1.臨床流行病學(xué)對(duì)臨床科研的科學(xué)價(jià)值.

1、臨床流行病學(xué)對(duì)臨床科研及臨床賣(mài)踐的科學(xué)價(jià)值The Scientific Value of Clinical Epidemiology onClinical Research and Clinical Practices川丸學(xué)華西醫(yī)俛i臨床流行病學(xué)絡(luò)訓(xùn)中心R-CERTC, INCLEN二00四年四月I內(nèi) 彖一. 臨床流行病學(xué)發(fā)展背景與現(xiàn)況二. 臨廉醫(yī)學(xué)科研C中西醫(yī)藥丿需要臨床 流行病學(xué)三. 臨床流行病學(xué)研老的方出學(xué)曲、臨廉流行病學(xué)的科學(xué)價(jià)值一、臨床流行病學(xué)的背景與現(xiàn)況Clinical Epidemiology (1936)3#國(guó)際臨床濟(jì)行病學(xué)網(wǎng)、(INCLEN1982) I級(jí)培訓(xùn)中會(huì)(Phase

2、 I CERTCs)n級(jí)培訓(xùn)中心(Phase II CERTCs)曲床濟(jì)行病學(xué)組(CEU)#International Clinical Epidemiology Network (INCLEN 1982-)Bogota PopayanI 'fk 金B(yǎng) Clinical Epidemiology Units (CEUs) Clinical Epidemiology Resource and Training Centers (CERTCs)"8金/28 Countries 5 FG-CERTCs 12 R-CERTCs 66CEUsChmaCBMin ChenHINCLENM

3、ission statement:We are dedicated to improving the health of the people by promoting clinical practice on the best evidence of effectiveness and the efficient use of resources.We achieve this through a network of physiciansstatisticians and social scientists throughout the world who work together to

4、 build and sustain institutional capacity for excellence and relevance in research and medical education臨床濟(jì)行病學(xué)扈中國(guó)Clinical Epidemiology in China1980他床科研設(shè)計(jì)、測(cè)量與評(píng)價(jià)D.M.E MOPH1984中國(guó)他廉流行病學(xué)網(wǎng)CHINACLEN1989中華醫(yī)學(xué)會(huì)臨廉濟(jì)行病學(xué)分會(huì)CCES,CMA1993二、臨床醫(yī)學(xué)科研(中西德藥)需要 臨床流行病學(xué)I 臨床科研與服務(wù)對(duì)象的復(fù)雜性(The Complexity of Clinical Research)A:研老的

5、對(duì)象(Study Subjects)各種類(lèi)型的病人及其群體(Patients and the Community)B :臨床特點(diǎn)的復(fù)雜性(Complexity of Clinical Characters)7C:彩響疾病轉(zhuǎn)歸的因素的復(fù)雜性(The factors of influencing progress and outcome of disease)D:社會(huì)、經(jīng)濟(jì)與心理因素影響復(fù)雜性能(Social，economic and psychologic factors)囂杲騒辨證論沒(méi)理垛方藥的復(fù)雜傳統(tǒng)的不完曇的臨廉研屯及傳統(tǒng)的經(jīng) 殮總結(jié)制約了臨床醫(yī)學(xué)的科學(xué)化II臨床醫(yī)學(xué)面臨的巨大挑戰(zhàn)(The

6、 big challenge confronted by clinical practice)9#<TI巨丸挑戰(zhàn)中醫(yī)藥現(xiàn) 代化滯后#A. 為了保障人氏健康、防治疾病要加強(qiáng)衛(wèi)生研究B. 要提富研丸質(zhì)量一走要加強(qiáng)衛(wèi)生研究能力(CE)C. 最住的研克成系要轉(zhuǎn)化防恰疾病的賣(mài)戲(EBM)采用新的防治播施必須嚴(yán)格評(píng)價(jià)(CE/EBM)#新的診療播嵐(New diagnostic and therapeutic maneuvers)I 、臨床賣(mài)戲(Clinical practice) 診治疾病0正赦負(fù)赦 +/.負(fù)敗正敢(Good>Harm)(Harm > Good)產(chǎn) 格評(píng)價(jià)(Critica

