Many allege that the FIRST trial, which randomized surgical residencies to strict versus flexible adherence to duty hour restrictions, was unethical because patients weren’t consented for the trial and, as this was an experiment, in the true sense of the word, consent was mandatory. The objection is best summarized by an epizeuxis in a Tweet from Alice Dreger, a writer, medical historian, and a courageous and tireless defender of intellectual freedom.
— Alice Dreger (@AliceDreger) November 20, 2015
It’s important understanding what the FIRST (Flexibility In duty hour Requirements for Surgical Trainees) trial did and didn’t show. It showed neither that working 120 hours a week has better outcomes than working 80 hours a week, nor the opposite. Neither did the trial, despite being a non-inferiority trial, show that working 100 hours was as safe as working 60 hours a week. The trial showed that violating duty hour restrictions didn’t worsen outcomes. The trial was neither designed nor powered to specify the degree to which the violation of duty hours was safe. This key point can be missed. To be fair, neither the trialists, nor the editorials about the trial, claimed so.