Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 16, 2020
Date Accepted: Sep 22, 2020
Safety and Biovigilance in Organ Donation (SAFEBOD) Study: a protocol for a population-based cohort study
ABSTRACT
Background:
The prevention of inadvertent transmission of infectious diseases or cancer from organ donors (biovigilance) is in tension with the need to increase access to transplantation. Evaluation of potential donors is often time-pressured and may rely on incomplete information.
Objective:
The Safety and Biovigilance in Organ Donation (SAFEBOD) study aims to better estimate infection and cancer transmission-risk and explore how real-time access to existing data could support decision-making.
Methods:
We will link existing donor referral, actual donor, recipient and health-outcome datasets in NSW, 2000-2015. Organ donor datasets will include; Organ donor Characterizing risk-profile of Donors Study; National Organ Matching System dataset; Australian and New Zealand Organ Donor Register; Australian and New Zealand Living Donor Kidney Register. Recipient datasets will include; Australian and New Zealand Dialysis and Transplant Register; Australian and New Zealand Cardiothoracic Register; Australian and New Zealand Islet and Pancreas Register; Australian and New Zealand Liver Transplant Register. NSW health outcome datasets will include; HIV and AIDS Notifications and Surveillance Data; Notifiable Conditions Information Management System; Admitted Patient Data Collection; Emergency Department Data Collection; Central Cancer Registry; and Cause of Death Data Collection. We will link organ donors to transplant recipients and health outcomes datasets using probabilistic data-matching based on personal identifiers. Transmission and non-transmission events will be determined by comparing previous cases in donors and post-transplant cases in recipients. We will compare the perceived-risk at referral with their verified-risk from linked health-outcome datasets and the odds of cancer or contracting an infectious disease in organ recipients from donors based on their transmission-risk profile and estimate recipient survival by donor transmission-risk group.
Results:
Data was requested from listed registries September 2018 and is ongoing. Linked data from all listed datasets is expected in September 2020.
Conclusions:
The SAFEBOD study will overcome current limitations in organ donation by accessing comprehensive information on referred organ donors and recipients in existing datasets. The study will provide robust estimates of disease transmission and non-transmission events based on contemporary data. It will also describe the agreement between perceived-risk estimated at the time of referral and verified-risk when all health-outcome data is accessible. The improved understanding of transmission and non-transmission events will inform clinical decisions and highlight where current policy can be revised to broaden acceptance of deceased donors. Clinical Trial: N/A
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