Department of Health Systems Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.
Office of Research Facilitation, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.
Clin Trials. 2020 Oct;17(5):545-551. doi: 10.1177/1740774520934910. Epub 2020 Jul 10.
Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia.
Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding.
At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments.
Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.
临床试验文章通常缺乏对参与者随机分组、隐藏分配以及对受试者和研究者进行分组盲法的方法的详细描述。我们描述了一种系统的方法，用于在一项针对针灸治疗外阴痛的双盲 2 期随机对照试验中实施并衡量盲法的成功，该试验旨在测试针灸的疗效。
根据外阴痛亚型进行分层随机化，由研究电子数据捕获软件的随机化模块管理，该模块经过改编以实现完全掩盖分组分配。对受试者和针灸师的盲法评估进行多次，以确定可能导致不盲法的相关因素。
目前，已有 48 名受试者被随机分组并完成了方案，共进行了 87 次受试者和 206 次针灸师的盲法评估。
我们的盲法和盲法评估方法有可能在存在可能的临床改善的情况下，随着时间的推移，提高我们对不盲法的理解。
