National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training
Open accessAbstract
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%…
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- 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
- Findingown data
All results were robust with respect to variations in modeling specifications and the inclusion of additional covariates for patients, hospitals, or both.
“All results were robust with respect to variations in modeling specifications and the inclusion of additional covariates for patients, hospitals, or both.”
Quote in the paperNot a substantial claim - Findingown data
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.
“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.”
Quote in the paperNot a substantial claim - Findingown data
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).
“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).”
Quote in the paperSubstantial claim - Findingown data
Flexible policies were deemed noninferior to standard policies with respect to death or serious complications.
“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.”
Quote in the paperSubstantial claim - Findingown data
Flexible policies were noninferior to standard policies with respect to surgical-site infection.
“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
Flexible policies were noninferior to standard policies with respect to sepsis.
“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
There were no significant subgroup effects for death or serious complications according to surgical setting (inpatient vs. outpatient).
“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
Flexible policies were noninferior to standard policies with respect to serious complications.
“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
Residents in flexible-policy programs were not significantly more likely than those in standard-policy programs to be dissatisfied with overall well-being.
“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)”
Quote in the paperSubstantial claim - Findingown data
There was no significant difference between study groups with respect to 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 paperNot a substantial claim - Findingown data
There was no significant difference between study groups with respect to 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 paperNot a substantial claim - Findingown data
Flexible policies were noninferior to standard policies with respect to urinary tract infection.
“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
Residents in flexible-policy programs were not significantly more likely than those in standard-policy programs to be dissatisfied with overall education quality.
“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 =”
Quote in the paperSubstantial claim - Findingown data
ABSITE survey data were obtained for a total of 4330 general surgery residents in 117 FIRST Trial programs.
“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).”
Quote in the paperSubstantial claim - Findingown data
Flexible policies were noninferior to standard policies with respect to any complication.
“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
Residents in the flexible-policy group were less likely than those in the standard-policy group to report handing off active patient issues (32.0% vs. 46.3%, P<0.001).
“or handing off active patient issues (32.0% vs. 46.3%,P<0.001).”
Quote in the paperSubstantial claim - Findingown data
Residents under flexible policies were more likely than those under standard policies to perceive negative effects of duty-hour policies on personal activities.
“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.”
Quote in the paperNot a substantial claim - Findingown data
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.
“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.”
Quote in the paperSubstantial claim - Findingown data
Flexible-policy residents were more likely than standard-policy residents to be dissatisfied with time for rest (odds ratio, 1.41; 95% CI, 1.06 to 1.89; P = 0.02).
“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)”
Quote in the paperSubstantial claim - Findingown data
There were no significant differences between the standard-policy and flexible-policy groups in resident-reported primary outcomes in subgroups defined according to resident sex, program geographic region, or program type.
“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 Sup-”
Quote in the paperNot a substantial claim - Findingown data
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).
“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).”
Quote in the paperNot a substantial claim - Findingown data
There were no significant differences between study groups in resident-reported perception of the effect of fatigue on personal or patient safety.
“There were no significant differences between study groups in resident-reported perception of the effect of fatigue on personal or patient safety.”
Quote in the paperNot a substantial claim - Findingown data
There was no significant difference between the standard-policy and flexible-policy groups with respect to residents' satisfaction regarding their overall well-being and education.
“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.”
Quote in the paperSubstantial claim - Findingown data
Residents' satisfaction regarding their overall well-being and education quality was similar in the flexible-policy and standard-policy groups.
“Residents' satisfaction regarding their overall well-being and education quality was similar in the flexible-policy and standard-policy groups.”
Quote in the paperSubstantial claim - Findingown data
Flexible-policy residents were significantly less likely than standard-policy residents to miss an operation at least once in the past month (29.9% vs. 42.0%, P<0.001; odds ratio, 0.56; 95% CI, 0.45 to 0.69; P<0.001).
“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;”
Quote in the paperSubstantial claim - Findingown data
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).
“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)”
Quote in the paperSubstantial claim - Findingown data
Flexible-policy residents were significantly less likely than standard-policy residents to hand off an active patient care issue at least once in the past month (32.0% vs. 46.3%, P<0.001; odds ratio, 0.53; 95% CI, 0.45 to 0.63; P<0.001).
“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;”
Quote in the paperSubstantial claim - Findingown data
Flexible-policy residents were significantly less likely than standard-policy residents to be dissatisfied 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).
“Flexible-policy residents were significantly less likely than standard-policy residents to be 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)”
Quote in the paperSubstantial claim - Findingown data
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.
“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.”
Quote in the paperSubstantial claim - Findingown data
There were no significant differences between the standard-policy and flexible-policy groups in primary outcomes in the subgroup defined according to postgraduate year (first vs. second and third vs. fourth and fifth).
