Using Linked Health Service Data in Multimodal Modeling of Kidney Transplant Waitlist Outcomes: Protocol for the Maximizing Organ Donor Utility Systemwide (MODUS) Study.

backgroundIncreasing 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.

objectiveWe aim to describe the impact of accepting or declining potential donors foregone for biovigilance concerns on patient and transplant outcomes.

methodsThe 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.

resultsLinked 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.

conclusionsThe 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.