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随机对照试验摘要的质量自 CONSORT 报告规范发布后是否有所提高?对四本知名麻醉学期刊的调查。

Has the quality of abstracts for randomised controlled trials improved since the release of Consolidated Standards of Reporting Trial guideline for abstract reporting? A survey of four high-profile anaesthesia journals.

机构信息

Department of Anaesthesiology and Intensive Care, Faculty of Medicine, Ankara University, Ankara, Turkey.

出版信息

Eur J Anaesthesiol. 2011 Jul;28(7):485-92. doi: 10.1097/EJA.0b013e32833fb96f.

Abstract

BACKGROUND AND OBJECTIVE

Randomised controlled trial (RCT) abstracts published in journal articles have traditionally been deficient of crucial information. To improve the quality of RCT abstracts, in January 2008, the Consolidated Standards of Reporting Trial (CONSORT) group published a checklist of essential information for inclusion. The current study assessed whether there has been an improvement in the quality of RCT abstracts published in main anaesthesia journals since this new guideline was introduced.

METHODS

Articles involving human RCTs published in four high-profile anaesthesia journals (Anaesthesia, Anesthesia & Analgesia, Anesthesiology and the European Journal of Anaesthesiology) were reviewed, comparing those published from October 2005 to September 2006 (pre-CONSORT abstracts) with those published from October 2008 to September 2009 (post-CONSORT abstracts). Trials involving healthy volunteers or cadavers, cost-effectiveness studies, meta-analyses and letters were excluded. Abstracts from remaining RCTs were randomly assigned to four reviewers in a blinded fashion and reviewed for content using the new CONSORT checklist.

RESULTS

In total, 527 RCT abstracts (pre-CONSORT RCTs, n = 275 and post-CONSORT RCTs, n = 252) were analysed. The majority of abstracts in both groups provided an appropriate description of study interventions (73.1 and 73.8%, pre-CONSORT abstracts versus post-CONSORT abstracts, respectively), objective (91.3 and 90.1%) and conclusions (72.4 and 66.3%). From pre-CONSORT to post-CONSORT guidelines for abstract reporting, there were significant improvements in correctly identifying blinding (18.2-29%) and harmful effects (31.6-42.1%). The improvement in reporting the nature of the trial in abstract titles (20.1-29%) and primary outcome measure in the methods section (22.9-30.6%) did not reach significance. There was no clear improvement in the already poor reporting of trial design, participants, randomisation, recruitment, outcomes, trial registration and funding sources.

CONCLUSIONS

Despite some promising improvements and inter-journal differences, the overall quality of RCT abstracts and adherence to the CONSORT checklist for abstracts remains poor.

摘要

背景与目的

传统上,发表在期刊文章中的随机对照试验(RCT)摘要缺乏关键信息。为了提高 RCT 摘要的质量,2008 年 1 月,CONSORT 组发布了一份包含纳入内容的基本信息清单。本研究评估了自引入新指南以来,主要麻醉学期刊发表的 RCT 摘要质量是否有所提高。

方法

回顾了发表在四份高影响力麻醉学期刊(《麻醉学》《麻醉与镇痛》《麻醉学》和《欧洲麻醉学杂志》)的涉及人体 RCT 的文章,比较了 2005 年 10 月至 2006 年 9 月(CONSORT 摘要前)和 2008 年 10 月至 2009 年 9 月(CONSORT 摘要后)发表的试验。排除涉及健康志愿者或尸体、成本效益研究、荟萃分析和信件的试验。将其余 RCT 的摘要随机分配给四名盲法评审员,并使用新的 CONSORT 清单评估内容。

结果

共分析了 527 篇 RCT 摘要(CONSORT 前 RCT 摘要 n = 275,CONSORT 后 RCT 摘要 n = 252)。两组摘要均提供了研究干预措施的适当描述(73.1%和 73.8%,CONSORT 前 RCT 摘要与 CONSORT 后 RCT 摘要相比)、目标(91.3%和 90.1%)和结论(72.4%和 66.3%)。从 CONSORT 前到 CONSORT 后指南,在正确识别盲法(18.2%-29%)和有害影响(31.6%-42.1%)方面有显著改进。在摘要标题中报告试验性质(20.1%-29%)和方法部分中主要结局测量(22.9%-30.6%)方面的改进没有达到统计学意义。试验设计、参与者、随机化、招募、结局、试验注册和资金来源等方面的报告质量仍然很差,没有明显改善。

结论

尽管有一些有希望的改进和期刊间差异,但 RCT 摘要的整体质量和对 CONSORT 摘要清单的遵循情况仍然很差。

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