As part of the Choosing Wisely^® campaign, the Society of Hospital Medicine recommends against performing “repetitive complete blood count [CBC] and chemistry testing in the face of clinical and lab stability.”¹ This recommendation stems from a body of research that shows that frequent or excessive phlebotomy can have negative consequences, including iatrogenic anemia (termed hospital-acquired anemia), which may necessitate blood transfusion.² The downstream effects of potentially unnecessary testing, including the evaluation of false-positive results, must also be considered. Additional important effects include patient discomfort and disruption of sleep and unproductive work by hospital staff, including nurses, phlebotomists, and laboratory technicians.

Though interventions to reduce unnecessary daily labs have been previously evaluated, there are no studies that focus on decreasing lab testing on patients deemed clinically stable and close to discharge. This is in part due to the absence of clear criteria or guidelines to define clinical stability in the context of lab utilization.

We therefore aimed to implement a multifaceted, patient-centered initiative—the Necessity of Labs Assessed Bedside (NO LABS)—that focused on reducing lab testing in patients at 24 to 48 hours before discharge. We targeted the 24 to 48-hour period before the anticipated date of discharge, as this may be a period of greater stability and provide an opportunity to identify and decrease unnecessary testing.

The study took place at Mount Sinai Hospital, which is an 1174-bed tertiary care teaching hospital in New York City. We targeted 2 inpatient medicine units where virtually all patients are assigned to a hospitalist rotating for a 2- to 4-week period, for the period of July 1, 2015, to July 31, 2016. These units employed bedside interdisciplinary rounds (IDR) attended by the hospitalist, social worker, case manager, nurse, nurse manager, and medical director. Bedside IDR focuses on the daily plan and patient safety by utilizing a scripted format.³ Our multifaceted intervention included prompting the hospitalist physician during bedside IDR, education of the clinicians, and regular data review for the hospitalists and unit staff.

As described by Dunn et al.,³ the IDR script included the following: a review of the plan of care by the hospitalist, identifying a patient’s personal goals for the day, a brief update of discharge planning (as appropriate), and a safety assessment performed by the nurse (identifying Foley catheters, falls risk, etc). We incorporated an inquiry into the daily IDR script identifying clinically stable patients for discharge in the next 24 to 48 hours (based on physician judgment), followed by a prompt to the hospitalist to discontinue labs when appropriate. The unit medical director and nurse manager were both tasked with prompting the hospitalist at the bedside. Our hospital utilizes computerized physician order entry. Lab orders were then discontinued by the clinician during rounds using a computer on wheels (or after rounds when one was not available). The hospitalist, unit medical director, and nurse manager were reminded about the project through weekly e-mails and in-person communication.

To assess whether the prompt was being incorporated consistently, an observer was added to rounds beginning in the second month of the project. The observer was present at least 3 times a week for the subsequent 3 months of the project. Our intervention also included education geared towards hospitalists, including a brief presentation on reducing unnecessary lab testing during a monthly hospitalist faculty meeting (the first and sixth month of the intervention). The group’s data on laboratory testing within the 24 to 48 hours prior to discharge were also presented at these monthly meetings (beginning 2 months into the intervention and monthly thereafter). Lastly, we provided the unit staff with unit-level metrics, biweekly for the first 3 months and every 2 to 3 months thereafter.

We extracted electronic medical record (EMR) data on lab utilization for patients on the 2 hospitalist units for the intervention period. Baseline data were obtained from July 1, 2014, to June 30, 2015. Patients with a length of stay (LOS) ≤7 days (75th percentile) were included; on these units, longer stays were considered more likely to have complex social issues delaying discharge and thus less likely to require laboratory testing. We tracked ordering for 4 common lab tests: basic metabolic panel, CBC, CBC with differential, and the comprehensive metabolic panel. The primary outcome was the monthly percentage of patients for whom testing was ordered in the 24 and 48 hours preceding discharge. A secondary outcome was testing at 72 hours preceding discharge to identify any potential compensatory (increased) testing the evening prior. We applied a quasi-experimental interrupted time series design with a segmented regression analysis to estimate changes before and after our intervention, expressed in acute changes (change in intercept) and over time (changes in trend) while adjusting for preintervention trends. All analyses were performed with SAS v9.4 statistical software (SAS Institute, Cary, NC). Our project was deemed a quality improvement project and thus an IRB submission was not required.

There were 1579 discharges in the preintervention period and 1308 discharges in the postintervention period. The average age of the patient population was similar in the baseline and postintervention groups (61.5 vs 59.3 years; P = 0.400), and there was no difference in the mean LOS before and after implementation (3.67 vs 3.68 days; P = 0.817).

Our structured, multifaceted approach effectively reduced daily lab testing in the 24 to 48 hours prior to discharge. Bedside IDR provided a unique opportunity to effectively communicate to the patient about necessary (or unnecessary) testing. Moreover, given the complexity of identifying clinical stability, our strategy focused on the onset of discharge planning, a more easily discernible and less obtrusive focal point to promote the discontinuation of lab testing.

Though the nature of bundled interventions can make it difficult to identify which intervention is most effective, we believe that all interventions were effective in different capacities during various phases in the intervention period. We believe that the decrease in lab testing in the 24 to 48 hours preceding discharge was primarily driven by the new rounding structure. This is evident in the significant decrease seen in the first few months of the intervention period. Six months into the intervention, we begin to see a decrease at 72 hours prior to discharge. Additionally, we see a decrease in the mean number of labs per patient day over the entire hospitalization period. We attribute these results to a gradual shift in the culture in our division as a direct consequence of educational sessions and individual feedback provided during this time.

To our knowledge, this is the first study to use anticipated discharge as a correlate for clinical stability and therefore as an opportunity to prompt discontinuation of laboratory testing. Other studies evaluated interventions targeting the EMR and the ease with which providers can order recurring labs. These include restricting recurring orders in the EMR,⁴ a robust education and awareness campaign targeting house staff,⁵ and other multifaceted approaches to decreasing lab utilization,⁶ all of which have shown promising results. While these approaches show varying degrees of success, ours is unique in its focus on the period prior to discharge. In addition, the intervention can be readily implemented in settings that utilize scripted IDR. It also brings high-value decision-making to the bedside by informing the patient that in the setting of presumed clinical stability, no additional tests are warranted.

Our study has several limitations. First, while interdisciplinary discharge rounds are widely implemented,^7,8 our rounds occur at the bedside and employ a script, potentially limiting generalizability. The structured prompting may be feasible during structured IDR in a standard conference room setting, though we did not assess this model. Second, bedside rounds only included patients who were able to participate. Rounding on patients unable to participate, such as patients with delirium with agitation, was done outside the patient room rather than at the bedside. A modified script was used in these instances (absent questions addressed to the patient), allowing for the prompt to be incorporated. These patients were included in the analysis. Lastly, as previously stated, we cannot clearly identify which intervention (the prompt, education, or feedback) most effectively led to a sustained decrease in lab ordering.

Our structured, multifaceted intervention reduced laboratory testing during the last 48 hours of admission. Hospitals that aim to decrease potentially unnecessary lab testing should consider implementing a bundle, including a prompt at a uniform and structured point during the hospitalization of patients who are expected to be discharged within 24 to 48 hours, clinician education, an audit, and feedback.

Disclosure

 All authors report no conflicts of interest to disclose.

As part of the Choosing Wisely^® campaign, the Society of Hospital Medicine recommends against performing “repetitive complete blood count [CBC] and chemistry testing in the face of clinical and lab stability.”¹ This recommendation stems from a body of research that shows that frequent or excessive phlebotomy can have negative consequences, including iatrogenic anemia (termed hospital-acquired anemia), which may necessitate blood transfusion.² The downstream effects of potentially unnecessary testing, including the evaluation of false-positive results, must also be considered. Additional important effects include patient discomfort and disruption of sleep and unproductive work by hospital staff, including nurses, phlebotomists, and laboratory technicians.

Though interventions to reduce unnecessary daily labs have been previously evaluated, there are no studies that focus on decreasing lab testing on patients deemed clinically stable and close to discharge. This is in part due to the absence of clear criteria or guidelines to define clinical stability in the context of lab utilization.

We therefore aimed to implement a multifaceted, patient-centered initiative—the Necessity of Labs Assessed Bedside (NO LABS)—that focused on reducing lab testing in patients at 24 to 48 hours before discharge. We targeted the 24 to 48-hour period before the anticipated date of discharge, as this may be a period of greater stability and provide an opportunity to identify and decrease unnecessary testing.

The study took place at Mount Sinai Hospital, which is an 1174-bed tertiary care teaching hospital in New York City. We targeted 2 inpatient medicine units where virtually all patients are assigned to a hospitalist rotating for a 2- to 4-week period, for the period of July 1, 2015, to July 31, 2016. These units employed bedside interdisciplinary rounds (IDR) attended by the hospitalist, social worker, case manager, nurse, nurse manager, and medical director. Bedside IDR focuses on the daily plan and patient safety by utilizing a scripted format.³ Our multifaceted intervention included prompting the hospitalist physician during bedside IDR, education of the clinicians, and regular data review for the hospitalists and unit staff.

As described by Dunn et al.,³ the IDR script included the following: a review of the plan of care by the hospitalist, identifying a patient’s personal goals for the day, a brief update of discharge planning (as appropriate), and a safety assessment performed by the nurse (identifying Foley catheters, falls risk, etc). We incorporated an inquiry into the daily IDR script identifying clinically stable patients for discharge in the next 24 to 48 hours (based on physician judgment), followed by a prompt to the hospitalist to discontinue labs when appropriate. The unit medical director and nurse manager were both tasked with prompting the hospitalist at the bedside. Our hospital utilizes computerized physician order entry. Lab orders were then discontinued by the clinician during rounds using a computer on wheels (or after rounds when one was not available). The hospitalist, unit medical director, and nurse manager were reminded about the project through weekly e-mails and in-person communication.

To assess whether the prompt was being incorporated consistently, an observer was added to rounds beginning in the second month of the project. The observer was present at least 3 times a week for the subsequent 3 months of the project. Our intervention also included education geared towards hospitalists, including a brief presentation on reducing unnecessary lab testing during a monthly hospitalist faculty meeting (the first and sixth month of the intervention). The group’s data on laboratory testing within the 24 to 48 hours prior to discharge were also presented at these monthly meetings (beginning 2 months into the intervention and monthly thereafter). Lastly, we provided the unit staff with unit-level metrics, biweekly for the first 3 months and every 2 to 3 months thereafter.

We extracted electronic medical record (EMR) data on lab utilization for patients on the 2 hospitalist units for the intervention period. Baseline data were obtained from July 1, 2014, to June 30, 2015. Patients with a length of stay (LOS) ≤7 days (75th percentile) were included; on these units, longer stays were considered more likely to have complex social issues delaying discharge and thus less likely to require laboratory testing. We tracked ordering for 4 common lab tests: basic metabolic panel, CBC, CBC with differential, and the comprehensive metabolic panel. The primary outcome was the monthly percentage of patients for whom testing was ordered in the 24 and 48 hours preceding discharge. A secondary outcome was testing at 72 hours preceding discharge to identify any potential compensatory (increased) testing the evening prior. We applied a quasi-experimental interrupted time series design with a segmented regression analysis to estimate changes before and after our intervention, expressed in acute changes (change in intercept) and over time (changes in trend) while adjusting for preintervention trends. All analyses were performed with SAS v9.4 statistical software (SAS Institute, Cary, NC). Our project was deemed a quality improvement project and thus an IRB submission was not required.

There were 1579 discharges in the preintervention period and 1308 discharges in the postintervention period. The average age of the patient population was similar in the baseline and postintervention groups (61.5 vs 59.3 years; P = 0.400), and there was no difference in the mean LOS before and after implementation (3.67 vs 3.68 days; P = 0.817).

Our structured, multifaceted approach effectively reduced daily lab testing in the 24 to 48 hours prior to discharge. Bedside IDR provided a unique opportunity to effectively communicate to the patient about necessary (or unnecessary) testing. Moreover, given the complexity of identifying clinical stability, our strategy focused on the onset of discharge planning, a more easily discernible and less obtrusive focal point to promote the discontinuation of lab testing.

Though the nature of bundled interventions can make it difficult to identify which intervention is most effective, we believe that all interventions were effective in different capacities during various phases in the intervention period. We believe that the decrease in lab testing in the 24 to 48 hours preceding discharge was primarily driven by the new rounding structure. This is evident in the significant decrease seen in the first few months of the intervention period. Six months into the intervention, we begin to see a decrease at 72 hours prior to discharge. Additionally, we see a decrease in the mean number of labs per patient day over the entire hospitalization period. We attribute these results to a gradual shift in the culture in our division as a direct consequence of educational sessions and individual feedback provided during this time.

To our knowledge, this is the first study to use anticipated discharge as a correlate for clinical stability and therefore as an opportunity to prompt discontinuation of laboratory testing. Other studies evaluated interventions targeting the EMR and the ease with which providers can order recurring labs. These include restricting recurring orders in the EMR,⁴ a robust education and awareness campaign targeting house staff,⁵ and other multifaceted approaches to decreasing lab utilization,⁶ all of which have shown promising results. While these approaches show varying degrees of success, ours is unique in its focus on the period prior to discharge. In addition, the intervention can be readily implemented in settings that utilize scripted IDR. It also brings high-value decision-making to the bedside by informing the patient that in the setting of presumed clinical stability, no additional tests are warranted.

Our study has several limitations. First, while interdisciplinary discharge rounds are widely implemented,^7,8 our rounds occur at the bedside and employ a script, potentially limiting generalizability. The structured prompting may be feasible during structured IDR in a standard conference room setting, though we did not assess this model. Second, bedside rounds only included patients who were able to participate. Rounding on patients unable to participate, such as patients with delirium with agitation, was done outside the patient room rather than at the bedside. A modified script was used in these instances (absent questions addressed to the patient), allowing for the prompt to be incorporated. These patients were included in the analysis. Lastly, as previously stated, we cannot clearly identify which intervention (the prompt, education, or feedback) most effectively led to a sustained decrease in lab ordering.

Our structured, multifaceted intervention reduced laboratory testing during the last 48 hours of admission. Hospitals that aim to decrease potentially unnecessary lab testing should consider implementing a bundle, including a prompt at a uniform and structured point during the hospitalization of patients who are expected to be discharged within 24 to 48 hours, clinician education, an audit, and feedback.

Disclosure

 All authors report no conflicts of interest to disclose.

As part of the Choosing Wisely^® campaign, the Society of Hospital Medicine recommends against performing “repetitive complete blood count [CBC] and chemistry testing in the face of clinical and lab stability.”¹ This recommendation stems from a body of research that shows that frequent or excessive phlebotomy can have negative consequences, including iatrogenic anemia (termed hospital-acquired anemia), which may necessitate blood transfusion.² The downstream effects of potentially unnecessary testing, including the evaluation of false-positive results, must also be considered. Additional important effects include patient discomfort and disruption of sleep and unproductive work by hospital staff, including nurses, phlebotomists, and laboratory technicians.

Though interventions to reduce unnecessary daily labs have been previously evaluated, there are no studies that focus on decreasing lab testing on patients deemed clinically stable and close to discharge. This is in part due to the absence of clear criteria or guidelines to define clinical stability in the context of lab utilization.

We therefore aimed to implement a multifaceted, patient-centered initiative—the Necessity of Labs Assessed Bedside (NO LABS)—that focused on reducing lab testing in patients at 24 to 48 hours before discharge. We targeted the 24 to 48-hour period before the anticipated date of discharge, as this may be a period of greater stability and provide an opportunity to identify and decrease unnecessary testing.

The study took place at Mount Sinai Hospital, which is an 1174-bed tertiary care teaching hospital in New York City. We targeted 2 inpatient medicine units where virtually all patients are assigned to a hospitalist rotating for a 2- to 4-week period, for the period of July 1, 2015, to July 31, 2016. These units employed bedside interdisciplinary rounds (IDR) attended by the hospitalist, social worker, case manager, nurse, nurse manager, and medical director. Bedside IDR focuses on the daily plan and patient safety by utilizing a scripted format.³ Our multifaceted intervention included prompting the hospitalist physician during bedside IDR, education of the clinicians, and regular data review for the hospitalists and unit staff.

As described by Dunn et al.,³ the IDR script included the following: a review of the plan of care by the hospitalist, identifying a patient’s personal goals for the day, a brief update of discharge planning (as appropriate), and a safety assessment performed by the nurse (identifying Foley catheters, falls risk, etc). We incorporated an inquiry into the daily IDR script identifying clinically stable patients for discharge in the next 24 to 48 hours (based on physician judgment), followed by a prompt to the hospitalist to discontinue labs when appropriate. The unit medical director and nurse manager were both tasked with prompting the hospitalist at the bedside. Our hospital utilizes computerized physician order entry. Lab orders were then discontinued by the clinician during rounds using a computer on wheels (or after rounds when one was not available). The hospitalist, unit medical director, and nurse manager were reminded about the project through weekly e-mails and in-person communication.

To assess whether the prompt was being incorporated consistently, an observer was added to rounds beginning in the second month of the project. The observer was present at least 3 times a week for the subsequent 3 months of the project. Our intervention also included education geared towards hospitalists, including a brief presentation on reducing unnecessary lab testing during a monthly hospitalist faculty meeting (the first and sixth month of the intervention). The group’s data on laboratory testing within the 24 to 48 hours prior to discharge were also presented at these monthly meetings (beginning 2 months into the intervention and monthly thereafter). Lastly, we provided the unit staff with unit-level metrics, biweekly for the first 3 months and every 2 to 3 months thereafter.

We extracted electronic medical record (EMR) data on lab utilization for patients on the 2 hospitalist units for the intervention period. Baseline data were obtained from July 1, 2014, to June 30, 2015. Patients with a length of stay (LOS) ≤7 days (75th percentile) were included; on these units, longer stays were considered more likely to have complex social issues delaying discharge and thus less likely to require laboratory testing. We tracked ordering for 4 common lab tests: basic metabolic panel, CBC, CBC with differential, and the comprehensive metabolic panel. The primary outcome was the monthly percentage of patients for whom testing was ordered in the 24 and 48 hours preceding discharge. A secondary outcome was testing at 72 hours preceding discharge to identify any potential compensatory (increased) testing the evening prior. We applied a quasi-experimental interrupted time series design with a segmented regression analysis to estimate changes before and after our intervention, expressed in acute changes (change in intercept) and over time (changes in trend) while adjusting for preintervention trends. All analyses were performed with SAS v9.4 statistical software (SAS Institute, Cary, NC). Our project was deemed a quality improvement project and thus an IRB submission was not required.

There were 1579 discharges in the preintervention period and 1308 discharges in the postintervention period. The average age of the patient population was similar in the baseline and postintervention groups (61.5 vs 59.3 years; P = 0.400), and there was no difference in the mean LOS before and after implementation (3.67 vs 3.68 days; P = 0.817).

Our structured, multifaceted approach effectively reduced daily lab testing in the 24 to 48 hours prior to discharge. Bedside IDR provided a unique opportunity to effectively communicate to the patient about necessary (or unnecessary) testing. Moreover, given the complexity of identifying clinical stability, our strategy focused on the onset of discharge planning, a more easily discernible and less obtrusive focal point to promote the discontinuation of lab testing.

Though the nature of bundled interventions can make it difficult to identify which intervention is most effective, we believe that all interventions were effective in different capacities during various phases in the intervention period. We believe that the decrease in lab testing in the 24 to 48 hours preceding discharge was primarily driven by the new rounding structure. This is evident in the significant decrease seen in the first few months of the intervention period. Six months into the intervention, we begin to see a decrease at 72 hours prior to discharge. Additionally, we see a decrease in the mean number of labs per patient day over the entire hospitalization period. We attribute these results to a gradual shift in the culture in our division as a direct consequence of educational sessions and individual feedback provided during this time.

To our knowledge, this is the first study to use anticipated discharge as a correlate for clinical stability and therefore as an opportunity to prompt discontinuation of laboratory testing. Other studies evaluated interventions targeting the EMR and the ease with which providers can order recurring labs. These include restricting recurring orders in the EMR,⁴ a robust education and awareness campaign targeting house staff,⁵ and other multifaceted approaches to decreasing lab utilization,⁶ all of which have shown promising results. While these approaches show varying degrees of success, ours is unique in its focus on the period prior to discharge. In addition, the intervention can be readily implemented in settings that utilize scripted IDR. It also brings high-value decision-making to the bedside by informing the patient that in the setting of presumed clinical stability, no additional tests are warranted.

Our study has several limitations. First, while interdisciplinary discharge rounds are widely implemented,^7,8 our rounds occur at the bedside and employ a script, potentially limiting generalizability. The structured prompting may be feasible during structured IDR in a standard conference room setting, though we did not assess this model. Second, bedside rounds only included patients who were able to participate. Rounding on patients unable to participate, such as patients with delirium with agitation, was done outside the patient room rather than at the bedside. A modified script was used in these instances (absent questions addressed to the patient), allowing for the prompt to be incorporated. These patients were included in the analysis. Lastly, as previously stated, we cannot clearly identify which intervention (the prompt, education, or feedback) most effectively led to a sustained decrease in lab ordering.

Our structured, multifaceted intervention reduced laboratory testing during the last 48 hours of admission. Hospitals that aim to decrease potentially unnecessary lab testing should consider implementing a bundle, including a prompt at a uniform and structured point during the hospitalization of patients who are expected to be discharged within 24 to 48 hours, clinician education, an audit, and feedback.

Disclosure

 All authors report no conflicts of interest to disclose.

Pneumonia is a major cause of hospitalization, mortality, and healthcare cost. ^1,2 The diagnosis involves clinical features plus radiographic evidence of infection. Hospital-acquired pneumonia (HAP) is defined by the Infectious Disease Society of America (IDSA) as a pneumonia that occurs ≥48 hours after admission and is not associated with mechanical ventilation. ³

IDSA recommendations suggest that patients with suspected HAP be treated based on results of noninvasively obtained sputum cultures rather than being treated empirically. ³ This recommendation is graded as weak with low-quality evidence based on a lack of both evidence showing that respiratory cultures improve clinical outcomes and studies examining the yield of noninvasive collection methods. ^4,5 However, resistant pathogens lead to a risk of inadequate empiric therapy, which is associated with increased mortality. ⁶ Culture data may provide an opportunity for escalation or de-escalation of antibiotic coverage. IDSA recommendations for microbiologic sampling are thus aimed at increasing appropriate coverage and minimizing unnecessary antibiotic exposure.

While the yield and clinical utility of sputum culture in community-acquired pneumonia has been studied extensively, data examining the yield of sputum culture in HAP (non–ventilator-associated pneumonia [non-VAP]) are sparse. In 1 small single-center study, researchers demonstrated positive sputum cultures in 17/35 (48.6%) patients with radiographically confirmed cases of HAP, ⁷ while in another study, researchers demonstrated positive sputum cultures in 57/63 (90.5%). ⁸ We aimed to identify the frequency with which sputum cultures positively identify an organism, identify predictors of positive sputum cultures, and characterize the microbiology of sputum cultures in a large cohort of HAP cases.

We conducted a retrospective cohort study of patients admitted to a large academic medical center in Boston, Massachusetts, from January 2007 to July 2013. All patients ≥18 years of age were eligible for inclusion. We excluded outside hospital transfers, those with a length of hospitalization <48 hours, and psychiatric admissions.

The study was approved by the institutional review board at the Beth Israel Deaconess Medical Center and granted a waiver of informed consent. Data were collected from electronic databases and supplemented by chart review.

Hospital-Acquired Pneumonia

We defined HAP as pneumonia occurring at least 48 hours after admission, consistent with American Thoracic Society and IDSA criteria.³ To identify cases, we reviewed the charts of all admissions identified as having a discharge International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code for bacterial pneumonia (481, 482, 483, 485, 486, 507), indicated as not “present-on-admission.” We validated that the treating clinician had clinically diagnosed pneumonia and initiated antibiotics for this purpose by performing chart review. We reviewed the radiologist interpretation of radiographs surrounding the date of the clinical diagnosis of pneumonia to confirm the presence of a new opacity. Uncertain cases (with respect to either the presence of pneumonia or the timing of the diagnosis) were reviewed by a second member of the study team and, in the case of disagreement, adjudicated by a third member of the study team. Only the first clinically validated HAP per hospitalization was included in the analysis. To focus on HAP rather than VAP, we excluded hospitalizations in which the date of a procedure code for mechanical ventilation preceded the date of pneumonia diagnosis.

Microbiology

In our analysis, we used sputum samples obtained from expectorated or induced samples to evaluate the yield of noninvasive sputum sampling, as recommended by the IDSA. We included sputum samples collected ≥48 hours after admission and within 7 days of the clinical diagnosis of HAP. Sputum samples with >10 epithelial cells per high-power field (hpf) were considered to be contaminated. Among noncontaminated samples, positive sputum cultures were defined as those with a microbiologic diagnosis other than “oral flora,” while those with no growth or growth of oral flora or only yeast were considered to be negative. The hospital’s microbiology laboratory does not routinely provide species identification for Gram-negative rods (GNRs) growing on culture in the presence of growth of ≥3 other colony types. We considered such GNRs (not further speciated) to represent a positive culture result in our analysis given that colonization versus pathogenicity is a clinical distinction and, as such, these results may impact antibiotic choice.

Statistical Analysis

Data were analyzed by using SAS software, version 9.3. We used a 2-sided P value of <0.05 to indicate statistical significance for all comparisons. We used the χ² test and the nonparametric median test for unadjusted comparisons.

To identify predictors of a positive (versus negative or contaminated) sputum culture among patients with HAP, we used a generalized estimating equation model with a Poisson distribution error term, log link, and first-order autoregressive correlation structure to account for multiple sputum specimens per patient. We combined culture negative and contaminated samples to highlight the clinical utility of sputum culture in a real-world setting. Potential predictors chosen based on clinical grounds included all variables listed in Table 1. We defined comorbidities specified in Table 1 via ICD-9-CM secondary diagnosis codes and diagnosis related groups (DRGs) using Healthcare Cost and Utilization Project Comorbidity Software, version 3.7, based on the work of Elixhauser et al.^9,10; dialysis use was defined by an ICD-9-CM procedure code of 39.95; inpatient steroid use was defined by a hospital pharmacy charge for a systemic steroid in the 7 days preceding the sputum sample.

There were 230,635 hospitalizations of patients ≥18 years of age from January 2007 to July 2013. After excluding outside hospital transfers (n = 14,422), hospitalizations <48 hours in duration (n = 59,774), and psychiatric hospitalizations (n = 9887), there were 146,552 hospitalizations in the cohort.

To our knowledge, our study is the first to assess the predictors of positive sputum culture among patients with HAP (non-VAP) who had sputum samples obtained noninvasively, and this study is larger than prior studies in which researchers reported on sputum culture yield in HAP. Sputum samples were obtained in 29.4% cases of clinically diagnosed HAP. Although 87% of specimens obtained were culture-negative or contaminated, 13% yielded a bacterial organism. Although we do not report the antibiotic sensitivity patterns of the isolated organisms, the organisms identified frequently demonstrate antibiotic resistance, highlighting the potential for both antibiotic escalation and de-escalation based on sputum culture. In a multivariable model, presence of chronic lung disease and steroid use in the preceding week were both significantly associated with culture positivity.

The retrospective nature of the study raises the possibility of selection bias from systematic differences between the 29.4% of patients with HAP who had sputum collected and those who did not. Patients with sputum cultures were similar to patients without cultures in most measured characteristics, but we are unable to know what the yield of noninvasive sputum culture would have been had all patients with HAP been sampled. As such, our findings reflect the yield of sputum culture among patients with HAP for whom cultures were successfully obtained. It is not clear why only 29.4% of HAP patients received IDSA guideline-concordant care, but similar rates of culture use are reported elsewhere.⁷ While physician decision-making could have contributed to this finding, it is also possible that many sick, hospitalized patients are simply unable to produce sputum for analysis. In future studies, researchers should examine barriers to guideline-concordant care.

We considered a culture result of GNRs (not further speciated) as positive in our analysis because this result indicates growth of mixed bacterial types, the pathogenicity of which is a clinical determination. Physicians may request speciation and antibiotic sensitivities and, as such, these results have the potential to impact antibiotic choice. Had we considered such cultures to be negative or contaminated, the rate of culture positivity would have been only slightly reduced from 63/478 (13.2%) to 50/478 (10.5%).

The strengths of our study include the chart-based validation of administratively identified cases of pneumonia and a large cohort. There are also limitations. The single-center nature of the study has implications for pretest probability and generalizability. Additionally, in our study, we did not examine outcomes among patients treated empirically versus those treated based on sputum culture results. Finally, our reliance on administrative codes to identify cases of HAP for subsequent validation could have resulted in incomplete capture of HAP cases.

In conclusion, in our study, we provide an estimate of the diagnostic yield of sputum culture in a large cohort with chart-validated HAP, a description of HAP microbiology, and predictors of positive sputum culture. Thirteen percent of patients who had sputum culture testing received a microbiologic diagnosis. Because of the relative ease of obtaining a sputum sample and the microbiologic distribution in our study (representing a mix of commonly drug-resistant pathogens and more typical community-acquired pathogens), we suggest that sputum culture in HAP is a useful diagnostic tool with the potential to inform antibiotic escalation or de-escalation.

Acknowledgments

Dr. Herzig was funded by grant number K23AG042459 from the National Institute on Aging. Dr. Marcantonio was funded by grant number K24AG035075 from the National Institute on Aging. The funding organizations had no involvement in any aspect of the study, including design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

Disclosure

No conflicts of interest apply for any of the authors.

Pneumonia is a major cause of hospitalization, mortality, and healthcare cost. ^1,2 The diagnosis involves clinical features plus radiographic evidence of infection. Hospital-acquired pneumonia (HAP) is defined by the Infectious Disease Society of America (IDSA) as a pneumonia that occurs ≥48 hours after admission and is not associated with mechanical ventilation. ³

IDSA recommendations suggest that patients with suspected HAP be treated based on results of noninvasively obtained sputum cultures rather than being treated empirically. ³ This recommendation is graded as weak with low-quality evidence based on a lack of both evidence showing that respiratory cultures improve clinical outcomes and studies examining the yield of noninvasive collection methods. ^4,5 However, resistant pathogens lead to a risk of inadequate empiric therapy, which is associated with increased mortality. ⁶ Culture data may provide an opportunity for escalation or de-escalation of antibiotic coverage. IDSA recommendations for microbiologic sampling are thus aimed at increasing appropriate coverage and minimizing unnecessary antibiotic exposure.

While the yield and clinical utility of sputum culture in community-acquired pneumonia has been studied extensively, data examining the yield of sputum culture in HAP (non–ventilator-associated pneumonia [non-VAP]) are sparse. In 1 small single-center study, researchers demonstrated positive sputum cultures in 17/35 (48.6%) patients with radiographically confirmed cases of HAP, ⁷ while in another study, researchers demonstrated positive sputum cultures in 57/63 (90.5%). ⁸ We aimed to identify the frequency with which sputum cultures positively identify an organism, identify predictors of positive sputum cultures, and characterize the microbiology of sputum cultures in a large cohort of HAP cases.

We conducted a retrospective cohort study of patients admitted to a large academic medical center in Boston, Massachusetts, from January 2007 to July 2013. All patients ≥18 years of age were eligible for inclusion. We excluded outside hospital transfers, those with a length of hospitalization <48 hours, and psychiatric admissions.

The study was approved by the institutional review board at the Beth Israel Deaconess Medical Center and granted a waiver of informed consent. Data were collected from electronic databases and supplemented by chart review.

Hospital-Acquired Pneumonia

We defined HAP as pneumonia occurring at least 48 hours after admission, consistent with American Thoracic Society and IDSA criteria.³ To identify cases, we reviewed the charts of all admissions identified as having a discharge International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code for bacterial pneumonia (481, 482, 483, 485, 486, 507), indicated as not “present-on-admission.” We validated that the treating clinician had clinically diagnosed pneumonia and initiated antibiotics for this purpose by performing chart review. We reviewed the radiologist interpretation of radiographs surrounding the date of the clinical diagnosis of pneumonia to confirm the presence of a new opacity. Uncertain cases (with respect to either the presence of pneumonia or the timing of the diagnosis) were reviewed by a second member of the study team and, in the case of disagreement, adjudicated by a third member of the study team. Only the first clinically validated HAP per hospitalization was included in the analysis. To focus on HAP rather than VAP, we excluded hospitalizations in which the date of a procedure code for mechanical ventilation preceded the date of pneumonia diagnosis.

Microbiology

In our analysis, we used sputum samples obtained from expectorated or induced samples to evaluate the yield of noninvasive sputum sampling, as recommended by the IDSA. We included sputum samples collected ≥48 hours after admission and within 7 days of the clinical diagnosis of HAP. Sputum samples with >10 epithelial cells per high-power field (hpf) were considered to be contaminated. Among noncontaminated samples, positive sputum cultures were defined as those with a microbiologic diagnosis other than “oral flora,” while those with no growth or growth of oral flora or only yeast were considered to be negative. The hospital’s microbiology laboratory does not routinely provide species identification for Gram-negative rods (GNRs) growing on culture in the presence of growth of ≥3 other colony types. We considered such GNRs (not further speciated) to represent a positive culture result in our analysis given that colonization versus pathogenicity is a clinical distinction and, as such, these results may impact antibiotic choice.

Statistical Analysis

Data were analyzed by using SAS software, version 9.3. We used a 2-sided P value of <0.05 to indicate statistical significance for all comparisons. We used the χ² test and the nonparametric median test for unadjusted comparisons.

To identify predictors of a positive (versus negative or contaminated) sputum culture among patients with HAP, we used a generalized estimating equation model with a Poisson distribution error term, log link, and first-order autoregressive correlation structure to account for multiple sputum specimens per patient. We combined culture negative and contaminated samples to highlight the clinical utility of sputum culture in a real-world setting. Potential predictors chosen based on clinical grounds included all variables listed in Table 1. We defined comorbidities specified in Table 1 via ICD-9-CM secondary diagnosis codes and diagnosis related groups (DRGs) using Healthcare Cost and Utilization Project Comorbidity Software, version 3.7, based on the work of Elixhauser et al.^9,10; dialysis use was defined by an ICD-9-CM procedure code of 39.95; inpatient steroid use was defined by a hospital pharmacy charge for a systemic steroid in the 7 days preceding the sputum sample.

There were 230,635 hospitalizations of patients ≥18 years of age from January 2007 to July 2013. After excluding outside hospital transfers (n = 14,422), hospitalizations <48 hours in duration (n = 59,774), and psychiatric hospitalizations (n = 9887), there were 146,552 hospitalizations in the cohort.

To our knowledge, our study is the first to assess the predictors of positive sputum culture among patients with HAP (non-VAP) who had sputum samples obtained noninvasively, and this study is larger than prior studies in which researchers reported on sputum culture yield in HAP. Sputum samples were obtained in 29.4% cases of clinically diagnosed HAP. Although 87% of specimens obtained were culture-negative or contaminated, 13% yielded a bacterial organism. Although we do not report the antibiotic sensitivity patterns of the isolated organisms, the organisms identified frequently demonstrate antibiotic resistance, highlighting the potential for both antibiotic escalation and de-escalation based on sputum culture. In a multivariable model, presence of chronic lung disease and steroid use in the preceding week were both significantly associated with culture positivity.

The retrospective nature of the study raises the possibility of selection bias from systematic differences between the 29.4% of patients with HAP who had sputum collected and those who did not. Patients with sputum cultures were similar to patients without cultures in most measured characteristics, but we are unable to know what the yield of noninvasive sputum culture would have been had all patients with HAP been sampled. As such, our findings reflect the yield of sputum culture among patients with HAP for whom cultures were successfully obtained. It is not clear why only 29.4% of HAP patients received IDSA guideline-concordant care, but similar rates of culture use are reported elsewhere.⁷ While physician decision-making could have contributed to this finding, it is also possible that many sick, hospitalized patients are simply unable to produce sputum for analysis. In future studies, researchers should examine barriers to guideline-concordant care.

We considered a culture result of GNRs (not further speciated) as positive in our analysis because this result indicates growth of mixed bacterial types, the pathogenicity of which is a clinical determination. Physicians may request speciation and antibiotic sensitivities and, as such, these results have the potential to impact antibiotic choice. Had we considered such cultures to be negative or contaminated, the rate of culture positivity would have been only slightly reduced from 63/478 (13.2%) to 50/478 (10.5%).

The strengths of our study include the chart-based validation of administratively identified cases of pneumonia and a large cohort. There are also limitations. The single-center nature of the study has implications for pretest probability and generalizability. Additionally, in our study, we did not examine outcomes among patients treated empirically versus those treated based on sputum culture results. Finally, our reliance on administrative codes to identify cases of HAP for subsequent validation could have resulted in incomplete capture of HAP cases.

In conclusion, in our study, we provide an estimate of the diagnostic yield of sputum culture in a large cohort with chart-validated HAP, a description of HAP microbiology, and predictors of positive sputum culture. Thirteen percent of patients who had sputum culture testing received a microbiologic diagnosis. Because of the relative ease of obtaining a sputum sample and the microbiologic distribution in our study (representing a mix of commonly drug-resistant pathogens and more typical community-acquired pathogens), we suggest that sputum culture in HAP is a useful diagnostic tool with the potential to inform antibiotic escalation or de-escalation.

Acknowledgments

Dr. Herzig was funded by grant number K23AG042459 from the National Institute on Aging. Dr. Marcantonio was funded by grant number K24AG035075 from the National Institute on Aging. The funding organizations had no involvement in any aspect of the study, including design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

Disclosure

No conflicts of interest apply for any of the authors.

Pneumonia is a major cause of hospitalization, mortality, and healthcare cost. ^1,2 The diagnosis involves clinical features plus radiographic evidence of infection. Hospital-acquired pneumonia (HAP) is defined by the Infectious Disease Society of America (IDSA) as a pneumonia that occurs ≥48 hours after admission and is not associated with mechanical ventilation. ³

IDSA recommendations suggest that patients with suspected HAP be treated based on results of noninvasively obtained sputum cultures rather than being treated empirically. ³ This recommendation is graded as weak with low-quality evidence based on a lack of both evidence showing that respiratory cultures improve clinical outcomes and studies examining the yield of noninvasive collection methods. ^4,5 However, resistant pathogens lead to a risk of inadequate empiric therapy, which is associated with increased mortality. ⁶ Culture data may provide an opportunity for escalation or de-escalation of antibiotic coverage. IDSA recommendations for microbiologic sampling are thus aimed at increasing appropriate coverage and minimizing unnecessary antibiotic exposure.

While the yield and clinical utility of sputum culture in community-acquired pneumonia has been studied extensively, data examining the yield of sputum culture in HAP (non–ventilator-associated pneumonia [non-VAP]) are sparse. In 1 small single-center study, researchers demonstrated positive sputum cultures in 17/35 (48.6%) patients with radiographically confirmed cases of HAP, ⁷ while in another study, researchers demonstrated positive sputum cultures in 57/63 (90.5%). ⁸ We aimed to identify the frequency with which sputum cultures positively identify an organism, identify predictors of positive sputum cultures, and characterize the microbiology of sputum cultures in a large cohort of HAP cases.

We conducted a retrospective cohort study of patients admitted to a large academic medical center in Boston, Massachusetts, from January 2007 to July 2013. All patients ≥18 years of age were eligible for inclusion. We excluded outside hospital transfers, those with a length of hospitalization <48 hours, and psychiatric admissions.

The study was approved by the institutional review board at the Beth Israel Deaconess Medical Center and granted a waiver of informed consent. Data were collected from electronic databases and supplemented by chart review.

Hospital-Acquired Pneumonia

We defined HAP as pneumonia occurring at least 48 hours after admission, consistent with American Thoracic Society and IDSA criteria.³ To identify cases, we reviewed the charts of all admissions identified as having a discharge International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code for bacterial pneumonia (481, 482, 483, 485, 486, 507), indicated as not “present-on-admission.” We validated that the treating clinician had clinically diagnosed pneumonia and initiated antibiotics for this purpose by performing chart review. We reviewed the radiologist interpretation of radiographs surrounding the date of the clinical diagnosis of pneumonia to confirm the presence of a new opacity. Uncertain cases (with respect to either the presence of pneumonia or the timing of the diagnosis) were reviewed by a second member of the study team and, in the case of disagreement, adjudicated by a third member of the study team. Only the first clinically validated HAP per hospitalization was included in the analysis. To focus on HAP rather than VAP, we excluded hospitalizations in which the date of a procedure code for mechanical ventilation preceded the date of pneumonia diagnosis.

Microbiology

In our analysis, we used sputum samples obtained from expectorated or induced samples to evaluate the yield of noninvasive sputum sampling, as recommended by the IDSA. We included sputum samples collected ≥48 hours after admission and within 7 days of the clinical diagnosis of HAP. Sputum samples with >10 epithelial cells per high-power field (hpf) were considered to be contaminated. Among noncontaminated samples, positive sputum cultures were defined as those with a microbiologic diagnosis other than “oral flora,” while those with no growth or growth of oral flora or only yeast were considered to be negative. The hospital’s microbiology laboratory does not routinely provide species identification for Gram-negative rods (GNRs) growing on culture in the presence of growth of ≥3 other colony types. We considered such GNRs (not further speciated) to represent a positive culture result in our analysis given that colonization versus pathogenicity is a clinical distinction and, as such, these results may impact antibiotic choice.

Statistical Analysis

Data were analyzed by using SAS software, version 9.3. We used a 2-sided P value of <0.05 to indicate statistical significance for all comparisons. We used the χ² test and the nonparametric median test for unadjusted comparisons.

To identify predictors of a positive (versus negative or contaminated) sputum culture among patients with HAP, we used a generalized estimating equation model with a Poisson distribution error term, log link, and first-order autoregressive correlation structure to account for multiple sputum specimens per patient. We combined culture negative and contaminated samples to highlight the clinical utility of sputum culture in a real-world setting. Potential predictors chosen based on clinical grounds included all variables listed in Table 1. We defined comorbidities specified in Table 1 via ICD-9-CM secondary diagnosis codes and diagnosis related groups (DRGs) using Healthcare Cost and Utilization Project Comorbidity Software, version 3.7, based on the work of Elixhauser et al.^9,10; dialysis use was defined by an ICD-9-CM procedure code of 39.95; inpatient steroid use was defined by a hospital pharmacy charge for a systemic steroid in the 7 days preceding the sputum sample.

There were 230,635 hospitalizations of patients ≥18 years of age from January 2007 to July 2013. After excluding outside hospital transfers (n = 14,422), hospitalizations <48 hours in duration (n = 59,774), and psychiatric hospitalizations (n = 9887), there were 146,552 hospitalizations in the cohort.

To our knowledge, our study is the first to assess the predictors of positive sputum culture among patients with HAP (non-VAP) who had sputum samples obtained noninvasively, and this study is larger than prior studies in which researchers reported on sputum culture yield in HAP. Sputum samples were obtained in 29.4% cases of clinically diagnosed HAP. Although 87% of specimens obtained were culture-negative or contaminated, 13% yielded a bacterial organism. Although we do not report the antibiotic sensitivity patterns of the isolated organisms, the organisms identified frequently demonstrate antibiotic resistance, highlighting the potential for both antibiotic escalation and de-escalation based on sputum culture. In a multivariable model, presence of chronic lung disease and steroid use in the preceding week were both significantly associated with culture positivity.

The retrospective nature of the study raises the possibility of selection bias from systematic differences between the 29.4% of patients with HAP who had sputum collected and those who did not. Patients with sputum cultures were similar to patients without cultures in most measured characteristics, but we are unable to know what the yield of noninvasive sputum culture would have been had all patients with HAP been sampled. As such, our findings reflect the yield of sputum culture among patients with HAP for whom cultures were successfully obtained. It is not clear why only 29.4% of HAP patients received IDSA guideline-concordant care, but similar rates of culture use are reported elsewhere.⁷ While physician decision-making could have contributed to this finding, it is also possible that many sick, hospitalized patients are simply unable to produce sputum for analysis. In future studies, researchers should examine barriers to guideline-concordant care.

We considered a culture result of GNRs (not further speciated) as positive in our analysis because this result indicates growth of mixed bacterial types, the pathogenicity of which is a clinical determination. Physicians may request speciation and antibiotic sensitivities and, as such, these results have the potential to impact antibiotic choice. Had we considered such cultures to be negative or contaminated, the rate of culture positivity would have been only slightly reduced from 63/478 (13.2%) to 50/478 (10.5%).

The strengths of our study include the chart-based validation of administratively identified cases of pneumonia and a large cohort. There are also limitations. The single-center nature of the study has implications for pretest probability and generalizability. Additionally, in our study, we did not examine outcomes among patients treated empirically versus those treated based on sputum culture results. Finally, our reliance on administrative codes to identify cases of HAP for subsequent validation could have resulted in incomplete capture of HAP cases.

In conclusion, in our study, we provide an estimate of the diagnostic yield of sputum culture in a large cohort with chart-validated HAP, a description of HAP microbiology, and predictors of positive sputum culture. Thirteen percent of patients who had sputum culture testing received a microbiologic diagnosis. Because of the relative ease of obtaining a sputum sample and the microbiologic distribution in our study (representing a mix of commonly drug-resistant pathogens and more typical community-acquired pathogens), we suggest that sputum culture in HAP is a useful diagnostic tool with the potential to inform antibiotic escalation or de-escalation.

Acknowledgments

Dr. Herzig was funded by grant number K23AG042459 from the National Institute on Aging. Dr. Marcantonio was funded by grant number K24AG035075 from the National Institute on Aging. The funding organizations had no involvement in any aspect of the study, including design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

Disclosure

No conflicts of interest apply for any of the authors.

Ascites is the most common complication of cirrhosis and often leads to hospitalization. ¹ Paracentesis is recommended for all patients admitted with ascites and cirrhosis. ¹ Additionally, the Society of Hospital Medicine considers the ability to perform paracenteses a core competency for hospitalists. ² Although considered a safe procedure, major bleeding complications occur in 0.2% to 1.7% of paracenteses. ^3-7 Patients with cirrhosis form new abdominal wall vessels because of portal hypertension, and hemoperitoneum from the laceration of these vessels during paracentesis carries a high morbidity and mortality. ^6,8 Ultrasound guidance using a low-frequency ultrasound probe is currently standard practice for paracentesis and has been shown to reduce bleeding complications. ^9-11 However, the use of vascular ultrasound (high-frequency probe) is also recommended to identify blood vessels within the intended needle pathway to reduce bleeding, but no studies have been performed to demonstrate a benefit. ^3,11 This study aimed to evaluate whether this “2-probe technique” reduces paracentesis-related bleeding complications.

The procedure service at Cedars Sinai Medical Center (CSMC) in Los Angeles performs paracentesis regularly with ultrasound guidance. CSMC is a tertiary care, academic medical center with 861 licensed beds. We performed a pre- to postintervention study of consecutive patients (admitted and ambulatory) who underwent paracentesis done by 1 proceduralist (MJA) from the procedure service at CSMC from February 2010 through February 2016. From February 1, 2010, through August 2011, paracenteses were performed using only low-frequency, phased array ultrasound probes (preintervention group). From September 1, 2011, through February 2016, a 2-probe technique was used, whereby ultrasound interrogation of the abdomen using a low-frequency, phased array probe (to identify ascites) was supplemented with a second scan using a high-frequency, linear probe to identify vasculature within the planned needle path (postintervention group). As a standard part of quality assurance, CSMC documented all paracentesis-related complications from procedures performed by their center. Northwestern University investigators (JHB, EC, JF) independently evaluated these data to look at bleeding complications before and after the implementation of the 2-probe technique. The CSMC and Northwestern University institutional review boards approved this study.

