回顧性臨床研究課件

回顧性病例對(duì)照研究回顧性研究：從過(guò)去某時(shí)點(diǎn)開(kāi)始的前瞻性研究的隨訪，但實(shí)際做的是在現(xiàn)在調(diào)查過(guò)去的既成事實(shí)，這時(shí)暴露與疾病或死亡均已成事實(shí)，而前瞻性研究的隨訪則是查尋在過(guò)程中新出現(xiàn)的樣本結(jié)果。是一種由“果”至“因”的研究方法。病例對(duì)照研究（case-controlstudy），按照疾病狀況將研究對(duì)象分為病例和對(duì)照。比較患某病者與未患某病的對(duì)照者在發(fā)病前暴露于某可能危險(xiǎn)因素的百分比差異，分析這些因素是否與該病存在聯(lián)系。研究目的廣泛探索疾病或健康狀態(tài)等事件發(fā)生的可疑危險(xiǎn)因素。疾病預(yù)后因素的研究。臨床療效影響因素分析。標(biāo)題研究?jī)?nèi)容，研究結(jié)果，研究創(chuàng)新點(diǎn)，研究類(lèi)型。研究?jī)?nèi)容+研究類(lèi)型例1：Associationbetweenbreastfeedingandasthmain6yearoldchildren:findingsofaprospectivebirthcohortstudy研究結(jié)果+研究類(lèi)型修改的例1：Breastfeedingreducestheriskofasthmain6yearoldchildren:findingsofaprospectivebirthcohortstudy.前言研究背景：疾病，危險(xiǎn)因素。為什么研究此內(nèi)容也就是做此研究的理由：前人研究的現(xiàn)狀，不足，本研究的必要性。研究?jī)?nèi)容和意義方法研究設(shè)計(jì)：病例收集，分組，以及隨訪觀察；病例的介紹：病例基本信息，納入和排除標(biāo)準(zhǔn)，診斷方式以及干預(yù)方式；數(shù)據(jù)收集：隨訪或調(diào)查期間需要收集的資料數(shù)據(jù)有哪些，如何收集，如何測(cè)量；統(tǒng)計(jì)分析研究設(shè)計(jì)病例收集：病例來(lái)源，病例信息來(lái)源，病例收集時(shí)間，病例進(jìn)入記錄時(shí)間.病例收集時(shí)間=病例進(jìn)入記錄時(shí)間（前瞻性研究）；病例收集時(shí)間≠病例進(jìn)入記錄時(shí)間（前瞻性，回顧性）。分組：根據(jù)暴露情況分組隊(duì)列研究：隊(duì)列內(nèi)根據(jù)暴露情況分組；一般病例對(duì)照研究：根據(jù)患病未患病同時(shí)納入兩個(gè)隊(duì)列；病例對(duì)照研究衍生類(lèi)型和橫斷面研究：以上均可。隨訪觀察：隨訪時(shí)間，隨訪方式，隨訪過(guò)程中需記錄的數(shù)據(jù)信息以及隨訪過(guò)程中并發(fā)癥或其他病癥的處理方式。病例介紹病例基本信息：據(jù)觀察類(lèi)研究報(bào)告規(guī)范，具體的人口統(tǒng)計(jì)資料應(yīng)該在在結(jié)果中展示。而樣本量，性別，年齡等基礎(chǔ)信息可以在方法中提及。病例納入和排除標(biāo)準(zhǔn)：對(duì)于病例對(duì)照研究，也包括對(duì)照組的納入和排除標(biāo)準(zhǔn)，病例和對(duì)照的匹配方式。診斷方式和干預(yù)方式：病例的診斷方式，病例在研究過(guò)程中所經(jīng)過(guò)的干預(yù)治療（預(yù)后分析和生存分析）。隨訪與數(shù)據(jù)收集并不是所有的研究都有隨訪，然而所有的研究都有數(shù)據(jù)收集。當(dāng)存在隨訪時(shí)，需在方法中說(shuō)明的內(nèi)容包括隨訪時(shí)間，隨訪方式，隨訪過(guò)程中需記錄的數(shù)據(jù)信息以及隨訪過(guò)程中對(duì)于并發(fā)癥以及其他病癥的處理方式等。對(duì)于數(shù)據(jù)收集，則需要描述的是數(shù)據(jù)收集方法，數(shù)據(jù)檢測(cè)方法。如果數(shù)據(jù)中存在實(shí)驗(yàn)室數(shù)據(jù)，則需要給出具體的方法流程。