FIRST Study

The
n e w e ng l a n d j o u r na l
of
m e dic i n e
Original Article
National Cluster-Randomized Trial

of Duty-Hour Flexibility in Surgical Training
KarlY. Bilimoria, M.D., M.S.C.I., JeanetteW. Chung, Ph.D.,
LarryV. Hedges, Ph.D., AllisonR. Dahlke, M.P.H., Remi Love, B.S.,
MarkE. Cohen, Ph.D., DavidB. Hoyt, M.D., AnthonyD. Yang, M.D.,
JohnL. Tarpley, M.D., JohnD. Mellinger, M.D., DavidM. Mahvi, M.D.,
RachelR. Kelz, M.D., M.S.C.E., CliffordY. Ko, M.D., M.S.H.S.,
DavidD. Odell, M.D., M.M.Sc., JonahJ. Stulberg, M.D., Ph.D., M.P.H.,
and FrankR. Lewis, M.D.
A BS T R AC T
BACKGROUND
Concerns persist regarding the effect of current surgical resident duty-hour policies on
patient outcomes, resident education, and resident well-being.
METHODS
We conducted a national, cluster-randomized, pragmatic, noninferiority trial involving

117 general surgery residency programs in the United States (20142015 academic year).
Programs were randomly assigned to current Accreditation Council for Graduate Medical
Education (ACGME) duty-hour policies (standard-policy group) or more flexible policies
that waived rules on maximum shift lengths and time off between shifts (flexible-policy
group). Outcomes included the 30-day rate of postoperative death or serious complications (primary outcome), other postoperative complications, and resident perceptions
and satisfaction regarding their well-being, education, and patient care.
RESULTS
In an analysis of data from 138,691 patients, flexible, less-restrictive duty-hour policies

were not associated with an increased rate of death or serious complications (9.1% in the
flexible-policy group and 9.0% in the standard-policy group, P=0.92; unadjusted odds
ratio for the flexible-policy group, 0.96; 92% confidence interval, 0.87 to 1.06; P=0.44;
noninferiority criteria satisfied) or of any secondary postoperative outcomes studied.
Among 4330 residents, those in programs assigned to flexible policies did not report
significantly greater dissatisfaction with overall education quality (11.0% in the flexiblepolicy group and 10.7% in the standard-policy group, P=0.86) or well-being (14.9% and
12.0%, respectively; P=0.10). Residents under flexible policies were less likely than those
under standard policies to perceive negative effects of duty-hour policies on multiple
aspects of patient safety, continuity of care, professionalism, and resident education but
were more likely to perceive negative effects on personal activities. There were no significant differences between study groups in resident-reported perception of the effect of fatigue on personal or patient safety. Residents in the flexible-policy group were less likely
than those in the standard-policy group to report leaving during an operation (7.0% vs.
13.2%, P<0.001) or handing off active patient issues (32.0% vs. 46.3%, P<0.001).
From the Surgical Outcomes and Quality

Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies, Feinberg School of Medicine
and Northwestern Medicine, Northwestern University (K.Y.B., J.W.C., A.R.D., R.L.,
A.D.Y., D.M.M., D.D.O., J.J.S.), and the
American College of Surgeons (K.Y.B.,
M.E.C., D.B.H., C.Y.K.), Chicago, the Department of Statistics, Northwestern
University, Evanston (L.V.H.), and the
Department of Surgery, Southern Illinois
University, Springfield (J.D.M.) all in
Illinois; the Department of Surgery,
Vanderbilt University, Nashville (J.L.T.);
the Department of Surgery and the Center for Surgery and Health Economics,
Perelman School of Medicine, University
of Pennsylvania (R.R.K.), and the American Board of Surgery (F.R.L.) both in
Philadelphia; and the Department of Surgery, University of California, Los Angeles, School of Medicine, Los Angeles
(C.Y.K.). Address reprint requests to Dr.
Bilimoria at the Surgical Outcomes and
Quality Improvement Center (SOQIC),
Department of Surgery, Feinberg School
of Medicine and Northwestern Medicine,
Northwestern University, 633 N. St. Clair
St., 20th Fl., Chicago, IL 60611, or at
[email protected].
This article was published on February 2,
2016, at NEJM.org.
DOI: 10.1056/NEJMoa1515724
Copyright 2016 Massachusetts Medical Society.
CONCLUSIONS
As compared with standard duty-hour policies, flexible, less-restrictive duty-hour policies

for surgical residents were associated with noninferior patient outcomes and no significant difference in residents satisfaction with overall well-being and education quality.
(FIRST ClinicalTrials.gov number, NCT02050789.)
n engl j mednejm.org
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Copyright 2016 Massachusetts Medical Society. All rights reserved.
The
A Quick Take
is available at
NEJM.org
n response to concerns about patient

safety and resident well-being, the Accreditation Council for Graduate Medical Education
(ACGME) introduced national regulations in 2003
that limited resident duty periods to 80 hours per
week, capped overnight shift lengths, and mandated minimum time off between shifts.1,2 Concerns persisted,3 and in 2011, the ACGME implemented further restrictions to shorten maximum
shift lengths for interns and increase time off
after overnight on-call duty for residents.1,4,5
Although most observers agree that some
duty-hour regulation was necessary, critics cite a
weak evidence base for the 2003 and 2011 reforms.3,6,7 Several retrospective studies and systematic reviews have questioned whether dutyhour reforms achieved their intended goals of
improved patient outcomes, resident education,
and resident well-being.6-18 In surgical settings,
most studies have shown no difference or a worsening in patient postoperative outcomes and resident education after duty-hour reforms.3,6,7,13-15,18-21
However, many studies have suggested that dutyhour reforms resulted in improved well-being
and less fatigue among surgical residents.6
Although the ACGME reforms were intended
to prevent fatigue-related errors in clinical care
delivered by residents,3,5 the restrictions may reduce continuity of care and increase the frequency
of handoffs,3,22-24 which could jeopardize patient
safety by forcing residents to leave at critical
times and could undermine the goals of surgical
training if residents are unable to follow patients
through critical aspects of their care.20,25-29 Evidence from large, prospective, randomized trials
to inform duty-hour regulations is currently lacking.3,6,7 In a widely cited report on resident duty
hours, the Institute of Medicine called for additional high-level research to inform policy.3
We conducted the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial30-32
to test whether surgical-patient outcomes under
flexible, less-restrictive duty-hour policies would be
no worse than outcomes under standard ACGME
policies. Resident satisfaction and perceptions of
patient care, resident education, and resident wellbeing were also assessed.
Me thods
of
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standard ACGME duty-hour policies with flexible duty-hour policies.32 The study was conducted from July 1, 2014, to June 30, 2015.
The initial trial protocol was reviewed by the
Northwestern University institutional review board
office, which determined the trial to be non
human-subjects research (see the Supplementary
Appendix, available with the full text of this article at NEJM.org).31,32 The authors vouch for the
accuracy and completeness of the data and data
analyses and for the fidelity of the study and this
report to the protocol (available at NEJM.org).
Members of the American Board of Surgery
(ABS) and the American College of Surgeons
(ACS) staff had a role in the design and conduct
of the study; collection, management, and interpretation of the data; preparation, review, and
approval of the manuscript; and the decision to
submit the manuscript for publication, because
the leaders of these organizations are coauthors
and collaborators. The ACGME had a role only
in the design of the study, insofar as it approved
the waiver requirements for the hospitals in the
flexible-policy group. The boards of these organizations had no role in the study design and
conduct, data analysis, manuscript preparation
or review, or the decision to submit the manuscript for publication.
Participants
The study population comprised all 252 ACGMEaccredited general surgery residency programs
in the United States in 2014 and, by extension,
residents in those programs, hospitals with which
they were affiliated, and general surgery patients
at those hospitals (Fig. S1 in the Supplementary
Appendix). Because the ACS National Surgical
Quality Improvement Program (ACS NSQIP)33
was the intended platform for patient data collection, program eligibility required affiliation with
at least one hospital in ACS NSQIP (77 programs
were therefore excluded).31,32 Programs located
in New York were excluded because resident duty
hours there are regulated by state law (27 programs were excluded).5 Programs were also excluded if they were new or in poor standing with
the ACGME (12 programs were excluded).
Randomization
A total of 118 general surgery residency programs (87% of the 136 eligible programs) and
This study was a prospective, cluster-random- 154 affiliated hospitals were enrolled in the
ized, pragmatic, noninferiority trial comparing FIRST Trial. Programs were stratified into three
Study Design and Oversight

