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

Dennis Revicki, Ron D. Hays, David Cella, Jeff A Sloan

Research output: Contribution to journalArticle

899 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)102-109
Number of pages8
JournalJournal of Clinical Epidemiology
Volume61
Issue number2
DOIs
StatePublished - Feb 2008

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Clinical Trials
Practice Guidelines
Patient Reported Outcome Measures
Population
Therapeutics

Keywords

  • Anchor-based methods
  • Clinical significance
  • Distribution-based methods
  • Health-related quality of life
  • Minimal important differences
  • Patient-reported outcomes

ASJC Scopus subject areas

  • Medicine(all)
  • Public Health, Environmental and Occupational Health
  • Epidemiology

Cite this

Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. / Revicki, Dennis; Hays, Ron D.; Cella, David; Sloan, Jeff A.

In: Journal of Clinical Epidemiology, Vol. 61, No. 2, 02.2008, p. 102-109.

Research output: Contribution to journalArticle

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