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應用實證於臨床醫療

應用實證於臨床醫療. 臺北巿立中興醫院副院長 沈希哲. 現象：某大城巿，機動車輛肇事　　 中有 30% ，是因為駕駛喝酒　　 過量。 結論：某大城巿機動車輛肇事，　　 70% 是因為駕駛喝酒未過　　　 量！？. Evidence. Patient. Doctor. 實證醫學. 醫療行為的決策 (Decision-Making). 永遠的真理 ……. Everlasting truth 教科書理論 …….. Proved theory 專業訓練 ……….. Practice training 臨床經驗 ………. Personal experience

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應用實證於臨床醫療

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  1. 應用實證於臨床醫療 臺北巿立中興醫院副院長 沈希哲

  2. 現象：某大城巿，機動車輛肇事　　 中有30%，是因為駕駛喝酒　　 過量。 結論：某大城巿機動車輛肇事，　　 70%是因為駕駛喝酒未過　　　 量！？

  3. Evidence Patient Doctor 實證醫學

  4. 醫療行為的決策(Decision-Making) • 永遠的真理……. Everlasting truth • 教科書理論…….. Proved theory • 專業訓練……….. Practice training • 臨床經驗………. Personal experience • 文獻探索………. Critical appraisal Research Clinical Evidence Practice GAPS EBM

  5. 實證醫學 • 各醫學相關領域專家以其良知，明確且明智地應用世上現有衛生醫療領域中可取得之最佳文獻（證據）來處理個別患者的醫療問題。 • EBM is a supplement to, not a substitute for, professional skills and experience.

  6. 實證醫學的效益 Medical Care Quality Cost Containment

  7. 實證醫學照顧Evidence-based Care • Better medical care • Cost containment • Reduce uncertainty of prognosis • Encourage clinical research

  8. 彰基經驗 • 1996.07 成立EBM推動小組 • 2002.06 協助中區健保局完成-證據醫學專案，共享醫學知識資料 • 推動步驟 閱讀EBM書刊→ 小組討論 → 選員進修 → 舉辦研討會 • 未來方向 將圖書館改為EBM-based的資料中心，重整或增加EBM雜誌圖書，結合現階段人力資源與本院臨床醫師共同學習

  9. 萬芳經驗 • 2001.02 成立實證醫學推動小組及實證醫學中心 • 2002.07 參加國家品質獎評鑑 • 2002.01 由臺灣證據醫學中心網站票選為優質及熱門實証醫學網站 • 2003.01 建立病患E-mail疾病群組收集流程，以期提高醫療服務品質 • 未來方向 實證醫學結合問題導向教學為主軸，助全院醫療單位學習實證醫學，進而應用於臨床工作

  10. 實證醫學－五大步驟 • 整理出一個可以回答的問題 　（Asking an answerable question） • 尋找文獻證據 　（Tracking down the best evidence） • 嚴格評讀文獻 　（Critical appraisal） • 應用於病人身上 　（Integrating the appraisal with clinical expertise & patients’ preference） • 對過程進行稽核及評估 　（Auditing performance and evaluation）

  11. 實證知識的難題 一、臨床醫療的新“證據”不斷地被發表 二、沒有時間去讀所有的論文 三、許多“證據”的解析非常困難 四、無法順利應用這些證據於臨床醫療

  12. EBM的推動為何爭論這麼多？ • EBM有落入新教條主義的危險，為了流行的議題，增加醫療人員之工作負擔 • EBM的基本錯誤就是將流行病學的資料分析結果用於個別的病人身上 • EBM很可能會提高醫療成本 • EBM的贊成者與反對者鮮少對話

  13. 面對EBM的幾個常見問題 • EBM是否與經驗傳承，無法相容？ • EBM的推動是在協助醫療的進步還是推翻現今醫療行為的正當性？ • EBM應用在醫療品質提升重要，還是醫療管理上重要？ • EBM是否改變了“ART of Medicine”的境界？

  14. How to ask a answerable question?

  15. 問題那裡來？ • Clinical finding • Etiology • Differential diagnosis • Diagnostic test • Prognosis • Therapy • Prevention • Self-improvement

  16. 如何檢視問題的完整性？ • 是否完全表述病患或其疾病的問題？ • 是否考慮所有的醫療流程？ • 是否與醫療病程的結果有關？

  17. How to search for the best evidence? • 有多少證據，做多少決定！ • 但文獻實在太多了！

  18. 證據那裡來？ • 建立檢索策略：KEYWORD個別檢索再組合或KEYWORDS合併檢索 • Pub Med, HINT, The Cochrane Library, Medline, World-Wide Web(WWW)

  19. 文獻資料有那些？ • Meta-analysis：集合許多文獻加以統計分析 • Systemic review：包含 a thorough literature and critical appraisal of individual studies • Overview：代表作者的expert opinion • Evaluating clinical practice guideline