Duty-Hour Flexibility in Surgical Tr aining
Table 1. Duty-Hour Requirements and Adherence Rates According to Study Group.*

Requirement Category
Standard-Policy Group
Standard ACGME Policies
Flexible-Policy Group
Adherent
Programs
Policies
no. (%)
Maximum shift length
Adherent
Programs
no. (%)
PGY 1 (interns): Duty periods may

not exceed 16 hr
59 (100)
PGY 1 (interns): Duty periods can

exceed 16 hr
58 (100)
PGY 25 (residents): Duty periods

may not exceed 28 hr (24 hr
plus 4 hr for transition)
59 (100)
PGY 25 (residents): Duty periods

can exceed 28 hr (24 hr plus
4 hr for transition)
49 (84)
Minimum time off between shifts Residents must have 8 hr off between shifts but should have
10 hr off between shifts
59 (100)
Residents are not required to have

810 hr off between shifts
47 (81)
Residents must have 14 hr off after 24 hr of continuous duty
57 (97)
Residents are not required to have

14 hr off after 24 hr of continuous duty
51 (88)
Maximum work hr/wk
Residents must not work >80 hr/

wk, averaged over 4 wk
Residents must not work >80 hr/

wk, averaged over 4 wk
Mandatory time free of duty
Residents must have 1 in every

7 days off from all educational
and clinical duties, averaged
over 4 wk
Residents must have 1 in every

7 days off from all educational
and clinical duties, averaged
over 4 wk
Frequency of on-call duty
Residents must not be on call

more frequently than every
third night
Residents must not be on call

more frequently than every
third night
* ACGME denotes Accreditation Council for Graduate Medical Education, and PGY postgraduate year.
Program adherence was defined by residency program directors regarding which policies were followed at their institution during the trial
period (100% response rate).
Residency programs assigned to the flexible-policy group were allowed to waive four ACGME duty-hour requirements concerning maximum
shift length and minimum time off between shifts.
These ACGME duty-hour requirements remained the same in both study groups.
strata on the basis of the rates in 2012 and 2013

of a composite measure of death or serious complications.31,32,34-38 Programs and their hospital
affiliates were then randomly assigned as clusters within strata to one of two study groups.39
Programs assigned to the standard-policy group
were to continue adhering to existing ACGME
duty-hour policies (Table1). Programs assigned
to the flexible-policy (intervention) group were required to adhere to ACGME duty-hour requirements of limiting work to 80 hours per week, 1 day
off in 7 days, and on-call duty no more frequently than every third night, but they were
granted a waiver by the ACGME to waive four
duty-hour requirements (from the 2003 and 2011
reforms) concerning maximum shift length and
minimum time off between shifts (to facilitate
continuity of care) (Table1).40,41 Residents were
not specifically kept from knowing their studygroup assignment.
Data Collection
Patient-level data on patient characteristics, coexisting conditions, operative details, and surgical outcomes were obtained for general surgery
cases from ACS NSQIP, a validated system developed in the 1990s for collection of high-quality
clinical data to measure surgical outcomes; the
system has been described extensively elsewhere.33,35,42 Data on patients 18 years of age or
older are collected in ACS NSQIP for most surgical specialties, excluding trauma and transplantation surgery, by trained, certified, and audited
data abstractors at each site.42 The abstractors ascertain patient outcomes by examining the medical record, discussing with treating physicians,
and contacting patients directly when needed. The
ACS NSQIP data abstractors were not specifically
informed of the study-group assignments.
Data on resident outcomes were collected in
collaboration with the ABS, which administered

The
a close-ended (i.e., multiple-choice) resident survey at the end of the January 2015 ABS In-Training Examination (ABSITE)43 to all surgical resident examinees in the United States (Table S7 in
the Supplementary Appendix). The ABSITE is a
computer-based multiple-choice examination given annually in January to assess resident knowledge and management of surgical problems.
Survey items were adapted from previously published surveys, pretested with residents through
cognitive interviews, and iteratively revised.32
Measures
Our primary patient outcome was based on the

ACS NSQIP composite outcome measure of the
30-day rate of postoperative death or serious
complications, which is based on a National
Quality Forumendorsed metric (NQF#0697).36,37
Serious complications include stroke, myocardial infarction, cardiac arrest with cardiopulmonary resuscitation, pulmonary embolism, ventilation for more than 48 hours, acute renal
failure, bleeding requiring transfusion of more
than 4 units, sepsis or septic shock, organ-space
surgical-site infection, or wound dehiscence.
Secondary outcomes included the following 10
other ACS NSQIP outcome measures: 30-day rate
of postoperative death, serious complications,
any complication, failure to rescue (i.e., death in
a patient who had a serious complication), pneumonia, renal failure, unplanned reoperation,
sepsis, surgical-site infection, and urinary tract
infection34,38 (Table S6 in the Supplementary Appendix).
Primary resident outcome measures were
specified before trial initiation and included
resident-reported level of satisfaction (very dissatisfied, dissatisfied, neutral, satisfied, or very
satisfied) with overall quality of resident education and overall well-being. Secondary resident
outcomes included residents perceptions and
satisfaction regarding the effect of 20142015
institutional duty-hour policies on aspects of
patient care, residency training, and personal
well-being; how often fatigue affected personal
safety and patient safety; and how often in the
past month residents had breaks in continuity of
care and education because of duty-hour policies
(Table S7 in the Supplementary Appendix).
Statistical Analysis
Using general surgery data from hospitals in 2012

before the trial began, we calculated a baseline
4
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raw rate of death or serious complications of

