@article{Waller2025,

title = {Transmission Risk of Intentional Transplantation of Kidneys From Donors With Active Hepatitis B to Recipients Without Active Hepatitis B: A Systematic Review and Meta-Analysis},

author = {Karen M.J. Waller and Nicole De La Mata and James A. Hedley and Trishala Sharma and Rachel Davies and Emma Garrett and Sarah White and William Rawlinson and Sacha Stelzer-Braid and Kate Wyburn and Angela C. Webster},

doi = {10.1097/tp.0000000000005575},

issn = {1534-6080},

year  = {2025},

date = {2025-12-19},

urldate = {2025-12-19},

publisher = {Ovid Technologies (Wolters Kluwer Health)},

abstract = {<jats:sec>

                    <jats:title>Background.</jats:title>

                    <jats:p>Potential kidney donors with active hepatitis B virus (HBV: positive hepatitis B surface antigen [HBsAg] and/or nucleic acid test [NAT]) are usually declined for HBsAg-negative recipients. Safety may be improved by recipient vaccination and/or antivirals, thereby increasing transplantation opportunities. We quantified HBV transmission risk in this setting to inform donation decisions.</jats:p>

                  </jats:sec>

                  <jats:sec>

                    <jats:title>Methods.</jats:title>

                    <jats:p>Systematic review and meta-analysis (MEDLINE, to November 2024) of cohorts comprised of kidney donors with active HBV intentionally used for HBsAg-negative recipients. Transmission was defined as new HBsAg or NAT positivity posttransplant. Transmission proportions and exact 95% confidence intervals (CIs) were pooled using generalized linear mixed models with logistic transformation and random effects.</jats:p>

                  </jats:sec>

                  <jats:sec>

                    <jats:title>Results.</jats:title>

                    <jats:p>

                      We included 20 cohorts involving 600 HBsAg-negative recipients from donors with active HBV. Most donors were living (52%), with negative NAT (60%). Most recipients had positive surface antibody (>10 IU/L, 86%); many were core antibody positive (47%). Antiviral prophylaxis was given to 49% recipients, varying in type, duration, and strategy. There were 29 of 600 HBV transmissions, mostly transient low-level viremia only (62%). The pooled transmission rate was 4.0% (95% CI, 1.8%-8.3%) with low heterogeneity (

                      <jats:italic toggle="yes">I</jats:italic>

                      <jats:sup>2</jats:sup>

                       = 0%) but some between-study variance (Tau

                      <jats:sup>2</jats:sup>

                       = 1.21). Transmission rates were higher where all donors had positive NAT (16.0%; 95% CI, 10.2%-24.3%), and lower where all recipients were living (0.8%; 95% CI, 0.1%-6.4%) or had positive surface antibody (1.4%; 95% CI, 0.2%-8.8%). Three deaths because of HBV transmissions occurred, all among recipients not taking posttransplant antiviral prophylaxis.

                    </jats:p>

                  </jats:sec>

                  <jats:sec>

                    <jats:title>Conclusions.</jats:title>

                    <jats:p>Given low transmission rates and mitigating strategies, kidney transplantation may be considered from donors with active HBV, with donor/recipient risk stratification, consent, and monitoring/prophylaxis.</jats:p>

                  </jats:sec>},

keywords = {MODUS, SAFEBOD},

pubstate = {published},

tppubtype = {article}

}

@article{Rosales2025,

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

author = {Brenda Maria Rosales and Karan Shah and Nicole De La Mata and Heather Baldwin and James Hedley and Philip Clayton and Melanie Wyld and Patrick Kelly and Kate Wyburn and Rachael Morton and Angela Webster},

doi = {10.2196/67588},

issn = {1929-0748},

year  = {2025},

date = {2025-07-29},

urldate = {2025-07-29},

journal = {JMIR Res Protoc},

volume = {14},

publisher = {JMIR Publications Inc.},

abstract = {<jats:sec>

            <jats:title>Background</jats:title>

            <jats:p>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.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Objective</jats:title>

            <jats:p>We aim to describe the impact of accepting or declining potential donors foregone for biovigilance concerns on patient and transplant outcomes.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Methods</jats:title>

            <jats:p>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.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Results</jats:title>

            <jats:p>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.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Conclusions</jats:title>

            <jats:p>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.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>International Registered Report Identifier (IRRID)</jats:title>

            <jats:p>DERR1-10.2196/67588</jats:p>

          </jats:sec>},

keywords = {MODUS},

pubstate = {published},

tppubtype = {article}

}

@article{Muscat2025,

title = {Understanding Factors Influencing Decision Making during Assessment of Potential Organ Donors: A Qualitative Study of Clinicians Assessing the Medical Suitability of Potential Donors},

author = {Danielle Marie Muscat and Pinika Patel and Rachel Davies and Rachel B. Cutting and Brenda M. Rosales and Shilpanjali Jesudason and Kirsten McCaffery and Kate R. Wyburn and Angela C. Webster},

doi = {10.1177/23814683251386881},

issn = {2381-4683},

year  = {2025},

date = {2025-07-00},

urldate = {2025-07-00},

journal = {MDM Policy & Practice},

volume = {10},

number = {2},

publisher = {SAGE Publications},

abstract = {<jats:p>

                    <jats:bold>Background.</jats:bold>

                    Potential organ donors are carefully assessed by expert clinicians (donation specialists) who evaluate a variety of factors, including balancing potential transplant benefits and biovigilance risks, under time constraints. We aimed to identify and understand the factors that donation specialists consider when appraising a potential organ donor and how they balance the risk and benefits when determining the medical suitability to proceed to donation.

