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按一下以編輯母片標題樣式,按一下以編輯母片,第二層,第三層,第四層,第五層,*,李文欽醫師,實證醫學中心主任,2013/11/08,實證醫學與個案討論,簡報大綱,簡述實證醫學五大步驟,如何問問題及形成,PICO,的內容,資料搜尋的,策略、使用,資料庫及,搜尋,結果,對,資料,的評讀,如何落實實證醫學於個案討論,過去,現在,未來,當一個醫生該具備的的能力,三日不讀書，面目可憎,醫病照護,教學,研究,2000,年,Sackett,將實證醫學定義為 “,整合最佳研究證據、臨床經驗以及病患價值以達成病患最佳治療的過程,”,實證醫學的實行是一種終身的、自發的、以問題為導向的學習過程,實證醫學的重要性,臨床經驗,病患價值,最佳研究證據,實證醫療,Sackett,et al 2000,實證醫學,的五個步驟,1. Asking an answerable question,(,提出可回答的臨床問題,),2. Tracking down the best evidence,(,搜尋最佳實證文獻資料,),3. Critical appraisal,(,嚴謹的文獻評讀,),4. Integrating the appraisal with clinical expertise,and patients preference,(,將臨床專業與病人價值觀相結合,),5. Evaluation the effectiveness and efficiency in,executing steps 1-4,(,評估改善,),A stroke patient who has long term gouty arthritis,Does gout cause a higher risk of stoke?,痛風會增加中風的風險嗎？,找資料來回答問題,Acquire,嚴格評讀文獻,Appraisal,是否可應用到病人身上,Apply,將病人的問題寫成,PICO,Asking,EBM,的步驟,Sir Austin Bradford Hill,(1897-1991), English epidemiologist and statistician,He described the clinical trial as being a CAREFULLY, and ETHICALLY, described experiment with the aim of answering some,PRECISELY FRAMED QUESTION,Greater precision is required in the objectives. We need to have,A defined population,Defined endpoints,Relatively few question to be answered.,問,題,要,怎,麼,問,？,1.,形成問題,(Clinical Question),Does gout cause a higher risk of stoke?,痛風會增加中風的風險嗎？,臨床的問題模型,(PICO),P: Patient, Population,指此病人或族群的年齡層,、,體質,、,疾病史,、,過去史等,I: Intervention,指治療,、,診斷,、,預後,、,成本效益分析等,，,為研究的主題,C: Comparison,指做與不做或不同處置間的比較,O: Outcome,指預後或與目前問題有關的比較基準,找資料來回答問題,Acquire,嚴格評讀文獻,Appraisal,是否可應用到病人身上,Apply,將病人的問題寫成,PICO,Asking,EBM,的步驟,PICO 1,Does gout cause a higher risk of stoke?,PICO type:,Therapy,Patient:,老年人,Intervention:,痛風,Comparison:,無痛風,Outcome:,中風的風險,問,題,要,怎,麼,問,？,2. Tracking down the best evidence,直接使用實證醫學資庫,(secondary databases),如,ACP journal club,Cochrane Library,UpToDate,MD Consult,Practice Guideline,找初步篩選的資庫,(primary databases),PubMed,OVID,Proquest,未經篩選的資庫,如,Google,可搜尋實證醫學的資料庫,如何尋找與,EBM,相關的館藏資源？,主題切入,本院一般綜合性資料庫,1.,PudMed,：可查出,abstract,2. Ovid,：可查出,abstract,、,Fulltext,3.,Proquest,：可查出,abstract,、,Fulltext,4.,Clinicalkey,：可查出,abstract,、,Fulltext,找實證醫學資料時可加上,Systemic Review (,系統性評論,),、,Meta-analysis (,整合分析,),、,Randomized Controlled Trial (,隨機對照臨床試驗研究,),、,Controlled Trials,利用資料庫功能鍵,MeSH,to identify every term for example,找資料來回答問題,Acquire,嚴格評讀文獻,Appraisal,是否可應用到病人身上,Apply,將病人的問題寫成,PICO,Asking,Searching Strategy,Finding out The Correct Keywords,原始關鍵字,Primary Term,或,MeSH,Term,同義字,1,同義字,2,P,(,or,or,),and,I,(,Gout,or,Hyperuricemia,or,),and,C,(,or,or,),and,O,(,stroke,or,or,),找資料來回答問題,Acquire,嚴格評讀文獻,Appraisal,是否可應用到病人身上,Apply,將病人的問題寫成,PICO,Asking,Searching Strategy,Finding out The Correct Keywords,Keywords from PICO item:,(“gout” OR “,hyperuricemia,”) AND “stroke”,MeSH,to identify every term for example,找資料來回答問題,Acquire,嚴格評讀文獻,Appraisal,是否可應用到病人身上,Apply,將病人的問題寫成,PICO,Asking,善用搜尋,Systematic review,關鍵字,: (,“gout” OR “,hyperuricemia,”) AND (“stroke” OR “cardiovascular disease”),找資料來回答問題,Acquire,嚴格評讀文獻,Appraisal,是否可應用到病人身上,Apply,將病人的問題寫成,PICO,Asking,The Evidence Pyramid,V,. Animal research,V,.,In vitro (test tube) research,IV,. Case series/ Reports,V,.,Ideas, Editorials, Opinions,III,. Case Control Studies,II,. Cohort studies,I.,Randomized Controlled,Studies (RCT),I.,Randomized Controlled,Double Blind,Studies,Meta - analysis,統計方法,Meta-analysis,圖示結果,Forest plot,*,Hierarchy of evidence,: arranges study designs by their susceptibility to bias. (Level IV),From: Oxford Center for EBM,研究設計 與 證據強度,Level,Therapy/Prevention,Aetiology,/Harm,Prognosis,Diagnosis,Differential diagnosis/symptom prevalence study,Economic and decision analyses,1a,SR (with homogeneity*) of,RCTs,SR (with homogeneity*) of inception cohort studies; CDR validated in different populations,SR (with homogeneity*) of Level 1 diagnostic studies; CDR with 1b studies from different clinical,centres,SR (with homogeneity*) of prospective cohort studies,SR (with homogeneity*) of Level 1 economic studies,1b,Individual RCT (with narrow Confidence Interval),Individual inception cohort study with 80% follow-up; CDR validated in a single population,Validating* cohort study with good reference standards; or CDR tested within one clinical centre,Prospective cohort study with good follow-up*,Analysis based on clinically sensible costs or alternatives; systematic,review(s,) of the evidence; and including multi-way sensitivity analyses,1c,All or none,All or none case-series,Absolute,SpPins,and,SnNouts,All or none case-series,Absolute better-value or worse-value analyses ,2a,SR (with homogeneity*) of cohort studies,SR (with homogeneity*) of either retrospective cohort studies or untreated control groups in,RCTs,SR (with homogeneity*) of Level 2 diagnostic studies,SR (with homogeneity*) of 2b and better studies,SR (with homogeneity*) of Level 2 economic studies,2b,Individual cohort study (including low quality RCT; e.g., 80% follow-up; CDR validated in a single population,Validating* cohort study with good reference standards; or CDR tested within one clinical centre,Prospective cohort study with good follow-up*,Analysis based on clinically sensible costs or alternatives; systematic,review(s,) of the evidence; and including multi-way sensitivity analyses,1c,All or none,All or none case-series,Absolute,SpPins,and,SnNouts,All or none case-series,Absolute better-value or worse-value analyses ,2a,SR (with homogeneity*) of cohort studies,SR (with homogeneity*) of either retrospective cohort studies or untreated control groups in,RCTs,SR (with homogeneity*) of Level 2 diagnostic studies,SR (with homogeneity*) of 2b and better studies,SR (with homogeneity*) of Level 2 economic studies,2b,Individual cohort study (including low quality RCT; e.g., 80% follow-up),Retrospective cohort study or follow-up of untreated control patients in an RCT; Derivation of CDR or validated on split-sample only,Exploratory* cohort study with good reference standards; CDR after derivation, or validated only on split-sample or databases,Retrospective cohort study, or poor follow-up,Analysis based on clinically sensible costs or alternatives; limited,review(s,) of the evidence, or single studies; and including multi-way sensitivity analyses,2c,Outcomes Research; Ecological studies,Outcomes Research,Ecological studies,Audit or outcomes research,3a,SR (with