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Human In Vitro Suppression as Screening Tool for the Recognition of an Early State of Immune Imbalance
Published on: July 22, 2011
Development of a pediatric urgent care research infrastructure to facilitate human immunology studies
John J Santos1,2, Alexandra C Keefe2,3, Richard Torres4
1Division of Urgent Care, Seattle Children's Hospital, Seattle, WA, USA.
Insights
Pediatric urgent care can be used for human immunology research. A novel two-phase design minimized clinical disruption, successfully enrolling diverse infant and maternal participants for immune response studies.
Area of Science:
- Immunology
- Pediatric Research
- Public Health
Background:
- Pediatric urgent care settings are underutilized for human subjects research due to time constraints.
- The
- conflict of urgency
- between acute care and research needs hinders participant recruitment.
- Human immunology studies require significant participant time and resources.
Purpose of the Study:
- To investigate infant and maternal immune responses to respiratory tract infection.
- To implement and evaluate a novel study design for participant recruitment in pediatric urgent care.
- To establish a scalable model for integrating basic science research into pediatric urgent care networks.
Main Methods:
- A two-phase study design was implemented across four Seattle Children's Hospital Urgent Care (SCHUC) clinics.
- The design uncoupled initial clinical contact from enrollment and specimen collection, enabling remote participation.
- Infant and maternal immune responses to respiratory tract infection were studied.
Main Results:
- Successfully enrolled 36 infants and 39 mothers, with complete biospecimen sets from 30 infants and 28 mothers.
- The recruited cohort is geographically diverse and reflects the racial and ethnic diversity of the SCHUC patient population.
- The novel approach minimized disruption to clinical workflows.
Conclusions:
- A novel, two-phase study design effectively overcomes the
- conflict of urgency
- in pediatric urgent care settings.
- This scalable and resource-efficient approach facilitates the study of human immunology in diverse pediatric populations.
- The model provides a framework for integrating research into hospital-affiliated urgent care networks.
Abstract:
The pediatric urgent care setting offers a unique opportunity to enroll pediatric patients and their families to facilitate the study of human immunology. However, it is an underutilized environment for recruiting participants into research studies, most likely driven by a fundamental "conflict of urgency" - the tension between the time-limited nature of acute ambulatory care and the time-intensive requirements of human subjects research. To address this challenge, we implemented a study of infant and maternal immune responses to respiratory tract infection (the MATMilk study) across four Seattle Children's Hospital Urgent Care (SCHUC) clinics using a novel, two-phase study design, which uncoupled initial clinical contact from enrollment and specimen collection. This approach allowed complete remote participation and minimized disruption to clinical workflows. To date, we have enrolled n = 36 infants and n = 39 mothers and have complete biospecimen sets from n = 30 infants and n = 28 mothers. The cohort is from a broad geographical catchment in the Puget Sound region and is racially and ethnically diverse, reflecting the demographics of the SCHUC patient population. Our scalable, resource-efficient approach provides a model for integrating basic science research into hospital-affiliated pediatric urgent care networks.
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