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Official news magazine of the Society of Hospital Medicine
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Community-based palliative care reduces hospitalizations
Clinical question: Does proactive home- and clinic-based palliative care impact hospital use and health care cost in Medicare Advantage beneficiaries?
Background: Studies demonstrate that community-based palliative care is becoming more common because of the need to better deliver individualized care, the positive effects on patient experience and outcomes, and payment model changes exerting pressure to reduce hospital use and cost.
Study design: Observational, retrospective study using propensity-based matching.
Setting: Southern California Health System.
Synopsis: Using the health systems’ databases of 368 community-based palliative care participants compared with 1,075 matched, non–palliative care individuals, this study showed that community-based palliative care participants had less hospital use and lower hospital costs than did the non–palliative care participants, which drove lower overall health care costs.
Hospitalists managing patients with acute exacerbations of chronic diseases and cancer should consider referral to ambulatory palliative care or comprehensive transitional care programs.
Bottom line: Proactive, ambulatory patient-centered palliative care lowers hospitalizations and end-of-life care costs.
Citations: Cassel JB, Kerr KM, McClish DK, et al. Effect of a Home-Based Palliative Care Program on Healthcare Use and Costs. J Am Geriatr Soc. 64:2288-2295, 2016.
Dr. McAllister is a hospitalist, assistant professor of medicine, and medical director of transitional care in the Department of Hospital Medicine at Cooper University Hospital, Camden, N.J.
Clinical question: Does proactive home- and clinic-based palliative care impact hospital use and health care cost in Medicare Advantage beneficiaries?
Background: Studies demonstrate that community-based palliative care is becoming more common because of the need to better deliver individualized care, the positive effects on patient experience and outcomes, and payment model changes exerting pressure to reduce hospital use and cost.
Study design: Observational, retrospective study using propensity-based matching.
Setting: Southern California Health System.
Synopsis: Using the health systems’ databases of 368 community-based palliative care participants compared with 1,075 matched, non–palliative care individuals, this study showed that community-based palliative care participants had less hospital use and lower hospital costs than did the non–palliative care participants, which drove lower overall health care costs.
Hospitalists managing patients with acute exacerbations of chronic diseases and cancer should consider referral to ambulatory palliative care or comprehensive transitional care programs.
Bottom line: Proactive, ambulatory patient-centered palliative care lowers hospitalizations and end-of-life care costs.
Citations: Cassel JB, Kerr KM, McClish DK, et al. Effect of a Home-Based Palliative Care Program on Healthcare Use and Costs. J Am Geriatr Soc. 64:2288-2295, 2016.
Dr. McAllister is a hospitalist, assistant professor of medicine, and medical director of transitional care in the Department of Hospital Medicine at Cooper University Hospital, Camden, N.J.
Clinical question: Does proactive home- and clinic-based palliative care impact hospital use and health care cost in Medicare Advantage beneficiaries?
Background: Studies demonstrate that community-based palliative care is becoming more common because of the need to better deliver individualized care, the positive effects on patient experience and outcomes, and payment model changes exerting pressure to reduce hospital use and cost.
Study design: Observational, retrospective study using propensity-based matching.
Setting: Southern California Health System.
Synopsis: Using the health systems’ databases of 368 community-based palliative care participants compared with 1,075 matched, non–palliative care individuals, this study showed that community-based palliative care participants had less hospital use and lower hospital costs than did the non–palliative care participants, which drove lower overall health care costs.
Hospitalists managing patients with acute exacerbations of chronic diseases and cancer should consider referral to ambulatory palliative care or comprehensive transitional care programs.
Bottom line: Proactive, ambulatory patient-centered palliative care lowers hospitalizations and end-of-life care costs.
Citations: Cassel JB, Kerr KM, McClish DK, et al. Effect of a Home-Based Palliative Care Program on Healthcare Use and Costs. J Am Geriatr Soc. 64:2288-2295, 2016.
Dr. McAllister is a hospitalist, assistant professor of medicine, and medical director of transitional care in the Department of Hospital Medicine at Cooper University Hospital, Camden, N.J.
More readmissions with delays in discharge summaries
Clinical question: Is there an association between time to completion of discharge summary and hospital readmission?
Background: Thirty-day hospital readmission is one of the quality indicators for inpatient care and a higher rate can result in monetary penalties. Several interventions aimed at reducing this occurrence have been studied in different settings with variable success. Timely completion of discharge summary can possibly affect readmissions by providing crucial information to outpatient providers caring for patients across the care continuum.
Study design: Retrospective cohort study.
Setting: Johns Hopkins University, Baltimore.
Bottom line: Delays in completion of discharge summaries was significantly associated with higher rates of hospital readmission. It’s unclear however whether timely completion is a surrogate indicator of other important causative factors.
Citations: Hoyer EH, Odonkor CA, Bhatia SN, et al. Association between days to complete inpatient discharge summaries with all-payer hospital readmissions in Maryland. J Hosp Med. 2016; 11(6):393-400.
Dr. Rachoin is an assistant professor of clinical medicine and associate division head, Hospital Medicine, at Cooper Medical School at Rowan University. He works as a hospitalist at Cooper University Hospital in Camden, N.J.
Clinical question: Is there an association between time to completion of discharge summary and hospital readmission?
Background: Thirty-day hospital readmission is one of the quality indicators for inpatient care and a higher rate can result in monetary penalties. Several interventions aimed at reducing this occurrence have been studied in different settings with variable success. Timely completion of discharge summary can possibly affect readmissions by providing crucial information to outpatient providers caring for patients across the care continuum.
Study design: Retrospective cohort study.
Setting: Johns Hopkins University, Baltimore.
Bottom line: Delays in completion of discharge summaries was significantly associated with higher rates of hospital readmission. It’s unclear however whether timely completion is a surrogate indicator of other important causative factors.
Citations: Hoyer EH, Odonkor CA, Bhatia SN, et al. Association between days to complete inpatient discharge summaries with all-payer hospital readmissions in Maryland. J Hosp Med. 2016; 11(6):393-400.
Dr. Rachoin is an assistant professor of clinical medicine and associate division head, Hospital Medicine, at Cooper Medical School at Rowan University. He works as a hospitalist at Cooper University Hospital in Camden, N.J.
Clinical question: Is there an association between time to completion of discharge summary and hospital readmission?
Background: Thirty-day hospital readmission is one of the quality indicators for inpatient care and a higher rate can result in monetary penalties. Several interventions aimed at reducing this occurrence have been studied in different settings with variable success. Timely completion of discharge summary can possibly affect readmissions by providing crucial information to outpatient providers caring for patients across the care continuum.
Study design: Retrospective cohort study.
Setting: Johns Hopkins University, Baltimore.
Bottom line: Delays in completion of discharge summaries was significantly associated with higher rates of hospital readmission. It’s unclear however whether timely completion is a surrogate indicator of other important causative factors.
Citations: Hoyer EH, Odonkor CA, Bhatia SN, et al. Association between days to complete inpatient discharge summaries with all-payer hospital readmissions in Maryland. J Hosp Med. 2016; 11(6):393-400.
Dr. Rachoin is an assistant professor of clinical medicine and associate division head, Hospital Medicine, at Cooper Medical School at Rowan University. He works as a hospitalist at Cooper University Hospital in Camden, N.J.
AKI is common in young, critically ill adults
Clinical question: What are the epidemiology, risk factors, and associated morbidity and mortality of acute kidney injury (AKI) in critically ill children and young adults?
Background: Adult studies on acute kidney injury have shown increasing mortality and morbidity when both plasma creatinine and urine output were used to diagnose AKI than when used alone. Studies of AKI in children have also been limited.
Setting: International (32 pediatric intensive care units across Asia, Australia, Europe, and North America).
Synopsis: 4,984 patients aged 3 months to 25 years with a predicted ICU stay of at least 48 hours were considered for enrollment, of which 4,683 were included in the final analysis. The primary outcome was 28-day mortality. Secondary outcomes were length of stay in the ICU, receipt and duration of mechanical ventilation, receipt of extracorporeal membrane oxygenation, and renal-replacement therapy. A total of 26.9% of patients developed AKI in the first 7 days of an ICU admission. Severe AKI increased mortality by day 28 (adjusted odds ratio, 1.77; 95% confidence interval, 1.17-2.68) and was associated with increased use of renal-replacement therapy and mechanical ventilation and longer stays in the ICU. Urine output predicted mortality more accurately than did plasma creatinine, and using plasma creatinine alone failed to identify two-thirds of patients with low urine output.