“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).”
Quote in the paperNot a substantial claim - Findingown data
Flexible-policy residents were significantly less likely than standard-policy residents to leave during an operation at least once in the past month (7.0% vs. 13.2%, P<0.001; odds ratio, 0.46; 95% CI, 0.32 to 0.65; P<0.001).
“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;”
Quote in the paperSubstantial claim - Findingown data
Flexible-policy residents were significantly less likely than standard-policy residents to be dissatisfied with continuity of care (odds ratio, 0.44; 95% CI, 0.32 to 0.60; P<0.001).
“Flexible-policy residents were significantly less likely than standard-policy residents to be dissatisfied with continuity of care (odds ratio, 0.44; 95% CI, 0.32 to 0.60; P<0.001)”
Quote in the paperSubstantial claim - Findingown data
Study group was not associated with resident-reported frequency at which fatigue affected either patient safety or personal safety.
“Study group was also not associated with resident-reported frequency at which fatigue affected either patient safety or personal safety (Table 3).”
Quote in the paperSubstantial claim - Findingown data
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, including high-risk patients, inpatient surgeries, and emergency cases.
“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.”
Quote in the paperSubstantial claim - Findingown data
There was no significant difference in satisfaction with duty-hour policies between the study groups.
“There was also no significant difference in satisfaction with duty-hour policies between the study groups.”
Quote in the paperSubstantial claim - Findingown data
Flexible-policy residents were more likely to perceive negative effects of duty-hour 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).
“However, flexible-policy residents were more likely to perceive negative effects of duty-hour 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).”
Quote in the paperNot a substantial claim - Study design and conductown data
The study groups were well balanced with respect to a broad range of program, hospital, patient, and resident characteristics.
“The study groups were well balanced with respect to a broad range of program, hospital, patient, and resident characteristics (Table 2).”
Quote in the paperSubstantial claim - Study design and conductcitation
Patient-level data were obtained from ACS NSQIP, a validated system for collection of high-quality clinical data to measure surgical outcomes.
“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”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [33] 33. American College of Surgeons Na- tional Surgical Quality Improvement Pro- gram (ACS NSQIP) (http://site .acsnsqip .org).
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- cites [35] 35. Cohen ME, Ko CY, Bilimoria KY, et al. Optimizing ACS NSQIP modeling for evaluation of surgical quality and risk: patient risk adjustment, procedure mix adjustment, shrinkage adjustment, and sur- gical focus. J Am Coll Surg 2013; 217(2): 336-46.e1. source
- cites [42] 42. The American Board of Surgery In- Training Exam (ABSITE) (http://www .absurgery .org/ default .jsp?examoffered_gs).
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Study design and conductcitation
The 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 Forum-endorsed metric (NQF#0697).
“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 Forum-endorsed metric (NQF#0697).36,37”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [36] 36. Merkow RP, Hall BL, Cohen ME, et al. Validity and feasibility of the American College of Surgeons colectomy composite outcome quality measure. Ann Surg 2013; 257: 483-9. source
- cites [37] 37. American College of Surgeons Na- tional Surgical Quality Improvement Pro- gram semiannual report: January 2015. Chicago: American College of Surgeons.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Study design and conductown data
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.
“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”
Quote in the paperSubstantial claim - Premisecitation
In surgical settings, most studies have shown no difference or a worsening in patient postoperative outcomes and resident education after duty-hour reforms.
“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][14][15][18][19][20][21]”
Quote in the paperSubstantial 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
- Study design and conductown data
A noninferiority margin was specified before trial initiation as an absolute difference of 1.25 percentage points (13% relative difference, corresponding to a noninferiority margin odds ratio of 1.15).
“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”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [31] 31. The Flexibility in Duty Hour Require- ments for Surgical Trainees Trial study protocol and statistical analysis plan (http://www .thefirsttrial .org/ Documents/ FIRSTTRIAL_StatisticalAnalysisPlan_ Updated03NOV2015 .pdf).
Couldn’t be matched to a paper in Crossref, so it can’t be 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.
- Study design and conductcitation
Programs and their hospital affiliates were randomly assigned as clusters within strata to one of two study groups.
“Programs and their hospital affiliates were then randomly assigned as clusters within strata to one of two study groups.39”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [39] 39. Bilimoria KY, Hoyt DB, Lewis F. Mak- ing the case for investigating flexibility in duty hour limits for surgical residents. JAMA Surg 2015; 150: 503-4.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Study design and conductreasoning
The level of statistical significance for final analyses of patient outcomes was adjusted to 0.04 because one midpoint interim analysis was performed.
