Research AppraisalRandomised Controlled Trial

A randomized trial to evaluate attitudes regarding pharmacogenomics among pregnant and pediatric populations: design and baseline characteristics.

The pharmacogenomics journalSundermann, Alexandra C, Marryshow Batson, Salisha E, Jasper, Elizabeth A et al.23 Apr 2026DOI

Clinical Snapshot

65CEBM
Evidence: ModerateRandomised Controlled Trial

PICO Framework

P — PopulationPregnant individuals and families/guardians of children aged 0-16 years with chronic health conditions
I — InterventionEducational video about pharmacogenomics testing with return of results
C — ComparatorPharmacogenomics test results alone (without educational video)
O — OutcomesKnowledge and attitudes regarding pharmacogenomics testing, understanding and perceived utility of PGx testing

Bottom Line

This randomized trial design addresses a critical gap in pharmacogenomics research by focusing on pregnant women and children - populations typically excluded from PGx studies. The study compares educational video plus results versus results alone to assess impact on patient knowledge and attitudes toward pharmacogenomic testing. While the intervention appears feasible and low-risk, this paper only presents the study design and baseline characteristics. The actual effectiveness of educational interventions on patient understanding remains to be demonstrated. The research is important for informing clinical implementation of pharmacogenomics in vulnerable populations, but clinicians should await the full results before drawing conclusions about optimal patient education strategies for PGx testing.

Evidence: Moderate

Key Findings

  • P Value: Not yet reported

  • Effect Size: Not yet reported

  • Primary Outcome: Not yet reported - this is a design and baseline characteristics paper

  • Nnt Or Sensitivity: Not applicable - this is an educational intervention study

  • Confidence Interval: Not yet reported

Clinical Application

Educational video intervention is highly feasible and low-cost to implement in clinical practice Relevant to Australian practice as pharmacogenomics becomes more integrated into precision medicine. Could inform TGA and PBS considerations for PGx testing implementation Pregnant women and families with children having chronic health conditions considering pharmacogenomic testing

Abstract

Pharmacogenomics (PGx) is a key component of precision medicine, yet most PGx studies exclude pregnant people and children. The VICE (Vanderbilt Integrated Center of Excellence)-MPRINT (Maternal and Pediatric Precision in Therapeutics): Maternal and Pediatric Pharmacogenetics Trial is a single-center, randomized control trial to assess how PGx testing and return of results influence patients' understanding and perceived utility of PGx testing in a pregnancy and pediatric cohort. Pregnant individuals and families or guardians of children with a chronic health condition aged 0-16 were recruited. We assessed participants' knowledge and attitudes regarding PGx testing at baseline and after receiving results with patient-friendly interpretations. Cases received an educational video about PGx testing with return of results. Controls received PGx test results alone. We aimed to determine perspectives regarding PGx in these understudied populations with the goal of promoting research and clinical implementation of PGx for pregnant women and children.

References

  1. 1.Sundermann, A. C., Marryshow Batson, S. E., Jasper, E. A., Jones, S. H., Fountain, D. F., Liu, M., Sunthankar, S. D., & Velez Edwards, D. R. (2026). A randomized trial to evaluate attitudes regarding pharmacogenomics among pregnant and pediatric populations: design and baseline characteristics. The Pharmacogenomics Journal. https://doi.org/10.1093/jalm/jfad064
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