safer alternatives in inpatient settings, non‐pharmacological measures to improve the sleep of hospitalized patients should be investigated as preferred methods to provide safe relief from complaints of disturbed sleep.

Acknowledgements

The authors acknowledge Anna Halverson, RN, from Nursing Practice Resources, for providing patient fall data from the Mayo Clinic Rochester Event Tracking System used in analysis; and Erek Lam, MD, for helping with data abstraction from the electronic medical record.

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References
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  2. Lane T,East LA.Sleep disruption experienced by surgical patients in an acute hospital.Br J Nurs.2008;17(12):766771.
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  8. Wang PS,Bohn RL,Glynn RJ,Mogun H,Avorn J.Zolpidem use and hip fractures in older people.J Am Geriatr Soc.2001;49:16851690.
  9. Chang C‐M,Chen M‐J,Tsai C‐Y, et al.Medical conditions and medications as risk factors of falls in the inpatient older people: a case‐control study.Int J Geriatr Psychiatry2011;26:602607.
  10. Department of Health and Human Services Partnership for Patients.2012. Available at: http://innovation.cms.gov/initiatives/partnership‐for‐patients/index.html. Accessed on July 1, 2012.
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Hospitalized patients have increased rates of sleep disturbances.1, 2 Sleep disturbances are perceived to be disruptive to both patients and staff, a putative reason for the high rates of hypnotic use in hospitalized patients.3, 4 Zolpidem, a short‐acting, non‐benzodiazepine, benzodiazepine receptor agonist that acts at the ‐aminobutyric acid (GABA)‐A receptor complex, is the most commonly prescribed hypnotic agent in the United States.5, 6 It is also extremely commonly used in inpatient settings. Although zolpidem is thought to have a relatively benign side‐effect profile, it has been found to impair balance in healthy volunteers, even after a single dose.7 Zolpidem use has been found to be higher in community‐dwelling adults who sustained a hip fracture.8, 9

Falls in the inpatient setting are associated with significantly increased morbidity, serious injury, and can result in a prolonged hospital stay and increased healthcare expenditure.10, 11 It is for these reasons that fall reduction is one of the target aims of the Department of Health and Human Services Partnership for Patients.10 While many fall prevention programs have been shown to be effective, they are resource intensive.11 If zolpidem use were associated with increased rates of falls in hospitalized patients, decreasing zolpidem prescription could be an easy and effective intervention in order to reduce fall risk.

A previous case‐control study showed increased zolpidem use in geriatric inpatients who sustained a fall.8 However, the literature linking zolpidem use with an increased fall risk in hospitalized patients is based upon a small sample and does not correct for potential confounders, such as other medication use, delirium, or insomnia.8

We aimed to conduct a cohort study in a large inpatient teaching hospital to ascertain whether zolpidem is associated with increased rates of falls after accounting for age, sex, insomnia, delirium, and use of other medications previously shown to be associated with increased fall risk.

METHODS

All inpatients 18 years or older, admitted in 2010 to hospitals at Mayo Clinic, Rochester, MN, who were prescribed zolpidem were eligible for inclusion in the study. We excluded all patients who were pregnant and those in the intensive care unit (ICU) setting. We compared the group that was prescribed zolpidem and received it, to the group that was prescribed zolpidem but did not receive the medication. We restricted the analysis to patients who were prescribed zolpidem because there may be systematic differences between patients eligible to receive zolpidem and patients in whom zolpidem is not prescribed at all. Our institutional admission order sets provide physicians and other healthcare providers an option of selecting as‐needed zolpidem or trazodone as sleep aids. Zolpidem was the most common sleep aid that was prescribed to inpatients with a ratio of zolpidem to trazodone prescriptions being 2:1.

We used the pharmacy database to identify all eligible inpatients who were prescribed or administered either scheduled or as needed (PRN) zolpidem during the study period. All details regarding zolpidem prescription and administration were obtained from the inpatient pharmacy electronic database. This database includes all zolpidem orders that were placed in the inpatient setting. The database also includes details of dose and time of all zolpidem administrations.

The institution uses electronic medication profiles, and automated dispensing machines with patient profiles and point‐of‐care barcode scan technology, which forces highly accurate electronic documentation of the medication administered. The documentation of medication not given or patient refusal would be documented as not administered.

We reviewed the electronic medical record to ascertain demographics, as well as diagnoses of visual impairment, gait abnormality, cognitive impairment/dementia, insomnia, and delirium, based on International Classification of Diseases, Ninth Revision (ICD‐9) diagnosis codes for these conditions (see Supporting Information, Appendix 1, in the online version of this article). These diagnostic codes were electronically abstracted from the medical record. The diagnosis codes are entered by medical coding specialists based on review of all provider notes. Hospital length of stay, Charlson comorbidity index scores, and Hendrich's fall risk scores from day of admission were abstracted from the individual electronic medical records. The nursing staff at our institution perform all the requisite assessments and electronically input all components required to calculate a Hendrich's fall risk score upon admission.

The Charlson index is a composite score calculated based on a patient's medical comorbidities. Each comorbidity is designated a score of 1, 2, 3, or 6 based on the risk of mortality associated with that condition.12 The Hendrich's fall risk is calculated based on the patient's current medication regimen, level of alertness, current medical condition, and the get up and go test.13A score of 5 or greater indicates increased risk of falling. These scores from the day of admission were available for all patients and were extracted from the nursing flow sheet.

