Evidence-Based Medicine (EBM) = Médecine Factuelle C-EBLM (IFCC-LM) (Cochrane, …) Evidence-Based Nursing, Evidence-Based Health-Care, … Evidence-Based Management, Evidence-Based Policy, … Evidence-Based Sociology, Evidence-Based History, … EvidenceBased Mathematics, … (EB)M = chaque décision médicale se fonde sur: 1) niveaux de preuve (les plus élevés) 2) expertise clinique (professionnelle/scientifique) 3) choix des patients Prejudice-, Belief-, Faith-, Tradition-, Ideology-, Authority-, Anarchy-Based Medicine, … Prejudice-based Medicine Fowler FJ Jr, McNaughton Collins M, Albertsen PC, Zietman A, Elliott Comparison of recommendations by urologists and radiation oncologists for treatment of clinically localized prostate cancer. DB, Barry MJ. JAMA 2000;283:3217-22. The quality of health care delivered to adults in the United States McGlynn EA, Asch SM, Adams J, Keesey J, Hicks J, DeCristofaro A, Kerr EA. N Engl J Med 2003 Jun 26; 348(26):2635-45. Design - 439 indicators of quality of care for 30 acute and chronic conditions, and preventive care - Telephone survey - Informed consent to examine their medical records + interview - Random sample of 6712 adults from 12 metropolitan areas Examples of quality indicators Hypertension Change in treatment when blood pressure is persistently high Coronary artery disease Beta-blockers after myocardial infarction Counselling on smoking cessation Colorectal cancer Treatment of high LDL cholesterol levels Screening for high-risk patients (genetics, colonoscopy) Screening in persons at average risk (FOBT) Recommended care received Medication 68,6 % Immunization 65,7 % Physical examination 62,9 % Laboratory testing or radiography 61,7 % Surgery 56,9 % History 43,4 % Counselling or education 18,3 % Recommended care received 85%: Influenzae vaccination >65y 45%: MI-beta-blockers 38%: Colorectal cancer/FOBT 24%: HbA1c X3/y Conclusions • patients received 54.9% (54.355.5) of recommended care • strategies to reduce these deficits are warranted Strategies? EBM? Niveaux de preuve? I - Randomised Trials II - Non -randomised Trials, Cohort studies III - Case-control studies, casereports IV – Expert opinion Annual biomedical literature: 17 000 books + 2 000 000 articles (in Medline: 200 000 articles) “The medical literature can be compared to a jungle. It is fast growing, full of dead wood, sprinkled with hidden treasure, and infested with spiders and snakes” Systematic Reviews (Revues Méthodiques) = la pierre angulaire de l’EBM Systematic Review (Introduction/) Question(s) (focussed) Materials et Methods (objectivity) Search (systematic) (EB-librarianship) Inclusion / Exclusion / Quality assessment Results - Discussion (limitations) (Conclusion/) Answer(s) - balance benefits/harms (probabilités) Meta-analysis - results of primary studies combined quantitatively and statistically - statistical power Trial (Year) Barber (1967) Reynolds (1972) Wilhelmsson (1974) Ahlmark (1974) Multicentre International (1975) Yusuf (1979) Andersen (1979) Rehnqvist (1980) Baber (1980) Wilcox Atenolol (1980) Wilcox Propanolol (1980) Hjalmarson (1981) Norwegian Multicentre (1981) Hansteen (1982) Julian (1982) BHAT (1982) Taylor (1982) Manger Cats (1983) Rehnqvist (1983) Australian-Swedish (1983) Mazur (1984) EIS (1984) Salathia (1985) Roque (1987) LIT 91987) Kaul (1988) Boissel (1990) Schwartz low risk (1992) Schwartz high risk (1992) SSSD (1993) Darasz (1995) Basu (1997) Aronow (1997) Mortality results