Bottom line: In critically ill young patients, AKI is a common occurrence and is associated with both an increased morbidity and mortality. In a majority of patients with low urine output, plasma creatinine was a poor discriminant of renal function.
Citations: Kaddourah A, Basu RK, Bagshaw SM, et al. Epidemiology of acute kidney injury in critically ill children and young adults. N Eng J Med. 2017; 376 (1):11-20.
Dr. Rachoin is an assistant professor of clinical medicine and associate division head, Hospital Medicine, at Cooper Medical School at Rowan University. He works as a hospitalist at Cooper University Hospital in Camden, N.J.
Clinical question: What are the epidemiology, risk factors, and associated morbidity and mortality of acute kidney injury (AKI) in critically ill children and young adults?
Background: Adult studies on acute kidney injury have shown increasing mortality and morbidity when both plasma creatinine and urine output were used to diagnose AKI than when used alone. Studies of AKI in children have also been limited.
Setting: International (32 pediatric intensive care units across Asia, Australia, Europe, and North America).
Synopsis: 4,984 patients aged 3 months to 25 years with a predicted ICU stay of at least 48 hours were considered for enrollment, of which 4,683 were included in the final analysis. The primary outcome was 28-day mortality. Secondary outcomes were length of stay in the ICU, receipt and duration of mechanical ventilation, receipt of extracorporeal membrane oxygenation, and renal-replacement therapy. A total of 26.9% of patients developed AKI in the first 7 days of an ICU admission. Severe AKI increased mortality by day 28 (adjusted odds ratio, 1.77; 95% confidence interval, 1.17-2.68) and was associated with increased use of renal-replacement therapy and mechanical ventilation and longer stays in the ICU. Urine output predicted mortality more accurately than did plasma creatinine, and using plasma creatinine alone failed to identify two-thirds of patients with low urine output.
Bottom line: In critically ill young patients, AKI is a common occurrence and is associated with both an increased morbidity and mortality. In a majority of patients with low urine output, plasma creatinine was a poor discriminant of renal function.
Citations: Kaddourah A, Basu RK, Bagshaw SM, et al. Epidemiology of acute kidney injury in critically ill children and young adults. N Eng J Med. 2017; 376 (1):11-20.
Dr. Rachoin is an assistant professor of clinical medicine and associate division head, Hospital Medicine, at Cooper Medical School at Rowan University. He works as a hospitalist at Cooper University Hospital in Camden, N.J.
Clinical question: What are the epidemiology, risk factors, and associated morbidity and mortality of acute kidney injury (AKI) in critically ill children and young adults?
Background: Adult studies on acute kidney injury have shown increasing mortality and morbidity when both plasma creatinine and urine output were used to diagnose AKI than when used alone. Studies of AKI in children have also been limited.
Setting: International (32 pediatric intensive care units across Asia, Australia, Europe, and North America).
Synopsis: 4,984 patients aged 3 months to 25 years with a predicted ICU stay of at least 48 hours were considered for enrollment, of which 4,683 were included in the final analysis. The primary outcome was 28-day mortality. Secondary outcomes were length of stay in the ICU, receipt and duration of mechanical ventilation, receipt of extracorporeal membrane oxygenation, and renal-replacement therapy. A total of 26.9% of patients developed AKI in the first 7 days of an ICU admission. Severe AKI increased mortality by day 28 (adjusted odds ratio, 1.77; 95% confidence interval, 1.17-2.68) and was associated with increased use of renal-replacement therapy and mechanical ventilation and longer stays in the ICU. Urine output predicted mortality more accurately than did plasma creatinine, and using plasma creatinine alone failed to identify two-thirds of patients with low urine output.
Bottom line: In critically ill young patients, AKI is a common occurrence and is associated with both an increased morbidity and mortality. In a majority of patients with low urine output, plasma creatinine was a poor discriminant of renal function.
Citations: Kaddourah A, Basu RK, Bagshaw SM, et al. Epidemiology of acute kidney injury in critically ill children and young adults. N Eng J Med. 2017; 376 (1):11-20.
Dr. Rachoin is an assistant professor of clinical medicine and associate division head, Hospital Medicine, at Cooper Medical School at Rowan University. He works as a hospitalist at Cooper University Hospital in Camden, N.J.
NSAIDs and cardiovascular risk
Clinical question: Which NSAID confers the least cardiovascular risk?
Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) reduce pain and inflammation by decreasing prostaglandin production through cyclo-oxygenase (COX) inhibition. However, the COX enzyme stimulates protective prostaglandins for the GI mucosa. The development of cyclo-oxygenase-2 (COX-2) inhibitors did reduce the gastrointestinal side effects of NSAIDs, but subsequent trials pointed to increased cardiovascular events and resulted in rofecoxib being removed from the market. Celecoxib remained on the market as the only COX-2 inhibitor, but the Food and Drug Administration required a cardiovascular safety trial.
Study design: Prospective randomized, double-blind noninferiority study.
Setting: International (926 centers in 13 countries).
Synopsis: The PRECISION trial enrolled 24,081 patients who required NSAIDs for arthritis pain and who either had established cardiovascular disease or an increased risk of CV disease. Patients were randomized to celecoxib 100 mg twice a day, ibuprofen 600 mg three times a day, or naproxen 375 mg twice a day. Patients were allowed to continue taking low-dose aspirin (325 mg or less daily). The primary composite outcome was cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke. A secondary composite outcome was major adverse CV events (the primary outcome plus coronary revascularization or hospitalization for unstable angina or transient ischemic attack) and significant gastrointestinal events.
The primary outcome occurred in 188 patients in the celecoxib group (2.3%), 201 in the naproxen group (2.5%), and 218 in the ibuprofen group (2.7%). Celecoxib, as compared with either naproxen or ibuprofen, met all four prespecified noninferiority requirements (P less than .01 for noninferiority in both comparisons. Ibuprofen, as compared with naproxen, just met the noninferiority criteria (P = .025).
Bottom line: The PRECISION trial provides statistically strong evidence that the cardiovascular risk associated with moderate doses of celecoxib is not greater than that associated with nonselective NSAIDs (ibuprofen and naproxen).
Citations: Nissen SE, Yeomans ND, Solomon DH, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis.” N Engl J M. 2016;375(26):2519-2529.
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: Which NSAID confers the least cardiovascular risk?
Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) reduce pain and inflammation by decreasing prostaglandin production through cyclo-oxygenase (COX) inhibition. However, the COX enzyme stimulates protective prostaglandins for the GI mucosa. The development of cyclo-oxygenase-2 (COX-2) inhibitors did reduce the gastrointestinal side effects of NSAIDs, but subsequent trials pointed to increased cardiovascular events and resulted in rofecoxib being removed from the market. Celecoxib remained on the market as the only COX-2 inhibitor, but the Food and Drug Administration required a cardiovascular safety trial.
Study design: Prospective randomized, double-blind noninferiority study.
Setting: International (926 centers in 13 countries).
Synopsis: The PRECISION trial enrolled 24,081 patients who required NSAIDs for arthritis pain and who either had established cardiovascular disease or an increased risk of CV disease. Patients were randomized to celecoxib 100 mg twice a day, ibuprofen 600 mg three times a day, or naproxen 375 mg twice a day. Patients were allowed to continue taking low-dose aspirin (325 mg or less daily). The primary composite outcome was cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke. A secondary composite outcome was major adverse CV events (the primary outcome plus coronary revascularization or hospitalization for unstable angina or transient ischemic attack) and significant gastrointestinal events.
The primary outcome occurred in 188 patients in the celecoxib group (2.3%), 201 in the naproxen group (2.5%), and 218 in the ibuprofen group (2.7%). Celecoxib, as compared with either naproxen or ibuprofen, met all four prespecified noninferiority requirements (P less than .01 for noninferiority in both comparisons. Ibuprofen, as compared with naproxen, just met the noninferiority criteria (P = .025).
Bottom line: The PRECISION trial provides statistically strong evidence that the cardiovascular risk associated with moderate doses of celecoxib is not greater than that associated with nonselective NSAIDs (ibuprofen and naproxen).
Citations: Nissen SE, Yeomans ND, Solomon DH, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis.” N Engl J M. 2016;375(26):2519-2529.
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: Which NSAID confers the least cardiovascular risk?
Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) reduce pain and inflammation by decreasing prostaglandin production through cyclo-oxygenase (COX) inhibition. However, the COX enzyme stimulates protective prostaglandins for the GI mucosa. The development of cyclo-oxygenase-2 (COX-2) inhibitors did reduce the gastrointestinal side effects of NSAIDs, but subsequent trials pointed to increased cardiovascular events and resulted in rofecoxib being removed from the market. Celecoxib remained on the market as the only COX-2 inhibitor, but the Food and Drug Administration required a cardiovascular safety trial.
Study design: Prospective randomized, double-blind noninferiority study.
Setting: International (926 centers in 13 countries).
Synopsis: The PRECISION trial enrolled 24,081 patients who required NSAIDs for arthritis pain and who either had established cardiovascular disease or an increased risk of CV disease. Patients were randomized to celecoxib 100 mg twice a day, ibuprofen 600 mg three times a day, or naproxen 375 mg twice a day. Patients were allowed to continue taking low-dose aspirin (325 mg or less daily). The primary composite outcome was cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke. A secondary composite outcome was major adverse CV events (the primary outcome plus coronary revascularization or hospitalization for unstable angina or transient ischemic attack) and significant gastrointestinal events.
The primary outcome occurred in 188 patients in the celecoxib group (2.3%), 201 in the naproxen group (2.5%), and 218 in the ibuprofen group (2.7%). Celecoxib, as compared with either naproxen or ibuprofen, met all four prespecified noninferiority requirements (P less than .01 for noninferiority in both comparisons. Ibuprofen, as compared with naproxen, just met the noninferiority criteria (P = .025).
Bottom line: The PRECISION trial provides statistically strong evidence that the cardiovascular risk associated with moderate doses of celecoxib is not greater than that associated with nonselective NSAIDs (ibuprofen and naproxen).
Citations: Nissen SE, Yeomans ND, Solomon DH, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis.” N Engl J M. 2016;375(26):2519-2529.
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Palliative care: a systematic review for patients and their caregivers
Clinical question: What is the association of palliative care programs on quality of life, symptoms, and survival for patients and their caregivers?
Background: Palliative care programs have expanded across the country: More than 65% of U.S. hospitals have such a program. Efforts have been made to assess their effectiveness for terminally ill patients and their caregivers.
Study design: Systematic review and meta-analysis of 43 randomized controlled trials.
Setting: Not applicable
Synopsis: Two reviewers independently assessed 43 trials (12,731 patients and 2,479 caregivers) with the main outcomes being quality of life, symptom burden, survival, mood, advance care planning, site of death, health care satisfaction, resource utilization, and health care expenditures. Estimates of QOL were translated to units of the Functional Assessment of Chronic Illness Therapy–palliative care scale (FACIT-Pal) instrument and symptom burden was translated into the Edmonton Symptom Assessment Scale (ESAS). Palliative care was associated with statistically and clinically significant improvements in patient QOL at the 1- to 3-month follow-up (standardized mean difference, 0.46; 95% CI, 0.08-0.83; FACIT-Pal mean difference, 11.36) and symptom burden at the 1- to 3-month follow-up (standardized mean difference, −0.66; 95% CI, −1.25 to −0.07; ESAS mean difference, −10.30).
When analyses were limited to trials at low risk of bias (n = 5), the association between palliative care and QOL was attenuated but remained statistically significant (standardized mean difference, 0.20; 95% CI, 0.06-0.34; FACIT-Pal mean difference, 4.94), whereas the association with symptom burden was no longer statistically significant (standardized mean difference, −0.21; 95% CI, −0.42-0.00; ESAS mean difference, −3.28). Caregiver outcomes were mixed but with limited quality of evidence.
Bottom line: Although there was no significant association between palliative care and survival, palliative interventions were associated with improved patient QOL, patient and caregiver satisfaction, lower health care utilization, and symptom burden.
Citations: Kavalieratos D, Corbelli J, Zhang D, et al. Association between palliative care and patient and caregiver outcomes: A systematic review and meta-analysis. JAMA. 2016;316(20):2104-2114. doi: 10.1001/jama.2016.16840
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: What is the association of palliative care programs on quality of life, symptoms, and survival for patients and their caregivers?
Background: Palliative care programs have expanded across the country: More than 65% of U.S. hospitals have such a program. Efforts have been made to assess their effectiveness for terminally ill patients and their caregivers.
Study design: Systematic review and meta-analysis of 43 randomized controlled trials.
Setting: Not applicable
Synopsis: Two reviewers independently assessed 43 trials (12,731 patients and 2,479 caregivers) with the main outcomes being quality of life, symptom burden, survival, mood, advance care planning, site of death, health care satisfaction, resource utilization, and health care expenditures. Estimates of QOL were translated to units of the Functional Assessment of Chronic Illness Therapy–palliative care scale (FACIT-Pal) instrument and symptom burden was translated into the Edmonton Symptom Assessment Scale (ESAS). Palliative care was associated with statistically and clinically significant improvements in patient QOL at the 1- to 3-month follow-up (standardized mean difference, 0.46; 95% CI, 0.08-0.83; FACIT-Pal mean difference, 11.36) and symptom burden at the 1- to 3-month follow-up (standardized mean difference, −0.66; 95% CI, −1.25 to −0.07; ESAS mean difference, −10.30).
When analyses were limited to trials at low risk of bias (n = 5), the association between palliative care and QOL was attenuated but remained statistically significant (standardized mean difference, 0.20; 95% CI, 0.06-0.34; FACIT-Pal mean difference, 4.94), whereas the association with symptom burden was no longer statistically significant (standardized mean difference, −0.21; 95% CI, −0.42-0.00; ESAS mean difference, −3.28). Caregiver outcomes were mixed but with limited quality of evidence.
Bottom line: Although there was no significant association between palliative care and survival, palliative interventions were associated with improved patient QOL, patient and caregiver satisfaction, lower health care utilization, and symptom burden.
Citations: Kavalieratos D, Corbelli J, Zhang D, et al. Association between palliative care and patient and caregiver outcomes: A systematic review and meta-analysis. JAMA. 2016;316(20):2104-2114. doi: 10.1001/jama.2016.16840
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: What is the association of palliative care programs on quality of life, symptoms, and survival for patients and their caregivers?
Background: Palliative care programs have expanded across the country: More than 65% of U.S. hospitals have such a program. Efforts have been made to assess their effectiveness for terminally ill patients and their caregivers.
Study design: Systematic review and meta-analysis of 43 randomized controlled trials.
Setting: Not applicable
Synopsis: Two reviewers independently assessed 43 trials (12,731 patients and 2,479 caregivers) with the main outcomes being quality of life, symptom burden, survival, mood, advance care planning, site of death, health care satisfaction, resource utilization, and health care expenditures. Estimates of QOL were translated to units of the Functional Assessment of Chronic Illness Therapy–palliative care scale (FACIT-Pal) instrument and symptom burden was translated into the Edmonton Symptom Assessment Scale (ESAS). Palliative care was associated with statistically and clinically significant improvements in patient QOL at the 1- to 3-month follow-up (standardized mean difference, 0.46; 95% CI, 0.08-0.83; FACIT-Pal mean difference, 11.36) and symptom burden at the 1- to 3-month follow-up (standardized mean difference, −0.66; 95% CI, −1.25 to −0.07; ESAS mean difference, −10.30).
When analyses were limited to trials at low risk of bias (n = 5), the association between palliative care and QOL was attenuated but remained statistically significant (standardized mean difference, 0.20; 95% CI, 0.06-0.34; FACIT-Pal mean difference, 4.94), whereas the association with symptom burden was no longer statistically significant (standardized mean difference, −0.21; 95% CI, −0.42-0.00; ESAS mean difference, −3.28). Caregiver outcomes were mixed but with limited quality of evidence.
Bottom line: Although there was no significant association between palliative care and survival, palliative interventions were associated with improved patient QOL, patient and caregiver satisfaction, lower health care utilization, and symptom burden.
Citations: Kavalieratos D, Corbelli J, Zhang D, et al. Association between palliative care and patient and caregiver outcomes: A systematic review and meta-analysis. JAMA. 2016;316(20):2104-2114. doi: 10.1001/jama.2016.16840
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Emergency department visits from adverse drug events
Clinical question: The purpose of this study was to describe emergency department (ED) visits for adverse drug events in year 2013-2014 compared to year 2005-2006 to learn changing patterns of ADEs and to help advance medication safety initiatives in outpatient settings.
