Race reporting and representation in onychomycosis clinical trials : A systematic review

© 2021 Wiley-VCH GmbH..

BACKGROUND: 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.

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 < .05. Photos in articles were categorised 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 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).

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.

Medienart:

E-Artikel

Erscheinungsjahr:

2021

Erschienen:

2021

Enthalten in:

Zur Gesamtaufnahme - volume:64

Enthalten in:

Mycoses - 64(2021), 8 vom: 17. Aug., Seite 954-966

Sprache:

Englisch

Beteiligte Personen:

Chang, Michelle J [VerfasserIn]
Qiu, Yuqing [VerfasserIn]
Lipner, Shari R [VerfasserIn]

Links:

Volltext

Themen:

Antifungal Agents
Clinical trials
Ethnicity
Fungal nail infection
Journal Article
Onychomycosis
Race
Review
Skin of colour
Systematic Review

Anmerkungen:

Date Completed 12.11.2021

Date Revised 18.09.2023

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1111/myc.13262

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM322130875