Improving Recruitment for a Newborn Screening Pilot Study with Adaptations in Response to the COVID-19 Pandemic

Abstract

Seven months after the launch of a pilot study to screen newborns for Duchenne Muscular Dystrophy (DMD) in New York State, New York City became an epicenter of the coronavirus disease 2019 (COVID-19) pandemic. All in-person research activities were suspended at the study enrollment institutions of Northwell Health and NewYork-Presbyterian Hospitals, and study recruitment was transitioned to 100% remote. Pre-pandemic, all recruitment was in-person with research staff visiting the postpartum patients 1–2 days after delivery to obtain consent. With the onset of pandemic, the multilingual research staff shifted to calling new mothers while they were in the hospital or shortly after discharge, and consent was collected via emailed e-consent links. With return of study staff to the hospitals, a hybrid approach was implemented with in-person recruitment for babies delivered during the weekdays and remote recruitment for babies delivered on weekends and holidays, a cohort not recruited pre-pandemic. There was a drop in the proportion of eligible babies enrolled with the transition to fully remote recruitment from 64% to 38%. In addition, the proportion of babies enrolled after being approached dropped from 91% to 55%. With hybrid recruitment, the proportion of eligible babies enrolled (70%) and approached babies enrolled (84%) returned to pre-pandemic levels. Our experience adapting our study during the COVID-19 pandemic led us to develop new recruitment strategies that we continue to utilize. The lessons learned from this pilot study can serve to help other research studies adapt novel and effective recruitment methods.

Newborn Screening for Duchenne Muscular Dystrophy: First Year Results of a Population-Based Pilot

“…Additionally, protocol changes were made for the confirmatory second-tier genetic testing, to allow for telehealth genetic counseling visits and for sending sample-collection kits to the patient’s residence. Remote sample collection was performed by the parent or guardian in their residence using a buccal swab to collect buccal cells from their infant [ 13 ].…”

Duchenne expert physician perspectives on Duchenne newborn screening and early Duchenne care

“…Given our understanding of the pathophysiology of DMD and the development of FDA‐approved therapies, there has been increased interest in newborn screening (NBS) for DMD, with three NBS pilots ongoing in 2021 in the USA (Parad, Sheldon, & Bhattacharjee, 2021 ; Wynn et al, 2022 ). Data is being consolidated to support a nomination package for the Recommended Uniform Screening Panel (RUSP), to include DMD as a recommended disorder for NBS across the country.…”

Diagnostic experiences of Duchenne families and their preferences for newborn screening: A mixed‐methods study

“…Duchenne is not routinely screened for at birth or prenatally in the US. Several NBS pilots for Duchenne are underway or have recently been completed, (Parad, Sheldon, & Bhattacharjee, 2021 ; Wynn et al, 2022 ) and a nomination package to include Duchenne on the RUSP is in preparation. Screening tests are highly sensitive to detect variants of Duchenne for which there are current therapies (Beckers et al, 2021 ).…”