At our institution, all falls are required to be called into a central event reporting system, and each fall receives an analysis regarding risk factors and proximal causes. We obtained details of all inpatient falls from this event system. The medication administration record, a part of the patient's electronic medical record, was accessed to identify all medications administered in the 24 hours prior to the fall. Medications were grouped into their respective pharmacologic classes. Antidepressants, antipsychotics, antihistamines, sedative antidepressants (this class included trazodone and mirtazapine), benzodiazepines, and opioids were included in the analyses. These medications have previously been shown to be associated with increased risk of falls.14

Statistical analyses were performed using JMP (version 9.03, Cary, NC). Univariate analyses were performed to calculate the odds ratio of falling in inpatients who were administered zolpidem, in male patients, those admitted to a surgical floor, and in those that had a diagnosis of insomnia, visual impairment, gait abnormality, cognitive impairment/dementia, or delirium. Hospital length of stay, age, zolpidem dose, Charlson comorbidity index scores, and Hendrich's fall risk scores were treated as continuous variables, and odds ratio of falling per unit increase was calculated for each of these variables.

Multivariable logistic regression analysis was performed to calculate the odds of falling in patients who received zolpidem, after accounting for age, gender, insomnia, visual impairment, gait abnormality, cognitive impairment/dementia, delirium, hospital length of stay, zolpidem dose, Charlson comorbidity index scores, and Hendrich's fall risk scores. Logistic regression analyses was repeated with only those factors that were significantly associated (P < 0.05) with falls or factors where the association was close to statistical significance (P < 0.08).

To account for the presence of other medications that might have increased fall risk, separate analyses using the MannWhitney U test comparing medication use in all hospitalized patients who sustained a fall were performed. We compared the rates of use of antidepressants, antipsychotics, antihistamines, sedative antidepressants (this class included trazodone and mirtazapine), benzodiazepines, and opioid medication in patients who were administered zolpidem to those patients not administered zolpidem in the 24 hours prior to sustaining a fall. This study had the requisite institutional review board approval.

RESULTS

There were 41,947 eligible admissions during the study period. Of these, a total of 16,320 (38.9%; mean age 54.7 18 years) patients were prescribed zolpidem. Among these patients, 4962 (30.4% of those prescribed, or 11.8% of all admissions) were administered zolpidem during the study period (Figure 1). The majority (88%) of zolpidem prescriptions were for PRN or as needed use. Patients who received zolpidem were older than those who were prescribed the medication but did not receive it (56.84 17.2 years vs 53.79 18.31 years; P < 0.001).

Figure 1
Breakdown of patient population and fall risk as it relates to zolpidem order and administration.

Patients who were prescribed and received zolpidem were more likely to be male, or have insomnia or delirium. They had higher Charlson comorbidity index scores and were more likely to be on a surgical floor. There was no statistically significant difference between patients who received zolpidem and patients who were prescribed but did not receive zolpidem in terms of their fall risk scores, length of hospital stay, rates of visual impairment, gait abnormalities, and cognitive impairment/dementia (all P > 0.05) (Table 1).

Demographic Characteristics of All Patients Who Were Prescribed Zolpidem
CharacteristicsZolpidem Administered N = 4962 (%)Zolpidem Not Administered N = 11,358 (%)P Value
  • Abbreviations: SD, standard deviation.

Age56.84 17.24 y53.8 18.30 y<0.0001
Males2442 (49.21)4490 (39.53)<0.0001
Falls151 (3.04)81 (0.71)<0.0001
Insomnia1595 (32.3)1942 (17.1)<0.0001
Delirium411 (8.28)378 (3.33)<0.0001
Cognitive impairment38 (0.77)63 (0.55)0.11
Visual impairment84 (1.69)198 (1.74)0.82
Gait abnormalities814 (16.40)1761 (15.50)0.15
Patients on surgical floors2423 (48.8)5736 (50.50)0.05
Length of hospital stay (mean/SD)4.26 8.03 d4.18 8.07 d0.60
Charlson index (mean/SD)4.07 3.813.76 3.70<0.0001
Hendrich's fall risk score (mean/SD)1.97 1.931.91 1.970.08

During the study period, there were a total of 672 total falls, with 609 unique patients falls (fall rate of 1.45/100 patients). Those who were administered zolpidem had an increased risk of falling compared to patients who were prescribed, but were not administered, zolpidem (fall rate of 3.04/100 patients vs 0.71/100 patients; odds ratio [OR] = 4.37, 95% confidence interval [CI] = 3.335.74; P < 0.001). Additionally, patients who received zolpidem had an increased risk of falling, as opposed to all other adult inpatients who did not receive zolpidemwhether prescribed zolpidem or not (3.04 falls/100 patients vs 1.24 falls/100 patients; OR = 2.50, 95% CI = 2.083.02; P < 0.001). The absolute increase in risk of sustaining a fall after receiving zolpidem as compared to all other adult inpatients was 1.8%, revealing a number needed to harm of 55.

During the study period, a total of 21,354 doses of zolpidem were administered, revealing a fall rate of 0.007 falls per dose of zolpidem administered (151/21,354). This was significantly greater than the baseline fall risk of 0.0028 falls per day of hospitalization (672/240,015 total hospital days) (P < 0.0001).

On univariate analyses, zolpidem use (OR = 4.37; 95% CI = 3.345.76; P < 0.001), male sex (OR = 1.36; 95% CI = 1.051.76; P = 0.02), insomnia (OR = 2.37; 95% CI = 1.813.08; P < 0.01), and delirium (OR = 4.96; 95% CI = 3.526.86; P < 0.001) were significantly associated with increased falls, as were increasing age, Charlson comorbidity index scores, fall risk scores, and dose of zolpidem (Table 2). While the association between the presence of cognitive impairment/dementia and falling was close to significant (OR = 2.89; 95% CI = 0.886.98; P = 0.075), the association between fall risk and the presence of visual impairment, gait abnormalities, and being on a surgical floor was not statistically significant.

