The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed.
The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed.
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DOI：
10.1136/bmj.c723
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发表时间：
2010-03-23
期刊：
影响因子：
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通讯作者：
Altman DG
中科院分区：
文献类型：
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作者：
Hopewell S;Dutton S;Yu LM;Chan AW;Altman DG
目的：研究2000年和2006年PubMed收录的随机试验的报告特点和方法细节，并评估2001年《综合试验报告标准（CONSORT）声明》出版后报告质量是否有所提高。两项横断面调查的设计比较。2000年12月（n=519）和2006年12月（n=616） PubMed检索的所有随机试验的主要报告，包括平行组、交叉、聚类、析因和分离体研究设计。主要结果测量报告的一般和方法学项目的比例，按年份和研究设计分层。以95%置信区间计算风险比，以表示2000年至2006年间报告的变化。结果大多数试验为双组(2000年为379/519 （73%)vs 2006年为468/616(76%)）和发表在专业期刊上的平行组研究(383/519 (74%)vs 477/616 (78%)) (482/519 （93%) vs 555/616(90%)）。在2000年和2006年，在平行组试验中，每个试验平均招募80名参与者。2000年至2006年间，报道药物试验的文章比例下降（从393/519（76%）降至356/616(58%)），而报道手术试验的文章比例上升(51/519 （10%)vs 128/616(21%)）。2000年至2006年间，包括主要结局（风险比（RR） 1.18, 95% CI 1.04至1.33）、样本量计算（RR 1.66, 95% CI 1.40至1.95）、随机序列生成方法（RR 1.62, 95% CI 1.32至1.97）和分配隐藏（RR 1.40, 95% CI 1.11至1.76）的试验报告比例有所增加。提供盲法患者具体细节的试验比例没有差异（RR 0.91, 95% CI 0.75至1.10）。2000年至2006年期间试验方法的几个重要方面的报告有所改善；但是，报告的质量仍然远远低于可接受的水平。如果没有完整和透明的试验设计和实施的报告，读者很难评估其行为和有效性。
Objectives To examine the reporting characteristics and methodological details of randomised trials indexed in PubMed in 2000 and 2006 and assess whether the quality of reporting has improved after publication of the Consolidated Standards of Reporting Trials (CONSORT) Statement in 2001. Design Comparison of two cross sectional investigations. Study sample All primary reports of randomised trials indexed in PubMed in December 2000 (n=519) and December 2006 (n=616), including parallel group, crossover, cluster, factorial, and split body study designs. Main outcome measures The proportion of general and methodological items reported, stratified by year and study design. Risk ratios with 95% confidence intervals were calculated to represent changes in reporting between 2000 and 2006. Results The majority of trials were two arm (379/519 (73%) in 2000 v 468/616 (76%) in 2006) parallel group studies (383/519 (74%) v 477/616 (78%)) published in specialty journals (482/519 (93%) v 555/616 (90%)). In both 2000 and 2006, a median of 80 participants were recruited per trial for parallel group trials. The proportion of articles that reported drug trials decreased between 2000 and 2006 (from 393/519 (76%) to 356/616 (58%)), whereas the proportion of surgery trials increased (51/519 (10%) v 128/616 (21%)). There was an increase between 2000 and 2006 in the proportion of trial reports that included details of the primary outcome (risk ratio (RR) 1.18, 95% CI 1.04 to 1.33), sample size calculation (RR 1.66, 95% CI 1.40 to 1.95), and the methods of random sequence generation (RR 1.62, 95% CI 1.32 to 1.97) and allocation concealment (RR 1.40, 95% CI 1.11 to 1.76). There was no difference in the proportion of trials that provided specific details on who was blinded (RR 0.91, 95% CI 0.75 to 1.10). Conclusions Reporting of several important aspects of trial methods improved between 2000 and 2006; however, the quality of reporting remains well below an acceptable level. Without complete and transparent reporting of how a trial was designed and conducted, it is difficult for readers to assess its conduct and validity.