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資料的評讀 : 危害

資料的評讀 : 危害. 神經內科 王志弘. 危害. 治療或處置的危害 環境的危害. Types of Reports. 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. Included Subjects. Randomised to aspirin or placebo. aspirin. placebo. yes. Myocardial infarction.

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資料的評讀 : 危害

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  1. 資料的評讀:危害 神經內科 王志弘

  2. 危害 • 治療或處置的危害 • 環境的危害

  3. Types of Reports • Systemic reviewof 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. IncludedSubjects Randomised to aspirin or placebo aspirin placebo yes Myocardial infarction 5 years no GIbleeding RandomizedControlledTrial Longitudinal study

  5. IncludedSubjects • Cohort study • Longitudinal study smoking status measured smokers non-smokers yes Lung cancer 5 years no

  6. IncludedSubjects • Case Control Study • Longitudinal study smoking status measured smokers non-smokers yes Lung cancer 10 years no

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

  8. 評讀

  9. ValidityImpactApplicability

  10. 正確性效用可運用性

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

  12. 正確性 • 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：losttofollowup （<20%） • 因果相關

  13. CaseControl RCTorcohort

  14. 幾個重點 Cohort • Confoundingfactor:exposedandnon-exposednotrandomized • Prospectivevsretrospective • Retrospective cohort • Administrativedatabases • 健保資料庫

  15. 幾個重點 case control • the outcome of interest is rare or takes a long time to develop • 腫瘤、矽肺病 • 只能使用 casecontrolstudy • 有些 confounder 無法測量 • Transient • Tosevereleadingtodeath • The selection of control • Statistical significance, if large number of association factors

  16. 幾個重點 cross section • Exposure and outcome are measured at the same time • case reports of one patient (or a case series of a few patients) • Thalidomideand 海豹肢症 • highlight the need for other studies

  17. Exposure/outcomemeasurement • Blind, objective • Administrative database • 健保資料庫，病歷紀錄 • Patient or doctor recall

  18. causation • 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?

  19. Are the valid results of this harm study important? 效用

  20. Magnitude, precision

  21. CaseControl RCTorcohort

  22. RCTorcohort

  23. CaseControl

  24. Odds, risk • 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 • Cohortstudy,RR>3 就認為有意義 • 還要考慮結果（outcome）的嚴重程度

  25. NumberneededtoharmNNH

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

  27. precision • 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.

  28. Can this valid and important evidence about harm be applied to our patient? 可運用性

  29. 研究方法? RCT,cohort,casecontrol,cross-sectional

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