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實施實證醫學五大步驟

實施實證醫學五大步驟. step 1. 整理出一個可以回答的問題 step 2. 尋找文獻證據 step 3. 嚴格評讀文獻 ( Critical appraisal ) step 4. 應用於病人身上 step 5. 對過程進行稽核. What is CAT?. Systematic evaluation of study/studies To critically appraise -- not only “ read ” , but also “ assess ”

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實施實證醫學五大步驟

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  1. 實施實證醫學五大步驟 step 1.整理出一個可以回答的問題 step 2. 尋找文獻證據 step 3. 嚴格評讀文獻 (Critical appraisal ) step 4. 應用於病人身上 step 5. 對過程進行稽核

  2. What is CAT? • Systematic evaluation of study/studies • To critically appraise -- not only “read”, but also “assess” • Simplify appraisal with VIP (or PICO/RAMbo)

  3. CRITICAL APPRAISAL SKILLSWhat is VIP? Validity (Reliability) 效度/信度 Can we believe it ? (研究方法的探討) Importance (Impact) 重要性 We believe it ! But does it matter? (研究結果的分析) Practice (Applicability) 臨床適用性 If we believe it - does it apply to our patients? (如何在臨床運用)

  4. Validity (Reliability)What is RAMbo? “Do we believe it? ” • Randomized：Was it randomised?Were the groups similar? • Accounted for all patients • Measurement: blinded or objective

  5. “該治療性研究結果是可信的嗎?” EVIDENCE-BASED MEDICINE How to Practice and Teach EBM • 病人的治療分派是否為隨機？隨機方式是否恰當？實驗開始前，實驗組及對照組是否相似、可比較？(R) • 病人追蹤是否夠久、夠完整？所有病人是否依其原先分派組別作分析？(A) • 病人及醫師是否對治療不知情(blind)？實驗組及對照組是否被同等對待？(M)

  6. Importance (Impact) “ We believe it !But-does it matter? ” • What were the results?-How large was the treatment effect? -How precise was the estimate of the treatment effect?

  7. In therapy study • Number needed to treat (NNT) • Relative risk (RR) • Relative risk reduction (RRR) • Absolute risk reduction (ARR)

  8. 將12,562位有不穩定型心絞痛的患者分兩組進行隨機對照試驗，分別接受aspirin或合併使用clopidogrel ，九個月後研究結果：單獨使用aspirin(對照組)其心肌梗塞、中風或心臟血管疾病死亡率為11.47%；合併使用aspirin及clopidogrel (實驗組)其心肌梗塞、中風或心臟血管疾病死亡率為9.28%。對照組發生非致死性出血副作用為2.7% ；實驗組為3.6% 。 CER=11.47%; EER=9.28% RR=9.28%/11.47%=0.81 RRR=(11.47%-9.28%)/11.47%=19% ARR=11.47%-9.28%=2.19% NNT=1/2.19%=46 ARI(絕對危險性增加率)=3.6%-2.7%=0.9% NNH=1/0.9%=111

  9. Practice (applicability) If we believe it, does it apply to our patient? • Can it be applied to my patient? 病患差異 • Can it be done here? 風土(可運用的資源) • How do patient values affect the decision? 民情(病患的偏好)

  10. How to Decide on the Applicability of Clinical Trials Results to Your Patient(1) • Biologic Issues If the treatment can work?有效~同樣的治療應用在不同的病患族群是否有不同的反應? ~我們的病人與研究中的病人是否非常不同，以致於無法應用這個研究結果？

  11. How to Decide on the Applicability of Clinical Trials Results to Your Patient(2) • Social and Economic Issues If the treatment will work?可行~這個治療適用於我們的診療環境嗎？ ~病患配合度?醫療提供者(醫事人員、醫療單位、保險制度)的配合度與能力?

  12. How to Decide on the Applicability of Clinical Trials Results to Your Patient(3) • Epidemiologic Issues How efficient the treatment will be?~我們的病人是否有其他共病狀況可能改變治療的結果?影響有多大? ~病人可能從治療中得到什麼好處或壞處？經由治療而減少的不良後果是否比不治療有明顯的差別?

  13. 如何進行文獻搜尋及評讀how to find and determine current best evidence • 直接搜尋已經評讀的文獻 - ACP journal club, Cochrane Library • 自行評讀文獻 - Simplify appraisal with VIP or PICO/RAMbo • 必要時使用評讀工具 - 如CATMaker, CASP

  14. 我們的臨床狀況 • An 80 year-old Chinese women with 20 years of type 2 DM with triopathy, dyslipidemia, and under medications. • Recent myocardial infarction 6 months ago. • Poor glycemic control, HbA1c: 10, fasting sugar usually above 200.

  15. 假設以下為您找到的文獻之一Am J Med. 2004 Feb 15;116(4):230-5

  16. 逐步逐項嚴格評讀該文獻(1)Paul Glasziou, University of Oxford 確認該研究所提出的問題及所回答的問題(PICO)-PURPOSE

  17. 逐步逐項嚴格評讀該文獻(2)Paul Glasziou, University of Oxford 確認該研究的內部效度 (V-R1-randomization) -METHOD

  18. 逐步逐項嚴格評讀該文獻(3)Paul Glasziou, University of Oxford 確認該研究的內部效度 (V-R2-similarity)- RESULTthe result should have a table of “baseline characteristics” (always table 1)

  19. 逐步逐項嚴格評讀該文獻(4)Paul Glasziou, University of Oxford 確認該研究的內部效度 (V-A-accounted)-RESULT

  20. 逐步逐項嚴格評讀該文獻(5)Paul Glasziou, University of Oxford 確認該研究的內部效度 (V-M-measurement/blind)-METHOD&RESULT

  21. 逐步逐項嚴格評讀該文獻(6)Paul Glasziou, University of Oxford 若該研究通過效度審核，審視並解讀其結果。該介入的效果有多大? 相關性如何?(I)—RESULT

  22. 逐步逐項嚴格評讀該文獻(7)Paul Glasziou, University of Oxford 確認該研究結果是否可以運用在我們上述的病人身上?應如何應用? (P) DO IT YOURSELF!!

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