title: Patient-reported outcomes in Danish implantable cardioverter defibrillator patients with a Sprint Fidelis lead advisory notification.
abstract: OBJECTIVE
  Few studies have investigated the association between implantable cardioverter defibrillators (ICDs) and lead advisory notifications and patient-reported outcomes (PROs). We examined (i) whether the mode used to inform patients about a device advisory is associated with PROs, and (ii) whether patients with a lead subject to a device advisory report poorer PROs than non-advisory controls.
  
  
  RESULTS
  Patients (n= 207) implanted with an ICD at Aarhus University Hospital, Denmark, with a Sprint Fidelis lead subject to an advisory and a non-advisory control group (n= 510), completed a set of standardized PRO measures. A Bonferroni correction was applied to all statistical PRO comparisons to adjust for multiple comparisons, with a P-value of 0.0038 (0.05/13 PROs) indicating statistical significance. Device advisory patients did not differ significantly on PROs according to mode of notification (all P-values >0.0038). They also did not differ significantly from controls on mean scores of depression, anxiety, device acceptance, and health status (all P > 0.0038). Differences were only found on ICD concerns (P< 0.0001) and on mental health status (P = 0.003), with advisory patients reporting fewer ICD concerns and a better mental health status than non-advisory controls.
  
  
  CONCLUSIONS
  The mode used to inform ICD patients about the advisory was not associated with PROs, nor was the overall well-being of device advisory patients impaired compared to non-advisory controls. These results indicate that ICD patients are generally able to cope with a device advisory.
authors: Department of Medical Psychology, CoRPS-Center of Research on Psychology in Somatic diseases, Tilburg University, Warandelaan 2, PO Box 90153, 5000 LE Tilburg, The Netherlands. s.s.pedersen@uvt.nl
authors: Susanne S
authors: SS
authors: Pedersen
authors: Henneke
authors: H
authors: Versteeg
authors: Jens C
authors: JC
authors: Nielsen
authors: Peter T
authors: PT
authors: Mortensen
authors: Jens B
authors: JB
authors: Johansen