What’s New in the Patient Safety World

March 2016

Does the Surgical Resident Hours Study Answer Anything?

 

 

When discussing the impact of healthcare worker fatigue on patient safety, we often begin with the question “Would you rather be cared for by a tired resident who knows you or a wide awake one who doesn’t know you?”. Of course, at this time we don’t have an unassailable answer to that question.

 

In our many columns (listed below) on the conflicting studies on the impact of housestaff workhour restrictions on patient safety we’ve laid our hopes for better answers on two ongoing randomized trials, one in surgery (the FIRST trial) and one in internal medicine (the iCOMPARE trial).

 

The results of the FIRST (surgical residency) trial were just published (Bilimoria 2016). But does it really answer critical questions?

 

The trial concluded that there were no significant differences in the primary or secondary patient outcomes between the standard (ACGME rules) group and the intervention (more flexible hours) group and that there were also no significant differences in residents’ satisfaction with overall well-being and education quality. Residents in the flexible hours arm, however, were more likely to perceive negative effects on personal activities such as time with family and friends, extracurricular activities, rest and health.

 

The FIRST trial was a well-designed prospective cluster-randomized (at the residency program level) trial that used data from a validated database (the ACS NSQIP database). But it was a noninferiority trial, really designed to show the two arms equal rather than one arm having superior outcomes.

 

Our biggest problem with the study is that, other than death within 30 days, all the patient level outcomes were likely more related to actions during the surgery or immediate perioperative period. They did not include things like medication errors, which one might reasonably argue would be expected to be more often affected by resident fatigue than would something like wound infections. And we can find no reference in the publication about length of stay or readmission rates, important parameters which often are impacted by both complications and continuity of care issues.

 

So perhaps the best way to summarize the FIRST results is “there is no difference in patient outcomes or residents’ perception of educational value between strict adherence to ACGME guidelines vs. more flexible workhours but residents have more negative feelings about the impact on their personal lives with the more flexible hours.” Given that, there is actually little reason for the ACGME to alter its recommendations regarding resident work hours.

 

In the editorial accompanying the FIRST trial results, John Birkmeyer points out that much of the work formerly done primarily by residents is now done primarily by others (Birkmeyer 2016). For example, there are often board-certified intensivists in the ICU’s and many associate providers working with multidisciplinary teams. We’ll add that many hospitals also have hospitalists that are attending to many of the non-surgical aspects of patient care in surgical patients, probably much more so than when the original ACGME resident workhour restrictions were enacted in 2003.

 

So what did we learn from the FIRST trial? There appear to be no overwhelming reasons that the ACGME workhour restrictions should be rescinded or modified.

 

 

 

Some of our other columns on housestaff workhour restrictions:

 

December 2008           “IOM Report on Resident Work Hours”

February 26, 2008       “Nightmares: The Hospital at Night”

January 2010               “Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety

January 2011               “No Improvement in Patient Safety: Why Not?”

November 2011          “Restricted Housestaff Work Hours and Patient Handoffs”

January 3, 2012           “Unintended Consequences of Restricted Housestaff Hours”

June 2012                    “Surgeon Fatigue”

November 2012          “The Mid-Day Nap”

December 10, 2013     “Better Handoffs, Better Results”

April 22, 2014             “Impact of Resident Workhour Restrictions”

January 2015               “More Data on Effect of Resident Workhour Restrictions”

August 2015               “Surgical Resident Duty Reform and Postoperative Outcomes”

September 2015          “Surgery Previous Night Does Not Impact Attending Surgeon Next Day”

 

 

 

Some of our other columns on the role of fatigue in Patient Safety:

 

November 9, 2010      “12-Hour Nursing Shifts and Patient Safety”

April 26, 2011             “Sleeping Air Traffic Controllers: What About Healthcare?”

February 2011             “Update on 12-hour Nursing Shifts”

September 2011          “Shiftwork and Patient Safety

November 2011          “Restricted Housestaff Work Hours and Patient Handoffs”

January 2010               “Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety

January 3, 2012           “Unintended Consequences of Restricted Housestaff Hours”

June 2012                    “June 2012 Surgeon Fatigue”

November 2012          “The Mid-Day Nap”

November 13, 2012    “The 12-Hour Nursing Shift: More Downsides”

July 29, 2014               “The 12-Hour Nursing Shift: Debate Continues”

October 2014              “Another Rap on the 12-Hour Nursing Shift”

December 2, 2014       “ANA Position Statement on Nurse Fatigue”

August 2015               “Surgical Resident Duty Reform and Postoperative Outcomes”

September 2015          “Surgery Previous Night Does Not Impact Attending Surgeon Next Day”

 

 

Our previous columns on the 12-hour nursing shift:

 

November 9, 2010      “12-Hour Nursing Shifts and Patient Safety”

February 2011             “Update on 12-hour Nursing Shifts”

November 13, 2012    “The 12-Hour Nursing Shift: More Downsides”

July 29, 2014               “The 12-Hour Nursing Shift: Debate Continues”

October 2014              “Another Rap on the 12-Hour Nursing Shift”

December 2, 2014       “ANA Position Statement on Nurse Fatigue”

September 29, 2015    “More on the 12-Hour Nursing Shift”

 

 

 

 

References:

 

 

Bilimoria KY, Chung JW, Hedges LV, et al. National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training. N Engl J Med 2016; published online first February 2, 2016

http://www.nejm.org/doi/full/10.1056/NEJMoa1515724?query=TOC

 

 

Birkmeyer JD. Surgical Resident Duty-Hour Rules - Weighing the New Evidence (editorial). N Engl J Med 2016; published online first February 2, 2016

http://www.nejm.org/doi/full/10.1056/NEJMe1516572?query=TOC

 

 

 

 

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