TY - JOUR
T1 - Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes
AU - Revicki, Dennis
AU - Hays, Ron D.
AU - Cella, David
AU - Sloan, Jeff
N1 - Funding Information:
This paper was supported in part by Genentech, South San Francisco, California, the UCLA/DREW Project EXPORT, National Institutes of Health, National Center on Minority Health & Health Disparities, (P20-MD00148-01), the UCLA Center for Health Improvement in Minority Elders/Resource, Centers for Minority Aging Research, National Institutes of Health, National Institute of Aging, (AG-02-004), and the National Institute of Aging (AG20679-01).
PY - 2008/2
Y1 - 2008/2
N2 - 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.
AB - 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.
KW - Anchor-based methods
KW - Clinical significance
KW - Distribution-based methods
KW - Health-related quality of life
KW - Minimal important differences
KW - Patient-reported outcomes
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U2 - 10.1016/j.jclinepi.2007.03.012
DO - 10.1016/j.jclinepi.2007.03.012
M3 - Review article
C2 - 18177782
AN - SCOPUS:37549004786
SN - 0895-4356
VL - 61
SP - 102
EP - 109
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
IS - 2
ER -