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PCP Communication at Discharge
Transitions of care from hospital to home are high‐risk times for patients.[1, 2] Increasing complexity of hospital admissions and shorter lengths of stay demand more effective coordination of care between hospitalists and outpatient clinicians.[3, 4, 5] Inaccurate, delayed, or incomplete clinical handoversthat is, transfer of information and professional responsibility and accountability[6]can lead to patient harm, and has been recognized as a key cause of preventable morbidity by the World Health Organization and The Joint Commission.[6, 7, 8] Conversely, when done effectively, transitions can result in improved patient health outcomes, reduced readmission rates, and higher patient and provider satisfaction.3
Previous studies note deficits in communication at discharge and primary care provider (PCP) dissatisfaction with discharge practices.[4, 9, 10, 11, 12, 13] In studies at academic medical centers, there were low rates of direct communication between inpatient and outpatient providers, mainly because of providers' belief that the discharge summary was adequate and the presence of significant barriers to direct communication.[14, 15] However, studies have shown that discharge summaries often omit critical information, and often are not available to PCPs in a timely manner.[10, 11, 12, 16] In response, the Society of Hospital Medicine developed a discharge checklist to aide in standardization of safe discharge practices.[1, 5] Discharge summary templates further attempt to improve documentation of patients' hospital courses. An electronic medical record (EMR) system shared by both inpatient and outpatient clinicians should impart several advantages: (1) automated alerts provide timely notification to PCPs regarding admission and discharge, (2) discharge summaries are available to the PCP as soon as they are written, and (3) all patient information pertaining to the hospitalization is available to the PCP.
Although it is plausible that shared EMRs should facilitate transitions of care by streamlining communication between hospitalists and PCPs, guidelines on format and content of PCP communication at discharge in the era of a shared EMR have yet to be defined. In this study, we sought to understand current discharge communication practices and PCP satisfaction within a shared EMR at our institution, and to identify key areas in which communication can be improved.
METHODS
Participants and Setting
We surveyed all resident and attending PCPs (n=124) working in the Division of General Internal Medicine (DGIM) Outpatient Practice at the University of California, San Francisco (UCSF). In June 2012, the outpatient and inpatient practices of UCSF transitioned from having separate medical record systems to a shared EMR (Epic Systems Corp., Verona, WI) where all informationboth inpatient and outpatientis accessible among healthcare professionals. The EMR provides automated notifications of admission and discharge to PCPs, allows for review of inpatient notes, labs, and studies, and immediate access to templated discharge summaries (see Supporting Information, Appendix 1, in the online version of this article). The EMR also enables secure communication between clinicians. At our institution, over 90% of discharge summaries are completed within 24 hours of discharge.[17]
Study Design and Analysis
We developed a survey about the discharge communication practices of inpatient medicine patients based on a previously described survey in the literature (see Supporting Information, Appendix 2, in the online version of this article).[9] The anonymous, 17‐question survey was electronically distributed to resident and attending PCPs at the DGIM practice. The survey was designed to determine: (1) overall PCP satisfaction with current communication practices from the inpatient team at patient discharge, (2) perceived adequacy of automatic discharge notifications, and (3) perception of the types of patients and hospitalizations requiring additional high‐touch communication at discharge.
We analyzed results of our survey using descriptive statistics. Differences in resident and attending responses were analyzed by 2tests.
RESULTS
Seventy‐five of 124 (60%) clinicians (46% residents, 54% attendings) completed the survey. Thirty‐nine (52%) PCPs were satisfied or very satisfied with communication at patient discharge. Although most reported receiving automated discharge notifications (71%), only 39% felt that the notifications plus the discharge summaries were adequate communication for safe transition of care from hospital to community. Fifty‐one percent desired direct contact beyond a discharge summary. There were no differences in preferences on discharge communication between resident and attending PCPs (P>0.05).
Over three‐fourths of PCPs surveyed preferred that for patients with complex hospitalizations (multiple readmissions, multiple active comorbidities, goals of care changes, high‐risk medication changes, time‐sensitive follow‐up needs), an additional e‐mail or verbal communication was needed to augment the information in the discharge summary (Figure 1). Only 31% reported receiving such communication.
When asked about important items to communicate for safer transitions of care, PCPs reported finding the following elements most critical: (1) medication changes (93%), (2) follow‐up actions for the PCP (88%), and (3) active medical issues (84%) (Figure 2).
CONCLUSIONS
In the era of shared EMRs, real‐time access to medication lists, pending test results, and discharge summaries should facilitate care transitions at discharge.[18, 19] We conducted a study to determine PCP perceptions of discharge communication after implementation of a shared EMR. We found that although PCPs largely acknowledged timely receipt of automated discharge notifications and discharge summaries, the majority of PCPs felt that most discharges required additional communication to ensure safe transition of care.
Guidelines for discharge communication emphasize timely communication with the PCP, primarily through discharge summaries containing key safety elements.[1, 5, 10] At our institution, we have improved the timeliness and quality of discharge summaries according to guideline recommendations,[17] and conducted quality improvement projects to improve rates of direct communication with PCPs.[9] In addition, the shared EMR provides automated notifications to PCPs when their patients are discharged. Despite these interventions, our survey shows that PCP satisfaction with discharge communication is still inadequate. PCPs desired direct communication that highlights active medical issues, medication changes, and specific follow‐up actions. Although all of these topics are included in our discharge summary template (see Supporting Information, Appendix 1, in the online version of this article), it is possible that the templated discharge summaries lend themselves to longer documents and information overload, as prior studies have documented the desire for more succinct discharge summaries.[18] We also found that automated notifications of discharge were less reliable and useful for PCPs than anticipated. There were several reasons for this: (1) discharge summaries sometimes were sent to PCPs uncoupled from the discharge notification, (2) there were errors with the generation and delivery of automated messages at the rollout of the new system, and (3) PCPs received many other automated system messages, meaning that discharge notifications could be easily missed. These factors all likely contribute to PCPs' desire for high‐touch communication that highlights the most salient aspects of each patient's hospitalization. It is also possible that automated notifications and depersonalized discharge summaries create distance and a less‐collaborative feeling to patient care. PCPs want more direct communication, and desire to play a more active role in inpatient management, especially for complex hospitalizations.[18] This emphasis on direct communication resonates with previous studies conducted before shared EMRs existed.[9, 12, 19]
Our study had several limitations. First, because this is a single‐institution study at a tertiary care academic setting, the results may not be generalizable to all shared EMR settings, and may not reflect all the challenges of communication with the wider community of outpatient providers. One can postulate that inpatient and outpatient clinician relationships are stronger in an academic setting than in other more disparate environments, where direct communication may happen even less frequently. Of note, our low rates of direct communication are consistent with other single‐ and multi‐institution studies, suggesting that our findings are generalizable.[14, 15] Second, our survey is limited in its ability to distinguish those patients who require high‐touch communication and those who do not. Third, although we have used the survey to assess PCP satisfaction in previous studies, it is not a validated instrument, and therefore we cannot reliably say that increasing direct PCP communication would increase their satisfaction around discharge. Last, the PCP‐reported rates of discharge communication are subjective and may be influenced by recall bias. We did not have a systematic way to confirm the actual rates of communication at discharge, which could have occurred through EMR messages, e‐mails, phone calls, or pages.
Although a shared EMR allows for real‐time access to patient data, it does not eliminate PCPs' desire for direct 2‐way dialogue at discharge, especially for complex patients. Key information desired in such communication should include active medical issues, medication changes, and follow‐up needs, which is consistent with prior studies. Standardizing this direct communication process in an efficient way can be challenging. Further elucidation of PCP preferences around which patients necessitate higher‐level communication and preferred methods and timing of communication is needed, as well as determining the most efficient and effective method for hospitalists to provide such communication. Improving communication between hospitalists and PCPs requires not just the presence of a shared EMR, but additional, systematic efforts to engage both inpatient and outpatient clinicians in collaborative care.
Disclosure
Nothing to report.
- , , , et al. Development of a checklist of safe discharge practices for hospital patients. J Hosp Med. 2013;8(8):444–449.
- , , , , The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161–167.
- , , , et al. Improving patient handovers from hospital to primary care: a systematic review. Ann Intern Med. 2012;157(6):417–428.
- , , , , “Did I do as best as the system would let me?” Healthcare professional views on hospital to home care transitions. J Gen Intern Med. 2012;27(12):1649–1656.
- , , , et al. Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med. 2006;1(6):354−660.
- , , , , Improving measurement in clinical handover. Qual Saf Health Care. 2009;18:272–277.
- World Health Organization. Patient safety: action on patient safety: high 5s. 2007. Available at: http://www.who.int/patientsafety/implementation/solutions/high5s/en/index.html. Accessed January 28, 2015.
- The Joint Commission Center for Transforming Healthcare. Hand‐off communications. 2012. Available at: http://www.centerfortransforminghealthcare.org/projects/detail.aspx?Project=1. Accessed January 28, 2015.
- , , , et al. The effect of a resident‐led quality improvement project on improving communication between hospital‐based and outpatient physicians. Am J Med Qual. 2013;28(6):472–479.
- , , , Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007;2(5):314–323.
- , , , , , Deficits in communication and information transfer between hospital‐based and primary care physicians: implications for patient safety and continuity of care. JAMA. 2007;297(8):831–841.
- , , , Primary care physician attitudes regarding communication with hospitalists. Am J Med. 2001;111(9B):15S–20S.
- , , , et al. Searching for the missing pieces between the hospital and primary care: mapping the patient process during care transitions. BMJ Qual Saf. 2012;21:i97–i105.
- , , , et al. Association of self‐reported hospital discharge handoffs with 30‐day readmissions. JAMA. 2013;173(8):624–629.
- , , , et al. Association of communication between hospital‐based physicians and primary care providers with patient outcomes. J Gen Intern Med. 2009;24(3):381–386.
- , , , Effect of discharge summary availability during post‐discharge visits on hospital readmission. J Gen Intern Med. 2002;17(3):186–192.
- , , , , The Housestaff Incentive Program: improving the timeliness and quality of discharge summaries by engaging residents in quality improvement. BMJ Qual Saf. 2013;22(9):768–774.
- , , , et al. A Failure to communicate: a qualitative exploration of care coordination between hospitalists and primary care providers around patient hospitalizations [published online ahead of print October 15, 2014]. J Gen Intern Med. doi: 10.1007/s11606-014-3056-x.
- , , , et al. Pediatric hospitalists and primary care providers: a communication needs assessment. J Hosp Med. 2009;4(3):187–193.
Transitions of care from hospital to home are high‐risk times for patients.[1, 2] Increasing complexity of hospital admissions and shorter lengths of stay demand more effective coordination of care between hospitalists and outpatient clinicians.[3, 4, 5] Inaccurate, delayed, or incomplete clinical handoversthat is, transfer of information and professional responsibility and accountability[6]can lead to patient harm, and has been recognized as a key cause of preventable morbidity by the World Health Organization and The Joint Commission.[6, 7, 8] Conversely, when done effectively, transitions can result in improved patient health outcomes, reduced readmission rates, and higher patient and provider satisfaction.3
Previous studies note deficits in communication at discharge and primary care provider (PCP) dissatisfaction with discharge practices.[4, 9, 10, 11, 12, 13] In studies at academic medical centers, there were low rates of direct communication between inpatient and outpatient providers, mainly because of providers' belief that the discharge summary was adequate and the presence of significant barriers to direct communication.[14, 15] However, studies have shown that discharge summaries often omit critical information, and often are not available to PCPs in a timely manner.[10, 11, 12, 16] In response, the Society of Hospital Medicine developed a discharge checklist to aide in standardization of safe discharge practices.[1, 5] Discharge summary templates further attempt to improve documentation of patients' hospital courses. An electronic medical record (EMR) system shared by both inpatient and outpatient clinicians should impart several advantages: (1) automated alerts provide timely notification to PCPs regarding admission and discharge, (2) discharge summaries are available to the PCP as soon as they are written, and (3) all patient information pertaining to the hospitalization is available to the PCP.
Although it is plausible that shared EMRs should facilitate transitions of care by streamlining communication between hospitalists and PCPs, guidelines on format and content of PCP communication at discharge in the era of a shared EMR have yet to be defined. In this study, we sought to understand current discharge communication practices and PCP satisfaction within a shared EMR at our institution, and to identify key areas in which communication can be improved.
METHODS
Participants and Setting
We surveyed all resident and attending PCPs (n=124) working in the Division of General Internal Medicine (DGIM) Outpatient Practice at the University of California, San Francisco (UCSF). In June 2012, the outpatient and inpatient practices of UCSF transitioned from having separate medical record systems to a shared EMR (Epic Systems Corp., Verona, WI) where all informationboth inpatient and outpatientis accessible among healthcare professionals. The EMR provides automated notifications of admission and discharge to PCPs, allows for review of inpatient notes, labs, and studies, and immediate access to templated discharge summaries (see Supporting Information, Appendix 1, in the online version of this article). The EMR also enables secure communication between clinicians. At our institution, over 90% of discharge summaries are completed within 24 hours of discharge.[17]
Study Design and Analysis
We developed a survey about the discharge communication practices of inpatient medicine patients based on a previously described survey in the literature (see Supporting Information, Appendix 2, in the online version of this article).[9] The anonymous, 17‐question survey was electronically distributed to resident and attending PCPs at the DGIM practice. The survey was designed to determine: (1) overall PCP satisfaction with current communication practices from the inpatient team at patient discharge, (2) perceived adequacy of automatic discharge notifications, and (3) perception of the types of patients and hospitalizations requiring additional high‐touch communication at discharge.
We analyzed results of our survey using descriptive statistics. Differences in resident and attending responses were analyzed by 2tests.
RESULTS
Seventy‐five of 124 (60%) clinicians (46% residents, 54% attendings) completed the survey. Thirty‐nine (52%) PCPs were satisfied or very satisfied with communication at patient discharge. Although most reported receiving automated discharge notifications (71%), only 39% felt that the notifications plus the discharge summaries were adequate communication for safe transition of care from hospital to community. Fifty‐one percent desired direct contact beyond a discharge summary. There were no differences in preferences on discharge communication between resident and attending PCPs (P>0.05).
Over three‐fourths of PCPs surveyed preferred that for patients with complex hospitalizations (multiple readmissions, multiple active comorbidities, goals of care changes, high‐risk medication changes, time‐sensitive follow‐up needs), an additional e‐mail or verbal communication was needed to augment the information in the discharge summary (Figure 1). Only 31% reported receiving such communication.
When asked about important items to communicate for safer transitions of care, PCPs reported finding the following elements most critical: (1) medication changes (93%), (2) follow‐up actions for the PCP (88%), and (3) active medical issues (84%) (Figure 2).
CONCLUSIONS
In the era of shared EMRs, real‐time access to medication lists, pending test results, and discharge summaries should facilitate care transitions at discharge.[18, 19] We conducted a study to determine PCP perceptions of discharge communication after implementation of a shared EMR. We found that although PCPs largely acknowledged timely receipt of automated discharge notifications and discharge summaries, the majority of PCPs felt that most discharges required additional communication to ensure safe transition of care.
Guidelines for discharge communication emphasize timely communication with the PCP, primarily through discharge summaries containing key safety elements.[1, 5, 10] At our institution, we have improved the timeliness and quality of discharge summaries according to guideline recommendations,[17] and conducted quality improvement projects to improve rates of direct communication with PCPs.[9] In addition, the shared EMR provides automated notifications to PCPs when their patients are discharged. Despite these interventions, our survey shows that PCP satisfaction with discharge communication is still inadequate. PCPs desired direct communication that highlights active medical issues, medication changes, and specific follow‐up actions. Although all of these topics are included in our discharge summary template (see Supporting Information, Appendix 1, in the online version of this article), it is possible that the templated discharge summaries lend themselves to longer documents and information overload, as prior studies have documented the desire for more succinct discharge summaries.[18] We also found that automated notifications of discharge were less reliable and useful for PCPs than anticipated. There were several reasons for this: (1) discharge summaries sometimes were sent to PCPs uncoupled from the discharge notification, (2) there were errors with the generation and delivery of automated messages at the rollout of the new system, and (3) PCPs received many other automated system messages, meaning that discharge notifications could be easily missed. These factors all likely contribute to PCPs' desire for high‐touch communication that highlights the most salient aspects of each patient's hospitalization. It is also possible that automated notifications and depersonalized discharge summaries create distance and a less‐collaborative feeling to patient care. PCPs want more direct communication, and desire to play a more active role in inpatient management, especially for complex hospitalizations.[18] This emphasis on direct communication resonates with previous studies conducted before shared EMRs existed.[9, 12, 19]
Our study had several limitations. First, because this is a single‐institution study at a tertiary care academic setting, the results may not be generalizable to all shared EMR settings, and may not reflect all the challenges of communication with the wider community of outpatient providers. One can postulate that inpatient and outpatient clinician relationships are stronger in an academic setting than in other more disparate environments, where direct communication may happen even less frequently. Of note, our low rates of direct communication are consistent with other single‐ and multi‐institution studies, suggesting that our findings are generalizable.[14, 15] Second, our survey is limited in its ability to distinguish those patients who require high‐touch communication and those who do not. Third, although we have used the survey to assess PCP satisfaction in previous studies, it is not a validated instrument, and therefore we cannot reliably say that increasing direct PCP communication would increase their satisfaction around discharge. Last, the PCP‐reported rates of discharge communication are subjective and may be influenced by recall bias. We did not have a systematic way to confirm the actual rates of communication at discharge, which could have occurred through EMR messages, e‐mails, phone calls, or pages.
Although a shared EMR allows for real‐time access to patient data, it does not eliminate PCPs' desire for direct 2‐way dialogue at discharge, especially for complex patients. Key information desired in such communication should include active medical issues, medication changes, and follow‐up needs, which is consistent with prior studies. Standardizing this direct communication process in an efficient way can be challenging. Further elucidation of PCP preferences around which patients necessitate higher‐level communication and preferred methods and timing of communication is needed, as well as determining the most efficient and effective method for hospitalists to provide such communication. Improving communication between hospitalists and PCPs requires not just the presence of a shared EMR, but additional, systematic efforts to engage both inpatient and outpatient clinicians in collaborative care.
Disclosure
Nothing to report.
Transitions of care from hospital to home are high‐risk times for patients.[1, 2] Increasing complexity of hospital admissions and shorter lengths of stay demand more effective coordination of care between hospitalists and outpatient clinicians.[3, 4, 5] Inaccurate, delayed, or incomplete clinical handoversthat is, transfer of information and professional responsibility and accountability[6]can lead to patient harm, and has been recognized as a key cause of preventable morbidity by the World Health Organization and The Joint Commission.[6, 7, 8] Conversely, when done effectively, transitions can result in improved patient health outcomes, reduced readmission rates, and higher patient and provider satisfaction.3
Previous studies note deficits in communication at discharge and primary care provider (PCP) dissatisfaction with discharge practices.[4, 9, 10, 11, 12, 13] In studies at academic medical centers, there were low rates of direct communication between inpatient and outpatient providers, mainly because of providers' belief that the discharge summary was adequate and the presence of significant barriers to direct communication.[14, 15] However, studies have shown that discharge summaries often omit critical information, and often are not available to PCPs in a timely manner.[10, 11, 12, 16] In response, the Society of Hospital Medicine developed a discharge checklist to aide in standardization of safe discharge practices.[1, 5] Discharge summary templates further attempt to improve documentation of patients' hospital courses. An electronic medical record (EMR) system shared by both inpatient and outpatient clinicians should impart several advantages: (1) automated alerts provide timely notification to PCPs regarding admission and discharge, (2) discharge summaries are available to the PCP as soon as they are written, and (3) all patient information pertaining to the hospitalization is available to the PCP.
Although it is plausible that shared EMRs should facilitate transitions of care by streamlining communication between hospitalists and PCPs, guidelines on format and content of PCP communication at discharge in the era of a shared EMR have yet to be defined. In this study, we sought to understand current discharge communication practices and PCP satisfaction within a shared EMR at our institution, and to identify key areas in which communication can be improved.
METHODS
Participants and Setting
We surveyed all resident and attending PCPs (n=124) working in the Division of General Internal Medicine (DGIM) Outpatient Practice at the University of California, San Francisco (UCSF). In June 2012, the outpatient and inpatient practices of UCSF transitioned from having separate medical record systems to a shared EMR (Epic Systems Corp., Verona, WI) where all informationboth inpatient and outpatientis accessible among healthcare professionals. The EMR provides automated notifications of admission and discharge to PCPs, allows for review of inpatient notes, labs, and studies, and immediate access to templated discharge summaries (see Supporting Information, Appendix 1, in the online version of this article). The EMR also enables secure communication between clinicians. At our institution, over 90% of discharge summaries are completed within 24 hours of discharge.[17]
Study Design and Analysis
We developed a survey about the discharge communication practices of inpatient medicine patients based on a previously described survey in the literature (see Supporting Information, Appendix 2, in the online version of this article).[9] The anonymous, 17‐question survey was electronically distributed to resident and attending PCPs at the DGIM practice. The survey was designed to determine: (1) overall PCP satisfaction with current communication practices from the inpatient team at patient discharge, (2) perceived adequacy of automatic discharge notifications, and (3) perception of the types of patients and hospitalizations requiring additional high‐touch communication at discharge.
