GRADE guidelines: 8. Rating the quality of evidence-indirectness

GRADE guidelines: 8. Rating the quality of evidence-indirectness
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DOI:
10.1016/j.jclinepi.2011.04.014
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发表时间:
2011-12-01
影响因子:
7.2
通讯作者:
Schuenemann, Holger J.
Schuenemann, Holger J.
中科院分区:
医学2区
文献类型:
--
作者:
Guyatt, Gordon H.;Oxman, Andrew D.;Schuenemann, Holger J.

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直接证据来自研究,这些研究直接比较了我们感兴趣的干预措施应用于我们感兴趣的人群并衡量对患者重要的结果。证据可以通过以下四种方式之一间接获得。首先,患者可能与感兴趣的患者不同(术语“适用性”通常用于这种形式的间接性)。第二,所测试的干预可能不同于利益干预。关于患者和干预措施的间接性的决定取决于对生物或社会因素是否足够不同的理解,以至于人们可能会期望效果的大小存在实质性差异。第三,结果可能不同于主要利益的结果-例如,本身并不重要的替代结果,但是在假设替代物的变化反映了对患者重要的结果的变化的情况下进行测量。第四种间接性,在概念上不同于前三种,当临床医生必须在未经头对头比较测试的干预措施之间进行选择时,就会发生这种情况。在这些情况下进行治疗之间的比较需要特定的统计方法,并且将根据患者人群之间的差异程度、共同干预、结局测量和候选干预试验方法的质量降低一到两个级别。(C)2011 Elsevier Inc. All rights reserved.
Direct evidence comes from research that directly compares the interventions in which we are interested when applied to the populations in which we are interested and measures outcomes important to patients. Evidence can be indirect in one of four ways. First, patients may differ from those of interest (the term applicability is often used for this form of indirectness). Secondly, the intervention tested may differ from the intervention of interest. Decisions regarding indirectness of patients and interventions depend on an understanding of whether biological or social factors are sufficiently different that one might expect substantial differences in the magnitude of effect.Thirdly, outcomes may differ from those of primary interest-for instance, surrogate outcomes that are not themselves important, but measured in the presumption that changes in the surrogate reflect changes in an outcome important to patients.A fourth type of indirectness, conceptually different from the first three, occurs when clinicians must choose between interventions that have not been tested in head-to-head comparisons. Making comparisons between treatments under these circumstances requires specific statistical methods and will be rated down in quality one or two levels depending on the extent of differences between the patient populations, co-interventions, measurements of the outcome, and the methods of the trials of the candidate interventions. (C) 2011 Elsevier Inc. All rights reserved.