MedicalResearch.com Interview with:
Jeffrey H. Silber, MD, PhD
Director, Center for Outcomes Research
Nancy Abramson Wolfson Endowed Chair
Health Services Research
Children’s Hospital of Philadelphia
Professor of Pediatrics, Anesthesiology and Critical Care
Perelman School of Medicine, University of Pennsylvania
Professor of Health Care Management
Wharton School, University of Pennsylvania
MedicalResearch.com: What is the background for this study?
Response: This was a year-long randomized trial that involved 63 internal medicine residency programs from around the US. In 2015-2016, about half of the programs were randomized to follow the existing rules about resident duty hours that included restrictions on the lengths of shifts and the rest time required between shifts (the standard arm of the trial) and the other half of the programs didn’t have those shift length or rest period rules (the flexible arm of the trial). We measured what happened to the patients cared for in those programs (the safety study), and other studies examined how much sleep the residents received, and how alert they were at the end of shifts (the sleep study), and previously we published on the educational outcomes of the interns.
To measure the impact on patient outcomes when allowing program directors the ability to use a flexible shift length for their interns, we compared patient outcomes after the flexible regimen went into place to outcomes the year before in the same program. We did the same comparison for the standard arm. Then we compared the difference between these comparisons. Comparing before and after the implementation of the trial within the same program allowed us to be more confident that a particularly strong or weak program, or a program with especially sick or healthy patients, would not throw off the results of the study. The trial was designed to determine, with 95% confidence, if the flexible arm did not do more than 1% worse than the standard arm. If this were true for the flexible arm, we could say the flexible regimen was “non-inferior” to the standard regimen.
MedicalResearch.com: What are the main findings?
Response: We found that for death within 30 days of admission (the primary outcome of the trial), we could say with 95% confidence that the flexible arm was non-inferior to the standard arm. We also found that for the flexible programs, complications measured by Patent Safety Indicators, and 7-day death or readmission rates also were non-inferior to the standard arm. We could not establish non-inferiority with 95% confidence for the outcome prolonged length of stay, but we also saw no evidence that one arm was statistically different from the other. In fact, for all the outcomes we studied, there was no statistical difference between the flexible or standard arms of the study.
MedicalResearch.com: What should readers take away from your report?
Response: The results of the iCOMPARE trial, taken as a whole, provides reassuring evidence that the more flexible approach to shift length did not pose significant risks to patients, compared to the conventional duty hours approach that was in place at the time.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: There are many questions still unanswered from this trial. Future work will need to better define the optimal shift length for specific work environments, taking into consideration patient safety as well as resident well-being and education. We need to better model the acute and chronic demands placed on residents, and we need to devise systems that track patient and resident outcomes over time, since the hospital environment is constantly changing.
Funding: We received financial support from the National Heart, Lung, and Blood Institute of NIH, as well as the ACGME, who also gave us permission to randomize programs to the flexible regimen.
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