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口腔专业杂志通过积极实施 CONSORT 依从性实施策略,提高了随机临床试验报告质量。

Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting.

机构信息

American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO), Department of Orthodontics, University of Washington, D-569 HSC, Box 357446, Seattle, WA 98195-7446, US; Department of Orthodontics and Dentofacial Orthopedics, School of Dental Medicine/Medical Faculty, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland.

Clinical Epidemiology Program, Ottawa Hospital Research Institute, 725 Parkdale Ave. Ottawa, ON K1Y 4E9, Canada; Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON K1H 8M5, Canada.

出版信息

J Clin Epidemiol. 2014 Sep;67(9):1044-8. doi: 10.1016/j.jclinepi.2014.04.001. Epub 2014 May 15.

Abstract

OBJECTIVE

To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials.

STUDY DESIGN AND SETTING

The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009.

RESULTS

Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011-2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable.

CONCLUSION

Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously.

摘要

目的

描述美国口腔正畸学杂志(AJO-DO)实施的一项新的 CONSolidated Standards of Reporting Trials(CONSORT)依从性策略,并报告其对已发表试验报告完整性的影响。

研究设计与设置

AJO-DO 的 CONSORT 依从性策略始于 2011 年 6 月,涉及在编辑过程中积极评估随机临床试验(RCT)报告。比较了实施期间(2011 年 7 月至 2013 年 9 月)提交和发表的试验与 2007 年 8 月至 2009 年 7 月发表的试验之间 CONSORT 项目报告的完整性。

结果

在提交的 42 项 RCT 中(2011 年 7 月至 2013 年 9 月),有 23 项被考虑发表并评估报告的完整性,其中 7 项最终发表。对于 2007 年至 2009 年发表的所有 RCT(n=20),CONSORT 项目报告的完整性从 0%到 100%不等(中位数为 40%,四分位距为 60%)。2011-2013 年发表的所有试验均报告了 37 项 CONSORT(分项)中的 33 项。即使实施了依从性策略,4 项 CONSORT 2010 清单项目仍然存在问题:方法变更(3b)、试验开始后结局变更(6b)、中期分析(7b)和试验停止(14b),这些通常仅在适用时报告。

结论

实施 AJO-DO CONSORT 依从性策略后发表的试验比以前发表或提交的试验更完整地报告了更多的 CONSORT 项目。

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