July 10, 2015
A new retrospective study that is the subject of an “article in press” that is to appear in the Journal of the American College of Surgeons later this year shows that the 2011 ACGME work hour restrictions had no impact on 30-day surgical outcomes.
In 1999, the Institute of Medicine (IOM) came out with their patient safety manifesto called “To Err Is Human.” In this report, the IOM published findings on the frequency of medical errors in American hospitals. They reported that each year some 98,000 patients in US hospitals die as a result of medical errors. Since that time, several additional estimates characterizing just how many patients die each year due to preventable errors, have come out. Some of these estimate the patient mortality caused by medical errors to be as high as 400,000 individuals each year.
In 2011 the ACGME established more restrictive work hour restrictions for residents in training. First year residents, also called interns, were restricted to working duty shifts of no longer than 16 continuous hours among other changes. The new 2011 ACGME regulations were in response to new research that had come out which showed resident physicians working shifts longer than 16 continuous hours were more prone to a variety of different cognitive and diagnostic medical errors.
With resident physicians no longer able to work extended shifts, the frequency of handovers increased. Handovers or medical handoffs entail the transfer of the professional responsibility for a patient or group of patients from one medical provider to another at shift changes. After the implementation of the more restrictive ACGME work hour restrictions, sign-outs, a term used to denote the process by which a patient is transferred to another provider, became focus of patient safety research.
Clinical training programs and patient safety experts alike were concerned that the decreased continuity of care caused by the more restrictive ACGME work hour regulations may lead to a rise in the rate of medical errors, a large source of which are communication failures at the time of sign-outs. They feared that the increased number of handoffs between providers that the new rules would necessitate, could potentially have the paradoxical effect of causing more patient harm and adversely affect patient outcomes, the very phenomenon the work hour regulations were conceived to prevent.
However, the findings from the new “in-press” study suggest the work hour limitations had no adverse or beneficial impact on 30-day surgical outcomes. The study examined surgical outcomes one year before and two years after implementation of the 2011 ACGME resident duty hour reforms at teaching hospitals. The study looked at outcomes within 30-days of an operation and included five surgical specialties: neurosurgery, urology, orthopedic surgery, obstetrics and gynecology, and vascular surgery. The patient outcomes data used in the study came from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) and same period data from non-teaching hospitals was used to adjust the teaching hospital data reported for factors that may affect surgical care universally over time. The investigators also controlled for additional factors that may have impacted surgical outcomes including patient demographics and pre-existing medical conditions.
The authors of the retrospective study concluded that the surgical outcomes observed were not adversely impacted by the additional resident work hour restrictions. They found no significant differences in 30-day surgical outcomes in the included surgical subspecialties at academic medical centers before and after the implementation of 2011 ACGME resident work hour restrictions.
So while prior to the 2011 ACGME work hour reform, continuity of care may have been achieved by the flexibility and convenience that longer resident work hours afforded, it appears that the increased number of handovers ushered in by the new 2011 work hour restrictions posed no additional risk to patient safety, at least as measured by 30-day surgical outcomes. It is possible that the concurrent implementation of better standardization of patient handoffs at sign-outs (2007 JCAHO Patient Safety Goal and requirement for hospital accreditation) and improved resident education on how to conduct patient handoffs (ACGME requirement for residency program accreditation) may have neutralized the potential additional danger that the increased frequency of handoffs potentially posed.
Of course, more research will be needed to definitively confirm or refute the associations identified in this new research. The authors of the current study state that in 2016, they will be publishing the results of a prospective study, dubbed ‘FIRST’ (Flexibility In duty hour Requirements for Surgical Trainee) that examines this in further depth.