回顾性临床研究课件.pptx

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1、回顾性病例对照研究回顾性病例对照研究回顾性回顾性研究研究:从过去某时点开始的前瞻性研究的随访,但实际做的是在现在调查过去的既成事实,这时暴露与疾病或死亡均已成事实,而前瞻性研究的随访则是查寻在过程中新出现的样本结果。是一种由“果”至“因”的研究方法。病例对照研究病例对照研究(case-control studycase-control study),按照疾病状况将研究对象分为病例和对照。比较患某病者与未患某病的对照者在发病前暴露于某可能危险因素的百分比差异,分析这些因素是否与该病存在联系。研究目的(1)广泛探索疾病或健康状态等事件发生的可疑危险因素。(2)疾病预后因素的研究。(3)临床疗效影响

2、因素分析。标题标题研究内容,研究结果,研究创新点,研究类型。研究内容,研究结果,研究创新点,研究类型。研究内容+研究类型例 1:Association between breast feeding and asthma in 6 year old children:findings of a prospective birth cohort study研究结果+研究类型修改的例1:Breast feeding reduces the risk of asthma in 6 year old children:findings of a prospective birth cohort stud

3、y.前言前言研究背景:疾病疾病,危险因素。危险因素。为什么研究此内容也就是做此研究的理由:前人研究的现状,不足,本研究的必要性。研究内容和意义方法方法研究设计:病例收集,分组,以及随访观察;病例的介绍:病例基本信息,纳入和排除标准,诊断方式以及干预方式;数据收集:随访或调查期间需要收集的资料数据有哪些,如何收集,如何测量;统计分析研究设计研究设计病例收集:病例收集:病例来源,病例信息来源,病例收集时间,病例进入记录时间.病例收集时间=病例进入记录时间(前瞻性研究);病例收集时间病例进入记录时间(前瞻性,回顾性)。分组分组:根据暴露情况分组队列研究:队列内根据暴露情况分组;一般病例对照研究:根据

4、患病未患病同时纳入两个队列;病例对照研究衍生类型和横断面研究:以上均可。随访观察随访观察:随访时间,随访方式,随访过程中需记录的数据信息以及随访过程中并发症或其他病症的处理方式。病例介绍病例介绍病例基本信息:据观察类研究报告规范,具体的人口统计资料应该在在结果中展示。而样本量,性别,年龄等基础信息可以在方法中提及。病例纳入和排除标准:对于病例对照研究,也包括对照组的纳入和排除标准,病例和对照的匹配方式。诊断方式和干预方式:病例的诊断方式,病例在研究过程中所经过的干预治疗(预后分析和生存分析)。随访与数据收集随访与数据收集并不是所有的研究都有随访,然而所有的研究都有数据收集。当存在随访时,需在方

5、法中说明的内容包括随访时间,随访方式,随访过程中需记录的数据信息以及随访过程中对于并发症以及其他病症的处理方式等。对于数据收集,则需要描述的是数据收集方法,数据检测方法。如果数据中存在实验室数据,则需要给出具体的方法流程。904,95%CI 1.Dong Liu,MD,Bing-Xiang Wu,MD,Na Sun,MD,Yi Yan,MD,Ping Yuan,MD,JieMing Qu,MD,Zhi-Cheng Jing,MDConclusions:Levels of circulating BMP7 correlate with mortality in PAH,and may be a

6、predictor of disease in HPAH and IPAH patients.Results:HPAH patients had significantly higher BMP7 concentrations than IPAH and controls(20.Clinical characteristics at baseline and long-term survival were compared according to the different BMPs levels.Shanghai Pulmonary hospital,Tongji Univericity

7、School of MedicineConclusions:Levels of circulating BMP7 correlate with mortality in PAH,and may be a predictor of disease in HPAH and IPAH patients.042,log rank test).研究背景:疾病,危险因素。当存在随访时,需在方法中说明的内容包括随访时间,随访方式,随访过程中需记录的数据信息以及随访过程中对于并发症以及其他病症的处理方式等。1,BMPR2 expression is reported to be greatly reduced

8、 in patients with heritable pulmonary arterial hypertension病例收集:病例来源,病例信息来源,病例收集时间,病例进入记录时间.Introduction病例基本信息:据观察类研究报告规范,具体的人口统计资料应该在在结果中展示。904,95%CI 1.Elevated levels of circulating BMP7 predict mortality in pulmonary arterial hypertension6)pg/ml,respectively;P 0.Methods:A total of 156 PAH patient

9、s including 43 HPAH and 113 IPAH diagnosed by gene screening were enrolled in the study.(b)选择经过统计分析发现与随访或临床结果有显著关联的因素做多因素回归分析,通常选择单因素回归分析分组:根据暴露情况分组结果总结结果总结Cox回归分析与logistic回归分析的过程是类似的。首先要选出潜在的独立危险因素,可以通过以下两种方式进行筛选:(a)选择感兴趣的混杂因素直接进行多因素;(b)选择经过统计分析发现与随访或临床结果有显著关联的因素做多因素回归分析,通常选择单因素回归分析另外还可以通过做单因素生存率比较

10、找到与生存率有显著关联的因素做多因素cox回归分析,用来筛选与生存率相关的独立预后因子。也可以通过简单的差异显著性分析(卡方检验,t检验和单因素方差分析)找到与临床结果有显著关联的因素,然后通过logistic多因素回归分析得出独立因素。讨论讨论研究结果的总结概括。针对研究结果的讨论分析(与前人研究的比较,相关机理的探讨。本研究的优势与局限性的分析。结论。讨论点讨论点发病率的讨论,与其他研究相比,发病率是否有交大差异,如果差异较大,分析原因。如果无差异,则说明此疾病的发病情况不收两地区差异的限制。分析危险因素与疾病发生相关的潜在机制。如果本研究发生的危险因素,在其他研究中并不是危险因素,则需通

11、过与其他研究比较,找出可能的原因。文献学习文献学习Elevated levels of circulating BMP7 predict mortality in pulmonary arterial hypertensionShanghai Pulmonary hospital,Tongji Univericity School of MedicineDong Liu,MD,Bing-Xiang Wu,MD,Na Sun,MD,Yi Yan,MD,Ping Yuan,MD,JieMing Qu,MD,Zhi-Cheng Jing,MDCHESTReceived Date:28 Septemb

12、er 2015Revised Date:18 February 2016Accepted Date:2 March 2016Background:This study aimed to show whether circulating BMPs levels are associated with increased risk of mortality in PAH patients.Methods:A total of 156 PAH patients including 43 HPAH and 113 IPAH diagnosed by gene screening were enroll

13、ed in the study.Circulating BMPs were measured by ELISA in plasma samples from HPAH(n=43),IPAH(n=113)and controls(n=51).Clinical characteristics at baseline and long-term survival were compared according to the different BMPs levels.Results:HPAH patients had significantly higher BMP7 concentrations

14、than IPAH and controls(20.1(9.4,55.2)vs.6.5(3.5,11.7)and 2.5(0.9,6.6)pg/ml,respectively;P 0.001).Elevated plasma BMP7 were associated with a higher risk of mortality after adjustment for sex,6-minute walk distance,mean right atrial pressure,mean pulmonary arterial pressure,pulmonary vascular resista

15、nce,and cardiac output(HR=1.904,95%CI 1.021-3.551;P=0.043).IPAH patients with a BMP7 level more than 7.85 pg/ml had a higher risk of mortality than those with a low BMP7 concentration(P=0.042,log rank test).Conclusions:Levels of circulating BMP7 correlate with mortality in PAH,and may be a predictor

16、 of disease in HPAH and IPAH patients.研究背景研究背景1,BMPR2 expression is reported to be greatly reduced in patients with heritable pulmonary arterial hypertension2,BMP2,4 and 7 have been shown to be the most important ligands for BMPR2 signaling in Pulmonary vesselsIntroductionMethodsStudy Design and Pat

17、ient Population纳入排除标准伦理问题:知情同意书,伦理协会批文随访Hemodynamic Measurements and 6-Minute Walk Distance(6MWD)TestMeasurement of Plasma BMPs ConcentrationsStatistical Analysis临床疗效影响因素分析。如果数据中存在实验室数据,则需要给出具体的方法流程。随访观察:随访时间,随访方式,随访过程中需记录的数据信息以及随访过程中并发症或其他病症的处理方式。Results:HPAH patients had significantly higher BMP7

18、concentrations than IPAH and controls(20.Background:This study aimed to show whether circulating BMPs levels are associated with increased risk of mortality in PAH patients.Measurement of Plasma BMPs Concentrations1,BMPR2 expression is reported to be greatly reduced in patients with heritable pulmon

19、ary arterial hypertensionRevised Date:18 February 20161,BMPR2 expression is reported to be greatly reduced in patients with heritable pulmonary arterial hypertensionCirculating BMPs were measured by ELISA in plasma samples from HPAH(n=43),IPAH(n=113)and controls(n=51).Results:HPAH patients had signi

20、ficantly higher BMP7 concentrations than IPAH and controls(20.分组:根据暴露情况分组Accepted Date:2 March 2016而样本量,性别,年龄等基础信息可以在方法中提及。分组:根据暴露情况分组分析危险因素与疾病发生相关的潜在机制。Received Date:28 September 2015(b)选择经过统计分析发现与随访或临床结果有显著关联的因素做多因素回归分析,通常选择单因素回归分析2,BMP2,4 and 7 have been shown to be the most important ligands for

21、 BMPR2 signaling in Pulmonary vessels如果本研究发生的危险因素,在其他研究中并不是危险因素,则需通过与其他研究比较,找出可能的原因。Results:HPAH patients had significantly higher BMP7 concentrations than IPAH and controls(20.文献学习文献学习Elevated levels of circulating BMP7 predict mortality in pulmonary arterial hypertensionShanghai Pulmonary hospital

22、,Tongji Univericity School of MedicineDong Liu,MD,Bing-Xiang Wu,MD,Na Sun,MD,Yi Yan,MD,Ping Yuan,MD,JieMing Qu,MD,Zhi-Cheng Jing,MDCHESTReceived Date:28 September 2015Revised Date:18 February 2016Accepted Date:2 March 2016Background:This study aimed to show whether circulating BMPs levels are associ

23、ated with increased risk of mortality in PAH patients.Methods:A total of 156 PAH patients including 43 HPAH and 113 IPAH diagnosed by gene screening were enrolled in the study.Circulating BMPs were measured by ELISA in plasma samples from HPAH(n=43),IPAH(n=113)and controls(n=51).Clinical characteris

24、tics at baseline and long-term survival were compared according to the different BMPs levels.Results:HPAH patients had significantly higher BMP7 concentrations than IPAH and controls(20.1(9.4,55.2)vs.6.5(3.5,11.7)and 2.5(0.9,6.6)pg/ml,respectively;P 0.001).Elevated plasma BMP7 were associated with a

25、 higher risk of mortality after adjustment for sex,6-minute walk distance,mean right atrial pressure,mean pulmonary arterial pressure,pulmonary vascular resistance,and cardiac output(HR=1.904,95%CI 1.021-3.551;P=0.043).IPAH patients with a BMP7 level more than 7.85 pg/ml had a higher risk of mortali

26、ty than those with a low BMP7 concentration(P=0.042,log rank test).Conclusions:Levels of circulating BMP7 correlate with mortality in PAH,and may be a predictor of disease in HPAH and IPAH patients.1,BMPR2 expression is reported to be greatly reduced in patients with heritable pulmonary arterial hyp

27、ertension2,BMP2,4 and 7 have been shown to be the most important ligands for BMPR2 signaling in Pulmonary vesselsIntroduction针对研究结果的讨论分析(与前人研究的比较,相关机理的探讨。1,BMPR2 expression is reported to be greatly reduced in patients with heritable pulmonary arterial hypertensionMethods:A total of 156 PAH patients

28、 including 43 HPAH and 113 IPAH diagnosed by gene screening were enrolled in the study.修改的例1:Breast feeding reduces the risk of asthma in 6 year old children:findings of a prospective birth cohort study.Methods:A total of 156 PAH patients including 43 HPAH and 113 IPAH diagnosed by gene screening we

29、re enrolled in the study.6)pg/ml,respectively;P 0.病例收集:病例来源,病例信息来源,病例收集时间,病例进入记录时间.如果无差异,则说明此疾病的发病情况不收两地区差异的限制。Dong Liu,MD,Bing-Xiang Wu,MD,Na Sun,MD,Yi Yan,MD,Ping Yuan,MD,JieMing Qu,MD,Zhi-Cheng Jing,MD当存在随访时,需在方法中说明的内容包括随访时间,随访方式,随访过程中需记录的数据信息以及随访过程中对于并发症以及其他病症的处理方式等。Results:HPAH patients had sig

30、nificantly higher BMP7 concentrations than IPAH and controls(20.病例收集时间=病例进入记录时间(前瞻性研究);Conclusions:Levels of circulating BMP7 correlate with mortality in PAH,and may be a predictor of disease in HPAH and IPAH patients.而样本量,性别,年龄等基础信息可以在方法中提及。2,BMP2,4 and 7 have been shown to be the most important li

31、gands for BMPR2 signaling in Pulmonary vesselsRevised Date:18 February 2016904,95%CI 1.分组:根据暴露情况分组Results:HPAH patients had significantly higher BMP7 concentrations than IPAH and controls(20.Dong Liu,MD,Bing-Xiang Wu,MD,Na Sun,MD,Yi Yan,MD,Ping Yuan,MD,JieMing Qu,MD,Zhi-Cheng Jing,MD如果本研究发生的危险因素,在其他

32、研究中并不是危险因素,则需通过与其他研究比较,找出可能的原因。如果数据中存在实验室数据,则需要给出具体的方法流程。Clinical characteristics at baseline and long-term survival were compared according to the different BMPs levels.1,BMPR2 expression is reported to be greatly reduced in patients with heritable pulmonary arterial hypertension针对研究结果的讨论分析(与前人研究的比

33、较,相关机理的探讨。针对研究结果的讨论分析(与前人研究的比较,相关机理的探讨。队列研究:队列内根据暴露情况分组;Elevated plasma BMP7 were associated with a higher risk of mortality after adjustment for sex,6-minute walk distance,mean right atrial pressure,mean pulmonary arterial pressure,pulmonary vascular resistance,and cardiac output(HR=1.Elevated plas

34、ma BMP7 were associated with a higher risk of mortality after adjustment for sex,6-minute walk distance,mean right atrial pressure,mean pulmonary arterial pressure,pulmonary vascular resistance,and cardiac output(HR=1.病例基本信息:据观察类研究报告规范,具体的人口统计资料应该在在结果中展示。Results:HPAH patients had significantly highe

35、r BMP7 concentrations than IPAH and controls(20.904,95%CI 1.分组:根据暴露情况分组Methods:A total of 156 PAH patients including 43 HPAH and 113 IPAH diagnosed by gene screening were enrolled in the study.病例收集时间病例进入记录时间(前瞻性,回顾性)。Accepted Date:2 March 2016病例收集时间=病例进入记录时间(前瞻性研究);1,BMPR2 expression is reported to

36、be greatly reduced in patients with heritable pulmonary arterial hypertension病例收集:病例来源,病例信息来源,病例收集时间,病例进入记录时间.IntroductionDong Liu,MD,Bing-Xiang Wu,MD,Na Sun,MD,Yi Yan,MD,Ping Yuan,MD,JieMing Qu,MD,Zhi-Cheng Jing,MD修改的例1:Breast feeding reduces the risk of asthma in 6 year old children:findings of a

37、prospective birth cohort study.Dong Liu,MD,Bing-Xiang Wu,MD,Na Sun,MD,Yi Yan,MD,Ping Yuan,MD,JieMing Qu,MD,Zhi-Cheng Jing,MD分组:根据暴露情况分组Statistical Analysis针对研究结果的讨论分析(与前人研究的比较,相关机理的探讨。6)pg/ml,respectively;P 0.Methods:A total of 156 PAH patients including 43 HPAH and 113 IPAH diagnosed by gene screen

38、ing were enrolled in the study.队列研究:队列内根据暴露情况分组;当存在随访时,需在方法中说明的内容包括随访时间,随访方式,随访过程中需记录的数据信息以及随访过程中对于并发症以及其他病症的处理方式等。病例收集:病例来源,病例信息来源,病例收集时间,病例进入记录时间.Methods:A total of 156 PAH patients including 43 HPAH and 113 IPAH diagnosed by gene screening were enrolled in the study.比较患某病者与未患某病的对照者在发病前暴露于某可能危险因素的

39、百分比差异,分析这些因素是否与该病存在联系。Dong Liu,MD,Bing-Xiang Wu,MD,Na Sun,MD,Yi Yan,MD,Ping Yuan,MD,JieMing Qu,MD,Zhi-Cheng Jing,MD病例基本信息:据观察类研究报告规范,具体的人口统计资料应该在在结果中展示。Received Date:28 September 2015Results:HPAH patients had significantly higher BMP7 concentrations than IPAH and controls(20.Methods:A total of 156 P

40、AH patients including 43 HPAH and 113 IPAH diagnosed by gene screening were enrolled in the study.分组:根据暴露情况分组Revised Date:18 February 2016Dong Liu,MD,Bing-Xiang Wu,MD,Na Sun,MD,Yi Yan,MD,Ping Yuan,MD,JieMing Qu,MD,Zhi-Cheng Jing,MD病例收集时间病例进入记录时间(前瞻性,回顾性)。随访观察:随访时间,随访方式,随访过程中需记录的数据信息以及随访过程中并发症或其他病症的处

41、理方式。2,BMP2,4 and 7 have been shown to be the most important ligands for BMPR2 signaling in Pulmonary vesselsElevated levels of circulating BMP7 predict mortality in pulmonary arterial hypertension如果本研究发生的危险因素,在其他研究中并不是危险因素,则需通过与其他研究比较,找出可能的原因。Shanghai Pulmonary hospital,Tongji Univericity School of

42、Medicine042,log rank test).队列研究:队列内根据暴露情况分组;Methods:A total of 156 PAH patients including 43 HPAH and 113 IPAH diagnosed by gene screening were enrolled in the study.1,BMPR2 expression is reported to be greatly reduced in patients with heritable pulmonary arterial hypertensionDong Liu,MD,Bing-Xiang

43、Wu,MD,Na Sun,MD,Yi Yan,MD,Ping Yuan,MD,JieMing Qu,MD,Zhi-Cheng Jing,MD发病率的讨论,与其他研究相比,发病率是否有交大差异,如果差异较大,分析原因。Shanghai Pulmonary hospital,Tongji Univericity School of Medicine(b)选择经过统计分析发现与随访或临床结果有显著关联的因素做多因素回归分析,通常选择单因素回归分析551;P=0.2,BMP2,4 and 7 have been shown to be the most important ligands for BM

44、PR2 signaling in Pulmonary vessels首先要选出潜在的独立危险因素,可以通过以下两种方式进行筛选:(a)选择感兴趣的混杂因素直接进行多因素;病例基本信息:据观察类研究报告规范,具体的人口统计资料应该在在结果中展示。Methods:A total of 156 PAH patients including 43 HPAH and 113 IPAH diagnosed by gene screening were enrolled in the study.Dong Liu,MD,Bing-Xiang Wu,MD,Na Sun,MD,Yi Yan,MD,Ping Yuan,MD,JieMing Qu,MD,Zhi-Cheng Jing,MD发病率的讨论,与其他研究相比,发病率是否有交大差异,如果差异较大,分析原因。分组:根据暴露情况分组随访观察:随访时间,随访方式,随访过程中需记录的数据信息以及随访过程中并发症或其他病症的处理方式。042,log rank test).

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