Aims Surgeon and patient reluctance to participate are potential significant barriers to conducting placebo-controlled trials of orthopaedic surgery. Understanding the preferences of orthopaedic surgeons and patients regarding the design of randomized placebo-controlled trials (RCT-Ps) of knee procedures can help to identify what RCT-P features will lead to the greatest participation. This information could inform future trial designs and feasibility assessments. Methods This study used two discrete choice experiments (DCEs) to determine which features of RCT-Ps of knee procedures influence surgeon and patient participation. A mixed-methods approach informed the DCE development. The DCEs were analyzed with a baseline category multinomial logit model. Results The proportion of respondents (surgeons n = 103; patients n = 140) who would not participate in any of the DCE choice sets (surgeons = 31%; patients = 40%), and the proportion who would participate in all (surgeons = 18%; patients = 30%), indicated strong views regarding the conduct of RCT-Ps. There were three main findings: for both surgeons and patients, studies which involved an arthroscopic procedure were more likely to result in participation than those with a total knee arthroplasty; as the age (for patients) and years of experience (for surgeons) increased, the overall likelihood of participation decreased; and, for surgeons, offering authorship and input into the RCT-P design was preferred for less experienced surgeons, while only completing the procedure was preferred by more experienced surgeons. Conclusion Patients and surgeons have strong views regarding participation in RCT-Ps. However, understanding their preferences can inform future trial designs and feasibility assessments with regard to recruitment rates.

中文翻译：

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愿意参加膝关节的安慰剂对照手术试验。


目的 外科医生和患者不愿意参与是进行骨科手术安慰剂对照试验的潜在重大障碍。了解骨科医生和患者对膝关节手术随机安慰剂对照试验 （RCT-Ps） 设计的偏好，有助于确定哪些 RCT-P 特征将导致最大的参与。这些信息可以为未来的试验设计和可行性评估提供信息。方法 本研究使用两个离散选择实验 （DCE） 来确定膝关节手术的 RCT-P 的哪些特征会影响外科医生和患者的参与。混合方法为 DCE 开发提供了信息。使用基线类别多项式 logit 模型分析 DCE。结果：不会参加任何 DCE 选择集的受访者比例 （外科医生 = 103;患者 n = 140） 和愿意参与所有选择集的比例 （外科医生 = 18%;患者 = 30%），表明对 RCT-P 的实施有强烈的看法。有三个主要发现：对于外科医生和患者来说，涉及关节镜手术的研究比全膝关节置换术的研究更有可能参与;随着年龄 （患者） 和经验年限 （外科医生） 的增加，参与的总体可能性降低;对于外科医生来说，经验不足的外科医生更倾向于为 RCT-P 设计提供作者身份和投入，而更有经验的外科医生更倾向于只完成手术。结论 患者和外科医生对参与 RCT-P 有强烈的看法。 然而，了解他们的偏好可以为未来的试验设计和招募率的可行性评估提供信息。