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.

Keywords: COVID-19 pandemic; Duchenne Muscular Dystrophy; newborn screening.

Figure 1

Recruitment, testing and reporting for the Duchene muscular dystrophy newborn screening. The three time periods of recruitment are depicted: pre-pandemic (top line), remote recruitment during the start of the pandemic (middle line), and hybrid recruitment (bottom line). During hybrid recruitment, phone and email recruitment were used to recruit babies who were delivered on weekends or holidays or were not available to recruit while they were in the hospital. Abbreviations: routine newborn screening (rNBS), creatine kinase-MM (CK-MM).

Figure 2

Approach and enrollment saturations and enrollment rates during pre-pandemic, fullremote and hybrid. Approach/Eligible is number approached as a fraction of total eligible babies with newborn screening (NBS), Enrolled/Eligible is number enrolled as a fraction of total eligible babies, Enrolled/Approached is number enrolled as a fraction of total approached, Active Decline/ Approached is the proportion who declined participation after being approached. Passive Decline/ Approached is the number who did not return a consent after being approached and agreeing to the study. The latter only exists for periods that had some remote recruitment. Recruitment took place at NewYork-Presbyterian (NYP) Hospitals: Children’s Hospital of New York, Allen, Cornell, and Lower Manhattan Hospital and Queens Hospital and Northwell Hospitals: Long Island Jewish Medical Center, North Shore University Hospital, Lenox Hill Hospital, and Southside Hospital unless otherwise indicated. Pre-pandemic period for NYP and Northwell includes 1 January 2020–15 March 2020. There was no recruitment at Queens between 1 January 2020–1 February 2020 and Southside for 1 January 2020–19 February 2020 and these hospitals are not included in total number for eligible babies for these time periods. The Remote period includes 16 Match 2020–1 September 2020 for NYP and 28 March 2020–12 July 2020 for Northwell. There was recruitment at Lower Manhattan Hospital from 16 Match 2020–20 April 2020 and no recruitment at NYP Queens or Southside for this total period and these hospitals are not included in total number eligible for these time periods. The Hybrid period includes 2 September 2020–31 December 2020 for NYP and 13 July 2020–31 December 2020 for Northwell. There was recruitment at NYP Queens from 2 September 2020–1 December 2020 and Southside from 13 July 2020–20 August 2020 and these hospitals are not included in total number for eligible babies for these dates. p-values for chi square analysis for pre-pandemic compared to remote or hybrid.