This article discusses the shortcomings of current methods for recording harms in behavioural change intervention trials, which primarily rely on definitions designed for drug trials. The authors argue that these definitions can miss important harms specific to behavioural interventions, leading to inefficient recording practices. They propose evidence-based recommendations for identifying and recording potential harms, encompassing a multidisciplinary approach, involving stakeholders, and incorporating a range of data collection methods. These recommendations aim to improve transparency, efficiency, and the overall understanding of potential risks and benefits of these interventions.
Research paper:
Papaioannou D, Hamer-Kiwacz S, Mooney C, Sprange K, Cooper C, O'Cathain A et al. Recommendations on recording harms in randomised controlled trials of behaviour change interventions BMJ 2024; 387:e077418
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