Cited by 460Hospital Admissions and OutcomesInnovations in Medical EducationPatient Safety and Medication Errors

National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training

Open access
Bilimoria, Karl Y., Chung, Jeanette W., Hedges, Larry V., Dahlke, Allison R., Love, Remi, Cohen, Mark E., Hoyt, David B., Yang, Anthony D. +8 more·2016·New England Journal of Medicine

Abstract

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 (2014-2015 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 flexible-policy group and 10.7%…

Integrity signals

Registry

Crossref · 10.1056/nejmoa1515724

Cites

41 of 41 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 39 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    There were no significant subgroup effects for death or serious complications according to risk of death or serious complications (highest quartile vs. lower three quartiles of patients).

    “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).”
    Quote in the paperNot a substantial claim
  • Findingown data

    There were no significant subgroup effects for death or serious complications according to type of surgery (emergency vs. elective).

    “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).”
    Quote in the paperNot a substantial claim
  • Findingown data

    Noninferiority was not established for renal failure.

    “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.”
    Quote in the paperSubstantial claim
  • Findingown data

    Flexible policies were noninferior to standard policies with respect to unplanned reoperation.

    “With respect to secondary outcomes, flexible policies were noninferior to standard policies with respect to serious complications, any complication, unplanned reoperation, sepsis, surgicalsite infection, and urinary tract infection in unadjusted and adjusted models (Fig. 1).”
    Quote in the paperSubstantial claim
  • Findingown data

    Noninferiority was not established for failure to rescue.

    “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.”
    Quote in the paperSubstantial claim
  • May combine two claims. 20
  • Classified as probably not a substantial claim. 21
  • May combine two claims.

    Findingown data

    For 30-day mortality, the results were inconclusive in the unadjusted analysis, but the noninferiority criterion was met in the adjusted analysis.

    “The results were inconclusive for 30-day mortality in the unadjusted analysis, but the noninferiority criterion was met in the adjusted analysis.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The results were qualitatively similar for conditional and population-averaged estimates.

    “The results were qualitatively similar for conditional and population-averaged estimates (Table S34 in the Supplementary Appendix).”
    • Also stated in: § Duty-Hour Flexibility in Surgical Tr aining · plain
      “The results were qualitatively similar for conditional and population-averaged estimates (Table S35 in the Supplementary Appendix).”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Findingown data

    Patient outcome analyses included 115 programs and 148 hospitals, which contributed data on 138,691 general surgery patients.

    “Thus, patient outcome analyses included 115 programs (58 in the standard-policy group and 57 in the flexiblepolicy group) and 148 hospitals (70 in the standard-policy group and 78 in the flexible-policy group), which contributed data on 138,691 general surgery patients (65,849 in the standard-policy group and 72,842 in the flexible-policy group).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    The study sample included 117 ACGME-accredited general surgery residency programs and 151 affiliated hospitals because 1 program and 3 hospitals dropped out after randomization but before the trial start date.

    “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.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Flexible-policy residents were significantly less likely than standard-policy residents to perceive a negative 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,

    “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”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    There were no significant differences between study groups regarding the perceived effects of duty hours on job satisfaction, satisfaction with career choice, or morale.

    “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 (Table 3).”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    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.

    “Importantly, although there was a trend favoring standard policies with respect to outcomes related to perceptions of personal time, residents' satisfaction with overall wellbeing did not differ significantly between study groups.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    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.

    “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.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    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.

    “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.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    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.

    “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.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    When correction for multiple comparisons was applied, the differences in three resident outcomes were no longer significant between 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

    “When correction for multiple comparisons was applied, the differences in three resident outcomes were no longer significant between 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”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    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.

    “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).”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The ACS NSQIP data abstractors were not specifically informed of the study-group assignments.

    “The ACS NSQIP data abstractors were not specifically informed of the study-group assignments.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Premisecitation

    The Accreditation Council for Graduate Medical Education 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.

    “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”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [1] 1. Accreditation Council for Graduate Medical Education. Resident duty hours in the learning and working environ- ment: comparison of 2003 and 2011 stan- dards (https:/ / www .acgme .org/ acgmeweb/ Portals/ 0/ PDFs/ dh-ComparisonTable2003 v2011 .pdf). source
    • cites [2] 2. Philibert I, Friedmann P, Williams WT. New requirements for resident duty hours. JAMA 2002; 288: 1112-4. source
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Primary resident outcome measures were specified before trial initiation.

    “Primary resident outcome measures were specified before trial initiation and included residentreported level of satisfaction (very dissatisfied, dissatisfied, neutral, satisfied, or very satisfied) with overall quality of resident education and overall well-being.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The Institute of Medicine called for additional high-level research to inform policy on resident duty hours.