Background: Adverse drug events (ADEs) are the most common cause of iatrogenic harm to patients and there have been significant national-level initiatives to prevent them as a part of patient safety. In the outpatient setting, where 90% of prescription drug expenditures occur, preventing ADEs remains a patient safety challenge because patients can have complex medication regimens, at times prescribed by multiple clinicians, with far less monitoring compared with hospitalized patients. 
Setting and study design: Active, public health surveillance in 58 EDs in the United States that participate in the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance Project (NEISS-CADES). Trained data abstractors at each hospital reviewed each ED visit to identify any clinician-diagnosed ADEs that were the reason for the ED visit. Reports were coded by CDC and analyzed.
Synopsis: Based on 42,585 cases, 4.0 (95% CI, 3.1-5) ED visits for ADEs per 1,000 individuals occurred annually in the United States in 2013-2014 and 27.3% (22.2%-32.4%) of ED visits for ADEs resulted in hospitalization.
An estimated 34.5 % (95% CI, 30.3-38.8) of ED visits for ADEs occurred among adults aged 65 or older in 2013 compared with an estimated 25.6% (95% CI, 21-30) in 2005-2006. The population rate for adults older than 65 years was 9.7 visits per 1,000 individuals, compared with 3.1 visits per 1,000 individuals for those younger than 65 years. Older adults experienced higher hospitalization rates 43.6% (95% CI, 36.6-50.5). When adjusted for the U.S. population, the hospitalization rate for ADEs among older individuals was seven times higher compared with younger patients.
A single medication was implicated in most ED visits for ADEs (83.8%; 95% CI, 81.5-86.1). Supratherapeutic effects of ingestion of excess dose was the most common type of ADE (37.2%; 95% CI, 34.7-39.6). Medication errors were documented in 1 of 10 ED visits for ADEs (10.5%; 95% CI, 8.9-12.2).
The most commonly implicated drug classes were anticoagulants (17.6%), systemic antibiotics (16.1%), diabetes agents (13.3%), opioid analgesics (6.8%), antiplatelets (6.6%), renin-angiotensin system inhibitors (3.5%), antineoplastic agents (3%) and sedative/hypnotics (3%). Since 2005-2006, the proportions of ED visits for ADEs involving anticoagulants, antiplatelets, and diabetic agents have increased, whereas proportions involving antibiotics have decreased.
In children aged 5 years or younger, antibiotics were the most common drug class (56.4; 95% CI, 51.8-61). Among children and adolescents aged 6-19 years, antibiotics also were the most common class (31.8%; 95% CI, 28.7-34.9), followed by antipsychotics (4.5%; 95% CI, 3.3-5.6).
Among older adults, three drug classes recently targeted by federal patient safety initiatives (anticoagulants, diabetes agents, and opioid analgesics) were implicated in an estimated 59.9% (95% CI, 56.8-62.9) of ED visits. Four anticoagulants (warfarin, rivaroxaban, dabigatran, and enoxaparin) and five diabetes agents (insulin and four oral agents) were among the 15 most common drugs implicated. Medications to always avoid in older adults according to Beers criteria were implicated in 1.8% (95% CI, 1.5-2.1) of ED visits for adverse drug events.
Summary: The most common drug classes implicated in ED visits for ADEs in the United States are the same ones identified a decade ago – anticoagulants, antibiotics, diabetes agents, and opioid analgesics. The proportion of ED visits for ADEs involving anticoagulants has increased during the last decade with increased anticoagulant use. The prevalence of potentially inappropriate medication use in older patients also remains high.
Citation: JAMA. 2016;316(20):2115-25. doi: 10.1001/jama.2016.16201.
Dr. Patel is a hospitalist in the division of hospital medicine and assistant professor of medicine at Cooper Medical School of Rowan University, Camden, N.J. He is CMSRU’s associate residency program director and serves as codirector of the Foundation of Medical Practice curriculum.
Clinical question: The purpose of this study was to describe emergency department (ED) visits for adverse drug events in year 2013-2014 compared to year 2005-2006 to learn changing patterns of ADEs and to help advance medication safety initiatives in outpatient settings.
Background: Adverse drug events (ADEs) are the most common cause of iatrogenic harm to patients and there have been significant national-level initiatives to prevent them as a part of patient safety. In the outpatient setting, where 90% of prescription drug expenditures occur, preventing ADEs remains a patient safety challenge because patients can have complex medication regimens, at times prescribed by multiple clinicians, with far less monitoring compared with hospitalized patients.
Setting and study design: Active, public health surveillance in 58 EDs in the United States that participate in the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance Project (NEISS-CADES). Trained data abstractors at each hospital reviewed each ED visit to identify any clinician-diagnosed ADEs that were the reason for the ED visit. Reports were coded by CDC and analyzed.
Synopsis: Based on 42,585 cases, 4.0 (95% CI, 3.1-5) ED visits for ADEs per 1,000 individuals occurred annually in the United States in 2013-2014 and 27.3% (22.2%-32.4%) of ED visits for ADEs resulted in hospitalization.
An estimated 34.5 % (95% CI, 30.3-38.8) of ED visits for ADEs occurred among adults aged 65 or older in 2013 compared with an estimated 25.6% (95% CI, 21-30) in 2005-2006. The population rate for adults older than 65 years was 9.7 visits per 1,000 individuals, compared with 3.1 visits per 1,000 individuals for those younger than 65 years. Older adults experienced higher hospitalization rates 43.6% (95% CI, 36.6-50.5). When adjusted for the U.S. population, the hospitalization rate for ADEs among older individuals was seven times higher compared with younger patients.
A single medication was implicated in most ED visits for ADEs (83.8%; 95% CI, 81.5-86.1). Supratherapeutic effects of ingestion of excess dose was the most common type of ADE (37.2%; 95% CI, 34.7-39.6). Medication errors were documented in 1 of 10 ED visits for ADEs (10.5%; 95% CI, 8.9-12.2).
The most commonly implicated drug classes were anticoagulants (17.6%), systemic antibiotics (16.1%), diabetes agents (13.3%), opioid analgesics (6.8%), antiplatelets (6.6%), renin-angiotensin system inhibitors (3.5%), antineoplastic agents (3%) and sedative/hypnotics (3%). Since 2005-2006, the proportions of ED visits for ADEs involving anticoagulants, antiplatelets, and diabetic agents have increased, whereas proportions involving antibiotics have decreased.
In children aged 5 years or younger, antibiotics were the most common drug class (56.4; 95% CI, 51.8-61). Among children and adolescents aged 6-19 years, antibiotics also were the most common class (31.8%; 95% CI, 28.7-34.9), followed by antipsychotics (4.5%; 95% CI, 3.3-5.6).
Among older adults, three drug classes recently targeted by federal patient safety initiatives (anticoagulants, diabetes agents, and opioid analgesics) were implicated in an estimated 59.9% (95% CI, 56.8-62.9) of ED visits. Four anticoagulants (warfarin, rivaroxaban, dabigatran, and enoxaparin) and five diabetes agents (insulin and four oral agents) were among the 15 most common drugs implicated. Medications to always avoid in older adults according to Beers criteria were implicated in 1.8% (95% CI, 1.5-2.1) of ED visits for adverse drug events.
Summary: The most common drug classes implicated in ED visits for ADEs in the United States are the same ones identified a decade ago – anticoagulants, antibiotics, diabetes agents, and opioid analgesics. The proportion of ED visits for ADEs involving anticoagulants has increased during the last decade with increased anticoagulant use. The prevalence of potentially inappropriate medication use in older patients also remains high.
Citation: JAMA. 2016;316(20):2115-25. doi: 10.1001/jama.2016.16201.
Dr. Patel is a hospitalist in the division of hospital medicine and assistant professor of medicine at Cooper Medical School of Rowan University, Camden, N.J. He is CMSRU’s associate residency program director and serves as codirector of the Foundation of Medical Practice curriculum.
Clinical question: The purpose of this study was to describe emergency department (ED) visits for adverse drug events in year 2013-2014 compared to year 2005-2006 to learn changing patterns of ADEs and to help advance medication safety initiatives in outpatient settings.
