title: Comparison of male and female psychological outcomes related to implantable cardioverter defibrillators (COMFORTID).
abstract: BACKGROUND
  While randomised, controlled trials have established the efficacy of the implantable cardioverter defibrillator (ICD) for primary and secondary prevention of life threatening arrhythmias, psychosocial responses remain complex and poorly understood, especially across Europe. There appears to be a greater need to understand differences in the experience of men and women.
  
  
  OBJECTIVE
  The aim of this prospective study was to explore differences in psychosocial adjustment over a 12 month period following ICD implantation.
  
  
  METHODS
  Fourteen female and thirty three male device recipients completed a series of questionnaires over a 12 month period. Instruments included a generic and an ICD specific Quality of Life (QOL) measure and the state-trait anxiety inventory.
  
  
  RESULTS
  Women reported higher levels of anxiety than men at discharge but over time demonstrated a significant improvement such that at 4, 8 and 12 months men were more anxious. Women reported significantly poorer emotional wellbeing at discharge, however by 12 months this was significantly improved with no difference in the perceptions held by men and women. Women consistently across the 12 months worried more than men about the impact of the device on appearance.
  
  
  CONCLUSIONS
  This study confirmed that most individuals adjust positively to the ICD during the first 12 months. Some gender differences in adjustment were evident. Further studies across Europe are warranted to establish gender specific interventions to support men and women as they adapt to life with ICD implants.
authors.affiliation: School of Healthcare, University of Leeds, UK. p.marshall@leeds.ac.uk
authors.forename: Paul
authors.initials: P
authors.lastname: Marshall
authors.forename: Alison
authors.initials: A
authors.lastname: Ketchell
authors.forename: Joan
authors.initials: J
authors.lastname: Maclean
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D000368:Aged; D001007:Anxiety / Q000209:etiology*; D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology; D012737:Sex Factors; D018709:Statistics, Nonparametric