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

Area of Science:

• Nephrology and Biomedical Engineering
• Medical Device Innovation
• Patient-Reported Outcomes

Background:

• Innovations in kidney failure treatment are emerging, potentially altering current care standards.
• Regulatory bodies like the FDA seek patient preference information (PPI) for new device decision-making.
• Premarket submission of PPI for kidney devices remains limited.

Purpose of the Study:

• To develop a valid survey instrument for collecting patient preference information (PPI).
• To capture patient trade-offs between benefits and risks of wearable dialysis devices and in-center hemodialysis.
• To inform the US Food and Drug Administration's decision-making process for novel kidney devices.

Main Methods:

• Concept elicitation interviews with dialysis patients informed survey content.
• Two rounds of pretest interviews assessed survey validity, comprehensibility, and relevance.
• Pilot testing with in-center hemodialysis patients further evaluated survey usability.
• Iterative refinements were made based on participant feedback throughout the development process.

Main Results:

• Key benefits of wearable devices identified include reduced fatigue, lower treatment burden, and enhanced freedom.
• Patient concerns focused on risks of device disconnection, specifically bleeding and infection.
• A survey was drafted including risk descriptions and willingness-to-wait assessments.
• Pilot testing confirmed acceptable survey comprehensibility and usability, with some need for patient assistance.

Conclusions:

• A 54-item web-based survey was finalized to collect patient preference data.
• The instrument will estimate maximal acceptable risk for wearable dialysis devices.
• It will also assess patient willingness to wait for safer wearable device options.