Procedure Protocol

Each patient’s primary team or outpatient physician requested a consultation for paracentesis from the CSMC procedure service. All patient evaluations began with an abdominal ultrasound using the low-frequency probe to determine the presence of ascites and a potential window of access to the fluid. After September 1, 2011, the CSMC procedure service implemented the 2-probe technique to also evaluate the abdominal wall for the presence of vessels. Color flow Doppler ultrasound further helped to differentiate blood vessels as necessary. The optimal window was then marked on the abdominal wall, and the paracentesis was performed. Per the routine of the CSMC procedure service, antiplatelet or anticoagulant medications were not held for paracenteses.

Measurement

All data were collected prospectively at the time of the procedure, including the volume of fluid removed, the number of needle passes required, and whether the patient was on antiplatelet or anticoagulant medications (including warfarin, direct oral anticoagulants, thrombin inhibitors, heparin, or low molecular weight heparins). Patients were followed for complications for up to 24 hours after the procedure or until a clinical question of a complication was reconciled. Minor bleeding was defined as new serosanguinous fluid on repeat paracentesis not associated with hemodynamic changes, local bruising or bleeding at the site, or abdominal wall hematoma. Major bleeding was defined by the development of hemodynamic instability or by reaccumulation of fluid on ultrasound within 24 hours postparacentesis and one of the following: an associated hemoglobin drop of greater than 2 g/dl, blood seen on repeat paracentesis, blood density fluid on a computed tomography scan, or the lack of an alternative explanation. All data were recorded in a handheld database (HanDbase; DDH Software, Wellington, FL).

A query of the electronic medical record was performed to obtain patient demographics and relevant clinical information, including age, sex, body mass index, International Normalized Ratio (INR), partial thromboplastin time (PTT), platelet counts (10³/uL, hematocrit (%) and creatinine (mg/dl). Our query for laboratory data retrieved the closest laboratory entry up to 48 hours before the procedure.

Statistical Analysis

We used a χ² test, Student t test, or Kruskal-Wallis test to compare demographic and clinical characteristics of procedure patients between the 2 study groups (pre- and postintervention). Major and minor bleeding were compared between the 2 groups using the χ² test.¹² We used the χ² test instead of the Fisher’s exact test for several reasons. The usual rule is that the Fisher’s exact test is necessary when 1 or more expected outcome values are less than 5. However, McDonald argues that the χ² test should be used with large sample sizes (more than 1000) in lieu of the outcome-value-of-5 rule.¹² The Fisher’s exact test also assumes that the row and column totals are fixed. However, the outcomes in our study were not fixed because any patient could have a bleeding complication during each procedure. When row and column totals are not fixed, only 5% of the time will a P value be less than 0.05, and the Fisher’s exact test is too conservative.¹² We performed all statistical analyses using IBM SPSS Statistics Version 22 (IBM Corp, Armonk, NY).

Patient demographic and clinical information can be found in the Table. The proceduralist (MJA) performed a total of 5777 paracenteses (1000 preintervention, 4777 postintervention) on 1639 patients. Four hundred eighty-nine (10.2%) vascular anomalies were identified within the intended needle path in the postintervention group (Figure). More patients in the preintervention group were on aspirin (93 [9.3%] vs 230 [4.8%]; P < 0.001) and therapeutic intravenous anticoagulants (33 [3.3%] vs 89 [1.9%]; P = 0.004), while more patients in the postintervention group were on both an antiplatelet and oral anticoagulant (1 [0.1%] vs 38 [0.8%]; P = 0.015) and subcutaneous prophylactic anticoagulants (184 [18.4%] vs 1120 [23.4%]; P = 0.001) at the time of the procedure. There were no other differences between groups with antiplatelet or anticoagulant drugs. We found no difference in minor bleeding between pre- and postintervention groups. Major bleeding was lower after the 2-probe technique was implemented (3 [0.3%] vs 4 [0.08%]; P = 0.07). There were no between-group differences in INR, PTT, or platelet counts among major bleeders. One patient in the postintervention group had hemodynamic instability and dropped his hemoglobin by 3.8 g/dl at 7 hours after the procedure. This was unexplained, as the patient had no abdominal symptoms or findings on examination. The patient received several liters of fluid before ultimately dying, and the primary team considered sepsis as a possible cause, but no postmortem examination was performed. This was the only death attributed to a major bleeding complication. We included this patient in our analysis because the cause of his demise was not completely clear. However, excluding this patient would change the results from a trend to a statistically significant difference between groups (3 [0.3%] vs 3 [0.06%]; P = 0.03).

To our knowledge, we report the largest series of paracentesis prospectively evaluated for bleeding complications, and this is the first study to evaluate whether adding a vascular ultrasound (high-frequency probe) avoids major bleeding. In our series, up to 10% of patients had abnormal vessels seen with a vascular ultrasound that were within the original intended trajectory path of the needle. These vessels were also likely present yet invisible when ultrasound-guided paracentesis using only the standard, low-frequency probe was being performed. It is unknown whether these vessels are routinely traversed with the needle, nicked, or narrowly avoided during paracenteses performed using only a low-frequency probe.

Procedure-related bleeding may not be completely avoidable, despite using the vascular probe. Some authors have suggested that the mechanism of bleeding is more related to the rapid reduction in intraperitoneal pressure, which increases the gradient across vessel walls, resulting in rupture and bleeding.⁶ However, in our series, using vascular ultrasound also reduced major bleeding to numbers lower than those historically reported in the literature (0.2%).^3-4 Our preintervention number needed to harm was 333 procedures to cause 1 major bleed, compared to 1250 (or 1666 using the 3-patient bleeding analysis) in the postintervention group. In 2008, 150,000 Medicare beneficiaries underwent paracentesis.¹³ Using our study analysis, if vascular ultrasound was used on these patients, up to 360 major bleeds may have been prevented, along with a corresponding reduction in unnecessary morbidity and mortality.

Our study has several limitations. First, it was limited to 1 center with 1 very experienced proceduralist. Although it is possible that the reduction in major bleeding may have been due to the increasing experience of the proceduralist over time, we do not think that this is likely because he had already performed thousands of paracenteses over 9 years before the start of our study. Second, major bleeding was rare and therefore precluded a multivariate analysis to control for temporal trends that might have occurred in our pre- to poststudy design. Statistically significant demographic and clinical variable differences between groups were likely not clinically meaningful. Although more patients were on intravenous anticoagulants in the preintervention group, coagulopathy or low platelets do not increase the bleeding risk during paracenteses,^1,8 and there was no clinical difference in INR, PTT, or platelets between groups (Table). Third, it is possible that unmeasured characteristics contributed to more patient complications in the preintervention group. Finally, we were unable to evaluate length of stay and mortality differences between groups that might have been attributable to the procedure because of the low number of major bleeding complications and the inability to perform a multivariate analysis.

Our results suggest that using the 2-probe technique to predetermine the needle path before performing paracentesis might prevent major bleeding. Based on our findings, we believe that the addition of a vascular ultrasound during paracentesis should be considered by all hospitalists.

Acknowledgments

The authors acknowledge Drs. Douglas Vaughan and Kevin O’Leary for their support and encouragement of this work. They would also like to thank the Cedars-Sinai Enterprise Information Systems Department for assistance with their data query.

Disclosure

The authors have no relevant financial disclosures or conflicts of interest to report.

Ascites is the most common complication of cirrhosis and often leads to hospitalization. ¹ Paracentesis is recommended for all patients admitted with ascites and cirrhosis. ¹ Additionally, the Society of Hospital Medicine considers the ability to perform paracenteses a core competency for hospitalists. ² Although considered a safe procedure, major bleeding complications occur in 0.2% to 1.7% of paracenteses. ^3-7 Patients with cirrhosis form new abdominal wall vessels because of portal hypertension, and hemoperitoneum from the laceration of these vessels during paracentesis carries a high morbidity and mortality. ^6,8 Ultrasound guidance using a low-frequency ultrasound probe is currently standard practice for paracentesis and has been shown to reduce bleeding complications. ^9-11 However, the use of vascular ultrasound (high-frequency probe) is also recommended to identify blood vessels within the intended needle pathway to reduce bleeding, but no studies have been performed to demonstrate a benefit. ^3,11 This study aimed to evaluate whether this “2-probe technique” reduces paracentesis-related bleeding complications.

The procedure service at Cedars Sinai Medical Center (CSMC) in Los Angeles performs paracentesis regularly with ultrasound guidance. CSMC is a tertiary care, academic medical center with 861 licensed beds. We performed a pre- to postintervention study of consecutive patients (admitted and ambulatory) who underwent paracentesis done by 1 proceduralist (MJA) from the procedure service at CSMC from February 2010 through February 2016. From February 1, 2010, through August 2011, paracenteses were performed using only low-frequency, phased array ultrasound probes (preintervention group). From September 1, 2011, through February 2016, a 2-probe technique was used, whereby ultrasound interrogation of the abdomen using a low-frequency, phased array probe (to identify ascites) was supplemented with a second scan using a high-frequency, linear probe to identify vasculature within the planned needle path (postintervention group). As a standard part of quality assurance, CSMC documented all paracentesis-related complications from procedures performed by their center. Northwestern University investigators (JHB, EC, JF) independently evaluated these data to look at bleeding complications before and after the implementation of the 2-probe technique. The CSMC and Northwestern University institutional review boards approved this study.

Procedure Protocol

Each patient’s primary team or outpatient physician requested a consultation for paracentesis from the CSMC procedure service. All patient evaluations began with an abdominal ultrasound using the low-frequency probe to determine the presence of ascites and a potential window of access to the fluid. After September 1, 2011, the CSMC procedure service implemented the 2-probe technique to also evaluate the abdominal wall for the presence of vessels. Color flow Doppler ultrasound further helped to differentiate blood vessels as necessary. The optimal window was then marked on the abdominal wall, and the paracentesis was performed. Per the routine of the CSMC procedure service, antiplatelet or anticoagulant medications were not held for paracenteses.

Measurement

All data were collected prospectively at the time of the procedure, including the volume of fluid removed, the number of needle passes required, and whether the patient was on antiplatelet or anticoagulant medications (including warfarin, direct oral anticoagulants, thrombin inhibitors, heparin, or low molecular weight heparins). Patients were followed for complications for up to 24 hours after the procedure or until a clinical question of a complication was reconciled. Minor bleeding was defined as new serosanguinous fluid on repeat paracentesis not associated with hemodynamic changes, local bruising or bleeding at the site, or abdominal wall hematoma. Major bleeding was defined by the development of hemodynamic instability or by reaccumulation of fluid on ultrasound within 24 hours postparacentesis and one of the following: an associated hemoglobin drop of greater than 2 g/dl, blood seen on repeat paracentesis, blood density fluid on a computed tomography scan, or the lack of an alternative explanation. All data were recorded in a handheld database (HanDbase; DDH Software, Wellington, FL).

A query of the electronic medical record was performed to obtain patient demographics and relevant clinical information, including age, sex, body mass index, International Normalized Ratio (INR), partial thromboplastin time (PTT), platelet counts (10³/uL, hematocrit (%) and creatinine (mg/dl). Our query for laboratory data retrieved the closest laboratory entry up to 48 hours before the procedure.

Statistical Analysis

We used a χ² test, Student t test, or Kruskal-Wallis test to compare demographic and clinical characteristics of procedure patients between the 2 study groups (pre- and postintervention). Major and minor bleeding were compared between the 2 groups using the χ² test.¹² We used the χ² test instead of the Fisher’s exact test for several reasons. The usual rule is that the Fisher’s exact test is necessary when 1 or more expected outcome values are less than 5. However, McDonald argues that the χ² test should be used with large sample sizes (more than 1000) in lieu of the outcome-value-of-5 rule.¹² The Fisher’s exact test also assumes that the row and column totals are fixed. However, the outcomes in our study were not fixed because any patient could have a bleeding complication during each procedure. When row and column totals are not fixed, only 5% of the time will a P value be less than 0.05, and the Fisher’s exact test is too conservative.¹² We performed all statistical analyses using IBM SPSS Statistics Version 22 (IBM Corp, Armonk, NY).

Patient demographic and clinical information can be found in the Table. The proceduralist (MJA) performed a total of 5777 paracenteses (1000 preintervention, 4777 postintervention) on 1639 patients. Four hundred eighty-nine (10.2%) vascular anomalies were identified within the intended needle path in the postintervention group (Figure). More patients in the preintervention group were on aspirin (93 [9.3%] vs 230 [4.8%]; P < 0.001) and therapeutic intravenous anticoagulants (33 [3.3%] vs 89 [1.9%]; P = 0.004), while more patients in the postintervention group were on both an antiplatelet and oral anticoagulant (1 [0.1%] vs 38 [0.8%]; P = 0.015) and subcutaneous prophylactic anticoagulants (184 [18.4%] vs 1120 [23.4%]; P = 0.001) at the time of the procedure. There were no other differences between groups with antiplatelet or anticoagulant drugs. We found no difference in minor bleeding between pre- and postintervention groups. Major bleeding was lower after the 2-probe technique was implemented (3 [0.3%] vs 4 [0.08%]; P = 0.07). There were no between-group differences in INR, PTT, or platelet counts among major bleeders. One patient in the postintervention group had hemodynamic instability and dropped his hemoglobin by 3.8 g/dl at 7 hours after the procedure. This was unexplained, as the patient had no abdominal symptoms or findings on examination. The patient received several liters of fluid before ultimately dying, and the primary team considered sepsis as a possible cause, but no postmortem examination was performed. This was the only death attributed to a major bleeding complication. We included this patient in our analysis because the cause of his demise was not completely clear. However, excluding this patient would change the results from a trend to a statistically significant difference between groups (3 [0.3%] vs 3 [0.06%]; P = 0.03).

To our knowledge, we report the largest series of paracentesis prospectively evaluated for bleeding complications, and this is the first study to evaluate whether adding a vascular ultrasound (high-frequency probe) avoids major bleeding. In our series, up to 10% of patients had abnormal vessels seen with a vascular ultrasound that were within the original intended trajectory path of the needle. These vessels were also likely present yet invisible when ultrasound-guided paracentesis using only the standard, low-frequency probe was being performed. It is unknown whether these vessels are routinely traversed with the needle, nicked, or narrowly avoided during paracenteses performed using only a low-frequency probe.

Procedure-related bleeding may not be completely avoidable, despite using the vascular probe. Some authors have suggested that the mechanism of bleeding is more related to the rapid reduction in intraperitoneal pressure, which increases the gradient across vessel walls, resulting in rupture and bleeding.⁶ However, in our series, using vascular ultrasound also reduced major bleeding to numbers lower than those historically reported in the literature (0.2%).^3-4 Our preintervention number needed to harm was 333 procedures to cause 1 major bleed, compared to 1250 (or 1666 using the 3-patient bleeding analysis) in the postintervention group. In 2008, 150,000 Medicare beneficiaries underwent paracentesis.¹³ Using our study analysis, if vascular ultrasound was used on these patients, up to 360 major bleeds may have been prevented, along with a corresponding reduction in unnecessary morbidity and mortality.

Our study has several limitations. First, it was limited to 1 center with 1 very experienced proceduralist. Although it is possible that the reduction in major bleeding may have been due to the increasing experience of the proceduralist over time, we do not think that this is likely because he had already performed thousands of paracenteses over 9 years before the start of our study. Second, major bleeding was rare and therefore precluded a multivariate analysis to control for temporal trends that might have occurred in our pre- to poststudy design. Statistically significant demographic and clinical variable differences between groups were likely not clinically meaningful. Although more patients were on intravenous anticoagulants in the preintervention group, coagulopathy or low platelets do not increase the bleeding risk during paracenteses,^1,8 and there was no clinical difference in INR, PTT, or platelets between groups (Table). Third, it is possible that unmeasured characteristics contributed to more patient complications in the preintervention group. Finally, we were unable to evaluate length of stay and mortality differences between groups that might have been attributable to the procedure because of the low number of major bleeding complications and the inability to perform a multivariate analysis.

Our results suggest that using the 2-probe technique to predetermine the needle path before performing paracentesis might prevent major bleeding. Based on our findings, we believe that the addition of a vascular ultrasound during paracentesis should be considered by all hospitalists.

Acknowledgments

The authors acknowledge Drs. Douglas Vaughan and Kevin O’Leary for their support and encouragement of this work. They would also like to thank the Cedars-Sinai Enterprise Information Systems Department for assistance with their data query.

Disclosure

The authors have no relevant financial disclosures or conflicts of interest to report.

Ascites is the most common complication of cirrhosis and often leads to hospitalization. ¹ Paracentesis is recommended for all patients admitted with ascites and cirrhosis. ¹ Additionally, the Society of Hospital Medicine considers the ability to perform paracenteses a core competency for hospitalists. ² Although considered a safe procedure, major bleeding complications occur in 0.2% to 1.7% of paracenteses. ^3-7 Patients with cirrhosis form new abdominal wall vessels because of portal hypertension, and hemoperitoneum from the laceration of these vessels during paracentesis carries a high morbidity and mortality. ^6,8 Ultrasound guidance using a low-frequency ultrasound probe is currently standard practice for paracentesis and has been shown to reduce bleeding complications. ^9-11 However, the use of vascular ultrasound (high-frequency probe) is also recommended to identify blood vessels within the intended needle pathway to reduce bleeding, but no studies have been performed to demonstrate a benefit. ^3,11 This study aimed to evaluate whether this “2-probe technique” reduces paracentesis-related bleeding complications.

The procedure service at Cedars Sinai Medical Center (CSMC) in Los Angeles performs paracentesis regularly with ultrasound guidance. CSMC is a tertiary care, academic medical center with 861 licensed beds. We performed a pre- to postintervention study of consecutive patients (admitted and ambulatory) who underwent paracentesis done by 1 proceduralist (MJA) from the procedure service at CSMC from February 2010 through February 2016. From February 1, 2010, through August 2011, paracenteses were performed using only low-frequency, phased array ultrasound probes (preintervention group). From September 1, 2011, through February 2016, a 2-probe technique was used, whereby ultrasound interrogation of the abdomen using a low-frequency, phased array probe (to identify ascites) was supplemented with a second scan using a high-frequency, linear probe to identify vasculature within the planned needle path (postintervention group). As a standard part of quality assurance, CSMC documented all paracentesis-related complications from procedures performed by their center. Northwestern University investigators (JHB, EC, JF) independently evaluated these data to look at bleeding complications before and after the implementation of the 2-probe technique. The CSMC and Northwestern University institutional review boards approved this study.

Procedure Protocol

Each patient’s primary team or outpatient physician requested a consultation for paracentesis from the CSMC procedure service. All patient evaluations began with an abdominal ultrasound using the low-frequency probe to determine the presence of ascites and a potential window of access to the fluid. After September 1, 2011, the CSMC procedure service implemented the 2-probe technique to also evaluate the abdominal wall for the presence of vessels. Color flow Doppler ultrasound further helped to differentiate blood vessels as necessary. The optimal window was then marked on the abdominal wall, and the paracentesis was performed. Per the routine of the CSMC procedure service, antiplatelet or anticoagulant medications were not held for paracenteses.

Measurement

All data were collected prospectively at the time of the procedure, including the volume of fluid removed, the number of needle passes required, and whether the patient was on antiplatelet or anticoagulant medications (including warfarin, direct oral anticoagulants, thrombin inhibitors, heparin, or low molecular weight heparins). Patients were followed for complications for up to 24 hours after the procedure or until a clinical question of a complication was reconciled. Minor bleeding was defined as new serosanguinous fluid on repeat paracentesis not associated with hemodynamic changes, local bruising or bleeding at the site, or abdominal wall hematoma. Major bleeding was defined by the development of hemodynamic instability or by reaccumulation of fluid on ultrasound within 24 hours postparacentesis and one of the following: an associated hemoglobin drop of greater than 2 g/dl, blood seen on repeat paracentesis, blood density fluid on a computed tomography scan, or the lack of an alternative explanation. All data were recorded in a handheld database (HanDbase; DDH Software, Wellington, FL).

A query of the electronic medical record was performed to obtain patient demographics and relevant clinical information, including age, sex, body mass index, International Normalized Ratio (INR), partial thromboplastin time (PTT), platelet counts (10³/uL, hematocrit (%) and creatinine (mg/dl). Our query for laboratory data retrieved the closest laboratory entry up to 48 hours before the procedure.

Statistical Analysis

We used a χ² test, Student t test, or Kruskal-Wallis test to compare demographic and clinical characteristics of procedure patients between the 2 study groups (pre- and postintervention). Major and minor bleeding were compared between the 2 groups using the χ² test.¹² We used the χ² test instead of the Fisher’s exact test for several reasons. The usual rule is that the Fisher’s exact test is necessary when 1 or more expected outcome values are less than 5. However, McDonald argues that the χ² test should be used with large sample sizes (more than 1000) in lieu of the outcome-value-of-5 rule.¹² The Fisher’s exact test also assumes that the row and column totals are fixed. However, the outcomes in our study were not fixed because any patient could have a bleeding complication during each procedure. When row and column totals are not fixed, only 5% of the time will a P value be less than 0.05, and the Fisher’s exact test is too conservative.¹² We performed all statistical analyses using IBM SPSS Statistics Version 22 (IBM Corp, Armonk, NY).

Patient demographic and clinical information can be found in the Table. The proceduralist (MJA) performed a total of 5777 paracenteses (1000 preintervention, 4777 postintervention) on 1639 patients. Four hundred eighty-nine (10.2%) vascular anomalies were identified within the intended needle path in the postintervention group (Figure). More patients in the preintervention group were on aspirin (93 [9.3%] vs 230 [4.8%]; P < 0.001) and therapeutic intravenous anticoagulants (33 [3.3%] vs 89 [1.9%]; P = 0.004), while more patients in the postintervention group were on both an antiplatelet and oral anticoagulant (1 [0.1%] vs 38 [0.8%]; P = 0.015) and subcutaneous prophylactic anticoagulants (184 [18.4%] vs 1120 [23.4%]; P = 0.001) at the time of the procedure. There were no other differences between groups with antiplatelet or anticoagulant drugs. We found no difference in minor bleeding between pre- and postintervention groups. Major bleeding was lower after the 2-probe technique was implemented (3 [0.3%] vs 4 [0.08%]; P = 0.07). There were no between-group differences in INR, PTT, or platelet counts among major bleeders. One patient in the postintervention group had hemodynamic instability and dropped his hemoglobin by 3.8 g/dl at 7 hours after the procedure. This was unexplained, as the patient had no abdominal symptoms or findings on examination. The patient received several liters of fluid before ultimately dying, and the primary team considered sepsis as a possible cause, but no postmortem examination was performed. This was the only death attributed to a major bleeding complication. We included this patient in our analysis because the cause of his demise was not completely clear. However, excluding this patient would change the results from a trend to a statistically significant difference between groups (3 [0.3%] vs 3 [0.06%]; P = 0.03).

To our knowledge, we report the largest series of paracentesis prospectively evaluated for bleeding complications, and this is the first study to evaluate whether adding a vascular ultrasound (high-frequency probe) avoids major bleeding. In our series, up to 10% of patients had abnormal vessels seen with a vascular ultrasound that were within the original intended trajectory path of the needle. These vessels were also likely present yet invisible when ultrasound-guided paracentesis using only the standard, low-frequency probe was being performed. It is unknown whether these vessels are routinely traversed with the needle, nicked, or narrowly avoided during paracenteses performed using only a low-frequency probe.