We analyzed results of our survey using descriptive statistics. Differences in resident and attending responses were analyzed by 2tests.
RESULTS
Seventy‐five of 124 (60%) clinicians (46% residents, 54% attendings) completed the survey. Thirty‐nine (52%) PCPs were satisfied or very satisfied with communication at patient discharge. Although most reported receiving automated discharge notifications (71%), only 39% felt that the notifications plus the discharge summaries were adequate communication for safe transition of care from hospital to community. Fifty‐one percent desired direct contact beyond a discharge summary. There were no differences in preferences on discharge communication between resident and attending PCPs (P>0.05).
Over three‐fourths of PCPs surveyed preferred that for patients with complex hospitalizations (multiple readmissions, multiple active comorbidities, goals of care changes, high‐risk medication changes, time‐sensitive follow‐up needs), an additional e‐mail or verbal communication was needed to augment the information in the discharge summary (Figure 1). Only 31% reported receiving such communication.
When asked about important items to communicate for safer transitions of care, PCPs reported finding the following elements most critical: (1) medication changes (93%), (2) follow‐up actions for the PCP (88%), and (3) active medical issues (84%) (Figure 2).
CONCLUSIONS
In the era of shared EMRs, real‐time access to medication lists, pending test results, and discharge summaries should facilitate care transitions at discharge.[18, 19] We conducted a study to determine PCP perceptions of discharge communication after implementation of a shared EMR. We found that although PCPs largely acknowledged timely receipt of automated discharge notifications and discharge summaries, the majority of PCPs felt that most discharges required additional communication to ensure safe transition of care.
Guidelines for discharge communication emphasize timely communication with the PCP, primarily through discharge summaries containing key safety elements.[1, 5, 10] At our institution, we have improved the timeliness and quality of discharge summaries according to guideline recommendations,[17] and conducted quality improvement projects to improve rates of direct communication with PCPs.[9] In addition, the shared EMR provides automated notifications to PCPs when their patients are discharged. Despite these interventions, our survey shows that PCP satisfaction with discharge communication is still inadequate. PCPs desired direct communication that highlights active medical issues, medication changes, and specific follow‐up actions. Although all of these topics are included in our discharge summary template (see Supporting Information, Appendix 1, in the online version of this article), it is possible that the templated discharge summaries lend themselves to longer documents and information overload, as prior studies have documented the desire for more succinct discharge summaries.[18] We also found that automated notifications of discharge were less reliable and useful for PCPs than anticipated. There were several reasons for this: (1) discharge summaries sometimes were sent to PCPs uncoupled from the discharge notification, (2) there were errors with the generation and delivery of automated messages at the rollout of the new system, and (3) PCPs received many other automated system messages, meaning that discharge notifications could be easily missed. These factors all likely contribute to PCPs' desire for high‐touch communication that highlights the most salient aspects of each patient's hospitalization. It is also possible that automated notifications and depersonalized discharge summaries create distance and a less‐collaborative feeling to patient care. PCPs want more direct communication, and desire to play a more active role in inpatient management, especially for complex hospitalizations.[18] This emphasis on direct communication resonates with previous studies conducted before shared EMRs existed.[9, 12, 19]
Our study had several limitations. First, because this is a single‐institution study at a tertiary care academic setting, the results may not be generalizable to all shared EMR settings, and may not reflect all the challenges of communication with the wider community of outpatient providers. One can postulate that inpatient and outpatient clinician relationships are stronger in an academic setting than in other more disparate environments, where direct communication may happen even less frequently. Of note, our low rates of direct communication are consistent with other single‐ and multi‐institution studies, suggesting that our findings are generalizable.[14, 15] Second, our survey is limited in its ability to distinguish those patients who require high‐touch communication and those who do not. Third, although we have used the survey to assess PCP satisfaction in previous studies, it is not a validated instrument, and therefore we cannot reliably say that increasing direct PCP communication would increase their satisfaction around discharge. Last, the PCP‐reported rates of discharge communication are subjective and may be influenced by recall bias. We did not have a systematic way to confirm the actual rates of communication at discharge, which could have occurred through EMR messages, e‐mails, phone calls, or pages.
Although a shared EMR allows for real‐time access to patient data, it does not eliminate PCPs' desire for direct 2‐way dialogue at discharge, especially for complex patients. Key information desired in such communication should include active medical issues, medication changes, and follow‐up needs, which is consistent with prior studies. Standardizing this direct communication process in an efficient way can be challenging. Further elucidation of PCP preferences around which patients necessitate higher‐level communication and preferred methods and timing of communication is needed, as well as determining the most efficient and effective method for hospitalists to provide such communication. Improving communication between hospitalists and PCPs requires not just the presence of a shared EMR, but additional, systematic efforts to engage both inpatient and outpatient clinicians in collaborative care.
Disclosure
Nothing to report.
- , , , et al. Development of a checklist of safe discharge practices for hospital patients. J Hosp Med. 2013;8(8):444–449.
- , , , , The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161–167.
- , , , et al. Improving patient handovers from hospital to primary care: a systematic review. Ann Intern Med. 2012;157(6):417–428.
- , , , , “Did I do as best as the system would let me?” Healthcare professional views on hospital to home care transitions. J Gen Intern Med. 2012;27(12):1649–1656.
- , , , et al. Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med. 2006;1(6):354−660.
- , , , , Improving measurement in clinical handover. Qual Saf Health Care. 2009;18:272–277.
- World Health Organization. Patient safety: action on patient safety: high 5s. 2007. Available at: http://www.who.int/patientsafety/implementation/solutions/high5s/en/index.html. Accessed January 28, 2015.
- The Joint Commission Center for Transforming Healthcare. Hand‐off communications. 2012. Available at: http://www.centerfortransforminghealthcare.org/projects/detail.aspx?Project=1. Accessed January 28, 2015.
- , , , et al. The effect of a resident‐led quality improvement project on improving communication between hospital‐based and outpatient physicians. Am J Med Qual. 2013;28(6):472–479.
- , , , Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007;2(5):314–323.
- , , , , , Deficits in communication and information transfer between hospital‐based and primary care physicians: implications for patient safety and continuity of care. JAMA. 2007;297(8):831–841.
- , , , Primary care physician attitudes regarding communication with hospitalists. Am J Med. 2001;111(9B):15S–20S.
- , , , et al. Searching for the missing pieces between the hospital and primary care: mapping the patient process during care transitions. BMJ Qual Saf. 2012;21:i97–i105.
- , , , et al. Association of self‐reported hospital discharge handoffs with 30‐day readmissions. JAMA. 2013;173(8):624–629.
- , , , et al. Association of communication between hospital‐based physicians and primary care providers with patient outcomes. J Gen Intern Med. 2009;24(3):381–386.
- , , , Effect of discharge summary availability during post‐discharge visits on hospital readmission. J Gen Intern Med. 2002;17(3):186–192.
- , , , , The Housestaff Incentive Program: improving the timeliness and quality of discharge summaries by engaging residents in quality improvement. BMJ Qual Saf. 2013;22(9):768–774.
- , , , et al. A Failure to communicate: a qualitative exploration of care coordination between hospitalists and primary care providers around patient hospitalizations [published online ahead of print October 15, 2014]. J Gen Intern Med. doi: 10.1007/s11606-014-3056-x.
- , , , et al. Pediatric hospitalists and primary care providers: a communication needs assessment. J Hosp Med. 2009;4(3):187–193.
- , , , et al. Development of a checklist of safe discharge practices for hospital patients. J Hosp Med. 2013;8(8):444–449.
- , , , , The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161–167.
- , , , et al. Improving patient handovers from hospital to primary care: a systematic review. Ann Intern Med. 2012;157(6):417–428.
- , , , , “Did I do as best as the system would let me?” Healthcare professional views on hospital to home care transitions. J Gen Intern Med. 2012;27(12):1649–1656.
- , , , et al. Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med. 2006;1(6):354−660.
- , , , , Improving measurement in clinical handover. Qual Saf Health Care. 2009;18:272–277.
- World Health Organization. Patient safety: action on patient safety: high 5s. 2007. Available at: http://www.who.int/patientsafety/implementation/solutions/high5s/en/index.html. Accessed January 28, 2015.
- The Joint Commission Center for Transforming Healthcare. Hand‐off communications. 2012. Available at: http://www.centerfortransforminghealthcare.org/projects/detail.aspx?Project=1. Accessed January 28, 2015.
- , , , et al. The effect of a resident‐led quality improvement project on improving communication between hospital‐based and outpatient physicians. Am J Med Qual. 2013;28(6):472–479.
- , , , Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007;2(5):314–323.
- , , , , , Deficits in communication and information transfer between hospital‐based and primary care physicians: implications for patient safety and continuity of care. JAMA. 2007;297(8):831–841.
- , , , Primary care physician attitudes regarding communication with hospitalists. Am J Med. 2001;111(9B):15S–20S.
- , , , et al. Searching for the missing pieces between the hospital and primary care: mapping the patient process during care transitions. BMJ Qual Saf. 2012;21:i97–i105.
- , , , et al. Association of self‐reported hospital discharge handoffs with 30‐day readmissions. JAMA. 2013;173(8):624–629.
- , , , et al. Association of communication between hospital‐based physicians and primary care providers with patient outcomes. J Gen Intern Med. 2009;24(3):381–386.
- , , , Effect of discharge summary availability during post‐discharge visits on hospital readmission. J Gen Intern Med. 2002;17(3):186–192.
- , , , , The Housestaff Incentive Program: improving the timeliness and quality of discharge summaries by engaging residents in quality improvement. BMJ Qual Saf. 2013;22(9):768–774.
- , , , et al. A Failure to communicate: a qualitative exploration of care coordination between hospitalists and primary care providers around patient hospitalizations [published online ahead of print October 15, 2014]. J Gen Intern Med. doi: 10.1007/s11606-014-3056-x.
- , , , et al. Pediatric hospitalists and primary care providers: a communication needs assessment. J Hosp Med. 2009;4(3):187–193.
Minimal residual disease could signify worse outcomes in acute myeloid leukemia treatment
Although peripheral count recovery and minimal residual disease level following induction therapy are linked, each is an independent prognostic factor for relapse and overall survival in patients with acute myeloid leukemia, investigators say in a report published online March 2 in Journal of Clinical Oncology. “Information about these post-treatment factors is likely more important than information about several traditional pretreatment prognostic factors and should play a major – and perhaps the dominant – role in planning postinduction therapy,” wrote Dr. Xueyan Chen and her associates.
The investigators retrospectively analyzed data from 245 adults with newly diagnosed, relapsed, or refractory acute myeloid leukemia (AML) who achieved either complete remission (CR), complete remission with incomplete platelet recovery (CRp), or complete remission with incomplete blood count recovery (CRi), after induction therapy. The 71% of patients who achieved CR had minimal residual disease (MRD) less frequently and had lower levels of MRD than the 19.6% of patients achieving CRp and 9.4% achieving CRi, suggesting that failure of blood count recovery may result from inadequate treatment of AML.
Read the entire article here: http://jco.ascopubs.org/content/early/2015/02/26/JCO.2014.58.3518
Although peripheral count recovery and minimal residual disease level following induction therapy are linked, each is an independent prognostic factor for relapse and overall survival in patients with acute myeloid leukemia, investigators say in a report published online March 2 in Journal of Clinical Oncology. “Information about these post-treatment factors is likely more important than information about several traditional pretreatment prognostic factors and should play a major – and perhaps the dominant – role in planning postinduction therapy,” wrote Dr. Xueyan Chen and her associates.
The investigators retrospectively analyzed data from 245 adults with newly diagnosed, relapsed, or refractory acute myeloid leukemia (AML) who achieved either complete remission (CR), complete remission with incomplete platelet recovery (CRp), or complete remission with incomplete blood count recovery (CRi), after induction therapy. The 71% of patients who achieved CR had minimal residual disease (MRD) less frequently and had lower levels of MRD than the 19.6% of patients achieving CRp and 9.4% achieving CRi, suggesting that failure of blood count recovery may result from inadequate treatment of AML.
Read the entire article here: http://jco.ascopubs.org/content/early/2015/02/26/JCO.2014.58.3518
Although peripheral count recovery and minimal residual disease level following induction therapy are linked, each is an independent prognostic factor for relapse and overall survival in patients with acute myeloid leukemia, investigators say in a report published online March 2 in Journal of Clinical Oncology. “Information about these post-treatment factors is likely more important than information about several traditional pretreatment prognostic factors and should play a major – and perhaps the dominant – role in planning postinduction therapy,” wrote Dr. Xueyan Chen and her associates.
The investigators retrospectively analyzed data from 245 adults with newly diagnosed, relapsed, or refractory acute myeloid leukemia (AML) who achieved either complete remission (CR), complete remission with incomplete platelet recovery (CRp), or complete remission with incomplete blood count recovery (CRi), after induction therapy. The 71% of patients who achieved CR had minimal residual disease (MRD) less frequently and had lower levels of MRD than the 19.6% of patients achieving CRp and 9.4% achieving CRi, suggesting that failure of blood count recovery may result from inadequate treatment of AML.
Read the entire article here: http://jco.ascopubs.org/content/early/2015/02/26/JCO.2014.58.3518
Studies of anesthesia’s effect on upper airway are limited
CORONADO, CALIF. – Studies of the most appropriate anesthetic agents for drug-induced sleep endoscopy are limited, but according to the best available evidence, local anesthetics appear to affect airway reflexes while inhalation anesthetics and opioids exaggerate dynamic airway collapse, so they may not be ideal.
Those are key conclusions from a systematic review of literature on the effects of commonly used anesthetic agents and opioids on the upper airway presented at the Triological Society’s Combined Sections meeting. Drug-induced sleep endoscopy (DISE) “is a great tool to assess upper airway dynamics in order to determine optimal surgical therapy for obstructive sleep apnea,” said Dr. Zarmina Ehsan, a pediatric pulmonary medicine fellow at Cincinnati Children’s Hospital Medical Center. “There’s a lack of understanding regarding how upper airway dynamics are altered by anesthetic agents, compared with normal sleep. This is important because this hinders the development of universal guidelines and protocols for the use of DISE.”
Using PubMed, EMBASE, and other sources, she and her associates conducted a qualitative systematic review of studies related to common anesthetic agents and opioids in the medical literature through September 2014. To be eligible for inclusion, a study must have evaluated the agent’s effect on the upper airway, must have contained an abstract, and must have been published in English. Studies with fewer than seven subjects, no original data, review articles, and those involving animals were excluded. The researchers reviewed 180 abstracts and included 56 full text articles in the final analysis, for a total study population of 8,540 patients. At the meeting Dr. Ehsan summarized the following findings by agent:
• Lidocaine. This agent is safe for topical use, has a rapid onset of action, and an intermediate duration of efficacy. Lidocaine acts on muscles “which are potent dilators and tensors of the pharyngeal and laryngeal structures,” she said. Of 10 studies included in the analysis, 7 assessed the impact of lidocaine on upper airway obstruction. Of these, three showed increased airway obstruction while four showed no significant effects. There were two studies on sleep parameters with conflicting results: One showed an increase in mean apnea duration with lidocaine use while the other did not. From this the researchers concluded that lidocaine does affect upper airway dynamics.
• Propofol. This lipophilic intravenous agent has a quick onset of action and acts by global central nervous system depression. Of 12 studies included in the analysis, 4 examined dose-response characteristics and showed a dose-dependent decrease in airway cross-sectional area with increased dosing of propofol. “So increasing your dose makes airway obstruction more likely,” Dr. Ehsan said. “The levels of obstruction were greatest at the base of tongue, and the closure was primarily in the anterior-posterior direction.” Three studies found that propofol caused a decrease in genioglossus electromyogram activity, while the remaining five studies assessed heterogeneous outcomes. “Overall, the studies showed that propofol had a dose-dependent effect on the upper airway with increasing doses making airway obstruction more likely,” she said.
• Dexmedetomidine (DEX). This agent is an alpha-2 adrenergic agonist with sedative, anxiolytic, and analgesic effects. It’s typically given as a 10-minute loading dose followed by a continuous infusion, and is recommended when you want to preserve spontaneous respiration. Of the four DEX-related studies that were included in the analysis, all demonstrated a minimal effect on upper airway cross-sectional area. “One of the studies looked at sleep parameters and concluded that DEX does approximate non-REM sleep without causing respiratory depression,” Dr. Ehsan added. “So overall, DEX was less likely to result in upper airway obstruction, compared with propofol.”
• Midazolam. This agent is commonly used for procedural sedation, with an onset of action within 1-3 minutes and a duration of 15-60 minutes. Of the six studies involving midazolam, two evaluated sleep staging. One reported lack of REM sleep and increased duration of stage N3 sleep, while the other study found that all sleep stages were observed at a lower dosage. The remaining four studies had heterogeneous outcomes. This led the researchers to conclude that midazolam “may lead to upper airway obstruction,” Dr. Ehsan said. “It’s unclear if this is dose dependent.”
• Pentobarbital. Of the two studies involving this short-acting barbiturate, one showed no effect on pharyngeal critical pressure or respiratory muscle function, while the other found that pentobarbital can increase the upper airway cross-sectional area. “So the effect of pentobarbital is unclear,” she said.
• Ketamine. This N-methyl-D-aspartate receptor has a rapid onset and a minimal effect on the central respiratory drive. Of the three studies involving ketamine, one found a 10% incidence of transient laryngospasm, one found that the incidence of transient laryngospasm was higher when it was delivered intramuscularly vs. intravenously, and one found that ketamine was safe in infants undergoing upper airway endoscopy. The researchers concluded that overall, ketamine “could be useful during DISE.”
• Inhalation anesthetics. There were 11 studies of these agents. Of these, six found that inhalation anesthetics caused upper airway collapse while five had heterogeneous outcomes. “Overall, a majority of studies found that inhalation anesthetics exaggerate dynamic airway collapse,” Dr. Ehsan said.
• Opioids. Of the nine studies involving these agents, six found that opioids caused upper airway obstruction; two found that they caused depression of upper airway reflexes, and one found that they caused a decrease in respiratory compliance. “Overall, opioids increase upper airway obstruction,” she said.
Dr. Ehsan acknowledged certain limitations of the analysis, including the fact that there was little information on sleep state approximated by many of these agents, “which makes it difficult to determine the ideal anesthetic protocol. There was substantial heterogeneity in outcomes, and few prospective studies comparing the ability of anesthetics to approximate natural sleep.” She recommended that future efforts focus on comparative effectiveness studies between the agents, as well as evaluate the impact of combining anesthetic agents. “This is important, because most DISE protocols use a combination of agents,” she said.
The meeting was jointly sponsored by the Triological Society and the American College of Surgeons
Dr. Ehsan reported having no relevant financial conflicts.
On Twitter @dougbrunk
CORONADO, CALIF. – Studies of the most appropriate anesthetic agents for drug-induced sleep endoscopy are limited, but according to the best available evidence, local anesthetics appear to affect airway reflexes while inhalation anesthetics and opioids exaggerate dynamic airway collapse, so they may not be ideal.
Those are key conclusions from a systematic review of literature on the effects of commonly used anesthetic agents and opioids on the upper airway presented at the Triological Society’s Combined Sections meeting. Drug-induced sleep endoscopy (DISE) “is a great tool to assess upper airway dynamics in order to determine optimal surgical therapy for obstructive sleep apnea,” said Dr. Zarmina Ehsan, a pediatric pulmonary medicine fellow at Cincinnati Children’s Hospital Medical Center. “There’s a lack of understanding regarding how upper airway dynamics are altered by anesthetic agents, compared with normal sleep. This is important because this hinders the development of universal guidelines and protocols for the use of DISE.”
