NDORMS, University of Oxford, Oxford, UK.
NDORMS, University of Oxford, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, UK.
Soc Sci Med. 2020 May;253:112961. doi: 10.1016/j.socscimed.2020.112961. Epub 2020 Mar 27.
Randomised controlled trials (RCTs) of surgical interventions are increasing. Such trials encounter challenges that are not present in RCTs of non-surgical interventions because of the nature of the intervention. Several studies have explored patients' experiences of surgical trials to improve recruitment or identify barriers and facilitators to research in this setting. Synthesizing these studies may reveal further insights or confirm whether saturation of relevant themes has been achieved.
This review aimed to understand the experiences of adults who are invited to participate in surgical RCTs.
MEDLINE, Web of Science, and CINAHL were searched to identify articles meeting the inclusion criteria. Assessment of quality was conducted with studies given an overall quality rating of good, fair, or poor. A segregated approach was used to synthesize the data. This method included a thematic synthesis of the qualitative data and a narrative review of the quantitative data. The findings of both syntheses were then integrated.
Thirty-four articles reporting 28 trials were included. This review found that the decision to participate in a surgical trial is influenced by multiple factors including patients' individual circumstances and attitudes, and the characteristics of the trial itself. The study identified three themes which encompass both qualitative and quantitative findings. These themes reveal it was important for patients to i) make sense of the trial and trial processes, ii) weigh up the risks and benefits of their different treatment options and participation, and iii) trust the trial and staff.
A patient-centred approach to trial recruitment may help staff build trusting relationships with patients and address their individual concerns about the trial and the risks and benefits of participation.
随机对照试验（RCT）的外科干预措施越来越多。由于干预措施的性质，这些试验遇到了非外科干预 RCT 中不存在的挑战。有几项研究探讨了患者对手术试验的体验，以改善招募或确定该环境下研究的障碍和促进因素。综合这些研究可能会揭示进一步的见解或证实相关主题是否已经达到饱和。
本综述旨在了解受邀参加外科 RCT 的成年人的经验。
检索 MEDLINE、Web of Science 和 CINAHL，以确定符合纳入标准的文章。对研究进行了整体质量评估，分为良好、中等或较差。采用单独的方法对数据进行综合。该方法包括对定性数据进行主题综合分析和对定量数据进行叙述性综述。然后将两种综合的结果进行整合。
34 篇报告 28 项试验的文章被纳入。本综述发现，参与外科试验的决定受到多种因素的影响，包括患者的个人情况和态度，以及试验本身的特点。研究确定了三个主题，包括定性和定量研究结果。这些主题揭示了患者需要 i）理解试验和试验过程，ii）权衡不同治疗方案和参与的风险和益处，以及 iii）信任试验和工作人员，这一点很重要。
以患者为中心的试验招募方法可能有助于工作人员与患者建立信任关系，并解决他们对试验以及参与的风险和益处的个人关注。
