179intervention period for the study was short, and perhaps running the trial over a
longer period time (i.e., 5 years, a full period of residency training) would result in
increased job dissatisfaction for the resident working longer hours. The markers of
patient safety are important ones (e.g., patient death or serious complication) but
perhaps not granular enough to capture errors as a result of resident fatigue.
The landmark FIRST trial demonstrated noninferior outcomes for patients and
high levels of resident satisfaction with when duty hours were made more flexible
for surgical residents. Another randomized trial has been constructed to examine the
effect of more flexible duty-hour policies as it applies to internal medicine trainees.
The iCOMPARE trial is led by physicians from the University of Pennsylvania,
Johns Hopkins University, and the Brigham and Women’s Hospital/Harvard Medical
School [ 53 ]. As with the FIRST trial, the standard group complies with current
ACGME standards including a 16-hour maximum work period for PGY-1 residents.
The flexible arm has an 80-hour maximum workweek, 1 day off in every 7, and in-
house call no more frequent than every third night (all averaged over 4 weeks). The
main outcome will be the measurement of patient safety data and educational out-
comes for the internal medicine trainees. The trial began in July of 2015 and has
ended in June of 2016. A total of 63 programs enrolled, 31 in the standard policy
arm, and 32 in the flexible duty-hour policy arm. As of the writing of this chapter,
no data is available about the primary trial endpoints. The results of this trial, if
consistent with those of the FIRST trial, will certainly help to justify some relax-
ation of the standards set for by the ACGME by ensuring patient safety is not com-
promised. If differences are noted between these studies, this may give way to
specialty specific duty-hour restrictions [ 54 ].
Several follow-up publications have addressed the residents’ perceptions on
patient outcomes in the standard duty-hour group compared to those in the flexible
duty-hour group. In a recent survey of residents who participated in the FIRST trial,
residents in the standard duty-hour group perceived a negative effect on patient
safety and continuity of care [ 55 ]. Also, PGY-1 residents in the standard duty hours
arm were much more likely to have to leave the operating room during a case to
abide by the duty-hour rules as compared to the flexible duty-hour group. This did
not appear as evident in the PGY-2 or higher group in the standard duty-hour group;
the rate of leaving the operating room in the flexible duty-hour group was signifi-
cantly lower, however. With respect to education and duty hours, there did not
appear to be a significant interaction between the duty-hour policy and the degree of
dissatisfaction with resident education quality in this study. In terms of the resi-
dents’ self-perceived domain of well-being as measured by their own health, rest,
extracurricular time, and time with family and friends, the flexible policy residents
felt more often that their work hours had a negative effect compared to the standard
policy arm. This was most prominent at the PGY-1 level, but the effect was signifi-
cant across all PGY years. This is not unexpected as the length of their time on duty
could be considerably longer in the flexible policy arm. However, when asked
whether they were “dissatisfied” or “very dissatisfied” with their well-being, there
was no difference between the standard and flexible policy arms. Importantly,
junior-level residents in the flexible-policy group perceived that the duty hours had
9 Resident Duty Hours in Surgical Education