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

Andrea Corsonello, Lisanne Tap, Regina Roller-Wirnsberger, Gerhard Wirnsberger, Carmine Zoccali, Tomasz Kostka, Agnieszka Guligowska, Francesco Mattace-Raso, Pedro Gil, Lara Guardado Fuentes, Itshak Meltzer, Ilan Yehoshua, Francesc Formiga-Perez, Rafael Moreno-González, Christian Weingart, Ellen Freiberger, Johan Ärnlöv, Axel C Carlsson, Silvia Bustacchini, Fabrizia Lattanzio, SCOPE investigators, Fabrizia Lattanzio, Andrea Corsonello, Silvia Bustacchini, Silvia Bolognini, Paola D'Ascoli, Raffaella Moresi, Giuseppina Di Stefano, Laura Cassetta, Anna Rita Bonfigli, Roberta Galeazzi, Federica Lenci, Stefano Della Bella, Enrico Bordoni, Mauro Provinciali, Robertina Giacconi, Cinzia Giuli, Demetrio Postacchini, Sabrina Garasto, Annalisa Cozza Romano Firmani, Moreno Nacciariti, Mirko Di Rosa, Paolo Fabbietti Roberto Bernabei, Christophe Bula, Hermann Haller, Carmine Zoccali, Kitty Jager, Wim Van Biesen, Paul E Stevens, Andrea Corsonello, Lisanne Tap, Regina Roller-Wirnsberger, Gerhard Wirnsberger, Carmine Zoccali, Tomasz Kostka, Agnieszka Guligowska, Francesco Mattace-Raso, Pedro Gil, Lara Guardado Fuentes, Itshak Meltzer, Ilan Yehoshua, Francesc Formiga-Perez, Rafael Moreno-González, Christian Weingart, Ellen Freiberger, Johan Ärnlöv, Axel C Carlsson, Silvia Bustacchini, Fabrizia Lattanzio, SCOPE investigators, Fabrizia Lattanzio, Andrea Corsonello, Silvia Bustacchini, Silvia Bolognini, Paola D'Ascoli, Raffaella Moresi, Giuseppina Di Stefano, Laura Cassetta, Anna Rita Bonfigli, Roberta Galeazzi, Federica Lenci, Stefano Della Bella, Enrico Bordoni, Mauro Provinciali, Robertina Giacconi, Cinzia Giuli, Demetrio Postacchini, Sabrina Garasto, Annalisa Cozza Romano Firmani, Moreno Nacciariti, Mirko Di Rosa, Paolo Fabbietti Roberto Bernabei, Christophe Bula, Hermann Haller, Carmine Zoccali, Kitty Jager, Wim Van Biesen, Paul E Stevens

Abstract

Background: Decline 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/design: An 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.

Discussion: Combining 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 registration: This study was registered prospectively on the 25th February 2016 at clinicaltrials.gov ( NCT02691546 ).

Keywords: Ageing; Chronic kidney disease; Disability; Frailty; Older people.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approvals have been obtained by Ethics Committees in participating institutions as follows:

  1. Italian National Research Center on Aging (INRCA), Italy, #2015 0522 IN, January 27, 2016.

  2. University of Lodz, Poland, #RNN/314/15/KE, November 17, 2015.

  3. Medizinische Universität Graz, Austria, #28–314 ex 15/16, August 5, 2016

  4. Erasmus Medical Center Rotterdam, The Netherland, #MEC-2016-036 - #NL56039.078.15, v.4, March 7, 2016.

  5. Hospital Clínico San Carlos, Madrid, Spain, # 15/532-E_BC, September 16, 2016

  6. Bellvitge University Hospital Barcellona, Spain, #PR204/15, January 29, 2016.

  7. Friedrich-Alexander University Erlangen-Nürnberg, Germany, #340_15B, January 21, 2016.

  8. Helsinki committee in Maccabi Healthcare services, Bait Ba-lev, Bat Yam, Israel, #45/2016, July 24, 2016.

All patients must give their written informed consent before entering the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design of the SCOPE project

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