临床注册研究过去现在和未来.pptxVIP

临床注册研究: 过去，现在和未来Eric D. Peterson, MD, MPH, FAHA, FACCProfessor of MedicineAssociate Vice Chair for Quality, Dept of Medicine, Duke University Medical CenterDirector of CV Research,Duke Clinical Research Institute (DCRI)来自DCRI的问候!Our Mission: To develop and share knowledge that improves the care of patients around the world through innovative clinical research The DCRI: 用过去引导未来“Chronic diseases can be studied, but not by the methods of the past. If one wishes to create useful data … computer technology must be exploited.”—Eugene Stead, MD “电子化的医学教科书”的概念 形成杜克心血管疾病数据库的基础 成就了一代临床研究学者用数据引导决策!杜克数据库的经验预后和相对有效性研究"There is a wealth of data available from large databases that enable us to research important clinical questions,""Robust methodology exists for comparing different therapies through observational database analysis.”Wilensky G Health Affairs Nov 2006:w572-w588促进相对有效性研究的因素作为ARRA的一部分: 11亿美元用于相对有效性 (CER)循证医疗提出问题?研究设计结果可靠吗?数据质量和分析方法结果适用于我的病人吗？典型病人、情况？有意义的临床终点?我们是否在实践中应用证据?—引自Kitching A, Sackett D, and Yusuf S in Evidence Based Cardiology, 1998循证医学面临的挑战发生不良反应危险最高的患者社区合并症疾病严重程度临床试验人群6068.3年龄应用注册提供证据并推广证据Clinical EvidenceConceptGuidelinesMulticenterClinical RegistriesOutcomesPerformanceIndicatorsQI Initiatives Measurement+ FeedbackAdapted from Califf RM, Peterson ED et al. JACC 2002;40:1895-901心血管疾病临床注册美国胸科医师学会: 1000+ 医院Coronary artery bypass surgeryValve surgeryCongenital heart surgeryThoracic surgery国家心血管疾病注册: 1600+ 医院Cath/Percutaneous coronary interventionImplantable cardiac defibrillators (ICD)Acute coronary syndromes (ACS)Carotid stentingIC3: Ambulatory CV disease (launching)AHA-依从指南项目: 1500+医院Coronary artery disease (CAD)Heart failure Stroke Outpatient: Ambulatory module (launching)这些临床注册…大规模并具有代表性患者，医生，病情包含详细的临床资料 就诊资料，治疗，短期预后采用相似的标准化的数据定义高质量的准确、完整、接受质控正在演变为纵向研究!与其它数据来源衔接贯穿治疗过程的心血管病注册HF/Stroke AMI/Care事件后:心脏康复二级预防导致入院 的事件一级预防出院住院住院治疗AHA H360ACC IC3 GWTG OutpatientTRANSLATE ACSORBIT-AFACTION GWTG HF, CVAACC-PCI, ICD PVD, CongenitalSTS-CABG, Valve链接临床注册与医疗支出数据Dok