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      Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life.

      Medical Care
      Adult, Aged, Aged, 80 and over, Analysis of Variance, Bias (Epidemiology), Chronic Disease, Coronary Disease, epidemiology, Female, Health Status Indicators, Heart Failure, Humans, Interviews as Topic, methods, Lung Diseases, Obstructive, Male, Middle Aged, Quality of Life, Questionnaires

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          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. Secondary analysis of data from a randomized controlled trial. Six hundred and five outpatients with a history of cardiac problems attending the general medicine clinics of a major academic medical center. 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. 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. 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.

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