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

In the paper

“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).”

In the paper

“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).”

In the paper

“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.”

In the paper

“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).”

In the paper

“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.”

In the paper

“All results were robust with respect to variations in modeling specifications and the inclusion of additional covariates for patients, hospitals, or both.”

In the paper

“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.”

In the paper

“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).”

In the paper

“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.”

In the paper

“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).”

In the paper

“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).”

In the paper

“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).”

In the paper

“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).”

In the paper

“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)”

In the paper

“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.”

In the paper

“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.”

In the paper

“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).”

In the paper

“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 =”

In the paper

“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).”

In the paper

“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).”

In the paper

“or handing off active patient issues (32.0% vs. 46.3%,P<0.001).”

In the paper

“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.”

In the paper

“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.”

In the paper

“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)”

In the paper

“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-”

In the paper

“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).”

In the paper

“There were no significant differences between study groups in resident-reported perception of the effect of fatigue on personal or patient safety.”

In the paper

“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.”

In the paper

“Residents' satisfaction regarding their overall well-being and education quality was similar in the flexible-policy and standard-policy groups.”

In the paper

“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;”

In the paper

“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)”

In the paper

“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;”

In the paper

“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)”

In the paper

“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.”

In the paper

“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).”

In the paper

“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;”

In the paper

“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)”

In the paper

“Study group was also not associated with resident-reported frequency at which fatigue affected either patient safety or personal safety (Table 3).”

In the paper

“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.”

In the paper

“There was also no significant difference in satisfaction with duty-hour policies between the study groups.”

In the paper

“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).”

In the paper

“The study groups were well balanced with respect to a broad range of program, hospital, patient, and resident characteristics (Table 2).”

In the paper

“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”

What the sources say

• ?Not matched

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

  cites [33] 33. American College of Surgeons Na- tional Surgical Quality Improvement Pro- gram (ACS NSQIP) (http://site .acsnsqip .org).
• ?Not checked — no full text of the sourcecites [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
• ?Not matched

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

  cites [42] 42. The American Board of Surgery In- Training Exam (ABSITE) (http://www .absurgery .org/ default .jsp?examoffered_gs).

In the paper

“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”

What the sources say

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

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

  cites [37] 37. American College of Surgeons Na- tional Surgical Quality Improvement Pro- gram semiannual report: January 2015. Chicago: American College of Surgeons.

In the paper

“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”

In the paper

“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]”

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

“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”

What the sources say

• ?Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be 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).
• ?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

“Programs and their hospital affiliates were then randomly assigned as clusters within strata to one of two study groups.39”

What the sources say

• ?Not matched

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

In the paper

“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”

What the sources say

• ?Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be 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).
• ?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).
• ?Not checked — no full text of the sourcecites [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

In the paper

“Evidence from large, prospective, randomized trials to inform duty-hour regulations is currently lacking.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

“Patient care and resident education can be compromised by interruptions in continuity of care (i.e., handoffs) [22][23][24]”

What the sources say

• ?Not matched

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

  cites [22][23][24]

In the paper

“Thus, these find-ings suggest that flexible duty-hour policies appear to be safe for patient care.”

In the paper

“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).”

In the paper

“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.”

In the paper

“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).”

In the paper

“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.”

In the paper

“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).”

In the paper

“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.”

In the paper

“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]”

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 [13][14][15][18][19][20][21]

In the paper

“In conclusion, flexible duty-hour policies for surgical residents were noninferior to current ACGME duty-hour policies with respect to patient outcomes.”

In the paper

“All results were robust with respect to minor variations in modeling specifications.”

In the paper

“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.”