Including service users in trials in health and social care: Developing guidance for researchers

2012 Conference

Abstract: Public involvement in conducting trials is limited and little information exists to support it.

Our work
We developed a standard operating procedure to give researchers detailed guidance on how to include service users in trials. Researchers and service users involved in trials adopted by the West Wales Organisation for Rigorous Trials in Health (WWORTH – Clinical Trials Unit based in Swansea University) collaborated to develop this guidance.

It includes:

• how to recruit and engage service users
• minimum core levels of collaboration
• how to include service users at the Medical Research Council’s five stages of developing and evaluating complex interventions in health
• research team members responsible for including service users and promoting an inclusion culture
• training requirements for researchers and service users.

We state that:

• service users should be included as early as possible in the research process with a minimum of two on all formal trial groups and committees
• a minimum 1% of total research budget should be set aside to include service users and sufficient additional time built in to allow for full inclusion.

Learning
Good practice about involving service users applies to trials.

Issues
How to evaluate use and impact of this guidance.

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Authors

Evans ~ Bridie

Bridie Evans is a health services researcher at Swansea University with special responsibility for involving people in emergency, unscheduled and trauma care research and trials. She is also undertaking a PhD, developing and evaluating a model for involving people in research about chronic conditions management.

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