Establishing a Sociodemographic Data Banking Study in Patients with Hematologic Disorders – a Feasibility Assessment

Introduction

Social determinants of health (SDOH) play a critical role in patient-related health outcomes. Several small-scale studies among patients with sickle cell disease have demonstrated an association between adverse SDOH and inferior health outcomes—with subsequent calls for SDOH-targeted interventions to improve outcomes. Few studies have investigated the impact of SDOH in other hematologic disorders. Systematic collection of modifiable SDOH data (e.g. transportation, food, utility, and housing insecurity) among patients with non-malignant hematologic disorders is essential to identify populations at risk for disparate outcomes and concurrently inform the design of interventions to mitigate health inequities.

Objective

To determine the feasibility of establishing a clinically annotated sociodemographic data banking protocol for patients establishing care in the hematology clinic of a tertiary academic pediatric center in the United States.

Methods

A single-center, prospective, sociodemographic banking study at Dana-Farber / Boston Children’s Cancer and Blood Disorders Center opened to accrual in non-malignant hematology in October 2022. Subjects <18 years old within 6 months of a new non-malignant hematologic diagnosis establishing care within the outpatient hematology clinic were considered eligible for the study. The research team (a physician, a research coordinator, and an intern) screened weekly hematology clinic lists to identify eligible patients beginning first with a single disease group (sickle cell disease) and subsequently expanding to include other disease groups (immune thrombocytopenia, thrombosis, iron deficiency anemia) as study support allowed. Patients were approached sequentially, in-person while at a scheduled clinic visit. Parents who consented to the study completed a single time-point survey at study enrollment asking questions about their home environment. Paper/pencil or REDCap surveys available in English and Spanish were self-completed or read aloud by study personnel in any language with an appropriate interpreter. At the time of consent, parents/guardians signed a HIPAA release allowing the study team to track the course of disease-targeted therapy received and associated treatment responses. Survey domains include demographics, household material hardship, household income, social support, resilience, anxiety/depression, and experiences of discrimination. Data were banked for future research studies with appropriate IRB approval.

Results

A total of 65 eligible patients with a new hematologic diagnosis of sickle cell disease, immune thrombocytopenia, thrombosis, or iron deficiency anemia were approached and offered an opportunity to participate, with 43 (66%) consenting to participation. Among the 22 who declined participation, 10 (46%) declined contact with all research study teams, 6 (27%) transferred care to a satellite clinic, and 6 (27%) declined participation following study introduction. Among consenting participants, 31 (72%) have completed the baseline survey, including n=28 in English and n=3 in Spanish. A total of n=9 surveys are pending and n=3 surveys are considered missing (>8 weeks since consent with survey not yet completed) data.

Conclusion

Systematic collection of SDOH data for research purposes in the context of a sociodemographic data banking study is feasible in a large, tertiary-care outpatient hematology clinic based on high participant willingness to enroll and complete surveys and successful implementation in four hematologic disease groups. This study will expand to include all hematologic disease groups by late 2023. This protocol has already been implemented successfully among pediatric oncology patients with de novo or relapsed/refractory cancers and those receiving cellular therapy, and is being expanded to 2 additional US institutions. Expanding this protocol to other care centers across the United States will provide essential data to advance health equity research in pediatric hematology/oncology.