Friedrich C Prischl1, Peter Rossing2, George Bakris3, Gert Mayer4, Christoph Wanner5. 1. Department of Nephrology, 4th Department of Internal Medicine, Klinikum WelsGrieskirchen, Wels, Austria. 2. Steno Diabetes Center Copenhagen, University of Copenhagen, Copenhagen, Denmark. 3. Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago, Chicago, IL, USA. 4. Department of Internal Medicine IV (Nephrology and Hypertension), Medical University Innsbruck, Innsbruck, Austria. 5. Division of Nephrology, University Hospital, Würzburg, Germany.
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.
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.
Authors: Michael K Sullivan; Bhautesh Dinesh Jani; Jennifer S Lees; Claire E Welsh; Alex McConnachie; Bethany Stanley; Paul Welsh; Barbara I Nicholl; Donald M Lyall; Juan-Jesus Carrero; Dorothea Nitsch; Naveed Sattar; Frances S Mair; Patrick B Mark Journal: Clin Kidney J Date: 2021-04-11
Authors: Sara Denicolò; Verena Vogi; Felix Keller; Stefanie Thöni; Susanne Eder; Hiddo J L Heerspink; László Rosivall; Andrzej Wiecek; Patrick B Mark; Paul Perco; Johannes Leierer; Andreas Kronbichler; Marion Steger; Simon Schwendinger; Johannes Zschocke; Gert Mayer; Emina Jukic Journal: Kidney Int Rep Date: 2022-02-03