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Thrombectomy Within Eight Hours of Stroke Onset Reduces Post-Stroke Disability
Clinical question: Does thrombectomy, in conjunction with medical therapy, improve functional independence in patients with an acute proximal anterior stroke?
Background: Revascularization of proximal anterior strokes with alteplase alone occurs less than 50% of the time. First-generation thrombectomy devices (i.e., Merci and Penumbra) have not shown improvement in revascularization or functional outcomes; however, the development of thrombectomy stent retriever devices has led to more promising results, with several recent studies demonstrating functional improvement using endovascular retrieval in addition to medical therapy in proximal anterior circulation strokes.
Study design: Prospective, multicenter, randomized, sequential, open-label, phase 3 study with blinded evaluation.
Setting: Four hospitals in Spain.
Synopsis: Approximately 200 patients who were diagnosed within eight hours of onset of a large vessel anterior stroke were randomly assigned to medical therapy (alteplase) plus endovascular treatment versus medical therapy alone. In order to reduce selection bias, the study was conducted within a population-based registry of acute stroke patients from the same area. The major exclusion criterion was evidence of a large infarct on imaging. The primary outcome was severity of disability at 90 days based on the modified Rankin score.
Study results showed a significant improvement in functional status in the thrombectomy group, with 66% of patients demonstrating revascularization. The rate of death and intracranial hemorrhage was similar between both groups.
The trial stopped recruitment after the first interim analysis given lack of equipoise, with emerging literature supporting endovascular therapy.
Bottom line: Thrombectomy performed in proximal, large vessel anterior circulation strokes within eight hours of onset of symptoms improves functional status at 90 days.
Citation: Jovin TG, Chamorro A, Cobo E, et al. Thrombectomy within 8 hours after symptoms onset in ischemic stroke. New Engl J Med. 2015;372(24):2296-2306.
Clinical question: Does thrombectomy, in conjunction with medical therapy, improve functional independence in patients with an acute proximal anterior stroke?
Background: Revascularization of proximal anterior strokes with alteplase alone occurs less than 50% of the time. First-generation thrombectomy devices (i.e., Merci and Penumbra) have not shown improvement in revascularization or functional outcomes; however, the development of thrombectomy stent retriever devices has led to more promising results, with several recent studies demonstrating functional improvement using endovascular retrieval in addition to medical therapy in proximal anterior circulation strokes.
Study design: Prospective, multicenter, randomized, sequential, open-label, phase 3 study with blinded evaluation.
Setting: Four hospitals in Spain.
Synopsis: Approximately 200 patients who were diagnosed within eight hours of onset of a large vessel anterior stroke were randomly assigned to medical therapy (alteplase) plus endovascular treatment versus medical therapy alone. In order to reduce selection bias, the study was conducted within a population-based registry of acute stroke patients from the same area. The major exclusion criterion was evidence of a large infarct on imaging. The primary outcome was severity of disability at 90 days based on the modified Rankin score.
Study results showed a significant improvement in functional status in the thrombectomy group, with 66% of patients demonstrating revascularization. The rate of death and intracranial hemorrhage was similar between both groups.
The trial stopped recruitment after the first interim analysis given lack of equipoise, with emerging literature supporting endovascular therapy.
Bottom line: Thrombectomy performed in proximal, large vessel anterior circulation strokes within eight hours of onset of symptoms improves functional status at 90 days.
Citation: Jovin TG, Chamorro A, Cobo E, et al. Thrombectomy within 8 hours after symptoms onset in ischemic stroke. New Engl J Med. 2015;372(24):2296-2306.
Clinical question: Does thrombectomy, in conjunction with medical therapy, improve functional independence in patients with an acute proximal anterior stroke?
Background: Revascularization of proximal anterior strokes with alteplase alone occurs less than 50% of the time. First-generation thrombectomy devices (i.e., Merci and Penumbra) have not shown improvement in revascularization or functional outcomes; however, the development of thrombectomy stent retriever devices has led to more promising results, with several recent studies demonstrating functional improvement using endovascular retrieval in addition to medical therapy in proximal anterior circulation strokes.
Study design: Prospective, multicenter, randomized, sequential, open-label, phase 3 study with blinded evaluation.
Setting: Four hospitals in Spain.
Synopsis: Approximately 200 patients who were diagnosed within eight hours of onset of a large vessel anterior stroke were randomly assigned to medical therapy (alteplase) plus endovascular treatment versus medical therapy alone. In order to reduce selection bias, the study was conducted within a population-based registry of acute stroke patients from the same area. The major exclusion criterion was evidence of a large infarct on imaging. The primary outcome was severity of disability at 90 days based on the modified Rankin score.
Study results showed a significant improvement in functional status in the thrombectomy group, with 66% of patients demonstrating revascularization. The rate of death and intracranial hemorrhage was similar between both groups.
The trial stopped recruitment after the first interim analysis given lack of equipoise, with emerging literature supporting endovascular therapy.
Bottom line: Thrombectomy performed in proximal, large vessel anterior circulation strokes within eight hours of onset of symptoms improves functional status at 90 days.
Citation: Jovin TG, Chamorro A, Cobo E, et al. Thrombectomy within 8 hours after symptoms onset in ischemic stroke. New Engl J Med. 2015;372(24):2296-2306.
Interdisciplinary Team Care on General Medical Units Does Not Improve Patient Outcomes
Clinical question: Does interdisciplinary care on general medical wards improve patient outcomes?
Background: Patients on general medical wards might experience errors and/or preventable deaths. One mechanism that could reduce the risk of errors or preventable death is the utilization of interdisciplinary team care.
Study design: Systematic review.
Setting: Studies published in English from 1998 through 2013 in Embase, MEDLINE, and PsycINFO.
Synopsis: Reports of interdisciplinary team care interventions on general medical wards in which the care was evaluated against an objective patient outcome were reviewed. Outcomes were grouped into early (less than 30 days) or late (30 days to 12 months). Thirty studies of more than 66,000 total patients were included; these were composed of RCTs, nonrandomized cluster trials, and controlled before-after studies.
Interventions either altered the composition of the care team or addressed the logistics of team practice. Studies evaluated complications of care, length of stay, readmissions, and mortality. Although some evidence showed interdisciplinary care reduces complications, the majority of studies did not show significant improvements in any other outcomes.
Bottom line: In a systematic review, interdisciplinary team care in general medical wards is not associated with reduced complications, length of stay, readmissions, or mortality.
Citation: Pannick S, Davis R, Ashrafian H, et al. Effects of interdisciplinary team care interventions on general medical wards: a systematic review. JAMA Intern Med. 2015;175(8):1288-1298.
Clinical question: Does interdisciplinary care on general medical wards improve patient outcomes?
Background: Patients on general medical wards might experience errors and/or preventable deaths. One mechanism that could reduce the risk of errors or preventable death is the utilization of interdisciplinary team care.
Study design: Systematic review.
Setting: Studies published in English from 1998 through 2013 in Embase, MEDLINE, and PsycINFO.
Synopsis: Reports of interdisciplinary team care interventions on general medical wards in which the care was evaluated against an objective patient outcome were reviewed. Outcomes were grouped into early (less than 30 days) or late (30 days to 12 months). Thirty studies of more than 66,000 total patients were included; these were composed of RCTs, nonrandomized cluster trials, and controlled before-after studies.
Interventions either altered the composition of the care team or addressed the logistics of team practice. Studies evaluated complications of care, length of stay, readmissions, and mortality. Although some evidence showed interdisciplinary care reduces complications, the majority of studies did not show significant improvements in any other outcomes.
Bottom line: In a systematic review, interdisciplinary team care in general medical wards is not associated with reduced complications, length of stay, readmissions, or mortality.
Citation: Pannick S, Davis R, Ashrafian H, et al. Effects of interdisciplinary team care interventions on general medical wards: a systematic review. JAMA Intern Med. 2015;175(8):1288-1298.
Clinical question: Does interdisciplinary care on general medical wards improve patient outcomes?
Background: Patients on general medical wards might experience errors and/or preventable deaths. One mechanism that could reduce the risk of errors or preventable death is the utilization of interdisciplinary team care.
Study design: Systematic review.
Setting: Studies published in English from 1998 through 2013 in Embase, MEDLINE, and PsycINFO.
Synopsis: Reports of interdisciplinary team care interventions on general medical wards in which the care was evaluated against an objective patient outcome were reviewed. Outcomes were grouped into early (less than 30 days) or late (30 days to 12 months). Thirty studies of more than 66,000 total patients were included; these were composed of RCTs, nonrandomized cluster trials, and controlled before-after studies.
