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系統性回顧文獻的評讀

系統性回顧文獻的評讀. 李智雄醫師 高雄醫學大學附設醫院 實證醫學中心. Critical Appraisal 文獻評讀. V alidity 研究方法評析以判斷結果之可信與否 I mportance 結果差異的重要性及對臨床的意義 P racticability 可否用來照顧我的病人. 對 大量 醫學相關訊 息的 真實性 和 可 用 性進行 去 偽 存真， 擷 取精 華的步驟. 系統性回顧文獻. 什麼是系統性回顧文獻？ 跟統合分析文獻或一般 回顧文獻有何不同？ 什麼 是 統合 分析？ 何謂文獻 的同質性與異質性 ？ 如何解讀森林圖？

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系統性回顧文獻的評讀

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  1. 系統性回顧文獻的評讀 李智雄醫師 高雄醫學大學附設醫院 實證醫學中心

  2. Critical Appraisal 文獻評讀 • Validity • 研究方法評析以判斷結果之可信與否 • Importance • 結果差異的重要性及對臨床的意義 • Practicability • 可否用來照顧我的病人 對大量醫學相關訊息的真實性和可用性進行去偽存真，擷取精華的步驟

  3. 系統性回顧文獻 • 什麼是系統性回顧文獻？ • 跟統合分析文獻或一般回顧文獻有何不同？ • 什麼是統合分析？ • 何謂文獻的同質性與異質性？ • 如何解讀森林圖？ • 什麼是出版偏差？如何檢驗？

  4. Systematic Reviews and Meta-Analyses系統性回顧與統合分析 Important Clinical Question 某一臨床問題 Study 1 研究一 Study 2 研究二 Study 3 研究三 Study 4 研究四 Study n 研究 n ……....... 1. Comprehensive survey of the primary studies of the highest level of evidence 嚴格搜尋高證據度的研究 2. Meta-analysis: A survey in which the results of all included studies are similar enough statistically that the results are combined and analyzed as if they were one study 統合分析：以統計方法將結論相似的各研究的結果整合分析做出結論 對臨床問題做出結論

  5. Pitfalls to Meta-Analysis統合分析的陷阱 • It’s rare that the results of different studies precisely agree • Difficult to have research with exactly the same measuring techniques, definitions of variables • The number of patients in a single study is not large enough to come up with a decisive conclusion • Authors selection bias • Publication bias

  6. Forest Plot 森林圖

  7. Explore Heterogeneity檢驗異質性 • Statistical Heterogeneity • “Eyeball” test • Cochran chi-square ( Cochran Q ) • Definite heterogeneity (確定有差異) • Cochran Q ( P < 0.1 ) • Possible heterogeneity (可能有差異) • Cochran Q is not statistically significant • Cochran Q / degrees of freedom (Q/df) > 1 • Heterogeneity unlikely (有差異機會不大) • Cochran Q is not statistically significant • Q/df < 1 • I2 test • <25%異質性不大；>50%異質性大，不宜統合 • Clinical Heterogeneity • Differences in patients, interventions, outcomes • Methodological Heterogeneity • Different study designs, degree of bias control

  8. Forest plots of two distinct hypothetical meta-analysis Fixed effect model: The summary result provided the best estimate of an assumed common treatment effect Same summary estimate and 95% CI Random effect model: The summary result gives the average from distribution of treatment effects across studies BMJ 2011; 342:d549

  9. Publication Bias and Funnel Plot Symmetric Funnel Plot Asymmetric Funnel Plot

  10. Critical Appraisal of Systematic Review (I)“系統性回顧”的評析（一） • Are the results of the review valid (效度如何)? • Did the review address a clearly focused question(問題清楚聚焦)? • Did the authors look for the right type of papers (文獻類型正確)? • Do you think the important, relevant studies were included (納入相關重要的文獻)? • Did the review’s authors do enough to assess the quality of the included studies (嚴謹的文獻品質的評估)? • If the results of the review have been combined, was it reasonable to do so (將各研究結果做統合，合理嗎)?

