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CORDIS - Resultados de investigaciones de la UE

Screening for Chronic Kidney Disease (CKD) among Older People across Europe (SCOPE)

Periodic Reporting for period 4 - SCOPE (Screening for Chronic Kidney Disease (CKD) among Older People across Europe (SCOPE))

Período documentado: 2019-05-01 hasta 2020-10-31

Although Chronic kidney disease (CKD) prevalence is increasing, screening programme in Europe are highly heterogeneous, fragmented, being in most cases based on opportunistic rather than structured assessments of patients. Such screening measures rely on creatinine-based estimated glomerular filtration rate (eGFR) and urinary albumin. Unfortunately, all creatinine-based eGFR equations have some degree of inaccuracy, especially when used in older people, which leads to an increased risk of both over- and under-diagnosis. In addition, while older patients are usually affected by multimorbidity, polypharmacy, frailty, and disability, CKD screening programs to date have not included the use of comprehensive geriatric assessment (CGA), the only assessment technology able to capture the numerous dimensions of health status and their complex interactions in older people.

CKD is an important public health problem worldwide, especially in older people. Whereas the disease prevalence ranges between 10.2% and 16.0% in the adult population, this may peak up to over 50% among the 75+ age group. This suggests that future population aging in industrialized countries will be accompanied by an increase in the prevalence of CKD and its complications. Developing cost-effective strategies to cope with CKD is fundamental for ensuring quality of care, quality of life in older age, and the sustainability of healthcare systems in the EU.

SCOPE is a 66-month project aimed at evaluating a 2-year screening programme for CKD in a population of older patients, aged 75 years or more, in seven European Countries, in an attempt to investigate whether and to which extent currently available screening methods may identify older people at risk of worsening kidney function. The specific objectives of the SCOPE project were:
1. to assess existing methodologies for CKD screening among older adults using real-life data from a cohort of 2,450 75+ older patients;
2. to investigate novel and potentially useful application of existing and innovative biomarkers of CKD in older people, also including the use of a gold standard measurement of kidney function;
3. to evaluate the cost-effectiveness of existing and innovative CKD screening strategies in a population at high risk of developing kidney function decline and End-Stage Renal Disease;
4. to provide evidence for further development of European recommendations and guidelines, as well as a European education programme in this field.
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.
SCOPE compared currently used screening measures, with alternative ones entailing a novel application of existing biomarkers of kidney filtration, in regards to their accuracy in predicting outcomes and cost-effectiveness.
Additionally, SCOPE assessed screening methodologies including the use of CGA for the global evaluation of functional and nutritional status.

Thanks to the implementation of the action, it was possible to provide first recommendations for clinical guidelines available for the public in the area of CKD screening:
N 1 – CKD screening help to improve CKD management and to reduce its burden among older people
N 2 – The analysis of classificatory properties of different screening methods in older population showed that eGFR equations should not be used interchangeably to assess kidney function or to apply risk assessment systems.
N 3 - Innovative biomarkers contribute to improve the clinical and risk assessment of CKD among older people
N 4 – Innovative biomarkers help to predict eGFR decline over time and improve the accuracy of baseline eGFR in predicting its decline over time, which is true only for selected eGFR equations
N 5 – Comorbidities and disability significantly affect the burden of CKD in multivariable models, indicating that comprehensive geriatric assessment is of paramount importance to address the need of reducing CKD-related healthcare costs.
N 6 – Relevant differences in cost-effectiveness of different CKD screening methods (i.e. eGFR equations) must be taken into consideration in clinical practice guidelines, as well as policy making

The SCOPE database will pave the way to increase Evidence Based approach in the screening for CKD among older people and to improve the overall quality of care provided to older people while promoting equal access and abating the differences.