Recording harms in randomised controlled trials of behaviour change interventions: a scoping review and map of the evidence

Objective Randomised controlled trials evaluate diverse interventions. This can include medical interventions such as drugs or surgical procedures, or behaviour change interventions that aim to change a habit, belief, or attitude to improve health e.g., healthy eating, psychological wellbeing. Harms are often recorded poorly or inconsistently within randomised controlled trials of behaviour change interventions. This scoping review aimed to collate and describe literature on categories, definitions, and mechanisms of harms from behaviour change interventions; methods of identifying plausible harms; and recommendations for recording harms. Study design and methods A scoping review was conducted. Three databases (MEDLINE, PsycINFO and CINAHL) were searched. Reference list checking and citation searching were performed. Articles were included if they discussed: i) interventions that aimed to modify behaviour; ii) categories or mechanisms of harms; iii) methods or recommendations for recording harms. All research designs were included. One reviewer reviewed titles, abstracts, and full texts; queries were checked with another reviewer. Data was extracted and synthesised descriptively by one reviewer and checked by another reviewer. A thematic map was constructed to summarise the review findings. Harms described from specific behaviour change interventions were identified, and examples were selected and summarised. Results The review included 37 articles. 19/37 articles contributed to a thematic review. Three articles described categories of harms, categories of harm included: Physical, Psychological, Group and Social interactions, Cultural, Equity, Opportunity Cost, Environmental and Economic. Seven articles included mechanisms or underlying factors for harms including feelings of failure leading to shame or stigma, and group interventions enabling knowledge exchange on unhealthy behaviours. Twelve articles provided recommendations for recording harms, including taking a proportionate approach by focusing on the most plausible and important harms, collecting different perspectives on whether harms had occurred (e.g., caregivers and family members) and using qualitative research methods to identify harms. One article described a three-step method to identify plausible harms from an intervention, and 6 articles supported aspects of the method. 18/37 articles contributed to a review which collated harms arising from specific interventions, e.g., a peer support intervention in inflammatory bowel disease caused distressing conversations which might lead to anxiety and confrontation with a possible negative future. Conclusion Behaviour change interventions can cause harm. This review identified categories and proposed mechanisms of harms, as well as methods and recommendations for identifying and recording harms in behaviour change interventions for inclusion in forthcoming guidance.