Medina Peñaranda Ricardo, Figg Lauren E, Hanes Sarah J, Shaw Gary M, Chamberlain Lisa J, Raymond Jennifer, Naranjo Diana, Maahs David M, Hood Korey K, Addala Ananta
Department of Pediatrics, Division of Pediatric Endocrinology, Stanford University, Stanford, California, USA.
Department of Pediatrics, Stanford University, Stanford, California, USA.
Horm Res Paediatr. 2024 Oct 4:1-9. doi: 10.1159/000541774.
To address disparities in clinical research, we present strategies to optimize recruitment of underrepresented families into the Building the Evidence to Address Disparities in Type 1 Diabetes (BEAD-T1D) study.
A bilingual/bicultural Latino research assistant (RA) was hired to facilitate culturally congruent recruitment for pediatric type 1 diabetes families. The RA screened, approached, and consented families using their preferred language, time of contact, and answered personal concerns around research. Families were given the option to consent during outpatient clinic visits (in-person, or virtually via video/phone call) at a pace set by the parent/guardian to ensure understanding.
Sixty-four families (Hispanic-65%, Non-Hispanic White [NHW]-17%, Non-Hispanic Black-1%, and Other-4%) were eligible. Of 49 approached, 32 consented (39 ± 7.9 years; female-81%; Hispanic-72%, NHW-28%, <50K income-69%, Spanish-speaking-50%). Clinic approaches were important to successful consent: 87% of the clinic approaches resulted in consent. Barriers to clinic approaches for RA included late/no response from clinicians, care team ending visit, and bandwidth/connectivity issues. Facilitators to clinic approaches included collaborative clinic care teams, flexible RA hours, and patient screening days in advance. We exceeded our recruitment goals for surveys (31/30), focus groups/interviews (26/20), and advisory board (22/10).
We identified that culturally and linguistically congruent staff, flexible recruitment practices, and prioritizing participant availability were solutions to recruit a diverse study cohort resulting exceeding recruitment goals. Cultural interpersonal relationships formed with families addressed barriers to research participation within and outside of the medical system. These strategies suggest equitable clinical trial recruitment is feasible in diabetes research.
为了解决临床研究中的差异问题,我们提出了一些策略,以优化将代表性不足的家庭纳入“构建解决1型糖尿病差异的证据”(BEAD-T1D)研究的招募工作。
聘请了一名双语/双文化的拉丁裔研究助理(RA),以促进对患有1型糖尿病的儿科家庭进行文化上合适的招募。该研究助理使用家庭偏好的语言、联系时间进行筛查、接触并征得家庭同意,并回答他们对研究的个人担忧。家庭可以选择在门诊就诊期间(亲自就诊,或通过视频/电话进行虚拟就诊),按照家长/监护人设定的节奏同意参与,以确保他们理解。
64个家庭符合条件(西班牙裔-65%,非西班牙裔白人[NHW]-17%,非西班牙裔黑人-1%,其他-4%)。在接触的49个家庭中,32个同意参与(年龄39±7.9岁;女性-81%;西班牙裔-72%,NHW-28%,收入<50K-69%,说西班牙语-50%)。在诊所进行招募对成功征得同意很重要:87%的诊所招募最终成功征得同意。研究助理在诊所进行招募时遇到的障碍包括临床医生回复晚/无回复、护理团队结束就诊以及带宽/连接问题。促进在诊所进行招募的因素包括协作的诊所护理团队、研究助理灵活的工作时间以及提前进行患者筛查日。我们在调查(31/30)、焦点小组/访谈(26/20)和咨询委员会(22/10)方面超过了招募目标。
我们发现,文化和语言上合适的工作人员、灵活的招募做法以及优先考虑参与者的可及性是招募多样化研究队列并超过招募目标的解决方案。与家庭建立的文化人际关系消除了医疗系统内外参与研究的障碍。这些策略表明,在糖尿病研究中进行公平的临床试验招募是可行的。