Abstracts

Rationale: In 2020, we were at an intersection of world events, including a global pandemic and racial reckoning. As such, there has been increasing awareness of inequities targeting marginalized communities and the pervasiveness of epistemic oppression in research, which was further highlighted by the COVID-19 pandemic. Consideration of diversity, equity, and inclusion (DEI) and the pandemic became critical for researchers conducting clinical trials during this time. The aims of this study are to highlight adaptations made to a Sequential Multiple Assignment Randomized Trial (SMART), with a focus on recruitment and retention and employment of best DEI strategies to successfully complete a pediatric epilepsy antiseizure medication (ASM) adherence trial.


Methods: This SMART trial was conducted across four US epilepsy centers and focused on improving ASM adherence for children 2-12 years old with epilepsy and their caregivers. The study strategically recruited underserved youth (e.g., public/no insurance, racial/ethnic minorities, living in medically underserved/rural areas). We pivoted recruitment and retention strategies during the trial to address lockdowns, assessed the impact of COVID on youth with epilepsy, and whether our study represented inclusive language and methods. Specifically, caregivers completed two questionnaires: 1) a 57-item measure assessing the impact of COVID on families’ management of pediatric epilepsy; and 2) a 10-item questionnaire assessing implementation of DEI research principles (i.e., study materials reflective families, use of inclusive language; respect conveyed by staff, if families felt valued). These measures were completed throughout the trial and at post-treatment, respectively.


Results: A total of 461 participants were enrolled in the trial, 71% of whom are from underserved populations. To address the lockdown during the pandemic, recruitment and retention methods were modified to enhance accessibility (e.g., remote recruitment, driving to homes of participants, fully online study components). Interestingly, the impact of COVID within the first six months of the pandemic on epilepsy management was minimal. Preliminary findings from our DEI measure suggest study staff conveyed respect and valued families’ opinions and study staff and materials were not perceived to be biased or discriminatory. The research team met routinely to discuss results from this measure and reevaluate research procedures in real-time, including increasing contact with families via newsletters, birthday and holiday cards, and study check-ins via preferred contact methods.


Conclusions: Conducting a pediatric clinical trial during two major events required significant pivots to address the needs of young children with epilepsy. Given the online and telehealth nature of our original trial, most of our changes were logistical and related to how best to improve recruitment. Assessment of our DEI approach was critical to ensuring that our participants felt heard and recognized throughout the trial and to support inclusivity and respect. Utilizing these strategies likely enhanced recruitment, retention, and engagement in our SMART.


Funding: National Institutes of Health R01 NR017794