Objective: To assess whether clinical trials guiding kidney stone care adequately describe the race, ethnicity, and other key demographic variables of their study populations. Guidelines such as those from the American Urological Association represent the highest level of evidence informing clinical practice. We aim to investigate if studies on which they are based include sufficiently diverse patient populations for generalizable results.
Methods: We reviewed American Urological Association/Endourological Society Guidelines for the Medical and Surgical Management of kidney stones for all referenced clinical trials reporting human subjects. Study populations were reviewed for reported sex/gender, race, ethnicity, and study country of origin.
Results: Of the 381 studies referenced, 287 met inclusion criteria. Only 18 (6.3%) reported the race or ethnicity of their subjects, and 254 (87%) reported sex/gender. Among studies reporting any race or ethnicity data, there were 468,281 participants, of which 48.5% were White, 1.0% Black, 0.6% Hispanic/Latino, 0.2% Asian, 0.3% other, 0.04% American Indian/Alaska Native, and 0.001% Native Hawaiian/other Pacific Islander. The remaining 49.4% of subjects had insufficient information to categorize into a race or ethnicity category. Factors associated with decreased likelihood of reporting race or ethnicity included cross-sectional studies (OR 0.14, P = .027) and international studies (OR 0.93, P = .012).
Conclusion: A small proportion of studies cited in the kidney stone guidelines report patient race or ethnicity. Among studies reporting these data, minority patients are underrepresented. Future research should include subject racial composition and strive to enroll underrepresented patients to ensure broadly generalizable kidney stone care recommendations.
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