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

Frances Rapport, Mel Storey, Alison Porter, Helen Snooks, Kerina Jones, Julie Peconi, Antonio Sánchez, Stefan Siebert, Kym Thorne, Clare Clement, Ian Russell

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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.

LanguageEnglish
Article number54
Pages1-8
Number of pages8
JournalTrials
Volume14
DOIs
Publication statusPublished - 2013

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Bibliographical note

Copyright the Author(s) 2013. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Cite this

Rapport, Frances ; Storey, Mel ; Porter, Alison ; Snooks, Helen ; Jones, Kerina ; Peconi, Julie ; Sánchez, Antonio ; Siebert, Stefan ; Thorne, Kym ; Clement, Clare ; Russell, Ian. / Qualitative research within trials : developing a standard operating procedure for a clinical trials unit. In: Trials. 2013 ; Vol. 14. pp. 1-8.
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Rapport, F, Storey, M, Porter, A, Snooks, H, Jones, K, Peconi, J, Sánchez, A, Siebert, S, Thorne, K, Clement, C & Russell, I 2013, 'Qualitative research within trials: developing a standard operating procedure for a clinical trials unit', Trials, vol. 14, 54, pp. 1-8. https://doi.org/10.1186/1745-6215-14-54

Qualitative research within trials : developing a standard operating procedure for a clinical trials unit. / Rapport, Frances; Storey, Mel; Porter, Alison; Snooks, Helen; Jones, Kerina; Peconi, Julie; Sánchez, Antonio; Siebert, Stefan; Thorne, Kym; Clement, Clare; Russell, Ian.

In: Trials, Vol. 14, 54, 2013, p. 1-8.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Storey, Mel

AU - Porter, Alison

AU - Snooks, Helen

AU - Jones, Kerina

AU - Peconi, Julie

AU - Sánchez, Antonio

AU - Siebert, Stefan

AU - Thorne, Kym

AU - Clement, Clare

AU - Russell, Ian

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