MODUS is funded by an NHMRC partnership grant. The CODE team’s partners in the MODUS study are the NSW Ministry of Health, Kidney Health Australia, and the NSW Organ and Tissue Donation Service.
MODUS will develop evidence to support policy and complex clinical decisions in the organ donor referral process in Australia. Using our SAFEBOD linked data as the cohort study platform, we will use advanced statistical methods to better understand retrospective donor referral risk profiles, and determine any potential donor gains that could be made through varying the acceptable biovigilance risk thresholds for accepting donors. Using dynamic compartmental economic modelling, we will investigate the impact of varying donor referral decisions on quality, safety and value of kidney transplant outcomes (transplant and recipient survival). Using results from these exercises, with a pre-post design, we will prospectively evaluate the impact of provision of donor risk profile and absolute biovigilance risk estimates to clinicians on donor referral decision-making.
MODUS – Maximising Organ Donor offer Utility System-wide
Research Publications
2024
Muscat Danielle M Cutting Rachel B, Patel Pinika
In: Transplantation , 2024.
@article{nokey,
title = {Values, Preferences, and Risk Tolerance of People Waitlisted for a Kidney Transplant Regarding Potential Deceased Donor Organ Profiles: A Systematic Review},
author = {Cutting Rachel B, Muscat Danielle M, Patel Pinika, De La Mata Nicole L, Irish Georgina L, Wyld Melanie White Sarah, Webster Angela C. },
doi = {10.1097/TP.0000000000005267},
year = {2024},
date = {2024-11-15},
urldate = {2024-11-15},
journal = {Transplantation },
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Shah, Karan K.; Hedley, James A.; Robledo, Kristy P.; Wyld, Melanie; Webster, Angela C.; Morton, Rachael L.
Cost-effectiveness of Accepting Kidneys From Deceased Donors With Common Cancers—A Modeling Study Journal Article
In: 2024, ISSN: 0041-1337.
@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 = {},
pubstate = {published},
tppubtype = {article}
}
<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>
<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>
Hedley J Rosales BM, De La Mata N
Transmission and Non-transmission of Melanoma From Deceased Solid Organ Donors to Transplant Recipients: Risks and Missed Opportunities Journal Article
In: 2024.
@article{nokey,
title = {Transmission and Non-transmission of Melanoma From Deceased Solid Organ Donors to Transplant Recipients: Risks and Missed Opportunities},
author = {Rosales BM, Hedley J, De La Mata N, Cavazzoni E, Vajdic CM, Thompson JF, Kelly PJ, Wyburn K, Webster AC},
doi = {10.1097/TP.0000000000004961},
year = {2024},
date = {2024-02-29},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
2023
Hedley, James A.; Kelly, Patrick J.; Wyld, Melanie; Shah, Karan; Morton, Rachael L.; Byrnes, Juliet; Rosales, Brenda M.; Mata, Nicole L. De La; Wyburn, Kate; Webster, Angela C.
In: vol. 9, no. 5, 2023, ISSN: 2373-8731.
@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 = {},
pubstate = {published},
tppubtype = {article}
}
<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>
<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>
Shah, Karan K.; Wyld, Melanie; Hedley, James A.; Waller, Karen M. J.; Mata, Nicole De La; Webster, Angela C.; Morton, Rachael L.
Cost-effectiveness of Kidney Transplantation From Donors at Increased Risk of Blood-borne Virus Infection Transmission Journal Article
In: vol. 107, no. 9, pp. 2028–2042, 2023, ISSN: 0041-1337.
@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 = {},
pubstate = {published},
tppubtype = {article}
}
<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>
<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>
2022
Thomson, Imogen K.; Hedley, James; Rosales, Brenda M.; Wyburn, Kate; O'Leary, Michael J.; Webster, Angela C.
In: ANZ Journal of Surgery, vol. 92, no. 11, pp. 2996–3003, 2022, ISSN: 1445-2197.
@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 = {},
pubstate = {published},
tppubtype = {article}
}
<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>
Waller, Karen M. J.; Mata, Nicole L. De La; Rosales, Brenda M.; Hedley, James A.; Kelly, Patrick J.; Thomson, Imogen K.; O’Leary, Michael J.; Cavazzoni, Elena; Ramachandran, Vidiya; Rawlinson, William D.; Wyburn, Kate R.; Webster, Angela C.
In: vol. 106, no. 2, pp. 348–357, 2022, ISSN: 0041-1337.
@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 = {},
pubstate = {published},
tppubtype = {article}
}
<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>
<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>
2020
Waller, Karen M. J.; Mata, Nicole L. De La; Hedley, James A.; Rosales, Brenda M.; O'Leary, Michael J.; Cavazzoni, Elena; Ramachandran, Vidiya; Rawlinson, William D.; Kelly, Patrick J.; Wyburn, Kate R.; Webster, Angela C.
In: Transplant Infectious Dis, vol. 22, no. 6, 2020, ISSN: 1399-3062.
@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 = {},
pubstate = {published},
tppubtype = {article}
}
<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>
2019
Waller, Karen MJ; Mata, Nicole L De La; Kelly, Patrick J; Ramachandran, Vidiya; Rawlinson, William D; Wyburn, Kate R; Webster, Angela C
In: Medical Journal of Australia, vol. 211, no. 9, pp. 414–420, 2019, ISSN: 1326-5377.
@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 = {},
pubstate = {published},
tppubtype = {article}
}