    “In a widely cited report on resident duty hours, the Institute of Medicine called for additional high-level research to inform policy.3”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [3] 3. Institute of Medicine. Resident duty hours: enhancing sleep, supervision, and safety. Washington, DC: National Acade- mies Press, 2008.

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductcitation

    Survey items were adapted from previously published surveys, pretested with residents through cognitive interviews, and iteratively revised.

    “Survey items were adapted from previous ly published surveys, pretested with residents through cognitive interviews, and iteratively revised.32”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [32] 32. Bilimoria KY, Chung JW, Hedges LV, et al. Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial protocol: a national cluster-randomized trial of resident duty hour policies. JAMA Surg 2015 December 30 (Epub ahead of print).

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    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.

    “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).”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Study design and conductcitation

    The study was a prospective, cluster-randomized, pragmatic, noninferiority trial comparing standard ACGME duty-hour policies with flexible duty-hour policies.

    “This study was a prospective, cluster-randomized, pragmatic, noninferiority trial comparing stan-dard ACGME duty-hour policies with flexible duty-hour policies.32”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [32] 32. Bilimoria KY, Chung JW, Hedges LV, et al. Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial protocol: a national cluster-randomized trial of resident duty hour policies. JAMA Surg 2015 December 30 (Epub ahead of print).

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Premisecitation

    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.

    “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”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [1] 1. Accreditation Council for Graduate Medical Education. Resident duty hours in the learning and working environ- ment: comparison of 2003 and 2011 stan- dards (https:/ / www .acgme .org/ acgmeweb/ Portals/ 0/ PDFs/ dh-ComparisonTable2003 v2011 .pdf). source
    • cites [4] 4. Nasca TJ, Day SH, Amis ES Jr. The new recommendations on duty hours from the ACGME Task Force. N Engl J Med 2010; 363(2): e3. source
    • cites [5] 5. Accreditation Council for Graduate Medical Education. The ACGME 2011 duty hour standards: enhancing quality of care, supervision, and resident professional devel- opment (http://www .acgme .org/ acgmeweb/ Portals/ 0/ PDFs/ jgme-monograph[1] .pdf).

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Residents were not specifically kept from knowing their study-group assignment.

    “Residents were not specifically kept from knowing their studygroup assignment.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Response rates varied across survey items, ranging from 84 to 87% for the outcomes examined.

    “Response rates varied across survey items, ranging from 84 to 87% for the outcomes examined (Tables S25 through S30 in the Supplementary Appendix).”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S1 (asserted).

    Premisecitation

    Critics cite a weak evidence base for the 2003 and 2011 duty-hour reforms.

    “critics cite a weak evidence base for the 2003 and 2011 reforms.3,6,7”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [3] 3. Institute of Medicine. Resident duty hours: enhancing sleep, supervision, and safety. Washington, DC: National Acade- mies Press, 2008.

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [6] 6. Ahmed N, Devitt KS, Keshet I, et al. A systematic review of the effects of resi- dent duty hour restrictions in surgery: impact on resident wellness, training, and patient outcomes. Ann Surg 2014; 259: 1041-53. source
    • cites [7] 7. Philibert I, Nasca T, Brigham T, Sha- piro J. Duty-hour limits and patient care and resident outcomes: can high-quality studies offer insight into complex rela- tionships? Annu Rev Med 2013; 64: 467-83. source
  • Classified as probably not a substantial claim.

    Study design and conductown data

    An intention-to-treat approach was used to model the association between patient outcomes and study-group assignment.

    “Using an intention-to-treat approach, we modeled the association between patient outcomes and study-group assignment using threelevel 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”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim.

    Premisecitation

    Several retrospective studies and systematic reviews have questioned whether duty-hour reforms achieved their intended goals of improved patient outcomes, resident education, and resident well-being.

    “Several retrospective studies and systematic reviews have questioned whether duty-hour reforms achieved their intended goals of improved patient outcomes, resident education, and resident well-being.[6][7][8][9][10][11][12][13][14][15][16][17][18]”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [6] 6. Ahmed N, Devitt KS, Keshet I, et al. A systematic review of the effects of resi- dent duty hour restrictions in surgery: impact on resident wellness, training, and patient outcomes. Ann Surg 2014; 259: 1041-53. source
    • cites [7] 7. Philibert I, Nasca T, Brigham T, Sha- piro J. Duty-hour limits and patient care and resident outcomes: can high-quality studies offer insight into complex rela- tionships? Annu Rev Med 2013; 64: 467-83. source
    • cites [8] 8. Rajaram R, Chung JW, Jones AT, et al. Association of the 2011 ACGME resident duty hour reform with general surgery pa- tient outcomes and with resident exami- nation performance. JAMA 2014; 312: 2374-84.

