New committee looks at ways to maximize organ transplants
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In many ways, organ donation and transplantation in the United States has seen great success.
A sustained increase in deceased organ donation has fueled more than a decade of annual record-setting transplants performed — more than double the number in the last 25 years — while maintaining excellent patient and graft outcomes.
Despite these successes, there is a need and a range of substantial opportunities for further growth and improvement. Many deceased donors today have factors that might have ruled out their use just a decade ago — factors such as advanced age and cardiorespiratory death, among others. Organs from these donors can extend and enhance the lives of many transplant patients, but these can be more complex to manage and require careful patient shared decision-making and selection to be successful.
With time, the inability of the system to manage expeditious placement of medically complex donors may have contributed to a marked increase in organs recovered for transplant but not used, often driven by the impact of too much time elapsed to find an appropriate recipient. Although it is a challenge for every organ type, the rate of nonuse of organs is most stark for kidneys, where 25% of deceased donor organs go unused each year. In addition, the number of out-of-sequence organ allocation has increased — organs that are accepted and transplanted, but outside the placement sequence prescribed by Organ Procurement and Transplant Network (OPTN) policy.
There has been great and appropriate focus on upholding equity in organ allocation — making sure every candidate has the best possible access to a transplant according to individual needs. One means of improving equity has been widening the distance for routine organ distribution, resulting in more frequent organ offers for more distant recipients. While the gains in equity are admirable, the changes have also increased the logistic complexity of the matching system, potentially decreasing its efficiency. We need to ensure that efficiency and equity are properly balanced.
Expeditious Task Force
With these considerations in mind, the board of directors of the OPTN established the Expeditious Task Force in September 2023 to study and make recommendations on ways to increase the number of donated organs used for transplant and to increase the efficiency of the organ placement process. This is in keeping with federal regulation that directs the OPTN to “seek to achieve the best use of donated organs” and “promote the efficient management of organ placement.”
The 51 members of the task force represent a large and diverse community of professionals and experiences in organ donation and transplant. They include transplant physicians and surgeons, transplant recipients, living donors, donor family members, organ procurement and histocompatibility lab professionals, and transplant administrators and coordinators. Many of the task force members have an extensive background in quality improvement. The Health Resources and Services Administration of HHS, which oversees the OPTN, including the contractors that support the OPTN, supports the work of the task force. We are also working closely with the Scientific Registry of Transplant Recipients for analytic support to help guide our efforts.
Our work is not confined to task force membership. It is, and must be, a collaborative approach with the entire donation and transplant community. On an ongoing basis, we are participating in many key meetings and events within the profession, sharing our progress to date and seeking broad input and recommendations to inform our discussions and help determine the next steps.
As we began our analysis, we found it vital to set a bold aim — an ambitious yet achievable goal to serve as the focus of our collaborative effort. With the involvement and encouragement of the OPTN board of directors, we determined that our bold aim will be to achieve 60,000 successful deceased donor transplants a year by 2026. This is clearly a large reach — it represents a jump of nearly 60% in the next 3 years. We believe we can reach this transformational goal by identifying, applying, testing and broadly sharing effective practices, a few of which are already in use by the highest-performing transplant hospitals and organ procurement organizations nationwide.
Innovative approaches
To help reach this bold aim, the task force will help the OPTN identify and coordinate rapid, smaller-scale trials of several different approaches at the same time, each intended to speed the organ acceptance process and improve placement efficiency. The OPTN executive committee has proposed a new framework for this approach through a modification of the variance process that has long been used in OPTN policy.
The trials will use the plan-do-study-act methodology, which allows for rapid implementation of small-scale approaches to determine whether these would be effective on a wider scale. The OPTN will publish the details of each proposed trial and will allow public feedback as each is considered. The OPTN will also publish data when available about the outcomes of each approach.
This methodology differs from the usual OPTN policymaking process in two ways. First, the timeframe from developing an idea to starting a trial will be more rapid, while still ensuring a pathway for public visibility and comment. These interventions would not undergo the full cycle often used in OPTN policy development, which includes multiple rounds of committee review and the approval of the full OPTN board, plus a several-month period of development of the OPTN matching system. The intent is to put ideas into place quickly, gather results quickly and determine which have merit to pursue in a more deliberate fashion.
The other difference is the ability to apply and study several approaches at the same time. While the OPTN policy development process is strong and accountable, it traditionally operates through a single project plan at a time. Having multiple, smaller-scale approaches may allow a considerably faster time to apply multiple improvements to the larger transplant system.
Even so, small-scale trials that show promise will be considered for national policy development through the established OPTN process. This would include analysis and an opportunity for public comment before any proposal advances for potential approval by the OPTN board of directors.
Shared focus, effort, solutions
The members of the Expeditious Task Force understand that no single idea or initiative will fix everything. It will take a patchwork of innovation, upgrades and new approaches to reach our goals. The task force brings a level of genuine excitement and a shared focus to approach the problems we all face as a community. There have been some truly remarkable conversations among people who have different experiences and views, and who would often be expected to project on someone else the burden of change. There is great energy toward working boldly — not incrementally — to make changes that will save and enhance many more lives.
As we continue to discuss and shape ideas for improvement, we hope to keep this momentum going throughout the entire transplant community. Contact the task force with your ideas at expeditious@unos.org.
- Acknowledgement:
- This work was supported wholly or in part by HRSA contract 250-2019-00001C. The content is the responsibility of the authors alone and does not necessarily reflect the views or policies of HHS, nor does mention of trade names, commercial products or organizations imply endorsement by the U.S. government.
- For more information:
- Alden Doyle, MD, MS, MPH & TM, FAST, is medical director of kidney and pancreas transplantation at the University of Virginia. He can be reached at expeditious@unos.org.
- David Marshman is the director of OPO Quality Systems for LifeLink Foundation. He can be reached at expeditious@unos.org.
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