Saskia E. Vanderloo

Comparative Safety and Effectiveness of Metformin in Patients With Diabetes Mellitus and Heart Failure Systematic Review of Observational Studies Involving 34 000 Patients

Background—There is an ongoing controversy regarding the safety and effectiveness of metformin in the setting of heart failure (HF). Therefore, we undertook a systematic review of the trial and nontrial evidence for metformin in patients with diabetes mellitus and HF. Methods and Results—We conducted a comprehensive search for controlled studies, evaluating the association between metformin and morbidity and mortality in people with diabetes mellitus and HF. Two reviewers independently identified citations, extracted data, and evaluated quality. Risk estimates were abstracted and pooled where appropriate. As measures of overall safety, we examined all-cause mortality and all-cause hospitalizations. Nine cohort studies were included; no randomized controlled trials were identified. Most (5 of 9) studies were published in 2010 and were of good quality. Metformin was associated with reduced mortality compared with controls (mostly sulfonylurea therapy): 23% versus 37% (pooled adjusted risk estimates: 0.80; 0.74–0.87; I2=15%; P<0.001). No increased risk was observed for metformin in those with reduced left ventricular ejection fraction (mortality pooled adjusted risk estimate: 0.91; 0.72–1.14; I2=0%; P=0.34), nor in those with HF and chronic kidney disease (pooled adjusted risk estimate: 0.81; 0.64–1.02; P=0.08). Metformin was associated with a small reduction in all-cause hospitalizations (pooled adjusted risk estimate: 0.93; 0.89–0.98; I2=0%; P=0.01). Metformin was not associated with increased risk of lactic acidosis. Conclusions—The totality of evidence indicates that metformin is at least as safe as other glucose-lowering treatments in patients with diabetes mellitus and HF and even in those with reduced left ventricular ejection fraction or concomitant chronic kidney disease. Until trial data become available, metformin should be considered the treatment of choice for patients with diabetes mellitus and HF.Background— There is an ongoing controversy regarding the safety and effectiveness of metformin in the setting of heart failure (HF). Therefore, we undertook a systematic review of the trial and nontrial evidence for metformin in patients with diabetes mellitus and HF. Methods and Results— We conducted a comprehensive search for controlled studies, evaluating the association between metformin and morbidity and mortality in people with diabetes mellitus and HF. Two reviewers independently identified citations, extracted data, and evaluated quality. Risk estimates were abstracted and pooled where appropriate. As measures of overall safety, we examined all-cause mortality and all-cause hospitalizations. Nine cohort studies were included; no randomized controlled trials were identified. Most (5 of 9) studies were published in 2010 and were of good quality. Metformin was associated with reduced mortality compared with controls (mostly sulfonylurea therapy): 23% versus 37% (pooled adjusted risk estimates: 0.80; 0.74–0.87; I 2=15%; P <0.001). No increased risk was observed for metformin in those with reduced left ventricular ejection fraction (mortality pooled adjusted risk estimate: 0.91; 0.72–1.14; I 2=0%; P =0.34), nor in those with HF and chronic kidney disease (pooled adjusted risk estimate: 0.81; 0.64–1.02; P =0.08). Metformin was associated with a small reduction in all-cause hospitalizations (pooled adjusted risk estimate: 0.93; 0.89–0.98; I 2=0%; P =0.01). Metformin was not associated with increased risk of lactic acidosis. Conclusions— The totality of evidence indicates that metformin is at least as safe as other glucose-lowering treatments in patients with diabetes mellitus and HF and even in those with reduced left ventricular ejection fraction or concomitant chronic kidney disease. Until trial data become available, metformin should be considered the treatment of choice for patients with diabetes mellitus and HF.

Comparing physical assessment with administrative data for detecting pressure ulcers in a large Canadian academic health sciences centre

