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3.
Circ Cardiovasc Qual Outcomes ; 13(7): e006606, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32683985

RESUMO

The pipeline of new cardiovascular drugs is relatively limited compared with many other clinical areas. Challenges causing lagging drug innovation include the duration and expense of cardiovascular clinical trials needed for regulatory evaluation and approvals, which generally must demonstrate noninferiority to existing standards of care and measure longer-term outcomes. By comparison, there has been substantial progress in cardiovascular device innovation. There has also been progress in cardiovascular trial participation equity in recent years, especially among women, due in part to important efforts by Food and Drug Administration, National Institutes of Health, American Heart Association, and others. Yet women and especially racial and ethnic minority populations remain underrepresented in cardiovascular trials, indicating much work ahead to continue recent success. Given these challenges and opportunities, the multistakeholder Partnering with Regulators Learning Collaborative of the Value in Healthcare Initiative, a collaboration of the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University, identified how to improve the evidence generation process for cardiovascular drugs and devices. Drawing on a series of meetings, literature reviews, and analyses of regulatory options, the Collaborative makes recommendations across four identified areas for improvement. First, we offer strategies to enhance patient engagement in trial design, convenient participation, and meaningful end points and outcomes to improve patient recruitment and retention (major expenses in clinical trials). Second, new digital technologies expand the potential for real-world evidence to streamline data collection and reduce cost and time of trials. However, technical challenges must be overcome to routinely leverage real-world data, including standardizing data, managing data quality, understanding data comparability, and ensuring real-world evidence does not worsen inequities. Third, as trials are driven by evidence needs of regulators and payers, we recommend ways to improve their collaboration in trial design to streamline and standardize efficient and innovative trials, reducing costs and delays. Finally, we discuss creative ways to expand the minuscule proportion of sites involved in cardiovascular evidence generation and medical product development. These actions, paired with continued policy research into better ways to pay for and equitably develop therapies, will help reduce the cost and complexity of drug and device research, development, and trials.


Assuntos
Ensaios Clínicos como Assunto , Aprovação de Equipamentos , Aprovação de Drogas , Medicina Baseada em Evidências , Comunicação Interdisciplinar , Assistência Centrada no Paciente , Projetos de Pesquisa , Comportamento Cooperativo , Difusão de Inovações , Humanos , Participação do Paciente , Seleção de Pacientes , Formulação de Políticas , Participação dos Interessados , Estados Unidos , United States Food and Drug Administration
4.
Circ Cardiovasc Qual Outcomes ; 13(5): e006483, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32393125

RESUMO

Heart failure (HF) is a leading cause of hospitalizations and readmissions in the United States. Particularly among the elderly, its prevalence and costs continue to rise, making it a significant population health issue. Despite tremendous progress in improving HF care and examples of innovation in care redesign, the quality of HF care varies greatly across the country. One major challenge underpinning these issues is the current payment system, which is largely based on fee-for-service reimbursement, leads to uncoordinated, fragmented, and low-quality HF care. While the payment landscape is changing, with an increasing proportion of all healthcare dollars flowing through value-based payment models, no longitudinal models currently focus on chronic HF care. Episode-based payment models for HF hospitalization have yielded limited success and have little ability to prevent early chronic disease from progressing to later stages. The available literature suggests that primary care-based longitudinal payment models have indirectly improved HF care quality and cardiovascular care costs, but these models are not focused on addressing patients' longitudinal chronic disease needs. This article describes the efforts and vision of the multi-stakeholder Value-Based Models Learning Collaborative of The Value in Healthcare Initiative, a collaboration of the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University. The Learning Collaborative developed a framework for a HF value-based payment model with a longitudinal focus on disease management (to reduce adverse clinical outcomes and disease progression among patients with stage C HF) and prevention (an optional track to prevent high-risk stage B pre-HF from progressing to stage C). The model is designed to be compatible with prevalent payment models and reforms being implemented today. Barriers to success and strategies for implementation to aid payers, regulators, clinicians, and others in developing a pilot are discussed.


Assuntos
Prestação Integrada de Cuidados de Saúde/economia , Custos de Cuidados de Saúde , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/terapia , Avaliação de Processos e Resultados em Cuidados de Saúde/economia , Seguro de Saúde Baseado em Valor/economia , Aquisição Baseada em Valor/economia , Redução de Custos , Análise Custo-Benefício , Custos Hospitalares , Humanos , Modelos Econômicos , Readmissão do Paciente , Melhoria de Qualidade/economia , Indicadores de Qualidade em Assistência à Saúde/economia , Participação dos Interessados , Fatores de Tempo , Resultado do Tratamento
5.
Health Aff (Millwood) ; 38(6): 1011-1020, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31158012

RESUMO

Care for people living with serious illness is suboptimal for many reasons, including underpayment for key services (such as care coordination and social supports) in fee-for-service reimbursement. Accountable care organizations (ACOs) have potential to improve serious illness care because of their widespread dissemination, strong financial incentives for care coordination in downside-risk models, and flexibility in shared savings spending. Through a national survey we found that 94 percent of ACOs at least partially identify their seriously ill beneficiaries, yet only 8-21 percent have widely implemented serious illness initiatives such as advance care planning or home-based palliative care. We selected six diverse ACOs with successful programs for case studies and interviewed fifty-three leaders and front-line personnel. Cross-cutting themes include the need for up-front investment beyond shared savings to build serious illness infrastructure and workforce; supporting the business case for organizational buy-in; how ACO contract specifications affect savings for serious illness populations; and using data and health information technology to manage populations. We discuss the implications of the recent Medicare ACO regulatory overhaul and other policies related to serious illness quality measures, risk adjustment, attribution methods, supporting rural ACOs, and enhancing timely data access.


Assuntos
Organizações de Assistência Responsáveis , Doença Crônica , Redução de Custos/economia , Gastos em Saúde/estatística & dados numéricos , Estudos de Casos Organizacionais , Cuidados Paliativos , Organizações de Assistência Responsáveis/economia , Organizações de Assistência Responsáveis/estatística & dados numéricos , Doença Crônica/economia , Doença Crônica/terapia , Planos de Pagamento por Serviço Prestado/economia , Humanos , Entrevistas como Assunto , Medicare/economia , Inovação Organizacional , Inquéritos e Questionários , Estados Unidos
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