Establishing a core outcome measure for life participation in children with chronic kidney disease: a Standardized Outcomes in Nephrology - children and adolescents with chronic kidney disease (SONG-Kids) consensus workshop report

Life participation is of critical importance to children and adolescents with chronic kidney disease (CKD), their caregivers, and health professionals. However, life participation is assessed and reported inconsistently and uncommonly in trials involving children with CKD. The consensus workshops aimed to describe the perspectives of patients, caregivers, and health professionals on developing a core outcome measure for life participation in children with CKD. Four consensus workshops (1 in-person [English language], 3 online [2 English language and 1 Spanish language]) were held to discuss the relevance of content, appropriateness, and feasibility of a proposed patient-reported core outcome measure. Transcripts were analyzed thematically. A total of 171 participants, including 79 patients and caregivers and 92 health professionals, from 16 countries attended. Four themes were identified. Allowing individual interpretation and valuation of life participation included encapsulating key domains of life participation, recognizing varying degrees of achieving participation in different domains, reflecting personal context and values, emphasizing meaningful participation in activities, acknowledging changes over time, and attributing responses to the intervention. Respecting developmental needs entailed developing age-specific measures, considering literacy, using relevant and clear language, using engaging formats, and establishing an appropriate recall period. Capturing broad perspectives included ensuring universal applicability across settings and allowing for proxy completion. Establishing widespread implementation by reducing the completion burden, validating for all stages and diagnoses of CKD, and enabling comparisons across CKD stages were suggested. A core outcome measure for life participation in children with CKD should be widely applicable and developmentally appropriate, allow patients to interpret life participation in their own context, and be psychometrically robust and feasible to implement. The proposed measure will be revised and validated to be included in all clinical trials in children with CKD. Measuring life participation in a consistent and meaningful way across trials can better support patient-centered decision-making, disease management, and outcomes in children with CKD.