SCOPE implemented an observational, multinational, multicenter, prospective cohort study which involves the recruitment of 2,435 patients with age 75 or more in 7 Countries: Italy, Austria, Germany, The Netherlands, Spain, Poland and Israel (NCT02691546). Within WP1,
SCOPE governance system was formally established. Both internal and external bodies (i.e. the “Scientific Advisory Board” –SAB- and the “Data and Ethics Management Board” –DEMB) were identified. The Communication infrastructure was set up, mainly using following tools: the protected web-site are (intranet), the project website, the project newsletter, the social media, the Educational Toolkit (MOOC), and scientific peer reviewed publication.
All study documents were finalized within WP2: the study protocol, CRF, informed consents, the Investigator Manual, and all the forms required for handling biological samples. Ethical Clearance was obtained in all the clinical sites. A 2-day Investigators Training Meeting was held in Lodz. Following SAB and DEMB recommendations, a protocol amendment was approved introducing the use of a gold-standard measurement of GFR (NCT04449172).
Within WP3, field activities have commenced. At the end of the project, 2435 patients were successfully enrolled. Data collected were inserted in an electronic CRF, while biological samples were stored at the INRCA BioGer BioBack (member of the Italian Node of the European Infrastructure BBMRI-ERIC) to Ancona, Italy, where the INRCA is realizing a large biobank. Results from WP3 are published in the D3.1.
Within WP4, researchers at UU following the comparative evaluation of metric characteristics of the biomarker, identify a list of promsing biomarkers using existing data from ULSSAM and PIVUS. Endostatin, Osteopontin and KIM1 as both circulating and urine biomarkers were first selected because of the evidence supporting their potential relevance within the SCOPE project scenario. Results from the statistical analysis on biomarker are published in the D4.2.
WP5 activities dealt with all the issues related to Data Management and Statistics. These included the implementation of the statistical section of the study protocol, the design and implementation of the electronic CRF and the generation and continuous monitoring of the study database. A Data Management and Statistical Plan was created and agreed among the partnership.
WP6 conducted Health Technology Assessment (HTA) and Health Economic Analyses (HEA). The first systematic review of SCOPE, addressing the relation between Kidney function and physical and cognitive disability was published and the final results are available in the D6.1.
A Dissemination, Communication and Exploitation plan was realized within WP7: the website and social media were periodically updated, fliers and brochure of the project or activities are available. An Educational Toolkit (MOOC) for student and general public was launched on October 2019 and n.10 open access publications were published on scientific ranked journals.
The final report including all the results of the project is available in the D7.5.
