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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 3 - SCOPE (Screening for Chronic Kidney Disease (CKD) among Older People across Europe (SCOPE))

Teaser

Summary

What is the problem/issue being addressed?
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.

Why is it important for society?
CKD is an important public health problem worldwide, especially in older people. Evidence shows that, 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.

What are the overall objectives?
SCOPE is a 48-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 are:
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.

Work performed

SCOPE is implementing an observational, multinational, multicenter, prospective cohort study which involves the recruitment of 2,450 patients in 7 Countries: Italy, Austria, Germany, Netherlands, Spain, Poland and Israel. In the first 18-month period, the consortium has been working on all those core activities which are essential to the success of the study.

Within WP1, SCOPE governance system has been formally established. Both internal and external bodies (i.e. the â€œScientific Advisory Boardâ€ â€“SAB- and the â€œData and Ethics Management Boardâ€ â€“DEMB) have been identified. Two meetings have been held, in Ancona (Italy, 21-22 May 2015) and Lodz (Poland, 23-24 February 2016). The Communication infrastructure has been set up, mainly using following tools: the project website, the project newsletter and the protected web-site (intranet).

All study documents have been 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 has been approved introducing the use of a gold-standard measurement of GFR.

Within WP3, field activities have commenced. At the time being, almost 500 patients have been successfully enrolled. Data collected are inserted in an electronic CRF, while biological samples are temporarily stored at the clinical sites and then sent to Ancona, Italy, where the INRCA is realizing a large biobank.

Within WP4, researchers at UU are currently implementing discovery and validation of new biomarkers of CKD, using existing data from ULSSAM and PIVUS. Results from this analysis have been published and will be tested within the new cohort after the data collection period.

WP5 activities have 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 has been created and agreed among the partnership.

WP6 has 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 is almost complete and will be submitted to a peer-reviewed journal within the next two months.

A Dissemination, Communication and Exploitation plan has been realized within WP7: the study has been registered on clinicaltrials.gov (NCT02691546), the website is periodically updated, fliers and brochure of the project are already available. The first official press conference of the project has been held in Vienna on May 22nd 2016, concomitant to the 53rd ERA-EDTA congress.

Final results

To date, no comprehensive screening strategy specifically targeting older subjects with CKD has been developed and validated. As such, this is the first attempt to demonstrate the impact of a comprehensive assessment methodology in this field.

SCOPE will compare 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 will assess screening methodologies including the use of CGA for the global evaluation of functional and nutritional status.

SCOPE will create a previously not available database which may pave the way to the creation of an Evidence Based approach in the screening for CKD among older people. This would finally achieve the goal of improving the overall quality of care provided while promoting equal access and abating the differences.

Ultimately, the SCOPE investigators have the ambition to provide clinicians a methodology for careful and comprehensive screening of CKD in older people, able to reduce incorrect labeling of patients and related interventions. SCOPE has thus the potential to radically change the method of screening for CKD, leading to a significant advancement beyond the state-of-the-art. Findings from the SCOPE project will be useful for developing European recommendations for CKD screening and management for older people, as well as a dedicated European education programme.