Gaps in diversity and inclusion reporting in United States knee injury clinical trials: A systematic review and meta-analysis

Purpose: Diversity and inclusion in clinical trials are critical for increasing the generalizability of research. Our objective was to examine the diversity and inclusion of historically marginalized populations in clinical trials focused on knee injuries in the United States. Methods: Our systematic review and meta-analysis evaluated the diversity and representation of clinical trials concerning knee injuries published between 2018 and 2023. Published manuscripts of relevant knee injury clinical trials were identified using the medical literature databases MEDLINE (PubMed) and Embase (Elsevier). Two masked authors independently completed data screening and extraction. We evaluated studies using the Clinical trial Diversity Rating framework to assess their inclusion across multiple demographic characteristics. Results: A total of 13 studies met the inclusion criteria for the final meta-analysis. Only 1 out of 13 (7.7%) received a ‘Fair’ representation score for race/ethnicity participation, and 1 out of 13 (7.7%) received a ‘Poor’ representation score. The remaining 11 out of 13 (84.6%) studies did not report information on the race/ethnicity of their participants. Eight out of 13 (61.5%) trials received a ‘Good’ representation score when evaluating the inclusion of males and females, 3/13 (23.1%) were ‘Fair’ and 2/13 (15.4%) were ‘Poor’. None of the studies reported the number of participants aged ≥65 years. Conclusion: The results of this study highlight a lack of demographic reporting in knee injury clinical trials, with the included studies consistently failing to report information about the race/ethnicity and age breakdown of participants. The lack of diversity goals and insufficient reporting of racial and ethnic minority populations underscores the necessity for strategic approaches going forward to ensure clinical trials are more inclusive and representative of the incidence of knee injuries in the population. Level of Evidence: Level III, systematic review and meta-analysis.