Butt F A, Nunez-Nunez M, Juhász B, Bueno-Cavanillas A, Khan K S
University of Granada, Department of Preventive Medicine and Public Health, Spain.
Biosanitary Research Institute of Granada (ibs.Granada), Granada, Spain; Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP), Madrid, Spain.
Semergen. 2025 Mar;51(2):102333. doi: 10.1016/j.semerg.2024.102333. Epub 2024 Dec 9.
Randomised clinical trials (RCTs) hold the highest validity level in effectiveness research. However, there is a growing concern regarding their trustworthiness. We aimed to appraise the quality and reporting of recommendation documents regarding research integrity to describe their contribution towards fostering RCT integrity.
Following prospective registration (https://doi.org/10.17605/OSF.IO/DN93K), searches of electronic databases (Scopus, PubMed, Google Scholar) and relevant websites were performed from inception to 30 July 2023 without language limitations. Data extraction and document appraisal using adapted versions of AGREE II, RIGHT and ACCORD checklists were carried out in duplicate. Appraisal data were synthesised as % of the maximum score and documents were classified as: good≥70%, average 50-69%, and poor<50%.
From 1310 citations 14 recommendation documents were selected. Of these, 11 documents (78%) were of poor quality according to all three appraisal checklists. Reviewer agreement was 86-100% regarding the checklist items. The top three documents were: "International multi-stakeholder consensus statement on clinical trial integrity" (score 70% on AGREE II, 96% on RIGHT and 88% on ACCORD); "Development of consensus on essential virtues for ethics and research integrity" (score 51% on AGREE II, 71% on RIGHT and 77% on ACCORD); and "Hong Kong principles for assessing researchers" (score 19% on AGREE II, 57% on RIGHT and 10% on ACCORD).
There is a room from improvement in the quality and reporting of recommendation documents to help fostering RCT integrity. All stakeholders in the RCT lifecycle making concerted efforts to improve trust in evidence-based medicine need robust guidance to underpin research integrity policies and guidelines.
随机临床试验（RCT）在有效性研究中具有最高的效度水平。然而，人们对其可信度的担忧日益增加。我们旨在评估关于研究诚信的推荐文件的质量和报告情况，以描述它们对促进RCT诚信的贡献。
在进行前瞻性注册（https://doi.org/10.17605/OSF.IO/DN93K）后，于2023年7月30日前对电子数据库（Scopus、PubMed、谷歌学术）和相关网站进行了检索，无语言限制。使用AGREE II、RIGHT和ACCORD清单的改编版本进行数据提取和文件评估，由两人独立进行。评估数据综合为最高分的百分比，文件分为：良好≥70%、中等50 - 69%和差<50%。
从1310条引用中筛选出14份推荐文件。其中，根据所有三项评估清单，11份文件（78%）质量较差。评审员在清单项目上的一致性为86 - 100%。排名前三的文件分别是：《关于临床试验诚信的国际多利益相关者共识声明》（AGREE II评分为70%，RIGHT评分为96%，ACCORD评分为88%）；《关于伦理与研究诚信基本美德的共识发展》（AGREE II评分为51%，RIGHT评分为71%，ACCORD评分为77%）；以及《香港研究人员评估原则》（AGREE II评分为19%，RIGHT评分为57%，ACCORD评分为10%）。
推荐文件的质量和报告情况有改进空间，以帮助促进RCT诚信。RCT生命周期中的所有利益相关者若要共同努力提高对循证医学的信任，需要有力的指导来支持研究诚信政策和指南。
