University of Washington, Seattle, WA 98195, USA.
J Clin Epidemiol. 2013 Apr;66(4):355-8. doi: 10.1016/j.jclinepi.2012.07.011. Epub 2012 Sep 13.
In recent years, a number of studies have achieved randomization of patients to alternative management strategies by blinding some patients (and their providers of medical care) to the results of tests that guide such strategies. Although this research approach has the potential to be a powerful means of measuring treatment effectiveness, the interpretation of the results may not be straightforward if the treatment received by test-positive persons is variable or not well documented, or if the analysis is not restricted to outcomes in test-positive persons. Studies in which the test results are withheld at random may face ethical issues that, to date, have received little discussion.
近年来，一些研究通过对指导这些策略的测试结果对部分患者（以及他们的医疗服务提供者）进行盲法处理，从而实现了患者随机分配至不同的治疗策略。尽管这种研究方法有可能成为衡量治疗效果的有力手段，但如果接受阳性检测结果的患者所接受的治疗存在差异或没有得到很好的记录，或者如果分析没有仅限于阳性检测结果患者的结局，那么对结果的解释可能并不简单。随机隐瞒检测结果的研究可能会面临一些尚未得到充分讨论的伦理问题。
