Global Disparities in Outcomes of Pregnant Individuals With Rheumatic Heart Disease: A Scoping Review.

Background: Rheumatic heart disease (RHD) remains as 1 of the major contributors to indirect pregnancy-related mortality and morbidity worldwide and disproportionately affects marginalized populations.

Objectives: In this scoping review, the authors sought to explore the socioeconomic, cultural, and health care access-related causes of global disparities in outcomes of pregnancy among individuals with RHD.

Methods: We performed a literature search of all studies published between January 1, 1990, and January 1, 2022, that investigated causes for disparate outcomes in pregnant individuals with RHD.

Longitudinal Management of Cardiovascular Risk Factors Among Postpartum Women.

Pregnancy-related cardiovascular (CV) conditions, including hypertensive disorders of pregnancy (HDP) and gestational diabetes (GDM), are associated with increased long-term CV risk. This retrospective cohort study defined the prevalence of HDP and GDM within a large, academic health system in the southeast United States between 2012 and 2015 and described health care utilization and routine CV screening up to 1-year following delivery among those with pregnancy-related CV conditions. Rates of follow-up visits and blood pressure, hemoglobin A1c (HbA1c), and lipid screening in the first postpartum year were compared by provider type and pregnancy-related CV condition.

Strategies for enhancing the representation of women in clinical trials: an evidence map.

Background: Equitable sex- and gender-based representation in clinical trials is an essential step to ensuring evidence-based care for women. While multi-institutional actions have led to significant improvements in the inclusion of women in trials, inequity persists in areas like sex-neutral cancers and cardiovascular disease. We sought to identify strategies described or evaluated to boost the inclusion of women in clinical trials.

Connected health in US, EU, and China: opportunities to accelerate regulation of connected health technologies to optimize their role in medicines development.

Connected health technology is playing an increasingly important role in healthcare. The power, complexity, functionality, and accessibility of connected health technologies are increasing rapidly, showing promise for improved and more equitable healthcare outcomes. They are integral to the lifecycle of medical products, from discovery and development to manufacturing and ultimately to the patient.

Establishing a core dossier for multiple regulatory submissions: a case study in the Latin America region.

The Latin America region comprises several countries that do not follow harmonized regulatory requirements for drug product (DP) marketing authorization applications (MAA), resulting in customized registration dossiers for each country. Here, we established a core dossier for multiple MAA in the Latin America region by examining the similarities between regulatory requirements and reconciling their potential discrepancies through discussions among all national regulatory representatives. The core dossier was used in the submission of a new small molecule, NME1, to nine markets.