                    <jats:bold>Methods.</jats:bold>

                    Exploratory qualitative study involving semi-structured interviews with 12 donation specialists in NSW, Australia. Interviews included 1) open-ended questions focused on the general potential organ donation pathway and 2) hypothetical potential donor scenarios, with participants invited to voice their decision-making process. Interviews were audio-recorded, transcribed verbatim, and analyzed using the framework method.

                    <jats:bold>Results.</jats:bold>

                    We identified 3 themes: 1) from automatic exclusions to more collaborative decision making; (2) “risk appetite,” uncertainty, and information gaps; and 3) the role of recipients and their families in decision making. Deceased donor medical suitability was determined by a complex interplay of clinical practice guidelines, guidance from colleagues, and personal risk propensity, with variability in decision making irrespective of standardized information provision. Decisions that a potential donor was unsuitable were often driven by compounding risks, accentuated in the context of missing information and incomplete medical histories. Considering both potential donor and potential recipient profiles in tandem and including potential recipients and/or their families in decision making was considered important. However, narratives were marked by frustration with patients’ risk propensity and challenges with communication under time pressure.

                    <jats:bold>Conclusion.</jats:bold>

                    Clinicians assessing the medical suitability of potential deceased organ donors face challenges such as incomplete medical histories and communication barriers. Decision-support tools and early engagement with potential recipients and their families to elicit their preferences and risk tolerance could aid clinicians in making more informed decisions under time pressure.

                  </jats:p>

                  <jats:sec>

                    <jats:title>Highlights</jats:title>

                    <jats:list list-type="bullet">

                      <jats:list-item>

                        <jats:p>In this qualitative study with Australian donation specialists, we found that potential deceased donor medical suitability was determined by a complex interplay of clinical practice guidelines, guidance from colleagues, and personal risk propensity, with variability in decision making irrespective of standardized information provision.</jats:p>

                      </jats:list-item>

                      <jats:list-item>

                        <jats:p>Decisions to forego a potential donor were often driven by compounding risks and worsened by missing information and incomplete medical histories.</jats:p>

                      </jats:list-item>

                      <jats:list-item>

                        <jats:p>Considering both potential donor and recipient profiles in tandem and including the recipient and/or their families in decision making were considered important but challenging under time pressure.</jats:p>

                      </jats:list-item>

                    </jats:list>

                  </jats:sec>},

keywords = {MODUS},

pubstate = {published},

tppubtype = {article}

}

@article{Cutting2025,

title = {Non‐Retrieval and Non‐Utilisation of Deceased Donor Kidneys for Transplantation: An Australian Cohort Study},

author = {Rachel B. Cutting and Nicole L. De La Mata and Animesh Singla and James A. Hedley and Helen Opdam and Philip Clayton and Kate Wyburn and Elena Cavazzoni and Paul Robertson and Henry Pleass and Angela C. Webster},

doi = {10.1111/ans.70208},

issn = {1445-2197},

year  = {2025},

date = {2025-07-00},

urldate = {2025-07-00},

journal = {ANZ Journal of Surgery},

volume = {95},

number = {7-8},

pages = {1584--1596},

publisher = {Wiley},

abstract = {<jats:title>ABSTRACT</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>An efficient organ donation programme must maximise transplantation following initiation of organ recovery procedures.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We conducted a cohort study of deceased donors in Australia (2014–2021) using Australia and New Zealand Organ Donation Registry data to characterise kidney non‐retrieval (post‐incision) and non‐utilisation (retrieved, not transplanted). Donor characteristics included kidney side (left/right), kidney‐only procurement, kidney donor profile index (KDPI), cause of death, resuscitation, donation after circulatory/neurological determination of death (DCDD/DNDD) and donor criteria (standard SCD/extended ECD), year, age, sex, blood group, ethnicity, comorbidities, smoking, BMI, weight, remoteness, occupation and socioeconomic disadvantage. System characteristics included jurisdiction of donor hospital, retrieval team and recipient's hospital.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Among 7211 kidneys (3683 donors) accepted for retrieval, 675 (9%) were non‐retrieved and 430 (7%) were non‐utilised. Crude non‐retrieval rates doubled from 5% to 10% between 2014 and 2021 (<jats:italic>p</jats:italic> = 0.01) while non‐utilisation remained around 7% (<jats:italic>p</jats:italic> = 0.1). After adjustment, non‐retrieval was greater among donors with KDPI ≥ 75 (OR: 4.28, 95% CI: 2.08–8.81, <jats:italic>p</jats:italic> < 0.001), diabetes (OR: 1.74, 95% CI: 1.25–2.43, <jats:italic>p</jats:italic> = 0.001) and in recent years (annual OR: 1.08, 95% CI: 1.03–1.55, <jats:italic>p</jats:italic> = 0.002), and lower for ECD DCDD (OR: 0.46, 95% CI: 0.26–0.81, <jats:italic>p</jats:italic> = 0.01). Non‐utilisation was greater for SCD DCDD (OR: 1.90, 95% CI: 1.28–2.82, <jats:italic>p</jats:italic> < 0.001), blood group AB (OR: 2.05, 95% CI: 1.16–3.64, <jats:italic>p</jats:italic> = 0.03) and in recent years (annual OR: 1.08, 95% CI: 1.02–1.15, <jats:italic>p</jats:italic> = 0.01), and lower in Tasmania (OR: 0.28, 95% CI: 0.08–0.97) and Queensland (OR: 0.57, 95% CI: 0.36–0.92, <jats:italic>p</jats:italic> = 0.03). Documented reasons for non‐utilisation lacked transparency but included poor perfusion (17%).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Increasing utilisation of higher KDPI kidneys and enhancing perfusion could help maximise kidney transplantation.</jats:p></jats:sec>},

