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Project Outputs

This project is now complete. Take a look at this short video to find out more:

The recommendations were published in the BMJ Research Methods and Reporting,
October 2024:

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) , 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:

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:

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.