Using PubMed, EMBASE, and other sources, she and her associates conducted a qualitative systematic review of studies related to common anesthetic agents and opioids in the medical literature through September 2014. To be eligible for inclusion, a study must have evaluated the agent’s effect on the upper airway, must have contained an abstract, and must have been published in English. Studies with fewer than seven subjects, no original data, review articles, and those involving animals were excluded. The researchers reviewed 180 abstracts and included 56 full text articles in the final analysis, for a total study population of 8,540 patients. At the meeting Dr. Ehsan summarized the following findings by agent:
• Lidocaine. This agent is safe for topical use, has a rapid onset of action, and an intermediate duration of efficacy. Lidocaine acts on muscles “which are potent dilators and tensors of the pharyngeal and laryngeal structures,” she said. Of 10 studies included in the analysis, 7 assessed the impact of lidocaine on upper airway obstruction. Of these, three showed increased airway obstruction while four showed no significant effects. There were two studies on sleep parameters with conflicting results: One showed an increase in mean apnea duration with lidocaine use while the other did not. From this the researchers concluded that lidocaine does affect upper airway dynamics.
• Propofol. This lipophilic intravenous agent has a quick onset of action and acts by global central nervous system depression. Of 12 studies included in the analysis, 4 examined dose-response characteristics and showed a dose-dependent decrease in airway cross-sectional area with increased dosing of propofol. “So increasing your dose makes airway obstruction more likely,” Dr. Ehsan said. “The levels of obstruction were greatest at the base of tongue, and the closure was primarily in the anterior-posterior direction.” Three studies found that propofol caused a decrease in genioglossus electromyogram activity, while the remaining five studies assessed heterogeneous outcomes. “Overall, the studies showed that propofol had a dose-dependent effect on the upper airway with increasing doses making airway obstruction more likely,” she said.
• Dexmedetomidine (DEX). This agent is an alpha-2 adrenergic agonist with sedative, anxiolytic, and analgesic effects. It’s typically given as a 10-minute loading dose followed by a continuous infusion, and is recommended when you want to preserve spontaneous respiration. Of the four DEX-related studies that were included in the analysis, all demonstrated a minimal effect on upper airway cross-sectional area. “One of the studies looked at sleep parameters and concluded that DEX does approximate non-REM sleep without causing respiratory depression,” Dr. Ehsan added. “So overall, DEX was less likely to result in upper airway obstruction, compared with propofol.”
• Midazolam. This agent is commonly used for procedural sedation, with an onset of action within 1-3 minutes and a duration of 15-60 minutes. Of the six studies involving midazolam, two evaluated sleep staging. One reported lack of REM sleep and increased duration of stage N3 sleep, while the other study found that all sleep stages were observed at a lower dosage. The remaining four studies had heterogeneous outcomes. This led the researchers to conclude that midazolam “may lead to upper airway obstruction,” Dr. Ehsan said. “It’s unclear if this is dose dependent.”
• Pentobarbital. Of the two studies involving this short-acting barbiturate, one showed no effect on pharyngeal critical pressure or respiratory muscle function, while the other found that pentobarbital can increase the upper airway cross-sectional area. “So the effect of pentobarbital is unclear,” she said.
• Ketamine. This N-methyl-D-aspartate receptor has a rapid onset and a minimal effect on the central respiratory drive. Of the three studies involving ketamine, one found a 10% incidence of transient laryngospasm, one found that the incidence of transient laryngospasm was higher when it was delivered intramuscularly vs. intravenously, and one found that ketamine was safe in infants undergoing upper airway endoscopy. The researchers concluded that overall, ketamine “could be useful during DISE.”
• Inhalation anesthetics. There were 11 studies of these agents. Of these, six found that inhalation anesthetics caused upper airway collapse while five had heterogeneous outcomes. “Overall, a majority of studies found that inhalation anesthetics exaggerate dynamic airway collapse,” Dr. Ehsan said.
• Opioids. Of the nine studies involving these agents, six found that opioids caused upper airway obstruction; two found that they caused depression of upper airway reflexes, and one found that they caused a decrease in respiratory compliance. “Overall, opioids increase upper airway obstruction,” she said.
Dr. Ehsan acknowledged certain limitations of the analysis, including the fact that there was little information on sleep state approximated by many of these agents, “which makes it difficult to determine the ideal anesthetic protocol. There was substantial heterogeneity in outcomes, and few prospective studies comparing the ability of anesthetics to approximate natural sleep.” She recommended that future efforts focus on comparative effectiveness studies between the agents, as well as evaluate the impact of combining anesthetic agents. “This is important, because most DISE protocols use a combination of agents,” she said.
The meeting was jointly sponsored by the Triological Society and the American College of Surgeons
Dr. Ehsan reported having no relevant financial conflicts.
On Twitter @dougbrunk
CORONADO, CALIF. – Studies of the most appropriate anesthetic agents for drug-induced sleep endoscopy are limited, but according to the best available evidence, local anesthetics appear to affect airway reflexes while inhalation anesthetics and opioids exaggerate dynamic airway collapse, so they may not be ideal.
Those are key conclusions from a systematic review of literature on the effects of commonly used anesthetic agents and opioids on the upper airway presented at the Triological Society’s Combined Sections meeting. Drug-induced sleep endoscopy (DISE) “is a great tool to assess upper airway dynamics in order to determine optimal surgical therapy for obstructive sleep apnea,” said Dr. Zarmina Ehsan, a pediatric pulmonary medicine fellow at Cincinnati Children’s Hospital Medical Center. “There’s a lack of understanding regarding how upper airway dynamics are altered by anesthetic agents, compared with normal sleep. This is important because this hinders the development of universal guidelines and protocols for the use of DISE.”
Using PubMed, EMBASE, and other sources, she and her associates conducted a qualitative systematic review of studies related to common anesthetic agents and opioids in the medical literature through September 2014. To be eligible for inclusion, a study must have evaluated the agent’s effect on the upper airway, must have contained an abstract, and must have been published in English. Studies with fewer than seven subjects, no original data, review articles, and those involving animals were excluded. The researchers reviewed 180 abstracts and included 56 full text articles in the final analysis, for a total study population of 8,540 patients. At the meeting Dr. Ehsan summarized the following findings by agent:
• Lidocaine. This agent is safe for topical use, has a rapid onset of action, and an intermediate duration of efficacy. Lidocaine acts on muscles “which are potent dilators and tensors of the pharyngeal and laryngeal structures,” she said. Of 10 studies included in the analysis, 7 assessed the impact of lidocaine on upper airway obstruction. Of these, three showed increased airway obstruction while four showed no significant effects. There were two studies on sleep parameters with conflicting results: One showed an increase in mean apnea duration with lidocaine use while the other did not. From this the researchers concluded that lidocaine does affect upper airway dynamics.
• Propofol. This lipophilic intravenous agent has a quick onset of action and acts by global central nervous system depression. Of 12 studies included in the analysis, 4 examined dose-response characteristics and showed a dose-dependent decrease in airway cross-sectional area with increased dosing of propofol. “So increasing your dose makes airway obstruction more likely,” Dr. Ehsan said. “The levels of obstruction were greatest at the base of tongue, and the closure was primarily in the anterior-posterior direction.” Three studies found that propofol caused a decrease in genioglossus electromyogram activity, while the remaining five studies assessed heterogeneous outcomes. “Overall, the studies showed that propofol had a dose-dependent effect on the upper airway with increasing doses making airway obstruction more likely,” she said.
• Dexmedetomidine (DEX). This agent is an alpha-2 adrenergic agonist with sedative, anxiolytic, and analgesic effects. It’s typically given as a 10-minute loading dose followed by a continuous infusion, and is recommended when you want to preserve spontaneous respiration. Of the four DEX-related studies that were included in the analysis, all demonstrated a minimal effect on upper airway cross-sectional area. “One of the studies looked at sleep parameters and concluded that DEX does approximate non-REM sleep without causing respiratory depression,” Dr. Ehsan added. “So overall, DEX was less likely to result in upper airway obstruction, compared with propofol.”
• Midazolam. This agent is commonly used for procedural sedation, with an onset of action within 1-3 minutes and a duration of 15-60 minutes. Of the six studies involving midazolam, two evaluated sleep staging. One reported lack of REM sleep and increased duration of stage N3 sleep, while the other study found that all sleep stages were observed at a lower dosage. The remaining four studies had heterogeneous outcomes. This led the researchers to conclude that midazolam “may lead to upper airway obstruction,” Dr. Ehsan said. “It’s unclear if this is dose dependent.”
• Pentobarbital. Of the two studies involving this short-acting barbiturate, one showed no effect on pharyngeal critical pressure or respiratory muscle function, while the other found that pentobarbital can increase the upper airway cross-sectional area. “So the effect of pentobarbital is unclear,” she said.
• Ketamine. This N-methyl-D-aspartate receptor has a rapid onset and a minimal effect on the central respiratory drive. Of the three studies involving ketamine, one found a 10% incidence of transient laryngospasm, one found that the incidence of transient laryngospasm was higher when it was delivered intramuscularly vs. intravenously, and one found that ketamine was safe in infants undergoing upper airway endoscopy. The researchers concluded that overall, ketamine “could be useful during DISE.”
• Inhalation anesthetics. There were 11 studies of these agents. Of these, six found that inhalation anesthetics caused upper airway collapse while five had heterogeneous outcomes. “Overall, a majority of studies found that inhalation anesthetics exaggerate dynamic airway collapse,” Dr. Ehsan said.
• Opioids. Of the nine studies involving these agents, six found that opioids caused upper airway obstruction; two found that they caused depression of upper airway reflexes, and one found that they caused a decrease in respiratory compliance. “Overall, opioids increase upper airway obstruction,” she said.
Dr. Ehsan acknowledged certain limitations of the analysis, including the fact that there was little information on sleep state approximated by many of these agents, “which makes it difficult to determine the ideal anesthetic protocol. There was substantial heterogeneity in outcomes, and few prospective studies comparing the ability of anesthetics to approximate natural sleep.” She recommended that future efforts focus on comparative effectiveness studies between the agents, as well as evaluate the impact of combining anesthetic agents. “This is important, because most DISE protocols use a combination of agents,” she said.
The meeting was jointly sponsored by the Triological Society and the American College of Surgeons
Dr. Ehsan reported having no relevant financial conflicts.
On Twitter @dougbrunk
AT THE COMBINED SECTIONS WINTER MEETING
Key clinical point: Choice of an appropriate anesthetic protocol for drug-induced sleep endoscopy must be based on a limited number of comparative studies.
Major finding: Local anesthetics appear to affect upper airway reflexes while inhalation anesthetics and opioids exaggerate dynamic airway collapse.
Data source: A qualitative systematic review of 56 studies related to common anesthetic agents and opioids published in the medical literature through September 2014.
Disclosures: Dr. Ehsan reported having no financial disclosures.
Smart diet remains potent cardiovascular medicine
SNOWMASS, COLO. – Cutting dietary fat intake remains a highly effective strategy for reducing coronary heart disease risk – but only so long as the replacement nutrients aren’t even bigger offenders, Dr. Robert A. Vogel said at the Annual Cardiovascular Conference at Snowmass.
In the face of decades of public health admonitions to reduce saturated fat intake, most Americans have increased their consumption of trans fats and simple carbohydrates, especially sugar. And therein lies a problem. Trans fats are far more harmful than saturated fats in terms of cardiovascular risk. And excessive sugar consumption is a major contributor to abdominal obesity, metabolic syndrome, hypertension, and endothelial dysfunction.
“In the United States, sugar is a bigger source of hypertension than is salt,” asserted Dr. Vogel, a cardiologist at the University of Colorado, Denver.
The editors of Time magazine ignited a public controversy last year with a cover story arrestingly titled, “Eat Butter – Scientists labelled fat the enemy. Why they were wrong.” The editors were picking up on a British meta-analysis of 32 observational studies that concluded there is no clear evidence to support the notion that saturated fats are harmful to cardiovascular health and that swapping them out for consumption of polyunsaturated fatty acids (PUFAs) is beneficial (Ann. Intern. Med. 2014;160:398-406).
Dr. Vogel said those investigators are in fact correct: Many of the observational studies – going all the way back to the pioneering work by Dr. Ancel Keys in the 1950s – are flawed. They don’t convincingly prove the case for PUFAs as a healthier alternative. But there is persuasive evidence from well-conducted, randomized, controlled trials that this is indeed so, he added.
Several of these studies were done in an earlier era when it was possible to slip around the challenges and limitations of dietary studies in free-living populations. These trials wouldn’t be possible today for ethical reasons involving lack of informed consent.
For example, in the Finnish Mental Hospital Study conducted during 1959-1971, the food served at two mental institutions was altered. Patients at one hospital got 6 years of a diet high in PUFAs, then were crossed over to a typical Finnish diet. At the other mental hospital, patients were fed a normal Finnish diet for 6 years, then crossed over to the high-PUFA diet for 6 years. During the experimental-diet years, the coronary heart disease event rate was reduced by nearly 60% (Int. J. Epidemiol. 1979;8:99-118).
Similarly, in a prospective randomized trial conducted at a Los Angeles Veterans Affairs institution for older, cognitively impaired men, a no-choice shift to a diet high in PUFAs with reduced saturated fats resulted in roughly a 30% reduction in CHD events compared to the usual institutional diet (Lancet 1968;2:1060-2). A similar magnitude of CHD event reduction was seen with a high-PUFA dietary intervention in the Oslo Diet-Heart Study, a prospective secondary prevention trial (Circulation 1970;42:935-42).
In the contemporary era, the standout randomized dietary intervention trial is the Lyon Diet Heart Study, a 46-month prospective secondary prevention trial in which a Mediterranean diet low in saturated fat and high in alpha-linoleic acid, a PUFA, reduced the combined endpoint of cardiac death and nonfatal MI by 70%, compared with the usual post-MI prudent diet recommended at that time. Yet total cholesterol levels in the two study arms did not differ (Circulation 1999;99:779-85).
To put these results into context, Dr. Vogel noted that the Cholesterol Treatment Trialists Collaboration headquartered at the University of Oxford (England) has shown that for every 40 mg/dL of LDL-lowering achieved with statin therapy, the result is roughly a 20% reduction in CHD. In contrast, the classic nonpharmacologic diet studies resulted in 30%-70% relative risk reductions.
“Heart disease is a dietary disease,” the cardiologist emphasized. “When you compare diet intervention to LDL lowering with statins, you see that diet is very, very effective. But you have to know the details of the diet. You can’t take something out and put just anything in. It doesn’t work like that.”
For example, an analysis of data from the National Health and Nutrition Examination Survey concluded that individuals who consumed 25% of their calories from added sugar – that’s the equivalent of three 12-oz cans of a sugary cola per day – had a 175% increased risk of cardiovascular mortality during a median 14.6 years of follow-up, compared with those who got less than 10% of their calories from added sugar (JAMA Intern. Med. 2014;174:516-24).
And as for the impact of the trans fat that’s liberally present in many processed foods, the Nurses Health Study showed that for every 5% increase in energy intake from saturated fat – that’s equivalent to one 8-oz steak per day – the relative risk for CHD rose by a relatively modest 17%, while for a 5% increase in energy intake from trans fat – the equivalent of 4 oz of butter – CHD risk shot up by 382% (N. Engl. J. Med. 1997;337:1491-9).
Dr. Vogel reported serving as a paid consultant to the National Football League and the Pritikin Longevity Center and receiving a research grant from Sanofi.
SNOWMASS, COLO. – Cutting dietary fat intake remains a highly effective strategy for reducing coronary heart disease risk – but only so long as the replacement nutrients aren’t even bigger offenders, Dr. Robert A. Vogel said at the Annual Cardiovascular Conference at Snowmass.
In the face of decades of public health admonitions to reduce saturated fat intake, most Americans have increased their consumption of trans fats and simple carbohydrates, especially sugar. And therein lies a problem. Trans fats are far more harmful than saturated fats in terms of cardiovascular risk. And excessive sugar consumption is a major contributor to abdominal obesity, metabolic syndrome, hypertension, and endothelial dysfunction.
“In the United States, sugar is a bigger source of hypertension than is salt,” asserted Dr. Vogel, a cardiologist at the University of Colorado, Denver.
The editors of Time magazine ignited a public controversy last year with a cover story arrestingly titled, “Eat Butter – Scientists labelled fat the enemy. Why they were wrong.” The editors were picking up on a British meta-analysis of 32 observational studies that concluded there is no clear evidence to support the notion that saturated fats are harmful to cardiovascular health and that swapping them out for consumption of polyunsaturated fatty acids (PUFAs) is beneficial (Ann. Intern. Med. 2014;160:398-406).
Dr. Vogel said those investigators are in fact correct: Many of the observational studies – going all the way back to the pioneering work by Dr. Ancel Keys in the 1950s – are flawed. They don’t convincingly prove the case for PUFAs as a healthier alternative. But there is persuasive evidence from well-conducted, randomized, controlled trials that this is indeed so, he added.
Several of these studies were done in an earlier era when it was possible to slip around the challenges and limitations of dietary studies in free-living populations. These trials wouldn’t be possible today for ethical reasons involving lack of informed consent.
For example, in the Finnish Mental Hospital Study conducted during 1959-1971, the food served at two mental institutions was altered. Patients at one hospital got 6 years of a diet high in PUFAs, then were crossed over to a typical Finnish diet. At the other mental hospital, patients were fed a normal Finnish diet for 6 years, then crossed over to the high-PUFA diet for 6 years. During the experimental-diet years, the coronary heart disease event rate was reduced by nearly 60% (Int. J. Epidemiol. 1979;8:99-118).
Similarly, in a prospective randomized trial conducted at a Los Angeles Veterans Affairs institution for older, cognitively impaired men, a no-choice shift to a diet high in PUFAs with reduced saturated fats resulted in roughly a 30% reduction in CHD events compared to the usual institutional diet (Lancet 1968;2:1060-2). A similar magnitude of CHD event reduction was seen with a high-PUFA dietary intervention in the Oslo Diet-Heart Study, a prospective secondary prevention trial (Circulation 1970;42:935-42).
In the contemporary era, the standout randomized dietary intervention trial is the Lyon Diet Heart Study, a 46-month prospective secondary prevention trial in which a Mediterranean diet low in saturated fat and high in alpha-linoleic acid, a PUFA, reduced the combined endpoint of cardiac death and nonfatal MI by 70%, compared with the usual post-MI prudent diet recommended at that time. Yet total cholesterol levels in the two study arms did not differ (Circulation 1999;99:779-85).
To put these results into context, Dr. Vogel noted that the Cholesterol Treatment Trialists Collaboration headquartered at the University of Oxford (England) has shown that for every 40 mg/dL of LDL-lowering achieved with statin therapy, the result is roughly a 20% reduction in CHD. In contrast, the classic nonpharmacologic diet studies resulted in 30%-70% relative risk reductions.
“Heart disease is a dietary disease,” the cardiologist emphasized. “When you compare diet intervention to LDL lowering with statins, you see that diet is very, very effective. But you have to know the details of the diet. You can’t take something out and put just anything in. It doesn’t work like that.”
For example, an analysis of data from the National Health and Nutrition Examination Survey concluded that individuals who consumed 25% of their calories from added sugar – that’s the equivalent of three 12-oz cans of a sugary cola per day – had a 175% increased risk of cardiovascular mortality during a median 14.6 years of follow-up, compared with those who got less than 10% of their calories from added sugar (JAMA Intern. Med. 2014;174:516-24).
And as for the impact of the trans fat that’s liberally present in many processed foods, the Nurses Health Study showed that for every 5% increase in energy intake from saturated fat – that’s equivalent to one 8-oz steak per day – the relative risk for CHD rose by a relatively modest 17%, while for a 5% increase in energy intake from trans fat – the equivalent of 4 oz of butter – CHD risk shot up by 382% (N. Engl. J. Med. 1997;337:1491-9).
Dr. Vogel reported serving as a paid consultant to the National Football League and the Pritikin Longevity Center and receiving a research grant from Sanofi.
SNOWMASS, COLO. – Cutting dietary fat intake remains a highly effective strategy for reducing coronary heart disease risk – but only so long as the replacement nutrients aren’t even bigger offenders, Dr. Robert A. Vogel said at the Annual Cardiovascular Conference at Snowmass.
In the face of decades of public health admonitions to reduce saturated fat intake, most Americans have increased their consumption of trans fats and simple carbohydrates, especially sugar. And therein lies a problem. Trans fats are far more harmful than saturated fats in terms of cardiovascular risk. And excessive sugar consumption is a major contributor to abdominal obesity, metabolic syndrome, hypertension, and endothelial dysfunction.
“In the United States, sugar is a bigger source of hypertension than is salt,” asserted Dr. Vogel, a cardiologist at the University of Colorado, Denver.
The editors of Time magazine ignited a public controversy last year with a cover story arrestingly titled, “Eat Butter – Scientists labelled fat the enemy. Why they were wrong.” The editors were picking up on a British meta-analysis of 32 observational studies that concluded there is no clear evidence to support the notion that saturated fats are harmful to cardiovascular health and that swapping them out for consumption of polyunsaturated fatty acids (PUFAs) is beneficial (Ann. Intern. Med. 2014;160:398-406).
