Year: 2022
Type: article
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.
Source: Journal of Perinatology
Authors: Elie G. Abu Jawdeh, Carl E. Hunt, Eric Eichenwald, Michael J. Corwin, Betty McEntire, Timothy Heeren, Lisa M. Crowell, Christine Ikponmwonba, Ariana Saroufim, Stephen Kerr, the ICAF Study Group, Robert Darnall, Christian Poets, Mary Revenis, Melissa Tyree, Ann Pokelsek, Ann Stark, Ivan Frantz, Neha Thakkar, Rachel Hansen, Toni Mancini, Megan Dhawan, Tyler Hartman, Mary McNally, Karlyn Martini, Prem Fort, Sarah Flanagan, Tamara Babushkin, Haley Sivilich, Venkataraman Balaraman, Micah Tong, Mitchell Goldstein, Tina Ramirez, Nikia Gray-Hutto, Ashra Tugung, Kimberly Quire, Sara Butler, Carrie Hobbs, Lawrence Rhein, Anjana Shenoy, Lindsey Simoncini, Jaimin Patel, Heather Williams, Chelsea Giachelli, Nicole Dobson, Elizabeth Schulz, Judith Fitzpatrick
Institutions: University of Kentucky, Uniformed Services University of the Health Sciences, Children's Hospital of Philadelphia, University of Pennsylvania, Boston University, American SIDS Institute, Dartmouth College, University of Tübingen, Children's National, George Washington University, AdventHealth for Children, Beth Israel Deaconess Medical Center, Dartmouth–Hitchcock Medical Center, Johns Hopkins All Children's Hospital, Kapiolani Medical Center for Women and Children, University of Hawaiʻi at Mānoa, University of Hawaii System, Loma Linda University Children's Hospital, University of Massachusetts Chan Medical School, University of Mississippi Medical Center, Walter Reed National Military Medical Center
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,190
OpenAlex ID: W4313238688