Centre for Statistics in Medicine, University of Oxford, Linton Road, Oxford OX2 6UD.
BMJ. 2010 Mar 23;340:c723. doi: 10.1136/bmj.c723.
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.
目的： 检查 2000 年和 2006 年在 PubMed 索引的随机试验的报告特征和方法学细节，并评估在 2001 年 CONSORT 报告标准发布后报告质量是否有所提高。
设计： 两项横断面研究的比较。 研究样本 2000 年 12 月（n=519）和 2006 年 12 月（n=616）在 PubMed 索引的所有随机试验的主要报告，包括平行组、交叉、群组、析因和分体研究设计。
主要结局指标： 按年份和研究设计分层报告的一般和方法项目的比例。 使用 95%置信区间的风险比来表示 2000 年至 2006 年报告的变化。
结果： 大多数试验为两臂（2000 年为 379/519（73%），2006 年为 468/616（76%））平行组研究（383/519（74%），477/616（78%））发表在专业期刊上（383/519（74%），482/616（93%））。 在 2000 年和 2006 年，每个平行组试验的中位数招募了 80 名参与者。 报告药物试验的文章比例在 2000 年至 2006 年间下降（从 393/519（76%）降至 356/616（58%）），而手术试验的比例增加（51/519（10%），128/616（21%））。 2000 年至 2006 年间，包括主要结局（风险比（RR）1.18，95%置信区间 1.04 至 1.33）、样本量计算（RR 1.66，95%置信区间 1.40 至 1.95）、随机序列生成（RR 1.62，95%置信区间 1.32 至 1.97）和分配隐藏（RR 1.40，95%置信区间 1.11 至 1.76）详细信息的试验报告比例有所增加。 没有关于谁被蒙蔽的具体细节的试验比例没有差异（RR 0.91，95%置信区间 0.75 至 1.10）。
结论： 2000 年至 2006 年间，试验方法的几个重要方面的报告有所改善；然而，报告的质量仍然远低于可接受的水平。 如果没有对试验设计和实施的完整和透明报告，读者就很难评估其实施和有效性。
Hematol Oncol Stem Cell Ther. 2008
Contemp Clin Trials. 2005-8
Plast Reconstr Surg Glob Open. 2024-10-11
JMIR Ment Health. 2024-4-25
BJPsych Open. 2024-3-7
Med J Islam Repub Iran. 2023-9-4
J Clin Endocrinol Metab. 2008-10
Zotero 插件
