Newly Designed Expedited Allocation Pathways Cannot be Expected to Rely On Data that Does Not Currently Exist

Abstract

Allocation out of sequence (AOOS) allows organ procurement organizations (OPOs) to bypass the standard match-run to expedite kidney placement and prevent nonuse. Inclusion of all AOOS attempts is vital when attempting to assess impact of AOOS on organ utility, including those attempts that do not lead to successful transplant. We assessed the frequency of AOOS documentation in discarded kidneys. Using Scientific Registry of Transplant Recipients (SRTR) Potential Transplant Recipient (PTR) offer data from 2021–2024, we identified match-runs with at least one discarded kidney. AOOS was defined according to Health Resources and Services Administration (HRSA) guidelines and match runs were stratified by kidney recovery and disposition patterns, focusing on 2024 when AOOS was well established. AOOS coding frequency was assessed within each group and across OPOs. In 2024, only 4.3% of all match-runs with at least one discarded kidney contained evidence of AOOS documentation. Across OPOs, AOOS-coded discards ranged from 0.0% to 17.1% (median 3.9%, IQR [2.7–7.6%]). AOOS documentation among discarded kidneys remains rare and inconsistent, suggesting major data-capture deficiencies when attempting to accurately assess AOOS efforts. Improved AOOS reporting is essential before future expedited allocation pathways can be effectively evaluated or implemented.

Competing Interest Statement

Sumit Mohan reports financial support was provided by National Institutes of Health. Sumit Mohan reports financial support was provided by Columbia University. Syed Ali Husain reports financial support was provided by National Institute of Diabetes and Digestive and Kidney Diseases. Sumit Mohan reports a relationship with Health Services Advisory Group Inc that includes: consulting or advisory. Sumit Mohan reports a relationship with Kidney international Reports that includes: board membership. Sumit Mohan reports a relationship with Sanofi that includes: consulting or advisory. Sumit Mohan reports a relationship with DEKA research that includes: consulting or advisory. Sumit Mohan reports a relationship with Specialist Direct that includes: consulting or advisory. S.M. serves as the UNOS DAC Chair; S.M. serves as a member of the ASN Quality Committee; J.S. is a member of the American Society of Transplantation; J.S. serves as the Chair on the OPTN Data Advisory Committee; J.S. serves on the SRTR Review Committee. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Funding Statement

SM is supported by DK116066, EB032910, DK126739, DK130058 and the Columbia University Research Stabilization Fund. SAH was supported by NIDDK grant K23DK133729.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The institutional review board of Columbia University Irving Medical Center approved this study.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability Statement

The data used for this analysis are available upon request to the SRTR.

AbbreviationsAOOSHHRIOPOOPTNPTRSRTR

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