Interventions either altered the composition of the care team or addressed the logistics of team practice. Studies evaluated complications of care, length of stay, readmissions, and mortality. Although some evidence showed interdisciplinary care reduces complications, the majority of studies did not show significant improvements in any other outcomes.
Bottom line: In a systematic review, interdisciplinary team care in general medical wards is not associated with reduced complications, length of stay, readmissions, or mortality.
Citation: Pannick S, Davis R, Ashrafian H, et al. Effects of interdisciplinary team care interventions on general medical wards: a systematic review. JAMA Intern Med. 2015;175(8):1288-1298.
Patient Satisfaction Scores, Objective Measures of Surgical Quality Have Positive Association
Clinical question: Is there an association between objective measures of surgical quality and patient satisfaction as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey?
Background: The Centers for Medicare and Medicaid Services (CMS) has tied financial reimbursement to patient satisfaction scores. It is unknown whether high-quality surgery correlates with higher patient satisfaction scores.
Study design: Retrospective, observational study.
Setting: One hundred eighty hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP).
Synopsis: The study included 103,866 Medicare patients 65 and older who had surgery at a participating ACS NSQIP hospital between 2004-2008. Data regarding these patients were collected from a linked database (including Medicare inpatient claims, ACS NSQIP, the American Hospital Association annual survey, and Hospital Compare). Analysis of five 30-day outcomes was performed in order to assess surgical quality:
- Post-operative mortality;
- Major complication;
- Minor complication;
- Death following a complication; and
- Readmission.
Participating hospitals were grouped into quartiles based upon their performance on the HCAHPS survey.
Hospitals that performed in the highest quartile on the HCAHPS survey had significantly lower 30-day mortality, death following complications, and minor complications. No differences were detected in hospital readmissions or major complications based on patient satisfaction.
The results of this study may not be generalizable to all hospitals given the fact that the dataset is from Medicare patients only and participation in the ACS NSQIP is voluntary.
Bottom line: Using data from a national database, researchers found a positive association between patient satisfaction scores and objective measures of surgical quality.
Citation: Sacks GD, Lawson EH, Dawes AJ, et al. Relationship between hospital performance on a patient satisfaction survey and surgical quality [published online ahead of print June 24, 2015]. JAMA Surg. doi:10.1001/jamasurg.2015.1108.
Clinical question: Is there an association between objective measures of surgical quality and patient satisfaction as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey?
Background: The Centers for Medicare and Medicaid Services (CMS) has tied financial reimbursement to patient satisfaction scores. It is unknown whether high-quality surgery correlates with higher patient satisfaction scores.
Study design: Retrospective, observational study.
Setting: One hundred eighty hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP).
Synopsis: The study included 103,866 Medicare patients 65 and older who had surgery at a participating ACS NSQIP hospital between 2004-2008. Data regarding these patients were collected from a linked database (including Medicare inpatient claims, ACS NSQIP, the American Hospital Association annual survey, and Hospital Compare). Analysis of five 30-day outcomes was performed in order to assess surgical quality:
- Post-operative mortality;
- Major complication;
- Minor complication;
- Death following a complication; and
- Readmission.
Participating hospitals were grouped into quartiles based upon their performance on the HCAHPS survey.
Hospitals that performed in the highest quartile on the HCAHPS survey had significantly lower 30-day mortality, death following complications, and minor complications. No differences were detected in hospital readmissions or major complications based on patient satisfaction.
The results of this study may not be generalizable to all hospitals given the fact that the dataset is from Medicare patients only and participation in the ACS NSQIP is voluntary.
Bottom line: Using data from a national database, researchers found a positive association between patient satisfaction scores and objective measures of surgical quality.
Citation: Sacks GD, Lawson EH, Dawes AJ, et al. Relationship between hospital performance on a patient satisfaction survey and surgical quality [published online ahead of print June 24, 2015]. JAMA Surg. doi:10.1001/jamasurg.2015.1108.
Clinical question: Is there an association between objective measures of surgical quality and patient satisfaction as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey?
Background: The Centers for Medicare and Medicaid Services (CMS) has tied financial reimbursement to patient satisfaction scores. It is unknown whether high-quality surgery correlates with higher patient satisfaction scores.
Study design: Retrospective, observational study.
Setting: One hundred eighty hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP).
Synopsis: The study included 103,866 Medicare patients 65 and older who had surgery at a participating ACS NSQIP hospital between 2004-2008. Data regarding these patients were collected from a linked database (including Medicare inpatient claims, ACS NSQIP, the American Hospital Association annual survey, and Hospital Compare). Analysis of five 30-day outcomes was performed in order to assess surgical quality:
- Post-operative mortality;
- Major complication;
- Minor complication;
- Death following a complication; and
- Readmission.
Participating hospitals were grouped into quartiles based upon their performance on the HCAHPS survey.
Hospitals that performed in the highest quartile on the HCAHPS survey had significantly lower 30-day mortality, death following complications, and minor complications. No differences were detected in hospital readmissions or major complications based on patient satisfaction.
The results of this study may not be generalizable to all hospitals given the fact that the dataset is from Medicare patients only and participation in the ACS NSQIP is voluntary.
Bottom line: Using data from a national database, researchers found a positive association between patient satisfaction scores and objective measures of surgical quality.
Citation: Sacks GD, Lawson EH, Dawes AJ, et al. Relationship between hospital performance on a patient satisfaction survey and surgical quality [published online ahead of print June 24, 2015]. JAMA Surg. doi:10.1001/jamasurg.2015.1108.
Extended Anticoagulation Therapy and Recurrent Rates of Venous Thromboembolism
Clinical question: Among patients with a first episode of unprovoked pulmonary embolism (PE), what are the benefits and harms of extending the duration of anticoagulation for secondary prophylaxis against recurrent VTE?
Background: Optimal duration of anticoagulation after initial unprovoked PE is not known. Prior studies demonstrated risk reduction of recurrent VTE while on therapy but have had inadequate long-term monitoring of patients or enrollment of patients with PE, who are known to have a higher case-fatality rate of recurrent VTE than patients with DVT.
Study design: Multicenter, randomized, double-blinded, parallel-grouped, placebo-controlled trial.
Setting: Fourteen French hospitals from 2007 to 2012.
Synopsis: Investigators randomized 371 patients with a first episode of symptomatic unprovoked PE who had completed six months of warfarin to 18 additional months of warfarin or placebo. Patients were followed for 24 months after discontinuation of therapy.
During the treatment period, the primary outcome (composite of recurrent VTE and major bleeding) occurred in 3.3% of the warfarin group vs. 13.5% of the placebo group (HR 0.22). This difference was primarily due to reduction in risk of recurrent VTE (1.7% vs. 13.5%, HR 0.15), with only minimal increased bleeding risk (2.2% vs. 0.5%, NS).
There was no significant difference in the composite outcome (20.8% in warfarin group vs. 24% in placebo) on analysis of the entire study period (treatment and follow-up), however, suggesting the benefit of extended warfarin therapy upon recurrent VTE risk diminished upon cessation.
Bottom line: Patients treated with extended-therapy warfarin after a first unprovoked PE have a decreased risk of recurrent VTE compared to standard therapy only while on treatment; the risk of recurrent VTE returns upon cessation of therapy.
Citation: Couturand F, Sanchez O, Pernod G, et al. Six months vs extended oral anticoagulation after a first episode of pulmonary embolism: The PADIS-PE randomized clinical trial. JAMA. 2015;314(1):31-40.
Clinical question: Among patients with a first episode of unprovoked pulmonary embolism (PE), what are the benefits and harms of extending the duration of anticoagulation for secondary prophylaxis against recurrent VTE?
Background: Optimal duration of anticoagulation after initial unprovoked PE is not known. Prior studies demonstrated risk reduction of recurrent VTE while on therapy but have had inadequate long-term monitoring of patients or enrollment of patients with PE, who are known to have a higher case-fatality rate of recurrent VTE than patients with DVT.
Study design: Multicenter, randomized, double-blinded, parallel-grouped, placebo-controlled trial.
Setting: Fourteen French hospitals from 2007 to 2012.
Synopsis: Investigators randomized 371 patients with a first episode of symptomatic unprovoked PE who had completed six months of warfarin to 18 additional months of warfarin or placebo. Patients were followed for 24 months after discontinuation of therapy.
During the treatment period, the primary outcome (composite of recurrent VTE and major bleeding) occurred in 3.3% of the warfarin group vs. 13.5% of the placebo group (HR 0.22). This difference was primarily due to reduction in risk of recurrent VTE (1.7% vs. 13.5%, HR 0.15), with only minimal increased bleeding risk (2.2% vs. 0.5%, NS).