7、l appraisal)10科學(xué)的證據(jù)(Scientific evidence)準(zhǔn)確的診靳(Correct diagnosis)儀晟設(shè)備(Equipment)資料可靠c(Reliable data)'>><=選擇性偏倚(Selection bias)統(tǒng)計(jì)學(xué)方宙(Biostatistical =>method)二測(cè)量性偏倚 (Measurement bias)醫(yī)德(Ethics)混亂(Noise)=>機(jī)遇(Chance)!<=爲(wèi)雜(Confounders)很從性(Compliance)彩響購(gòu)廉研老真賣(mài)性的有關(guān)因素為了使臨床醫(yī)學(xué)研農(nóng)從經(jīng)臉醫(yī)學(xué) 發(fā)畏為臨床

8、醫(yī)學(xué)科學(xué)學(xué)P十世紀(jì) 70年代創(chuàng)建了臨床流行病壑o他床流行病學(xué)衣購(gòu)床醫(yī)列跋中的指導(dǎo)與應(yīng)用，發(fā)畏了循醫(yī)學(xué)O13I什么是臨廉流行病學(xué)(What is Clinical Epidemiology)臨床濟(jì)行病學(xué)是虛臨床醫(yī)學(xué)領(lǐng)城內(nèi)P引入了現(xiàn)代流 行病學(xué)及衛(wèi)生統(tǒng)計(jì)學(xué)的方法學(xué)，從總者個(gè)體的診治P護(hù)丸到總病群體的研究，以採(cǎi)討疾病的病因、診飾、 預(yù)防、治療以及預(yù)后等臨廉規(guī)律，并進(jìn)行嚴(yán)格地設(shè)計(jì)、 街量和評(píng)價(jià)的他床基礎(chǔ)科學(xué)。Definition: Clinical epidemiology is a basic science for the clinical medicine into which the mode

9、rn methodology of the epidemiology and biostatistics has been introduced to make a rigorous design，scientific measurement and evaluation for studying the objective rule of the causation, diagnosis, preventiontreatment and prognosis from individual patient to the community.#Ill 臨廉流行病學(xué)的主要特色(The main t

10、ask of clinical epidemiology)A. 臨床沆行病學(xué)是的廉醫(yī)學(xué)的基礎(chǔ)科學(xué)(Clinical epidemiology the basic science for clinical medicine)B. 尹出優(yōu)秀成果服務(wù)于醫(yī)學(xué)賣(mài)踐和衛(wèi)生決策(Recommend the Best evidence for health care decision-making)循證醫(yī)學(xué) 具有強(qiáng)烈的臨床性，是覆蓋整個(gè)臨廉醫(yī)學(xué)領(lǐng)城的。三.臨廉流行病學(xué)的主要研老方出學(xué) (The main research methodology of clinical epidemiology)研老的 段計(jì)(

11、Research design)1-1 朗確 研老的目的(Research objective)1-2 科學(xué)的假-(Scientific hypothesis of study)1-3合理地缺擇役計(jì)方秦(To select research architecture reasonably)1-4 選擇研老對(duì)象(To select study subject)1-5洪驗(yàn)措施的創(chuàng)新、有效和科學(xué)性、設(shè)計(jì)對(duì)照 (Innovative effective，scientific experimental maneuver with control group)1-6試臉終點(diǎn)的指標(biāo)：標(biāo)準(zhǔn)、確切、可量度(Th

12、eend points of the study should be standard definitive and measurable)171-7要有防止偏倚的播施與方廉(The method to prevent and control bias)1-8正確應(yīng)用統(tǒng)計(jì)方出與計(jì)算機(jī)軼件包（To usebiostatistical methods statistical software correctly)(II)測(cè)童(Measurement)對(duì)研農(nóng)結(jié)系的測(cè)量(Measurement)應(yīng)用禁些科學(xué)的指標(biāo)來(lái)測(cè)洪渕驗(yàn)播施的赦應(yīng)，作 %評(píng)價(jià)試a殮赦果的科學(xué) 依據(jù)(To evaluate the e