Dr. Vogel said those investigators are in fact correct: Many of the observational studies – going all the way back to the pioneering work by Dr. Ancel Keys in the 1950s – are flawed. They don’t convincingly prove the case for PUFAs as a healthier alternative. But there is persuasive evidence from well-conducted, randomized, controlled trials that this is indeed so, he added.
Several of these studies were done in an earlier era when it was possible to slip around the challenges and limitations of dietary studies in free-living populations. These trials wouldn’t be possible today for ethical reasons involving lack of informed consent.
For example, in the Finnish Mental Hospital Study conducted during 1959-1971, the food served at two mental institutions was altered. Patients at one hospital got 6 years of a diet high in PUFAs, then were crossed over to a typical Finnish diet. At the other mental hospital, patients were fed a normal Finnish diet for 6 years, then crossed over to the high-PUFA diet for 6 years. During the experimental-diet years, the coronary heart disease event rate was reduced by nearly 60% (Int. J. Epidemiol. 1979;8:99-118).
Similarly, in a prospective randomized trial conducted at a Los Angeles Veterans Affairs institution for older, cognitively impaired men, a no-choice shift to a diet high in PUFAs with reduced saturated fats resulted in roughly a 30% reduction in CHD events compared to the usual institutional diet (Lancet 1968;2:1060-2). A similar magnitude of CHD event reduction was seen with a high-PUFA dietary intervention in the Oslo Diet-Heart Study, a prospective secondary prevention trial (Circulation 1970;42:935-42).
In the contemporary era, the standout randomized dietary intervention trial is the Lyon Diet Heart Study, a 46-month prospective secondary prevention trial in which a Mediterranean diet low in saturated fat and high in alpha-linoleic acid, a PUFA, reduced the combined endpoint of cardiac death and nonfatal MI by 70%, compared with the usual post-MI prudent diet recommended at that time. Yet total cholesterol levels in the two study arms did not differ (Circulation 1999;99:779-85).
To put these results into context, Dr. Vogel noted that the Cholesterol Treatment Trialists Collaboration headquartered at the University of Oxford (England) has shown that for every 40 mg/dL of LDL-lowering achieved with statin therapy, the result is roughly a 20% reduction in CHD. In contrast, the classic nonpharmacologic diet studies resulted in 30%-70% relative risk reductions.
“Heart disease is a dietary disease,” the cardiologist emphasized. “When you compare diet intervention to LDL lowering with statins, you see that diet is very, very effective. But you have to know the details of the diet. You can’t take something out and put just anything in. It doesn’t work like that.”
For example, an analysis of data from the National Health and Nutrition Examination Survey concluded that individuals who consumed 25% of their calories from added sugar – that’s the equivalent of three 12-oz cans of a sugary cola per day – had a 175% increased risk of cardiovascular mortality during a median 14.6 years of follow-up, compared with those who got less than 10% of their calories from added sugar (JAMA Intern. Med. 2014;174:516-24).
And as for the impact of the trans fat that’s liberally present in many processed foods, the Nurses Health Study showed that for every 5% increase in energy intake from saturated fat – that’s equivalent to one 8-oz steak per day – the relative risk for CHD rose by a relatively modest 17%, while for a 5% increase in energy intake from trans fat – the equivalent of 4 oz of butter – CHD risk shot up by 382% (N. Engl. J. Med. 1997;337:1491-9).
Dr. Vogel reported serving as a paid consultant to the National Football League and the Pritikin Longevity Center and receiving a research grant from Sanofi.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
Experimental vaccine may have worked on Ebola-exposed physician
A U.S. physician exposed to Ebola virus received an investigational vaccine afterward and didn’t contract the disease, but the vaccine’s effectiveness remains unknown, according to report published online March 5 in JAMA.
The vaccine, VSV[Delta]G-ZEBOV, is based on a vesicular stomatitis virus with the glycoprotein gene replaced by a Zaire Ebola glycoprotein gene.
The physician received the vaccine slightly less than 2 days after Ebola exposure. After 12 hours, symptoms appeared that are associated with vesicular stomatitis virus. Those dissipated after 3-4 days, noted Dr. Lilin Lai of Emory University, Atlanta, and her colleagues.
No Ebola symptoms were detected, but the patient tested positive for Ebola virus glycoprotein-specific antibodies and T cells, which was an intended effect of the vaccine.
A single case report cannot provide a definitive answer to the effectiveness of VSV[Delta]G-ZEBOV, noted Thomas W. Geisbert, Ph.D. of the Galveston National Laboratory, University of Texas Medical Branch, in a related editorial. However, “this incident serves as an example of how important it is to have safe and effective countermeasures available in sufficient quantities that can be rapidly deployed for emergency use for both medical workers and affected populations.”
Find the full study and editorial in JAMA: (doi: 10.1001/jama.2015.1995) and (doi: 10.1001/jama.2015.2057).
A U.S. physician exposed to Ebola virus received an investigational vaccine afterward and didn’t contract the disease, but the vaccine’s effectiveness remains unknown, according to report published online March 5 in JAMA.
The vaccine, VSV[Delta]G-ZEBOV, is based on a vesicular stomatitis virus with the glycoprotein gene replaced by a Zaire Ebola glycoprotein gene.
The physician received the vaccine slightly less than 2 days after Ebola exposure. After 12 hours, symptoms appeared that are associated with vesicular stomatitis virus. Those dissipated after 3-4 days, noted Dr. Lilin Lai of Emory University, Atlanta, and her colleagues.
No Ebola symptoms were detected, but the patient tested positive for Ebola virus glycoprotein-specific antibodies and T cells, which was an intended effect of the vaccine.
A single case report cannot provide a definitive answer to the effectiveness of VSV[Delta]G-ZEBOV, noted Thomas W. Geisbert, Ph.D. of the Galveston National Laboratory, University of Texas Medical Branch, in a related editorial. However, “this incident serves as an example of how important it is to have safe and effective countermeasures available in sufficient quantities that can be rapidly deployed for emergency use for both medical workers and affected populations.”
Find the full study and editorial in JAMA: (doi: 10.1001/jama.2015.1995) and (doi: 10.1001/jama.2015.2057).
A U.S. physician exposed to Ebola virus received an investigational vaccine afterward and didn’t contract the disease, but the vaccine’s effectiveness remains unknown, according to report published online March 5 in JAMA.
The vaccine, VSV[Delta]G-ZEBOV, is based on a vesicular stomatitis virus with the glycoprotein gene replaced by a Zaire Ebola glycoprotein gene.
The physician received the vaccine slightly less than 2 days after Ebola exposure. After 12 hours, symptoms appeared that are associated with vesicular stomatitis virus. Those dissipated after 3-4 days, noted Dr. Lilin Lai of Emory University, Atlanta, and her colleagues.
No Ebola symptoms were detected, but the patient tested positive for Ebola virus glycoprotein-specific antibodies and T cells, which was an intended effect of the vaccine.
A single case report cannot provide a definitive answer to the effectiveness of VSV[Delta]G-ZEBOV, noted Thomas W. Geisbert, Ph.D. of the Galveston National Laboratory, University of Texas Medical Branch, in a related editorial. However, “this incident serves as an example of how important it is to have safe and effective countermeasures available in sufficient quantities that can be rapidly deployed for emergency use for both medical workers and affected populations.”
Find the full study and editorial in JAMA: (doi: 10.1001/jama.2015.1995) and (doi: 10.1001/jama.2015.2057).
Regimen prolongs PFS, increases AEs in MCL
Results of a phase 3 study suggest the VR-CAP regimen is more effective but less safe than R-CHOP in patients with newly diagnosed mantle cell lymphoma (MCL).
Patients who received VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) had superior progression-free survival (PFS) when compared to patients who received R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
But VR-CAP was also associated with more adverse events (AEs), particularly hematologic toxicities.
Tadeusz Robak, MD, of the Medical University of Lodz in Poland, and his colleagues reported results from this trial, known as LYM-3002, in NEJM. The study was funded by Janssen Research and Development and Millennium Pharmaceuticals.
LYM-3002 included 487 patients newly diagnosed with MCL who were not eligible for stem cell transplant.
Patients were randomized to receive six to eight 21-day cycles of R-CHOP intravenously on day 1 (with prednisone administered orally on days 1 to 5) or VR-CAP (similar to the R-CHOP regimen, but replacing vincristine with bortezomib at a dose of 1.3 mg per square meter of body-surface area on days 1, 4, 8, and 11).
The median follow-up was 40 months. The VR-CAP regimen significantly improved PFS, the primary endpoint, when compared to R-CHOP.
According to an independent review committee, there was a 59% improvement in PFS for the VR-CAP arm compared to the R-CHOP arm, with median PFS times of 24.7 months and 14.4 months, respectively (hazard ratio [HR]=0.63, P<0.001).
Study investigators reported a 96% increase in PFS with VR-CAP compared to R-CHOP, with median PFS times of 30.7 months and 16.1 months, respectively (HR=0.51, P<0.001).
Patients in the VR-CAP arm also fared better with regard to some secondary endpoints. The complete response rate was higher in the VR-CAP arm than the R-CHOP arm—53% and 42%, respectively (HR=1.29, P=0.007).
And patients in the VR-CAP arm had a longer median treatment-free interval—40.6 months and 20.5 months, respectively (HR=0.50, P<0.001).
However, there was no significant difference in overall survival between the treatment arms. The median overall survival was not reached in the VR-CAP arm and was 56.3 months in the R-CHOP arm (HR=0.80, P=0.17). The 4-year overall survival rate was 64% and 54%, respectively.
The investigators said VR-CAP was associated with additional, but manageable, toxicity when compared to R-CHOP. Serious AEs were reported in 38% and 30% of patients, respectively. And grade 3 or higher AEs were reported in 93% and 85% of patients, respectively.
Hematologic toxicity was more common in the VR-CAP arm than the R-CHOP arm. This included thrombocytopenia (72% vs 19%), neutropenia (88% vs 74%), anemia (51% vs 37%), leukopenia (50% vs 38%), lymphocytopenia (31% vs 13%), and febrile neutropenia (17% vs 14%).
Treatment discontinuation due to AEs occurred in 8% of patients in the VR-CAP arm and 6% in the R-CHOP arm. On-treatment, drug-related deaths occurred in 2% and 3% of patients, respectively.
It was based on these results that bortezomib was approved for use in patients with newly diagnosed MCL in the Europe Union and the US. 
Results of a phase 3 study suggest the VR-CAP regimen is more effective but less safe than R-CHOP in patients with newly diagnosed mantle cell lymphoma (MCL).
Patients who received VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) had superior progression-free survival (PFS) when compared to patients who received R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
But VR-CAP was also associated with more adverse events (AEs), particularly hematologic toxicities.
Tadeusz Robak, MD, of the Medical University of Lodz in Poland, and his colleagues reported results from this trial, known as LYM-3002, in NEJM. The study was funded by Janssen Research and Development and Millennium Pharmaceuticals.
LYM-3002 included 487 patients newly diagnosed with MCL who were not eligible for stem cell transplant.
Patients were randomized to receive six to eight 21-day cycles of R-CHOP intravenously on day 1 (with prednisone administered orally on days 1 to 5) or VR-CAP (similar to the R-CHOP regimen, but replacing vincristine with bortezomib at a dose of 1.3 mg per square meter of body-surface area on days 1, 4, 8, and 11).
The median follow-up was 40 months. The VR-CAP regimen significantly improved PFS, the primary endpoint, when compared to R-CHOP.
According to an independent review committee, there was a 59% improvement in PFS for the VR-CAP arm compared to the R-CHOP arm, with median PFS times of 24.7 months and 14.4 months, respectively (hazard ratio [HR]=0.63, P<0.001).
Study investigators reported a 96% increase in PFS with VR-CAP compared to R-CHOP, with median PFS times of 30.7 months and 16.1 months, respectively (HR=0.51, P<0.001).
Patients in the VR-CAP arm also fared better with regard to some secondary endpoints. The complete response rate was higher in the VR-CAP arm than the R-CHOP arm—53% and 42%, respectively (HR=1.29, P=0.007).
And patients in the VR-CAP arm had a longer median treatment-free interval—40.6 months and 20.5 months, respectively (HR=0.50, P<0.001).
However, there was no significant difference in overall survival between the treatment arms. The median overall survival was not reached in the VR-CAP arm and was 56.3 months in the R-CHOP arm (HR=0.80, P=0.17). The 4-year overall survival rate was 64% and 54%, respectively.
The investigators said VR-CAP was associated with additional, but manageable, toxicity when compared to R-CHOP. Serious AEs were reported in 38% and 30% of patients, respectively. And grade 3 or higher AEs were reported in 93% and 85% of patients, respectively.
Hematologic toxicity was more common in the VR-CAP arm than the R-CHOP arm. This included thrombocytopenia (72% vs 19%), neutropenia (88% vs 74%), anemia (51% vs 37%), leukopenia (50% vs 38%), lymphocytopenia (31% vs 13%), and febrile neutropenia (17% vs 14%).
Treatment discontinuation due to AEs occurred in 8% of patients in the VR-CAP arm and 6% in the R-CHOP arm. On-treatment, drug-related deaths occurred in 2% and 3% of patients, respectively.
It was based on these results that bortezomib was approved for use in patients with newly diagnosed MCL in the Europe Union and the US.
Results of a phase 3 study suggest the VR-CAP regimen is more effective but less safe than R-CHOP in patients with newly diagnosed mantle cell lymphoma (MCL).
Patients who received VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) had superior progression-free survival (PFS) when compared to patients who received R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
But VR-CAP was also associated with more adverse events (AEs), particularly hematologic toxicities.
Tadeusz Robak, MD, of the Medical University of Lodz in Poland, and his colleagues reported results from this trial, known as LYM-3002, in NEJM. The study was funded by Janssen Research and Development and Millennium Pharmaceuticals.
LYM-3002 included 487 patients newly diagnosed with MCL who were not eligible for stem cell transplant.
Patients were randomized to receive six to eight 21-day cycles of R-CHOP intravenously on day 1 (with prednisone administered orally on days 1 to 5) or VR-CAP (similar to the R-CHOP regimen, but replacing vincristine with bortezomib at a dose of 1.3 mg per square meter of body-surface area on days 1, 4, 8, and 11).
The median follow-up was 40 months. The VR-CAP regimen significantly improved PFS, the primary endpoint, when compared to R-CHOP.
According to an independent review committee, there was a 59% improvement in PFS for the VR-CAP arm compared to the R-CHOP arm, with median PFS times of 24.7 months and 14.4 months, respectively (hazard ratio [HR]=0.63, P<0.001).
Study investigators reported a 96% increase in PFS with VR-CAP compared to R-CHOP, with median PFS times of 30.7 months and 16.1 months, respectively (HR=0.51, P<0.001).
Patients in the VR-CAP arm also fared better with regard to some secondary endpoints. The complete response rate was higher in the VR-CAP arm than the R-CHOP arm—53% and 42%, respectively (HR=1.29, P=0.007).
And patients in the VR-CAP arm had a longer median treatment-free interval—40.6 months and 20.5 months, respectively (HR=0.50, P<0.001).
However, there was no significant difference in overall survival between the treatment arms. The median overall survival was not reached in the VR-CAP arm and was 56.3 months in the R-CHOP arm (HR=0.80, P=0.17). The 4-year overall survival rate was 64% and 54%, respectively.
The investigators said VR-CAP was associated with additional, but manageable, toxicity when compared to R-CHOP. Serious AEs were reported in 38% and 30% of patients, respectively. And grade 3 or higher AEs were reported in 93% and 85% of patients, respectively.
Hematologic toxicity was more common in the VR-CAP arm than the R-CHOP arm. This included thrombocytopenia (72% vs 19%), neutropenia (88% vs 74%), anemia (51% vs 37%), leukopenia (50% vs 38%), lymphocytopenia (31% vs 13%), and febrile neutropenia (17% vs 14%).
Treatment discontinuation due to AEs occurred in 8% of patients in the VR-CAP arm and 6% in the R-CHOP arm. On-treatment, drug-related deaths occurred in 2% and 3% of patients, respectively.
It was based on these results that bortezomib was approved for use in patients with newly diagnosed MCL in the Europe Union and the US.
Placenta-derived cells may improve recovery after HSCT
Cells derived from placenta can increase blood counts after hematopoietic stem cell transplant (HSCT), preclinical research suggests.
Investigators evaluated PLX-R18, a product consisting of mesenchymal-like adherent stromal cells derived from full-term human placentas, in mice undergoing HSCT.
Mice that received PLX-R18 in conjunction with HSCT had significantly faster hematopoietic recovery than mice that received placebo with their transplants.
Pluristem Therapeutics, Inc., the company developing PLX-R18, recently announced these results.
The study included 78 irradiated mice divided into 4 groups. One group received a transplant of 4 million HSCs plus an intra-muscular (IM) injection of 1 million PLX-R18 cells on days 1 and 10. A second group received 8 million HSCs plus an IM injection of 1 million PLX-R18 cells on days 1 and 10.
The first control group received 4 million HSCs plus an IM injection of placebo on days 1 and 10. And the second control group received 8 million HSCs plus an IM injection of placebo on days 1 and 10.
The investigators performed complete blood counts on day 9 after HSCT and the first dose of PLX-R18 or placebo, on day 16 after the second dose of PLX-R18 or placebo, and on day 23.
Nine days after transplantation with a low dose of HSCs (4 million) and concurrent administration of either PLX-R18 or placebo, mice treated with PLX-R18 had statistically significant increases in platelets and granulocytes when compared to controls (P=0.0059 and P=0.0267, respectively).
PLX-R18-treated mice also had more lymphocytes and total white blood cells, but these increases were not statistically significant.
Nine days after transplantation with a high dose of HSCs (8 million) and concurrent administration of either PLX-R18 or placebo, mice treated with PLX-R18 had statistically significant increases in platelet levels (P=0.0015).
One week later, at 16 days after a low-dose HSCT, mice treated with PLX-R18 had more platelets than controls, although the difference wasn’t significant.
Also on day 16, mice treated with PLX-R18 and a high dose of HSCs had statistically significant increases in platelets, granulocytes, and total white blood cells compared to controls (P=0.0053, P=0.0122, and P=0.0262 respectively).
On day 23, there were no significant differences in the number of cells between the treatment groups.
Taking these results together, the investigators concluded that PLX-R18 cells can significantly accelerate the recovery of several components of normal blood counts.
“A statistically significant increase in blood counts soon after bone marrow transplant is very meaningful,” said Reuven Or, MD, of Hadassah Medical Center in Haifa, Israel.
“We were particularly encouraged to see that the administration of PLX-R18 cells resulted in the greatest early improvement when using a lower dose of bone marrow cells. This means we could one day potentially achieve success with lower bone marrow transplant doses, thus addressing both treatment costs and donor availability.”
Cells derived from placenta can increase blood counts after hematopoietic stem cell transplant (HSCT), preclinical research suggests.
Investigators evaluated PLX-R18, a product consisting of mesenchymal-like adherent stromal cells derived from full-term human placentas, in mice undergoing HSCT.
Mice that received PLX-R18 in conjunction with HSCT had significantly faster hematopoietic recovery than mice that received placebo with their transplants.
Pluristem Therapeutics, Inc., the company developing PLX-R18, recently announced these results.
The study included 78 irradiated mice divided into 4 groups. One group received a transplant of 4 million HSCs plus an intra-muscular (IM) injection of 1 million PLX-R18 cells on days 1 and 10. A second group received 8 million HSCs plus an IM injection of 1 million PLX-R18 cells on days 1 and 10.
The first control group received 4 million HSCs plus an IM injection of placebo on days 1 and 10. And the second control group received 8 million HSCs plus an IM injection of placebo on days 1 and 10.
The investigators performed complete blood counts on day 9 after HSCT and the first dose of PLX-R18 or placebo, on day 16 after the second dose of PLX-R18 or placebo, and on day 23.
Nine days after transplantation with a low dose of HSCs (4 million) and concurrent administration of either PLX-R18 or placebo, mice treated with PLX-R18 had statistically significant increases in platelets and granulocytes when compared to controls (P=0.0059 and P=0.0267, respectively).
PLX-R18-treated mice also had more lymphocytes and total white blood cells, but these increases were not statistically significant.
Nine days after transplantation with a high dose of HSCs (8 million) and concurrent administration of either PLX-R18 or placebo, mice treated with PLX-R18 had statistically significant increases in platelet levels (P=0.0015).
One week later, at 16 days after a low-dose HSCT, mice treated with PLX-R18 had more platelets than controls, although the difference wasn’t significant.
