Measuring functional outcomes in therapeutic trials for chronic disease

Research output: Contribution to journalArticle

86 Citations (Scopus)

Abstract

For clinical trials of many chronic diseases, the outcome of greatest interest may be patient function. Unfortunately, most scales for measuring functional status are crude and rarely consider important psychosocial impacts of disease. This paper briefly considers the pressures for improving functional status measurement, propose six criteria for assessing functional or "health status" scales, and selectively reviews representative instruments using these criteria. Older functional classifications and many scales used for quality-of-care assessment are narrowly focussed on physical function. Their reliability, validity, and sensitivity to clinical changes are generally unknown. Traditional scales of "Activities of Daily Living" are similarly focused on physical function, and are most appropriate for severely disabled inpatients. A new generation of "health status" instruments offers wider applicability, more comprehensiveness, and feasibility for clinical applications. Their validity and reliability are generally quite good. None of the instruments reviewed, however, has yet demonstrated convincing success as a "transition" variable (sensitivity to small but clinically important changes). Based on this analysis, future investigation should seek to (1) define the optimal balance between brevity on the one hand, and comprehensiveness and reliability on the other, (2) describe the sensitivity of scales to clinically important changes, and (3) directly compare existing instruments to aid selection by investigators who are considering their use in clinical trials.

Original languageEnglish (US)
Pages (from-to)223-240
Number of pages18
JournalControlled Clinical Trials
Volume5
Issue number3
DOIs
StatePublished - 1984
Externally publishedYes

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Reproducibility of Results
Health Status
Chronic Disease
Clinical Trials
Quality of Health Care
Activities of Daily Living
Inpatients
Research Personnel
Pressure
Therapeutics

ASJC Scopus subject areas

  • Pharmacology

Cite this

Measuring functional outcomes in therapeutic trials for chronic disease. / Deyo, Richard (Rick).

In: Controlled Clinical Trials, Vol. 5, No. 3, 1984, p. 223-240.

Research output: Contribution to journalArticle

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