keywords = {MODUS},

pubstate = {published},

tppubtype = {article}

}

@article{Cutting2024,

title = {Values, Preferences, and Risk Tolerance of People Waitlisted for a Kidney Transplant Regarding Potential Deceased Donor Organ Profiles: A Systematic Review},

author = {Rachel B. Cutting and Danielle M. Muscat and Pinika Patel and Nicole L. De La Mata and Georgina L. Irish and Melanie Wyld and Sarah White and Angela C. Webster},

doi = {10.1097/tp.0000000000005267},

issn = {1534-6080},

year  = {2025},

date = {2025-00-00},

urldate = {2025-00-00},

volume = {109},

number = {6},

pages = {e326--e339},

publisher = {Ovid Technologies (Wolters Kluwer Health)},

abstract = {<jats:sec>

            <jats:title>Background.</jats:title>

            <jats:p>Incorporating the views of people waitlisted for a kidney transplant is important when clinicians consider any donor kidney offer.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Methods.</jats:title>

            <jats:p>We conducted a systematic review of quantitative and qualitative studies in adult patients on, or under assessment for, the kidney waitlist. We focused on views of extended criteria, increased viral (blood-borne virus), or increased cancer risk in deceased donor kidneys. We systematically searched databases and conference proceedings until April 2024, excluding studies of children, case reports, and commentaries. Studies were appraised using the Johanna Briggs Institute checklists and synthesized using a convergent segregated approach, incorporating narrative and thematic methods.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Results.</jats:title>

            <jats:p>We included 25 studies (2630 participants) comprising quantitative surveys, questionnaires, conjoint analysis, and discrete choice experiments (n = 16; 64%) and qualitative semi-structured, in-depth interviews and focus groups (n = 9; 36%). Most studies were from the United States (n = 19; 76%) and focused on extended criteria and increased viral risk donors (n = 24; 96%), with 1 study considering general risks (4%). None focused on increased cancer-risk donors. We identified 4 themes and 2 subthemes: (1) I want to be free from dialysis, (2) I do not want more health problems, (3) I might not get another chance, (4) I desire shared decision-making but feel powerless to contribute, (4a) I need more information about my health status, prognosis and the transplant process, and (4b) I need more information about donor risk factors.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Conclusions.</jats:title>

            <jats:p>Waitlist patients desired information and involvement in decision-making, yet individual prognoses were not fully understood. Integrating shared decision-making from pre- to post-offer will increase knowledge and enhance treatment satisfaction.</jats:p>

          </jats:sec>},

keywords = {MODUS},

pubstate = {published},

tppubtype = {article}

}

@article{DeLaMata2023,

title = {Journey to kidney transplantation: patient dynamics, suspensions, transplantation and deaths in the Australian kidney transplant waitlist},

author = {Nicole L De La Mata and Victor Khou and James A Hedley and Patrick J Kelly and Rachael L Morton and Kate Wyburn and Angela C Webster},

doi = {10.1093/ndt/gfad253},

issn = {1460-2385},

year  = {2024},

date = {2024-06-28},

urldate = {2024-06-28},

volume = {39},

number = {7},

pages = {1138--1149},

publisher = {Oxford University Press (OUP)},

abstract = {<jats:title>ABSTRACT</jats:title>

               <jats:sec>

                  <jats:title>Background</jats:title>

                  <jats:p>People on the kidney waitlist are less informed about potential suspensions. Disparities may exist among those who are suspended and who return to the waitlist. We evaluated the patient journey after entering the waitlist, including suspensions and outcomes, and factors associated with these transitions.</jats:p>

               </jats:sec>

               <jats:sec>

                  <jats:title>Methods</jats:title>

                  <jats:p>We included all incident patients waitlisted for their first transplant from deceased donors in Australia from 2006 to 2019. We described all clinical transitions after entering the waitlist. We predicted the restricted mean survival time (unadjusted and adjusted) until first transplant by the number of prior suspensions. We evaluated factors associated with transitions using flexible survival models and clinical endpoints using Cox models.</jats:p>