“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”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [31] 31. The Flexibility in Duty Hour Require- ments for Surgical Trainees Trial study protocol and statistical analysis plan (http://www .thefirsttrial .org/ Documents/ FIRSTTRIAL_StatisticalAnalysisPlan_ Updated03NOV2015 .pdf).
Couldn’t be matched to a paper in Crossref, so it can’t be 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.
- cites [44] 44. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG. Reporting of non- inferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA 2012; 308: 2594-604. source
- Premisecitation
Evidence from large, prospective, randomized trials to inform duty-hour regulations is currently lacking.
“Evidence from large, prospective, randomized trials to inform duty-hour regulations is currently lacking.3,6,7”
Quote in the paperSubstantial 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
- Premisecitation
Patient care and resident education can be compromised by interruptions in continuity of care (i.e., handoffs).
“Patient care and resident education can be compromised by interruptions in continuity of care (i.e., handoffs) [22][23][24]”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [22][23][24]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Interpretationown data
These findings suggest that flexible duty-hour policies appear to be safe for patient care.
“Thus, these find-ings suggest that flexible duty-hour policies appear to be safe for patient care.”
Quote in the paperSubstantial claim - Study design and conductown data
Results of per-protocol, as-treated, and instrumental-variables analyses were highly consistent with intention-to-treat results for patient and resident outcomes.
“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).”
Quote in the paperNot a substantial claim - Interpretationown data
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 the primary patient outcome of the 30-day rate of postoperative death or serious complications.
“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 30day rate of postoperative death or serious complications.”
Quote in the paperSubstantial claim - Study design and conductown data
Overall program-level adherence to study-group conditions was 98% (97% in the standard-policy group and 100% in the flexible-policy group).
“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).”
Quote in the paperSubstantial claim - Interpretationown data
The authors were unable to collect data on medication errors and other potentially resident-sensitive outcomes.
“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.”
Quote in the paperSubstantial claim - Study design and conductreasoning
The alpha level was adjusted to 0.04 for the final analysis to account for interim analysis (overall trial alpha 0.05).
“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).”
Quote in the paperSubstantial claim - Interpretationown data
As compared with standard duty-hour policies, flexible, less-restrictive duty-hour policies for surgical residents were associated with no significant difference in residents' satisfaction with overall well-being and education quality.
“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.”
Quote in the paperSubstantial claim - Interpretationcitation
The 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.
“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][14][15][18][19][20][21]”
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 [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 [13][14][15][18][19][20][21]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Interpretationown data
Flexible duty-hour policies for surgical residents were noninferior to current ACGME duty-hour policies with respect to patient outcomes.
“In conclusion, flexible duty-hour policies for surgical residents were noninferior to current ACGME duty-hour policies with respect to patient outcomes.”
Quote in the paperSubstantial claim - Study design and conductnone given
All results were robust with respect to minor variations in modeling specifications.
“All results were robust with respect to minor variations in modeling specifications.”
Quote in the paperNot a substantial claim - Interpretationown data
As compared with standard duty-hour policies, flexible, less-restrictive duty-hour policies for surgical residents were associated with noninferior patient outcomes.
“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.”
Quote in the paperSubstantial claim
- May combine two claims. 20
- Classified as probably not a substantial claim. 21
May combine two claims.
Findingown dataFor 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 claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataThe 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- Also stated in: § Duty-Hour Flexibility in Surgical Tr aining · plain
Classified as probably not a substantial claim.
Findingown dataPatient 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 claimMay combine two claims.
Findingown dataThe 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 claimMay combine two claims.
Findingown dataFlexible-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 claimMay combine two claims.
Findingown dataThere 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 claimMay combine two claims.
Findingown dataAlthough 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 claimMay combine two claims.
Findingown dataResidents 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 claimMay combine two claims.
Findingown dataFlexible-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 claimMay combine two claims.
Findingown dataThe 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 claimMay combine two claims.
Findingown dataWhen 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 claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenNo 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 claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenThe 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 claimMay combine two claims.
PremisecitationThe 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 dataPrimary 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 claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe 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 conductcitationSurvey 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 dataPrespecified 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 claimMay combine two claims.
Study design and conductcitationThe 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.
PremisecitationIn 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 givenResidents 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 claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataResponse 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 claimProbably not a substantial claim: may not pass S1 (asserted).
PremisecitationCritics 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 dataAn 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 claimClassified as probably not a substantial claim.
PremisecitationSeveral 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.
PremisecitationMany 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 dataThe 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 claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Interpretationnone givenPatient 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 claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.
Interpretationnone givenPatient 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 claimMay combine two claims.
Interpretationown dataThe 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 claimMay combine two claims.
Interpretationnone givenThe 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 claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationPrevious 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 givenAdherence 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 claimClassified as probably not a substantial claim.
