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Meta分析方案与发表之间报告的不一致性——一项横断面研究

Inconsistent Reporting Between Meta-analysis Protocol and Publication - A Cross-Sectional Study.

作者信息

Delgado Alberto Falk, Delgado Anna Falk

机构信息

Department of Surgical Sciences, Plastic and Reconstructive Surgery, Uppsala University, Uppsala, Sweden.

Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden

出版信息

Anticancer Res. 2017 Sep;37(9):5101-5107. doi: 10.21873/anticanres.11928.

Abstract

BACKGROUND

Inconsistent reporting in published meta-analyses compared to registered protocol are poorly understood. The aim of the study was to assess inconsistencies between registered protocols and published reports among oncology drug meta-analyses.

MATERIALS AND METHODS

A cross-sectional study was performed including oncology drug meta-analyses published between January 1st and November 14th 2016 with a published protocol. Two investigators extracted data on: selection criteria, outcome(s) and statistical plan in protocol and manuscript, plus self-acknowledgement of inconsistent reporting between protocol and publication.

RESULTS

Protocol registration was present in 19% (23/119) of all oncology drug meta-analyses. In meta-analyses with protocol (n=23), 70% (16/23) had issues with inconsistent reporting between protocol and published report concerning; inclusion criteria, comparator group, intervention, outcome (PICO) or statistical analysis. Self-acknowledgement of changes between protocol and publication was found in 50% (8/16).

CONCLUSION

In meta-analyses with protocol, discrepancies between registered protocols and publications are frequent.

摘要

背景

与注册方案相比,已发表的荟萃分析中报告不一致的情况尚未得到充分理解。本研究的目的是评估肿瘤学药物荟萃分析中注册方案与已发表报告之间的不一致性。

材料与方法

进行了一项横断面研究,纳入2016年1月1日至11月14日期间发表且有已发表方案的肿瘤学药物荟萃分析。两名研究人员提取了以下数据:方案和手稿中的纳入标准、结局和统计计划,以及方案与发表内容之间报告不一致的自我承认情况。

结果

在所有肿瘤学药物荟萃分析中,19%(23/119)有方案注册。在有方案的荟萃分析(n = 23)中,70%(16/23)在方案与已发表报告之间的报告不一致方面存在问题,涉及纳入标准、对照组、干预措施、结局(PICO)或统计分析。在50%(8/16)的研究中发现了对方案与发表内容之间变化的自我承认。

结论

在有方案的荟萃分析中,注册方案与发表内容之间的差异很常见。

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