期刊
CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS
卷 3, 期 -, 页码 117-121出版社
ELSEVIER INC
DOI: 10.1016/j.conctc.2016.05.003
关键词
Bias; Blinding; Blinding index; Clinical trial
资金
- National Center for Advancing Translational Sciences, National Institutes of Health [UL1 TR000002]
Blinding is a methodologic safeguard of treatment evaluation, yet severely understudied empirically. Mathieu et al.'s theoretical analysis (2014) provided an important message that blinding cannot eliminate potential for bias associated with belief about allocation in randomized controlled trial; just like the intent-to-treat principle does not guarantee unbiased estimation under noncompliance, the blinded randomized trial as a golden standard may produce bias. They showed possible biases but did not assess how large the bias could be in different scenarios. In this paper, we examined their findings, and numerically assessed and compared the bias in treatment effect parameters by simulation under frequently encountered blinding scenarios, aiming to identify the most ideal blinding scenarios in practice. We conclude that Random Guess and Wishful Thinking (e.g., participants tend to believe they received treatment) are the most ideal blinding scenarios, incurring minimal bias. We also find some evidence that imperfect or partial blinding can be better than no blinding. (C) 2016 The Author. Published by Elsevier Inc. This is an open access article under the CC BY license.
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