文獻評讀 楊宗翰 12/6, 2008
Contents <ul><li>實證概念 </li></ul><ul><li>證據評等 </li></ul><ul><ul><li>Type of articles </li></ul></ul><ul><ul><li>Level of ev...
<ul><li>The application of the  best available evidence  to patient care. </li></ul>
Dr. Sackett <ul><li>EBM is the integration of  best research evidence  with  clinical expertise  and  patient values . </l...
What – 4 E of EBM EASY <ul><li>Communication </li></ul><ul><li>Hx/PE, Reasoning </li></ul><ul><li>patient value </li></ul>...
5 Steps for EBM approach <ul><li>問   Ask </li></ul><ul><li>查   Acquire </li></ul><ul><li>讀   Appraise </li></ul><ul><li>用 ...
實證概念 五步驟(問查讀用審) 實證精神(用最好的證據來照顧病人) 什麼是好的證據
Levels of Evidence 何種研究方法最適合解決這個問題(那種證據的等級最好)?
橫斷面研究 病例系列或由輕重不等的病患所組成的世代研究 病例系列 病例系列 IV <ul><li>回溯性世代研究 </li></ul><ul><li>病例對照研究 </li></ul><ul><li>隨機對照試驗的 未治療對照組 </li></...
Quality of Evidence <ul><li>評分方式:紿合 研究方法 , 研究品質 , 一致性 , 相關性 等四點。 </li></ul><ul><li>high  = further research is  very unlik...
Grading I -  研究方法 <ul><li>Randomized trial = high </li></ul><ul><li>Observational study = low </li></ul><ul><li>Any other ...
Grading II – Critical Appraisal <ul><li>扣分 </li></ul><ul><li>研究品質 : </li></ul><ul><ul><li>serious ( − 1) limitation  </li>...
Contents <ul><li>實證概念 </li></ul><ul><li>證據評等 </li></ul><ul><ul><li>Type of articles </li></ul></ul><ul><ul><li>Level of ev...
證據評等 <ul><li>Type of articles </li></ul><ul><ul><li>Original or Review (narrative or systematic) </li></ul></ul><ul><li>Ty...
Type of articles <ul><li>Original </li></ul><ul><ul><li>Systematic Review </li></ul></ul><ul><li>Narrative Review </li></u...
Methodology <ul><ul><li>Systematic Review </li></ul></ul><ul><ul><li>RCT </li></ul></ul><ul><ul><li>Cohort </li></ul></ul>...
橫斷面研究 病例系列或由輕重不等的病患所組成的世代研究 病例系列 病例系列 IV <ul><li>回溯性世代研究 </li></ul><ul><li>病例對照研究 </li></ul><ul><li>隨機對照試驗的 未治療對照組 </li></...
Exercise – 5 seconds <ul><li>Type of articles </li></ul><ul><ul><li>Original or Review (narrative or systematic) </li></ul...
Faces / Structure of a Paper <ul><li>Title </li></ul><ul><li>Abstract </li></ul><ul><li>Full Text </li></ul><ul><ul><li>In...
Question – PICO & Type <ul><li>Study Questions / Objectives -  Only One </li></ul><ul><li>Reformat Question from Abstract ...
橫斷面研究 病例系列或由輕重不等的病患所組成的世代研究 病例系列 病例系列 IV <ul><li>回溯性世代研究 </li></ul><ul><li>病例對照研究 </li></ul><ul><li>隨機對照試驗的 未治療對照組 </li></...
Exercise – PICO
Why PICO -  相關性 O C I P 審 查 問
Study Design or Statistics? <ul><li>Material & Methods </li></ul><ul><ul><li>Population </li></ul></ul><ul><ul><li>Sample ...
Contents <ul><li>實證概念 </li></ul><ul><li>證據評等 </li></ul><ul><ul><li>Type of articles </li></ul></ul><ul><ul><li>Level of ev...
研究方法 <ul><li>GATE Frame </li></ul><ul><ul><li>Graphic Appraisal Tool for Epidemiology </li></ul></ul><ul><ul><li>PICOT Pic...
