This study sought to develop a psychometrically sound instrument for breast cancer survivors to self-report symptoms related to urogenital atrophy. An extensive literature search was performed to generate items that provided representation of pain and discomfort, function, satisfaction, and urogenital quality of life from urologic, genital, and sexual domains. A 45-item urogenital atrophy questionnaire was developed. Initial psychometric properties of face and content validity were established through an expert panel, as measured by a CVI score. Approvals to conduct a study with the newly-devised instrument were obtained from institutional research and ethics boards. Subsequently, a pilot study (N=30) was conducted to test the new instrument and establish a reliability measure of test-retest.
The larger study (N=334) was conducted with a slightly modified version of the original urogenital atrophy instrument to establish baseline reliability and validity psychometric properties. Women without breast cancer and breast cancer survivors were invited to participate in this study at their clinic visits using a collection of self-report instruments to survey symptoms. Written, informed consent was obtained. Electronic chart reviews were performed on the demographic sections of the survey to validate aspects of obstetric and gynecologic, medication, breast cancer and treatment histories.
Factor analyses were used to statistically establish factors and related items for the urogenital atrophy questionnaire, and to determine if items could include all women, regardless of sexual orientation, partner status, practice of penile vaginal intercourse, and levels of sexual activity. Reliability was established using the domain sampling model and internal consistency measures. Psychometrically sound instruments were used to establish convergent and divergent validity. A 10-factor, 30-item instrument resulted that enables women, specifically breast cancer survivors, to self-report symptoms related to uogenital atrophy. Further item reduction will occur to eliminate redundant factors and items, and create a brief and concise instrument for use in the clinical setting. Future research includes establishment of an accompanying objective instrument to measure the signs of urogenital atrophy. Only then will clinicians possess a psychometrically sound instrument to measure the signs and symptoms of urogenital atrophy in breast cancer survivors.