Systemic Errors in Prior Spine Research Uncovered

The Spine Journal, Spine, and Journal of Neurosurgery: Spine, all have published studies which, it appears, suffer from a systemic under-reporting of study subject demographics—raising the distressing possibility that published study evidence is NOT applicable to a general population of spine surgery patients.

According to co-author and President of the Rothman Orthopaedic Institute at Thomas Jefferson University Hospital in Philadelphia Alexander R. Vaccaro, M.D., Ph.D., M.B.A., “It’s a truly regrettable finding, but our results show that a mere 9.35% (N=26) of the studies reported race and 3.9% (N=11) of studies reported ethnicity.”

“Many health disparity studies are underpowered and not capable of accurately assessing differences among racial or ethnic groups,” explained Dr. Vaccaro. “How can we provide accurate treatment recommendations if the data we are working from is not reflective of the general population?”

“We found that demographic reporting frequency did not vary by journal; reporting of age and body mass index increased over time, but reporting of race and ethnicity remained the same. A whopping 85.71% of the patients in the U.S. studies were white.” [emphasis added]

The full study, “Reporting demographics in randomized control trials in spine surgery – we must do better,” appears in the May 2023 edition of The Spine Journal.

The Rothman-based research team designed a systematic review of existing randomized controlled trials in three spine-focused journals with the highest impact factors: The Spine Journal, Spine, and Journal of Neurosurgery: Spine.

Taking papers published between January 2012 and January 2022, the authors looked at the frequency of demographic reporting, sample size, and the demographic composition of studies. Specifically, they noted whether age, gender, body mass index, race, and ethnicity were reported and analyzed for each study. A total of 278 randomized controlled trials were included (166 in Spine, 65 in The Spine Journal, and 47 in Journal of Neurosurgery: Spine.

Studies from 37 different countries were included, with randomized controlled trials most frequently conducted in the U.S. (67), China (30), South Korea (17), and Japan (14). Eight studies were conducted in multiple countries.

“We in spine—in all of orthopedics—have not done well as far as conducting studies with broad generalizability,” stated co-author Dr. Vaccaro to OTW. “This is a fundamental issue as we already know that age, sex, race, and ethnicity play major roles in patients’ lives, healthcare inequalities, and surgical outcomes.”

Prior research has determined that non-White participants made up only 25% of study participants in all funded trials. However, according to the 2020 United States Census Report, 42.1% of the national U.S. population is non-White.

“From a systemic standpoint, there is research showing that minority individuals are significantly more likely to seek spine surgery care from a low-volume facility, which may impact their complication and reoperation rates. Going forward we need to compel public health and policy interventions that open up care opportunities for marginalized communities at high-quality, high-volume academic centers.”

“We should demand that authors include this data. In addition, it is critical that researchers are transparent about the limitations of their work…we must say, ‘This is not applicable to the general population.’”

“Without the inclusion of all patient populations in clinical trials, disparities in care may continue to widen…so we always need work that is generalizable. We can’t keep writing papers if they don’t apply to everyone we treat.”

The word “demographic” is comprised of two parts that mean: “pertaining to the common people” and “process of writing or recording.” And the Hippocratic Oath mentions “special obligations to all my fellow human beings.” (Note the “all”)