In the March 2, 2016 edition of JBJS, Rongen et al. air some dirty laundry regarding the orthopaedic community’s registering and reporting on randomized controlled trials (RCTs). According to the authors, only 25% of 362 RCTs published in the top-ten orthopaedic journals between January 2010 and December 2014 were reported as having been registered. Furthermore, of those 25%, only 47% were registered before the end of the trial, and only 38% of those 25% were registered before the enrollment of the first patient, as specified by the International Committee of Medical Journal Editors (ICMJE).
Additionally disheartening is the finding that among the 26 trial reports that the authors deemed eligible for evaluation of consistency between the registered outcome measure(s) and outcomes reported in the published article, 14 (54%) were found to have one or more outcome-measure discrepancies.
Let us re-commit collectively to meeting the timely registration standards required by federal payors such as the NIH and encouraged by the ICMJE. Doing so will ultimately improve the care of patients who have the conditions we study. In general, orthopaedic surgeons are leaders among the surgical specialties when it comes to initiatives that improve patient care. But adequate trial registration and prevention of selective outcome reporting are areas where we are behind the curve, and we need to fix that ASAP. As Rongen et al. emphasize, improvement will require the “full involvement of authors, editors, and reviewers.”
Marc Swiontkowski, MD