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

AUTHORS: 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, Richard N. Ross, David M. Shade, Dylan S. Small, Alice L. Sternberg, James Tonascia, Kevin G. Volpp, and David A. Asch for the iCOMPARE Research Group

JOURNAL: N Engl J Med. 2019 Mar 7;380(10):905-914. doi: 10.1056/NEJMoa1810642.

Abstract

BACKGROUND: Concern persists that extended shifts in medical residency programs may adversely affect patient safety.

METHODS: We 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.

RESULTS: The 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.

CONCLUSIONS: Allowing 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.).

For a link to the full article, click here: https://www.nejm.org/doi/full/10.1056/NEJMoa1810642?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed

Link to abstract online: https://www.ncbi.nlm.nih.gov/pubmed/30855740

ARTICLE: Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine

AUTHORS: Mathias Basner, David A. Asch, Judy A. Shea, Lisa M. Bellini, Michele Carlin, Adrian J. Ecker, Susan K. Malone, Sanjay V. Desai, Alice L. Sternberg, James Tonascia, David M. Shade, Joel T. Katz, David W. Bates, Orit Even-Shoshan, Jeffrey H. Silber, Dylan S. Small, Kevin G. Volpp, Christopher G. Mott, Sara Coats, Daniel J. Mollicone, and David F. Dinges for the iCOMPARE Research Group

JOURNAL: N Engl J Med. 2019 Mar 7;380(10):915-923. doi: 10.1056/NEJMoa1810641.

Abstract

BACKGROUND: A purpose of duty-hour regulations is to reduce sleep deprivation in medical trainees, but their effects on sleep, sleepiness, and alertness are largely unknown.

METHODS: We randomly assigned 63 internal-medicine residency programs in the United States to follow either standard 2011 duty-hour policies or flexible policies that maintained an 80-hour workweek without limits on shift length or mandatory time off between shifts. Sleep duration and morning sleepiness and alertness were compared between the two groups by means of a noninferiority design, with outcome measures including sleep duration measured with actigraphy, the Karolinska Sleepiness Scale (with scores ranging from 1 [extremely alert] to 9 [extremely sleepy, fighting sleep]), and a brief computerized Psychomotor Vigilance Test (PVT-B), with long response times (lapses) indicating reduced alertness.

RESULTS: Data were obtained over a period of 14 days for 205 interns at six flexible programs and 193 interns at six standard programs. The average sleep time per 24 hours was 6.85 hours (95% confidence interval [CI], 6.61 to 7.10) among those in flexible programs and 7.03 hours (95% CI, 6.78 to 7.27) among those in standard programs. Sleep duration in flexible programs was noninferior to that in standard programs (between-group difference, -0.17 hours per 24 hours; one-sided lower limit of the 95% confidence interval, -0.45 hours; noninferiority margin, -0.5 hours; P = 0.02 for noninferiority), as was the score on the Karolinska Sleepiness Scale (between-group difference, 0.12 points; one-sided upper limit of the 95% confidence interval, 0.31 points; noninferiority margin, 1 point; P<0.001). Noninferiority was not established for alertness according to the PVT-B (between-group difference, -0.3 lapses; one-sided upper limit of the 95% confidence interval, 1.6 lapses; noninferiority margin, 1 lapse; P = 0.10).

CONCLUSIONS: This noninferiority trial showed no more chronic sleep loss or sleepiness across trial days among interns in flexible programs than among those in standard programs. Noninferiority of the flexible group for alertness was not established. (Funded by the National Heart, Lung, and Blood Institute and American Council for Graduate Medical Education; ClinicalTrials.gov number, NCT02274818.).

For a link to the full article, click here: https://www.nejm.org/doi/full/10.1056/NEJMoa1810641?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed

Link to abstract online: https://www.ncbi.nlm.nih.gov/pubmed/?term=Sleep+and+Alertness+in+a+Duty-Hour+Flexibility+Trial+in+Internal+Medicine

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