9.94%. Our rationale for the noninferiority design has been described previously.32 A noninferiority margin was specified before trial initiation as an absolute difference of 1.25 percentage
points (13% relative difference, which corresponds to a noninferiority margin odds ratio of
1.15) on the basis of examination of the empirical distribution of hospital-level 30-day rates of
death or serious complications, intracluster correlations, and power calculations.31,32 Using a
noninferiority margin of an absolute difference
of 1.25 percentage points in 30-day rates of postoperative death or serious complications, we estimated that minimum sample sizes of 90 programs
(45 per group) with an average of 1.1 hospitals per
program and an average of 950 patients per hospital would be necessary to obtain 80% power at
an alpha level of 0.05 (see the Supplementary
Appendix).
Data analyses were performed at Northwestern University. Because one midpoint interim
analysis was performed for data and safety
monitoring purposes, the level of statistical significance for our final analyses of only patient
outcomes was adjusted to 0.04 in order to maintain an overall significance level for the entire
trial of 0.05.31,32,44 In the context of a hypothesis
of no difference in outcomes across study
groups, correction for multiple comparisons was
not a conservative approach for reducing the
false discovery rate; thus, we report nonBonferroni-corrected P values for all estimates. Bonferroni adjustment of P values for patient outcomes
entails lowering the value from0.04 to 0.004
(adjustment for 11 tests), whereas adjustment of
P values for resident outcomes entails lowering
the value from0.05 to 0.0015 (adjustment for
34 tests).
We assessed how well randomization balanced observable characteristics of programs,
hospitals, patients, and residents between the
flexible-policy and standard-policy groups by comparing differences in means and frequencies
using Students t-tests and chi-square tests with
cluster-corrected P values. Program characteristics were obtained from the ABS, and hospitallevel characteristics were obtained from the American Hospital Association (AHA) annual survey.
Using an intention-to-treat approach, we modeled the association between patient outcomes
and study-group assignment using three-level
hierarchical logistic-regression models with

program-level and hospital-level random intercepts and controls for program-level strata of
2013 rates of postoperative death or serious
complications (i.e., performance in the previous
year was used as the stratifying variable in randomization).31,32 These analyses are referred to in
the results as unadjusted and were the primary
prespecified analyses. Given a noninferiority design with a 0.04 alpha level, 92% confidence intervals [100(12)] were used on the basis of
a two one-sided tests (TOST) approach.45,46 A
significant odds ratio of less than 1.00 favored
flexible policies over standard policies. Noninferiority was assessed by comparison of the odds
ratio and 92% confidence interval with the noninferiority margin expressed as an odds ratio.
An outcome was deemed to be noninferior if the
point estimate and upper boundary of the 92%
confidence interval were less than the prespecified noninferiority margin odds ratio of 1.15.
Analyses were also performed that adjusted for
any residual differences in patient demographic
characteristics, coexisting conditions, and procedural case mix35,38 (referred to in the results as
adjusted analyses). For secondary patient outcomes, the noninferiority margin was defined in
a manner analogous to that for the primary
outcome as a 13% relative difference in rates
Numerous additional prespecified analyses
were conducted to examine the sensitivity of our
results with respect to minor variations in modeling or estimation approaches (e.g., conditional
and population-averaged estimates). We performed
prespecified subgroup analyses of primary patient outcomes to test for significant interactions between study-group assignment and subgroups defined according to type of surgery
(emergency vs. elective), risk of death or serious
complications (highest quartile vs. lower three
quartiles of patients), and surgical setting (inpatient vs. outpatient).34
The association between resident outcomes
and study-group assignment was modeled with
the use of two-level hierarchical logistic regression with program-level random intercepts and
controls for program-level strata of 2013 rates of
postoperative death or serious complications
(i.e., the stratifying variable in randomization).31,32 A noninferiority margin for assessing
resident outcomes was not specified; thus, we
used two-tailed tests and standard 95% confidence intervals.
Prespecified sensitivity analyses were performed to examine the robustness of our results with respect to alternative modeling
approaches for resident outcomes (e.g., hierarchical ordered and multinomial logistic-regression models and conditional and populationaveraged estimates) and the inclusion of
additional program-level covariates. Prespecified subgroup analyses tested for significant
interactions between study-group assignment
and subgroups defined according to resident sex,
postgraduate year, program geographic region,
and program type (academic, community, or
military).
Because implementation and enforcement of
study-group conditions were at the discretion
of program directors (i.e., flexible-policy programs were not required to eliminate all four
policies waived by the ACGME), a separate
survey of residency program directors in the
FIRST Trial was conducted in June and July
2015 to collect data on program-level adherence
to study-group conditions (i.e., policy changes
enacted). Standard-policy programs were defined as adherent if their duty-hour policies
had zero departures from the four ACGME
duty-hour requirements regarding minimum
time off between shifts and maximum shift
length (Table1).31,32 Flexible-policy programs
were defined as adherent if they instituted at
least one of these four allowed policy changes.
Three types of analyses were undertaken to
explore the influence of adherence on our main
results: a per-protocol analysis (limited to adherent programs), an as-treated analysis (which
assessed actual exposure to policy change), and
analysis of local average treatment effects with
the use of instrumental variables, with studygroup assignment serving as an instrumental
variable for actual exposure to policy change
(see the Supplementary Appendix).31,32 No data
were collected regarding on-call schedules,
duty-hour logs, sleep, midlevel providers, handoff protocols, or adherence to policies that remained unchanged across the two study groups
(e.g., 80-hour workweek).
Analyses were conducted with the use of
Stata statistical software, release 13 (StataCorp).47 Details of our methods have been
described previously30-32 and can also be found
in the Supplementary Appendix and study protocol.

The
of
m e dic i n e
Table 2. Characteristics of the Residency Programs, Hospitals, Patients, and Residents According to Study Group.*
Characteristic
Total
Standard-Policy
Group
Flexible-Policy
Group
117
59
58
P Value
Residency programs
No. of programs
Program type no. (%)
Academic
70 (60)
37 (63)
33 (57)
Community
45 (38)
21 (36)
24 (41)
2 (2)
1 (2)
1 (2)
Northeast
34 (29)
14 (24)
20 (34)
Southeast
26 (22)
16 (27)
10 (17)
Midwest
33 (28)
18 (31)
15 (26)
Military
0.81
Geographic region no. (%)
Southwest
11 (9)
8 (14)
3 (5)
West
13 (11)
3 (5)
10 (17)
No. of chief residents per program
0.07
4.72.2
4.82.2
4.62.2
0.59
Proportion of international medical graduates
0.170.17
0.160.17
0.190.17
0.34
First-attempt pass rate on qualifying board examination, 20092013
88.68.0
89.08.5
88.47.5
0.65
First-attempt pass rate on certifying board examination, 20092014
83.910.7
84.910.4
83.011.0
0.27
Hospitals
No. of hospitals
148
70
78
Total bed capacity
578287
598290
560285
0.42
23,38716,089
23,23915,480
23,51916,716
0.92
Nurse-to-bed ratio
2.560.90
2.540.82
2.580.97
0.73
Resident-to-bed ratio
0.390.26
0.400.26
0.380.27
0.71
CMS case-mix index**
1.900.24
1.870.27
1.930.21
0.15
30-Day rate of postoperative death or serious complications in previous year, 2013
8.953.36
9.163.76
8.762.95
0.47
Total surgical volume
Patients
No. of patients
Age yr
Nonwhite race no. (%)
138,691
65,849
72,842
54.316.4
53.916.4
54.716.4
30,848 (22.2)
13,784 (20.9)
17,064 (23.4)
0.92
0.19
0.23
ASA classification score no. (%)

1
10,233 (7.4)
4,866 (7.4)
5,367 (7.4)
61,491 (44.3)
29,262 (44.4)
32,229 (44.2)
59,958 (43.2)
28,399 (43.1)
31,559 (43.3)
7,009 (5.1)
3,322 (5.0)
3,687 (5.1)
15,433 (11.1)
7,706 (11.7)
7,727 (10.6)
4 or 5
Emergency surgery no. (%)
0.80
Inpatient surgery no. (%)
82,698 (59.6)
39,451 (59.9)
43,247 (59.4)
0.83
Diabetes requiring medication no. (%)
20,743 (15.0)
10,067 (15.3)
10,676 (14.7)
0.26
<0.001
BMI classification no. (%)

Normal weight
35,187 (25.4)
16,327 (24.8)
18,860 (25.9)
Underweight
2,754 (2.0)
1,259 (1.9)
1,495 (2.1)
Overweight
40,990 (29.6)
19,221 (29.2)
21,769 (29.9)
Class I obesity
27,483 (19.8)
13,052 (19.8)
14,431 (19.8)
Class II obesity
14,822 (10.7)
7,162 (10.9)
7,660 (10.5)

Table 2. (Continued.)
Characteristic
Total
Class III obesity

COPD no. (%)
Preoperative SIRS, sepsis, or septic shock no. (%)
Flexible-Policy
Group
P Value
17,455 (12.6)
8,828 (13.4)
8,627 (11.8)
5,318 (3.8)
2,579 (3.9)
2,739 (3.8)
0.52
632 (0.5)
305 (0.5)
327 (0.4)
0.93
2,648 (1.9)
1,276 (1.9)
1,372 (1.9)
0.40
10,983 (7.9)
5,188 (7.9)
5,795 (8.0)
0.92
4330
2220
2110
Renal failure no. (%)

Functional status of partially or totally dependent
no. (%)
Standard-Policy
Group
Residents
No. of residents
Sex no. (%)
Female
1,737 (40.1)
866 (39.0)
871 (41.3)
Male
2,593 (59.9)
1,354 (61.0)
1,239 (58.7)
1,156 (26.7)
616 (27.7)
540 (25.6)
0.23
Postgraduate year no. (%)

2
1,081 (25.0)
554 (25.0)
527 (25.0)
872 (20.1)
438 (19.7)
434 (20.6)
628 (14.5)
313 (14.1)
315 (14.9)
593 (13.7)
299 (13.5)
294 (13.9)
Categorical
3,699 (85.4)
1,874 (84.4)
1,825 (86.5)
Preliminary
621 (14.3)
340 (15.3)
281 (13.3)
10 (0.2)
6 (0.3)
4 (0.2)
0.57
Resident type no. (%)
Other
0.73
* Plusminus values are means SD. COPD denotes chronic obstructive pulmonary disease, and SIRS the systemic inflammatory response syndrome.
The P value was calculated with the use of a two-tailed chi-square test.
Chief residents are fifth-year residents who are eligible to take the American Board of Surgery qualifying examination
(written boards).
The P value was calculated with the use of Students t-test.
Two hospitals were not included in the final patient-level analysis owing to data-availability issues. Two pairs of hospitals reported hospital data to the American Hospital Association jointly, and thus each pair was treated as a single
hospital-level unit in these analyses.
The P value was calculated with the use of hierarchical linear regression with program intercepts.
** The Centers for Medicare and Medicaid Services (CMS) case-mix index represents the average diagnosis-related group
(DRG) relative weight for that hospital, with higher values indicating that the hospital provides care for sicker patients.
Race was determined on the basis of clinical records by American College of Surgeons National Surgical Quality
Improvement Program abstractors at each site.
The P value was calculated with the use of hierarchical logistic regression with program intercepts.
An American Society of Anesthesiologists (ASA) classification score of 1 indicates a normal healthy patient, 2 a patient with mild systemic disease, 3 a patient with severe systemic disease, 4 a patient with severe systemic disease
that is a constant threat to life, and 5 a moribund patient who is not expected to survive without the operation.
The P value was calculated with the use of hierarchical multinomial logistic regression with program intercepts.
The body-mass index (BMI) is the weight in kilograms divided by the square of the height in meters. BMI classifications are as follows: underweight, less than 18.5; normal weight, 18.5 to 24.9; overweight, 25.0 to 29.9; class I obesity,
30.0 to 34.9; class II obesity, 35.0 to 39.9; and class III obesity, 40.0 or more.
R e sult s
Study Sample
Participating programs had more residents per

year, a lower proportion of international medical
graduates, and higher board-examination scores
than nonparticipating programs (Tables S31 and
S32 in the Supplementary Appendix). Our study
sample included 117 ACGME-accredited general

surgery residency programs and 151 affiliated
hospitals (Fig. S1 in the Supplementary Appendix), because 1 program and 3 hospitals dropped
out after randomization but before the trial start
date. Of these, 59 programs and their affiliated
71 hospitals were assigned to the standard-policy

