Design and methodology of the screening for CKD among older patients across Europe (SCOPE) study: a multicenter cohort observational study

Abstract

BackgroundDecline of renal function is common in older persons and the prevalence of chronic kidney disease (CKD) is rising with ageing. CKD affects different outcomes relevant to older persons, additionally to morbidity and mortality which makes CKD a relevant health burden in this population. Still, accurate laboratory measurement of kidney function is under debate, since current creatinine-based equations have a certain degree of inaccuracy when used in the older population. The aims of the study are as follows: to assess kidney function in a cohort of 75+ older persons using existing methodologies for CKD screening; to investigate existing and innovative biomarkers of CKD in this cohort, and to align laboratory and biomarker results with medical and functional data obtained from this cohort. The study was registered at ClinicalTrials.gov, identifier NCT02691546, February 25th 2016.Methods/designAn observational, multinational, multicenter, prospective cohort study in community dwelling persons aged 75 years and over, visiting the outpatient clinics of participating institutions. The study will enroll 2450 participants and is carried out in Austria, Germany, Israel, Italy, the Netherlands, Poland and Spain. Participants will undergo clinical and laboratory evaluations at baseline and after 12 and 24 months- follow-up. Clinical evaluation also includes a comprehensive geriatric assessment (CGA). Local laboratory will be used for ‘basic’ parameters (including serum creatinine and albumin-to-creatinine ratio), whereas biomarker assessment will be conducted centrally. An intermediate telephone follow-up will be carried out at 6 and 18 months.DiscussionCombining the use of CGA and the investigation of novel and existing independent biomarkers within the SCOPE study will help to provide evidence in the development of European guidelines and recommendations in the screening and management of CKD in older people.Trial registrationThis study was registered prospectively on the 25th February 2016 at clinicaltrials.gov (NCT02691546).

Clinical Implications of Estimating Glomerular Filtration Rate with Three Different Equations among Older People. Preliminary Results of the Project “Screening for Chronic Kidney Disease among Older People across Europe (SCOPE)”

“…To date, only few studies including multimorbid older subjects, also including those with physical functional deficits, have focused on this burning issue for clinical practice, but also research. The older people participating in the SCOPE study represent a rich source and wealth in several dimensions: people older than 75 years and living in a community were recruited and followed up for two years on a voluntary basis in this observational study with a wide recruitment frame and only few exclusion criteria [20]. Not surprisingly, women are outnumbering men participants as it is a fact that women account for a higher percentage of older community dwelling persons in many EU countries nowadays [27].…”

“…Given the fact that recent data on prevalence of CKD clearly demonstrated a sex bias for CKD, men being at higher risk for development of CKD [28], it was the major interest of the study team to also address sex differences when looking at the impact of the method used to calculate eGFR on staging of CKD based on creatinine-and albuminuria-based guidelines [4]. The access to data from a cohort older than 75 years, many of them multimorbid and prone to loss of muscle mass, made it possible for the consortium to further test the hypothesis that impaired physical performance and loss of muscle mass may impact the degree of agreement among eGFR equations in this cohort of older European citizens [20].…”

“…The SCOPE study (grant agreement number 436849), is a multicenter 2-year prospective cohort study involving patients older than 75 years attending geriatric and nephrology outpatient services in participating institutions in Austria, Germany, Israel, Italy, the Netherlands, Poland and Spain. Methods of the SCOPE study have been extensively described elsewhere [20]. Patients were requested to sign a written informed consent before entering the study.…”

“…It is therefore evident that a knowledge gap still exists and ongoing studies will likely help to bridge it [20]. Meanwhile, creatinine-based eGFR remains the less expensive and most widely available screening measure of kidney function.…”

Massive open online courses (MOOCs) for long-distance education in geriatric medicine across Europe

“…The SCOPE project (screening for chronic kidney disease among older people across Europe, grant agreement number 634869) was funded under the umbrella of the Horizon 2020 program of the European Commission (EC) in 2015. The project involves nine partners across Europe and Israel and aims at developing new standards in diagnostics and treatment of older citizens at risk for chronic kidney disease (CKD), as screening programs in Europe are highly heterogeneous, fragmented and in most cases based on opportunistic rather than structured assessments of patients [20,21]. During the SCOPE project, the impact of an innovative comprehensive screening methodology specifically targeting CKD among older people across Europe is addressed.…”