New Toolkit Aims to Boost Diversity in Skin Research

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To achieve optimal outcomes in medical research, study populations must reflect real-world patient demographics. However, many studies suffer from biased populations, particularly affecting socioeconomically disadvantaged groups, older adults, and those with multiple health conditions. Ethnic minorities are notably underrepresented in research despite evidence indicating their increased risk of adverse health outcomes and greater health disparities.^1-2 Barriers to inclusion can include language issues, lack of research understanding, financial constraints, and systemic challenges such as inequitable healthcare access and medical distrust.³ Existing tools, such as the FDA’s Diversity Plans and the NIHR toolkit, aim to address these issues broadly but lack specific focus on skin diseases.

A recent study noted dermatology research is particularly affected, with significant gaps in ethnic diversity which can impact the understanding and treatment of skin conditions across different ethnic groups. The study explored the perspectives of ethnic minority individuals with skin diseases to identify barriers and enablers to their participation in research, and introduced a new toolkit designed to enhance their representation and improve research inclusivity and cultural competence.⁴

Methods

The study was broken down into 4 phases. During phase 1 of the study, a focus group discussion was led by pre-established topic guides designed by the study team to explore the perception of adults from ethnic minority groups who have an inflammatory skin disease on barriers and enablers to skin research participation. During phase 2, a search was done on PubMed, Embase, Scopus and Google Scholar of the keywords ‘ethnic minority’, ‘dermatology’ and ‘medical research’. For phase 3, the skin research inclusion toolkit was developed based on the findings of phases 1 and 2. Finally, during phase 4 focus group attendees were invited to a follow-up dissemination exercise, where findings from phases 1, 2, and 3 were discussed.Participants were encouraged to provide additional comments they felt should be captured within the study’s findings.

Phase 1: Focus Group Discussions

During the study, 2 focus groups were conducted with 6 adults from ethnic minority backgrounds who had a clinician-confirmed diagnosis of an inflammatory skin disease. Participants in the focus group discussions identified several key factors influencing their willingness to engage in skin research.

Positive Value Model: Many felt motivated to participate because they believed research could drive societal progress and innovation, seeing it as a chance to contribute meaningfully and advance medicine. Researchers found personal experiences and educational backgrounds reinforced this belief. Additionally, participants valued receiving feedback from research, beyond just monetary incentives, as it reinforced their sense of contribution.

Inclusive Recruitment Strategies: The study found effective recruitment strategies included building strong relationships between patients and recruiters, potentially through existing healthcare connections, and using purposive recruitment methods such as outreach through community groups and online forums. Improving communication by translating materials and simplifying explanations was also deemed important to address literacy and language barriers.

Mistrust in Research: Researchers stated that mistrust stemmed from historical research abuses and concerns about research methods and transparency. This mistrust was exacerbated by complex language and insufficient communication about research objectives.

Social Stigma: Ethnic minority participants often faced social stigma associated with skin diseases, which was exacerbated by misconceptions and cultural attitudes. The study found this stigma led to feelings of shame and isolation, affecting their willingness to discuss their conditions openly or participate in research involving personal experiences. The visibility of skin conditions and associated psychological impacts were seen as significant barriers to engagement.

Phase 2: Narrative Literature Review

Researchers found the barriers in participation in medical research identified in the literature review reiterated and built upon the themes of social stigma and mistrust in research identified during phase 1. They stated that ethnic minorities often experience greater skin disease related embarrassment compared to White individuals. This embarrassment, along with social stigma, is intensified by sociocultural factors, impacting their quality of life and mental well-being, which in turn hinders research participation.^5-6

Research included in the study highlighted5 significant barriers to participation in dermatology trials for ethnic minorities: limited access to trial sites, inadequate education about trials, lack of awareness about specific trials, language barriers, and mistrust of researchers.⁷ A survey of Black parents revealed they were significantly more likely to perceive their child might be exploited in research studies compared to White parents. Additionally, the study found White parents were more inclined to enroll their child in research if they had an established relationship with the recruiting healthcare professional.⁸

Researchers stated emerging solutions aim to address these barriers, such as Trial Forge Guidance and the NIHR INCLUDE Ethnicity Framework. Additionally, the FDA recommends standardized methods for collecting ethnicity data and developing targeted enrollment strategies. These strategies were incorporated into the toolkit to enhance the inclusivity and effectiveness of research involving diverse ethnic groups.

