PMID- 38438935
OWN - NLM
STAT- MEDLINE
DCOM- 20240306
LR  - 20240307
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 25
IP  - 1
DP  - 2024 Mar 4
TI  - Recording harms in randomised controlled trials of behaviour change 
      interventions: a qualitative study of UK clinical trials units and NIHR trial 
      investigators.
PG  - 163
LID - 10.1186/s13063-024-07978-1 [doi]
LID - 163
AB  - 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.
CI  - (c) 2024. Crown.
FAU - Papaioannou, Diana
AU  - Papaioannou D
AUID- ORCID: 0000-0002-6259-0822
AD  - Sheffield Clinical Trials Research Unit, Division of Population Health, School of 
      Medicine and Population Health, University of Sheffield, Regent Court, 30 Regent 
      Street, Sheffield, S1 4DA, UK. d.papaioannou@sheffield.ac.uk.
FAU - Sprange, Kirsty
AU  - Sprange K
AD  - Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, NG7 2RD, 
      UK.
FAU - Hamer-Kiwacz, Sienna
AU  - Hamer-Kiwacz S
AD  - Sheffield Clinical Trials Research Unit, Division of Population Health, School of 
      Medicine and Population Health, University of Sheffield, Regent Court, 30 Regent 
      Street, Sheffield, S1 4DA, UK.
FAU - Mooney, Cara
AU  - Mooney C
AD  - Sheffield Clinical Trials Research Unit, Division of Population Health, School of 
      Medicine and Population Health, University of Sheffield, Regent Court, 30 Regent 
      Street, Sheffield, S1 4DA, UK.
FAU - Moody, Gwenllian
AU  - Moody G
AD  - Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, 
      Cardiff, UK.
FAU - Cooper, Cindy
AU  - Cooper C
AD  - Sheffield Clinical Trials Research Unit, Division of Population Health, School of 
      Medicine and Population Health, University of Sheffield, Regent Court, 30 Regent 
      Street, Sheffield, S1 4DA, UK.
LA  - eng
GR  - CTU Support Funding/National Institute for Health and Care Research/
PT  - Journal Article
DEP - 20240304
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - Humans
MH  - Focus Groups
MH  - Knowledge
MH  - Language
MH  - Qualitative Research
MH  - Randomized Controlled Trials as Topic
MH  - United Kingdom
MH  - *Behavior Therapy
PMC - PMC10910772
OTO - NOTNLM
OT  - Adverse events
OT  - Behavioural interventions
OT  - Clinical trials
OT  - Clinical trials unit
OT  - Focus groups
OT  - Harms
OT  - Non-CTIMP
OT  - Non-drug
OT  - Qualitative
COIS- The authors declare that they have no competing interests.
EDAT- 2024/03/05 00:45
MHDA- 2024/03/06 06:43
PMCR- 2024/03/04
CRDT- 2024/03/04 23:47
PHST- 2023/08/15 00:00 [received]
PHST- 2024/02/09 00:00 [accepted]
PHST- 2024/03/06 06:43 [medline]
PHST- 2024/03/05 00:45 [pubmed]
PHST- 2024/03/04 23:47 [entrez]
PHST- 2024/03/04 00:00 [pmc-release]
AID - 10.1186/s13063-024-07978-1 [pii]
AID - 7978 [pii]
AID - 10.1186/s13063-024-07978-1 [doi]
PST - epublish
SO  - Trials. 2024 Mar 4;25(1):163. doi: 10.1186/s13063-024-07978-1.