outcomeevaluationofimmunization.ppt

outcome research Outcome evaluation of immunization Wei-Chu Chie Immunization Primary prevention specific protection baseline (basic) immunization booster immunization active vs. passive special groups infants and children, elderly adults, high risk groups 實驗性方法的三要素 實驗單位 (experimental unit) 處置 (treatment) 評估 (evaluation) 實驗單位 個人為單位 病人 藥物臨床試驗 教育介入 如病人衛生教育 健康人 疫苗預防性試驗 篩檢工具試驗 教育介入 如健康行為的養成 群體為單位 社區 班級 團體 處置 新藥 新的飲食 診斷或篩檢 手術 醫療器材 教育介入 無治療 評估 有效性 事件/事件史資料 (event/time to event) well-being指標: 生活品質(quality of life) 成本: 直接與間接醫療成本 暫時性或替代性指標: 生理 生化 病理資料 又稱終點 (end-points) 安全性 不良反應及相關指標 經濟學: 成本效益 Three elements for immunization Experiment unit Individual, usually healthy Treatments can be viewed as drugs Evaluation efficacy safety Basic characteristics Easy to follow the rule of randomized controlled double-blinded trials placebo control with blindness: easy to make, usually difficult to guess individual randomization possible requires a large sample size low incidence of the disease to prevent low incidence of adverse effects ethical concerns administered on healthy people autonomy emphasized: informed consent safety emphasized: lower tolerance to adverse effects active drug or placebo controls placebo controls: standard design, required by FDA active drug: ethical reason-the best available 人體實驗方法的倫理 以藥物臨床試驗發展最完備 赫爾辛基宣言 ICH: International Conference on Harmonisation GCP: Good Clinical Practice IRB: Institutional Review Board 人體試驗委員會 人體實驗方法的倫理 赫爾辛基宣言: 醫學倫理四原則 仁愛 無害 自主 公正 研究重要性與風險相稱 (什麼題目不可做?) 好處風險及不適感應有最好診治方法加以權衡 每個病人都應保證得到最好和被證實的診治技術 研究人員或調查小組判斷如果繼續進行會產生不良影響就應停止 自主性: 受試者同意書 informed consent informed 信息的揭示 理解 consent 自願的同意 同意的能力 Cost and effectiveness/utility Usually proved to be cost-effective Old schedule and contents of immunization has been established New vaccines: suffers high cost for RD diminishing of marginal return very difficult to find new, large-sampled, disease outcome research Examples Salmonella typhi Vi conjugate vaccine for children HPV vac