BACKGROUND AND PURPOSE:

• Silber et al. (New England Journal of Medicine, 2019) compared the standard resident work hours vs flexible hours and their impact on patient safety

METHODS:

• Cluster-randomized non-inferiority trial
  • 63 internal-medicine residency programs (2015-2016 academic year)
• Programs were randomly assigned to either
  • Standard duty hours as defined by the Accreditation Council for Graduate Medical Education (ACGME)
  • Flexible duty-hour rules that did not specify limits on shift length or mandatory time off between shifts
• Primary outcome: Change in unadjusted 30-day mortality from the year before the trial and the trial year as determined from Medicare claims
• Secondary outcomes
  • 7-day and 30-day rates of hospital readmission or death | Patient safety indicators (AHRQ) | Prolonged length of hospital stay | Medicare Payments
• Statistical Analysis
  • Noninferiority margin was set at 1% (mortality would not be more than 1% worse in the flexible program compared to the standard hours by program)

RESULTS:

• 32 flexible programs with 121,951 admissions | 31 standard programs with 142,634 admissions
• The change in 30-day mortality among patients in the flexible programs was noninferior to that among patients in the standard programs
• There were also no statistical differences in changes between the flexible programs and standard programs in
  • Unadjusted rate of readmission at 7 days
  • Patient safety indicators
  • Medicare payments
• The noninferiority criterion was not met for
  • 30-day readmissions
  • Prolonged length of hospital stay

CONCLUSION:

• ‘Flexible resident schedules did not result in harm to patients
  • Authors note that the flexible programs did not consistently use extended shifts
  • Ability of program directors to use extended shifts at their discretion was a feature to promote ‘pragmatic’ study design
• Another companion study showed no more chronic sleep loss or sleepiness among interns in flexible programs than those in standard programs (See ‘Learn More – Primary Sources’ below)
• The authors state that

…allowing program directors the discretion to make their own schedules without continuous duty-hour limits did not result in worse patient outcomes.

Learn More – Primary Sources:

Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules

Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine

Eyes Wide Open — Examining the Data on Duty-Hour Reform

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