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

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 pret

SUBMITTER: Flythe JE 

PROVIDER: S-EPMC9337889 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature