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INTEGRITA’ DELLA RICERCA:INTEGRITA’ DELLA RICERCA:programmazione, esecuzione e programmazione, esecuzione e
utilizzo dei datiutilizzo dei datiG.W. Canonica G.W. Canonica && F. Braido F. Braido
Roma 11 febbraio 2006Roma 11 febbraio 2006
Clinica Pneumologica e AllergologiaClinica Pneumologica e AllergologiaDIMI-Dip. Medicina InternaDIMI-Dip. Medicina InternaUNIVERSITA’ di GENOVAUNIVERSITA’ di GENOVA
SegretarioSegretarioFISMFISM
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““simply common sense at itssimply common sense at its best; that is, best; that is, rigidly accurate in observation and rigidly accurate in observation and
merciless to a fallacy in logic.”merciless to a fallacy in logic.”
Thomas Henry HuxleyThe Crayfish: An Introduction to the Study of Zoology 1880
science science is
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Biomedical research guidelinesBiomedical research guidelines
Biomedical research: research involving human subjects including research on identifiable human material or identifiable data.
Medical research is only justified ifMedical research is only justified if there is a reasonable likelihood thatthere is a reasonable likelihood that the populations in which thethe populations in which the research research is carried out stand tois carried out stand to benefit from benefit from the results of thethe results of the research.research.
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PROGRAMMAZIONEPROGRAMMAZIONEdelladella
RICERCARICERCA
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0
5
10
15
20
1955 1965 1975 1985 1995
AustraliaCanadaHong-KongIsraelJapanNew ZealandNew ZealandPapua New GuineaSingaporeTahitiTaiwanUnited StatesUnited StatesVietnam
%
Trends of Asthma Prevalence in EuropeTrends of Asthma Prevalence in Europe
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Linneberg A. British Medical Journal,British Medical Journal,
August 2005August 2005
Changes in atopy over 25 years
Allergic Epidemic has spread to Old Age
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Lenfant C.Lenfant C.N.E.J.M. N.E.J.M. August 2004August 2004
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19991999 20202020
DALY = Disability-adjusted life year
1. Acute lower respiratory infections2. HIV/AIDS3. Perinatal conditions4. Diarrhoeal diseases5. Unipolar major depression6. Ischaemic heart disease7. Cerebrovascular disease8. Malaria9. Road traffic injuries10. COPD11. Congenital abnormalities12. Tuberculosis13. Falls 14. Measles15. Anaemias
1. Ischaemic heart disease2. Unipolar major depression3. Road traffic injuries4. Cerebrovascular disease5. COPD5. COPD6. Lower respiratory infections7. Tuberculosis7. Tuberculosis8. War9. Diarrhoeal diseases10. HIV11. Perinatal conditions12. Violence 13. Congenital abnormalities14. Self-inflicted injuries15. Trachea, bronchus and lung cancers15. Trachea, bronchus and lung cancers
Source: WHOEvidence, Information and Policy, 2000
Increasing burden of noncommunicable diseases and injuriesIncreasing burden of noncommunicable diseases and injurieschange in rank order of DALYs for the 15 leading causeschange in rank order of DALYs for the 15 leading causes
(baseline scenario)(baseline scenario)
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ischemic heart disease 1cerebrovascular disease 2 lower respiratory infection 3diarrheal diseases 4conditions arising during the 5perinatal periodchronic obstructive pulmonary 6diseasestubercolosis 7measles 8road traffic accidents 9trachea, bronchus and lung cancer 10malaria 11self induced injuries 12cirrosis of the liver 13stomach cancer 14diabetes mellitus 15violence 16war 20liver cancer 21HIV 30
1241116
3
727652910128191415139
1990 2020
Changes in ranking for Changes in ranking for most important most important
causes of deathcauses of death from 1990 to 2020from 1990 to 2020
C.J.L. Murray, A.D. Lopez The LANCET 1997
gw28
799
1990 20201990 2020
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the opposite trend the opposite trend of communicableof communicable
and non-communicableand non-communicablediseases in transition economiesdiseases in transition economies
Source: WHO, Evidence, Information and Policy, 2000Source: WHO, Evidence, Information and Policy, 2000
WHOWHO
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% %
communicable
non-communicablenon-communicableXXth XXIth
Respiratory diseases in MIC & Transition Countries
tbc, pneumoina, etc.