Also on day 16, mice treated with PLX-R18 and a high dose of HSCs had statistically significant increases in platelets, granulocytes, and total white blood cells compared to controls (P=0.0053, P=0.0122, and P=0.0262 respectively).
On day 23, there were no significant differences in the number of cells between the treatment groups.
Taking these results together, the investigators concluded that PLX-R18 cells can significantly accelerate the recovery of several components of normal blood counts.
“A statistically significant increase in blood counts soon after bone marrow transplant is very meaningful,” said Reuven Or, MD, of Hadassah Medical Center in Haifa, Israel.
“We were particularly encouraged to see that the administration of PLX-R18 cells resulted in the greatest early improvement when using a lower dose of bone marrow cells. This means we could one day potentially achieve success with lower bone marrow transplant doses, thus addressing both treatment costs and donor availability.”
Cells derived from placenta can increase blood counts after hematopoietic stem cell transplant (HSCT), preclinical research suggests.
Investigators evaluated PLX-R18, a product consisting of mesenchymal-like adherent stromal cells derived from full-term human placentas, in mice undergoing HSCT.
Mice that received PLX-R18 in conjunction with HSCT had significantly faster hematopoietic recovery than mice that received placebo with their transplants.
Pluristem Therapeutics, Inc., the company developing PLX-R18, recently announced these results.
The study included 78 irradiated mice divided into 4 groups. One group received a transplant of 4 million HSCs plus an intra-muscular (IM) injection of 1 million PLX-R18 cells on days 1 and 10. A second group received 8 million HSCs plus an IM injection of 1 million PLX-R18 cells on days 1 and 10.
The first control group received 4 million HSCs plus an IM injection of placebo on days 1 and 10. And the second control group received 8 million HSCs plus an IM injection of placebo on days 1 and 10.
The investigators performed complete blood counts on day 9 after HSCT and the first dose of PLX-R18 or placebo, on day 16 after the second dose of PLX-R18 or placebo, and on day 23.
Nine days after transplantation with a low dose of HSCs (4 million) and concurrent administration of either PLX-R18 or placebo, mice treated with PLX-R18 had statistically significant increases in platelets and granulocytes when compared to controls (P=0.0059 and P=0.0267, respectively).
PLX-R18-treated mice also had more lymphocytes and total white blood cells, but these increases were not statistically significant.
Nine days after transplantation with a high dose of HSCs (8 million) and concurrent administration of either PLX-R18 or placebo, mice treated with PLX-R18 had statistically significant increases in platelet levels (P=0.0015).
One week later, at 16 days after a low-dose HSCT, mice treated with PLX-R18 had more platelets than controls, although the difference wasn’t significant.
Also on day 16, mice treated with PLX-R18 and a high dose of HSCs had statistically significant increases in platelets, granulocytes, and total white blood cells compared to controls (P=0.0053, P=0.0122, and P=0.0262 respectively).
On day 23, there were no significant differences in the number of cells between the treatment groups.
Taking these results together, the investigators concluded that PLX-R18 cells can significantly accelerate the recovery of several components of normal blood counts.
“A statistically significant increase in blood counts soon after bone marrow transplant is very meaningful,” said Reuven Or, MD, of Hadassah Medical Center in Haifa, Israel.
“We were particularly encouraged to see that the administration of PLX-R18 cells resulted in the greatest early improvement when using a lower dose of bone marrow cells. This means we could one day potentially achieve success with lower bone marrow transplant doses, thus addressing both treatment costs and donor availability.”
New radiation guidelines for pediatric HL
New guidelines on radiation therapy aim to help physicians more effectively treat pediatric Hodgkin lymphoma (HL) while reducing the radiation dose to normal tissue.
Previous guidelines for pediatric HL have focused on 2D imaging and bony landmarks to define dose volumes for radiation therapy, and they’ve recommended treating large volumes of normal tissue, in part, because of uncertainty about which lymph node areas were involved.
The new guidelines, published in Practical Radiation Oncology, describe how to use modern imaging and advances in radiation therapy planning technology to treat patients with pediatric HL while decreasing the risk of late side effects, including second cancers and heart disease.
The authors describe methods for identifying target volumes for radiation therapy and how to implement the concept of involved-site radiation to define radiation target volumes and limit the dose to normal organs at risk.
According to the guidelines, accurate assessment of the extent and location of disease requires both contrast-enhanced CT as well as FDG-PET.
The document describes how the evaluation of response to chemotherapy influences the targeting of the lymphoma and the volume of normal tissue treated, by fusing CT and FDG-PET images taken before and after chemotherapy to CT imaging taken for radiation therapy planning.
“The emergence of new imaging technologies, more accurate ways of delivering radiation therapy, and more detailed patient selection criteria have made a significant change in our ability to customize treatment for many cancer patients,” said lead guideline author David C. Hodgson, MD, of the University of Toronto in Ontario, Canada.
“This guideline has the potential to reduce the radiation therapy breast dose by about 80% and the heart dose by about 65% for an adolescent girl with Hodgkin lymphoma. This shift in more personalized treatment planning tailored to the individual patient’s disease will optimize risk-benefit considerations for our patients and reduce the likelihood that they will suffer late effects from radiation therapy.”
New guidelines on radiation therapy aim to help physicians more effectively treat pediatric Hodgkin lymphoma (HL) while reducing the radiation dose to normal tissue.
Previous guidelines for pediatric HL have focused on 2D imaging and bony landmarks to define dose volumes for radiation therapy, and they’ve recommended treating large volumes of normal tissue, in part, because of uncertainty about which lymph node areas were involved.
The new guidelines, published in Practical Radiation Oncology, describe how to use modern imaging and advances in radiation therapy planning technology to treat patients with pediatric HL while decreasing the risk of late side effects, including second cancers and heart disease.
The authors describe methods for identifying target volumes for radiation therapy and how to implement the concept of involved-site radiation to define radiation target volumes and limit the dose to normal organs at risk.
According to the guidelines, accurate assessment of the extent and location of disease requires both contrast-enhanced CT as well as FDG-PET.
The document describes how the evaluation of response to chemotherapy influences the targeting of the lymphoma and the volume of normal tissue treated, by fusing CT and FDG-PET images taken before and after chemotherapy to CT imaging taken for radiation therapy planning.
“The emergence of new imaging technologies, more accurate ways of delivering radiation therapy, and more detailed patient selection criteria have made a significant change in our ability to customize treatment for many cancer patients,” said lead guideline author David C. Hodgson, MD, of the University of Toronto in Ontario, Canada.
“This guideline has the potential to reduce the radiation therapy breast dose by about 80% and the heart dose by about 65% for an adolescent girl with Hodgkin lymphoma. This shift in more personalized treatment planning tailored to the individual patient’s disease will optimize risk-benefit considerations for our patients and reduce the likelihood that they will suffer late effects from radiation therapy.”
New guidelines on radiation therapy aim to help physicians more effectively treat pediatric Hodgkin lymphoma (HL) while reducing the radiation dose to normal tissue.
Previous guidelines for pediatric HL have focused on 2D imaging and bony landmarks to define dose volumes for radiation therapy, and they’ve recommended treating large volumes of normal tissue, in part, because of uncertainty about which lymph node areas were involved.
The new guidelines, published in Practical Radiation Oncology, describe how to use modern imaging and advances in radiation therapy planning technology to treat patients with pediatric HL while decreasing the risk of late side effects, including second cancers and heart disease.
The authors describe methods for identifying target volumes for radiation therapy and how to implement the concept of involved-site radiation to define radiation target volumes and limit the dose to normal organs at risk.
According to the guidelines, accurate assessment of the extent and location of disease requires both contrast-enhanced CT as well as FDG-PET.
The document describes how the evaluation of response to chemotherapy influences the targeting of the lymphoma and the volume of normal tissue treated, by fusing CT and FDG-PET images taken before and after chemotherapy to CT imaging taken for radiation therapy planning.
“The emergence of new imaging technologies, more accurate ways of delivering radiation therapy, and more detailed patient selection criteria have made a significant change in our ability to customize treatment for many cancer patients,” said lead guideline author David C. Hodgson, MD, of the University of Toronto in Ontario, Canada.
“This guideline has the potential to reduce the radiation therapy breast dose by about 80% and the heart dose by about 65% for an adolescent girl with Hodgkin lymphoma. This shift in more personalized treatment planning tailored to the individual patient’s disease will optimize risk-benefit considerations for our patients and reduce the likelihood that they will suffer late effects from radiation therapy.”
Parasite discovery could aid malaria treatment
Image by Ke Hu & John Murray
Researchers say they have gained new insight into how malaria-related parasites spread inside humans and other animals.
The team discovered how the malaria relative Toxoplasma gondii manages to replicate its chromosomes up to thousands of times before spinning off into daughter cells—all while avoiding cell death.
The findings, published in PLOS Biology, may have implications for malaria treatment, according to the researchers.
Once transmitted into an animal or human, malaria-related parasites can hide out in a single cell in many different tissues, replicating thousands of times before the host’s immune system can detect them.
Then, they burst forth as daughter cells, which are unleashed in massive quantities, quickly overwhelming the body’s immune response.
The researchers found that Toxoplasma parasites pull this off thanks to the centrosome, which imposes order on the replication chaos.
“Unlike the comparatively simple centrosome present in human cells, the parasite [centrosome] has 2 distinct operating machines,” said study author Michael White, PhD, of the University of South Florida in Tampa.
“One machine controls chromosome copying, while the other machine regulates when to form daughter cell bodies. Working together, but with independent responsibilities, parasite centrosome machines can dictate the scale and timing of pathogen replication.”
This discovery of the centrosome’s function leads to a critical conclusion, Dr White said. Disrupting the centrosome machines kills the parasite. Breaking any part of the highly efficient but highly fragile replication function shuts everything down.
With these findings and the new knowledge of the parasites’ vulnerabilities, Dr White and his fellow researchers are planning to explore drug development for malaria. Whether the team is able to find an already-approved drug or must develop one from scratch, they said the drug will need to be used in conjunction with other therapies.
Dr White noted that current drugs used to treat malaria target the pathogen’s metabolism. But the goal of the new drug will be to undermine the parasite’s foundation in enough of the spreading cells to allow the immune system to fight back and not become overwhelmed.
Image by Ke Hu & John Murray
Researchers say they have gained new insight into how malaria-related parasites spread inside humans and other animals.
The team discovered how the malaria relative Toxoplasma gondii manages to replicate its chromosomes up to thousands of times before spinning off into daughter cells—all while avoiding cell death.
The findings, published in PLOS Biology, may have implications for malaria treatment, according to the researchers.
Once transmitted into an animal or human, malaria-related parasites can hide out in a single cell in many different tissues, replicating thousands of times before the host’s immune system can detect them.
Then, they burst forth as daughter cells, which are unleashed in massive quantities, quickly overwhelming the body’s immune response.
The researchers found that Toxoplasma parasites pull this off thanks to the centrosome, which imposes order on the replication chaos.
“Unlike the comparatively simple centrosome present in human cells, the parasite [centrosome] has 2 distinct operating machines,” said study author Michael White, PhD, of the University of South Florida in Tampa.
“One machine controls chromosome copying, while the other machine regulates when to form daughter cell bodies. Working together, but with independent responsibilities, parasite centrosome machines can dictate the scale and timing of pathogen replication.”
This discovery of the centrosome’s function leads to a critical conclusion, Dr White said. Disrupting the centrosome machines kills the parasite. Breaking any part of the highly efficient but highly fragile replication function shuts everything down.
With these findings and the new knowledge of the parasites’ vulnerabilities, Dr White and his fellow researchers are planning to explore drug development for malaria. Whether the team is able to find an already-approved drug or must develop one from scratch, they said the drug will need to be used in conjunction with other therapies.
Dr White noted that current drugs used to treat malaria target the pathogen’s metabolism. But the goal of the new drug will be to undermine the parasite’s foundation in enough of the spreading cells to allow the immune system to fight back and not become overwhelmed.
Image by Ke Hu & John Murray
Researchers say they have gained new insight into how malaria-related parasites spread inside humans and other animals.
The team discovered how the malaria relative Toxoplasma gondii manages to replicate its chromosomes up to thousands of times before spinning off into daughter cells—all while avoiding cell death.
The findings, published in PLOS Biology, may have implications for malaria treatment, according to the researchers.
Once transmitted into an animal or human, malaria-related parasites can hide out in a single cell in many different tissues, replicating thousands of times before the host’s immune system can detect them.
Then, they burst forth as daughter cells, which are unleashed in massive quantities, quickly overwhelming the body’s immune response.
The researchers found that Toxoplasma parasites pull this off thanks to the centrosome, which imposes order on the replication chaos.
“Unlike the comparatively simple centrosome present in human cells, the parasite [centrosome] has 2 distinct operating machines,” said study author Michael White, PhD, of the University of South Florida in Tampa.
“One machine controls chromosome copying, while the other machine regulates when to form daughter cell bodies. Working together, but with independent responsibilities, parasite centrosome machines can dictate the scale and timing of pathogen replication.”
This discovery of the centrosome’s function leads to a critical conclusion, Dr White said. Disrupting the centrosome machines kills the parasite. Breaking any part of the highly efficient but highly fragile replication function shuts everything down.
With these findings and the new knowledge of the parasites’ vulnerabilities, Dr White and his fellow researchers are planning to explore drug development for malaria. Whether the team is able to find an already-approved drug or must develop one from scratch, they said the drug will need to be used in conjunction with other therapies.
Dr White noted that current drugs used to treat malaria target the pathogen’s metabolism. But the goal of the new drug will be to undermine the parasite’s foundation in enough of the spreading cells to allow the immune system to fight back and not become overwhelmed.
OUs and Patient Outcomes
Many pediatric hospitalizations are of short duration, and more than half of short‐stay hospitalizations are designated as observation status.[1, 2] Observation status is an administrative label assigned to patients who do not meet hospital or payer criteria for inpatient‐status care. Short‐stay observation‐status patients do not fit in traditional models of emergency department (ED) or inpatient care. EDs often focus on discharging or admitting patients within a matter of hours, whereas inpatient units tend to measure length of stay (LOS) in terms of days[3] and may not have systems in place to facilitate rapid discharge of short‐stay patients.[4] Observation units (OUs) have been established in some hospitals to address the unique care needs of short‐stay patients.[5, 6, 7]
Single‐site reports from children's hospitals with successful OUs have demonstrated shorter LOS and lower costs compared with inpatient settings.[6, 8, 9, 10, 11, 12, 13, 14] No prior study has examined hospital‐level effects of an OU on observation‐status patient outcomes. The Pediatric Health Information System (PHIS) database provides a unique opportunity to explore this question, because unlike other national hospital administrative databases,[15, 16] the PHIS dataset contains information about children under observation status. In addition, we know which PHIS hospitals had a dedicated OU in 2011.7
We hypothesized that overall observation‐status stays in hospitals with a dedicated OU would be of shorter duration with earlier discharges at lower cost than observation‐status stays in hospitals without a dedicated OU. We compared hospitals with and without a dedicated OU on secondary outcomes including rates of conversion to inpatient status and return care for any reason.
METHODS
We conducted a cross‐sectional analysis of hospital administrative data using the 2011 PHIS databasea national administrative database that contains resource utilization data from 43 participating hospitals located in 26 states plus the District of Columbia. These hospitals account for approximately 20% of pediatric hospitalizations in the United States.
For each hospital encounter, PHIS includes patient demographics, up to 41 International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) diagnoses, up to 41 ICD‐9‐CM procedures, and hospital charges for services. Data are deidentified prior to inclusion, but unique identifiers allow for determination of return visits and readmissions following an index visit for an individual patient. Data quality and reliability are assured jointly by the Children's Hospital Association (formerly Child Health Corporation of America, Overland Park, KS), participating hospitals, and Truven Health Analytics (New York, NY). This study, using administrative data, was not considered human subjects research by the policies of the Cincinnati Children's Hospital Medical Center Institutional Review Board.
Hospital Selection and Hospital Characteristics
The study sample was drawn from the 31 hospitals that reported observation‐status patient data to PHIS in 2011. Analyses were conducted in 2013, at which time 2011 was the most recent year of data. We categorized 14 hospitals as having a dedicated OU during 2011 based on information collected in 2013.7 To summarize briefly, we interviewed by telephone representatives of hospitals responding to an email query as to the presence of a geographically distinct OU for the care of unscheduled patients from the ED. Three of the 14 representatives reported their hospital had 2 OUs, 1 of which was a separate surgical OU. Ten OUs cared for both ED patients and patients with scheduled procedures; 8 units received patients from non‐ED sources. Hospitalists provided staffing in more than half of the OUs.
We attempted to identify administrative data that would signal care delivered in a dedicated OU using hospital charge codes reported to PHIS, but learned this was not possible due to between‐hospital variation in the specificity of the charge codes. Therefore, we were unable to determine if patient care was delivered in a dedicated OU or another setting, such as a general inpatient unit or the ED. Other hospital characteristics available from the PHIS dataset included the number of inpatient beds, ED visits, inpatient admissions, observation‐status stays, and payer mix. We calculated the percentage of ED visits resulting in admission by dividing the number of ED visits with associated inpatient or observation status by the total number of ED visits and the percentage of admissions under observation status by dividing the number of observation‐status stays by the total number of admissions under observation or inpatient status.
Visit Selection and Patient Characteristics
All observation‐status stays regardless of the point of entry into the hospital were eligible for this study. We excluded stays that were birth‐related, included intensive care, or resulted in transfer or death. Patient demographic characteristics used to describe the cohort included age, gender, race/ethnicity, and primary payer. Stays that began in the ED were identified by an emergency room charge within PHIS. Eligible stays were categorized using All Patient Refined Diagnosis Related Groups (APR‐DRGs) version 24 using the ICD‐9‐CM code‐based proprietary 3M software (3M Health Information Systems, St. Paul, MN). We determined the 15 top‐ranking APR‐DRGs among observation‐status stays in hospitals with a dedicated OU and hospitals without. Procedural stays were identified based on procedural APR‐DRGs (eg, tonsil and adenoid procedures) or the presence of an ICD‐9‐CM procedure code (eg, 331 spinal tap).
Measured Outcomes
Outcomes of observation‐status stays were determined within 4 categories: (1) LOS, (2) standardized costs, (3) conversion to inpatient status, and (4) return visits and readmissions. LOS was calculated in terms of nights spent in hospital for all stays by subtracting the discharge date from the admission date and in terms of hours for stays in the 28 hospitals that report admission and discharge hour to the PHIS database. Discharge timing was examined in 4, 6‐hour blocks starting at midnight. Standardized costs were derived from a charge master index that was created by taking the median costs from all PHIS hospitals for each charged service.[17] Standardized costs represent the estimated cost of providing any particular clinical activity but are not the cost to patients, nor do they represent the actual cost to any given hospital. This approach allows for cost comparisons across hospitals, without biases arising from using charges or from deriving costs using hospitals' ratios of costs to charges.[18] Conversion from observation to inpatient status was calculated by dividing the number of inpatient‐status stays with observation codes by the number of observation‐statusonly stays plus the number of inpatient‐status stays with observation codes. All‐cause 3‐day ED return visits and 30‐day readmissions to the same hospital were assessed using patient‐specific identifiers that allowed for tracking of ED return visits and readmissions following the index observation stay.
Data Analysis
Descriptive statistics were calculated for hospital and patient characteristics using medians and interquartile ranges (IQRs) for continuous factors and frequencies with percentages for categorical factors. Comparisons of these factors between hospitals with dedicated OUs and without were made using [2] and Wilcoxon rank sum tests as appropriate. Multivariable regression was performed using generalized linear mixed models treating hospital as a random effect and used patient age, the case‐mix index based on the APR‐DRG severity of illness, ED visit, and procedures associated with the index observation‐status stay. For continuous outcomes, we performed a log transformation on the outcome, confirmed the normality assumption, and back transformed the results. Sensitivity analyses were conducted to compare LOS, standardized costs, and conversation rates by hospital type for 10 of the 15 top‐ranking APR‐DRGs commonly cared for by pediatric hospitalists and to compare hospitals that reported the presence of an OU that was consistently open (24 hours per day, 7 days per week) and operating during the entire 2011 calendar year, and those without. Based on information gathered from the telephone interviews, hospitals with partially open OUs were similar to hospitals with continuously open OUs, such that they were included in our main analyses. All statistical analyses were performed using SAS version 9.3 (SAS Institute, Cary, NC). P values <0.05 were considered statistically significant.