               </jats:sec>

               <jats:sec>

                  <jats:title>Results</jats:title>

                  <jats:p>Of 8466 patients waitlisted and followed over 45 757.4 person-years (median 4.8 years), 6741 (80%) were transplanted, 381 (5%) died waiting and 1344 (16%) were still waiting. A total of 3127 (37%) people were suspended at least once. Predicted mean time from waitlist to transplant was 3.0 years [95% confidence interval (CI) 2.8–3.2] when suspended versus 1.9 years (95% CI 1.8–1.9) when never suspended. Prior suspension increased the likelihood of further suspensions 4.2-fold (95% CI 3.8–4.6) and returning to the waitlist by 50% (95% CI 36–65) but decreased the likelihood of transplantation by 29% (95% CI 62–82). Death risk while waiting was increased 12-fold (95% CI 8.0–18.3) when currently suspended. Australian non-Indigenous males were 13% [hazard ratio (HR) 1.13 (95% CI 1.04–1.23)] and Asian males 23% [HR 1.23 (95% CI 1.06–1.42)] more likely to return to the waitlist compared with females of the same ethnicity.</jats:p>

               </jats:sec>

               <jats:sec>

                  <jats:title>Conclusion</jats:title>

                  <jats:p>The waitlist journey was not straightforward. Suspension was common, impacted the chance of transplantation and meant waiting an average of 1 year longer until transplant. We have provided estimates for and factors associated with suspension, relisting and outcomes after waitlisting to support more informed discussions. This evidence is critical to further understand drivers of inequitable access to transplantation.</jats:p>

               </jats:sec>},

keywords = {MODUS},

pubstate = {published},

tppubtype = {article}

}

@article{Shah2024,

title = {Cost-effectiveness of Accepting Kidneys From Deceased Donors With Common Cancers—A Modeling Study},

author = {Karan K. Shah and James A. Hedley and Kristy P. Robledo and Melanie Wyld and Angela C. Webster and Rachael L. Morton},

doi = {10.1097/tp.0000000000004984},

issn = {0041-1337},

year  = {2024},

date = {2024-03-19},

urldate = {2024-03-19},

publisher = {Ovid Technologies (Wolters Kluwer Health)},

abstract = {<jats:sec>

            <jats:title>Background.</jats:title>

            <jats:p>The disparity between the demand for and supply of kidney transplants has resulted in prolonged waiting times for patients with kidney failure. A potential approach to address this shortage is to consider kidneys from donors with a history of common cancers, such as breast, prostate, and colorectal cancers.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Methods.</jats:title>

            <jats:p>We used a patient-level Markov model to evaluate the outcomes of accepting kidneys from deceased donors with a perceived history of breast, prostate, or colorectal cancer characterized by minimal to intermediate transmission risk. Data from the Australian transplant registry were used in this analysis. The study compared the costs and quality-adjusted life years (QALYs) from the perspective of the Australian healthcare system between the proposed practice of accepting these donors and the conservative practice of declining them. The model simulated outcomes for 1500 individuals waitlisted for a deceased donor kidney transplant for a 25-y horizon.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Results.</jats:title>

            <jats:p>Under the proposed practice, when an additional 15 donors with minimal to intermediate cancer transmission risk were accepted, QALY gains ranged from 7.32 to 20.12. This translates to an approximate increase of 7 to 20 additional years of perfect health. The shift in practice also led to substantial cost savings, ranging between $1.06 and $2.3 million.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Conclusions.</jats:title>

            <jats:p>The proposed practice of accepting kidneys from deceased donors with a history of common cancers with minimal to intermediate transmission risk offers a promising solution to bridge the gap between demand and supply. This approach likely results in QALY gains for recipients and significant cost savings for the health system.</jats:p>

          </jats:sec>},

keywords = {MODUS},

pubstate = {published},

tppubtype = {article}

}

@article{Rosales2024,

title = {Transmission and Non-transmission of Melanoma From Deceased Solid Organ Donors to Transplant Recipients: Risks and Missed Opportunities},

author = {Brenda Maria Rosales and James Hedley and Nicole De La Mata and Elena Cavazzoni and Claire M. Vajdic and John F. Thompson and Patrick J. Kelly and Kate Wyburn and Angela C. Webster},

doi = {10.1097/tp.0000000000004961},

issn = {0041-1337},

year  = {2024},

date = {2024-00-00},

urldate = {2024-00-00},

volume = {108},

number = {7},

pages = {1623--1631},

publisher = {Ovid Technologies (Wolters Kluwer Health)},

abstract = {<jats:sec>

            <jats:title>Background.</jats:title>

            <jats:p>Biovigilance concerns are in tension with the need to increase organ donation. Cancer transmission risk from donor to recipient may be overestimated, as non-transmission events are rarely reported. We sought to estimate melanoma transmission risk in deceased organ donation and identify missed opportunities for donation in an Australian cohort with high melanoma prevalence.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Methods.</jats:title>

            <jats:p>We used a population-based approach and linked deceased organ donors, transplant recipients, and potential donors forgone, 2010–2018, with the Central Cancer Registry (CCR), 1976–2018. We identified melanomas using ICD-O-3 classification, assessed the probability of transmission, and compared suspected melanoma history in potential donors forgone with melanoma notifications in the CCR.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Results.</jats:title>

