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.

The authors have declared no competing interest.

The study was funded by the Canadian Institutes of Health Research (CIHR) Team Grant : Intervention Trial in Inflammation for Chronic Conditions - Evidence to Impact; Funding Reference Number LI3 189373.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Conjoint Health Research Ethics Board of the University of Calgary give ethical approval for this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

All data produced in the present study are available upon reasonable request to the authors.