Study shows intentional strategies enhance recruitment, retainment of diverse populations
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Key takeaways:
- Allowing patients to self-report race and ethnicity, in addition to objective measures, can foster a diverse study.
- Reducing transportation, language and cultural competency barriers will also help retainment.
The VISIBLE trial demonstrated that intentional efforts to recruit and retain patients with skin of color result in a speedy enrollment process and diverse patient pool, according to a study.
The Varying Skin Tones in Body and Scalp Psoriasis: Guselkumab Efficacy and Safety (VISIBLE) randomized clinical trial is dedicated to evaluating disease and treatment outcomes in participants of all skin tones with psoriasis. The study is unique because it utilized enrollment and retainment strategies that were meant to increase diversity in the trial.
“This study demonstrated that novel approaches to dermatologic studies in psoriasis can overcome barriers to enrolling participants with skin of color — a broad and diverse patient population that has historically been underrepresented in psoriasis clinical trials,” Andrew F. Alexis, MD, MPH, FAAD, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, told Healio.
In this publication, Alexis and colleagues assessed the strategies used to recruit and retain diverse participants in the study as well as how successful these strategies were.
Strategies
First, the investigators ensured that their site selections for enrollment were in locations with high proportions of underrepresented populations. They did this by utilizing census and claims data as well as feasibility questionnaires to assess the diversity of the potential site.
Transportation services as well as reimbursement for missed work were offered to participants as these are often barriers to care among underserved communities. Other barriers that were mitigated to enhance recruitment included translation services and broader inclusion criteria. In fact, the researchers collected all patient-reported data in the participants’ native languages.
During the trial, investigators were provided cultural sensitivity training materials and underwent training modules that included quizzes complete with images of patients with different skin tones in order to best prepare the researchers for interacting with diverse participants. The researchers also consulted dermatologists with experience in treating underserved populations.
The study did not require frequent in-person visits so that those with time constraints did not feel pressure to drop out of the study.
Along with objectively measuring skin tones, the investigators encouraged participants to self-report their race and ethnicity to foster cultural diversity. Based on their reported race and ethnicity, the investigators monitored the participants for genetic and comorbidity biomarkers specific to that population.
Periodically, investigators would undergo a blinded central review complete with feedback to ensure that they were evaluating the disease level and progress of patients with skin of color consistently and accurately.
Lastly, the researchers used cross-polarizing photography to better capture erythema and other abnormalities that would normally be overlooked in richly pigmented skin.
Results
According to the study, the steps taken to recruit and retain patients with skin of color were successful, with recruitment occurring seven times faster than historical recruitment lengths for this population.
While the study states that the investigators expected a slightly faster recruitment period, the final rate “exceeded” their expectations and was mainly credited to the preparations of a detailed site selection process.
The study ultimately included 211 participants (mean age, 43 years; 64% men). Patients self-reported as American Indian/Alaska Native (n = 1), Asian (n = 63), Black (n = 24), Hispanic/Latino (n = 94), Middle Eastern (n =13), Pacific Islander/Native Hawaiian (n = 1), multiracial (n = 12) and “other” (n = 3). None of the participants were white and more than 50% had Fitzpatrick IV to VI skin types.
“The study offers an opportunity to better understand clinical features, and their progression over time in patients with skin of color,” Alexis told Healio. “This will fill important educational and data gaps for this historically understudied patient population.”