The
group, and 58 programs and their 80 affiliated

hospitals were assigned to the flexible-policy
group. The study groups were well balanced with
respect to a broad range of program, hospital,
patient, and resident characteristics (Table2).
Patient Outcomes
Owing to issues with respect to the availability

of final data, 2 hospitals were dropped from the
final analysis, resulting in the loss of 2 programs in our sample for patient outcomes only
(Fig. S1 in the Supplementary Appendix). Two
pairs of hospitals, each pair from the same residency program, reported data under the same
AHA identification number, so each pair was
treated as a single unit for analysis. Thus, patient outcome analyses included 115 programs
(58 in the standard-policy group and 57 in the
flexible-policy group) and 148 hospitals (70 in
the standard-policy group and 78 in the flexiblepolicy group), which contributed data on 138,691
general surgery patients (65,849 in the standardpolicy group and 72,842 in the flexible-policy
group).
The rate of death or serious complications did
not differ significantly between study groups
(9.1% in the flexible-policy group and 9.0% in
the standard-policy group, P
=
0.92). Figure1
presents both unadjusted and adjusted (for patient characteristics) odds ratios comparing the
association between study-group assignment
and patient outcomes. The risk of death or serious complications did not differ significantly
between patients who underwent surgery in
hospitals affiliated with programs assigned to
flexible, less-restrictive duty-hour policies and
those who underwent surgery in standard-policy
hospitals (unadjusted odds ratio for the flexiblepolicy group, 0.96; 92% confidence interval [CI],
0.87 to 1.06; P=0.44; adjusted odds ratio, 0.96;
92% CI, 0.90 to 1.04; P=0.38) (Fig.1). The upper
boundaries of the 92% confidence interval from
both unadjusted and adjusted models were
greater than 1.00 but less than the noninferiority margin odds ratio of 1.15; thus, flexible
policies were deemed to be noninferior to standard policies with respect to death or serious
complications.
With respect to secondary outcomes, flexible
policies were noninferior to standard policies
with respect to serious complications, any complication, unplanned reoperation, sepsis, surgi8
of
m e dic i n e
cal-site infection, and urinary tract infection in

unadjusted and adjusted models (Fig.1). The
results were inconclusive for 30-day mortality in
the unadjusted analysis, but the noninferiority
criterion was met in the adjusted analysis. There
was no significant difference between study
groups with respect to failure to rescue and renal failure, but the upper boundary of the 92%
confidence interval exceeded the margin; therefore, noninferiority was not established for these
outcomes. The upper boundaries of the 92%
confidence intervals from unadjusted and adjusted analyses of the 30-day rate of postoperative pneumonia coincided exactly with the noninferiority margin.
There were no significant subgroup effects
for death or serious complications according to
type of surgery (emergency vs. elective), risk of
death or serious complications (highest quartile
vs. lower three quartiles of patients), or surgical
setting (inpatient vs. outpatient) (Table S13 in
the Supplementary Appendix). All results were
robust with respect to variations in modeling
specifications and the inclusion of additional
covariates for patients, hospitals, or both. The
results were qualitatively similar for conditional
and population-averaged estimates (Table S34 in
the Supplementary Appendix).
Resident Outcomes
ABSITE survey data were obtained for a total of

4330 general surgery residents who were undergoing training in 117 FIRST Trial programs (2110
residents in the flexible-policy group and 2220 in
the standard-policy group). Response rates varied
across survey items, ranging from 84 to 87% for
the outcomes examined (Tables S25 through S30
in the Supplementary Appendix).
With respect to the two primary resident outcomes, residents in flexible-policy programs
were not significantly more likely than those in
standard-policy programs to be dissatisfied (very
dissatisfied or dissatisfied vs. neutral, satisfied,
or very satisfied) with overall education quality
(11.0% in the flexible-policy group and 10.7% in
the standard-policy group, P=0.86; odds ratio
for the flexible-policy group, 1.08; 95% CI, 0.77
to 1.52; P=0.64) or overall well-being (14.9% and
12.0%, respectively; P=0.10; odds ratio, 1.31;
95% CI, 0.99 to 1.74; P=0.06) (Table3).
Flexible-policy residents were significantly
less likely than standard-policy residents to be

30-Day Postoperative Patients Included

Outcomes
in Analysis
Death or serious
complication
Unadjusted
Adjusted
Death
Unadjusted
Adjusted
Serious complication
Unadjusted
Adjusted
Any complication
Unadjusted
Adjusted
Failure to rescue
Unadjusted
Adjusted
Pneumonia
Unadjusted
Adjusted
Renal failure
Unadjusted
Adjusted
Unplanned reoperation
Unadjusted
Adjusted
Sepsis
Unadjusted
Adjusted
Surgical-site infection
Unadjusted
Adjusted
Urinary tract infection
Unadjusted
Adjusted
Odds Ratio (92% CI)
138,691
138,691
138,691
138,691
11,937
138,375
138,596
138,691
138,258
Regions of noninferiority
Superior
Noninferior
137,346
Inferior
Inconclusive
138,691
0.0
0.5
1.0
1.5
0.50 0.55 0.60 0.65 0.70 0.75 0.80 0.85 0.90 0.95 1.00 1.05 1.10 1.15 1.20 1.25 1.30 1.35 1.40 1.45 1.50
Flexible Policies Better
Standard Policies Better
Figure 1. Comparison of Postoperative Outcomes between Flexible, Less-Restrictive Duty-Hour Policies and Standard Policies.
In all regressions, 115 programs and 148 hospitals were included. Solid black circles indicate the unadjusted effect of assignment to the
flexible-policy group (vs. the standard-policy group). Open circles indicate the adjusted effect of assignment to the flexible-policy group
(vs. the standard-policy group), expressed as an odds ratio from similar models that also adjusted for patient characteristics. Estimates
reported are conditional estimates (not population-averaged effects) that were obtained from three-level hierarchical mixed-effects logistic-regression models. In these models, outcomes were regressed on assignment to the flexible-policy group (vs. the standard-policy
group) with controls for program-level strata of 30-day rates of postoperative death or serious complications in 2013 (variable used in
randomization) with program- and hospital-level random intercepts. To account for interim analysis, the alpha level was adjusted to
0.04 for the final analysis (alpha level for the overall trial, 0.05). Given a noninferiority design with a 0.04 alpha level, 92% confidence
intervals [100(12)] were used on the basis of a two one-sided tests (TOST) approach. Thus, error bars indicate 92% confidence
intervals, and shaded blue regions represent the area of noninferiority for each outcome. Flexible policies were considered to be noninferior to standard policies if the estimated odds ratio (circle) and upper boundary of the 92% confidence interval are contained within
the shaded region; inferior to standard policies if the estimated odds ratio and lower boundary of the 92% confidence interval are both
to the right, outside the shaded region for an outcome; and superior to standard policies if the estimated odds ratio and upper boundary of the 92% confidence interval are both within the shaded region and below 1.00 (see inset). If the estimated odds ratio is within the
shaded region but the upper boundary of the 92% confidence interval extends outside the region, the results were considered to be inconclusive. The number of patients per outcome differs because patients were excluded from the analysis if the condition was preexisting at the time of surgery. The number of patients is reduced for failure to rescue (i.e., death in a patient who had a serious complication), because only patients who had a serious complication were included in the analysis.

