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From the Department of Medicine (Dr. Birbeck), Robert Wood Johnson Clinical Scholars Program, and the Departments of Neurology (Drs. Kim and Vickrey) and Medicine (Dr. Hays), University of California at Los Angeles.
Address correspondence and reprint requests to Dr. Gretchen L. Birbeck, 10833 Le Conte Ave., Factor B-545, Los Angeles, CA 90095-1736; e-mail: gdike{at}ucla.edu
OBJECTIVE: To evaluate the ability of health-related quality of life (HRQOL) measures to detect change over time in persons with epilepsy.
BACKGROUND: The application of HRQOL measures in clinical trials has been limited by a dearth of information regarding their abilities to measure change over time (i.e., their responsiveness). To calculate responsiveness, one must categorize subjects as "changed" or "unchanged" by a priori criteria.
METHODS: The authors analyzed data collected at baseline and at 28-week follow-up from an antiepileptic drug trial. Two different criteria for classifying subjects as changed or unchangedone based on seizure frequency (where changed = attainment of seizure freedom) and one based on self-reported overall condition (where changed = improvement in overall condition)were used. We compared responsiveness indices for two generic (Short Form [SF]-36 and SF-12) and two epilepsy-targeted (Quality of Life in Epilepsy [QOLIE]-89 and QOLIE-31) HRQOL measures. Two scoring procedures for the SF-36, one based on classic test theory and the other on item response theory (IRT), were compared.
RESULTS: Effect sizes of the most responsive HRQOL measures were medium to large. The shorter epilepsy-targeted measure had similar responsiveness indices to those of the longer measure. Epilepsy-targeted measures were consistently more responsive than generic measures under the overall condition criterion, but for the seizure freedom criterion, IRT scoring of the SF-36 yielded responsiveness indices comparable to those of the epilepsy-targeted measures.
CONCLUSION: Epilepsy-targeted health-related quality of life measures may be preferable to generic ones in longitudinal studies. Selection of a shorter epilepsy-targeted measure does not compromise responsiveness. Item response theory scoring should be applied to epilepsy-targeted HRQOL measures.
Key words: ResponsivenessEpilepsyHealth-related quality of lifeQuality of life
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