Univariate Analysis of Potential Risk Factors for Falling in All Patients Prescribed Zolpidem
Risk FactorOdds Ratio of FallingLower Confidence Interval*Upper Confidence Interval*P Value
  • 95% Confidence intervals;

  • per 1 year increase in age;

  • per 1 day increase in length of hospital stay;

  • per unit increase in Charlson score;

  • per unit increase in Hendrich's fall risk score;

  • per 1 mg increase in dose.

Zolpidem administration4.373.345.76<0.001
Male sex1.361.051.760.02
Insomnia2.371.813.08<0.001
Delirium4.963.526.86<0.001
Cognitive impairment2.890.886.980.075
Visual impairment1.260.442.760.63
Gait abnormalities1.220.861.680.26
Being on a surgical floors0.880.681.150.36
Age1.011.011.02<0.001
Length of hospital stay0.990.981.010.93
Charlson index1.291.261.32<0.001
Hendrich's fall risk score1.361.291.42<0.001
Dose of zolpidem1.211.171.26<0.001

Zolpidem use continued to be significantly associated with increased fall risk (adjusted OR = 6.39; 95% CI = 3.0714.49; P < 0.001) after multivariable logistic regression analyses accounting for all factors where the association with increased fall risk was statistically significant or close to significant on univariate analyses (Table 3). On further analyses, of all adult non‐ICU, non‐pregnant inpatients who sustained a fall, those who sustained a fall after receiving zolpidem did not differ from other inpatients who did not sustain a fall in terms of their age (59.6 17.95 vs 63.2 16.8 years; P = 0.07), antidepressant (42.62% vs 39.70%; P = 0.39), antipsychotic (9.83% vs 13.78%; P = 0.24), antihistamine (6.55% vs 3.49%; P = 0.10), sedative antidepressant (14.75% vs 15.80%; P = 0.31), benzodiazepine (36.06% vs 26.86%; P = 0.83), or opioid use (55.73% vs 43.01%; P = 0.66).

Multivariate Analysis of Potential Risk Factors for Falls
CharacteristicAdjusted Odds Ratio of FallingLower Confidence Interval*Upper Confidence Interval*P Value
  • 95% Confidence intervals;

  • per 1 year increase in age;

  • per unit increase in Hendrich's fall risk score;

  • per unit increase in Charlson index;

  • per 1 mg increase in dose.

Zolpidem administration6.393.0714.49<0.001
Male sex1.240.931.670.14
Insomnia1.601.172.170.003
Delirium2.621.733.88<0.001
Cognitive impairment1.470.334.530.56
Age1.041.031.05<0.001
Hendrich's fall risk score1.301.231.36<0.001
Charlson index1.331.291.36<0.001
Dose0.940.821.060.37

DISCUSSION

In this study, zolpidem use was associated with an increased risk of falling in hospitalized patients. We calculate that for every 55 inpatients administered zolpidem, we might expect one more fall than would otherwise have occurred. To our knowledge, this is the largest study examining the association between zolpidem use and falls in an inpatient setting. Previous literature have not accounted for the presence of several other factors that could increase fall risk in hospitalized patients using zolpidem, such as visual impairment, gait abnormalities, and type of admission. In our study, insomnia and delirium were associated with higher rates of falls, however, the risk of sustaining a fall after receiving zolpidem continued to remain elevated even after accounting for these and multiple other risk factors.

Previous research in healthy volunteers found that subjects who received zolpidem experienced increased difficulty maintaining their balance.15, 16 The subject's ability to correct their balance, with their eyes closed and also with their eyes open, was adversely affected, indicating that both proprioception and visually enabled balance correction were impacted. Navigating obstacles in a hospital setting, where the patient is in a novel environment and on other medications that could impact balance, is potentially made significantly worse by zolpidem, thus resulting in an increased fall risk.

While a previous case‐control study of inpatients, 65 years and older, reported increased rates of zolpidem use among inpatients who sustained a fall, it did not report whether this association continued to remain significant after accounting for potential confounders.9 Another study, in a similar age group and carried out in an ambulatory community setting, found that patients who sustained a hip fracture were more likely to have received zolpidem in the 6 months prior to their fall.8 In this study, zolpidem use continued to be significantly associated with hip fractures after accounting for potential confounders such as the use of other medication, age, comorbidity index score, the number of hospital days, and the number of nursing days. Our study differs from these studies in that it was a cohort study in an inpatient setting, and we included all non‐pregnant adult hospitalized patients outside of the ICU. Also, we examined medication administration in the 24 hours prior to a fall rather than medications simply prescribed in the months prior to a fall.8 In our cohort of adult inpatients, the odds of zolpidem use among patients who fell was greater than those previously reported. This could indicate increased vulnerability in hospitalized patients compared to community‐dwelling elderly.

Insomnia, older age, and delirium have all been shown to be associated with an increased risk of falls in previous research.1517 In one study of community‐dwelling older adults, the authors found a higher risk of falling in subjects with insomnia, but not in those who received a hypnotic agent.15 Delirium increases the likelihood of nocturnal wandering, also associated with increased risk of fall. Our inpatient cohort study confirms these prior findings: insomnia, delirium, and older age were all associated with an increased risk of falling. However, zolpidem use continued to remain a significant risk factor for falls even after accounting for these risk factors.

Hospitalized patients are more likely to be physically compromised and on a greater number of medications compared to community‐dwelling subjects, and hence at increased risk of falling. Multiple classes of medications have been shown to be associated with an increased fall risk in hospitalized patients.14 In our study, the patients who sustained a fall after receiving zolpidem did not differ from other patients who sustained a fall in terms of their medication use. Zolpidem thus appears to increase the risk of falling beyond that attributable to other medications in hospitalized patients.

