Evidence map›Paper›PMID 30855740›Full record

Trial reportThe New England journal of medicine2019

Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules.

Jeffrey H Silber, Lisa M Bellini, Judy A Shea, Sanjay V Desai, David F Dinges, Mathias Basner, Orit Even-Shoshan, Alexander S Hill, Lauren L Hochman, Joel T Katz and 8 more

Registry-linked trialAbstract readComparative StudyEquivalence TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02274818 (Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education), which is not on this map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02274818 nacompletednot on this map

Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).

TypeinterventionalSponsorUniversity of PennsylvaniaRan2015 to 2020Enrolled3,500ConditionsSafety, Education, Medical, SleepArmsFlexible Duty Hour Schedule
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. A systematic review of evidence-based practices for clinical education and health care delivery in the clinical teaching unit.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2022
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Observational
  9. Article
  10. Article
  11. Observational
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  13. Acute Medical Care by Nocturnists: A Narrative Review.Journal of general internal medicine · 2025
    Review
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  15. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Jeffrey H SilberFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
Lisa M BelliniFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
Judy A SheaFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
Sanjay V DesaiFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
David F DingesFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
Mathias BasnerFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).ORCID 0000-0002-8453-0812
Orit Even-ShoshanFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
Alexander S HillFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
Lauren L HochmanFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
Joel T KatzFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
Richard N RossFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
David M ShadeFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
Dylan S SmallFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
Alice L SternbergFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
James TonasciaFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
Kevin G VolppFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
David A AschFrom the Center for Outcomes Research, Children's Hospital of Philadelphia (J.H.S., O.E.-S., A.S.H., L.L.H., R.N.R.), the Departments of Pediatrics (J.H.S.), Anesthesiology and Critical Care (J.H.S.), and Medicine (L.M.B., J.A.S., K.G.V., D.A.A.), University of Pennsylvania School of Medicine, the Departments of Health Care Management (J.H.S., K.G.V., D.A.A.) and Statistics (D.S.S.), the Wharton School, the Leonard Davis Institute of Health Economics (J.H.S., J.A.S., D.S.S., K.G.V., D.A.A.), and the Department of Psychiatry (D.F.D., M.B.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (K.G.V., D.A.A.) - all in Philadelphia; the Departments of Medicine (S.V.D.), Epidemiology (D.M.S., A.L.S., J.T.), and Biostatistics (J.T.), Johns Hopkins University, Baltimore; and the Department of Medicine, Brigham and Women's Hospital, Boston (J.T.K.).
iCOMPARE Research Group

Funding

ICOMPARE-CCCU01HL125388 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI ASCH, DAVID A · 2015 to 2018
$5.7M
iCOMPARE - DCCU01HL126088 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI TONASCIA, JAMES A · 2015 to 2018
$3.4M
NHLBI NIH HHS U01 HL125388NHLBI NIH HHS U01HL125388NHLBI NIH HHS U01 HL126088NHLBI NIH HHS U01HL126088
6 · The paper itself

Abstract

backgroundConcern persists that extended shifts in medical residency programs may adversely affect patient safety.

methodsWe conducted a cluster-randomized noninferiority trial in 63 internal-medicine residency programs during the 2015-2016 academic year. Programs underwent randomization to a group with standard duty hours, as adopted by the Accreditation Council for Graduate Medical Education (ACGME) in July 2011, or to a group with more flexible duty-hour rules that did not specify limits on shift length or mandatory time off between shifts. The primary outcome for each program was the change in unadjusted 30-day mortality from the pretrial year to the trial year, as ascertained from Medicare claims. We hypothesized that the change in 30-day mortality in the flexible programs would not be worse than the change in the standard programs (difference-in-difference analysis) by more than 1 percentage point (noninferiority margin). Secondary outcomes were changes in five other patient safety measures and risk-adjusted outcomes for all measures.

resultsThe change in 30-day mortality (primary outcome) among the patients in the flexible programs (12.5% in the trial year vs. 12.6% in the pretrial year) was noninferior to that in the standard programs (12.2% in the trial year vs. 12.7% in the pretrial year). The test for noninferiority was significant (P = 0.03), with an estimate of the upper limit of the one-sided 95% confidence interval (0.93%) for a between-group difference in the change in mortality that was less than the prespecified noninferiority margin of 1 percentage point. Differences in changes between the flexible programs and the standard programs in the unadjusted rate of readmission at 7 days, patient safety indicators, and Medicare payments were also below 1 percentage point; the noninferiority criterion was not met for 30-day readmissions or prolonged length of hospital stay. Risk-adjusted measures generally showed similar findings.

conclusionsAllowing program directors flexibility in adjusting duty-hour schedules for trainees did not adversely affect 30-day mortality or several other measured outcomes of patient safety. (Funded by the National Heart, Lung, and Blood Institute and Accreditation Council for Graduate Medical Education; iCOMPARE ClinicalTrials.gov number, NCT02274818.).

Indexed as

Hospital MortalityPatient SafetyPersonnel Staffing and SchedulingHumansInternal MedicineInternship and ResidencyLength of StayPatient ReadmissionUnited StatesWorkload

Identifiers

PMID30855740
PMCPMC6476299

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