Comparison between the QOLIE-31 and derived QOLIE-10 in a clinical trial of levetiracetam
Comparison between the QOLIE-31 and derived QOLIE-10 in a clinical trial of levetiracetam
复制标题
DOI：
10.1016/s0920-1211(00)00127-3
复制
发表时间：
2000-08-01
影响因子：
2.2
通讯作者：
Bromfield, EB
中科院分区：
文献类型：
--
作者：
Cramer, JA;Arrigo, C;Bromfield, EB
目的：确定当10个项目来自QOLIE-31时，QOLIE-10（一种简化的生活质量问卷）是否提供与更详细的QOLIE-31工具相似的结果。研究方法：QOLIE-31由参与UCB方案N132的246名患者在基线和在标准治疗中加入左乙拉西坦（LEV 1000或3000 mg）或安慰剂治疗18周后完成。根据QOLIE-31数据计算QOLIE-10组分和总分。结果如下：在基线和随访时，基线QOLIE-10组分和总分与相应的QOLIE-31评分高度相关（范围0.70-0.95）。治疗组间QOLIE-10和QOLIE-31总分（分别为P = 0.02，P = 0.009）、癫痫发作担忧（P = 0.005，P = 0.0003）和认知功能（P = 0.01，P = 0.01）从基线到随访的变化存在显著差异（ANCOVA）。一个子量表（总体QOL）显示QOLIE-31（P = 0.04）有显著变化，但QOLIE-10（P = 0.07）无显著变化。应答者（部分发作减少≥ 50%）和非应答者的QOLIE-10总分（P = 0.0001）和两个组成部分（总体QOL P = 0.002，社会功能P = 0.0003）存在差异。QOLIE-31总分及除药物疗效外的6个分量表得分差异均有统计学意义。两种仪器都能够检测到随时间的变化。两种工具通过效应量（无应答者为-0.1，应答者为0.4，无复发患者为0.8）和Guyatt统计量（分别为-0.1，0.6和1.0）评估的应答性相似。结论：虽然QOLIE-10是作为一种筛选工具设计的，但它可以评分并用于研究。在临床试验中，总评分确实可以看出治疗之间的差异。尽管如此，具有多个、多项目分量表的调查表提供了比缩写形式更详细的信息。QOLIE-31在时间和资源可用的情况下首选。(C)2000 Elsevier Science B. V.保留所有权利。
Purpose: to determine whether the QOLIE-10, an abbreviated quality of life questionnaire, provides results similar to the more detailed QOLIE-31 instrument when the ten items are derived from the QOLIE-31. Methods: the QOLIE-31 was completed by 246 patients participating in UCB protocol N132 at baseline and after 18 weeks of treatment with levetiracetam (LEV 1000 or 3000 mg) or placebo added to standard therapy. QOLIE-10 components and total scores were calculated from the QOLIE-31 data. Results: baseline QOLIE-10 components and total score correlated highly with corresponding QOLIE-31 scores, both at baseline and follow-up (range 0.70-0.95). Changes from baseline to follow-up were significantly different (ANCOVA) among treatment groups for both the QOLIE-10 and QOLIE-31 for the total score (P = 0.02, P = 0.009, respectively), seizure worry (P = 0.005, P = 0.0003) and cognitive functioning (P = 0.01, P = 0.01). One subscale (overall QOL) showed significant change with the QOLIE-31 (P = 0.04), but not with the QOLIE-10 (P = 0.07). Differences in QOLIE-10 scores were found between responders (greater than or equal to 50% partial onset seizure reduction) and non-responders for the total score (P = 0.0001) and two components (overall QOL P = 0.002, social function P = 0.0003). In the QOLIE-31, the total score and six subscale scores tall except medication effects) were significantly different. Both instruments were able to detect change over time. Responsiveness assessed by effect sizes (- 0.1 for non-responders, 0.4 for responders, 0.8 for seizure-free patients) and the Guyatt statistic (- 0.1, 0.6 and 1.0, respectively) was similar for both instruments. Conclusions: although the QOLIE-10 was designed as a screening tool, it can be scored and used in research. The total score did discern differences among treatments in a clinical trial. Nonetheless, questionnaires with multiple, multi-item subscales provide more detailed information than abbreviated forms. The QOLIE-31 is preferred where time and resources are available. (C) 2000 Elsevier Science B.V. All rights reserved.