Department of Psychology, University of Bath, Bath BA2 7AY; King's College London, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London SE5 8AF.
Acute and Rehabilitation Directorate Psychology Team, North East London NHS Foundation Trust, Goodmayes Hospital, Barley Lane, Ilford IG3 8XJ; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road W1T 7DN.
J Clin Epidemiol. 2020 Aug;124:8-15. doi: 10.1016/j.jclinepi.2020.04.005. Epub 2020 Apr 12.
The objective of this study was to develop and pilot a standard framework that could be used to assess risk of contamination in psychological therapy trials, at the protocol development stage.
We developed and piloted a risk of contamination framework on a sample of 100 psychological therapy trial protocols registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry (www.isrctn.com). We assessed all protocols as being low or high risk via three possible sources of contamination: 1) participants in the control arm, 2) participants in the intervention arm, 3) therapists in the intervention arm.
Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%). We identified 14 studies that had a potentially high risk for contamination. Most of these (N = 10) were identified as risk of contamination arising from a therapist in the intervention arm.
The risk of contamination framework we piloted in this study could be a helpful tool for researchers aiming to identify and manage risk of contamination in their trial protocol development. We found that the risk of contamination was relatively low in the psychological therapy trials we sampled for this study, as measured by our framework, and could usually be mitigated through reasonable adjustments to the study design.
本研究旨在制定并试行一个标准框架，以便在试验方案制定阶段评估心理治疗试验中污染的风险。
我们在国际标准随机对照试验编号（ISRCTN）登记处（www.isrctn.com）注册的 100 个心理治疗试验方案样本上开发并试行污染风险框架。我们通过三种可能的污染源（1）对照组参与者，2）干预组参与者，3）干预组治疗师，对所有方案进行低风险或高风险评估。
总体而言，我们发现大多数研究（100 项试验方案中的 86 项；86%）的所有三种来源的污染风险均较低。我们确定了 14 项研究存在潜在的高污染风险。其中大多数（N=10）被认为是干预组治疗师引起的污染风险。
我们在本研究中试行的污染风险框架可以成为研究人员在试验方案制定中识别和管理污染风险的有用工具。我们发现，我们的框架衡量的心理治疗试验中的污染风险相对较低，并且通常可以通过对研究设计进行合理调整来减轻。
