Kane Robert L, Wang Jye, Garrard Judith
University of Minnesota Clinical Outcomes Research Center, Minneapolis, MN 55455, USA.
J Clin Epidemiol. 2007 Mar;60(3):241-9. doi: 10.1016/j.jclinepi.2006.06.016. Epub 2006 Oct 2.
To examine the extent to which the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines improved clinical trials reporting and subject attrition, which may undermine the credibility of published randomized clinical trials (RCTs).
Published RCTs reported in two major medical journals before and after the CONSORT guidelines were systematically reviewed; one used the CONSORT statement (JAMA) and one did not (NEJM).
The quality of RCT reporting improved for both journals, but JAMA showed more significant and consistent improvements in all aspects of RCT reporting. Subject attrition was better accounted for after the publication of CONSORT, although the attrition rates for various reasons actually increased. Attrition due to unknown reasons, as a percentage of total attrition, declined dramatically, from 68.7% pre-CONSORT to 13.0% post-CONSORT.
Attrition of study subjects remains a serious problem in RCTs. Bias from selective attrition can undermine the presumptive scientific advantage of RCTs. The CONSORT guidelines improved RCT reporting when they were implemented but did not substantially improve reported attrition rates.
探讨《试验报告统一标准》（CONSORT）报告指南在多大程度上改善了临床试验报告及受试者流失情况，受试者流失可能会削弱已发表的随机临床试验（RCT）的可信度。
对CONSORT指南发布前后在两份主要医学期刊上发表的RCT进行系统综述；一份使用CONSORT声明（《美国医学会杂志》），另一份未使用（《新英格兰医学杂志》）。
两份期刊的RCT报告质量均有所提高，但《美国医学会杂志》在RCT报告的各个方面都有更显著且一致的改善。CONSORT发布后，对受试者流失情况的说明有所改善，尽管因各种原因导致的流失率实际上有所上升。因不明原因导致的流失占总流失的比例大幅下降，从CONSORT发布前的68.7%降至发布后的13.0%。
研究受试者的流失在RCT中仍然是一个严重问题。选择性流失导致的偏倚可能会削弱RCT假定的科学优势。CONSORT指南实施后改善了RCT报告，但并未大幅提高报告的流失率。
