Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois2Center for Healthcare Studies in the Institute for Public Health and Medicine, Feinberg School of Medi.
Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
JAMA Surg. 2016 Mar;151(3):273-81. doi: 10.1001/jamasurg.2015.4990.
Debate continues regarding whether to further restrict resident duty hour policies, but little high-level evidence is available to guide policy changes.
To inform decision making regarding duty hour policies, the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial is being conducted to evaluate whether changing resident duty hour policies to permit greater flexibility in work hours affects patient postoperative outcomes, resident education, and resident well-being.
DESIGN, SETTING, AND PARTICIPANTS: Pragmatic noninferiority cluster-randomized trial of general surgery residency programs with 2 study arms. Participating in the study are Accreditation Council for Graduate Medical Education (ACGME)-approved US general surgery residency programs (n = 118), their affiliated hospitals (n = 154), surgical residents and program directors, and general surgery patients from July 1, 2014, to June 30, 2015, with additional patient safety outcomes collected through June 30, 2016. The data collection platform for patient outcomes is the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP), thus only hospitals participating in the ACS NSQIP were included.
In the usual care arm, programs adhered to current ACGME resident duty hour standards. In the intervention arm, programs were allowed to deviate from current standards regarding maximum shift lengths and minimum time off between shifts through an ACGME waiver.
Death or serious morbidity within 30 days of surgery measured through ACS NSQIP, as well as resident satisfaction and well-being measured through a survey delivered at the time of the 2015 American Board of Surgery in Training Examination (ABSITE).
A total of 118 general surgery residency programs and 154 hospitals were enrolled in the FIRST Trial and randomized. Fifty-nine programs (73 hospitals) were randomized to the usual care arm and 59 programs (81 hospitals) were randomized to the intervention arm. Intent-to-treat analysis will be used to estimate the effectiveness of assignment to the intervention arm on patient outcomes, resident education, and resident well-being compared with the usual care arm. Several sensitivity analyses will be performed to determine whether there were differential effects when examining only inpatients, high-risk patients, and emergent/urgent cases.
To our knowledge, the FIRST Trial is the first national randomized clinical trial of duty hour policies. Results of this study may be informative to policymakers and other stakeholders engaged in restructuring graduate medical training to enhance the quality of patient care and resident education.
clinicaltrials.org Identifier: NCT02050789.
关于是否进一步限制住院医师工作时间政策的争论仍在继续，但几乎没有高水平的证据可用于指导政策的改变。
为了为工作时间政策的决策提供信息，正在进行“外科住院医师工作时间要求灵活性研究（FIRST）”，以评估改变住院医师工作时间政策以允许更大的工作时间灵活性是否会影响患者术后结果、住院医师教育和住院医师幸福感。
设计、地点和参与者：这是一项具有 2 个研究臂的普通外科住院医师培训计划的实用性非劣效性聚类随机试验。该研究包括美国普通外科住院医师培训计划（n=118）及其附属医院（n=154）、外科住院医师和主任、普通外科患者，研究时间为 2014 年 7 月 1 日至 2015 年 6 月 30 日，通过美国外科医师学院国家外科质量改进计划（ACS NSQIP）收集了额外的患者安全结果，因此只包括参与 ACS NSQIP 的医院。
在常规护理臂中，各计划均遵守当前的 ACGME 住院医师工作时间标准。在干预臂中，通过 ACGME 豁免，各计划可以偏离当前关于最大轮班长度和轮班之间最小休息时间的标准。
通过 ACS NSQIP 测量术后 30 天内的死亡或严重发病率，以及通过 2015 年美国外科学院住院医师培训考试（ABSITE）时进行的调查测量住院医师满意度和幸福感。
共有 118 个普通外科住院医师培训计划和 154 家医院参加了 FIRST 试验并进行了随机分组。59 个计划（73 家医院）被随机分配到常规护理臂，59 个计划（81 家医院）被随机分配到干预臂。将使用意向治疗分析来估计与常规护理臂相比，将患者分配到干预臂对患者结局、住院医师教育和住院医师幸福感的有效性。将进行几项敏感性分析，以确定在仅检查住院患者、高危患者和紧急/紧急情况下是否存在差异效应。
据我们所知，FIRST 试验是第一个关于工作时间政策的全国性随机临床试验。这项研究的结果可能为政策制定者和其他参与重构研究生医学培训以提高患者护理和住院医师教育质量的利益相关者提供信息。
clinicaltrials.gov 标识符：NCT02050789。
