Heart failure clinics
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Heart failure clinics · Oct 2011
ReviewReporting of clinical trials: publication, authorship, and trial registration.
Transparency is the foundation on which all of research integrity rests. The public trust from patients, providers, and policy makers depends on fidelity to the mandates of accountability and access. Two important foundational practices for maintaining transparency in research and the reporting of clinical trials discussed in this review concern manuscript authorship and clinical trial registry, recognizing recent controversies regarding honorary and ghost authorship in the publication of industry-sponsored studies.
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Heart failure clinics · Oct 2011
ReviewCovariate adjustment in heart failure randomized controlled clinical trials: a case analysis of the HF-ACTION trial.
Randomized controlled clinical trials are predominantly used to determine the benefit of a therapeutic intervention in patients with congestive heart failure (HF). These trials are commonly lengthy and expensive, and enroll patients with baseline imbalances that may influence outcome, even after randomization. ⋯ Covariate adjustment may provide more individualized effect estimates and a potential improvement in power and reduction in type 1 error. This article reviews the HF-ACTION trial to better understand whether covariate adjustment should be prespecified as the primary end point in HF clinical trials.