Background: Adverse drug events (ADEs) are the most common cause of iatrogenic harm to patients and there have been significant national-level initiatives to prevent them as a part of patient safety. In the outpatient setting, where 90% of prescription drug expenditures occur, preventing ADEs remains a patient safety challenge because patients can have complex medication regimens, at times prescribed by multiple clinicians, with far less monitoring compared with hospitalized patients.
Setting and study design: Active, public health surveillance in 58 EDs in the United States that participate in the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance Project (NEISS-CADES). Trained data abstractors at each hospital reviewed each ED visit to identify any clinician-diagnosed ADEs that were the reason for the ED visit. Reports were coded by CDC and analyzed.
Synopsis: Based on 42,585 cases, 4.0 (95% CI, 3.1-5) ED visits for ADEs per 1,000 individuals occurred annually in the United States in 2013-2014 and 27.3% (22.2%-32.4%) of ED visits for ADEs resulted in hospitalization.
An estimated 34.5 % (95% CI, 30.3-38.8) of ED visits for ADEs occurred among adults aged 65 or older in 2013 compared with an estimated 25.6% (95% CI, 21-30) in 2005-2006. The population rate for adults older than 65 years was 9.7 visits per 1,000 individuals, compared with 3.1 visits per 1,000 individuals for those younger than 65 years. Older adults experienced higher hospitalization rates 43.6% (95% CI, 36.6-50.5). When adjusted for the U.S. population, the hospitalization rate for ADEs among older individuals was seven times higher compared with younger patients.
A single medication was implicated in most ED visits for ADEs (83.8%; 95% CI, 81.5-86.1). Supratherapeutic effects of ingestion of excess dose was the most common type of ADE (37.2%; 95% CI, 34.7-39.6). Medication errors were documented in 1 of 10 ED visits for ADEs (10.5%; 95% CI, 8.9-12.2).
The most commonly implicated drug classes were anticoagulants (17.6%), systemic antibiotics (16.1%), diabetes agents (13.3%), opioid analgesics (6.8%), antiplatelets (6.6%), renin-angiotensin system inhibitors (3.5%), antineoplastic agents (3%) and sedative/hypnotics (3%). Since 2005-2006, the proportions of ED visits for ADEs involving anticoagulants, antiplatelets, and diabetic agents have increased, whereas proportions involving antibiotics have decreased.
In children aged 5 years or younger, antibiotics were the most common drug class (56.4; 95% CI, 51.8-61). Among children and adolescents aged 6-19 years, antibiotics also were the most common class (31.8%; 95% CI, 28.7-34.9), followed by antipsychotics (4.5%; 95% CI, 3.3-5.6).
Among older adults, three drug classes recently targeted by federal patient safety initiatives (anticoagulants, diabetes agents, and opioid analgesics) were implicated in an estimated 59.9% (95% CI, 56.8-62.9) of ED visits. Four anticoagulants (warfarin, rivaroxaban, dabigatran, and enoxaparin) and five diabetes agents (insulin and four oral agents) were among the 15 most common drugs implicated. Medications to always avoid in older adults according to Beers criteria were implicated in 1.8% (95% CI, 1.5-2.1) of ED visits for adverse drug events.
Summary: The most common drug classes implicated in ED visits for ADEs in the United States are the same ones identified a decade ago – anticoagulants, antibiotics, diabetes agents, and opioid analgesics. The proportion of ED visits for ADEs involving anticoagulants has increased during the last decade with increased anticoagulant use. The prevalence of potentially inappropriate medication use in older patients also remains high.
Citation: JAMA. 2016;316(20):2115-25. doi: 10.1001/jama.2016.16201.
Dr. Patel is a hospitalist in the division of hospital medicine and assistant professor of medicine at Cooper Medical School of Rowan University, Camden, N.J. He is CMSRU’s associate residency program director and serves as codirector of the Foundation of Medical Practice curriculum.
Anticoagulants: more harm than good in isolated calf DVT
Clinical question: Is therapeutic anticoagulation superior to placebo in patients with symptomatic acute calf deep venous thrombosis (DVT)?
Background: Medical evidence supporting the usage of therapeutic anticoagulation in symptomatic acute isolated calf DVT is lacking. This type of DVT has a low embolic potential. The bleeding risk of anticoagulation might therefore be higher than its benefit.
Study design: Double-blind, placebo-controlled trial.
Setting: Twenty-three centers in Canada, France and Switzerland.
Synopsis: A total of 259 outpatients with a first acute symptomatic objectively confirmed isolated calf DVT were enrolled to receive either a therapeutic dose of the low-molecular weight heparin nadroparin (122 patients), or a placebo (130 patients).
The primary efficacy outcome (a composite endpoint of extension of calf DVT to proximal veins, contralateral proximal DVT and symptomatic pulmonary embolism) was not statistically significant between the two groups (3% in the nadroparin group and 5% in the placebo group, P = .54). The primary safety outcome (the number of patients with major or clinically relevant non-major bleeding) was significantly higher in the nadroparin group (4% in nadroparin group, 0 patients in the placebo group, P = .0255).
The study was limited by the relative low number of patients (goal was 286 patients). The results of the study do not apply to inpatients and to cancer patients as patients with high risk for extension or recurrence of their DVT were excluded.
Bottom line: Therapeutic anticoagulation in low-risk outpatients with isolated calf DVT will likely cause more harm from bleeding than benefit.
Citation: Righini M, Galanaud J, Guenneguez H, et al. Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): A randomised, double-blind, placebo-controlled trial. The Lancet Haematology. 2016;3(12):e556-e562. doi: 10.1016/S2352-3026(16)30131-4.
Dr. Badr is a hospitalist at Cooper University Hospital in Camden, N.J., and an assistant professor of clinical medicine at the Cooper Medical School of Rowan University.
Clinical question: Is therapeutic anticoagulation superior to placebo in patients with symptomatic acute calf deep venous thrombosis (DVT)?
Background: Medical evidence supporting the usage of therapeutic anticoagulation in symptomatic acute isolated calf DVT is lacking. This type of DVT has a low embolic potential. The bleeding risk of anticoagulation might therefore be higher than its benefit.
Study design: Double-blind, placebo-controlled trial.
Setting: Twenty-three centers in Canada, France and Switzerland.
Synopsis: A total of 259 outpatients with a first acute symptomatic objectively confirmed isolated calf DVT were enrolled to receive either a therapeutic dose of the low-molecular weight heparin nadroparin (122 patients), or a placebo (130 patients).
The primary efficacy outcome (a composite endpoint of extension of calf DVT to proximal veins, contralateral proximal DVT and symptomatic pulmonary embolism) was not statistically significant between the two groups (3% in the nadroparin group and 5% in the placebo group, P = .54). The primary safety outcome (the number of patients with major or clinically relevant non-major bleeding) was significantly higher in the nadroparin group (4% in nadroparin group, 0 patients in the placebo group, P = .0255).
The study was limited by the relative low number of patients (goal was 286 patients). The results of the study do not apply to inpatients and to cancer patients as patients with high risk for extension or recurrence of their DVT were excluded.
Bottom line: Therapeutic anticoagulation in low-risk outpatients with isolated calf DVT will likely cause more harm from bleeding than benefit.
Citation: Righini M, Galanaud J, Guenneguez H, et al. Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): A randomised, double-blind, placebo-controlled trial. The Lancet Haematology. 2016;3(12):e556-e562. doi: 10.1016/S2352-3026(16)30131-4.
Dr. Badr is a hospitalist at Cooper University Hospital in Camden, N.J., and an assistant professor of clinical medicine at the Cooper Medical School of Rowan University.
Clinical question: Is therapeutic anticoagulation superior to placebo in patients with symptomatic acute calf deep venous thrombosis (DVT)?
Background: Medical evidence supporting the usage of therapeutic anticoagulation in symptomatic acute isolated calf DVT is lacking. This type of DVT has a low embolic potential. The bleeding risk of anticoagulation might therefore be higher than its benefit.
Study design: Double-blind, placebo-controlled trial.
Setting: Twenty-three centers in Canada, France and Switzerland.
Synopsis: A total of 259 outpatients with a first acute symptomatic objectively confirmed isolated calf DVT were enrolled to receive either a therapeutic dose of the low-molecular weight heparin nadroparin (122 patients), or a placebo (130 patients).
