乌鸦传媒

Educational outcomes in hospitals' intern-residency programs that set no limit on the duration of trainees' work shifts did not differ from those in standard programs limiting shifts to 16-28 hours, the cluster-randomized found.

There was no significant differences between groups in how interns spent their time, nor was there a difference in how interns perceived the balance between their clinical demands and their education, reported Sanjay V. Desai, MD, of Johns Hopkins University School of Medicine in Baltimore, and colleagues.

But a separate survey of trainees in flexible and standard programs showed more dissatisfaction with other aspects of the programs allowing longer hours, including educational quality and overall well-being. At the same time, directors of flexible programs said the educational quality was improved.

The results were presented at in San Antonio, and published online early in the

"The 1984 death of Libby Zion under the care of house officers in a New York Hospital started the move from the long standing 36 hour shift to a schedule designed to minimize errors compounded by fatigue. With the 2011 publication of the , one would think that the issue would be solved," Marc Leavey, MD, of Mercy Medical Center in Baltimore told 乌鸦传媒. Leavey was not involved with the research.

But Desai and colleagues noted that research "revealed essentially no differences" in patient outcomes following the 2011 change in Accreditation Council for Graduate Medical Education (ACGME) policies. However, program directors reported "a reduced quality of training and professional maturation, increased frequency of handoffs of care, and decreased continuity, without improved patient safety or quality of care," they said.

In iCOMPARE, 63 internal medicine residency programs were randomized to be governed by policies then in force under ACGME rules or "more flexible policies" that did not specify any limits on shift duration or mandatory time off between shifts. Researchers collected this data through observations on the activities of interns, surveys of trainees, and intern examination scores.

In standard programs, shift duration was capped at 16 hours for PGY-1 trainees and 28 hours (24 plus up to 4 hours to manage transitions) for PGY-2 and beyond; also, trainees were allowed at least 8-14 hours off between shifts. In both types of program, total work hours could not exceed 80 per week and each trainee had at least one day off every 7 days; in-house call could not be more frequent than every third night.

The trial was highly controversial, with the watchdog group Public Citizen and the American Medical Students Association calling it unethical, since trainees in participating programs could not opt out. They charged that allowing first-year trainees to work extended shifts put them and their patients at risk. Despite these complaints, and even before the iCOMPARE results were released, the ACGME last year approved increasing maximum shift lengths for PGY-1 trainees to 28 hours.

Trainees in these programs as well as program directors were surveyed multiple times with different instruments during the study period, which ran from July 1, 2015, to June 30, 2016.

Approximately 4,200 trainees -- roughly 40% at the PGY-1 level -- were in participating programs and contributed at least some data to the study.

For the study's key outcomes, the investigators found no significant between-group difference in percentage of shift time spent on direct patient care (13.0% in flexible hour programs versus 11.8% in standard programs, P=0.21) or in mean time spent on education (7.3% in both groups). There were some numerical differences in secondary outcomes favoring the flexible programs, including time spent on handoffs and rounds, but these were not statistically significant either. Actual maximum shift lengths averaged 24 hours in the flexible programs.

There were also no significant differences between groups in response to a prespecified primary question on the ACGME survey about "appropriate balance of education" nor were there differences between groups in faculty responses to the same survey about whether "residents' workload exceeded their capability to do the work."

In addition, the difference in average scores on in-training examinations did not meet the prespecified non-inferiority margin, the authors said (68.9% in flexible programs versus 69.4% in standard programs, difference -0.43, 95% CI -2.38 to 1.52, P=0.06 for non-inferiority).

But an end-of-year iCOMPARE survey found that interns in the flexible group were more likely to report dissatisfaction with the overall quality of education than the standard group. By contrast, in this survey, directors of flexible programs were less likely than directors of standard programs to report dissatisfaction with aspects of the learning environment.

An by Graham T. McMahon, MD, of the in Chicago noted the "mismatch" between program directors and residents in terms of satisfaction.

"This [...] suggests that many program directors are unaware of their residents' perceptions and thus may be making well-intentioned, but ultimately ill-formed decisions about the design and delivery of the residency program," he wrote.

But he cautioned against the risk that regulators and program leaders "will be tempted to revert to standard work hours rather than revisiting the entire learning environment for both clinicians and trainees."

McMahon also cited several limitations to the study, such as generalizability, desirability bias in survey responses and low response rates to some elements. Indeed, Desai and colleagues noted that the iCOMPARE trainee survey response rate was 45%, and that the actual number of hours interns worked were not measured, though interns in both groups "were limited to the same average total number of hours worked per week."

Importantly, they wrote that outcomes for patient mortality and intern sleep and alertness are "not yet available," which Leavey noted.

"The seminal issue which started this whole process -- that of quality of care by fatigued interns -- does not appear to be addressed by this study," he wrote. "I am glad that the groups could express their satisfaction, but I am troubled by the lack of information on outcomes of patient care."