A recent United States Preventive Services Task Force on Prevention of Falls in Community Dwelling Older Adults recommendation indicates that withdrawal of medication alone does not appear to have a significant impact on fall rates.18 Another study indicates that reduced benozodiazepine use did not significantly reduce the rates of hip fractures in the community.19 While these studies indicate that fall risk is multifactorial and requires a complex set of interventions, our results indicate that there might be an association between zolpidem administration and falls in an inpatient setting. Changing order sets so that zolpidem use is not encouraged could potentially reduce fall rates in hospitalized patients, a step that we have already taken in our institution based upon these findings. Other potential measures to reduce fall risk include the use of fall precautions in patients who are prescribed zolpidem or use of non‐pharmacologic treatments for insomnia. However, these interventions would need to be empirically tested before they could be recommended with confidence.

The results of this study must be viewed in the light of some limitations. Although we included age, sex, zolpidem dose, length of hospital stay, Charlson comorbidity index score, fall risk score, and diagnoses of insomnia, visual impairment, gait abnormality, cognitive impairment/dementia, and delirium in our analyses, we were unable to account for the degree of severity of these conditions. There could also be other possible medical conditions that result in an increased risk of falling that were not accounted for in our analyses. While we did attempt to correct for insomnia and delirium diagnoses, transient complaints of insomnia or altered mental status may have been missed by our retrospective methodology, and perhaps could co‐associate with risk of falling. Furthermore, administration of zolpidem was associated with a higher risk of falls when compared to other patients who were prescribed zolpidem, and also when compared to all other patients regardless of zolpidem prescription. We used ICD‐9 codes to identify patients with insomnia, delirium, visual impairment, and gait abnormalities, and these could be prone to misclassification and possible ascertainment bias. Finally, we were unable to account for use of medications that might potentially increase the risk of falling in the entire cohort. We were, however, able to account for this in the subset of patients who sustained a fall, and did not note a difference between the group that received zolpidem and the group that did not. In these analyses, we were able to account for administration of these other medications, but not the dose or cumulative dose.

CONCLUSIONS

Our study, the largest in an inpatient cohort, reveals that zolpidem administration is associated with increased risk of falling even after accounting for insomnia, delirium, and multiple other risk factors. Patients who sustained a fall after receiving zolpidem did not differ from other patients who sustained a fall, in terms of age or use of other medications conferring increased fall risk. Although insomnia and delirium are also associated with an increased risk of falling, addition of zolpidem in this situation appears to result in a further increase in fall risk. Presently, because there is limited evidence to recommend other hypnotic agents as safer alternatives in inpatient settings, non‐pharmacological measures to improve the sleep of hospitalized patients should be investigated as preferred methods to provide safe relief from complaints of disturbed sleep.

Acknowledgements

The authors acknowledge Anna Halverson, RN, from Nursing Practice Resources, for providing patient fall data from the Mayo Clinic Rochester Event Tracking System used in analysis; and Erek Lam, MD, for helping with data abstraction from the electronic medical record.

Hospitalized patients have increased rates of sleep disturbances.1, 2 Sleep disturbances are perceived to be disruptive to both patients and staff, a putative reason for the high rates of hypnotic use in hospitalized patients.3, 4 Zolpidem, a short‐acting, non‐benzodiazepine, benzodiazepine receptor agonist that acts at the ‐aminobutyric acid (GABA)‐A receptor complex, is the most commonly prescribed hypnotic agent in the United States.5, 6 It is also extremely commonly used in inpatient settings. Although zolpidem is thought to have a relatively benign side‐effect profile, it has been found to impair balance in healthy volunteers, even after a single dose.7 Zolpidem use has been found to be higher in community‐dwelling adults who sustained a hip fracture.8, 9

Falls in the inpatient setting are associated with significantly increased morbidity, serious injury, and can result in a prolonged hospital stay and increased healthcare expenditure.10, 11 It is for these reasons that fall reduction is one of the target aims of the Department of Health and Human Services Partnership for Patients.10 While many fall prevention programs have been shown to be effective, they are resource intensive.11 If zolpidem use were associated with increased rates of falls in hospitalized patients, decreasing zolpidem prescription could be an easy and effective intervention in order to reduce fall risk.

A previous case‐control study showed increased zolpidem use in geriatric inpatients who sustained a fall.8 However, the literature linking zolpidem use with an increased fall risk in hospitalized patients is based upon a small sample and does not correct for potential confounders, such as other medication use, delirium, or insomnia.8

We aimed to conduct a cohort study in a large inpatient teaching hospital to ascertain whether zolpidem is associated with increased rates of falls after accounting for age, sex, insomnia, delirium, and use of other medications previously shown to be associated with increased fall risk.

METHODS

All inpatients 18 years or older, admitted in 2010 to hospitals at Mayo Clinic, Rochester, MN, who were prescribed zolpidem were eligible for inclusion in the study. We excluded all patients who were pregnant and those in the intensive care unit (ICU) setting. We compared the group that was prescribed zolpidem and received it, to the group that was prescribed zolpidem but did not receive the medication. We restricted the analysis to patients who were prescribed zolpidem because there may be systematic differences between patients eligible to receive zolpidem and patients in whom zolpidem is not prescribed at all. Our institutional admission order sets provide physicians and other healthcare providers an option of selecting as‐needed zolpidem or trazodone as sleep aids. Zolpidem was the most common sleep aid that was prescribed to inpatients with a ratio of zolpidem to trazodone prescriptions being 2:1.

