Reporting and Analyzing Race and Ethnicity in Orthopaedic Clinical Trials: A Systematic Review

Abstract

Background: The distinction between race and ethnicity should be carefully understood and described for demographic data collection. Racial healthcare differences have been observed across many orthopaedic subspecialties. However, the frequency of reporting and analyzing race and ethnicity in orthopaedic clinical trials has not been determined. Therefore, the primary purpose of this systematic review was to determine how frequently race and ethnicity are reported and analyzed in orthopaedic clinical trials. Methods: The top 10 journals by impact factor in the field of orthopaedics were manually screened from 2015 to 2019. All randomized controlled trials related to orthopaedics and assessing clinical outcomes were included. Eligible studies were evaluated for bias using the Cochrane risk-of-bias tool and for whether the trial reported and analyzed several demographics, including age, sex, height, weight, race, and ethnicity. The frequency of reporting and analyzing by each demographic was accessed. In addition, comparisons of reporting and analyzing race/ethnicity were made based on orthopaedic subspecialty and journal of publication. Results: A total of 15,488 publications were screened and 482 met inclusion criteria. Of these 482 trials, 460 (95.4%) reported age and 456 (94.6%) reported sex, whereas 35 (7.3%) reported race and 15 (3.1%) reported ethnicity for the randomized groups; 79 studies (16.4%) analyzed age and 72 studies (14.9%) analyzed sex, whereas 6 studies (1.2%) analyzed race and 1 study (0.2%) analyzed ethnicity. The orthopaedic subspecialty of spine was found to report race (23.5%) and ethnicity (17.6%) more frequently than all the other subspecialties, whereas sports medicine reported race and/or ethnicity in only 3 of 150 trials (2.0%). Conclusions: Race and ethnicity are not frequently reported or analyzed in orthopaedic randomized controlled trials. Social context, personal challenges, and economic challenges should be considered while analyzing the effect of race and ethnicity on outcomes.

Is Our Science Representative? A Systematic Review of Racial and Ethnic Diversity in Orthopaedic Clinical Trials from 2000 to 2020

“…Despite rising awareness of orthopaedic healthcare disparities and efforts to mitigate differences in patient outcomes based on race and ethnicity, previous investigations of the orthopaedic evidence base have demonstrated limited diversity among study participants [40,47]. A systematic review of 158 United States orthopaedic randomized controlled trials (RCTs) that were published between 2008 and 2011 found that only 20.3% (32) of trials reported at least one race or ethnicity variable.…”

“…Previous research has suggested that a lack of minority representation in the orthopaedic evidence base may perpetuate disparities in metrics such as utilization [3,41], postoperative complications [7,20,38,48], and functional outcomes [21,27,44]. Likewise, others have suggested that increased reporting of racial and ethnic data may be an avenue to identify targets for policy intervention and to improve health equity [40,47]. Racial differences in tumor pathophysiology and the incidence of important genetic loci, for example, have been studied for soft tissue sarcomas and osteosarcomas [1,[33][34][35].…”

“…The practice of superficial, isolated racial and ethnic reporting may lead to the generation of misleading inferences or the reinforcement of harmful stereotypes regarding the inevitability of poorer outcomes among minority patients [30]. Furthermore, previous systematic reviews have limited their searches to clinical trials in the United States and have yet to address the need for differing approaches to race and ethnicity reporting in multinational, multicenter trials [40,47]. Finally, existing reviews of race and ethnicity reporting are limited to periods of 5 years at the most, and therefore are unable to assess for temporal trends across multiple decades [40,47].…”

“…Furthermore, previous systematic reviews have limited their searches to clinical trials in the United States and have yet to address the need for differing approaches to race and ethnicity reporting in multinational, multicenter trials [40,47]. Finally, existing reviews of race and ethnicity reporting are limited to periods of 5 years at the most, and therefore are unable to assess for temporal trends across multiple decades [40,47].…”

Implementing patient-reported outcomes in routine clinical care for diverse and underrepresented patients in the United States

“…PRO implementation in routine clinical care has been documented to have low adoption nationwide [ 13 ], which may further impede efforts to capture diverse populations. Additionally, reporting of certain factors such as race and ethnicity in clinical trials has not been widespread [ 14 ].…”