Duke Cardiovascular CERTs

描述：(由申请人提供)：心血管疾病仍然是美国最致命的疾病之一，而心血管疾病的护理仍然很不理想，而且心血管疾病护理费用是最昂贵的之一。在某些患者群体和社区环境中，许多心血管药物和设备的安全性和有效性是不确定的，有充分的证据表明这些药物的使用不足、过度和不当。为了解决这些问题，杜克大学临床研究所(DCRI)与所有主要的心血管专业协会建立了广泛的联盟。这些合作为我们提供了一个前所未有的机会来评估心血管疗法的“真实世界”安全性、有效性和效率，同时也提供了将所获得的知识转化为实践的手段；最终目标是在全国范围内改善患者的预后。我们的建议还涉及从住院环境到患者长期依从性问题的心血管治疗，以及五个主要心血管重点领域，包括：急性冠脉综合征、心力衰竭、中风、心脏性猝死和冠状动脉血运重建。这项建议致力于推动心血管疾病药物和器械上市后评估和质量改进的科学状况，同时也为临床医生、政策制定者和公众提供实用和可操作的信息和产品。我们的公爵CERT的具体目标是： 1.促进优化由专业协会主导的心血管疾病登记，作为国家监测系统，用于评估和确保社区环境中心血管疗法和设备的安全性和有效性；并满足FDA、CMS、NIH和AHRQ的信息需求。 2.找出将心血管疾病治疗和设备证据转化为常规证据的具体障碍 临床实践和患者长期坚持有效的心血管疗法。 3.制定并严格评估以患者和提供者为基础的干预措施，旨在改善 安全、有效和高效地使用血管紧张素转换酶疗法，并提高长期治疗依从性。 4.广泛传播那些被认为有效的干预措施。 5.培养下一代简历成果研究人员。

DESCRIPTION: (Provided by the Applicant): Cardiovascular (CV) disease remains the nation's #1 deadliest medical condition while CV care remains far from ideal and CV care costs are among the most expensive. The safety and effectiveness of many CV drugs and devices are uncertain in certain patient populations and in community settings, and there is ample evidence of under-, over- and mis-use of such agents. To address these issues, the Duke Clinical Research Institute (DCRI) has established a broad set of alliances with all of the major CV professional societies. These collaborations provide us with an unprecedented opportunity to evaluate 'real world' safety, effectiveness and efficiency of CV therapeutics, but also the means to translate knowledge gained into practice; with an ultimate goal of improving patient outcomes on a national scale. Our proposal also addresses CV therapeutics across the continuum; from in-patient settings to issues of long-term patient adherence; and for five major CV emphasis areas including: acute coronary syndromes; heart failure; stroke; sudden cardiac death; and coronary revascularization. This proposal is dedicated to advancing the state of the science of post-market CV drug and device evaluation and quality improvement, but also to generating practical and actionable information and products for clinicians, policy makers, and the public. Our Duke CERTs Specific Aims are to: 1. Promote the optimization of professional society-led CV registries as national surveillance systems for evaluating and assuring the safety and effectiveness of CV therapeutics and devices in community based settings; and meeting the informational needs of FDA, CMS, NIH, and AHRQ. 2. Identify specific barriers to both the translation of CV therapeutic and device evidence into routine clinical practice and long-term patient adherence to effective CV therapeutics. 3. Develop and rigorously evaluate patient- and provider-based interventions designed to improve the safe, effective, and efficient use of CV therapies and to improve long-term treatment adherence. 4. Widely disseminate those interventions found to be effective. 5. Train the next generation of CV outcomes researchers.