We used the pharmacy database to identify all eligible inpatients who were prescribed or administered either scheduled or as needed (PRN) zolpidem during the study period. All details regarding zolpidem prescription and administration were obtained from the inpatient pharmacy electronic database. This database includes all zolpidem orders that were placed in the inpatient setting. The database also includes details of dose and time of all zolpidem administrations.

The institution uses electronic medication profiles, and automated dispensing machines with patient profiles and point‐of‐care barcode scan technology, which forces highly accurate electronic documentation of the medication administered. The documentation of medication not given or patient refusal would be documented as not administered.

We reviewed the electronic medical record to ascertain demographics, as well as diagnoses of visual impairment, gait abnormality, cognitive impairment/dementia, insomnia, and delirium, based on International Classification of Diseases, Ninth Revision (ICD‐9) diagnosis codes for these conditions (see Supporting Information, Appendix 1, in the online version of this article). These diagnostic codes were electronically abstracted from the medical record. The diagnosis codes are entered by medical coding specialists based on review of all provider notes. Hospital length of stay, Charlson comorbidity index scores, and Hendrich's fall risk scores from day of admission were abstracted from the individual electronic medical records. The nursing staff at our institution perform all the requisite assessments and electronically input all components required to calculate a Hendrich's fall risk score upon admission.

The Charlson index is a composite score calculated based on a patient's medical comorbidities. Each comorbidity is designated a score of 1, 2, 3, or 6 based on the risk of mortality associated with that condition.12 The Hendrich's fall risk is calculated based on the patient's current medication regimen, level of alertness, current medical condition, and the get up and go test.13A score of 5 or greater indicates increased risk of falling. These scores from the day of admission were available for all patients and were extracted from the nursing flow sheet.

At our institution, all falls are required to be called into a central event reporting system, and each fall receives an analysis regarding risk factors and proximal causes. We obtained details of all inpatient falls from this event system. The medication administration record, a part of the patient's electronic medical record, was accessed to identify all medications administered in the 24 hours prior to the fall. Medications were grouped into their respective pharmacologic classes. Antidepressants, antipsychotics, antihistamines, sedative antidepressants (this class included trazodone and mirtazapine), benzodiazepines, and opioids were included in the analyses. These medications have previously been shown to be associated with increased risk of falls.14

Statistical analyses were performed using JMP (version 9.03, Cary, NC). Univariate analyses were performed to calculate the odds ratio of falling in inpatients who were administered zolpidem, in male patients, those admitted to a surgical floor, and in those that had a diagnosis of insomnia, visual impairment, gait abnormality, cognitive impairment/dementia, or delirium. Hospital length of stay, age, zolpidem dose, Charlson comorbidity index scores, and Hendrich's fall risk scores were treated as continuous variables, and odds ratio of falling per unit increase was calculated for each of these variables.

Multivariable logistic regression analysis was performed to calculate the odds of falling in patients who received zolpidem, after accounting for age, gender, insomnia, visual impairment, gait abnormality, cognitive impairment/dementia, delirium, hospital length of stay, zolpidem dose, Charlson comorbidity index scores, and Hendrich's fall risk scores. Logistic regression analyses was repeated with only those factors that were significantly associated (P < 0.05) with falls or factors where the association was close to statistical significance (P < 0.08).

To account for the presence of other medications that might have increased fall risk, separate analyses using the MannWhitney U test comparing medication use in all hospitalized patients who sustained a fall were performed. We compared the rates of use of antidepressants, antipsychotics, antihistamines, sedative antidepressants (this class included trazodone and mirtazapine), benzodiazepines, and opioid medication in patients who were administered zolpidem to those patients not administered zolpidem in the 24 hours prior to sustaining a fall. This study had the requisite institutional review board approval.

RESULTS

There were 41,947 eligible admissions during the study period. Of these, a total of 16,320 (38.9%; mean age 54.7 18 years) patients were prescribed zolpidem. Among these patients, 4962 (30.4% of those prescribed, or 11.8% of all admissions) were administered zolpidem during the study period (Figure 1). The majority (88%) of zolpidem prescriptions were for PRN or as needed use. Patients who received zolpidem were older than those who were prescribed the medication but did not receive it (56.84 17.2 years vs 53.79 18.31 years; P < 0.001).

Figure 1
Breakdown of patient population and fall risk as it relates to zolpidem order and administration.

Patients who were prescribed and received zolpidem were more likely to be male, or have insomnia or delirium. They had higher Charlson comorbidity index scores and were more likely to be on a surgical floor. There was no statistically significant difference between patients who received zolpidem and patients who were prescribed but did not receive zolpidem in terms of their fall risk scores, length of hospital stay, rates of visual impairment, gait abnormalities, and cognitive impairment/dementia (all P > 0.05) (Table 1).

Demographic Characteristics of All Patients Who Were Prescribed Zolpidem
CharacteristicsZolpidem Administered N = 4962 (%)Zolpidem Not Administered N = 11,358 (%)P Value
  • Abbreviations: SD, standard deviation.

