Abstract
The outcomes reported in trials across all stages of chronic kidney disease (CKD) are highly variable, and often do not include outcomes that are directly relevant to patients and caregivers. Frequently, the outcomes reported in trials are often unvalidated surrogate biochemical endpoints. The omission of outcomes that are meaningful and important to patients can diminish the value of trials in supporting treatment decisions. In response, there have been increasing efforts across many health and medical disciplines to develop core outcome sets, defined as the minimum set of outcomes to be reported in all trials in a specific health area, to improve the relevance and consistency of reporting trial outcomes. The international Standardised Outcomes in Nephrology (SONG) Initiative was established in 2014 and has since developed seven core outcome sets for different diagnosis and treatment stages of CKD. The core outcomes were based on consensus among patients, caregivers, and health professionals. Each core outcomes set includes at least one patient-reported outcome including fatigue (for haemodialysis), life participation (kidney transplantation, peritoneal dialysis, early CKD not yet requiring kidney replacement therapy, children and adolescents and glomerular disease,) and pain (polycystic kidney disease). This article will outline how patient-reported outcomes are currently reported in trials, discuss core patient-reported outcomes that have been established for trials in kidney disease, and outline strategies for implementing core patient-reported outcomes in trials.
Published Version
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