盆腔器官脱垂随机对照试验的报告质量
The quality of reporting of randomized controlled trials in pelvic organ prolapse.
作者信息
Cavadas Vítor, Branco Frederico, Carvalho Filipe L, Osório Luís, Gomes Mário J, Silva-Ramos Miguel
机构信息
Department of Urology, Centro Hospitalar do Porto, Porto, Portugal.
出版信息
Int Urogynecol J. 2011 Sep;22(9):1117-25. doi: 10.1007/s00192-011-1426-z. Epub 2011 Apr 12.
INTRODUCTION AND HYPOTHESIS
Randomized controlled trials (RCTs) must comply with the strict rules of design and conduct and their reporting should reflect it. Our aim was to evaluate how the quality of RCT reporting in pelvic organ prolapse (POP) has evolved.
METHODS
RCTs in POP published between 1997 and 2010 were retrieved through a PubMed search. The quality of reporting was assessed by applying the 2010 revised Consolidated Standards of Reporting Trials (CONSORT) statement. Appropriate statistical analysis was performed.
RESULTS
Forty-one RCTs were identified for review. The implementation of randomization, recruitment, blinding, outcomes with effect size and precision, trial registration, and full protocol availability were reported in less than half of the trials. Comparing two periods (1997-2006 and 2007-2010), there was no improvement in the quality of reporting for any of the CONSORT criteria.
CONCLUSIONS
RCTs in POP are scarce. The quality of reporting is suboptimal in many aspects and has not improved in recent years.
引言与假设
随机对照试验（RCT）必须遵循严格的设计与实施规则，其报告也应体现这一点。我们的目的是评估盆腔器官脱垂（POP）随机对照试验报告的质量是如何演变的。
方法
通过PubMed检索1997年至2010年间发表的POP随机对照试验。采用2010年修订的《报告试验的统一标准》（CONSORT）声明评估报告质量，并进行适当的统计分析。
结果
共确定41项随机对照试验进行综述。不到一半的试验报告了随机化、招募、盲法、效应量和精密度的结果、试验注册以及完整方案的可用性。比较两个时期（1997 - 2006年和2007 - 2010年），CONSORT标准的任何一项报告质量均未改善。
结论
POP随机对照试验较少。报告质量在许多方面欠佳，且近年来没有改善。
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