Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules
Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules
复制标题
DOI：
10.1056/nejmoa1810642
复制
发表时间：
2019-03-07
影响因子：
158.5
通讯作者：
Asch, David A.
中科院分区：
文献类型：
--
作者：
Silber, Jeffrey H.;Bellini, Lisa M.;Asch, David A.
关注持续存在，在医疗住院医师项目的延长转变可能会对患者safety. METHODS产生不利影响，我们进行了一项群集随机非劣效性试验，在63内科住院医师项目在2015-2016学年。程序进行了随机分组，一组标准的工作时间，通过认证理事会的研究生医学教育（ACGME）在2011年7月，或一组更灵活的工作时间规则，没有规定轮班长度或强制性的轮班之间的时间限制。每个项目的主要结果是从试验前一年到试验年未调整的30天死亡率的变化，这是从医疗保险索赔中确定的。我们假设，灵活方案中30天死亡率的变化不会比标准方案中的变化差（差异中差异分析）超过1个百分点（非劣效性界值）。次要结果是其他5项患者安全性指标的变化和所有指标的风险调整结果。灵活方案患者30天死亡率（主要结果）的变化（试验年12.5%对试验前一年12.6%）不劣于标准方案（试验年12.2%对试验前一年12.7%）。非劣效性检验具有显著性（P = 0.03），组间死亡率变化差异的单侧95%置信区间上限（0.93%）估计值小于预先规定的非劣效性界值1个百分点。灵活方案和标准方案在7天未调整的再入院率、患者安全指标和医疗保险支付方面的变化差异也低于1个百分点; 30天再入院或住院时间延长不符合非劣效性标准。风险调整措施一般表现出类似的findings. CONCLUSIONSAallowing程序主任的灵活性，在调整值班时间表的学员没有不利影响30天的死亡率或其他几个测量结果的病人安全。
BACKGROUNDConcern persists that extended shifts in medical residency programs may adversely affect patient safety.METHODSWe 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.RESULTSThe 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.CONCLUSIONSAllowing 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.