Phase 3: Develop a Toolkit

Based on the findings from phases 1 and 2, a toolkit was developed comprising strategies that complement and expand on existing best practice guidelines. The toolkit emphasizes 3 main strategies.

First, the toolkit recommends researchers should create an inclusion plan during study design, considering the differences in skin disease pathophysiology, epidemiology, and treatment efficacy across ethnic groups. It also suggests evaluating how study design elements, including inclusion criteria and recruitment locations, impact the representation of underrepresented groups and setting specific goals and resource allocation for their inclusion and retention.

Second, researchers recommended inclusive study enrolment strategies. These include developing culturally relevant study materials with input from individuals with skin conditions, translating materials into appropriate languages, and training study teams to communicate effectively and competently. They found building trust within ethnic minority communities through positive relationships with community leaders and targeted recruitment methods is also crucial. Additionally, addressing social and cultural barriers by providing skin of color education and showcasing diverse participants in study materials could help combat stigma and enhance engagement.

Third, researchers should ensure robust support for participants throughout the study by establishing clear communication channels with culturally competent team members and providing timely reimbursements. Feedback of research findings should be communicated through various channels, including lay summaries, infographics, and digital platforms, to maintain participant engagement and demonstrate the impact of their contribution.

Phase 4: Dissemination Exercise

Focus group participants from phase 1 were invited to discuss the findings from phases 1, 2, and 3. Researchers stated that discussions in the feedback session showed support for the inclusion toolkit and further developed the findings from phase 1. One attendee of South Asian descent stated that the social stigma faced by women with a skin condition in their community may differ from that faced by men, so different strategies may be required to encourage research participation. This reinforced to researchers the importance of formulating an inclusion plan that considers the demographic of the population of interest for the research study.

Conclusion

The study outlined key actions to enhance the participation of individuals from ethnic minority backgrounds in skin research through the development of a comprehensive inclusion toolkit. Researchers stated future efforts on the wider implementation of the toolkit and feedback from both researchers and patients will aid in evaluating its effectiveness in reducing ethnic disparities in skin research. They suggested further research should explore the stigma associated with skin diseases among ethnic minority groups and develop strategies to address this issue.

References

1. Evandrou M, Falkingham J, Feng Z, et al. Ethnic inequalities in limiting health and self-reported health in later life revisited. J Epidemiol Community Health. 2016;70(7):653-662. doi:10.1136/jech-2015-206074
2. Mathur R, Rentsch CT, Morton CE, et al. Ethnic differences in SARS-CoV-2 infection and COVID-19-related hospitalisation, intensive care unit admission, and death in 17 million adults in England: an observational cohort study using the OpenSAFELY platform [published correction appears in Lancet. 2021 Jun 12;397(10291):2252. doi: 10.1016/S0140-6736(21)01066-7]. Lancet. 2021;397(10286):1711-1724. doi:10.1016/S0140-6736(21)00634-6
3. Mineroff J, Nguyen JK, Jagdeo J. Racial and ethnic underrepresentation in dermatology clinical trials. J Am Acad Dermatol. 2023;89(2):293-300. doi:10.1016/j.jaad.2023.04.011
4. Choy SP, Naveed M, Prasad J, et al. A toolkit to facilitate skin research participation in underrepresented ethnic populations: A Co‐designed, mixed methods refinement exercise. JEADV Clinical Practice. August 18, 2024. doi:10.1002/jvc2.516
5. Alexis AF, Blackcloud P. Psoriasis in skin of color: epidemiology, genetics, clinical presentation, and treatment nuances. J Clin Aesthet Dermatol. 2014;7(11):16-24.
6. Alexis A, Woolery-Lloyd H, Andriessen A, et al. Insights in skin of color patients with atopic dermatitis and the role of skincare in improving outcomes. J Drugs Dermatol. 2022;21(5):462-470. doi:10.36849/JDD.6609