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提高口腔健康随机试验报告的完整性和透明度:CONSORT声明。

Improving the completeness and transparency of reports of randomized trials in oral health: the CONSORT statement.

作者信息

Needleman Ian, Worthington Helen, Moher David, Schulz Ken, Altman Douglas G

机构信息

International Centre for Evidence-Based Oral Health, Unit of Periodontology, UCL Eastman Dental Institute, 256 Gray's Inn Road, London WC1X 8LD, United Kingdom.

出版信息

Am J Dent. 2008 Feb;21(1):7-12.

Abstract

PURPOSE

Randomized trials provide essential evidence of the effect of interventions in oral health. Such trials need to be appraised by readers in order to decide whether to incorporate new findings into clinical practice and policy in a timely manner. The CONSORT (Consolidated Standards of Reporting of Trials) Statement is a guidance to facilitate reporting of randomized controlled trials (RCTs) and was first introduced in 1996. The purpose of this article is to highlight the importance of rigorous reporting of trials in oral health and to discuss the impact of CONSORT on trial reporting.

RESULTS

Empirical studies demonstrate that key aspects of trial methods influence the size of estimates of studied interventions and bias is a plausible mechanism for some of this effect. Complete and transparent reporting of these methods allows appraisal of the value of trials to be undertaken and the potential for bias to be estimated. Systematic reviews have shown that the reported quality of trials in dentistry is poor, thus hindering the understanding of the value of individual trials. Since 1996, CONSORT has been adopted by hundreds of medical journals, international editorial groups, and five dental journals. A systematic review has shown that the quality of reporting of trials improves in journals that have adopted this guidance, although with significant variation, most likely due to differing levels of editorial adherence to it.

摘要

目的

随机试验为口腔健康干预效果提供了重要证据。此类试验需要读者进行评估,以便决定是否及时将新发现纳入临床实践和政策中。CONSORT(试验报告统一标准)声明是促进随机对照试验(RCT)报告的指南,于1996年首次推出。本文的目的是强调在口腔健康领域严格报告试验的重要性,并讨论CONSORT对试验报告的影响。

结果

实证研究表明,试验方法的关键方面会影响所研究干预措施估计值的大小,偏差是造成这种影响的一个可能机制。对这些方法进行完整且透明的报告,有助于对试验价值进行评估,并估计偏差的可能性。系统评价表明,牙科试验报告的质量较差,从而妨碍了对单个试验价值的理解。自1996年以来,数百种医学期刊、国际编辑团体以及五本牙科期刊采用了CONSORT。一项系统评价表明,采用该指南的期刊中试验报告的质量有所提高,尽管存在显著差异,这很可能是由于编辑对其遵循程度不同所致。

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