Colwell H H, Mathias S D, Pasta D J, Henning J M, Steege J F
Lewin-TAG, Inc, San Francisco, California 94107, USA.
Am J Obstet Gynecol. 1998 Jul;179(1):47-55. doi: 10.1016/s0002-9378(98)70250-9.
This study was designed to evaluate the reliability, validity, and responsiveness of a newly developed, health-related quality-of-life measure.
A total of 137 women (122 from a Phase III clinical trial and 15 from a private practice setting) with endometriosis completed the questionnaire several times.
Reproducibility and internal-consistency reliability were acceptable with intraclass correlation coefficients ranging from 0.94 to 1.00 and Cronbach's alpha coefficients ranging from 0.84 to 0.97. Construct validity was demonstrated on the basis of correlations between items and scales. Health-related quality of life varied in a consistent manner according to clinician-rated measures of pelvic pain and dysmenorrhea and patient-reported levels of endometriosis pain, but no relationship emerged according to the revised American Fertility Society classification. In general, the questionnaire was moderately to highly responsive to change.
This is the first comprehensive health-related quality-of-life questionnaire available for use with endometriosis patients that has demonstrated reliability, validity, and responsiveness.
本研究旨在评估一种新开发的与健康相关的生活质量测量方法的可靠性、有效性和反应性。
共有137名患有子宫内膜异位症的女性(122名来自III期临床试验,15名来自私人诊所)多次完成了问卷调查。
组内相关系数在0.94至1.00之间,克朗巴哈系数在0.84至0.97之间,再现性和内部一致性可靠性可接受。基于项目与量表之间的相关性证明了结构效度。根据临床医生对盆腔疼痛和痛经的评分以及患者报告的子宫内膜异位症疼痛程度,与健康相关的生活质量以一致的方式变化,但根据修订后的美国生育协会分类未发现相关性。总体而言,该问卷对变化具有中度至高度的反应性。
这是首个可用于子宫内膜异位症患者的全面的与健康相关的生活质量问卷,已证明其具有可靠性、有效性和反应性。