Objective This study aimed to compare classification of pressure ulcers from administrative data with a gold standard assessment, specifically; pressure ulcers confirmed by an independent physical assessment performed by trained nurse surveyors. Setting A retrospective analysis of pooled cross-sectional samples of inpatients assessed across 3 consecutive prevalence surveys in a large academic health sciences centre between 2012 and 2013. Participants There were 2001 patients for whom physical and chart assessments were completed, and for whom a discharge abstract was also available at the time of analysis. The cohorts mean age was 65 years and 55% were women. Results Based on the physical assessment findings, 14.6% of patients (n=292) had at least 1 pressure ulcer, with a total of 345 pressure ulcers documented among these patients: (stage I=162; stage II=120; stage III=22; stage IV=22 and unstageable=19). Based on coded information, 78 (3.9%) of patients had a pressure ulcer. Of patients with a pressure ulcer determined by the physical assessment, only 21% also had a pressure ulcer captured in the administrative data. Furthermore, only 6% of the patients with a hospital-acquired pressure ulcer, stage II or greater determined by the physical assessment were coded in the Discharge Abstract Database (DAD). Conclusions The results of this study demonstrate that coding in the DAD may under-report and fail to accurately reflect the true burden of pressure ulcers in hospitalised patients. This may occur because the presence of pressure ulcers is currently documented in the health record by nurses and not by physicians, yet the administrative data recorded in the DAD only includes physician documented pressure ulcers. We recommend enhancements to the coding methods to monitor and report on pressure ulcers.

Measuring and improving quality in university hospitals in Canada: The Collaborative for Excellence in Healthcare Quality

Measuring and monitoring overall health system performance is complex and challenging but is crucial to improving quality of care. Todays health care organizations are increasingly being held accountable to develop and implement actions aimed at improving the quality of care, reducing costs, and achieving better patient-centered care. This paper describes the development of the Collaborative for Excellence in Healthcare Quality (CEHQ), a 5-year initiative to achieve higher quality of patient care in university hospitals across Canada. This bottom-up initiative took place between 2010 and 2015, and was successful in engaging health care leaders in the development of a common framework and set of performance measures for reporting and benchmarking, as well as working on initiatives to improve performance. Despite its successes, future efforts are needed to provide clear national leadership on standards for measuring performance.

Comparative Safety and Effectiveness of Metformin in Patients With Diabetes Mellitus and Heart FailureClinical Perspective

Background—There is an ongoing controversy regarding the safety and effectiveness of metformin in the setting of heart failure (HF). Therefore, we undertook a systematic review of the trial and nontrial evidence for metformin in patients with diabetes mellitus and HF. Methods and Results—We conducted a comprehensive search for controlled studies, evaluating the association between metformin and morbidity and mortality in people with diabetes mellitus and HF. Two reviewers independently identified citations, extracted data, and evaluated quality. Risk estimates were abstracted and pooled where appropriate. As measures of overall safety, we examined all-cause mortality and all-cause hospitalizations. Nine cohort studies were included; no randomized controlled trials were identified. Most (5 of 9) studies were published in 2010 and were of good quality. Metformin was associated with reduced mortality compared with controls (mostly sulfonylurea therapy): 23% versus 37% (pooled adjusted risk estimates: 0.80; 0.74–0.87; I2=15%; P<0.001). No increased risk was observed for metformin in those with reduced left ventricular ejection fraction (mortality pooled adjusted risk estimate: 0.91; 0.72–1.14; I2=0%; P=0.34), nor in those with HF and chronic kidney disease (pooled adjusted risk estimate: 0.81; 0.64–1.02; P=0.08). Metformin was associated with a small reduction in all-cause hospitalizations (pooled adjusted risk estimate: 0.93; 0.89–0.98; I2=0%; P=0.01). Metformin was not associated with increased risk of lactic acidosis. Conclusions—The totality of evidence indicates that metformin is at least as safe as other glucose-lowering treatments in patients with diabetes mellitus and HF and even in those with reduced left ventricular ejection fraction or concomitant chronic kidney disease. Until trial data become available, metformin should be considered the treatment of choice for patients with diabetes mellitus and HF.Background— There is an ongoing controversy regarding the safety and effectiveness of metformin in the setting of heart failure (HF). Therefore, we undertook a systematic review of the trial and nontrial evidence for metformin in patients with diabetes mellitus and HF. Methods and Results— We conducted a comprehensive search for controlled studies, evaluating the association between metformin and morbidity and mortality in people with diabetes mellitus and HF. Two reviewers independently identified citations, extracted data, and evaluated quality. Risk estimates were abstracted and pooled where appropriate. As measures of overall safety, we examined all-cause mortality and all-cause hospitalizations. Nine cohort studies were included; no randomized controlled trials were identified. Most (5 of 9) studies were published in 2010 and were of good quality. Metformin was associated with reduced mortality compared with controls (mostly sulfonylurea therapy): 23% versus 37% (pooled adjusted risk estimates: 0.80; 0.74–0.87; I 2=15%; P <0.001). No increased risk was observed for metformin in those with reduced left ventricular ejection fraction (mortality pooled adjusted risk estimate: 0.91; 0.72–1.14; I 2=0%; P =0.34), nor in those with HF and chronic kidney disease (pooled adjusted risk estimate: 0.81; 0.64–1.02; P =0.08). Metformin was associated with a small reduction in all-cause hospitalizations (pooled adjusted risk estimate: 0.93; 0.89–0.98; I 2=0%; P =0.01). Metformin was not associated with increased risk of lactic acidosis. Conclusions— The totality of evidence indicates that metformin is at least as safe as other glucose-lowering treatments in patients with diabetes mellitus and HF and even in those with reduced left ventricular ejection fraction or concomitant chronic kidney disease. Until trial data become available, metformin should be considered the treatment of choice for patients with diabetes mellitus and HF.

