Patient mortality and morbidity outcomes have not changed since the most recent round of reforms to medical residents’ duty hours in 2011, according to two of the first nationwide studies to assess these “improvements,” which both were published online Dec. 9 in JAMA.
In addition, one of the studies found no difference between pre-reform and post-reform scores or on pass rates for oral or written national in-training and board certification examinations.
Thus, two separate studies involving millions of hospitalized patients across the country have both found that these reforms had no discernible effect on patient care. However, both groups of researchers cautioned that their studies were observational and therefore subject to potential biases and that they covered only the first 2 years that the duty-hours reforms have been in place.
The 2011 requirements expanded on those enacted in 2003 by further restricting residents’ duty hours, in the hope of reducing medical errors attributed to exhausted residents. The hours of continuous in-hospital duty were reduced from 30 to 16 for first-year residents and to 24 for upper-year residents, and the interval between shifts was increased to at least 8 hours off for first-year residents and at least 14 hours off for upper-year residents.
“Duty hour reform is arguably one of the largest efforts ever undertaken to improve the quality and safety of patient care in teaching hospitals,” said Dr. Mitesh S. Patel of the University of Pennsylvania and the Veterans Affairs Hospital Center for Health Equity Research and Promotion, both in Philadelphia, and his associates.
They assessed 30-day mortality and readmissions among 2,790,356 Medicare patients who were treated either for acute MI, stroke, gastrointestinal bleeding, or heart failure, or who underwent general, orthopedic, or vascular surgery, at 3,104 hospitals between 2009 and 2012. The investigators found no significant associations, either positive or negative, between the reforms to residents’ duty hours and any patient outcomes. Sensitivity analyses confirmed the results of the primary data analyses.
“Our findings suggest that … the goals of improving the quality and safety of patient care … were not being achieved. Conversely, concerns that outcomes might actually worsen because of decreased continuity of care have not been borne out,” Dr. Patel and his associates said (JAMA 2014 Dec. 9 [doi:10.1001/jama.2014.15273]).
The investigators noted that their study was limited in that it could not take into account hospitals’ adherence to the new requirements. Their study also did not assess other outcomes such as patient safety indicators or complication rates, which “may better elucidate the relative effects of decreased resident fatigue and increased patient hand offs.” And their study couldn’t address any possible confounding effects from other concurrent policy initiatives aimed at improving care for Medicare beneficiaries, such as the Hospital Readmissions Reduction Program.
In the other study, a separate group of researchers used data from the American College of Surgeons National Surgical Quality Improvement Program to assess outcomes for 535,499 patients who underwent general surgery at 131 hospitals during the 2 years before and the 2 years after the reforms to residents’ duty hours were implemented. This included 23 teaching hospitals in which residents were involved in at least 95% of general surgeries, said Dr. Ravi Rajaram of the division of research and optimal patient care, American College of Surgeons, and the Institute for Public Health and Medicine at Northwestern University, both in Chicago, and his associates.
The reforms were not associated with any change in rates of patient mortality or serious morbidity, either in the study population as a whole or in the subgroups of high-risk and low-risk patients. They also had no effect on secondary outcomes such as surgical-site infection or sepsis. These results remained consistent across several sensitivity analyses.
Neither mean scores for in-training, written board, and oral board examinations nor pass rates for those examinations showed any significant changes during the study period.
“Moreover, first-year trainees, who were most directly affected by the 2011 reforms, did not improve their ABSITE [American Board of Surgery In-Training Examination] scores, despite presumably more free time to prepare,” Dr. Rajaram and his associates said (JAMA 2014 Dec. 9 [doi:10.1001/JAMA.2014.15277]).
They cautioned that their study assessed only the first 2 years following duty-hour reform, and “there may be differences in patient care or resident examination performance that are evident only several years after implementation and adoption of new duty-hour requirements.” In addition, a retrospective observational study such as this one could not produce the high-level evidence needed to guide policy decisions. “To that end, a national multicenter cluster-randomized trial is being conducted (the Flexibility In duty hour Requirements for Surgical Trainees [FIRST] trial), comparing current duty-hour requirements with flexible duty hours to assess the effects of this intervention on patient outcomes and resident well-being. This trial may further inform the debate of how to optimally structure postgraduate training,” they said.