A new study from the group at Rothman Orthopaedic Institute in Philadelphia is highlighting the surprising lack of consistent demographics reporting in randomized control spine trials—regardless of journal.
Hello! What ARE the Demographics in Spine Clinical Trials?
2 min read Premium comments
#spinesurgery#demographics#ethnicity
The study, “Reporting Demographics in Randomized Control Trial Trials in Spine Surgery,” was published online on November 15, 2022 in The Spine Journal.
“Demographic factors contribute significantly to spine surgery outcomes. Although race and ethnicity are not proxies for disease states, the intersection between these patient characteristics and socioeconomic status significantly impact patient outcomes,” the researchers wrote.
The Rothman team collected data regarding the frequency of demographic reporting and then analyzed the randomized control trials published in the three highest impact spine journals.
In total, the team pulled data from 278 trials, of which 65 appeared in The Spine Journal, 166 in Spine, and 47 Journal of Neurosurgery: Spine between January 2012 and January 2022. The researchers particularly focused on the frequency of demographic reporting, sample size, and demographic composition of studies.
In addition to overall frequency of demographic reporting, the Rothman team also collected annual reporting trends data by journal. The populations for those studies that did report demographics were then compared to national census data for the United States.
Only 9.35% of the studies reported race and only 3.9% reported ethnicity. There was no difference in demographic reporting frequency between the journals.
Age and body mass index reporting increased over time, but race and ethnicity did not. Among the trials that reported race, 88% were U.S. trials and 85.71% of the patients in them were white. The researchers found that non-white or Black patients were underrepresented in the trials.
They wrote, “Randomized control trials published in the three highest impact factor spine journals failed to frequently report patient race or ethnicity…As we strive to care for an increasingly diverse population and reduce disparities to care, spine surgeons must do a better job reporting these variables to increase the external validity and generalizability of random control trials.”
Study authors include Tariq Ziad Issa, B.A.; Mark J. Lambrechts, M.D.; Jose A. Canseco, M.D., Ph.D.; Alan S. Hilibrand, M.D.; Christopher K. Kepler, M.D., MBA; Alexander R. Vaccaro, M.D., MBA, Ph.D.; Gregory D. Schroeder, M.D., all of Rothman Orthopaedic Institute at Thomas Jefferson University Hospital.
React:
Discussion
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.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.