Acupuncture for osteoarthritis: A qualitative analysis to interpret the results of a randomised controlled trial

Abstract

Objective To develop explanations for the quantitative findings of an RCT by systematically interrogating data from the nested qualitative study. Design Qualitative study (narrative interviews and framework analysis) nested within an RCT. Participants A total of 27 RCT participants were purposively selected to interview, to encompass all treatment conditions. Setting The single-blind RCT examined the efficacy of real acupuncture for pain relief in hip and knee osteoarthritis. Patients were randomised to 3 treatment conditions (real acupuncture vs 2 placebo treatments) and 2 consultation conditions (empathic vs non-empathic). The study involved 3 experienced acupuncturists who delivered all interventions. Findings Interviewees were active participants who sought to make meaning of their experiences in the trial. They wanted to try 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. Evidence for a reciprocal process is outlined 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 non-empathic consultations, and inferred empathy from experiences associated with the trial but outside the protocol treatments. Conclusions 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 particularly for interventions such as acupuncture when equipoise is unlikely.