The Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark.
Clin Pharmacol Ther. 2011 Nov;90(5):732-6. doi: 10.1038/clpt.2011.207. Epub 2011 Oct 12.
Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations and empirical analyses support the blinding of patients, health-care providers, and outcome assessors as to the trial intervention to which patients have been allocated. We encourage extensive pretrial testing of blinding procedures and explicit reporting of who was in the blinded condition and the methods used to ensure blinding.
盲法，又称“设盲”，是减少随机临床试验偏倚的重要方法。本文综述了盲法的重要方法学问题，重点介绍了术语、报告、偏倚机制、实证证据和破盲风险。理论考虑和实证分析支持对患者、医疗服务提供者和结局评估者实施针对患者分配的试验干预的盲法。我们鼓励在试验前充分测试盲法程序，并明确报告哪些人处于盲态以及用于确保盲法的方法。