Study design and conductreasoningGiven 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 claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductreasoningGiven 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 claimProbably not a substantial claim: may not pass S3 (load-bearing).
InterpretationreasoningThe 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
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)”
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 measuredA 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 measuredSeveral 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 measuredIn 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 measuredThe 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.”
From Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine (2019) · cites this paper as [11]
In the FIRST trial, first-year resident physicians at surgical programmes assigned to the flexible work-hour group were allowed to exceed 16 consecutive hours of work and required time off between shifts was reduced.
“In the FIRST (Flexibility in duty hour Requirements for Surgical Trainees) trial, first-year resident physicians at surgical programmes assigned to the flexible work-hour group were allowed to exceed 16 consecutive hours of work and required time off between shifts was reduced.17”
Residents given more time to sleep were more worried about decreases in their quality of work as a result of working less.
“Paradoxically, residents given more time to sleep were more worried about decreases in their quality of work as a result of working less, yet they were more satisfied with the quality of their life and social functioning.”
From Sleep, Health, and Society (2017) · cites this paper as [223]
In a study comparing two groups of residency programs, those that gave more time off for sleep did not show measurable changes in work performance.
“In a landmark study that compared 2 groups of residency programs, those that gave more time off for sleep did not show measurable changes in work performance.223”
From Sleep, Health, and Society (2017) · cites this paper as [223]
Residents given more time to sleep were more satisfied with the quality of their life and social functioning.
“Paradoxically, residents given more time to sleep were more worried about decreases in their quality of work as a result of working less, yet they were more satisfied with the quality of their life and social functioning.”
From Sleep, Health, and Society (2017) · cites this paper as [223]
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Self-citationChanges in Hospital Mortality Associated with Residency Work-Hour Regulations
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Self-citationResident Work Hour Limits and Patient Safety
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Residents' Response to Duty-Hour Regulations — A Follow-up National Survey
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Residents' Perspectives on ACGME Regulation of Supervision and Duty Hours — A National Survey
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Self-citationACGME Duty-Hour Recommendations — A National Survey of Residency Program Directors
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Did Duty Hour Reform Lead to Better Outcomes Among the Highest Risk Patients?
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The Effect of House Staff Working Hours on the Quality of Obstetric and Gynecologic Care
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Resident Duty-Hour Reform Associated with Increased Morbidity Following Hip Fracture
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Self-citationRajaram, R., Chung, J. W., Cohen, M. E., Dahlke, A. R., Yang, A. D., Meeks, J. J., Ko, C. Y., Tarpley, J. L., Hoyt, D. B., & Bilimoria, K. Y. (2015) · Journal of the American College of Surgeons · doi:10.1016/j.jamcollsurg.2015.06.010 · Cited by 33 · see citing works
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Self-citationMaking the Case for Investigating Flexibility in Duty Hour Limits for Surgical Residents
Bilimoria, K. Y., Hoyt, D. B., & Lewis, F. (2015) · JAMA Surgery · doi:10.1001/jamasurg.2015.0239 · Cited by 17 · see citing works
Self-citationEffects of Limited Work Hours on Surgical Training
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Research works printed but not linked: 3
- Institute of Medicine. Resident duty hours: enhancing sleep, supervision, and safety. Washington, DC: National Academies Press, 2008.
- Rajaram R, BMJ Qual Saf
- Bilimoria KY, JAMA Surg
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“The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial in 2016 evaluated standard duty hours vs flexible duty hours, both with an 80-h work week maximum; no differences were recorded in patient safety or resident well-being, but sleep was not evaluated with the use of objective measures.(60) In…”
Education Outcomes in a Duty-Hour Flexibility Trial in Internal Medicine
Desai, S. V., Asch, D. A., Bellini, L. M., Chaiyachati, K. H., Liu, M., Sternberg, A. L., Tonascia, J. A., Yeager, A. M., Asch, J. M., Katz, J. T., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1800965 · Cited by 174 · see citing works
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Schlick, C. J. R., Ellis, R. J., Etkin, C. D., Greenberg, C. C., Greenberg, J. A., Turner, P. L., Buyske, J., Hoyt, D. B., Nasca, T. J., Bilimoria, K. Y., et al. (2021) · JAMA Surgery · doi:10.1001/jamasurg.2021.3195 · Cited by 149 · see citing works
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Self-citationImplementation of Entrustable Professional Activities in General Surgery
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“The FIRST trial did not find statistically significant differences between residents in the two groups in terms of perceived well-being [40].”
InfluentialKilty, C., Wiese, A., Bergin, C. J., Flood, P. C., Fu, N., Horgan, M. M., Higgins, A., Maher, B., O'Kane, G. M., Prihodová, L., et al. (2017) · BMC Medical Education · doi:10.1186/s12909-017-1065-2 · Cited by 107 · see citing works
“that affording training programmes flexibility [67] and undertaking precise workload analysis might be helpful [66].”
