Standardised Outcomes in Nephrology – Glomerular Disease (SONG-GD): developing a core outcome set for trials in glomerular disease

Abstract

Glomerular diseases are a major cause of kidney failure worldwide and are responsible for a large burden on patients and health systems. Patients may experience fatigue, reduced mobility, cognitive dysfunction, infertility, bone disease, cancer and impaired psychosocial wellbeing. Trials are the primary means of assessing interventions that may improve health outcomes, however outcomes reported in trials may lack relevance during treatment decision-making or be inconsistently reported which limits the effective comparison of treatments. The aim of the Standardised Outcomes in Nephrology – Glomerular Disease initiative (SONG-GD) was to establish a core outcome set for trials in adults with glomerular disease. The methods included this thesis are: a systematic review to analyse the scope and heterogeneity of reported outcomes for glomerular disease activity; focus groups with nominal group technique to identify and rank patient-important outcomes; an international two-round Delphi survey to develop consensus among diverse stakeholder groups; and two stakeholder workshops to discuss and endorse the proposed core outcomes. SONG-GD established the core outcomes of kidney function, disease activity, death, life participation and cardiovascular disease to be reported in all trials in adults with glomerular disease. Ultimately, this core outcome set will ensure the shared priorities of patients, care partners and health professionals are addressed by trial outcomes and improve the evidence base for shared treatment decision-making.