A health-related quality-of-life instrument for symptomatic patients with endometriosis: A validation study, , ,

OBJECTIVE: This study was designed to evaluate the reliability, validity, and responsiveness of a newly developed, health-related quality-of-life measure. STUDY DESIGN: 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. RESULTS: Reproducibility and internal-consistency reliability were acceptable with intraclass correlation coefficients ranging from 0.94 to 1.00 and Cronbach’s α 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. CONCLUSION: This is the first comprehensive health-related quality-of-life questionnaire available for use with endometriosis patients that has demonstrated reliability, validity, and responsiveness. (Am J Obstet Gynecol 1998;179:47-55.)