homogeneity*) of case-control studies,SR (with homogeneity*) of 3b and better studies,SR (with homogeneity*) of 3b and better studies,SR (with homogeneity*) of 3b and better studies,3b,Individual Case-Control Study,Non-consecutive study; or without consistently applied reference standards,Non-consecutive cohortstudy, or very limited population,Analysis based on limited alternatives or costs, poor quality estimates of data, but including sensitivity analyses incorporating clinically sensible variations.,4,Case-series (and poor quality cohort and case-control studies),Case-series (and poor quality prognostic cohort studies*),Case-control study, poor or non-independent reference standard,Case-series or superseded reference standards,Analysis with no sensitivity analysis,5,Expert opinion without explicit critical appraisal, or based on physiology, bench research or first principles,Expert opinion without explicit critical appraisal, or based on physiology, bench research or first principles,Expert opinion without explicit critical appraisal, or based on physiology, bench research or first principles,Expert opinion without explicit critical appraisal, or based on physiology, bench research or first principles,Expert opinion without explicit critical appraisal, or based on economic theory or first principles,Oxford Centre for Evidence-based Medicine - Levels of Evidence (March 2009),http:/, risk of stroke: a systematic,review and meta-analysis.(2009), Source:,Arthritis Rheum. 2009 Jul 15;61(7):885-92, Level: 2a,Large epidemiologic studies have shown that,hyperuricemia,is associated with an increased incidence of,coronary heart disease (CHD),and,increased mortality,in those withand withoutpreexisting CHD .,Fang J, Alderman MH. Serum uric acid and cardiovascular mortality the NHANES I epidemiologic follow-up study, 1971-1992. National Health and Nutrition Examination Survey. JAMA 2000; 283:2404.,Freedman DS, Williamson DF, Gunter EW, Byers T. Relation of serum uric acid to mortality and ischemic heart disease. The NHANES I Epidemiologic Follow-up Study. Am J,Epidemiol,1995; 141:637.,Brand FN, McGee DL,Kannel,WB, et al.,Hyperuricemia,as a risk factor of coronary heart disease: The Framingham Study. Am J,Epidemiol,1985; 121:11.,Niskanen,LK,Laaksonen,DE,Nyyssnen,K, et al. Uric acid level as a risk factor for cardiovascular and all-cause mortality in middle-aged men: a prospective cohort study. Arch Intern Med 2004; 164:1546.,Choi,HK,Curhan,G. Independent impact of gout on mortality and risk for coronary heart disease. Circulation 2007; 116:894.,Proposed mechanisms,for such an increase in risk include the,development of hypertension,and,oxidative stress,.,Johnson RJ, Segal MS,Srinivas,T, et al. Essential hypertension, progressive renal disease, and uric acid: a,pathogenetic,link? J Am Soc,Nephrol,2005; 16:1909.,Baker JF, Krishnan E, Chen L, Schumacher HR. Serum uric acid and cardiovascular disease: recent developments, and where do they leave us? Am J Med 2005; 118:816.,It is unclear if,hyperuricemia,has a,causal effect,or, as has been more often suggested, is,simply a marker,for other risk factors, such as hypertension,dyslipidemia, and