The primary efficacy outcome (a composite endpoint of extension of calf DVT to proximal veins, contralateral proximal DVT and symptomatic pulmonary embolism) was not statistically significant between the two groups (3% in the nadroparin group and 5% in the placebo group, P = .54). The primary safety outcome (the number of patients with major or clinically relevant non-major bleeding) was significantly higher in the nadroparin group (4% in nadroparin group, 0 patients in the placebo group, P = .0255).
The study was limited by the relative low number of patients (goal was 286 patients). The results of the study do not apply to inpatients and to cancer patients as patients with high risk for extension or recurrence of their DVT were excluded.
Bottom line: Therapeutic anticoagulation in low-risk outpatients with isolated calf DVT will likely cause more harm from bleeding than benefit.
Citation: Righini M, Galanaud J, Guenneguez H, et al. Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): A randomised, double-blind, placebo-controlled trial. The Lancet Haematology. 2016;3(12):e556-e562. doi: 10.1016/S2352-3026(16)30131-4.
Dr. Badr is a hospitalist at Cooper University Hospital in Camden, N.J., and an assistant professor of clinical medicine at the Cooper Medical School of Rowan University.
The cost of misdiagnosing cellulitis
Clinical question: What are the national health care costs of misdiagnosing cellulitis?
Background: Lower extremity cellulitis is primarily a clinical diagnosis but many mimickers such as venous stasis, lymphedema, gout, deep venous thrombosis, and contact dermatitis can lead to a misdiagnosis rate of 30%-90%. Between 14% and 17% of emergency department patients with cellulitis are admitted, accounting for 10% of all infectious disease-related hospitalizations. Overdiagnosis leads to antibiotic misuse and increased hospital utilization.
Study design: Retrospective cross-sectional study.
Setting: Emergency department of Massachusetts General Hospital.
Synopsis: Among 259 ED patients identified from all screened (840 patients total) from June 2010 to December 2012, 79 (30.5%) were incorrectly diagnosed with lower extremity cellulitis and 52 of these misdiagnosed patients were admitted primarily for their cellulitis, resulting in 92.3% of this group receiving unnecessary antibiotics and 84.6% unnecessarily hospitalized.
The authors used cost estimates and previously published data from the Medical Expenditure Panel Survey (MEPS) provided by the Agency for Healthcare Research and Quality (AHRQ) 2010 to project that cellulitis misdiagnosis leads to 50,000-130,000 unnecessary hospitalizations and $195-$515 million in avoidable health care expense annually. The estimates include over 44,000 pseudocellulitis patients being exposed to antibiotics annually with an associated 13% readmission rate and medication complications such as rash and gastrointestinal side effects and implications for resistance selection and antimicrobial stewardship efforts. Nationally, the unnecessary antibiotics and hospitalization associated with misdiagnosis were estimated to cause more than 9,000 nosocomial infections, 1,000 to 5,000 Clostridium difficile infections, and two to six cases of anaphylaxis annually.
Bottom line: Misdiagnosis of lower extremity cellulitis is common and leads to unnecessary patient exposures (antibiotics, hospitalization) and excessive health care spending.
Citations: Weng QY, Raff AB, Cohen JM, et al. Costs and consequences associated with misdiagnosed lower extremity cellulitis. JAMA Dermatol. 2016; doi: 10.1001/jamadermatol.2016.3816.
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: What are the national health care costs of misdiagnosing cellulitis?
Background: Lower extremity cellulitis is primarily a clinical diagnosis but many mimickers such as venous stasis, lymphedema, gout, deep venous thrombosis, and contact dermatitis can lead to a misdiagnosis rate of 30%-90%. Between 14% and 17% of emergency department patients with cellulitis are admitted, accounting for 10% of all infectious disease-related hospitalizations. Overdiagnosis leads to antibiotic misuse and increased hospital utilization.
Study design: Retrospective cross-sectional study.
Setting: Emergency department of Massachusetts General Hospital.
Synopsis: Among 259 ED patients identified from all screened (840 patients total) from June 2010 to December 2012, 79 (30.5%) were incorrectly diagnosed with lower extremity cellulitis and 52 of these misdiagnosed patients were admitted primarily for their cellulitis, resulting in 92.3% of this group receiving unnecessary antibiotics and 84.6% unnecessarily hospitalized.
The authors used cost estimates and previously published data from the Medical Expenditure Panel Survey (MEPS) provided by the Agency for Healthcare Research and Quality (AHRQ) 2010 to project that cellulitis misdiagnosis leads to 50,000-130,000 unnecessary hospitalizations and $195-$515 million in avoidable health care expense annually. The estimates include over 44,000 pseudocellulitis patients being exposed to antibiotics annually with an associated 13% readmission rate and medication complications such as rash and gastrointestinal side effects and implications for resistance selection and antimicrobial stewardship efforts. Nationally, the unnecessary antibiotics and hospitalization associated with misdiagnosis were estimated to cause more than 9,000 nosocomial infections, 1,000 to 5,000 Clostridium difficile infections, and two to six cases of anaphylaxis annually.
Bottom line: Misdiagnosis of lower extremity cellulitis is common and leads to unnecessary patient exposures (antibiotics, hospitalization) and excessive health care spending.
Citations: Weng QY, Raff AB, Cohen JM, et al. Costs and consequences associated with misdiagnosed lower extremity cellulitis. JAMA Dermatol. 2016; doi: 10.1001/jamadermatol.2016.3816.
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: What are the national health care costs of misdiagnosing cellulitis?
Background: Lower extremity cellulitis is primarily a clinical diagnosis but many mimickers such as venous stasis, lymphedema, gout, deep venous thrombosis, and contact dermatitis can lead to a misdiagnosis rate of 30%-90%. Between 14% and 17% of emergency department patients with cellulitis are admitted, accounting for 10% of all infectious disease-related hospitalizations. Overdiagnosis leads to antibiotic misuse and increased hospital utilization.
Study design: Retrospective cross-sectional study.
Setting: Emergency department of Massachusetts General Hospital.
Synopsis: Among 259 ED patients identified from all screened (840 patients total) from June 2010 to December 2012, 79 (30.5%) were incorrectly diagnosed with lower extremity cellulitis and 52 of these misdiagnosed patients were admitted primarily for their cellulitis, resulting in 92.3% of this group receiving unnecessary antibiotics and 84.6% unnecessarily hospitalized.
The authors used cost estimates and previously published data from the Medical Expenditure Panel Survey (MEPS) provided by the Agency for Healthcare Research and Quality (AHRQ) 2010 to project that cellulitis misdiagnosis leads to 50,000-130,000 unnecessary hospitalizations and $195-$515 million in avoidable health care expense annually. The estimates include over 44,000 pseudocellulitis patients being exposed to antibiotics annually with an associated 13% readmission rate and medication complications such as rash and gastrointestinal side effects and implications for resistance selection and antimicrobial stewardship efforts. Nationally, the unnecessary antibiotics and hospitalization associated with misdiagnosis were estimated to cause more than 9,000 nosocomial infections, 1,000 to 5,000 Clostridium difficile infections, and two to six cases of anaphylaxis annually.
Bottom line: Misdiagnosis of lower extremity cellulitis is common and leads to unnecessary patient exposures (antibiotics, hospitalization) and excessive health care spending.
Citations: Weng QY, Raff AB, Cohen JM, et al. Costs and consequences associated with misdiagnosed lower extremity cellulitis. JAMA Dermatol. 2016; doi: 10.1001/jamadermatol.2016.3816.
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
New CF guidelines include lower sweat chloride threshold
Updated guidelines for the diagnosis and treatment of cystic fibrosis (CF) include two major changes.
The first important update is that clinicians use the latest classifications of the specific CF transmembrane conductance regulator (CFTR) gene mutations, from the Clinical and Functional TRanslation of CFTR (CFTR2) database, to aid with making a CF diagnosis in any patient, newborn to adult. The other of these changes relates to the chloride concentration level used to confirm CF diagnosis through a sweat test. Under the new guidelines, the sweat chloride threshold for “possible” CF or a CF-related disease was reduced to 30 mmol/L of chloride concentration from 40 mmol/L across all ages. The guidelines, written by an international team of collaborators and published by the Cystic Fibrosis Foundation, are available online in the Journal of Pediatrics (J Pediatr 2017 Feb;181(suppl):S4-S15.e1. doi: 10.1016/j.jpeds.2016.09.064).
