Understanding involvement in surgical orthopaedic randomized controlled trials: A qualitative study of patient and health professional views and experiences.
Understanding involvement in surgical orthopaedic randomized controlled trials: A qualitative study of patient and health professional views and experiences.
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DOI：
10.1016/j.ijotn.2015.05.002
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发表时间：
2016-02
影响因子：
1.4
通讯作者：
Gooberman-Hill R
中科院分区：
文献类型：
--
作者：
Horwood J;Johnson E;Gooberman-Hill R
影响患者参加骨科随机对照试验 (RCT) 的动机及其经历的因素尚不完全清楚。关于医疗保健专业人员 (HCP) 参与 RCT 的经验知之甚少。本研究调查了患者和 HCP 对 RCT 参与和实施的看法和经验，为未来 RCT 的规划提供信息。对参与术中麻醉干预的单中心双盲 APEX RCT 的全髋关节或膝关节置换患者 (n = 24) 和参与试验交付的 HCP (n = 15) 进行了访谈。数据经过录音、转录、匿名处理和主题分析。尽管参与 RCT 的利他原因很常见，但患者也会权衡 RCT 的需求与参与的潜在益处，这表明了试验参与的复杂性和条件性。 HCP 对参与 RCT 感兴趣，将其作为促进医学知识进步的一种手段，并且还考虑了 RCT 参与的成本和收益。患者和 HCP 重视参与他们认为相关且有价值的随机对照试验，同时将负担降至最低。这些发现对于设计随机对照试验招募患者的方法以及规划随机对照试验如何最好地与 HCP 临床承诺结合具有重要意义。
Factors influencing patients' motivations for enrolling in, and their experiences of, orthopaedic randomized controlled trials (RCTs) are not fully understood. Less is known about healthcare professionals' (HCP) experiences of RCT involvement. This study investigates patients' and HCPs' views and experiences of RCT participation and delivery to inform the planning of future RCTs. Total hip or knee replacement patients (n = 24) participating in the single-center double-blind APEX RCTs of an intra-operative anesthetic intervention and HCPs (n = 15) involved in trial delivery were interviewed. Data were audio-recorded, transcribed, anonymized and thematically analyzed. Although altruistic reasons for RCT participation were common, patients also weighed up demands of the RCT with the potential benefits of taking part, demonstrating the complex and conditional nature of trial participation. HCPs were interested in RCT involvement as a means of contributing towards advances in medical knowledge and also considered the costs and benefits of RCT involvement. Patients and HCPs value involvement in RCTs that they see as relevant and of value, while imposing minimum burden. These findings have important implications for the design of methods to recruit patients to RCTs and for planning how an RCT might best interface with HCP clinical commitments.