asthma, COPD, lung cancer
changes in:demographics, HCSsschooling, income, tobacco
Respiratory diseases in MIC & Transition CountriesRespiratory diseases in MIC & Transition Countries
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ISAAC
most Low-Middlemost Low-Middleincome countriesincome countries
most High-income most High-income countriescountries
ASTHMA
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Several changes in the lifestyle have resulted in the reduction of microbial burden during childhood, thus
provoking a missing immune deviation from Th2 to Th1
Romagnani: Curr. Opin. Immunol., 6, 838, 1994
Hygiene hypothes
is
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Th1Th1-mediated nephropathies are increasing in poor countries (-mediated nephropathies are increasing in poor countries (poor poor hygienehygiene),),
whereas whereas Th2Th2-mediated nephropaties are increasing in rich -mediated nephropaties are increasing in rich countries countries
((high hygienehigh hygiene))
Johnson et al. Am J Kidney Dis 42, 575, 2003
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L’analisi delle evidenze L’analisi delle evidenze scientifichescientifiche
deve costituire la base dei deve costituire la base dei successivisuccessivi
indirizzi di ricercaindirizzi di ricerca
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PROGRAMMAZIONEPROGRAMMAZIONE&&
ESECUZIONEESECUZIONE
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Subjects physical/mental condition must be necessaryto research. Protocols have to be approved by IEC. Informed consents have to be obtained from subject or legal representative.Sources of funding, institutional affiliations, conflicts of interest specified
Negative and positive results shouldNegative and positive results should be publishedbe published
Biomedical research guidelinesBiomedical research guidelines
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Evidence-Based Health CareEvidence-Based Health CareJ.A. Muir Gray 2001J.A. Muir Gray 2001
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VALUTAZIONE VALUTAZIONE dei dei
DATIDATI
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A filter of A filter of medical medical knowledge knowledge and scientific and scientific data based on data based on predifined predifined rules.rules.
Why EBM is a practical and correct tool? Why EBM is a practical and correct tool?
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Evidence-Based Health CareEvidence-Based Health CareJ. A. Muir Gray 2001J. A. Muir Gray 2001
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Bousquet J. et alBousquet J. et al.,.,Allergy 2004 Allergy 2004
A critical appraisal of A critical appraisal of ““evidence-based medicine”evidence-based medicine”in allergy and asthmain allergy and asthma
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Bousquet J. et al.,Allergy 2004 Bousquet J. et al.,Allergy 2004
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Bousquet J. et al.,Allergy 2004 Bousquet J. et al.,Allergy 2004
META-ANALYSESMETA-ANALYSES
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Bousquet J. et al.,Allergy 2004 Bousquet J. et al.,Allergy 2004
USA criteria of evidenceUSA criteria of evidence
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Bousquet J. et al.,Allergy 2004 Bousquet J. et al.,Allergy 2004
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Bousquet J. et al.,Allergy 2004 Bousquet J. et al.,Allergy 2004
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EBM,EBM,Do we have better criteria??Do we have better criteria??
Presently, NO!!!!!Presently, NO!!!!!
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STANDARDS FOR PRACTICALSTANDARDS FOR PRACTICAL
ALLERGEN-SPECIFIC ALLERGEN-SPECIFIC IMMUNOTHERAPYIMMUNOTHERAPY
E Alvarez-Cuesta (chairman),E Alvarez-Cuesta (chairman), J Bousquet, G W Canonica, J Bousquet, G W Canonica,S Durham, H-J Malling, E ValovirtaS Durham, H-J Malling, E Valovirta
EAACIEAACI
Immunotherapy Task Force Immunotherapy Task Force 20052005
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SIT Efficacy by E.B.M.SIT Efficacy by E.B.M.
SCIT SCIT : Ia for Asthma: Ia for Asthma Ib for RhinitisIb for Rhinitis
SLITSLIT: Ia for Rhinitis: Ia for Rhinitis Ib for Asthma Ib for Asthma
EAACI Immunotherapy Task Force 2005EAACI Immunotherapy Task Force 2005
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NIH-NIAID Meeting NIH-NIAID Meeting Bethesda, November 14,2005Bethesda, November 14,2005
-Immune Tolerance Network-Immune Tolerance Network((Sublingual administration of 4 allergens to 18-30 months old kidsSublingual administration of 4 allergens to 18-30 months old kids))
-Consortium for Food Allergy Research-Consortium for Food Allergy Research(Mucosal Immunotherapy for peanut allergy)(Mucosal Immunotherapy for peanut allergy)
-Inner City Asthma Consortium-Inner City Asthma Consortium(SLIT for Asthma)(SLIT for Asthma)
Charles Hackett,Charles Hackett,Deputy Director, Div.Allergy, Immunol &TransplantationDeputy Director, Div.Allergy, Immunol &TransplantationNIAID,NIHNIAID,NIH
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IntegratesIntegrates pathophysiologic rationale, care-giver pathophysiologic rationale, care-giver experience,experience, patient preferences with valid and patient preferences with valid and current clinicalcurrent clinical research evidence.research evidence.Must be able to critically review the research andMust be able to critically review the research andknow if it applies to your patient-care problem.know if it applies to your patient-care problem.
