Kline Leidy N, Rentz A M, Grace E M
Center for Health Outcomes Research, MEDTAP International, Bethesda, Maryland 20814, USA.
Epilepsia. 1998 Sep;39(9):965-77. doi: 10.1111/j.1528-1157.1998.tb01446.x.
To provide an overview of condition-specific 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.
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.
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 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.
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 utilities will provide needed data for evaluating the cost-effectiveness of new treatments.
概述成人抗癫痫药物（AED）治疗临床试验中特定疾病的健康相关生活质量（HRQL）评估。我们描述了HRQL评估中的关键测量问题，确定了在该人群中使用的工具，总结了这些工具的心理测量特征，提出了HRQL中最可能随治疗发生变化的领域，并为进一步研究提供建议。
我们通过反复检索MEDLINE数据库并回顾已发表论文的参考文献列表，对文献进行了全面综述。从已发表的文献中收集了有关这些工具的心理测量信息。
确定了三种癫痫特异性HRQL测量方法：癫痫手术量表（ESI-55）、利物浦评估量表和癫痫生活质量量表（QOLIE，89项、31项和10项版本）。还发现了一种新的测量方法，即美国癫痫基金会（EFA）关注指数。结合临床试验环境中的表现或预期表现，讨论了这些工具的心理测量特征。对迄今为止的描述性研究和试验的综述表明，反映HRQL心理和社会领域的子量表可能对旨在增加无癫痫发作期、降低癫痫发作严重程度和最小化不良副作用的治疗最为敏感。
尽管癫痫临床试验中HRQL结果的评估仍处于起步阶段，但有几种可靠且有效的特定疾病测量方法可用于了解疾病和治疗对HRQL的影响。需要进一步研究以确定最小临床重要变化分数，并评估测量方法在不同文化和给药方式（自我、访谈、电话）下的心理测量稳定性。以效用形式对患者健康结果偏好的研究将为评估新治疗方法的成本效益提供所需数据。