10
226/1876 (12.0)
Dissatisfaction with overall well-being
On patient safety
232/1782 (13.0)
330/1778 (18.6)
663/1888 (35.1)
148/1780 (8.3)
226/1782 (12.7)
240/1891 (12.7)
262/1888 (13.9)
172/1887 (9.1)
301/1892 (15.9)
168/1888 (8.9)
On professionalism
On job satisfaction
On satisfaction with career choice
On morale
On time with family and friends
427/1781 (24.0)
441/1779 (24.8)
294/1782 (16.5)
164/1777 (9.2)
373/1780 (21.0)
176/1887 (9.3)
172/1888 (9.1)
On case preparation away from hospital
262/1781 (14.7)
199/1782 (11.2)
On participation in research
523/1888 (27.7)
On time for teaching medical students
218/1780 (12.2)
431/1886 (22.9)
488/1892 (25.8)
<0.001
<0.001
0.73
0.92
0.43
0.002
<0.001
<0.001
<0.001
<0.001
3.66 (2.704.97)
1.09 (0.851.40)
1.03 (0.791.33)
0.94 (0.731.23)
0.65 (0.490.87)
2.81 (2.123.73)
3.37 (2.544.47)
0.45 (0.370.56)
0.38 (0.290.49)
0.47 (0.360.62)
0.30 (0.240.39)
0.20 (0.160.25)
0.22 (0.170.28)
0.26 (0.200.34)
0.22 (0.170.27)
0.24 (0.190.31)
0.16 (0.120.21)
0.40 (0.320.51)
1.41 (1.061.89)
0.95 (0.711.27)
0.99 (0.711.40)
0.69 (0.520.92)
0.44 (0.320.60)
0.85 (0.551.31)
1.31 (0.991.74)
1.08 (0.771.52)
Odds Ratio for FlexiblePolicy Group (95% CI)
<0.001
0.51
0.84
0.67
0.003
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
0.02
0.72
0.97
0.01
<0.001
0.46
0.06
0.64
P Value
of
On attendance at educational conferences
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
0.08
0.76
0.74
0.009
<0.001
0.48
0.10
0.86
P Value
On relationship between interns and residents
264/1781 (14.8)
651/1889 (34.5)
On availability for elective cases
266/1783 (14.9)
915/1887 (48.5)
845/1890 (44.7)
On operative volume
On availability for urgent cases
337/1781 (18.9)
On resident autonomy
232/1777 (13.1)
688/1888 (36.4)
928/1885 (49.2)
On clinical-skills acquisition
339/1786 (19.0)
1053/1892 (55.7)
223/1782 (12.5)
329/1768 (18.6)
214/1767 (12.1)
144/1768 (8.1)
124/1766 (7.0)
83/1769 (4.7)
62/1770 (3.5)
263/1769 (14.9)
194/1768 (11.0)
On operative-skills acquisition
On continuity of care
491/1891 (26.0)
280/1875 (14.9)
With time for rest
Perception of negative effect of institutional duty hours
161/1876 (8.6)
236/1874 (12.6)
With work hours and scheduling
190/1873 (10.1)
With quality and ease of handoffs and transitions in care
With duty-hour regulations of the program
77/1875 (4.1)
188/1876 (10.0)
With patient safety
With continuity of care
Dissatisfaction
Secondary outcomes
200/1874 (10.7)
no./total no. (%)
Standard-Policy Group Flexible-Policy Group
Dissatisfaction with overall quality of resident education
Primary outcomes
Outcome
Table 3. Resident-Reported Satisfaction and Perceptions of Well-Being, Education, and Patient Safety.*
The
m e dic i n e

118/1878 (6.3)
188/1774 (10.6)
544/1821 (29.9)
817/1944 (42.0)
901/1944 (46.3)
Missed an operation
Handed off an active patient issue
<0.001
<0.001
<0.001
0.17
0.26
<0.001
<0.001
<0.001
P Value
0.53 (0.450.63)
0.56 (0.450.69)
0.46 (0.320.65)
1.18 (0.911.53)
1.15 (0.911.47)
3.22 (2.374.36)
3.85 (2.885.15)
3.81 (2.845.11)
Odds Ratio for FlexiblePolicy Group (95% CI)
<0.001
<0.001
<0.001
0.21
0.25
<0.001
<0.001
<0.001
P Value
* Denominators represent the number of respondents per survey item in the trial sample of residents. Response rates varied across survey items, ranging from 84 to 87%. When the
Bonferroni correction was applied to the 34 resident outcomes assessed, the level of significance was adjusted from 0.05 to 0.0015, and the differences between the study groups
were no longer significant for three outcomes: time for rest, quality and ease of handoffs and transitions in care, and professionalism.
Cluster-corrected P values were calculated by means of a chi-square test of association between study-group assignment and dichotomized resident outcome.
Odds ratios and 95% confidence intervals (CI) and two-tailed P values were calculated by means of two-level hierarchical logistic regression with program-level random intercepts.
Models assessed the association between outcomes and study-group assignment, with adjustment for program-level strata based on 30-day rates of postoperative death or serious
complications in 2013 (stratifying variable for randomization). Significant odds ratios of less than 1.00 favor flexible policies over standard policies. Significant odds ratios of more
than 1.00 favor standard policies over flexible policies.
The numerator represents the number of residents who reported being very dissatisfied or dissatisfied versus neutral, satisfied, or very satisfied.
The numerator represents the number of residents who perceived a negative effect of 20142015 institutional duty hours versus no effect or a positive effect.
The numerator represents the number of residents who reported that fatigue always or often affects personal safety or patient safety versus sometimes, rarely, or never.
** The numerator represents the number of residents who reported one or more occurrences in the past month versus no occurrence.
583/1821 (32.0)
128/1821 (7.0)
133/1774 (7.5)
256/1944 (13.2)
Left during an operation
Occurrence during past month owing to duty-hour regulations**
175/1878 (9.3)
Fatigue always or often affects personal safety
Fatigue always or often affects patient safety
470/1781 (26.4)
178/1887 (9.4)
128/1883 (6.8)
On rest
On health
326/1778 (18.3)
458/1779 (25.7)
no./total no. (%)
Standard-Policy Group Flexible-Policy Group

