Current Situation and Methodological Reflections on Blinding Assessment in Randomised Controlled Trials of Acupuncture
10.13288/j.11-2166/r.2024.19.005
- VernacularTitle:针刺随机对照试验中盲法评价现状与方法学思考
- Author:
Hang ZHOU
1
;
Liqiong WANG
1
;
Jianfeng TU
1
;
Guangxia SHI
1
;
Jingwen YANG
1
;
Shiyan YAN
1
;
Cunzhi LIU
1
Author Information
1. School of Acupuncture-Moxibustion and Tuina，Beijing University of Chinese Medicine，Beijing，100029
- Publication Type:Journal Article
- Keywords:
blinding;
blinding assessment;
acupuncture;
randomized controlled trials
- From:
Journal of Traditional Chinese Medicine
2024;65(19):1978-1982
- CountryChina
- Language:Chinese
-
Abstract:
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.
