Zhang Zhongheng, Wang Stephen D, Li Grace S, Kong Guilan, Gu Hongqiu, Alfonso Fernando
Department of Emergency Medicine, Sir Run-Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310016, China.
AME Publishing Company, Hong Kong, China.
Ann Transl Med. 2019 Dec;7(24):812. doi: 10.21037/atm.2019.12.96.
The past decade has witnessed a rapid increase in the number of contributors per article, which has made explicitly defining the roles of each contributor even more challenging. The Contributor Roles Taxonomy (CRediT) was developed to explicitly define author roles, but there is a lack of empirical data on how CRediT is used in clinical trials. This study aimed to provide empirical data on the use of CRediT in randomized controlled trials (RCTs) and discuss some limitations of CRediT. A new taxonomy (CRediT-RCT) is proposed to explicitly define the author roles in RCTs.
The electronic database of PubMed was searched from July 2017 to October 2019 to identify component trials with a randomized controlled design. Publications from the Public Library of Science (PLoS) were included because they embed the CRediT roles within the authors' metadata rather than solely as a separate paragraph of text.
A total of 446 articles involving 4,185 authors were included in the study. Most authors participated in the study's conceptualization (44.9%) and investigation (48.8%), but only a fraction of the authors participated in software management (7.4%). Many CRediT roles were correlated with each other: the strongest correlation was the one between funding acquisition and conceptualization (correlation metric =0.39), followed by the one between conceptualization and methodology (0.37). The authors who acquired funding (OR: 2.06; 95% CI: 1.54-2.76; P<0.001), did project administration (OR: 1.54; 95% CI: 1.17-2.03; P=0.002), performed supervision (OR: 2. 60; 95% CI: 1.93-3.52; P<0.001), wrote the original draft (OR: 4.83; 95% CI: 3.54-6.60; P<0.001), or were the first author (OR: 7.85; 95% CI: 5.71-10.87; P<0.001), were more likely to be the corresponding author. Also, while the original draft writing was significantly associated with the designation of the first author (OR: 37.49; 95% CI: 25.29-57.57; P<0.001), the first author did not perform review and editing (OR: 0.55; 95% CI: 0.40-0.75; P<0.001), supervision (OR: 0.49; 95% CI: 0.36-0.67; P<0.001), or resource management (OR: 0.71; 95% CI: 0.50-1.00; P=0.053). We further propose a novel Contributor Roles Taxonomy for Randomized Controlled Trials (CRediT-RCT) which includes 10 roles.
The present study provides empirical data on the use of CRediT for RCTs, and some limitations of the taxonomy are discussed. We further propose a new CRediT-RCT which includes 10 roles.
在过去十年中，每篇文章的作者数量迅速增加，这使得明确界定每位作者的角色更具挑战性。贡献者角色分类法（CRediT）旨在明确界定作者角色，但缺乏关于CRediT在临床试验中如何使用的实证数据。本研究旨在提供关于CRediT在随机对照试验（RCT）中使用情况的实证数据，并讨论CRediT的一些局限性。我们提出了一种新的分类法（CRediT-RCT），以明确界定RCT中的作者角色。
检索2017年7月至2019年10月期间PubMed的电子数据库，以识别采用随机对照设计的组成试验。纳入了来自科学公共图书馆（PLoS）的出版物，因为它们将CRediT角色嵌入作者的元数据中，而不是仅作为单独的一段文本。
该研究共纳入446篇文章，涉及4185位作者。大多数作者参与了研究的概念化（44.9%）和调查（48.8%），但只有一小部分作者参与了软件管理（7.4%）。许多CRediT角色之间相互关联：最强的关联是资金获取与概念化之间的关联（相关系数=0.39），其次是概念化与方法学之间的关联（0.37）。获得资金的作者（比值比：2.06；95%置信区间：1.54-2.76；P<0.001）、进行项目管理的作者（比值比：1.54；95%置信区间：1.17-2.03；P=0.002）、进行监督的作者（比值比：2.60；95%置信区间：1.93-3.52；P<0.001）、撰写初稿的作者（比值比：4.83；95%置信区间：3.54-6.60；P<0.001）或第一作者（比值比：7.85；95%置信区间：5.71-10.87；P<0.001）更有可能成为通讯作者。此外，虽然撰写初稿与第一作者的指定显著相关（比值比：37.49；95%置信区间：25.29-57.57；P<0.001），但第一作者不进行审核和编辑（比值比：0.55；95%置信区间：0.40-0.75；P<0.001）、监督（比值比：0.49；95%置信区间：0.36-0.67；P<0.001）或资源管理（比值比：0.71；95%置信区间：0.50-1.00；P=0.053）。我们进一步提出了一种新的随机对照试验贡献者角色分类法（CRediT-RCT），其中包括10个角色。
本研究提供了关于CRediT在RCT中使用情况的实证数据，并讨论了该分类法的一些局限性。我们进一步提出了一种新的CRediT-RCT，其中包括10个角色。
