@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{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{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{Waller2020b,

title = {Effect of language and country of birth on the consent process and medical suitability of potential organ donors; a linked-data cohort study 2010–2015},

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

doi = {10.1016/j.jcrc.2020.01.025},

issn = {0883-9441},

year  = {2020},

date = {2020-06-00},

urldate = {2020-06-00},

journal = {Journal of Critical Care},

volume = {57},

pages = {23--29},

publisher = {Elsevier BV},

abstract = {Australia has unmet need for transplantation. We sought to assess the impact of cultural and linguistic diversity (CALD) on family consent and medical suitability for organ donation.

Cohort study of New South Wales donor referrals, 2010–2015. Logistic regression estimated effects of primary language other than English and birthplace outside Australia (odds ratios OR, with 95% confidence intervals, 95%CI). Outcomes were whether families were asked for consent to donation, provided consent for donation, and whether the referral was medically suitable for donation.

Of 2977 organ donor referrals, a similar proportion of families had consent for donation was sought between non-English speakers and English speakers (p = .07), and between overseas-born compared to Australian-born referrals (p = .3). However, consent was less likely to be given for both non-English speakers than English speakers (OR 0.44, 95%CI:0.29–0.67), and those overseas-born than Australian-born (OR 0.54, 95%CI:0.41–0.72). For referrals both overseas-born and non-English speaking, families were both less likely to be asked for consent (OR 0.67; 95%CI:0.49–0.91) or give consent (OR 0.24; 95%CI0.16–0.37). There was no difference in medical suitability between English speakers and non-English speakers (p = .6), or between Australian-born and overseas-born referrals (p = .6).

Intervention to improve consent rates from CALD families may increase donation.},

keywords = {SAFEBOD},

pubstate = {published},

tppubtype = {article}

}

@article{Rosales2020,

title = {Safety and Biovigilance in Organ Donation (SAFEBOD): Protocol for a Population-Based Cohort Study},

author = {Brenda Rosales and James Hedley and Nicole De La Mata and Claire M Vajdic and Patrick Kelly and Kate Wyburn and Angela C Webster},

doi = {10.2196/18282},

issn = {1929-0748},

year  = {2020},

date = {2020-00-00},

urldate = {2020-00-00},

journal = {JMIR Res Protoc},

volume = {9},

number = {10},

publisher = {JMIR Publications Inc.},

abstract = {<jats:sec>

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

            <jats:p>Tension lies between the need to increase access to organ transplantation and the equally urgent need to prevent inadvertent transmission of infectious diseases or cancer from organ donors. Biovigilance, or the evaluation of potential donors, is often time-pressured and may be based on incomplete information.</jats:p>

          </jats:sec>

          <jats:sec>

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

            <jats:p>The Safety and Biovigilance in Organ Donation (SAFEBOD) study aims to improve estimates of infection and cancer transmission risk and explore how real-time data access could support decision-making.</jats:p>

          </jats:sec>

          <jats:sec>

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

            <jats:p>We will link existing donor referral, actual donor, recipient, and health-outcome data sets from 2000-2015 in New South Wales. Organ donor data sets will include the Organ Donor Characterizing Risk-Profile of Donors Study, the National Organ Matching System, the Australian and New Zealand Organ Donor Register, and the Australian and New Zealand Living Donor Kidney Register. Recipient data sets will include the Australian and New Zealand Dialysis and Transplant Register, the Australian and New Zealand Cardiothoracic Register, the Australian and New Zealand Islet and Pancreas Register, and the Australian and New Zealand Liver Transplant Register. New South Wales health outcome data sets will include HIV and AIDS Notifications and Surveillance Data, the Notifiable Conditions Information Management System, Admitted Patient Data Collection, Emergency Department Data Collection, the Central Cancer Registry, and the Cause of Death Data Collection. We will link organ donors to transplant recipients and health outcomes data sets using probabilistic data-matching based on personal identifiers. Transmission and nontransmission events will be determined by comparing previous cases in donors and posttransplant cases in recipients. We will compare the perceived-risk at referral with the verified risk from linked health outcome data sets 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.</jats:p>

          </jats:sec>

          <jats:sec>

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

            <jats:p>Data were requested from each of the listed registries in September 2018, and data collection is ongoing. Linked data from all listed data sets are expected to be complete in September 2020.</jats:p>

          </jats:sec>

          <jats:sec>

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

            <jats:p>The SAFEBOD study will overcome current limitations in organ donation by accessing comprehensive information on referred organ donors and recipients in existing data sets. The study will provide robust estimates of disease transmission and nontransmission events based on recent data. It will also describe the agreement between perceived risk estimated at the time of referral and verified risk when all health outcome data are accessible. The improved understanding of transmission and nontransmission events will inform clinical decisions and highlight where current policies can be revised to broaden the acceptance of deceased donors.</jats:p>

          </jats:sec>

          <jats:sec>

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

            <jats:p>DERR1-10.2196/18282</jats:p>

          </jats:sec>},

keywords = {SAFEBOD},

pubstate = {published},

tppubtype = {article}

}