175
The study was conducted over a single academic year from July 1, 2014 to June
30, 2015. The randomized design created two well-balanced groups in regard to
residents, hospital metrics, residency program types, and patient populations under
study. The NSQIP database provided outcomes on 138,691 patients during the study
period. As shown in Fig. 9.1, the rate of primary outcomes (e.g., death or serious
complications) did not differ between the groups and met criteria for noninferiority.
In a similar fashion, the rate of the secondary outcomes was the same in each group
and also noninferior. The only exception was renal failure and failure to rescue,
which in the adjusted model did not meet criteria for noninferiority. Subgroup anal-
ysis of the type of surgery, risk of death, and surgical setting also showed no differ-
ence between the two study arms.
The resident-related outcomes in this study were obtained by a questionnaire
administered to participating residents (2220 in the standard-policy group and
2110 in the flexible-policy group) during the January 2015 ABSITE exam. Those
results are shown in Table 9.3. Importantly, there was no difference between resi-
dent dissatisfaction with education quality, overall well-being, patient safety, and
work hours between the standard-policy group and the flexible-policy group. The
flexible-policy group was significantly less likely to perceive a negative effect of
30-day postoperative
outcomes
Death or serious
complication
Unadjusted
Adjusted
Death
Unadjusted
Adjusted
Unadjusted
Adjusted
Unadjusted
Adjusted
Unadjusted
Adjusted
Unadjusted
Adjusted
Unadjusted
Adjusted
Unadjusted
Adjusted
Unadjusted
Adjusted
Unadjusted
Adjusted
Unadjusted
Adjusted
Serious complication
Any complication
Failure to rescue
Pneumonia
Renal failure
Unplanned reoperation
Sepsis
Surgical-site infection 137,346
138,258
138,691
138,596
138,375
11,937
138,691
138,691
138,691
Urinary tract infection 138,691
0.500.550.600.650.700.750.800.850.900.951.001.051.101.151.20
Flexible policies better Standard policies better
1.251.301.351.401.451.50
138,691
Patients included
in analysis Odds ratio (92% CI)
0.0
Inconclusive
Inferior
Noninferior
Superior
Regions of noninferiority
0.5 1.0 1.5
Fig. 9.1 Patient related outcomes from the FIRST trial
9 Resident Duty Hours in Surgical Education