Standardised Outcomes in Nephrology—Children and Adolescents (SONG-Kids): a protocol for establishing a core outcome set for children with chronic kidney disease

Abstract

BackgroundChildren with chronic kidney disease (CKD), requiring dialysis or kidney transplantation, have a mortality rate of up to 30-fold higher than the general aged-matched population, and severely impaired quality of life. Symptoms such as fatigue and pain are prevalent and debilitating. Children with CKD are at risk of cognitive impairment, and poorer educational, vocational, and psychosocial outcomes compared with their well peers, which have consequences through to adulthood. Treatment regimens for children with CKD are long-term, complex, and highly intrusive. While many trials have been conducted to improve outcomes in children with CKD, the outcomes measured and reported are often not relevant to patients and clinicians, and are highly variable. These problems can diminish the value of trials as a means to improve the lives of children with CKD. The Standardised Outcomes in Nephrology—Children and Adolescents (SONG-Kids) study aims to develop a core outcome set for trials in children and adolescents with any stage of CKD that is based on the shared priorities of all stakeholders.Methods/DesignSONG-Kids involves five phases: a systematic review to identify outcomes (both domains and measures) that have been reported in randomised controlled trials involving children aged up to 21 years with CKD; focus groups (using nominal group technique) with adolescent patients and caregivers of paediatric patients (all ages) to identify outcomes that are relevant and important to patients and their family and the reasons for their choices; semistructured key informant interviews with health professionals involved in the care of children with CKD to ascertain their views on establishing core outcomes in paediatric nephrology; an international three-round online Delphi survey with patients, caregivers, clinicians, researchers, policy-makers, and members from industry to develop consensus on important outcome domains; and a stakeholder workshop to review and finalise the set of core outcome domains for trials in children with CKD (including nondialysis-dependent, dialysis, and kidney transplantation).DiscussionEstablishing a core outcome set to be reported in all trials conducted in children with any stage of CKD will enhance the relevance, transparency, and impact of research to improve the lives of children and adolescents with CKD.

Identifying Important Outcomes for Young People With CKD and Their Caregivers: A Nominal Group Technique Study

“…The outcomes identified in this study will inform the development of a core outcome set through the SONG-Kids Initiative . 24…”

“…14 Prior studies have systematically identified outcomes that are important to adults with CKD, 21,22 but the outcomes that are highly prioritized by children with CKD and caregivers are unknown. 23,24 This study aims to identify outcomes that are important to children across all stages of CKD, and their caregivers, and the reasons for their prioritization. This may inform the choice of research outcomes to inform patient-centered decision-making in CKD care.…”

Standardized Outcomes in Nephrology—Peritoneal Dialysis (SONG-PD): Study Protocol for Establishing a Core Outcome Set in PD

“…The Standardised Outcomes in Nephrology (SONG) initiative aims to establish core outcome domains and outcome measures across the full spectrum of chronic kidney disease, with the streams SONG-HD (haemodialysis),(42) SONG-Tx (kidney transplantation),(43) and SONG-Kids (children and adolescents)(44) currently underway. The specific aims of SONG-PD are to: 1) describe the scope, quality, and consistency of outcomes used in PD trials; 2) identify outcomes that are important to patients and caregivers; 3) ascertain health professional attitudes, values, and beliefs regarding outcomes for PD trials; 4) generate a consensus-based prioritised list of core outcome domains; and 5) establish a set of core outcome domains for trials conducted in people on PD.…”

A qualitative exploration of Australian eyecare professional perspectives on Age-Related Macular Degeneration (AMD) care

“…The study endeavoured to comply with the COnsolidated Criteria for REporting Qualitative Research (COREQ) [27]. The original intent was for this research to adopt a multimethod approach which combined several methods to collect information on a given topic [28]. A combination of focus groups (with the nominal group technique) [29] and semi-structured face to face or phone interviews were used to collect data from eyecare professionals.…”

“…Strengths of this study include the mixed methods approach that allowed triangulation of the data and enabled the participants to express concerns in their own words, the involvement of primary and secondary eyecare professionals, and the use of nominal group technique which allowed quantification of barriers and enablers. The concurrent use of an explorative and consensus-oriented method allowed both qualitative and semi-quantitative data to be collected, inform and complement each other but the lack of ophthalmology involvement in the focus group aspect of this research is a limitation [28]. These strategies are known to be helpful when trying to understand complex behaviours and characterise knowledge, attitudes, and barriers of diverse stakeholder groups [30,58,59].…”