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The Kidney Health Initiative Renal Replacement Therapy Roadmap: A patient-centered blueprint for innovation in renal replacement therapy
Innovation in renal replacement therapy, especially in dialysis, is long overdue. During Kidney Week, I will provide the Celeste Castillo Lee Endowed Lecture on “Designing alternatives to renal replacement therapy: Patients as partners.” This lecture will examine the role of patients, care partners and patient advocates in the Kidney Health Initiative project, “Development of a Roadmap for Innovations in Renal Replacement Therapy,” and discuss the results and implications of a patient preferences survey developed by members of the project’s patient advisory committee. This project outlines a patient-driven future state of kidney care; and provides a blueprint to aid developers in the creation of devices and therapies to improve the lives of people living with kidney diseases.
When President Nixon signed the bipartisan Congressional legislation that authorized Medicare payment for dialysis services beginning in 1973, hemodialysis was intended to be a life-sustaining bridge to a kidney transplant and a return to a more productive and rewarding life. Since then, misaligned financial incentives have transformed the best intentions of Congress into an industry with barriers to innovation that are an insult to American ingenuity.
Changes in American lifestyle and culture have also played a significant role in the growth of a U.S. renal care model that provides a poor quality of life for many and is economically unsustainable. Worse yet, 13 patients die every day waiting for a kidney transplant,1 and the waitlist for a life-giving kidney transplant grows every year. An overhaul in kidney care is long overdue, and those who stand to benefit the most – people living with kidney diseases – should have an opportunity to define the future state of kidney care.
The Kidney Health Initiative (KHI) project, “Development of a roadmap for innovations in renal replacement therapy,” has been guided by a patient-centered approach since the initial development meeting in Washington, in early November 2016. The following spring, the KHI, a public-private partnership between the FDA and the American Society of Nephrology, convened a 2-day workshop in Silver Spring, Maryland that brought together more than 100 stakeholders, including 60 patients, care partners and patient advocates, to discuss challenges and opportunities in renal therapy innovation and to develop an approach to create a living document that could be used to spur innovation in renal replacement therapy. During the workshop, a series of mechanical and cellular breakout discussions confirmed the need to create standing workgroups to continue focusing on those areas, and a patient preferences session on the final afternoon concluded with the creation of a patient advisory committee charged with ensuring patient preferences were honored in all KHI Renal Replacement Therapy (RRT) Roadmap activities. Members of the patient advisory committee were members of the steering committee and the mechanical, cellular and vascular access workgroups that were created.2 The committee also developed a survey to give patients and care partners an opportunity to record their opinions about treatment options and design criteria to help inform the creation of new and better alternatives to current therapies. The KHI RRT Roadmap, patient advisory committee and patient survey demonstrate ways that patients can take an active role in creating a better experience of care and quality of life both for themselves and for those who will follow in their footsteps.
It is no coincidence that most members of the KHI RRT Roadmap’s Patient Advisory Committee are also members of the American Association of Kidney Patients. On Dec. 4, 1971, representatives of the National Association of Patients on Hemodialysis, which was later renamed the American Association of Kidney Patients, testified in a House Ways and Means Committee hearing in support of Medicare payment for dialysis services.3 In the years since, the AAKP has grown to become the nation’s largest fully independent kidney disease organization, reaching close to 2 million people annually. The commitment of the AAKP to place patients at the center of every discussion from concept to results is part of its new national strategy to target the patient voice to decisively impact issues across the kidney disease spectrum, including federal agencies, private sector, research communities, federally funded research organizations and Congressional lawmakers and their staffs. As AAKP President Paul T. Conway has stated, “The heroes and heroines of the HIV/AIDS movement, similar to AAKP founders, reminded America of a key advocacy lesson – no one other than a patient who bears the burden of disease can communicate the clear sense of urgency necessary to unite others to act boldly to transcend the status quo in available health treatments.”
Launched in 2015, the AAKP Center for Patient Research and Education has grown rapidly through a sophisticated database and expansive social media channels. These allow AAKP to better connect and learn from its constituents. In turn, AAKP provides education to patients and caregivers on what it means to be substantively involved in research initiatives as well as opportunities to get involved in research, such as focus groups, cognitive interviews, surveys, clinical trials and more.
AAKP members, board of directors and ambassadors are involved in numerous programs including and beyond the RRT Roadmap, National Institute of Diabetic and Digestive Kidney Diseases Kidney Precision Medicine Project, a CMS dialysis facility compare focus group project of vulnerable and hard-to-reach populations, a large patient survey conducted for TVA Medical, multiple partnerships including Hemocyte and The Kidney Project, and numerous comparative effectiveness research projects funded by the Patient-Centered Outcomes Research Institute (PCORI).
“By last count, I believe every PCORI grant in the renal space during the past 9 years has included at least one AAKP member,” AAKP Director Diana Clynes, said.
Patients and care partners are the most underutilized resource in health care. I believe our insights and preferences should be the drivers of innovation in renal therapy and am confident we will answer the challenge. The KHI RRT Roadmap will not only serve as a catalyst for change in renal care, but will also illustrate how to unleash the potential of patient-driven research.
References:
- www.kidney.org/news/newsroom/factsheets/organ-donation-and-transplantation-stats. Accessed Aug. 27, 2018.
- www.asn-online.org/khi/project.aspx?ID=65. Accessed Aug. 28, 2018.
- Rettig R. Origins of the Medicare kidney disease entitlement: The Social Security amendments of 1972; 1991. www.ncbi.nlm.nih.gov/books/NBK234191. Accessed Aug. 25, 2018.
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- David M. White is a health care consultant living in Hillcrest Heights, Maryland and is on the board of the Kidney Health Initiative. He can be reached at davidmwhite@aya.yale.edu.
Disclosure: White reports no relevant financial disclosures.