Wagner A K, Keller S D, Kosinski M, Baker G A, Jacoby A, Hsu M A, Chadwick D W, Ware J E
Health Institute, New England Medical Center, Boston, MA 02111, USA.
Qual Life Res. 1995 Apr;4(2):115-34. doi: 10.1007/BF01833606.
We studied 31 previously validated and newly developed generic and epilepsy-specific scales to evaluate their usefulness for assessing the impact of epilepsy and anti-epileptic drug (AED) therapy on health-related quality of life (HRQOL). Included were the MOS SF-36 Health Survey, additional measures of mental health, cognition, epilepsy-specific perception of control, behavioural problems, distress, worries and experiences, the Liverpool Epilepsy Impact and Seizure Severity scales, and a patient-completed symptom checklist. Questionnaires were completed twice by 136 patients on AED therapy in a multicentre study in the UK. Validity was assessed in relation to disease severity, defined as time since last seizure, and to patient-reported symptoms. Statistical analyses to estimate the contribution of HRQOL information of each scale relative to that of others were conducted. The 171-item questionnaire could be completed by out-patients with epilepsy with good data quality. With few exceptions, generic and epilepsy-specific measures satisfied psychometric tests of hypothesized item groupings and scale score reliability (internal consistency and test-retest reliability) and differentiated well between groups of patients differing in time since last seizure and in symptom impact, regardless of time since last seizure. However, scales differed widely in their validity in discriminating between groups of patients known to differ clinically. The SF-36 Role Physical scale best discriminated among groups differing in disease severity. The epilepsy-specific Mastery, Impact, Experience, Worry, Distress, and Agitation scales were among the 10 best measures in discriminating among groups differing in disease severity. Generic measures, especially measures of social and role functioning and mental health, were best at differentiating groups of patients differing in symptom impact. Recommendations are offered for concepts and specific scales most likely to be useful in future studies of the HRQOL burden of epilepsy and the HRQOL benefits of AED therapy.
我们研究了31种先前经过验证以及新开发的通用量表和癫痫特异性量表，以评估它们在评估癫痫及抗癫痫药物（AED）治疗对健康相关生活质量（HRQOL）影响方面的效用。其中包括医学结局研究简明健康调查（MOS SF-36）、心理健康、认知、癫痫特异性控制感、行为问题、痛苦、担忧及经历的其他测量指标、利物浦癫痫影响量表和发作严重程度量表，以及一份患者自行填写的症状清单。在英国的一项多中心研究中，136名接受AED治疗的患者两次填写了问卷。根据疾病严重程度（定义为距上次发作的时间）和患者报告的症状对效度进行了评估。进行了统计分析，以估计每种量表的HRQOL信息相对于其他量表的贡献。这份包含171个条目的问卷，癫痫门诊患者能够很好地完成，数据质量良好。除少数例外情况外，通用量表和癫痫特异性测量指标均符合对假设的条目分组和量表分数可靠性（内部一致性和重测信度）的心理测量测试，并且能够很好地区分距上次发作时间不同以及症状影响不同的患者组，无论距上次发作时间如何。然而，各量表在区分已知临床情况不同的患者组时，效度差异很大。医学结局研究简明健康调查（MOS SF-36）中的角色身体功能量表在区分疾病严重程度不同的组方面表现最佳。癫痫特异性的掌控感、影响、经历、担忧、痛苦和激动量表是区分疾病严重程度不同的组的10种最佳测量指标之一。通用测量指标，尤其是社会功能、角色功能和心理健康测量指标，在区分症状影响不同的患者组方面表现最佳。针对未来癫痫HRQOL负担研究以及AED治疗的HRQOL益处研究中最可能有用的概念和具体量表提出了建议。
