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系统评价在 justifies 麻醉学试验中的使用:一项 meta 流行病学研究。

The use of systematic reviews to justify anaesthesiology trials: A meta-epidemiological study.

机构信息

Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia.

Department of Radiology, University Hospital Split, Split, Croatia.

出版信息

Eur J Pain. 2018 Nov;22(10):1844-1849. doi: 10.1002/ejp.1280. Epub 2018 Jul 24.

Abstract

AIMS

New randomized clinical trials (RCTs) should be initiated if previous systematic reviews (SRs) indicate that new trials are needed. We analysed whether RCTs published in anaesthesiology journals mentioned previous SRs as a rationale for conducting trial and for discussing results.

METHODS

This was a meta-epidemiological, descriptive cross-sectional study. We analysed RCTs published in the seven first-quartile anaesthesiology journals between 2014 and 2016. We studied text and bibliography of the RCTs to assess whether the authors made a reference to previous SRs when justifying the need for their own clinical trial and discussing the results.

RESULTS

In the 622 studied RCTs 126 (20%) mentioned verbatim or cited one or more SRs as justification for conducting a trial, most commonly in introduction of a manuscript. Almost half of the included RCTs (44%) did not cite a single systematic review. There was no significant difference between the years in the number of explicitly mentioned SRs as justification for conducting a trial (F = 0.540, p = 0.583). Trials citing, mentioning or explicitly using SRs as a justification were published in journals with significantly higher impact factor and included significantly higher number of participants, while there was no difference in using SRs in trials in terms of funding type, type of intervention or positive versus negative results.

CONCLUSIONS

Trialists should use evidence from existing SRs for planning a trial, while ethics committees, peer-reviewers and editors should require authors to provide evidence that a new trial is indeed necessary.

SIGNIFICANCE

Since less than a fifth of trials published in high-impact journals in the field of anaesthesiology explicitly mention previous systematic review as a justification for conducting the trial, authors, ethics committees, editors and peer-reviewers need to increase their awareness of the need for proper justification regarding the necessity for a new trial.

摘要

目的

如果之前的系统评价(SR)表明需要新的试验,则应启动新的随机临床试验(RCT)。我们分析了麻醉学杂志上发表的 RCT 是否将之前的 SR 作为进行试验和讨论结果的理由。

方法

这是一项meta 流行病学、描述性的横断面研究。我们分析了 2014 年至 2016 年期间发表在七个第一四分位数麻醉学杂志上的 RCT。我们研究了 RCT 的文本和参考文献,以评估作者在为自己的临床试验辩护并讨论结果时是否参考了之前的 SR。

结果

在 622 项研究的 RCT 中,有 126 项(20%)逐字或引用了一份或多份 SR,作为进行试验的理由,最常见于手稿的引言部分。几乎一半的纳入 RCT (44%)没有引用过一次系统评价。作为进行试验的理由明确提及 SR 的数量在不同年份之间没有显著差异(F=0.540,p=0.583)。引用、提及或明确将 SR 作为试验理由的试验发表在影响因子较高的期刊上,参与者人数明显较多,而在基于资金类型、干预类型或阳性与阴性结果的试验中使用 SR 方面没有差异。

结论

试验设计者应使用现有 SR 的证据来规划试验,而伦理委员会、同行评审员和编辑应要求作者提供证据证明新试验确实是必要的。

意义

由于发表在麻醉学领域高影响力杂志上的试验中,不到五分之一的试验明确将之前的系统评价作为进行试验的理由,因此作者、伦理委员会、编辑和同行评审员需要提高对新试验必要性的适当理由的认识。

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