Bunzli Samantha, Nelson Elizabeth, Wall Laura, Schilling Chris, Lohmander L Stefan, Balogh Zsolt J, Tran Phong, Paolucci Francesco, Clarke Philip, Choong Peter F M, Dowsey Michelle M
From the Department of Surgery, St. Vincent's Hospital Melbourne, The University of Melbourne, Melbourne, VIC, Australia.
Newcastle Business School, The University of Newcastle Faculty of Business and Law, Newcastle, NSW, Australia.
Ann Surg Open. 2021 Nov 4;2(4):e104. doi: 10.1097/AS9.0000000000000104. eCollection 2021 Dec.
To investigate the factors underlying willingness to participate in a hypothetical trial among patients and surgeons, to inform the design of future placebo surgery controlled trials.
Placebo surgery controlled trials are the gold standard for testing the efficacy of surgical procedures. However, these trials commonly fail to meet the target sample size and terminate underpowered.
From October 2019 to July 2020, eligible patients were identified from the orthopedic waiting list at a single tertiary hospital and surgeons were identified from orthopedic clinics at three tertiary hospitals in Australia. Qualitative interviews explored factors underlying willingness to participate in a hypothetical trial, including understanding of trial concepts; attitudes; and trial design preferences. Data collection and analysis were conducted in parallel. Recruitment ceased when no new concepts emerged. Interview data were analyzed using reflexive thematic analysis.
The majority of surgeons and only a few patients indicated a willingness to participate in a placebo surgery controlled trial. Factors underlying willingness were captured in four themes: (1) Understanding and attitudes toward placebo; (2) Attitudes towards randomization/perception of equipoise; (3) Perception of risk; and (4) Ethical concerns.
To optimize recruitment in the future, trialists may consider embedding strategies into the recruitment process that validate patients' symptoms, encourage an altruistic mindset, address surgeon biases, and involve surgeons in explaining trial concepts to patients. Trialists may also consider designing three arm trials that meet surgeons' preferences for a "low" and "high" fidelity placebo.
调查患者和外科医生参与一项假设性试验的意愿背后的因素，为未来安慰剂手术对照试验的设计提供参考。
安慰剂手术对照试验是测试手术程序疗效的金标准。然而，这些试验通常未能达到目标样本量并在效能不足的情况下终止。
2019年10月至2020年7月，从一家三级医院的骨科候诊名单中确定符合条件的患者，并从澳大利亚三家三级医院的骨科诊所中确定外科医生。定性访谈探讨了参与假设性试验意愿背后的因素，包括对试验概念的理解、态度和试验设计偏好。数据收集和分析并行进行。当没有新的概念出现时停止招募。访谈数据采用反思性主题分析进行分析。
大多数外科医生和只有少数患者表示愿意参与安慰剂手术对照试验。意愿背后的因素归纳为四个主题：（1）对安慰剂的理解和态度；（2）对随机化的态度/对 equipoise 的认知；（3）对风险的认知；（4）伦理问题。
为了在未来优化招募，试验者可能会考虑在招募过程中嵌入一些策略，这些策略可以验证患者的症状、鼓励利他心态、解决外科医生的偏见，并让外科医生参与向患者解释试验概念。试验者还可以考虑设计满足外科医生对“低”和“高”保真度安慰剂偏好的三臂试验。
