title: Systematic review investigating the reporting of comorbidities and medication in randomized controlled trials of people with dementia.
abstract: OBJECTIVE
  dementia is a debilitating condition characterised by global loss of cognitive and intellectual functioning, which reduces social and occupational performance. This population frequently presents with medical co-morbidities such as hypertension, cardiovascular disease and diabetes. The CONSORT statement outlines recommended guidance on reporting of participant characteristics in clinical trials. It is, however, unclear how much these are adhered to in trials assessing people with dementia. This paper assesses the reporting of medical co-morbidities and prescribed medications for people with dementia within randomised controlled trial (RCT) reports.
  
  
  METHODS
  a systematic review of the published literature from the databases AMED, CINAHL, MEDLINE, EMBASE and the Cochrane Clinical Trial Registry from 1 January 1997 to 9 January 2014 was undertaken in order to identify RCTs detailing baseline medical co-morbidities and prescribed medications . Eligible studies were appraised using the Critical Appraisal Skills Programme (CASP) RCT appraisal tool, and descriptive statistical analyses were calculated to determine point prevalence.
  
  
  RESULTS
  nine trials, including 1474 people with dementia, were identified presenting medical co-morbidity data. These indicated neurological disorders (prevalence 91%), vascular disorders (prevalence 91%), cardiac disorders (prevalence 74%) and ischaemic cerebrovascular disease (prevalence 53%) were most frequently seen.
  
  
  CONCLUSIONS
  published RCTs poorly report medical co-morbidities and medications for people with dementia. Future trials should include the report of these items to allow interpretation of whether the results are generalisable to frailer older populations.
  CRD42013006735.
authors.affiliation: Faculty of Medicine and Health Sciences, University of East Anglia, Norwich Research Park, Norwich NR4 7TJ, UK.
authors.forename: Toby
authors.initials: T
authors.lastname: Smith
authors.affiliation: School of Life and Health Sciences, Medicines and Devices in Ageing, Aston Research Centre for Healthy Ageing (ARCHA), Aston University, Birmingham, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Maidment
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, UK.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Hebding
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, UK.
authors.forename: Tairo
authors.initials: T
authors.lastname: Madzima
authors.affiliation: Faculty of Medicine and Health Sciences, University of East Anglia, Norwich Research Park, Norwich NR4 7TJ, UK.
authors.forename: Francine
authors.initials: F
authors.lastname: Cheater
authors.affiliation: Faculty of Medicine and Health Sciences, University of East Anglia, Norwich Research Park, Norwich NR4 7TJ, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Cross
authors.affiliation: Faculty of Medicine and Health Sciences, University of East Anglia, Norwich Research Park, Norwich NR4 7TJ, UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: Poland
authors.affiliation: Department of Psychological Health and Wellbeing, Faculty of Health and Social Care, University of Hull, Hull, UK.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: White
authors.affiliation: Bradford Teaching Hospitals NHS Foundation Trust Head, Academic Unit of Elderly Care and Rehabilitation, University of Leeds, Leeds, UK.
authors.forename: John
authors.initials: J
authors.lastname: Young
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Fox
mesh_terms: D000367:Age Factors; D015897:Comorbidity; D003625:Data Collection / Q000592:standards; D003704:Dementia / Q000175:diagnosis / Q000453:epidemiology* / Q000523:psychology; D006801:Humans; D019338:Polypharmacy; D015995:Prevalence; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D012107:Research Design / Q000592:standards
keywords: co-morbidity; cognitive impairment; dementia; older people; systematic review