加拿大多伦多总医院Mustafa Al-Durra研究组近日取得一项新成果。他们分析了随机临床试验中的前瞻性注册和试验编号报告。相关论文于2020年4月14日发表于《英国医学杂志》上。
为了评估已发表的随机临床试验（RCT）是否符合前瞻性注册并包含试验注册号（TRN），分析背后原因，并检查回顾性试验注册是否有选择性偏倚，研究组进行了一项全球性横断面研究。
研究组使用的数据源自PubMed、世卫组织（WHO）的17个试验注册机构、多伦多大学图书馆、国际医学期刊编辑委员会（ICMJE）成员期刊列表以及期刊引文报告，筛选2018年在WHO注册试验，且在Pubmed任意期刊上发表的试验论文。
最终确定了在2105个期刊上发表的10500篇论文。总体而言，有71.2％的论文报告了TRN，41.7%进行了前瞻性试验注册。单变量和多变量分析表明报告TRN与出版期刊的影响因子和ICMJE成员之间存在显著相关性。
前瞻性试验注册与注册、地区、条件、经费、试验规模、论文注册与投稿日期之间的间隔、期刊影响因子和期刊的ICMJE成员之间也有显著相关性。在ICMJE成员期刊上发表的论文中包含TRN的可能性是其他期刊的5.8倍，而在ICMJE成员期刊上发表的试验进行前瞻性注册的可能性是其他期刊的1.8倍。
这项研究发现了一种新形式的偏倚，即选择性注册偏倚，在提交发表后的一年内，有较高比例（85.2%）的试验进行了回顾性注册。在研究参与者入组后的前3-8周内观察到较高的回顾性注册率。
在286个回顾性注册并在ICMJE成员期刊上发表的RCT中，只有2.8%的作者发表了声明，来证明延迟注册的正当性。原因包括缺乏意识、遗漏错误以及注册过程花费了比预期更长的时间。
总之，在ICMJE成员期刊上发表试验论文的TRN报告具有较高的依从性，但前瞻性试验注册率较低。
附：英文原文
Title: Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations
Author: Mustafa Al-Durra, Robert P Nolan, Emily Seto, Joseph A Cafazzo
Issue&Volume: 2020/04/14
Abstract: Abstract
Objectives To evaluate the compliance with prospective registration and inclusion of the trial registration number (TRN) in published randomised controlled trials (RCTs), and to analyse the rationale behind, and detect selective registration bias in, retrospective trial registration.
Design Cross sectional analysis.
Data sources PubMed, the 17 World Health Organization’s trial registries, University of Toronto library, International Committee of Medical Journal Editors (ICMJE) list of member journals, and the InCites Journal Citation Reports.
Study selection criteria RCTs registered in any WHO trial registry and published in any PubMed indexed journal in 2018.
Results This study included 10500 manuscripts published in 2105 journals. Overall, 71.2% (7473/10500) reported the TRN and 41.7% (3013/7218) complied with prospective trial registration. The univariable and multivariable analyses reported significant relations (P<0.05) between reporting the TRN and the impact factor and ICMJE membership of the publishing journal. A significant relation (P<0.05) was also observed between prospective trial registration and the registry, region, condition, funding, trial size, interval between paper registration and submission dates, impact factor, and ICMJE membership of the publishing journal. A manuscript published in an ICMJE member journal was 5.8 times more likely to include the TRN (odds ratio 5.8, 95% confidence interval 4.0 to 8.2), and a published trial was 1.8 times more likely to be registered prospectively (1.8, 1.5 to 2.2) when published in an ICMJE member journal compared with other journals. This study detected a new form of bias, selective registration bias, with a higher proportion (85.2% (616/723)) of trials registered retrospectively within a year of submission for publication. Higher rates of retrospective registrations were observed within the first three to eight weeks after enrolment of study participants. Within the 286 RCTs registered retrospectively and published in an ICMJE member journal, only 2.8% (8/286) of the authors included a statement justifying the delayed registration. Reasons included lack of awareness, error of omission, and the registration process taking longer than anticipated.
Conclusions This study found a high compliance in reporting of the TRN for trial papers published in ICMJE member journals, but prospective trial registration was low.
DOI: 10.1136/bmj.m982
Source: https://www.bmj.com/content/369/bmj.m982
BMJ-British Medical Journal:《英国医学杂志》，创刊于1840年。隶属于BMJ出版集团，最新IF：93.333
官方网址：http://www.bmj.com/
投稿链接：https://mc.manuscriptcentral.com/bmj
本期文章：《英国医学杂志》：Online/在线发表