Effect on patient safety of a resident physician schedule without 24-hour shifts
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“As reported elsewhere, compliance with the policy was not universal, (25, 26) and randomized trials of flexible hours permitted training programs at some institutions to exceed existing work hour limitations.(6, 8) Participants in both cohorts reporting exceeding 80 weekly work hours and working extended duration shif…”
Exploring the use of virtual reality in surgical education
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Otolaryngology workforce analysis
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How Is Work–Life Balance Arrangement Associated with Organisational Performance? A Meta-Analysis
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“The greatest sample size was 74,952 participants [74], while the smallest sample size was 80 participants [75].”
Background“Ethics and Clinical Research” — The 50th Anniversary of Beecher’s Bombshell
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Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine
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Challenges in Building Usable Knowledge in Education
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“I helped design the Flexibility In duty-hour Requirements for Surgical Trainees Trial (known to its intimates as the FIRST Trial) to answer questions about whether offering some flexibility in these requirements would compromise patient care or intern/resident education (see Bilimoria et al., 2016).”
Self-citationDenson, J. L., Jensen, A., Saag, H. S., Wang, B., Fang, Y., Horwitz, L. I., Evans, L., & Sherman, S. E. (2016) · JAMA · doi:10.1001/jama.2016.17424 · Cited by 62 · see citing works
Secondary data sources for health services research in urologic oncology
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Self-citationA study of resident duty hours and burnout in a sample of Saudi residents
Hameed, T. K., Masuadi, E., Asmary, N. A. A., Al‐Anzi, F., & Dubayee, M. S. A. (2018) · BMC Medical Education · doi:10.1186/s12909-018-1300-5 · Cited by 57 · see citing works
Large-scale implementation of the I-PASS handover system at an academic medical centre
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Association of Surgical Resident Wellness With Medical Errors and Patient Outcomes
Hewitt, D. B., Ellis, R. J., Chung, J. W., Cheung, E. O., Moskowitz, J. T., Huang, R., Merkow, R. P., Yang, A. D., Hu, Y., Cohen, M. E., et al. (2020) · Annals of Surgery · doi:10.1097/sla.0000000000003909 · Cited by 57 · see citing works
“The survey was then iteratively revised and re-tested.(12,14) To measure burnout, a modified, abbreviated Maslach Burnout Inventory Human Services Survey for Medical Personnel, a wellvalidated tool for assessing burnout, was used.”
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Extended Work Shifts and Neurobehavioral Performance in Resident-Physicians
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Prevalence and risk factors for burnout in U.S. vascular surgery trainees
Chia, M. C., Hu, Y., Li, R. D., Cheung, E. O., Eng, J. S., Zhan, T., Sheahan, M. G., Bilimoria, K. Y., & Coleman, D. M. (2021) · Journal of Vascular Surgery · doi:10.1016/j.jvs.2021.06.476 · Cited by 53 · see citing works
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Addressing Surgeon Fatigue: Current Understanding and Strategies for Mitigation
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The Resident-Run Minor Surgery Clinic: A Pilot Study to Safely Increase Operative Autonomy
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Brajcich, B. C., Chung, J. W., Wood, D. E., Horvath, K. D., Tolley, P. D., Yates, E. F., Are, C., Ellis, R. J., Hu, Y., & Bilimoria, K. Y. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2021.23412 · Cited by 50 · see citing works
“of examinees 25 (18-40) 35 (20-49) 25 (17-39)”
Self-citationBarger, L. K., Weaver, M. D., Sullivan, J. P., Qadri, S., Landrigan, C. P., & Czeisler, C. A. (2023) · BMJ Medicine · doi:10.1136/bmjmed-2022-000320 · Cited by 47 · see citing works
Perceived Stress, Stressors, and Coping Mechanisms Among PGY1 Pharmacy Residents
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Resident duty hours and resident and patient outcomes: Systematic review and meta‐analysis
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“the FIRST and ICOMPARE trial led to decreased dissatisfaction with overall well-being.(4,10) In a systematic review by Ahmed et al.”
