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.
METHODS: Qualitative study using semi-structured interviews and reflexive thematic analysis.
METHODS: 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.
CONCLUSIONS: Participating in the CUTIES trial required osteopaths to overcome clinical ethical dilemmas for the benefit of patients, the research, and the profession.
METHODS: Qualitative study using semi-structured interviews and reflexive thematic analysis.
METHODS: 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.
CONCLUSIONS: Participating in the CUTIES trial required osteopaths to overcome clinical ethical dilemmas for the benefit of patients, the research, and the profession.
摘要：
背景：参与临床研究包括面临关于结果的不确定性和结果在实践中可能产生的后果的挑战。这与骨病有关，对临床试验中涉及的骨病的经验知之甚少。这项研究的目的是探索参与小儿绞痛随机对照试验的骨科医生的生活经历。该研究基于基于原则的临床伦理学方法及其在实践中的应用。
方法：使用半结构化访谈和反身主题分析的定性研究。
方法：一项国际双臂实用随机对照试验（CUTIES试验），旨在评估骨科治疗婴儿绞痛的有效性。
方法：采用了基于原则的临床伦理学方法，并将其应用于被要求做出参与临床试验决定的骨科医生的实践。来自英国和澳大利亚的完成了CUTIES试验培训的骨科医生被邀请接受关于他们的经历的采访。无论他们是否继续在试验中招募婴儿。受访者被问及他们想要参加CUTIES审判的原因，为什么他们决定继续或不继续审判，对于那些完成审判的人来说，他们作为试验参与者的个人经历。使用反身性主题分析对数据进行了分析。
结果：对9名骨科医生进行了访谈。从数据中确定了三个主题：范式困境-观察到的临床结果与影响机制的科学证据；与试验相关的伦理困境；和试验结果困境。
结论：参与CUTIES试验需要骨科医生克服临床伦理困境，以造福患者，研究,和职业。
方法：使用半结构化访谈和反身主题分析的定性研究。
方法：一项国际双臂实用随机对照试验（CUTIES试验），旨在评估骨科治疗婴儿绞痛的有效性。
方法：采用了基于原则的临床伦理学方法，并将其应用于被要求做出参与临床试验决定的骨科医生的实践。来自英国和澳大利亚的完成了CUTIES试验培训的骨科医生被邀请接受关于他们的经历的采访。无论他们是否继续在试验中招募婴儿。受访者被问及他们想要参加CUTIES审判的原因，为什么他们决定继续或不继续审判，对于那些完成审判的人来说，他们作为试验参与者的个人经历。使用反身性主题分析对数据进行了分析。
结果：对9名骨科医生进行了访谈。从数据中确定了三个主题：范式困境-观察到的临床结果与影响机制的科学证据；与试验相关的伦理困境；和试验结果困境。
结论：参与CUTIES试验需要骨科医生克服临床伦理困境，以造福患者，研究,和职业。