“…“…the conscientious, explicit, and the conscientious, explicit, and
judicious use of current best evidence judicious use of current best evidence in making decisions about care of the in making decisions about care of the
individual patients”.individual patients”.
Evidence-Evidence-based Medicine (EBM)based Medicine (EBM)
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Areas where EBM has helped to clarified some issues:
COPD Therapy Asthma Therapy ARDS Management Airway Management Weaning Upper Respiratory Infections Community Acquired Pneumonia Lung Cancer
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Pulmonary research in the first quarter of Pulmonary research in the first quarter of the 21st centurythe 21st century will focus on will focus on thesethese major major
areasareas
Crystal RG Crystal RG JAMA.JAMA. 2001 2001
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INTEGRITA’INTEGRITA’delladella
RICERCA RICERCA
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““fudge factor”fudge factor”Fattore di falsificazioneFattore di falsificazione
Sapendo, sulla base di speculazioni Sapendo, sulla base di speculazioni puramente teoriche, quali devono essere i puramente teoriche, quali devono essere i risultati cambiare il valore dei parametri risultati cambiare il valore dei parametri valutati finché non si ottengono i risultati valutati finché non si ottengono i risultati desiderati.desiderati.
Metodo utilizzato da Newton per calcolare la velocità del suonoMetodo utilizzato da Newton per calcolare la velocità del suono
Federico Di Trocchio: Le bugie della scienza Mondadori 1993
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Human basophil degranulation triggered by very dilute antiserum against IgE
E. Davenas, F. Beauvais, J. Amara, M. Oberbaum, B. Robinzon, A. Miadonnai, A. Tedeschi, B. Pomeranz, P. Fortner, P. Belon, J. Sainte-Laudy, B. Poitevin, J. Benveniste Nature 1988Nature 1988
Anti-IgE Ab obtained injecting human IgE in animalsDiluted anti IgE by a factor of 10 until no trace of antibodies was detected
Added white cells derived from human bloodObtained basophil degranulation!
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High-dilution experiments a delusion
Maddox J Randi J Stewart WW Nature 1988Nature 1988
““Repeating Dr Repeating Dr BenvenisteBenveniste experiments we were experiments we were surprised that do not always work”surprised that do not always work”
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Review international literatureReview international literature
Collect/ produce dataCollect/ produce data
Analyse dataAnalyse data
Control Control repeatabilityrepeatability and and reproducibilityreproducibility of methods of methods
DrawDraw conclusions conclusions
What to do for a scientific research:What to do for a scientific research:
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Impact FactorsImpact Factors
The The journal impact factorjournal impact factor is a measure of the is a measure of the frequency with which the "frequency with which the "average articleaverage article" in " in a journal has been cited in a particular year. a journal has been cited in a particular year.
The The impact factorimpact factor will help you evaluate a will help you evaluate a journal’s relative importance, especially journal’s relative importance, especially when you compare it to others in the same when you compare it to others in the same field. field.
WARNING:WARNING: a higher I.F. means a higher I.F. means a higher commercial value of the journala higher commercial value of the journal
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RESEARCH FOUNDINGRESEARCH FOUNDING
PUBLIC PUBLIC RESOURCESRESOURCES
PRIVATE PRIVATE RESOURCESRESOURCES
FoundationsFoundationsAssociationsAssociations
etc.etc.
CompaniesCompaniesIndustriesIndustries
etc.etc.
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INTEGRITA’INTEGRITA’delladella
RICERCA RICERCA
……e utilizzo dei dati….e utilizzo dei dati….
11
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Subjects physical/mental condition must be necessaryto research. Protocols have to be approved by IEC. Informed consents have to be obtained from subject or legal representative.
