临床注册研究-过去、现在和未来.ppt

* * AHA and Microsoft have collaborated to extend vision and scope of the center into a comprehensive wellness management tool Consumers, patients, physicians and other medical professionals and caregivers can use the tool to help: TRACK, TREAT and TRAIN their disease states which factor into cardiovascular disease, including hypertension, diabetes and cholesterol Allows providers to observe their patients progress, view personal trends and watch for red flags Acts as a integral component of AHA’s patient education offerings and complements AHA’s other programs, products, services and causes. ------------------------------------------------------- Data model will follow the data points created in the first phase The Cardiovascular Wellness Center will store de-identifiable data on AHA servers Any patient or provider identifiable data will be stored by Microsoft with the HealthVault platform Key Note: The user does have the option to provide consent for AHA to receive a copy of the information and utilize it for research purposes 开放手术或内镜手术采集静脉对CABG术后死亡率的影响 % deaths 0 0.5 1.0 1.5 2.0 2.5 3.0 0.00 0.02 0.04 0.06 0.08 0.10 Years from surgery EVH Open HR 1.52, 95%CI 1.13-2.04 Lopes R et al NEJM 2009 临床注册的作用: 支持临床试验 注册可以为随机对照试验提供依据 设计: 事件率, 目标人群 实施: 确定研究者，适合的病人 数据收集流程 检验临床试验结果在更广泛的患者人群和临床情况中的适用性 观察研究不足的人群 评估收益/支出比 相对有效性: 早期 GP IIb-IIIa 拮抗剂: 临床试验、NRMI和CRUSADE的结果 NRMI NSTE MI2 (N=60,770) 95% CI Odds Ratio 1.0 2.0 0.5 No Early GP IIb-IIIa inhibitor better Early GP IIb-IIIa inhibitor better 0.91 (0.81, 1.03) CRUSADE Overall (n=56,087)3 0.88 (0.79, 0.97) 0.93 (0.83, 1.05) 6 RCTs ACS1 (n=31,402) 1. Boersma et al. Lancet. 2002;359:189.2. Peterson et al. J Am Coll Cardiol. 2003;42:45. 3. Hoekstra et al. Acad Emerg Med 2005;12:431-438 0.88 (0.77, 1.00) CRUSADE NSTEMI (n=37,433)3 相对有效性: 低分子肝素与普通肝素CRUSADE 与SYNERGY 1.0 1.5 LMWH better 0.78 (0.70, 0.86) 0.81 (0.76, 0.87) UFH better (Reference) 0.5 Death or MI Any RBC transfusions 0.96 (0.87, 1.06) 1.0