There was no significant difference in the composite outcome (20.8% in warfarin group vs. 24% in placebo) on analysis of the entire study period (treatment and follow-up), however, suggesting the benefit of extended warfarin therapy upon recurrent VTE risk diminished upon cessation.
Bottom line: Patients treated with extended-therapy warfarin after a first unprovoked PE have a decreased risk of recurrent VTE compared to standard therapy only while on treatment; the risk of recurrent VTE returns upon cessation of therapy.
Citation: Couturand F, Sanchez O, Pernod G, et al. Six months vs extended oral anticoagulation after a first episode of pulmonary embolism: The PADIS-PE randomized clinical trial. JAMA. 2015;314(1):31-40.
Clinical question: Among patients with a first episode of unprovoked pulmonary embolism (PE), what are the benefits and harms of extending the duration of anticoagulation for secondary prophylaxis against recurrent VTE?
Background: Optimal duration of anticoagulation after initial unprovoked PE is not known. Prior studies demonstrated risk reduction of recurrent VTE while on therapy but have had inadequate long-term monitoring of patients or enrollment of patients with PE, who are known to have a higher case-fatality rate of recurrent VTE than patients with DVT.
Study design: Multicenter, randomized, double-blinded, parallel-grouped, placebo-controlled trial.
Setting: Fourteen French hospitals from 2007 to 2012.
Synopsis: Investigators randomized 371 patients with a first episode of symptomatic unprovoked PE who had completed six months of warfarin to 18 additional months of warfarin or placebo. Patients were followed for 24 months after discontinuation of therapy.
During the treatment period, the primary outcome (composite of recurrent VTE and major bleeding) occurred in 3.3% of the warfarin group vs. 13.5% of the placebo group (HR 0.22). This difference was primarily due to reduction in risk of recurrent VTE (1.7% vs. 13.5%, HR 0.15), with only minimal increased bleeding risk (2.2% vs. 0.5%, NS).
There was no significant difference in the composite outcome (20.8% in warfarin group vs. 24% in placebo) on analysis of the entire study period (treatment and follow-up), however, suggesting the benefit of extended warfarin therapy upon recurrent VTE risk diminished upon cessation.
Bottom line: Patients treated with extended-therapy warfarin after a first unprovoked PE have a decreased risk of recurrent VTE compared to standard therapy only while on treatment; the risk of recurrent VTE returns upon cessation of therapy.
Citation: Couturand F, Sanchez O, Pernod G, et al. Six months vs extended oral anticoagulation after a first episode of pulmonary embolism: The PADIS-PE randomized clinical trial. JAMA. 2015;314(1):31-40.
Wells Score Can't Rule Out Deep Vein Thrombosis in Inpatient Setting
Clinical question: Should the Wells score be used for DVT risk stratification in the hospital?
Background: The Wells score was derived to reduce lower extremity ultrasounds (LEUS) in the outpatient evaluation of DVTs. There has never been a large prospective trial to validate its use in hospitalized patients.
Study design: Single-center, prospective cohort study.
Setting: Quaternary care, academic hospital.
Synopsis: Between November 2012 and December 2013, all inpatients at a single medical center who underwent a LEUS for suspected DVT, including 1,135 inpatients 16 years or older, had Wells risk factors recorded. The incidence of proximal DVTs noted for low, moderate, and high pretest probability groups were 5.9%, 9.5%, and 16.4%, respectively. Compared to the outpatient incidence of 3.0%, 16.6%, and 74.6% reported by Wells and colleagues, there were nonsignificant differences among inpatient groups. The difference between low and moderate pretest probability groups was not significant.
Discrimination of risk for DVT in hospitalized patients performed only slightly better than chance (AUC, 0.60) and the failure rate was double that of the original outpatient study (5.9% vs. 3.0%).
A possible explanation for these findings is the increased prevalence of immobilization (6x), cancer (3x), and risk factors not included in the Wells score (COPD, heart failure, and infection) in hospitalized patients.
Bottom line: The Wells score may not be sufficient to rule out DVT or influence management in the inpatient setting.
Citation: Silveira PC, Ip IK, Goldhaber SZ, Piazza G, Benson CB, Khorasani R. Performance of Wells score for deep vein thrombosis in the inpatient setting. JAMA Intern Med. 2015;175(7):1112-1117.
Clinical question: Should the Wells score be used for DVT risk stratification in the hospital?
Background: The Wells score was derived to reduce lower extremity ultrasounds (LEUS) in the outpatient evaluation of DVTs. There has never been a large prospective trial to validate its use in hospitalized patients.
Study design: Single-center, prospective cohort study.
Setting: Quaternary care, academic hospital.
Synopsis: Between November 2012 and December 2013, all inpatients at a single medical center who underwent a LEUS for suspected DVT, including 1,135 inpatients 16 years or older, had Wells risk factors recorded. The incidence of proximal DVTs noted for low, moderate, and high pretest probability groups were 5.9%, 9.5%, and 16.4%, respectively. Compared to the outpatient incidence of 3.0%, 16.6%, and 74.6% reported by Wells and colleagues, there were nonsignificant differences among inpatient groups. The difference between low and moderate pretest probability groups was not significant.
Discrimination of risk for DVT in hospitalized patients performed only slightly better than chance (AUC, 0.60) and the failure rate was double that of the original outpatient study (5.9% vs. 3.0%).
A possible explanation for these findings is the increased prevalence of immobilization (6x), cancer (3x), and risk factors not included in the Wells score (COPD, heart failure, and infection) in hospitalized patients.
Bottom line: The Wells score may not be sufficient to rule out DVT or influence management in the inpatient setting.
Citation: Silveira PC, Ip IK, Goldhaber SZ, Piazza G, Benson CB, Khorasani R. Performance of Wells score for deep vein thrombosis in the inpatient setting. JAMA Intern Med. 2015;175(7):1112-1117.
Clinical question: Should the Wells score be used for DVT risk stratification in the hospital?
Background: The Wells score was derived to reduce lower extremity ultrasounds (LEUS) in the outpatient evaluation of DVTs. There has never been a large prospective trial to validate its use in hospitalized patients.
Study design: Single-center, prospective cohort study.
Setting: Quaternary care, academic hospital.
Synopsis: Between November 2012 and December 2013, all inpatients at a single medical center who underwent a LEUS for suspected DVT, including 1,135 inpatients 16 years or older, had Wells risk factors recorded. The incidence of proximal DVTs noted for low, moderate, and high pretest probability groups were 5.9%, 9.5%, and 16.4%, respectively. Compared to the outpatient incidence of 3.0%, 16.6%, and 74.6% reported by Wells and colleagues, there were nonsignificant differences among inpatient groups. The difference between low and moderate pretest probability groups was not significant.
Discrimination of risk for DVT in hospitalized patients performed only slightly better than chance (AUC, 0.60) and the failure rate was double that of the original outpatient study (5.9% vs. 3.0%).
A possible explanation for these findings is the increased prevalence of immobilization (6x), cancer (3x), and risk factors not included in the Wells score (COPD, heart failure, and infection) in hospitalized patients.
Bottom line: The Wells score may not be sufficient to rule out DVT or influence management in the inpatient setting.
Citation: Silveira PC, Ip IK, Goldhaber SZ, Piazza G, Benson CB, Khorasani R. Performance of Wells score for deep vein thrombosis in the inpatient setting. JAMA Intern Med. 2015;175(7):1112-1117.
Antibiotic Therapy, Appendectomy for Uncomplicated Acute Appendicitis
Clinical question: Is antibiotic therapy noninferior to appendectomy for treatment of uncomplicated acute appendicitis?
Background: Previous randomized clinical trials have compared antibiotic therapy versus appendectomy for the treatment of uncomplicated, acute appendicitis. Each of these studies had significant limitations, and appendectomy has remained the standard of care.
Study design: Noninferiority, randomized clinical trial.
Setting: Six hospitals in Finland.
Synopsis: Investigators randomized 530 patients with uncomplicated appendicitis confirmed on CT to appendectomy or antibiotic therapy, with a noninferiority margin of 24%. Of the 256 patients randomized to antibiotics who were available for follow-up, 70 received surgical intervention within one year. This resulted in a difference between treatment groups of -27%. Further analysis revealed that five of those patients had normal appendices and did not actually require appendectomy. Secondary outcome analysis demonstrated a significantly lower complication rate among patients in the antibiotic group (2.8%) compared with the surgical group (20.5%); however, the open operative approach used on most patients may have resulted in increased wound complications.
Although noninferiority of antibiotic treatment was not demonstrated, the majority of patients in the antibiotic group (73%) were found to have successful treatment with antibiotics alone. None of these patients, including those eventually undergoing appendectomy, suffered major complications. Although the overall approach to uncomplicated appendicitis may not change, physicians and patients should utilize this data to make an informed decision between antibiotic treatment and appendectomy.
Bottom line: In patients with CT-proven, uncomplicated acute appendicitis, antibiotic treatment did not meet the pre-specified threshold for noninferiority compared with appendectomy, yet a significant majority of patients in the antibiotic arm had successful recovery.
Citation: Salminen P, Paajanen H, Rautio T, et al. Antibiotic therapy vs appendectomy for treatment of uncomplicated acute appendicitis: The APPAC randomized clinical trial. JAMA. 2015;313(23):2340-2348
Clinical question: Is antibiotic therapy noninferior to appendectomy for treatment of uncomplicated acute appendicitis?
Background: Previous randomized clinical trials have compared antibiotic therapy versus appendectomy for the treatment of uncomplicated, acute appendicitis. Each of these studies had significant limitations, and appendectomy has remained the standard of care.
Study design: Noninferiority, randomized clinical trial.
Setting: Six hospitals in Finland.
Synopsis: Investigators randomized 530 patients with uncomplicated appendicitis confirmed on CT to appendectomy or antibiotic therapy, with a noninferiority margin of 24%. Of the 256 patients randomized to antibiotics who were available for follow-up, 70 received surgical intervention within one year. This resulted in a difference between treatment groups of -27%. Further analysis revealed that five of those patients had normal appendices and did not actually require appendectomy. Secondary outcome analysis demonstrated a significantly lower complication rate among patients in the antibiotic group (2.8%) compared with the surgical group (20.5%); however, the open operative approach used on most patients may have resulted in increased wound complications.
Although noninferiority of antibiotic treatment was not demonstrated, the majority of patients in the antibiotic group (73%) were found to have successful treatment with antibiotics alone. None of these patients, including those eventually undergoing appendectomy, suffered major complications. Although the overall approach to uncomplicated appendicitis may not change, physicians and patients should utilize this data to make an informed decision between antibiotic treatment and appendectomy.
Bottom line: In patients with CT-proven, uncomplicated acute appendicitis, antibiotic treatment did not meet the pre-specified threshold for noninferiority compared with appendectomy, yet a significant majority of patients in the antibiotic arm had successful recovery.
Citation: Salminen P, Paajanen H, Rautio T, et al. Antibiotic therapy vs appendectomy for treatment of uncomplicated acute appendicitis: The APPAC randomized clinical trial. JAMA. 2015;313(23):2340-2348
Clinical question: Is antibiotic therapy noninferior to appendectomy for treatment of uncomplicated acute appendicitis?
Background: Previous randomized clinical trials have compared antibiotic therapy versus appendectomy for the treatment of uncomplicated, acute appendicitis. Each of these studies had significant limitations, and appendectomy has remained the standard of care.
Study design: Noninferiority, randomized clinical trial.
Setting: Six hospitals in Finland.
Synopsis: Investigators randomized 530 patients with uncomplicated appendicitis confirmed on CT to appendectomy or antibiotic therapy, with a noninferiority margin of 24%. Of the 256 patients randomized to antibiotics who were available for follow-up, 70 received surgical intervention within one year. This resulted in a difference between treatment groups of -27%. Further analysis revealed that five of those patients had normal appendices and did not actually require appendectomy. Secondary outcome analysis demonstrated a significantly lower complication rate among patients in the antibiotic group (2.8%) compared with the surgical group (20.5%); however, the open operative approach used on most patients may have resulted in increased wound complications.
Although noninferiority of antibiotic treatment was not demonstrated, the majority of patients in the antibiotic group (73%) were found to have successful treatment with antibiotics alone. None of these patients, including those eventually undergoing appendectomy, suffered major complications. Although the overall approach to uncomplicated appendicitis may not change, physicians and patients should utilize this data to make an informed decision between antibiotic treatment and appendectomy.
Bottom line: In patients with CT-proven, uncomplicated acute appendicitis, antibiotic treatment did not meet the pre-specified threshold for noninferiority compared with appendectomy, yet a significant majority of patients in the antibiotic arm had successful recovery.
Citation: Salminen P, Paajanen H, Rautio T, et al. Antibiotic therapy vs appendectomy for treatment of uncomplicated acute appendicitis: The APPAC randomized clinical trial. JAMA. 2015;313(23):2340-2348
Social, System Factors Can Influence Decisions to Continue Patient Care
Clinical question: Why do healthcare providers work while sick?
Background: Healthcare providers generally are aware of the risks of infection to hospitalized patients; however, despite this knowledge, several studies have revealed providers continue to work while ill.
Study design: Mixed-method analysis of a cross-sectional survey.
Setting: Large academic children’s hospital.
Synopsis: Investigators completed 538 of 929 surveys of attending physicians and advanced practice clinicians (APCs), a response rate of 58%. Of the respondents, 95% agreed that sick providers continuing patient care increased their patients’ risk for infection; however, 83% admitted to caring for patients while sick, with physicians being more likely to do so.
Several factors contributed to this behavior, including fear of letting colleagues or patients down, fear of ostracism by colleagues, and concerns for understaffing or discontinuity of care. Qualitative analysis of free-text responses revealed additional factors, including the difficulty of finding sick coverage, the strong cultural norms to continue working unless severely ill, and the ambiguity of defining “too sick to work.”
Limitations of this study included possible response bias, lack of a validated survey, and inclusion of only a single center; however, results confirm prior studies and reveal additional systems factors that hospital leadership could address, supporting providers and improving patient care.
Bottom line: Sick healthcare providers face several challenges that drive them to put their patients at risk by continuing patient care, and these factors could be addressed by healthcare systems as a means of improving overall quality of care.
Citation: Szymczak JE, Smathers S, Hoegg C, Klieger S, Coffin SE, Sammons JS. Reasons why physicians and advanced practice clinicians work while sick: a mixed-methods analysis. JAMA Pediatr. 2015;169(9):815-821. doi:10.1001/jamapediatrics.2015.0684.
Clinical question: Why do healthcare providers work while sick?
Background: Healthcare providers generally are aware of the risks of infection to hospitalized patients; however, despite this knowledge, several studies have revealed providers continue to work while ill.
Study design: Mixed-method analysis of a cross-sectional survey.
Setting: Large academic children’s hospital.
Synopsis: Investigators completed 538 of 929 surveys of attending physicians and advanced practice clinicians (APCs), a response rate of 58%. Of the respondents, 95% agreed that sick providers continuing patient care increased their patients’ risk for infection; however, 83% admitted to caring for patients while sick, with physicians being more likely to do so.
Several factors contributed to this behavior, including fear of letting colleagues or patients down, fear of ostracism by colleagues, and concerns for understaffing or discontinuity of care. Qualitative analysis of free-text responses revealed additional factors, including the difficulty of finding sick coverage, the strong cultural norms to continue working unless severely ill, and the ambiguity of defining “too sick to work.”
Limitations of this study included possible response bias, lack of a validated survey, and inclusion of only a single center; however, results confirm prior studies and reveal additional systems factors that hospital leadership could address, supporting providers and improving patient care.
Bottom line: Sick healthcare providers face several challenges that drive them to put their patients at risk by continuing patient care, and these factors could be addressed by healthcare systems as a means of improving overall quality of care.
Citation: Szymczak JE, Smathers S, Hoegg C, Klieger S, Coffin SE, Sammons JS. Reasons why physicians and advanced practice clinicians work while sick: a mixed-methods analysis. JAMA Pediatr. 2015;169(9):815-821. doi:10.1001/jamapediatrics.2015.0684.
Clinical question: Why do healthcare providers work while sick?
Background: Healthcare providers generally are aware of the risks of infection to hospitalized patients; however, despite this knowledge, several studies have revealed providers continue to work while ill.
Study design: Mixed-method analysis of a cross-sectional survey.
Setting: Large academic children’s hospital.
Synopsis: Investigators completed 538 of 929 surveys of attending physicians and advanced practice clinicians (APCs), a response rate of 58%. Of the respondents, 95% agreed that sick providers continuing patient care increased their patients’ risk for infection; however, 83% admitted to caring for patients while sick, with physicians being more likely to do so.
Several factors contributed to this behavior, including fear of letting colleagues or patients down, fear of ostracism by colleagues, and concerns for understaffing or discontinuity of care. Qualitative analysis of free-text responses revealed additional factors, including the difficulty of finding sick coverage, the strong cultural norms to continue working unless severely ill, and the ambiguity of defining “too sick to work.”
Limitations of this study included possible response bias, lack of a validated survey, and inclusion of only a single center; however, results confirm prior studies and reveal additional systems factors that hospital leadership could address, supporting providers and improving patient care.
Bottom line: Sick healthcare providers face several challenges that drive them to put their patients at risk by continuing patient care, and these factors could be addressed by healthcare systems as a means of improving overall quality of care.
