1. MPOG study overview Anesthesia mortality: –1/5,000 in 1950 –1/200,000 in 2008 Significant morbidity for RARE events –Renal Failure, Myocardial Infarction, Stroke, Loss of Airway, Blindness –Unknown incidence, impact, anesthetic relationship

2. Study overview Recent retrospective data Renal failure: 0.8% –Myocardial infarction: 1.0% –Stroke: 0.7 - 1% –Impossible airway: 0.16% –Blindness: 0.013% Collect completely limited data set (only date of service) AFTER clinical care

3. Benefits First data to enable –Patient consent –Prospective prevention trials (with separate IRB) Major morbidity, “common” if aggregated Alter anesthetic management fundamentally Complete absence of data currently

4. Patient Risk Clinical –Zero: no changes in care Privacy –Less than minimal –All identifiers removed, not available to PI, statisticians, authors –Only PHI: date of surgery –Behind UM firewall, MCIT computers –Informatics specialists ensuring security

5. Waiver of consent Selection bias reducing scientific validity –Even one or two patients can alter scientific validity: 37 events out of 22,600 for airway emergencies –Patients not consenting may be essential to population: chronic pain analysis

6. Waiver of consent Not practicable –Need to “enroll” hundreds of thousands of patients to detect sufficient events –Impossible to consent or inform this number of patients –“Opt-out” concept (ie, line on surgical consent) requires personnel infrastructure and process –Would INCREASE privacy risk to record MRN of these patients