Sources of funding, institutional affiliations, conflicts of interest specified
Negative and positive Negative and positive results results
shouldshould be publishedbe published
Biomedical research guidelinesBiomedical research guidelines
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authors’ disclosure of interestsauthors’ disclosure of interests
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authors’ disclosure of interests authors’ disclosure of interests
Dr.G.W.CanonicaDr.G.W.Canonica reports having received reports having received honoraria for educational presentations, honoraria for educational presentations, and/or funding for research, and/or travel and/or funding for research, and/or travel expenses, and/or for service in advisory expenses, and/or for service in advisory boards from:boards from:
A.Menarini, Alk Abello, Almirall, Altana, Astra A.Menarini, Alk Abello, Almirall, Altana, Astra Zeneca, Boeringher Ingelheim, Chiesi Zeneca, Boeringher Ingelheim, Chiesi Farmaceutici, Gentili, GSK, Lofarma, MSD, Farmaceutici, Gentili, GSK, Lofarma, MSD, Novartis, Pfizer, Schering Plough, Novartis, Pfizer, Schering Plough, Stallergenes, UCB Pharma, Uriach. Stallergenes, UCB Pharma, Uriach.
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302 millions302 millions 971 millions971 millions
1998 2003 USDUSD
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N.E.J.M. 2005N.E.J.M. 2005
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ROME, April 25 - 26 , 2004ROME, April 25 - 26 , 2004
Milan - March Milan - March 20032003 Rome - OctoberRome - October 20032003 Rome - April Rome - April 20042004 Rome - April 2005Rome - April 2005
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G. Walter Canonica, Chairman, European Academy of Allergology & Clinical Immunology Accreditation Council, Secretary General, World Allergy Organization, Secretary, Italian Federation of Scientific Medical Societies, Genoa Italy
Murray Kopelow, Chief Executive, Accreditation Council for Continuing Medical Education,Chicago, IL USA
Kate Lancey, Royal College of Physicians, London, UK
Bernard Maillet, Secretary General, European Union of Medical Specialists, Brussels, Belgium
Herve Maisonneuve, French National Agency for Accreditation and Evaluation in the Health Sector, Paris, France
Alfonso Negri, Secretary General, Italian Council for Accreditation in Pneumology, Milan, Italy
Helios Pardell, Director, Spanish Accreditation Council for Continuing Medical Education Barcelona, Spain
Teodor Popov, European Academy of Allergology and Clinical Immunology, Sofia Bulgaria
Barbara Schneidman, Vice President for Education, American Medical Association, Chicago, IL USA
Pasquale Spinelli, Vice President, Italian Federation of Scientific Medical Societies Milan, Italy
Riccardo Vigneri, Chairman, Long Distance Learning Sub-Committee, Italian Continuing Medical Education Commission of the Ministry, Catania, Italy
Maria Grazia Cali, President, Serono Symposia International Foundation Rome, Italy
Participants
USA-EUROPE: SHARING THE EDUCATIONAL USA-EUROPE: SHARING THE EDUCATIONAL EFFORTEFFORT
INTERNATIONAL RECIPROCITY OF CME CREDITSINTERNATIONAL RECIPROCITY OF CME CREDITS
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B.M.J. B.M.J. MayMay 2004 2004
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ResponsibilitiesResponsibilities of the learner learner to be fulfilled in order to claim credit,
Learners have responsibility for, 1.1. Participating in CME/CPD that is based on Participating in CME/CPD that is based on their their individual educational needs.individual educational needs.2.2. Ensuring that the needs are relevant to their Ensuring that the needs are relevant to their professional practice.professional practice.3.3. Evaluating the extent to which their needs Evaluating the extent to which their needs have been met, in the context of a change in have been met, in the context of a change in knowledge, competence or performance. knowledge, competence or performance.
4. Verifying that mechanisms are in place to keep 4. Verifying that mechanisms are in place to keep educational activities free of commercial bias.educational activities free of commercial bias.
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INTEGRITA’INTEGRITA’delladella
RICERCA RICERCA
……e utilizzo dei dati….e utilizzo dei dati….
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Systematic Reviews to support EBMSystematic Reviews to support EBMKhalid S Khan et AlKhalid S Khan et AlRoyal Society of Medicine Press 2003Royal Society of Medicine Press 2003
CONCLUSIONICONCLUSIONIsenza integritàsenza integrità
della ricercadella ricerca
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