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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. Study overview. Recent retrospective data
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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
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
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
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
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
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