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.
Jazyk:	angličtina
Zdroj:	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.
DOI:	10.1053/j.ajkd.2017.03.013
Abstrakt:	New technologies challenge current dialysis treatment paradigms as devices become smaller, more portable, and increasingly used outside the dialysis clinic. It is unclear how patients will view this care transition, and it will be important to consider patient and care partner perspectives during all aspects of development for novel dialysis therapies, from design and clinical trials to regulatory approval. To gain insight into this area, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, the US Food and Drug Administration, and nearly 80 member organizations and companies dedicated to enhancing patient safety and fostering innovation in kidney disease, convened a workshop of patients, care partners, and other kidney community stakeholders. The workshop included background presentations followed by focused small group discussions in 3 areas (device design, clinical trials, and regulatory approval). Participants explored how to involve patients throughout the life cycle of a medical device, including discussions of how patients can influence device design, assist in the planning and implementation of clinical trials, and provide input to affect regulatory decisions. Patients were engaged in the workshop discussion and interested in sharing their perspectives, but they recommended additional efforts around education, communication, and outreach in these areas. (Published by Elsevier Inc.)
Databáze:	MEDLINE
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