近日，比利时鲁汶大学教授Tom Adriaenssens及其研究组提出，主要医学期刊随机对照试验及其研究方案中患者与公众参与度的演变：一项Meta流行病学评价。2025年4月10日出版的《英国医学杂志》发表了这项成果。

目的：调查在主要医学期刊及其试验方案中随时间发表的随机对照试验中患者和公众参与（PPI）的报告和演变。

设计：Meta流行病学评价。

数据来源：检索PubMed检索自2015年以来在四大顶级医学期刊上发表的报告随机对照试验的文章及其相应的同行评议协议。

入选标准：入选每年在各期刊上发表的前10项随机对照试验。

数据提取：数据提取的重点是涉及的利益相关者、PPI活动/过程的描述和程度，以及对PPI贡献的认可。对已发表的文章和方案进行评估，以确定两者报告的PPI的一致性。

结果：在360篇报道随机对照试验和299个相关方案的已发表文章中，PPI仅在64篇（18%）文章和56篇（19%）方案中报道。当报告PPI时，患者及其代表主要参与其中，最常见的PPI活动是参加试验委员会(44/64篇PPI报告文章；39/56协议)。PPI主要发生在试验开发阶段，包括对研究的反馈、资料审核及评估可行性。方案偶尔会比已发表的文章提供更详细的信息，但在大多数情况下，PPI的贡献通常是模糊的，没有关于随机对照试验中具体结果和对决策的影响的详细信息。在已发表的文章中，对PPI贡献的认可更为频繁(n=37；58%)比方案(n=18；32%)，主要是在致谢部分。

结论：本研究发现，在主要医学期刊及其各自的研究方案中发表的随机对照试验中，PPI报告的数量有限，这强调了在临床研究中需要一致、详细和透明的PPI报告实践。

附：英文原文

Title: Evolution of reported patient and public involvement over time in randomised controlled trials in major medical journals and in their protocols: meta-epidemiological evaluation

Author: Alice Vanneste, Io Wens, Peter Sinnaeve, Claudia Louati, Isabelle Huys, John P A Ioannidis, Tom Adriaenssens

Issue&Volume: 2025/04/10

Abstract: Objective To investigate the reporting and evolution of patient and public involvement (PPI) in randomised controlled trials published over time in major medical journals and in their trial protocols.

Design Meta-epidemiological evaluation.

Data source PubMed was searched for articles reporting randomised controlled trials published since 2015 in four major medical journals and their corresponding peer reviewed protocols.

Eligibility criteria for selecting studies The first 10 randomised controlled trials published each year in each journal were included.

Data extraction Data extraction focused on involved stakeholders, description and extent of PPI activities/processes, and recognition of PPI contributions. Published articles and protocols were assessed for consistency of the reported PPI in both.

Results Of the 360 published articles reporting randomised controlled trials and 299 respective protocols, PPI was only reported in 64 (18%) articles and 56 (19%) protocols. When PPI was reported, patients and their representatives were mainly involved, with the most common PPI activity being participation in trial committees (44/64 PPI reporting articles; 39/56 protocols). PPI primarily occurred during the trial development phase, including feedback on study design, review of study materials, and assessment of feasibility. Protocols occasionally had more detailed information than the published articles, but in most cases the PPI contributions were often vague without detailed information on specific outcomes and the effect on decision making within the randomised controlled trial. Recognition of PPI contributions was more frequent in published articles (n=37; 58%) than in protocols (n=18; 32%), mainly in the acknowledgment section.

Conclusion This study found limited PPI reported in randomised controlled trials published in major medical journals and in their respective protocols, underscoring the need for consistent, detailed, and transparent PPI reporting practices in clinical research.

DOI: 10.1136/bmj-2024-082697

Source: https://www.bmj.com/content/389/bmj-2024-082697