Duke Cardiovascular CERTs

产品说明：（由申请人提供）：心血管（CV）疾病仍然是美国最致命的疾病，而CV护理仍然远远不够理想，CV护理费用是最昂贵的。在某些患者人群和社区环境中，许多心血管药物和器械的安全性和有效性尚不确定，并且有充分的证据表明此类药物使用不足、过度和误用。为了解决这些问题，杜克临床研究所（DCRI）与所有主要的CV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CV治疗的“真实的世界”安全性、有效性和效率，同时也是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结局。我们的提案还涉及整个连续体的CV治疗;从住院患者设置到长期患者依从性问题;以及五个主要CV重点领域，包括：急性冠状动脉综合征;心力衰竭;中风;心源性猝死;和冠状动脉血运重建。该提案致力于推进上市后CV药物和器械评价和质量改进的科学状态，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。我们的杜克CERT具体目标是： 1.促进专业协会主导的CV登记系统的优化，将其作为国家监测系统，用于评价和确保CV治疗和器械在社区环境中的安全性和有效性;并满足FDA、CMS、NIH和AHRQ的信息需求。 2.识别将CV治疗和器械证据转化为常规证据的具体障碍 临床实践和长期患者对有效CV治疗的依从性。 3.制定并严格评估基于患者和提供者的干预措施，旨在改善 安全、有效和高效地使用CV治疗，并改善长期治疗依从性。 4.广泛宣传那些被认为有效的干预措施。 5.培训下一代简历结果研究人员。

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.