Mycoses. 2021 Mar 2. doi: 10.1111/myc.13262. Online ahead of print.
ABSTRACT
BACKGROUND: Onychomycosis is the most common nail disease seen in clinical practice. Inclusion of diverse groups in onychomycosis clinical trials subjects is necessary to generalize efficacy data.
OBJECTIVES: We aimed to systematically review race and ethnicity reporting and representation, as well as, treatment outcomes in onychomycosis clinical trials.
METHODS: 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<0.05. Photos in articles were categorized by Fitzpatrick skin type.
RESULTS: Only 32/182 (17.5%) trials reported on race and/or ethnicity and only one trial compared treatment efficacy in different subgroups. Darker skin colors 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<0.05 for all comparisons).
LIMITATIONS: Demographics on excluded subjects and methods of recruitment were not available. Assigning Fitzpatrick skin type is inherently subjective.
CONCLUSIONS: This study highlights a need for consistent reporting of races and ethnicities of onychomycosis clinical trial participants with subgroup analyses of treatment efficacies.
PMID:33655595 | DOI:10.1111/myc.13262
