Do women derive the same benefits as men?

Projekt title

A one-size fits all approach to implantable cardioverter defibrillator therapy - do women derive the same benefits as men?

Project manager

Vivi Skibdal Frydensberg

Project description

Background: 
The implantable cardioverter defibrillator (ICD) is the first-line therapy for the prevention of sudden cardiac death. Despite unequivocal medical benefits, ICD therapy is associated with increased risk of complications and psychological morbidity. There is a lack of large-scale studies examining whether women experience the same benefits from ICD therapy as men and whether body image concerns are more prevalent in women than in men.

Objectives:
To evaluate:

• The prevalence and impact of body image concerns in ICD patients;
• The prevalence of body image concerns in women versus men, and the association between body image concerns and symptoms of anxiety and depression;
• The influence of indication for ICD implantation on patient-reported outcomes (PROs) at 12 months stratified by gender;
• The influence of gender on time to ventricular tachyarrhythmia (VT)/ventricular fibrillation (VF) and mortality at 3-years follow-up

Methods:
National, multi-center prospective observational study (DEFIB-WOMEN; n = 1790) and a mixed-methods study.

Perspectives:
To date, no study has been set up a priori to examine gender differences in PROs, complications, morbidity and mortality. Should women prove to have poorer outcomes and experience more body concerns than men, the study has the potential to impact clinical practice and improve the quality of care for women, through differentiated and optimized treatment and care. If patients are shown to have an increased risk of mortality depending on their levels of anxiety and depression, it will be paramount to introduce systematic screening for anxiety and depression in the outpatient clinics. Whether this risk is gender specific or not, this would support a revision of the national clinical guideline on cardiac rehabilitation (where patients are screened for psychological morbidity) to also encompass ICD patients. This patient group is currently not included in the guideline.

Start date and expected end date

01.01.2017 – 31.12.2019

Main supervisor

Professor Susanne S. Pedersen, Institut for Psykologi, SDU

Co-supervisors

Consultant Dr. Jens Brock Johansen, Odense University Hospital

The project is carried out under

INSIDE Research Group

Collaborators

Aarhus University Hospital, Aalborg University Hospital, Copenhagen University Hospital, Gentofte Hospital

Funding

Foundation (for the original DEFIB-WOMEN study)

Keywords

Implantable cardioverter defibrillator, depression, anxiety, body image concerns, PROs, morbidity, mortality