Procedure-related bleeding may not be completely avoidable, despite using the vascular probe. Some authors have suggested that the mechanism of bleeding is more related to the rapid reduction in intraperitoneal pressure, which increases the gradient across vessel walls, resulting in rupture and bleeding.⁶ However, in our series, using vascular ultrasound also reduced major bleeding to numbers lower than those historically reported in the literature (0.2%).^3-4 Our preintervention number needed to harm was 333 procedures to cause 1 major bleed, compared to 1250 (or 1666 using the 3-patient bleeding analysis) in the postintervention group. In 2008, 150,000 Medicare beneficiaries underwent paracentesis.¹³ Using our study analysis, if vascular ultrasound was used on these patients, up to 360 major bleeds may have been prevented, along with a corresponding reduction in unnecessary morbidity and mortality.

Our study has several limitations. First, it was limited to 1 center with 1 very experienced proceduralist. Although it is possible that the reduction in major bleeding may have been due to the increasing experience of the proceduralist over time, we do not think that this is likely because he had already performed thousands of paracenteses over 9 years before the start of our study. Second, major bleeding was rare and therefore precluded a multivariate analysis to control for temporal trends that might have occurred in our pre- to poststudy design. Statistically significant demographic and clinical variable differences between groups were likely not clinically meaningful. Although more patients were on intravenous anticoagulants in the preintervention group, coagulopathy or low platelets do not increase the bleeding risk during paracenteses,^1,8 and there was no clinical difference in INR, PTT, or platelets between groups (Table). Third, it is possible that unmeasured characteristics contributed to more patient complications in the preintervention group. Finally, we were unable to evaluate length of stay and mortality differences between groups that might have been attributable to the procedure because of the low number of major bleeding complications and the inability to perform a multivariate analysis.

Our results suggest that using the 2-probe technique to predetermine the needle path before performing paracentesis might prevent major bleeding. Based on our findings, we believe that the addition of a vascular ultrasound during paracentesis should be considered by all hospitalists.

Acknowledgments

The authors acknowledge Drs. Douglas Vaughan and Kevin O’Leary for their support and encouragement of this work. They would also like to thank the Cedars-Sinai Enterprise Information Systems Department for assistance with their data query.

Disclosure

The authors have no relevant financial disclosures or conflicts of interest to report.

The value placed on bedside clinical observation in the decision-making process of a patient’s illness has been diminished by today’s armamentarium of sophisticated technology. Increasing reliance is now placed on the result of nonspecific tests in preference to bedside clinical judgement in the diagnostic and management process. While diagnostic investigations have undoubtedly provided great advancements in medical care, they come at time and financial costs. Physicians should therefore continue to be encouraged to make clinical decisions based on their bedside assessment.

With hospital overcrowding a significant problem within the healthcare system and the expectation that it will worsen with an ageing population, identifying factors that predict patient suitability for discharge has become an important focus for clinicians.^1,2 There exists a paucity of literature predicting discharge suitability of general surgical patients admitted through the emergency department (ED). Furthermore, despite the extensive research into the effectiveness of discharge planning,³ little research has been conducted to describe positive predictive indicators for discharge. Observations made during surgical rounds have led the authors to consider that individuals who are using a smartphone during their bedside assessment may be clinically well enough for discharge.

The aim of this study was to assess whether the clinical assessment of an acute surgical patient could be usefully augmented by the observation of the active use of smartphones (the smartphone sign) and whether this could be used as a surrogate marker to indicate a patient’s well-being and suitability for same-day discharge from the hospital in acute surgical patients.

Design and Setting

This was a prospective observational study performed over 2 periods at a tertiary hospital in South Australia, Australia. At our institution, acute surgical patients are admitted to the acute surgical unit (ASU) from the ED by junior surgical doctors. Patients are then reviewed by the on-call surgical consultant, who implements management plans or advises discharge on 2 occasions per day.

Participants

All patients admitted under the ASU were considered eligible for the study. Exclusion criteria included patients that (i) required immediate surgical intervention (defined as time of review to theatre of less than 4 hours) and (ii) had immediate admission to the intensive care unit.

Consultant surgeons are employed within a general surgical subspecialty, including upper gastrointestinal, hepatobiliary, breast and endocrine, and colorectal. All surgeons from each team partake in the general surgery on-call roster. Each surgeon was included at least once within the observation periods. Experience of consultant surgeons ranged from 5 years of postfellowship experience to surgeons with more than 30 years of experience, with the majority having more than 10 years of postfellowship experience.

Patients were stratified into 2 distinct cohorts upon consultant review: smartphone positive (spP) was defined as a patient who was using a smartphone or who had their phone on their bed; a patient was classified as smartphone negative (spN) if they did not fulfil these criteria. The presence or absence of a smartphone was recorded by the authors, who were present on consultant ward rounds but not involved in the decision-making process of patient care. In order to minimize bias, only 1 surgeon (PGD) was aware that the study was being conducted and all patients were blinded to the study. Additional information that was collected included patient demographics, requirement for surgery, and length of stay (LOS). A patient who was discharged on the same day as the consultant review was considered to be discharged on day 1, all other patients were considered to have LOS greater than 1 day. Requirement for surgery was defined as a patient who underwent a surgical procedure in an operating suite. Thirty-day unplanned readmission rates for all patients were examined. Readmission to another public hospital within the state was also included within the readmission data.

Observation Periods

An initial 4-week pilot study was conducted to assess for a possible association between spP and same-day discharge. A second 8-week study period was undertaken 1 year later accounting for the employment of the authors at the study’s institution. Unless stated, the results described are the accumulation of both study periods.

Statistical Analysis

As this is the first study of its kind, no prior estimates of numbers were known. After 2 weeks of data collection, data were analyzed in order to provide an estimate of the total number of patients required to provide a statistically valid result (α = 0.05; power = 0.80). Sample size was calculated to be 40 subjects. It was agreed that in order to make the study as robust as possible, data should be collected for the 2 observation periods.

Demographic data are presented as means with standard deviations (SDs) or frequencies with percentages. A 2-sample Student t test was used to compare the age of spP and spN patients. A χ² test and logistic regressions were used to assess the association between smartphone status and patient demographics, LOS, and requirement for surgery. Results are presented as odds ratios (ORs) with 95% confidence intervals (CIs). A P value of <0.05 was considered significant. All data were analyzed by using R 3.2.3 (R Foundation for Statistical Computing, Vienna, Austria).

During the 2 observation periods, a total of 227 eligible surgical admissions were observed with complete data for 221 patients. Six patients were excluded as their smartphone status was not recorded. The study sample represents our population of interest within an ASU, and we had complete data for 97.4% of participants with a 100% follow-up. There was no significant effect of study between the 2 observation periods (χ² = 140.19; P = 0.10). The mean age of patients was 50.24 years. Further demographic data are presented in Table 1. Twenty-five (11.3%) patients were spP and 196 (88.7%) were spN. Fifty-two (23.5%) patients were discharged home on day 1, and 169 (76.5%) had admissions longer than 1 day (see Figure). Sixty (27%) patients underwent surgery during their admission. Twenty-two patients had unplanned readmissions; only 1 of these patients had been observed to be spP.

There was a statistically significant difference in ages between the spP and spN groups (t = 8.40; P < 0.0005), with the average age of spP patients being 31.84 years compared with 52.58 years for spN patients. There was no statistical difference between gender and smartphone status (χ² = 1.78; P = 0.18; Table 2).

For those patients discharged home on day 1, there was a statistically significant association with being spP (χ² = 14.55, P = 0.0001). Patients who were spP were 5.29 times more likely to be discharged on day 1 (95% CI, 2.24-12.84). Of the variables analyzed, only gender failed to demonstrate an effect on discharge home on day 1 (Table 3). Overall, the presence of a smartphone was found to have a sensitivity of 56.0% (95% CI, 34.93-75.60) and a specificity of 80.6% (95% CI, 74.37-85.90) in regard to same-day discharge. However, it was found to have a negative predictive value of 93.49% (95% CI, 88.65-96.71).

When examining readmission rates, only 4% of spP patients were readmitted versus 10.7% of spN patients. Accounting for variables, spP patients were 4 times less likely to be readmitted, though this was not statistically significant (OR 4.02; 95% CI, 0.43-37.2; P = 0.22). Furthermore, when examining only those patients discharged on day 1, smartphone status was not a predictor of readmission (OR 0.94; 95% CI, 0.06-15.2; P = 0 .97).

To mitigate the effect of age, analysis was conducted excluding those aged over 55 years (the previous retirement age in Australia), leaving 131 patients for analysis. The average age of spP patients was 31.8 years (SD 10.0) compared with 36.7 years (SD 10.9) for spN patients, representing a significant difference (t = 2.14; P = 0.04); 51.1% of patients were male, 19.1% of patients were spP, 26.0% of patients proceeded to an operation, the oldest spP was 51 years, and 29.0% of patients were discharged home on day 1. There was no difference in gender and smartphone status (χ² = 0.33; P = 0.6). When analyzing those discharged on day 1, again spP patients were more likely to be discharged home (χ² = 9.4; P = 0.002), and spP patients were 3.6 times more likely to be discharged home on day 1.

There were 4 spP patients who underwent an operation. Two patients had an incision and drainage of a perianal abscess, 1 patient underwent a laparotomy for an internal hernia after recently undergoing a Roux-en-Y gastric bypass at another hospital, and the final patient underwent a laparoscopic appendicectomy. One of these patients was still discharged home on day 1.

As J. A. Lindsay⁴ said, “For one mistake made for not knowing, ten mistakes are made for not looking.” At medical school, we are taught the finer techniques of the physical examination in order to support our diagnosis made from the history. It is not until we are experienced clinicians do we develop the clinical acumen and ability to tell an unwell patient from a well patient at a glance—colloquially known as the “end of the bed” assessment. In the pretechnology era, a well patient could frequently be seen reading their book, eg, the “novel-sign.” With the advent of the smartphone and electronic devices upon which novels can be read, statuses updated, and locations “checked into” (ie, the modern “vital signs”), the book sign may be a thing of the past. However, the ability for the clinician to assess a patient’s wellness is still crucial, and the value of any additional “physical signs” need to be estimated.

We observed a cohort of patients through a busy ASU in a tertiary hospital in South Australia, Australia. Acute surgical patients admitted to the hospital who were observed to be on their phones upon consultant review were more than 5 times likely to be discharged that same day. To the best of our knowledge, this is the first study to prospectively collect data to assess a frequently used but unevaluated clinical observation.

The use of a smartphone can tell us a lot about an individual’s physiology. We can assume the individual’s airway and breathing are adequate, allowing enough oxygen to reach the lungs and subsequently circulate. The individual is usually sitting up in bed and thus has an adequate blood pressure and blood oxygenation that can maintain cerebral perfusion. They have the cognitive and cerebral processing in place to function the device, and we can examine their cerebellar function by looking for fine-motor movements.

Mobile phone ownership is pervasive within Australia,⁵ with a conservative estimated 85.7% of the population (20.57 million people of a total population of approximately 24 million) owning a mobile phone and an estimated 50% to 79% of mobile phone ownership being of a smartphone.^6,7 This ownership is not just limited to the young, with 74% of Australians over 65 owning or using a mobile phone.⁸ Despite this high phone ownership among those over 65, it is still significantly less than their younger counterparts and may be one reason for the absence of spP in those older than 51 years. A key point in the study is that overall phone ownership was not known, and, thus, it is not possible to determine the proportion of spN patients who were negative because they did not own a phone. However, based on general population data, the incidence of spP patients was well below that seen in the community (11.3%)⁵ and even when excluding those over 55, the percentage of spP patients only rose to 19.1%. Unsurprisingly, increasing age was associated with a decreased likelihood of being spP (P < 0.0005), as younger people are more likely to own a phone.⁸ There was no association with gender (P = 0.18). There are a number of explanations that may explain the lower than expected percentage of spP patients, including the inability for the patient to gather their possessions during a medical emergency, patients storing their phones prior to doctor review (72%-85% of Australians report talking on phones in public places to be rude or intrusive⁵), but more importantly, that our hypothesis that patients were too unwell to use their device appears to hold true.

There are potential alternate reasons other than smartphone status that may account for patients being discharged home on day 1. While there was no association seen with gender, the need for an operation prolonged a patient’s stay (OR 1.64; 95% CI, 0.046-0.46), and there was a trend seen with increasing age (OR 0.98; 95% CI, 0.96-1.00). Neither of these 2 demographics are unsurprising: increasing age is associated with increasing medical comorbidities and thus complexity; even the simplest of operations require a postprocedure observation period, automatically increasing their LOS. Additionally, measured demographics are limited and there may be further unmeasured reasons that account for earlier discharge.

The other key component to this study is the value of the physical examination, albeit only assessing 1 component: the general inspection. In their review of the value of the physical examination of the cardiovascular system, Elder et al. highlight an important point: in traditional teaching, the value of a physical sign is compared with a diagnostic reference, typically imaging or an invasive test.⁹ They argue that this definition undervalues the physical examination and list other values aside from accuracy including accessibility, contribution to clinical care beyond diagnoses, cost effectiveness, patients’ safety, patients’ perceptions, and pedagogic value; and they argue that the physical examination should always be considered in regard to the clinical context—in this case, the newly admitted general surgical patient.

The assessment of the presence or absence of a smartphone is readily performed upon general inspection and is easily visible; general inspection of the patient and failure to observe the clinical sign when present are 2 of the greatest errors associated with physical examination.¹⁰ Furthermore, given its unique status as a physical sign, the authors’ opinion and experience is that it is readily teachable. McGee states, “…a fundamental lesson [in regards to teaching] is that the diagnosis of many clinical problems, despite modern testing, still depends primarily on what the clinician sees, hears, and feels.”¹¹ In their article, Paley et al. found that more than 80% of patients admitted from the ED under internal medicine could be accurately diagnosed based largely on history and examination alone and concluded that basic clinical skills are sufficient for achieving an accurate diagnosis in most cases.¹² Although Paley et al. were assisted with basic tests (such as electrocardiogram and basic haematological and biochemistry results), the point of clinical skills is not lost. Furthermore, this assessment was made in a group of patients generally considered to be complex in contrast to the “standard” appendicitis or cholecystitis patient that makes up a significant proportion of general surgical patients.

There are a number of limitations to this study, however, including smartphones that may have been missed during the observational period. Potential confounding variables such as socioeconomic status and the overall smartphone ownership of our subjects were not known. We did not ask all admitted patients whether they owned a phone or whether they had a phone in their possession. Knowledge of those who owned phones but were not in possession of them could strengthen our argument that spN patients were not using their phone because they were unwell, rather than just not having access to it.

However, this study has a number of strengths, including a large sample size and data that were prospectively collected by a method and in a setting that was the same for all participants. Clear and appropriate definitions were used, which minimizes misclassification bias. Participants and decision makers were blinded to the study, and potentially confounding variables such as age and sex were accounted for.

Assessing the suitability for discharge from the hospital is a decision encountered by hospital-based clinicians every day. These skills are not taught, but are rather learned as a junior doctor acquires experience. It is unlikely that protocols will be developed to aid identification of potential discharges from an acute surgical ward; acute surgical conditions are too varied and dynamic to be able to pool all data. We continue to rely on our own and fellow colleagues’ (doctors, nurses, and other staff) input and assessment. However, our study has shown that it is possible to identify and quantify clinical findings that are already regularly used, albeit potentially subconsciously, to assess suitability for discharge. We have shown in this large, prospectively collected observational study that if a surgical patient is seen using their electronic device, they are more likely to be safe to go home. Thus, surgeons can reliably use this observation as a trigger to consider discharging the patient following a more thorough assessment.

While these observations might appear to be rather a simplistic way of trying to quantify whether or not a patient is fit for discharge, any clues that hint towards a patient’s well-being should be taken into account when making an overall assessment. The active use of a smartphone is one such measure.

Acknowledgments

The authors thank Emma Knight and Nancy Briggs from the Data Management & Analysis Centre, Discipline of Public Health, University of Adelaide.

Disclosure

No author nor the institution received any payment or services from a third party for any aspect of the submitted work and report no conflict of interest. There are no reported financial relationships with any entities by any of the authors. There are no patents pending based upon this publication. There are no relationships or activities that readers could perceive to have influenced, or give the appearance of influencing, the submitted work. The corresponding author is not in receipt of a research scholarship. The paper is not based on a previous communication.

The value placed on bedside clinical observation in the decision-making process of a patient’s illness has been diminished by today’s armamentarium of sophisticated technology. Increasing reliance is now placed on the result of nonspecific tests in preference to bedside clinical judgement in the diagnostic and management process. While diagnostic investigations have undoubtedly provided great advancements in medical care, they come at time and financial costs. Physicians should therefore continue to be encouraged to make clinical decisions based on their bedside assessment.

With hospital overcrowding a significant problem within the healthcare system and the expectation that it will worsen with an ageing population, identifying factors that predict patient suitability for discharge has become an important focus for clinicians.^1,2 There exists a paucity of literature predicting discharge suitability of general surgical patients admitted through the emergency department (ED). Furthermore, despite the extensive research into the effectiveness of discharge planning,³ little research has been conducted to describe positive predictive indicators for discharge. Observations made during surgical rounds have led the authors to consider that individuals who are using a smartphone during their bedside assessment may be clinically well enough for discharge.

The aim of this study was to assess whether the clinical assessment of an acute surgical patient could be usefully augmented by the observation of the active use of smartphones (the smartphone sign) and whether this could be used as a surrogate marker to indicate a patient’s well-being and suitability for same-day discharge from the hospital in acute surgical patients.

Design and Setting

This was a prospective observational study performed over 2 periods at a tertiary hospital in South Australia, Australia. At our institution, acute surgical patients are admitted to the acute surgical unit (ASU) from the ED by junior surgical doctors. Patients are then reviewed by the on-call surgical consultant, who implements management plans or advises discharge on 2 occasions per day.

Participants

All patients admitted under the ASU were considered eligible for the study. Exclusion criteria included patients that (i) required immediate surgical intervention (defined as time of review to theatre of less than 4 hours) and (ii) had immediate admission to the intensive care unit.

Consultant surgeons are employed within a general surgical subspecialty, including upper gastrointestinal, hepatobiliary, breast and endocrine, and colorectal. All surgeons from each team partake in the general surgery on-call roster. Each surgeon was included at least once within the observation periods. Experience of consultant surgeons ranged from 5 years of postfellowship experience to surgeons with more than 30 years of experience, with the majority having more than 10 years of postfellowship experience.

Patients were stratified into 2 distinct cohorts upon consultant review: smartphone positive (spP) was defined as a patient who was using a smartphone or who had their phone on their bed; a patient was classified as smartphone negative (spN) if they did not fulfil these criteria. The presence or absence of a smartphone was recorded by the authors, who were present on consultant ward rounds but not involved in the decision-making process of patient care. In order to minimize bias, only 1 surgeon (PGD) was aware that the study was being conducted and all patients were blinded to the study. Additional information that was collected included patient demographics, requirement for surgery, and length of stay (LOS). A patient who was discharged on the same day as the consultant review was considered to be discharged on day 1, all other patients were considered to have LOS greater than 1 day. Requirement for surgery was defined as a patient who underwent a surgical procedure in an operating suite. Thirty-day unplanned readmission rates for all patients were examined. Readmission to another public hospital within the state was also included within the readmission data.

Observation Periods

An initial 4-week pilot study was conducted to assess for a possible association between spP and same-day discharge. A second 8-week study period was undertaken 1 year later accounting for the employment of the authors at the study’s institution. Unless stated, the results described are the accumulation of both study periods.

Statistical Analysis

As this is the first study of its kind, no prior estimates of numbers were known. After 2 weeks of data collection, data were analyzed in order to provide an estimate of the total number of patients required to provide a statistically valid result (α = 0.05; power = 0.80). Sample size was calculated to be 40 subjects. It was agreed that in order to make the study as robust as possible, data should be collected for the 2 observation periods.

Demographic data are presented as means with standard deviations (SDs) or frequencies with percentages. A 2-sample Student t test was used to compare the age of spP and spN patients. A χ² test and logistic regressions were used to assess the association between smartphone status and patient demographics, LOS, and requirement for surgery. Results are presented as odds ratios (ORs) with 95% confidence intervals (CIs). A P value of <0.05 was considered significant. All data were analyzed by using R 3.2.3 (R Foundation for Statistical Computing, Vienna, Austria).

During the 2 observation periods, a total of 227 eligible surgical admissions were observed with complete data for 221 patients. Six patients were excluded as their smartphone status was not recorded. The study sample represents our population of interest within an ASU, and we had complete data for 97.4% of participants with a 100% follow-up. There was no significant effect of study between the 2 observation periods (χ² = 140.19; P = 0.10). The mean age of patients was 50.24 years. Further demographic data are presented in Table 1. Twenty-five (11.3%) patients were spP and 196 (88.7%) were spN. Fifty-two (23.5%) patients were discharged home on day 1, and 169 (76.5%) had admissions longer than 1 day (see Figure). Sixty (27%) patients underwent surgery during their admission. Twenty-two patients had unplanned readmissions; only 1 of these patients had been observed to be spP.

There was a statistically significant difference in ages between the spP and spN groups (t = 8.40; P < 0.0005), with the average age of spP patients being 31.84 years compared with 52.58 years for spN patients. There was no statistical difference between gender and smartphone status (χ² = 1.78; P = 0.18; Table 2).

For those patients discharged home on day 1, there was a statistically significant association with being spP (χ² = 14.55, P = 0.0001). Patients who were spP were 5.29 times more likely to be discharged on day 1 (95% CI, 2.24-12.84). Of the variables analyzed, only gender failed to demonstrate an effect on discharge home on day 1 (Table 3). Overall, the presence of a smartphone was found to have a sensitivity of 56.0% (95% CI, 34.93-75.60) and a specificity of 80.6% (95% CI, 74.37-85.90) in regard to same-day discharge. However, it was found to have a negative predictive value of 93.49% (95% CI, 88.65-96.71).

When examining readmission rates, only 4% of spP patients were readmitted versus 10.7% of spN patients. Accounting for variables, spP patients were 4 times less likely to be readmitted, though this was not statistically significant (OR 4.02; 95% CI, 0.43-37.2; P = 0.22). Furthermore, when examining only those patients discharged on day 1, smartphone status was not a predictor of readmission (OR 0.94; 95% CI, 0.06-15.2; P = 0 .97).

To mitigate the effect of age, analysis was conducted excluding those aged over 55 years (the previous retirement age in Australia), leaving 131 patients for analysis. The average age of spP patients was 31.8 years (SD 10.0) compared with 36.7 years (SD 10.9) for spN patients, representing a significant difference (t = 2.14; P = 0.04); 51.1% of patients were male, 19.1% of patients were spP, 26.0% of patients proceeded to an operation, the oldest spP was 51 years, and 29.0% of patients were discharged home on day 1. There was no difference in gender and smartphone status (χ² = 0.33; P = 0.6). When analyzing those discharged on day 1, again spP patients were more likely to be discharged home (χ² = 9.4; P = 0.002), and spP patients were 3.6 times more likely to be discharged home on day 1.

There were 4 spP patients who underwent an operation. Two patients had an incision and drainage of a perianal abscess, 1 patient underwent a laparotomy for an internal hernia after recently undergoing a Roux-en-Y gastric bypass at another hospital, and the final patient underwent a laparoscopic appendicectomy. One of these patients was still discharged home on day 1.

As J. A. Lindsay⁴ said, “For one mistake made for not knowing, ten mistakes are made for not looking.” At medical school, we are taught the finer techniques of the physical examination in order to support our diagnosis made from the history. It is not until we are experienced clinicians do we develop the clinical acumen and ability to tell an unwell patient from a well patient at a glance—colloquially known as the “end of the bed” assessment. In the pretechnology era, a well patient could frequently be seen reading their book, eg, the “novel-sign.” With the advent of the smartphone and electronic devices upon which novels can be read, statuses updated, and locations “checked into” (ie, the modern “vital signs”), the book sign may be a thing of the past. However, the ability for the clinician to assess a patient’s wellness is still crucial, and the value of any additional “physical signs” need to be estimated.

