ABSTRACT
BACKGROUND: Engaging in clinical research includes confronting challenges about the uncertainty around outcomes and ramifications the results may have on practice. This is pertinent for osteopathy where little is known about the experiences of osteopaths involved in clinical trials. The aim of this study was to explore the lived experience of osteopaths who participated in a randomised controlled trial for infantile colic. The study was informed by a principles-based approach to clinical ethics and their application to practice. DESIGN: Qualitative study using semi-structured interviews and reflexive thematic analysis. SETTING: An international two-arm pragmatic randomised controlled trial (the CUTIES trial) to evaluate the effectiveness of osteopathic care for infantile colic. METHODS: A principles-based approach to clinical ethics and their application to practice for osteopaths asked to make decisions about participating in a clinical trial was used. Osteopaths from the UK and Australia who completed the CUTIES trial training were invited to be interviewed about their experiences, regardless of whether they went on to recruit infants in the trial. Interviewees were asked about their reasons for wanting to participate in the CUTIES trial, why they decided to continue or not to continue in the trial and, for those who completed the trial, their personal experiences as participants in the trial. Data were analysed using reflexive thematic analysis. RESULTS: Nine osteopaths were interviewed. Three themes were identified from the data: Paradigm dilemma - observed clinical outcomes vs scientific evidence for mechanism of effects; trial-related ethical dilemmas; and trial outcome dilemmas. CONCLUSION: Participating in the CUTIES trial required osteopaths to overcome clinical ethical dilemmas for the benefit of patients, the research, and the profession.