RESULTS
Hospital Characteristics
Dedicated OUs were present in 14 of the 31 hospitals that reported observation‐status patient data to PHIS (Figure 1). Three of these hospitals had OUs that were open for 5 months or less in 2011; 1 unit opened, 1 unit closed, and 1 hospital operated a seasonal unit. The remaining 17 hospitals reported no OU that admitted unscheduled patients from the ED during 2011. Hospitals with a dedicated OU had more inpatient beds and higher median number of inpatient admissions than those without (Table 1). Hospitals were statistically similar in terms of total volume of ED visits, percentage of ED visits resulting in admission, total number of observation‐status stays, percentage of admissions under observation status, and payer mix.
| Overall, Median (IQR) | Hospitals With a Dedicated Observation Unit, Median (IQR) | Hospitals Without a Dedicated Observation Unit, Median (IQR) | P Value | |
|---|---|---|---|---|
| ||||
| No. of hospitals | 31 | 14 | 17 | |
| Total no. of inpatient beds | 273 (213311) | 304 (269425) | 246 (175293) | 0.006 |
| Total no. ED visits | 62971 (47,50497,723) | 87,892 (55,102117,119) | 53,151 (4750470,882) | 0.21 |
| ED visits resulting in admission, % | 13.1 (9.715.0) | 13.8 (10.5, 19.1) | 12.5 (9.714.5) | 0.31 |
| Total no. of inpatient admissions | 11,537 (9,26814,568) | 13,206 (11,32517,869) | 10,207 (8,64013,363) | 0.04 |
| Admissions under observation status, % | 25.7 (19.733.8) | 25.5 (21.431.4) | 26.0 (16.935.1) | 0.98 |
| Total no. of observation stays | 3,820 (27935672) | 4,850 (3,309 6,196) | 3,141 (2,3654,616) | 0.07 |
| Government payer, % | 60.2 (53.371.2) | 62.1 (54.9, 65.9) | 59.2 (53.373.7) | 0.89 |
Observation‐Status Patients by Hospital Type
In 2011, there were a total of 136,239 observation‐status stays69,983 (51.4%) within the 14 hospitals with a dedicated OU and 66,256 (48.6%) within the 17 hospitals without. Patient care originated in the ED for 57.8% observation‐status stays in hospitals with an OU compared with 53.0% of observation‐status stays in hospitals without (P<0.001). Compared with hospitals with a dedicated OU, those without a dedicated OU had higher percentages of observation‐status patients older than 12 years and non‐Hispanic and a higher percentage of observation‐status patients with private payer type (Table 2). The 15 top‐ranking APR‐DRGs accounted for roughly half of all observation‐status stays and were relatively consistent between hospitals with and without a dedicated OU (Table 3). Procedural care was frequently associated with observation‐status stays.
| Overall, No. (%) | Hospitals With a Dedicated Observation Unit, No. (%)* | Hospitals Without a Dedicated Observation Unit, No. (%) | P Value | |
|---|---|---|---|---|
| ||||
| Age | ||||
| <1 year | 23,845 (17.5) | 12,101 (17.3) | 11,744 (17.7) | <0.001 |
| 15 years | 53,405 (38.5) | 28,052 (40.1) | 24,353 (36.8) | |
| 612 years | 33,674 (24.7) | 17,215 (24.6) | 16,459 (24.8) | |
| 1318 years | 23,607 (17.3) | 11,472 (16.4) | 12,135 (18.3) | |
| >18 years | 2,708 (2) | 1,143 (1.6) | 1,565 (2.4) | |
| Gender | ||||
| Male | 76,142 (55.9) | 39,178 (56) | 36,964 (55.8) | 0.43 |
| Female | 60,025 (44.1) | 30,756 (44) | 29,269 (44.2) | |
| Race/ethnicity | ||||
| Non‐Hispanic white | 72,183 (53.0) | 30,653 (43.8) | 41,530 (62.7) | <0.001 |
| Non‐Hispanic black | 30,995 (22.8) | 16,314 (23.3) | 14,681 (22.2) | |
| Hispanic | 21,255 (15.6) | 16,583 (23.7) | 4,672 (7.1) | |
| Asian | 2,075 (1.5) | 1,313 (1.9) | 762 (1.2) | |
| Non‐Hispanic other | 9,731 (7.1) | 5,120 (7.3) | 4,611 (7.0) | |
| Payer | ||||
| Government | 68,725 (50.4) | 36,967 (52.8) | 31,758 (47.9) | <0.001 |
| Private | 48,416 (35.5) | 21,112 (30.2) | 27,304 (41.2) | |
| Other | 19,098 (14.0) | 11,904 (17) | 7,194 (10.9) | |
| Observation‐Status Patients in Hospitals With a Dedicated Observation Unit* | Observation‐Status Patients in Hospitals Without a Dedicated Observation Unit | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Rank | APR‐DRG | No. | % of All Observation Status Stays | % Began in ED | Rank | APR‐DRG | No. | % of All Observation Status Stays | % Began in ED |
| |||||||||
| 1 | Tonsil and adenoid procedures | 4,621 | 6.6 | 1.3 | 1 | Tonsil and adenoid procedures | 3,806 | 5.7 | 1.6 |
| 2 | Asthma | 4,246 | 6.1 | 85.3 | 2 | Asthma | 3,756 | 5.7 | 79.0 |
| 3 | Seizure | 3,516 | 5.0 | 52.0 | 3 | Seizure | 2,846 | 4.3 | 54.9 |
| 4 | Nonbacterial gastroenteritis | 3,286 | 4.7 | 85.8 | 4 | Upper respiratory infections | 2,733 | 4.1 | 69.6 |
| 5 | Bronchiolitis, RSV pneumonia | 3,093 | 4.4 | 78.5 | 5 | Nonbacterial gastroenteritis | 2,682 | 4.0 | 74.5 |
| 6 | Upper respiratory infections | 2,923 | 4.2 | 80.0 | 6 | Other digestive system diagnoses | 2,545 | 3.8 | 66.3 |
| 7 | Other digestive system diagnoses | 2,064 | 2.9 | 74.0 | 7 | Bronchiolitis, RSV pneumonia | 2,544 | 3.8 | 69.2 |
| 8 | Respiratory signs, symptoms, diagnoses | 2,052 | 2.9 | 81.6 | 8 | Shoulder and arm procedures | 1,862 | 2.8 | 72.6 |
| 9 | Other ENT/cranial/facial diagnoses | 1,684 | 2.4 | 43.6 | 9 | Appendectomy | 1,785 | 2.7 | 79.2 |
| 10 | Shoulder and arm procedures | 1,624 | 2.3 | 79.1 | 10 | Other ENT/cranial/facial diagnoses | 1,624 | 2.5 | 29.9 |
| 11 | Abdominal pain | 1,612 | 2.3 | 86.2 | 11 | Abdominal pain | 1,461 | 2.2 | 82.3 |
| 12 | Fever | 1,494 | 2.1 | 85.1 | 12 | Other factors influencing health status | 1,461 | 2.2 | 66.3 |
| 13 | Appendectomy | 1,465 | 2.1 | 66.4 | 13 | Cellulitis/other bacterial skin infections | 1,383 | 2.1 | 84.2 |
| 14 | Cellulitis/other bacterial skin infections | 1,393 | 2.0 | 86.4 | 14 | Respiratory signs, symptoms, diagnoses | 1,308 | 2.0 | 39.1 |
| 15 | Pneumonia NEC | 1,356 | 1.9 | 79.1 | 15 | Pneumonia NEC | 1,245 | 1.9 | 73.1 |
| Total | 36,429 | 52.0 | 57.8 | Total | 33,041 | 49.87 | 53.0 | ||
Outcomes of Observation‐Status Stays
A greater percentage of observation‐status stays in hospitals with a dedicated OU experienced a same‐day discharge (Table 4). In addition, a higher percentage of discharges occurred between midnight and 11 am in hospitals with a dedicated OU. However, overall risk‐adjusted LOS in hours (12.8 vs 12.2 hours, P=0.90) and risk‐adjusted total standardized costs ($2551 vs $2433, P=0.75) were similar between hospital types. These findings were consistent within the 1 APR‐DRGs commonly cared for by pediatric hospitalists (see Supporting Information, Appendix 1, in the online version of this article). Overall, conversion from observation to inpatient status was significantly higher in hospitals with a dedicated OU compared with hospitals without; however, this pattern was not consistent across the 10 APR‐DRGs commonly cared for by pediatric hospitalists (see Supporting Information, Appendix 1, in the online version of this article). Adjusted odds of 3‐day ED return visits and 30‐day readmissions were comparable between hospital groups.
| Observation‐Status Patients in Hospitals With a Dedicated Observation Unit | Observation‐Status Patients in Hospitals Without a Dedicated Observation Unit | P Value | |
|---|---|---|---|
| |||
| No. of hospitals | 14 | 17 | |
| Length of stay, h, median (IQR) | 12.8 (6.923.7) | 12.2 (721.3) | 0.90 |
| 0 midnights, no. (%) | 16,678 (23.8) | 14,648 (22.1) | <.001 |
| 1 midnight, no. (%) | 46,144 (65.9) | 44,559 (67.3) | |
| 2 midnights or more, no. (%) | 7,161 (10.2) | 7,049 (10.6) | |
| Discharge timing, no. (%) | |||
| Midnight5 am | 1,223 (1.9) | 408 (0.7) | <0.001 |
| 6 am11 am | 18,916 (29.3) | 15,914 (27.1) | |
| Noon5 pm | 32,699 (50.7) | 31,619 (53.9) | |
| 6 pm11 pm | 11,718 (18.2) | 10,718 (18.3) | |
| Total standardized costs, $, median (IQR) | 2,551.3 (2,053.93,169.1) | 2,433.4 (1,998.42,963) | 0.75 |
| Conversion to inpatient status | 11.06% | 9.63% | <0.01 |
| Return care, AOR (95% CI) | |||
| 3‐day ED return visit | 0.93 (0.77‐1.12) | Referent | 0.46 |
| 30‐day readmission | 0.88 (0.67‐1.15) | Referent | 0.36 |
We found similar results in sensitivity analyses comparing observation‐status stays in hospitals with a continuously open OU (open 24 hours per day, 7 days per week, for all of 2011 [n=10 hospitals]) to those without(see Supporting Information, Appendix 2, in the online version of this article). However, there were, on average, more observation‐status stays in hospitals with a continuously open OU (median 5605, IQR 42077089) than hospitals without (median 3309, IQR 26784616) (P=0.04). In contrast to our main results, conversion to inpatient status was lower in hospitals with a continuously open OU compared with hospitals without (8.52% vs 11.57%, P<0.01).
DISCUSSION
Counter to our hypothesis, we did not find hospital‐level differences in length of stay or costs for observation‐status patients cared for in hospitals with and without a dedicated OU, though hospitals with dedicated OUs did have more same‐day discharges and more morning discharges. The lack of observed differences in LOS and costs may reflect the fact that many children under observation status are treated throughout the hospital, even in facilities with a dedicated OU. Access to a dedicated OU is limited by factors including small numbers of OU beds and specific low acuity/low complexity OU admission criteria.[7] The inclusion of all children admitted under observation status in our analyses may have diluted any effect of dedicated OUs at the hospital level, but was necessary due to the inability to identify location of care for children admitted under observation status. Location of care is an important variable that should be incorporated into administrative databases to allow for comparative effectiveness research designs. Until such data are available, chart review at individual hospitals would be necessary to determine which patients received care in an OU.
We did find that discharges for observation‐status patients occurred earlier in the day in hospitals with a dedicated OU when compared with observation‐status patients in hospitals without a dedicated OU. In addition, the percentage of same‐day discharges was higher among observation‐status patients treated in hospitals with a dedicated OU. These differences may stem from policies and procedures that encourage rapid discharge in dedicated OUs, and those practices may affect other care areas. For example, OUs may enforce policies requiring family presence at the bedside or utilize staffing models where doctors and nurses are in frequent communication, both of which would facilitate discharge as soon as a patient no longer required hospital‐based care.[7] A retrospective chart review study design could be used to identify discharge processes and other key characteristics of highly performing OUs.
We found conflicting results in our main and sensitivity analyses related to conversion to inpatient status. Lower percentages of observation‐status patients converting to inpatient status indicates greater success in the delivery of observation care based on established performance metrics.[19] Lower rates of conversion to inpatient status may be the result of stricter admission criteria for some diagnosis and in hospitals with a continuously open dedicate OU, more refined processes for utilization review that allow for patients to be placed into the correct status (observation vs inpatient) at the time of admission, or efforts to educate providers about the designation of observation status.[7] It is also possible that fewer observation‐status patients convert to inpatient status in hospitals with a continuously open dedicated OU because such a change would require movement of the patient to an inpatient bed.
These analyses were more comprehensive than our prior studies[2, 20] in that we included both patients who were treated first in the ED and those who were not. In addition to the APR‐DRGs representative of conditions that have been successfully treated in ED‐based pediatric OUs (eg, asthma, seizures, gastroenteritis, cellulitis),[8, 9, 21, 22] we found observation‐status was commonly associated with procedural care. This population of patients may be relevant to hospitalists who staff OUs that provide both unscheduled and postprocedural care. The colocation of medical and postprocedural patients has been described by others[8, 23] and was reported to occur in over half of the OUs included in this study.[7] The extent to which postprocedure observation care is provided in general OUs staffed by hospitalists represents another opportunity for further study.
Hospitals face many considerations when determining if and how they will provide observation services to patients expected to experience short stays.[7] Some hospitals may be unable to justify an OU for all or part of the year based on the volume of admissions or the costs to staff an OU.[24, 25] Other hospitals may open an OU to promote patient flow and reduce ED crowding.[26] Hospitals may also be influenced by reimbursement policies related to observation‐status stays. Although we did not observe differences in overall payer mix, we did find higher percentages of observation‐status patients in hospitals with dedicated OUs to have public insurance. Although hospital contracts with payers around observation status patients are complex and beyond the scope of this analysis, it is possible that hospitals have established OUs because of increasingly stringent rules or criteria to meet inpatient status or experiences with high volumes of observation‐status patients covered by a particular payer. Nevertheless, the brief nature of many pediatric hospitalizations and the scarcity of pediatric OU beds must be considered in policy changes that result from national discussions about the appropriateness of inpatient stays shorter than 2 nights in duration.[27]
Limitations
The primary limitation to our analyses is the lack of ability to identify patients who were treated in a dedicated OU because few hospitals provided data to PHIS that allowed for the identification of the unit or location of care. Second, it is possible that some hospitals were misclassified as not having a dedicated OU based on our survey, which initially inquired about OUs that provided care to patients first treated in the ED. Therefore, OUs that exclusively care for postoperative patients or patients with scheduled treatments may be present in hospitals that we have labeled as not having a dedicated OU. This potential misclassification would bias our results toward finding no differences. Third, in any study of administrative data there is potential that diagnosis codes are incomplete or inaccurately capture the underlying reason for the episode of care. Fourth, the experiences of the free‐standing children's hospitals that contribute data to PHIS may not be generalizable to other hospitals that provide observation care to children. Finally, return care may be underestimated, as children could receive treatment at another hospital following discharge from a PHIS hospital. Care outside of PHIS hospitals would not be captured, but we do not expect this to differ for hospitals with and without dedicated OUs. It is possible that health information exchanges will permit more comprehensive analyses of care across different hospitals in the future.
CONCLUSION
Observation status patients are similar in hospitals with and without dedicated observation units that admit children from the ED. The presence of a dedicated OU appears to have an influence on same‐day and morning discharges across all observation‐status stays without impacting other hospital‐level outcomes. Inclusion of location of care (eg, geographically distinct dedicated OU vs general inpatient unit vs ED) in hospital administrative datasets would allow for meaningful comparisons of different models of care for short‐stay observation‐status patients.
Acknowledgements
The authors thank John P. Harding, MBA, FACHE, Children's Hospital of the King's Daughters, Norfolk, Virginia for his input on the study design.
Disclosures: Dr. Hall had full access to the data and takes responsibility for the integrity of the data and the accuracy of the data analysis. Internal funds from the Children's Hospital Association supported the conduct of this work. The authors have no financial relationships or conflicts of interest to disclose.
Many pediatric hospitalizations are of short duration, and more than half of short‐stay hospitalizations are designated as observation status.[1, 2] Observation status is an administrative label assigned to patients who do not meet hospital or payer criteria for inpatient‐status care. Short‐stay observation‐status patients do not fit in traditional models of emergency department (ED) or inpatient care. EDs often focus on discharging or admitting patients within a matter of hours, whereas inpatient units tend to measure length of stay (LOS) in terms of days[3] and may not have systems in place to facilitate rapid discharge of short‐stay patients.[4] Observation units (OUs) have been established in some hospitals to address the unique care needs of short‐stay patients.[5, 6, 7]
Single‐site reports from children's hospitals with successful OUs have demonstrated shorter LOS and lower costs compared with inpatient settings.[6, 8, 9, 10, 11, 12, 13, 14] No prior study has examined hospital‐level effects of an OU on observation‐status patient outcomes. The Pediatric Health Information System (PHIS) database provides a unique opportunity to explore this question, because unlike other national hospital administrative databases,[15, 16] the PHIS dataset contains information about children under observation status. In addition, we know which PHIS hospitals had a dedicated OU in 2011.7
We hypothesized that overall observation‐status stays in hospitals with a dedicated OU would be of shorter duration with earlier discharges at lower cost than observation‐status stays in hospitals without a dedicated OU. We compared hospitals with and without a dedicated OU on secondary outcomes including rates of conversion to inpatient status and return care for any reason.
METHODS
We conducted a cross‐sectional analysis of hospital administrative data using the 2011 PHIS databasea national administrative database that contains resource utilization data from 43 participating hospitals located in 26 states plus the District of Columbia. These hospitals account for approximately 20% of pediatric hospitalizations in the United States.
For each hospital encounter, PHIS includes patient demographics, up to 41 International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) diagnoses, up to 41 ICD‐9‐CM procedures, and hospital charges for services. Data are deidentified prior to inclusion, but unique identifiers allow for determination of return visits and readmissions following an index visit for an individual patient. Data quality and reliability are assured jointly by the Children's Hospital Association (formerly Child Health Corporation of America, Overland Park, KS), participating hospitals, and Truven Health Analytics (New York, NY). This study, using administrative data, was not considered human subjects research by the policies of the Cincinnati Children's Hospital Medical Center Institutional Review Board.
Hospital Selection and Hospital Characteristics
The study sample was drawn from the 31 hospitals that reported observation‐status patient data to PHIS in 2011. Analyses were conducted in 2013, at which time 2011 was the most recent year of data. We categorized 14 hospitals as having a dedicated OU during 2011 based on information collected in 2013.7 To summarize briefly, we interviewed by telephone representatives of hospitals responding to an email query as to the presence of a geographically distinct OU for the care of unscheduled patients from the ED. Three of the 14 representatives reported their hospital had 2 OUs, 1 of which was a separate surgical OU. Ten OUs cared for both ED patients and patients with scheduled procedures; 8 units received patients from non‐ED sources. Hospitalists provided staffing in more than half of the OUs.
We attempted to identify administrative data that would signal care delivered in a dedicated OU using hospital charge codes reported to PHIS, but learned this was not possible due to between‐hospital variation in the specificity of the charge codes. Therefore, we were unable to determine if patient care was delivered in a dedicated OU or another setting, such as a general inpatient unit or the ED. Other hospital characteristics available from the PHIS dataset included the number of inpatient beds, ED visits, inpatient admissions, observation‐status stays, and payer mix. We calculated the percentage of ED visits resulting in admission by dividing the number of ED visits with associated inpatient or observation status by the total number of ED visits and the percentage of admissions under observation status by dividing the number of observation‐status stays by the total number of admissions under observation or inpatient status.
Visit Selection and Patient Characteristics
All observation‐status stays regardless of the point of entry into the hospital were eligible for this study. We excluded stays that were birth‐related, included intensive care, or resulted in transfer or death. Patient demographic characteristics used to describe the cohort included age, gender, race/ethnicity, and primary payer. Stays that began in the ED were identified by an emergency room charge within PHIS. Eligible stays were categorized using All Patient Refined Diagnosis Related Groups (APR‐DRGs) version 24 using the ICD‐9‐CM code‐based proprietary 3M software (3M Health Information Systems, St. Paul, MN). We determined the 15 top‐ranking APR‐DRGs among observation‐status stays in hospitals with a dedicated OU and hospitals without. Procedural stays were identified based on procedural APR‐DRGs (eg, tonsil and adenoid procedures) or the presence of an ICD‐9‐CM procedure code (eg, 331 spinal tap).
