Drexel University College of Medicine, Philadelphia, PA, USA.
Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.
Mycoses. 2021 Aug;64(8):954-966. doi: 10.1111/myc.13262. Epub 2021 Mar 13.
Onychomycosis is the most common nail disease seen in clinical practice. Inclusion of diverse groups in onychomycosis clinical trials subjects is necessary to generalise efficacy data.
We aimed to systematically review race and ethnicity reporting and representation, as well as, treatment outcomes in onychomycosis clinical trials.
A PubMed search for onychomycosis clinical trials was performed in August 2020. Primary clinical trial data were included and post hoc analyses were excluded. Categorical variables were compared using chi-squared and Fisher's exact tests. Statistical significance was set at p < .05. Photos in articles were categorised by Fitzpatrick skin type.
Only 32/182 (17.5%) trials reported on race and/or ethnicity and only one trial compared treatment efficacy in different subgroups. Darker skin colours were infrequently depicted in articles. Topical treatment, location with ≥1 US-based site, industry funding type and publication date after 2000 were significantly associated with reporting of racial/ethnic data (p < .05 for all comparisons).
Demographics on excluded subjects and methods of recruitment were not available. Assigning Fitzpatrick skin type is inherently subjective.
This study highlights a need for consistent reporting of races and ethnicities of onychomycosis clinical trial participants with subgroup analyses of treatment efficacies.
甲真菌病是临床实践中最常见的指甲疾病。在甲真菌病临床试验中纳入不同人群，对于推广疗效数据是必要的。
我们旨在系统地回顾甲真菌病临床试验中种族和民族报告及代表性，以及治疗结果。
2020 年 8 月，我们在 PubMed 上对甲真菌病临床试验进行了检索。纳入了主要的临床试验数据，排除了事后分析。使用卡方检验和 Fisher 确切检验比较分类变量。统计学显著性设为 p <.05。文章中的照片按 Fitzpatrick 皮肤类型进行分类。
只有 32/182（17.5%）项试验报告了种族和/或民族情况，只有一项试验比较了不同亚组的治疗效果。文章中很少描述深色皮肤的颜色。局部治疗、有≥1 个美国基地的位置、产业资助类型和 2000 年后发表的文章与报告种族/民族数据显著相关（所有比较的 p 值均<.05）。
无法获得排除的受试者的人口统计学数据和招募方法。Fitzpatrick 皮肤类型的分配是主观的。
本研究强调了需要一致报告甲真菌病临床试验参与者的种族和民族情况，并对治疗效果进行亚组分析。
