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

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 pretest interviews to evaluate survey face validity, comprehensibility, and perceived relevance. We pilot tested the survey with in-center hemodialysis patients to assess comprehensibility and usability further. Throughout, we used participant input to guide survey refinements. Results: Thirty-six individuals receiving in-center or home dialysis participated in concept elicitation (N=20) and pretest (N=16) interviews. Participants identified reduced fatigue, lower treatment burden, and enhanced freedom as important benefits of a wearable device, and many expressed concerns about risks related to device disconnection-specifically bleeding and infection. We drafted a survey that included descriptions of the risks of serious bleeding and serious infection and an assessment of respondent willingness to wait for a safer device. Input from pretest interviewees led to various instrument modifications, including treatment descriptions, item wording, and risk-level explanations. Pilot testing of the updated survey among 24 in-center hemodialysis patients demonstrated acceptable survey comprehensibility and usability, although 50% of patients required some assistance. Conclusions: The final survey is a 54-item web-based instrument that will yield estimates of the maximal acceptable risk for the described wearable device and willingness to wait for wearable devices with lower risk.

Evaluation of a Pharmacists' Patient Care Process Approach for Hypertension.

INTRODUCTION: An estimated 116 million American adults (47.3%) have hypertension. Most adults with hypertension do not have it controlled-3 in 4 (92.1 million) U.S. adults with hypertension have a blood pressure ≥130/80 mmHg. The Pharmacists' Patient Care Process is a standardized patient-centered approach to the provision of pharmacist care that is done in collaboration with other healthcare providers. Through the Michigan Medicine Hypertension Pharmacists' Program, pharmacists use the Pharmacists' Patient Care Process to provide hypertension management services in collaboration with physicians in primary care and community pharmacy settings. In 2019, the impact of Michigan Medicine Hypertension Pharmacists' Program patient participation on blood pressure control was evaluated. METHODS: Propensity scoring was used to match patients in the intervention group with patients in the comparison group and regression analyses were then conducted to compare the 2 groups on key patient outcomes. Negative binomial regression was used to examine the number of days with blood pressure under control. The findings presented in this brief are part of a larger multimethod evaluation. RESULTS: More patients in the intervention group than in the comparison group achieved blood pressure control at 3 months (66.3% vs 42.4%) and 6 months (69.1% vs 56.5%). The intervention group experienced more days with blood pressure under control within a 3-month (18.6 vs 9.5 days) and 6-month period (57.0 vs 37.4 days) than the comparison group did. CONCLUSIONS: Findings support the effectiveness of the Michigan Medicine Hypertension Pharmacists' Program approach to implementing the Pharmacists' Patient Care Process to improve blood pressure control.