Citation: Szymczak JE, Smathers S, Hoegg C, Klieger S, Coffin SE, Sammons JS. Reasons why physicians and advanced practice clinicians work while sick: a mixed-methods analysis. JAMA Pediatr. 2015;169(9):815-821. doi:10.1001/jamapediatrics.2015.0684.
COPD Exacerbation Prevention: April 2015 CHEST Guidelines
Background
The CHEST guidelines for the prevention of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) were developed through a collaboration between the American College of Chest Physicians (CHEST) and the Canadian Thoracic Society (CTS). They are the first evidence-based guidelines dedicated entirely to the prevention of AECOPD and largely exclude material related to the treatment of symptomatic disease.1
Patients with AECOPD are commonly cared for by hospitalists, so we fill an important role in the longitudinal treatment of this disease. Acute exacerbations and hospitalizations for COPD account for 50% of all COPD-related expenses.2,3 Further, the Agency for Healthcare Research and Quality showed a 20% readmission rate nationally for AECOPD, far higher than the rate for most other diagnoses.4 Consequently, COPD readmission has been added to Medicare’s Hospital Readmissions Reduction Program for fiscal year 2015.5
Hospitalization, when the patient is a captive audience and many of the necessary resources are available, may be a time to initiate preventative strategies.
Guideline Updates
The guidelines for non-pharmacologic interventions start with vaccination and continue with behavioral modification. They support the use of the 23-valent polysaccharide pneumococcal vaccine and annual influenza vaccination, noting that only influenza vaccination has been shown to decrease AECOPD.
Pulmonary rehabilitation is recommended for patients with a recent (fewer than four weeks) exacerbation. Several recommendations favor combining social work interventions with education, adding that face-to-face verbal education is superior to written educational materials. Interestingly, smoking cessation interventions received a weak recommendation, based upon lack of literature specifically focusing on the prevention of AECOPD. Despite this recommendation, smoking cessation intervention is strongly encouraged by the authors, given evidence of a marked reduction in morbidity, mortality, and healthcare utilization among smokers with COPD who quit.6 Finally, telemonitoring is not considered to be superior to usual care.
The guidelines concerning inhaled therapies fall into three major drug classes, including short- and long-acting inhaled muscarinic antagonists (anticholinergic agents), short- and long-acting inhaled beta-agonists, and inhaled corticosteroids.
Long-acting medications are generally considered more effective in preventing exacerbations than those that are short acting. Long-acting muscarinic antagonists (LAMAs) are highlighted for their efficacy, and combination inhaled long-acting beta-agonists (LABAs) and inhaled corticosteroids are preferred over monotherapy with either agent alone. LAMAs are preferred to inhaled corticosteroids or LABAs when given as monotherapy.
Short-acting agents are rated as inferior at preventing exacerbations compared to their long-acting analogs, but short-acting medications are better than placebo when combined with long-acting agents from other drug classes. Triple drug therapy (inhaled LAMAs, LABAs, and corticosteroids) can be considered based on current evidence.
The final recommendations address the use of oral medications. A potentially practice-changing guideline is the recommendation for long-term use of N-acetylcysteine tablets twice daily for patients who have experienced more than two exacerbations within two years. A more intuitive recommendation in this group is that treating an AECOPD with oral or IV steroids decreases the chance of recurrent exacerbations in the future.
The remaining recommendations include daily macrolide therapy, the phosphodiesterate-4 inhibitor roflumilast for those with chronic bronchitis and a recent exacerbation, and slow-release theophylline for stable disease. These guidelines also point out that statins do not have a role in AECOPD prevention. An expert consensus also recommends carbocysteine for patients who have failed “maximal” therapy.1
Established Guideline Analysis
Prior guidelines that address stable COPD do exist, most notably from Quaseem and colleagues in the 2011 Annals of Internal Medicine (AIM) and the 2015 GOLD guidelines.7,8 The prior guidelines published in AIM offered limited recommendations on the preventative interventions of bronchodilator use, pulmonary rehabilitation, and oxygen use.
The recommendations made in AIM are similar to those in the CHEST guidelines; the lack of breadth in the AIM report reflects new data generated over the last half decade. They include preventing causative exposures (e.g. tobacco, occupational), recommending bronchodilator use (with or without inhaled corticosteroids), possibly using phosphodiesterase-4 inhibitors (PD-4 inhibitors), administering appropriate vaccines, and providing education; however, GOLD does not actually present or rate the evidence associated with those recommendations. GOLD does specifically state that statins have no role in AECOPD prevention, a position that is updated from more recent literature.8,9
The National Guideline Clearinghouse (NGC) also includes some references to prevention of AECOPD but has no sections explicitly dedicated to prevention. Of note, the NGC still endorses statin use and does not appear to have incorporated data from newer studies.8,10
Hospitalist Takeaways
Given the high rate of COPD readmissions and its broad impact on morbidity and healthcare costs, measures to prevent COPD exacerbations cannot remain out of scope of care for inpatient physicians. It is important to initiate pulmonary rehab within four weeks of an exacerbation of COPD to prevent future exacerbations. Systems should be put in place to assure that all patients who qualify are vaccinated for influenza and patients who continue to smoke receive cessation counseling.
Today, hospitalists are comfortable with these non-pharmacologic interventions, as well as medications that include inhaled bronchodilators, nebulized medications, macrolide maintenance therapy, and oral steroids; however, other oral medications, such as phosphodiesterase inhibitors, theophylline, and N-acetylcysteine, may be appropriate for select patients, and hospitalists should become more familiar with their utility.11,12,13,14
Finally, it is important to note that both short- and long-acting inhaled muscarinic antagonists have come to the forefront of pharmacologic interventions for COPD exacerbation prevention.
Dr. Lampman, MD, is a hospitalist, consulting provider, and physician leader of the physician advisor program at Duke Regional Hospital in Durham, N.C. Dr. Lovins is a hospitalist, associate chief medical informatics officer, and assistant professor of medicine at Duke University and Duke Regional Hospital.
References
- Criner GJ, Bourbeau J, Diekemper RL, et al. Prevention of acute exacerbations of COPD: American College of Chest Physicians and Canadian Thoracic Society Guideline. Chest. 2015;147(4):894-942.
- Miravitlles M, Garcia-Polo C, Domenech A, Villegas G, Conget F, de la Roza C. Clinical outcomes and cost analysis of exacerbations in chronic obstructive pulmonary disease. Lung. 2013;191(5):523-530.
- Miravitlles M, Murio C, Guerrero T, Gisbert R; DAFNE Study Group. Pharmacoeconomic evaluation of acute exacerbations of chronic bronchitis and COPD. Chest. 2002;121(5):1449-1455.
- Elixhauser A, Au DH, Podulka J. Readmissions for Chronic Obstructive Pulmonary Disease, 2008: Statistical Brief #121.In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, Md.: Agency for Health Care Policy and Research: 2006.
- Readmissions Reduction Program. Centers for Medicare and Medicaid Services website. Accessed September 8, 2015.
- Sicras-Mainar A, Rejas-Gutiérrez J, Navarro-Artieda R, Ibáñez-Nolla J. The effect of quitting smoking on costs and healthcare utilization in patients with chronic obstructive pulmonary disease: a comparison of current smokers versus ex-smokers in routine clinical practice. Lung. 2014;192(4):505-518.
- Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011;155(3):179-191.
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Global Strategy for the Diagnosis, Management, and Prevention of COPD. Accessed September 8, 2015.
- Criner GJ, Connett JE, Aaron SK, et al. Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. N Engl J Med. 2014;370(23):2201-2210.
- Agency for Healthcare Research and Quality. National Guideline Clearinghouse. COPD – chronic obstructive pulmonary disease. In: Pulmonary (acute & chronic). Accessed September 8, 2015.
- Cazzola M, Matera MG. N-acetylcysteine in COPD may be beneficial, but for whom? Lancet Respir Med. 2014;2(3):166-167.
- Turner RD Bothamley. N-acetylcysteine for COPD: the evidence remains inconclusive. Lancet Respir Med. 2014;2(4):e3.
- Zheng JP, Wen FQ, Bai CX, et al. Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2014;2(3):187-194.
- Amazon.com. Amazon Search. 2015 06/1/2015].
