RHABIT
A mixed methods study funded by the NIHR, which aimed to suggest principles or considerations for recording harms in behavioural change intervention trials.
Project Outputs
This project is now complete. Take a look at this short video to find out more:
RHABIT video
The recommendations were published in the BMJ Research Methods and Reporting,
October 2024:
BMJ RHABIT recommendations
A summary of the recommendations including an infographic are available here:
RHABIT recommendations summary
RHABIT infographic
Background
In drug trials, researchers record and report the medical harms that participants may experience during a trial. For example, if a participant becomes very unwell or has to go into hospital. It is much less clear on which harms to record and how to identify and report them in trials where interventions try to change behaviour (like stopping smoking, or eating more healthily), Researchers may miss harms that are important to patients or spend lots of time measuring what is not important.
We have found Behaviour Change Intervention (BCI) trials record harms in different ways or sometimes not at all1. There is no consistency and so it is hard to compare trials. It is difficult for researchers to decide what they should record and to identify where participants may be being harmed.
1 Papaioannou, P. et al. (2021) ‘Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions’, Journal of Clinical Epidemiology, 136, pp. 64-76
Aims
This study aimed to suggest principles or considerations on how to record harms in BCI trials. This will hopefully improve the efficiency, consistency, and transparency of harms recording.
There were four work packages (WP):
WP1: Scoping literature review
The review aimed to scope and map the literature to identify definitions, typologies/frameworks of harms, and suggested principles for recording harms in BCI trials.
The scoping review is published here:
Scoping review
WP2: Qualitative interviews with experts
WP2 aimed to elicit perspectives and experiences of CTU and NIHR investigators involved in designing and delivering BCI trials. Focus groups and individual interviews were undertaken with multi-disciplinary experts delivering NIHR trials.
The qualitative study is published here:
Qualitative study
WP3: Workshops
It was originally planned to conduct a two-stage online Delphi survey and consensus meeting. However, following the interviews in WP2, it was decided with the Project Steering Committee that clear, concise statements could not be developed and would likely result in findings from an online Delphi study that were difficult to interpret.
Instead, the findings from WP1 and WP2 were used to develop a guidance document for CTU staff and other investigators on how to identify and record harms in BCI trials.
Multi-disciplinary CTU staff, NIHR investigators and Patient and Public Involvement (PPI) members were invited to an online workshop to review the draft guidance.
WP4: Suggested principles and considerations for harms recording
Recommendations and a summary guidance document for AE recording in BCI trials were developed.
The RHABIT Project Protocol is available here:
RHABIT Project Protocol Version 2.0 (Word, 168KB)
Funding
This study was funded through NIHR CTU Support funding.
Study team
Contact us at rhabit@sheffield.ac.uk
This project is a collaboration between four UK CRC Clinical Trials Units: Sheffield, Nottingham, Cardiff and Imperial.
| Name | Job title/Role on project | Organisation | Contact |
| Diana Papaioannou | Senior Research Fellow and Assistant Director Principal Investigator | Clinical Trial Research Unit, The University of Sheffield | d.papaioannou@sheffield.ac.uk |
| Cara Mooney | Study Manager Project management/oversight | Clinical Trial Research Unit, The University of Sheffield | c.d.mooney@sheffield.ac.uk |
| Sienna Hamer-Kiwacz | Research Assistant | Clinical Trial Research Unit, The University of Sheffield | s.a.hamer-kiwacz@sheffield.ac.uk |
| Louise Turner | Project Support Officer | Clinical Trial Research Unit, The University of Sheffield | louise.turner@sheffield.ac.uk |
| Kirsty Sprange | Assistant Professor of Clinical Trials Collaborator (Qualitative study oversight) | Nottingham Clinical Trials Unit, University of Nottingham | Kirsty.Sprange@nottingham.ac.uk |
| Prof Alicia O’Cathain | NIHR Senior Investigator and Professor in Health Services Research Collaborator (Consenus study oversight) | ScHARR, The University of Sheffield | a.ocathain@sheffield.ac.uk |
| Prof Cindy Cooper | Director of Sheffield CTRU and Professor of Health Services Research & Clinical Trials Project steering committee member | Clinical Trial Research Unit, The University of Sheffield | c.l.cooper@sheffield.ac.uk |
| Prof Mike Robling | Director of Population Health Trials Project steering committee member | Centre for Trials Research, Cardiff University | RoblingMR@cardiff.ac.uk |
| Dr Gwenllian Moody | Trial Manager Project steering committee member | Centre for Trials Research, Cardiff University | moodyg@cardiff.ac.uk |
| Dr Victoria Cornelius | Reader in Medical Statistics and Head of Statistics and Trial Methodology Project steering committee member | Imperial Clinical Trials Unit, Imperial College London | v.cornelius@imperial.ac.uk |