Looking forward – March 2016

David B. Hoyt

David B. Hoyt, MD, FACS

Resident work hour limits have been the source of considerable consternation in the surgical community since they were introduced by the Accreditation Council for Graduate Medical Education (ACGME) in 2003. The ACGME revised the guidelines in 2011, making them more restrictive. This action added to the growing concerns that members of the American College of Surgeons (ACS) and the leaders of the American Board of Surgery (ABS) have expressed about the effects of the rules on surgical training.

To help address these issues, leaders from the ACS and the ABS approached the ACGME about the possibility of working together to study the effects of adding some flexibility to the current duty hour requirements. After months of discussion, the groups agreed to conduct the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial.

The results of the FIRST Trial were published in the New England Journal of Medicine in February and show that granting training programs the latitude to allow trainees to work longer shifts or take less time off between shifts is not associated with greater risk of patient morbidity or mortality. This landmark trial, I believe, will ultimately take well-intentioned policies with unintended consequences and transform them into best practices for surgical training.

FIRST Trial leaders

Northwestern University

Karl Y. Bilimoria, MD, MS, FACS,
FIRST Trial Principal Investigator

Jeanette W. Chung, PhD,
Research assistant professor

American College of Surgeons

Mark E. Cohen, PhD,
Senior Statistician/Data Analyst,
Division of Research and Optimal Patient Care

David B. Hoyt, MD, FACS,
Executive Director

Clifford Y. Ko, MD, MS, MSHS, FACS,
Director, ACS NSQIP

American Board of Surgery

Frank R. Lewis, MD, FACS, executive director

Background

The ACGME first issued the resident work hour restrictions in response to growing public concerns that overworked, fatigued residents were more prone to medical error. The 2003 ACGME guidelines limited resident duty hours to 80 per week, mandated that residents be provided with one day per week free from all educational and clinical responsibilities, capped continuous on-site duty at 24 consecutive hours, and required that residents have an 8-hour rest period between all daily duty periods and after in-house call. Although many members of the surgical community expressed trepidation that these restrictions would negatively affect continuity of care and surgical training, most residency programs adapted.

In 2011, the ACGME issued additional measures, which, among other provisions, shortened the shift length for interns to a maximum of 16 hours and to 24 hours for residents in their second year or more of training. The new guidelines also increased resident time off from work to 14 hours after a 24-hour in-house shift.

Residents and surgical educators have voiced concern that these additional restrictions have led to an increase in patient handoffs, thereby disrupting continuity of care and creating new opportunities for medical error. Moreover, many members of the surgical education community believe that the duty hour restrictions may limit surgical training by inhibiting residents’ ability to follow the natural history and progress of their patients.

FIRST Trial design

To determine whether modified restrictions on resident work hours would affect patient care, surgical outcomes, and resident perceptions, the ACS, ABS, and ACGME undertook the FIRST Trial. Karl Y. Bilimoria, MD, MS, FACS, ACS Faculty Scholar and director, Surgical Outcomes and Quality Improvement Center (SOQIC), Northwestern University Feinberg School of Medicine, Chicago, IL, served as the lead investigator of the study, which involved 117 ACGME-approved U.S. general surgery residency programs and their 151 affiliated hospitals. (See sidebar for a list of other study leaders.) These institutions represent 95 percent of the programs that were eligible to participate in the study and were randomly assigned to either an intervention group with flexible duty hours or a control group. To gauge trainee satisfaction, we administered a survey at the January 2015 ABS In-Training Examination (ABSITE).

Both groups of training institutions that participated in the FIRST Trial adhered to ACGME policies, limiting the workweek to an average of 80 hours; residents on average got one day off per week, and residents could take call no more often than every third night. The Standard Policy control group, composed of 59 training programs and 71 affiliated hospitals, also complied with all ACGME mandates from 2003 and 2011 described previously. The 58 training programs and 80 affiliate hospitals in the Flexible Policy group received permission from the ACGME to waive the rules pertaining to intern work shifts, duty hours for senior residents, time off between shifts, and time off after 24 hours of continuous duty.

The audience at the FIRST Trial results announcement

The audience at the FIRST Trial results announcement

Findings

Using the ACS National Surgical Quality Improvement Program (ACS NSQIP®) platform to measure death or serious morbidity within 30 days of an operation, we found that of the nearly 139,000 patients who underwent surgery, the rate of this composite outcome was similar in both study groups (9 percent). We also found no differences between study arms for the 10 other patient outcomes studied, including the need for a second operation.

Furthermore, among the 4,330 residents who responded to the ABSITE survey, those trainees in the flexible group (2,220 respondents) reported no significant difference in their overall well-being compared with residents in the control group (2,110). There also was no difference between the first two study arms with respect to resident satisfaction with duty hours at their program and with job satisfaction.

Residents in the Flexible Policy group were more likely than participants in the Standard Policy group to report improved continuity of patient care, patient safety, acquisition of operative skills, and professionalism. Residents in the flexible work hour group also were more likely to report being present for the entirety of an operation and being able to treat their patients through critical times without interruption due to duty hour limits.

The FIRST Trial results were announced February 2 at the Academic Surgical Congress in Jacksonville, FL, hosted by the Association for Academic Surgery and the Society of University Surgeons.

For further details about the FIRST Trial, see the article in this issue, or visit the FIRST Trial page on the ACS website.

A way forward

The FIRST Trial is a landmark study because it provides the first evidence we have to show that modifying work hours is safe and actually may enhance the surgical learning environment. And I think it’s good news for patients because they are going to have physicians following them throughout the entire episode of care.

In light of the FIRST Trial findings, the ACGME has agreed to review its work hour policies. I am confident that the ACS, ABS, ACGME, and the American Board of Medical Specialties—which recently issued a statement supporting the FIRST Trial—will be able to use this initiative to develop new consensus-based protocols for resident work hours.

Overall, this study and its likely effects provide a great example of how professional organizations that are committed to setting standards for surgical education and patient care can work together to resolve issues of mutual concern. As always, we welcome your suggestions on how we can help you provide quality surgical care to your patients.

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