title: Study Design and Cohort Description of DEFIB-WOMEN: A National Danish Study in Patients with an ICD.
abstract: BACKGROUND
  Little systematic evidence is available on potential gender differences in patients with an implantable cardioverter defibrillator (ICD) from a real-world cohort. We designed the DEFIB-WOMEN (The Utilization of Implantable Cardioverter DEFIBrillator Therapy in the Treatment of Heart Disease: Clinical and Psychological outcomes in WOMEN) study to examine gender differences on (1) patient-reported outcomes (PROs), (2) procedure- and device-related complications, and (3) ventricular tachyarrhythmia and mortality. This presents the study design and baseline characteristics of the cohort.
  
  
  METHODS
  DEFIB-WOMEN is a national, multicenter, prospective, observational study. First-time implanted patients are asked to complete PROs at several time points. Information on baseline and follow-up characteristics are captured from patients' medical records, purpose-designed questions, and the Danish national registers. The DEFIB-WOMEN cohort is composed of 1,790 (19% women; 343/1,790) patients implanted between June 2010 and April 2013.
  
  
  RESULTS
  Women and men differed on several demographic and clinical baseline characteristics, including on the prescription of β-blockers, statins, angiotensin-converting enzyme inhibitors, and psychotropic agents. Although women generally had a healthier clinical profile, they reported significantly more symptoms of anxiety and depression and ICD concerns (fear of shock) as compared to men. These differences were not only statistically significant but also clinically relevant, with the magnitude of the differences in anxiety and ICD concerns being 0.44 and 0.42, respectively, as indicated by Cohen's effect size index.
  
  
  CONCLUSIONS
  These preliminary results indicate that women with an ICD experience particularly more anxiety and ICD concerns as compared to men at the time of implant. Future results of DEFIB-WOMEN will show whether these gender differences persist and whether there are also gender differences in complications and survival.
authors: Department of Psychology, University of Southern Denmark, Odense, Denmark.|Department of Cardiology, Odense University Hospital, Odense, Denmark.|Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands.
authors: Susanne S
authors: SS
authors: Pedersen
authors: Department of Cardiology, Skejby, Aarhus University Hospital, Aarhus, Denmark.
authors: Jens Cosedis
authors: JC
authors: Nielsen
authors: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors: Sam
authors: S
authors: Riahi
authors: Department of Cardiology, Gentofte Hospital, Copenhagen University Hospital, Copenhagen, Denmark.
authors: Jens
authors: J
authors: Haarbo
authors: Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors: Regitze
authors: R
authors: VidebAEk
authors: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors: Mogens Lytken
authors: ML
authors: Larsen
authors: Department of Psychology, University of Southern Denmark, Odense, Denmark.
authors: Ole
authors: O
authors: Skov
authors: Department of Psychology, University of Southern Denmark, Odense, Denmark.
authors: Charlotte
authors: C
authors: Knudsen
authors: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors: Jens Brock
authors: JB
authors: Johansen
mesh_terms: D015331:Cohort Studies; D017147:Defibrillators, Implantable / Q000523:psychology*; D003718:Denmark; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012107:Research Design; D012737:Sex Factors; D016896:Treatment Outcome
keywords: complications; gender differences; implantable cardioverter defibrillator; mortality; patient-reported outcomes; ventricular tachyarrhythmia
  