Background
The CHEST guidelines for the prevention of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) were developed through a collaboration between the American College of Chest Physicians (CHEST) and the Canadian Thoracic Society (CTS). They are the first evidence-based guidelines dedicated entirely to the prevention of AECOPD and largely exclude material related to the treatment of symptomatic disease.1
Patients with AECOPD are commonly cared for by hospitalists, so we fill an important role in the longitudinal treatment of this disease. Acute exacerbations and hospitalizations for COPD account for 50% of all COPD-related expenses.2,3 Further, the Agency for Healthcare Research and Quality showed a 20% readmission rate nationally for AECOPD, far higher than the rate for most other diagnoses.4 Consequently, COPD readmission has been added to Medicare’s Hospital Readmissions Reduction Program for fiscal year 2015.5
Hospitalization, when the patient is a captive audience and many of the necessary resources are available, may be a time to initiate preventative strategies.
Guideline Updates
The guidelines for non-pharmacologic interventions start with vaccination and continue with behavioral modification. They support the use of the 23-valent polysaccharide pneumococcal vaccine and annual influenza vaccination, noting that only influenza vaccination has been shown to decrease AECOPD.
Pulmonary rehabilitation is recommended for patients with a recent (fewer than four weeks) exacerbation. Several recommendations favor combining social work interventions with education, adding that face-to-face verbal education is superior to written educational materials. Interestingly, smoking cessation interventions received a weak recommendation, based upon lack of literature specifically focusing on the prevention of AECOPD. Despite this recommendation, smoking cessation intervention is strongly encouraged by the authors, given evidence of a marked reduction in morbidity, mortality, and healthcare utilization among smokers with COPD who quit.6 Finally, telemonitoring is not considered to be superior to usual care.
The guidelines concerning inhaled therapies fall into three major drug classes, including short- and long-acting inhaled muscarinic antagonists (anticholinergic agents), short- and long-acting inhaled beta-agonists, and inhaled corticosteroids.
Long-acting medications are generally considered more effective in preventing exacerbations than those that are short acting. Long-acting muscarinic antagonists (LAMAs) are highlighted for their efficacy, and combination inhaled long-acting beta-agonists (LABAs) and inhaled corticosteroids are preferred over monotherapy with either agent alone. LAMAs are preferred to inhaled corticosteroids or LABAs when given as monotherapy.
Short-acting agents are rated as inferior at preventing exacerbations compared to their long-acting analogs, but short-acting medications are better than placebo when combined with long-acting agents from other drug classes. Triple drug therapy (inhaled LAMAs, LABAs, and corticosteroids) can be considered based on current evidence.
The final recommendations address the use of oral medications. A potentially practice-changing guideline is the recommendation for long-term use of N-acetylcysteine tablets twice daily for patients who have experienced more than two exacerbations within two years. A more intuitive recommendation in this group is that treating an AECOPD with oral or IV steroids decreases the chance of recurrent exacerbations in the future.
The remaining recommendations include daily macrolide therapy, the phosphodiesterate-4 inhibitor roflumilast for those with chronic bronchitis and a recent exacerbation, and slow-release theophylline for stable disease. These guidelines also point out that statins do not have a role in AECOPD prevention. An expert consensus also recommends carbocysteine for patients who have failed “maximal” therapy.1
Established Guideline Analysis
Prior guidelines that address stable COPD do exist, most notably from Quaseem and colleagues in the 2011 Annals of Internal Medicine (AIM) and the 2015 GOLD guidelines.7,8 The prior guidelines published in AIM offered limited recommendations on the preventative interventions of bronchodilator use, pulmonary rehabilitation, and oxygen use.
The recommendations made in AIM are similar to those in the CHEST guidelines; the lack of breadth in the AIM report reflects new data generated over the last half decade. They include preventing causative exposures (e.g. tobacco, occupational), recommending bronchodilator use (with or without inhaled corticosteroids), possibly using phosphodiesterase-4 inhibitors (PD-4 inhibitors), administering appropriate vaccines, and providing education; however, GOLD does not actually present or rate the evidence associated with those recommendations. GOLD does specifically state that statins have no role in AECOPD prevention, a position that is updated from more recent literature.8,9
The National Guideline Clearinghouse (NGC) also includes some references to prevention of AECOPD but has no sections explicitly dedicated to prevention. Of note, the NGC still endorses statin use and does not appear to have incorporated data from newer studies.8,10
Hospitalist Takeaways
Given the high rate of COPD readmissions and its broad impact on morbidity and healthcare costs, measures to prevent COPD exacerbations cannot remain out of scope of care for inpatient physicians. It is important to initiate pulmonary rehab within four weeks of an exacerbation of COPD to prevent future exacerbations. Systems should be put in place to assure that all patients who qualify are vaccinated for influenza and patients who continue to smoke receive cessation counseling.
Today, hospitalists are comfortable with these non-pharmacologic interventions, as well as medications that include inhaled bronchodilators, nebulized medications, macrolide maintenance therapy, and oral steroids; however, other oral medications, such as phosphodiesterase inhibitors, theophylline, and N-acetylcysteine, may be appropriate for select patients, and hospitalists should become more familiar with their utility.11,12,13,14
Finally, it is important to note that both short- and long-acting inhaled muscarinic antagonists have come to the forefront of pharmacologic interventions for COPD exacerbation prevention.
Dr. Lampman, MD, is a hospitalist, consulting provider, and physician leader of the physician advisor program at Duke Regional Hospital in Durham, N.C. Dr. Lovins is a hospitalist, associate chief medical informatics officer, and assistant professor of medicine at Duke University and Duke Regional Hospital.
References
- Criner GJ, Bourbeau J, Diekemper RL, et al. Prevention of acute exacerbations of COPD: American College of Chest Physicians and Canadian Thoracic Society Guideline. Chest. 2015;147(4):894-942.
- Miravitlles M, Garcia-Polo C, Domenech A, Villegas G, Conget F, de la Roza C. Clinical outcomes and cost analysis of exacerbations in chronic obstructive pulmonary disease. Lung. 2013;191(5):523-530.
- Miravitlles M, Murio C, Guerrero T, Gisbert R; DAFNE Study Group. Pharmacoeconomic evaluation of acute exacerbations of chronic bronchitis and COPD. Chest. 2002;121(5):1449-1455.
- Elixhauser A, Au DH, Podulka J. Readmissions for Chronic Obstructive Pulmonary Disease, 2008: Statistical Brief #121.In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, Md.: Agency for Health Care Policy and Research: 2006.
- Readmissions Reduction Program. Centers for Medicare and Medicaid Services website. Accessed September 8, 2015.
- Sicras-Mainar A, Rejas-Gutiérrez J, Navarro-Artieda R, Ibáñez-Nolla J. The effect of quitting smoking on costs and healthcare utilization in patients with chronic obstructive pulmonary disease: a comparison of current smokers versus ex-smokers in routine clinical practice. Lung. 2014;192(4):505-518.
- Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011;155(3):179-191.
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Global Strategy for the Diagnosis, Management, and Prevention of COPD. Accessed September 8, 2015.
- Criner GJ, Connett JE, Aaron SK, et al. Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. N Engl J Med. 2014;370(23):2201-2210.
- Agency for Healthcare Research and Quality. National Guideline Clearinghouse. COPD – chronic obstructive pulmonary disease. In: Pulmonary (acute & chronic). Accessed September 8, 2015.
- Cazzola M, Matera MG. N-acetylcysteine in COPD may be beneficial, but for whom? Lancet Respir Med. 2014;2(3):166-167.
- Turner RD Bothamley. N-acetylcysteine for COPD: the evidence remains inconclusive. Lancet Respir Med. 2014;2(4):e3.
- Zheng JP, Wen FQ, Bai CX, et al. Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2014;2(3):187-194.
- Amazon.com. Amazon Search. 2015 06/1/2015].
Background
The CHEST guidelines for the prevention of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) were developed through a collaboration between the American College of Chest Physicians (CHEST) and the Canadian Thoracic Society (CTS). They are the first evidence-based guidelines dedicated entirely to the prevention of AECOPD and largely exclude material related to the treatment of symptomatic disease.1
Patients with AECOPD are commonly cared for by hospitalists, so we fill an important role in the longitudinal treatment of this disease. Acute exacerbations and hospitalizations for COPD account for 50% of all COPD-related expenses.2,3 Further, the Agency for Healthcare Research and Quality showed a 20% readmission rate nationally for AECOPD, far higher than the rate for most other diagnoses.4 Consequently, COPD readmission has been added to Medicare’s Hospital Readmissions Reduction Program for fiscal year 2015.5
Hospitalization, when the patient is a captive audience and many of the necessary resources are available, may be a time to initiate preventative strategies.
Guideline Updates
The guidelines for non-pharmacologic interventions start with vaccination and continue with behavioral modification. They support the use of the 23-valent polysaccharide pneumococcal vaccine and annual influenza vaccination, noting that only influenza vaccination has been shown to decrease AECOPD.
