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Methods and rationale of the DISCOVER CKD global observational study

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 improv...

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Published in:Clinical Kidney Journal 2021-06, Vol.14 (6), p.1570-1578
Main Authors: Pecoits-Filho, Roberto, James, Glen, Carrero, Juan Jesus, Wittbrodt, Eric, Fishbane, Steven, Sultan, Alyshah Abdul, Heerspink, Hiddo J L, Hedman, Katarina, Kanda, Eiichiro, Chen, Hungta (Tony), Kashihara, Naoki, Sloand, James, Kosiborod, Mikhail, Kumar, Supriya, Lainscak, Mitja, Arnold, Matthew, Lam, Carolyn S P, Holmqvist, Björn, Pollock, Carol, Fenici, Peter, Stenvinkel, Peter, Medin, Jennie, Wheeler, David C
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container_issue 6
container_start_page 1570
container_title Clinical Kidney Journal
container_volume 14
creator Pecoits-Filho, Roberto
James, Glen
Carrero, Juan Jesus
Wittbrodt, Eric
Fishbane, Steven
Sultan, Alyshah Abdul
Heerspink, Hiddo J L
Hedman, Katarina
Kanda, Eiichiro
Chen, Hungta (Tony)
Kashihara, Naoki
Sloand, James
Kosiborod, Mikhail
Kumar, Supriya
Lainscak, Mitja
Arnold, Matthew
Lam, Carolyn S P
Holmqvist, Björn
Pollock, Carol
Fenici, Peter
Stenvinkel, Peter
Medin, Jennie
Wheeler, David C
description 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.
doi_str_mv 10.1093/ckj/sfab046
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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 &gt;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 &gt;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.</description><identifier>ISSN: 2048-8505</identifier><identifier>EISSN: 2048-8513</identifier><identifier>DOI: 10.1093/ckj/sfab046</identifier><identifier>PMID: 34249352</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Analysis ; Chronic kidney failure ; Epidemiology ; Exercise ; Food habits ; Medicin och hälsovetenskap ; Methods ; Original ; Pharmaceutical industry</subject><ispartof>Clinical Kidney Journal, 2021-06, Vol.14 (6), p.1570-1578</ispartof><rights>The Author(s) 2021. Published by Oxford University Press on behalf of ERA-EDTA. 2021</rights><rights>The Author(s) 2021. 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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 &gt;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 &gt;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.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>34249352</pmid><doi>10.1093/ckj/sfab046</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-4763-2024</orcidid><orcidid>https://orcid.org/0000-0002-0255-6710</orcidid><oa>free_for_read</oa></addata></record>
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subjects Analysis
Chronic kidney failure
Epidemiology
Exercise
Food habits
Medicin och hälsovetenskap
Methods
Original
Pharmaceutical industry
title Methods and rationale of the DISCOVER CKD global observational study
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