Mean-making and efficacy research: A qualitative analysis to interpret the results of a randomised controlled trial. Presented at the 5th International Congress on Complementary Medicine, Tromso

Purpose: This study aimed to develop explanations for the quantitative findings of an RCT by systematically interrogating data from the nested qualitative study (narrative interviews, framework analysis). Methods: The single-blind RCT examined the efficacy of real acupuncture (and empathic consultations) for pain relief in hip and knee osteoarthritis. 27 RCT participants were purposively selected to interview, to encompass all treatment conditions. Results: Interviewees were active participants who sought to make meaning of their experiences in the trial. They wanted acupuncture and thought it might benefit them, thus subverting patient equipoise. Interviewees sought to determine whether they were receiving real treatment and drew on cues including perceived outcomes, treatment sensations, and practitioner behaviours. We outline evidence for a reciprocal process in which interviewees’ perceptions of treatment veracity and outcomes were mutually reinforcing. The most successful practitioner was seen as an authoritative doctor. Interviewees reported colluding with practitioners in nonempathic consultations, and inferred empathy from experiences associated with the trial but outside the protocol treatments. Conclusion : This nested qualitative analysis offered novel insights into the RCT findings that would not have been possible from the quantitative data alone. Conceptualising and understanding RCT subjects as active participants has important implications for trial design.