Women's Cardiovascular Health Awareness in Lombardy: a Call for Urgent Appraisal Starting From a Population-based Web-survey: "A Call for Women" Project

[Background] Despite dramatic improvements in the prevention, diagnosis, and treatment of cardiovascular diseases (CVD) in women, CVD continues to be the leading cause of death in women in every major developed country and most emerging economies (1-2). The increasing awareness of sex- (because of the biological factors) and gender differences (those affected by broader social, environmental, and community factors) has stimulated action plans around the world to improve care for women. In the United States, different programs have been launched to promote education among women, including Go Red for Women by the American Heart Association, the Heart Truth by the National Heart, Lung, and Blood Institute, and Make the Call, Don't Miss a Beat by the US Department of Health and Human Services. In doing so, since 1997, the AHA has conducted numerous surveys among US women, proving an increase in awareness of heart disease as the leading cause of death between 1997 and 2012 (from 30% to 56%), especially among younger women (25-34 years of age)(3). Surprisingly, an opposite trend was recently reported. The last released study on behalf of the AHA showed a significant decline in women awareness between 2009 and 2019 (from 65% to 44%), particular in among Hispanic and non-Hispanic Black women and in younger women (in whom primary prevention may be most effective!), calling for an urgent effort to reverse this trend (4). In Europe, such initiatives are scarce, not well organized, with focused plans on a national basis, without adequate dissemination within the scientific community (5). Previous web-based studies have found that around 7% of women (an average number from many ethnic and demographic groups) are aware that heart disease is a real health concern (6). The Italian National Health Service carries out three screening programs for the prevention of tumors, two of which are typically female, breast and cervix, and the third dedicated to both sexes, colorectal. Screening for CVD risk factors is less common in general and in particular among women, without attention for young women and minorities, and most important, has no effect on lowering CVD morbidity and mortality (WHO Health Evidence Network - HEN - synthesis report 7, 2021) Awareness of adverse health conditions, including heart disease, or knowledge of risk factors is the first step in promoting prevention aimed to reduce mortality and morbidity, promoting individual and collective health and well-being. Unfortunately, still today, it is widely believed that cardiovascular diseases concern mainly men, and the great majority of women have a very low perception of the bad outcome caused by these pathologies (7). Furthermore, alongside traditional risk factors, such as high blood pressure, hypercholesterolemia, diabetes, smoking, and overweight, emerging, unrecognized risk factors should be taken into account, including pregnancy-related complications, sedentariness, early menopause, and depression, while potential relationships between eating disorders, lifestyles, chronic inflammatory bowel disease or autoimmune disorders, including celiac disease, and cross complications (e.g., osteopenia and osteoporosis) still deserve to be explored. Surprisingly, the latest released 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice (7) do not recommend systematic CVD risk assessment in women <50 years of age with no known CV risk factors (class III, Level of evidence C), omitting any consideration on potential, emerging risk factors. Indeed, information on whether female-specific conditions improve risk classification is considered a gap in the available evidence. Increasing women's understanding of CVD risk factors and enhancing opportunities to screen women across the lifespan is critical in this scenario with the ultimate goal to better identify women at risk and to improve outcomes. Thus, the first step is to assess the awareness of cardiovascular health and risk factors in a large cohort of women across different social, economic, cultural and health environments.

[Methods] Descriptive observational study, collecting data using a population-based web-survey.

[Study design] Descriptive observational cross-sectional study. The study will be coordinated by a Women Research Group - a multidisciplinary team of women active in the Clinical, Managerial, and Research sectors.

[Data collection] The data will be collected via a population-based web-survey (8-10) created with the SurveyMonkey® software. The collected data will be sent into an electronic data collector, whose output will be saved as an eCRF file in REDCap. The start and end of the data collection are scheduled for April 2022 and April 2023, respectively. Taking into consideration a population of roughly 5 million women in the Lombardy region and an estimated response rate of 80%, the required sample size is calculated in 2182 subjects. More precisely, a sample size of 2182 from a population of 5.000.000 produces a two-sided 80% confidence interval with a precision (half-width) of 0,0070 when the actual proportion is near 0,0700 [from previous web-based studies, roughly 7% of women - an average percentage from several ethnic and demographic groups - were aware regarding CVD (6)]. Consequently, the number of individuals out of the population needed to ask for participation to achieve the required sample size based on the expected response rate is roughly 12.000. The sample size was calculated using the statistical package PASS 2019, v19.0.1.

[Measured variables] All variables will be collected in a self-reporting format. To describe the web-survey-related camp, questions related to socio-demographic profile will be asked, taking into account age, sex, education, and marital status. The proposed item in the population-based web-survey will also face a process of validation: a group of 10/12 health professionals will be asked to express their opinion on the relevance of each item of the questionnaire with regard to the measurement objective of the scale itself. They will express a rating by evaluating each item with a 4-step Likert scale (1 = completely irrelevant; 4 = completely relevant). This approach is useful for content validation and was described by Lawshe (1975) to calculate two quantitative content validation indices (i.e., CVI, CVR). For the face validation (i.e., qualitative validation) three open questions will be asked to the same group of expert clinicians. These questions will be qualitatively analyzed, and any proposals for clarification on the linguistic form of the items will be taken into consideration.