Department of Health Sciences, University of York, York, UK; Department of Diagnostics and Public Health, University of Verona, Italy.
York Trials Unit, Department of Health Sciences, University of York, York, UK.
Contemp Clin Trials. 2022 Jul;118:106788. doi: 10.1016/j.cct.2022.106788. Epub 2022 May 10.
Ideally all participants in a randomised controlled trial (RCT) should fully receive their allocated intervention; however, this rarely occurs in practice. Intervention adherence affects Type II error so influences the interpretation of trial results and subsequent implementation. We aimed to describe current practice in the definition, measurement, and reporting of intervention adherence in non-pharmacological RCTs, and how this data is incorporated into a trial's interpretation and conclusions.
We conducted a systematic review of phase III RCTs published between January 2018 and June 2020 in the National Institute for Health Research Journals Library for the Health Technology Assessment, Programme Grants for Applied Research, and Public Health Research funding streams.
Of 237 reports published, 76 met the eligibility criteria and were included. Most RCTs (n = 68, 89.5%) reported adherence, though use of terminology varied widely; nearly three quarters of these (n = 49, 72.1%) conducted a sensitivity analysis. Adherence measures varied between intervention types: behavioural change (n = 10, 43.5%), psychological therapy (n = 5, 83.3%) and physiotherapy/rehabilitation (n = 8, 66.7%) interventions predominately measured adherence based on session attendance. Whereas medical device and surgical interventions (n = 17, 73.9%) primarily record the number of participants receiving the allocated intervention, a third (n = 33, 67.3%) of studies reported a difference in findings between primary and sensitivity analyses.
Although most trials report elements of adherence, terminology was inconsistent, and there was no systematic approach to its measurement, analyses, interpretation, or reporting. Given the importance of adherence within clinical trials, there is a pressing need for a standardised approach or framework.
理想情况下，所有参与随机对照试验（RCT）的参与者都应充分接受其分配的干预措施；但实际上很少发生这种情况。干预措施的依从性会影响Ⅱ型错误，从而影响试验结果的解释和后续实施。我们旨在描述非药物 RCT 中干预措施依从性的定义、测量和报告的当前实践，以及这些数据如何纳入试验的解释和结论。
我们对 2018 年 1 月至 2020 年 6 月期间在国家卫生研究院期刊图书馆卫生技术评估、应用研究计划赠款和公共卫生研究资助渠道中发表的 III 期 RCT 进行了系统评价。
在 237 份报告中，有 76 份符合入选标准并被纳入。大多数 RCT（n=68，89.5%）报告了依从性，但术语的使用差异很大；其中近四分之三（n=49，72.1%）进行了敏感性分析。干预措施的依从性测量值因干预类型而异：行为改变（n=10，43.5%）、心理治疗（n=5，83.3%）和物理治疗/康复（n=8，66.7%）干预主要基于治疗次数来衡量依从性。而医疗器械和手术干预（n=17，73.9%）主要记录接受分配干预措施的参与者人数，三分之一（n=33，67.3%）的研究报告了主要分析和敏感性分析之间结果的差异。
尽管大多数试验报告了依从性的某些方面，但术语不一致，且没有系统的方法来测量、分析、解释或报告依从性。鉴于依从性在临床试验中的重要性，迫切需要一种标准化的方法或框架。
