内科轮班灵活性试验中的睡眠与警觉性。
Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine.
机构信息
From the University of Pennsylvania (M.B., D.A.A., J.A.S., L.M.B., M.C., A.J.E., S.K.M., D.S.S., K.G.V., D.F.D.), Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A., K.G.V.), Children's Hospital of Philadelphia (O.E.-S., J.H.S.), and Pulsar Informatics (C.G.M., S.C., D.J.M.) - all in Philadelphia; Johns Hopkins University, Baltimore (S.V.D., A.L.S., J.T., D.M.S.); and Brigham and Women's Hospital, Boston (J.T.K., D.W.B.).
出版信息
N Engl J Med. 2019 Mar 7;380(10):915-923. doi: 10.1056/NEJMoa1810641.
BACKGROUND
A purpose of duty-hour regulations is to reduce sleep deprivation in medical trainees, but their effects on sleep, sleepiness, and alertness are largely unknown.
METHODS
We randomly assigned 63 internal-medicine residency programs in the United States to follow either standard 2011 duty-hour policies or flexible policies that maintained an 80-hour workweek without limits on shift length or mandatory time off between shifts. Sleep duration and morning sleepiness and alertness were compared between the two groups by means of a noninferiority design, with outcome measures including sleep duration measured with actigraphy, the Karolinska Sleepiness Scale (with scores ranging from 1 [extremely alert] to 9 [extremely sleepy, fighting sleep]), and a brief computerized Psychomotor Vigilance Test (PVT-B), with long response times (lapses) indicating reduced alertness.
RESULTS
Data were obtained over a period of 14 days for 205 interns at six flexible programs and 193 interns at six standard programs. The average sleep time per 24 hours was 6.85 hours (95% confidence interval [CI], 6.61 to 7.10) among those in flexible programs and 7.03 hours (95% CI, 6.78 to 7.27) among those in standard programs. Sleep duration in flexible programs was noninferior to that in standard programs (between-group difference, -0.17 hours per 24 hours; one-sided lower limit of the 95% confidence interval, -0.45 hours; noninferiority margin, -0.5 hours; P = 0.02 for noninferiority), as was the score on the Karolinska Sleepiness Scale (between-group difference, 0.12 points; one-sided upper limit of the 95% confidence interval, 0.31 points; noninferiority margin, 1 point; P<0.001). Noninferiority was not established for alertness according to the PVT-B (between-group difference, -0.3 lapses; one-sided upper limit of the 95% confidence interval, 1.6 lapses; noninferiority margin, 1 lapse; P = 0.10).
CONCLUSIONS
This noninferiority trial showed no more chronic sleep loss or sleepiness across trial days among interns in flexible programs than among those in standard programs. Noninferiority of the flexible group for alertness was not established. (Funded by the National Heart, Lung, and Blood Institute and American Council for Graduate Medical Education; ClinicalTrials.gov number, NCT02274818.).
背景
工时法规的目的之一是减少医学实习生的睡眠剥夺，但它们对睡眠、困倦和警觉的影响在很大程度上仍不清楚。
方法
我们将美国 63 个内科住院医师培训项目随机分为两组，一组遵循标准的 2011 年工时政策，另一组遵循灵活的政策，在不限制轮班长度或轮班之间强制休息时间的情况下保持每周 80 小时的工作时间。通过非劣效性设计比较两组之间的睡眠持续时间以及早晨的困倦和警觉性，包括使用活动记录仪测量的睡眠持续时间、卡罗林斯卡困倦量表（得分范围为 1 [非常警觉]至 9 [非常困倦，难以入睡]）和简短的计算机化精神运动警觉性测试（PVT-B），长反应时间（失误）表示警觉性降低。
结果
在六个灵活项目中的 205 名实习生和六个标准项目中的 193 名实习生进行了为期 14 天的研究。在灵活项目中的平均睡眠时间为每 24 小时 6.85 小时（95%置信区间[CI]为 6.61 至 7.10），而在标准项目中的平均睡眠时间为 7.03 小时（95%CI 为 6.78 至 7.27）。灵活项目中的睡眠时间并不劣于标准项目（组间差异，每 24 小时 0.17 小时；95%CI 的单侧下限，0.45 小时；非劣效性边界，0.5 小时；P<0.001），卡罗林斯卡困倦量表的评分也是如此（组间差异，0.12 分；95%CI 的单侧上限，0.31 分；非劣效性边界，1 分；P<0.001）。根据 PVT-B，警觉性的非劣效性未得到证实（组间差异，-0.3 次失误；95%CI 的单侧上限，1.6 次失误；非劣效性边界，1 次失误；P=0.10）。
结论
这项非劣效性试验表明，在灵活项目中的实习生中，没有比在标准项目中更慢性的睡眠损失或困倦。灵活组的警觉性非劣效性未得到证实。（由美国国立心肺血液研究所和美国研究生医学教育理事会资助；临床试验.gov 编号，NCT02274818。）
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