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INTEGRITA’ DELLA RICERCA: programmazione, esecuzione e utilizzo dei dati

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

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INTEGRITA’ DELLA RICERCA: programmazione, esecuzione e utilizzo dei dati

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

  2. science is “simply common sense at itsbest; 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

  3. Biomedical research guidelines • Biomedical research: research involving humansubjects including research onidentifiable human material oridentifiable data. • Medical research is only justified ifthere is a reasonable likelihood thatthe populations in which theresearch is carried out stand tobenefit from the results of theresearch.

  4. PROGRAMMAZIONE della RICERCA

  5. Australia Canada Hong-Kong Israel Japan New Zealand New Zealand Papua New Guinea Singapore Tahiti Taiwan United States United States Vietnam Trends of Asthma Prevalence in Europe 20 15 % 10 5 0 1955 1965 1975 1985 1995

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

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

  8. Increasing burden of noncommunicable diseases and injuries change in rank order of DALYs for the 15 leading causes (baseline scenario) 1999 2020 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 DALY = Disability-adjusted life year Source: WHO Evidence, Information and Policy, 2000

  9. 1990 2020 1990 2020 ischemic heart disease 1 cerebrovascular disease 2 lower respiratory infection 3 diarrheal diseases 4 conditions arising during the 5 perinatal period chronic obstructive pulmonary 6 diseases tubercolosis 7 measles 8 road traffic accidents 9 trachea, bronchus and lung cancer 10 malaria 11 self induced injuries 12 cirrosis of the liver 13 stomach cancer 14 diabetes mellitus 15 violence 16 war 20 liver cancer 21 HIV 30 1 2 4 11 16 3 7 27 6 5 29 10 12 8 19 14 15 13 9 Changes in ranking for most important causes of death from 1990 to 2020 gw28799 C.J.L. Murray, A.D. Lopez The LANCET 1997

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

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

  12. ASTHMA ISAAC most High-income countries most Low-Middle income countries

  13. 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 Hygiene hypothesis Romagnani: Curr. Opin. Immunol., 6, 838, 1994

  14. 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

  15. L’analisi delle evidenze scientifiche deve costituire la base dei successivi indirizzi di ricerca

  16. PROGRAMMAZIONE & ESECUZIONE

  17. Biomedical research guidelines • Subjects physical/mental condition must be necessary to research. • Protocols have to be approved by IEC. • Informed consents have to beobtained from subject or legalrepresentative. • Sources of funding, institutionalaffiliations, conflicts of interestspecified Negative and positive results shouldbe published

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

  19. VALUTAZIONE dei DATI

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

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

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

  23. Bousquet J. et al.,Allergy 2004

  24. META-ANALYSES Bousquet J. et al.,Allergy 2004

  25. USA criteria of evidence Bousquet J. et al.,Allergy 2004

  26. Bousquet J. et al.,Allergy 2004

  27. Bousquet J. et al.,Allergy 2004

  28. EBM, Do we have better criteria?? Presently, NO!!!!!

  29. STANDARDS FOR PRACTICALALLERGEN-SPECIFIC IMMUNOTHERAPYE Alvarez-Cuesta (chairman), J Bousquet, G W Canonica, S Durham, H-J Malling, E ValovirtaEAACI Immunotherapy Task Force 2005

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

  31. NIH-NIAID Meeting Bethesda, November 14,2005 Charles Hackett, Deputy Director, Div.Allergy, Immunol &Transplantation NIAID,NIH -Immune Tolerance Network (Sublingual administration of 4 allergens to 18-30 months old kids) -Consortium for Food Allergy Research (Mucosal Immunotherapy for peanut allergy) -Inner City Asthma Consortium (SLIT for Asthma)

  32. Evidence-based Medicine (EBM) Integratespathophysiologic rationale, care-giver experience,patient preferences with valid and current clinicalresearch 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”.

  33. 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

  34. Pulmonary research in the first quarter of the 21st centurywill focus on these major areas Crystal RG JAMA. 2001

  35. INTEGRITA’ della RICERCA

  36. “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 scienzaMondadori 1993

  37. 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!

  38. 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”

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

  40. 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 journal’s relative importance, especially when you compare it to others in the same field. WARNING: a higher I.F. means a higher commercial value of the journal

  41. RESEARCH FOUNDING PUBLIC RESOURCES PRIVATE RESOURCES Foundations Associations etc. Companies Industries etc.

  42. INTEGRITA’ della RICERCA …e utilizzo dei dati…. 1

  43. Biomedical research guidelines • Subjects physical/mental condition must be necessary to research. • Protocols have to be approved by IEC. • Informed consents have to beobtained from subject or legalrepresentative. • Sources of funding, institutionalaffiliations, conflicts of interestspecified Negative and positive results shouldbe published

  44. authors’ disclosure of interests

  45. authors’ disclosure of interests 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.

  46. 1998 2003 USD 302 millions 971 millions

  47. N.E.J.M. 2005

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