AHRQ Series Paper 4: Assessing harms when comparing medical interventions: AHRQ and the Effective Health-Care Program
AHRQ Series Paper 4: Assessing harms when comparing medical interventions: AHRQ and the Effective Health-Care Program
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DOI：
10.1016/j.jclinepi.2008.06.007
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发表时间：
2010-05-01
影响因子：
7.2
通讯作者：
Moher, David
中科院分区：
文献类型：
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作者：
Chou, Roger;Aronson, Naomi;Moher, David
比较有效性综述（CER）是系统性综述，旨在评估替代干预措施的证据，以帮助临床医生、政策制定者和患者做出明智的治疗选择。审查应评估危害和益处，以提供替代干预措施的平衡评估。识别治疗的重要危害并量化任何风险的程度需要CER作者考虑广泛的数据来源，包括随机对照试验（RCT）和观察性研究。这可能需要对已发表报告以外的未发表数据进行评价。伤害数据的适当综合还必须考虑与罕见或不常见事件的评价、等效性或非劣效性评估以及间接比较的使用相关的问题。本文提供了在进行和报告CER时评价伤害的指南。我们包括以下方面的建议：确定待评价伤害的优先顺序、使用与伤害报告相关的术语、选择伤害证据来源、评估伤害报告的偏倚风险（质量）、综合伤害证据以及报告伤害证据。(C)2010年爱思唯尔公司All rights reserved.
Comparative effectiveness reviews (CERs) are systematic reviews that evaluate evidence on alternative interventions to help clinicians, policy makers, and patients make informed treatment choices. Reviews should assess harms and benefits to provide balanced assessments of alternative interventions. Identifying important harms of treatment and quantifying the magnitude of any risks require CER authors to consider a broad range of data sources, including randomized controlled trials (RCTs) and observational studies. This may require evaluation of unpublished data in addition to published reports. Appropriate synthesis of harms data must also consider issues related to evaluation of rare or uncommon events, assessments of equivalence or noninferiority, and use of indirect comparisons. This article presents guidance for evaluating harms when conducting and reporting CERs. We include suggestions for prioritizing harms to be evaluated, use of terminology related to reporting of harms, selection of sources of evidence on harms, assessment of risk of bias (quality) of harms reporting, synthesis of evidence on harms, and reporting of evidence on harms. (C) 2010 Elsevier Inc. All rights reserved.