904,95%CI1.DongLiu,MD,Bing-XiangWu,MD,NaSun,MD,YiYan,MD,PingYuan,MD,JieMingQu,MD,Zhi-ChengJing,MDConclusions:LevelsofcirculatingBMP7correlatewithmortalityinPAH,andmaybeapredictorofdiseaseinHPAHandIPAHpatients.Results:HPAHpatientshadsignificantlyhigherBMP7concentrationsthanIPAHandcontrols(20.Clinicalcharacteristicsatbaselineandlong-termsurvivalwerecomparedaccordingtothedifferentBMPslevels.ShanghaiPulmonaryhospital,TongjiUnivericitySchoolofMedicineConclusions:LevelsofcirculatingBMP7correlatewithmortalityinPAH,andmaybeapredictorofdiseaseinHPAHandIPAHpatients.042,logranktest).研究背景：疾病，危險(xiǎn)因素。當(dāng)存在隨訪時(shí)，需在方法中說(shuō)明的內(nèi)容包括隨訪時(shí)間，隨訪方式，隨訪過(guò)程中需記錄的數(shù)據(jù)信息以及隨訪過(guò)程中對(duì)于并發(fā)癥以及其他病癥的處理方式等。1,BMPR2expressionisreportedtobegreatlyreducedinpatientswithheritablepulmonaryarterialhypertension病例收集：病例來(lái)源，病例信息來(lái)源，病例收集時(shí)間，病例進(jìn)入記錄時(shí)間.Introduction病例基本信息：據(jù)觀察類(lèi)研究報(bào)告規(guī)范，具體的人口統(tǒng)計(jì)資料應(yīng)該在在結(jié)果中展示。904,95%CI1.ElevatedlevelsofcirculatingBMP7predictmortalityinpulmonaryarterialhypertension6)pg/ml,respectively;P<0.Methods:Atotalof156PAHpatientsincluding43HPAHand113IPAHdiagnosedbygenescreeningwereenrolledinthestudy.（b）選擇經(jīng)過(guò)統(tǒng)計(jì)分析發(fā)現(xiàn)與隨訪或臨床結(jié)果有顯著關(guān)聯(lián)的因素做多因素回歸分析，通常選擇單因素回歸分析分組：根據(jù)暴露情況分組結(jié)果總結(jié)Cox回歸分析與logistic回歸分析的過(guò)程是類(lèi)似的。首先要選出潛在的獨(dú)立危險(xiǎn)因素，可以通過(guò)以下兩種方式進(jìn)行篩選：（a）選擇感興趣的混雜因素直接進(jìn)行多因素；（b）選擇經(jīng)過(guò)統(tǒng)計(jì)分析發(fā)現(xiàn)與隨訪或臨床結(jié)果有顯著關(guān)聯(lián)的因素做多因素回歸分析，通常選擇單因素回歸分析另外還可以通過(guò)做單因素生存率比較找到與生存率有顯著關(guān)聯(lián)的因素做多因素cox回歸分析，用來(lái)篩選與生存率相關(guān)的獨(dú)立預(yù)后因子。也可以通過(guò)簡(jiǎn)單的差異顯著性分析（卡方檢驗(yàn)，t檢驗(yàn)和單因素方差分析）找到與臨床結(jié)果有顯著關(guān)聯(lián)的因素，然后通過(guò)logistic多因素回歸分析得出獨(dú)立因素。討論研究結(jié)果的總結(jié)概括。針對(duì)研究結(jié)果的討論分析（與前人研究的比較，相關(guān)機(jī)理的探討。本研究的優(yōu)勢(shì)與局限性的分析。結(jié)論。討論點(diǎn)發(fā)病率的討論，與其他研究相比，發(fā)病率是否有交大差異，如果差異較大，分析原因。如果無(wú)差異，則說(shuō)明此疾病的發(fā)病情況不收兩地區(qū)差異的限制。分析危險(xiǎn)因素與疾病發(fā)生相關(guān)的潛在機(jī)制。如果本研究發(fā)生的危險(xiǎn)因素，在其他研究中并不是危險(xiǎn)因素，則需通過(guò)與其他研究比較，找出可能的原因。文獻(xiàn)學(xué)習(xí)ElevatedlevelsofcirculatingBMP7predictmortalityinpulmonaryarterialhypertensionShanghaiPulmonaryhospital,TongjiUnivericitySchoolofMedicineDongLiu,MD,Bing-XiangWu,MD,NaSun,MD,YiYan,MD,PingYuan,MD,JieMingQu,MD,Zhi-ChengJing,MDCHESTReceivedDate:28September2015RevisedDate:18February2016AcceptedDate:2March2016Background:ThisstudyaimedtoshowwhethercirculatingBMPslevelsareassociatedwithincreasedriskofmortalityinPAHpatients.Methods:Atotalof156PAHpatientsincluding43HPAHand113IPAHdiagnosedbygenescreeningwereenrolledinthestudy.CirculatingBMPsweremeasuredbyELISAinplasmasamplesfromHPAH(n=43),IPAH(n=113)andcontrols(n=51).Clinicalcharacteristicsatbaselineandlong-termsurvivalwerecomparedaccordingtothedifferentBMPslevels.Results:HPAHpatientshadsignificantlyhigherBMP7concentrationsthanIPAHandcontrols(20.1(9.4,55.2)vs.6.5(3.5,11.7)and2.5(0.9,6.6)pg/ml,respectively;P<0.001).ElevatedplasmaBMP7wereassociatedwithahigherriskofmortalityafteradjustmentforsex,6-minutewalkdistance,meanrightatrialpressure,meanpulmonaryarterialpressure,pulmonaryvascularresistance,andcardiacoutput(HR=1.904,95%CI1.021-3.551;P=0.043).IPAHpatientswithaBMP7levelmorethan7.85pg/mlhadahigherriskofmortalitythanthosewithalowBMP7concentration(P=0.042,logranktest).Conclusions:LevelsofcirculatingBMP7correlatewithmortalityinPAH,andmaybeapredictorofdiseaseinHPAHandIPAHpatients.研究背景研究背景1,BMPR2expressionisreportedtobegreatlyreducedinpatientswithheritablepulmonaryarterialhypertension2,BMP2,4and7havebeenshowntobethemostimportantligandsforBMPR2signalinginPulmonaryvesselsIntroductionMethodsStudyDesignandPatientPopulation

納入排除標(biāo)準(zhǔn)倫理問(wèn)題：知情同意書(shū)，倫理協(xié)會(huì)批文隨訪HemodynamicMeasurementsand6-MinuteWalkDistance(6MWD)TestMeasurementofPlasmaBMPsConcentrationsStatisticalAnalysis臨床療效影響因素分析。如果數(shù)據(jù)中存在實(shí)驗(yàn)室數(shù)據(jù)，則需要給出具體的方法流程。隨訪觀察：隨訪時(shí)間，隨訪方式，隨訪過(guò)程中需記錄的數(shù)據(jù)信息以及隨訪過(guò)程中并發(fā)癥或其他病癥的處理方式。Results:HPAHpatientshadsignificantlyhigherBMP7concentrationsthanIPAHandcontrols(20.Background:ThisstudyaimedtoshowwhethercirculatingBMPslevelsareassociatedwithincreasedriskofmortalityinPAHpatients.MeasurementofPlasmaBMPsConcentrations1,BMPR2expressionisreportedtobegreatlyreducedinpatientswithheritablepulmonaryarterialhypertensionRevisedDate:18February20161,BMPR2expressionisreportedtobegreatlyreducedinpatientswithheritablepulmonaryarterialhypertensionCirculatingBMPsweremeasuredbyELISAinplasmasamplesfromHPAH(n=43),IPAH(n=113)andcontrols(n=51).Results:HPAHpatientshadsignificantlyhigherBMP7concentrationsthanIPAHandcontrols(20.