P I/E C O T GATE Frame P articipants I ntervention ( e xposure) C omparison (control) O utcomes T ime Time (T) T Time (T) T
Participant Population: Source Population: Eligible Population: 68,561 women screened from 20 outpatients/community screen...
The GATE Approach <ul><li>there is only one study design: </li></ul><ul><li>RCT - interventions </li></ul><ul><li>Cohort s...
Epidemiologic evidence clinical considerations Policy issues Patient preferences X-factor: making evidence-based decisions...
Exercise – GATE Frame
Contents <ul><li>實證概念 </li></ul><ul><li>證據評等 </li></ul><ul><ul><li>Type of articles </li></ul></ul><ul><ul><li>Level of ev...
Validity  <ul><li>R epresentation </li></ul><ul><ul><li>Who did the subjects  represent ? </li></ul></ul><ul><li>A llocati...
GATE + RAM(M)bo O utcome I ntervention C omparator Test M aintained? R epresentation? P opulation B linded or  O bjective?...
Exercise – RAMbo / CASP
Representation ( 代表性 ) <ul><li>Random sample </li></ul><ul><li>Consecutive sample </li></ul>
隨機化  (Randomization) <ul><li>Why? </li></ul><ul><li>How? </li></ul><ul><li>Concealment </li></ul>
Randomization <ul><li>If sample size is sufficiently large, both known and unknown determinants of outcome are evenly dist...
隨機化是否成功?
對照組  (Control Group) <ul><li>Why </li></ul><ul><li>Placebo effect </li></ul><ul><li>Treat Equally </li></ul>
調整  (Adjustment) <ul><li>Inclusion / Exclusion criteria </li></ul><ul><li>Subgroup analysis </li></ul><ul><li>Statistical ...
追蹤  ( Maintenance) <ul><li>Treat equally </li></ul><ul><li>Lost to follow-up </li></ul><ul><ul><li>ITT = Intention-to-trea...
Loss follow-up (ITT vs PP) survival rate Rx B Rx A Rx B Rx A Loss or not complete 10% Rx B Rx A 80 80 80 70 80 80 survive ...
如何維持隨機化的好處? <ul><li>Allocation concealment </li></ul><ul><li>Maintenance </li></ul><ul><ul><li>Lost to follow-up </li></ul...
測量  (Measure) <ul><li>Blind </li></ul><ul><li>Objective </li></ul>
Summary
讀  -  如何嚴格評讀實證 <ul><li>論文討論的主要問題: PICO /  PECOT </li></ul><ul><li>研究設計: GATE Frame </li></ul><ul><li>臨床研究的類型 : 治療、診斷、病因、預後...
讀 <ul><li>Valid </li></ul><ul><ul><li>R - Representative / Random (2) </li></ul></ul><ul><ul><li>A - Ascertain / Allocatio...
讀  -  用 <ul><li>Impact (estimate & precision) </li></ul><ul><ul><li>Pre- / Post- test probability </li></ul></ul><ul><ul><...
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20081206 Appraisal

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A talk about critical appraisal, and how to read clinical research

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  • 20081206 Appraisal

    1. 1. 文獻評讀 楊宗翰 12/6, 2008
    2. 2. Contents <ul><li>實證概念 </li></ul><ul><li>證據評等 </li></ul><ul><ul><li>Type of articles </li></ul></ul><ul><ul><li>Level of evidence </li></ul></ul><ul><ul><li>研究方法 - GATE Frame </li></ul></ul><ul><ul><li>研究品質 – RAMbo / CASP </li></ul></ul><ul><li>練習 </li></ul><ul><ul><li>Question – PICO & Type </li></ul></ul><ul><ul><li>Critical appraisal </li></ul></ul>
    3. 3. <ul><li>The application of the best available evidence to patient care. </li></ul>
    4. 4. Dr. Sackett <ul><li>EBM is the integration of best research evidence with clinical expertise and patient values . </li></ul>
    5. 5. What – 4 E of EBM EASY <ul><li>Communication </li></ul><ul><li>Hx/PE, Reasoning </li></ul><ul><li>patient value </li></ul><ul><li>preference </li></ul>Evidence Expectation Expertise
    6. 6. 5 Steps for EBM approach <ul><li>問 Ask </li></ul><ul><li>查 Acquire </li></ul><ul><li>讀 Appraise </li></ul><ul><li>用 Apply </li></ul><ul><li>審 Audit/Access </li></ul>
    7. 7. 實證概念 五步驟(問查讀用審) 實證精神(用最好的證據來照顧病人) 什麼是好的證據
    8. 8. Levels of Evidence 何種研究方法最適合解決這個問題(那種證據的等級最好)?
