Covariate adjustment in heart failure randomized controlled clinical trials: a case analysis of the HF-ACTION trial.
Publication/Presentation Date
10-1-2011
Abstract
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. Methods allowing for greater precision, power, and adjustment for treatment effect would be welcomed. 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.
Volume
7
Issue
4
First Page
497
Last Page
500
ISSN
1551-7136
Published In/Presented At
O'Connor, C. M., Mentz, R. J., & Whellan, D. J. (2011). Covariate adjustment in heart failure randomized controlled clinical trials: a case analysis of the HF-ACTION trial. Heart failure clinics, 7(4), 497–500. https://doi.org/10.1016/j.hfc.2011.06.011
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
21925432
Department(s)
Administration and Leadership
Document Type
Article