  20. 實證醫學的基礎－多重分析的文獻整理（Meta-analysis）實證醫學的基礎－多重分析的文獻整理（Meta-analysis） • A statistical analysis of the results from independent studies, which generally aims to produce a single estimate of a treatment effect. 　為了確立單一療效，而引用許多獨立且有統計分析之資料所做之文獻。 • Is quantitative

  21. 實證醫學的基礎－系統化的文獻回顧（Systemic Reviews） 特色： 1.文內有清楚的主題與完整地內含或除外之定義。 2.引用多源之文獻資料。 3.引用之各文獻中皆有分析評估其個別之研究品質。 4.有將各文獻結果依其品質程度或統計分析水準做『統合』 。

  22. 實證醫學的基礎－綜論(Overview) • Summary of the medical literature on a focused clinical problem • Represent the author’s expert opinion on the basis of clinical experience and nonsystematic review of the literature • Is qualitative

  23. 實證醫學的基礎－臨床醫療指引(Practice Guidelines) • Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances • Attempt to identify diagnostic and treatment strategies for common clinical problems • Are recommendations

  24. How to appraising the evidence?

  25. 如何評估證據？ • Assessing study design:Concealed, Blinding, Equal use , Completefollow-up , intention-to-treat analysis • Interpreting the results:Determining treatment effect, Precision of the results, Enrollment of adequate sample size • Applying the results to a specific patient

  26. Applying the results to aspecific patient Are the results applicable to the patient? Are the potential treatment benefits worth the potential side effects, costs, and inconvenience? (NNT is a useful tool)

  27. Critical Appraisal Topic Background: Objectives: Search strategy: Selection criteria: Data collection and analysis: Main result: Reviewer’s conclusion:

  28. 如何運用實證於醫療行為？ • 各單位發展實證之取得方式 • 靈活運用電腦網路資訊（eEverything!） • 運用小群組討論的方式，進行群體學習 • 製作醫療的標準流程（Practice guideline）

  29. 醫護人員該如何來看待及運用EBM 1.首先必須先了解什麼是EBM? Medical decision-making based on evidence 2.不要懷疑EBM的必要性，所需要的是該如應用在臨床實務上！ 3.要懂得如何搜尋資料 4.瞭解實證強度（Level of Evidence）

  30. Level of Evidence • Level I:從多個設計優良含對照組研究之統計學合成（meta-analysis）或從high-power隨機有比較標準的臨床試驗得到的證據。 • Level II:從至少一個設計優良的驗證(experimental)研究或從low-power隨機有比較標準的臨床試驗得到的證據。

  31. Level of Evidence • Level III:從設計優良的半驗證（quasiexperimental）研究如非隨機，controlled single-group, pre-post, cohort, time或matched case-control series得到的證據。

  32. Level of Evidence • Level IV:從設計優良的非實驗證明之研究，如comparative和correlational描述性和個案研究得到的證據。 • Level V:從個案報告和臨床範例得到的證據。

  33. 評讀文獻(Evaluating integrative literature) • Is the problem framed in a clinically relevant manner? • Does the integrative framework incorporate all valid information? • Is the process of integrating information rigorous? • What is the finding or recommendation and is it presented appropriately? • Is the finding or recommendation applicable to the care of my patient?

  34. Is the problem framed in a clinically relevant manner? • Are the population, predictor, and outcome clearly individual variable and relevant?

  35. Does the integrative framework incorporate all valid information? • Are prospective inclusion and exclusion criteria identified? • Is the search strategy comprehensive and explicitly described? • Is there an assessment of validity of the individual studies? • Is the process of study selection, searching, assessing validity and data abstraction reliable?

  36. Is the process of integrating information rigorous? • Are the individual studies sufficiently similar that they can be combined? • Is the summary finding representative of the largest and most rigorously performed studies?

  37. What is the finding or recommendation and is it presented appropriately? • Are the key elements of each individual study clearly displayed? • What is the magnitude of the finding and is it statistically significant? • Is the finding homogeneous or heterogeneous? • Is a sensitivity analysis performed?

  38. Is the finding or recommendation applicable to the care of my patient? • Are the subjects adequately described and similar to my patient? • Is the predictor variable adequately described and applicable to my patient? • Will the finding result in an overall net benefit for my patient?

  39. 評讀文獻常犯的錯誤 • 隨便找一篇文章。 • 花很時間，但找到品質不是很好的文章。 • 先看結果，再看討論，對於研究背景和方法卻不詳讀。 • 將上述原則當作“食譜”一樣，一項一項對著打勾，而不瞭解其為什麼重要。 • 看完文章對照顧病人並沒有幫助。

  40. All men by nature desire to learn. －Aristotle 人類本質上都有學習的慾望。 －亞里士多德

  41. 謝謝您的聆聽！

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