Summary: Purpose:To provide an overview of conditionspecific health-related quality of life (HRQL) assessment in clinical trials of antiepileptic drug (AED) therapy in adults. We describe the key measurement issues in HRQL evaluation, identify the instruments that have been used in this population, summarize the psychometric characteristics of these instruments, propose areas of HRQL most likely to change with treatment, and offer recommendations for further research.Methods: We conducted a comprehensive review of the literature using repeated searches of the MEDLINE database together with a review of reference lists from published papers. Psychometric information on the instruments was gathered from published literature.Results: Three epilepsy-specific HRQL measures were identified: the Epilepsy-Surgery Inventory (ESI-55), the Liverpool Assessment Battery, and the Quality of Life in Epilepsy Inventory (QOLIE, the 89-, 31-, and 10-item versions). One new measure, the Epilepsy Foundation of America (EFA) Concerns Index was also found. The psychometric characteristics of these The social and psychological consequences of epilepsy are numerous. Patients often describe social stigma and the fear that friends who discover they have epilepsy or witness a seizure will change their behavior or withdraw their friendship or support. Self-imposed social isolation can be intensified by restrictions on driving, which are tied by law to seizure-free periods and by treatment side effects, which can interfere with day-to-day activities (1). Men and women with epilepsy also experience limitations in employment opportunities, including restraints on physical labor such as machine or power tool operation, and constraints in upward mobility due to concern that the stress involved could contribute to an increase in seizure activity. Difficulty in obtaining health, life, and automobile insurance can be a financial burden and an additional source of stress. Together, these diffiAccepted April 6, 1998 Address correspondence and reprint requests to Dr. N. Kline Leidy at MEDTAP International, Inc., 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, U.S.A. instruments are discussed in relationship to performance or expected performance in a clinical trial setting. A review of descriptive studies and trials to date suggests that subscales reflecting the psychological and social domains of HRQL may be most sensitive to treatment designed to increase seizure-free periods, reduce seizure severity, and minimize undesirable side effects.Conclusions: Although evaluation of HRQL outcomes in clinical trials of epilepsy is still in its infancy, several reliable and valid condition-specific measures are available for understanding the impact of disease and treatment on HRQL. Further research is needed to determine minimal clinically important change scores and to assess the psychometric stability of measures across cultures and mode of administration (self, interview, telephone). Studies of patient preferences for health outcomes in the form of u...
