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L’INERZIA CLINICA Clinica Medica 3 Unità di Malattie Metaboliche e Rischio cardiovascolare Centro per lo Studio e la Terapia Integrata dell’Obesità Laboratorio Endocrino metabolico Dipartimento di Scienze Mediche e Chirurgiche Università di Padova Roberto Vettor

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Page 1: L’INERZIA CLINICA · ACCORD Study Group, NEJM 2008, 358:2545-2559. ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572. VADT Study Results ADA Scientific Session San Francisco,

L’INERZIA CLINICA

Clinica Medica 3Unità di Malattie Metaboliche e Rischio cardiovascolareCentro per lo Studio e la Terapia Integrata dell’Obesità

Laboratorio Endocrino metabolicoDipartimento di Scienze Mediche e Chirurgiche

Università di Padova

Roberto Vettor

Page 2: L’INERZIA CLINICA · ACCORD Study Group, NEJM 2008, 358:2545-2559. ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572. VADT Study Results ADA Scientific Session San Francisco,
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Phillips et al. (2001): “failure of health care providers to initiate or intensify therapy when indicated” and “recognition of the problem, but failure to act.”

Okonofua et al. (2006) : “failure of providers to begin new medications or increase dosages of existing medications when an abnormal clinical parameter is recorded.”

Clinical Inertia or Therapeutic Inertia

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Clinical inertia

Clinical inertia is more than failure to act, and it has been shown that other factors such as clinician communication affect adherence.

a meta-analysis of 127 studies showed that the odds of adherence for patients whose physicians had been trained in communication skills were 1.62 times those of patients whose physicians did not receive communication training.(Zolnierek and DiMatteo (2009)

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Factors contributing to apparent clinical inertia

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COMPETING DEMANDS OR CLINICAL INERTIA?

Is the failure to aggressively advance care along evidence-based guidelines (termed clinical inertia) a failure of medical practice?

Is balancing multiple problems, including those

not guided by evidence-based guidelines (termed competing demands or competing opportunities), a fundamental feature of the added value of primary care?

Kurt C. Stange

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Diabetes care in the hospital: Is there clinical inertia?

Journal of Hospital Medicine Volume 1, Issue 3, pages 151-160, 2 JUN 2006

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Diabetes care in the hospital: Is there clinical inertia?

Journal of Hospital Medicine Volume 1, Issue 3, pages 151-160, 2 JUN 2006

Page 9: L’INERZIA CLINICA · ACCORD Study Group, NEJM 2008, 358:2545-2559. ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572. VADT Study Results ADA Scientific Session San Francisco,

Diabetes care in the hospital: Is there clinical inertia?

Journal of Hospital Medicine Volume 1, Issue 3, pages 151-160, 2 JUN 2006

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Our review reveals that delay in diagnosis of diabetes cannot be attributed to patient nonadherence as a result of missing appointments or blood tests. To the contrary, there were multiple opportunities when a diagnosis could have been but was not made, suggesting provider factors (clinical inertia) as the cause of delay.

DELAY IN DIAGNOSIS OF DIABETES IS NOT THE PATIENT'S FAULT

Fraser LA., et al. DIABETES CARE, VOLUME 33, NUMBER 1, JANUARY 2010

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Michael L. Parchman Annals of Family Medicine 5:196-201 (2007)

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Competing Demands or Clinical Inertia: The Case of Elevated Glycosylated Hemoglobin

Percentage of patients with a change in medication, by encounter length and presence of patient concerns.

Michael L. Parchman Annals of Family Medicine 5:196-201 (2007)

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Audit Nazionale AMD su Inerzia Terapeutica

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Clinical Inertia as a Clinical Safeguard Why physicians—who may have

knowledge of and may be familiar with standard-of-care guidelines—seem to be subject to clinical inertia is still an open question. However, there may be an alternative interpretation for the phenomenon: clinical inertia may be a clinical safeguard for the drug-intensive style of medicine fueled by the current medical literature.Giuliano D & Catherine Esposito JAMA. 2011;305(15):1591-1592

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ACCORD, ADVANCE, and VADT TrialsResearch Question

ACCORD Study Group, NEJM 2008, 358:2545-2559.ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572.VADT Study Results ADA Scientific Session San Francisco, 2008 In Press, Diabetes Obesity and Metabolism, 2008

Does Intensive Glucose Control Reduce Risk for Cardiovascular Disease in Type 2 Diabetes?