172/1886 (9.1)
On time for extracurricular activities
Outcome
dissatisfied with continuity of care (odds ratio,

0.44; 95% CI, 0.32 to 0.60; P<0.001) and with the
quality and ease of handoffs and transitions in
care (odds ratio, 0.69; 95% CI, 0.52 to 0.92;
P=0.01) but were more likely to be dissatisfied
with time for rest (odds ratio, 1.41; 95% CI, 1.06
to 1.89; P=0.02) (Table3). There was no significant difference between study groups regarding
resident satisfaction with the duty-hour regulations of their program (odds ratio, 0.99; 95% CI,
0.71 to 1.40; P=0.97).
Flexible-policy residents were significantly
less likely than standard-policy residents to perceive a negative effect (vs. a positive effect or no
effect) of institutional duty-hour policies on patient safety, continuity of care, clinical-skills
acquisition, operative-skills acquisition, autonomy, operative volume, availability for elective and
urgent cases, conference attendance, time for
teaching medical students, the relationship between interns and residents, and professionalism (all odds ratios <1.00, P<0.001 for all comparisons except P=0.003 for professionalism)
(Table3). However, flexible-policy residents were
more likely to perceive negative effects of dutyhour policies on resident outcomes that depended on time away from the hospital, such as case
preparation after work, research participation,
time with family and friends, time for extracurricular activities, rest, and health (all odds ratios
>1.00, P<0.001 for all comparisons). Nonetheless, there were no significant differences between study groups regarding the perceived effects of duty hours on job satisfaction, satisfaction
with career choice, or morale (Table3). Study
group was also not associated with resident-reported frequency at which fatigue affected either
patient safety or personal safety (Table3).
In analyses of breaks in continuity of care,
flexible-policy residents were significantly less
likely than standard-policy residents to leave during an operation (7.0% vs. 13.2%, P<0.001; odds
ratio, 0.46; 95% CI, 0.32 to 0.65; P<0.001), miss an
operation (29.9% vs. 42.0%, P<0.001; odds ratio,
0.56; 95% CI, 0.45 to 0.69; P<0.001), or hand off
an active patient care issue (32.0% vs. 46.3%,
P<0.001; odds ratio, 0.53; 95% CI, 0.45 to 0.63;
P<0.001) at least once in the past month (Table3).
When correction for multiple comparisons
was applied, the differences in three resident
outcomes were no longer significant between

11
The
the standard-policy and flexible-policy groups:

resident satisfaction with time for rest, perception of the quality and ease of handoffs and
transitions in care, and perception of professionalism (P>0.0015 with correction for multiple
comparisons, for all comparisons). There were
no significant differences between the standardpolicy and flexible-policy groups in our residentreported primary outcomes in subgroups defined
according to resident sex, program geographic
region, or program type (Table S19 in the Supplementary Appendix). There were also no significant differences between the standard-policy
and flexible-policy groups in the primary outcomes in the subgroup defined according to
postgraduate year (first vs. second and third vs.
fourth and fifth) (Table S19 in the Supplementary Appendix). All results were robust with respect to minor variations in modeling specifications. The results were qualitatively similar for
conditional and population-averaged estimates
Adherence Analyses
Overall program-level adherence to study-group

conditions was 98% (97% in the standard-policy
group and 100% in the flexible-policy group)
(Tables S4 and S5 in the Supplementary Appendix). Thus, results of per-protocol, as-treated,
and instrumental-variables analyses were highly
consistent with intention-to-treat results for patient and resident outcomes (Tables S14 through
S18 and S20 through S24 in the Supplementary
Appendix). The number of policies waived at an
institution was not associated with death or serious complications, nor were there any significant effects of waiving specific policies on death
or serious complications.
Discussion
This national, prospective, randomized trial
showed that flexible, less-restrictive duty-hour
policies for surgical residents were noninferior to
standard ACGME duty-hour policies with respect
to our primary patient outcome of the 30-day rate
of postoperative death or serious complications.
There was also no significant difference between the standard-policy and flexible-policy
groups with respect to residents satisfaction
regarding their overall well-being and education.
12
of
m e dic i n e
Our finding of noninferior patient outcomes

under flexible, less-restrictive duty-hour policies
as compared with standard duty-hour policies
for most postoperative outcomes examined is
consistent with the results of previous studies.6,7,13-15,18-21 Moreover, there were no significant
differences between the standard-policy and
flexible-policy groups in outcomes for subgroups that may be more sensitive to differences
in duty-hour policies,8,48 including high-risk patients, inpatient surgeries, and emergency cases.
Thus, these findings suggest that flexible dutyhour policies appear to be safe for patient care.
Previous surveys showed that residents were
concerned about the negative effect of duty-hour
policies on patient care and resident education;
however, most generally did show improvements
in residents quality of life and well-being.6,16,19
Similarly, we found that residents in programs
with flexible duty-hour policies (as compared
with current ACGME duty-hour restrictions) noted numerous benefits with respect to nearly all
aspects of patient safety, continuity of care, surgical training, and professionalism. However,
residents reported that less-restrictive duty-hour
policies had a negative effect on time with family and friends, time for extracurricular activities, rest, and health. Importantly, although
there was a trend favoring standard policies with
respect to outcomes related to perceptions of
personal time, residents satisfaction with overall well-being did not differ significantly between study groups. Flexible-policy residents did
not report less satisfaction with their overall resident education, and they did not perceive that
fatigue affected their personal safety or patient
safety. There was also no significant difference
in satisfaction with duty-hour policies between
the study groups. These results suggest that
residents found that flexible duty-hour policies
improved multiple aspects of patient care and
resident education without an appreciable difference in their personal safety, but these benefits
came with the recognition that the flexible policies affected time for personal activities and
certain aspects of well-being.
Patient care and resident education can be
compromised by interruptions in continuity of
care (i.e., handoffs)22-24; thus, another important
finding in our study was that residents in the
flexible-policy group were about half as likely to

