Use of the CONSORT statement and quality of reports of randomized trials - A comparative before-and-after evaluation
Use of the CONSORT statement and quality of reports of randomized trials - A comparative before-and-after evaluation
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DOI：
10.1001/jama.285.15.1992
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发表时间：
2001-04-18
影响因子：
120.7
通讯作者：
Lepage, L
中科院分区：
文献类型：
--
作者：
Moher, D;Jones, A;Lepage, L
背景 试验报告综合标准 (CONSORT) 声明的制定是为了帮助提高随机对照试验 (RCT) 报告的质量。迄今为止，关于是否实现这一目标的数据还很少。 目的 确定 CONSORT 语句的使用是否与 RCT 报告质量的提高相关。 设计和设置 前后比较评估，将 1994 年发表的 RCT 报告（CONSORT 前）与 1998 年（CONSORT 后）发表的同一期刊的 RCT 报告进行比较。我们纳入了 BMI、JAMA 和 The RCT 的 211 份报告。 《柳叶刀》（采用 CONSORT 的期刊）和《新英格兰医学杂志》（未采用 CONSORT 的期刊，用作对照）。主要指标：报告中 CONSORT 项目数、分配隐藏报告不明确的频率、基于 5 分质量评估工具 Jadad 量表的总体试验质量评分。 结果 与 1994 年相比，RCT 报告中 CONSORT 检查表项目数1998 年，所有 4 种期刊的变化率均有所增加，并且对于 3 种采用者期刊而言，这种增长具有统计显着性（CONSORT 前，23.4；平均变化，3.7；95% 置信区间 [CI]，2.1-5.3）。 4 种期刊中每一种期刊的分配隐藏报告不明确的频率均有所下降，这种变化对于采用者期刊具有统计显着性（CONSORT 前，61%，平均变化，-22%；95% CI，-38% 至 -6%）。同样，4 种期刊中的 3 种显示 RCT 报告的质量得分有所提高，这种增加对于采用者期刊整体而言具有统计显着性（CONSORT 前，2.7；平均变化， 0.4；95% CI，0.1-0.8）。结论 CONSORT 语句的使用与 RCT 报告质量的提高相关。
Context The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to help improve the quality of reports of randomized controlled trials (RCTs). To date, a paucity of data exists regarding whether it has achieved this goal.Objective To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs.Design and Setting Comparative before-and-after evaluation in which reports of RCTs published in 1994 (pre-CONSORT) were compared with RCT reports from the same journals published in 1998 (post-CONSORT), We included 211 reports from BMI, JAMA, and The Lancet (journals that adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator).Main Outcome Measures Number of CONSORT items included in a report, frequency of unclear reporting of allocation concealment, and overall trial quality score based on the Jadad scale, a 5-point quality assessment instrument.Results Compared with 1994, the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998, and this increase was statistically significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7; 95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals, and this change was statistically significant for adopters (pre-CONSORT, 61%, mean change, -22%; 95% CI, -38% to -6%), Similarly, 3 of the 4 journals showed an improvement in the quality score for reports of RCTs, and this increase was statistically significant for adopter journals overall (pre-CONSORT, 2.7; mean change, 0.4; 95% CI, 0.1-0.8).Conclusion Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs.