Development of a Patient Preference Survey for Wearable Kidney Replacement Therapy Devices.

Background: Recent innovations have the potential to disrupt the current paradigm for kidney failure treatment. The US Food and Drug Administration is committed to incorporating valid scientific evidence about how patients weigh the benefits and risks of new devices into their decision making, but to date, premarket submission of patient preference information (PPI) has been limited for kidney devices. With input from stakeholders, we developed a survey intended to yield valid PPI, capturing how patients trade off the potential benefits and risks of wearable dialysis devices and in-center hemodialysis.
Methods: We conducted concept elicitation interviews with individuals receiving dialysis to inform instrument content. After instrument drafting, we conducted two rounds of pretest interviews to evaluate survey face validity, comprehensibility, and perceived relevance. We pilot tested the survey with in-center hemodialysis patients to assess comprehensibility and usability further. Throughout, we used participant input to guide survey refinements.
Results: Thirty-six individuals receiving in-center or home dialysis participated in concept elicitation ( N =20) and pretest ( N =16) interviews. Participants identified reduced fatigue, lower treatment burden, and enhanced freedom as important benefits of a wearable device, and many expressed concerns about risks related to device disconnection-specifically bleeding and infection. We drafted a survey that included descriptions of the risks of serious bleeding and serious infection and an assessment of respondent willingness to wait for a safer device. Input from pretest interviewees led to various instrument modifications, including treatment descriptions, item wording, and risk-level explanations. Pilot testing of the updated survey among 24 in-center hemodialysis patients demonstrated acceptable survey comprehensibility and usability, although 50% of patients required some assistance.
Conclusions: The final survey is a 54-item web-based instrument that will yield estimates of the maximal acceptable risk for the described wearable device and willingness to wait for wearable devices with lower risk.
Competing Interests: K.L. Cavanaugh reports consultancy for the Kidney Health Initiative, REATA Pharmaceuticals, and Responsum Health; ownership interest in HCA Healthcare; and an advisory or leadership role for the National Kidney Foundation (KDQOI education committee), Clinical Journal of American Society of Nephrology (editorial board), American Journal of Kidney Diseases (editorial board), Kidney360 (associate editor), and Medical Decision Making (editorial board). J.E. Flythe reports consultancy for AstraZeneca and Fresenius Medical Care Medical Advisory Board; research funding from National Institutes of Health/National Heart, Lung, and Blood Institute, National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases, Patient-Centered Outcomes Research Institute, Renal Research Institute (subsidiary of Fresenius Medical Care, North America), and Robert Wood Johnson Foundation; honoraria from the American Society of Nephrology, National Kidney Foundation, and numerous universities; and an advisory or leadership role for the American Journal of Kidney Diseases (editorial board 2017–2021), Clinical Journal of American Society of Nephrology (editorial board 2017–), Hemodialysis (theme editor 2018–), KDIGO Executive Committee (2020–), Kidney Health Initiative (board of directors 2019–), Kidney Health Initiative (Patient Preferences Project chairperson 2019–), Kidney Medicine (editorial board 2019–), Kidney360 (associate editor 2019–), and Nephrology Dialysis and Transplantation (editorial board). D. Forfang reports employment by the American Society of Nephrology Kidney Health Initiative; consultancy for Ardelyx, Inc., Scientific Advisory Board, the American Society of Nephrology and Responsum, CareDX, HSAG, and University of North Carolina Kidney Center; honoraria from the American Society of Nephrology, European Association for Dialysis, HSAG ESRD Network #17, National Kidney Foundation; an advisory or leadership role for Arbor Research, HSAG ESRD Network #17 (board member), Kidney Health Initiative (Patient Advisory Committee), National Forum of ESRD Networks (board member), National Forum of ESRD Networks Kidney Patient Advisory Council (chair); National Kidney Foundation, SONG Group, and Unity Health Toronto OPPUS, UCSF Kidney Project (patient advisor); and other interests or relationships as a volunteer for the Forum of ESRD Networks as Kidney Patient Advisory Council chair and board member, a volunteer for ESRD Network #17 as Patient Advisory Committee Chair and Network board member, a volunteer for the National Kidney Foundation as a member of their Public Policy Committee, and a volunteer for the National Kidney Foundation as a Regional Leader of their Kidney Advocacy Committee, Kidney Health Initiative PFPC member. N. Gedney reports honoraria from the American Society of Nephrology, IDEAs, and the University of Washington. R.C. Harris reports consultancy for Bayer, Fibrocor, and Nicoya; ownership interest in Apple; research funding from Bayer; patents or royalties from eNOS db/db mouse; an advisory or leadership role for the Kidney Health Initiative (paid); and other interests or relationships with the Kidney Health Initiative (co-chair, board of directors). F.P. Hurst reports employment by the Food and Drug Administration/Center for Drug Evaluation and Research, and other interests or relationships with a US government employee. C. Mansfield reports the employment by RTI Health Solutions, which receives funding from for-profit pharmaceutical companies to conduct research. C.Y. Neuland reports being a member of the board of directors for the Kidney Health Initiative, representing the Food and Drug Administration/Center for Devices and Radiological Health during this time period. A. Saha reports employment by the Food and Drug Administration. C.S. Soloe reports employment by RTI International. G. Squillaci reports consultancy for The Griff Group. M.E. Tarver reports employment by the Food and Drug Administration/Center for Devices and Radiological Health. K. Treiman reports employment by RTI International. M.L. Unruh reports consultancy for Cara Therapeutics to chair of Data Monitoring Committee; a consulting agreement between Cara and the University of New Mexico; research funding from DCI; and honoraria related to lectures from the American Society of Nephrology, National Kidney Foundation, and Renal Research Institute. M. West reports employment by the American Society of Nephrology. D.M. White reports employment by Debevoise & Plimpton; consultancy for the Kidney Transplant Collaborative, the National Committee for Quality Assurance, and Responsum Health; ownership interest in Amgen, Inc.; honoraria from AstraZeneca, Hennepin Healthcare, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institutes of Health, New York Academy of Medicine, and PFCC partners; and other interests or relationships with the American Association of Kidney Patients, American Society of Transplantation, Kidney Health Initiative, National Kidney Foundation, National Patient Advocate Foundation, Patient Advocate Foundation, and Quality Insights. C. Wilkie reports employment by Kuhns Law Firm, PLLC; consultancy for the University of North Carolina, University of Pennsylvania, and University of Pittsburg; ownership interest in Kuhns Law Firm, PLLC; an advisory or leadership role for the Kidney Health Initiative, University of Pennsylvania with the HOPE Consortium, and University of Pittsburgh; and other interests or relationships with the Kidney Health Initiative, National Kidney Foundation, University of Pennsylvania with the HOPE Consortium, University of North Carolina at Chapel Hill, and University of Pittsburgh. D. Wood reports employment by RTI International. The remaining authors have nothing to disclose.
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