Prof. Giorgio Walter Canonica Allergy and Respiratory Diseases Department University of Genoa

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personale.

Prof. Giorgio Walter CanonicaAllergy and Respiratory Diseases Department

University of Genoa

Modena LIBRA, March 1st,2011

Past President 1°vice President

Unmet Needs in Unmet Needs in ASTHMA and COPDASTHMA and COPD

COPDCOPD

Calverley, B.J.P. 2008

Decramer et al. Resp.Med.2011

Decramer et al. Resp.Med.2011

CONCLUSIONS

Morales Asenco et al. BMC 2010Morales Asenco et al. BMC 2010

PROsPatient Reported OutcomesPatient Reported Outcomes

Diseasecontrol

measures

Patientreported

outcomesTherapyDisease

phenotype

Real-life observational studies

Preference Preference

AwarenessAwareness

SatisfactionSatisfaction

BehaviourBehaviour

CopingCoping

AdherenceAdherence

StressStress

Anxiety/Anxiety/depressiondepression

Quality of lifeQuality of life

AlexithymiaAlexithymia

MoodMood

Aetiology

Severity

Comorbidities

Drugs

Schedule

Symptoms Score

Composite Score

Function

Biology

Clinical parameters

Resource utilisation

Braido et al. CMRO 2011

ASTHMAASTHMA

GUIDELINES

Asthma guidelines

Asthma Control in

Real Life

Worldwide epidemiological evaluation of asthma control level

1. Rabe et al. Eur Respir J 2000; 16: 802-8072. www.asthmainamerica.com

3. Lai et al. Eur Respir J 2003; 111: 263-268

AIRLAAsthma Insights and Reality

in Latin America

AIRLAAsthma Insights and Reality

in Latin America

7 European countries 2803 patients with asthma1

2509 patients with asthma2

8 Asian-Pacific countries 3206 patients with asthma3

11 Latin American countries 2184 patients with asthma

Achieving control in asthmatic patients: still a critical issue?

Levels of asthma control in the total sample (right), and in the subgroup of patients treated with high-dose ICS + LABA (left)

122 patients51.3% LABA + ICS

16 PTZ high-dose L + I

122 patients51.3% LABA + ICS

16 PTZ high-dose L + I

56.25 25.00

18.75

44.30

47.50

8.20

Total control Well controlled Uncontrolled

Braido et al. Allergy 2009; 64: 937-943

the total sample patients treated with high-dose ICS + LABA

Patients’ opinions on their asthma

Asthma

96 patients

Do you think your disease is under control?

Do you think you relied on qualified professionals?

How do you cope with your disease?

Have drugs improved your disease?

Are you following doctors’ prescriptions?

Do you think your disease will improve?

Do you feel helped by your family?

Do you feel helped by all the medical staff?

Not at all

–

–

3.1%

–

1.0%

19.8%

8.3%

–

A little

12.5%

7.3%

16.7%

14.6%

5.2%

33.3%

7.3%

10.4%

Fairly

58.3%

53.1%

51.0%

53.1%

50.0%

26.0%

36.5%

66.7%

A lot

22.9%

32.3%

24.0%

26.0%

39.6%

9.4%

33.3%

21.9%

Not indicated

6.3%

7.3%

5.2%

6.3%

4.2%

11.5%

14.6%

1.0%

Baiardini et al. J Investig Allergol Clin Immunol 2006; 16: 218-223

0-20% 20-40% 40-80% 80-100%2

In which percentage of patients do patient’s or asthma characteristics impose a non-compulsive treatment?Responders: 756 GPs; 214 specialists

GPs Spec GPs Spec GPs Spec GPs Spec

484

(64.02%)

137

(64.02%)

211

(27.91%)

64

(29.91%)

46

(6.08%)

10

(4.67%)

15

(1.98%)

3

(1.40%)

1.12

p=0.77

In which percentage is a model of self-management of the pathology realisable?Responders: 670 GPs; 204 specialists

436

(65.07%)

121

(59.31%)

181

(27.02%)

75

(36.77%)

31

(4.63%)

8

(3.92%)

22

(3.28%)

0

(0%)

12.76

p=0.0052

In which percentage are the results of clinical trials confirmed in real life?Responders: 727 GPs; 205 specialists

179

(24.62%)

43

(20.98%)

311

(42.78%)

92

(44.88%)

158

(21.73%)

53

(25.85%)

79

(10.87%)

17

(8.29%)

3.28

p=0.35

In which percentage are guideline indications applicable in real life?Responders: 720 GPs; 207 specialists

107

(14.86%)

27

(13.04%)

287

(39.86%)

62

(29.95%)

178

(24.72%)

65

(31.40%)

148

(20.56%)

53

(25.60%)

9.19

p=0.0269

Braido et al. J Investig Allergol Clin Immunol 2010; 20: 9-12

Real-life asthma management

Baiardini et al. Curr Opin Allergy Clin Immunol 2009; 9: 228-233

LACK of:

•Consciousness

•Familiarity

•Agreement

•Auto- effectiveness

•Success expectation

•Motivation and consolidation

External barriers

Why do doctorsdoctors not follow guidelines?


Why do patientspatients not follow guidelines?


