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

In the paper

“The results were inconclusive for 30-day mortality in the unadjusted analysis, but the noninferiority criterion was met in the adjusted analysis.”

In the paper

“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).”

In the paper

“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).”

In the paper

“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.”

In the paper

“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”

In the paper

“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).”

In the paper

“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.”

In the paper

“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.”

In the paper

“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.”

In the paper

“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.”

In the paper

“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”

In the paper

“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).”

In the paper

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

In the paper

“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”

What the sources say

• ?Not checked — no full text of the sourcecites [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
• ?Not checked — no full text of the sourcecites [2] 2. Philibert I, Friedmann P, Williams WT. New requirements for resident duty hours. JAMA 2002; 288: 1112-4. source

In the paper

“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.”

In the paper

“In a widely cited report on resident duty hours, the Institute of Medicine called for additional high-level research to inform policy.3”

What the sources say

• ?Not matched

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

  cites [3] 3. Institute of Medicine. Resident duty hours: enhancing sleep, supervision, and safety. Washington, DC: National Acade- mies Press, 2008.

In the paper

“Survey items were adapted from previous ly published surveys, pretested with residents through cognitive interviews, and iteratively revised.32”

What the sources say

• ?Not matched

  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).

In the paper

“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).”

In the paper

“This study was a prospective, cluster-randomized, pragmatic, noninferiority trial comparing stan-dard ACGME duty-hour policies with flexible duty-hour policies.32”

What the sources say

• ?Not matched

  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).

In the paper

“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”

What the sources say

• ?Not checked — no full text of the sourcecites [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
• ?Not checked — no full text of the sourcecites [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
• ?Not matched

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

  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).

In the paper

“Residents were not specifically kept from knowing their studygroup assignment.”

In the paper

“Response rates varied across survey items, ranging from 84 to 87% for the outcomes examined (Tables S25 through S30 in the Supplementary Appendix).”

In the paper

“critics cite a weak evidence base for the 2003 and 2011 reforms.3,6,7”

What the sources say

• ?Not matched

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

  cites [3] 3. Institute of Medicine. Resident duty hours: enhancing sleep, supervision, and safety. Washington, DC: National Acade- mies Press, 2008.
• ?Not checked — no full text of the sourcecites [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
• ?Not checked — no full text of the sourcecites [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

In the paper

“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”

In the paper

“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]”

What the sources say

• ?Not checked — no full text of the sourcecites [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
• ?Not checked — no full text of the sourcecites [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
• ?Not matched

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

  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.

In the paper

“However, many studies have suggested that dutyhour reforms resulted in improved well-being and less fatigue among surgical residents.6”

What the sources say

• ?Not checked — no full text of the sourcecites [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

In the paper

“Third, we conducted this study for a full academic year, but we cannot extrapolate the ways in which flexible duty-hour policies might affect the training and experience of an entire cohort of surgical residents over multiple years.”

In the paper

“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.”

In the paper

“Similarly, patient outcomes could improve or worsen with more time under flexible duty-hour policies.”

In the paper

“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.”

In the paper

“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.”

In the paper

“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”

What the sources say

• ?Not checked — no full text of the sourcecites [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
• ?Not checked — no full text of the sourcecites [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
• ?Not checked — no full text of the sourcecites [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

In the paper

“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.”

In the paper

“Given a noninferiority design with a 0.04 alpha level, 92% confidence intervals [100 × (1 -2α)] were used on the basis of a”

In the paper

“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.”

In the paper

“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.”