Study Design: Patients from 5 surgical specialties (neurosurgery, obstetrics/gynecology, orthopaedic surgery, urology, and vascular surgery) were identified from the American College of Surgeons NSQIP. Data from one year prior and two years after the reform was implemented were obtained for teaching and non-teaching hospitals. Hospital teaching status was defined based on the percentage of operations with a resident present intraoperatively. Difference-in-differences models were developed separately for each specialty and adjusted for patient demographics, comorbidities, procedural case mix, and time trends. The association between duty hour reform and a composite measure of death or serious morbidity within 30-days of surgery was estimated for each specialty.
Results: The unadjusted rate of death or serious morbidity decreased during the study period in both teaching and non-teaching hospitals for all surgical specialties. In multivariable analyses, there were no significant associations between duty hour reform and the composite outcome of death or serious morbidity in the two years post-reform for any surgical specialty evaluated (neurosurgery: OR 0.90, 95% CI 0.75-1.08, P=0.26; obstetrics/gynecology: OR 0.96, 95% CI 0.71-1.30, P=0.80; orthopedic surgery: OR 0.95, 95% CI 0.74-1.22, P=0.70; urology: OR 1.16, 95% CI 0.89-1.51, P=0.26; vascular surgery: OR 1.07, 95% CI 0.93-1.22, P=0.35).
It was revealed that the resident and intern on call that night were finishing out a 36 hour in house shift. An autopsy confirmed that Ms Zion had died from serotonin syndrome, arising from the lethal combination of phenelzine, demerol, and the cocaine abuse. Mr Zion launched an offensive against the hospital, the residents involved in the case, and the entire medical resident training paradigm. He was convinced that the long, unregulated work hours of the residents directly contributed to his daughter's death. Criminal proceedings were considered but ultimately a grand jury declined to indict for murder. At civil trial, a jury found for the Zion estate that the physicians involved in the case were negligent and a $375,000 settlement was ordered to be paid to the Zion family for "pain and suffering."
Afterwards the New York State Health Commissioner established an ad hoc advisory committee, led by Bertrand Bell MD, tasked with evaluating the training and supervision of residents in the state of New York. This "Bell Commission" then formalized a set of guidelines that was implemented by residency training programs in the state of New York in 1989. Specifically, it was mandated that residents could not work more than 80 hours in a week. Over the course of the next 15 years, the idea of work hour reform seeped into the national consciousness and, in 2003, the ACGME enforced the 80 hour work week nationwide, with residents being limited to no more than 30 consecutive hours of continuous duty. By the 2011, the reforms were further revised. Interns are now not allowed to work more than 16 hours continuously and there is some nonsense in there about senior residents being forced to take naps if on call for a 24 hour period.
The impact of work hour reform has been hard to quantify. Theoretically it would see to make sense--- less tired residents would be more attuned to detail, less likely to make errors. Further, putting more onus of responsibility on the shoulders of senior residents and Attending physicians would presumably lead to fewer errors, better patient outcomes. The data from numerous studies, however, has been less than compelling. This, this, this, this, this, and this all magnify the conclusions drawn from the above referenced Bilimoria paper----work hour reform has had no appreciable impact on patient outcomes. Keeping trainees out of the OR, sending them home, forcing them to take naps----none of it has improved patient morbidity or mortality. Not to mention the unforeseen consequences of resident hand-off errors and the still yet to be quantified impact on the quality of medical and surgical training.
But we really ought not to be too surprised. Libby Zion died tragically at the too young age of 18. She died in a hospital, under the watchful eye of two inexperienced, overworked residents. But her death may have been unavoidable. Serotonin syndrome was a poorly understood mechanism back in 1984 and the interaction between phenelzine, demerol, and cocaine was even less well recognized. After the Grand Jury indicted the resident and intern for "gross negligence" the Hearing Committee of the State Board for Professional Misconduct investigated the charges over the course of 30 hearings. Several of the witnesses were Chairmen of Internal Medicine Departments at prominent medical schools who, under oath, testified that they had never heard of the interaction between demerol and phenelzine prior to the Zion case. The initial autopsy, for gods's sake, listed cause of death as "bronchopneumonia". The cause of death was a true medical zebra. Most of the best medical minds of the time would have missed it, well rested or otherwise.