Flythe JE, et al. Kidney360.2022;doi:10.34067/KID.0001862022.
Flythe JE, et al. Kidney360.2022;doi:10.34067/KID.0001862022.
Researchers developed a patient preference survey intended to show maximal acceptable risk for using a kidney replacement device and willingness-to-wait for devices with lower risk.
“Catalyzed by U.S. regulatory reform and the Kidney Innovation Accelerator (KidneyX) prize competition, there has been unprecedented [kidney replacement therapy] KRT research and development in recent years. It is anticipated that this focus will yield innovations in wearable and implantable KRT technologies – products that could disrupt the current KRT paradigm and improve the lives of people affected by kidney failure,” Jennifer E. Flythe, MD, MPH, an associate professor of medicine in the division of Nephrology and Hypertension at the University of North Carolina Kidney Center, and colleagues wrote. They added, “With an overall objective of supporting the incorporation of patient perspectives into regulatory decision-making regarding KRT technologies, we partnered with patients, regulators, innovators and clinicians to develop a survey intended to yield valid, regulatory-grade [patient preference information] PPI, capturing how patients trade off the potential benefits and risks of KRT devices.”
Using a steering committee of four patients, four preference experts, four academic nephrologists and seven regulators, researchers determined that wearable KRT devices (both hemodialysis and peritoneal dialysis) would be the alternative treatment and in-center hemodialysis would be the reference treatment for the PPI survey.
Researchers recruited and surveyed 36 patients receiving in-center hemodialysis, home hemodialysis or PD for the study. Twenty patients participated in concept elicitation interviews to inform instrument content. The remaining 16 patients participated in the pre-test surveys to determine survey face validity, comprehensibility and perceived relevance.
Paper copies of the devices were given to a pre-test group to use while providing feedback on instructions, wording, response options and graphics. Researchers modified the survey based on the feedback.
Following pre-test surveys, researchers performed a pilot test with 24 patients receiving in-center hemodialysis. Half of the group needed assistance to complete the online survey due to limited computer experience.
Overall, researchers conducted 20 concept elicitation and 16 pre-test interviews with 17 patients on in-center hemodialysis, 11 patients on home hemodialysis and eight patients on PD. According to results of the surveys, interviewees reported that the important benefits of a wearable device include reduced fatigue, lower treatment burden and enhanced freedom. Additionally, a common concern among patients was risks related to device disconnection, such as bleeding and infection.
After evaluation, researchers designed the final PPI survey as a 54-question online instrument that included descriptions of the risks of serious bleeding and infection in addition to an assessment of respondent willingness to wait for a safer device.
“We described the development of a PPI survey that captures patient preferences for wearable KRT devices in comparison to in-center hemodialysis based on the potential benefits of the treatments and their potential risks of serious bleeding and serious infection. We engaged diverse stakeholders throughout survey development and followed best practices in preference science to maximize the validity and scientific rigor of our final instrument. We intend for the survey and our development approach to serve as models in future endeavors to capture regulatory-grade PPI for other innovative KRT technologies,” Flythe and colleagues wrote. They added, “The next step is to assess the risk tolerance of patients for hypothetical wearable devices and to demonstrate the feasibility of administration of a PPI survey to people receiving dialysis by administering the survey to its target population.”
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