            <jats:p>There were 9 of 993 donors with melanoma in CCR; 4 in situ low-risk and 5 invasive high-to-unacceptable risk. Four were unrecognized before donation. Of 16 transplant recipients at risk, we found 0 of 14 transmission events (2 recipients had insufficient follow-up). Of 35 of 3588 potential donors forgone for melanoma risk alone, 17 were otherwise suitable for donation; 6 of 35 had no melanoma in CCR, 2 of 35 had in situ melanomas and 9 of 35 had thin invasive melanomas (localized, ≤0.8 mm thickness).</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Conclusions.</jats:title>

            <jats:p>Our findings contribute to current evidence that suggests donors with melanomas of low metastatic potential may provide an opportunity to safely increase organ donation and so access to transplantation.</jats:p>

          </jats:sec>},

keywords = {MODUS, SAFEBOD},

pubstate = {published},

tppubtype = {article}

}

@article{Hedley2023,

title = {Cost-effectiveness of Interventions to Increase Utilization of Kidneys From Deceased Donors With Primary Brain Malignancy in an Australian Setting},

author = {James A. Hedley and Patrick J. Kelly and Melanie Wyld and Karan Shah and Rachael L. Morton and Juliet Byrnes and Brenda M. Rosales and Nicole L. De La Mata and Kate Wyburn and Angela C. Webster},

doi = {10.1097/txd.0000000000001474},

issn = {2373-8731},

year  = {2023},

date = {2023-00-00},

urldate = {2023-00-00},

volume = {9},

number = {5},

publisher = {Ovid Technologies (Wolters Kluwer Health)},

abstract = {<jats:sec>

            <jats:title>Background.</jats:title>

            <jats:p>Kidneys from potential deceased donors with brain cancer are often foregone due to concerns of cancer transmission risk to recipients. There may be uncertainty around donors’ medical history and their absolute transmission risk or risk-averse decision-making among clinicians. However, brain cancer transmissions are rare, and prolonging waiting time for recipients is harmful.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Methods.</jats:title>

            <jats:p>We assessed the cost-effectiveness of increasing utilization of potential deceased donors with brain cancer using a Markov model simulation of 1500 patients waitlisted for a kidney transplant, based on linked transplant registry data and with a payer perspective (Australian government). We estimated costs and quality-adjusted life-years (QALYs) for three interventions: decision support for clinicians in assessing donor risk, improved cancer classification accuracy with real-time data-linkage to hospital records and cancer registries, and increased risk tolerance to allow intermediate-risk donors (up to 6.4% potential transmission risk).</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Results.</jats:title>

            <jats:p>Compared with current practice, decision support provided 0.3% more donors with an average transmission risk of 2%. Real-time data-linkage provided 0.6% more donors (1.1% average transmission risk) and increasing risk tolerance (accepting intermediate-risk 6.4%) provided 2.1% more donors (4.9% average transmission risk). Interventions were dominant (improved QALYs and saved costs) in 78%, 80%, and 87% of simulations, respectively. The largest benefit was from increasing risk tolerance (mean +18.6 QALYs and AU$2.2 million [US$1.6 million] cost-savings).</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Conclusions.</jats:title>

            <jats:p>Despite the additional risk of cancer transmission, accepting intermediate-risk donors with brain cancer is likely to increase the number of donor kidneys available for transplant, improve patient outcomes, and reduce overall healthcare expenditure.</jats:p>

          </jats:sec>},

keywords = {MODUS},

pubstate = {published},

tppubtype = {article}

}

@article{Shah2023,

title = {Cost-effectiveness of Kidney Transplantation From Donors at Increased Risk of Blood-borne Virus Infection Transmission},

author = {Karan K. Shah and Melanie Wyld and James A. Hedley and Karen M.J. Waller and Nicole De La Mata and Angela C. Webster and Rachael L. Morton},

doi = {10.1097/tp.0000000000004632},

issn = {0041-1337},

year  = {2023},

date = {2023-00-00},

urldate = {2023-00-00},

volume = {107},

number = {9},

pages = {2028--2042},

publisher = {Ovid Technologies (Wolters Kluwer Health)},

abstract = {<jats:sec>

            <jats:title>Background.</jats:title>

            <jats:p>Demand for donor kidneys outstrips supply. Using kidneys from selected donors with an increased risk of blood-borne virus (BBV) transmission (hepatitis B virus and hepatitis C virus [HCV], human immunodeficiency virus) may expand the donor pool, but cost-effectiveness of this strategy is uncertain.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Methods.</jats:title>

            <jats:p>A Markov model was developed using real-world evidence to compare healthcare costs and quality-adjusted life years (QALYs) of accepting kidneys from deceased donors with potential increased risk of BBV transmission, because of increased risk behaviors and/or history of HCV, versus declining these kidneys. Model simulations were run over a 20-y time horizon. Parameter uncertainty was assessed through deterministic and probabilistic sensitivity analyses.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Results.</jats:title>

