Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators

Papaioannou, Diana; Sprange, Kirsty; Hamer-Kiwacz, Sienna; Mooney, Cara; Moody, Gwenllian; Cooper, Cindy

Abstract

Background: Harms, also known as adverse events (AEs), are recorded and monitored in randomised controlled trials (RCTs) to ensure participants’ safety. Harms are recorded poorly or inconsistently in RCTs of Behaviour Change Interventions (BCI); however, limited guidance exists on how to record harms in BCI trials. This qualitative study explored experiences and perspectives from multi-disciplinary trial experts on recording harms in BCI trials. Methods: Data were collected through fifteen in-depth semi-structured qualitative interviews and three focus groups with thirty-two participants who work in the delivery and oversight of clinical trials. Participants included multi-disciplinary staff from eight CTUs, Chief investigators, and patient and public representatives. Interviews and focus group recordings were transcribed verbatim and thematic analysis was used to analyse the transcripts. Results: Five themes were identified, namely perception and understanding of harm, proportionate reporting and plausibility, the need for a multi-disciplinary approach, language of BCI harms and complex harms for complex interventions. Participants strongly believed harms should be recorded in BCI trials; however, making decisions on “how and what to record as harms” was difficult. Recording irrelevant harms placed a high burden on trial staff and participants, drained trial resources and was perceived as for little purpose. Participants believed proportionate recording was required that focused on events with a strong plausible link to the intervention. Multi-disciplinary trial team input was essential for identifying and collecting harms; however, this was difficult in practice due to lack of knowledge on harms from BCIs, lack of input or difference in opinion. The medical language of harms was recognised as a poor fit for BCI trial harms but was familiar and established within internal processes. Future guidance on this topic would be welcomed and could include summarised literature. Conclusions: Recording harms or adverse events in behaviour change intervention trials is complex and challenging; multi-disciplinary experts in trial design and implementation welcome forthcoming guidance on this topic. Issues include the high burden of recording irrelevant harms and use of definitions originally designed for drug trials. Proportionate recording of harms focused on events with a strong plausible link to the intervention and multi-disciplinary team input into decision making are essential.

Citation

Papaioannou, D., Sprange, K., Hamer-Kiwacz, S., Mooney, C., Moody, G., & Cooper, C. (2024). Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators. Trials, 25(1), Article 163. https://doi.org/10.1186/s13063-024-07978-1

• Journal Article Type: Article
• Acceptance Date: Feb 9, 2024
• Online Publication Date: Mar 4, 2024
• Publication Date: 2024
• Deposit Date: Apr 25, 2024
• Publicly Available Date: Apr 25, 2024
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 25
• Issue: 1
• Article Number: 163
• DOI: https://doi.org/10.1186/s13063-024-07978-1
• Keywords: Harms, Non-drug, Adverse events, Qualitative, Focus groups, Non-CTIMP, Clinical trials unit, Clinical trials, Behavioural interventions
• Public URL: https://nottingham-repository.worktribe.com/output/32450990
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-07978-1
• Additional Information: Received: 15 August 2023; Accepted: 9 February 2024; First Online: 4 March 2024; : ; : Ethics approval and consent to participate. Ethical approval was obtained from the Research Ethics Committee (REC) of the School of Health and Related Research (ScHARR) at the University of Sheffield on 28th January 2022 (ethical approval (ref: 044669). Consent was accepted as a return of email (to the invitation email) stating the participant had read and understood the consent form and agreed to participate. This correspondence was filed as the record of consent. The researcher(s) explained to participants that entry into the study was entirely voluntary and that they could withdraw at any time. In the event of withdrawal, it was clear to the participants that their data collected could not be erased and would be used in the final analyses where appropriate.; : Not applicable.; : The authors declare that they have no competing interests.