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.