    9. 9. 橫斷面研究 病例系列或由輕重不等的病患所組成的世代研究 病例系列 病例系列 IV <ul><li>回溯性世代研究 </li></ul><ul><li>病例對照研究 </li></ul><ul><li>隨機對照試驗的 未治療對照組 </li></ul><ul><li>回溯性世代研究 </li></ul><ul><li>非連續取樣 的橫斷面研究 </li></ul><ul><li>診斷型病例對照研究 </li></ul><ul><li>非隨機 的對照 試驗型 研究 </li></ul><ul><li>觀察型研究 ,但需有同時進行中的對照組,如: 世代研究 或 病例對照研究 </li></ul>III 前瞻性 世代研究 前瞻性起始 世代研究 由連續或隨機取樣組成的 橫斷面研究 隨機對照 試驗 II 第 II 級 證據的 系統回顧 (systematic review) I 病因 預後 診斷 治療 等級
    10. 10. Quality of Evidence <ul><li>評分方式:紿合 研究方法 , 研究品質 , 一致性 , 相關性 等四點。 </li></ul><ul><li>high = further research is very unlikely to change our confidence in the estimate of effect </li></ul><ul><li>moderate = further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate </li></ul><ul><li>low = further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate </li></ul><ul><li>very low = any estimate of effect is very uncertain </li></ul>The GRADE Working Group - http://www.gradeworkinggroup.org/
    11. 11. Grading I - 研究方法 <ul><li>Randomized trial = high </li></ul><ul><li>Observational study = low </li></ul><ul><li>Any other evidence = very low </li></ul>
    12. 12. Grading II – Critical Appraisal <ul><li>扣分 </li></ul><ul><li>研究品質 : </li></ul><ul><ul><li>serious ( − 1) limitation </li></ul></ul><ul><ul><li>very serious ( − 2) limitation </li></ul></ul><ul><li>一致性 </li></ul><ul><ul><li>Important inconsistency ( − 1) </li></ul></ul><ul><li>相關性 </li></ul><ul><ul><li>Some ( − 1) uncertainty </li></ul></ul><ul><ul><li>major ( − 2) uncertainty </li></ul></ul><ul><li>Imprecise or sparse data ( − 1) </li></ul><ul><li>High probability of reporting bias ( − 1) </li></ul><ul><li>加分 </li></ul><ul><li>Strong evidence of association </li></ul><ul><ul><li>significant RR >2 (< 0.5) based on consistent evidence from two or more observational studies , with no plausible confounders (+1) </li></ul></ul><ul><li>Very strong evidence of association </li></ul><ul><ul><li>significant RR of >5 (< 0.2) based on direct evidence with no major threats to validity (+2) </li></ul></ul><ul><li>Evidence of a dose response gradient (+1) </li></ul><ul><li>All plausible confounders would have reduced the effect (+1) </li></ul>
    13. 13. Contents <ul><li>實證概念 </li></ul><ul><li>證據評等 </li></ul><ul><ul><li>Type of articles </li></ul></ul><ul><ul><li>Level of evidence </li></ul></ul><ul><ul><li>研究方法 - GATE Frame </li></ul></ul><ul><ul><li>研究品質 – RAMbo / CASP </li></ul></ul><ul><li>練習 </li></ul><ul><ul><li>Question – PICO & Type </li></ul></ul><ul><ul><li>Critical appraisal </li></ul></ul>
    14. 14. 證據評等 <ul><li>Type of articles </li></ul><ul><ul><li>Original or Review (narrative or systematic) </li></ul></ul><ul><li>Type to study </li></ul><ul><ul><li>Clinical or Bench work </li></ul></ul><ul><ul><li>Dx / Rx / Etiology / Prognosis </li></ul></ul><ul><li>Methodology </li></ul><ul><ul><li>RCT, Cohort, cross-sectional, case-control, case series, case report. </li></ul></ul>