leave or miss an operation or hand off an active

patient care issue than were those in the standard-policy group. This suggests that the flexible, less-restrictive duty hours had their intended
effect of improving continuity of care, as further
reflected in the residents perceptions of benefit
with respect to continuity and patient safety in
the intervention group.
Several limitations should be acknowledged.
First, our study was limited to programs affiliated with ACS NSQIP hospitals, so the findings
may not be generalizable to programs not represented in ACS NSQIP. Second, we focused on
general surgery, and although our results may be
relevant to other surgical disciplines, they may
not be generalizable to nonsurgical specialties.
However, given differences in training requirements and previous evidence of differential effects of resident duty hours between surgery and
internal medicine,7 it may be reasonable to have
specialty-specific duty-hour requirements. Third,
we conducted this study for a full academic year,
but we cannot extrapolate the ways in which
flexible duty-hour policies might affect the training and experience of an entire cohort of surgical residents over multiple years. In addition, the
resident survey was conducted halfway through
the trial during standard dates for ABSITE administration. Although this eased data-collection
logistics and increased response rates, measures
of residents perceptions and experiences could
vary over a longer exposure period before survey
administration (i.e., residents perceptions over
time under flexible policies could improve as
they become accustomed to the policies or could
worsen if the effects are cumulatively strenuous).
Similarly, patient outcomes could improve or
worsen with more time under flexible duty-hour
policies. Fourth, our patient outcomes were limited to those captured in ACS NSQIP, so there
may be other outcomes that would be more
sensitive to resident duty-hour policies. Although
postoperative complications are the ultimate
outcomes that must be assessed for any change
in surgical duty-hour policies, we were unable to
collect data on medication errors and other potentially resident-sensitive outcomes. Given that
ACS NSQIP already performs data-quality checks
and audits (see the Supplementary Appendix), no
additional data-quality checks were performed
by the study team. Fifth, although there was no
significant difference between the standardpolicy and flexible-policy groups in residents

report that fatigue affected personal safety, we
did not specifically collect data on needle
sticks and car accidents, because these are notoriously challenging outcomes to capture in
surveys.
Finally, adherence to assigned study-group
policies was evaluated on the basis of a survey
of program directors and the policy changes implemented at that program. Although that does
not reflect resident-level adherence, the intention-to-treat analysis is the policy-relevant test:
programs are given the flexibility to change
policies, and outcomes reflect real-world implementation conditions, irrespective of the level
of adherence (i.e., whether they change no policies, one policy, or all four policies).
In conclusion, flexible duty-hour policies for
surgical residents were noninferior to current
ACGME duty-hour policies with respect to patient outcomes. Residents satisfaction regarding
their overall well-being and education quality
was similar in the flexible-policy and standardpolicy groups.
The results and conclusions in this article are the authors
own and do not represent the views of organizations providing
support or otherwise involved.
Results of the FIRST Trial were presented at the 11th Annual
Academic Surgical Congress, February 24, 2016, in Jacksonville, Florida.
Supported equally by the American Board of Surgery (ABS),
the American College of Surgeons (ACS), and the Accreditation
Council for Graduate Medical Education (ACGME).
Disclosure forms provided by the authors are available with
the full text of this article at NEJM.org.
We thank those who have contributed to the administration
and execution of the trial: Jonathan Fryer, M.D., Anne Grace,
Ph.D., Julie K. Johnson, Ph.D., Lindsey J. Kreutzer, M.P.H., Shari
Meyerson, M.D., Emily S. Pavey, M.A., Sean Perry, J.D., Christopher M. Quinn, M.S., Alfred Rademaker, Ph.D., and Ravi Rajaram, M.D. (Northwestern University); Judy Shea, Ph.D. (University of Pennsylvania); Sameera Ali, M.P.H., Amy Hart, B.S.,
Emma Malloy, B.A., Brian Matel, B.A., Craig Miller, B.S.E.E.,
Lynn Modla, M.S., Ajit Sachdeva, M.D., and Lynn Zhou, Ph.D.
(ACS); James Hebert, M.D. (University of Vermont); Michael Englesbe, M.D., M.P.H., and Paul Gauger, M.D. (University of
Michigan); Christine V. Kinnier, M.D. (Massachusetts General
Hospital); Joseph Cofer, M.D. (University of Tennessee, Chattanooga); Mitchell Posner, M.D. (University of Chicago); Eugene
Foley, M.D. (University of Wisconsin); Thomas Louis, Ph.D.
(Johns Hopkins); Thomas Biester, M.S., and Andrew Jones,
Ph.D. (ABS); Rebecca Miller, M.S., Thomas Nasca, M.D., and
John Potts, M.D. (ACGME); Margaret M. Class (Defense Health
Agency); all the surgeon champions and surgical clinical reviewers at the 151 participating ACS National Surgical Quality Improvement Program hospitals; and all the program directors and
program coordinators at the 117 participating general surgery
residency programs (see the Supplementary Appendix).

13
The
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The

National Cluster-Randomized Trial

We conducted a national, cluster-randomized, pragmatic, noninferiority trial involving

In an analysis of data from 138,691 patients, flexible, less-restrictive duty-hour policies

From the Surgical Outcomes and Quality

As compared with standard duty-hour policies, flexible, less-restrictive duty-hour policies

The New England Journal of Medicine

n response to concerns about patient

The New England Journal of Medicine

Duty-Hour Flexibility in Surgical Tr aining

Table 1. Duty-Hour Requirements and Adherence Rates According to Study Group.*

PGY 1 (interns): Duty periods may

PGY 1 (interns): Duty periods can

PGY 25 (residents): Duty periods

PGY 25 (residents): Duty periods

Residents are not required to have

Residents must have 14 hr off after 24 hr of continuous duty

Residents are not required to have

Maximum work hr/wk

Residents must not work >80 hr/

Residents must not work >80 hr/

Mandatory time free of duty

Residents must have 1 in every

Residents must have 1 in every

Frequency of on-call duty

Residents must not be on call

Residents must not be on call

strata on the basis of the rates in 2012 and 2013

The New England Journal of Medicine

Our primary patient outcome was based on the

Using general surgery data from hospitals in 2012

raw rate of death or serious complications of

The New England Journal of Medicine

Duty-Hour Flexibility in Surgical Tr aining

The New England Journal of Medicine

Geographic region no. (%)

No. of chief residents per program

Proportion of international medical graduates

First-attempt pass rate on qualifying board examination, 20092013

First-attempt pass rate on certifying board examination, 20092014

Total bed capacity

CMS case-mix index**

30-Day rate of postoperative death or serious complications in previous year, 2013

Total surgical volume

ASA classification score no. (%)

Inpatient surgery no. (%)

Diabetes requiring medication no. (%)

BMI classification no. (%)

The New England Journal of Medicine

Duty-Hour Flexibility in Surgical Tr aining

Class III obesity

Preoperative SIRS, sepsis, or septic shock no. (%)

Renal failure no. (%)

Postgraduate year no. (%)

Resident type no. (%)

Participating programs had more residents per

sample included 117 ACGME-accredited general

The New England Journal of Medicine

group, and 58 programs and their 80 affiliated

Owing to issues with respect to the availability