Organ transplant patients in the U.S. deserve better.
While organ transplantation is one of the true modern miracles of healthcare, oversight of the U.S. national system regulating and governing solid organ transplantation has been criticized on multiple levels. Ultimately, an overhaul is needed to grow the number of organ transplants, reduce waste, eliminate inequities, and usher in a state-of-the-art information system.
Seventeen Americans die each day on lengthy organ transplant waitlists. Meanwhile, countless donor organs go unused, sometimes costing patients their lives.
Inequities in access to life-saving organs and insecure patient data management are among the additional drawbacks to the current system documented in recent years in peer-reviewed reports, journal publications, media reports, and detailed in a 2022 U.S. Senate Finance Committee hearing.
Now, a group of experts in transplant surgery, organ procurement, technology, data, cybersecurity, and innovation are working to transform the system to make drastic improvements in organ transplantation throughout the United States.
The group — a consortium led by the Duke School of Medicine Department of Surgery with support from technology and data experts at the Duke Clinical Research Institute — hopes to address the problems causing undue patient suffering, wasted organs and unnecessary deaths.
“We have great opportunity for improving the care we deliver patients with end stage organ failure. Specifically, we need to improve the partnerships between the entities that procure organs, transplant them, and pay for organ transplantation,” said Stuart Knechtle, MD, a professor of surgery in the Duke School of Medicine and Executive Director of the Duke Transplant Center. “We believe that patients will ultimately benefit from equitable access to organs, growth in the number of organs donated, reduced waste of organs, and an information platform that gives patients direct access, tracking their progress from referral through transplantation and afterwards.”
A new initiative announced by the Health Resources & Services Administration (HRSA) offers hope for improvement, namely by offering new entities opportunities to contract and manage components of the nation’s Organ Procurement and Transplantation Network (OPTN), which has been managed solely by the United Network for Organ Sharing (UNOS) since 1986.
The HRSA announcement follows a National Academies report with 14 Recommendations for Creating a More Equitable, Transparent, and Efficient System for Deceased Donor Organs and a Department of Health and Human Services Request for Information (RFI) last year on how to improve the current organ transplant system. Duke Health responded to the RFI in May 2022, outlining a multifaceted plan to strengthen the OPTN.
Since then, consortium members Eric Perakslis, PhD, Chief Science and Digital Officer at the DCRI, and Knechtle have taken the vision for information design and data management established in that response and published it in the American Journal for Transplantation.
Re-envisioning Data Management and Use for Organ Transplantation
Instead of the linear technology system currently used by OPTN, the proposal reimagines a platform for organ matching and distribution that places donors, recipients, and their data at the center. The spoke-and-hub platform model, the group contends, can improve the efficiency of the processes so they can happen simultaneously — as opposed to sequentially — reducing the potential for error or waste and the time required to get donated organs to the patients for which they are best suited.
“When a potential donor organ is made available, the allocation rules rank who the potential recipients would be, and each transplant center is given one hour to accept or decline that organ. It turns a very time-sensitive process into this serial set of tasks that consume the life of that organ, literally,” senior director of Technology and Data Solutions for DCRI Brian McCourt said. “When you think of all of the organizations that have a hand in that workflow, the communications hub is what makes good decisions and fast decisions possible. Putting that hub in the middle of all those hands that have to touch it is, we think, one of the most critical changes that can happen.”
“You would run it like a silent auction,” Perakslis said. “Once you get a match run done — and there are algorithms for auction theory — you would put it up for the 10 people most likely to benefit no matter where they are, and they would request it in parallel. No organs go to waste.”
In the current model, organ procurement organizations (OPOs) evaluate patients to be potential donors. Like healthcare providers, OPO representatives are able to access patient medical records, contact family members, request information from the patient’s providers and perform patient examinations – yet they are not subject to the same rules and requirements that protect patient privacy.
In an opinion piece published in Patterns earlier this month, authors from the consortium insist, “It is essential that this opportunity includes better safety surveillance across the network and protection of the digital rights of patients cared for by OPOs, organ donors, transplant recipients and patients awaiting transplants across the nation.”
In addition to being more efficient, the proposed model of data management would be less vulnerable to cybersecurity threats, Perakslis said.
With a central location for the data, “you can put it someplace you can actually protect it,” he said. “If you’re thinking about 56 OPOs, and none of them have any cybersecurity requirements, I’d rather put them into a federated (model) where all of those sites are certified, all the sites have support, where if something happens at those sites, somebody’s backing them up. I can protect a network of 200 things easier than I can protect 200 individual things.”
Improved data practices would also allow for more equitable access to organs and an enhanced understanding of outcomes.
“Since you’re acting on complete data, then you can learn from the system — you can find better ways to allocate organs, you can find faster ways to move them around the country, you can find more equitable approaches to the disparity that exists, whether it’s by geographic region or by race or ethnicity,” McCourt said.
“Right now, if you don’t get on a transplant list, you just get bumped. You basically have a death sentence,” Perakslis said. “I believe that everybody that gets sent to a transplant center for evaluation should be put on a registry, even if they don’t make it onto the waitlist. We can’t compare transplant outcomes if we don’t know what happens to people who don’t get transplants.”
Key Industry Partnerships
The distinguished interdisciplinary list of collaborators includes representatives from industry and e-commerce platforms such as Amazon. Their participation adds expertise in the logistics and infrastructure needed to deliver in-demand products to their destinations at a time that aligns with the recipients’ ability to accommodate them is invaluable.
“Learning from outside of the health care industry and looking at contemporary e-commerce and the technology that they use is a place where we in healthcare can learn from these industries,” McCourt said. “There are existing transportation or logistics companies entirely supporting the niche of organ transplant, but there’s no way that they have the same depth and breadth of experience as business platforms like Amazon, who have the insights on how technology infrastructure can tightly integrate with that business model.”
Overall, the group’s vision is ambitious. Through a broad set of collaborations and partnerships the group intends to:
- Increase the number of solid organ transplants in the United States and reduce the waitlist to zero.
- Achieve equity in organ transplantation with respect to transplantation access for everyone regardless of race, gender, geographic location, or other demography.
- Collect data that addresses the process of transplantation from time of referral forward, including evaluation, transplantation, and post-transplant including exits from the system for any causes including death; to provide data security, information and direct service to patients and families facing organ failure and transplantation.
- Build an information system that is dynamic and permits testing of novel allocation methods in pilot studies, obtaining data that guides future policy revision and broader implementation of best practices.
- Improve data acquisition and transparency from OPOs and transplant centers that will support better quality programs to drive growth and process improvement in collaboration with the SRTR.
- Work in partnership with CMS, government agencies, payors, and transplant affinity groups to develop improved payment methods that drive organ donation and transplantation; working with federal health experts to promote policies that support cost-effective and broader implementation of transplantation and post-transplant care in the community.
- Engage with industries to promote improved logistics, tracking organs through chain-of-custody methods, and facilitating transportation speed and efficiency.
“Duke has expertise in managing large medical databases, partnering with other academic transplant centers and with industry leaders to implement technologies that will transform the delivery of care to transplant patients,” Knechtle said. “We are working with patient advocacy groups and experts within and without Duke to improve the way transplant care is delivered.”