INSERM, UMR1153 Epidemiology and Biostatistics Research Center (CRESS), Methods of Therapeutic Evaluation of Chronic Diseases Team (METHODS), F-75004 Paris, France; Faculté de Médecine, Université Paris Descartes, France; Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP (Assistance Publique des Hôpitaux de Paris), Paris, France.
INSERM, UMR1153 Epidemiology and Biostatistics Research Center (CRESS), Methods of Therapeutic Evaluation of Chronic Diseases Team (METHODS), F-75004 Paris, France; Faculté de Médecine, Université Paris Descartes, France; Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP (Assistance Publique des Hôpitaux de Paris), Paris, France; Cochrane France, Paris, France.
J Clin Epidemiol. 2019 Sep;113:168-175. doi: 10.1016/j.jclinepi.2019.05.030. Epub 2019 May 30.
Our aim was to determine the coverage of randomized controlled trials (RCTs) by the Consolidated Standards of Reporting Trial (CONSORT) Statement and its extensions and to evaluate the potential workload for authors to adhere to the guidelines.
We identified CONSORT extensions from the CONSORT Web site. We randomly selected a sample of 1,000 RCTs indexed in PubMed in 2016 and recorded whether they were covered by CONSORT extensions for specific study designs or interventions. We evaluated the potential workload for authors by counting the number of documents and pages they have to consult to have a full understanding of the guidelines.
We identified 14 extensions. Only one extension was updated concurrently with the main CONSORT in 2010, three were updated after 2-7 years, and three are still based on CONSORT 2001. Overall, 81% of RCTs are covered by relevant CONSORT guidelines; missing extensions for specific study designs were under development at the time of the search (Nov 2018). However, 6 of 10 extensions covered <2% of the trials. A median [Q1-Q3] of 4 [4-5] documents and 67 [57-78] pages should be consulted.
Most RCTs indexed in PubMed are covered by the CONSORT Statement and extensions, but the potential workload for authors could be high.
本研究旨在确定随机对照试验（RCT）被 CONSORT 声明及其扩展涵盖的范围，并评估作者遵守指南的潜在工作量。
我们从 CONSORT 网站确定了 CONSORT 扩展。我们随机抽取了 2016 年在 PubMed 中索引的 1000 项 RCT 样本，并记录它们是否涵盖了特定研究设计或干预措施的 CONSORT 扩展。我们通过计算作者需要查阅的文件和页面数量来评估作者的潜在工作量，以全面了解指南。
我们确定了 14 个扩展。只有一个扩展在 2010 年与主要 CONSORT 同时更新，三个在 2-7 年后更新，三个仍基于 CONSORT 2001。总体而言，81%的 RCT 都有相关的 CONSORT 指南涵盖；在搜索时（2018 年 11 月），特定研究设计的缺失扩展正在开发中。然而，覆盖 <2%的试验的扩展只有 6 个。中位数[Q1-Q3]为 4 [4-5]份文件和 67 [57-78]页。
PubMed 索引的大多数 RCT 都被 CONSORT 声明及其扩展涵盖，但作者的潜在工作量可能很高。
