The American Heart Association's Call to Action for Reducing the Global Burden of Rheumatic Heart Disease: A Policy Statement From the American Heart Association.

Rheumatic heart disease (RHD) affects ≈40 million people and claims nearly 300 000 lives each year. The historic passing of a World Health Assembly resolution on RHD in 2018 now mandates a coordinated global response. The American Heart Association is committed to serving as a global champion and leader in RHD care and prevention. Here, we pledge support in 5 key areas: (1) professional healthcare worker education and training, (2) technical support for the implementation of evidence-based strategies for rheumatic fever/RHD prevention, (3) access to essential medications and technologies, (4) research, and (5) advocacy to increase global awareness, resources, and capacity for RHD control. In bolstering the efforts of the American Heart Association to combat RHD, we hope to inspire others to collaborate, communicate, and contribute.

The WHF Roadmap for Reducing CV Morbidity and Mortality Through Prevention and Control of RHD.

Rheumatic heart disease (RHD) is a preventable non-communicable condition that disproportionately affects the world's poorest and most vulnerable. The World Heart Federation Roadmap for improved RHD control is a resource designed to help a variety of stakeholders raise the profile of RHD nationally and globally, and provide a framework to guide and support the strengthening of national, regional and global RHD control efforts. The Roadmap identifies the barriers that limit access to and uptake of proven interventions for the prevention and control of RHD. It also highlights a variety of established and promising solutions that may be used to overcome these barriers. As a general guide, the Roadmap is meant to serve as the foundation for the development of tailored plans of action to improve RHD control in specific contexts.

A Comprehensive Needs Assessment Tool for Planning RHD Control Programs in Limited Resource Settings.

Rheumatic heart disease (RHD) is an important cause of disability and death in low- and middle-income countries. However, evidence-based interventions have not been implemented systematically in many countries. We present a RHD Needs Assessment Tool (NAT) that can be used at country or regional levels to systematically develop and plan comprehensive RHD control programs and to provide baseline data for program monitoring and evaluation. The RHD NAT follows a mixed-methods approach using quantitative and qualitative data collection instruments. Evidence is mapped to a conceptual model that follows a patient through the natural history of RHD. The NAT has 4 phases: 1) situational assessment; 2) facility-based assessment of epidemiology and health system capacity; 3) patient and provider experience of RHD using ethnographic methods; and 4) intervention planning, including stakeholder mapping and development of a monitoring and evaluation framework. The RHD NAT is designed to paint a comprehensive picture of RHD care in an endemic setting and to identify the major gaps to disseminating and implementing evidence-based interventions.

Benefit-risk assessment in a post-market setting: a case study integrating real-life experience into benefit-risk methodology.

PURPOSE: Difficulties may be encountered when undertaking a benefit-risk assessment for an older product with well-established use but with a benefit-risk balance that may have changed over time. This case study investigates this specific situation by applying a formal benefit-risk framework to assess the benefit-risk balance of warfarin for primary prevention of patients with atrial fibrillation. METHODS: We used the qualitative framework BRAT as the starting point of the benefit-risk analysis, bringing together the relevant available evidence. We explored the use of a quantitative method (stochastic multi-criteria acceptability analysis) to demonstrate how uncertainties and preferences on multiple criteria can be integrated into a single measure to reduce cognitive burden and increase transparency in decision making. RESULTS: Our benefit-risk model found that warfarin is favourable compared with placebo for the primary prevention of stroke in patients with atrial fibrillation. This favourable benefit-risk balance is fairly robust to differences in preferences. The probability of a favourable benefit-risk for warfarin against placebo is high (0.99) in our model despite the high uncertainty of randomised clinical trial data. In this case study, we identified major challenges related to the identification of relevant benefit-risk criteria and taking into account the diversity and quality of evidence available to inform the benefit-risk assessment. CONCLUSION: The main challenges in applying formal methods for medical benefit-risk assessment for a marketed drug are related to outcome definitions and data availability. Data exist from many different sources (both randomised clinical trials and observational studies), and the variability in the studies is large.