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肥胖症研究中随机对照试验的注册状态和方法学报告:综述。

Registration status and methodological reporting of randomized controlled trials in obesity research: A review.

机构信息

Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.

Autism Research Centre, Glenrose Rehabilitation Hospital, Alberta Health Services, Edmonton, Alberta, Canada.

出版信息

Obesity (Silver Spring). 2017 Apr;25(4):665-670. doi: 10.1002/oby.21784. Epub 2017 Mar 11.

DOI:10.1002/oby.21784
PMID:28294560
Abstract

OBJECTIVE

To assess registration and reporting details of randomized controlled trials (RCTs) published from 2011 to 2016 across four obesity journals.

METHODS

All issues from four leading obesity journals were searched systematically for RCTs from January 2011 to June 2016. Data on registration status were extracted from manuscripts, online trial registries, and a trial database; corresponding authors were contacted for registration details, when necessary. The methodological reporting of RCTs was assessed on specific criteria from the Consolidated Standards of Reporting Trials.

RESULTS

A total of 223 RCTs were reviewed. Three-quarters (n = 170) were registered publicly; 94 (55.3%) reported registration details in the manuscript, and 82 (48.2%) were registered prospectively. Newer RCTs were more likely to be registered prospectively than older RCTs (2014-2016: 57.3% vs. 2011-2013: 39.2%; c  = 5.5, P = 0.02). Assessment on the Consolidated Standards of Reporting Trials demonstrated that less than half of all studies reported data collection dates (n = 108; 48.4%) or included "randomized trial" in the title (n = 89; 39.9%).

CONCLUSIONS

The methodological reporting of RCTs published in obesity journals is suboptimal, despite current guidelines and policies. To complement existing standards, editorial boards should incorporate mandatory fields within the online manuscript submission process to enhance the quality, transparency, and comprehensiveness of reporting RCTs in obesity journals.

摘要

目的

评估 2011 年至 2016 年期间在四份肥胖期刊上发表的随机对照试验(RCT)的注册和报告详情。

方法

系统搜索四份主要肥胖期刊的所有问题,以获取 2011 年 1 月至 2016 年 6 月的 RCT。从手稿、在线试验注册处和试验数据库中提取注册状态数据;在必要时联系主要作者以获取注册详细信息。根据《临床试验报告统一标准》的具体标准评估 RCT 的方法学报告。

结果

共审查了 223 项 RCT。四分之三(n=170)进行了公开注册;94 项(55.3%)在稿件中报告了注册详细信息,82 项(48.2%)进行了前瞻性注册。较新的 RCT 比旧 RCT 更有可能进行前瞻性注册(2014-2016:57.3%比 2011-2013:39.2%;c=5.5,P=0.02)。根据《临床试验报告统一标准》评估,不到一半的研究报告了数据收集日期(n=108;48.4%)或在标题中包含“随机试验”(n=89;39.9%)。

结论

尽管有现行指南和政策,但肥胖期刊上发表的 RCT 的方法学报告仍不理想。为了补充现有标准,编辑委员会应在在线稿件提交过程中纳入强制性字段,以提高肥胖期刊中 RCT 报告的质量、透明度和全面性。

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