Adverse effects of COVID-19 pandemic on a multicenter randomized controlled trial
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Published:2022-12-29
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Volume:
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ISSN:0743-8346
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Container-title:Journal of Perinatology
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language:en
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Short-container-title:J Perinatol
Author:
Abu Jawdeh Elie G.ORCID, Hunt Carl E., Eichenwald Eric, Corwin Michael J., McEntire Betty, Heeren Timothy, Crowell Lisa M., Ikponmwonba Christine, Saroufim Ariana, Kerr Stephen, Darnall Robert, Poets Christian, Revenis Mary, Tyree Melissa, Pokelsek Ann, Stark Ann, Frantz Ivan, Thakkar Neha, Hansen Rachel, Mancini Toni, Dhawan Megan, Hartman Tyler, McNally Mary, Martini Karlyn, Fort Prem, Flanagan Sarah, Babushkin Tamara, Sivilich Haley, Balaraman Venkataraman, Tong Micah, Goldstein Mitchell, Ramirez Tina, Gray-Hutto Nikia, Tugung Ashra, Quire Kimberly, Butler Sara, Hobbs Carrie, Rhein Lawrence, Shenoy Anjana, Simoncini Lindsey, Patel Jaimin, Williams Heather, Giachelli Chelsea, Dobson Nicole, Schulz Elizabeth, Fitzpatrick Judith, , ,
Abstract
Abstract
Objective
Describe the effects of the COVID-19 pandemic on subject enrollment in a multicenter randomized controlled trial.
Study design
We assessed the number of eligible infants approached and consented for enrollment over five separate epochs including baseline, peak pandemic, and gradual but incomplete recovery.
Result
The pandemic had a major effect on ability to approach parents for consent. Parents approached dropped from 95.4% baseline to 13.1% in the peak pandemic epoch and has not recovered to baseline even in the just-completed post-pandemic epoch (84.9%). Despite the decrease in subjects approached, there was no significant change in the overall consent rate for the study
Conclusion
The pandemic has significantly limited ability to approach parents of eligible infants for consent, with only partial recovery. Opportunities for interactions of investigators and study coordinators with parents continue to present challenges limiting full recovery.
Funder
U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences
Publisher
Springer Science and Business Media LLC
Subject
Obstetrics and Gynecology,Pediatrics, Perinatology and Child Health
Reference8 articles.
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