Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
CLEAR Methods Center, Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
JAMA Netw Open. 2023 Jun 1;6(6):e2317651. doi: 10.1001/jamanetworkopen.2023.17651.
Numerous studies have shown that adherence to reporting guidelines is suboptimal.
To evaluate whether asking peer reviewers to check if specific reporting guideline items were adequately reported would improve adherence to reporting guidelines in published articles.
DESIGN, SETTING, AND PARTICIPANTS: Two parallel-group, superiority randomized trials were performed using manuscripts submitted to 7 biomedical journals (5 from the BMJ Publishing Group and 2 from the Public Library of Science) as the unit of randomization, with peer reviewers allocated to the intervention or control group.
The first trial (CONSORT-PR) focused on manuscripts that presented randomized clinical trial (RCT) results and reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline, and the second trial (SPIRIT-PR) focused on manuscripts that presented RCT protocols and reported following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline. The CONSORT-PR trial included manuscripts that described RCT primary results (submitted July 2019 to July 2021). The SPIRIT-PR trial included manuscripts that contained RCT protocols (submitted June 2020 to May 2021). Manuscripts in both trials were randomized (1:1) to the intervention or control group; the control group received usual journal practice. In the intervention group of both trials, peer reviewers received an email from the journal that asked them to check whether the 10 most important and poorly reported CONSORT (for CONSORT-PR) or SPIRIT (for SPIRIT-PR) items were adequately reported in the manuscript. Peer reviewers and authors were not informed of the purpose of the study, and outcome assessors were blinded.
The difference in the mean proportion of adequately reported 10 CONSORT or SPIRIT items between the intervention and control groups in published articles.
In the CONSORT-PR trial, 510 manuscripts were randomized. Of those, 243 were published (122 in the intervention group and 121 in the control group). A mean proportion of 69.3% (95% CI, 66.0%-72.7%) of the 10 CONSORT items were adequately reported in the intervention group and 66.6% (95% CI, 62.5%-70.7%) in the control group (mean difference, 2.7%; 95% CI, -2.6% to 8.0%). In the SPIRIT-PR trial, of the 244 randomized manuscripts, 178 were published (90 in the intervention group and 88 in the control group). A mean proportion of 46.1% (95% CI, 41.8%-50.4%) of the 10 SPIRIT items were adequately reported in the intervention group and 45.6% (95% CI, 41.7% to 49.4%) in the control group (mean difference, 0.5%; 95% CI, -5.2% to 6.3%).
These 2 randomized trials found that it was not useful to implement the tested intervention to increase reporting completeness in published articles. Other interventions should be assessed and considered in the future.
ClinicalTrials.gov Identifiers: NCT05820971 (CONSORT-PR) and NCT05820984 (SPIRIT-PR).
许多研究表明，对报告指南的遵守情况并不理想。
评估让同行评审员检查特定报告指南项目是否得到充分报告，是否会提高已发表文章对报告指南的遵守程度。
设计、设置和参与者：使用提交给 7 种生物医学期刊（5 种来自 BMJ 出版集团，2 种来自公共科学图书馆）的手稿作为随机分组单位，进行了两项平行组、优势随机试验，将同行评审员分配到干预组或对照组。
第一项试验（CONSORT-PR）重点关注报告随机临床试验（RCT）结果并遵循《临床试验报告统一标准》（CONSORT）指南的手稿，第二项试验（SPIRIT-PR）重点关注报告 RCT 方案并遵循《干预性临床试验标准议定书项目：建议》（SPIRIT）指南的手稿。CONSORT-PR 试验包括描述 RCT 主要结果的手稿（2019 年 7 月至 2021 年 7 月提交）。SPIRIT-PR 试验包括包含 RCT 方案的手稿（2020 年 6 月至 2021 年 5 月提交）。两项试验中的手稿均随机（1:1）分配到干预组或对照组；对照组接受常规期刊实践。在两项试验的干预组中，同行评审员收到期刊的电子邮件，要求他们检查手稿中 10 个最重要和报告最差的 CONSORT（对于 CONSORT-PR）或 SPIRIT（对于 SPIRIT-PR）项目是否得到充分报告。同行评审员和作者均未被告知研究目的，结果评估者被设盲。
发表文章中干预组和对照组之间充分报告的 10 个 CONSORT 或 SPIRIT 项目的平均比例差异。
在 CONSORT-PR 试验中，随机分配了 510 篇手稿。其中，243 篇发表（干预组 122 篇，对照组 121 篇）。干预组 10 项 CONSORT 项目中，充分报告的比例平均为 69.3%（95%CI，66.0%-72.7%），对照组为 66.6%（95%CI，62.5%-70.7%）（平均差异，2.7%；95%CI，-2.6%至 8.0%）。在 SPIRIT-PR 试验中，244 篇随机手稿中，178 篇发表（干预组 90 篇，对照组 88 篇）。干预组中充分报告的 10 项 SPIRIT 项目的平均比例为 46.1%（95%CI，41.8%-50.4%），对照组为 45.6%（95%CI，41.7%至 49.4%）（平均差异，0.5%；95%CI，-5.2%至 6.3%）。
这两项随机试验发现，实施经过测试的干预措施来提高已发表文章的报告完整性是没有用的。未来应评估和考虑其他干预措施。
ClinicalTrials.gov 标识符：NCT05820971（CONSORT-PR）和 NCT05820984（SPIRIT-PR）。