Since its inception in 2008, the CFTR2 project has described 300 of the 2,000 known CF-related mutations and their various functional and clinical impacts. The project involves amassing phenotypic and genotypic information from patient registries to collect, quantify, and describe mutations reported in individuals with CF. Such mutations are categorized as CF-causing, carrying a variety of potential clinical consequences, non–cystic fibrosis causing, or unknown. The previous guidelines, written in 2008, relied on a 23-mutation panel from the American College of Medical Genetics and Genomics and the American Congress of Obstetricians and Gynecologists.
“We’ve more precisely defined what cystic fibrosis is,” Patrick R. Sosnay, MD, assistant professor of medicine at Johns Hopkins University, Baltimore, and coauthor of the guidelines, said in a statement. “The stakes in categorizing a mutation are particularly high. For example, claiming that a mutation 100% causes cystic fibrosis may affect people’s reproductive decisions if they believe their child will have the mutation.”
In the CFTR2 project, the “disease-liability” of each mutation is evaluated through a combination of sweat chloride and functional activity identified in cell-based systems, according to a supplement published simultaneously with the updated guidelines (J Pediatr 2017 Feb;181(suppl):S52-S57.e2. doi: 10.1016/j.jpeds.2016.09.068). Data from this project led to the discovery of a cohort of 746 persons diagnosed with CF despite sweat chloride levels less than 60 mmol/L. These findings were the basis for the guideline authors’ decision to lower the threshold of chloride concentration in sweat in order for an individual to be considered having a possible CF diagnosis, according to the supplement.
The guidelines include 27 approved consensus statements spanning four overlapping categories, and applying to screened and nonscreened populations; newborn screened populations and fetuses undergoing prenatal testing; infants with an uncertain diagnosis and designated as having either CFTR gene-related metabolic syndrome or being CF-screen positive, inconclusive diagnosis; and nonscreened patients who present with symptoms, including children before newborn screening implementation, those with false negative tests and older, nonscreened patients.
Although not specified in the consensus statements, the authors of a second supplement published simultaneously with the updated guidelines (J Pediatr 2017;181(suppl):S27-S32.e1. doi: 10.1016/j.jpeds.2016.09.063), wrote that they supported genotyping all individuals diagnosed with CF, even if physiologic tests establish the diagnosis, to better understand the disease’s genetic epidemiology and to refine future therapies. “If the identified mutations are known to be associated with variable outcomes, or have unknown consequence, that genotype may not result in a CF phenotype. In these cases, other tests of CFTR function may help,” this supplement’s authors concluded.
The updated guideline authors recommend avoiding the use of terms such as “atypical” or “nonclassical” CF, as there is no consensus on the specific taxonomy of CF, since the genetic data are still emerging.
When administering a newborn test, the guidelines warn that the heterogenous nature of newborn screening often leads to false positive results, thus the need for the sweat test. Although obtaining an adequate sweat specimen for chloride measurements can be difficult, the authors say it is possible, especially in full-term infants aged 1 month. Repeat sweat testing is recommended, as is nasal potential difference (NPD) and intestinal current measurement (ICM) in some cases.
Another change to the guidelines is that newborns with a high immunoreactive trypsinogen level and inconclusive CFTR functional and genetic testing may now be designated as having CFTR-related metabolic syndrome/CF screen positive inconclusive diagnosis (CRMS/CFSPID), instead of CFTR-related metabolic syndrome or CF screen positive, inconclusive diagnosis. Regarding changes to screening for CRMS/CFSPID, the older guidelines called for such an assessment by age 2 months, repeated every 6-12 months, while the new guidelines say their recommendation on the duration and frequency of follow-up “remains to be determined.”
The authors of the first supplement decry the lack of standardized CF diagnostic criteria for those diagnosed with CF outside of the neonatal period, and urge clinicians to rely on clinical evidence including organ pathologies typical in CF, such as bronchiectasis or pancreatic insufficiency, along with testing for the presence of CFTR dysfunction with sweat chloride testing, CFTR molecular genetic analysis, or CFTR physiologic tests.
In contrast, the second supplement states that “clinical suspicion should always take precedence” in making a CF diagnoses for individuals in this age group.
Dr. Sosnay and Philip M. Farrell, MD, PhD, a coauthor of the guidelines, received funds from the Cystic Fibrosis Foundation, where guideline coauthor Terry B. White, PhD, is an employee. Kris De Boeck, MD, a coauthor of the first supplement, receives funding from Vertex Pharmaceuticals, Ablynx, Aptalis, Galapagos, Gilead, Pharmaxis, and PTC Therapeutics. The guideline and supplements’ other authors have no disclosures.
[email protected]
On Twitter @whitneymcknight
Susan Millard, MD, FCCP, comments: A comprehensive supplement in the Journal of Pediatrics entitled, “Introduction to ‘Cystic Fibrosis Foundation Consensus Guidelines for Diagnosis of Cystic Fibrosis,’ ” reflects information introduced at the North American Cystic Fibrosis Conference in the fall 2016 (J Pediatr.2017 Feb;181[suppl]:S1-3. doi:10.1016/jpeds.2016.09.062).
Susan Millard, MD, FCCP, comments: A comprehensive supplement in the Journal of Pediatrics entitled, “Introduction to ‘Cystic Fibrosis Foundation Consensus Guidelines for Diagnosis of Cystic Fibrosis,’ ” reflects information introduced at the North American Cystic Fibrosis Conference in the fall 2016 (J Pediatr.2017 Feb;181[suppl]:S1-3. doi:10.1016/jpeds.2016.09.062).
Susan Millard, MD, FCCP, comments: A comprehensive supplement in the Journal of Pediatrics entitled, “Introduction to ‘Cystic Fibrosis Foundation Consensus Guidelines for Diagnosis of Cystic Fibrosis,’ ” reflects information introduced at the North American Cystic Fibrosis Conference in the fall 2016 (J Pediatr.2017 Feb;181[suppl]:S1-3. doi:10.1016/jpeds.2016.09.062).
Updated guidelines for the diagnosis and treatment of cystic fibrosis (CF) include two major changes.
The first important update is that clinicians use the latest classifications of the specific CF transmembrane conductance regulator (CFTR) gene mutations, from the Clinical and Functional TRanslation of CFTR (CFTR2) database, to aid with making a CF diagnosis in any patient, newborn to adult. The other of these changes relates to the chloride concentration level used to confirm CF diagnosis through a sweat test. Under the new guidelines, the sweat chloride threshold for “possible” CF or a CF-related disease was reduced to 30 mmol/L of chloride concentration from 40 mmol/L across all ages. The guidelines, written by an international team of collaborators and published by the Cystic Fibrosis Foundation, are available online in the Journal of Pediatrics (J Pediatr 2017 Feb;181(suppl):S4-S15.e1. doi: 10.1016/j.jpeds.2016.09.064).
Since its inception in 2008, the CFTR2 project has described 300 of the 2,000 known CF-related mutations and their various functional and clinical impacts. The project involves amassing phenotypic and genotypic information from patient registries to collect, quantify, and describe mutations reported in individuals with CF. Such mutations are categorized as CF-causing, carrying a variety of potential clinical consequences, non–cystic fibrosis causing, or unknown. The previous guidelines, written in 2008, relied on a 23-mutation panel from the American College of Medical Genetics and Genomics and the American Congress of Obstetricians and Gynecologists.
“We’ve more precisely defined what cystic fibrosis is,” Patrick R. Sosnay, MD, assistant professor of medicine at Johns Hopkins University, Baltimore, and coauthor of the guidelines, said in a statement. “The stakes in categorizing a mutation are particularly high. For example, claiming that a mutation 100% causes cystic fibrosis may affect people’s reproductive decisions if they believe their child will have the mutation.”
In the CFTR2 project, the “disease-liability” of each mutation is evaluated through a combination of sweat chloride and functional activity identified in cell-based systems, according to a supplement published simultaneously with the updated guidelines (J Pediatr 2017 Feb;181(suppl):S52-S57.e2. doi: 10.1016/j.jpeds.2016.09.068). Data from this project led to the discovery of a cohort of 746 persons diagnosed with CF despite sweat chloride levels less than 60 mmol/L. These findings were the basis for the guideline authors’ decision to lower the threshold of chloride concentration in sweat in order for an individual to be considered having a possible CF diagnosis, according to the supplement.
The guidelines include 27 approved consensus statements spanning four overlapping categories, and applying to screened and nonscreened populations; newborn screened populations and fetuses undergoing prenatal testing; infants with an uncertain diagnosis and designated as having either CFTR gene-related metabolic syndrome or being CF-screen positive, inconclusive diagnosis; and nonscreened patients who present with symptoms, including children before newborn screening implementation, those with false negative tests and older, nonscreened patients.
