Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium
Authors:
Paramanandam, V. S., Lensen, S., Gabes, M., Kann, G., Donhauser, T., Waters, N. F., Li, A. D., Peate, M., Susanto, N. S., Caughey, L. E., Rangoonwal, F., Liu, J., Condron, P., Obalowu, I. A., Archer, D. F., Bell, R. J., Christmas, M., Davies, M., Davis, S. R., Giblin, K., Iliodromiti, S., Jaisamrarn, U., Khandelwal, S., Kiesel, L., Aggarwal, N., Mitchell, C. M., Mishra, G. D., Nappi, R. E., Panay, N., Roberts, H., Rozenberg, S., Shifren, J., Simon, J. A., Stute, P., Vincent, A. J., Wolfman, W., and Hickey, M.
Abstract:
OBJECTIVE: The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects.
METHODS: We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome.
RESULTS: A total of 87 publications reporting on 34 PROMs were identified from 21,207 publications screened. Of these 34 PROMs, 29 were not considered to sufficiently map onto the core outcomes, and 26 of these also had insufficient measurement properties. Therefore, only five PROMs corresponding to two core outcomes were considered for recommendation. We recommend the PROMIS Scale v2.0 - Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity to measure the outcome of "pain with sexual activity" and the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire to measure "distress, bother or interference" from genitourinary symptoms. Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events in study participants, which is a requirement of Good Clinical Practice.
CONCLUSIONS: Suitable PROMs and definitions were identified to measure three of eight core outcomes. Because of the lack of existing measures, which align with the core outcomes and have evidence of high-quality measurement properties, future work will focus on developing or validating PROMs for the remaining five core outcomes.