@article{cfe1853506764a4fbf45707367d3bd3e,
title = "Challenges encountered in conducting donor-based research: Lessons learned from the Donor Heart Study",
abstract = "Solid organ transplantation continues to be constrained by a lack of suitable donor organs. Advances in donor management and evaluation are needed to address this shortage, but the performance of research studies in deceased donors is fraught with challenges. Here we discuss several of the major obstacles we faced in the conduct of the Donor Heart Study—a prospective, multi-site, observational study of donor management, evaluation, and acceptance for heart transplantation. These included recruitment and engagement of participating organ procurement organizations, ambiguities related to study oversight, obtaining authorization for donor research, logistical challenges encountered during donor management, sustaining study momentum, and challenges related to study data management. By highlighting these obstacles encountered, as well as the solutions implemented, we hope to stimulate further discussion and actions that will facilitate the design and execution of future donor research studies.",
keywords = "clinical research/practice, donor evaluation, donors and donation, editorial/personal viewpoint, ethics, heart transplantation/cardiology, organ procurement and allocation",
author = "Khush, {Kiran K.} and Helen Luikart and Nikole Neidlinger and Ahmad Salehi and John Nguyen and Geraghty, {P. J.} and John Belcher and Bruce Nicely and Martin Jendrisak and Thomas Pearson and Wood, {R. Patrick} and Tahnee Groat and Brian Wayda and Zaroff, {Jonathan G.} and Darren Malinoski",
note = "Funding Information: This study was funded by the National Institutes of Health/National Heart Lung and Blood Institute (R01 HL125303). The investigators would like to acknowledge the thousands of donors enrolled in this study who selflessly gave the gift of life. We would also like to acknowledge the donor families, who agreed to research data collection, and the donor hospital staff who performed the required testing and procedures. Importantly, we would like to recognize the organ procurement organizations that participated in the Donor Heart Study (Donor Network West [San Ramon, California], Donor Network of Arizona [Tempe, Arizona], Gift of Hope [Itasca, Illinois], Gift of Life Michigan [Ann Arbor, Michigan], LifeGift [Houston, Fort Worth, and Lubbock, Texas], LifeLink [Norcross, Georgia], New England Donor Services [Waltham, Massachusetts], and LifeChoice Donor Services [Bloomfield, Connecticut]) and their staff who collected and entered study data. We finally would like to thank the coordinators and staff at the United Network for Organ Sharing, Oregon Health and Science University, Kaiser Permanente, and Stanford University for their contributions to this study. Funding Information: This study was funded by the National Institutes of Health/National Heart Lung and Blood Institute (R01 HL125303). Publisher Copyright: {\textcopyright} 2022 The American Society of Transplantation and the American Society of Transplant Surgeons.",
year = "2022",
month = jul,
doi = "10.1111/ajt.17051",
language = "English (US)",
volume = "22",
pages = "1760--1765",
journal = "American Journal of Transplantation",
issn = "1600-6135",
publisher = "Wiley-Blackwell",
number = "7",
}