title: COGNITIVE-HD study: protocol of an observational study of neurocognitive functioning and association with clinical outcomes in adults with end-stage kidney disease treated with haemodialysis.
abstract: BACKGROUND
  The prevalence of cognitive impairment may be increased in adults with end-stage kidney disease compared with the general population. However, the specific patterns of cognitive impairment and association of cognitive dysfunction with activities of daily living and clinical outcomes (including withdrawal from treatment) among haemodialysis patients remain incompletely understood. The COGNITIVE impairment in adults with end-stage kidney disease treated with HemoDialysis (COGNITIVE-HD) study aims to characterise the age-adjusted and education-adjusted patterns of cognitive impairment (using comprehensive testing for executive function, perceptual-motor function, language, learning and memory, and complex attention) in patients on haemodialysis and association with clinical outcomes.
  
  
  METHODS
  A prospective, longitudinal, cohort study of 750 adults with end-stage kidney disease treated with long-term haemodialysis has been recruited within haemodialysis centres in Italy (July 2013 to April 2014). Testing for neurocognitive function was carried out by a trained psychologist at baseline to assess cognitive functioning. The primary study factor is cognitive impairment and secondary study factors will be specific domains of cognitive function. The primary outcome will be total mortality. Secondary outcomes will be cause-specific mortality, major cardiovascular events, fatal and non-fatal myocardial infarction and stroke, institutionalisation, and withdrawal from treatment at 12 months.
  
  
  BACKGROUND
  This protocol was approved before study conduct by the following responsible ethics committees: Catania (approval reference 186/BE; 26/09/2013), Agrigento (protocol numbers 61-62; 28/6/2013), USL Roma C (CE 39217; 24/6/2013), USL Roma F (protocol number 0041708; 23/7/2013), USL Latina (protocol number 20090/A001/2011; 12/7/2013), Trapani (protocol number 3413; 16/7/2013) and Brindisi (protocol number 40259; 6/6/2013). All participants have provided written and informed consent and can withdraw from the study at any time. The findings of the study will be disseminated through peer-reviewed journals and national and international conference presentations and to the participants through communication within the dialysis network in which this study is conducted.
authors.affiliation: Department of Medicine, University of Otago Christchurch, Christchurch, New Zealand.
authors.forename: Suetonia C
authors.initials: SC
authors.lastname: Palmer
authors.affiliation: Diaverum Medical Scientific Office, Lund, Sweden Division of Nephrology and Transplantation, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy.
authors.forename: Marinella
authors.initials: M
authors.lastname: Ruospo
authors.affiliation: Neurodegenerative Diseases Unit, Department of Clinical Research in Neurology, University of Bari "A. Moro", Tricase, Lecce, Italy.
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Barulli
authors.affiliation: Neurodegenerative Diseases Unit, Department of Clinical Research in Neurology, University of Bari "A. Moro", Tricase, Lecce, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Iurillo
authors.affiliation: Diaverum Medical Scientific Office, Lund, Sweden.
authors.forename: Valeria
authors.initials: V
authors.lastname: Saglimbene
authors.affiliation: Diaverum Medical Scientific Office, Lund, Sweden.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Natale
authors.affiliation: Diaverum Medical Scientific Office, Lund, Sweden.
authors.forename: Letizia
authors.initials: L
authors.lastname: Gargano
authors.affiliation: Diaverum Medical Scientific Office, Lund, Sweden.
authors.forename: Angelo M
authors.initials: AM
authors.lastname: Murgo
authors.affiliation: Huntington Disease Service, Westmead Hospital, Westmead, NSW, Australia.
authors.forename: Clement
authors.initials: C
authors.lastname: Loy
authors.affiliation: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.
authors.forename: Anita
authors.initials: A
authors.lastname: van Zwieten
authors.affiliation: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.
authors.forename: Germaine
authors.initials: G
authors.lastname: Wong
authors.affiliation: Neurodegenerative Diseases Unit, Department of Clinical Research in Neurology, University of Bari "A. Moro", Tricase, Lecce, Italy.
authors.forename: Rosanna
authors.initials: R
authors.lastname: Tortelli
authors.affiliation: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Craig
authors.affiliation: Department of Nephrology, Princess Alexandra Hospital, Woolloongabba, Australia.
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
authors.affiliation: Cumming School of Medicine, Health Services, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Marcello
authors.initials: M
authors.lastname: Tonelli
authors.affiliation: Diaverum Medical Scientific Office, Lund, Sweden.
authors.forename: Jörgen
authors.initials: J
authors.lastname: Hegbrant
authors.affiliation: Diaverum Medical Scientific Office, Lund, Sweden.
authors.forename: Charlotta
authors.initials: C
authors.lastname: Wollheim
authors.affiliation: Neurodegenerative Diseases Unit, Department of Clinical Research in Neurology, University of Bari "A. Moro", Tricase, Lecce, Italy Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari "A. Moro", Bari, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Logroscino
authors.affiliation: Diaverum Medical Scientific Office, Lund, Sweden Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia Department of Emergency and Organ Transplantation, University of Bari, Piazza Giulio Cesare, Bari, Italy Diaverum Academy, Bari, Italy.
authors.forename: G F M
authors.initials: GF
authors.lastname: Strippoli
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D002423:Cause of Death; D002985:Clinical Protocols; D003071:Cognition; D003072:Cognition Disorders / Q000209:etiology*; D056344:Executive Function; D006801:Humans; D007558:Italy; D007676:Kidney Failure, Chronic / Q000150:complications / Q000401:mortality / Q000523:psychology* / Q000628:therapy; D007858:Learning; D008137:Longitudinal Studies; D008568:Memory; D009048:Motor Skills; D009483:Neuropsychological Tests; D010352:Patient Dropouts; D011446:Prospective Studies; D006435:Renal Dialysis; D012107:Research Design; D016896:Treatment Outcome