The great divide: A qualitative investigation of factors influencing researcher access to potential randomised controlled trial participants in mental health settings

Abstract

Background. External validity is central to pragmatic trials. Recruitment of a ‘representative’ sample is fundamental to this. However, recruitment is a complex process, requiring, first researcher access to eligible participants. Questions have been asked about the match between study samples and real-world clinical patients and the impact this has on generalisability of findings.

Method. Using interview and observational data from a grounded theory process evaluation of a multicentre trial, we investigated factors influencing referral.

Results. We found evidence of a fundamental disjunction between research and clinical practice manifested in varying ‘filtering’ processes. Organisational culture and the knowledge and attitudes of service providers regarding research generally and specifically in this RCT resulted in exclusion of very many potentially eligible participants.

Conclusions. These findings have policy and practical implications and highlight the need for development of genuinely collaborative partnerships between the research and clinical communities. Importantly, we suggest that the CONSORT recommendations be further refined to identify the potential study population.

Keywords:

• Research design and methods
• randomised controlled trial
• recruitment

Acknowledgements

MATISSE is funded by the UK Health Technology Assessment programme part of the National Institute for Health Research. We gratefully acknowledge the participation of CSOs and dedicated researchers working on the MATISSE project, the service managers, clinicians and others who have made recruitment possible. We also thank the anonymous reviewers for their considered and insightful critique.