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Page 1: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,
Page 2: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

George A. Diamond, MD, FACCGeorge A. Diamond, MD, FACCSanjay Kaul, MD, FACCSanjay Kaul, MD, FACC

Division of CardiologyDivision of CardiologyCedars-Sinai Medical Center and Geffen School of Medicine at UCLACedars-Sinai Medical Center and Geffen School of Medicine at UCLA

Los Angeles, CaliforniaLos Angeles, California

Lost in Translation

From Clinical Trial Evidence to Practice

Guidelines

Page 3: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

The following presentation is rated

PGPG BLUNT LANGUAGENAKED TRUTH

LLLL

NNNN

PEDANTIC GIBBERISH

Page 4: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

JOSEPH R. Di PALMAJOSEPH R. Di PALMA

From Evidence to GuidelineLost in Translation

1967

Page 5: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

JOSEPH R. Di PALMAJOSEPH R. Di PALMA

From Evidence to GuidelineLost in Translation

1967

Page 6: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

1.1. Buy an ECG machine.Buy an ECG machine.

2.2. Use it as often as you can!Use it as often as you can!

Di Palma’s Laws

From Evidence to GuidelineLost in Translation

1967

Page 7: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

From Evidence to GuidelineLost in Translation

CARDIOLOGYCirca 1967

Page 8: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

From Evidence to GuidelineLost in Translation

CognitiveFirewall

Exoskeleton

StentDeploymentProsthesis

RadiationShield

NeuralTransceiver

HolographicImagingSystem

GuidelineSupports

StonePlatform

LoinGirds

CARDIOLOGYCirca 2009

Page 9: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

From Evidence to GuidelineLost in Translation

Bill

ions

of

Dol

lars

2500

2000

1500

1000

500

0 1967 2009

46 5

2220

475

Health care

CV care

29532

Page 10: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

Cardiovascular disease

Perinatal disease

Injuries

Cancer

COPD

HIV/AIDS

Other causes

Change in Life Expectancy(yrs)

N Engl J Med 2003;349:868N Engl J Med 2007;356:2388

-1 0 1 2 3 4 5

• 54% Risk factors• 40% Treatment

• 3.5% CABG• 1.5% PCI

• 6% Unexplained

From Evidence to GuidelineLost in Translation

Page 11: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

G. B. SHAW

“Having observed that you could provide for the supply of bread by giving bakers a pecuniary interest in baking, we go on to give a surgeon a pecuniary interest in cutting off your leg.”

The Doctor’s Dilemma, 1911

From Evidence to GuidelineLost in Translation

Page 12: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

“Right now, doctors, a lot of times, are forced to make decisions based on the fee payment schedule that's out there. So if…your child has a bad sore throat…the doctor may look at the reimbursement system and say to himself, ‘You know what? I make a lot more moneyif I take this kid's tonsils out.’”

BARACK OBAMA

From Evidence to GuidelineLost in Translation

July 22, 2009

Page 13: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

“Right now, if a physician helps a diabetic lose weight, modify diet, monitors their medications in a timely fashion, they might get reimbursed a pittance. But if that same diabetic ends up getting their foot amputated, that's $30,000, $40,000, $50,000 immediately the surgeon is reimbursed.”

BARACK OBAMA

From Evidence to GuidelineLost in Translation

August 12, 2009

Page 14: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

“Health insurance

companies and their

executives have reaped

windfall profits from a

broken system.”

From Evidence to GuidelineLost in Translation

BARACK OBAMAJuly 22, 2009

Page 15: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

-20

-10

0

10

20

Per

cent

Pro

fit

Forbes, 2009

From Evidence to GuidelineLost in Translation

BARACK OBAMA Industry Ranking

HEALTH INSURANCE

2.2%

Page 16: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

The Complete Lives System

Hastings Center Rep 1996;26:12

“[Healthcare] services that promote the continuation of the polity – those that ensure healthy future generations, practical reasoning skills, and full participation in public deliberations – are to be socially guaranteed as basic. Conversely, services to individuals who are irreversibly prevented from being or becoming participating citizens are not basic and should not be guaranteed.”

EZEKIEL J. EMANUEL

From Evidence to GuidelineLost in Translation

Page 17: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

0 10 20 30 40 50 60 70

Age

Prob

abilit

y of

Rec

eivin

g an

Inte

rven

tion

Lancet 2009;373:423

The Complete Lives System

From Evidence to GuidelineLost in Translation

EZEKIEL J. EMANUEL

Page 18: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

“Any health care funding plan that is just, equitable, civilized and humane must – must – redistribute wealth from the richer among us to the poorer and the less fortunate. Excellent health care is by definition re-distributional.”

DONALD BERWICK

From Evidence to GuidelineLost in Translation

July 1, 2008

Page 19: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

“I cannot say that I vehemently support or oppose any of the provisions in the proposed health care reform legislation. I am prepared to leave the details to others, and pray that they know what they are doing.”

J Am Coll Cardiol 2009;21:1991

TONY DeMARIA

From Evidence to GuidelineLost in Translation

Page 20: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

ACC/AHA “Useful and Effective”

FDAFDA “Safety and Efficacy”“Safety and Efficacy”

CMSCMS “Reasonable and Necessary”“Reasonable and Necessary”

PayersPayers “Usual and Customary”“Usual and Customary”

CourtsCourts “Prudent and Cautious”“Prudent and Cautious”

Regulatory Standards

From Evidence to GuidelineLost in Translation

Page 21: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

From Evidence to GuidelineLost in Translation

• Empirical evidence trumps expert opinion

• Clinical importance trumps statistical significance

• Individual outcomes trump population averages

• Professional principles trump regulatory standards

We hold these truths to be self-evident…

Page 22: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

From Evidence to GuidelineLost in Translation

1. Establish the scientific evidence• Assess quality and quantity

• Publish meta-analytic summaries

Page 23: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

From Evidence to GuidelineLost in Translation

1. Establish the scientific evidence

2. Elucidate the clinical context

• Weighted composite outcomes

• Minimum clinically important difference

Page 24: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

From Evidence to GuidelineLost in Translation

1. Establish the scientific evidence

2. Elucidate the clinical context

3. Encourage optimal processes of care

• Performance measures

• Reimbursement incentives

Page 25: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,

From Evidence to GuidelineLost in Translation

Guideline Management

Clinical Care

Page 26: George A. Diamond, MD, FACC Sanjay Kaul, MD, FACC Division of Cardiology Cedars-Sinai Medical Center and Geffen School of Medicine at UCLA Los Angeles,