IMPORTANCE: Accurate classification of the stages of reproductive ageing is vital for conducting reliable and valid research in menopause health. However, the lack of a validated tool to classify menopausal status has led to inconsistencies in the description of study populations and limits high-quality menopause research. This study aimed to develop and validate a questionnaire to improve the classification of menopause, and advance the current understanding of reproductive ageing, and its impact on women’s health.  

METHODOLOGY: The Reproductive Ageing in Women (RAW) questionnaire was developed based upon the Stages of Reproductive Ageing (STRAW+10) guidelines, with the addition of questions to elucidate menstrual/menopause history, and menopause symptoms. Content and face validity was evaluated through expert feedback (n=3) and, participant interviews and focus groups (n=14), respectively. Construct validity was assessed by comparing responses from a pilot sample (n=30) to the STRAW+10 criteria. Test-retest reliability will be evaluated in 130 participants who completed the questionnaire twice (6-21 days apart). Biological validity will be assessed by comparing questionnaire outcomes against hormonal markers of reproductive ageing (n=155).

FINDINGS: Content validity led to the inclusion of additional questions related to hysterectomy, adapted from The Health and Wellbeing After Breast Cancer study menopausal classification algorithm (HWABC). Face validity confirmed relevance, and usability of the questionnaire, and suggested changes were made to include additional menopause symptoms and questions pertaining to menstrual cycle changes outside of the STRAW+10 guidelines. Construct validity was achieved through comparison of questionnaire outcomes against   STRAW+10 and HWABC criteria to ensure responses aligned with guidelines. Test re-test reliability and biological validity is ongoing.

IMPACT: The development and validation of the RAW questionnaire will provide researchers with an effective and reliable tool to classify the stages of reproductive ageing, to enhance research outcomes and improve the current understanding of menopause on health and wellbeing.