神经外科学随机对照试验报告标准。

Standards for reporting randomized controlled trials in neurosurgery.

机构信息

Department of Neurosurgery, University of Virginia Health System, Charlottesville, Virginia, USA.

出版信息

J Neurosurg. 2011 Feb;114(2):280-5. doi: 10.3171/2010.8.JNS091770. Epub 2010 Nov 5.

DOI:10.3171/2010.8.JNS091770

PMID:21054137

Abstract

OBJECT

The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials.

METHODS

The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist.

RESULTS

In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p < 0.0001). Jadad scores were also significantly higher for the major medical journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05).

CONCLUSIONS

Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could improve the methodology and reporting of RCTs in neurosurgery.

摘要

目的

《临床试验报告统一标准》（CONSORT）于 1996 年发布，旨在规范临床试验报告并提高其质量。尽管该标准已被主要医学期刊认可，并已证明可提高报告临床试验的质量，但神经外科期刊尚未正式采用这些报告标准。本研究旨在评估神经外科随机对照试验（RCT）的质量和报告情况，以及可能影响报告试验质量的因素。

方法

作者评估了 2006 年和 2007 年在主要神经外科期刊（《神经外科杂志》、《神经外科》、《神经外科学杂志》、《神经病学、神经外科学与精神病学杂志》和《神经外科学纪事》）和 3 种主要普通医学期刊（《美国医学会杂志》、《柳叶刀》和《新英格兰医学杂志》）上发表的所有神经外科 RCT。本分析纳入了涉及手术决策或神经外科患者治疗的 RCT。使用 Jadad 评分和 CONSORT 清单评估 RCT 质量。

结果

2006 年和 2007 年，报道了 27 项与颅内神经外科相关的 RCT。这些试验中，仅有 59%的试验 Jadad 评分≥3。3 种主要医学期刊均认可 CONSORT 指南，而没有一种神经外科期刊采用这些指南。发表在 3 种主要医学期刊上的 RCT 的平均 CONSORT 评分明显更高（平均 41，范围 39-44），而发表在神经外科期刊上的 RCT 平均 CONSORT 评分较低（平均 26.4，范围 17-38；p＜0.0001）。主要医学期刊的 Jadad 评分也明显高于神经外科期刊（平均 3.42，范围 2-5；p=0.05）。