Adherence to treatmentAdherence to treatmentis a weak pointis a weak point

in asthma managementin asthma management

World Health Organisation20032003

World Health Organisation

Cutler and Everett. NEJM 2010; 362: 1553-1555

COPDCOPD

Breekveldt-Postma et al. Pharmacoepidemiol Drug Saf 2008; 17: 411-422

1.0

0.8

0.6

0.4

0.2

0.0

Prop

ortio

n of

per

sist

ent I

CS u

sers

by

form

ulati

on in

adu

lts

400350300250200150100500

Time since start of therapy (days)

1.0

0.8

0.6

0.4

0.2

0.0

Prop

ortio

n of

per

sist

ent I

CS u

sers

by

form

ulati

on in

chi

ldre

n an

d ad

oles

cent

s

400350300250200150100500

Time since start of therapy (days)

Fixed Single

Adults Children and adolescents

Overall persistence with single andOverall persistence with single and fixed ICS treatment in new users with asthma fixed ICS treatment in new users with asthma

Unmet needs in asthma: Global Asthma Physician and Patient (GAPP Survey):

global adult findings

Canonica et al. Allergy 2007; 62: 668-674

Patients and physicians disagree on content of education provided and received

11

22

42

53

69

30

44

73

78

95

0 20 40 60 80 100

Physicians

PatientsContact patient support organisation

Keep daily symptom/medication diaries

Monitor peak expiratory flow

Develop individual management plan

Correct inhaler technique

Respondents (%)

Does your doctor or other healthcare professional in his or her office discuss any of the following with you? Base: all respondents (patients)Do you regularly discuss the following with your asthma patients? Base: all respondents (physicians)

Patients perceive that only 25% of office visit time is devoted to asthma education

Patients perceive that only 25% of office visit time is devoted to asthma education


Treatment compliance increases with increased patient education

<51%

15%

51-80%

27%

81-99%

29%

100%

30%

Patient treatment compliance

Amount of time spent on patient education

Increase in compliance (%)


Time with doctor in primary careMalaysia 5-10 minsPakistan <3 minsUK 8 minsAustralia 15 minsSouth Africa 8-11 minsItaly 8 mins

E BatemanE Bateman

This should be avoided!!!This should be avoided!!!

Horne et al. BMC Pulm Med 2007; 7: 8

Can asthma control be improved by understanding the patient’s perspective?

Patient

Asthma: physician’s and patient’s viewpoint – two different perspectives

Physician

Asthma

InflammationComorbidityIgEAtopyHistamineBronchoconstrictionFEV1

Asthma

SleepEatingPhysical functioningSocial lifeSportWork PerformanceMental functioningSchool Performance

Patient

A general process in guidelines evolution

Evidence-based

medicine

Evidence-based

medicine

Factors that influence the strength of a recommendation

• Balance between desirable and undesirable effects

• Quality of evidence

• Patients’ values and Patients’ values and preferencespreferences

• Costs

PROs to support medical product labelling claims:FDA perspective

PROs provide a unique perspective on medical therapy, because some effects of a health condition and its therapy are known

only to patients

PROs provide a unique perspective on medical therapy, because some effects of a health condition and its therapy are known

only to patients

Patrick et al. Value Health 2007; 10 (Suppl 2): S125-S137FDA, Food and Drug Administration

Braido et al. Allergy 2010: DOI: 10.1111/j.1398-9995.2010.02383.x.

Baiardini et al. J.ASTHMA 2011

Physician’s and patient’s viewpoint

Physician Patient

Limits Emotions

KnowledgeSatisfaction

FearSleep

SchoolRelationships

DiagnosisDrugsFollow-upGuidelinesSeverityComorbidityCostsClinical parametersFunctional parameters

Education

Consideration

Disease management

Characterisation of chronic diseases• Persistance, more years of disability and handicap,

shorter life expectancy and can totally or partly be abrogated by a continuous action by healthcare professionals

World Health Organisation

Physical functioning

Life expectancy

Chronic disease management

Disease Management is crucial

PROs should be priority outcomes of treatments

Adherence to treatment is our ultimate goal

Take home messages

Knowledge and health care resources allocation in asthma management: impact of one-year guidelines based CME/CPD course

Braido F*, Comaschi M°, Valle I§, Delgado L+, Coccini A§,

Guerrera P°°, Stagi E**, Canonica GW* on behalf of ARGA Study Group and EAACI/CME Committee f.

Braido F* et al. submitted


• Material and methods

• Study design

• The educational program was made up

of 5 residential events with 4 short distance of 5 residential events with 4 short distance learning courses in-betweenlearning courses in-between.

• The scientific contents of the courses were based on the economical analysis of Anatomical Therapeutic Chemical Classification System (ATC) Respiratory (R) drugs prescription and healthcare resource usage data related to the previous three-months, blindly obtained from the database of Local Health Unit ASL No 3 of Genoa.

Single Drug Prescriptions


Results • Fourteen GPs (46.7%) completed the training

course and 6 (20%) completed the distance-the distance-learning part.learning part.

• Knowledge improved Knowledge improved significantly after training (p <0.001, correct answers to key questions +13%).

• Training resulted in pharmaceutical cost containment (trained GPs +0.5% vs controls +18.8%) and greater attention to diagnosis and monitoring (increase in spirometry +63.4% , p 0.01).


Final Take Home Message

GUIDELINES ARE INTERVENTIONALLY EFFECTIVEWHENEVER PROPERLY IMPLEMENTED

Thank you

[email protected]

Fulvio BRAIDO Ilaria BAIARDINI

Prof. Giorgio Walter Canonica Allergy and Respiratory Diseases Department University of Genoa

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