Randomized Order Safety Trial Evaluating Resident-physician Schedules Study (ROSTERS)
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July 2013 – March 2017
June 8, 2021
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Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
The primary goal of the ROSTERS study was to assess whether implementation of a schedule that eliminated shifts ≥24 hours for resident-physicians [Post Graduate year (PGY) 2 or higher] would result in improved patient safety. Specifically, rates of serious medical errors when resident-physicians worked a traditional extended duration work roster (EDWR) were compared with a rapidly cycling work roster (RCWR), during which shifts were limited to 16 consecutive hours.
Beginning in July 2011, the Accreditation Council for Graduate Medical Education (ACGME) limited interns to 16 consecutive hours of work; second year (PGY2) and higher resident-physicians were permitted to work up to 28 consecutive hours and 88 hours weekly, averaged over 4 weeks. Despite extensive literature demonstrating the hazards of sleep deprivation, however, questions have persisted about whether the 2011 ACGME standards would be beneficial, as this mandate increased the number of handovers of care and may lead to decreases in staffing and physician-patient ratios. Prior studies evaluating the effects on the safety of the ACGME’s 2011 standards have shown mixed results. Furthermore, the outcomes in these prior studies may not have been sufficiently sensitive to measure important adverse effects and did not rigorously capture the work hours, sleep, or neurobehavioral performance of the resident-physicians. In addition, most prior studies have not assessed the effects of roster changes on PGY2 and higher resident-physicians.
The study involved 6,577 patients (n=3,267 EDWR, n=3,310 RCWR) with a total of 38,821 patient days (n=18,749 EDWR, n=20,072 RCWR). The study included 336 resident-physicians (n=172 EDWR, n=188 RCWR, n=27 both, n=3 withdrawn) observed over 413 rotations (n=203 EDWR, n=210 RCWR).
The ROSTERS Study was a multi-center cluster-randomized crossover trial conducted from July 1, 2013 to March 5, 2017 in six pediatric intensive care units (PICUs) across the United States. Sites were paired on the basis of the date they began the trial; one site from each pair was randomly assigned to start with the extended-shift schedule (EDWR; control schedule), and the other site started with the schedule that eliminated extended shifts (RCWR; intervention schedule). Each site had a 4-month wash-in interval before data collection began during which resident physicians followed the schedule that was about to be tested. Eight months of data were then collected on this schedule. This interval was followed by another 4-month wash-in interval during which sites crossed over to the other schedule. Then 8 months of data were collected on this second schedule.
At each hospital, a team of centrally trained chart reviewers (nurses) and observers (physicians) collected data, supplemented by voluntary reports from clinical staff. The team of physician observers followed participating resident physicians around the clock during each schedule, gathering information on any suspected serious errors. Concurrently, research nurses performed chart reviews and gathered reports of incidents of suspected serious errors from clinical staff. All suspected incidents were then classified by trained physician reviewers who were unaware of site and schedule.
The primary outcome was serious medical errors), defined as a preventable adverse event or near miss, made by resident-physicians. The novel study design included data from many levels (patient-level, resident-physician-level, hospital unit level). This allowed for assessment of additional secondary aims, including the relationship between schedules and resident-physician outcomes including sleep duration, motor vehicle collision risk, work-related accidents, depression, quality of work experience, neurobehavioral performance, and sleepiness during tasks.
Resident physicians who were randomly assigned to schedules that eliminated extended shifts made more serious errors than resident physicians assigned to schedules with extended shifts, although the effect varied by site. The number of ICU patients cared for by each resident physician was higher during schedules that eliminated extended shifts.
Landrigan CP, Rahman SA, Sullivan JP, et al. Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts. N Engl J Med. 2020;382(26):2514-2523. doi:10.1056/NEJMoa1900669
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