A controversial study that was branded as unethical by some critics because it altered surgical residents’ training hours without informed consent from patients has found that “flexible, less restrictive” duty hours did not increase patient mortality or serious complications.
The recently published Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial1 was determined to be non-human subject research by the IRB at Northwestern University in Chicago. In addition, the Accreditation Council for Graduate Medical Education (ACGME) waived some of its current requirements to allow the study to proceed.
“This national, prospective, randomized trial showed that flexible, less-restrictive duty-hour policies for surgical residents were noninferior to standard ACGME duty-hour policies with respect to our primary patient outcome of the 30-day rate of postoperative death or serious complications,” the authors concluded. “There was also no significant difference between the standard-policy and flexible-policy groups with respect to residents’ satisfaction regarding their well-being and education.”
The ACGME waivers of its current requirements for the FIRST study and the ongoing Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial were strongly criticized last November by the watchdog group Public Citizen and the American Medical Student Association (AMSA). They charged that the studies were unethical due to the waived requirements and the lack of informed consent to patients. (For more information, see the January 2016 issue of IRB Advisor.) Public Citizen stayed on the attack after publication of the FIRST trial, saying in a statement2 that it produced “self-serving results … needed to roll back the ACGME’s 2011 mandatory limits on physician resident work hours that were adopted to protect both the residents and their patients from serious harm.”
The ACGME has completely refuted the charges and did not rescind waivers of its 2011 duty-hour requirements for physician training that allowed the FIRST trial and iCOMPARE study to proceed. While the current 16 consecutive duty-hour limits adopted in 2011 were designed to protect patients, studies comparing the 2011 to the 2003 ACGME (24 consecutive hours on-site; six additional for other activities) duty-hour requirements suggests that patient safety has not been improved, ACGME argued in granting the waivers.
The FIRST study compared standard ACGME duty-hour policies with flexible duty-hour policies in general surgery residency programs from July 1, 2014 to June 30, 2015. The investigators randomly assigned general surgery residency programs to use one of two types of duty hour policies. However, both groups adhered to three main ACGME policies: the workweek was limited to 80 hours, one day off in seven was required, and residents could not be on call more often than every third night.
A total of 117 programs at 151 hospitals completed the study. One group of 59 programs and their affiliated 71 hospitals participated in the “standard policy” arm of the study, complying with all current ACGME duty hour policies. The other group, consisting of 58 programs and 80 affiliated hospitals, received permission from the ACGME to waive rules on maximum shift lengths and time off between shifts. In this flexible duty-hour group, programs were allowed to implement one or more of the following policy changes:
- interns’ work shifts could extend beyond the current maximum of 16 hours,
- more senior residents’ duty-hour periods could exceed 24 hours,
- residents were not required to have at least eight hours off between shifts, and
- residents were not required to have at least 14 hours off after 24 hours of continuous duty.
FOCUS ON 'HANDOFFS’
“Our goal was to revise only the policies that would interfere with continuity of care or would result in increased ‘handoffs,’ [between surgeons] particularly at unsafe times,” lead study investigator Karl Bilimoria, MD, MS, FACS, director of the Surgical Outcomes and Quality Improvement Center at Northwestern, said in a statement released with the study. “In surgery, this more frequent turnover may compromise continuity of patient care, potentially jeopardize patient safety, and decrease the quality of resident education by forcing residents to leave at critical times, such as in the middle of an operation or while stabilizing a critically ill patient.”
The rate of death or serious complications did not differ significantly between study groups (9.1% in the flexible policy group and 9.0% in the standard policy group). In addition, the risk of death or serious complications did not differ significantly between patients who underwent surgery in hospitals affiliated with programs assigned to flexible, less-restrictive duty-hour policies and those who underwent surgery in standard policy hospitals. Flexible policies were noninferior to standard policies with respect to serious complications, any complication, unplanned reoperation, sepsis, surgical-site infection, and urinary tract infection in unadjusted and adjusted models, the investigators reported.
In addition, survey data were obtained from 4,330 general surgery residents who were undergoing training in 117 FIRST trial programs (2,110 residents in the flexible policy group and 2,220 in the standard policy group). Residents in flexible policy programs were not significantly more likely than those in standard policy programs to be dissatisfied with overall education quality (11.0% in the flexible policy group and 10.7% in the standard policy group); or overall well-being (14.9% and 12.0%, respectively).
Flexible policy residents were significantly less likely than standard policy residents to be dissatisfied with continuity of care but were more likely to be dissatisfied with time for rest, the authors noted. There was no significant difference between study groups regarding resident satisfaction with the duty-hour regulations of their program. Flexible policy residents were significantly less likely than standard policy residents to perceive a negative effect of institutional duty-hour policies on patient safety, continuity of care, clinical skills acquisition, operative skills acquisition, autonomy, operative volume, availability for elective and urgent cases, conference attendance, time for teaching medical students, the relationship between interns and residents, and professionalism.
However, flexible policy residents were more likely to perceive negative effects of duty-hour policies on resident outcomes that depended on time away from the hospital, such as case preparation after work, research participation, time with family and friends, time for extracurricular activities, rest, and health. Nonetheless, there were no significant differences between study groups regarding the perceived effects of duty hours on job satisfaction, satisfaction with career choice, or morale, the authors concluded.
In an editorial3 accompanying the study, a leading surgeon did not challenge the results but took a contrarian’s view of the perceived benefits and risks experienced by patients and surgical residents. Yes, the study showed that flexible hours did not increase risk, but — since the findings for the two groups were essentially a wash — it also confirmed that the residents working under the existing policies were not putting patients at higher risk, either.
“It is not surprising that outcomes did not vary according to whether programs adhered to ACGME requirements on maximum shift length and time off between shifts,” noted John D. Birkmeyer, MD, surgeon and executive vice president at Dartmouth Hitchcock Health System in Lebanon, NH. “The patients most likely to be affected by resident handoffs — those with acute or deteriorating clinical conditions — represent only a small percentage of surgical patients at teaching hospitals. More important, teaching hospitals have become far less reliant on surgical residents than they used to be. In earlier eras, surgical residents had considerable autonomy. During my own residency, surgical residents often operated independently, particularly at night and on weekends. Today, they operate almost exclusively in the presence of an attending surgeon.”
Birkmeyer then raises the critical question: What do the results of the FIRST Trial mean for ACGME policy on resident duty hours?
“The authors conclude, as will many surgeons, that surgical training programs should be afforded more flexibility in applying work-hour rules,” he stated in the editorial. “…I reach a different conclusion. The FIRST Trial effectively debunks concerns that patients will suffer as a result of increased handoffs and breaks in the continuity of care. Rather than backtrack on the ACGME duty-hour rules, surgical leaders should focus on developing safe, resilient health systems that do not depend on overworked resident physicians. They should also recognize the changing expectations of postmillennial learners. To many current residents and medical students, 80-hour (or even 72-hour) workweeks and 24-hour shifts probably seem long enough. Although few surgical residents would ever acknowledge this publicly, I’m sure that many love to hear, ‘We can take care of this case without you. Go home, see your family, and come in fresh tomorrow.’”
- Bilimoria KY, Chung JW, Hedges LV, et al. National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training. N Engl J Med 2016; 374:713-727.
- Carome M. New England Journal of Medicine Violates Its Own Policy, Publishes Results of Unethical Clinical Trial That Put Resident Doctors at Risk. Public Citizen, Feb. 2, 2016. http://bit.ly/1YrJ4ze.
- Birkmeyer JD. Surgical Resident Duty-Hour Rules — Weighing the New Evidence. N Engl J Med 2016; 374:783-784.