Improving Comparative Effectiveness Research of Complex Health Interventions: Standards from the Patient-Centered Outcomes Research Institute (PCORI).
Improving Comparative Effectiveness Research of Complex Health Interventions: Standards from the Patient-Centered Outcomes Research Institute (PCORI).
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DOI：
10.1007/s11606-020-06093-6
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发表时间：
2020-11
影响因子：
5.7
通讯作者：
Hickam DH
中科院分区：
文献类型：
--
作者：
Esmail LC;Barasky R;Mittman BS;Hickam DH
在比较有效性研究(CER)中，越来越多地研究复杂的卫生干预措施(CHI)，需要改进CHI研究实践。以患者为中心的结果研究所(PCORI)方法学委员会(MC)于2016年发起了一项努力，以制定关于这一主题的正式指导。为CHI的CER研究制定一套科学有效、透明和可重复性的最低标准。这些标准旨在适用于检查广泛的医疗干预措施的研究，包括递送系统、行为改变和其他非药物干预措施。我们进行了文献回顾，回顾了现有的方法指南，并通过MC、两个外部研究方法专家小组和60天公众评议期的迭代过程制定了标准。最终标准由PCORI MC批准，并于2018年4月30日由PCORI理事会通过。最终标准包括：(1)全面描述干预和比较器并定义其核心功能，(2)指定假设的因果路径及其理论基础，(3)指定允许和记录如何适应干预和比较器的形式，(4)计划和描述过程评估，以及(5)选择通过因果路径了解的患者结果。新标准为研究提供了三个主要贡献：(1)它们提供了一个简单的框架，帮助研究人员解决CHI研究的主要方法特征；(2)它们强调因果模型的重要性，以及理解CHI如何实现其效果的必要性，而不是简单地衡量这些效果；以及(3)它们要求使用核心功能和形式的概念来描述CHI。虽然这些标准正式适用于PCORI资助的CER研究，但它们具有广泛的适用性。本文的在线版本(10.1007/s11606-020-06093-6)包含向授权用户提供的补充材料。
Complex health interventions (CHIs) are increasingly studied in comparative effectiveness research (CER), and there is a need for improvements in CHI research practices. The Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee (MC) launched an effort in 2016 to develop formal guidance on this topic. To develop a set of minimal standards for scientifically valid, transparent, and reproducible CER studies of CHIs. The standards are intended to apply to research examining a broad range of healthcare interventions including delivery system, behavior change, and other non-pharmacological interventions. We conducted a literature review, reviewed existing methods guidance, and developed standards through an iterative process involving the MC, two panels of external research methods experts, and a 60-day public comment period. The final standards were approved by the PCORI MC and adopted by the PCORI Board of Governors on April 30, 2018. The final standards include the following: (1) fully describe the intervention and comparator and define their core functions, (2) specify the hypothesized causal pathways and their theoretical basis, (3) specify how adaptations to the form of the intervention and comparator will be allowed and recorded, (4) plan and describe a process evaluation, and (5) select patient outcomes informed by the causal pathway. The new standards offer three major contributions to research: (1) they provide a simple framework to help investigators address the major methodological features of a CHI study, (2) they emphasize the importance of the causal model and the need to understand how a CHI achieves its effects rather than simply measuring these effects, and (3) they require description of a CHI using the concepts of core functions and forms. While these standards apply formally to PCORI-funded CER studies, they have broad applicability. The online version of this article (10.1007/s11606-020-06093-6) contains supplementary material, which is available to authorized users.
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DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
--
作者：
Damschroder LJ;Aron DC;Keith RE;Kirsh SR;Alexander JA;Lowery JC
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DOI：
10.1136/bmj.h1258
发表时间：
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期刊：
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影响因子：
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影响因子：
120.7
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