Patient preferences and priorities for the design of an acute kidney injury prevention trial: Findings from a consensus workshop

Abstract

Background: Hospitalized patients who develop acute kidney injury (AKI) as a result of nephrotoxic medication exposure are at high risk of adverse outcomes, such as prolonged hospitalization, chronic kidney disease, and cardiovascular events. High-quality clinical trials are needed to establish the safety and efficacy of potential therapies to prevent AKI. Incorporation of the preferences of people with lived experience into trial design can increase the feasibility, acceptability, and relevance of trials. Objective: The purpose of this consensus workshop was to identify patient and caregiver priorities for recruitment, intervention delivery, and outcomes of a clinical trial of cilastatin to prevent nephrotoxic AKI, which will be integrated into development of the trial protocol. Design: Consensus workshop using a modified nominal group technique (NGT) approach. Setting: We conducted a half-day hybrid in-person/virtual workshop at the University of Calgary in December 2023 to engage participants from across Alberta, Canada. Participants: Eligible participants included adults with experience of or caring for someone with AKI, chronic kidney disease, or risk factors for AKI (e.g., diabetes, critical care hospitalization). Methods: With reference to vignettes (i.e., patient scenarios) and a question guide, experienced facilitators led a series of small- and large-group discussions focused on the following 3 topic areas related to clinical trial design: (1) consent and recruitment; (2) intervention delivery; and (3) trial outcomes. In a final prioritization exercise, participants voted on their top 3 preferences within each topic area, which were categorized as high, medium, or low priority. We analyzed transcripts from small- and large-group discussions inductively using conventional content analysis to elaborate on prioritization results. Results: Thirteen individuals participated in the consensus workshop, including 11 patients and 2 caregivers. In the voting exercise for consent and recruitment, participants prioritized use of technological means for identifying eligible participants (i.e., technology enabled pre-screening) and involvement of family members in the consent process. For intervention delivery, participants prioritized the importance of measures to facilitate intervention administration (e.g., intravenous cannula placement) and providing support for return visits. For trial outcomes, participants identified short and long-term kidney-related and other clinical outcomes (e.g., AKI, chronic kidney disease, cardiovascular events) as top priorities. Analysis of discussion transcripts largely reinforced voting results and provided additional insight into preferences for care team and family involvement in trial-related decisions, participants desire to avert AKI and implications of allocation to a placebo arm, and their varied experiences of AKI and critical illness. Limitations: The short duration of group discussions and hybrid in-person/virtual format may have impacted group dynamics and participants ability to meaningfully contribute to discussions. Use of vignettes to guide discussions may have limited participants sharing of their own experiences. Conclusions: Findings from our workshop will directly inform development of a clinical trial protocol of cilastatin for nephrotoxic AKI prevention and can also help others to develop patient-centered approaches for recruitment and consent, intervention delivery, and outcome selection for AKI trials.