1. 神經內科 王志弘

2. + 治療或處置的危害 + 環境的危害

3. + Systemic review of randomized trials – 單獨一個研究，常常無法顯示出一些少見的不 良反應 + Cohort study + Case control studies + Cross-sectional studies

4. 4 Included Subjects placeboaspirin Myocardial infarction yes no 5 years Randomised to aspirin or placebo Randomized Controlled Trial Longitudinal study

5. + Cohort study + Longitudinal study 5 Included Subjects non-smokerssmokers Lung cancer yes no 5 years smoking status measured

6. + Case Control Study + Longitudinal study 6 Included Subjects non-smokerssmokers Lung cancer yes no 10 years smoking status measured

7. + Cross-sectional study 7 Included Subjects non-smokerssmokers Lung function normal abnormal smoking status measured

11. Are the results of this harm/etiology study valid?

13. + 控制組 + 客觀、或盲化（ blind ） – 治療、暴露、結果 + 追蹤： – 時間：是否夠長 – 完整性： lost to follow up （ <20% ） + 因果相關

14. RCT or cohort Case Control

15. + Confounding factor: exposed and non- exposed not randomized + Prospective vs retrospective  Retrospective cohort  Administrative databases  健保資料庫

16. + the outcome of interest is rare or takes a long time to develop – 腫瘤、矽肺病 – 只能使用 case control study + 有些 confounder 無法測量 – Transient – To severe leading to death + The selection of control + Statistical significance, if large number of association factors

17. + Exposure and outcome are measured at the same time + case reports of one patient (or a case series of a few patients) – Thalidomide and 海豹肢症 + highlight the need for other studies

18. + Blind, objective + Administrative database – 健保資料庫，病歷紀錄 + Patient or doctor recall

19. + 統計相關不等於因果相關 + Diagnostic tests for causation – the exposure preceded the onset of the outcome – a dose–response gradient? – dechallenge–rechallenge – the association consistent from study to study + Does the association make biological sense?

20. Are the valid results of this harm study important?

21. Magnitude, precision

22. RCT or cohort Case Control

23. + 20980 2998 RCT or cohort

24. + 9045 1055 Case Control

25. + risks = odds/(1 + odds) + odds = (risk/1 – risk) + ORs and RRs >1 ：接觸者得病的機會增加 + ORs and RRs <1 ：接觸者得病的機會減少 + 通常 – case control study, OR >4, 認為有意義 – Cohort study, RR>3 就認為有意義 – 還要考慮結果（ outcome ）的嚴重程度

26. +

29. http://ktclearinghouse.ca/cebm/toolbox/ortonnt

30. + Confidence Interval + the adjusted OR for ischemic heart disease or stroke associated with a 25% lower serum homocysteine level was 0.89 with 95% CI 0.83–0.96. + In our caffeine study, the OR was 2.4 (adjusted for age and smoking) with 95% CI 1.1–6.5.

31. Can this valid and important evidence about harm be applied to our patient?

38. 研究方法 ? RCT, cohort, case control, cross-sectional