13、fficacy by measuring the reaction of experimental maneuver via some indices)對(duì)測(cè)量指標(biāo)的要求(Requirement of the indices)A.鐵感性(Sensitivity) 特異性(Specificity)B可量度性(Measurability)C異常標(biāo)準(zhǔn)的確災(zāi)、公認(rèn)(The definition of abnormality should be definitive and acceptable)測(cè)董指標(biāo)的種類(lèi)(Tpe of measuring indices) A臨床指標(biāo)(Clinical indice

14、s)硬福標(biāo)(Hard indices):死亡(death),存活(alive), 病 /(handicap).軼指標(biāo)(Soft indices):減經(jīng)(remission),好轉(zhuǎn) (improvement), 惡 L(exacerbation).B生楊學(xué)指標(biāo)(Biologic indices)生化指標(biāo)(Biochemistry indices)生理指標(biāo)(Physiologic indices)C生存質(zhì)量指標(biāo)(indices for quality of life)D衛(wèi)生經(jīng)濟(jì)學(xué)福標(biāo)(Indices for health economics)E中醫(yī)辨證指標(biāo)(Ill)評(píng)價(jià)(Evaluation)科學(xué)

15、評(píng)價(jià)研老結(jié)果的真賣(mài)性和可索性(Evaluate the validity and reliability of study results)對(duì)研老結(jié)果價(jià)值的評(píng)價(jià)，通常應(yīng)注總?cè)齻€(gè)方面臨床意義(Clinical Significance)統(tǒng)計(jì)學(xué)總義(Statistical Significance)經(jīng)濟(jì)學(xué)意義(Health economic Significance)生存質(zhì)量(Quality of life)A.購(gòu)床和統(tǒng)計(jì)學(xué)評(píng)價(jià)Evaluation of both the clinical and biostatistical significanceClinicalBiostatisticalC

16、onclusionSignificanceSignificanceIYesYesPositiven.YesNoPositive or negativehi.NoYesNegativeIV.NoNoNegativeB衛(wèi)生 經(jīng)濟(jì)評(píng) 價(jià)(Health economics)成本一效系評(píng)價(jià)(Cost-effectiveness analysis) 成本-效益評(píng)價(jià)(Cost-benefit analysis) 成本一效用評(píng)價(jià)(Cost-utility analysis)27結(jié)語(yǔ)(Summary)1臨床流行病學(xué)是相關(guān)的多學(xué)科湊入臨床醫(yī)學(xué)的 門(mén)新興學(xué)科(Clinical epidemiology basic

17、science of clinical medicine with multi-disciplines involvement)2主要目的：推動(dòng)臨床醫(yī)學(xué)科學(xué)化，提需研究和 學(xué)術(shù)質(zhì)量，促進(jìn)臨床醫(yī)學(xué)與教學(xué)水平的提壽(Focus on:scientifically promote clinical medicine， improve the quality of academic level and education)3有利于衛(wèi)生管理政策的制(Benefit for thehealth policy decision-making)叫當(dāng)前國(guó)際衛(wèi)生研丸的狀況關(guān)國(guó)際衛(wèi)生學(xué)術(shù)組織正丸力促進(jìn)衛(wèi)生研老WHO

18、 （世界衛(wèi)生組織丿Ad. HocCommittee on H.R Global Forum for H.R （全球衛(wèi)生研究論態(tài) 壇丿 COHRD （X生研究發(fā)展委員會(huì)丿 Advisory Committee on H.R.Approach （衛(wèi)生研 盤(pán)指導(dǎo)萋員會(huì)） INCLEN（國(guó)際臨床流行病學(xué)網(wǎng)）2要?dú)g耳人類(lèi)健康，一定要加強(qiáng)富質(zhì)量的 衛(wèi)生研老：、衛(wèi)生研老要富度重視倫理道德準(zhǔn)則衛(wèi)生研老要重視衣平原則經(jīng)濟(jì)全球化與人類(lèi)生楊學(xué)知識(shí)與信 息技術(shù)革命，推動(dòng)全球化-國(guó)家、 地區(qū).全球衛(wèi)生合作研老3Ad. Hoc Committee on H.R.WHO（選題五環(huán)節(jié)）in健康干預(yù)知識(shí)及成本效系分析(Knowledge of health intervention and cost-effectiveness analysis)IV進(jìn)一步干預(yù)的成本"效系分析(Cost-effectiveness analysis for further interventions)V 投入研究資源分