RHABIT

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 all ¹. 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 https://doi.org/10.1016/j.jclinepi.2021.03.002

Aims

This study aims 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 are four work packages (WP): 

WP1: Scoping literature review

The  review aims to scope and map the literature to identify definitions, typologies/frameworks of harms, and suggested principles for recording harms in BCI trials .

WP2: Qualitative interviews with experts 

To elicit perspectives and experiences of CTU and NIHR investigators involved in designing and delivering BCI trials. This will be done through focus groups and individual interviews with multi-disciplinary experts delivering NIHR trials. Topics will include views on purpose or need for monitoring harms in BCI trials, perspectives on how adverse event (AE) recording should be undertaken, problems during implementation of AE data collection and interpretation. 

WP3: Delphi consensus study

A two-stage online Delphi study aims to achieve consensus on a proposed list of items describing principles and considerations for AE recording in BCI trials. Multi-disciplinary CTU and NIHR investigators will be asked to rate their agreement on the proposed items list. WP1 and WP2 will inform the statements for the consensus study. 

WP4: Suggested principles and considerations for harms recording 

Recommendations and an explanatory guidance document for AE recording in BCI trials will be developed These will be made available on the project website.

RHABIT Project Protocol Version 1.0

Project timelines 

This project commenced on 1^st October 2021

Funding

This study has been funded through NIHR CTU Support funding.

Study Team

Please contact us at: rhabit@sheffield.ac.uk

This project is a collaboration between four UK CRC Clinical Trials Units: Sheffield, Nottingham, Cardiff and Imperial.