Toward Patient-Centered Innovation: A Conceptual Framework for Patient-Reported Outcome Measures for Transformative Kidney Replacement Devices.
Clin J Am Soc Nephrol
; 15(10): 1522-1530, 2020 10 07.
Article
en En
| MEDLINE
| ID: mdl-32276947
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.
Palabras clave
Patient Reported Outcome Measures; Patient-Centered Care; Public-Private Sector Partnerships; Renal Insufficiency; Renal Replacement Therapy; United States Food and Drug Administration; clinical trial; dialysis; end-stage renal disease; hemodialysis; innovation; kidney; medical devices; patient priorities; patient-reported outcomes; quality of life; renal dialysis
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Calidad de Vida
/
Terapia de Reemplazo Renal
/
Insuficiencia Renal Crónica
/
Medición de Resultados Informados por el Paciente
/
Diseño Centrado en el Usuario
Tipo de estudio:
Etiology_studies
/
Prognostic_studies
Aspecto:
Patient_preference
Límite:
Humans
Idioma:
En
Revista:
Clin J Am Soc Nephrol
Asunto de la revista:
NEFROLOGIA
Año:
2020
Tipo del documento:
Article
Pais de publicación:
Estados Unidos