We observed a cohort of patients through a busy ASU in a tertiary hospital in South Australia, Australia. Acute surgical patients admitted to the hospital who were observed to be on their phones upon consultant review were more than 5 times likely to be discharged that same day. To the best of our knowledge, this is the first study to prospectively collect data to assess a frequently used but unevaluated clinical observation.

The use of a smartphone can tell us a lot about an individual’s physiology. We can assume the individual’s airway and breathing are adequate, allowing enough oxygen to reach the lungs and subsequently circulate. The individual is usually sitting up in bed and thus has an adequate blood pressure and blood oxygenation that can maintain cerebral perfusion. They have the cognitive and cerebral processing in place to function the device, and we can examine their cerebellar function by looking for fine-motor movements.

Mobile phone ownership is pervasive within Australia,⁵ with a conservative estimated 85.7% of the population (20.57 million people of a total population of approximately 24 million) owning a mobile phone and an estimated 50% to 79% of mobile phone ownership being of a smartphone.^6,7 This ownership is not just limited to the young, with 74% of Australians over 65 owning or using a mobile phone.⁸ Despite this high phone ownership among those over 65, it is still significantly less than their younger counterparts and may be one reason for the absence of spP in those older than 51 years. A key point in the study is that overall phone ownership was not known, and, thus, it is not possible to determine the proportion of spN patients who were negative because they did not own a phone. However, based on general population data, the incidence of spP patients was well below that seen in the community (11.3%)⁵ and even when excluding those over 55, the percentage of spP patients only rose to 19.1%. Unsurprisingly, increasing age was associated with a decreased likelihood of being spP (P < 0.0005), as younger people are more likely to own a phone.⁸ There was no association with gender (P = 0.18). There are a number of explanations that may explain the lower than expected percentage of spP patients, including the inability for the patient to gather their possessions during a medical emergency, patients storing their phones prior to doctor review (72%-85% of Australians report talking on phones in public places to be rude or intrusive⁵), but more importantly, that our hypothesis that patients were too unwell to use their device appears to hold true.

There are potential alternate reasons other than smartphone status that may account for patients being discharged home on day 1. While there was no association seen with gender, the need for an operation prolonged a patient’s stay (OR 1.64; 95% CI, 0.046-0.46), and there was a trend seen with increasing age (OR 0.98; 95% CI, 0.96-1.00). Neither of these 2 demographics are unsurprising: increasing age is associated with increasing medical comorbidities and thus complexity; even the simplest of operations require a postprocedure observation period, automatically increasing their LOS. Additionally, measured demographics are limited and there may be further unmeasured reasons that account for earlier discharge.

The other key component to this study is the value of the physical examination, albeit only assessing 1 component: the general inspection. In their review of the value of the physical examination of the cardiovascular system, Elder et al. highlight an important point: in traditional teaching, the value of a physical sign is compared with a diagnostic reference, typically imaging or an invasive test.⁹ They argue that this definition undervalues the physical examination and list other values aside from accuracy including accessibility, contribution to clinical care beyond diagnoses, cost effectiveness, patients’ safety, patients’ perceptions, and pedagogic value; and they argue that the physical examination should always be considered in regard to the clinical context—in this case, the newly admitted general surgical patient.

The assessment of the presence or absence of a smartphone is readily performed upon general inspection and is easily visible; general inspection of the patient and failure to observe the clinical sign when present are 2 of the greatest errors associated with physical examination.¹⁰ Furthermore, given its unique status as a physical sign, the authors’ opinion and experience is that it is readily teachable. McGee states, “…a fundamental lesson [in regards to teaching] is that the diagnosis of many clinical problems, despite modern testing, still depends primarily on what the clinician sees, hears, and feels.”¹¹ In their article, Paley et al. found that more than 80% of patients admitted from the ED under internal medicine could be accurately diagnosed based largely on history and examination alone and concluded that basic clinical skills are sufficient for achieving an accurate diagnosis in most cases.¹² Although Paley et al. were assisted with basic tests (such as electrocardiogram and basic haematological and biochemistry results), the point of clinical skills is not lost. Furthermore, this assessment was made in a group of patients generally considered to be complex in contrast to the “standard” appendicitis or cholecystitis patient that makes up a significant proportion of general surgical patients.

There are a number of limitations to this study, however, including smartphones that may have been missed during the observational period. Potential confounding variables such as socioeconomic status and the overall smartphone ownership of our subjects were not known. We did not ask all admitted patients whether they owned a phone or whether they had a phone in their possession. Knowledge of those who owned phones but were not in possession of them could strengthen our argument that spN patients were not using their phone because they were unwell, rather than just not having access to it.

However, this study has a number of strengths, including a large sample size and data that were prospectively collected by a method and in a setting that was the same for all participants. Clear and appropriate definitions were used, which minimizes misclassification bias. Participants and decision makers were blinded to the study, and potentially confounding variables such as age and sex were accounted for.

Assessing the suitability for discharge from the hospital is a decision encountered by hospital-based clinicians every day. These skills are not taught, but are rather learned as a junior doctor acquires experience. It is unlikely that protocols will be developed to aid identification of potential discharges from an acute surgical ward; acute surgical conditions are too varied and dynamic to be able to pool all data. We continue to rely on our own and fellow colleagues’ (doctors, nurses, and other staff) input and assessment. However, our study has shown that it is possible to identify and quantify clinical findings that are already regularly used, albeit potentially subconsciously, to assess suitability for discharge. We have shown in this large, prospectively collected observational study that if a surgical patient is seen using their electronic device, they are more likely to be safe to go home. Thus, surgeons can reliably use this observation as a trigger to consider discharging the patient following a more thorough assessment.

While these observations might appear to be rather a simplistic way of trying to quantify whether or not a patient is fit for discharge, any clues that hint towards a patient’s well-being should be taken into account when making an overall assessment. The active use of a smartphone is one such measure.

Acknowledgments

The authors thank Emma Knight and Nancy Briggs from the Data Management & Analysis Centre, Discipline of Public Health, University of Adelaide.

Disclosure

No author nor the institution received any payment or services from a third party for any aspect of the submitted work and report no conflict of interest. There are no reported financial relationships with any entities by any of the authors. There are no patents pending based upon this publication. There are no relationships or activities that readers could perceive to have influenced, or give the appearance of influencing, the submitted work. The corresponding author is not in receipt of a research scholarship. The paper is not based on a previous communication.

The value placed on bedside clinical observation in the decision-making process of a patient’s illness has been diminished by today’s armamentarium of sophisticated technology. Increasing reliance is now placed on the result of nonspecific tests in preference to bedside clinical judgement in the diagnostic and management process. While diagnostic investigations have undoubtedly provided great advancements in medical care, they come at time and financial costs. Physicians should therefore continue to be encouraged to make clinical decisions based on their bedside assessment.

With hospital overcrowding a significant problem within the healthcare system and the expectation that it will worsen with an ageing population, identifying factors that predict patient suitability for discharge has become an important focus for clinicians.^1,2 There exists a paucity of literature predicting discharge suitability of general surgical patients admitted through the emergency department (ED). Furthermore, despite the extensive research into the effectiveness of discharge planning,³ little research has been conducted to describe positive predictive indicators for discharge. Observations made during surgical rounds have led the authors to consider that individuals who are using a smartphone during their bedside assessment may be clinically well enough for discharge.

The aim of this study was to assess whether the clinical assessment of an acute surgical patient could be usefully augmented by the observation of the active use of smartphones (the smartphone sign) and whether this could be used as a surrogate marker to indicate a patient’s well-being and suitability for same-day discharge from the hospital in acute surgical patients.

Design and Setting

This was a prospective observational study performed over 2 periods at a tertiary hospital in South Australia, Australia. At our institution, acute surgical patients are admitted to the acute surgical unit (ASU) from the ED by junior surgical doctors. Patients are then reviewed by the on-call surgical consultant, who implements management plans or advises discharge on 2 occasions per day.

Participants

All patients admitted under the ASU were considered eligible for the study. Exclusion criteria included patients that (i) required immediate surgical intervention (defined as time of review to theatre of less than 4 hours) and (ii) had immediate admission to the intensive care unit.

Consultant surgeons are employed within a general surgical subspecialty, including upper gastrointestinal, hepatobiliary, breast and endocrine, and colorectal. All surgeons from each team partake in the general surgery on-call roster. Each surgeon was included at least once within the observation periods. Experience of consultant surgeons ranged from 5 years of postfellowship experience to surgeons with more than 30 years of experience, with the majority having more than 10 years of postfellowship experience.

Patients were stratified into 2 distinct cohorts upon consultant review: smartphone positive (spP) was defined as a patient who was using a smartphone or who had their phone on their bed; a patient was classified as smartphone negative (spN) if they did not fulfil these criteria. The presence or absence of a smartphone was recorded by the authors, who were present on consultant ward rounds but not involved in the decision-making process of patient care. In order to minimize bias, only 1 surgeon (PGD) was aware that the study was being conducted and all patients were blinded to the study. Additional information that was collected included patient demographics, requirement for surgery, and length of stay (LOS). A patient who was discharged on the same day as the consultant review was considered to be discharged on day 1, all other patients were considered to have LOS greater than 1 day. Requirement for surgery was defined as a patient who underwent a surgical procedure in an operating suite. Thirty-day unplanned readmission rates for all patients were examined. Readmission to another public hospital within the state was also included within the readmission data.

Observation Periods

An initial 4-week pilot study was conducted to assess for a possible association between spP and same-day discharge. A second 8-week study period was undertaken 1 year later accounting for the employment of the authors at the study’s institution. Unless stated, the results described are the accumulation of both study periods.

Statistical Analysis

As this is the first study of its kind, no prior estimates of numbers were known. After 2 weeks of data collection, data were analyzed in order to provide an estimate of the total number of patients required to provide a statistically valid result (α = 0.05; power = 0.80). Sample size was calculated to be 40 subjects. It was agreed that in order to make the study as robust as possible, data should be collected for the 2 observation periods.

Demographic data are presented as means with standard deviations (SDs) or frequencies with percentages. A 2-sample Student t test was used to compare the age of spP and spN patients. A χ² test and logistic regressions were used to assess the association between smartphone status and patient demographics, LOS, and requirement for surgery. Results are presented as odds ratios (ORs) with 95% confidence intervals (CIs). A P value of <0.05 was considered significant. All data were analyzed by using R 3.2.3 (R Foundation for Statistical Computing, Vienna, Austria).

During the 2 observation periods, a total of 227 eligible surgical admissions were observed with complete data for 221 patients. Six patients were excluded as their smartphone status was not recorded. The study sample represents our population of interest within an ASU, and we had complete data for 97.4% of participants with a 100% follow-up. There was no significant effect of study between the 2 observation periods (χ² = 140.19; P = 0.10). The mean age of patients was 50.24 years. Further demographic data are presented in Table 1. Twenty-five (11.3%) patients were spP and 196 (88.7%) were spN. Fifty-two (23.5%) patients were discharged home on day 1, and 169 (76.5%) had admissions longer than 1 day (see Figure). Sixty (27%) patients underwent surgery during their admission. Twenty-two patients had unplanned readmissions; only 1 of these patients had been observed to be spP.

There was a statistically significant difference in ages between the spP and spN groups (t = 8.40; P < 0.0005), with the average age of spP patients being 31.84 years compared with 52.58 years for spN patients. There was no statistical difference between gender and smartphone status (χ² = 1.78; P = 0.18; Table 2).

For those patients discharged home on day 1, there was a statistically significant association with being spP (χ² = 14.55, P = 0.0001). Patients who were spP were 5.29 times more likely to be discharged on day 1 (95% CI, 2.24-12.84). Of the variables analyzed, only gender failed to demonstrate an effect on discharge home on day 1 (Table 3). Overall, the presence of a smartphone was found to have a sensitivity of 56.0% (95% CI, 34.93-75.60) and a specificity of 80.6% (95% CI, 74.37-85.90) in regard to same-day discharge. However, it was found to have a negative predictive value of 93.49% (95% CI, 88.65-96.71).

When examining readmission rates, only 4% of spP patients were readmitted versus 10.7% of spN patients. Accounting for variables, spP patients were 4 times less likely to be readmitted, though this was not statistically significant (OR 4.02; 95% CI, 0.43-37.2; P = 0.22). Furthermore, when examining only those patients discharged on day 1, smartphone status was not a predictor of readmission (OR 0.94; 95% CI, 0.06-15.2; P = 0 .97).

To mitigate the effect of age, analysis was conducted excluding those aged over 55 years (the previous retirement age in Australia), leaving 131 patients for analysis. The average age of spP patients was 31.8 years (SD 10.0) compared with 36.7 years (SD 10.9) for spN patients, representing a significant difference (t = 2.14; P = 0.04); 51.1% of patients were male, 19.1% of patients were spP, 26.0% of patients proceeded to an operation, the oldest spP was 51 years, and 29.0% of patients were discharged home on day 1. There was no difference in gender and smartphone status (χ² = 0.33; P = 0.6). When analyzing those discharged on day 1, again spP patients were more likely to be discharged home (χ² = 9.4; P = 0.002), and spP patients were 3.6 times more likely to be discharged home on day 1.

There were 4 spP patients who underwent an operation. Two patients had an incision and drainage of a perianal abscess, 1 patient underwent a laparotomy for an internal hernia after recently undergoing a Roux-en-Y gastric bypass at another hospital, and the final patient underwent a laparoscopic appendicectomy. One of these patients was still discharged home on day 1.

As J. A. Lindsay⁴ said, “For one mistake made for not knowing, ten mistakes are made for not looking.” At medical school, we are taught the finer techniques of the physical examination in order to support our diagnosis made from the history. It is not until we are experienced clinicians do we develop the clinical acumen and ability to tell an unwell patient from a well patient at a glance—colloquially known as the “end of the bed” assessment. In the pretechnology era, a well patient could frequently be seen reading their book, eg, the “novel-sign.” With the advent of the smartphone and electronic devices upon which novels can be read, statuses updated, and locations “checked into” (ie, the modern “vital signs”), the book sign may be a thing of the past. However, the ability for the clinician to assess a patient’s wellness is still crucial, and the value of any additional “physical signs” need to be estimated.

We observed a cohort of patients through a busy ASU in a tertiary hospital in South Australia, Australia. Acute surgical patients admitted to the hospital who were observed to be on their phones upon consultant review were more than 5 times likely to be discharged that same day. To the best of our knowledge, this is the first study to prospectively collect data to assess a frequently used but unevaluated clinical observation.

The use of a smartphone can tell us a lot about an individual’s physiology. We can assume the individual’s airway and breathing are adequate, allowing enough oxygen to reach the lungs and subsequently circulate. The individual is usually sitting up in bed and thus has an adequate blood pressure and blood oxygenation that can maintain cerebral perfusion. They have the cognitive and cerebral processing in place to function the device, and we can examine their cerebellar function by looking for fine-motor movements.

Mobile phone ownership is pervasive within Australia,⁵ with a conservative estimated 85.7% of the population (20.57 million people of a total population of approximately 24 million) owning a mobile phone and an estimated 50% to 79% of mobile phone ownership being of a smartphone.^6,7 This ownership is not just limited to the young, with 74% of Australians over 65 owning or using a mobile phone.⁸ Despite this high phone ownership among those over 65, it is still significantly less than their younger counterparts and may be one reason for the absence of spP in those older than 51 years. A key point in the study is that overall phone ownership was not known, and, thus, it is not possible to determine the proportion of spN patients who were negative because they did not own a phone. However, based on general population data, the incidence of spP patients was well below that seen in the community (11.3%)⁵ and even when excluding those over 55, the percentage of spP patients only rose to 19.1%. Unsurprisingly, increasing age was associated with a decreased likelihood of being spP (P < 0.0005), as younger people are more likely to own a phone.⁸ There was no association with gender (P = 0.18). There are a number of explanations that may explain the lower than expected percentage of spP patients, including the inability for the patient to gather their possessions during a medical emergency, patients storing their phones prior to doctor review (72%-85% of Australians report talking on phones in public places to be rude or intrusive⁵), but more importantly, that our hypothesis that patients were too unwell to use their device appears to hold true.

There are potential alternate reasons other than smartphone status that may account for patients being discharged home on day 1. While there was no association seen with gender, the need for an operation prolonged a patient’s stay (OR 1.64; 95% CI, 0.046-0.46), and there was a trend seen with increasing age (OR 0.98; 95% CI, 0.96-1.00). Neither of these 2 demographics are unsurprising: increasing age is associated with increasing medical comorbidities and thus complexity; even the simplest of operations require a postprocedure observation period, automatically increasing their LOS. Additionally, measured demographics are limited and there may be further unmeasured reasons that account for earlier discharge.

The other key component to this study is the value of the physical examination, albeit only assessing 1 component: the general inspection. In their review of the value of the physical examination of the cardiovascular system, Elder et al. highlight an important point: in traditional teaching, the value of a physical sign is compared with a diagnostic reference, typically imaging or an invasive test.⁹ They argue that this definition undervalues the physical examination and list other values aside from accuracy including accessibility, contribution to clinical care beyond diagnoses, cost effectiveness, patients’ safety, patients’ perceptions, and pedagogic value; and they argue that the physical examination should always be considered in regard to the clinical context—in this case, the newly admitted general surgical patient.

The assessment of the presence or absence of a smartphone is readily performed upon general inspection and is easily visible; general inspection of the patient and failure to observe the clinical sign when present are 2 of the greatest errors associated with physical examination.¹⁰ Furthermore, given its unique status as a physical sign, the authors’ opinion and experience is that it is readily teachable. McGee states, “…a fundamental lesson [in regards to teaching] is that the diagnosis of many clinical problems, despite modern testing, still depends primarily on what the clinician sees, hears, and feels.”¹¹ In their article, Paley et al. found that more than 80% of patients admitted from the ED under internal medicine could be accurately diagnosed based largely on history and examination alone and concluded that basic clinical skills are sufficient for achieving an accurate diagnosis in most cases.¹² Although Paley et al. were assisted with basic tests (such as electrocardiogram and basic haematological and biochemistry results), the point of clinical skills is not lost. Furthermore, this assessment was made in a group of patients generally considered to be complex in contrast to the “standard” appendicitis or cholecystitis patient that makes up a significant proportion of general surgical patients.

There are a number of limitations to this study, however, including smartphones that may have been missed during the observational period. Potential confounding variables such as socioeconomic status and the overall smartphone ownership of our subjects were not known. We did not ask all admitted patients whether they owned a phone or whether they had a phone in their possession. Knowledge of those who owned phones but were not in possession of them could strengthen our argument that spN patients were not using their phone because they were unwell, rather than just not having access to it.

However, this study has a number of strengths, including a large sample size and data that were prospectively collected by a method and in a setting that was the same for all participants. Clear and appropriate definitions were used, which minimizes misclassification bias. Participants and decision makers were blinded to the study, and potentially confounding variables such as age and sex were accounted for.

Assessing the suitability for discharge from the hospital is a decision encountered by hospital-based clinicians every day. These skills are not taught, but are rather learned as a junior doctor acquires experience. It is unlikely that protocols will be developed to aid identification of potential discharges from an acute surgical ward; acute surgical conditions are too varied and dynamic to be able to pool all data. We continue to rely on our own and fellow colleagues’ (doctors, nurses, and other staff) input and assessment. However, our study has shown that it is possible to identify and quantify clinical findings that are already regularly used, albeit potentially subconsciously, to assess suitability for discharge. We have shown in this large, prospectively collected observational study that if a surgical patient is seen using their electronic device, they are more likely to be safe to go home. Thus, surgeons can reliably use this observation as a trigger to consider discharging the patient following a more thorough assessment.

While these observations might appear to be rather a simplistic way of trying to quantify whether or not a patient is fit for discharge, any clues that hint towards a patient’s well-being should be taken into account when making an overall assessment. The active use of a smartphone is one such measure.

Acknowledgments

The authors thank Emma Knight and Nancy Briggs from the Data Management & Analysis Centre, Discipline of Public Health, University of Adelaide.

Disclosure

No author nor the institution received any payment or services from a third party for any aspect of the submitted work and report no conflict of interest. There are no reported financial relationships with any entities by any of the authors. There are no patents pending based upon this publication. There are no relationships or activities that readers could perceive to have influenced, or give the appearance of influencing, the submitted work. The corresponding author is not in receipt of a research scholarship. The paper is not based on a previous communication.

Annual healthcare costs in the United States are over $3 trillion and are garnering significant national attention.¹ The United States spends approximately 2.5 times more per capita on healthcare when compared to other developed nations.² One source of unnecessary cost in healthcare is defensive medicine. Defensive medicine has been defined by Congress as occurring “when doctors order tests, procedures, or visits, or avoid certain high-risk patients or procedures, primarily (but not necessarily) because of concern about malpractice liability.”³

Though difficult to assess, in 1 study, defensive medicine was estimated to cost $45 billion annually.⁴ While general agreement exists that physicians practice defensive medicine, the extent of defensive practices and the subsequent impact on healthcare costs remain unclear. This is especially true for a group of clinicians that is rapidly increasing in number: hospitalists. Currently, there are more than 50,000 hospitalists in the United States,⁵ yet the prevalence of defensive medicine in this relatively new specialty is unknown. Inpatient care is complex and time constraints can impede establishing an optimal therapeutic relationship with the patient, potentially raising liability fears. We therefore sought to quantify hospitalist physician estimates of the cost of defensive medicine and assess correlates of their estimates. As being sued might spur defensive behaviors, we also assessed how many hospitalists reported being sued and whether this was associated with their estimates of defensive medicine.

Survey Questionnaire

In a previously published survey-based analysis, we reported on physician practice and overuse for 2 common scenarios in hospital medicine: preoperative evaluation and management of uncomplicated syncope.⁶ After responding to the vignettes, each physician was asked to provide demographic and employment information and malpractice history. In addition, they were asked the following: In your best estimation, what percentage of healthcare-related resources (eg, hospital admissions, diagnostic testing, treatment) are spent purely because of defensive medicine concerns? __________% resources

Survey Sample & Administration

The survey was sent to a sample of 1753 hospitalists, randomly identified through the Society of Hospital Medicine’s (SHM) database of members and annual meeting attendees. It is estimated that almost 30% of practicing hospitalists in the United States are members of the SHM.⁵ A full description of the sampling methodology was previously published.⁶ Selected hospitalists were mailed surveys, a $20 financial incentive, and subsequent reminders between June and October 2011.

The study was exempted from institutional review board review by the University of Michigan and the VA Ann Arbor Healthcare System.

Variables

The primary outcome of interest was the response to the “% resources” estimated to be spent on defensive medicine. This was analyzed as a continuous variable. Independent variables included the following: VA employment, malpractice insurance payer, employer, history of malpractice lawsuit, sex, race, and years practicing as a physician.

Statistical Analysis

Analyses were conducted using SAS, version 9.4 (SAS Institute). Descriptive statistics were first calculated for all variables. Next, bivariable comparisons between the outcome variables and other variables of interest were performed. Multivariable comparisons were made using linear regression for the outcome of estimated resources spent on defensive medicine. A P value of < 0.05 was considered statistically significant.