Age56.84 17.24 y53.8 18.30 y<0.0001
Males2442 (49.21)4490 (39.53)<0.0001
Falls151 (3.04)81 (0.71)<0.0001
Insomnia1595 (32.3)1942 (17.1)<0.0001
Delirium411 (8.28)378 (3.33)<0.0001
Cognitive impairment38 (0.77)63 (0.55)0.11
Visual impairment84 (1.69)198 (1.74)0.82
Gait abnormalities814 (16.40)1761 (15.50)0.15
Patients on surgical floors2423 (48.8)5736 (50.50)0.05
Length of hospital stay (mean/SD)4.26 8.03 d4.18 8.07 d0.60
Charlson index (mean/SD)4.07 3.813.76 3.70<0.0001
Hendrich's fall risk score (mean/SD)1.97 1.931.91 1.970.08

During the study period, there were a total of 672 total falls, with 609 unique patients falls (fall rate of 1.45/100 patients). Those who were administered zolpidem had an increased risk of falling compared to patients who were prescribed, but were not administered, zolpidem (fall rate of 3.04/100 patients vs 0.71/100 patients; odds ratio [OR] = 4.37, 95% confidence interval [CI] = 3.335.74; P < 0.001). Additionally, patients who received zolpidem had an increased risk of falling, as opposed to all other adult inpatients who did not receive zolpidemwhether prescribed zolpidem or not (3.04 falls/100 patients vs 1.24 falls/100 patients; OR = 2.50, 95% CI = 2.083.02; P < 0.001). The absolute increase in risk of sustaining a fall after receiving zolpidem as compared to all other adult inpatients was 1.8%, revealing a number needed to harm of 55.

During the study period, a total of 21,354 doses of zolpidem were administered, revealing a fall rate of 0.007 falls per dose of zolpidem administered (151/21,354). This was significantly greater than the baseline fall risk of 0.0028 falls per day of hospitalization (672/240,015 total hospital days) (P < 0.0001).

On univariate analyses, zolpidem use (OR = 4.37; 95% CI = 3.345.76; P < 0.001), male sex (OR = 1.36; 95% CI = 1.051.76; P = 0.02), insomnia (OR = 2.37; 95% CI = 1.813.08; P < 0.01), and delirium (OR = 4.96; 95% CI = 3.526.86; P < 0.001) were significantly associated with increased falls, as were increasing age, Charlson comorbidity index scores, fall risk scores, and dose of zolpidem (Table 2). While the association between the presence of cognitive impairment/dementia and falling was close to significant (OR = 2.89; 95% CI = 0.886.98; P = 0.075), the association between fall risk and the presence of visual impairment, gait abnormalities, and being on a surgical floor was not statistically significant.

Univariate Analysis of Potential Risk Factors for Falling in All Patients Prescribed Zolpidem
Risk FactorOdds Ratio of FallingLower Confidence Interval*Upper Confidence Interval*P Value
  • 95% Confidence intervals;

  • per 1 year increase in age;

  • per 1 day increase in length of hospital stay;

  • per unit increase in Charlson score;

  • per unit increase in Hendrich's fall risk score;

  • per 1 mg increase in dose.

Zolpidem administration4.373.345.76<0.001
Male sex1.361.051.760.02
Insomnia2.371.813.08<0.001
Delirium4.963.526.86<0.001
Cognitive impairment2.890.886.980.075
Visual impairment1.260.442.760.63
Gait abnormalities1.220.861.680.26
Being on a surgical floors0.880.681.150.36
Age1.011.011.02<0.001
Length of hospital stay0.990.981.010.93
Charlson index1.291.261.32<0.001
Hendrich's fall risk score1.361.291.42<0.001
Dose of zolpidem1.211.171.26<0.001

Zolpidem use continued to be significantly associated with increased fall risk (adjusted OR = 6.39; 95% CI = 3.0714.49; P < 0.001) after multivariable logistic regression analyses accounting for all factors where the association with increased fall risk was statistically significant or close to significant on univariate analyses (Table 3). On further analyses, of all adult non‐ICU, non‐pregnant inpatients who sustained a fall, those who sustained a fall after receiving zolpidem did not differ from other inpatients who did not sustain a fall in terms of their age (59.6 17.95 vs 63.2 16.8 years; P = 0.07), antidepressant (42.62% vs 39.70%; P = 0.39), antipsychotic (9.83% vs 13.78%; P = 0.24), antihistamine (6.55% vs 3.49%; P = 0.10), sedative antidepressant (14.75% vs 15.80%; P = 0.31), benzodiazepine (36.06% vs 26.86%; P = 0.83), or opioid use (55.73% vs 43.01%; P = 0.66).

Multivariate Analysis of Potential Risk Factors for Falls
CharacteristicAdjusted Odds Ratio of FallingLower Confidence Interval*Upper Confidence Interval*P Value
  • 95% Confidence intervals;

  • per 1 year increase in age;

  • per unit increase in Hendrich's fall risk score;

  • per unit increase in Charlson index;

  • per 1 mg increase in dose.

Zolpidem administration6.393.0714.49<0.001
Male sex1.240.931.670.14
Insomnia1.601.172.170.003
Delirium2.621.733.88<0.001
Cognitive impairment1.470.334.530.56
Age1.041.031.05<0.001
Hendrich's fall risk score1.301.231.36<0.001
Charlson index1.331.291.36<0.001
Dose0.940.821.060.37

DISCUSSION

In this study, zolpidem use was associated with an increased risk of falling in hospitalized patients. We calculate that for every 55 inpatients administered zolpidem, we might expect one more fall than would otherwise have occurred. To our knowledge, this is the largest study examining the association between zolpidem use and falls in an inpatient setting. Previous literature have not accounted for the presence of several other factors that could increase fall risk in hospitalized patients using zolpidem, such as visual impairment, gait abnormalities, and type of admission. In our study, insomnia and delirium were associated with higher rates of falls, however, the risk of sustaining a fall after receiving zolpidem continued to remain elevated even after accounting for these and multiple other risk factors.

Previous research in healthy volunteers found that subjects who received zolpidem experienced increased difficulty maintaining their balance.15, 16 The subject's ability to correct their balance, with their eyes closed and also with their eyes open, was adversely affected, indicating that both proprioception and visually enabled balance correction were impacted. Navigating obstacles in a hospital setting, where the patient is in a novel environment and on other medications that could impact balance, is potentially made significantly worse by zolpidem, thus resulting in an increased fall risk.

