TY - JOUR
T1 - Research protocol and recruitment redesign of a study of pregnant women and their infants during the COVID-19 pandemic
T2 - Childhood Allergy and the NeOnatal Environment (CANOE)
AU - ECHO Children's Respiratory and Environmental Workgroup
AU - Afshan, Tonia S.
AU - Kulkarni, Aishwarya
AU - Smith, Jennifer M.
AU - Tesson, Elizabeth
AU - Blackshere, Talissa
AU - Joseph, Christine
AU - Zoratti, Edward M.
AU - Rivera-Spoljaric, Katherine
AU - Hartert, Tina
AU - Gern, James E.
AU - Singh, Anne Marie
N1 - Publisher Copyright:
© 2024
PY - 2024/8
Y1 - 2024/8
N2 - Background: Recruitment for research studies is a challenging endeavor that was further complicated by the coronavirus disease 2019 pandemic. We launched a new multicenter birth cohort, Childhood Allergy and the NeOnatal Environment (CANOE), supported by the National Institutes of Health in January 2020 across 4 sites. Although the pandemic temporarily halted clinical research, we restructured the study and instituted novel recruitment methods that we hypothesized would enable brisk enrollment when research activities resumed. Objective: We sought to develop protocol modifications and recruitment methods that promote successful recruitment of diverse populations in clinical research despite a global pandemic. Methods: Even though study activities were suspended, we modified recruitment strategies to limit in-person contact, shifting toward alternative HIPAA-compliant methods such as clinician referrals, institutional social media, and telemedicine screening and consent procedures. Protocol changes included reducing the frequency of in-person visits, leveraging clinical care visits to collect biospecimens, expanded self-collection of samples at home, and making study materials available online. Results: Remote methods, including targeted social media posts, mailed letters, and email, combined with in-clinic recruitment with modifications for social distancing led to successful recruitment at all sites. Rates of consent have been similar across recruitment sites, with the highest rates of enrollment of mother-infant dyads realized by sites that implemented multiple recruitment strategies. Conclusions: Study procedures that prioritize health and safety measures such as social distancing, study participant convenience, and use diverse recruitment strategies enable successful enrollment of pregnant women and their newborns into clinical research while adhering to public health restrictions during a global pandemic.
AB - Background: Recruitment for research studies is a challenging endeavor that was further complicated by the coronavirus disease 2019 pandemic. We launched a new multicenter birth cohort, Childhood Allergy and the NeOnatal Environment (CANOE), supported by the National Institutes of Health in January 2020 across 4 sites. Although the pandemic temporarily halted clinical research, we restructured the study and instituted novel recruitment methods that we hypothesized would enable brisk enrollment when research activities resumed. Objective: We sought to develop protocol modifications and recruitment methods that promote successful recruitment of diverse populations in clinical research despite a global pandemic. Methods: Even though study activities were suspended, we modified recruitment strategies to limit in-person contact, shifting toward alternative HIPAA-compliant methods such as clinician referrals, institutional social media, and telemedicine screening and consent procedures. Protocol changes included reducing the frequency of in-person visits, leveraging clinical care visits to collect biospecimens, expanded self-collection of samples at home, and making study materials available online. Results: Remote methods, including targeted social media posts, mailed letters, and email, combined with in-clinic recruitment with modifications for social distancing led to successful recruitment at all sites. Rates of consent have been similar across recruitment sites, with the highest rates of enrollment of mother-infant dyads realized by sites that implemented multiple recruitment strategies. Conclusions: Study procedures that prioritize health and safety measures such as social distancing, study participant convenience, and use diverse recruitment strategies enable successful enrollment of pregnant women and their newborns into clinical research while adhering to public health restrictions during a global pandemic.
KW - COVID-19 pandemic
KW - Study recruitment
KW - childhood allergy
KW - pregnancy
KW - protocol redesign
KW - public health
KW - women and infants
UR - http://www.scopus.com/inward/record.url?scp=85194965169&partnerID=8YFLogxK
U2 - 10.1016/j.jacig.2024.100270
DO - 10.1016/j.jacig.2024.100270
M3 - Article
C2 - 38881739
AN - SCOPUS:85194965169
SN - 2772-8293
VL - 3
JO - Journal of Allergy and Clinical Immunology: Global
JF - Journal of Allergy and Clinical Immunology: Global
IS - 3
M1 - 100270
ER -