Eyes wide open

Rosenbaum L, Lamas D. Eyes Wide Open - Examining the Data on Duty-Hour Reform. N Engl J Med. 2019 Mar 7;380(10):969-970.

In a world moved by story, medicine — we like to believe — is still moved by measurement. That is why, when resident work-hour limits were implemented in 2003, catalyzed by the tragic death of Libby Zion, many in the medical community pointed out the paucity of evidence to support these sweeping changes.1 Although the harms of excess fatigue were evident,2 there was also concern that the policy conferred new risks, such as those associated with increased handoffs of care or inadequate educational exposure. When the Accreditation Council for Graduate Medical Education (ACGME) enacted even more stringent requirements in 2011, we were among those who urged the ACGME to grant the profession enough flexibility to conduct randomized trials; we emphasized that a policy that could substantially affect patients’ lives should be subject to the same empirical rigor as any other medical intervention.3 The ACGME soon granted programs a waiver, allowing some flexibility in shift length, as well as time off between shifts; caps on weekly hours worked, total days off, and the frequency of overnight call were maintained. Pragmatic randomized trials soon followed, comparing programs that hewed to the standard requirements with those that had this discretionary flexibility. What have we learned?

The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial, a national, prospective, randomized trial involving surgical residency programs that was published in 2016, compared residencies that had flexible requirements with those that had standard requirements — and found no significant between-group differences in rates of death and surgical complications.4 Residents in the flexible group reported less dissatisfaction with continuity of care and handoffs than those in the standard group, but there was no meaningful difference between the two groups in terms of quality of training or overall morale. A randomized trial called the Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial was simultaneously under way among internal-medicine residency programs. The three objectives of the trial were to assess patient safety and educational outcomes, as well as sleep and alertness among a subgroup of the interns enrolled. The educational outcomes were published in 2018.5 Although program directors were more satisfied with the flexible work hours, and there was no significant difference in the proportion of time that interns spent on patient care and education between the two models, interns in the flexible group were more dissatisfied with their educational experience and had lower levels of overall well-being than those in the standard group. 

In this issue of the Journal, the iCOMPARE investigators report the patient safety outcomes and provide the most rigorous assessment to date on trainee sleep and alertness. Using Medicare claims data to assess patient outcomes, Silber et al.6 found that 30-day mortality — in addition to 7-day and 30-day risk-adjusted readmissions and Medicare payments — in the flexible group were noninferior to those in programs in which doctors worked standard hours. Similarly, Basner et al.7 found that sleep duration was noninferior in flexible programs as compared with standard programs, with interns in both groups averaging approximately 7 hours of sleep per night. Essentially, interns made up for lost sleep on extended shifts by sleeping more during time off.

Can the issue of duty hours now be laid to rest? In many ways, yes. We can confidently say that working flexible hours, still within the 80-hour constraints, does not result in higher patient mortality than working standard hours. We also now know that interns do not sleep significantly more or less when following either of these schedules. One can always identify questions these data do not answer. Are the existing work-hour constraints, somewhat arbitrary in their derivation, ideally suited to the diverse training requirements across specialties? Given the discretionary nature of the flexible group in the iCOMPARE trial and the large variability among programs in terms of how time was spent, how can we really know which approach best balances resident well-being with the demands of patient care? And though all these data offer reassurance about immediate patient safety outcomes, can we be sure that we are preparing trainees to handle the challenges of practice in the real world where such protections clearly do not exist?

Although at this point neither of us would argue for additional randomized trials to answer these questions, we also do not believe that the reckoning for the profession is over. Conspicuously absent in any of these trials is the patient voice. What is the experience of being a hospitalized patient in a world where “your doctor” is constantly shifting? Because these changes occurred within a broader cultural transformation — which included the rise of the hospitalist, the implementation of the electronic health record, and a burgeoning movement to address workforce burnout — trying to isolate the effect of shift length on patient experience is likely to be fruitless. Yet, the convergence of these ecologic changes, and consequent attitudinal shifts, remain equally deserving of our attention.

We both now are attending physicians at the same hospital, and we recently cared for the same patient, one of us as a cardiology consultant and the other as the primary attending physician in the intensive care unit for one overnight shift. The patient died, and when we discussed our sadness, as well as surprise at the rapidity of his demise, we both marveled at the kindness of his wife, with whom we had each interacted at the bedside. We talked about our shared desire to reach out to her, and then each of us independently concluded that if we called her, she would have no idea who we were. She would not identify us as her husband’s doctors. It is this unfortunate reality — that hospitalized patients often do not even know who their doctors are and that we, as doctors, are increasingly removed from the experience of longitudinal care — that is one of the immeasurable consequences of our professional transformation. This cultural shift is certainly not attributable to work-hour restrictions alone. But as we move beyond the question of how many consecutive hours our most junior doctors can safely work, we will continue to ask how we might design a system capable of fostering the morale of its workforce, while simultaneously sustaining the relationships that remain fundamental to the well-being of both patients and their doctors. To that end, stories are likely to always have a role.

