文章基本信息

标题：Improved adherence adjustment in the Coronary Drug Project
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作者：Eleanor J. Murray ; Miguel A. Hernán
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2018
卷号：19
期号：1
页码：158
DOI：10.1186/s13063-018-2519-5
语种：English
出版社：BioMed Central
摘要：The survival difference between adherers and non-adherers to placebo in the Coronary Drug Project has been used to support the thesis that adherence adjustment in randomized trials is not generally possible and, therefore, that only intention-to-treat analyses should be trusted. We previously demonstrated that adherence adjustment can be validly conducted in the Coronary Drug Project using a simplistic approach. Here, we re-analyze the data using an approach that takes full advantage of recent methodological developments. We used inverse-probability weighted hazards models to estimate the 5-year survival and mortality risk when individuals in the placebo arm of the Coronary Drug Project adhere to at least 80% of the drug continuously or never during the 5-year follow-up period. Adjustment for post-randomization covariates resulted in 5-year mortality risk difference estimates ranging from − 0.7 (95% confidence intervals (CI), − 12.2, 10.7) to 4.5 (95% CI, − 6.3, 15.3) percentage points. Our analysis confirms that appropriate adjustment for post-randomization predictors of adherence largely removes the association between adherence to placebo and mortality originally described in this trial. ClinicalTrials.gov, Identifier: NCT00000482 . Registered retrospectively on 27 October 1999.
关键词：Per-protocol effect ; Intention-to-treat effect ; Inverse-probability weighting ; Coronary Drug Project ; Adherence