Patient Preferences and Priorities for the Design of an Acute Kidney Injury Prevention Trial: Findings from a Consensus Workshop.

KEY POINTS

For AKI prevention trial recruitment, patients prioritized technology enabled prescreening and involvement of family members in the consent process. For trial intervention delivery, participants prioritized measures to facilitate ease of trial intervention administration and return visits. For AKI prevention trial outcomes, patient participants identified effects on kidney-related and other clinical outcomes as top priorities.

BACKGROUND

High-quality clinical trials are needed to establish the efficacy and safety of novel therapies for AKI prevention. In this consensus workshop, we identified patient and caregiver priorities for recruitment, intervention delivery, and outcomes of a clinical trial of cilastatin to prevent nephrotoxic AKI.

METHODS

We included adults with lived experience of AKI, CKD, or risk factors of AKI (., critical care hospitalization) and their caregivers. Using a modified nominal group technique approach, we conducted a series of hybrid in-person/virtual discussions covering three clinical trial topic areas: () consent and recruitment, () intervention delivery, and () trial outcomes. Participants voted on their top preferences in each topic area, and discussion transcripts were analyzed inductively using conventional content analysis.

RESULTS

Thirteen individuals (11 patients, two caregivers) participated in the workshop. For consent and recruitment, participants prioritized technology enabled prescreening and involvement of family members in the consent process. For intervention delivery, participants prioritized measures to facilitate ease of intervention administration and return visits. For trial outcomes, participants identified kidney-related and other clinical outcomes (., AKI, CKD, cardiovascular events) as top priorities. Analysis of transcripts provided insight into care team and family involvement in trial-related decisions, implications of allocation to a placebo arm, and impact of participants' experiences of AKI and critical illness.

CONCLUSIONS

Findings from our workshop will directly inform development of a clinical trial protocol of cilastatin for nephrotoxic AKI prevention and can assist others in patient-centered approaches to AKI trial design.