Pulmonary rehabilitation is recommended for patients with a recent (fewer than four weeks) exacerbation. Several recommendations favor combining social work interventions with education, adding that face-to-face verbal education is superior to written educational materials. Interestingly, smoking cessation interventions received a weak recommendation, based upon lack of literature specifically focusing on the prevention of AECOPD. Despite this recommendation, smoking cessation intervention is strongly encouraged by the authors, given evidence of a marked reduction in morbidity, mortality, and healthcare utilization among smokers with COPD who quit.6 Finally, telemonitoring is not considered to be superior to usual care.
The guidelines concerning inhaled therapies fall into three major drug classes, including short- and long-acting inhaled muscarinic antagonists (anticholinergic agents), short- and long-acting inhaled beta-agonists, and inhaled corticosteroids.
Long-acting medications are generally considered more effective in preventing exacerbations than those that are short acting. Long-acting muscarinic antagonists (LAMAs) are highlighted for their efficacy, and combination inhaled long-acting beta-agonists (LABAs) and inhaled corticosteroids are preferred over monotherapy with either agent alone. LAMAs are preferred to inhaled corticosteroids or LABAs when given as monotherapy.
Short-acting agents are rated as inferior at preventing exacerbations compared to their long-acting analogs, but short-acting medications are better than placebo when combined with long-acting agents from other drug classes. Triple drug therapy (inhaled LAMAs, LABAs, and corticosteroids) can be considered based on current evidence.
The final recommendations address the use of oral medications. A potentially practice-changing guideline is the recommendation for long-term use of N-acetylcysteine tablets twice daily for patients who have experienced more than two exacerbations within two years. A more intuitive recommendation in this group is that treating an AECOPD with oral or IV steroids decreases the chance of recurrent exacerbations in the future.
The remaining recommendations include daily macrolide therapy, the phosphodiesterate-4 inhibitor roflumilast for those with chronic bronchitis and a recent exacerbation, and slow-release theophylline for stable disease. These guidelines also point out that statins do not have a role in AECOPD prevention. An expert consensus also recommends carbocysteine for patients who have failed “maximal” therapy.1
Established Guideline Analysis
Prior guidelines that address stable COPD do exist, most notably from Quaseem and colleagues in the 2011 Annals of Internal Medicine (AIM) and the 2015 GOLD guidelines.7,8 The prior guidelines published in AIM offered limited recommendations on the preventative interventions of bronchodilator use, pulmonary rehabilitation, and oxygen use.
The recommendations made in AIM are similar to those in the CHEST guidelines; the lack of breadth in the AIM report reflects new data generated over the last half decade. They include preventing causative exposures (e.g. tobacco, occupational), recommending bronchodilator use (with or without inhaled corticosteroids), possibly using phosphodiesterase-4 inhibitors (PD-4 inhibitors), administering appropriate vaccines, and providing education; however, GOLD does not actually present or rate the evidence associated with those recommendations. GOLD does specifically state that statins have no role in AECOPD prevention, a position that is updated from more recent literature.8,9
The National Guideline Clearinghouse (NGC) also includes some references to prevention of AECOPD but has no sections explicitly dedicated to prevention. Of note, the NGC still endorses statin use and does not appear to have incorporated data from newer studies.8,10
Hospitalist Takeaways
Given the high rate of COPD readmissions and its broad impact on morbidity and healthcare costs, measures to prevent COPD exacerbations cannot remain out of scope of care for inpatient physicians. It is important to initiate pulmonary rehab within four weeks of an exacerbation of COPD to prevent future exacerbations. Systems should be put in place to assure that all patients who qualify are vaccinated for influenza and patients who continue to smoke receive cessation counseling.
Today, hospitalists are comfortable with these non-pharmacologic interventions, as well as medications that include inhaled bronchodilators, nebulized medications, macrolide maintenance therapy, and oral steroids; however, other oral medications, such as phosphodiesterase inhibitors, theophylline, and N-acetylcysteine, may be appropriate for select patients, and hospitalists should become more familiar with their utility.11,12,13,14
Finally, it is important to note that both short- and long-acting inhaled muscarinic antagonists have come to the forefront of pharmacologic interventions for COPD exacerbation prevention.
Dr. Lampman, MD, is a hospitalist, consulting provider, and physician leader of the physician advisor program at Duke Regional Hospital in Durham, N.C. Dr. Lovins is a hospitalist, associate chief medical informatics officer, and assistant professor of medicine at Duke University and Duke Regional Hospital.
References
- Criner GJ, Bourbeau J, Diekemper RL, et al. Prevention of acute exacerbations of COPD: American College of Chest Physicians and Canadian Thoracic Society Guideline. Chest. 2015;147(4):894-942.
- Miravitlles M, Garcia-Polo C, Domenech A, Villegas G, Conget F, de la Roza C. Clinical outcomes and cost analysis of exacerbations in chronic obstructive pulmonary disease. Lung. 2013;191(5):523-530.
- Miravitlles M, Murio C, Guerrero T, Gisbert R; DAFNE Study Group. Pharmacoeconomic evaluation of acute exacerbations of chronic bronchitis and COPD. Chest. 2002;121(5):1449-1455.
- Elixhauser A, Au DH, Podulka J. Readmissions for Chronic Obstructive Pulmonary Disease, 2008: Statistical Brief #121.In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, Md.: Agency for Health Care Policy and Research: 2006.
- Readmissions Reduction Program. Centers for Medicare and Medicaid Services website. Accessed September 8, 2015.
- Sicras-Mainar A, Rejas-Gutiérrez J, Navarro-Artieda R, Ibáñez-Nolla J. The effect of quitting smoking on costs and healthcare utilization in patients with chronic obstructive pulmonary disease: a comparison of current smokers versus ex-smokers in routine clinical practice. Lung. 2014;192(4):505-518.
- Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011;155(3):179-191.
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Global Strategy for the Diagnosis, Management, and Prevention of COPD. Accessed September 8, 2015.
- Criner GJ, Connett JE, Aaron SK, et al. Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. N Engl J Med. 2014;370(23):2201-2210.
- Agency for Healthcare Research and Quality. National Guideline Clearinghouse. COPD – chronic obstructive pulmonary disease. In: Pulmonary (acute & chronic). Accessed September 8, 2015.
- Cazzola M, Matera MG. N-acetylcysteine in COPD may be beneficial, but for whom? Lancet Respir Med. 2014;2(3):166-167.
- Turner RD Bothamley. N-acetylcysteine for COPD: the evidence remains inconclusive. Lancet Respir Med. 2014;2(4):e3.
- Zheng JP, Wen FQ, Bai CX, et al. Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2014;2(3):187-194.
- Amazon.com. Amazon Search. 2015 06/1/2015].
Coronary Computed Tomography Angiography, Radionuclide Stress Testing Similar for Evaluation of Chest Pain
Clinical question: Is coronary computed tomography angiography better than stress testing for detecting coronary artery disease?
Bottom line: For the evaluation of chest pain in intermediate-risk patients, coronary computed tomography angiography (CCTA) is comparable with myocardial perfusion imaging (MPI) in its ability to select patients for invasive management. Both modalities are also similar when it comes to downstream resource use and adverse cardiovascular events. CCTA is associated with less radiation exposure (LOE = 1b).
Reference: Levsky JM, Spevack DM, Travin MI, et al. Coronary computed tomography angiography versus radionuclide myocardial perfusion imaging in patients with chest pain admitted to telemetry. Ann Intern Med 2015;163(3):174-183.
Study design: Randomized controlled trial (nonblinded)
Funding source: Foundation
Allocation: Concealed
Setting: Inpatient (any location) with outpatient follow-up
Synopsis
The effectiveness of a noninvasive coronary imaging modality lies in its ability to identify patients who will need invasive management. In this study, intermediate-risk patients admitted to telemetry for the evaluation of chest pain who clinically required noninvasive imaging were randomized, using concealed allocation, to receive either CCTA or radionuclide stress MPI.
At baseline, the mean age in both groups was 57 years, two-thirds of the patients were female, and more than 90% were ethnic minorities. Analysis was by intention to treat. The primary outcome was the rate of cardiac catheterization that did not lead to revascularization within one year of the imaging test. There was no significant difference between the two groups for this outcome. However, in a subgroup analysis of patients with signficantly abnormal results on their imaging test, there was a nonsignificant trend toward fewer catheterizations without revascularization in the CCTA group (25% vs 52%; P=0.083).
For secondary outcomes, there were no differences detected between the two groups in length of stay, major adverse cardiovascular events, or downstream resource use, including rehospitalizations and further imaging. The CCTA group had less radiation exposure and reported a better patient experience.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Clinical question: Is coronary computed tomography angiography better than stress testing for detecting coronary artery disease?