Although not specified in the consensus statements, the authors of a second supplement published simultaneously with the updated guidelines (J Pediatr 2017;181(suppl):S27-S32.e1. doi: 10.1016/j.jpeds.2016.09.063), wrote that they supported genotyping all individuals diagnosed with CF, even if physiologic tests establish the diagnosis, to better understand the disease’s genetic epidemiology and to refine future therapies. “If the identified mutations are known to be associated with variable outcomes, or have unknown consequence, that genotype may not result in a CF phenotype. In these cases, other tests of CFTR function may help,” this supplement’s authors concluded.
The updated guideline authors recommend avoiding the use of terms such as “atypical” or “nonclassical” CF, as there is no consensus on the specific taxonomy of CF, since the genetic data are still emerging.
When administering a newborn test, the guidelines warn that the heterogenous nature of newborn screening often leads to false positive results, thus the need for the sweat test. Although obtaining an adequate sweat specimen for chloride measurements can be difficult, the authors say it is possible, especially in full-term infants aged 1 month. Repeat sweat testing is recommended, as is nasal potential difference (NPD) and intestinal current measurement (ICM) in some cases.
Another change to the guidelines is that newborns with a high immunoreactive trypsinogen level and inconclusive CFTR functional and genetic testing may now be designated as having CFTR-related metabolic syndrome/CF screen positive inconclusive diagnosis (CRMS/CFSPID), instead of CFTR-related metabolic syndrome or CF screen positive, inconclusive diagnosis. Regarding changes to screening for CRMS/CFSPID, the older guidelines called for such an assessment by age 2 months, repeated every 6-12 months, while the new guidelines say their recommendation on the duration and frequency of follow-up “remains to be determined.”
The authors of the first supplement decry the lack of standardized CF diagnostic criteria for those diagnosed with CF outside of the neonatal period, and urge clinicians to rely on clinical evidence including organ pathologies typical in CF, such as bronchiectasis or pancreatic insufficiency, along with testing for the presence of CFTR dysfunction with sweat chloride testing, CFTR molecular genetic analysis, or CFTR physiologic tests.
In contrast, the second supplement states that “clinical suspicion should always take precedence” in making a CF diagnoses for individuals in this age group.
Dr. Sosnay and Philip M. Farrell, MD, PhD, a coauthor of the guidelines, received funds from the Cystic Fibrosis Foundation, where guideline coauthor Terry B. White, PhD, is an employee. Kris De Boeck, MD, a coauthor of the first supplement, receives funding from Vertex Pharmaceuticals, Ablynx, Aptalis, Galapagos, Gilead, Pharmaxis, and PTC Therapeutics. The guideline and supplements’ other authors have no disclosures.
[email protected]
On Twitter @whitneymcknight
Updated guidelines for the diagnosis and treatment of cystic fibrosis (CF) include two major changes.
The first important update is that clinicians use the latest classifications of the specific CF transmembrane conductance regulator (CFTR) gene mutations, from the Clinical and Functional TRanslation of CFTR (CFTR2) database, to aid with making a CF diagnosis in any patient, newborn to adult. The other of these changes relates to the chloride concentration level used to confirm CF diagnosis through a sweat test. Under the new guidelines, the sweat chloride threshold for “possible” CF or a CF-related disease was reduced to 30 mmol/L of chloride concentration from 40 mmol/L across all ages. The guidelines, written by an international team of collaborators and published by the Cystic Fibrosis Foundation, are available online in the Journal of Pediatrics (J Pediatr 2017 Feb;181(suppl):S4-S15.e1. doi: 10.1016/j.jpeds.2016.09.064).
Since its inception in 2008, the CFTR2 project has described 300 of the 2,000 known CF-related mutations and their various functional and clinical impacts. The project involves amassing phenotypic and genotypic information from patient registries to collect, quantify, and describe mutations reported in individuals with CF. Such mutations are categorized as CF-causing, carrying a variety of potential clinical consequences, non–cystic fibrosis causing, or unknown. The previous guidelines, written in 2008, relied on a 23-mutation panel from the American College of Medical Genetics and Genomics and the American Congress of Obstetricians and Gynecologists.
“We’ve more precisely defined what cystic fibrosis is,” Patrick R. Sosnay, MD, assistant professor of medicine at Johns Hopkins University, Baltimore, and coauthor of the guidelines, said in a statement. “The stakes in categorizing a mutation are particularly high. For example, claiming that a mutation 100% causes cystic fibrosis may affect people’s reproductive decisions if they believe their child will have the mutation.”
In the CFTR2 project, the “disease-liability” of each mutation is evaluated through a combination of sweat chloride and functional activity identified in cell-based systems, according to a supplement published simultaneously with the updated guidelines (J Pediatr 2017 Feb;181(suppl):S52-S57.e2. doi: 10.1016/j.jpeds.2016.09.068). Data from this project led to the discovery of a cohort of 746 persons diagnosed with CF despite sweat chloride levels less than 60 mmol/L. These findings were the basis for the guideline authors’ decision to lower the threshold of chloride concentration in sweat in order for an individual to be considered having a possible CF diagnosis, according to the supplement.
The guidelines include 27 approved consensus statements spanning four overlapping categories, and applying to screened and nonscreened populations; newborn screened populations and fetuses undergoing prenatal testing; infants with an uncertain diagnosis and designated as having either CFTR gene-related metabolic syndrome or being CF-screen positive, inconclusive diagnosis; and nonscreened patients who present with symptoms, including children before newborn screening implementation, those with false negative tests and older, nonscreened patients.
Although not specified in the consensus statements, the authors of a second supplement published simultaneously with the updated guidelines (J Pediatr 2017;181(suppl):S27-S32.e1. doi: 10.1016/j.jpeds.2016.09.063), wrote that they supported genotyping all individuals diagnosed with CF, even if physiologic tests establish the diagnosis, to better understand the disease’s genetic epidemiology and to refine future therapies. “If the identified mutations are known to be associated with variable outcomes, or have unknown consequence, that genotype may not result in a CF phenotype. In these cases, other tests of CFTR function may help,” this supplement’s authors concluded.
The updated guideline authors recommend avoiding the use of terms such as “atypical” or “nonclassical” CF, as there is no consensus on the specific taxonomy of CF, since the genetic data are still emerging.
When administering a newborn test, the guidelines warn that the heterogenous nature of newborn screening often leads to false positive results, thus the need for the sweat test. Although obtaining an adequate sweat specimen for chloride measurements can be difficult, the authors say it is possible, especially in full-term infants aged 1 month. Repeat sweat testing is recommended, as is nasal potential difference (NPD) and intestinal current measurement (ICM) in some cases.
Another change to the guidelines is that newborns with a high immunoreactive trypsinogen level and inconclusive CFTR functional and genetic testing may now be designated as having CFTR-related metabolic syndrome/CF screen positive inconclusive diagnosis (CRMS/CFSPID), instead of CFTR-related metabolic syndrome or CF screen positive, inconclusive diagnosis. Regarding changes to screening for CRMS/CFSPID, the older guidelines called for such an assessment by age 2 months, repeated every 6-12 months, while the new guidelines say their recommendation on the duration and frequency of follow-up “remains to be determined.”
The authors of the first supplement decry the lack of standardized CF diagnostic criteria for those diagnosed with CF outside of the neonatal period, and urge clinicians to rely on clinical evidence including organ pathologies typical in CF, such as bronchiectasis or pancreatic insufficiency, along with testing for the presence of CFTR dysfunction with sweat chloride testing, CFTR molecular genetic analysis, or CFTR physiologic tests.
In contrast, the second supplement states that “clinical suspicion should always take precedence” in making a CF diagnoses for individuals in this age group.
Dr. Sosnay and Philip M. Farrell, MD, PhD, a coauthor of the guidelines, received funds from the Cystic Fibrosis Foundation, where guideline coauthor Terry B. White, PhD, is an employee. Kris De Boeck, MD, a coauthor of the first supplement, receives funding from Vertex Pharmaceuticals, Ablynx, Aptalis, Galapagos, Gilead, Pharmaxis, and PTC Therapeutics. The guideline and supplements’ other authors have no disclosures.
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FROM JOURNAL OF PEDIATRICS