Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes

被引：1727

作者：

Revicki, Dennis ^{[1
]}

Hays, Ron D. ^{[2
,3
,4
]}

Cella, David ^{[5
,6
]}

Sloan, Jeff ^{[7
]}

机构：

[1] United Biosource Corp, Ctr Hlth Outcomes Res, Bethesda, MD 20814 USA

[2] Univ Calif Los Angeles, Div Gen Internal Med, Los Angeles, CA USA

[3] Univ Calif Los Angeles, Hlth Serv Res, Los Angeles, CA USA

[4] RAND Corp, Hlth Sci Program, Los Angeles, CA USA

[5] Evanston Northwestern Healthcare Res Inst, Ctr Outcomes Res & Educ, Evanston, IL USA

[6] Northwestern Univ, Feinberg Sch Med, Evanston, IL USA

[7] Mayo Clin, Biostat Sect, Rochester, MN USA

来源：

JOURNAL OF CLINICAL EPIDEMIOLOGY | 2008年 / 61卷 / 02期

基金：

美国国家卫生研究院;

关键词：

patient-reponed outcomes; health-related quality of life; minimal important differences; clinical significance; anchor-based methods; distribution-based methods;

D O I：

10.1016/j.jclinepi.2007.03.012

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Objective: The objective of this review is to summarize recommendations on methods for evaluating responsiveness and minimal important difference (MID) for patient-reported outcome (PRO) measures. Study Design and Setting: We review, summarize, and integrate information on issues and methods for evaluating responsiveness and determining MID estimates for PRO measures. Recommendations are made on best-practice methods for evaluating responsiveness and MID. Results: The MID for a PRO instrument is not an immutable characteristic, but may vary by population and context, and no one MID may be valid for all study applications. MID estimates should be based on multiple approaches and triangulation of methods. Anchor-based methods applying various relevant patient-rated, clinician-rated, and disease-specific variables provide primary and meaningful estimates of an instrument's MID. Results for the PRO measures from clinical trials can also provide insight into observed effects based on treatment comparisons and should be used to help determine MID. Distribution-based methods can support estimates from anchor-based approaches and can be used in situations where anchor-based estimates are unavailable. Conclusion: We recommend that the MID is based primarily on relevant patient-based and clinical anchors, with clinical trial experience used to further inform understanding of MID. (C) 2008 Elsevier Inc. All rights reserved.

引用

页码：102 / 109

页数：8

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