Trial DesignDesign and rationale of a retrospective clinical effectiveness study of aldosterone antagonist therapy in patients with heart failure
Section snippets
Methods
The proposed study is a retrospective cohort study comparing outcomes of eligible Medicare beneficiaries who receive aldosterone antagonist therapy with outcomes of eligible beneficiaries who do not receive this therapy, overall and by clinically relevant subgroups. The null hypothesis is that receipt of aldosterone antagonist therapy at discharge has no effect on mortality and readmission rates at 1 and 3 years among Medicare beneficiaries aged ≥65 years who were hospitalized for heart
Results
Figure 1 shows the derivation of the study cohort. The initial linked data set included 33,652 patients, from which we excluded 8,899 patients who were not discharged home and 4,192 patients who did not have a documented history of heart failure before the index hospitalization. The restricted data set included 20,656 patients, from which we further excluded 14,722 patients who were not eligible for aldosterone antagonist therapy. After all exclusions, the study cohort included 5,934 patients
Discussion
In establishing priorities for comparative effectiveness research, the Institute of Medicine described the breadth of study designs, including “systematic reviews, database research, observational studies, and randomized trials,” that could be used to assess real-world outcomes.6 The need for openness and transparency in the registration and reporting of clinical trials is widely recognized, yet similar expectations have not been established for the range of nonrandomized study designs used
Disclosures
This study was funded under contract number HHSA29020050032I (Duke University DEcIDE Center) from the Agency for Healthcare Research and Quality, US Department of Health and Human Services, as part of the Developing Evidence to Inform Decisions About Effectiveness (DEcIDE) program. The GWTG-HF program is provided by the American Heart Association and is currently supported by an unrestricted educational grant from Medtronic, Inc. GWTG-HF has been supported previously by GlaxoSmithKline,
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Implementation of management strategies for diabetes and hypertension: From local to global health in cardiovascular diseases
2015, Global HeartCitation Excerpt :To address this dual need for implementing emerging evidence more quickly while surveying for potential unexpected adverse outcomes in these unique populations, national registries linked to Medicare claims offer a promising solution. In multiple studies, our group has used national cardiovascular registries to examine the comparative effectiveness and safety of therapies in understudied populations such as older patients or patients with multiple comorbidities, including diabetes and hypertension [31]. As access to more real-time data, such as the Medicare Data Enclave, improves, the power to simultaneously assess the diffusion of new therapies using registries and to survey longitudinal outcomes becomes an important element in delivering high-quality care in an expedient, effective, and safe fashion.
Philip F. Binkley, MD, MPH served as guest editor for this article.