diabetes.,Culleton,BF, Larson MG,Kannel,WB, Levy D. Serum uric acid and risk for cardiovascular disease and death: the Framingham Heart Study. Ann Intern Med 1999; 131:7.,Wannamethee,SG, Shaper AG,Whincup,PH. Serum,urate,and the risk of major coronary heart disease events. Heart 1997; 78:147.,Wheeler JG,Juzwishin,KD,Eiriksdottir,G, et al. Serum uric acid and coronary heart disease in 9,458 incident cases and 155,084 controls: prospective study and meta-analysis.,PLoS,Med 2005; 2:e76.,Feig,DI, Kang DH, Johnson RJ. Uric acid and cardiovascular risk. N,Engl,J Med 2008; 359:1811.,文獻評讀三部曲,文獻評讀最主要的三個步驟,，,即是,VIP,V,：,Validity,/Reliability,;,效度,/,信度,我們能相信這篇文章嗎,?,I,：,Importance/Impact,;,重要性,我們相信它,，,但這個結論重要嗎,?,P,：,Practice,/Applicability,;,臨床適用性,如果我們相信它,，,這個結論可以應用在我們所照護的病患嗎,?,找資料來回答問題,Acquire,嚴格評讀文獻,Appraisal,是否可應用到病人身上,Apply,將病人的問題寫成,PICO,Asking,According to “Sharon E. Straus et al, Evidence-based medicine: how to practice and,teach EBM, Elsevier, 2005: 33-7. “,Validity,Importance,Applicability,Results from,secondary,database,Results from,primary,database,Appraised by,experts,Needed to,be,appraised,Results(NNT,),Results,Consider,population,and feasibility,Consider,population,and feasibility,效度,(,V,alidity),：可以用,RAM-,bo,方式審視效度,研究族群是否有隨機分配,(,Randomized,),？,隨機分配的方法是否適當,(,Accounted,),？,結果的衡量,(,M,easurement),，,即是否依照,盲法,(,b,lind),及客觀,(,o,bjective),二要素操作,治療意圖分析,(Intention-to-treat analysis, ITT),隨機試驗的一種分析方法,所有被分配在治療組,/,對照組的病人無論是否完成該項,治療,/,安慰劑都應該被放進治療組,/,對照組,(,原分派組別,),中做分析,文獻評讀三部曲,重要性,(Importance/,I,mpact),：,研究結果是什麼,?,研究結果如何被估計,?,經過多久的時間,?,文獻結果的評估方式：,勝算比,(odds ratio),代表生物學上的影響。,相對危險,(relative risk),、,絕對危險降低度,(absolute risk reduction),、,相對危險降低度,(relative risk reduction),、,益一需治數,(NNT, number needed to treat):,為預防一個不良結果或使一個病人達實驗所求之有益結果所需治療的病人數,NNT=1/ARR,文獻評讀三部曲,可行性,(,P,ractical , Applicability ?),：臨床實用性如何？,1.,應考量病患的生物因素,(biological issues):,-,同樣的治療應用在不同的病患族群是否有不同反應,?,-,我們的病人與研究中的病人是否非常不同，以致無法應用,在研究結果？,2.,其他的社會經濟因素,（,social and economic issues,）,的考量,:,-,這個治療適用於我們的診療環境嗎？病患的配合度如何？,-,醫療提供者的配合度及能力如何？,3.,流行病學因素,(epidemiological issues,）的考量,:,-,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？,文獻評讀三部曲,幫助文獻評讀的工具,依所搜尋文獻類別,，,評讀所問的問題,4.,將臨床專業與病人價值觀相結合,您的病人是否與研究中的病人差別很大，以,至於無法適用該研究結果？,族群,/,地域,/,文化差異,您期望您的病人從研究結果中獲得多大的好處？,還有哪些替代方案？,研究結果適用於您的病人嗎？,5.,評估執行效果及改善過程,您是否開始使用實證手法搜尋最佳證據？,您搜尋及評讀證據的速度有多快？,您有能力將這些證據應用在適當的病人身上嗎？,您是否依循這些新證據來改變您的診療習慣？,如何落實實證醫學於個案討論會,?,如何落實實證醫學於個案討論會,1.,由討論的個案找尋問題,(,形成,PICO,),2.,進行文獻搜尋,(PUB Med, Cochrane, Ovid),3.,進行文獻評讀,(Evidence level, Recommend grade),會議中報告文章重點與結論,4.,所搜尋的文獻值得應用到本病人身上嗎,?,實證醫學個案討論會順序,Case report (,個案報告,),提出問題,，,建立,PICO,格式,文獻搜尋,(,所使用關鍵字,、,資料庫,),所搜尋到文獻的題目,、,出處,、,及,文獻,的證據等級,5.,報告文獻的重點與結論,6.,是否可應用到我們的病人身上,Clinical question:,Does gout cause a higher risk of stoke?,PICO type:,Therapy,Patient:,Old patient,Intervention:,Gout,Comparison:,Without gout,Outcome:,Risk of stroke,Title:,Hyperuricemia,and risk of stroke: a systematic review and meta-analysis.(2009), Source:,Arthritis Rheum. 2009 Jul 15;61(7):885-92, Level: 2a,科別選定與討論頻率,1.,科別,:,內、外、婦、兒、皮膚科,藥劑、護理、,(,檢驗、放射,),2.,頻率,:,每月一次,3.,會議主題設定,:,實證醫學個案討論會,4.,請科部主任定期檢視結果與統計,Thank You For Your Attention!,
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