實證醫學文獻 查證與嚴格評讀

1. 實證醫學文獻查證與嚴格評讀 高雄榮民總醫院 藥劑部 洪碧蓮藥師

2. 課程大綱 • 提出問題 (Question Formulation) • 搜尋證據 (Evidence Search) • 嚴格評讀 (Critical Appraisal) • 恰當運用 (Evidence Application) • 結果評估 (Outcome Evaluation)

3. Clinical Question • 無法使用Rifampicin的結核病患者，Rifabutin是否可以取Rifampicin，作為6個月短程治療的替代藥物？

4. 結核病患者可以Rifabutin取代Rifampicin作為6個月短程治療的替代藥物？

5. 搜尋證據 Evidence Search

6. 檢索策略 System Summaries Synopses Syntheses Studies

7. 嚴格評讀 嚴格評讀 找出結論 提供建議 找出結論 提供建議 檢索策略 是否有符合臨床問題的 綜合分析(Meta-analysis) 是 否 隨機分配 研究(RCT) 是 否 非隨機分配 研究(RCT)

8. Search Database • PubMed • Cochrane Library

9. Cochrane Library_Advanced Search P and I and C and O

10. PubMed檢索程序 • 個人化登入My NCBI • 選取合適的MeSH當作檢索字 • 結合MeSH與所知的natural language • 利用AND和OR • 設定Alert • 應用書目管理軟體EndNote

16. Queries 1

17. C O P I P and I and C and O 20091008

18. C O P I 18 篩選有研究品質的藥物資訊 163 SR RCT in process 從交集PICO的語法而得的 163篇中,分別與搜尋SR/RCT文獻及in process的語法作交集, 以搜尋得高品質研究方法的文獻篇數 20091008

20. RCT Queries 2_Clinical Queries- Search byClinical Study Category

21. SR Queries 3_Clinical Queries- FindSystematic Reviews

22. Queries 4 _inprocess in process (檢索日期：2010/06/08)

23. Queries 5_Combination 163篇 24篇

24. Studies Extraction PubMed (24) Cochrane(1) References (25) Meta-Analysis 2010 (1) References2010 (4) Excluded from Title & Abstract (3) Meta-Analysis 2010 (1) RCT (0)

25. Critical Appraisal嚴格評讀 Are the results of the article valid? (V) What are the result? (I) Will the results help me in caring for patients? (P)

28. Validity: 研究方法的討論 • Randomized • Concealed assignment • Sufficiently long & complete follow-up (> 80%) • Double blinded • Groups similar & treated equally except for the therapy

29. Important: 結論的分析 • The magnitude of the treatment effect • NNT: number needed to treat • NNT= 1/ARR = 1 / l CER –EER l, ARR: absolute risk reduction • NNH: number needed to harm • NNH= 1/ARI = 1 / l EER –CER l, ARI: absolute risk increase • RRR: relative risk reduction = (CER-EER)/CER • RRI: relative risk increase = (EER-CER)/CER

30. Calculation • Experimental Event Risk (EER) = a/(a+b) Control Event Risk (CER) = c/(c+d) Relative Risk (RR) = EER/CER = (a/(a+b))/ (c/(c+d)) • Experimental Event Odd (EEO) = a/b Control Event Odd (CEO) = c/d Relative Odds = Odds Ratio = EEO/CEO = (a/b)/ (c/d) Odds: a ratio of events to non-events(勝算比)

31. 網址: http://www.cebm.net

32. SYSTEMATIC REVIEW Are the results of the review valid ?

33. Critical Appraisal Skills Programme 網址: http://www.phru.nhs.uk/pages/phd/CASP.htm

34. Critical Appraisal Tools

35. Critical Appraisal Skills Programme (CASP)Systemic Review

36. A. Is the study valid (效度)? 1. Did the study ask a clearly-focused question? • Consider if the question is “focused” in terms of : • the population studied • the intervention given or exposure • the outcomes considered

37. P I C O

38. 2. Did the review include the right type of study? • Consider: • Address the review’s question • Have an appropriate study design Is it worth continuing?

39. 3.Did the reviewers try to identify all relevant studies? (沒有遺漏重要的文獻)? • Consider: • which bibliographic databases were used • if there was follow-up from reference lists • if there was personal contact with experts • if the reviewers searched for unpublished studies • if the reviewers searched for non-English-language studies

40. 搜尋資料來源 最後檢索時間

41. 4. Did the reviewers assess the quality of the included studies? • Consider: • if a clear, pre-determined strategy was used to determine which studies were included. Look for: - a scoring system - more than one assessor

42. 5. If the results of the studies have been combined, was it reasonable to do so? • Consider whether: • the results of each study are clearly displayed • the results were similar from study to study (look for tests of heterogeneity) • the reasons for any variations in results are discussed

43. 6.How are the results presented and what is the main result? • Consider: • how the results are expressed (e.g. odds ratio, relative risk, etc.) • how large this size of result is and how meaningful it is • How you would sum up the bottom-line result of the review in one sentence

44. 7.How precise are these results? • Consider: • if a confidence interval were reported. Would your decision about whether or not to use this intervention be the same at the upper confidence limit as at the lower confidence limit? • if a p-value is reported where confidence interval are unavailable

45. 8.Can the results be applied to the local population? • Consider whether: • the population sample covered by the review could be different from your population in ways that would produce different results • your local setting differs much from that of the review • you can provide the same intervention in you setting

46. 9. Were all important outcomes considered? • Consider outcomes from the point of view of the: • Individual • policy makers and professionals • Family/carers • Wider community

47. 10. Should policy or practice change as a result of the evidence contained in this review? • Consider: • whether any benefit reported outweighs any harm and/or cost. If this information is not reported can it be filled in from elsewhere?

48. Consider outcomes from the point of view of the: • individual • policy maker and professionals • family/carers • wider community • Consider whether: • any benefit reported outweighs any harm and/or cost. If this information is not reported can it be filled from elsewhere? • policy or practice should change as a result of the evidence contained in this trial