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神经外科学文献中的证据水平:困难多于试验。

Levels of evidence in the neurosurgical literature: more tribulations than trials.

机构信息

Division of Neurosurgery, McMaster University, Hamilton, Ontario, Canada.

出版信息

Neurosurgery. 2012 Dec;71(6):1131-7; discussion 1137-8. doi: 10.1227/NEU.0b013e318271bc99.

Abstract

BACKGROUND

The importance of evidence-based medicine has been well documented and supported across various surgical subspecialties.

OBJECTIVE

To quantify the levels of evidence across publications in the neurosurgical literature, to assess the change in evidence over time, and to indicate predictive factors of higher-level evidence.

METHODS

We reviewed the levels of evidence across published clinical studies in 3 neurosurgical journals from 2009 to 2010. Randomized trials were evaluated by use of the Detsky quality of reporting scale. Levels-of-evidence data for the same journals in 1999 were obtained from the literature, and regression analysis was performed to identify predictive factors for higher-level evidence.

RESULTS

Of 660 eligible articles, 14 (2.1%) were Level I, 54 (8.2%) were level II, 73 (11.1%) were Level III, 287 (43.5%) were level IV, and 232 (35.2%) were level V. The number of level I studies decreased significantly between 1999 and 2010 (3.4% vs. 2.1%, respectively; P = .01). Seven randomized clinical trials were identified, and 1 trial had significant methodological limitations (mean Detsky index = 16.3; SD = 1.8). Publications with larger sample size were significantly associated with higher levels of evidence (levels I and II; odds ratio, 1.7; 95% confidence interval, 1.45-2.05; P = .001). The ratio of higher levels of evidence to lower levels was 0.11.

CONCLUSION

Higher levels of evidence (levels I and II) represent only 1 in 10 neurosurgical clinical papers in the top neurosurgical journals. Increased awareness of the need for better evidence in the field through education and adoption of the levels of evidence may improve the conduct and publication of prospective studies.

摘要

背景

循证医学的重要性已在各个外科亚专业得到充分证明和支持。

目的

量化神经外科学文献中出版物的证据水平,评估随时间推移的证据变化,并指出更高证据水平的预测因素。

方法

我们回顾了 2009 年至 2010 年 3 种神经外科学杂志上发表的临床研究的证据水平。使用 Detsky 报告质量量表评估随机试验。从文献中获得了 1999 年相同杂志的证据水平数据,并进行回归分析以确定更高证据水平的预测因素。

结果

在 660 篇合格文章中,14 篇(2.1%)为 I 级,54 篇(8.2%)为 II 级,73 篇(11.1%)为 III 级,287 篇(43.5%)为 IV 级,232 篇(35.2%)为 V 级。I 级研究数量在 1999 年至 2010 年之间显著下降(分别为 3.4%和 2.1%;P = .01)。确定了 7 项随机临床试验,其中 1 项试验存在明显的方法学局限性(平均 Detsky 指数=16.3;标准差=1.8)。样本量较大的出版物与更高水平的证据显著相关(I 级和 II 级;优势比,1.7;95%置信区间,1.45-2.05;P = .001)。较高证据水平与较低证据水平的比例为 0.11。

结论

在顶级神经外科学杂志上,只有 1/10 的神经外科学临床论文属于较高证据水平(I 级和 II 级)。通过教育和采用证据水平,提高对该领域需要更好证据的认识,可能会改善前瞻性研究的实施和发表。

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