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 ORCID: https://orcid.org/0000-0002-2000-4944 and Cooper, Cindy 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) , 163. 10.1186/s13063-024-07978-1

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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.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Medicine Centre for Trials Research (CNTRR)
Additional Information:	License information from Publisher: LICENSE 1: URL: http://creativecommons.org/licenses/by/4.0/, Type: open-access
Publisher:	BioMed Central
ISSN:	1745-6215
Date of First Compliant Deposit:	5 March 2024
Date of Acceptance:	9 February 2024
Last Modified:	05 Mar 2024 09:45
URI:	https://orca.cardiff.ac.uk/id/eprint/166861

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