Methods and rationale of the DISCOVER CKD global observational study

Roberto Pecoits-Filho, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil.
Glen James, AstraZeneca, Cambridge, UK.
Juan Jesus Carrero, Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
Eric Wittbrodt, AstraZeneca, Gaithersburg, MD, USA.
Steven Fishbane, Division of Nephrology, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
Alyshah Abdul Sultan, AstraZeneca, Cambridge, UK.
Hiddo J. Heerspink, Department of Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, the Netherlands.
Katarina Hedman, AstraZeneca, Gothenburg, Sweden.
Eiichiro Kanda, Medical Science, Kawasaki Medical School, Kurashiki, Japan.
Hungta Tony Chen, AstraZeneca, Gaithersburg, MD, USA.
Naoki Kashihara, Department of Nephrology and Hypertension, Kawasaki Medical School, Kurashiki, Japan.
James Sloand, AstraZeneca, Gaithersburg, MD, USA.
Mikhail Kosiborod, Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA.
Supriya Kumar, AstraZeneca, Gaithersburg, MD, USA.
Mitja Lainscak, Division of Cardiology, General Hospital Murska Sobota, Murska Sobota, Slovenia.
Matthew Arnold, AstraZeneca, Cambridge, UK.
Carolyn S. Lam, National Heart Centre, Singapore.
Björn Holmqvist, AstraZeneca, Gothenburg, Sweden.
Carol Pollock, Kolling Institute, Royal North Shore Hospital, University of Sydney, Sydney, NSW, Australia.
Peter Fenici, AstraZeneca, Cambridge, UK.
Peter Stenvinkel, Division of Renal Medicine, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden.
Jennie Medin, AstraZeneca, Gothenburg, Sweden.
David C. Wheeler, Department of Renal Medicine, University College London, London, UK.

Document Type

Journal Article

Publication Date

6-1-2021

Journal

Clinical kidney journal

Volume

14

Issue

6

DOI

10.1093/ckj/sfab046

Keywords

chronic kidney disease; methods and rationale; patient-reported outcomes; quality of life; real-world evidence

Abstract

BACKGROUND: Real-world data for patients with chronic kidney disease (CKD), specifically pertaining to clinical management, metabolic control, treatment patterns, quality of life (QoL) and dietary patterns, are limited. Understanding these gaps using real-world, routine care data will improve our understanding of the challenges and consequences faced by patients with CKD, and will facilitate the long-term goal of improving their management and prognosis. METHODS: DISCOVER CKD follows an enriched hybrid study design, with both retrospective and prospective patient cohorts, integrating primary and secondary data from patients with CKD from China, Italy, Japan, Sweden, the UK and the USA. Data will be prospectively captured over a 3-year period from >1000 patients with CKD who will be followed up for at least 1 year via electronic case report form entry during routine clinical visits and also via a mobile/tablet-based application, enabling the capture of patient-reported outcomes (PROs). In-depth interviews will be conducted in a subset of ∼100 patients. Separately, secondary data will be retrospectively captured from >2 000 000 patients with CKD, extracted from existing datasets and registries. RESULTS: The DISCOVER CKD program captures and will report on patient demographics, biomarker and laboratory measurements, medical histories, clinical outcomes, healthcare resource utilization, medications, dietary patterns, physical activity and PROs (including QoL and qualitative interviews). CONCLUSIONS: The DISCOVER CKD program will provide contemporary real-world insight to inform clinical practice and improve our understanding of the epidemiology and clinical and economic burden of CKD, as well as determinants of clinical outcomes and PROs from a range of geographical regions in a real-world CKD setting.

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