Of the 1753 surveys mailed, 253 were excluded due to incorrect addresses or because the recipients were not practicing hospitalists. A total of 1020 were completed and returned, yielding a 68% response rate (1020 out of 1500 eligible). The hospitalist respondents were in practice for an average of 11 years (range 1-40 years). Respondents represented all 50 states and had a diverse background of experience and demographic characteristics, which has been previously described.⁶

Resources Estimated Spent on Defensive Medicine

Hospitalists reported, on average, that they believed defensive medicine accounted for 37.5% (standard deviation, 20.2%) of all healthcare spending. Results from the multivariable regression are presented in the Table. Hospitalists affiliated with a VA hospital reported 5.5% less in resources spent on defensive medicine than those not affiliated with a VA hospital (32.2% VA vs 37.7% non-VA, P = 0.025). For every 10 years in practice, the estimate of resources spent on defensive medicine decreased by 3% (P = 0.003). Those who were male (36.4% male vs 39.4% female, P = 0.023) and non-Hispanic white (32.5% non-Hispanic white vs 44.7% other, P ≤ 0.001) also estimated less resources spent on defensive medicine. We did not find an association between a hospitalist reporting being sued and their perception of resources spent on defensive medicine.  

Risk of Being Sued

Over a quarter of our sample (25.6%) reported having been sued at least once for medical malpractice. The proportion of hospitalists that reported a history of being sued generally increased with more years of practice (Figure). For those who had been in practice for at least 20 years, more than half (55%) had been sued at least once during their career.

In a national survey, hospitalists estimated that almost 40% of all healthcare-related resources are spent purely because of defensive medicine concerns. This estimate was affected by personal demographic and employment factors. Our second major finding is that over one-quarter of a large random sample of hospitalist physicians reported being sued for malpractice.

Hospitalist perceptions of defensive medicine varied significantly based on employment at a VA hospital, with VA-affiliated hospitalists reporting less estimated spending on defensive medicine. This effect may reflect a less litigious environment within the VA, even though physicians practicing within the VA can be reported to the National Practitioner Data Bank.⁷ The different environment may be due to the VA’s patient mix (VA patients tend to be poorer, older, sicker, and have more mental illness)⁸; however, it could also be due to its de facto practice of a form of enterprise liability, in which, by law, the VA assumes responsibility for negligence, sheltering its physicians from direct liability.

We also found that the higher the number of years a hospitalist reported practicing, the lower the perception of resources being spent on defensive medicine. The reason for this finding is unclear. There has been a recent focus on high-value care and overspending, and perhaps younger hospitalists are more aware of these initiatives and thus have higher estimates. Additionally, non-Hispanic white male respondents estimated a lower amount spent on defensive medicine compared with other respondents. This is consistent with previous studies of risk perception which have noted a “white male effect” in which white males generally perceive a wide range of risks to be lower than female and non-white individuals, likely due to sociopolitical factors.⁹ Here, the white male effect is particularly interesting, considering that male physicians are almost 2.5 times as likely as female physicians to report being sued.¹⁰

Similar to prior studies,¹¹ there was no association with personal liability claim experience and perceived resources spent on defensive medicine. It is unclear why personal experience of being sued does not appear to be associated with perceptions of defensive medicine practice. It is possible that the fear of being sued is worse than the actual experience or that physicians believe that lawsuits are either random events or inevitable and, as a result, do not change their practice patterns.

The lifetime risk of being named in a malpractice suit is substantial for hospitalists: in our study, over half of hospitalists in practice for 20 years or more reported they had been sued. This corresponds with the projection made by Jena and colleagues,¹² which estimated that 55% of internal medicine physicians will be sued by the age of 45, a number just slightly higher than the average for all physicians.

Our study has important limitations. Our sample was of hospitalists and therefore may not be reflective of other medical specialties. Second, due to the nature of the study design, the responses to spending on defensive medicine may not represent actual practice. Third, we did not confirm details such as place of employment or history of lawsuit, and this may be subject to recall bias. However, physicians are unlikely to forget having been sued. Finally, this survey is observational and cross-sectional. Our data imply association rather than causation. Without longitudinal data, it is impossible to know if years of practice correlate with perceived defensive medicine spending due to a generational effect or a longitudinal effect (such as more confidence in diagnostic skills with more years of practice).

Despite these limitations, our survey has important policy implications. First, we found that defensive medicine is perceived by hospitalists to be costly. Although physicians likely overestimated the cost (37.5%, or an estimated $1 trillion is far higher than previous estimates of approximately 2% of all healthcare spending),⁴ it also demonstrates the extent to which physicians feel as though the medical care that is provided may be unnecessary. Second, at least a quarter of hospitalist physicians have been sued, and the risk of being named as a defendant in a lawsuit increases the longer they have been in clinical practice.

Given these findings, policies aimed to reduce the practice of defensive medicine may help the rising costs of healthcare. Reducing defensive medicine requires decreasing physician fears of liability and related reporting. Traditional tort reforms (with the exception of damage caps) have not been proven to do this. And damage caps can be inequitable, hard to pass, and even found to be unconstitutional in some states.¹³ However, other reform options hold promise in reducing liability fears, including enterprise liability, safe harbor legislation, and health courts.¹³ Finally, shared decision-making models may also provide a method to reduce defensive fears as well.⁶

Acknowledgments

The authors thank the Society of Hospital Medicine, Dr. Scott Flanders, Andrew Hickner, and David Ratz for their assistance with this project.

Disclosure

The authors received financial support from the Blue Cross Blue Shield of Michigan Foundation, the Department of Veterans Affairs Health Services Research and Development Center for Clinical Management Research, the University of Michigan Specialist-Hospitalist Allied Research Program, and the Ann Arbor University of Michigan VA Patient Safety Enhancement Program.

Disclaimer

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of Blue Cross Blue Shield of Michigan Foundation, the Department of Veterans Affairs, or the Society of Hospital Medicine.

Annual healthcare costs in the United States are over $3 trillion and are garnering significant national attention.¹ The United States spends approximately 2.5 times more per capita on healthcare when compared to other developed nations.² One source of unnecessary cost in healthcare is defensive medicine. Defensive medicine has been defined by Congress as occurring “when doctors order tests, procedures, or visits, or avoid certain high-risk patients or procedures, primarily (but not necessarily) because of concern about malpractice liability.”³

Though difficult to assess, in 1 study, defensive medicine was estimated to cost $45 billion annually.⁴ While general agreement exists that physicians practice defensive medicine, the extent of defensive practices and the subsequent impact on healthcare costs remain unclear. This is especially true for a group of clinicians that is rapidly increasing in number: hospitalists. Currently, there are more than 50,000 hospitalists in the United States,⁵ yet the prevalence of defensive medicine in this relatively new specialty is unknown. Inpatient care is complex and time constraints can impede establishing an optimal therapeutic relationship with the patient, potentially raising liability fears. We therefore sought to quantify hospitalist physician estimates of the cost of defensive medicine and assess correlates of their estimates. As being sued might spur defensive behaviors, we also assessed how many hospitalists reported being sued and whether this was associated with their estimates of defensive medicine.

Survey Questionnaire

In a previously published survey-based analysis, we reported on physician practice and overuse for 2 common scenarios in hospital medicine: preoperative evaluation and management of uncomplicated syncope.⁶ After responding to the vignettes, each physician was asked to provide demographic and employment information and malpractice history. In addition, they were asked the following: In your best estimation, what percentage of healthcare-related resources (eg, hospital admissions, diagnostic testing, treatment) are spent purely because of defensive medicine concerns? __________% resources

Survey Sample & Administration

The survey was sent to a sample of 1753 hospitalists, randomly identified through the Society of Hospital Medicine’s (SHM) database of members and annual meeting attendees. It is estimated that almost 30% of practicing hospitalists in the United States are members of the SHM.⁵ A full description of the sampling methodology was previously published.⁶ Selected hospitalists were mailed surveys, a $20 financial incentive, and subsequent reminders between June and October 2011.

The study was exempted from institutional review board review by the University of Michigan and the VA Ann Arbor Healthcare System.

Variables

The primary outcome of interest was the response to the “% resources” estimated to be spent on defensive medicine. This was analyzed as a continuous variable. Independent variables included the following: VA employment, malpractice insurance payer, employer, history of malpractice lawsuit, sex, race, and years practicing as a physician.

Statistical Analysis

Analyses were conducted using SAS, version 9.4 (SAS Institute). Descriptive statistics were first calculated for all variables. Next, bivariable comparisons between the outcome variables and other variables of interest were performed. Multivariable comparisons were made using linear regression for the outcome of estimated resources spent on defensive medicine. A P value of < 0.05 was considered statistically significant.

Of the 1753 surveys mailed, 253 were excluded due to incorrect addresses or because the recipients were not practicing hospitalists. A total of 1020 were completed and returned, yielding a 68% response rate (1020 out of 1500 eligible). The hospitalist respondents were in practice for an average of 11 years (range 1-40 years). Respondents represented all 50 states and had a diverse background of experience and demographic characteristics, which has been previously described.⁶

Resources Estimated Spent on Defensive Medicine

Hospitalists reported, on average, that they believed defensive medicine accounted for 37.5% (standard deviation, 20.2%) of all healthcare spending. Results from the multivariable regression are presented in the Table. Hospitalists affiliated with a VA hospital reported 5.5% less in resources spent on defensive medicine than those not affiliated with a VA hospital (32.2% VA vs 37.7% non-VA, P = 0.025). For every 10 years in practice, the estimate of resources spent on defensive medicine decreased by 3% (P = 0.003). Those who were male (36.4% male vs 39.4% female, P = 0.023) and non-Hispanic white (32.5% non-Hispanic white vs 44.7% other, P ≤ 0.001) also estimated less resources spent on defensive medicine. We did not find an association between a hospitalist reporting being sued and their perception of resources spent on defensive medicine.  

Risk of Being Sued

Over a quarter of our sample (25.6%) reported having been sued at least once for medical malpractice. The proportion of hospitalists that reported a history of being sued generally increased with more years of practice (Figure). For those who had been in practice for at least 20 years, more than half (55%) had been sued at least once during their career.

In a national survey, hospitalists estimated that almost 40% of all healthcare-related resources are spent purely because of defensive medicine concerns. This estimate was affected by personal demographic and employment factors. Our second major finding is that over one-quarter of a large random sample of hospitalist physicians reported being sued for malpractice.

Hospitalist perceptions of defensive medicine varied significantly based on employment at a VA hospital, with VA-affiliated hospitalists reporting less estimated spending on defensive medicine. This effect may reflect a less litigious environment within the VA, even though physicians practicing within the VA can be reported to the National Practitioner Data Bank.⁷ The different environment may be due to the VA’s patient mix (VA patients tend to be poorer, older, sicker, and have more mental illness)⁸; however, it could also be due to its de facto practice of a form of enterprise liability, in which, by law, the VA assumes responsibility for negligence, sheltering its physicians from direct liability.

We also found that the higher the number of years a hospitalist reported practicing, the lower the perception of resources being spent on defensive medicine. The reason for this finding is unclear. There has been a recent focus on high-value care and overspending, and perhaps younger hospitalists are more aware of these initiatives and thus have higher estimates. Additionally, non-Hispanic white male respondents estimated a lower amount spent on defensive medicine compared with other respondents. This is consistent with previous studies of risk perception which have noted a “white male effect” in which white males generally perceive a wide range of risks to be lower than female and non-white individuals, likely due to sociopolitical factors.⁹ Here, the white male effect is particularly interesting, considering that male physicians are almost 2.5 times as likely as female physicians to report being sued.¹⁰

Similar to prior studies,¹¹ there was no association with personal liability claim experience and perceived resources spent on defensive medicine. It is unclear why personal experience of being sued does not appear to be associated with perceptions of defensive medicine practice. It is possible that the fear of being sued is worse than the actual experience or that physicians believe that lawsuits are either random events or inevitable and, as a result, do not change their practice patterns.

The lifetime risk of being named in a malpractice suit is substantial for hospitalists: in our study, over half of hospitalists in practice for 20 years or more reported they had been sued. This corresponds with the projection made by Jena and colleagues,¹² which estimated that 55% of internal medicine physicians will be sued by the age of 45, a number just slightly higher than the average for all physicians.

Our study has important limitations. Our sample was of hospitalists and therefore may not be reflective of other medical specialties. Second, due to the nature of the study design, the responses to spending on defensive medicine may not represent actual practice. Third, we did not confirm details such as place of employment or history of lawsuit, and this may be subject to recall bias. However, physicians are unlikely to forget having been sued. Finally, this survey is observational and cross-sectional. Our data imply association rather than causation. Without longitudinal data, it is impossible to know if years of practice correlate with perceived defensive medicine spending due to a generational effect or a longitudinal effect (such as more confidence in diagnostic skills with more years of practice).

Despite these limitations, our survey has important policy implications. First, we found that defensive medicine is perceived by hospitalists to be costly. Although physicians likely overestimated the cost (37.5%, or an estimated $1 trillion is far higher than previous estimates of approximately 2% of all healthcare spending),⁴ it also demonstrates the extent to which physicians feel as though the medical care that is provided may be unnecessary. Second, at least a quarter of hospitalist physicians have been sued, and the risk of being named as a defendant in a lawsuit increases the longer they have been in clinical practice.

Given these findings, policies aimed to reduce the practice of defensive medicine may help the rising costs of healthcare. Reducing defensive medicine requires decreasing physician fears of liability and related reporting. Traditional tort reforms (with the exception of damage caps) have not been proven to do this. And damage caps can be inequitable, hard to pass, and even found to be unconstitutional in some states.¹³ However, other reform options hold promise in reducing liability fears, including enterprise liability, safe harbor legislation, and health courts.¹³ Finally, shared decision-making models may also provide a method to reduce defensive fears as well.⁶

Acknowledgments

The authors thank the Society of Hospital Medicine, Dr. Scott Flanders, Andrew Hickner, and David Ratz for their assistance with this project.

Disclosure

The authors received financial support from the Blue Cross Blue Shield of Michigan Foundation, the Department of Veterans Affairs Health Services Research and Development Center for Clinical Management Research, the University of Michigan Specialist-Hospitalist Allied Research Program, and the Ann Arbor University of Michigan VA Patient Safety Enhancement Program.

Disclaimer

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of Blue Cross Blue Shield of Michigan Foundation, the Department of Veterans Affairs, or the Society of Hospital Medicine.

Annual healthcare costs in the United States are over $3 trillion and are garnering significant national attention.¹ The United States spends approximately 2.5 times more per capita on healthcare when compared to other developed nations.² One source of unnecessary cost in healthcare is defensive medicine. Defensive medicine has been defined by Congress as occurring “when doctors order tests, procedures, or visits, or avoid certain high-risk patients or procedures, primarily (but not necessarily) because of concern about malpractice liability.”³

Though difficult to assess, in 1 study, defensive medicine was estimated to cost $45 billion annually.⁴ While general agreement exists that physicians practice defensive medicine, the extent of defensive practices and the subsequent impact on healthcare costs remain unclear. This is especially true for a group of clinicians that is rapidly increasing in number: hospitalists. Currently, there are more than 50,000 hospitalists in the United States,⁵ yet the prevalence of defensive medicine in this relatively new specialty is unknown. Inpatient care is complex and time constraints can impede establishing an optimal therapeutic relationship with the patient, potentially raising liability fears. We therefore sought to quantify hospitalist physician estimates of the cost of defensive medicine and assess correlates of their estimates. As being sued might spur defensive behaviors, we also assessed how many hospitalists reported being sued and whether this was associated with their estimates of defensive medicine.

Survey Questionnaire

In a previously published survey-based analysis, we reported on physician practice and overuse for 2 common scenarios in hospital medicine: preoperative evaluation and management of uncomplicated syncope.⁶ After responding to the vignettes, each physician was asked to provide demographic and employment information and malpractice history. In addition, they were asked the following: In your best estimation, what percentage of healthcare-related resources (eg, hospital admissions, diagnostic testing, treatment) are spent purely because of defensive medicine concerns? __________% resources

Survey Sample & Administration

The survey was sent to a sample of 1753 hospitalists, randomly identified through the Society of Hospital Medicine’s (SHM) database of members and annual meeting attendees. It is estimated that almost 30% of practicing hospitalists in the United States are members of the SHM.⁵ A full description of the sampling methodology was previously published.⁶ Selected hospitalists were mailed surveys, a $20 financial incentive, and subsequent reminders between June and October 2011.

The study was exempted from institutional review board review by the University of Michigan and the VA Ann Arbor Healthcare System.

Variables

The primary outcome of interest was the response to the “% resources” estimated to be spent on defensive medicine. This was analyzed as a continuous variable. Independent variables included the following: VA employment, malpractice insurance payer, employer, history of malpractice lawsuit, sex, race, and years practicing as a physician.

Statistical Analysis

Analyses were conducted using SAS, version 9.4 (SAS Institute). Descriptive statistics were first calculated for all variables. Next, bivariable comparisons between the outcome variables and other variables of interest were performed. Multivariable comparisons were made using linear regression for the outcome of estimated resources spent on defensive medicine. A P value of < 0.05 was considered statistically significant.

Of the 1753 surveys mailed, 253 were excluded due to incorrect addresses or because the recipients were not practicing hospitalists. A total of 1020 were completed and returned, yielding a 68% response rate (1020 out of 1500 eligible). The hospitalist respondents were in practice for an average of 11 years (range 1-40 years). Respondents represented all 50 states and had a diverse background of experience and demographic characteristics, which has been previously described.⁶

Resources Estimated Spent on Defensive Medicine

Hospitalists reported, on average, that they believed defensive medicine accounted for 37.5% (standard deviation, 20.2%) of all healthcare spending. Results from the multivariable regression are presented in the Table. Hospitalists affiliated with a VA hospital reported 5.5% less in resources spent on defensive medicine than those not affiliated with a VA hospital (32.2% VA vs 37.7% non-VA, P = 0.025). For every 10 years in practice, the estimate of resources spent on defensive medicine decreased by 3% (P = 0.003). Those who were male (36.4% male vs 39.4% female, P = 0.023) and non-Hispanic white (32.5% non-Hispanic white vs 44.7% other, P ≤ 0.001) also estimated less resources spent on defensive medicine. We did not find an association between a hospitalist reporting being sued and their perception of resources spent on defensive medicine.  

Risk of Being Sued

Over a quarter of our sample (25.6%) reported having been sued at least once for medical malpractice. The proportion of hospitalists that reported a history of being sued generally increased with more years of practice (Figure). For those who had been in practice for at least 20 years, more than half (55%) had been sued at least once during their career.

In a national survey, hospitalists estimated that almost 40% of all healthcare-related resources are spent purely because of defensive medicine concerns. This estimate was affected by personal demographic and employment factors. Our second major finding is that over one-quarter of a large random sample of hospitalist physicians reported being sued for malpractice.

Hospitalist perceptions of defensive medicine varied significantly based on employment at a VA hospital, with VA-affiliated hospitalists reporting less estimated spending on defensive medicine. This effect may reflect a less litigious environment within the VA, even though physicians practicing within the VA can be reported to the National Practitioner Data Bank.⁷ The different environment may be due to the VA’s patient mix (VA patients tend to be poorer, older, sicker, and have more mental illness)⁸; however, it could also be due to its de facto practice of a form of enterprise liability, in which, by law, the VA assumes responsibility for negligence, sheltering its physicians from direct liability.

We also found that the higher the number of years a hospitalist reported practicing, the lower the perception of resources being spent on defensive medicine. The reason for this finding is unclear. There has been a recent focus on high-value care and overspending, and perhaps younger hospitalists are more aware of these initiatives and thus have higher estimates. Additionally, non-Hispanic white male respondents estimated a lower amount spent on defensive medicine compared with other respondents. This is consistent with previous studies of risk perception which have noted a “white male effect” in which white males generally perceive a wide range of risks to be lower than female and non-white individuals, likely due to sociopolitical factors.⁹ Here, the white male effect is particularly interesting, considering that male physicians are almost 2.5 times as likely as female physicians to report being sued.¹⁰

Similar to prior studies,¹¹ there was no association with personal liability claim experience and perceived resources spent on defensive medicine. It is unclear why personal experience of being sued does not appear to be associated with perceptions of defensive medicine practice. It is possible that the fear of being sued is worse than the actual experience or that physicians believe that lawsuits are either random events or inevitable and, as a result, do not change their practice patterns.

The lifetime risk of being named in a malpractice suit is substantial for hospitalists: in our study, over half of hospitalists in practice for 20 years or more reported they had been sued. This corresponds with the projection made by Jena and colleagues,¹² which estimated that 55% of internal medicine physicians will be sued by the age of 45, a number just slightly higher than the average for all physicians.

Our study has important limitations. Our sample was of hospitalists and therefore may not be reflective of other medical specialties. Second, due to the nature of the study design, the responses to spending on defensive medicine may not represent actual practice. Third, we did not confirm details such as place of employment or history of lawsuit, and this may be subject to recall bias. However, physicians are unlikely to forget having been sued. Finally, this survey is observational and cross-sectional. Our data imply association rather than causation. Without longitudinal data, it is impossible to know if years of practice correlate with perceived defensive medicine spending due to a generational effect or a longitudinal effect (such as more confidence in diagnostic skills with more years of practice).

Despite these limitations, our survey has important policy implications. First, we found that defensive medicine is perceived by hospitalists to be costly. Although physicians likely overestimated the cost (37.5%, or an estimated $1 trillion is far higher than previous estimates of approximately 2% of all healthcare spending),⁴ it also demonstrates the extent to which physicians feel as though the medical care that is provided may be unnecessary. Second, at least a quarter of hospitalist physicians have been sued, and the risk of being named as a defendant in a lawsuit increases the longer they have been in clinical practice.

Given these findings, policies aimed to reduce the practice of defensive medicine may help the rising costs of healthcare. Reducing defensive medicine requires decreasing physician fears of liability and related reporting. Traditional tort reforms (with the exception of damage caps) have not been proven to do this. And damage caps can be inequitable, hard to pass, and even found to be unconstitutional in some states.¹³ However, other reform options hold promise in reducing liability fears, including enterprise liability, safe harbor legislation, and health courts.¹³ Finally, shared decision-making models may also provide a method to reduce defensive fears as well.⁶

Acknowledgments

The authors thank the Society of Hospital Medicine, Dr. Scott Flanders, Andrew Hickner, and David Ratz for their assistance with this project.

Disclosure

The authors received financial support from the Blue Cross Blue Shield of Michigan Foundation, the Department of Veterans Affairs Health Services Research and Development Center for Clinical Management Research, the University of Michigan Specialist-Hospitalist Allied Research Program, and the Ann Arbor University of Michigan VA Patient Safety Enhancement Program.

Disclaimer

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of Blue Cross Blue Shield of Michigan Foundation, the Department of Veterans Affairs, or the Society of Hospital Medicine.

Click here to access the 2018 Directory of VA and DoD Facilities Digital Edition

Table of Contents

• Department of Defense Health Care Facilities

Click here to access the 2018 Directory of VA and DoD Facilities Digital Edition

Table of Contents

• Department of Defense Health Care Facilities

Click here to access the 2018 Directory of VA and DoD Facilities Digital Edition

Table of Contents

• Department of Defense Health Care Facilities

Click here to access the December 2017 Digital Edition.

Table of Contents

• Driving-Related Coping Thoughts in Post-9/11 Combat Veterans With and Without Comorbid PTSD and TBI
• Innovative Therapies for Severe Asthma
• Lumbar Microlaminectomy vs Traditional Laminectomy
• Medication-Induced Pruritus From Direct Oral Anticoagulants
• She’s Not My Mother: 24-Year-Old Man With Capgras Delusion
• A Needs Review of Caregivers for Adults With Traumatic Brain Injury

Click here to access the December 2017 Digital Edition.

Table of Contents

• Driving-Related Coping Thoughts in Post-9/11 Combat Veterans With and Without Comorbid PTSD and TBI
• Innovative Therapies for Severe Asthma
• Lumbar Microlaminectomy vs Traditional Laminectomy
• Medication-Induced Pruritus From Direct Oral Anticoagulants
• She’s Not My Mother: 24-Year-Old Man With Capgras Delusion
• A Needs Review of Caregivers for Adults With Traumatic Brain Injury

Click here to access the December 2017 Digital Edition.