from 33 trials of beta-blockers in secondary prevention after myocardial infarction. Adapted from Freemantle et al BMJ 1999 0.80 (0.74 - 0.86) Overall (95% CI) 0.1 0.2 0.5 1 2 5 10 Relative risk (95% confidence interval) Cumulative meta-analysis of 33 trials of beta-blockers in secondary prevention after myocardial infarction Year 1967 1972 1974 “ 1975 1979 “ 1980 “ “ “ 1981 “ 1982 “ “ “ “ “ “ 1984 “ 1985 1987 “ 1988 1990 1992 “ 1993 1995 1997 “ 0.5 0.8 2 1 Relative Risk (95% Confidence Interval) Calculated from Freemantle et al BMJ 1999 Publication bias All studies conducted All studies published Grey literature All studies reviewed Systematic reviews ↓ Levels of evidence (EB) Guidelines ↓ Levels of evidence (I-IV) CONSENSUS ↓ JUDGMENT Strength of recommendation (A-D) JUDGMENT /CONSENSUS I → A I→D IV → D II/III/IV → A Cancer colorectal dépistage de masse - FOBT 12 guidelines USA (ACS, 2006) USA (AGA, 2003) OUI OUI UK (BSG, 2000) Canada (CAG, 2004) Canada (CTFPHC, 2001) Europe (2000) NON OUI OUI OUI USA (ICSI, 2005) USA (NCCN, 2005) Australie (NHMRC, 2000) OUI OUI OUI Nouvelle Zélande (NZGG, 2004) Canada (QAG, 2003) Ecosse (SIGN, 2003) NON OUI NON 8 revues systématiques dont 3 publiées en 2006-2007 Heresbach D, Manfredi S, D'halluin PN, Bretagne JF, Branger B. Review in depth and meta-analysis of controlled trials on colorectal cancer screening by faecal occult blood test . Eur J Gastroenterol Hepatol 2006; 18:427-433 Méta-analyse de 4 essais contrôlés (336 000 pts) (France, UK, USA, Danemark) Réduction de la mortalité par CCR (RR= 0.79-0.94), pendant la durée du dépistage uniquement (10 ans) Moayyedi P, systematic review data. Achkar E. Does fecal occult blood testing really reduce mortality? A reanalysis of Am J Gastroenterol 2006 ; 101:380-4 Méta-analyse de 3 essais contrôlés randomisés (245 000 pts) (UK, USA, Danemark) Réduction de la mortalité par CCR (RR= 0.80-0.95) Augmentation de la mortalité non liée au CCR (RR= 1.00-1.04, p=0.015) [Hypothèse: FOBT = vaccin anti-cancer?] Hewitson P , Glasziou P, Irwig L, Towler B, Watson E. Screening for colorectal cancer using the faecal occult blood test, Hemoccult. Cochrane Database Syst Rev 2007 Jan 24;(1):CD001216. Revue systématique + méta-analyse de 4 essais contrôlés randomisés (UK, USA, Danemark, Suède) Réduction de la mortalité par CCR (RR= 0.78-0.90) Augmentation de la mortalité non liée au CCR (RR= 1.00-1.03, non significatif) Hewitson P , Glasziou P, Irwig L, Towler B, Watson E. Screening for Cochrane Database Syst Rev 2007 colorectal cancer using the faecal occult blood test, Hemoccult. Jan 24;(1):CD001216. Effets bénéfiques du dépistage de masse: - Réduction modeste de la mortalité par CCR - une possible reduction de l’incidence du CCR - potentiellement, une chirurgie moins invasive Effets délétères du dépistage de masse: - faux-positifs: conséquences psycho-sociales - complications des colonoscopies, des faux négatifs - possibilité de sur diagnostic (investigations ou traitements inutiles et leurs complications) 9 YES: JUDGMENT: benefits outweighs harms VALID judgment, provided both benefits and harms are mentioned in guidelines 3 NO (UK, Scotland, NewZealand): JUDGMENT: benefits may or may not outweigh harms, but the structure of health-system does not allow to recommend for mass-screening VALID judgment too CONCLUSION 1) niveaux de preuve (balance bénéfices/risques) 2) expertise professionnelle (multidisciplinarité) 3) choix des patients 38%