InfluentialEllis, R. J., Hewitt, D. B., Hu, Y., Johnson, J. K., Merkow, R. P., Yang, A. D., Potts, J. R., Hoyt, D. B., Buyske, J., & Bilimoria, K. Y. (2019) · Annals of Surgery · doi:10.1097/sla.0000000000003545 · Cited by 44 · see citing works
“Pretest cognitive interviews were conducted with general surgery residents to evaluate survey coherence and clarity, followed by iterative revisions.(15,17)”
MethodSelf-citationAwan, M., Zagales, I., McKenney, M. G., Kinslow, K., & Elkbuli, A. (2021) · Journal of surgical education · doi:10.1016/j.jsurg.2021.06.001 · Cited by 40 · see citing works
Yang, A. D., Chung, J. W., Dahlke, A. R., Biester, T. W., Quinn, C. M., Matulewicz, R. S., Odell, D. D., Kelz, R. R., Shea, J. A., Lewis, F. R., et al. (2016) · Journal of the American College of Surgeons · doi:10.1016/j.jamcollsurg.2016.10.045 · Cited by 41 · see citing works
“For all domains, the outcomes were dichotomized to enhance the clarity of our analyses and exposition without any demonstrated loss of generality, as was previously described in the FIRST Trial main analys is.(4) In general, the responses were dichotomized to contrast negative responses against combined neutral and po…”
Self-citationOptimizing GME by Measuring Its Outcomes
Weinstein, D. F. (2017) · New England Journal of Medicine · doi:10.1056/nejmp1711483 · Cited by 39 · see citing works
Leviatan, I., Oberman, B., Zimlichman, E., et al. (2020) · Journal of the American Medical Informatics Association · doi:10.1093/jamia/ocaa219 · Cited by 38 · see citing works
Graßl, N., Nees, J., Schramm, K., Spratte, J., Sohn, C., Schott, T. C., & Schott, S. (2018) · JMIR mhealth and uhealth · doi:10.2196/10063 · Cited by 37 · see citing works
“Yet, despite the XSL • FO RenderX potential of telemedicine to alleviate this problem, it has not been widely adopted in obstetrics [8,30,32-34].”
BackgroundResident Duty Hours and Medical Education Policy — Raising the Evidence Bar
Asch, D. A., Bilimoria, K. Y., & Desai, S. V. (2017) · New England Journal of Medicine · doi:10.1056/nejmp1703690 · Cited by 36 · see citing works
Self-citationNational Survey of Burnout and Distress Among Cardiothoracic Surgery Trainees
Chow, O. S., Sudarshan, M., Maxfield, M. W., Seese, L., Watkins, A. A., Fleishman, A., & Gangadharan, S. P. (2020) · The Annals of Thoracic Surgery · doi:10.1016/j.athoracsur.2020.06.062 · Cited by 37 · see citing works
Weaver, M. D., Landrigan, C. P., Sullivan, J. P., O'Brien, C. S., Qadri, S., Viyaran, N., Czeisler, C. A., & Barger, L. K. (2023) · BMJ Quality & Safety · doi:10.1136/bmjqs-2021-014375 · Cited by 35 · see citing works
“17 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.”
Bilimoria, K. Y., Quinn, C. M., Dahlke, A. R., Kelz, R. R., Shea, J. A., Rajaram, R., Love, R. R., Kreutzer, L., Biester, T. W., Yang, A. D., et al. (2016) · Journal of the American College of Surgeons · doi:10.1016/j.jamcollsurg.2016.10.046 · Cited by 35 · see citing works
Self-citationResident physician extended work hours and burnout
McHill, A. W., Czeisler, C. A., & Shea, S. A. (2018) · SLEEP · doi:10.1093/sleep/zsy112 · Cited by 37 · see citing works
“06 for comparison of odds ratios between groups), and lower secondary well-being outcomes such as health [6].”