    15. 15. Type of articles <ul><li>Original </li></ul><ul><ul><li>Systematic Review </li></ul></ul><ul><li>Narrative Review </li></ul><ul><li>EBM Review </li></ul><ul><ul><li>Article review (Synopsis) </li></ul></ul><ul><ul><li>Critically Appraised Topic (CAT) </li></ul></ul>
    16. 16. Methodology <ul><ul><li>Systematic Review </li></ul></ul><ul><ul><li>RCT </li></ul></ul><ul><ul><li>Cohort </li></ul></ul><ul><ul><li>Cross-sectional </li></ul></ul><ul><ul><li>Case-control </li></ul></ul><ul><ul><li>Case series / report </li></ul></ul>
    17. 17. 橫斷面研究 病例系列或由輕重不等的病患所組成的世代研究 病例系列 病例系列 IV <ul><li>回溯性世代研究 </li></ul><ul><li>病例對照研究 </li></ul><ul><li>隨機對照試驗的 未治療對照組 </li></ul><ul><li>回溯性世代研究 </li></ul><ul><li>非連續取樣 的橫斷面研究 </li></ul><ul><li>診斷型病例對照研究 </li></ul><ul><li>非隨機 的對照 試驗型 研究 </li></ul><ul><li>觀察型研究 ,但需有同時進行中的對照組,如: 世代研究 或 病例對照研究 </li></ul>III 前瞻性 世代研究 前瞻性起始 世代研究 由連續或隨機取樣組成的 橫斷面研究 隨機對照 試驗 II 第 II 級 證據的 系統回顧 (systematic review) I 病因 預後 診斷 治療 等級
    18. 18. Exercise – 5 seconds <ul><li>Type of articles </li></ul><ul><ul><li>Original or Review (narrative or systematic) </li></ul></ul><ul><li>Type to study </li></ul><ul><ul><li>Clinical or Bench work </li></ul></ul><ul><ul><li>Dx / Rx / Etiology / Prognosis </li></ul></ul><ul><li>Methodology </li></ul>
    19. 19. Faces / Structure of a Paper <ul><li>Title </li></ul><ul><li>Abstract </li></ul><ul><li>Full Text </li></ul><ul><ul><li>Introduction </li></ul></ul><ul><ul><li>Material & Methods </li></ul></ul><ul><ul><li>Results </li></ul></ul><ul><ul><li>Discussions </li></ul></ul><ul><li>Tables & Figures </li></ul>
    20. 20. Question – PICO & Type <ul><li>Study Questions / Objectives - Only One </li></ul><ul><li>Reformat Question from Abstract </li></ul><ul><ul><li>P atients </li></ul></ul><ul><ul><li>I ntervention </li></ul></ul><ul><ul><li>C omparison </li></ul></ul><ul><ul><li>O utcomes </li></ul></ul><ul><li>Type of Question – Dx / Rx / Ex / Px </li></ul><ul><li>Best solution to this question </li></ul>
    21. 21. 橫斷面研究 病例系列或由輕重不等的病患所組成的世代研究 病例系列 病例系列 IV <ul><li>回溯性世代研究 </li></ul><ul><li>病例對照研究 </li></ul><ul><li>隨機對照試驗的 未治療對照組 </li></ul><ul><li>回溯性世代研究 </li></ul><ul><li>非連續取樣 的橫斷面研究 </li></ul><ul><li>診斷型病例對照研究 </li></ul><ul><li>非隨機 的對照 試驗型 研究 </li></ul><ul><li>觀察型研究 ,但需有同時進行中的對照組,如: 世代研究 或 病例對照研究 </li></ul>III 前瞻性 世代研究 前瞻性起始 世代研究 由連續或隨機取樣組成的 橫斷面研究 隨機對照 試驗 II 第 II 級 證據的 系統回顧 (systematic review) I 病因 預後 診斷 治療 等級
    22. 22. Exercise – PICO
    23. 23. Why PICO - 相關性 O C I P 審 查 問
    24. 24. Study Design or Statistics? <ul><li>Material & Methods </li></ul><ul><ul><li>Population </li></ul></ul><ul><ul><li>Sample </li></ul></ul><ul><ul><li>Inclusion & Exclusion criteria </li></ul></ul><ul><ul><li>Diagnostic / Treatment / Follow-up Protocol </li></ul></ul><ul><ul><li>Statistics </li></ul></ul>
    25. 25. Contents <ul><li>實證概念 </li></ul><ul><li>證據評等 </li></ul><ul><ul><li>Type of articles </li></ul></ul><ul><ul><li>Level of evidence </li></ul></ul><ul><ul><li>研究方法 - GATE Frame </li></ul></ul><ul><ul><li>研究品質 – RAMbo / CASP </li></ul></ul><ul><li>練習 </li></ul><ul><ul><li>Question – PICO & Type </li></ul></ul><ul><ul><li>Critical appraisal </li></ul></ul>
    26. 26. 研究方法 <ul><li>GATE Frame </li></ul><ul><ul><li>Graphic Appraisal Tool for Epidemiology </li></ul></ul><ul><ul><li>PICOT Picture </li></ul></ul><ul><ul><li>a framework for thinking about epidemiological evidence </li></ul></ul>
    27. 27. P I/E C O T GATE Frame P articipants I ntervention ( e xposure) C omparison (control) O utcomes T ime Time (T) T Time (T) T
    28. 28. Participant Population: Source Population: Eligible Population: 68,561 women screened from 20 outpatients/community screening centres all eligibles invited (2763) Post-menopausal, established CHD, < 80 yrs, no MI in last 6 mths, no HRT last 3 months P
    29. 29. The GATE Approach <ul><li>there is only one study design: </li></ul><ul><li>RCT - interventions </li></ul><ul><li>Cohort studies - prognosis / interv./ aetiology </li></ul><ul><li>Cross-sectional studies - diagnosis </li></ul><ul><li>Case-control studies - interv./aetiol. </li></ul>O yes no E/GS+ C/GS-
    30. 30. Epidemiologic evidence clinical considerations Policy issues Patient preferences X-factor: making evidence-based decisions clinical expertise: ‘putting it all together’ the art of medicine
    31. 31. Exercise – GATE Frame
    32. 32. Contents <ul><li>實證概念 </li></ul><ul><li>證據評等 </li></ul><ul><ul><li>Type of articles </li></ul></ul><ul><ul><li>Level of evidence </li></ul></ul><ul><ul><li>研究方法 - GATE Frame </li></ul></ul><ul><ul><li>研究品質 – RAMbo / CASP </li></ul></ul><ul><li>練習 </li></ul><ul><ul><li>Question – PICO & Type </li></ul></ul><ul><ul><li>Critical appraisal </li></ul></ul>
    33. 33. Validity <ul><li>R epresentation </li></ul><ul><ul><li>Who did the subjects represent ? </li></ul></ul><ul><li>A llocation </li></ul><ul><ul><li>Was the assignment to treatments randomized ? </li></ul></ul><ul><ul><li>Was the randomization list concealed ? </li></ul></ul><ul><ul><li>Were the groups similar at the trial’s start? </li></ul></ul><ul><li>M aintenance </li></ul><ul><ul><li>Were the groups treated equally ? </li></ul></ul><ul><ul><li>Were outcomes ascertained & analyzed for most patients? </li></ul></ul><ul><li>M easurements </li></ul><ul><ul><li>Were patients and clinicians “ b linded ” to treatment? OR </li></ul></ul><ul><ul><li>Were measurements o bjective & standardized? </li></ul></ul>JAMA 1993; 270(21): 2598-2601
    34. 34. GATE + RAM(M)bo O utcome I ntervention C omparator Test M aintained? R epresentation? P opulation B linded or O bjective? M easures O utcome M easures A llocation?
