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住院医师灵活和标准值班时间规则下的患者安全性结局
Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules


Jeffrey H. Silber ... 其他 • 2019.03.07

摘要


背景

人们一直担心,在内科住院医师培训计划中,住院医师长时间值班可能对患者安全性有不良影响。


方法

2015—2016学年,我们对63项内科住院医师培训计划开展了一项整群随机非劣效性试验。将培训计划随机分成两组,一组采用标准值班时间(美国毕业后医学教育认证理事会[Accreditation Council for Graduate Medical Education,ACGME]于2011年7月采纳的值班时间),另一组采用较灵活的值班时间(对值班时长或各班之间的强制休息时间未设定限制)。标准计划和灵活计划的主要结局为试验学年与试验前一学年相比30日死亡率的未校正变化情况(根据美国老年医疗保险[Medicare]理赔数据确定)。我们假设,灵活计划中30日死亡率的变化情况不比标准计划差(双重差分分析)1个百分点(非劣效性界值)以上。次要结局为其他五项患者安全指标的变化情况,以及所有指标的风险校正的结局。

 

结果

灵活计划中患者30日死亡率的变化情况(主要结局)(试验学年12.5% vs.试验前一学年12.6%)不劣于标准计划(试验学年12.2% vs.试验前一学年12.7%)。非劣效性检验的结果显著(P=0.03),死亡率变化情况的组间差异的单侧95%置信区间上限估计值(0.93%)小于预设的非劣效性界值(1个百分点)。在灵活计划和标准计划之间,以下各项的变化情况的差异也小于1个百分点:未校正的7日再次住院率、患者安全性指标和Medicare支出;30日再次住院或延长住院时间这两项未达到非劣效性标准。风险校正的指标通常产生类似结果。

 

结论

允许培训计划主管灵活调整受训者的值班时间安排对患者的30日死亡率或其他几项患者安全性结局无不良影响(由美国国立心、肺和血液研究所[National Heart, Lung, and Blood Institute]和ACGME资助;iCOMPARE在ClinicalTrials.gov注册号为NCT02274818)。





作者信息

Jeffrey H. Silber, M.D., Ph.D., Lisa M. Bellini, M.D., Judy A. Shea, Ph.D., Sanjay V. Desai, M.D., David F. Dinges, Ph.D., Mathias Basner, M.D., Ph.D., Orit Even-Shoshan, M.S., Alexander S. Hill, B.S., Lauren L. Hochman, B.A., Joel T. Katz, M.D., Richard N. Ross, M.S., David M. Shade, J.D., Dylan S. Small, Ph.D., Alice L. Sternberg, Sc.M., James Tonascia, Ph.D., Kevin G. Volpp, M.D., Ph.D., and David A. Asch, M.D., M.B.A. for the iCOMPARE Research Group*
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.). Address reprint requests to Dr. Silber at the Center for Outcomes Research, Children’s Hospital of Philadelphia, Roberts Center, 2716 South St., Rm. 5123, Philadelphia, PA 19146-2305, or at silber@email.chop.edu. *A complete list of the members of the iCOMPARE Research Group is provided in the Supplementary Appendix, available at NEJM.org.

 

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