Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China; Key Laboratory of Evidence-Based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, China.
Gansu University of Chinese Medicine, Lanzhou 730000, China.
J Clin Epidemiol. 2021 Mar;131:59-69. doi: 10.1016/j.jclinepi.2020.11.009. Epub 2020 Nov 21.
The objective of the study was to assess inconsistencies between individual protocols and associated full-text publications in the development of core outcome sets (COSs).
Protocols and subsequent full-text publications were retrieved by searching the following electronic databases: PubMed, Embase, Web of Science, and the Core Outcome Measures in Effectiveness Trials database from inception to October 1, 2019. We summarized changes in the general and methodological characteristics by comparing the protocols with the full-text publications and reported change as information frequency and proportion.
A total of 24 protocols and 32 corresponding full-text publications that encompassed 14 study topics were identified from databases. In the identified initial list of outcomes, five COSs (20.8%) changed the included study type, none of which explained the reasons for these changes. In addition, eight COSs showed inconsistencies between the protocols and full-text publications in the searched databases, of which, only two studies explained the reasons for these changes. Compared with the protocols, three COSs changed the number of Delphi rounds, eight COSs changed the participants (stakeholder groups), and three COSs changed the consensus definition of the Delphi survey. Only two COSs explained the reason for changing the number of Delphi rounds, and none of the studies explained why the participants changed. For the face-to-face consensus meeting, we found that nine COSs changed the participants and none explained the reasons for these changes.
Our study found many inconsistencies between protocols and the full-text publications concerning COS development. These inconsistencies related to the included study types, databases searched, Delphi surveys, and face-to-face consensus meetings. As it is necessary to publish protocols before developing COSs, transparency regarding any changes to the methods is needed.
本研究旨在评估核心结局集（COS）制定过程中各方案与其相关全文出版物之间的不一致性。
通过检索以下电子数据库，检索方案和随后的全文出版物：PubMed、Embase、Web of Science 和核心结局测量在有效性试验数据库，从成立到 2019 年 10 月 1 日。我们通过比较方案与全文出版物，总结了一般和方法学特征的变化，并报告了变化信息的频率和比例。
从数据库中确定了 24 项方案和 32 项相应的全文出版物，涵盖了 14 个研究主题。在确定的初始结局清单中，有 5 个 COS（20.8%）改变了纳入的研究类型，但没有一个解释了这些变化的原因。此外，在搜索数据库中，有 8 个 COS 方案与全文出版物之间存在不一致，其中只有 2 项研究解释了这些变化的原因。与方案相比，有 3 个 COS 改变了 Delphi 轮数，8 个 COS 改变了参与者（利益相关者群体），3 个 COS 改变了 Delphi 调查的共识定义。只有 2 个 COS 解释了改变 Delphi 轮数的原因，没有研究解释参与者为何发生变化。对于面对面共识会议，我们发现有 9 个 COS 改变了参与者，没有一个解释这些变化的原因。
我们的研究发现，COS 制定过程中方案与全文出版物之间存在许多不一致性。这些不一致性与纳入的研究类型、搜索的数据库、Delphi 调查和面对面共识会议有关。由于在制定 COS 之前需要发表方案，因此需要对方法的任何变化保持透明。
