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Abstract: SA-PO057

Next-Generation Renal Replacement Therapies (RRT): How Do Patients Weigh the Risks and Benefits?

Session Information

Category: Bioengineering

  • 300 Bioengineering

Authors

  • Wilson, Leslie, University of California, San Francisco, California, United States
  • Frassetto, Lynda A., University of California, San Francisco, California, United States
  • Sarathy, Harini, University of California, San Francisco, California, United States
  • Fissell, William Henry, Vanderbilt University, Nashville, Tennessee, United States
  • Roy, Shuvo, University of California, San Francisco, California, United States
Background

Device developers are increasingly asking patients for input on product developments, and the FDA now uses patients’ risk-benefit preferences in approving new devices. Implantable/wearable devices under development may revolutionize patient lives by providing more frequent/prolonged RRT, releasing them from in-center/home dialysis (ICHD). Our objective was to determine key risks/benefit considerations that would drive ESRD patient choices.

Methods

We developed a choice-based conjoint discrete choice instrument (CBCDCI) and surveyed by computer 498 ESRD patients. The CBCDCI consists of 9 attributes of risk and benefit derived from literature reviews, patient/clinician interviews, and pilot testing. Attributes include risk of: serious infection, death within 5 years, permanent rejection, surgical requirements, diet restrictions, flexibility in mobility (no ICHD), follow-up requirements, pill burden, and fatigue reduction. We used a random, full profile, balanced overlap design from Sawtooth Software with 12 choice pairs and 2 fixed tasks to test validity. We used a mixed effects regression with attribute levels as independent predictor variables and choice decisions as dependent variables.

Results

In univariate and multivariate analyses, all variables were significantly important to choice preferences except follow-up requirements.


For each 1% increase in risk of death within 5 years, preference utility across factors decreased by 2.2, while for each 1% increase in infection, utility decreased by 1.4. Avoiding a 1% risk of infection or death was 1 and 1.5 times preferred over no ICHD, respectively. Pill burden and diet restrictions were less important.

Conclusion

ESRD patients had a strong aversion to even a 1% increase in death within 5 years, infection risk or permanent device rejection, but were willing to trade-off these risks for the benefit of moving to complete mobility. These results will inform device developers on acceptable benefit-risk thresholds for next generation RRT.

AttributesBeta (preference utilities)p value
avoiding death in 5 yrs-2.217<0.01
no ICHD1.520<0.01
avoiding infection-1.384<0.01
risk of rejection-1.066<0.01
70% fatigue decrease0.977<0.01
only 1 implant surgery0.844<0.01

Funding

  • Other NIH Support