Ricardo Jose W, Qiu Yuqing, Lipner Shari R
Department of Dermatology, Weill Cornell Medicine, New York, New York, USA.
Department of Population Health Sciences, Weill Cornell Medicine, New York, New York, USA.
Skin Appendage Disord. 2022 May;8(3):171-178. doi: 10.1159/000520469. Epub 2022 Jan 14.
Nail psoriasis (NP) disproportionally affects quality of life in females versus males. Demographics of NP research cohorts are not well characterized. In this systematic review, we characterize the representation of racial/ethnic groups and women in NP randomized clinical trials (RCTs).
A systematic search of MEDLINE was performed; RCTs of NP pharmacologic treatments or cutaneous psoriasis/psoriatic arthritis with the number of NP patients described were included.
Overall, 45 RCTs were analyzed, with 91.1% reporting sex, and 67.9% of participants were men. 7/41 (17%) studies reporting sex included ≥45% female participants. Of 45 RCTs, 35.6% reported race and/or ethnicity. Of the 22 studies with ≥1 US-based site, 13 (59%) reported race/ethnicity; 3 out of 23 (13%) studies with <1 US-based site reported these data. Enrollment of nonwhite participants was significantly lower than representation within the US census (13.4% vs. 39.9%; < 0.001). Treatment type, route of administration, location with ≥1 US-based site, funding, and journal type were significantly associated with race/ethnicity reporting ( < 0.05 all comparisons).
DISCUSSION/CONCLUSION: Reporting of racial/ethnic demographics is lacking in NP RCTs. Women and racial/ethnic minorities remain underrepresented in NP research. There is a need for increased reporting and diversification of NP clinical trial participants.
与男性相比，指甲银屑病（NP）对女性生活质量的影响更为严重。NP研究队列的人口统计学特征尚未得到充分描述。在本系统评价中，我们描述了NP随机临床试验（RCT）中种族/族裔群体和女性的代表性。
对MEDLINE进行系统检索；纳入描述了NP患者数量的NP药物治疗或皮肤银屑病/银屑病关节炎的RCT。
总体而言，分析了45项RCT，91.1%报告了性别，67.9%的参与者为男性。报告性别的41项研究中有7项（17%）纳入了≥45%的女性参与者。在这45项RCT中，35.6%报告了种族和/或族裔。在22项有≥1个美国研究点的研究中，13项（59%）报告了种族/族裔；在23项美国研究点<1个的研究中，23项中有3项（13%）报告了这些数据。非白人参与者的入组率显著低于美国人口普查中的比例（13.4%对39.9%；<0.001）。治疗类型、给药途径、有≥1个美国研究点的地点、资金和期刊类型与种族/族裔报告显著相关（所有比较均<0.05）。
讨论/结论：NP的RCT缺乏种族/族裔人口统计学报告。女性和种族/族裔少数群体在NP研究中的代表性仍然不足。需要增加NP临床试验参与者的报告并使其多样化。
