S Wiebe1, M Eliasziw, S Matijevic. 1. Department of Clinical Neurological Sciences, University of Western Ontario, Ontario, Canada. swiebe@julian.uwo.ca
Abstract
PURPOSE: The study goal was to assess the magnitude of change in generic and epilepsy-specific health-related quality-of-life (HRQOL) instruments needed to exclude chance or error at various levels of certainty in patients with medically refractory epilepsy. METHODS: Forty patients with temporal lobe epilepsy and clearly defined criteria of clinical stability received HRQOL measurements twice, 3 months apart, using the Quality of Life in Epilepsy Inventory-89 and -31 (QOLIE-89 and QOLIE-31), Liverpool Impact of Epilepsy, adverse drug events, seizure severity scales, and the Generic Health Utilities Index (HUI-III). Standard error of measurement and test-retest reliability were obtained for all scales and for QOLIE-89 subscales. Using the Reliable Change Index described by Jacobson and Truax, we assessed the magnitude of change required by HRQOL instruments to be 90 and 95% certain that real change has occurred, as opposed to change due to chance or measurement error. RESULTS: Clinical features, point estimates and distribution of HRQOL measures, and test-retest reliability (all > 0.70) were similar to those previously reported. Score changes of +/-13 points in QOLIE-89, +/-15 in QOLIE-31, +/-6.3 in Liverpool seizure severity-ictal, +/-11 in Liverpool adverse drug events, +/-0.25 in HUI-III, and +/-9.5 in impact of epilepsy exclude chance or measurement error with 90% certainty. These correspond, respectively, to 13, 15, 17, 18, 25, and 32% of the potential range of change of each instrument. CONCLUSIONS: Threshold values for real change varied considerably among HRQOL tools but were relatively small for QOLIE-89, QOLIE-31, Liverpool Seizure Severity, and adverse drug events. In some instruments, even relatively large changes cannot rule out chance or measurement error. The relation between the Reliable Change Index and other measures of change and its distinction from measures of minimum clinically important change are discussed.
PURPOSE: The study goal was to assess the magnitude of change in generic and epilepsy-specific health-related quality-of-life (HRQOL) instruments needed to exclude chance or error at various levels of certainty in patients with medically refractory epilepsy. METHODS: Forty patients with temporal lobe epilepsy and clearly defined criteria of clinical stability received HRQOL measurements twice, 3 months apart, using the Quality of Life in Epilepsy Inventory-89 and -31 (QOLIE-89 and QOLIE-31), Liverpool Impact of Epilepsy, adverse drug events, seizure severity scales, and the Generic Health Utilities Index (HUI-III). Standard error of measurement and test-retest reliability were obtained for all scales and for QOLIE-89 subscales. Using the Reliable Change Index described by Jacobson and Truax, we assessed the magnitude of change required by HRQOL instruments to be 90 and 95% certain that real change has occurred, as opposed to change due to chance or measurement error. RESULTS: Clinical features, point estimates and distribution of HRQOL measures, and test-retest reliability (all > 0.70) were similar to those previously reported. Score changes of +/-13 points in QOLIE-89, +/-15 in QOLIE-31, +/-6.3 in Liverpool seizure severity-ictal, +/-11 in Liverpool adverse drug events, +/-0.25 in HUI-III, and +/-9.5 in impact of epilepsy exclude chance or measurement error with 90% certainty. These correspond, respectively, to 13, 15, 17, 18, 25, and 32% of the potential range of change of each instrument. CONCLUSIONS: Threshold values for real change varied considerably among HRQOL tools but were relatively small for QOLIE-89, QOLIE-31, Liverpool Seizure Severity, and adverse drug events. In some instruments, even relatively large changes cannot rule out chance or measurement error. The relation between the Reliable Change Index and other measures of change and its distinction from measures of minimum clinically important change are discussed.
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