Whats 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 doesnt know you?. Of course, at this time we dont 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 weve 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 ICUs and many associate providers working with multidisciplinary teams. Well 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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