            <jats:p>Accepting kidneys from donors at increased risk of BBVs (2% from donors with increased-risk behaviors and 5% from donors with active or past HCV infection) incurred total costs of 311 303 Australian dollars with a gain of 8.53 QALYs. Foregoing kidneys from these donors incurred total costs of $330 517 and a gain of 8.44 QALYs. A cost-saving of $19 214 and additional 0.09 QALYs (~33 d in full health) per person would be generated compared with declining these donors. Increasing the availability of kidneys with increased risk by 15% led to further cost-savings of $57 425 and additional 0.23 QALY gains (~84 d in full health). Probabilistic sensitivity analysis using 10 000 iterations showed accepting kidneys from donors at increased risk led to lower costs and higher QALY gains.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Conclusions.</jats:title>

            <jats:p>Shifting clinical practice to accept increased BBV risk donors would likely produce lower costs and higher QALYs for health systems.</jats:p>

          </jats:sec>},

keywords = {MODUS},

pubstate = {published},

tppubtype = {article}

}

@article{Thomson2022,

title = {Potential organ donors with primary brain tumours: missed opportunities for donation and transplantation identified in Australian cohort study 2010–2015},

author = {Imogen K. Thomson and James Hedley and Brenda M. Rosales and Kate Wyburn and Michael J. O'Leary and Angela C. Webster},

doi = {10.1111/ans.18037},

issn = {1445-2197},

year  = {2022},

date = {2022-11-00},

urldate = {2022-11-00},

journal = {ANZ Journal of Surgery},

volume = {92},

number = {11},

pages = {2996--3003},

publisher = {Wiley},

abstract = {<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Potential organ donors with primary brain tumours (PBT) frequently donate, however some may be declined due to uncertainty about tumour classification or transmission risk to transplant recipients. We sought to describe transmission risk and donation outcome of potential donors with PBT, including identifying missed opportunities for transplantation, and any PBT transmission events.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We undertook a population‐based cohort study in NSW of all potential donors 2010–2015. PBT potential donors were characterized according to tumour grade and transmission risk, and whether they donated organs. Data linkage was used to determine agreement of risk assessment of potential donors to that in the Biovigilance Register, and to identify any PBT transmissions.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 2957 potential donors, 76 (3%) had PBTs. There was agreement of risk assessment in 44 (58%) cases. PBT potential donors had fewer comorbidities (1.6 vs. 2.1, <jats:italic>P</jats:italic> = 0.006) than non‐PBT potential donors. Forty‐eight (63%) potential donors were declined for non‐PBT reasons, 18 (24%) were declined because of perceived PBT transmission risk and 10 (13%) donated. All PBT donors had WHO‐I or ‐II tumours, and none had a ventriculo‐pertioneal shunt. No transmission events occurred.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Donors with WHO‐I/II PBT appear to have minimal risk of tumour transmission in solid organ transplantation; it is reassuring that no PBT transmission occurred. There is evidence of risk aversion to referrals with WHO‐III/IV tumours. There exists opportunity to improve potential donor risk assessment at the time of referral using integrated data sets, and to increase organ donation and transplantation rates through greater utilization of PBT referrals.</jats:p></jats:sec>},

keywords = {MODUS, SAFEBOD},

pubstate = {published},

tppubtype = {article}

}

@article{Waller2022,

title = {Notifiable Infectious Diseases Among Organ Transplant Recipients: A Data-Linked Cohort Study, 2000–2015},

author = {Karen M J Waller and Nicole L De La Mata and Kate R Wyburn and James A Hedley and Brenda M Rosales and Patrick J Kelly and Vidiya Ramachandran and Karan K Shah and Rachael L Morton and William D Rawlinson and Angela C Webster},

doi = {10.1093/ofid/ofac337},

issn = {2328-8957},

year  = {2022},

date = {2022-08-02},

urldate = {2022-08-02},

volume = {9},

number = {8},

publisher = {Oxford University Press (OUP)},

abstract = {<jats:title>Abstract</jats:title>

               <jats:sec>

                  <jats:title>Background</jats:title>

                  <jats:p>Infections, including common communicable infections such as influenza, frequently cause disease after organ transplantation, although the quantitative extent of infection and disease remains uncertain.</jats:p>

               </jats:sec>

               <jats:sec>

                  <jats:title>Methods</jats:title>

                  <jats:p>A cohort study was conducted to define the burden of notifiable infectious diseases among all solid organ recipients transplanted in New South Wales, Australia, 2000–2015. Data linkage was used to connect transplant registers to hospital admissions, notifiable diseases, and the death register. Standardized incidence ratios (SIRs) were calculated relative to general population notification rates, accounting for age, sex, and calendar year. Infection-related hospitalizations and deaths were identified.</jats:p>

               </jats:sec>

               <jats:sec>

                  <jats:title>Results</jats:title>

                  <jats:p>Among 4858 solid organ recipients followed for 39 183 person-years (PY), there were 792 notifications. Influenza was the most common infection (532 cases; incidence, 1358 [95% CI, 1247–1478] per 100 000 PY), highest within 3 months posttransplant. Next most common was salmonellosis (46 cases; incidence, 117 [95% CI, 87–156] per 100 000 PY), then pertussis (38 cases; incidence, 97 [95% CI, 71–133] per 100 000 PY). Influenza and invasive pneumococcal disease (IPD) showed significant excess cases compared with the general population (influenza SIR, 8.5 [95% CI, 7.8–9.2]; IPD SIR, 9.8 [95% CI, 6.9–13.9]), with high hospitalization rates (47% influenza cases, 68% IPD cases) and some mortality (4 influenza and 1 IPD deaths). By 10 years posttransplant, cumulative incidence of any vaccine-preventable disease was 12%, generally similar by transplanted organ, except higher among lung recipients. Gastrointestinal diseases, tuberculosis, and legionellosis had excess cases among transplant recipients, although there were few sexually transmitted infections and vector-borne diseases.</jats:p>

               </jats:sec>

               <jats:sec>

                  <jats:title>Conclusions</jats:title>

                  <jats:p>There is potential to avoid preventable infections among transplant recipients with improved vaccination programs, health education, and pretransplant donor and recipient screening.</jats:p>

               </jats:sec>},

keywords = {MODUS, SAFEBOD},

pubstate = {published},

tppubtype = {article}

}

@article{Waller2022b,

title = {Characteristics and Donation Outcomes of Potential Organ Donors Perceived to Be at Increased Risk for Blood-borne Virus Transmission: An Australian Cohort Study 2010–2018},

author = {Karen M.J. Waller and Nicole L. De La Mata and Brenda M. Rosales and James A. Hedley and Patrick J. Kelly and Imogen K. Thomson and Michael J. O’Leary and Elena Cavazzoni and Vidiya Ramachandran and William D. Rawlinson and Kate R. Wyburn and Angela C. Webster},

doi = {10.1097/tp.0000000000003715},

issn = {0041-1337},

year  = {2022},

date = {2022-00-00},

urldate = {2022-00-00},

volume = {106},

number = {2},

pages = {348--357},

publisher = {Ovid Technologies (Wolters Kluwer Health)},

abstract = {<jats:sec>

            <jats:title>Background.</jats:title>

            <jats:p>Safely increasing organ donation to meet need is a priority. Potential donors may be declined because of perceived blood-borne virus (BBV) transmission risk. With hepatitis C (HCV) curative therapy, more potential donors may now be suitable. We sought to describe potential deceased donors with increased BBV transmission risk.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Methods.</jats:title>

            <jats:p>We conducted a cohort study of all potential organ donors referred in NSW, Australia, 2010–2018. We compared baseline risk potential donors to potential donors with increased BBV transmission risk, due to history of HIV, HCV or hepatitis B, and/or behavioral risk factors.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Results.</jats:title>

            <jats:p>There were 624 of 5749 potential donors (10.9%) perceived to have increased BBV transmission risk. This included 298 of 5749 (5.2%) with HCV (including HBV coinfections) and 239 of 5749 (4.2%) with increased risk behaviors (no known BBV). Potential donors with HCV and those with increased risk behaviors were younger and had fewer comorbidities than baseline risk potential donors (<jats:italic toggle="yes">P</jats:italic> < 0.001). Many potential donors (82 with HCV, 38 with risk behaviors) were declined for donation purely because of perceived BBV transmission risk. Most were excluded before BBV testing. When potential donors with HCV did donate, they donated fewer organs than baseline risk donors (median 1 versus 3, <jats:italic toggle="yes">P</jats:italic> < 0.01), especially kidneys (odds ratio 0.08, <jats:italic toggle="yes">P</jats:italic> < 0.001) and lungs (odds ratio 0.11, <jats:italic toggle="yes">P</jats:italic> = 0.006).</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Conclusions.</jats:title>

            <jats:p>Many potential donors were not accepted because of perceived increased BBV transmission risk, without viral testing, and despite otherwise favorable characteristics. Transplantation could be increased from potential donors with HCV and/or increased risk behaviors.</jats:p>

          </jats:sec>},

keywords = {MODUS, SAFEBOD},

pubstate = {published},

tppubtype = {article}

}

@article{Hedley2022b,

title = {Perceived Versus Verified Cancer History and Missed Opportunities for Donation in an Australian Cohort of Potential Deceased Solid Organ Donors},

author = {James A. Hedley and Patrick J. Kelly and Karen M.J. Waller and Imogen K. Thomson and Nicole L. De La Mata and Brenda M. Rosales and Kate Wyburn and Angela C. Webster},

doi = {10.1097/txd.0000000000001252},

issn = {2373-8731},

year  = {2022},

date = {2022-00-00},

urldate = {2022-00-00},

volume = {8},

number = {2},

publisher = {Ovid Technologies (Wolters Kluwer Health)},

abstract = {<jats:sec>

            <jats:title>Background.</jats:title>

            <jats:p>There is an imperative to maximize donation opportunities given ongoing organ shortages, but donor suitability assessments can be challenging.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Methods.</jats:title>

