针刺随机对照试验中盲法评价现状与方法学思考

Current Situation and Methodological Reflections on Blinding Assessment in Randomised Controlled Trials of Acupuncture

盲法是控制和降低临床研究中测量偏倚的重要手段,其中盲法评价是衡量盲法实施成功与否的主要方法。通过总结针刺随机对照试验(RCT)中盲法评价现状,发现针刺RCT对盲法评价的报告率不高,而报告盲法评价的研究存在评价对象不全面、评价问卷不合理、分析方法不科学等问题,且关于评价时点的设置存在争议。针对上述问题,围绕盲法评价对象、评价问卷、评价时点以及分析方法等关键要素展开论述。建议对研究中所有施盲对象进行盲法评价,评价问卷应采用直接询问的方式设计问题,采用包含“不清楚”选项的三分类或多分类选项设计回答,将试验早期作为评价的必选时点,整合James盲法评价指数和Bang盲法评价指数,以规范盲法评价在针刺RCT中的应用,提高针刺临床研究质量。

Blinding is an important means to control and reduce measurement bias in clinical research,and blinding assessment is the main method to measure the success of the blinding method.By summarizing the current situation of blinding assessment in randomized controlled trials(RCT)of acupuncture,it was found that the report rate of blinding assessment by acupuncture RCT was relatively low,and the studies reporting blinding assessment had several problems,such as incomplete assessment individuals,unreasonable assessment questionnaires,and unscientific analysis methods,and the setting of the assessment time point is controversial.Given the above problems,this paper discussed the key elements of blinding assessment individuals,assessment questionnaires,assessment time points,and analysis methods.It is suggested that blinding assessment should be carried out on all blinded participants and personnel in the study;the assessment questionnaire should be designed by direct inquiry,with responses designed using three or more categorical options that include an"unclear"option;the early stage of the trial should be taken as the mandatory time point for assessment,integrating the evaluation index of the James blinding index and the Bang blinding index,in order to standardize the application of blinding assessment in acupuncture RCT and improve the quality of acupuncture clinical research.