title: Capacity, consent, and selection bias in a study of delirium.
abstract: OBJECTIVE
  To investigate whether different methods of obtaining informed consent affected recruitment to a study of delirium in older, medically ill hospital inpatients.
  
  
  METHODS
  Open randomised study.
  
  
  METHODS
  Acute medical service for older people in an inner city teaching hospital.
  
  
  METHODS
  Patients 70 years or older admitted to the unit within three days of hospital admission randomised into two groups.
  
  
  METHODS
  Attempted recruitment of subjects to a study of the natural history of delirium. This was done by either (a) a formal test of capacity, followed by either a request for consent or an attempt at obtaining assent from a proxy, or (b) a combined informal capacity/consent process.
  
  
  METHODS
  Prevalence and severity of delirium, and, as case mix measures, length of hospital stay and destination on discharge.
  
  
  RESULTS
  Recruitment of subjects through establishing formal capacity and then informed consent was less successful (43.9% v 74% of those approached) and, compared with those recruited through the usual combined capacity/consent approach, yielded a sample with less cognitive impairment, lower severity of delirium, lower probability of case note diagnosis of delirium and lower rate of entering a care home.
  
  
  CONCLUSIONS
  Methods of obtaining informed consent may significantly influence the case mix of subjects recruited to a study of delirium. Stringent testing of capacity may exclude patients with delirium from studies, thus rendering findings less generalizable. A different method is necessary to achieve an ethical balance between respecting autonomy through obtaining adequate informed consent and avoiding sample bias.
authors.affiliation: Academic Unit, Ladywell House, 330 Lewisham High Street, London SE13 6JZ, UK. dimaadamis@yahoo.com
authors.forename: D
authors.initials: D
authors.lastname: Adamis
authors.forename: F C
authors.initials: FC
authors.lastname: Martin
authors.forename: A
authors.initials: A
authors.lastname: Treloar
authors.forename: A J D
authors.initials: AJ
authors.lastname: Macdonald
mesh_terms: D000368:Aged; D003693:Delirium / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D016743:Mental Competency; D018579:Patient Selection; D012107:Research Design; D015983:Selection Bias
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