Bottom line: For the evaluation of chest pain in intermediate-risk patients, coronary computed tomography angiography (CCTA) is comparable with myocardial perfusion imaging (MPI) in its ability to select patients for invasive management. Both modalities are also similar when it comes to downstream resource use and adverse cardiovascular events. CCTA is associated with less radiation exposure (LOE = 1b).
Reference: Levsky JM, Spevack DM, Travin MI, et al. Coronary computed tomography angiography versus radionuclide myocardial perfusion imaging in patients with chest pain admitted to telemetry. Ann Intern Med 2015;163(3):174-183.
Study design: Randomized controlled trial (nonblinded)
Funding source: Foundation
Allocation: Concealed
Setting: Inpatient (any location) with outpatient follow-up
Synopsis
The effectiveness of a noninvasive coronary imaging modality lies in its ability to identify patients who will need invasive management. In this study, intermediate-risk patients admitted to telemetry for the evaluation of chest pain who clinically required noninvasive imaging were randomized, using concealed allocation, to receive either CCTA or radionuclide stress MPI.
At baseline, the mean age in both groups was 57 years, two-thirds of the patients were female, and more than 90% were ethnic minorities. Analysis was by intention to treat. The primary outcome was the rate of cardiac catheterization that did not lead to revascularization within one year of the imaging test. There was no significant difference between the two groups for this outcome. However, in a subgroup analysis of patients with signficantly abnormal results on their imaging test, there was a nonsignificant trend toward fewer catheterizations without revascularization in the CCTA group (25% vs 52%; P=0.083).
For secondary outcomes, there were no differences detected between the two groups in length of stay, major adverse cardiovascular events, or downstream resource use, including rehospitalizations and further imaging. The CCTA group had less radiation exposure and reported a better patient experience.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Clinical question: Is coronary computed tomography angiography better than stress testing for detecting coronary artery disease?
Bottom line: For the evaluation of chest pain in intermediate-risk patients, coronary computed tomography angiography (CCTA) is comparable with myocardial perfusion imaging (MPI) in its ability to select patients for invasive management. Both modalities are also similar when it comes to downstream resource use and adverse cardiovascular events. CCTA is associated with less radiation exposure (LOE = 1b).
Reference: Levsky JM, Spevack DM, Travin MI, et al. Coronary computed tomography angiography versus radionuclide myocardial perfusion imaging in patients with chest pain admitted to telemetry. Ann Intern Med 2015;163(3):174-183.
Study design: Randomized controlled trial (nonblinded)
Funding source: Foundation
Allocation: Concealed
Setting: Inpatient (any location) with outpatient follow-up
Synopsis
The effectiveness of a noninvasive coronary imaging modality lies in its ability to identify patients who will need invasive management. In this study, intermediate-risk patients admitted to telemetry for the evaluation of chest pain who clinically required noninvasive imaging were randomized, using concealed allocation, to receive either CCTA or radionuclide stress MPI.
At baseline, the mean age in both groups was 57 years, two-thirds of the patients were female, and more than 90% were ethnic minorities. Analysis was by intention to treat. The primary outcome was the rate of cardiac catheterization that did not lead to revascularization within one year of the imaging test. There was no significant difference between the two groups for this outcome. However, in a subgroup analysis of patients with signficantly abnormal results on their imaging test, there was a nonsignificant trend toward fewer catheterizations without revascularization in the CCTA group (25% vs 52%; P=0.083).
For secondary outcomes, there were no differences detected between the two groups in length of stay, major adverse cardiovascular events, or downstream resource use, including rehospitalizations and further imaging. The CCTA group had less radiation exposure and reported a better patient experience.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Interdisciplinary Team Interventions Have Little Impact on Traditional Quality Measures
Clinical question: Do interdisciplinary team care interventions affect outcomes for hospitalized patients in general medical wards?
Bottom line: Interdisciplinary team care interventions do not significantly affect oft-used quality measures such as length of stay, readmissions, or mortality. However, some experts question whether these measures are appropriate for assessing the effectiveness of such interventions. A small body of evidence suggests that interdisciplinary interventions may affect complications of care or preventable adverse events. In the future, these and other more appropriate measures should be used when assessing interdisciplinary team care interventions. (LOE = 2a)
Reference: Pannick S, Davis R, Ashrafian H, et al. Effects of interdisciplinary team care interventions on general medical wards. JAMA Intern Med 2015;175(8):1288-1298.
Study design: Systematic review
Funding source: Government
Allocation: Uncertain
Setting: Inpatient (any location)
Synopsis
These investigators searched multiple databases including EMBASE and MEDLINE, as well as reference lists of included studies, to find trials that evaluated the effects of interdisciplinary team care on objective patient outcomes in the general medical wards. Study selection, data extraction, and assessment of bias were performed by independent reviewers.
Thirty studies (randomized controlled trials, cluster studies, and before-after studies) were included in the review. The studies had heterogeneous designs and outcome measures and all of them had a medium or high risk of bias. The majority of the studies, however, reported on complications of care, length of stay, readmission, or mortality.
Out of 10 studies that examined complications of care, five showed a reduction in this outcome by formalizing interdisciplinary rounds or adding specialized clinicians or pharmacists to the interdisciplinary team. Overall, 20% of the studies that looked at length of stay showed a reduction in this measure, but these results may have been confounded by secular trends toward length of stay reduction. No study showed a consistent or persistent effect on readmissions or mortality.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Clinical question: Do interdisciplinary team care interventions affect outcomes for hospitalized patients in general medical wards?
Bottom line: Interdisciplinary team care interventions do not significantly affect oft-used quality measures such as length of stay, readmissions, or mortality. However, some experts question whether these measures are appropriate for assessing the effectiveness of such interventions. A small body of evidence suggests that interdisciplinary interventions may affect complications of care or preventable adverse events. In the future, these and other more appropriate measures should be used when assessing interdisciplinary team care interventions. (LOE = 2a)
Reference: Pannick S, Davis R, Ashrafian H, et al. Effects of interdisciplinary team care interventions on general medical wards. JAMA Intern Med 2015;175(8):1288-1298.
Study design: Systematic review
Funding source: Government
Allocation: Uncertain
Setting: Inpatient (any location)
Synopsis
These investigators searched multiple databases including EMBASE and MEDLINE, as well as reference lists of included studies, to find trials that evaluated the effects of interdisciplinary team care on objective patient outcomes in the general medical wards. Study selection, data extraction, and assessment of bias were performed by independent reviewers.
Thirty studies (randomized controlled trials, cluster studies, and before-after studies) were included in the review. The studies had heterogeneous designs and outcome measures and all of them had a medium or high risk of bias. The majority of the studies, however, reported on complications of care, length of stay, readmission, or mortality.
Out of 10 studies that examined complications of care, five showed a reduction in this outcome by formalizing interdisciplinary rounds or adding specialized clinicians or pharmacists to the interdisciplinary team. Overall, 20% of the studies that looked at length of stay showed a reduction in this measure, but these results may have been confounded by secular trends toward length of stay reduction. No study showed a consistent or persistent effect on readmissions or mortality.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Clinical question: Do interdisciplinary team care interventions affect outcomes for hospitalized patients in general medical wards?
Bottom line: Interdisciplinary team care interventions do not significantly affect oft-used quality measures such as length of stay, readmissions, or mortality. However, some experts question whether these measures are appropriate for assessing the effectiveness of such interventions. A small body of evidence suggests that interdisciplinary interventions may affect complications of care or preventable adverse events. In the future, these and other more appropriate measures should be used when assessing interdisciplinary team care interventions. (LOE = 2a)
Reference: Pannick S, Davis R, Ashrafian H, et al. Effects of interdisciplinary team care interventions on general medical wards. JAMA Intern Med 2015;175(8):1288-1298.
Study design: Systematic review
Funding source: Government
Allocation: Uncertain
Setting: Inpatient (any location)
Synopsis
These investigators searched multiple databases including EMBASE and MEDLINE, as well as reference lists of included studies, to find trials that evaluated the effects of interdisciplinary team care on objective patient outcomes in the general medical wards. Study selection, data extraction, and assessment of bias were performed by independent reviewers.
Thirty studies (randomized controlled trials, cluster studies, and before-after studies) were included in the review. The studies had heterogeneous designs and outcome measures and all of them had a medium or high risk of bias. The majority of the studies, however, reported on complications of care, length of stay, readmission, or mortality.
Out of 10 studies that examined complications of care, five showed a reduction in this outcome by formalizing interdisciplinary rounds or adding specialized clinicians or pharmacists to the interdisciplinary team. Overall, 20% of the studies that looked at length of stay showed a reduction in this measure, but these results may have been confounded by secular trends toward length of stay reduction. No study showed a consistent or persistent effect on readmissions or mortality.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.