What are the race and ethnicity patterns in orthopedic randomized clinical trials and is it a clinically relevant factor?
Race and Ethnicity Patterns in Ortho Clinical Trials
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#ethnicity#orthopedicclinicaltrials#race
A new study, “Reporting and Analyzing Race and Ethnicity in Orthopaedic Clinical Trials: A Systematic Review,” which tackles these vitally important questions appears in the May 2021 edition of JAAOS: Global Research and Reviews.
Kevin B. Freedman, M.D., co-author and professor of Orthopaedic Surgery at Rothman Orthopaedic Institute, explained to OTW how he and his team decided to tackle this complicated and important subject, “This issue has been explored in other fields, but this is the first study to evaluate the reporting and analysis of race and ethnicity in randomized control trials in the field of orthopaedics.”
“Although we know that race and ethnicity can affect health care outcomes, we found that very few studies in orthopaedics either report or analyze outcomes by race. When we council patients on their expected outcomes from surgery, this may not be accurate for people of all races.”
The study authors examined the 10 orthopedic journals with the highest impact factor. They even compared reporting and analysis of race and ethnicity based on subspecialty and journal.
450+ Publications, Little Mention of Race/Ethnicity
The investigators reviewed 15,488 publications, of which 482 met the inclusion criteria. Out of this lot, 460 reported age and 456 reported sex—35 reported race and 15 reported ethnicity for the randomized groups. Seventy-nine analyzed age and 72 analyzed sex; 6 studies analyzed race and 1 reported ethnicity.
Spine randomized clinical trials led the way among subspecialties, with 23.5% of studies reporting race and 17.6% reporting ethnicity. At the other end of the spectrum were sports medicine studies, which reported race and/or ethnicity in 3 out of 150 RCTs.
Dr. Freedman summarized the conclusions of this study to OTW, “We need to account for differences in race and ethnicity in our clinical trials so we can make the results generalizable to each segment of the population. In addition, if certain complications after surgery are more common for those of a particular race, we can account for this and work to minimize any adverse outcomes in the future.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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