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许多随机试验和系统评价中存在选择性纳入和报告结果的情况。

Many scenarios exist for selective inclusion and reporting of results in randomized trials and systematic reviews.

机构信息

School of Public Health and Preventive Medicine, Monash University, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne, Victoria 3004, Australia.

出版信息

J Clin Epidemiol. 2013 May;66(5):524-37. doi: 10.1016/j.jclinepi.2012.10.010. Epub 2013 Jan 18.

Abstract

OBJECTIVE

To collate and categorize the ways in which selective inclusion and reporting can occur in randomized controlled trials (RCTs) and systematic reviews.

STUDY DESIGN AND SETTING

Searches of the Cochrane Methodology Register, PubMed, and PsycInfo were conducted in April 2011. Methodological reports describing empirically investigated or hypothetical examples of selective inclusion or reporting were eligible for inclusion. Examples were extracted from the reports by one author and categorized by three authors independently. Discrepancies in categorization were resolved via discussion.

RESULTS

Two hundred ninety reports were included. The majority were empirical method studies (45.5%) or commentaries (29.3%). Eight categories (30 examples) of selective reporting in RCTs, eight categories (27 examples) of selective inclusion in systematic reviews, and eight categories (33 examples) of selective reporting in systematic reviews were collated. Broadly, these describe scenarios in which multiple outcomes or multiple data for the same outcome are available, yet only a subset is included or reported; outcome data are reported with inadequate detail; or outcome data are given different prominence through its placement across or within reports.

CONCLUSION

An extensive list of examples of selective inclusion and reporting was collated. Increasing trialists' and systematic reviewers' awareness of these examples may minimize their occurrence.

摘要

目的

整理和分类随机对照试验(RCT)和系统评价中选择性纳入和报告可能出现的方式。

研究设计和设置

2011 年 4 月对 Cochrane 方法学注册库、PubMed 和 PsycInfo 进行了检索。有资格纳入描述经验性调查或假设选择性纳入或报告示例的方法学报告。一个作者从报告中提取示例,并由三个作者独立进行分类。通过讨论解决分类差异。

结果

纳入了 290 份报告。其中大多数是经验方法研究(45.5%)或评论(29.3%)。整理出 RCT 中选择性报告的 8 个类别(30 个示例)、系统评价中选择性纳入的 8 个类别(27 个示例)和系统评价中选择性报告的 8 个类别(33 个示例)。这些广泛描述了多种结局或同一结局的多种数据可用,但只纳入或报告了一部分;结局数据报告细节不足;或者结局数据通过在报告中的位置或在报告内的位置给予不同的突出程度。

结论

整理出大量选择性纳入和报告的示例。提高试验者和系统评价者对这些示例的认识,可能会最大限度地减少其发生。

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