Reproductive Ageing in Women (RAW) Questionnaire: multi-phase development and validation of a questionnaire for the classification of menopause stage

Objectives: Accurate classification of menopausal stage is fundamental to midlife health research. Although the Stages of Reproductive Ageing Workshop (STRAW+10) criteria provide gold-standard criteria, their application in research settings is inconsistent. Classification challenges are compounded in individuals without observable menstrual cycles due to surgical or contraceptive-induced amenorrhoea. The Reproductive Ageing in Women (RAW) Questionnaire and accompanying classification Framework was developed and validated to improve consistency and inclusivity when classifying menopausal stage. Study design: A multi-phase study was conducted between May 2022 and July 2025. Phase one involved questionnaire development based on STRAW+10 and the Menopause-Specific Quality of Life Questionnaire. Phase two assessed content validity via expert review (n=3). Phase three evaluated face validity using think-aloud interviews and focus groups (n=14). Phase four validated RAW within a cross-sectional cohort study (n=156), and assessed construct validity (n=30), test-retest reliability (6-21 days; n=128; Kendall's Tau-b and Cohen's kappa), and biological validity using follicle stimulating hormone (FSH). Results: Feedback supported clarity, relevance and usability, with refinements improving inclusivity for surgical and contraceptive-induced amenorrhoea. Construct validity demonstrated consistent application of classification criteria. Questionnaire classification showed 93% concordance with self-identified menopausal status in the construct sample and 87.8% agreement within the cohort sample. Test-retest reliability was excellent ({tau}, p=0.940, p<0.001). Follicle stimulating hormone levels differed across RAW-classified stages (p<0.001), with 96.1% concordance between RAW pre and postmenopausal classifications and FSH thresholds. Conclusions: Prioritising menstrual characteristics while incorporating age and symptom criteria improves methodological consistency and inclusivity in menopausal stage classification. Longitudinal validation is warranted to assess temporal sensitivity across the menopausal transition.