分組：根據(jù)暴露情況分組AcceptedDate:2March2016而樣本量，性別，年齡等基礎(chǔ)信息可以在方法中提及。分組：根據(jù)暴露情況分組分析危險(xiǎn)因素與疾病發(fā)生相關(guān)的潛在機(jī)制。ReceivedDate:28September2015（b）選擇經(jīng)過(guò)統(tǒng)計(jì)分析發(fā)現(xiàn)與隨訪或臨床結(jié)果有顯著關(guān)聯(lián)的因素做多因素回歸分析，通常選擇單因素回歸分析2,BMP2,4and7havebeenshowntobethemostimportantligandsforBMPR2signalinginPulmonaryvessels如果本研究發(fā)生的危險(xiǎn)因素，在其他研究中并不是危險(xiǎn)因素，則需通過(guò)與其他研究比較，找出可能的原因。Results:HPAHpatientshadsignificantlyhigherBMP7concentrationsthanIPAHandcontrols(20.文獻(xiàn)學(xué)習(xí)ElevatedlevelsofcirculatingBMP7predictmortalityinpulmonaryarterialhypertensionShanghaiPulmonaryhospital,TongjiUnivericitySchoolofMedicineDongLiu,MD,Bing-XiangWu,MD,NaSun,MD,YiYan,MD,PingYuan,MD,JieMingQu,MD,Zhi-ChengJing,MDCHESTReceivedDate:28September2015RevisedDate:18February2016AcceptedDate:2March2016Background:ThisstudyaimedtoshowwhethercirculatingBMPslevelsareassociatedwithincreasedriskofmortalityinPAHpatients.Methods:Atotalof156PAHpatientsincluding43HPAHand113IPAHdiagnosedbygenescreeningwereenrolledinthestudy.CirculatingBMPsweremeasuredbyELISAinplasmasamplesfromHPAH(n=43),IPAH(n=113)andcontrols(n=51).Clinicalcharacteristicsatbaselineandlong-termsurvivalwerecomparedaccordingtothedifferentBMPslevels.Results:HPAHpatientshadsignificantlyhigherBMP7concentrationsthanIPAHandcontrols(20.1(9.4,55.2)vs.6.5(3.5,11.7)and2.5(0.9,6.6)pg/ml,respectively;P<0.001).ElevatedplasmaBMP7wereassociatedwithahigherriskofmortalityafteradjustmentforsex,6-minutewalkdistance,meanrightatrialpressure,meanpulmonaryarterialpressure,pulmonaryvascularresistance,andcardiacoutput(HR=1.904,95%CI1.021-3.551;P=0.043).IPAHpatientswithaBMP7levelmorethan7.85pg/mlhadahigherriskofmortalitythanthosewithalowBMP7concentration(P=0.042,logranktest).Conclusions:LevelsofcirculatingBMP7correlatewithmortalityinPAH,andmaybeapredictorofdiseaseinHPAHandIPAHpatients.1,BMPR2expressionisreportedtobegreatlyreducedinpatientswithheritablepulmonaryarterialhypertension2,BMP2,4and7havebeenshowntobethemostimportantligandsforBMPR2signalinginPulmonaryvesselsIntroduction針對(duì)研究結(jié)果的討論分析（與前人研究的比較，相關(guān)機(jī)理的探討。