title: Measurement tools of resource use and quality of life in clinical trials for dementia or cognitive impairment interventions: protocol for a scoping review.
abstract: Dementia and cognitive impairment could severely impact patients' life and bring heavy burden to patients, caregivers and societies. Some interventions are suggested for the older patients with these conditions to help them live well, but economic evaluation is needed to assess the cost-effectiveness of these interventions. Trial-based economic evaluation is an ideal method; however, little is known about the tools used to collect data of resource use and quality of life alongside the trials. Therefore, the aim of this review is to identify and describe the resource use and quality of life instruments in clinical trials of interventions for older patients with dementia or cognitive impairment.
  
  
  
  We will perform a search in main electronic databases (Ovid MEDLINE, PsycINFO, EMBASE, CINAHL, Cochrane Databases of Systematic Reviews, Web of Science and Scopus) using the key terms or their synonyms: older, dementia, cognitive impairment, cost, quality of life, intervention and tools. After removing duplicates, two independent reviewers will screen each entry for eligibility, initially by title and abstract, then by full-text. A hand search of the references of included articles and general search, e.g. Google Scholar, will also be conducted to identify potential relevant studies. All disagreements will be resolved by discussion or consultation with a third reviewer if necessary. Data analysis will be completed and reported in a narrative review.
  
  
  
  This review will identify the instruments used in clinical trials to collect resource use and quality of life data for dementia or cognitive impairment interventions. This will help to guide the study design of future trial-based economic evaluation of these interventions.
  
  
  
  PROSPERO CRD42016038495.
authors.affiliation: Manchester Centre for Health Economics, The University of Manchester, Manchester, UK.
authors.forename: Fan
authors.initials: F
authors.lastname: Yang
authors.affiliation: Manchester Centre for Audiology and Deafness, The University of Manchester, Manchester, UK.
authors.forename: Piers
authors.initials: P
authors.lastname: Dawes
authors.affiliation: Institute of Brain, Behaviour and Mental Health, The University of Manchester, Manchester, UK.
authors.forename: Iracema
authors.initials: I
authors.lastname: Leroi
authors.affiliation: The University of Queensland, Centre for Business and Economics of Health, Brisbane, Australia. brenda.gannon@uq.edu.au.
authors.forename: Brenda
authors.identifier: 0000-0002-3672-4030
authors.initials: B
authors.lastname: Gannon
mesh_terms: D000368:Aged; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D060825:Cognitive Dysfunction / Q000191:economics / Q000628:therapy*; D003362:Cost-Benefit Analysis; D003704:Dementia / Q000191:economics / Q000628:therapy*; D006801:Humans; D011788:Quality of Life / Q000523:psychology; D000098584:Scoping Reviews as Topic
keywords: Clinical trial; Cognitive impairment; Dementia; Quality of life; Resource use; Tool