Papaioannou Diana, Hamer-Kiwacz Sienna, Mooney Cara, Sprange Kirsty, Cooper Cindy, O'Cathain Alicia
Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, S1 4DA, UK
Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, S1 4DA, UK.
BMJ. 2024 Oct 2;387:e077418. doi: 10.1136/bmj-2023-077418.
Harms are possible from behaviour change interventions, such as the worsening of a health behaviour intended for change (rebound effect), improving a health behaviour but with subsequent worsening of another behaviour (risk compensation), and participants feeling targeted or stigmatised by an intervention. The processes and definitions originally designed to record harms within drug trials are typically followed to record harms in trials of behaviour change interventions owing to the lack of alternative guidance. Therefore, important harms could be missed in the evaluations of behaviour change interventions or irrelevant harms data may be recorded, leading to inefficiency. This paper presents evidence informed recommendations on how to record harms in randomised controlled trials of behaviour change interventions.
行为改变干预措施可能会带来危害，例如原本打算改变的健康行为恶化（反弹效应）、一种健康行为得到改善但随后另一种行为恶化（风险补偿），以及参与者感到受到干预的针对性或污名化。由于缺乏其他指导，在行为改变干预试验中记录危害时，通常遵循最初设计用于记录药物试验中危害的流程和定义。因此，在行为改变干预的评估中可能会遗漏重要危害，或者可能记录不相关的危害数据，从而导致效率低下。本文就如何在行为改变干预的随机对照试验中记录危害提出了基于证据的建议。
