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Toward Patient-Centered Innovation

A Conceptual Framework for Patient-Reported Outcome Measures for Transformative Kidney Replacement Devices

Jennifer E. Flythe, Tandrea S. Hilliard, Kourtney Ikeler, San Keller, Debbie S. Gipson, Amanda C. Grandinetti, Robert J. Nordyke, Ronald D. Perrone, Prabir Roy-Chaudhury, Mark Unruh, Melissa West, Fraser Bocell and Frank P. Hurst
CJASN October 2020, 15 (10) 1522-1530; DOI: https://doi.org/10.2215/CJN.00110120
Jennifer E. Flythe
1Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina Kidney Center, University of North Carolina School of Medicine, Chapel Hill, North Carolina
2Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
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Tandrea S. Hilliard
3American Institutes for Research, Chapel Hill, North Carolina
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Kourtney Ikeler
3American Institutes for Research, Chapel Hill, North Carolina
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San Keller
3American Institutes for Research, Chapel Hill, North Carolina
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Debbie S. Gipson
4Division of Nephrology, Department of Pediatrics, University of Michigan, Ann Arbor, Michigan
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Amanda C. Grandinetti
5Kidney Health Initiative Patient and Family Partnership Council, Elmhurst, Illinois
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Robert J. Nordyke
6Beta6 Consulting Group, Los Angeles, California
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Ronald D. Perrone
7Division of Nephrology, Tufts Medical Center, Boston, Massachusetts
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Prabir Roy-Chaudhury
1Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina Kidney Center, University of North Carolina School of Medicine, Chapel Hill, North Carolina
8W.G. (Bill) Hefner Veterans Affairs Medical Center, Salisbury, North Carolina
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Mark Unruh
9School of Medicine, University of New Mexico, Albuquerque, New Mexico
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Melissa West
10Kidney Health Initiative and American Society of Nephrology, Washington, DC
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Fraser Bocell
11Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland
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Frank P. Hurst
11Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland
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Abstract

Individuals with dialysis-dependent kidney failure experience considerable disease- and treatment-related decline in functional status and overall well-being. Despite these experiences, there have been few substantive technological advances in KRT in decades. As such, new federal initiatives seek to accelerate innovation. Historically, integration of patient perspectives into KRT product development has been limited. However, the US Food and Drug Administration recognizes the importance of incorporating patient perspectives into the total product life cycle (i.e., from product conception to postmarket surveillance) and encourages the consideration of patient-reported outcomes in regulatory-focused clinical trials when appropriate. Recognizing the significance of identifying patient-reported outcome measures (PROMs) that capture contemporary patient priorities, the Kidney Health Initiative, a public–private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to (1) develop a conceptual framework for a health-related quality of life PROM; (2) identify and map existing PROMs to the conceptual framework, prioritizing them on the basis of their supporting evidence for use in the regulatory environment; and (3) describe next steps for identifying PROMs for use in regulatory clinical trials of transformative KRT devices. This paper summarizes the proposed health-related quality-of-life PROM conceptual framework, maps and prioritizes PROMs, and identifies gaps and future needs to advance the development of rigorous, meaningful PROMS for use in clinical trials of transformative KRT devices.

  • patient-reported outcomes
  • medical devices
  • innovation
  • dialysis
  • hemodialysis
  • end-stage renal disease
  • patient priorities
  • clinical trial
  • renal dialysis
  • quality of life
  • Public-Private Sector Partnerships
  • United States Food and Drug Administration
  • Patient Reported Outcome Measures
  • Renal Insufficiency
  • Renal Replacement Therapy
  • kidney
  • Patient-Centered Care
  • Copyright © 2020 by the American Society of Nephrology
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Clinical Journal of the American Society of Nephrology: 15 (10)
Clinical Journal of the American Society of Nephrology
Vol. 15, Issue 10
October 07, 2020
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Toward Patient-Centered Innovation
Jennifer E. Flythe, Tandrea S. Hilliard, Kourtney Ikeler, San Keller, Debbie S. Gipson, Amanda C. Grandinetti, Robert J. Nordyke, Ronald D. Perrone, Prabir Roy-Chaudhury, Mark Unruh, Melissa West, Fraser Bocell, Frank P. Hurst
CJASN Oct 2020, 15 (10) 1522-1530; DOI: 10.2215/CJN.00110120

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Toward Patient-Centered Innovation
Jennifer E. Flythe, Tandrea S. Hilliard, Kourtney Ikeler, San Keller, Debbie S. Gipson, Amanda C. Grandinetti, Robert J. Nordyke, Ronald D. Perrone, Prabir Roy-Chaudhury, Mark Unruh, Melissa West, Fraser Bocell, Frank P. Hurst
CJASN Oct 2020, 15 (10) 1522-1530; DOI: 10.2215/CJN.00110120
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    • Introduction
    • Kidney Health Initiative Transformative KRT Devices PROM Project
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More in this TOC Section

  • Integrating Patient Priorities with Science by Community Engagement in the Kidney Precision Medicine Project
  • Risk Factors for CKD Progression
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Keywords

  • patient-reported outcomes
  • medical devices
  • innovation
  • dialysis
  • hemodialysis
  • end-stage renal disease
  • patient priorities
  • clinical trial
  • renal dialysis
  • quality of life
  • Public-Private Sector Partnerships
  • United States Food and Drug Administration
  • Patient Reported Outcome Measures
  • renal insufficiency
  • Renal Replacement Therapy
  • kidney
  • Patient-Centered Care

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