  11. 解答不同類型臨床問題之最佳研究設計

  12. Did the review address a clearly focused question問題清楚聚焦? □是　　　　　　　□否　　　　　　　□不清楚 評論：＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿

  13. Did the authors look for the right type of papers 文獻類型正確? □是　　　　　　　□否　　　　　　　□不清楚 評論：＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿

  14. Do you think the important, relevant studies were included 納入相關重要的文獻? □是　　　　　　　□否　　　　　　　□不清楚 評論：＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿

  15. Did the review’s authors do enough to assess the quality of the included studies 嚴謹的文獻品質的評估? □是　　　　　　　□否　　　　　　　□不清楚 評論：＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿

  16. If the results of the review have been combined, was it reasonable to do so 統合各研究結果合理嗎? □是　　　　　　　□否　　　　　　　□不清楚 評論：＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿

  17. Critical Appraisal of Systematic Review (II)“系統性回顧”的評析（二） • What were the results (結果為何)? • What are the overall results of the review (回顧文獻的整體結果為何)? • How precise are the results(結果的準確性如何)? • Will the results help locally (結果對本地有幫助嗎)? • Can the results be applied to the local population (結果適用於本地病人嗎)? • Were all important outcomes considered (所有重要結果是否都考慮到了)? • Are the benefits worth the harms and costs (考量利弊，花費，是否值得)?

  18. 不同類型的研究結果分析 (1) • Therapy / Prevention (治療/預防) • Relative risk reduction (RRR, 相對風險性降低度) • Absolute risk reduction (ARR, 絕對風險性降低度) • Number needed to treat (NNT, 益一需治數) • Harm / Etiology (傷害/病因) • Relative risk (RR, 風險比) • Odds ratio (OR, 勝算比) • Number needed to harm (NNH, 害一需治數)

  19. 不同類型的研究結果分析 (2) • Diagnosis (診斷) • Sensitivity (敏感度) • Specificity (特異度) • Positive predictive value (陽性預測值) • Negative predictive value (陰性預測值) • Likelihood ratio (相似比) • Prognosis (預後) • Event rate (事件發生率) • Odds ratio (OR, 勝算比) • Survival curve

  20. What are the overall results of the review 回顧文獻的整體結果為何? □是　　　　　　　□否　　　　　　　□不清楚 評論：＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿

  21. How precise are the results 結果的準確性如何? □是　　　　　　　□否　　　　　　　□不清楚 評論：＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿

  22. Meta-analysis Forest Plot Comparison: Treatment VS Placebo Outcome: Effect of treatment on mortality Treatment reduces mortality by 34% Treatment Control OR Weight OR Study n/N n/N (95% CI) % (95% CI) Brown 1998 24/472 35/499 9.6 0.71(0.42, 1.21) Geoffrey 1997 120/2850 182/2838 51.8 0.64(0.51, 0.81) Mason 1996 56/2051 84/2030 24.4 0.65(0.46, 0.92) Peters 2000 5/81 4/78 1.1 1.22(0.31, 4.71) Scott 1998 31/788 46/792 13.1 0.66(0.42, 1.06) Total (95% CI) 236/6242 351/6237 100.0 0.66(0.56, 0.78) .1 .2 1 5 10 Test for heterogeneity chi-square=0.92 df=4 p=0.92 Test for overall effect z=-4.82 p<0.00001 Favors treatment Favors control No effect of treatment

  23. Explore Heterogeneity Eyeball test – Overlap of the confidence intervals of the trials with the summary estimate Cochran Q and Q / df Vertical light blue line through the combined odds ratio crosses the horizontal lines of all the individual studies Treatment Control OR Weight OR Study n/N n/N (95% CI) % (95% CI) Brown 1998 24/472 35/499 9.6 0.71(0.42, 1.21) Geoffrey 1997 120/2850 182/2838 51.8 0.64(0.51, 0.81) Mason 1996 56/2051 84/2030 24.4 0.65(0.46, 0.92) Peters 2000 5/81 4/78 1.1 1.22(0.31, 4.71) Scott 1998 31/788 46/792 13.1 0.66(0.42, 1.06) Total (95% CI) 236/6242 351/6237 100.0 0.66(0.56, 0.78) .1 .2 1 5 10 Test for heterogeneity chi-square=0.92 df=4 p=0.92 Test for overall effect z=-4.82 p<0.00001 Cochran Q p=0.92 Q / df = 0.92 / 4 = 0.23 (<1) Favors treatment Favors control

  24. Can the results be applied to the local population 結果適用於本地病人嗎? □是　　　　　　　□否　　　　　　　□不清楚 評論：＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿

  25. Were all important outcomes considered 所有重要結果是否都考慮到了? □是　　　　　　　□否　　　　　　　□不清楚 評論：＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿

  26. Are the benefits worth the harms and costs 考量利弊花費，是否值得? □是　　　　　　　□否　　　　　　　□不清楚 評論：＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿

  27. 謝謝聆聽！

  28. BMJ 2011; 342:d549

  29. BMJ 2011; 342:d549

  30. Methodology for a Systematic Review of RCTs

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