BackgroundMethodInfluentialLebares, C. C., Greenberg, A. L., Ascher, N. L., Delucchi, K., Reilly, L. M., van der Schaaf, M. F., Bååthe, F., O’Sullivan, P., & Rø, K. I. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2020.32676 · Cited by 35 · see citing works
Cox, M. L., Deng, Z., Palmer, H., Watts, A., Beynel, L., Young, J. R., Lisanby, S. H., Migaly, J., & Appelbaum, L. G. (2020) · Brain stimulation · doi:10.1016/j.brs.2020.03.009 · Cited by 32 · see citing works
Aziz, F., Talhelm, L., Keefer, J., & Krawiec, C. (2019) · Journal of Vascular Surgery · doi:10.1016/j.jvs.2018.08.173 · Cited by 31 · see citing works
Patient-specific predictors of failure to rescue after pancreaticoduodenectomy
Gleeson, E., Clarke, J. R., Morano, W. F., Shaikh, M. F., Bowne, W. B., & Pitt, H. A. (2018) · HPB · doi:10.1016/j.hpb.2018.07.022 · Cited by 33 · see citing works
Impact of extended duty hours on medical trainees
Weiss, P. G., Kryger, M. H., & Knauert, M. P. (2016) · Sleep Health · doi:10.1016/j.sleh.2016.08.003 · Cited by 31 · see citing works
Artificial intelligence can predict daily trauma volume and average acuity
Stonko, D. P., Dennis, B. M., Betzold, R., Peetz, A. B., Gunter, O. L., & Guillamondegui, O. D. (2018) · The Journal of Trauma: Injury, Infection, and Critical Care · doi:10.1097/ta.0000000000001947 · Cited by 31 · see citing works
Workstyle reform for Japanese doctors
Tsutsumi, A. (2020) · Environmental and Occupational Health Practice · doi:10.1539/eohp.2020-0008-op · Cited by 31 · see citing works
McTaggart, L. S., & Walker, J. P. (2022) · Health Sciences Review · doi:10.1016/j.hsr.2022.100049 · Cited by 30 · see citing works
Ellis, R. J., Holmstrom, A. L., Hewitt, D. B., Engelhardt, K. E., Yang, A. D., Merkow, R. P., Bilimoria, K. Y., & Hu, Y. (2019) · The American Journal of Surgery · doi:10.1016/j.amjsurg.2019.10.040 · Cited by 30 · see citing works
Self-citationSleepy Surgeons: A Multi-Method Assessment of Sleep Deprivation and Performance in Surgery
Whelehan, D. F., Alexander, M. D., Connelly, T. M., McEvoy, C., & Ridgway, P. F. (2021) · Journal of Surgical Research · doi:10.1016/j.jss.2021.06.047 · Cited by 31 · see citing works
Schwartz, L. P., Hursh, S. R., Boyle, L., Davis, J. E., Stafford‐Smith, M., & Fitzgibbons, S. (2020) · The American Journal of Surgery · doi:10.1016/j.amjsurg.2020.08.015 · Cited by 28 · see citing works
Educational Targets to Reduce Medication Errors by General Surgery Residents
Chaitoff, A., Strong, A. T., Bauer, S. R., Garber, A., Landreneau, J. P., French, J. C., Rothberg, M. B., & Lipman, J. M. (2019) · Journal of surgical education · doi:10.1016/j.jsurg.2019.04.009 · Cited by 29 · see citing works
Bernstrøm, V. H., Alves, D. E., Ellingsen, D., & Ingelsrud, M. H. (2019) · BMC Health Services Research · doi:10.1186/s12913-019-3993-5 · Cited by 30 · see citing works
Duty Hour Reform and the Outcomes of Patients Treated by New Surgeons
Kelz, R. R., Niknam, B. A., Sellers, M. M., Sharpe, J. E., Rosenbaum, P. R., Hill, A. S., Zhou, H. H., Hochman, L. L., Bilimoria, K. Y., Itani, K. M. F., et al. (2019) · Annals of Surgery · doi:10.1097/sla.0000000000003304 · Cited by 28 · see citing works
Self-citationReading and conducting instrumental variable studies: guide, glossary, and checklist
Walker, V. M., Sanderson, E. C. M., Levin, M. G., Damraurer, S. M., Feeney, T., & Davies, N. M. (2024) · BMJ · doi:10.1136/bmj-2023-078093 · Cited by 30 · see citing works
“…to treatment in randomised controlled trials with non-compliance is an instrumental variable previously used to investigate the effects of flexible duty hour conditions for surgeons on patient outcomes and surgeons’ training and wellbeing 12 and the effects of reducing amyloid levels on cognition.”
Joung, R. H., Amórtegui, D., Silver, C. M., Mackiewicz, N. I., Eng, J. S., Rosenkranz, K. M., Johnson, J. K., Bilimoria, K. Y., & Hu, Y. (2022) · Journal of surgical education · doi:10.1016/j.jsurg.2022.05.004 · Cited by 27 · see citing works
Self-citationNational Evaluation of Needlestick Events and Reporting Among Surgical Residents
Yang, A. D., Quinn, C. M., Hewitt, B., Chung, J. W., Zembower, T., Jones, A., Buyske, J., Hoyt, D. B., Nasca, T. J., & Bilimoria, K. Y. (2019) · Journal of the American College of Surgeons · doi:10.1016/j.jamcollsurg.2019.09.001 · Cited by 27 · see citing works
Self-citationThe well-being of Swiss general internal medicine residents
Zumbrunn, B., Stalder, O., Limacher, A., Ballmer, P. E., Bassetti, S., Battegay, E., Beer, J. H., Brändle, M., Genné, D., Hayoz, D., et al. (2020) · Swiss Medical Weekly · doi:10.4414/smw.2020.20255 · Cited by 26 · see citing works
Anesthesiology Residents’ Experiences and Perspectives of Residency Training
Sun, H., Chen, D., Warner, D. O., et al. (2021) · Anesthesia & Analgesia · doi:10.1213/ane.0000000000005316 · Cited by 26 · see citing works
Head‐Mounted Display Virtual Reality Is Effective in Orthopaedic Training: A Systematic Review
Berthold, D. P., Muench, L. N., Rupp, M., et al. (2022) · Arthroscopy Sports Medicine and Rehabilitation · doi:10.1016/j.asmr.2022.05.009 · Cited by 26 · see citing works
“Studies found in this search were included if they (1) concerned orthopaedic surgery, (2) dealt with a HMD virtual reality device, (3) the technology was being used for training purposes, and (4) was specifically an RCT.”
