RHABIT

Recording harms in behavioural change intervention trials.

Background

In drug trials, researchers will record and report the medical harms that patients may experience, for example, if they become very unwell or have to go to hospital. In trials of interventions which aim to change behaviours (like stopping smoking or eating more healthily), it is much less clear which harms should be recorded and how to report them. Researchers may miss harms that are important to patients or spend time measuring what is not important.

We have found trials which aim to change behaviour record harms in different ways or not all. It is hard for researchers to identify where participants may be being harmed and what they should record

Study aims

RHABIT aims to write guidance on how to record harms in behavioural change intervention trials. This will hopefully improve the efficiency of harms recording, as well as consistency and transparency.

Methods

We will look at the literature to find types of harms that might occur in behavioural change interventions. We will interview people who run trials to find out problems they have experienced when recording harms, and what they have done to solve them. The information we find from the literature and interviews will be brought together to suggest guidance. We will ask experts in clinical trials to see if they agree with these suggestions and write some recommendationsor principlesto consider for harms recording and reporting.

Patient and public involvement (PPI)

Although a PPI group will not be set up for this project, clinical trial participants or PPI representatives will be asked for their views on how harms should be recorded in behavioural change intervention trials.

Dissemination

The results will be published in academic journals and conferences. The guidance document will be made freely available. We will also make a short video of the study findings.