A HEALTH-RELATED QUALITY-OF-LIFE INSTRUMENT FOR SYMPTOMATIC PATIENTS WITH ENDOMETRIOSIS - A VALIDATION-STUDY

OBJECTIVE: This study was designed to evaluate the reliability, validi ty, and responsiveness of a newly developed, health-related quality-of -life measure. STUDY DESIGN: A total of 137 women (122 from a Phase II I clinical trial and 15 from a private practice setting) with endometr iosis completed the questionnaire several times. RESULTS: Reproducibil ity and internal-consistency reliability were acceptable with intracla ss correlation coefficients ranging from 0.94 to 1.00 and Cronbach's a lpha coefficients ranging from 0.84 to 0.97. Construct validity was de monstrated on the basis of correlations between items and scales. Heal th-related quality of life varied in a consistent manner according to clinician-rated measures of pelvic pain and dysmenorrhea and patient-r eported levels of endometriosis pain, but no relationship emerged acco rding to the revised American Fertility Society classification. In gen eral, 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.