            <jats:p>We analyzed an Australian cohort of potential deceased donors 2010 to 2013 to explore misclassification of cancer risk and potential strategies for improvement (decision support, real-time data linkage to existing data sets, and increasing risk tolerance). Cancer history perceived at referral was compared with verified cancer history in linked health records. Transmission risks were based on clinical guidelines. Potential donors declined due to cancer but verified low risk were missed opportunities; those accepted but verified high risk were excess-risk donors.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Results.</jats:title>

            <jats:p>Among 472 potentially suitable donor referrals, 132 (28%) were declined because of perceived transmission risk and 340 (72%) donated. Assuming a low-risk threshold, there were 38/132 (29%) missed opportunities and 5/340 (1%) excess-risk donors. With decision support, there would have been 5 (13%) fewer missed opportunities and 2 (40%) more excess-risk donors; with real-time data linkage, 6 (16%) fewer missed opportunities and 2 (40%) fewer excess-risk donors; and with increased risk tolerance, 6 (16%) fewer missed opportunities and 11 (220%) more excess-risk donors.</jats:p>

          </jats:sec>

          <jats:sec>

            <jats:title>Conclusions.</jats:title>

            <jats:p>Potential donors’ cancer history is typically incomplete at referral. There are missed opportunities where decision support or more accurate cancer history could safely increase organ donors.</jats:p>

          </jats:sec>},

keywords = {MODUS, SAFEBOD},

pubstate = {published},

tppubtype = {article}

}

@article{Hedley2021,

title = {Cancer transmissions and non‐transmissions from solid organ transplantation in an Australian cohort of deceased and living organ donors},

author = {James A. Hedley and Claire M. Vajdic and Melanie Wyld and Karen M.J. Waller and Patrick J. Kelly and Nicole L. De La Mata and Brenda M. Rosales and Kate Wyburn and Angela C. Webster},

doi = {10.1111/tri.13989},

issn = {1432-2277},

year  = {2021},

date = {2021-09-00},

urldate = {2021-09-00},

journal = {Transpl Int},

volume = {34},

number = {9},

pages = {1667--1679},

publisher = {Frontiers Media SA},

keywords = {MODUS, SAFEBOD},

pubstate = {published},

tppubtype = {article}

}

@article{Waller2020,

title = {New blood‐borne virus infections among organ transplant recipients: An Australian data‐linked cohort study examining donor transmissions and other HIV, hepatitis C and hepatitis B notifications, 2000‐2015},

author = {Karen M. J. Waller and Nicole L. De La Mata and James A. Hedley and Brenda M. Rosales and Michael J. O'Leary and Elena Cavazzoni and Vidiya Ramachandran and William D. Rawlinson and Patrick J. Kelly and Kate R. Wyburn and Angela C. Webster},

doi = {10.1111/tid.13437},

issn = {1399-3062},

year  = {2020},

date = {2020-12-00},

urldate = {2020-12-00},

journal = {Transplant Infectious Dis},

volume = {22},

number = {6},

publisher = {Wiley},

abstract = {<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Blood‐borne viral infections can complicate organ transplantation. Systematic monitoring to distinguish donor‐transmitted infections from other new infections post transplant is challenging. Administrative health data can be informative. We aimed to quantify post‐transplant viral infections, specifically those transmitted by donors and those reactivating or arising new in recipients.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We linked transplant registries with administrative health data for all solid organ donor‐recipient pairs in New South Wales, Australia, 2000‐2015. All new recipient notifications of hepatitis B (HBV), C (HCV), or human immunodeficiency virus (HIV) after transplant were identified. Proven/probable donor transmissions within 12 months of transplant were classified using an international algorithm.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 2120 organ donors, there were 72 with a viral infection (9/72 active, 63/72 past). These 72 donors donated to 173 recipients, of whom 24/173 already had the same infection as their donor, and 149/173 did not, so were at risk of donor transmission. Among those at risk, 3/149 recipients had proven/probable viral transmissions (1 HCV, 2 HBV); none were unrecognized by donation services. There were no deaths from transmissions. There were no donor transmissions from donors without known blood‐borne viruses. An additional 68 recipients had new virus notifications, of whom 2/68 died, due to HBV infection.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>This work confirms the safety of organ donation in an Australian cohort, with no unrecognized viral transmissions and most donors with viral infections not transmitting the virus. This may support targeted increases in donation from donors with viral infections. However, other new virus notifications post transplant were substantial and are preventable. Data linkage can enhance current biovigilance systems.</jats:p></jats:sec>},

keywords = {MODUS, SAFEBOD},

pubstate = {published},

tppubtype = {article}

}

@article{Waller2019,

title = {Residual risk of infection with blood‐borne viruses in potential organ donors at increased risk of infection: systematic review and meta‐analysis},

author = {Karen MJ Waller and Nicole L De La Mata and Patrick J Kelly and Vidiya Ramachandran and William D Rawlinson and Kate R Wyburn and Angela C Webster},

doi = {10.5694/mja2.50315},

issn = {1326-5377},

year  = {2019},

date = {2019-11-00},

urldate = {2019-11-00},

journal = {Medical Journal of Australia},

volume = {211},

number = {9},

pages = {414--420},

publisher = {Wiley},

keywords = {MODUS},

pubstate = {published},

tppubtype = {article}

}