Acute kidney injury (AKI) is a common and heterogeneous clinical syndrome associated with substantial short- and long-term morbidity and mortality. Despite decades of research, few interventions have demonstrated consistent benefit in preventing or treating AKI, in part due to the lack of standardized, patient-centered outcome reporting across clinical trials. Outcomes are often inconsistently defined, selectively reported, or focused on surrogate measures that may not reflect the priorities of patients and caregivers. The development of a Core Outcome Set for Acute Kidney Injury (COS-AKI) aims to establish a standardized set of outcomes that are meaningful to patients and other key stakeholders and should be reported in future AKI trials.
Emily See (Royal Melbourne Hospital), Kristin Dolan (Texas Children’s Hospital), Dana Fuhrman (Cincinnati Children’s Hospital Medical Center), Bruno Garcia (Saint-Pierre University Hospital), Natalja Stanski (Cincinnati Children’s Hospital Medical Center), Ayse Akcan Arikan (Texas Children’s Hospital), Sean M. Bagshaw (University of Alberta), Javier Neyra (University of Alabama at Birmingham), Andrea Viecelli (University Hospital Zurich), D’Arcy Duquette (Health Quality Council of Alberta), Matthieu Legrand (University of California, San Francisco)
Disease Category: Kidney disease
Disease Name: Acute kidney injury (AKI)
Age Range: 0 - 99
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Researchers
- Service providers
- COS for clinical trials or clinical research
- Consensus conference
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Nominal group technique (NGT)
- Semi structured discussion
- Survey
- Systematic review
COS-AKI is an international, multi-stakeholder initiative comprising five sequential phases. First, a scoping review will identify and characterize outcomes reported in randomized controlled trials of interventions to prevent or treat AKI. Second, focus groups using nominal group technique will be conducted with adults and children with lived experience of AKI and their caregivers to identify and prioritize outcomes of importance. Third, semi-structured interviews with key stakeholders, including nephrologists, intensivists, nurses, pharmacists, researchers, and pediatric specialists, will explore perspectives on outcome relevance, feasibility, and implementation. Fourth, findings from earlier phases will inform a three-round international Delphi survey involving patients, caregivers, health professionals, researchers, and industry representatives to achieve consensus on the most important outcome domains. Finally, a multi-stakeholder consensus workshop will review and refine Delphi findings, establish final consensus criteria, and agree upon the core outcome domains for inclusion in AKI trials.