While a previous case‐control study of inpatients, 65 years and older, reported increased rates of zolpidem use among inpatients who sustained a fall, it did not report whether this association continued to remain significant after accounting for potential confounders.9 Another study, in a similar age group and carried out in an ambulatory community setting, found that patients who sustained a hip fracture were more likely to have received zolpidem in the 6 months prior to their fall.8 In this study, zolpidem use continued to be significantly associated with hip fractures after accounting for potential confounders such as the use of other medication, age, comorbidity index score, the number of hospital days, and the number of nursing days. Our study differs from these studies in that it was a cohort study in an inpatient setting, and we included all non‐pregnant adult hospitalized patients outside of the ICU. Also, we examined medication administration in the 24 hours prior to a fall rather than medications simply prescribed in the months prior to a fall.8 In our cohort of adult inpatients, the odds of zolpidem use among patients who fell was greater than those previously reported. This could indicate increased vulnerability in hospitalized patients compared to community‐dwelling elderly.

Insomnia, older age, and delirium have all been shown to be associated with an increased risk of falls in previous research.1517 In one study of community‐dwelling older adults, the authors found a higher risk of falling in subjects with insomnia, but not in those who received a hypnotic agent.15 Delirium increases the likelihood of nocturnal wandering, also associated with increased risk of fall. Our inpatient cohort study confirms these prior findings: insomnia, delirium, and older age were all associated with an increased risk of falling. However, zolpidem use continued to remain a significant risk factor for falls even after accounting for these risk factors.

Hospitalized patients are more likely to be physically compromised and on a greater number of medications compared to community‐dwelling subjects, and hence at increased risk of falling. Multiple classes of medications have been shown to be associated with an increased fall risk in hospitalized patients.14 In our study, the patients who sustained a fall after receiving zolpidem did not differ from other patients who sustained a fall in terms of their medication use. Zolpidem thus appears to increase the risk of falling beyond that attributable to other medications in hospitalized patients.

A recent United States Preventive Services Task Force on Prevention of Falls in Community Dwelling Older Adults recommendation indicates that withdrawal of medication alone does not appear to have a significant impact on fall rates.18 Another study indicates that reduced benozodiazepine use did not significantly reduce the rates of hip fractures in the community.19 While these studies indicate that fall risk is multifactorial and requires a complex set of interventions, our results indicate that there might be an association between zolpidem administration and falls in an inpatient setting. Changing order sets so that zolpidem use is not encouraged could potentially reduce fall rates in hospitalized patients, a step that we have already taken in our institution based upon these findings. Other potential measures to reduce fall risk include the use of fall precautions in patients who are prescribed zolpidem or use of non‐pharmacologic treatments for insomnia. However, these interventions would need to be empirically tested before they could be recommended with confidence.

The results of this study must be viewed in the light of some limitations. Although we included age, sex, zolpidem dose, length of hospital stay, Charlson comorbidity index score, fall risk score, and diagnoses of insomnia, visual impairment, gait abnormality, cognitive impairment/dementia, and delirium in our analyses, we were unable to account for the degree of severity of these conditions. There could also be other possible medical conditions that result in an increased risk of falling that were not accounted for in our analyses. While we did attempt to correct for insomnia and delirium diagnoses, transient complaints of insomnia or altered mental status may have been missed by our retrospective methodology, and perhaps could co‐associate with risk of falling. Furthermore, administration of zolpidem was associated with a higher risk of falls when compared to other patients who were prescribed zolpidem, and also when compared to all other patients regardless of zolpidem prescription. We used ICD‐9 codes to identify patients with insomnia, delirium, visual impairment, and gait abnormalities, and these could be prone to misclassification and possible ascertainment bias. Finally, we were unable to account for use of medications that might potentially increase the risk of falling in the entire cohort. We were, however, able to account for this in the subset of patients who sustained a fall, and did not note a difference between the group that received zolpidem and the group that did not. In these analyses, we were able to account for administration of these other medications, but not the dose or cumulative dose.

CONCLUSIONS

Our study, the largest in an inpatient cohort, reveals that zolpidem administration is associated with increased risk of falling even after accounting for insomnia, delirium, and multiple other risk factors. Patients who sustained a fall after receiving zolpidem did not differ from other patients who sustained a fall, in terms of age or use of other medications conferring increased fall risk. Although insomnia and delirium are also associated with an increased risk of falling, addition of zolpidem in this situation appears to result in a further increase in fall risk. Presently, because there is limited evidence to recommend other hypnotic agents as safer alternatives in inpatient settings, non‐pharmacological measures to improve the sleep of hospitalized patients should be investigated as preferred methods to provide safe relief from complaints of disturbed sleep.

Acknowledgements

The authors acknowledge Anna Halverson, RN, from Nursing Practice Resources, for providing patient fall data from the Mayo Clinic Rochester Event Tracking System used in analysis; and Erek Lam, MD, for helping with data abstraction from the electronic medical record.

