Abstract / Summary
Abstract Background Cardiovascular disease (CVD) is the leading cause of death among women worldwide, with risk increasing during menopause as oestrogen levels decline. Despite this, awareness of the menopause-CVD relationship remains low. As part of the EU Horizon Cardiovascular Risk Assessment in Menopausal Women (CARAMEL) study, the ‘Menopause and Heart Health Questionnaire’ (MHHQ) was developed to assess women’s knowledge, experiences, behaviours and perceived cardiovascular risk during menopause. The aim of this paper is to describe the development and preliminary evaluation of the MHHQ, including content validity, face validity, acceptability, and test-retest reliability. Methods A 65-item self-report questionnaire was developed following best practice guidelines for instrument design and evaluation. Items were adapted from validated menopause and cardiovascular health questionnaires and supplemented with new items informed by evidence and expert consensus. Content validity was assessed through qualitative review by a multidisciplinary expert panel that included a patient and public involvement contributor. Face validity and acceptability were assessed among 31 women aged 40–60 years. Test-retest reliability was assessed in a separate sample, with 30 women completing the questionnaire at baseline and 15 completing the second administration one-week later. Reliability was evaluated for 22 variables selected a priori using Cohen’s kappa (κ), weighted Cohen’s kappa (κ w ) and intraclass correlation coefficients (ICC). Results Expert review informed refinements to questionnaire wording, structure and content. Face validity and acceptability testing indicated that the questionnaire was clear and acceptable with an approximate completion time of 30 min. Test-retest reliability was generally good across the variables assessed. Nominal categorical variables demonstrated fair to excellent agreement (κ = 0.40-1.00), ordinal categorical variables demonstrated moderate to very good agreement (κ w = 0.51–0.96) and continuous variables demonstrated good to excellent reliability (ICC = 0.72-1.00). However, the 95% confidence intervals were wide for some reliability estimates. Conclusion The MHHQ is a novel multidomain questionnaire integrating menopausal experiences, cardiovascular health, lifestyle behaviours and perceived cardiovascular risk. Preliminary evaluation provides evidence supporting its content validity, face validity and acceptability, with generally good test-retest reliability across the variables assessed. Further evaluation in larger and more diverse populations is warranted to further access its measurement properties and broader applicability.