Maximizing Organ Donor Utility System-wide (MODUS): A study protocol for using linked health services data in multi-modal modelling of kidney transplant waitlist outcomes

Simple item page
dc.contributor.authorRosales, B.M.
dc.contributor.authorShah, K.
dc.contributor.authorDe La Mata, N.
dc.contributor.authorBaldwin, H.
dc.contributor.authorHedley, J.
dc.contributor.authorClayton, P.
dc.contributor.authorWyld, M.
dc.contributor.authorKelly, P.
dc.contributor.authorWyburn, K.
dc.contributor.authorMorton, R.
dc.contributor.authorWebster, A.
dc.date.issued2025
dc.description.abstractBackground: Increasing deceased organ donation is a worldwide priority constrained by concerns of inadvertent transmission of cancer or infectious diseases from deceased organ donors. Up to 60% of potential donors referred for consideration for deceased organ donation in Australia do not proceed due to biovigilance concerns. Objective: We aim to describe the impact of accepting or declining potential donors foregone for biovigilance concerns on patient and transplant outcomes. Methods: The MODUS (Maximizing Organ Donor Utility Systemwide) study will use data for patients ever waitlisted for kidney transplantation and all potential donors referred for consideration for deceased organ donation. First, we will use binational data from the Australian and New Zealand Dialysis and Transplant Registry 2010-2020 to describe and evaluate factors impacting the current patient journey on the kidney transplant waitlist, including episodes of suspension and reactivation, time waiting, and whether transplanted. Second, we will quantify the time from offer decline to deceased donor transplantation and the impact of the intersectional disadvantage on the waiting time after decline for patients on the waitlist using flexible parametric survival models. Third, the MODUS study will use an established dataset of outcome data for all candidates for deceased organ donors referred to the New South Wales (NSW) Organ and Tissue Donation Service (OTDS) in 2010-2020 to describe donor referral risk profiles and determine any potential donor gains that could be made through better access to donor information at the time of decision-making, more accurate estimation of the absolute biovigilance risk, and varying of the acceptable biovigilance risk thresholds for accepting donors. Lastly, we will use the estimates derived from the first 3 aims as inputs for health economic models, where, using cohort- and individual patient-level simulations, we will quantify the impact of varying donor referral decisions on health care costs, quality-adjusted survival, the time on the waitlist, and the time to a kidney transplant. Results: Linked health data were received in 2023. Data analysis is ongoing, and results will be disseminated at scientific conferences, published in the scientific media, and published via collaborator networks in 2025. Conclusions: The MODUS study will provide evidence of the individual-level and health service effects of increasing acceptance of deceased donor kidneys that would otherwise be declined due to biovigilance concerns. Specifically, we expect to report our findings on improvements in overall patient survival and quality of life by increasing the number of waitlisted people transplanted from donors with an acceptable biovigilance risk who are currently foregone. We will also report on the cost-effectiveness of a potential “informed biovigilance strategy” versus current practice. In doing so, we will develop evidence to support policy and complex clinical decisions in Australia’s organ donor referral process with potential worldwide application. International Registered Report Identifier (IRRID): DERR1-10.2196/67588
dc.description.statementofresponsibilityBrenda Maria Rosales, Karan Shah, Nicole De La Mata, Heather Baldwin, James Hedley, Philip Clayton, Melanie Wyld, Patrick Kelly, Kate Wyburn, Rachael Morton, Angela Webster, MODUS Study Group
dc.identifier.citationJMIR Research Protocols, 2025; 14:e67588-1-e67588-10
dc.identifier.doi10.2196/67588
dc.identifier.issn1929-0748
dc.identifier.issn1929-0748
dc.identifier.orcidClayton, P. [0000-0001-9190-6753]
dc.identifier.urihttps://hdl.handle.net/2440/147836
dc.language.isoen
dc.publisherJMIR Publications
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1171364
dc.rights© Brenda Maria Rosales, Karan Shah, Nicole De La Mata, Heather Baldwin, James Hedley, Philip Clayton, Melanie Wyld, Patrick Kelly, Kate Wyburn, Rachael Morton, Angela Webster, MODUS Study Group. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.07.2025. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
dc.source.urihttps://doi.org/10.2196/67588
dc.subjectkidney failure; transplant waitlist; organ allocation; biovigilance; population study; health economic evaluation
dc.subject.meshHumans
dc.subject.meshKidney Transplantation
dc.subject.meshRegistries
dc.subject.meshTissue Donors
dc.subject.meshTissue and Organ Procurement
dc.subject.meshWaiting Lists
dc.subject.meshAustralia
dc.subject.meshNew Zealand
dc.titleMaximizing Organ Donor Utility System-wide (MODUS): A study protocol for using linked health services data in multi-modal modelling of kidney transplant waitlist outcomes
dc.typeJournal article
pubs.publication-statusPublished

Files

Collections

Research Outputs