BackgroundMethodWork like a Doc: A comparison of regulations on residents' working hours in 14 high-income countries
Maoz-Breuer, R., Waitzberg, R., Breuer, A., Cram, P. M., Bryndová, L., Williams, G. A., Kasekamp, K., Keskimäki, I., Tynkkynen, L., van Ginneken, V., et al. (2023) · Health Policy · doi:10.1016/j.healthpol.2023.104753 · Cited by 27 · see citing works
“The first focused on internal medicine residencies (iCompare study, [72,73]) and the second on general surgery residencies (FIRST study, [74]).”
BackgroundExploring Qualitative Perspectives on Surgical Resident Training, Well-Being, and Patient Care
Kreutzer, L., Dahlke, A. R., Love, R. R., Ban, K. A., Yang, A. D., Bilimoria, K. Y., & Johnson, J. K. (2016) · Journal of the American College of Surgeons · doi:10.1016/j.jamcollsurg.2016.10.041 · Cited by 26 · see citing works
Self-citationIs a Doctor Like a Toaster? Earning Trust in the Profession of Medicine
Roberts, L. W. (2017) · Academic Psychiatry · doi:10.1007/s40596-017-0715-3 · Cited by 25 · see citing works
“Moreover, and unexpectedly, no difference was found to exist in the residents’ perceptions of overall well-being and quality of their educational experience [32].”
Ban, K. A., Chung, J. W., Matulewicz, R. S., Kelz, R. R., Shea, J. A., Dahlke, A. R., Quinn, C. M., Yang, A. D., & Bilimoria, K. Y. (2016) · Journal of the American College of Surgeons · doi:10.1016/j.jamcollsurg.2016.10.043 · Cited by 24 · see citing works
Self-citationNagasaki, K., & Kobayashi, H. (2023) · Journal of General and Family Medicine · doi:10.1002/jgf2.649 · Cited by 26 · see citing works
“17,44 These results were significant enough to prompt a regulatory change in the U.S., which led to the deregulation of shift length of PGY-1 residents in 2017.”
BackgroundPatient Outcomes when Housestaff Exceed 80 Hours per Week
Ouyang, D., Chen, J. H., Krishnan, G., Hom, J., Witteles, R. M., & Chi, J. (2016) · The American Journal of Medicine · doi:10.1016/j.amjmed.2016.03.023 · Cited by 23 · see citing works
Hilaire, M. A. S., Anderson, C., Anwar, J., Sullivan, J. P., Cade, B. E., Flynn‐Evans, E. E., Czeisler, C. A., Lockley, S. W., & Harvard Work Hours Health and Safety Group (2019) · SLEEP · doi:10.1093/sleep/zsz041 · Cited by 23 · see citing works
“These changes were made in part due to a recent cluster-randomized noninferiority trial that reported noninferior patient outcomes and no significant difference in resident wellbeing and quality of educational training between resident physicians in programs subject to the then-standard work policy (≤16 hr for PGY 1 r…”
BackgroundTaylor, T., Raynard, A. L., & Lingard, L. A. (2019) · Medical Education · doi:10.1111/medu.13998 · Cited by 23 · see citing works
Practical trials in medical education: linking theory, practice and decision making
Tolsgaard, M. G., Kulasegaram, K. M., & Ringsted, C. V. (2016) · Medical Education · doi:10.1111/medu.13135 · Cited by 22 · see citing works
Coxe, F. R., Stauffer, T. P., & Ast, M. P. (2025) · Current Reviews in Musculoskeletal Medicine · doi:10.1007/s12178-025-09973-8 · Cited by 21 · see citing works
Factors Associated With Orthopaedic Resident Burnout: A Pilot Study
Driesman, A. S., Strauss, E. J., Konda, S. R., & Egol, K. A. (2020) · Journal of the American Academy of Orthopaedic Surgeons · doi:10.5435/jaaos-d-19-00648 · Cited by 21 · see citing works
- 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)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-02-25
- Volume
- 374
- Issue
- 8
- Pages
- 713-727
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2324257729
- Semantic Scholar
- 7619f11ae1a4f21fe37dec8da0c803cc0a2b8ed8
- 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
- bronze
- doi.org
- 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.
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