National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training
National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training
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DOI：
10.1056/nejmoa1515724
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发表时间：
2016-02-25
影响因子：
158.5
通讯作者：
Lewis, Frank R.
中科院分区：
文献类型：
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作者：
Bilimoria, Karl Y.;Chung, Jeanette W.;Lewis, Frank R.
关于当前外科住院医师职责时间政策对患者预后、住院医师教育和住院医师幸福感的影响，人们一直存在担忧。方法：我们进行了一项全国性、集群随机、实用、非劣效性试验，涉及美国117个普外科住院医师项目（2014-2015学年）。项目被随机分配到现行的研究生医学教育认证委员会（ACGME）的值班时间政策（标准政策组）或更灵活的政策（灵活政策组），这些政策放弃了最大轮班长度和轮班之间的休息时间（灵活政策组）。结果包括术后30天的死亡率或严重并发症（主要结果）、其他术后并发症、住院医师对其健康、教育和患者护理的认知和满意度。结果在对138,691例患者的数据分析中，灵活的、限制较少的值班时间政策与死亡率或严重并发症的增加（灵活政策组为9.1%，标准政策组为9.0%,P = 0.92；灵活政策组的未调整优势比为0.96；92%可信区间为0.87至1.06;P = 0.44；满足非效性标准）或任何术后次要结果的研究无关。在4330名居民中，那些被分配到灵活政策项目的人对整体教育质量（灵活政策组为11.0%，标准政策组为10.7%,P = 0.86）或福祉（分别为14.9%和12.0%,P = 0.10）的不满程度并没有显著增加。弹性政策下的住院医师比标准政策下的住院医师更不可能感知到值班时间政策对患者安全、护理连续性、专业性和住院医师教育等多个方面的负面影响，但更有可能感知到个人活动的负面影响。在住院医生报告的疲劳对个人或患者安全影响的感知方面，研究组之间没有显著差异。灵活政策组的住院医生比标准政策组的住院医生报告在手术期间离开的可能性要小（7.0%比13.2%,P . 571）
BACKGROUNDConcerns persist regarding the effect of current surgical resident duty-hour policies on patient outcomes, resident education, and resident well-being.METHODSWe conducted a national, cluster-randomized, pragmatic, noninferiority trial involving 117 general surgery residency programs in the United States (2014-2015 academic year). Programs were randomly assigned to current Accreditation Council for Graduate Medical Education (ACGME) duty-hour policies (standard-policy group) or more flexible policies that waived rules on maximum shift lengths and time off between shifts (flexible-policy group). Outcomes included the 30-day rate of postoperative death or serious complications (primary outcome), other postoperative complications, and resident perceptions and satisfaction regarding their well-being, education, and patient care.RESULTSIn an analysis of data from 138,691 patients, flexible, less-restrictive duty-hour policies were not associated with an increased rate of death or serious complications (9.1% in the flexible-policy group and 9.0% in the standard-policy group, P = 0.92; unadjusted odds ratio for the flexible-policy group, 0.96; 92% confidence interval, 0.87 to 1.06; P = 0.44; noninferiority criteria satisfied) or of any secondary postoperative outcomes studied. Among 4330 residents, those in programs assigned to flexible policies did not report significantly greater dissatisfaction with overall education quality (11.0% in the flexible-policy group and 10.7% in the standard-policy group, P = 0.86) or well-being (14.9% and 12.0%, respectively; P = 0.10). Residents under flexible policies were less likely than those under standard policies to perceive negative effects of duty-hour policies on multiple aspects of patient safety, continuity of care, professionalism, and resident education but were more likely to perceive negative effects on personal activities. There were no significant differences between study groups in resident-reported perception of the effect of fatigue on personal or patient safety. Residents in the flexible-policy group were less likely than those in the standard-policy group to report leaving during an operation (7.0% vs. 13.2%, P