发表在 3 种医学和外科期刊上的随机临床试验中患者和家属的代表性：系统评价。
Patient and Family Representation in Randomized Clinical Trials Published in 3 Medical and Surgical Journals: A Systematic Review.
机构信息
Division of Internal Medicine, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.
McGill Faculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada.
出版信息
JAMA Netw Open. 2022 Sep 1;5(9):e2230858. doi: 10.1001/jamanetworkopen.2022.30858.
IMPORTANCE
Patient and family engagement in research may improve the design, conduct, and dissemination of clinical research, but little is known about whether these stakeholder groups are involved in the design and conduct of randomized clinical trials.
OBJECTIVE
To characterize the involvement and role of patient and family representatives in the design and conduct of randomized clinical trials by reviewing randomized clinical trials from 3 peer-reviewed medical and surgical journals with high impact factors.
EVIDENCE REVIEW
In this systematic review, the first 50 consecutive randomized clinical trials published on or after January 1, 2021, until September 30, 2021, from each of 3 medical and surgical journals with high impact factors were reviewed for patient or family involvement in trial design and/or conduct. The manuscript, supplemental data, and trial registry records were searched for trial design and governance structures. Two independent, blinded reviewers screened citations and extracted data. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines.
FINDINGS
Only 7 of 150 randomized clinical trials (5%) reported patient or family representation in their study design or conduct. Most studies with patient or family representation (n = 5) were from a single journal. Stakeholder involvement was mainly in the execution phase (n = 7), although in 2 studies stakeholders were also involved in the translation phase.
CONCLUSIONS AND RELEVANCE
The findings of this systematic review suggest that patient or family involvement in the design and conduct of randomized clinical trials in the publications with high impact factors is lacking. We found that when patient or family groups are involved in research, the focus was mainly on the execution phase of research design. There is a need to increase stakeholder involvement in the research design, conduct, and translation of randomized clinical trials.
重要性
患者和家属参与研究可能会改进临床研究的设计、实施和传播，但对于这些利益相关者群体是否参与随机临床试验的设计和实施知之甚少。
目的
通过审查来自 3 种具有高影响力因素的同行评审医学和外科期刊的随机临床试验，描述和确定患者和家属代表在随机临床试验设计和实施中的参与情况和作用。
证据回顾
在这项系统评价中，回顾了 2021 年 1 月 1 日或之后至 2021 年 9 月 30 日期间，3 种具有高影响力因素的医学和外科期刊上发表的前 50 项连续随机临床试验，以了解患者或家属是否参与试验设计和/或实施。对手稿、补充数据和试验注册记录进行了检索，以寻找试验设计和治理结构。两名独立的、盲目的评审员筛选了引用和提取了数据。本研究遵循系统评价和荟萃分析的首选报告项目 (PRISMA) 指南。
发现
只有 150 项随机临床试验中的 7 项（5%）报告了患者或家属在其研究设计或实施中的代表。大多数有患者或家属代表的研究（n=5）来自单一期刊。利益相关者的参与主要在执行阶段（n=7），尽管在 2 项研究中，利益相关者也参与了研究设计的翻译阶段。
结论和相关性
这项系统评价的结果表明，在具有高影响力因素的出版物中，随机临床试验的设计和实施中缺乏患者或家属的参与。我们发现，当患者或家属群体参与研究时，重点主要是研究设计的执行阶段。需要增加利益相关者对随机临床试验的研究设计、实施和翻译的参与。
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