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Many studies have suggested that duty-hour reforms resulted in improved well-being and less fatigue among surgical residents.

    “However, many studies have suggested that dutyhour reforms resulted in improved well-being and less fatigue among surgical residents.6”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [6] 6. Ahmed N, Devitt KS, Keshet I, et al. A systematic review of the effects of resi- dent duty hour restrictions in surgery: impact on resident wellness, training, and patient outcomes. Ann Surg 2014; 259: 1041-53. source
  • May combine two claims.

    Interpretationown data

    The study was conducted for a full academic year, but the authors 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.

    “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.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Interpretationnone given

    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.

    “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.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

    Interpretationnone given

    Patient outcomes could improve or worsen with more time under flexible duty-hour policies.

    “Similarly, patient outcomes could improve or worsen with more time under flexible duty-hour policies.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationown data

    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.

    “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.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationnone given

    The study focused on general surgery, and although the results may be relevant to other surgical disciplines, they may not be generalizable to nonsurgical specialties.

    “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.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    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.

    “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”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [6] 6. Ahmed N, Devitt KS, Keshet I, et al. A systematic review of the effects of resi- dent duty hour restrictions in surgery: impact on resident wellness, training, and patient outcomes. Ann Surg 2014; 259: 1041-53. source
    • cites [16] 16. Drolet BC, Christopher DA, Fischer SA. Residents' response to duty-hour regulations -a follow-up national survey. N Engl J Med 2012; 366(24): e35. source
    • cites [19] 19. Antiel RM, Reed DA, Van Arendonk KJ, et al. Effects of duty hour restrictions on core competencies, education, quality of life, and burnout among general sur- gery interns. JAMA Surg 2013; 148: 448- 55. source
  • Classified as probably not a substantial claim.

    Study design and conductnone given

    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.

    “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.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    Given a noninferiority design with a 0.04 alpha level, 92% confidence intervals were used on the basis of a two one-sided tests (TOST) approach.

    “Given a noninferiority design with a 0.04 alpha level, 92% confidence intervals [100 × (1 -2α)] were used on the basis of a”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    Given that ACS NSQIP already performs data-quality checks and audits, no additional data-quality checks were performed by the study team.

    “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.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning

    The authors did not specifically collect data on needle sticks and car accidents.

    “Fifth, although there was no significant difference between the standard-policy 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.”
    Quote in the paperNot a substantial claim
36 of 36
  • The paper relies on this without support.

    Residency program directors' reports accurately reflect the duty-hour policies followed at their institutions during the trial period.

    “Program adherence was defined by residency program directors regarding which policies were followed at their institution during the trial period (100% response rate).”
  • The paper relies on this without support.

    Policies that remained unchanged across the two study groups (e.g., the 80-hour workweek) were adhered to by programs.

    “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).”
  • The paper relies on this without support.

    Resident survey responses accurately reflect residents' perceptions and experiences.

    “Response rates varied across survey items, ranging from 84 to 87%.”
  • The paper relies on this without support.

    The noninferiority margin (shaded region) used in the trial is clinically appropriate.

    “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”
  • The paper relies on this without support.

    The program-level strata based on 30-day rates of postoperative death or serious complications in 2013 is an adequate stratifying variable for the trial.

    “with controls for program-level strata of 30-day rates of postoperative death or serious complications in 2013 (variable used in randomization)”
5 of 5

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Neither the FIRST nor the iCOMPARE trial suggested that limiting work hours is harmful to patient safety.

    “In any case, neither of these studies suggested limiting work hours is harmful to patient safety.”

    From National improvements in resident physician-reported patient safety after limiting first-year resident physicians’ extended duration work shifts: a pooled analysis of prospective cohort studies (2023) · cites this paper as [17]

    The FIRST paper reports no significant difference in its primary patient outcome between standard and flexible duty-hour policies (Discussion). But it also explicitly suggests that restrictions could jeopardize patient safety by increasing handoffs, and reports better continuity of care under flexible policies (Introduction and Discussion). Thus, its copy contradicts the categorical claim that FIRST did not suggest a potential safety harm from limiting hours; it does not assess iCOMPARE. (LLM, conf=0.81)

    Checked by a reasoning model — may be wrong.

    Experimental — accuracy not yet measured
  • A limitation of several studies that informed the policy change is that the primary end points lacked sensitivity or were only tangentially related to the care provided by first-year resident physicians.

