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

This paper presents the multi-phase development and validation of the Reproductive Ageing in Women (RAW) Questionnaire, a new tool designed to improve the consistency and inclusivity of menopausal stage classification by integrating menstrual characteristics, age, and symptoms, which demonstrated strong validity, reliability, and concordance with biological markers like FSH.

The Gist

Imagine you are trying to sort a massive library of books about women's health. To do this effectively, you need to know exactly which "chapter" of life each woman is in. Is she in the "Pre-Teen" chapter (pre-menopause), the "Chaotic Teen Years" (perimenopause), or the "Golden Years" (post-menopause)?

For decades, scientists have had a very strict rulebook called STRAW+10 to sort these books. It says: "You are in the 'Chaotic Teen Years' only if your monthly visitor (your period) has become irregular."

The Problem:
This rulebook breaks down for a huge number of women. What if a woman had surgery to remove her uterus? What if she's on birth control that stops her period entirely? For these women, the "monthly visitor" is gone, so the old rulebook can't tell scientists which chapter they are in. It's like trying to sort books by their cover color, but some books have no covers. These women were often left out of research, or scientists had to guess.

The Solution: The RAW Questionnaire
The authors of this paper created a new, smarter tool called the RAW Questionnaire (Reproductive Ageing in Women). Think of it as a GPS for menopause that works even when the main road (your period) is closed.

Here is how they built and tested it, explained simply:

1. Building the Map (Development)

The team started with the old, strict rulebook (STRAW+10) but realized they needed to add "detours." They asked: "How do we know where someone is if we can't see their period?"

• The Detour Rule: If you can't see the period, look at your age and your symptoms. If you are over 58 and having bad hot flashes, the GPS says, "You're likely in the Post-Menopause chapter," even without seeing a period.

2. Testing the Map (Validation)

They didn't just guess; they put the new GPS through a rigorous training camp with four phases:

• Phase 1: The Draft. They wrote the questions based on the old rules and a quality-of-life survey.
• Phase 2: The Expert Review. They showed the draft to three "super-scientists" (doctors and researchers). The experts said, "This is good, but let's make sure we understand surgery and birth control clearly."
• Phase 3: The "Think Aloud" Test. They sat down with 14 real women and asked them to read the questions out loud while thinking.
  • The Result: The women said, "I didn't know what 'perimenopause' meant," or "I have hair loss, but that wasn't on the list." The team fixed the language and added new symptoms like hair loss and belly weight gain.
• Phase 4: The Big Test. They gave the questionnaire to 156 women and took their blood.
  • The "Lie Detector" Test (Reliability): They asked the women to take the test again a few weeks later. The answers were almost identical (95% agreement). The GPS is stable!
  • The "Truth Serum" Test (Biological Validity): They checked the women's blood for a hormone called FSH. Think of FSH as the "engine light" on a car dashboard. When the engine (ovaries) is winding down, the light gets brighter.
    • The women the questionnaire said were "Post-Menopause" had high "engine lights" (high FSH).
    • The women the questionnaire said were "Pre-Menopause" had low "engine lights."
    • The Verdict: The GPS matched the engine light 96% of the time.

Why This Matters

Before this, if a woman had her uterus removed, she was often invisible in research. Scientists couldn't study her heart health, bone density, or memory because they couldn't figure out her "menopause stage."

The RAW Questionnaire is like a universal translator. It translates the complex, messy reality of women's lives (surgery, birth control, irregular periods) into a clear, scientific language.

The Bottom Line:
This study created a new, inclusive tool that helps scientists finally "see" all women, not just those with regular periods. It ensures that when we research how to keep women healthy in midlife, we aren't leaving anyone out of the conversation. It's a step toward a future where every woman's health journey is accurately mapped and understood.

Technical Summary

1. Problem Statement

Accurate classification of menopausal stage is critical for midlife health research, particularly given the influence of reproductive hormones on cardiometabolic, skeletal, and neurocognitive health. While the Stages of Reproductive Ageing Workshop (STRAW+10) criteria are the gold standard for defining reproductive stages, their application in research is inconsistent.

• Limitations of Current Methods: Many studies rely on single time-point hormone levels or simplified definitions (e.g., any bleeding in the last 12 months), which fail to capture the nuances of the menopausal transition.
• Exclusion of Key Populations: A significant limitation is the inability to classify individuals without observable menstrual cycles due to surgical interventions (hysterectomy, oophorectomy) or contraceptive-induced amenorrhoea. These individuals are often excluded from research or misclassified, reducing the generalizability and inclusivity of midlife health studies.
• Need: There is a lack of a standardized, implementable tool that translates STRAW+10 criteria into a self-administered format while accommodating those without observable cycles.

