弹性和标准住院医师值班时间规则下的患者安全结局。
Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules.
机构信息
From 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.).
出版信息
N Engl J Med. 2019 Mar 7;380(10):905-914. doi: 10.1056/NEJMoa1810642.
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.).
背景
人们仍然担心，医学住院医师培训项目的延长轮班可能会对患者安全产生不利影响。
方法
我们在 2015-2016 学年期间，在 63 个内科住院医师培训项目中进行了一项集群随机非劣效性试验。这些项目被随机分配到一组，采用 2011 年 7 月由研究生医学教育认证委员会（ACGME）采用的标准工作时间，或一组更灵活的工作时间规则，该规则不规定轮班长度或轮班之间强制休息时间的限制。每个项目的主要结局是从医疗保险索赔中确定的从审判前一年到审判年的未经调整的 30 天死亡率变化。我们假设，在灵活计划中，30 天死亡率的变化（主要结局）不会比标准计划中的变化差（差异分析）超过 1 个百分点（非劣效性边缘）。次要结局是其他五项患者安全措施的变化以及所有措施的风险调整结果。
结果
在灵活计划中患者的 30 天死亡率变化（主要结局）（试验年为 12.5%，试验前一年为 12.6%）与标准计划中患者的 30 天死亡率变化（试验年为 12.2%，试验前一年为 12.7%）无差异。非劣效性检验具有统计学意义（P=0.03），组间死亡率变化差异的单侧 95%置信区间上限（0.93%）估计值小于预定的 1 个百分点非劣效性边界。在调整后的 7 天内再入院率、患者安全指标和医疗保险支付方面，灵活计划与标准计划之间的变化差异也低于 1 个百分点；30 天再入院率或延长住院时间不符合非劣效性标准。风险调整后的措施通常显示出类似的发现。
结论
允许项目主任灵活调整受训者的工作时间表不会对 30 天死亡率或其他几个患者安全测量结果产生不利影响。（由美国国立心肺血液研究所和研究生医学教育认证委员会资助；iCOMPARE ClinicalTrials.gov 编号，NCT02274818.）。
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