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

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.).

SUBMITTER: Silber JH

PROVIDER: S-EPMC6476299 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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

Silber Jeffrey H JH Bellini Lisa M LM Shea Judy A JA Desai Sanjay V SV Dinges David F DF Basner Mathias M Even-Shoshan Orit O Hill Alexander S AS Hochman Lauren L LL Katz Joel T JT Ross Richard N RN Shade David M DM Small Dylan S DS Sternberg Alice L AL Tonascia James J Volpp Kevin G KG Asch David A DA

The New England journal of medicine 20190301 10

<h4>Background</h4>Concern persists that extended shifts in medical residency programs may adversely affect patient safety.<h4>Methods</h4>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 sp ...[more]

PMID: 30855740

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Project description:ContextThe ACGME-released revisions to the 2003 duty hour standards.ObjectiveTo review the impact of the 2003 duty hour reform as it pertains to resident and patient outcomes.Data sourcesMedline (1989-May 2010), Embase (1989-June 2010), bibliographies, pertinent reviews, and meeting abstracts.Study selectionWe included studies examining the relationship between the pre- and post-2003 time periods and patient outcomes (mortality, complications, errors), resident education (standardized test scores, clinical experience), and well-being (as measured by the Maslach Burnout Inventory). We excluded non-US studies.Data extractionOne rater used structured data collection forms to abstract data on study design, quality, and outcomes. We synthesized the literature qualitatively and included a meta-analysis of patient mortality.ResultsOf 5,345 studies identified, 60 met eligibility criteria. Twenty-eight studies included an objective outcome related to patients; 10 assessed standardized resident examination scores; 26 assessed resident operative experience. Eight assessed resident burnout. Meta-analysis of the mortality studies revealed a significant improvement in mortality in the post-2003 time period with a pooled odds ratio (OR) of 0.9 (95% CI: 0.84, 0.95). These results were significant for medical (OR 0.91; 95% CI: 0.85, 0.98) and surgical patients (OR 0.86; 95% CI: 0.75, 0.97). However, significant heterogeneity was present (I(2) 83%). Patient complications were more nuanced. Some increased in frequency; others decreased. Outcomes for resident operative experience and standardized knowledge tests varied substantially across studies. Resident well-being improved in most studies.LimitationsMost studies were observational. Not all studies of mortality provided enough information to be included in the meta-analysis. We used unadjusted odds ratios in the meta-analysis; statistical heterogeneity was substantial. Publication bias is possible.ConclusionsSince 2003, patient mortality appears to have improved, although this could be due to secular trends. Resident well-being appears improved. Change in resident educational experience is less clear.

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

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

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