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
School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil.
Arbor Research Collaborative for Health, Ann Arbor, MI, USA.
Clin Kidney J. 2021 Apr 11;14(6):1570-1578. doi: 10.1093/ckj/sfab046. eCollection 2021 Jun.
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.
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.
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).
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.
慢性肾脏病（CKD）患者的真实世界数据有限，尤其是在临床管理、代谢控制、治疗模式、生活质量（QoL）和饮食模式方面。利用真实世界的常规护理数据来了解这些差距，将增进我们对CKD患者所面临挑战及后果的理解，并有助于实现改善其管理和预后的长期目标。
DISCOVER CKD采用丰富的混合研究设计，包括回顾性和前瞻性患者队列，整合来自中国、意大利、日本、瑞典、英国和美国的CKD患者的一级和二级数据。数据将在3年时间内前瞻性收集，涉及1000多名CKD患者，这些患者将在常规临床就诊期间通过电子病例报告表录入，并通过移动/平板电脑应用程序进行至少1年的随访，从而能够收集患者报告的结局（PROs）。将对约100名患者进行深入访谈。另外，将从现有的数据集和登记处回顾性收集超过200万CKD患者的二级数据。
DISCOVER CKD项目收集并将报告患者人口统计学、生物标志物和实验室测量值、病史、临床结局、医疗资源利用、药物、饮食模式、身体活动和PROs（包括QoL和定性访谈）。
DISCOVER CKD项目将提供当代真实世界的见解，为临床实践提供参考，并增进我们对CKD的流行病学、临床和经济负担以及在真实世界CKD环境中一系列地理区域的临床结局和PROs决定因素的理解。