Silber JH, Bellini LM, Shea JA, Desai SV, Dinges DF, Basner M, Even-Shoshan O, Hill AS, Hochman LL, Katz JT, Ross RN, Shade DM, Small DS, Sternberg AL, Tonascia J, Volpp KG, Asch DA; iCOMPARE Research Group. Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules. N Engl J Med. 2019 Mar 7;380(10):905-914.

Abstract

BACKGROUND:

Concern persists that extended shifts in medical residency programs may adversely affect patient safety.

METHODS:

We conducted a cluster-randomized noninferiority trial in 63 internal-medicine residency programs during the 2015-2016 academic year. Programs underwent randomization to a group with standard duty hours, as adopted by the Accreditation Council for Graduate Medical Education (ACGME) in July 2011, or to a group with more flexible duty-hour rules that did not specify limits on shift length or mandatory time off between shifts. The primary outcome for each program was the change in unadjusted 30-day mortality from the pretrial year to the trial year, as ascertained from Medicare claims. We hypothesized that the change in 30-day mortality in the flexible programs would not be worse than the change in the standard programs (difference-in-difference analysis) by more than 1 percentage point (noninferiority margin). Secondary outcomes were changes in five other patient safety measures and risk-adjusted outcomes for all measures.

RESULTS:

The change in 30-day mortality (primary outcome) among the patients in the flexible programs (12.5% in the trial year vs. 12.6% in the pretrial year) was noninferior to that in the standard programs (12.2% in the trial year vs. 12.7% in the pretrial year). The test for noninferiority was significant (P = 0.03), with an estimate of the upper limit of the one-sided 95% confidence interval (0.93%) for a between-group difference in the change in mortality that was less than the prespecified noninferiority margin of 1 percentage point. Differences in changes between the flexible programs and the standard programs in the unadjusted rate of readmission at 7 days, patient safety indicators, and Medicare payments were also below 1 percentage point; the noninferiority criterion was not met for 30-day readmissions or prolonged length of hospital stay. Risk-adjusted measures generally showed similar findings.

CONCLUSIONS:

Allowing program directors flexibility in adjusting duty-hour schedules for trainees did not adversely affect 30-day mortality or several other measured outcomes of patient safety. (Funded by the National Heart, Lung, and Blood Institute and Accreditation Council for Graduate Medical Education; iCOMPARE ClinicalTrials.gov number, NCT02274818.).

Basner M, Asch DA, Shea JA, Bellini LM, Carlin M, Ecker AJ, Malone SK, Desai SV, Sternberg AL, Tonascia J, Shade DM, Katz JT, Bates DW, Even-Shoshan O, Silber JH, Small DS, Volpp KG, Mott CG, Coats S, Mollicone DJ, Dinges DF; iCOMPARE Research Group. Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med. 2019 Mar 7;380(10):915-923.

Abstract

BACKGROUND:

A purpose of duty-hour regulations is to reduce sleep deprivation in medical trainees, but their effects on sleep, sleepiness, and alertness are largely unknown.

METHODS:

We randomly assigned 63 internal-medicine residency programs in the United States to follow either standard 2011 duty-hour policies or flexible policies that maintained an 80-hour workweek without limits on shift length or mandatory time off between shifts. Sleep duration and morning sleepiness and alertness were compared between the two groups by means of a noninferiority design, with outcome measures including sleep duration measured with actigraphy, the Karolinska Sleepiness Scale (with scores ranging from 1 [extremely alert] to 9 [extremely sleepy, fighting sleep]), and a brief computerized Psychomotor Vigilance Test (PVT-B), with long response times (lapses) indicating reduced alertness.

RESULTS:

Data were obtained over a period of 14 days for 205 interns at six flexible programs and 193 interns at six standard programs. The average sleep time per 24 hours was 6.85 hours (95% confidence interval [CI], 6.61 to 7.10) among those in flexible programs and 7.03 hours (95% CI, 6.78 to 7.27) among those in standard programs. Sleep duration in flexible programs was noninferior to that in standard programs (between-group difference, -0.17 hours per 24 hours; one-sided lower limit of the 95% confidence interval, -0.45 hours; noninferiority margin, -0.5 hours; P = 0.02 for noninferiority), as was the score on the Karolinska Sleepiness Scale (between-group difference, 0.12 points; one-sided upper limit of the 95% confidence interval, 0.31 points; noninferiority margin, 1 point; P<0.001). Noninferiority was not established for alertness according to the PVT-B (between-group difference, -0.3 lapses; one-sided upper limit of the 95% confidence interval, 1.6 lapses; noninferiority margin, 1 lapse; P = 0.10).

CONCLUSIONS:

This noninferiority trial showed no more chronic sleep loss or sleepiness across trial days among interns in flexible programs than among those in standard programs. Noninferiority of the flexible group for alertness was not established. (Funded by the National Heart, Lung, and Blood Institute and American Council for Graduate Medical Education; ClinicalTrials.gov number, NCT02274818.).