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ACCORD, ADVANCE and VADT Study Design

ACCORD ADVANCE VADT

Major Endpoints CV death,Non-fatal MI/Stroke

CV death,Non-fatal MI/Stroke,

macrovacs event

CV death,Non-fatal

MI/Stroke, CHF macrovacs event

Study RCT RCT RCT

design Glucose Intensive vs

Standard Arm2x2

BP control+/-fenofibrate v

placebo

Glucose Intensive vs

Standard Arm2x2

Perindopril +indamide v placebo

GlucoseIntensive vs

Standard Arm2x1

All received BP and Lipid Rx

ACCORD Study Group, NEJM 2008, 358:2545-2559.ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572.VADT Study Results ADA Scientific Session San Francisco, 2008 In Press, Diabetes Obesity and Metabolism, 2008

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ACCORD, ADVANCE, and VADT Lessons Learned

• Intensive glucose control does not reduce CVD mortality in T2DM, and may increase risk, especially in patients with pre-existing CHD

• Aggressive A1c targets (<6.5%) were associated with a 3-fold increased risk hypoglycemia

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Clinical Inertia and Uncertainty in Medicine

Although clinical inertia may reflect uncertainty regarding the precise goals of treatment and disagreement with clinical guidelines, data show that other factors are more common. Lack of familiarity with guidelines, lack of confidence in ability or preparation, and external barriers such as time limitations better explain why physicians do not follow practice guidelines

………While inaction may sometimes be the best option, more often physicians should act but do not. Ignoring the best available evidence is rarely the best approach.

Arun V. Mohan & Lawrence S. Phillips JAMA, 306 (4) 383, 2011

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THE EPIDEMIOLOGICAL J CURVE

All

caus

es

Cancers

18.5 25 30 35 40 BMI

adu

lt m

ort

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y (r

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CHD

Type

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iab

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1

3

2

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27 Impact of Weight Loss on Risk Factors

~5%Weight Loss

5%-10%Weight Loss

HbA1c

Blood Pressure

Total Cholesterol

HDL Cholesterol

Triglycerides

1. Wing RR et al. Arch Intern Med. 1987.2. Mertens IL, Van Gaal LF. Obes Res. 2000.3. Blackburn G. Obes Res. 1995.4. Ditschunheit HH et al. Eur J Clin Nutr. 2002.

1

2

3

3

1

2

3

3

4

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28

Action for Health in Diabetes (Look AHEAD):Action for Health in Diabetes (Look AHEAD):effetti della riduzione del peso in soggetti sovrappeso con DM2effetti della riduzione del peso in soggetti sovrappeso con DM2

-35

-30

-25

-20

-15

-10

-5

0

5

-21.5 mg/dl

-0.64%

-6.8 mmHg

-3 mmHg

-30.3 mg/dl

+3.4 mg/dl

* After 8.6% weight reduction by lifestyle mofications

Look AHEAD Research Group. Diabetes Care 2007;30:13741383.

FPG HbA1C SBP DBP TG

HDL-C

(%)

VA

RIA

TIO

N

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La terapia dell’obesità:

un caso di inerzia clinica e

terapeutica assoluta?

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Obesity and Type 2 Diabetes: What Can Be Unified and What Needs to Be Individualized?

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Comorbidities reduced after bariatric surgery and weight loss.

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-45

-40

-35

-30

-25

-20

-15

-10

-5

0

5

0 1 2 3 4 5 6 7 8 9 10

Years of Follow-up

Wei

gh

t C

ha

ng

e (%

)

controls

Banding

VBG

GBP

Lifestyle, Diabetes, and Cardiovascular Risk Factors 10 Years after Bariatric Surgery

Sjostrom et al. NEJM 2004;351:2683

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Sjostrom et al. NEJM 2004;351:2683

Lifestyle, Diabetes, and Cardiovascular Risk Factors 10 Years after Bariatric Surgery

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Sjostrom et al. NEJM 2007;357:741

Effects of bariatric surgery on mortality in Swedish Obese Subjects.

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Sjostrom et al. Lancet Oncol 2009;10:653

Effects of bariatric surgery on cancer incidence in obese patients in Sweden (SOS Study).

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Long term mortality after gastric bypass surgery.

Adams et al. NEJM 2007;357:753

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Dixon et al. JAMA 2008;299:316

Adjustable gastric banding and conventional therapy for type 2 diabetes: a Adjustable gastric banding and conventional therapy for type 2 diabetes: a

randomized controlled trial.randomized controlled trial.

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Dixon et al. JAMA 2008;299:316

Adjustable gastric banding and conventional therapy for type 2 diabetes: a Adjustable gastric banding and conventional therapy for type 2 diabetes: a

randomized controlled trial.randomized controlled trial.

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SleeveGastrectomy

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44

Rev Esp Cardiol. 2010;63(12):1428-37

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COME PUO’ AGIRE IL MEDICO

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In the present, however, data are messy and it is up to physicians to interpret and implement data in a way that benefits patients the most.

While inaction may sometimes be the best option, more often physicians should act but do not.

Ignoring the best available evidence is rarely the best approach.

Arun V. Mohan, MD, MBALawrence S. Phillips, MD

JAMA, July 27, 2011—Vol 306, No. 4 383