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. 2022 May 5;3(7):1197-1209.
doi: 10.34067/KID.0001862022. eCollection 2022 Jul 28.

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

Jennifer E Flythe  1   2 , Derek Forfang  3 , Nieltje Gedney  4 , David M White  5 , Caroline Wilkie  6 , Kerri L Cavanaugh  7   8 , Raymond C Harris  7 , Mark Unruh  9 , Grace Squillaci  10 , Melissa West  10 , Carol Mansfield  11 , Cindy S Soloe  11 , Katherine Treiman  12 , Dallas Wood  11 , Frank P Hurst  13 , Carolyn Y Neuland  13 , Anindita Saha  13 , Murray Sheldon  13 , Michelle E Tarver  13
Affiliations

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

Jennifer E Flythe et al. Kidney360. .

Abstract

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.

Keywords: ESRD; chronic dialysis; clinical trial; dialysis; end stage kidney disease; end stage renal disease; hemodialysis; innovation; kidney failure; patient preference; renal replacement therapy; wearable electronic devices.

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Conflict of interest statement

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.

Figures

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Graphical abstract
Figure 1.
Figure 1.
Survey development process. Survey development involved a five-step process: (1) conducting concept elicitation interviews, (2) constructing a draft survey, (3) pretesting and responsively updating the survey, (4) pilot testing the survey in the in-center hemodialysis setting, and (5) planning final survey fielding.
Figure 2.
Figure 2.
Evolution of dialysis treatment graphics based on stakeholder input. The survey graphics of in-center hemodialysis, the reference treatment, and wearable RRT devices, the alternative treatment, underwent iterative stakeholder-guided revisions. Changes to the in-center hemodialysis treatment graphic included: addition of a blood line and a health care professional (B), followed by addition of a second blood line, elevation of the patients’ feet, addition of machine detail, and change in color of the blood lines from gold to red to resemble actual in-center bloodlines better (C). Changes to the wearable device graphics included: addition of a blood line, change in color of the people from black to gray, and removal of the vest-based graphic (B), followed by change in color of the people from gray to tan, conversion of the backpack style from bulky to more compact, and change in color of the blood lines from red to gold to signify the potential discreteness of the device (C).
Figure 3.
Figure 3.
Survey content overview. The final survey is a 54-item web-based instrument that includes (1) risk trade-off questions designed to quantify the levels of potential risks of serious bleeding and serious infection that patients are willing to accept in exchange for the benefits of the wearable RRT devices; (2) modified time trade-off questions to determine respondents’ discount rate for time until wearable RRT devices are available; (3) comprehension questions to assess understanding of the presented information; and (4) health and background information questions The full survey is available in the Supplemental Material.
Figure 4.
Figure 4.
Example of a treatment choice question in the question series for eliciting maximum risk of serious bleeding patients would accept from a wearable RRT device in exchange for the benefits of the device relative to in-center hemodialysis. To estimate the maximum acceptable risk for different devices, the survey includes two sets of three risk trade-off questions, where respondents must choose between pairs of treatments: fixed reference treatment (in-center hemodialysis) and the alternative wearable RRT device as risk levels are varied. In the first set of risk trade-off questions, the respondent must choose between pairs of treatment that differ in terms of the risk of serious bleeding (as shown in the figure). In the second set of risk trade-off questions, the respondent must choose between pairs of treatment that differ in terms of the risk of serious infection (not shown). For each respondent, the survey generates a range in which the respondent’s maximum acceptable risk for switching from the reference treatment to the alternative treatment. The data from the threshold technique portion of the survey will be analyzed using an interval regression model. The coefficients from this model will allow us to determine the average maximum acceptable risk for the sample and how that maximum acceptable risk varies by patient characteristics.
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References

    1. United States Renal Data System. 2021 USRDS annual data report: Epidemiology of kidney disease in the United States. Available at https://adr.usrds.org/2021. Accessed May 25, 2022 - PMC - PubMed
    1. The White House : Executive Order on Advancing American Kidney Health. Available at: https://www.asn-online.org/policy/webdocs/ExecutiveOrderonAdvancingAmeri.... Accessed November 17, 2021
    1. US Department of Health and Human Services : KidneyX. Available at https://www.kidneyx.org/. Accessed November 17, 2021
    1. Salani M, Roy S, Fissell WH 4th: Innovations in wearable and implantable artificial kidneys. Am J Kidney Dis 72: 745–751, 2018. 10.1053/j.ajkd.2018.06.005 - DOI - PubMed
    1. US Department of Health and Human Services : Federal Register Part 860—Medical Device Classification Procedures. Available at: https://www.govinfo.gov/content/pkg/CFR-2020-title21-vol8/pdf/CFR-2020-t.... Accessed November 17, 2021

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