References
  1. Yoder JC,Staisiunas PG,Meltzer DO,Knutson KL,Arora VM.Noise and sleep among adult medical inpatients: far from a quiet night.Arch Intern Med.2012;172:6870.
  2. Lane T,East LA.Sleep disruption experienced by surgical patients in an acute hospital.Br J Nurs.2008;17(12):766771.
  3. Humphries JD.Sleep disruption in hospitalized adults.Medsurg Nurs.2008;17:391395.
  4. Missildine K,Bergstrom N,Meininger J,Richards K,Foreman MD.Sleep in hospitalized elders: a pilot study.Geriatr Nurs.2010;31(4):263271.
  5. Walsh JK,Schweitzer PK.Ten‐year trends in the pharmacological treatment of insomnia.Sleep.1999;22:371375.
  6. Kripke DF,Langer RD,Kline LE.Hypnotics' association with mortality or cancer: a matched cohort study.BMJ Open2012:2:e000850e000850.
  7. Mets MAJ,Volkerts ER,Olivier B,Verster JC.Effect of hypnotic drugs on body balance and standing steadiness.Sleep Med Rev.2010;14:259267.
  8. Wang PS,Bohn RL,Glynn RJ,Mogun H,Avorn J.Zolpidem use and hip fractures in older people.J Am Geriatr Soc.2001;49:16851690.
  9. Chang C‐M,Chen M‐J,Tsai C‐Y, et al.Medical conditions and medications as risk factors of falls in the inpatient older people: a case‐control study.Int J Geriatr Psychiatry2011;26:602607.
  10. Department of Health and Human Services Partnership for Patients.2012. Available at: http://innovation.cms.gov/initiatives/partnership‐for‐patients/index.html. Accessed on July 1, 2012.
  11. Dibardino D,Cohen ER,Didwania A.Meta‐analysis: multidisciplinary fall prevention strategies in the acute care inpatient population.J Hosp Med.2012;7(6):497503.
  12. Charlson ME,Pompei P,Ales KL,MacKenzie CR.A new method of classifying prognostic comorbidity in longitudinal studies: development and validation.J Chronic Dis.1987;40:373383.
  13. Hendrich A,Nyhuis A,Kippenbrock T,Soja ME.Hospital falls: development of a predictive model for clinical practice.Appl Nurs Res.1995;8:129139.
  14. Woolcott JC,Richardson KJ,Wiens MO, et al.Meta‐analysis of the impact of 9 medication classes on falls in elderly persons.Arch Intern Med.2009;169:19521960.
  15. Avidan AY,Fries BE,James ML, et al.Insomnia and hypnotic use, recorded in the minimum data set, as predictors of falls and hip fractures in Michigan nursing homes.J Am Geriatr Soc.2005;53:955962.
  16. von Renteln‐Kruse W,Krause T.Fall events in geriatric hospital in‐patients. Results of prospective recording over a 3 year period [in German].Z Gerontol Geriatr2004;37:914.
  17. Bates DW,Pruess K,Souney P,Platt R.Serious falls in hospitalized patients: correlates and resource utilization.Am J Med.1995;99;137143.
  18. United States Preventive Services Task Force on the Prevention of Falls in Community‐Dwelling Older Adults.2012. Available at: http://www.uspreventiveservicestaskforce.org/uspstf/uspsfalls.htm. Accessed on July 1, 2012.
  19. Wagner AK,Ross‐Degnan D,Gurwitz JH, et al.Effect of New York State regulatory action on benzodiazepine prescribing and hip fracture rates.Ann Intern Med.2007;146;96103.
References
  1. Yoder JC,Staisiunas PG,Meltzer DO,Knutson KL,Arora VM.Noise and sleep among adult medical inpatients: far from a quiet night.Arch Intern Med.2012;172:6870.
  2. Lane T,East LA.Sleep disruption experienced by surgical patients in an acute hospital.Br J Nurs.2008;17(12):766771.
  3. Humphries JD.Sleep disruption in hospitalized adults.Medsurg Nurs.2008;17:391395.
  4. Missildine K,Bergstrom N,Meininger J,Richards K,Foreman MD.Sleep in hospitalized elders: a pilot study.Geriatr Nurs.2010;31(4):263271.
  5. Walsh JK,Schweitzer PK.Ten‐year trends in the pharmacological treatment of insomnia.Sleep.1999;22:371375.
  6. Kripke DF,Langer RD,Kline LE.Hypnotics' association with mortality or cancer: a matched cohort study.BMJ Open2012:2:e000850e000850.
  7. Mets MAJ,Volkerts ER,Olivier B,Verster JC.Effect of hypnotic drugs on body balance and standing steadiness.Sleep Med Rev.2010;14:259267.
  8. Wang PS,Bohn RL,Glynn RJ,Mogun H,Avorn J.Zolpidem use and hip fractures in older people.J Am Geriatr Soc.2001;49:16851690.
  9. Chang C‐M,Chen M‐J,Tsai C‐Y, et al.Medical conditions and medications as risk factors of falls in the inpatient older people: a case‐control study.Int J Geriatr Psychiatry2011;26:602607.
  10. Department of Health and Human Services Partnership for Patients.2012. Available at: http://innovation.cms.gov/initiatives/partnership‐for‐patients/index.html. Accessed on July 1, 2012.
  11. Dibardino D,Cohen ER,Didwania A.Meta‐analysis: multidisciplinary fall prevention strategies in the acute care inpatient population.J Hosp Med.2012;7(6):497503.
  12. Charlson ME,Pompei P,Ales KL,MacKenzie CR.A new method of classifying prognostic comorbidity in longitudinal studies: development and validation.J Chronic Dis.1987;40:373383.
  13. Hendrich A,Nyhuis A,Kippenbrock T,Soja ME.Hospital falls: development of a predictive model for clinical practice.Appl Nurs Res.1995;8:129139.
  14. Woolcott JC,Richardson KJ,Wiens MO, et al.Meta‐analysis of the impact of 9 medication classes on falls in elderly persons.Arch Intern Med.2009;169:19521960.
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Issue
Journal of Hospital Medicine - 8(1)
Issue
Journal of Hospital Medicine - 8(1)
Page Number
1-6
Page Number
1-6
Article Type
Display Headline
Zolpidem is independently associated with increased risk of inpatient falls
Display Headline
Zolpidem is independently associated with increased risk of inpatient falls
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Copyright © 2012 Society of Hospital Medicine

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