1,BMPR2expressionisreportedtobegreatlyreducedinpatientswithheritablepulmonaryarterialhypertensionMethods:Atotalof156PAHpatientsincluding43HPAHand113IPAHdiagnosedbygenescreeningwereenrolledinthestudy.修改的例1：Breastfeedingreducestheriskofasthmain6yearoldchildren:findingsofaprospectivebirthcohortstudy.Methods:Atotalof156PAHpatientsincluding43HPAHand113IPAHdiagnosedbygenescreeningwereenrolledinthestudy.6)pg/ml,respectively;P<0.病例收集：病例來(lái)源，病例信息來(lái)源，病例收集時(shí)間，病例進(jìn)入記錄時(shí)間.如果無(wú)差異，則說(shuō)明此疾病的發(fā)病情況不收兩地區(qū)差異的限制。DongLiu,MD,Bing-XiangWu,MD,NaSun,MD,YiYan,MD,PingYuan,MD,JieMingQu,MD,Zhi-ChengJing,MD當(dāng)存在隨訪時(shí)，需在方法中說(shuō)明的內(nèi)容包括隨訪時(shí)間，隨訪方式，隨訪過(guò)程中需記錄的數(shù)據(jù)信息以及隨訪過(guò)程中對(duì)于并發(fā)癥以及其他病癥的處理方式等。Results:HPAHpatientshadsignificantlyhigherBMP7concentrationsthanIPAHandcontrols(20.病例收集時(shí)間=病例進(jìn)入記錄時(shí)間（前瞻性研究）；Conclusions:LevelsofcirculatingBMP7correlatewithmortalityinPAH,andmaybeapredictorofdiseaseinHPAHandIPAHpatients.而樣本量，性別，年齡等基礎(chǔ)信息可以在方法中提及。2,BMP2,4and7havebeenshowntobethemostimportantligandsforBMPR2signalinginPulmonaryvesselsRevisedDate:18February2016904,95%CI1.分組：根據(jù)暴露情況分組Results:HPAHpatientshadsignificantlyhigherBMP7concentrationsthanIPAHandcontrols(20.DongLiu,MD,Bing-XiangWu,MD,NaSun,MD,YiYan,MD,PingYuan,MD,JieMingQu,MD,Zhi-ChengJing,MD如果本研究發(fā)生的危險(xiǎn)因素，在其他研究中并不是危險(xiǎn)因素，則需通過(guò)與其他研究比較，找出可能的原因。如果數(shù)據(jù)中存在實(shí)驗(yàn)室數(shù)據(jù)，則需要給出具體的方法流程。Clinicalcharacteristicsatbaselineandlong-termsurvivalwerecomparedaccordingtothedifferentBMPslevels.1,BMPR2expressionisreportedtobegreatlyreducedinpatientswithheritablepulmonaryarterialhypertension針對(duì)研究結(jié)果的討論分析（與前人研究的比較，相關(guān)機(jī)理的探討。針對(duì)研究結(jié)果的討論分析（與前人研究的比較，相關(guān)機(jī)理的探討。隊(duì)列研究：隊(duì)列內(nèi)根據(jù)暴露情況分組；ElevatedplasmaBMP7wereassociatedwithahigherriskofmortalityafteradjustmentforsex,6-minutewalkdistance,meanrightatrialpressure,meanpulmonaryarterialpressure,pulmonaryvascularresistance,andcardiacoutput(HR=1.ElevatedplasmaBMP7wereassociatedwithahigherriskofmortalityafteradjustmentforsex,6-minutewalkdistance,meanrightatrialpressure,meanpulmonaryarterialpressure,pulmonaryvascularresistance,andcardiacoutput(HR=1.