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INTEGRITA DELLA RICERCA: programmazione, esecuzione e utilizzo dei dati G.W. Canonica & F. Braido Roma 11 febbraio 2006 Clinica Pneumologica e Allergologia.

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Presentation on theme: "INTEGRITA DELLA RICERCA: programmazione, esecuzione e utilizzo dei dati G.W. Canonica & F. Braido Roma 11 febbraio 2006 Clinica Pneumologica e Allergologia."— Presentation transcript:

1 INTEGRITA DELLA RICERCA: programmazione, esecuzione e utilizzo dei dati G.W. Canonica & F. Braido Roma 11 febbraio 2006 Clinica Pneumologica e Allergologia DIMI-Dip. Medicina Interna UNIVERSITA di GENOVA SegretarioFISM

2 simply common sense at its best; that is, rigidly accurate in observation and merciless to a fallacy in logic. Thomas Henry Huxley The Crayfish: An Introduction to the Study of Zoology 1880 science is

3 Biomedical research guidelines Biomedical research: research involving human subjects including research on identifiable human material or identifiable data. Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research. Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.

4 PROGRAMMAZIONEdellaRICERCA

5 England Finland France Norway Scotland Sweden Wales % Trends of Asthma Prevalence in Europe

6 Australia Canada Hong-Kong Israel Japan New Zealand Papua New Guinea Singapore Tahiti Taiwan United States Vietnam % Trends of Asthma Prevalence in Europe

7 British Medical Journal, August 2005 Linneberg A. British Medical Journal, August 2005 Changes in atopy over 25 years Allergic Epidemic has spread to Old Age

8 Lenfant C. N.E.J.M. August 2004

9 DALY = Disability-adjusted life year 1. Acute lower respiratory infections 2. HIV/AIDS 3. Perinatal conditions 4. Diarrhoeal diseases 5. Unipolar major depression 6. Ischaemic heart disease 7. Cerebrovascular disease 8. Malaria 9. Road traffic injuries 10. COPD 11. Congenital abnormalities 12. Tuberculosis 13. Falls 14. Measles 15. Anaemias 1. Ischaemic heart disease 2. Unipolar major depression 3. Road traffic injuries 4. Cerebrovascular disease 5. COPD 6. Lower respiratory infections 7. Tuberculosis 8. War 9. Diarrhoeal diseases 10. HIV 11. Perinatal conditions 12. Violence 13. Congenital abnormalities 14. Self-inflicted injuries 15. Trachea, bronchus and lung cancers Source: WHO Evidence, Information and Policy, 2000 Increasing burden of noncommunicable diseases and injuries change in rank order of DALYs for the 15 leading causes (baseline scenario)

10 ischemic heart disease1 cerebrovascular disease2 lower respiratory infection3 diarrheal diseases4 conditions arising during the 5 perinatal period chronic obstructive pulmonary 6 diseases tubercolosis7 measles8 road traffic accidents9 trachea, bronchus and lung cancer10 malaria11 self induced injuries12 cirrosis of the liver13 stomach cancer14 diabetes mellitus15 violence 16 war20 liver cancer21 HIV Changes in ranking for most important causes of death from 1990 to 2020 C.J.L. Murray, A.D. Lopez The LANCET 1997 gw

11 the opposite trend of communicable and non-communicable diseases in transition economies Source: WHO, Evidence, Information and Policy, 2000 WHO

12 % communicable non-communicable XXthXXIth Respiratory diseases in MIC & Transition Countries tbc, pneumoina, etc. asthma, COPD, lung cancer changes in: demographics, HCSs schooling, income, tobacco Respiratory diseases in MIC & Transition Countries

13 ISAAC most Low-Middle income countries most High-income countries ASTHMA

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15 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 hypothesis

16 Th1-mediated nephropathies are increasing in poor countries (poor hygiene), whereas Th2-mediated nephropaties are increasing in rich countries (high hygiene) Johnson et al. Am J Kidney Dis 42, 575, 2003

17 Lanalisi delle evidenze scientifiche deve costituire la base dei successivi indirizzi di ricerca

18 PROGRAMMAZIONE&ESECUZIONE

19 Subjects physical/mental condition must be necessary to 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 should be published Biomedical research guidelines

20 Evidence-Based Health Care J.A. Muir Gray 2001

21 VALUTAZIONEdeiDATI

22 A filter of medical knowledge and scientific data based on predifined rules. A filter of medical knowledge and scientific data based on predifined rules. Why EBM is a practical and correct tool?

23 Evidence-Based Health Care J. A. Muir Gray 2001

24 Bousquet J. et al., Allergy 2004 A critical appraisal of evidence-based medicine in allergy and asthma

25 Guidelines for Clinical Guidelines

26 Opinion Based Medicine

27 Evidence Based Medicine

28 Bousquet J. et al.,Allergy 2004

29 META-ANALYSES

30 USA criteria of evidence

31 Bousquet J. et al.,Allergy 2004

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33 EBM, Do we have better criteria?? Presently, NO!!!!!