Table of Contents

• Driving-Related Coping Thoughts in Post-9/11 Combat Veterans With and Without Comorbid PTSD and TBI
• Innovative Therapies for Severe Asthma
• Lumbar Microlaminectomy vs Traditional Laminectomy
• Medication-Induced Pruritus From Direct Oral Anticoagulants
• She’s Not My Mother: 24-Year-Old Man With Capgras Delusion
• A Needs Review of Caregivers for Adults With Traumatic Brain Injury

CE/CME No: CR-1801

PROGRAM OVERVIEW
Earn credit by reading this article and successfully completing the posttest and evaluation. Successful completion is defined as a cumulative score of at least 70% correct.

EDUCATIONAL OBJECTIVES
• Differentiate between acute and chronic urticaria.
• List common history questions required for the diagnosis of chronic urticaria.
• Explain a stepwise plan for treatment of chronic urticaria.
• Describe serologic testing that should be ordered for chronic urticaria.
• Demonstrate knowledge of when to refer patients to a specialist for alternative treatment options.

FACULTY
Randy D. Danielsen is Professor and Dean of the Arizona School of Health Sciences, and  Director of the Center for the Future of the Health Professions at A.T. Still University in Mesa, Arizona. Gabriel Ortiz practices at Breathe America El Paso in Texas and is a former AAPA liaison to the American Academy of Allergy, Asthma & Immunology (AAAAI) and National Institutes of Health/National Asthma Education and Prevention Program—Coordinating Committee. Susan Symington has practiced in allergy, asthma, and immunology for more than 10 years. She is the current AAPA liaison to theAAAAI and is President-Elect of the AAPA-Allergy, Asthma, and Immunology subspecialty organization.

The authors have no financial relationships to disclose.

ACCREDITATION STATEMENT

This program has been reviewed and is approved for a maximum of 1.0 hour of American Academy of Physician Assistants (AAPA) Category 1 CME credit by the Physician Assistant Review Panel. [NPs: Both ANCC and the AANP Certification Program recognize AAPA as an approved provider of Category 1 credit.] Approval is valid through December 31, 2018.

Article begins on next page >>

The discomfort caused by an urticarial rash, along with its unpredictable course, can interfere with a patient’s sleep and work/school. Adding to the frustration of patients and providers alike, an underlying cause is seldom identified. But a stepwise treatment approach can bring relief to all.

Urticaria, often referred to as hives, is a common cutaneous disorder with a lifetime incidence between 15% and 25%.¹ Urticaria is characterized by recurring pruritic wheals that arise due to allergic and nonallergic reactions to internal and external agents. The name urticaria comes from the Latin word for “nettle,” urtica, derived from the Latin word uro, meaning “to burn.”²

Urticaria can be debilitating for patients, who may complain of a burning sensation. It can last for years in some and reduces quality of life for many. Recently, more successful treatments for urticaria have emerged that can provide tremendous relief.

It is important to understand some of the ways to diagnose and treat patients in a primary care setting and also to know when referral is appropriate. This article will discuss the diagnosis, treatment, and referral process for patients with chronic urticaria.

PATHOPHYSIOLOGY

Hives most commonly arise from an immunologic reaction in the superficial skin layers that results in the release of histamine, which causes swelling, itching, and erythema. The mast cell is the major effector cell in the pathophysiology of urticaria.³ In immunologic urticaria, the antigen binds to immunoglobulin (Ig) E on the mast cell surface, causing degranulation and release of histamine, which accounts for the wheals and itching associated with the condition. Histamine binds to H₁ and H₂ receptors in the skin to cause arteriolar dilation, venous constriction, and increased capillary permeability, accounting for the accompanying swelling.³ Not all urticaria is mediated by IgE; it can result from systemic disease processes in the body that are immune related but not related to IgE. An example would be autoimmune urticaria.

Urticaria commonly occurs with angioedema, which is marked by a greater degree of swelling and results from mast cell activation in the deeper dermis and subcutaneous tissue. Either condition can occur independently, however. Angioedema typically affects the lips, tongue, face, pharynx, and bilateral extremities; rarely, it affects the gastrointestinal tract. Angioedema may be hereditary, but its nonhereditary causes can be similar to those of urticaria.³ For example, a patient could be severely allergic to cat dander and, when exposed to this allergic trigger, develop swelling of the lips, facial edema, and flushing.

FORMS OF URTICARIA

Urticaria can be broadly divided based on the duration of illness: less than six weeks is termed acute urticaria, and continuous or intermittent presence for six weeks or more, chronic urticaria.⁴

Acute urticaria may occur in any age group but is most often seen in children.¹ Acute urticaria and angioedema frequently resolve within a few days, without an identified cause. An inciting cause can be identified in only about 15% to 20% of cases; the most common cause is viral infection, followed by foods, drugs, insect stings, transfusion reactions, and, rarely, contactants and inhalants (see Table 1).^1,5 Acute urticaria that is not associated with angioedema or respiratory distress is usually self-limited. The condition typically resolves before extensive evaluation, including testing for possible allergic triggers, can be done. The associated skin lesions are often self-limited or can be controlled symptomatically with antihistamines and avoidance of known possible triggers.¹

Chronic urticaria, sometimes called chronic idiopathic urticaria, is more common in adults, occurs on most days of the week, and, as noted, persists for more than six weeks with no identifiable triggers.⁶ It affects about 0.5% to 1% of the population (lifetime prevalence).³ Approximately 45% of patients with chronic urticaria have accompanying episodes of angioedema, and 30% to 50% have an autoimmune process involving autoantibodies against the thyroid, IgE, or the high-affinity IgE receptor (FcR1).³ The diagnosis is based primarily on clinical history and presentation; this will guide the determination of what types of diagnostic testing are necessary.

Chronic urticaria requires an extensive, but not indiscriminate, evaluation with history, physical examination, allergy testing, and laboratory testing for immune system, liver, kidney, thyroid, and collagen vascular diseases.³ Unfortunately, an identifiable cause of chronic urticaria is found in only 10% to 20% of patients; most cases are idiopathic.^3,7

Several forms of chronic urticaria can be precipitated by physical stimuli, such as exercise, generalized heat, or sweating (cholinergic urticaria); localized heat (localized heat urticaria); low temperatures (cold urticaria); sun exposure (solar urticaria); water (aquagenic urticaria); and vibration.¹ In another form (pressure urticaria), pressure on the skin increases histamine release, leading to the development of wheals and itching; this form is also called dermatographism, which means “write on skin” (see Figure 1). These types of urticaria should be evaluated and treated by a board-certified allergist, as there are special evaluations that can confirm the diagnosis.

CLINICAL FEATURES

The main feature of urticaria is raised skin lesions that appear pale to pink to erythematous and most commonly are intensely pruritic (see Figure 2). These lesions range from a few millimeters to several centimeters in size and may coalesce.

Characteristically, evanescent old lesions resolve, and new ones develop over 24 hours, usually without scarring. Scratching generally worsens dermatographism, with new urticaria produced over the scratched area. Any area of the body may be involved.

The lesions of early urticaria may vary in size and blanch when pressure is applied. An individual hive may last minutes or up to 24 hours and may reoccur intermittently on various sites on the body for an unspecified period of time.^1,6

DIFFERENTIAL DIAGNOSIS

Other dermatologic conditions may be mistaken for chronic urticaria. Common rashes that may mimic it include anaphylaxis, atopic dermatitis, medication allergy or fixed drug eruption, ACE inhibitor–related angioedema, mastocytosis, contact dermatitis, autoimmune thyroid disease, bullous pemphigoid, and dermatitis herpetiformis.

Patients should be encouraged to bring pictures of the rash to the office visit, since the rash may have waned at the time of the visit and diagnosis based on the patient’s description alone can be challenging. Most rashes in the differential can be identified or eliminated through a careful history and complete physical exam. When necessary, serologic testing and skin punch biopsies can elucidate and confirm the diagnosis.

EVALUATION

History and physical examination

The medical history is the most important part of the evaluation of a patient with urticaria. The information that should be elicited and documented during the history is shown in Table 2.

A general comprehensive physical exam should be undertaken and the findings carefully documented. As noted, it can be helpful for patients to bring in pictures of the rash if the lesions wax and wane. It is also important to assess whether the urticarial lesions blanch when palpated, since this is a characteristic feature of acute and chronic urticarial lesions (but not of those with an autoimmune, cholinergic, or vasculitic cause). Thus, blanching of the wheal is a key finding on physical exam to discriminate between possible causes.⁸ Lesions pigmented with purpuric areas that scar or last longer than 24 hours suggest urticarial vasculitis; other features that distinguish urticarial vasculitis from chronic urticaria are listed in Table 3.²

Laboratory evaluation

Although there is no consensus regarding appropriate laboratory testing, the following tests should be considered for patients with chronic urticaria after completion of a thorough history and physical exam: complete blood count (CBC) with differential; erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP); chemistry panel and hepatic panel; and thyroid-stimulating hormone, antimicrosomal antibodies, and antithyroglobulin antibodies measurements.⁷

While the CBC is usually within normal limits, if eosinophilia is present, a workup for an atopic disorder or parasitic infection should be considered. If the ESR/CRP results are positive, consider ordering a larger antinuclear antibody (ANA) panel. Note: The utility of performing these tests routinely for chronic urticaria patients is unclear, as studies have demonstrated that results are usually normal. But it is important to order the appropriate tests to help you rule in or out a likely diagnosis.

Additional testing may be indicated by non-IgE or possible autoimmune findings on the history and/or physical exam. This can include a functional autoantibody assay (for autoantibodies to the high-affinity IgE receptor [FcR1]); complement analysis (eg, C3, C4, CH50), especially when concerned about hereditary angioedema; stool analysis for ova and parasites; Helicobacter pylori workup (there is limited experimental evidence to recommend this, however); hepatitis B and C workup; chest radiograph and/or other imaging studies; ANA panel; rheumatoid factor; cryoglobulin levels; skin biopsy; and urinalysis.⁷

Local urticaria can occur following contact with allergens via an IgE-mediated mechanism. If an allergen is suspected as a possible trigger, serologic testing to assess allergen-specific IgE levels that may be contributing to the urticaria can be performed in a primary care setting. The specific IgE levels most commonly assessed are for the endemic outdoor aeroallergens (eg, pets [cat, dog], dust mites); measurement of food-specific IgE levels can be ordered if a specific allergy is a concern. Allergy skin prick testing for immediate hypersensitivity and a physical challenge test are usually performed in an allergy office by board-certified allergists.

Skin biopsy should be done on all lesions concerning for urticarial vasculitis (see Table 4).² Biopsy is also important if the hives are painful rather than pruritic, as this may suggest a different cause. The clinician should consider more detailed lab testing and skin biopsy if urticaria does not respond to therapy as anticipated. Also, specific lab testing may be required screening for certain planned medical therapies (eg, glucose-6-phosphate dehydrogenase enzyme deficiency screening before dapsone or hydroxychloroquine therapy).³

MANAGEMENT

Nonpharmacologic therapy

Treatment of the underlying cause, if identified, may be helpful and should be considered. For example, if a thyroid disorder is found on serologic testing, correcting the disorder may resolve the urticaria.⁹ Similarly, if a complement deficiency consistent with hereditary angioedema is detected, there are medications to correct it, which can be life-saving.³ Medications for treating hereditary angioedema are best prescribed in an allergy practice.

If triggers are discovered, the patient must be made aware of them and advised to avoid them as much as possible; however, total avoidance can be very difficult. Other common potentiating factors—such as alcohol overuse, excessive tiredness, emotional stress, hyperthermia, and use of aspirin and NSAIDs—should be avoided.¹⁰ These factors can worsen what is already triggering the urticaria and make it more difficult to treat; an example would be a patient who develops urticaria from a new household dog and is taking anti-inflammatory drugs for arthritis symptoms.

Topical agents rarely result in any improvement, and their use is therefore discouraged. In fact, high-potency corticosteroids may cause dermal atrophy.¹¹ Also, dietary changes are not indicated for most patients with chronic urticaria, because undiscovered allergy to food or food additives is not likely to be responsible.⁴

Antihistamines

Antihistamines are the most commonly used pharmacologic treatment for chronic urticaria (see Table 4). H₂-receptor blockers, taken in combination with first- and second-generation H₁-receptor blockers, have been reported to be more efficacious than H₁ antihistamines alone for the treatment of chronic urticaria.⁶ This added efficacy may be related to pharmacologic interactions and increased blood levels achieved with first-generation antihistamines. Increased doses of second-generation antihistamines—as high as four times the standard dose—are advocated by the 2014 Joint Task Force on Practice Parameters (JTFPP) for the diagnosis and management of acute and chronic urticaria.⁴

A stepwise approach to treatment is imperative. The JTFPP guidelines (available at www.allergyparameters.org) are summarized below.

Step 1: Administer a second-generation antihistamine at the standard therapeutic dose (see Table 4) and avoid triggers, NSAIDs, and other exacerbating ­factors.

If symptom control is not achieved in one to two weeks, move on to

Step 2: Increase therapy by one or more of the following methods: increase the dose of the second-generation antihistamine used in Step 1 (up to 4x the standard dose); add another second-generation antihistamine to the regimen; add an H₂ blocker (ranitidine, famotidine, cimetidine); and/or add a leukotriene-receptor antagonist (montelukast 10 mg/d).

If these measures do not result in adequate symptom control, it’s time for

Step 3: Gradually increase the dose of H₁ antihistamine(s) and discontinue any medications added in Step 2 that did not appear beneficial. Add a first-generation antihistamine (hydroxyzine, doxepin, cyproheptadine), which should be taken at bedtime due to risk for sedation.¹²

If symptoms are not controlled by Step 3 measures, or if the patient is unable to tolerate an increased dose of first-generation antihistamines, the urticaria is considered refractory. At this point, the clinician should consider referral to an allergy specialist for

Step 4: Add an alternative medication, such as cyclosporine (an anti-inflammatory, immunosuppressive agent) or omalizumab (a monoclonal antibody that selectively binds to IgE).

It should be noted that while the recent FDA approval of omalizumab for treatment of chronic urticaria has been life-changing for many patients, the product label does carry a black box warning about anaphylaxis. Because special monitoring is needed (and prior authorization will likely be required by the patient’s insurer), omalizu­mab is best prescribed in an allergy office.

It is not uncommon for patients with chronic urticaria to require multiple medications to control their symptoms. Once controlled, they will require maintenance and reevaluation on a regular basis.¹³

When to refer

Clinicians must know when to refer a patient with chronic urticaria to an allergist/immunologist. Referral is indicated when an underlying disorder is suspected, when symptoms are not controlled with Steps 1 to 3 of the management guidelines, or when the patient requires repeated or prolonged treatment with glucocorticoids.

Unfortunately, out of frustration on both the provider and the patient side, glucocorticoids may be started, after determining that that is “all that works” for the patient. There appears to be a limited role for glucocorticoids, so they should be avoided unless absolutely necessary (ie, if there is no response to antihistamines).

If signs and symptoms suggest urticarial vasculitis, it is prudent to consider referral to a specialist in rheumatology. Urticarial vasculitis requires a special skin punch biopsy to confirm the diagnosis.⁸ The biopsy procedure may be performed by a primary care provider; if the clinician is not comfortable doing so, referral to an appropriate dermatology provider is indicated.

PATIENT EDUCATION/REASSURANCE

Effective patient education is critical, because patients often experience considerable distress as the symptoms of chronic urticaria wax and wane unpredictably. It is not uncommon for patients with this condition to complain of symptoms that interfere with work, school, and sleep. Reassurance can help to alleviate frustration and anxiety. Patients should understand that the symptoms of chronic urticaria can be successfully managed in the majority of patients, and that chronic idiopathic urticaria is rarely permanent, with about 50% of patients experiencing remission within one year.⁶

CONCLUSION

The diagnosis of chronic urticaria is based primarily on the presentation, clinical history, and laboratory workup. Management of this chronic and uncomfortable condition requires the identification and exclusion of possible triggers, followed by effective patient education/counseling and a personalized management plan. By knowing when to suspect chronic urticaria, being familiar with the approach to evaluation and initial treatment, and knowing when referral to a specialist is indicated, primary care providers can help their patients find a path to relief.

CE/CME No: CR-1801

PROGRAM OVERVIEW
Earn credit by reading this article and successfully completing the posttest and evaluation. Successful completion is defined as a cumulative score of at least 70% correct.

EDUCATIONAL OBJECTIVES
• Differentiate between acute and chronic urticaria.
• List common history questions required for the diagnosis of chronic urticaria.
• Explain a stepwise plan for treatment of chronic urticaria.
• Describe serologic testing that should be ordered for chronic urticaria.
• Demonstrate knowledge of when to refer patients to a specialist for alternative treatment options.

FACULTY
Randy D. Danielsen is Professor and Dean of the Arizona School of Health Sciences, and  Director of the Center for the Future of the Health Professions at A.T. Still University in Mesa, Arizona. Gabriel Ortiz practices at Breathe America El Paso in Texas and is a former AAPA liaison to the American Academy of Allergy, Asthma & Immunology (AAAAI) and National Institutes of Health/National Asthma Education and Prevention Program—Coordinating Committee. Susan Symington has practiced in allergy, asthma, and immunology for more than 10 years. She is the current AAPA liaison to theAAAAI and is President-Elect of the AAPA-Allergy, Asthma, and Immunology subspecialty organization.

The authors have no financial relationships to disclose.

ACCREDITATION STATEMENT

This program has been reviewed and is approved for a maximum of 1.0 hour of American Academy of Physician Assistants (AAPA) Category 1 CME credit by the Physician Assistant Review Panel. [NPs: Both ANCC and the AANP Certification Program recognize AAPA as an approved provider of Category 1 credit.] Approval is valid through December 31, 2018.

Article begins on next page >>

The discomfort caused by an urticarial rash, along with its unpredictable course, can interfere with a patient’s sleep and work/school. Adding to the frustration of patients and providers alike, an underlying cause is seldom identified. But a stepwise treatment approach can bring relief to all.

Urticaria, often referred to as hives, is a common cutaneous disorder with a lifetime incidence between 15% and 25%.¹ Urticaria is characterized by recurring pruritic wheals that arise due to allergic and nonallergic reactions to internal and external agents. The name urticaria comes from the Latin word for “nettle,” urtica, derived from the Latin word uro, meaning “to burn.”²

Urticaria can be debilitating for patients, who may complain of a burning sensation. It can last for years in some and reduces quality of life for many. Recently, more successful treatments for urticaria have emerged that can provide tremendous relief.

It is important to understand some of the ways to diagnose and treat patients in a primary care setting and also to know when referral is appropriate. This article will discuss the diagnosis, treatment, and referral process for patients with chronic urticaria.

PATHOPHYSIOLOGY

Hives most commonly arise from an immunologic reaction in the superficial skin layers that results in the release of histamine, which causes swelling, itching, and erythema. The mast cell is the major effector cell in the pathophysiology of urticaria.³ In immunologic urticaria, the antigen binds to immunoglobulin (Ig) E on the mast cell surface, causing degranulation and release of histamine, which accounts for the wheals and itching associated with the condition. Histamine binds to H₁ and H₂ receptors in the skin to cause arteriolar dilation, venous constriction, and increased capillary permeability, accounting for the accompanying swelling.³ Not all urticaria is mediated by IgE; it can result from systemic disease processes in the body that are immune related but not related to IgE. An example would be autoimmune urticaria.

Urticaria commonly occurs with angioedema, which is marked by a greater degree of swelling and results from mast cell activation in the deeper dermis and subcutaneous tissue. Either condition can occur independently, however. Angioedema typically affects the lips, tongue, face, pharynx, and bilateral extremities; rarely, it affects the gastrointestinal tract. Angioedema may be hereditary, but its nonhereditary causes can be similar to those of urticaria.³ For example, a patient could be severely allergic to cat dander and, when exposed to this allergic trigger, develop swelling of the lips, facial edema, and flushing.

FORMS OF URTICARIA

Urticaria can be broadly divided based on the duration of illness: less than six weeks is termed acute urticaria, and continuous or intermittent presence for six weeks or more, chronic urticaria.⁴

Acute urticaria may occur in any age group but is most often seen in children.¹ Acute urticaria and angioedema frequently resolve within a few days, without an identified cause. An inciting cause can be identified in only about 15% to 20% of cases; the most common cause is viral infection, followed by foods, drugs, insect stings, transfusion reactions, and, rarely, contactants and inhalants (see Table 1).^1,5 Acute urticaria that is not associated with angioedema or respiratory distress is usually self-limited. The condition typically resolves before extensive evaluation, including testing for possible allergic triggers, can be done. The associated skin lesions are often self-limited or can be controlled symptomatically with antihistamines and avoidance of known possible triggers.¹

Chronic urticaria, sometimes called chronic idiopathic urticaria, is more common in adults, occurs on most days of the week, and, as noted, persists for more than six weeks with no identifiable triggers.⁶ It affects about 0.5% to 1% of the population (lifetime prevalence).³ Approximately 45% of patients with chronic urticaria have accompanying episodes of angioedema, and 30% to 50% have an autoimmune process involving autoantibodies against the thyroid, IgE, or the high-affinity IgE receptor (FcR1).³ The diagnosis is based primarily on clinical history and presentation; this will guide the determination of what types of diagnostic testing are necessary.

Chronic urticaria requires an extensive, but not indiscriminate, evaluation with history, physical examination, allergy testing, and laboratory testing for immune system, liver, kidney, thyroid, and collagen vascular diseases.³ Unfortunately, an identifiable cause of chronic urticaria is found in only 10% to 20% of patients; most cases are idiopathic.^3,7

Several forms of chronic urticaria can be precipitated by physical stimuli, such as exercise, generalized heat, or sweating (cholinergic urticaria); localized heat (localized heat urticaria); low temperatures (cold urticaria); sun exposure (solar urticaria); water (aquagenic urticaria); and vibration.¹ In another form (pressure urticaria), pressure on the skin increases histamine release, leading to the development of wheals and itching; this form is also called dermatographism, which means “write on skin” (see Figure 1). These types of urticaria should be evaluated and treated by a board-certified allergist, as there are special evaluations that can confirm the diagnosis.

CLINICAL FEATURES

The main feature of urticaria is raised skin lesions that appear pale to pink to erythematous and most commonly are intensely pruritic (see Figure 2). These lesions range from a few millimeters to several centimeters in size and may coalesce.

Characteristically, evanescent old lesions resolve, and new ones develop over 24 hours, usually without scarring. Scratching generally worsens dermatographism, with new urticaria produced over the scratched area. Any area of the body may be involved.

The lesions of early urticaria may vary in size and blanch when pressure is applied. An individual hive may last minutes or up to 24 hours and may reoccur intermittently on various sites on the body for an unspecified period of time.^1,6

DIFFERENTIAL DIAGNOSIS

Other dermatologic conditions may be mistaken for chronic urticaria. Common rashes that may mimic it include anaphylaxis, atopic dermatitis, medication allergy or fixed drug eruption, ACE inhibitor–related angioedema, mastocytosis, contact dermatitis, autoimmune thyroid disease, bullous pemphigoid, and dermatitis herpetiformis.

Patients should be encouraged to bring pictures of the rash to the office visit, since the rash may have waned at the time of the visit and diagnosis based on the patient’s description alone can be challenging. Most rashes in the differential can be identified or eliminated through a careful history and complete physical exam. When necessary, serologic testing and skin punch biopsies can elucidate and confirm the diagnosis.

EVALUATION

History and physical examination

The medical history is the most important part of the evaluation of a patient with urticaria. The information that should be elicited and documented during the history is shown in Table 2.