病例基本信息：據(jù)觀察類(lèi)研究報(bào)告規(guī)范，具體的人口統(tǒng)計(jì)資料應(yīng)該在在結(jié)果中展示。Results:HPAHpatientshadsignificantlyhigherBMP7concentrationsthanIPAHandcontrols(20.904,95%CI1.分組：根據(jù)暴露情況分組Methods:Atotalof156PAHpatientsincluding43HPAHand113IPAHdiagnosedbygenescreeningwereenrolledinthestudy.病例收集時(shí)間≠病例進(jìn)入記錄時(shí)間（前瞻性，回顧性）。AcceptedDate:2March2016病例收集時(shí)間=病例進(jìn)入記錄時(shí)間（前瞻性研究）；1,BMPR2expressionisreportedtobegreatlyreducedinpatientswithheritablepulmonaryarterialhypertension病例收集：病例來(lái)源，病例信息來(lái)源，病例收集時(shí)間，病例進(jìn)入記錄時(shí)間.IntroductionDongLiu,MD,Bing-XiangWu,MD,NaSun,MD,YiYan,MD,PingYuan,MD,JieMingQu,MD,Zhi-ChengJing,MD修改的例1：Breastfeedingreducestheriskofasthmain6yearoldchildren:findingsofaprospectivebirthcohortstudy.DongLiu,MD,Bing-XiangWu,MD,NaSun,MD,YiYan,MD,PingYuan,MD,JieMingQu,MD,Zhi-ChengJing,MD分組：根據(jù)暴露情況分組StatisticalAnalysis針對(duì)研究結(jié)果的討論分析（與前人研究的比較，相關(guān)機(jī)理的探討。6)pg/ml,respectively;P<0.Methods:Atotalof156PAHpatientsincluding43HPAHand113IPAHdiagnosedbygenescreeningwereenrolledinthestudy.隊(duì)列研究：隊(duì)列內(nèi)根據(jù)暴露情況分組；當(dāng)存在隨訪時(shí)，需在方法中說(shuō)明的內(nèi)容包括隨訪時(shí)間，隨訪方式，隨訪過(guò)程中需記錄的數(shù)據(jù)信息以及隨訪過(guò)程中對(duì)于并發(fā)癥以及其他病癥的處理方式等。病例收集：病例來(lái)源，病例信息來(lái)源，病例收集時(shí)間，病例進(jìn)入記錄時(shí)間.Methods:Atotalof156PAHpatientsincluding43HPAHand113IPAHdiagnosedbygenescreeningwereenrolledinthestudy.比較患某病者與未患某病的對(duì)照者在發(fā)病前暴露于某可能危險(xiǎn)因素的百分比差異，分析這些因素是否與該病存在聯(lián)系。DongLiu,MD,Bing-XiangWu,MD,NaSun,MD,YiYan,MD,PingYuan,MD,JieMingQu,MD,Zhi-ChengJing,MD病例基本信息：據(jù)觀察類(lèi)研究報(bào)告規(guī)范，具體的人口統(tǒng)計(jì)資料應(yīng)該在在結(jié)果中展示。ReceivedDate:28September2015Results:HPAHpatientshadsignificantlyhigherBMP7concentrationsthanIPAHandcontrols(20.Methods:Atotalof156PAHpatientsincluding43HPAHand113IPAHdiagnosedbygenescreeningwereenrolledinthestudy.分組：根據(jù)暴露情況分組RevisedDate:18February2016DongLiu,MD,Bing-XiangWu,MD,NaSun,MD,YiYan,MD,PingYuan,MD,JieMingQu,MD,Zhi-ChengJing,MD病例收集時(shí)間≠病例進(jìn)入記錄時(shí)間（前瞻性，回顧性）。隨訪觀察：隨訪時(shí)間，隨訪方式，隨訪過(guò)程中需記錄的數(shù)據(jù)信息以及隨訪過(guò)程中并發(fā)癥或其他病癥的處理方式。2,BMP2,4and7havebe