Patient Safety under Flexible and Standard Duty-Hour Rules

To the Editor: In the iCOMPARE (Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education) trial, Silber et al. (March 7 issue) 1 prespecified an unreasonable noninferiority threshold based on an increase in 30-day mortality from 12.5% to 13.5%. Even the highest estimates 2 would project that fewer than a quarter of deaths (and probably far fewer) in hospitals are due to medical errors. 2,3 An absolute increase of 1 percentage point in error-related mortality (i.e., from approximately 3% to approximately 4%) would therefore represent an increase of more than 30% in error-related mortality. It was unreasonable to set such a . . .