    35. 35. Exercise – RAMbo / CASP
    36. 36. Representation ( 代表性 ) <ul><li>Random sample </li></ul><ul><li>Consecutive sample </li></ul>
    37. 37. 隨機化 (Randomization) <ul><li>Why? </li></ul><ul><li>How? </li></ul><ul><li>Concealment </li></ul>
    38. 38. Randomization <ul><li>If sample size is sufficiently large, both known and unknown determinants of outcome are evenly distributed between treatment and control groups. </li></ul><ul><li>Increase COMPARABILITY . </li></ul><ul><li>The most important part of randomization </li></ul><ul><ul><li>Unpredictability (Concealment) </li></ul></ul>
    39. 39. 隨機化是否成功?
    40. 40. 對照組 (Control Group) <ul><li>Why </li></ul><ul><li>Placebo effect </li></ul><ul><li>Treat Equally </li></ul>
    41. 41. 調整 (Adjustment) <ul><li>Inclusion / Exclusion criteria </li></ul><ul><li>Subgroup analysis </li></ul><ul><li>Statistical analysis (regression) </li></ul>
    42. 42. 追蹤 ( Maintenance) <ul><li>Treat equally </li></ul><ul><li>Lost to follow-up </li></ul><ul><ul><li>ITT = Intention-to-treat analysis </li></ul></ul><ul><ul><li>PP = Per Protocol analysis </li></ul></ul><ul><ul><li>Sensitivity analysis </li></ul></ul>
    43. 43. Loss follow-up (ITT vs PP) survival rate Rx B Rx A Rx B Rx A Loss or not complete 10% Rx B Rx A 80 80 80 70 80 80 survive 20 0 10 20 20 20 mortality 80.0% 100.0% 88.9% 77.8% 80% 80% PP 80% (80/100) 80% (80/100) 80% (80/100) 70% (70/100) ITT
    44. 44. 如何維持隨機化的好處? <ul><li>Allocation concealment </li></ul><ul><li>Maintenance </li></ul><ul><ul><li>Lost to follow-up </li></ul></ul>
    45. 45. 測量 (Measure) <ul><li>Blind </li></ul><ul><li>Objective </li></ul>
    46. 46. Summary
    47. 47. 讀 - 如何嚴格評讀實證 <ul><li>論文討論的主要問題: PICO / PECOT </li></ul><ul><li>研究設計: GATE Frame </li></ul><ul><li>臨床研究的類型 : 治療、診斷、病因、預後、其他… </li></ul><ul><li>評讀論文: V (RAMbo) I P </li></ul>
    48. 48. 讀 <ul><li>Valid </li></ul><ul><ul><li>R - Representative / Random (2) </li></ul></ul><ul><ul><li>A - Ascertain / Allocation & Account (2) </li></ul></ul><ul><ul><li>Measure </li></ul></ul><ul><ul><ul><li>Blind </li></ul></ul></ul><ul><ul><ul><li>Objective </li></ul></ul></ul>
    49. 49. 讀 - 用 <ul><li>Impact (estimate & precision) </li></ul><ul><ul><li>Pre- / Post- test probability </li></ul></ul><ul><ul><ul><li>event rate (control vs experiment) </li></ul></ul></ul><ul><ul><li>Dx – Sn/Sp - PPV/NPV - PLR/NLR </li></ul></ul><ul><ul><li>Rx – RR/OR - RRR/ARR - NNT/NNT </li></ul></ul><ul><li>Practical </li></ul><ul><ul><li>patient characteristics, clinical setting </li></ul></ul><ul><ul><li>applicable, benefit > risk </li></ul></ul>

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