Abstract
BACKGROUND: In renal studies, various outcome endpoints are used with variable definitions, making it nearly impossible to perform meta-analyses and deduce meaningful conclusions. Increasing attention is directed towards standardization of renal outcome reporting.
METHODS: A working group was formed to produce a unifying definition of renal outcomes that can be used by all investigators. We propose major adverse renal events (MARE) as the term for a standardized composite of hard renal outcomes. We discuss the components for inclusion in MARE from existing evidence.
RESULTS: MARE could include three to five items, considered relevant to patients and regulators. New onset of kidney injury, that is persistent albuminuria/proteinuria and/or decreasing glomerular filtration rate (GFR) <60 ml/min/1.73 m2, persistent signs of worsening kidney disease, development of end-stage kidney disease with estimated GFR <15 ml/min/1.73 m2 without or with initiation of kidney replacement therapy, and death from renal cause are core items of MARE. Additionally, patient reported outcomes should be reported in parallel to MARE as a standard set of primary (or secondary) endpoints in studies on kidney disease of diabetic, hypertensive-vascular, or other origin.
CONCLUSIONS: MARE as a reporting standard will enhance the ability to compare studies and thus, facilitate meaningful meta-analyses. This will result in standardized endpoints that should result in guideline improvement to better individualize care of patients with kidney disease.
| Original language | English |
|---|---|
| Journal | Nephrology Dialysis Transplantation |
| Volume | 36 |
| Issue number | 3 |
| Pages (from-to) | 491-497 |
| Number of pages | 7 |
| ISSN | 0931-0509 |
| DOIs | |
| Publication status | Published - Mar 2021 |
Keywords
- composite endpoint
- major adverse events
- outcome endpoint
- renal endpoint
- renal outcome
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