Quality of Reporting in Randomized Trials Published in High-Quality Surgical Journals
Quality of Reporting in Randomized Trials Published in High-Quality Surgical Journals
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DOI：
10.1016/j.jamcollsurg.2009.07.019
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发表时间：
2009-11-01
影响因子：
5.2
通讯作者：
Grocott, Michael P. W.
中科院分区：
文献类型：
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作者：
Sinha, Sidhartha;Sinha, Shrestha;Grocott, Michael P. W.
背景：外科随机对照试验（RCT）如果设计良好、执行得当并得到充分报告，可以为干预措施的有效性提供有价值的证据。众所周知，外科随机对照试验的方法学报告不够充分，而且外科研究中的不良事件报告也不一致。报告试验综合标准 (CONSORT) 声明是一个帮助作者以透明方式报告其发现的框架。最近发布了 CONSORT 声明的扩展，以解决不良事件报告和与非药物治疗相关的具体标准报告方面的缺陷。本研究的目的是使用 CONSORT 声明中指定的标准，评估高质量外科期刊上发表的普通外科 RCT 样本的试验方法和不良事件的报告质量。研究设计：我们使用影响因子来确定 2004 年排名前三的外科期刊。然后，我们获得了 2005 日历年在这些期刊上发表的所有 RCT 的信息。我们使用 Jadad 评分评估报告质量，比较 CONS ORT 认可期刊与非认可期刊的 RCT 质量，并评估充分报告关键通用方法学、不良事件相关和特定非药理学标准的 RCT 数量。 结果：在分析的 42 个 RCT 中，只有 40%（42 个中的 17 个）的 Jadad 评分 >= 3。高质量 RCT 的数量没有显着差异与非认可期刊相比，发表在 CONSORT 认可的期刊上 (p = 0.3)。充分报告通用方法学、不良事件相关和特定非药物标准的随机对照试验的中位百分比分别为 32.5%、17% 和 36.5%。 结论：外科随机对照试验中通用方法学、不良事件相关和特定非药物标准的报告质量较差。如果研究要满足已发布的标准，就需要更加关注外科随机对照试验的报告质量。 （J Am Coll Surg 2009；209：565-571。(C) 2009 年，美国外科医师学会）
BACKGROUND: Randomized controlled trials (RCTs) in surgery can provide valuable evidence of the efficacy of interventions if they are well-designed, appropriately executed, and adequately reported. Adequate reporting of methodology in surgical RCTs is known to be poor, and adverse-event reporting in surgical research is inconsistent. The Consolidated Standards of Reporting Trials (CONSORT) statement is a framework to help authors report their findings in a transparent manner. Extensions to the CONSORT statement have been published recently to address deficiencies in adverse-event reporting and in reporting of specific criteria related to nonpharmacologic treatments. The aim of this study was to assess the quality of reporting of trial methodology and adverse events in a sample of general surgical RCTs published in high-quality surgical journals using the criteria specified in the CONSORT statements.STUDY DESIGN: We used Impact factor to identify the top three ranked surgical journals in 2004. We then obtained information on all RCTs published in these journals in the 2005 calendar year. We assessed quality of reporting using Jadad score, compared the quality of RCTs from CONS ORT-endorsing journals with nonendorsers, and assessed the number of RCTs adequately reporting key generic methodologic, adverse-event-related, and specific nonpharmacologic criteria.RESULTS: Of 42 RCTs analyzed, only 40% (17 of 42) had a Jadad score >= 3. There was no significant difference in the number of high-quality RCTs published in CONSORT-endorsing journals compared with nonendorsers (p = 0.3). The median percentage of RCTs adequately reporting generic methodologic, adverse-event-related, and specific nonpharmacologic criteria was 32.5%, 17%, and 36.5%, respectively.CONCLUSIONS: Quality of reporting of generic methodologic, adverse-event-related, and specific nonpharmacologic criteria in surgical RCTs is poor. Increased attention to quality of reporting of surgical RCTs is required If studies are to meet published criteria. (J Am Coll Surg 2009;209:565-571. (C) 2009 by the American College of Surgeons)