Abstract

OBJECTIVES Understanding the properties of an outcome measure is essential in choosing the appropriate instrument and interpreting the information it generates. The MOS 36 item short form health survey questionnaire (SF-36) is widely acknowledged as the gold standard generic measure of health status; few studies however have evaluated its use for clinical trials in multiple sclerosis. Its clinical appropriateness, internal consistency reliability, validity, and responsiveness was investigated across a broad range of patients with multiple sclerosis.

METHODS A prospective study in which 150 adults with clinically definite multiple sclerosis completed a battery of questionnaires evaluating generic health status, disability, handicap, and emotional wellbeing. Of these, 44 patients undergoing inpatient rehabilitation completed the questionnaires before and after intervention to evaluate responsiveness.

RESULTS Score distributions demonstrated significant floor and ceiling effects in four of the eight dimensions which were particularly marked when patient selection was restricted to a narrow band of disease severity (as is the case in most clinical trials). Internal consistency exceeded the standard for group comparisons for all dimensions. Convergent and discriminant construct validity was supported by the direction, magnitude, and pattern of correlations with other health measures. In comparison with instruments measuring associated constructs, the responsiveness of the SF-36 was poor in evaluating change in moderate to severely disabled patients participating in a programme of inpatient rehabilitation.

CONCLUSIONS The SF-36 has some limitations as an outcome measure in multiple sclerosis. The results highlight the need for all instruments to be examined in the specific sample population under question and for the specific research question being investigated. In multiple sclerosis clinical trials, the SF-36 should be supplemented with other relevant measures.