Measured Outcomes
Outcomes of observation‐status stays were determined within 4 categories: (1) LOS, (2) standardized costs, (3) conversion to inpatient status, and (4) return visits and readmissions. LOS was calculated in terms of nights spent in hospital for all stays by subtracting the discharge date from the admission date and in terms of hours for stays in the 28 hospitals that report admission and discharge hour to the PHIS database. Discharge timing was examined in 4, 6‐hour blocks starting at midnight. Standardized costs were derived from a charge master index that was created by taking the median costs from all PHIS hospitals for each charged service.[17] Standardized costs represent the estimated cost of providing any particular clinical activity but are not the cost to patients, nor do they represent the actual cost to any given hospital. This approach allows for cost comparisons across hospitals, without biases arising from using charges or from deriving costs using hospitals' ratios of costs to charges.[18] Conversion from observation to inpatient status was calculated by dividing the number of inpatient‐status stays with observation codes by the number of observation‐statusonly stays plus the number of inpatient‐status stays with observation codes. All‐cause 3‐day ED return visits and 30‐day readmissions to the same hospital were assessed using patient‐specific identifiers that allowed for tracking of ED return visits and readmissions following the index observation stay.
Data Analysis
Descriptive statistics were calculated for hospital and patient characteristics using medians and interquartile ranges (IQRs) for continuous factors and frequencies with percentages for categorical factors. Comparisons of these factors between hospitals with dedicated OUs and without were made using [2] and Wilcoxon rank sum tests as appropriate. Multivariable regression was performed using generalized linear mixed models treating hospital as a random effect and used patient age, the case‐mix index based on the APR‐DRG severity of illness, ED visit, and procedures associated with the index observation‐status stay. For continuous outcomes, we performed a log transformation on the outcome, confirmed the normality assumption, and back transformed the results. Sensitivity analyses were conducted to compare LOS, standardized costs, and conversation rates by hospital type for 10 of the 15 top‐ranking APR‐DRGs commonly cared for by pediatric hospitalists and to compare hospitals that reported the presence of an OU that was consistently open (24 hours per day, 7 days per week) and operating during the entire 2011 calendar year, and those without. Based on information gathered from the telephone interviews, hospitals with partially open OUs were similar to hospitals with continuously open OUs, such that they were included in our main analyses. All statistical analyses were performed using SAS version 9.3 (SAS Institute, Cary, NC). P values <0.05 were considered statistically significant.
RESULTS
Hospital Characteristics
Dedicated OUs were present in 14 of the 31 hospitals that reported observation‐status patient data to PHIS (Figure 1). Three of these hospitals had OUs that were open for 5 months or less in 2011; 1 unit opened, 1 unit closed, and 1 hospital operated a seasonal unit. The remaining 17 hospitals reported no OU that admitted unscheduled patients from the ED during 2011. Hospitals with a dedicated OU had more inpatient beds and higher median number of inpatient admissions than those without (Table 1). Hospitals were statistically similar in terms of total volume of ED visits, percentage of ED visits resulting in admission, total number of observation‐status stays, percentage of admissions under observation status, and payer mix.
| Overall, Median (IQR) | Hospitals With a Dedicated Observation Unit, Median (IQR) | Hospitals Without a Dedicated Observation Unit, Median (IQR) | P Value | |
|---|---|---|---|---|
| ||||
| No. of hospitals | 31 | 14 | 17 | |
| Total no. of inpatient beds | 273 (213311) | 304 (269425) | 246 (175293) | 0.006 |
| Total no. ED visits | 62971 (47,50497,723) | 87,892 (55,102117,119) | 53,151 (4750470,882) | 0.21 |
| ED visits resulting in admission, % | 13.1 (9.715.0) | 13.8 (10.5, 19.1) | 12.5 (9.714.5) | 0.31 |
| Total no. of inpatient admissions | 11,537 (9,26814,568) | 13,206 (11,32517,869) | 10,207 (8,64013,363) | 0.04 |
| Admissions under observation status, % | 25.7 (19.733.8) | 25.5 (21.431.4) | 26.0 (16.935.1) | 0.98 |
| Total no. of observation stays | 3,820 (27935672) | 4,850 (3,309 6,196) | 3,141 (2,3654,616) | 0.07 |
| Government payer, % | 60.2 (53.371.2) | 62.1 (54.9, 65.9) | 59.2 (53.373.7) | 0.89 |
Observation‐Status Patients by Hospital Type
In 2011, there were a total of 136,239 observation‐status stays69,983 (51.4%) within the 14 hospitals with a dedicated OU and 66,256 (48.6%) within the 17 hospitals without. Patient care originated in the ED for 57.8% observation‐status stays in hospitals with an OU compared with 53.0% of observation‐status stays in hospitals without (P<0.001). Compared with hospitals with a dedicated OU, those without a dedicated OU had higher percentages of observation‐status patients older than 12 years and non‐Hispanic and a higher percentage of observation‐status patients with private payer type (Table 2). The 15 top‐ranking APR‐DRGs accounted for roughly half of all observation‐status stays and were relatively consistent between hospitals with and without a dedicated OU (Table 3). Procedural care was frequently associated with observation‐status stays.
| Overall, No. (%) | Hospitals With a Dedicated Observation Unit, No. (%)* | Hospitals Without a Dedicated Observation Unit, No. (%) | P Value | |
|---|---|---|---|---|
| ||||
| Age | ||||
| <1 year | 23,845 (17.5) | 12,101 (17.3) | 11,744 (17.7) | <0.001 |
| 15 years | 53,405 (38.5) | 28,052 (40.1) | 24,353 (36.8) | |
| 612 years | 33,674 (24.7) | 17,215 (24.6) | 16,459 (24.8) | |
| 1318 years | 23,607 (17.3) | 11,472 (16.4) | 12,135 (18.3) | |
| >18 years | 2,708 (2) | 1,143 (1.6) | 1,565 (2.4) | |
| Gender | ||||
| Male | 76,142 (55.9) | 39,178 (56) | 36,964 (55.8) | 0.43 |
| Female | 60,025 (44.1) | 30,756 (44) | 29,269 (44.2) | |
| Race/ethnicity | ||||
| Non‐Hispanic white | 72,183 (53.0) | 30,653 (43.8) | 41,530 (62.7) | <0.001 |
| Non‐Hispanic black | 30,995 (22.8) | 16,314 (23.3) | 14,681 (22.2) | |
| Hispanic | 21,255 (15.6) | 16,583 (23.7) | 4,672 (7.1) | |
| Asian | 2,075 (1.5) | 1,313 (1.9) | 762 (1.2) | |
| Non‐Hispanic other | 9,731 (7.1) | 5,120 (7.3) | 4,611 (7.0) | |
| Payer | ||||
| Government | 68,725 (50.4) | 36,967 (52.8) | 31,758 (47.9) | <0.001 |
| Private | 48,416 (35.5) | 21,112 (30.2) | 27,304 (41.2) | |
| Other | 19,098 (14.0) | 11,904 (17) | 7,194 (10.9) | |
| Observation‐Status Patients in Hospitals With a Dedicated Observation Unit* | Observation‐Status Patients in Hospitals Without a Dedicated Observation Unit | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Rank | APR‐DRG | No. | % of All Observation Status Stays | % Began in ED | Rank | APR‐DRG | No. | % of All Observation Status Stays | % Began in ED |
| |||||||||
| 1 | Tonsil and adenoid procedures | 4,621 | 6.6 | 1.3 | 1 | Tonsil and adenoid procedures | 3,806 | 5.7 | 1.6 |
| 2 | Asthma | 4,246 | 6.1 | 85.3 | 2 | Asthma | 3,756 | 5.7 | 79.0 |
| 3 | Seizure | 3,516 | 5.0 | 52.0 | 3 | Seizure | 2,846 | 4.3 | 54.9 |
| 4 | Nonbacterial gastroenteritis | 3,286 | 4.7 | 85.8 | 4 | Upper respiratory infections | 2,733 | 4.1 | 69.6 |
| 5 | Bronchiolitis, RSV pneumonia | 3,093 | 4.4 | 78.5 | 5 | Nonbacterial gastroenteritis | 2,682 | 4.0 | 74.5 |
| 6 | Upper respiratory infections | 2,923 | 4.2 | 80.0 | 6 | Other digestive system diagnoses | 2,545 | 3.8 | 66.3 |
| 7 | Other digestive system diagnoses | 2,064 | 2.9 | 74.0 | 7 | Bronchiolitis, RSV pneumonia | 2,544 | 3.8 | 69.2 |
| 8 | Respiratory signs, symptoms, diagnoses | 2,052 | 2.9 | 81.6 | 8 | Shoulder and arm procedures | 1,862 | 2.8 | 72.6 |
| 9 | Other ENT/cranial/facial diagnoses | 1,684 | 2.4 | 43.6 | 9 | Appendectomy | 1,785 | 2.7 | 79.2 |
| 10 | Shoulder and arm procedures | 1,624 | 2.3 | 79.1 | 10 | Other ENT/cranial/facial diagnoses | 1,624 | 2.5 | 29.9 |
| 11 | Abdominal pain | 1,612 | 2.3 | 86.2 | 11 | Abdominal pain | 1,461 | 2.2 | 82.3 |
| 12 | Fever | 1,494 | 2.1 | 85.1 | 12 | Other factors influencing health status | 1,461 | 2.2 | 66.3 |
| 13 | Appendectomy | 1,465 | 2.1 | 66.4 | 13 | Cellulitis/other bacterial skin infections | 1,383 | 2.1 | 84.2 |
| 14 | Cellulitis/other bacterial skin infections | 1,393 | 2.0 | 86.4 | 14 | Respiratory signs, symptoms, diagnoses | 1,308 | 2.0 | 39.1 |
| 15 | Pneumonia NEC | 1,356 | 1.9 | 79.1 | 15 | Pneumonia NEC | 1,245 | 1.9 | 73.1 |
| Total | 36,429 | 52.0 | 57.8 | Total | 33,041 | 49.87 | 53.0 | ||
Outcomes of Observation‐Status Stays
A greater percentage of observation‐status stays in hospitals with a dedicated OU experienced a same‐day discharge (Table 4). In addition, a higher percentage of discharges occurred between midnight and 11 am in hospitals with a dedicated OU. However, overall risk‐adjusted LOS in hours (12.8 vs 12.2 hours, P=0.90) and risk‐adjusted total standardized costs ($2551 vs $2433, P=0.75) were similar between hospital types. These findings were consistent within the 1 APR‐DRGs commonly cared for by pediatric hospitalists (see Supporting Information, Appendix 1, in the online version of this article). Overall, conversion from observation to inpatient status was significantly higher in hospitals with a dedicated OU compared with hospitals without; however, this pattern was not consistent across the 10 APR‐DRGs commonly cared for by pediatric hospitalists (see Supporting Information, Appendix 1, in the online version of this article). Adjusted odds of 3‐day ED return visits and 30‐day readmissions were comparable between hospital groups.
| Observation‐Status Patients in Hospitals With a Dedicated Observation Unit | Observation‐Status Patients in Hospitals Without a Dedicated Observation Unit | P Value | |
|---|---|---|---|
| |||
| No. of hospitals | 14 | 17 | |
| Length of stay, h, median (IQR) | 12.8 (6.923.7) | 12.2 (721.3) | 0.90 |
| 0 midnights, no. (%) | 16,678 (23.8) | 14,648 (22.1) | <.001 |
| 1 midnight, no. (%) | 46,144 (65.9) | 44,559 (67.3) | |
| 2 midnights or more, no. (%) | 7,161 (10.2) | 7,049 (10.6) | |
| Discharge timing, no. (%) | |||
| Midnight5 am | 1,223 (1.9) | 408 (0.7) | <0.001 |
| 6 am11 am | 18,916 (29.3) | 15,914 (27.1) | |
| Noon5 pm | 32,699 (50.7) | 31,619 (53.9) | |
| 6 pm11 pm | 11,718 (18.2) | 10,718 (18.3) | |
| Total standardized costs, $, median (IQR) | 2,551.3 (2,053.93,169.1) | 2,433.4 (1,998.42,963) | 0.75 |
| Conversion to inpatient status | 11.06% | 9.63% | <0.01 |
| Return care, AOR (95% CI) | |||
| 3‐day ED return visit | 0.93 (0.77‐1.12) | Referent | 0.46 |
| 30‐day readmission | 0.88 (0.67‐1.15) | Referent | 0.36 |
We found similar results in sensitivity analyses comparing observation‐status stays in hospitals with a continuously open OU (open 24 hours per day, 7 days per week, for all of 2011 [n=10 hospitals]) to those without(see Supporting Information, Appendix 2, in the online version of this article). However, there were, on average, more observation‐status stays in hospitals with a continuously open OU (median 5605, IQR 42077089) than hospitals without (median 3309, IQR 26784616) (P=0.04). In contrast to our main results, conversion to inpatient status was lower in hospitals with a continuously open OU compared with hospitals without (8.52% vs 11.57%, P<0.01).
DISCUSSION
Counter to our hypothesis, we did not find hospital‐level differences in length of stay or costs for observation‐status patients cared for in hospitals with and without a dedicated OU, though hospitals with dedicated OUs did have more same‐day discharges and more morning discharges. The lack of observed differences in LOS and costs may reflect the fact that many children under observation status are treated throughout the hospital, even in facilities with a dedicated OU. Access to a dedicated OU is limited by factors including small numbers of OU beds and specific low acuity/low complexity OU admission criteria.[7] The inclusion of all children admitted under observation status in our analyses may have diluted any effect of dedicated OUs at the hospital level, but was necessary due to the inability to identify location of care for children admitted under observation status. Location of care is an important variable that should be incorporated into administrative databases to allow for comparative effectiveness research designs. Until such data are available, chart review at individual hospitals would be necessary to determine which patients received care in an OU.
We did find that discharges for observation‐status patients occurred earlier in the day in hospitals with a dedicated OU when compared with observation‐status patients in hospitals without a dedicated OU. In addition, the percentage of same‐day discharges was higher among observation‐status patients treated in hospitals with a dedicated OU. These differences may stem from policies and procedures that encourage rapid discharge in dedicated OUs, and those practices may affect other care areas. For example, OUs may enforce policies requiring family presence at the bedside or utilize staffing models where doctors and nurses are in frequent communication, both of which would facilitate discharge as soon as a patient no longer required hospital‐based care.[7] A retrospective chart review study design could be used to identify discharge processes and other key characteristics of highly performing OUs.
We found conflicting results in our main and sensitivity analyses related to conversion to inpatient status. Lower percentages of observation‐status patients converting to inpatient status indicates greater success in the delivery of observation care based on established performance metrics.[19] Lower rates of conversion to inpatient status may be the result of stricter admission criteria for some diagnosis and in hospitals with a continuously open dedicate OU, more refined processes for utilization review that allow for patients to be placed into the correct status (observation vs inpatient) at the time of admission, or efforts to educate providers about the designation of observation status.[7] It is also possible that fewer observation‐status patients convert to inpatient status in hospitals with a continuously open dedicated OU because such a change would require movement of the patient to an inpatient bed.
These analyses were more comprehensive than our prior studies[2, 20] in that we included both patients who were treated first in the ED and those who were not. In addition to the APR‐DRGs representative of conditions that have been successfully treated in ED‐based pediatric OUs (eg, asthma, seizures, gastroenteritis, cellulitis),[8, 9, 21, 22] we found observation‐status was commonly associated with procedural care. This population of patients may be relevant to hospitalists who staff OUs that provide both unscheduled and postprocedural care. The colocation of medical and postprocedural patients has been described by others[8, 23] and was reported to occur in over half of the OUs included in this study.[7] The extent to which postprocedure observation care is provided in general OUs staffed by hospitalists represents another opportunity for further study.
Hospitals face many considerations when determining if and how they will provide observation services to patients expected to experience short stays.[7] Some hospitals may be unable to justify an OU for all or part of the year based on the volume of admissions or the costs to staff an OU.[24, 25] Other hospitals may open an OU to promote patient flow and reduce ED crowding.[26] Hospitals may also be influenced by reimbursement policies related to observation‐status stays. Although we did not observe differences in overall payer mix, we did find higher percentages of observation‐status patients in hospitals with dedicated OUs to have public insurance. Although hospital contracts with payers around observation status patients are complex and beyond the scope of this analysis, it is possible that hospitals have established OUs because of increasingly stringent rules or criteria to meet inpatient status or experiences with high volumes of observation‐status patients covered by a particular payer. Nevertheless, the brief nature of many pediatric hospitalizations and the scarcity of pediatric OU beds must be considered in policy changes that result from national discussions about the appropriateness of inpatient stays shorter than 2 nights in duration.[27]
Limitations
The primary limitation to our analyses is the lack of ability to identify patients who were treated in a dedicated OU because few hospitals provided data to PHIS that allowed for the identification of the unit or location of care. Second, it is possible that some hospitals were misclassified as not having a dedicated OU based on our survey, which initially inquired about OUs that provided care to patients first treated in the ED. Therefore, OUs that exclusively care for postoperative patients or patients with scheduled treatments may be present in hospitals that we have labeled as not having a dedicated OU. This potential misclassification would bias our results toward finding no differences. Third, in any study of administrative data there is potential that diagnosis codes are incomplete or inaccurately capture the underlying reason for the episode of care. Fourth, the experiences of the free‐standing children's hospitals that contribute data to PHIS may not be generalizable to other hospitals that provide observation care to children. Finally, return care may be underestimated, as children could receive treatment at another hospital following discharge from a PHIS hospital. Care outside of PHIS hospitals would not be captured, but we do not expect this to differ for hospitals with and without dedicated OUs. It is possible that health information exchanges will permit more comprehensive analyses of care across different hospitals in the future.
CONCLUSION
Observation status patients are similar in hospitals with and without dedicated observation units that admit children from the ED. The presence of a dedicated OU appears to have an influence on same‐day and morning discharges across all observation‐status stays without impacting other hospital‐level outcomes. Inclusion of location of care (eg, geographically distinct dedicated OU vs general inpatient unit vs ED) in hospital administrative datasets would allow for meaningful comparisons of different models of care for short‐stay observation‐status patients.
Acknowledgements
The authors thank John P. Harding, MBA, FACHE, Children's Hospital of the King's Daughters, Norfolk, Virginia for his input on the study design.
Disclosures: Dr. Hall had full access to the data and takes responsibility for the integrity of the data and the accuracy of the data analysis. Internal funds from the Children's Hospital Association supported the conduct of this work. The authors have no financial relationships or conflicts of interest to disclose.
Many pediatric hospitalizations are of short duration, and more than half of short‐stay hospitalizations are designated as observation status.[1, 2] Observation status is an administrative label assigned to patients who do not meet hospital or payer criteria for inpatient‐status care. Short‐stay observation‐status patients do not fit in traditional models of emergency department (ED) or inpatient care. EDs often focus on discharging or admitting patients within a matter of hours, whereas inpatient units tend to measure length of stay (LOS) in terms of days[3] and may not have systems in place to facilitate rapid discharge of short‐stay patients.[4] Observation units (OUs) have been established in some hospitals to address the unique care needs of short‐stay patients.[5, 6, 7]
Single‐site reports from children's hospitals with successful OUs have demonstrated shorter LOS and lower costs compared with inpatient settings.[6, 8, 9, 10, 11, 12, 13, 14] No prior study has examined hospital‐level effects of an OU on observation‐status patient outcomes. The Pediatric Health Information System (PHIS) database provides a unique opportunity to explore this question, because unlike other national hospital administrative databases,[15, 16] the PHIS dataset contains information about children under observation status. In addition, we know which PHIS hospitals had a dedicated OU in 2011.7
We hypothesized that overall observation‐status stays in hospitals with a dedicated OU would be of shorter duration with earlier discharges at lower cost than observation‐status stays in hospitals without a dedicated OU. We compared hospitals with and without a dedicated OU on secondary outcomes including rates of conversion to inpatient status and return care for any reason.
METHODS
We conducted a cross‐sectional analysis of hospital administrative data using the 2011 PHIS databasea national administrative database that contains resource utilization data from 43 participating hospitals located in 26 states plus the District of Columbia. These hospitals account for approximately 20% of pediatric hospitalizations in the United States.
For each hospital encounter, PHIS includes patient demographics, up to 41 International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) diagnoses, up to 41 ICD‐9‐CM procedures, and hospital charges for services. Data are deidentified prior to inclusion, but unique identifiers allow for determination of return visits and readmissions following an index visit for an individual patient. Data quality and reliability are assured jointly by the Children's Hospital Association (formerly Child Health Corporation of America, Overland Park, KS), participating hospitals, and Truven Health Analytics (New York, NY). This study, using administrative data, was not considered human subjects research by the policies of the Cincinnati Children's Hospital Medical Center Institutional Review Board.
