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Observational Study
. 2022 Jul;22(7):1760-1765.
doi: 10.1111/ajt.17051. Epub 2022 Apr 18.

Challenges encountered in conducting donor-based research: Lessons learned from the Donor Heart Study

Kiran K Khush  1 , Helen Luikart  1 , Nikole Neidlinger  2 , Ahmad Salehi  3 , John Nguyen  4 , P J Geraghty  5 , John Belcher  6 , Bruce Nicely  7 , Martin Jendrisak  8 , Thomas Pearson  9 , R Patrick Wood  10 , Tahnee Groat  11 , Brian Wayda  1 , Jonathan G Zaroff  12 , Darren Malinoski  11
Affiliations
Observational Study

Challenges encountered in conducting donor-based research: Lessons learned from the Donor Heart Study

Kiran K Khush et al. Am J Transplant. 2022 Jul.

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.

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Conflict of interest statement

Disclosures: The authors have no conflicts of interest to disclose.

Figures

Figure 1:
Figure 1:
Supply-demand mismatch created by the shortage of suitable donor organs for solid organ transplantation. Solid lines represent the ratio of waitlist additions to the number of transplants performed per year. Dashed lines represent the percent of candidates who died or were too sick to be transplanted. Data shown for kidney, liver, heart, and lung transplants from 2015–2019. Source: 2019 Annual Data Report. Scientific Registry of Transplant Recipients http://srtr.transplant.hrsa.gov/annual_reports/Default.aspx Accessed February 9, 2022 2017 Annual Data Report. Scientific Registry of Transplant Recipients http://srtr.transplant.hrsa.gov/annual_reports/Default.aspx Accessed February 9, 2022
Figure 2:
Figure 2:
Challenges encountered during conduct of the Donor Heart Study, and solutions implemented.
See this image and copyright information in PMC

References

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