Linking Clinical Relevance and Statistical Significance in Evaluating Intra-Individual Changes in Health-Related Quality of Life

Kathleen W. Wyrwich, Nancy A. Nienaber, William M. Tierney, Fredric D. Wolinsky

Research output: Contribution to journalArticle

426 Scopus citations

Abstract

OBJECTIVE. To compare the standard error of measurement (SEM) with established standards for clinically relevant intra-individual change in an evaluation of health-related quality of life. DESIGN. Secondary analysis of data from a randomized controlled trial. SUBJECTS. Six hundred and five outpatients with a history of cardiac problems attending the general medicine clinics of a major academic medical center. MEASURES. Baseline and follow-up interviews included a modified version of the Chronic Heart Failure Questionnaire (CHQ) and the SF-36. The SEM values corresponding to established standards for minimal clinically important differences (MCIDs) on the CHQ were determined. Individual change on the SF-36 was explored using the same SEM criterion. RESULTS. One-SEM changes in this population corresponded well to the patient-driven MCID standards on all CHQ dimensions (weighted kappas (0.87; P < 0.001). The distributions of outpatients who improved, remained stable, or declined (defined by the one-SEM criterion) were generally consistent between CHQ dimensions and SF-36 subscales. CONCLUSIONS. The use of the SEM to evaluate individual patient change should be explored among other health-related quality of life instruments with established standards for clinically relevant differences. Only then can it be determined whether the one-SEM criterion can be consistently applied as a proxy for clinically meaningful change.

Original languageEnglish (US)
Pages (from-to)469-478
Number of pages10
JournalMedical care
Volume37
Issue number5
DOIs
StatePublished - May 1 1999

Keywords

  • Clinically relevant change
  • Coronary heart disease
  • Measurement
  • Quality of life
  • Standard error of measurement

ASJC Scopus subject areas

  • Nursing(all)
  • Public Health, Environmental and Occupational Health
  • Health(social science)
  • Health Professions(all)

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