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Open Access Highly Accessed Methodology

Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

Frances Rapport1*, Mel Storey1, Alison Porter1, Helen Snooks1, Kerina Jones1, Julie Peconi1, Antonio Sánchez2, Stefan Siebert1, Kym Thorne1, Clare Clement1 and Ian Russell1

Author Affiliations

1 College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP,UK

2 Department of Medicine, Cardiff University Llandough Hospital, CF64 2XX, Penarth, UK

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Trials 2013, 14:54  doi:10.1186/1745-6215-14-54

Published: 21 February 2013

Abstract

Background

Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design.

Methods

Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP).

Results

The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component.

Conclusions

We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials.