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我国心血管病防治:挑战、成因和对策. 中国医学科学院 阜外心血管病医院 国家心血管病中心 医学研究统计中心 杨进刚. China P atient-centered E valuative A ssessment of C ardiac E vents. Trends in Characteristics, Treatment and. Outcomes Among Patients With AMI. in China from 2001 to 2011. China PEACE-Retrospective AMI Study.

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slide1
我国心血管病防治:挑战、成因和对策

中国医学科学院 阜外心血管病医院

国家心血管病中心 医学研究统计中心

杨进刚

slide3

ChinaPatient-centered Evaluative Assessment of Cardiac Events

TrendsinCharacteristics,Treatmentand

OutcomesAmongPatientsWithAMI

inChinafrom2001to2011

ChinaPEACE-RetrospectiveAMIStudy

onbehalfofChinaPEACEinvestigators

FuwaiHospital,NationalCenterforCardiovascularDiseases,China

slide4

ChinaPEACE-RetrospectiveAMIStudy

Three time points over a decade: 2001, 2006, 2011

A nationally representative sample of

hospitalizations for AMI using two-stage random

sampling.

Standardized central medical chart abstraction

(accuracy >98%)

Rigorous data quality monitoring at each stage

4

slide7

TrendsinTesting

2001

2006

2011

*

P<0.001

*

100

*

*

% 50

0

Troponin

Creatinine

Echocardiogram

slide8

TrendsinMedications

*

P<0.001

2001

2006

2011

100

*

*

*

P=0.13

P=0.24

%50

0

Aspirin*

Clopidogrel*

Statins

BB*

ACE-I/ARB

slide11

Summary:AMIinChina2001-2011

MarkedincreasesinrateofAMIhospitalization

Morefrequentuseofproceduresandtesting

Persistentgapsinqualityofcare

Nosignificantimprovementinmortality

EvidenceforFutureQualityImprovementStrategies

slide19

Hospital Distribution throughout mainland of China

  • Hospitals
  • 30 Provincial level
  • 44 Prefecture level
  • 31 County level

N=12999

NINGXIA

Provincial level

Prefecture level

County level

conclusion
Conclusion
  • Findings from the China Acute Myocardial Infarction Registry provide an overview of the treatment that patients actually receive and the outcome, providing the opportunity to assess daily practice in a large population of patients with AMI in China.
  • The variation in the management and outcome in patients with AMI by region and by type of hospitals reported in this study in China merit further investigation to reduce the observed disparities.
slide25

Cost-effectivenessofoptimaluseofAMI

treatmentsandimpactonCHDmortalityin

China

DongZhao

CapitalMedicalUniversityBeijingAnzhenHospital

BeijingInstituteofHeart,Lung&BloodVesselDiseases

slide27

StrategiesofreducingAMImortality

Primaryprevention

Acutetreatment

Secondaryprevention

5

slide29

KeytreatmentstrategiesofAMI

recommendedbytheguidelines

11

slide30

Questions&Hypotheses:

1.Whichoftheserecommendedtreatment

strategieswouldbecost-effectiveinChinaif

theutilitiesofeachorcombinationsofthem

wereoptimalto100%.

2.Iftheopitmaluseofrecommenedtreatment

haveremarkableimpactontotalCHDmortality

inChina?

17

slide31

Treatmentsstrategiesinacuteperiod

A1RisingtheuseofAspirin, β-blockers,statinsandACEIduring

Thefirst30daysafteronsetfromcurrentutilityrateto100%

A2Rising

theuseofclopidogrelinpatientswithAMIto100%

B

RisingtheuseofunfractinatedheparininpatientswithNSTEMIto100%

C1RisingtheuseofprimaryPCIintertiaryhospitalandthrombolysis

insecondaryhospitalinpatientswithSTEMI (withconsideration

oftheavailibilityofPCItechnology)to100%

C2RisingtheuseofprimaryPCIinallpatientswithSTEMIto100%

C3RisingtheuseofprimaryPCI

inhighriskpatientswithNSTEMIintertiary

hospitalto100%

20

slide32

Cost-effectivenessmeasurements

•Incrementalcost-effectivenessratioswereusedtoevaluate

thecost-effectivenessofoptimaluseofthekeytreatments.

ICERswerecalculatedbydividingtheincrementalchanges

intotalhealthcarecostsbytheincrementalchangesin

QALYs.

•WHO-CHOICEcriteriawereusedtoassessthedegreeof

cost-effectiveness.

•Highlycost-effective:ICERlessthantheGDPpercapita.

•Moderatelycost-effective:ICERswerebetween1to3times

ofGDPpercapita.

•Notcost-effective:ICERmorethan3timesofGDPper

21

capita.

slide33

Numberofdeathpreventedduring

Comparisonofoptionsofoptimaluseoftreatment

strategiesforeffects,costandcost-effectiveness

pPCI

inSTEMI

pPCI+

Thrombolysis

Four

medications

PCIin

NSTEMI

Clopidogrel

inAMI

Unfractionated

heparin

(C2)

inSTEMI(C1)

(A1)

(C3)

(A2)

(B)

0

-1900.00

-10000

acuteperiod

-3300.00

-3200.00

-9800.00

-20000

-30000

ICER

B

A1

C1

C2

A2

C3

-40000

-50000

-60000

1200

1000

800

600

-36300deaths

-53600deaths

$1099millions

$610millions

$2800

$3100

$9000

$10700

$17600

$23400

(Increasedacutetreatmentcostinmillions)

400

$152millions$112millons

200

$34millions

Four

medications

(A1)

$5millions

Unfractionated

heparin23

(B)

0

pPCI

inSTEMI

(C2)

pPCI+

Thrombolysis

inSTEMI(C1)

PCIin

NSTEMI

(C3)

Clopidogrel

inAMI

(A2)

slide34

Numberofdeathpreventedduring

Cost-effectivenessofcombinedstrategies

pPCI

inSTEMI

pPCI+

Thrombolysis

Four

medications

PCIin

NSTEMI

Clopidogrel

inAMI

Unfractionated

heparin

(C2)

inSTEMI(C1)

(A1)

(C3)

(A2)

(B)

0

-1900.00

-10000

acuteperiod

-3300.00

-3200.00

-9800.00

-20000

-30000

-40000

-50000

-60000

1200

-36300deaths

-53600deaths

A1+B

A1+B+A2

A1+B+C1

Highlycost-effective

Notcost-effective

Moderatecosteffective

(Increasedacutetreatmentcostinmillions)

$1099millions

A1+B+C1+C3Notcost-effective

1000

800

$610millions

600

400

$152millions

$112.millions

200

$34millons

$5millons

Unfractionated

heparin24

(B)

0

pPCI

inSTEMI

(C2)

pPCI+

Thrombolysis

inSTEMI(C1)

PCIin

NSTEMI

(C3)

Clopidogrel

inAMI

(A2)

Four

medications

(A1)

slide35

ImpactonCHDmortalitybyoptimaluseofthe

treatmentstrategies

pPCI

inSTEMI

pPCI+

Thrombolysis

Four

medications

PCIin

NSTEMI

Clopidogrel

inAMI

Unfractionated

heparin

Numberofdeathpreventedduring

(C2)

inSTEMI(C1)

(A1)

(C3)

(A2)

(B)

0

-1900.00

-10000

-3300.00

-3200.00

-9800.00

-20000

-30000

acuteperiod

-40000

-50000

-60000

0

-1

-36300deaths

-53600deaths

-0.3%

-0.4%

-0.4%

-1.3%

-2

(Percentageofreductionin

-3

-4

A1+B+C1+C3Maximuma10%

reductioninmortalityrateofCHD.

-5

-6

-7

-8

-5%

mortalityrate

-7.5%

pPCI

inSTEMI

(C2)

pPCI+

Thrombolysis

inSTEMI(C1)

PCIin

NSTEMI

(C3)

Clopidogrel

inAMI

(A2)

Four

medications

(A1)

Unfractionated

heparin25

(B)

slide36

Conclusions

oMosthospital-basedAMItreatmentstrategies recommendedbytheguidelineswouldbehighlyor moderatelycost-effectiveinChina;

o Full and simultaneous improvements of all standard hospital based AMI treatment strategies assessed in this study would only attributed to 9.6% reduction in the CHD mortality rate;

oGiventhetrendtowardhigherabsolutenumbersandrates ofCHDinChina,prehospitalemergencycare, public educationonsymptomsofAMIandavailabilityof treatmentsforAMIshouldbeimproved.

26

slide37

ExplainingthefallinCHDdeathsinUSA

1980-2000:RESULTS

NEJM2007;356:2388.

RiskFactorsworse+17%

Obesity(increase)

Diabetes(increase)

+7%

+10%

10000

RiskFactorsbetter-65%

PopulationBPfall-20%

Smoking-12%

Cholesterol(diet)-24%

Physicalactivity-5%

-10000

Treatments-47%

AMItreatments-10%

Secondaryprevention-11%

Heartfailure-9%

Angina:CABG&PTCA-5%

Hypertensiontherapies-7%

Statins(primaryprevention)-5%

Unexplained-9%

341,745

-30000

-50000

fewerdeaths

in2000

1980

2000

slide38

Explainingthefallincoronaryheartdisease

deathsinEngland&Wales1981-2000

RiskFactorsworse+13%

Obesity(increase)+3.5%

Diabetes(increase)+4.8%

Physicalactivity(less)+4.4%

RiskFactorsbetter-71%

Smoking-41%

Cholesterol-9%

PopulationBPfall-9%

Deprivation-3%

Otherfactors-8%

0

-20000

-40000

68,230

fewerdeaths

in2000

2000

Treatments-42%

AMItreatments-8%

Secondaryprevention-11%

Heartfailure-12%

Angina:CABG&PTCA-4%

Angina:Aspirinetc-5%

Hypertensiontherapies-3%

Unal,Critchley&Capewell

Circulation2004109(9)1101

-60000

-80000

1981

slide39

2007-2009年北京市男女两性

急性冠心病事件院前死亡构成比(%)

院前死亡构成比(%)

女性

男性

39

孙佳艺,等. 《中华心血管病杂志》,2012

slide40

2007-2009年合计北京市男女两性各年龄组

急性冠心病事件院前死亡构成比(%)

85+

75-84

65-74

55-64

45-54

35-44

25-34

男性

女性

40

孙佳艺,等. 《中华心血管病杂志》,2012

slide41

ClinicalPathwaysforAcuteCoronarySyndromesinChina

Dr.DuXin

TheGeorgeInstituteforGlobalHealth

BeijingAnzhenHospital,CapitalMedicalUniversity

slide42

CPACS:Aqualityofcareimprovement

initiativeinChina

•Along-termcollaborationbetweenTheGeorgeInstitute,

ChineseSocietyofCardiologyandMinistryofHealth

•ThestudywassponsoredbySanofi

•CPACSPhase1(2004-2006):Prospectiveregisterstudy

–51hospitalsacrossthecountry

–3000patients

•CPACSPhase2(2007-2011):clusterrandomisedtrialof

clinicalpathwayforevidence-basedmanagementofACS

–75hospitalsacrossthecountry

–>16,000patients

slide43

CPACS2:clusterrandomisedtrial

Implementandevaluateaqualityimprovement

initiativeforthecareofhospitalisedACS

patientsinChina

slide44

Participatingcentres

75participatingcenters

50level3hospitals

25level2hospitals

slide45

Intervention:performancemeasurementand

feedback

Clinicalpathwayimplementationwithcyclical

auditfeedbackandpathwaymodification

slide46

keyperformanceindicatorsusedin

CPACS-2

•%ofreperfusiontherapyforSTEMI

•Door-to-needletime

•Door-to-balloontime

•%diagnosesconsistentwithECGandbiomarkerfindings

•%ofhigh-riskpatientsundergoinginvasivetherapy

•%oflow-riskpatientsundergoingfunctionaltesting

•%onoptimummedicaltherapyondischarge

•Lengthofhospitalstay

slide47

Primaryandsecondaryoutcomes

•Primaryoutcome:8keyperformanceindicators

•Secondaryoutcome:inhospitalevents

•Death

•Cardiacdeath

•MajorAdverseCardiovascularEvents(MACE)comprisingall-

causemortality,MIandstroke

Majorbleedingepisodes

slide48

CPACS-2results

Assessedforeligibility:82hospitals

Excluded:7hospitals

Refusedtoparticipate(4)

Otherreason(3)

Eligible:75hospitals

Pilothospitals:5hospitals

Randomised:70hospitals

GroupA(earlyintervention):32hospitals

Losttofollow-up:0hospital

Analysis:32hospitals

50(range50-50)patientsperhospital

GroupB(lateintervention):38hospitals

Losttofollow-up:0hospital

Analysis:38hospitals

50(range50-50)patientsperhospital

slide49

Primaryoutcome:ContinuousKPIs

Meandifference

Control

Intervention

Favours

Favours

(n=1900)

(n=1600)

Control

Intervention

(95%CI)

p-value

Lengthofstayindays(ICC=0.107)

12.05(9.03)

11.31(7.43)

Un-adjusted

Adjusted

-0.74(-2.11,0.63)

-0.77(-2.15,0.62)

0.290

0.278

-3

0

3

Meandifference(day)

Control

Intervention

Favours

Favours

Meandifference

(n=1900)

(n=1600)

Control

Intervention

(95%CI)

p-value

DTNtimeforSTEMIpatientsundergoingthrombolysisinmin(ICC=0.191)

Un-adjusted

Adjusted

99.00(81.41)

79.06(66.15)

11.89(-21.3,45.06)

18.06(-13.4,49.54)

0.483

0.261

DTBtimeforSTEMIpatientsundergoingprimaryPCIinmin(ICC=0.114)

Un-adjusted

Adjusted

130.09(90.98)

141.09(103.69)

-10.6(-44.4,23.21)

-11.0(-45.2,23.22)

0.539

0.528

-25

025

Meandifference(min)

slide50

Primaryoutcome:BinaryKPIs

Control

(n=1900)

Intervention

(n=1600)

FavoursFavours

ControlIntervention

Riskratio

(95%CI)

p-value

Patientswithfinaldiagnosis(UAPorMI)consistentwithbiomarkerfinding(ICC=0.08)

Un-adjusted

Adjusted

1720/1855(92.7%)

1398/1568(89.2%)

0.96(0.91,1.01)

0.95(0.89,1.02)

0.118

0.163

Low-riskpatientsundergoingfunctionaltesting(ICC=0.058)

0.25(0.03,2.07)

9/141(6.4%)

1/90(1.1%)

0.197

Un-adjusted

Adjusted

High-riskpatientsundergoingcoronaryangiography(ICC=0.462)

Un-adjusted

Adjusted

689/1504(45.8%)

690/1350(51.1%)

1.14(0.82,1.58)

1.02(0.81,1.29)

0.444

0.849

Patientsdischargedonappropriatemedicaltherapy(ICC=0.112)

932/1822(51.2%)

976/1555(62.8%)

1.23(1.06,1.42)

1.21(1.06,1.37)

0.007

0.004

Un-adjusted

Adjusted

STEMIpatientsreceivingappropriatereperfusiontherapy(ICC=0.096)

1.24(0.98,1.55)

1.25(0.98,1.59)

10

229/720(31.8%)

Un-adjusted

Adjusted

290/679(42.7%)

0.069

0.070

1

Riskratio

0.1

slide51

Secondaryoutcomes:inhospitalevents

Control

(n=1900)

Intervention

(n=1600)

Favours

Control

Favours

Intervention

Riskratio

(95%CI)

p-value

Death(ICC=0.018)

Un-adjusted

Adjusted

0.066

0.128

78/19004.11%

41/15962.57%

1.60(0.97,2.64)

1.78(0.85,3.72)

Cardiacdeath(ICC=0.013)

Un-adjusted

Adjusted

1.44(0.85,2.45)

1.37(0.67,2.80)

0.178

0.390

60/19003.16%

35/15962.19%

Majoradversecardiovascularevents(ICC=0.087)

Un-adjusted

Adjusted

1.12(0.58,2.14)

1.59(0.86,2.96)

0.741

0.142

122/19006.42%

92/15965.76%

Majorbleedingepisodes(ICC=0.131)

Un-adjusted

Adjusted

19/15961.19%

1.87(0.84,4.19)

1.91(0.59,6.15)

0.125

0.277

42/18932.22%

0.20

1

5

Riskratio

Abbreviations:DNT,door-to-needle;DTB,door-to-balloon;PCI,Percutaneouscoronaryinterventions;STEMI,STsegementelevationmyocardial

infarction;ICC,inter-clustercoordination

slide54

Systembarrierstotheevidence-based

careof ACSpatients

•Lackofleadershipandsupportforimplementingquality

improvement

VariationinthecapacityofclinicalservicesandQIresources

Healthcarefundingconstraintsandhighout-of-pocket

expenses

Fearsofpatientdisputesandlitigation

Patient-relatedfactors

slide55

2004年和2008年城乡男女两性心血管病死亡率

粗死亡率 (1/100 000)

55

张啸飞,等. 《中华心血管病杂志》,2012

slide56

2004年和2008年我国人群缺血性心脏病死亡率

粗死亡率 (1/100 000)

标化率:2004:57.9/10万

2008:56.2/10万

56

张啸飞,等. 《中华心血管病杂志》,2012

slide57

中国城市农村人群高总胆固醇血症(TC ≥6.22mmol/L)的患病率

(97 409 名18岁以上人群,2010年)

年龄

总患病率 3.3%

李剑虹等 中华预防医学杂志 2012 46:414-418

slide58

中国各地区人群高LDL-C (LDL-C≥4.14 mmol/L)的患病率

(97 409 名18岁以上人群,2010年)

2.1%

李剑虹等 中华预防医学杂志 2012 46:414-418

slide59

中国城市农村人群低HDL-C(HDL-C < 1.04 mmol/L)的患病率

(97 409 名18岁以上人群,2010年)

总患病率 44.3%

李剑虹等 中华预防医学杂志 2012 46:414-418

slide60

中国各地区人群低HDL-C(HDL-C < 1.04 mmol/L)的患病率

(97 409 名18岁以上人群,2010年)

李剑虹等 中华预防医学杂志 2012 46:414-418

slide61

2007-2009年北京市男女两性不同年龄组

急性冠心病事件发病率(1/10万)

61

孙佳艺,等. 《中华心血管病杂志》,2012

slide62

2007-2009年北京市各区县25岁以上居民

急性冠心病事件年龄标化发病率

2007

2008

2009

62

孙佳艺,等. 《中华心血管病杂志》,2012

slide63

2007-2009年北京市不同地区

急性冠心病事件年龄标化发病率

标化发病率(1/10万)

2007年

2008年

2009年

63

孙佳艺,等. 《中华心血管病杂志》,2012

slide64
北京急性冠心病院前死亡占95.0%
  • 2007-2009年北京地区25-45岁急性冠心病事件共3489例(男3183例,女306例),年龄(40.5±4.3)岁
  • 总病死率3年合计为26.0%,女性明显高于男性(51.0%比23.6%,P<0.05)
  • 郊区和农村地区的总病死率高于城区(28.9%比22.9%,P<0.05)。
  • 25~45岁急性冠心病事件院前死亡在总死亡中的比例3年合计为95.0%(男95.2%,女94.2%)
  • 64.8%的院前死亡发生地点在家中。

在最近的3年里,深圳一共发生了4619例心源性猝死,平均每天4例;在这4619例病例中,只有143例(3.1%)被“活着”送往医院,最后只有3例(0.06%)出院。

slide67
冠心病患者的初次临床表现

Framingham Heart Study (n=5144)

首次事件为心梗或猝死的患者比例

男性

约60%

约45%

女性

0

20

40

60

患者比例 (%)

Murabito et al Circ 1993 88: 2548

framingham

____________________________________________________________

首次冠心病的表现: Framingham研究

________________________________________________________

表现(%)

心肌梗死心绞痛猝死

年龄男女 男女 男女

35-64 43% 28% 41% 59% 9% 4%

65-84 55% 44% 28% 41% 11% 7.4%

跟踪了44年

____________________________________________________________

slide70

内膜

脂核

纤维帽

管腔

中膜

–T lymphocyte

– Macrophagefoam cell (tissue factor+)

– “Activated” intimal SMC

(HLA-DR+)

–Normal medial SMC

斑块的解剖

Libby P. Lancet.1996;348:S4-S7.

slide71
引起心肌梗死的斑块所致的狭窄

68%

60

心梗

(%)

40

20

18%

14%

0

50%–70%

>70%

<50%

狭窄程度

Falk et al:Circulation1995;92:657–671

slide73

火山爆发

www.drsarma.in

slide74

血栓

纤维帽

脂肪核

slide75
小结1:中国心肌梗死诊疗面临的几个问题
  • 医院内心肌梗死患者在增加
  • 院前死亡率高
  • 患者从发病到达医院较晚,1/4在发病24小时后到达
  • 心血管病年轻化趋势明显
  • 再灌注治疗仍然不足,县医院有待提高
  • 提高医疗质量需要强有力的有效的干预措施
  • 我国血脂异常有新动向,农村心血管病发病率增加迅猛
daly 10
中国居民DALY中所占比例最高的10种危险因素

肿瘤

心血管病循环系统疾病

糖尿病和内分泌系统疾病

慢性呼吸道疾病

Rapid health transition in China, 1990–2010. Lancet 2013; 381: 1987

slide79

The Prospective Urban Rural Epidemiologic (PURE) study of 154,000 people from 628 communities in 17 countries

p rospective u rban r ural e pidemiologic pure study
Prospective Urban Rural Epidemiologic (PURE) Study

155,000 adults(400,000 people) from 17 countries (LIC, MIC, HIC)

Urban and Rural600 communities

Societal level influences (Socioeconomic, tobacco & other health policies, relative food prices and availability, built environment, indoor/outdoor pollution)

Lifestyle behaviours X genes

Individual risk factors

CVD, DM, Obesity, Cancers,Obstructive Airways Disease,Renaldis,Injuries,Depression.

slide81

Sweden - 31

Turkey - 44

Canada - 82

Poland - 4

China - 115

Iran - 20

UAE-3

B’desh - 56

India - 90

Colombia - 58

Pakistan - 4

Malaysia - 71

Brazil - 14

Chile - 5

Zimbabwe - 3

South Africa - 8

Argentina - 20

classification of countries
Classification of Countries

Based on World Bank classifications at the beginning of the study (2003 – 2007):

HIC: Canada, Sweden & UAE.

  • UMIC: Argentina,Brasil,Chile,Poland,Turkey, S Africa,Malaysia.
  • LMIC: Colombia,Iran,China .
  • LIC: India,Bangladesh,Pakistan,Zimbabwe.
age and gender standardized rates per 1000 pers years by economic levels
Age and gender standardized rates per 1000 pers-years by Economic Levels

†MI = MI/Sudden Unexpected Death/Non-sudden Unexpected Death/Other Heart Disease

‡CVD = MI/Stroke/heart failure

age and gender standardized rates per 1000 pers years by economic levels1
Age and gender standardized rates per 1000 pers-years by Economic Levels

Note: CVD = MI + Stroke + Heart Failure + other hospitalized CVD

Fatal CVD = Fatal MI + Fatal Stroke + Fatal Heart Failure + other fatal CVD

Severe CVD = Fatal CVD + MI + Stroke + Heart Failure

case fatality rates by economic levels
Case fatality rates by Economic Levels

Fatality rate = (N Fatal/N overall)*100.

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PURE: Contrasting associations between risk factor burden, CVD incidence and mortality in high, middle and low income countries 
1984 1999
1984到1999年北京冠心病死亡率变化
  • 胆固醇77%
    • 糖尿病  19%
    • BMI4%
    • 吸烟 1%
  • 治疗改善减少的死亡
    • AMI治疗 41%
    • 二级预防 20%
    • 心衰 10%
    • 心绞痛:CABG & PTCA 2%
    • 降压治疗24%

增加了1608例死亡

危险因素恶化

治疗改善减少了642例死亡

2000

1984

Circulation J Critchley, J Liu D Zhao 2004 110:1236-1244

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小结2
  • 疾病谱的转变
    • 从传染性疾病转向慢性非传染性疾病
    • 从严重致命性心血管病转向非致命性心血管病
    • 从心血管病转向肿瘤
  • 从社会角度看,单纯从生物医学技术角度看(危险因素的多少)并不能说明一个人的心血管危险情况。
  • 心血管病的干预有充分的循证医学证据
  • 两国心血管病流行面临双重压力:危险因素的流行和疾病治疗的薄弱
  • 全社会动员,而非仅依靠医生,才能做好心血管病的防治。
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Intermediate Outcome

Good Outcome

Bad Outcome

Outcomes from an RCT

Mean Treatment Effect

Traditional EBM Approach

  • Clinical trials and EBM provide answers for “average” patients
  • In real life, however, there are no average patients
slide106

From craft-based practice

  • individual physicians, working alone (house/staff = apprentices)
  • handcraft a customized solution for each patient
  • based on a core ethical commitment to the patient and
  • vast personal knowledge gained from training and experience
  • To profession-based practice
  • groups of peers, treating similar patients in a shared setting
  • plan coordinated care delivery processes (e.g., standing order sets)
  • which individual clinicians adapt to specific patient needs
  • early experience shows
    • less expensive (facility can staff, train, supply an organize to a single core process)
    • less complex (which means fewer mistakes and dropped handoffs, less conflict)
    • better patient outcomes
  • Challenges and opportunities in applying new research methodologies.

The health professions - and health care delivery –are changing ...

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美国心血管疾病临床注册
  • 美国胸科医师学会: 1000+ 医院
    • Coronary artery bypass surgery
    • Valve surgery
    • Congenital heart surgery
    • Thoracic surgery
  • 国家心血管疾病注册: 1600+ 医院
    • Cath/Percutaneous coronary intervention
    • Implantable cardiac defibrillators (ICD)
    • Acute coronary syndromes (ACS)
    • Carotid stenting
    • IC3: Ambulatory CV disease (launching)
  • AHA-依从指南项目: 1500+医院
    • Coronary artery disease (CAD)
    • Heart failure
    • Stroke
    • Outpatient: Ambulatory module (launching)
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这些临床注册…
  • 大规模并具有代表性
    • 患者,医生,病情
  • 包含详细的临床资料
    • 就诊资料,治疗,短期预后
  • 采用相似的标准化的数据定义
  • 高质量的
    • 准确、完整、接受质控
  • 正在演变为纵向研究!
    • 与其它数据来源衔接
slide110
贯穿治疗过程的心血管病注册

HF/Stroke AMI/Care

事件后:

心脏康复

二级预防

导致入院

的事件

一级预防

出院

住院

住院治疗

AHA H360

ACC IC3

GWTG Outpatient

TRANSLATE ACS

ORBIT-AF

ACTION GWTG HF, CVA

ACC-PCI, ICD PVD, Congenital

STS-CABG, Valve

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临床注册: 促进实践的改变!
  • 发现进步的“机会”
    • 追踪有效治疗的应用
    • 发现治疗的差异(e.g., disparities)
    • 追踪不恰当的治疗
  • 医生行为的评价
    • 标准治疗及预后
    • 支持质量控制 (与P4P或公开信息链接)
  • 易化医生主导的质量改进
    • 应用反馈工具来促进治疗时间的变化
slide112

住院死亡率与总的指南依从性的联系

Every 10%  in guidelines adherence 

10%  in mortality (OR=0.90, 95% CI: 0.84-0.97)

Peterson et al, JAMA 2006;295:1863-1912

at the end of the day
At the End of the Day…

注册研究能够

  • 有效地收集高质量的临床数据
  • 追踪患者的长期治疗
  • 作为科学发现的源泉
  • 促进新的证据转化为治疗常规
slide114
“Humanity’s greatest advances are not in its discoveries – but in how those discoveries are applied ...”

Bill Gates, June 7, 2007

Harvard Commencement Address

new paradigm of research

New Paradigm of Research

  • Learn from real-world results
  • Focus on system and teams
  • Involve patients and clinicians
  • Integrate learning and doing
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中国临床研究面临的问题是,医生普遍不善于提出临床研究问题,也没有掌握临床研究的科学设计方法。中国临床研究面临的问题是,医生普遍不善于提出临床研究问题,也没有掌握临床研究的科学设计方法。

  • 临床研究是诊疗工作密切结合、不可或缺,是改变临床实践的最根本的手段。
  • 中国的医学研究人员还是“兼职、作坊和游击队式的工作方式”。
slide117
中国的临床资源丰富,潜力巨大。中国能够出最好的研究主要在临床研究方面。中国的临床资源丰富,潜力巨大。中国能够出最好的研究主要在临床研究方面。