SAFEBOD – the SAFEty and Biovigilance in Organ Donation Public Health Register

The Safety and biovigilance in organ donation (SAFEBOD) Public Health Register draws together health records from all people considered as organ donors, all actual donors and all organs recipients in NSW. SAFEBOD was conceived by the CODE team and created as a Public Health Register, under the Public Health Act, NSW 2010, by the NSW Ministry of Health. The aim of SAFEBOD is to provide evidence to support an increase in donors that can be safely used for transplantation, so that more people waiting can receive a transplant.

Insights from the ORCHARD database showed the CODE team that the information available for decision-making at the time of making organ donor decisions was far from perfect. Full medical records are not always available, and next of kin are often unaware of the specifics of their family member’s past medical history. The CODE team also thought it was important to know if there had been any transmissions of infection of cancer from donors to recipients, that transplant services had not planned for. The SAFEBOD database has allowed the CODE team to check how accurate the medical history information was at the time the donation decision was made, by going back and checking all the medical history available for each potential donor from a range of other data sources. Using SAFEBOD, the CODE team has also produced reliable estimates of how likely infection or cancer transmission is from donor to recipient, over the past 10 years. The SAFEBOD register is being harnessed to provide insights into systems issues in the organ procurement pathway, establishes incidence of biovigilance transmission and non-transmission events from organ donors to recipients, and illuminates the potential for missed opportunities (potential donors who could have been safely used but were not) for donation.

Download the SAFEBOD 2020 Technical Report Download

Research Publications

2024

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.

Links | BibTeX

2022

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

Notifiable Infectious Diseases Among Organ Transplant Recipients: A Data-Linked Cohort Study, 2000–2015 Journal Article

In: vol. 9, no. 8, 2022, ISSN: 2328-8957.

Abstract | Links | BibTeX

@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 = {},

pubstate = {published},

tppubtype = {article}

}

Abstract

Background
Infections, including common communicable infections such as influenza, frequently cause disease after organ transplantation, although the quantitative extent of infection and disease remains uncertain.

Methods
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.

Results
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.

Conclusions
There is potential to avoid preventable infections among transplant recipients with improved vaccination programs, health education, and pretransplant donor and recipient screening.

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

Perceived Versus Verified Cancer History and Missed Opportunities for Donation in an Australian Cohort of Potential Deceased Solid Organ Donors Journal Article

In: vol. 8, no. 2, 2022, ISSN: 2373-8731.

Abstract | Links | BibTeX

@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 = {},

pubstate = {published},

tppubtype = {article}

}

2021

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

Cancer transmissions and non‐transmissions from solid organ transplantation in an Australian cohort of deceased and living organ donors Journal Article

In: Transpl Int, vol. 34, no. 9, pp. 1667–1679, 2021, ISSN: 1432-2277.

Links | BibTeX

2020

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

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 Journal Article

In: Journal of Critical Care, vol. 57, pp. 23–29, 2020, ISSN: 0883-9441.

Abstract | Links | BibTeX

@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 = {},

pubstate = {published},

tppubtype = {article}

}

Rosales, Brenda; Hedley, James; Mata, Nicole De La; Vajdic, Claire M; Kelly, Patrick; Wyburn, Kate; Webster, Angela C

Safety and Biovigilance in Organ Donation (SAFEBOD): Protocol for a Population-Based Cohort Study Journal Article

In: JMIR Res Protoc, vol. 9, no. 10, 2020, ISSN: 1929-0748.

Abstract | Links | BibTeX

@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 = {},

pubstate = {published},

tppubtype = {article}

}

Background
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.

Objective
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.

Methods
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.

Results
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.

Conclusions
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.

International Registered Report Identifier (IRRID)
DERR1-10.2196/18282