A general comprehensive physical exam should be undertaken and the findings carefully documented. As noted, it can be helpful for patients to bring in pictures of the rash if the lesions wax and wane. It is also important to assess whether the urticarial lesions blanch when palpated, since this is a characteristic feature of acute and chronic urticarial lesions (but not of those with an autoimmune, cholinergic, or vasculitic cause). Thus, blanching of the wheal is a key finding on physical exam to discriminate between possible causes.⁸ Lesions pigmented with purpuric areas that scar or last longer than 24 hours suggest urticarial vasculitis; other features that distinguish urticarial vasculitis from chronic urticaria are listed in Table 3.²

Laboratory evaluation

Although there is no consensus regarding appropriate laboratory testing, the following tests should be considered for patients with chronic urticaria after completion of a thorough history and physical exam: complete blood count (CBC) with differential; erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP); chemistry panel and hepatic panel; and thyroid-stimulating hormone, antimicrosomal antibodies, and antithyroglobulin antibodies measurements.⁷

While the CBC is usually within normal limits, if eosinophilia is present, a workup for an atopic disorder or parasitic infection should be considered. If the ESR/CRP results are positive, consider ordering a larger antinuclear antibody (ANA) panel. Note: The utility of performing these tests routinely for chronic urticaria patients is unclear, as studies have demonstrated that results are usually normal. But it is important to order the appropriate tests to help you rule in or out a likely diagnosis.

Additional testing may be indicated by non-IgE or possible autoimmune findings on the history and/or physical exam. This can include a functional autoantibody assay (for autoantibodies to the high-affinity IgE receptor [FcR1]); complement analysis (eg, C3, C4, CH50), especially when concerned about hereditary angioedema; stool analysis for ova and parasites; Helicobacter pylori workup (there is limited experimental evidence to recommend this, however); hepatitis B and C workup; chest radiograph and/or other imaging studies; ANA panel; rheumatoid factor; cryoglobulin levels; skin biopsy; and urinalysis.⁷

Local urticaria can occur following contact with allergens via an IgE-mediated mechanism. If an allergen is suspected as a possible trigger, serologic testing to assess allergen-specific IgE levels that may be contributing to the urticaria can be performed in a primary care setting. The specific IgE levels most commonly assessed are for the endemic outdoor aeroallergens (eg, pets [cat, dog], dust mites); measurement of food-specific IgE levels can be ordered if a specific allergy is a concern. Allergy skin prick testing for immediate hypersensitivity and a physical challenge test are usually performed in an allergy office by board-certified allergists.

Skin biopsy should be done on all lesions concerning for urticarial vasculitis (see Table 4).² Biopsy is also important if the hives are painful rather than pruritic, as this may suggest a different cause. The clinician should consider more detailed lab testing and skin biopsy if urticaria does not respond to therapy as anticipated. Also, specific lab testing may be required screening for certain planned medical therapies (eg, glucose-6-phosphate dehydrogenase enzyme deficiency screening before dapsone or hydroxychloroquine therapy).³

MANAGEMENT

Nonpharmacologic therapy

Treatment of the underlying cause, if identified, may be helpful and should be considered. For example, if a thyroid disorder is found on serologic testing, correcting the disorder may resolve the urticaria.⁹ Similarly, if a complement deficiency consistent with hereditary angioedema is detected, there are medications to correct it, which can be life-saving.³ Medications for treating hereditary angioedema are best prescribed in an allergy practice.

If triggers are discovered, the patient must be made aware of them and advised to avoid them as much as possible; however, total avoidance can be very difficult. Other common potentiating factors—such as alcohol overuse, excessive tiredness, emotional stress, hyperthermia, and use of aspirin and NSAIDs—should be avoided.¹⁰ These factors can worsen what is already triggering the urticaria and make it more difficult to treat; an example would be a patient who develops urticaria from a new household dog and is taking anti-inflammatory drugs for arthritis symptoms.

Topical agents rarely result in any improvement, and their use is therefore discouraged. In fact, high-potency corticosteroids may cause dermal atrophy.¹¹ Also, dietary changes are not indicated for most patients with chronic urticaria, because undiscovered allergy to food or food additives is not likely to be responsible.⁴

Antihistamines

Antihistamines are the most commonly used pharmacologic treatment for chronic urticaria (see Table 4). H₂-receptor blockers, taken in combination with first- and second-generation H₁-receptor blockers, have been reported to be more efficacious than H₁ antihistamines alone for the treatment of chronic urticaria.⁶ This added efficacy may be related to pharmacologic interactions and increased blood levels achieved with first-generation antihistamines. Increased doses of second-generation antihistamines—as high as four times the standard dose—are advocated by the 2014 Joint Task Force on Practice Parameters (JTFPP) for the diagnosis and management of acute and chronic urticaria.⁴

A stepwise approach to treatment is imperative. The JTFPP guidelines (available at www.allergyparameters.org) are summarized below.

Step 1: Administer a second-generation antihistamine at the standard therapeutic dose (see Table 4) and avoid triggers, NSAIDs, and other exacerbating ­factors.

If symptom control is not achieved in one to two weeks, move on to

Step 2: Increase therapy by one or more of the following methods: increase the dose of the second-generation antihistamine used in Step 1 (up to 4x the standard dose); add another second-generation antihistamine to the regimen; add an H₂ blocker (ranitidine, famotidine, cimetidine); and/or add a leukotriene-receptor antagonist (montelukast 10 mg/d).

If these measures do not result in adequate symptom control, it’s time for

Step 3: Gradually increase the dose of H₁ antihistamine(s) and discontinue any medications added in Step 2 that did not appear beneficial. Add a first-generation antihistamine (hydroxyzine, doxepin, cyproheptadine), which should be taken at bedtime due to risk for sedation.¹²

If symptoms are not controlled by Step 3 measures, or if the patient is unable to tolerate an increased dose of first-generation antihistamines, the urticaria is considered refractory. At this point, the clinician should consider referral to an allergy specialist for

Step 4: Add an alternative medication, such as cyclosporine (an anti-inflammatory, immunosuppressive agent) or omalizumab (a monoclonal antibody that selectively binds to IgE).

It should be noted that while the recent FDA approval of omalizumab for treatment of chronic urticaria has been life-changing for many patients, the product label does carry a black box warning about anaphylaxis. Because special monitoring is needed (and prior authorization will likely be required by the patient’s insurer), omalizu­mab is best prescribed in an allergy office.

It is not uncommon for patients with chronic urticaria to require multiple medications to control their symptoms. Once controlled, they will require maintenance and reevaluation on a regular basis.¹³

When to refer

Clinicians must know when to refer a patient with chronic urticaria to an allergist/immunologist. Referral is indicated when an underlying disorder is suspected, when symptoms are not controlled with Steps 1 to 3 of the management guidelines, or when the patient requires repeated or prolonged treatment with glucocorticoids.

Unfortunately, out of frustration on both the provider and the patient side, glucocorticoids may be started, after determining that that is “all that works” for the patient. There appears to be a limited role for glucocorticoids, so they should be avoided unless absolutely necessary (ie, if there is no response to antihistamines).

If signs and symptoms suggest urticarial vasculitis, it is prudent to consider referral to a specialist in rheumatology. Urticarial vasculitis requires a special skin punch biopsy to confirm the diagnosis.⁸ The biopsy procedure may be performed by a primary care provider; if the clinician is not comfortable doing so, referral to an appropriate dermatology provider is indicated.

PATIENT EDUCATION/REASSURANCE

Effective patient education is critical, because patients often experience considerable distress as the symptoms of chronic urticaria wax and wane unpredictably. It is not uncommon for patients with this condition to complain of symptoms that interfere with work, school, and sleep. Reassurance can help to alleviate frustration and anxiety. Patients should understand that the symptoms of chronic urticaria can be successfully managed in the majority of patients, and that chronic idiopathic urticaria is rarely permanent, with about 50% of patients experiencing remission within one year.⁶

CONCLUSION

The diagnosis of chronic urticaria is based primarily on the presentation, clinical history, and laboratory workup. Management of this chronic and uncomfortable condition requires the identification and exclusion of possible triggers, followed by effective patient education/counseling and a personalized management plan. By knowing when to suspect chronic urticaria, being familiar with the approach to evaluation and initial treatment, and knowing when referral to a specialist is indicated, primary care providers can help their patients find a path to relief.

CE/CME No: CR-1801

PROGRAM OVERVIEW
Earn credit by reading this article and successfully completing the posttest and evaluation. Successful completion is defined as a cumulative score of at least 70% correct.

EDUCATIONAL OBJECTIVES
• Differentiate between acute and chronic urticaria.
• List common history questions required for the diagnosis of chronic urticaria.
• Explain a stepwise plan for treatment of chronic urticaria.
• Describe serologic testing that should be ordered for chronic urticaria.
• Demonstrate knowledge of when to refer patients to a specialist for alternative treatment options.

FACULTY
Randy D. Danielsen is Professor and Dean of the Arizona School of Health Sciences, and  Director of the Center for the Future of the Health Professions at A.T. Still University in Mesa, Arizona. Gabriel Ortiz practices at Breathe America El Paso in Texas and is a former AAPA liaison to the American Academy of Allergy, Asthma & Immunology (AAAAI) and National Institutes of Health/National Asthma Education and Prevention Program—Coordinating Committee. Susan Symington has practiced in allergy, asthma, and immunology for more than 10 years. She is the current AAPA liaison to theAAAAI and is President-Elect of the AAPA-Allergy, Asthma, and Immunology subspecialty organization.

The authors have no financial relationships to disclose.

ACCREDITATION STATEMENT

This program has been reviewed and is approved for a maximum of 1.0 hour of American Academy of Physician Assistants (AAPA) Category 1 CME credit by the Physician Assistant Review Panel. [NPs: Both ANCC and the AANP Certification Program recognize AAPA as an approved provider of Category 1 credit.] Approval is valid through December 31, 2018.

Article begins on next page >>

The discomfort caused by an urticarial rash, along with its unpredictable course, can interfere with a patient’s sleep and work/school. Adding to the frustration of patients and providers alike, an underlying cause is seldom identified. But a stepwise treatment approach can bring relief to all.

Urticaria, often referred to as hives, is a common cutaneous disorder with a lifetime incidence between 15% and 25%.¹ Urticaria is characterized by recurring pruritic wheals that arise due to allergic and nonallergic reactions to internal and external agents. The name urticaria comes from the Latin word for “nettle,” urtica, derived from the Latin word uro, meaning “to burn.”²

Urticaria can be debilitating for patients, who may complain of a burning sensation. It can last for years in some and reduces quality of life for many. Recently, more successful treatments for urticaria have emerged that can provide tremendous relief.

It is important to understand some of the ways to diagnose and treat patients in a primary care setting and also to know when referral is appropriate. This article will discuss the diagnosis, treatment, and referral process for patients with chronic urticaria.

PATHOPHYSIOLOGY

Hives most commonly arise from an immunologic reaction in the superficial skin layers that results in the release of histamine, which causes swelling, itching, and erythema. The mast cell is the major effector cell in the pathophysiology of urticaria.³ In immunologic urticaria, the antigen binds to immunoglobulin (Ig) E on the mast cell surface, causing degranulation and release of histamine, which accounts for the wheals and itching associated with the condition. Histamine binds to H₁ and H₂ receptors in the skin to cause arteriolar dilation, venous constriction, and increased capillary permeability, accounting for the accompanying swelling.³ Not all urticaria is mediated by IgE; it can result from systemic disease processes in the body that are immune related but not related to IgE. An example would be autoimmune urticaria.

Urticaria commonly occurs with angioedema, which is marked by a greater degree of swelling and results from mast cell activation in the deeper dermis and subcutaneous tissue. Either condition can occur independently, however. Angioedema typically affects the lips, tongue, face, pharynx, and bilateral extremities; rarely, it affects the gastrointestinal tract. Angioedema may be hereditary, but its nonhereditary causes can be similar to those of urticaria.³ For example, a patient could be severely allergic to cat dander and, when exposed to this allergic trigger, develop swelling of the lips, facial edema, and flushing.

FORMS OF URTICARIA

Urticaria can be broadly divided based on the duration of illness: less than six weeks is termed acute urticaria, and continuous or intermittent presence for six weeks or more, chronic urticaria.⁴

Acute urticaria may occur in any age group but is most often seen in children.¹ Acute urticaria and angioedema frequently resolve within a few days, without an identified cause. An inciting cause can be identified in only about 15% to 20% of cases; the most common cause is viral infection, followed by foods, drugs, insect stings, transfusion reactions, and, rarely, contactants and inhalants (see Table 1).^1,5 Acute urticaria that is not associated with angioedema or respiratory distress is usually self-limited. The condition typically resolves before extensive evaluation, including testing for possible allergic triggers, can be done. The associated skin lesions are often self-limited or can be controlled symptomatically with antihistamines and avoidance of known possible triggers.¹

Chronic urticaria, sometimes called chronic idiopathic urticaria, is more common in adults, occurs on most days of the week, and, as noted, persists for more than six weeks with no identifiable triggers.⁶ It affects about 0.5% to 1% of the population (lifetime prevalence).³ Approximately 45% of patients with chronic urticaria have accompanying episodes of angioedema, and 30% to 50% have an autoimmune process involving autoantibodies against the thyroid, IgE, or the high-affinity IgE receptor (FcR1).³ The diagnosis is based primarily on clinical history and presentation; this will guide the determination of what types of diagnostic testing are necessary.

Chronic urticaria requires an extensive, but not indiscriminate, evaluation with history, physical examination, allergy testing, and laboratory testing for immune system, liver, kidney, thyroid, and collagen vascular diseases.³ Unfortunately, an identifiable cause of chronic urticaria is found in only 10% to 20% of patients; most cases are idiopathic.^3,7

Several forms of chronic urticaria can be precipitated by physical stimuli, such as exercise, generalized heat, or sweating (cholinergic urticaria); localized heat (localized heat urticaria); low temperatures (cold urticaria); sun exposure (solar urticaria); water (aquagenic urticaria); and vibration.¹ In another form (pressure urticaria), pressure on the skin increases histamine release, leading to the development of wheals and itching; this form is also called dermatographism, which means “write on skin” (see Figure 1). These types of urticaria should be evaluated and treated by a board-certified allergist, as there are special evaluations that can confirm the diagnosis.

CLINICAL FEATURES

The main feature of urticaria is raised skin lesions that appear pale to pink to erythematous and most commonly are intensely pruritic (see Figure 2). These lesions range from a few millimeters to several centimeters in size and may coalesce.

Characteristically, evanescent old lesions resolve, and new ones develop over 24 hours, usually without scarring. Scratching generally worsens dermatographism, with new urticaria produced over the scratched area. Any area of the body may be involved.

The lesions of early urticaria may vary in size and blanch when pressure is applied. An individual hive may last minutes or up to 24 hours and may reoccur intermittently on various sites on the body for an unspecified period of time.^1,6

DIFFERENTIAL DIAGNOSIS

Other dermatologic conditions may be mistaken for chronic urticaria. Common rashes that may mimic it include anaphylaxis, atopic dermatitis, medication allergy or fixed drug eruption, ACE inhibitor–related angioedema, mastocytosis, contact dermatitis, autoimmune thyroid disease, bullous pemphigoid, and dermatitis herpetiformis.

Patients should be encouraged to bring pictures of the rash to the office visit, since the rash may have waned at the time of the visit and diagnosis based on the patient’s description alone can be challenging. Most rashes in the differential can be identified or eliminated through a careful history and complete physical exam. When necessary, serologic testing and skin punch biopsies can elucidate and confirm the diagnosis.

EVALUATION

History and physical examination

The medical history is the most important part of the evaluation of a patient with urticaria. The information that should be elicited and documented during the history is shown in Table 2.

A general comprehensive physical exam should be undertaken and the findings carefully documented. As noted, it can be helpful for patients to bring in pictures of the rash if the lesions wax and wane. It is also important to assess whether the urticarial lesions blanch when palpated, since this is a characteristic feature of acute and chronic urticarial lesions (but not of those with an autoimmune, cholinergic, or vasculitic cause). Thus, blanching of the wheal is a key finding on physical exam to discriminate between possible causes.⁸ Lesions pigmented with purpuric areas that scar or last longer than 24 hours suggest urticarial vasculitis; other features that distinguish urticarial vasculitis from chronic urticaria are listed in Table 3.²

Laboratory evaluation

Although there is no consensus regarding appropriate laboratory testing, the following tests should be considered for patients with chronic urticaria after completion of a thorough history and physical exam: complete blood count (CBC) with differential; erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP); chemistry panel and hepatic panel; and thyroid-stimulating hormone, antimicrosomal antibodies, and antithyroglobulin antibodies measurements.⁷

While the CBC is usually within normal limits, if eosinophilia is present, a workup for an atopic disorder or parasitic infection should be considered. If the ESR/CRP results are positive, consider ordering a larger antinuclear antibody (ANA) panel. Note: The utility of performing these tests routinely for chronic urticaria patients is unclear, as studies have demonstrated that results are usually normal. But it is important to order the appropriate tests to help you rule in or out a likely diagnosis.

Additional testing may be indicated by non-IgE or possible autoimmune findings on the history and/or physical exam. This can include a functional autoantibody assay (for autoantibodies to the high-affinity IgE receptor [FcR1]); complement analysis (eg, C3, C4, CH50), especially when concerned about hereditary angioedema; stool analysis for ova and parasites; Helicobacter pylori workup (there is limited experimental evidence to recommend this, however); hepatitis B and C workup; chest radiograph and/or other imaging studies; ANA panel; rheumatoid factor; cryoglobulin levels; skin biopsy; and urinalysis.⁷

Local urticaria can occur following contact with allergens via an IgE-mediated mechanism. If an allergen is suspected as a possible trigger, serologic testing to assess allergen-specific IgE levels that may be contributing to the urticaria can be performed in a primary care setting. The specific IgE levels most commonly assessed are for the endemic outdoor aeroallergens (eg, pets [cat, dog], dust mites); measurement of food-specific IgE levels can be ordered if a specific allergy is a concern. Allergy skin prick testing for immediate hypersensitivity and a physical challenge test are usually performed in an allergy office by board-certified allergists.

Skin biopsy should be done on all lesions concerning for urticarial vasculitis (see Table 4).² Biopsy is also important if the hives are painful rather than pruritic, as this may suggest a different cause. The clinician should consider more detailed lab testing and skin biopsy if urticaria does not respond to therapy as anticipated. Also, specific lab testing may be required screening for certain planned medical therapies (eg, glucose-6-phosphate dehydrogenase enzyme deficiency screening before dapsone or hydroxychloroquine therapy).³

MANAGEMENT

Nonpharmacologic therapy

Treatment of the underlying cause, if identified, may be helpful and should be considered. For example, if a thyroid disorder is found on serologic testing, correcting the disorder may resolve the urticaria.⁹ Similarly, if a complement deficiency consistent with hereditary angioedema is detected, there are medications to correct it, which can be life-saving.³ Medications for treating hereditary angioedema are best prescribed in an allergy practice.

If triggers are discovered, the patient must be made aware of them and advised to avoid them as much as possible; however, total avoidance can be very difficult. Other common potentiating factors—such as alcohol overuse, excessive tiredness, emotional stress, hyperthermia, and use of aspirin and NSAIDs—should be avoided.¹⁰ These factors can worsen what is already triggering the urticaria and make it more difficult to treat; an example would be a patient who develops urticaria from a new household dog and is taking anti-inflammatory drugs for arthritis symptoms.

Topical agents rarely result in any improvement, and their use is therefore discouraged. In fact, high-potency corticosteroids may cause dermal atrophy.¹¹ Also, dietary changes are not indicated for most patients with chronic urticaria, because undiscovered allergy to food or food additives is not likely to be responsible.⁴

Antihistamines

Antihistamines are the most commonly used pharmacologic treatment for chronic urticaria (see Table 4). H₂-receptor blockers, taken in combination with first- and second-generation H₁-receptor blockers, have been reported to be more efficacious than H₁ antihistamines alone for the treatment of chronic urticaria.⁶ This added efficacy may be related to pharmacologic interactions and increased blood levels achieved with first-generation antihistamines. Increased doses of second-generation antihistamines—as high as four times the standard dose—are advocated by the 2014 Joint Task Force on Practice Parameters (JTFPP) for the diagnosis and management of acute and chronic urticaria.⁴

A stepwise approach to treatment is imperative. The JTFPP guidelines (available at www.allergyparameters.org) are summarized below.

Step 1: Administer a second-generation antihistamine at the standard therapeutic dose (see Table 4) and avoid triggers, NSAIDs, and other exacerbating ­factors.

If symptom control is not achieved in one to two weeks, move on to

Step 2: Increase therapy by one or more of the following methods: increase the dose of the second-generation antihistamine used in Step 1 (up to 4x the standard dose); add another second-generation antihistamine to the regimen; add an H₂ blocker (ranitidine, famotidine, cimetidine); and/or add a leukotriene-receptor antagonist (montelukast 10 mg/d).

If these measures do not result in adequate symptom control, it’s time for

Step 3: Gradually increase the dose of H₁ antihistamine(s) and discontinue any medications added in Step 2 that did not appear beneficial. Add a first-generation antihistamine (hydroxyzine, doxepin, cyproheptadine), which should be taken at bedtime due to risk for sedation.¹²

If symptoms are not controlled by Step 3 measures, or if the patient is unable to tolerate an increased dose of first-generation antihistamines, the urticaria is considered refractory. At this point, the clinician should consider referral to an allergy specialist for

Step 4: Add an alternative medication, such as cyclosporine (an anti-inflammatory, immunosuppressive agent) or omalizumab (a monoclonal antibody that selectively binds to IgE).

It should be noted that while the recent FDA approval of omalizumab for treatment of chronic urticaria has been life-changing for many patients, the product label does carry a black box warning about anaphylaxis. Because special monitoring is needed (and prior authorization will likely be required by the patient’s insurer), omalizu­mab is best prescribed in an allergy office.

It is not uncommon for patients with chronic urticaria to require multiple medications to control their symptoms. Once controlled, they will require maintenance and reevaluation on a regular basis.¹³

When to refer

Clinicians must know when to refer a patient with chronic urticaria to an allergist/immunologist. Referral is indicated when an underlying disorder is suspected, when symptoms are not controlled with Steps 1 to 3 of the management guidelines, or when the patient requires repeated or prolonged treatment with glucocorticoids.

Unfortunately, out of frustration on both the provider and the patient side, glucocorticoids may be started, after determining that that is “all that works” for the patient. There appears to be a limited role for glucocorticoids, so they should be avoided unless absolutely necessary (ie, if there is no response to antihistamines).

If signs and symptoms suggest urticarial vasculitis, it is prudent to consider referral to a specialist in rheumatology. Urticarial vasculitis requires a special skin punch biopsy to confirm the diagnosis.⁸ The biopsy procedure may be performed by a primary care provider; if the clinician is not comfortable doing so, referral to an appropriate dermatology provider is indicated.

PATIENT EDUCATION/REASSURANCE

Effective patient education is critical, because patients often experience considerable distress as the symptoms of chronic urticaria wax and wane unpredictably. It is not uncommon for patients with this condition to complain of symptoms that interfere with work, school, and sleep. Reassurance can help to alleviate frustration and anxiety. Patients should understand that the symptoms of chronic urticaria can be successfully managed in the majority of patients, and that chronic idiopathic urticaria is rarely permanent, with about 50% of patients experiencing remission within one year.⁶

CONCLUSION

The diagnosis of chronic urticaria is based primarily on the presentation, clinical history, and laboratory workup. Management of this chronic and uncomfortable condition requires the identification and exclusion of possible triggers, followed by effective patient education/counseling and a personalized management plan. By knowing when to suspect chronic urticaria, being familiar with the approach to evaluation and initial treatment, and knowing when referral to a specialist is indicated, primary care providers can help their patients find a path to relief.

This video was filmed at Metabolic & Endocrine Disease Summit (MEDS). Click here to learn more.

This video was filmed at Metabolic & Endocrine Disease Summit (MEDS). Click here to learn more.

This video was filmed at Metabolic & Endocrine Disease Summit (MEDS). Click here to learn more.

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