Resident Duty Hour Limits Haven't Improved Patient Safety

Megan Brooks

December 11, 2014

Restrictions on resident duty hours do not appear to have had any significant effect on mortality or readmission rates for hospitalized patients or outcomes for general surgery patients, findings of two new studies show.

Concerns about drowsy and fatigued residents led the Accreditation Council for Graduate Medical Education to restrict duty hours in 2003, with further restrictions set in 2011.

The 2011 revisions maintain the weekly limit of 80 hours set forth by the 2003 reforms but reduced the work hour limit from 30 consecutive hours to 16 hours for first-year residents and 24 hours for upper-year residents (with another 4 hours to perform transitions of care and participate in educational activities).

There has been concern that the reforms may adversely affect patient care, in part by creating more patient hand-offs and less continuity of care, as well as education, with fewer hours for training.

The lack of significant effect on either outcomes or educational performance by these residents seen in the new studies should assuage fears that the duty hour limits would in fact be detrimental to patient outcomes but shows no benefit either in improving outcomes.

The studies are published December 9 in JAMA, a theme issue on medical education.

General Surgery Outcomes

In their study, Karl Y. Bilimoria, MD, director, Surgical Outcomes and Quality Improvement Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois, and colleagues analyzed general surgery patient outcomes 2 years before and 2 years after the 2011 duty hour reforms. The main analysis included 102,525 patients from 23 teaching hospitals and 102,116 patients from 31 nonteaching hospitals.

After adjustment for potentially confounding factors, duty hour reforms were not associated with a significant change in death or serious illness in postreform year 1 (odds ratio [OR], 1.12; 95% confidence interval [CI], 0.98 - 1.28) or postreform year 2 (OR, 1.00; 95% CI, 0.86 - 1.17), or when both postreform years were combined (OR, 1.06; 95% CI, 0.93 - 1.20).

The researchers also failed to find an association between duty hour reforms and any other postoperative adverse outcome.

Until now, there have been no large-scale empirical evaluations of the 2011 reforms, Dr Bilimoria told Medscape Medical News.

"Our study shows that the duty hour restrictions implemented in 2011 were not associated with improved safety. The results are consistent with what we expected," he said. "While it seems logical that limiting duty hours would improve safety, it actually does not appear to do so, and most surgeons and residents would have expected this finding given the effect of these rules on continuity of care."

Duty hour reforms also didn't affect general surgery residents' performance on the annual in-training written and oral examinations.

"Most of the surgical community believes that these duty hours actually hurt patient care and resident education by impairing continuity of care — the doctors who know the patient best are not able to stay and see the patient through critical times. Thus, we do not believe that these 2011 duty hour restrictions are beneficial," Dr Bilimoria said.

Improved Safety Goals "Not Achieved"

In the other study, Mitesh S. Patel, MD, from the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, and colleagues assessed the effect of duty hour reforms on mortality and readmissions among hospitalized Medicare patients in the first year after the reforms.

Their analysis included nearly 6.4 million admissions to 3104 short-term, acute care hospitals with principal medical diagnoses of heart attack, stroke, gastrointestinal bleeding, or congestive heart failure or a classification of general, orthopedic, or vascular surgery.

The researchers found no significant positive or negative associations of duty hour reforms with 30-day mortality for any of the medical conditions or surgical categories, and no significant positive or negative associations of these reforms with 30-day all-cause readmissions for combined medical conditions or combined surgical categories.

This suggests that the reform goals of improving the quality and safety of patient care, as measured in this study by decreased 30-day mortality and all-cause readmissions rates, "were not being achieved," the authors say. "Conversely, concerns that outcomes might actually worsen because of decreased continuity of care have not been borne out."

The coauthors of an accompanying editorial discuss how the findings of these studies should be interpreted.

"First, with regard to potential short-term policy decisions on duty hour requirements, is it important to decide whether a null association with safety and education metrics is a positive or negative finding?" write James A. Arrighi, MD, from the Warren Alpert Medical School of Brown University, Providence, Rhode Island, and James C. Hebert, MD, from the University of Vermont College of Medicine, Burlington. "In our roles as residency review committee chairs, we think this is the wrong question to ask because there was no justification for making the rules more complex or restrictive, as occurred in 2011."

They point out that many program directors have expressed "great concern about the potential negative effects of this second set of changes, including effects on resident education, preparedness for senior roles, patient safety, and continuity of care."

"Thus, in the absence of clear data demonstrating benefit, the concerns of the educational community should be given credence and not be dismissed as mere perceptions."

 
" … in the absence of clear data demonstrating benefit, the concerns of the educational community should be given credence and not be dismissed as mere perceptions. Dr James A. Arrighi and Dr James C. Hebert
 

Dr Arrighi and Dr Herbert say 2 planned randomized trials on duty hours proposed by the medical education community "may provide more definitive information."

The findings in these 2 studies are "no surprise," Hunt Batjer, MD, president of the Society of Neurological Surgeons and president-elect of the American Association of Neurological Surgeons, told Medscape Medical News. The neurosurgery community has been particularly concerned about the possible effects of duty hour restrictions on hand-off of complex neurosurgical patients.

"There is no evidence whatsoever that patient safety was enhanced by the 2003 and 2011 changes and there is some evidence that surgical outcomes are worse," said Dr Batjer, chair of neurological surgery, UT Southwestern Medical Center, Dallas, Texas. He did not participate in the studies.

"The mythology that patient safety is enhanced by duty hour restrictions is not proven," Dr Batjer added. Still, he thinks the weekly work limit of 80 hours is "appropriate."

"I think you can train high-quality surgeons with an 80-hour work week under the current rules. I do not think you can train high-quality surgeons with a 56-hour work week, that's a no-go, and you definitely can't in 48 hours," he added.

The studies had no commercial funding. A complete list of author disclosures is listed with the original articles.

JAMA. 2014;312:2342-2344, 2364-2373, 2374-2384. Abstract Abstract Editorial

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