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Early Check: A Partnership to Advance the

Science and Practice of Newborn Screening


Don Bailey, Ph.D., RTI International
Director, Center for Newborn Screening, Ethics, and Disability Studies
North Carolina Neonatology Meeting
March 25, 2019

RTI International is a registered trademark and a trade name of Research Triangle Institute. www.rti.org
What is Early Check?
§ An Innovation Award from the National Center for Advancing Translational
Sciences, with additional support from NICHD, The John Merck Fund,
Asuragen, Cure SMA
§ A research study designed to
– Develop and evaluate methods to offer free, voluntary screening to 120,000
parents/year for conditions not currently part of newborn screening (NBS)
– Acquire data to inform policy (which conditions should be included in NBS)
§ gauge parents’ interests in screening for new conditions
§ develop and test feasibility of the full complement of systems needed to implement screening
§ understand early natural history of “screen positive” infants
§ identify infants who could participate in pre-symptomatic treatment trials
§ The foundation for
– A long-term research resource to which new conditions can be added when ready
– An envisioned future in which states offer a voluntary panel of “non-RUSP” conditions

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Unique features of Early Check
§ Collaboration among multiple research partners
§ Consortium of funders
§ Statewide recruitment
§ Systematic evaluation of recruitment methods
§ E-consent
§ Highly secure information management system
§ Short and long-term follow-up, individually tailored to
each disorder
§ Telegenetic counseling
§ Studying or supporting evidence of benefits and harms
Early Check partners
Megan
Lewis
RTI Center for
Communication
Science
Cynthia Michael
Powell Cotten

UNC Duke
Chapel Hill RTI Center for
University
Newborn
Screening, Ethics,
and Disability
Studies
Nancy Scott
King Zimmerman

Wake Forest NC State


Baptist Laboratory
Medical of Public
Center Funding Health
Partners and
Advocates
Early Check flow
A major goal is to test recruitment strategies
§ We want to offer Early Check to almost
every birthing parent in the state
§ We want to study recruitment strategies
that do not involve in-person requests for
permission
§ Ultimately we want to determine the best
combination of approaches and what the
“ceiling” might be that we can expect
through “virtual” recruitment
§ At some point we will need to decide about
in-person recruitment in selected locations
Phased studies of targeted outreach strategies

Phase 1: Postnatal Phase 2: Pre- & Phase 3: Multiple


Postnatal hospital,
(letter, flyer,
postcard reminder) (Social media: FB, community, and
Instagram) state strategies

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Phase III: Hospital partnerships
§ Immediate goal is to ramp up awareness and explore ways that pregnant and
new mothers affiliated with a hospital could learn more about Early Check
§ We will start with our CTSA partner hospitals and 2-3 other sites who are
interested in a collaboration
§ We will use hospital level data to target high birthrate and/or low consent
sites
§ We plan a systematic evaluation of the effectiveness of recruiting through
patient portals
We are tracking hospital-level data and will use this to target
selected hospitals and evaluate hospital-level approaches
ANNUAL BIRTHS EARLY CHECK ENROLLMENT (2/12/19)
HOSPITAL # % of State # % of Early Check
A 3732 3.1 79 4.8
B 5742 4.8 134 8.2
C 2256 1.9 65 4.0
D 3564 3.0 75 4.6
E 6456 5.2 104 6.4
F 7800 6.6 68 4.2
G 4848 4.4 94 5.8
H 4308 3.6 46 2.8
I 1044 .9 38 2.3
J 696 .6 10 .6
Our ask of you

§ If a pregnant or new mom asks you about Early Check, please


– Acknowledge that you have heard of it and that it is a legitimate statewide
program
– Encourage them to go to the web site (www.earlycheck.org) to decide if
participation is right for them
§ Help share information about Early Check through Facebook or
Twitter
§ Let me know if you can think of ways that you or your colleagues
could help
Contact information

Don Bailey
dbailey@rti.org
1-919-541-6488
www.earlycheck.org

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