34 STANDARDS FOR PRACTICAL ALLERGEN-SPECIFIC IMMUNOTHERAPY E Alvarez-Cuesta (chairman), J Bousquet, G W Canonica, S Durham, H-J Malling, E Valovirta EAACI Immunotherapy Task Force 2005

35 SIT Efficacy by E.B.M. SCIT : Ia for Asthma Ib for Rhinitis Ib for Rhinitis SLIT : Ia for Rhinitis Ib for Asthma Ib for Asthma EAACI Immunotherapy Task Force 2005 EAACI Immunotherapy Task Force 2005

36 NIH-NIAID Meeting Bethesda, November 14,2005 -Immune Tolerance Network (Sublingual administration of 4 allergens to months old kids) -Consortium for Food Allergy Research (Mucosal Immunotherapy for peanut allergy) -Inner City Asthma Consortium (SLIT for Asthma) Charles Hackett, Deputy Director, Div.Allergy, Immunol &Transplantation NIAID,NIH

37 Integrates pathophysiologic rationale, care-giver experience, patient preferences with valid and current clinical research evidence. Must be able to critically review the research and know if it applies to your patient-care problem. …the conscientious, explicit, and judicious use of current best evidence in making decisions about care of the individual patients. Evidence-based Medicine (EBM)

38 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

39 Pulmonary research in the first quarter of the 21st century will focus on these major areas Crystal RG JAMA. 2001

40 INTEGRITAdellaRICERCA

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42 fudge factor Fattore di falsificazione Sapendo, sulla base di speculazioni puramente teoriche, quali devono essere i risultati cambiare il valore dei parametri valutati finché non si ottengono i risultati desiderati. Metodo utilizzato da Newton per calcolare la velocità del suono Federico Di Trocchio: Le bugie della scienza Mondadori 1993

43 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 1988 Anti-IgE Ab obtained injecting human IgE in animals Diluted anti IgE by a factor of 10 until no trace of antibodies was detected Added white cells derived from human blood Obtained basophil degranulation!

44 High-dilution experiments a delusion Maddox J Randi J Stewart WW Nature 1988 Repeating Dr Benveniste experiments we were surprised that do not always work

45 Review international literature Collect/ produce data Analyse data Control repeatability and reproducibility of methods Draw conclusions What to do for a scientific research:

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47 Impact Factors The journal impact factor is a measure of the frequency with which the "average article" in a journal has been cited in a particular year. The impact factor will help you evaluate a journals relative importance, especially when you compare it to others in the same field. WARNING: a higher I.F. means a higher I.F. means a higher commercial value of the journal

48 RESEARCH FOUNDING PUBLIC RESOURCES PRIVATERESOURCES FoundationsAssociationsetc. CompaniesIndustriesetc.

49 INTEGRITAdellaRICERCA …e utilizzo dei dati…. 1

50 Subjects physical/mental condition must be necessary to 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 should be published Biomedical research guidelines

51 authors disclosure of interests

52 Dr.G.W.Canonica reports having received honoraria for educational presentations, and/or funding for research, and/or travel expenses, and/or for service in advisory boards from: A.Menarini, Alk Abello, Almirall, Altana, Astra Zeneca, Boeringher Ingelheim, Chiesi Farmaceutici, Gentili, GSK, Lofarma, MSD, Novartis, Pfizer, Schering Plough, Stallergenes, UCB Pharma, Uriach. A.Menarini, Alk Abello, Almirall, Altana, Astra Zeneca, Boeringher Ingelheim, Chiesi Farmaceutici, Gentili, GSK, Lofarma, MSD, Novartis, Pfizer, Schering Plough, Stallergenes, UCB Pharma, Uriach.

53 302 millions 971 millions USD

54 N.E.J.M. 2005

55 ROME, April , 2004 Milan - March 2003 Milan - March 2003 Rome - October2003 Rome - October2003 Rome - April 2004 Rome - April 2004 Rome - April 2005 Rome - April 2005

56 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 EFFORT INTERNATIONAL RECIPROCITY OF CME CREDITS

57 B.M.J. May 2004

58 Responsibilities learner Responsibilities of the learner to be fulfilled in order to claim credit, Learners have responsibility for, 1.Participating in CME/CPD that is based on their individual educational needs. 2.Ensuring that the needs are relevant to their professional practice. 3.Evaluating the extent to which their needs have been met, in the context of a change in knowledge, competence or performance. 4. Verifying that mechanisms are in place to keep educational activities free of commercial bias. educational activities free of commercial bias.

59 INTEGRITAdellaRICERCA …e utilizzo dei dati…. 2

60 Systematic Reviews to support EBM Khalid S Khan et Al Royal Society of Medicine Press 2003 CONCLUSIONI senza integrità della ricerca X


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