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Prof. Giorgio Walter Canonica Allergy and Respiratory Diseases Department University of Genoa Modena LIBRA, March 1st,2011 Past President 1°vice President Unmet Needs in ASTHMA and COPD

COPD

Calverley, B.J.P. 2008

Decramer et al. Resp.Med.2011

CONCLUSIONS

Morales Asenco et al. BMC 2010

Patient Reported Outcomes PROs Patient Reported Outcomes

Disease control measures Patient reported outcomes Therapy Disease phenotype Real-life observational studies PreferenceAwarenessSatisfactionBehaviourCopingAdherenceStress Anxiety/ depression Quality of life AlexithymiaMood Aetiology Severity Comorbidities Drugs Schedule Symptoms Score Composite Score Function Biology Clinical parameters Resource utilisation

Braido et al. CMRO 2011

ASTHMA

GUIDELINES

Asthma guidelines

Asthma Control in Real Life

Worldwide epidemiological evaluation of asthma control level 1. Rabe et al. Eur Respir J 2000; 16: Lai et al. Eur Respir J 2003; 111: AIRLA Asthma Insights and Reality in Latin America AIRLA Asthma Insights and Reality in Latin America 7 European countries 2803 patients with asthma patients with asthma 2 8 Asian-Pacific countries 3206 patients with asthma 3 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 patients 51.3% LABA + ICS 16 PTZ high-dose L + I Total controlWell controlledUncontrolled Braido et al. Allergy 2009; 64: 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:

0-20%20-40%40-80%80-100% 22 In which percentage of patients do patient’s or asthma characteristics impose a non-compulsive treatment? Responders: 756 GPs; 214 specialists GPsSpecGPsSpecGPsSpecGPsSpec 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%) p= 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= 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:

LACK of: Consciousness Familiarity Agreement Auto- effectiveness Success expectation Motivation and consolidation External barriers doctors Why do doctors not follow guidelines? Baiardini et al. Curr Opin Allergy Clin Immunol 2009; 9:

patients Why do patients not follow guidelines? Baiardini et al. Curr Opin Allergy Clin Immunol 2009; 9:

Adherence to treatment is a weak point in asthma management

2003 World Health Organisation 2003 World Health Organisation

Cutler and Everett. NEJM 2010; 362:

COPD

Breekveldt-Postma et al. Pharmacoepidemiol Drug Saf 2008; 17: Proportion of persistent ICS users by formulation in adults Time since start of therapy (days) Proportion of persistent ICS users by formulation in children and adolescents Time since start of therapy (days) FixedSingle AdultsChildren and adolescents Overall persistence with single and 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:

Patients and physicians disagree on content of education provided and received Contact 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 Canonica et al. Allergy 2007; 62:

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 (%) Canonica et al. Allergy 2007; 62:

Time with doctor in primary care Malaysia5-10 mins Pakistan<3 mins UK8 mins Australia15 mins South Africa 8-11 mins Italy 8 mins E Bateman

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 Inflammation Comorbidity IgE Atopy Histamine Bronchoconstriction FEV1 Asthma Sleep Eating Physical functioning Social life Sport Work Performance Mental functioning School Performance Patient

A general process in guidelines evolution Evidence- based medicine

Factors that influence the strength of a recommendation Balance between desirable and undesirable effects Quality of evidence Patients’ values and preferencesPatients’ values and preferences 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 Patrick et al. Value Health 2007; 10 (Suppl 2): S125-S137 FDA, Food and Drug Administration

Braido et al. Allergy 2010: DOI: /j x.

Baiardini et al. J.ASTHMA 2011

Physician’s and patient’s viewpoint PhysicianPatient Limits Emotions Knowledge Satisfaction Fear Sleep School Relationships Diagnosis Drugs Follow-up Guidelines Severity Comorbidity Costs Clinical parameters Functional 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 learning courses in-between of 5 residential events with 4 short distance learning 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.

Braido F* et al. submitted

Single Drug Prescriptions Braido F* et al. submitted

Results the distance- learning part.Fourteen GPs (46.7%) completed the training course and 6 (20%) completed the distance- 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). Braido F* et al. submitted

Final Take Home Message GUIDELINES ARE INTERVENTIONALLY EFFECTIVE WHENEVER PROPERLY IMPLEMENTED

Thank you Fulvio BRAIDO Ilaria BAIARDINI