Investigating clinical heterogeneity in systematic reviews: a methodologic review of guidance in the literature.

Investigating clinical heterogeneity in systematic reviews: a methodologic review of guidance in the literature.
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DOI:
10.1186/1471-2288-12-111
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发表时间:
2012-07-30
影响因子:
4
通讯作者:
Bombardier C
Bombardier C
中科院分区:
医学3区
文献类型:
--
作者:
Gagnier JJ;Moher D;Boon H;Beyene J;Bombardier C

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虽然在研究统计学和方法学异质性的方法上有一些共识,但对异质性的临床方面关注很少。本研究的目的是总结和整理在系统评价中调查临床异质性的建议方法。我们搜索了数据库(Medline、EMBASE、CINAHL、Cochrane Library和CONSORT,截至2010年12月)和参考列表,并联系专家以确定提供建议的资源,以调查纳入系统评价的受控临床试验之间的临床异质性。我们提取了建议,评估了偏向风险的资源,并对建议进行了整理。共收集了101份资料,包括叙事性综述、方法论综述、统计方法论文和教科书。这些资源通常具有较低的偏见风险,但它们之间的共识很小。参考资料建议,临床异质性的计划调查应在审查方案中明确;临床专家应包括在审查小组中;一组临床协变量的选择应考虑来自参与者水平、干预水平、结果水平、研究环境或研究问题特有的其他变量;协变量应具有明确的科学基础;每个协变量应有足够的试验次数;任何此类调查的结果都应谨慎解释。尽管共识很少,但文献中有许多关于在系统评价中调查临床异质性的建议。在对照试验的系统评价中调查临床异质性的正式建议是必需的。
While there is some consensus on methods for investigating statistical and methodological heterogeneity, little attention has been paid to clinical aspects of heterogeneity. The objective of this study is to summarize and collate suggested methods for investigating clinical heterogeneity in systematic reviews. We searched databases (Medline, EMBASE, CINAHL, Cochrane Library, and CONSORT, to December 2010) and reference lists and contacted experts to identify resources providing suggestions for investigating clinical heterogeneity between controlled clinical trials included in systematic reviews. We extracted recommendations, assessed resources for risk of bias, and collated the recommendations. One hundred and one resources were collected, including narrative reviews, methodological reviews, statistical methods papers, and textbooks. These resources generally had a low risk of bias, but there was minimal consensus among them. Resources suggested that planned investigations of clinical heterogeneity should be made explicit in the protocol of the review; clinical experts should be included on the review team; a set of clinical covariates should be chosen considering variables from the participant level, intervention level, outcome level, research setting, or others unique to the research question; covariates should have a clear scientific rationale; there should be a sufficient number of trials per covariate; and results of any such investigations should be interpreted with caution. Though the consensus was minimal, there were many recommendations in the literature for investigating clinical heterogeneity in systematic reviews. Formal recommendations for investigating clinical heterogeneity in systematic reviews of controlled trials are required.
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