The Role of Qualitative Research in Clinical Trial Development: The EASE Back Study

Holden

doi:10.1177/1558689816656740

The Role of Qualitative Research in Clinical Trial Development: The EASE Back Study

Holden

Authors

Melanie Holden m.holden@keele.ac.uk

Abstract

This article outlines the rationale for adopting a mixed methods approach within randomized controlled trials (RCTs) and explores challenges associated in doing so. Taking the example of the EASE Back feasibility and pilot study (Evaluating Acupuncture and Standard care for pregnant womEn with BACK pain: ISRCTN49955124), we detail why and how we operationalized a concurrent-sequential mixed methods research design. We present key findings from the exploratory research (focus groups and interviews) and explain how these were integrated with descriptive findings (a national survey of physical therapists) in order to inform and refine the design of the explanatory phase (the pilot RCT). We conclude with a discussion of lessons learned and implications for future research design and conduct.

Acceptance Date	May 23, 2016
Publication Date	Jul 13, 2016
Journal	Journal of Mixed Methods Research
Print ISSN	1558-6898
Publisher	SAGE Publications
Pages	325-343
DOI	https://doi.org/10.1177/1558689816656740
Keywords	pregnancy-related back pain; acupuncture; randomised controlled trials; mixed methods research; interdisciplinary health research
Publisher URL	https://doi.org/10.1177/1558689816656740

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The Role of Qualitative Research in Clinical Trial Development: The EASE Back Study

Holden

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Abstract

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