2. Methodology

The study employed a multi-phase development and validation design conducted between May 2022 and July 2025.

• Phase 1: Questionnaire Development:
  • Items were derived from STRAW+10 criteria and the Menopause-Specific Quality of Life Questionnaire (MENQOL).
  • The draft included questions on menstrual characteristics, symptom severity, exogenous hormone use, and reasons for amenorrhoea.
• Phase 2: Content Validity:
  • Reviewed by three menopause experts (PhD/MD level) for clarity, relevance, and completeness.
  • Revisions were made to improve inclusivity for surgical and contraceptive-induced amenorrhoea.
• Phase 3: Face Validity:
  • Conducted via think-aloud interviews and focus groups ($n=14$) stratified by menopausal status (pre, peri, post, and surgical).
  • Thematic analysis identified issues with terminology, menstrual descriptors, and symptom coverage, leading to refinements (e.g., adding hair loss and abdominal weight gain to symptom matrices).
• Phase 4: Validation (LIFE Cohort):
  • Study Design: Cross-sectional cohort study ($n=156$) at the University of the Sunshine Coast.
  • Construct Validity: Assessed in 30 participants to ensure the framework yielded unambiguous classifications.
  • Test-Retest Reliability: Assessed in 128 participants over 6–21 days using Kendall's Tau-b and Cohen's kappa.
  • Biological Validity: Serum Follicle Stimulating Hormone (FSH) and Oestradiol (E2) were measured via ELISA to validate classifications against biological markers.
  • Classification Framework:
    • Step 1: Primary classification based on menstrual cycle characteristics and age.
    • Step 2: For those without observable cycles (e.g., hysterectomy), classification relies on a conservative age threshold ($\ge$58 years) refined by moderate-to-severe hot flushes and/or Menopausal Hormone Therapy (MHT) use.

3. Key Contributions

• The RAW Questionnaire & Framework: A validated, self-administered tool that operationalizes STRAW+10 criteria.
• Inclusivity: The framework specifically addresses the "missing data" problem for women with surgical or contraceptive-induced amenorrhoea, allowing them to be classified into reproductive stages rather than excluded.
• Standardization: Provides a consistent algorithm for researchers to apply across diverse cohorts, enhancing comparability between studies.
• Symptom Integration: Incorporates vasomotor symptoms (hot flushes) as a secondary refinement tool, acknowledging evidence that these may precede overt cycle disruption.

4. Key Results

• Validity & Usability:
  • Expert and participant feedback confirmed the questionnaire's clarity and relevance.
  • Construct Validity: The framework demonstrated 93% concordance with self-identified menopausal status in the construct sample.
  • Cohort Agreement: In the LIFE cohort ($n=156$), there was 87.8% agreement between RAW classification and self-identified status.
• Reliability:
  • Test-Retest Reliability: Excellent agreement over 6–21 days ($\tau_b = 0.940, p < 0.001$).
  • Individual classification variables (e.g., menstrual status) showed "almost perfect" agreement (Kappa > 0.80).
• Biological Validity:
  • FSH levels differed significantly across RAW-classified stages ($p < 0.001$).
  • 96.1% concordance was found between RAW pre/postmenopausal classifications and established FSH thresholds ($\le$20 mIU/mL for pre, $\ge$25 mIU/mL for post).
  • Oestradiol levels showed expected group differences, with lower medians in postmenopause.
• Demographics: The study successfully classified participants across premenopausal (48), perimenopausal (45), and postmenopausal (63) groups, including those with surgical amenorrhoea.

5. Significance and Implications

• Methodological Advancement: The RAW Questionnaire bridges the gap between theoretical staging criteria (STRAW+10) and practical application in cross-sectional research. It solves the methodological bottleneck of excluding women without observable cycles.
• Research Quality: By enabling consistent staging, the tool reduces misclassification bias, which is crucial for accurately interpreting stage-specific associations with disease risks (e.g., cardiovascular, bone density).
• Clinical & Public Health Relevance: As midlife is recognized as a critical window for disease risk modification, inclusive staging allows for better identification of at-risk populations, including those with surgical histories.
• Future Directions: The authors note that while short-term reliability is high, longitudinal validation is required to assess the tool's temporal sensitivity in tracking the dynamic transition from late reproductive stages to early menopause. Additionally, the tool is not suitable for individuals with Premature Ovarian Insufficiency (POI).

Conclusion: The RAW Questionnaire is a robust, validated instrument that enhances the inclusivity and methodological rigor of menopause research by providing a standardized framework for classifying reproductive ageing in both naturally cycling and amenorrhoeic women.