Hospital Selection and Hospital Characteristics
The study sample was drawn from the 31 hospitals that reported observation‐status patient data to PHIS in 2011. Analyses were conducted in 2013, at which time 2011 was the most recent year of data. We categorized 14 hospitals as having a dedicated OU during 2011 based on information collected in 2013.7 To summarize briefly, we interviewed by telephone representatives of hospitals responding to an email query as to the presence of a geographically distinct OU for the care of unscheduled patients from the ED. Three of the 14 representatives reported their hospital had 2 OUs, 1 of which was a separate surgical OU. Ten OUs cared for both ED patients and patients with scheduled procedures; 8 units received patients from non‐ED sources. Hospitalists provided staffing in more than half of the OUs.
We attempted to identify administrative data that would signal care delivered in a dedicated OU using hospital charge codes reported to PHIS, but learned this was not possible due to between‐hospital variation in the specificity of the charge codes. Therefore, we were unable to determine if patient care was delivered in a dedicated OU or another setting, such as a general inpatient unit or the ED. Other hospital characteristics available from the PHIS dataset included the number of inpatient beds, ED visits, inpatient admissions, observation‐status stays, and payer mix. We calculated the percentage of ED visits resulting in admission by dividing the number of ED visits with associated inpatient or observation status by the total number of ED visits and the percentage of admissions under observation status by dividing the number of observation‐status stays by the total number of admissions under observation or inpatient status.
Visit Selection and Patient Characteristics
All observation‐status stays regardless of the point of entry into the hospital were eligible for this study. We excluded stays that were birth‐related, included intensive care, or resulted in transfer or death. Patient demographic characteristics used to describe the cohort included age, gender, race/ethnicity, and primary payer. Stays that began in the ED were identified by an emergency room charge within PHIS. Eligible stays were categorized using All Patient Refined Diagnosis Related Groups (APR‐DRGs) version 24 using the ICD‐9‐CM code‐based proprietary 3M software (3M Health Information Systems, St. Paul, MN). We determined the 15 top‐ranking APR‐DRGs among observation‐status stays in hospitals with a dedicated OU and hospitals without. Procedural stays were identified based on procedural APR‐DRGs (eg, tonsil and adenoid procedures) or the presence of an ICD‐9‐CM procedure code (eg, 331 spinal tap).
Measured Outcomes
Outcomes of observation‐status stays were determined within 4 categories: (1) LOS, (2) standardized costs, (3) conversion to inpatient status, and (4) return visits and readmissions. LOS was calculated in terms of nights spent in hospital for all stays by subtracting the discharge date from the admission date and in terms of hours for stays in the 28 hospitals that report admission and discharge hour to the PHIS database. Discharge timing was examined in 4, 6‐hour blocks starting at midnight. Standardized costs were derived from a charge master index that was created by taking the median costs from all PHIS hospitals for each charged service.[17] Standardized costs represent the estimated cost of providing any particular clinical activity but are not the cost to patients, nor do they represent the actual cost to any given hospital. This approach allows for cost comparisons across hospitals, without biases arising from using charges or from deriving costs using hospitals' ratios of costs to charges.[18] Conversion from observation to inpatient status was calculated by dividing the number of inpatient‐status stays with observation codes by the number of observation‐statusonly stays plus the number of inpatient‐status stays with observation codes. All‐cause 3‐day ED return visits and 30‐day readmissions to the same hospital were assessed using patient‐specific identifiers that allowed for tracking of ED return visits and readmissions following the index observation stay.
Data Analysis
Descriptive statistics were calculated for hospital and patient characteristics using medians and interquartile ranges (IQRs) for continuous factors and frequencies with percentages for categorical factors. Comparisons of these factors between hospitals with dedicated OUs and without were made using [2] and Wilcoxon rank sum tests as appropriate. Multivariable regression was performed using generalized linear mixed models treating hospital as a random effect and used patient age, the case‐mix index based on the APR‐DRG severity of illness, ED visit, and procedures associated with the index observation‐status stay. For continuous outcomes, we performed a log transformation on the outcome, confirmed the normality assumption, and back transformed the results. Sensitivity analyses were conducted to compare LOS, standardized costs, and conversation rates by hospital type for 10 of the 15 top‐ranking APR‐DRGs commonly cared for by pediatric hospitalists and to compare hospitals that reported the presence of an OU that was consistently open (24 hours per day, 7 days per week) and operating during the entire 2011 calendar year, and those without. Based on information gathered from the telephone interviews, hospitals with partially open OUs were similar to hospitals with continuously open OUs, such that they were included in our main analyses. All statistical analyses were performed using SAS version 9.3 (SAS Institute, Cary, NC). P values <0.05 were considered statistically significant.
RESULTS
Hospital Characteristics
Dedicated OUs were present in 14 of the 31 hospitals that reported observation‐status patient data to PHIS (Figure 1). Three of these hospitals had OUs that were open for 5 months or less in 2011; 1 unit opened, 1 unit closed, and 1 hospital operated a seasonal unit. The remaining 17 hospitals reported no OU that admitted unscheduled patients from the ED during 2011. Hospitals with a dedicated OU had more inpatient beds and higher median number of inpatient admissions than those without (Table 1). Hospitals were statistically similar in terms of total volume of ED visits, percentage of ED visits resulting in admission, total number of observation‐status stays, percentage of admissions under observation status, and payer mix.
| Overall, Median (IQR) | Hospitals With a Dedicated Observation Unit, Median (IQR) | Hospitals Without a Dedicated Observation Unit, Median (IQR) | P Value | |
|---|---|---|---|---|
| ||||
| No. of hospitals | 31 | 14 | 17 | |
| Total no. of inpatient beds | 273 (213311) | 304 (269425) | 246 (175293) | 0.006 |
| Total no. ED visits | 62971 (47,50497,723) | 87,892 (55,102117,119) | 53,151 (4750470,882) | 0.21 |
| ED visits resulting in admission, % | 13.1 (9.715.0) | 13.8 (10.5, 19.1) | 12.5 (9.714.5) | 0.31 |
| Total no. of inpatient admissions | 11,537 (9,26814,568) | 13,206 (11,32517,869) | 10,207 (8,64013,363) | 0.04 |
| Admissions under observation status, % | 25.7 (19.733.8) | 25.5 (21.431.4) | 26.0 (16.935.1) | 0.98 |
| Total no. of observation stays | 3,820 (27935672) | 4,850 (3,309 6,196) | 3,141 (2,3654,616) | 0.07 |
| Government payer, % | 60.2 (53.371.2) | 62.1 (54.9, 65.9) | 59.2 (53.373.7) | 0.89 |
Observation‐Status Patients by Hospital Type
In 2011, there were a total of 136,239 observation‐status stays69,983 (51.4%) within the 14 hospitals with a dedicated OU and 66,256 (48.6%) within the 17 hospitals without. Patient care originated in the ED for 57.8% observation‐status stays in hospitals with an OU compared with 53.0% of observation‐status stays in hospitals without (P<0.001). Compared with hospitals with a dedicated OU, those without a dedicated OU had higher percentages of observation‐status patients older than 12 years and non‐Hispanic and a higher percentage of observation‐status patients with private payer type (Table 2). The 15 top‐ranking APR‐DRGs accounted for roughly half of all observation‐status stays and were relatively consistent between hospitals with and without a dedicated OU (Table 3). Procedural care was frequently associated with observation‐status stays.
| Overall, No. (%) | Hospitals With a Dedicated Observation Unit, No. (%)* | Hospitals Without a Dedicated Observation Unit, No. (%) | P Value | |
|---|---|---|---|---|
| ||||
| Age | ||||
| <1 year | 23,845 (17.5) | 12,101 (17.3) | 11,744 (17.7) | <0.001 |
| 15 years | 53,405 (38.5) | 28,052 (40.1) | 24,353 (36.8) | |
| 612 years | 33,674 (24.7) | 17,215 (24.6) | 16,459 (24.8) | |
| 1318 years | 23,607 (17.3) | 11,472 (16.4) | 12,135 (18.3) | |
| >18 years | 2,708 (2) | 1,143 (1.6) | 1,565 (2.4) | |
| Gender | ||||
| Male | 76,142 (55.9) | 39,178 (56) | 36,964 (55.8) | 0.43 |
| Female | 60,025 (44.1) | 30,756 (44) | 29,269 (44.2) | |
| Race/ethnicity | ||||
| Non‐Hispanic white | 72,183 (53.0) | 30,653 (43.8) | 41,530 (62.7) | <0.001 |
| Non‐Hispanic black | 30,995 (22.8) | 16,314 (23.3) | 14,681 (22.2) | |
| Hispanic | 21,255 (15.6) | 16,583 (23.7) | 4,672 (7.1) | |
| Asian | 2,075 (1.5) | 1,313 (1.9) | 762 (1.2) | |
| Non‐Hispanic other | 9,731 (7.1) | 5,120 (7.3) | 4,611 (7.0) | |
| Payer | ||||
| Government | 68,725 (50.4) | 36,967 (52.8) | 31,758 (47.9) | <0.001 |
| Private | 48,416 (35.5) | 21,112 (30.2) | 27,304 (41.2) | |
| Other | 19,098 (14.0) | 11,904 (17) | 7,194 (10.9) | |
| Observation‐Status Patients in Hospitals With a Dedicated Observation Unit* | Observation‐Status Patients in Hospitals Without a Dedicated Observation Unit | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Rank | APR‐DRG | No. | % of All Observation Status Stays | % Began in ED | Rank | APR‐DRG | No. | % of All Observation Status Stays | % Began in ED |
| |||||||||
| 1 | Tonsil and adenoid procedures | 4,621 | 6.6 | 1.3 | 1 | Tonsil and adenoid procedures | 3,806 | 5.7 | 1.6 |
| 2 | Asthma | 4,246 | 6.1 | 85.3 | 2 | Asthma | 3,756 | 5.7 | 79.0 |
| 3 | Seizure | 3,516 | 5.0 | 52.0 | 3 | Seizure | 2,846 | 4.3 | 54.9 |
| 4 | Nonbacterial gastroenteritis | 3,286 | 4.7 | 85.8 | 4 | Upper respiratory infections | 2,733 | 4.1 | 69.6 |
| 5 | Bronchiolitis, RSV pneumonia | 3,093 | 4.4 | 78.5 | 5 | Nonbacterial gastroenteritis | 2,682 | 4.0 | 74.5 |
| 6 | Upper respiratory infections | 2,923 | 4.2 | 80.0 | 6 | Other digestive system diagnoses | 2,545 | 3.8 | 66.3 |
| 7 | Other digestive system diagnoses | 2,064 | 2.9 | 74.0 | 7 | Bronchiolitis, RSV pneumonia | 2,544 | 3.8 | 69.2 |
| 8 | Respiratory signs, symptoms, diagnoses | 2,052 | 2.9 | 81.6 | 8 | Shoulder and arm procedures | 1,862 | 2.8 | 72.6 |
| 9 | Other ENT/cranial/facial diagnoses | 1,684 | 2.4 | 43.6 | 9 | Appendectomy | 1,785 | 2.7 | 79.2 |
| 10 | Shoulder and arm procedures | 1,624 | 2.3 | 79.1 | 10 | Other ENT/cranial/facial diagnoses | 1,624 | 2.5 | 29.9 |
| 11 | Abdominal pain | 1,612 | 2.3 | 86.2 | 11 | Abdominal pain | 1,461 | 2.2 | 82.3 |
| 12 | Fever | 1,494 | 2.1 | 85.1 | 12 | Other factors influencing health status | 1,461 | 2.2 | 66.3 |
| 13 | Appendectomy | 1,465 | 2.1 | 66.4 | 13 | Cellulitis/other bacterial skin infections | 1,383 | 2.1 | 84.2 |
| 14 | Cellulitis/other bacterial skin infections | 1,393 | 2.0 | 86.4 | 14 | Respiratory signs, symptoms, diagnoses | 1,308 | 2.0 | 39.1 |
| 15 | Pneumonia NEC | 1,356 | 1.9 | 79.1 | 15 | Pneumonia NEC | 1,245 | 1.9 | 73.1 |
| Total | 36,429 | 52.0 | 57.8 | Total | 33,041 | 49.87 | 53.0 | ||
Outcomes of Observation‐Status Stays
A greater percentage of observation‐status stays in hospitals with a dedicated OU experienced a same‐day discharge (Table 4). In addition, a higher percentage of discharges occurred between midnight and 11 am in hospitals with a dedicated OU. However, overall risk‐adjusted LOS in hours (12.8 vs 12.2 hours, P=0.90) and risk‐adjusted total standardized costs ($2551 vs $2433, P=0.75) were similar between hospital types. These findings were consistent within the 1 APR‐DRGs commonly cared for by pediatric hospitalists (see Supporting Information, Appendix 1, in the online version of this article). Overall, conversion from observation to inpatient status was significantly higher in hospitals with a dedicated OU compared with hospitals without; however, this pattern was not consistent across the 10 APR‐DRGs commonly cared for by pediatric hospitalists (see Supporting Information, Appendix 1, in the online version of this article). Adjusted odds of 3‐day ED return visits and 30‐day readmissions were comparable between hospital groups.
| Observation‐Status Patients in Hospitals With a Dedicated Observation Unit | Observation‐Status Patients in Hospitals Without a Dedicated Observation Unit | P Value | |
|---|---|---|---|
| |||
| No. of hospitals | 14 | 17 | |
| Length of stay, h, median (IQR) | 12.8 (6.923.7) | 12.2 (721.3) | 0.90 |
| 0 midnights, no. (%) | 16,678 (23.8) | 14,648 (22.1) | <.001 |
| 1 midnight, no. (%) | 46,144 (65.9) | 44,559 (67.3) | |
| 2 midnights or more, no. (%) | 7,161 (10.2) | 7,049 (10.6) | |
| Discharge timing, no. (%) | |||
| Midnight5 am | 1,223 (1.9) | 408 (0.7) | <0.001 |
| 6 am11 am | 18,916 (29.3) | 15,914 (27.1) | |
| Noon5 pm | 32,699 (50.7) | 31,619 (53.9) | |
| 6 pm11 pm | 11,718 (18.2) | 10,718 (18.3) | |
| Total standardized costs, $, median (IQR) | 2,551.3 (2,053.93,169.1) | 2,433.4 (1,998.42,963) | 0.75 |
| Conversion to inpatient status | 11.06% | 9.63% | <0.01 |
| Return care, AOR (95% CI) | |||
| 3‐day ED return visit | 0.93 (0.77‐1.12) | Referent | 0.46 |
| 30‐day readmission | 0.88 (0.67‐1.15) | Referent | 0.36 |
We found similar results in sensitivity analyses comparing observation‐status stays in hospitals with a continuously open OU (open 24 hours per day, 7 days per week, for all of 2011 [n=10 hospitals]) to those without(see Supporting Information, Appendix 2, in the online version of this article). However, there were, on average, more observation‐status stays in hospitals with a continuously open OU (median 5605, IQR 42077089) than hospitals without (median 3309, IQR 26784616) (P=0.04). In contrast to our main results, conversion to inpatient status was lower in hospitals with a continuously open OU compared with hospitals without (8.52% vs 11.57%, P<0.01).
DISCUSSION
Counter to our hypothesis, we did not find hospital‐level differences in length of stay or costs for observation‐status patients cared for in hospitals with and without a dedicated OU, though hospitals with dedicated OUs did have more same‐day discharges and more morning discharges. The lack of observed differences in LOS and costs may reflect the fact that many children under observation status are treated throughout the hospital, even in facilities with a dedicated OU. Access to a dedicated OU is limited by factors including small numbers of OU beds and specific low acuity/low complexity OU admission criteria.[7] The inclusion of all children admitted under observation status in our analyses may have diluted any effect of dedicated OUs at the hospital level, but was necessary due to the inability to identify location of care for children admitted under observation status. Location of care is an important variable that should be incorporated into administrative databases to allow for comparative effectiveness research designs. Until such data are available, chart review at individual hospitals would be necessary to determine which patients received care in an OU.
We did find that discharges for observation‐status patients occurred earlier in the day in hospitals with a dedicated OU when compared with observation‐status patients in hospitals without a dedicated OU. In addition, the percentage of same‐day discharges was higher among observation‐status patients treated in hospitals with a dedicated OU. These differences may stem from policies and procedures that encourage rapid discharge in dedicated OUs, and those practices may affect other care areas. For example, OUs may enforce policies requiring family presence at the bedside or utilize staffing models where doctors and nurses are in frequent communication, both of which would facilitate discharge as soon as a patient no longer required hospital‐based care.[7] A retrospective chart review study design could be used to identify discharge processes and other key characteristics of highly performing OUs.
We found conflicting results in our main and sensitivity analyses related to conversion to inpatient status. Lower percentages of observation‐status patients converting to inpatient status indicates greater success in the delivery of observation care based on established performance metrics.[19] Lower rates of conversion to inpatient status may be the result of stricter admission criteria for some diagnosis and in hospitals with a continuously open dedicate OU, more refined processes for utilization review that allow for patients to be placed into the correct status (observation vs inpatient) at the time of admission, or efforts to educate providers about the designation of observation status.[7] It is also possible that fewer observation‐status patients convert to inpatient status in hospitals with a continuously open dedicated OU because such a change would require movement of the patient to an inpatient bed.
These analyses were more comprehensive than our prior studies[2, 20] in that we included both patients who were treated first in the ED and those who were not. In addition to the APR‐DRGs representative of conditions that have been successfully treated in ED‐based pediatric OUs (eg, asthma, seizures, gastroenteritis, cellulitis),[8, 9, 21, 22] we found observation‐status was commonly associated with procedural care. This population of patients may be relevant to hospitalists who staff OUs that provide both unscheduled and postprocedural care. The colocation of medical and postprocedural patients has been described by others[8, 23] and was reported to occur in over half of the OUs included in this study.[7] The extent to which postprocedure observation care is provided in general OUs staffed by hospitalists represents another opportunity for further study.
Hospitals face many considerations when determining if and how they will provide observation services to patients expected to experience short stays.[7] Some hospitals may be unable to justify an OU for all or part of the year based on the volume of admissions or the costs to staff an OU.[24, 25] Other hospitals may open an OU to promote patient flow and reduce ED crowding.[26] Hospitals may also be influenced by reimbursement policies related to observation‐status stays. Although we did not observe differences in overall payer mix, we did find higher percentages of observation‐status patients in hospitals with dedicated OUs to have public insurance. Although hospital contracts with payers around observation status patients are complex and beyond the scope of this analysis, it is possible that hospitals have established OUs because of increasingly stringent rules or criteria to meet inpatient status or experiences with high volumes of observation‐status patients covered by a particular payer. Nevertheless, the brief nature of many pediatric hospitalizations and the scarcity of pediatric OU beds must be considered in policy changes that result from national discussions about the appropriateness of inpatient stays shorter than 2 nights in duration.[27]
Limitations
The primary limitation to our analyses is the lack of ability to identify patients who were treated in a dedicated OU because few hospitals provided data to PHIS that allowed for the identification of the unit or location of care. Second, it is possible that some hospitals were misclassified as not having a dedicated OU based on our survey, which initially inquired about OUs that provided care to patients first treated in the ED. Therefore, OUs that exclusively care for postoperative patients or patients with scheduled treatments may be present in hospitals that we have labeled as not having a dedicated OU. This potential misclassification would bias our results toward finding no differences. Third, in any study of administrative data there is potential that diagnosis codes are incomplete or inaccurately capture the underlying reason for the episode of care. Fourth, the experiences of the free‐standing children's hospitals that contribute data to PHIS may not be generalizable to other hospitals that provide observation care to children. Finally, return care may be underestimated, as children could receive treatment at another hospital following discharge from a PHIS hospital. Care outside of PHIS hospitals would not be captured, but we do not expect this to differ for hospitals with and without dedicated OUs. It is possible that health information exchanges will permit more comprehensive analyses of care across different hospitals in the future.
CONCLUSION
Observation status patients are similar in hospitals with and without dedicated observation units that admit children from the ED. The presence of a dedicated OU appears to have an influence on same‐day and morning discharges across all observation‐status stays without impacting other hospital‐level outcomes. Inclusion of location of care (eg, geographically distinct dedicated OU vs general inpatient unit vs ED) in hospital administrative datasets would allow for meaningful comparisons of different models of care for short‐stay observation‐status patients.
Acknowledgements
The authors thank John P. Harding, MBA, FACHE, Children's Hospital of the King's Daughters, Norfolk, Virginia for his input on the study design.
Disclosures: Dr. Hall had full access to the data and takes responsibility for the integrity of the data and the accuracy of the data analysis. Internal funds from the Children's Hospital Association supported the conduct of this work. The authors have no financial relationships or conflicts of interest to disclose.
© 2015 Society of Hospital Medicine