Comparative Safety and Effectiveness of Metformin in Patients With Diabetes Mellitus and Heart FailureClinical Perspective: Systematic Review of Observational Studies Involving 34 000 Patients

Background—There is an ongoing controversy regarding the safety and effectiveness of metformin in the setting of heart failure (HF). Therefore, we undertook a systematic review of the trial and nontrial evidence for metformin in patients with diabetes mellitus and HF. Methods and Results—We conducted a comprehensive search for controlled studies, evaluating the association between metformin and morbidity and mortality in people with diabetes mellitus and HF. Two reviewers independently identified citations, extracted data, and evaluated quality. Risk estimates were abstracted and pooled where appropriate. As measures of overall safety, we examined all-cause mortality and all-cause hospitalizations. Nine cohort studies were included; no randomized controlled trials were identified. Most (5 of 9) studies were published in 2010 and were of good quality. Metformin was associated with reduced mortality compared with controls (mostly sulfonylurea therapy): 23% versus 37% (pooled adjusted risk estimates: 0.80; 0.74–0.87; I2=15%; P<0.001). No increased risk was observed for metformin in those with reduced left ventricular ejection fraction (mortality pooled adjusted risk estimate: 0.91; 0.72–1.14; I2=0%; P=0.34), nor in those with HF and chronic kidney disease (pooled adjusted risk estimate: 0.81; 0.64–1.02; P=0.08). Metformin was associated with a small reduction in all-cause hospitalizations (pooled adjusted risk estimate: 0.93; 0.89–0.98; I2=0%; P=0.01). Metformin was not associated with increased risk of lactic acidosis. Conclusions—The totality of evidence indicates that metformin is at least as safe as other glucose-lowering treatments in patients with diabetes mellitus and HF and even in those with reduced left ventricular ejection fraction or concomitant chronic kidney disease. Until trial data become available, metformin should be considered the treatment of choice for patients with diabetes mellitus and HF.Background— There is an ongoing controversy regarding the safety and effectiveness of metformin in the setting of heart failure (HF). Therefore, we undertook a systematic review of the trial and nontrial evidence for metformin in patients with diabetes mellitus and HF. Methods and Results— We conducted a comprehensive search for controlled studies, evaluating the association between metformin and morbidity and mortality in people with diabetes mellitus and HF. Two reviewers independently identified citations, extracted data, and evaluated quality. Risk estimates were abstracted and pooled where appropriate. As measures of overall safety, we examined all-cause mortality and all-cause hospitalizations. Nine cohort studies were included; no randomized controlled trials were identified. Most (5 of 9) studies were published in 2010 and were of good quality. Metformin was associated with reduced mortality compared with controls (mostly sulfonylurea therapy): 23% versus 37% (pooled adjusted risk estimates: 0.80; 0.74–0.87; I 2=15%; P <0.001). No increased risk was observed for metformin in those with reduced left ventricular ejection fraction (mortality pooled adjusted risk estimate: 0.91; 0.72–1.14; I 2=0%; P =0.34), nor in those with HF and chronic kidney disease (pooled adjusted risk estimate: 0.81; 0.64–1.02; P =0.08). Metformin was associated with a small reduction in all-cause hospitalizations (pooled adjusted risk estimate: 0.93; 0.89–0.98; I 2=0%; P =0.01). Metformin was not associated with increased risk of lactic acidosis. Conclusions— The totality of evidence indicates that metformin is at least as safe as other glucose-lowering treatments in patients with diabetes mellitus and HF and even in those with reduced left ventricular ejection fraction or concomitant chronic kidney disease. Until trial data become available, metformin should be considered the treatment of choice for patients with diabetes mellitus and HF.