The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence
The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence
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DOI：
10.1186/s12916-019-1476-5
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发表时间：
2020-01-20
期刊：
影响因子：
9.3
通讯作者：
Boutron, Isabelle
中科院分区：
文献类型：
--
作者：
Naidoo, Nivantha;Nguyen, Van Thu;Boutron, Isabelle
背景参与随机对照试验(RCT)可能要求很高，并可能成为患者的重要负担。我们的目的是探索患者通过参与随机对照试验所经历的研究负担(即心理、身体和经济负担)。方法对定性研究进行系统回顾，探讨成人患者参与RCT治疗的经验。我们在MEDLINE(PubMed)、CINAHL、ousinfo和Embase(搜索日期为2018年3月)上搜索符合条件的报告。NVivo协助对定性数据进行编码和索引。使用关键评估技能计划(CASP)工具对报告质量进行评估。结果我们纳入了45项定性研究，涉及1732名随机对照试验参与者。在试验过程的每个阶段都发现了重要的心理负担。参与者报告说，他们感到焦虑和害怕“成为一只‘豚鼠’”，并描述说，接受随机分组和分配给安慰剂特别困难，会导致失望、愤怒和抑郁。患者的随访和试验结束也造成了广泛的心理、身体和经济负担。此外，还查明了与负担沉重的影响和后果有关的因素。这些因素包括试验信息、组织不善和要求过高的后续行动，以及在患者参与结束时缺乏适当的管理。参与试验还与有益的效果有关，例如感到“有用”的满足感，获得“控制感”，以及受到特别关注。结论：我们的发现提供了整个随机对照试验过程中研究负担的详细描述。所描述的许多负担是可以预见的，有些是在迈向最小干扰临床研究的运动中避免的。这种办法可以改善试用期征聘和留用。审查注册PROSPERO CRD42018098994
Background Participation in randomized controlled trials (RCTs) may be quite demanding and could represent an important burden for patients. We aimed to explore this research burden (i.e., the psychological, physical, and financial burdens) experienced by patients through their participation in a RCT. Methods We conducted a systematic review of qualitative studies exploring adult patients' experiences with RCT participation. We searched MEDLINE (PubMed), CINAHL, PSYCHINFO, and Embase (search date March 2018) for eligible reports. Qualitative data coding and indexing were assisted by NVivo. The quality of reports was assessed by using the Critical Appraisal Skills Program (CASP) tool. Results We included 45 qualitative studies that involved 1732 RCT participants. Important psychological burdens were identified at every stage of the trial process. Participants reported feeling anxiety and being afraid of "being a 'guinea pig'" and described undergoing randomization and allocation to a placebo as particularly difficult resulting in disappointment, anger, and depression. Patients' follow-up and trial closure were also responsible for a wide range of psychological, physical, and financial burdens. Furthermore, factors related to burdensome impacts and consequences were discerned. These factors involved trial information, poorly organized and too-demanding follow-up, and lack of appropriate management when the patient's participation ended. Trial participation was also associated with beneficial effects such as the satisfaction of feeling "useful," gaining "a sense of control," and receiving special attention. Conclusions Our finding provides a detailed description of research burden across the whole RCT process. Many of the burdens described could be anticipated, and some avoided in a movement toward minimally disruptive clinical research. Such an approach could improve trial recruitment and retention. Review registration PROSPERO CRD42018098994