The CHI-RON Study

Using PCORnet® and Patient Engagement Strategies to Improve Diversity Among Research Participants in the Congenital Heart Initiative

Datos Bibliográficos

ID9103345
AutoresAnitha S John (0000-0002-7355-6304, Children’s National Hospital, Washington, DC, autor de correspondencia), Scott Leezer (CURA Strategies, Washington, DC), Lindsey Rudov (Louisiana Public Health Institute, New Orleans, LA), Jamie L Jackson (0000-0002-1752-1377, Nationwide Children’s Hospital, Columbus, OH), Mindi Messmer (0000-0001-9984-4016, Children’s National Hospital, Washington, DC, autor de correspondencia), Sneha Saraf (Children’s National Hospital, Washington, DC, autor de correspondencia), Rittal Mehta (0000-0002-0807-4763, Children’s National Hospital, Washington, DC, autor de correspondencia), Shreya Papneja (Children’s National Hospital, Washington, DC, autor de correspondencia), Arwa S Saidi (University of Florida, Gainesville, FL), Aliza Marlin (Adult Congenital Heart Association, Philadelphia, PA), Danielle Hile (Adult Congenital Heart Association, Philadelphia, PA), Anushree Agarwal (0000-0001-8535-3152, University of California, San Francisco, San Francisco, CA), Matthew Lewis (0000-0003-3891-4169, Texas Health Dallas, autor de correspondencia), Matthew J Lewis (Columbia Presbyterian, New York, NY), Ronald J Kanter (Nicklaus Children’s Hospital, Miami, FL), Walter Li (Miami Children's Hospital), Satinder Sandhu (0000-0001-7348-7284, University of Miami, Miami, FL), Thomas Young (0000-0002-2103-6585, Ochsner Health, New Orleans, LA), Roni Jacobsen (0000-0002-3851-9786, Children’s Hospital of Colorado, Denver, CO), Emily S Ruckdeschel (Children’s Hospital of Philadelphia, Philadelphia, PA), Emily Ruckdeschel (Children's Hospital of Philadelphia), Adam M Lubert (0000-0001-6401-9980, Cincinnati Children’s Hospital, Cincinnati, OH), Harsimran S Singh (Weill Cornell Medical Center, New York, NY), Harsimran Singh (Cornell University, autor de correspondencia), Ali N Zaidi (0000-0001-8255-1591, Mount Sinai Hospital, New York, NY), Dan G Halpern (0000-0002-1656-798X, NYU Langone Health, New York, NY), Richard A Krasuski (0000-0003-3150-5215, Duke Clinical Research Institute, Durham, NC), Kirubel Asfaw (Duke Clinical Research Institute, Durham, NC), Keith Marsolo (0000-0002-4416-1549, Duke Clinical Research Institute, Durham, NC), Ruth Phillippi (Children’s National Hospital, Washington, DC, autor de correspondencia), Adebola Owolabi (Children’s National Hospital, Washington, DC, autor de correspondencia), Thomas Carton (0000-0001-9995-7483, Louisiana Public Health Institute, New Orleans, LA)
Año2026
Volumen64
Número3S
PáginasS196-S204
Fecha de publicación2026-02-01
Peer ReviewedSí
Open AccessSí
TipoARTICLE
RevistaMedical Care (JOURNAL)
Identificadores de la revistaISSN: 0025-7079 • E-ISSN: 1537-1948
EditorialOvid Technologies (Wolters Kluwer Health) (PUBLISHER)
DOI10.1097/mlr.0000000000002222
PMID41504747
OpenAlexW7119538520
IdiomaEN
Citas recibidas1
Referencias citadas27

BACKGROUND: The Congenital Heart Initiative-Redefining Outcomes and Navigation to Adult-Centered Care (CHI-RON) study is a unique collaboration between the PCORnet and Congenital Heart Initiative (CHI), the first patient powered registry for adult congenital heart disease (ACHD) patients. The CHI-RON study examines the effects of gaps in recommended care in ACHD. OBJECTIVE: Recruitment of racially diverse, younger, out-of-care, and male participants has been challenging in ACHD studies. Our goal was to design patient engagement and recruitment strategies to improve representation. RESEARCH DESIGN: Launched in December 2020, patients from any location can self-enroll in the CHI registry, while the CHI-RON study (5/2022 - 10/2023) recruited ACHD patients at 12 sites participating in PCORnet. CHI-RON Recruitment methodology included a patient partner engagement toolkit and a recruitment algorithm using the PCORnet® Common Data Model designed specifically to improve diversity and reduce self-enrollment biases in comparison to the CHI registry. SUBJECTS: ACHD patients, age 18 years or older, with the ability to complete PROs independently. MEASURES: Demographic/Recruitment Statistics for study participants and Patient Engagement in Research Scale (PEIRS-22) for the study team partners. RESULTS: As of October 2023, a total of 2652 participants were recruited through CHI-RON recruitment methodology while 1326 were self-enrolled in the CHI. CHI-RON recruitment methodologies have increased representation when compared with self-enrolled CHI participants in terms of ethnicity (10.9% vs. 7.4% Hispanic, P<0.001), race (5.4% vs. 2.6%, Black/African American, P<0.001), sex (41% vs. 28% male, P<0.001), younger age (35.5 +/-12.8 y vs. 43.5±14.5 y, P<0.001), and education (33.4% vs. 24% high school equivalent or less, P<0.001).Most study team patient partners (n=12, 86%) reported a very to extremely high degree of engagement (PEIRS-22 average score 101.6), especially in the subdomains of contributions, support, feeling valued, and benefits. CONCLUSIONS: Patient engagement and novel recruitment strategies are critical to improving the inclusion of under-represented populations in clinical research and ensuring alignment with the needs of ACHD patients

Clinical trial · Inclusion (mineral) · MEDLINE · Patient participation · Research design · BRCA gene mutations in cancer · Congenital Heart Disease Studies · Prenatal Screening and Diagnostics