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Rationale Nutzen / Risikoabwägung – hilft Decision Analysis?

Rationale Nutzen / Risikoabwägung – hilft Decision Analysis?. Lucas M. Bachmann 22.3.2007. Ann Intern Med. 2007;146:133-141.

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Rationale Nutzen / Risikoabwägung – hilft Decision Analysis?

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  1. Rationale Nutzen / Risikoabwägung –hilft Decision Analysis? Lucas M. Bachmann 22.3.2007

  2. Ann Intern Med. 2007;146:133-141. “Many clinicians and policymakers view decision analytic modeling as interesting but ultimately esoteric and unhelpful (1). Anecdotally, model users find it difficult to know when they can “trust the model” and often express bewilderment when confronted with data sources from a wide range of study designs, personal opinions, and convergence with the target population.”

  3. Allokationsproblem • Massive Zunahme diagnostischer und therapeutischer Möglichkeiten im 20 Jhr. • mehr Entscheidungsmöglichkeiten • Entscheide werden wichtiger (medizinisch, ökonomisch, gesellschaftlich, legal) • Konsequenz: Gesteigertes Interesse an Optimierung medizinischer Entscheide

  4. Allokationsproblem Anzahl von Medikamentenzulassungen der FDA

  5. Rationale Nutzen / Risikoabwägung • Eine Behandlung

  6. Frau Müller • 85 jährig • neues VHF • l. Niereninsuffizienz • fortgeschrittene a. Makuladegeneration • alleinstehend • wohnt zu Hause (Mahlzeitendienst) V. v. G. Old Woman of Arles 1888

  7. Decision Analysis expected utility: The hypothesis in economics that the utility (happiness) of a person facing uncertainty is calculated by considering utility in each possible state and constructing a weighted average. The weights are the agent's estimate of the probability of each state.

  8. Health-related Quality of Life 1 0 Dead Perfect health

  9. Schlaganfälle unter oraler Antikoagulation oder Thrombozytenaggregationshemmung1 1 Segal JB, et al. Anticoagulants or antiplatelet therapy for non-rheumatic atrial fibrillation and flutter (Cochrane Review)

  10. Vaskuläre Mortalität unter oraler Antikoagulation oder Thrombozytenaggregationshemmung2 2 Taylor F.C. et al. Systematic review of long term anticoagulation or antiplatelet treatment in patients with non-rheumatic atrial fibrillation BMJ 2001;322:321-326

  11. AFASAK 1 Studie5 Einzige Vergleichsstudie mit einem signifikanten positiven Effekt der Antikoagulation. Ausschluss aus der Analyse in der BMJ-Studie wegen methodischen Mängeln. Einschluss im Cochrane Review Petersen P, et al., Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Lancet 1989;1:175-9.

  12. Schwere Blutungskomplikation: Wer ist betroffen? • 579 Patienten (98.5 % Männer, 65 Jahre) • Kumulative Blutungsinzidenz unter oraler Antikoagulation war 7 % pro Jahr. • Unabhängige Prädiktoren waren: • Alkoholismus • Chronische Niereninsuffizienz • Status nach gastrointestinaler Blutung McMahan DA, et al. Risk of major hemorrhage for outpatients treated with warfarin. Journal of General Internal Medicine 1998;13:311-16.

  13. Fazit aus Clinical Evidence • Die Patienten in den RCT‘s waren selektiert(< 10%, range 3–40% der verfügbaren Patienten wurden randomisiert) • Kaum Studien an über 80 jährigen • Viele Studien wurden nicht doppelblind durchgeführt. • Die häufige Überwachung der Warfarinbehandlung unter Studienbedingungen war wahrscheinlich intensiver als in der üblichen klinischen Praxis. (Weniger Schlaganfälle als in populationsbasierten Studien)

  14. Frau Müller • 85 jährig • neues VHF • l. Niereninsuffizienz • fortgeschrittene a. Makuladegeneration • alleinstehend • wohnt zu Hause (Mahlzeitendienst)

  15. Ann Intern Med. 2007;146:133-141. “Many clinicians and policymakers view decision analytic modeling as interesting but ultimately esoteric and unhelpful (1). Anecdotally, model users find it difficult to know when they can “trust the model” and often express bewilderment when confronted with data sources from a wide range of study designs, personal opinions, and convergence with the target population.”

  16. Rationale Nutzen / Risikoabwägung • Zwischen mehreren Behandlungen

  17. QALY • quality adjusted life-year (QALY) • A measure of the outcome of actions in terms of their health impact. • If an action gives a person an extra year of healthy life expectancy, that counts as one QALY. • If an action gives a person an extra year of unhealthy life expectancy (partly disabled or in some distress), it has a value of less than one. • Death is rated at zero

  18. Berechnung:Quality-Adjusted Life Years If, HRQL= 0.7 And, A treatment gives 10 extra years of life (@ 0.7 per year) Then…. People receiving the treatment gain Seven Quality-Adjusted Life Years (7 QALYs)

  19. A QALY is a QALY is a QALY #Leute HRQL LE = QALYs rettet Leben 100 x 0.8 x50 = 4000 verbessert HRQL 10,000 x0.1 x 4 = 4000

  20. Der Vergleich:Cost per QALY Kosten Behandlung A – Kosten Behandlung B QALY Behandlung A – QALY Behandlung B = COST per QALY

  21. What’s a “Good” Buy?* “Expensive” more than 100K/QALY “Reasonable” 50K/QALY “Very Efficient” less than 25K/QALY * Zahlen aus USA

  22. Condition/Treatment Cost per QALY Treatment for Erectile Dysfunction $6,400/QALY Physician Counseling for Smoking $7,200/QALY Total Hip Replacement $9,900/QALY Outreach for Flu and Pneumonia $13,000/QALY Treatment of Major Depression $20,000/QALY Gastric Bypass Surgery $20,000/QALY Treatment for Osteoporosis $38,000/QALY Screening For Colon Cancer $40,000/QALY Implantable Cardioverter Defibrillator $75,000/QALY Lung-Volume Reduction Surgery $98,000/QALY Tight Control of Diabetes $154,000/QALY Treating Elevated Cholesterol ( + 1 risk factor) $200,000/QALY Resuscitation After Cardiac Arrest $270,000/QALY Left Ventricular Assist Device $900,000/QALY Zahlen aus USA

  23. Decision Analysis • ‘Expected’ outcome/utility never materializes in the context of a client’s singular decision. • A rational client may well prefer a decision that does not maximize probability-averaged – ‘expected’ – utility. O.S. Miettinen 2003

  24. Schlussfolgerungen • Allokationsproblem fordert Entscheidungs-und Selektionsstrategien • Entscheidungsmodelle haben ihre Schwächen • Modellannahmen • Transparenz • Kommunikation • Rationale Nutzen / Risikoabwägung –hilft Decision Analysis?

  25. Rationale Nutzen / Risikoabwägung –hilft Decision Analysis? Lucas M. Bachmann 22.3.2007

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