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Akademický článek

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

Autor: Flythe JE; University of North Carolina (UNC) Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, UNC School of Medicine, Chapel Hill, North Carolina.; Cecil G. Sheps Center for Health Services Research, UNC, Chapel Hill, North Carolina., Forfang D; Kidney Health Initiative Patient and Family Partnership Council, San Pablo, California., Gedney N; Home Dialyzors United, Shepherdstown, West Virginia., White DM; Kidney Health Initiative Patient and Family Partnership Council, Hillcrest Heights, Maryland., Wilkie C; Kidney Health Initiative Patient and Family Partnership Council, Punta Gorda, Florida., Cavanaugh KL; Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, Tennessee.; Center for Effective Health Communication, Vanderbilt University Medical Center, Nashville, Tennessee., Harris RC; Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, Tennessee., Unruh M; School of Medicine, University of New Mexico, Albuquerque, New Mexico., Squillaci G; Kidney Health Initiative and American Society of Nephrology, Washington, DC., West M; Kidney Health Initiative and American Society of Nephrology, Washington, DC., Mansfield C; RTI Health Solutions, Research Triangle Park, North Carolina., Soloe CS; RTI Health Solutions, Research Triangle Park, North Carolina., Treiman K; RTI International, Research Triangle Park, North Carolina., Wood D; RTI Health Solutions, Research Triangle Park, North Carolina., Hurst FP; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland., Neuland CY; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland., Saha A; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland., Sheldon M; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland., Tarver ME; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: Kidney360 [Kidney360] 2022 May 05; Vol. 3 (7), pp. 1197-1209. Date of Electronic Publication: 2022 May 05 (Print Publication: 2022).

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Akademický článek

Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop.

Autor: Hurst FP; Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD. Electronic address: khi@asn-online.org., Chianchiano D; National Kidney Foundation, New York, NY., Upchurch L; NxStage Medical, Inc, Lawrence, MA., Fisher BR; Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD., Flythe JE; University of North Carolina Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC., Castillo Lee C; Kidney Health Initiative Patient and Family Partnership Council, Washington, DC., Hill T; Fresenius Renal Therapies, Fresenius Medical Care North America, Waltham, MA., Neuland CY; Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.

Publikováno v: American journal of kidney diseases : the official journal of the National Kidney Foundation [Am J Kidney Dis] 2017 Oct; Vol. 70 (4), pp. 561-569. Date of Electronic Publication: 2017 Apr 27.

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Akademický článek

Overcoming Barriers in Kidney Health-Forging a Platform for Innovation.

Autor: Linde PG; AbbVie, Inc., Global Pharmaceutical Research and Development, North Chicago, Illinois; peter.linde@abbvie.com ronald_falk@med.unc.edu., Archdeacon P; Center for Drug Evaluation and Research, Office of Medical Policy and., Breyer MD; Eli Lilly, Biotechnology Discovery Research, Indianapolis, Indiana;, Ibrahim T; American Society of Nephrology, Washington, DC;, Inrig JK; Quintiles Therapeutic Science and Strategy Unit, San Diego, California;, Kewalramani R; Amgen, Inc., Thousand Oaks, California;, Lee CC; Vasculitis Foundation, Patient Advisor, Chapel Hill, North Carolina;, Neuland CY; Center for Devices and Radiological Health, Office of Device Evaluation, Division of Reproductive, Gastro-Renal and Urological Devices, US Food and Drug Administration, Silver Spring, Maryland;, Roy-Chaudhury P; Division of Nephrology, University of Arizona, Tucson, Arizona;, Sloand JA; Baxter Healthcare Corporation, Deerfield, Illinois;, Meyer R; American Society of Nephrology, Washington, DC;, Smith KA; Center for Clinical Standards and Quality, Centers for Medicare and Medicaid Services, Baltimore, Maryland;, Snook J; American Society of Nephrology, Chicago, Illinois; and., West M; American Society of Nephrology, Washington, DC;, Falk RJ; Division of Nephrology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina peter.linde@abbvie.com ronald_falk@med.unc.edu.

Publikováno v: Journal of the American Society of Nephrology : JASN [J Am Soc Nephrol] 2016 Jul; Vol. 27 (7), pp. 1902-10. Date of Electronic Publication: 2016 Apr 28.

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Akademický článek

Incorporating patient-preference evidence into regulatory decision making.

Autor: Ho MP; Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Building 66, Room 2232, Silver Spring, MD, 20993-0002, USA. martin.ho@fda.hhs.gov., Gonzalez JM; RTI Health Solutions, Durham, USA. jgonzalez@rti.org., Lerner HP; Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Building 66, Room 2232, Silver Spring, MD, 20993-0002, USA. herbert.lerner@fda.hhs.gov., Neuland CY; Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Building 66, Room 2232, Silver Spring, MD, 20993-0002, USA. carolyn.neuland@fda.hhs.gov., Whang JM; Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Building 66, Room 2232, Silver Spring, MD, 20993-0002, USA. joyce.whang@fda.hhs.gov., McMurry-Heath M; Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Building 66, Room 2232, Silver Spring, MD, 20993-0002, USA. michelle.mcmurry-heath@fda.hhs.gov.; FaegreBD Consulting, Washington, USA. michelle.mcmurry-heath@fda.hhs.gov., Hauber AB; RTI Health Solutions, Durham, USA. abhauber@rti.org., Irony T; Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Building 66, Room 2232, Silver Spring, MD, 20993-0002, USA. telba.irony@fda.hhs.gov.

Publikováno v: Surgical endoscopy [Surg Endosc] 2015 Oct; Vol. 29 (10), pp. 2984-93. Date of Electronic Publication: 2015 Jan 01.

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