循证医学概论.pptVIP

FDA 指导原则 (I, II, III 期临床试验) 试验的可行性，逻辑上的连续性 以临床经验和临床观察为基础 参考文献的支持 进行预初试验 提供样本量计算的依据 建立跨学科综合性研究团队 提出合适的研究问题 选择适合于中医治疗的病症 设计适当有效的中医治疗方案 采用一切必要的和可行的循证医学研究方法 -- 恰当的随机 -- 严格的盲法及屏蔽措施 -- 独立的疗效检测 -- 选择可比性好的对照组 -- 明确的 纳入/排除标准 -- 标准的疗效评价方法 -- 合适的样本量 -- 专业恰当的统计分析 The measure of success of a scientific paper is how many other papers it makes irrelevant.  David Hilbert  * * According to FDA description, these are small, usually do not have a control group, and are designed to establish basic parameters of dose and safety. Acupuncture research in the past has frequently overlooked the importance of Phase I and moved immediately to RCT’s and in doing so a number of acupuncture RCTs have used acupuncture treatments which were not based on preliminary effectiveness data. These trials are cost-effective – if patients do not respond, the researcher knows early on that it’s probably not worth pursuing These are the key items that should be considered in Phase I Read slide ? * * According to FDA description, these are small, usually do not have a control group, and are designed to establish basic parameters of dose and safety. Acupuncture research in the past has frequently overlooked the importance of Phase I and moved immediately to RCT’s and in doing so a number of acupuncture RCTs have used acupuncture treatments which were not based on preliminary effectiveness data. These trials are cost-effective – if patients do not respond, the researcher knows early on that it’s probably not worth pursuing These are the key items that should be considered in Phase I Read slide ? 一个系统评价不一定非要包括Meta-分析 如果缺乏相关的或可靠的资料，或研究之间有显著的异质性时，Meta-分析就不可能进行 一个结论合理而真实的系统评价比结论不真实的Meta-分析更有价值 系统评价可以指出研究的缺口并对未来应进行的研究提出建议 做一个系统评价不难，难的是做一个高质量的系统评价 学习做系统评价的最好途径是做一个Cochrane系统评价 做好系统评价所需要的相关知识 临床流行病学知识 临床专业知识 统计学知识 计算机能力 文献检索能力 英语能力 也可以从做的过程中不断补充学习相关知识 按图索骥 Cochrane handbook 系统评价的质量评价 PRISMA --报告质量 —27项 AMSTAR —方法学质量 —11项 AMSTAR----A measurement tool for the assessment of multiple systematic r