Zelen M
Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts 02115.
Stat Med. 1990 Jun;9(6):645-56. doi: 10.1002/sim.4780090611.
Randomized consent designs were introduced to make it easier for physicians to enter patients in randomized clinical trials. Physician reluctance to participate in randomized clinical trials is often a reflection that the physician-patient relationship could be compromised if the physician makes known to the patient his/her inability to select a preferred therapy. Clinical trials having a no-treatment control or placebo amplify this concern. This paper reviews the main ideas of randomized consent designs (single and double) and the statistical model underlying the analysis, and presents some recent experiences.
引入随机同意设计是为了让医生更容易将患者纳入随机临床试验。医生不愿参与随机临床试验往往反映出，如果医生向患者表明自己无法选择首选治疗方法，医患关系可能会受到损害。设有无治疗对照组或安慰剂的临床试验加剧了这种担忧。本文回顾了随机同意设计（单组和双组）的主要理念以及分析所依据的统计模型，并介绍了一些近期的经验。