    “A limitation of several studies that informed this latest policy change is that the primary end points lacked sensitivity (eg, hospital-wide mortality) or were only tangentially related to the care provided by first-year resident physicians”

    From National improvements in resident physician-reported patient safety after limiting first-year resident physicians’ extended duration work shifts: a pooled analysis of prospective cohort studies (2023) · cites this paper as [19]

    The Discussion (page unavailable) acknowledges that the trial’s patient outcomes may be less sensitive to duty-hour policies than outcomes it did not collect, such as medication errors. The Measures section (page unavailable) identifies postoperative death or serious complications as this trial’s primary patient outcome. The paper does not establish that several studies informing the policy change had insensitive endpoints, or characterize that outcome as only tangentially related to care by first-year residents. (LLM, conf=0.83)

    Experimental — accuracy not yet measured
  • Several studies of the 16 hours 2011 ACGME work-hour limit found that it had no impact on hospital-level mortality or mortality following surgical procedures.

    “Several studies of the 16 hours 2011 ACGME work-hour limit found that it had no impact on hospital-level mortality or mortality following surgical procedures.”

    From National improvements in resident physician-reported patient safety after limiting first-year resident physicians’ extended duration work shifts: a pooled analysis of prospective cohort studies (2023) · cites this paper as [17]

    The paper’s introductory discussion says that most surgical studies found no difference or worse postoperative outcomes after duty-hour reforms, and its Patient Outcomes section reports no significant difference in postoperative death between its flexible- and standard-policy groups (page not available in our copy). It does not establish that several studies of the specific 2011 16-hour limit found no effect on both hospital-level mortality and mortality after surgery; its own trial compared policies in 2014–2015. (LLM, conf=0.84)

    Experimental — accuracy not yet measured
  • In the FIRST trial, mortality following general surgery was not inferior at teaching hospitals allowed to exceed the 16-hour 2011 ACGME work-hour limit compared with hospitals assigned to follow those limits.

    “The mortality rate following general surgery was not inferior at teaching hospitals allowed to exceed the 16 hours 2011 ACGME work-hour limit compared with hospitals assigned to follow those limits.17”

    From National improvements in resident physician-reported patient safety after limiting first-year resident physicians’ extended duration work shifts: a pooled analysis of prospective cohort studies (2023) · cites this paper as [17]

    The Patient Outcomes section reports that 30-day mortality met the noninferiority criterion in the adjusted analysis, but the unadjusted analysis was inconclusive. The citing sentence omits that qualification and presents mortality noninferiority without qualification. (LLM, conf=0.86)

    Experimental — accuracy not yet measured
  • The FIRST Trial found surgical complication and death rates were no worse under flexible duty-hour rules without shift-length restrictions than under standard rules.

    “a national, prospective, cluster-randomized trial of surgical residency programs that showed that surgical-complication and death rates were no worse under flexible duty-hour rules (without restrictions on shift length) than under standard rules.”

Cites

Flagged first, then by citations

Research works printed but not linked: 3

  1. Institute of Medicine. Resident duty hours: enhancing sleep, supervision, and safety. Washington, DC: National Academies Press, 2008.
  2. Rajaram R, BMJ Qual Saf
  3. Bilimoria KY, JAMA Surg

Cited by

Sorted by citations

Authors
Bilimoria, K. Y., Chung, J. W., Hedges, L. V., Dahlke, A. R., Love, R., Cohen, M. E., Hoyt, D. B., Yang, A. D., Tarpley, J. L., Mellinger, J. D., Mahvi, D. M., Kelz, R. R., Ko, C. Y., Odell, D. D., Stulberg, J. J., & Lewis, F. R.
Affiliations
Northwestern University (US)
Venue
New England Journal of Medicine
Published
2016-02-25
Volume
374
Issue
8
Pages
713-727
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2324257729
Cited by
460
References
40
Citations by year
2026: 19 · 2025: 30 · 2024: 25 · 2023: 27 · 2022: 31 · 2021: 39 · 2020: 60 · 2019: 70 · 2018: 41 · 2017: 67 · 2016: 50
FWCI
100.53
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Massachusetts General Hospital
  • University of Pennsylvania
  • Northwestern University
  • Johns Hopkins University
  • University of Tennessee at Chattanooga
  • Defense Health Agency
Topics
  • Health Sciences › Medicine › Emergency Medicine › Hospital Admissions and Outcomes
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Innovations in Medical Education
  • Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
Keywords
surgical residency, resident fatigue, postoperative complications, resident well-being, resident education, patient safety, continuity of care, Accreditation Council for Graduate Medical Education, non-inferiority, shift length, resident satisfaction, professionalism, personal activity
MeSH terms
Accreditation, Continuity of Patient Care, Education, Medical, Graduate, Fatigue, Hospital Administration, Humans, Internship and Residency, Job Satisfaction, Personnel Staffing and Scheduling, Postoperative Complications, General Surgery, Surgical Procedures, Operative, United States, Work Schedule Tolerance, Workload, Patient Safety

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-11.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-11.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

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