Short summary

This study will focus on quantifying and elucidating the prevalence of "Body image concerns" in women versus men, using a mixed-methods design (both qualitative and quantitative data).  

Rationale

The implantable cardioverter defibrillator (ICD) is the first-line therapy for the primary and secondary prevention of sudden cardiac death. Despite the unequivocal medical benefits, ICD therapy is associated with increased risk of device-related complications that may have a negative influence on patients' well-being and quality of life. It has been proposed that women are more likely to report body image concerns post implant, due to the scar at the site of implant, as compared to men. Overall, there is a lack of consensus whether body image concerns are more prevalent in women than in men.   

Description of the cohort

Patients implanted with a first-time ICD (lived from 3 months to 2 years with their ICD), >18 years of age, speaking and understanding Danish.

Patients implanted with a first-time ICD within the last 2 years at Odense University Hospital (expected sample size 400 patients), as identified via the "Danish Pacemaker and ICD Register", >18 years of age, speaking and understanding Danish.

Data and biological material

PHASE ONE:

The qualitative part will consist of four parts:

(I)

A scoping literature review will be conducted to provide input to design an interview guide. 

(II)

Three focus group interviews with patients will be conducted to identify themes and topics that can be included in a quantitative questionnaire (expected sample size per group = 10). These patients will be identified via the ICD clinic at the Department of Cardiology, Odense University Hospital. Participants in the focus group interviews will receive verbal and written information about the study and sign an informed consent form.

(III)

The quantitative questionnaire will be designed on the basis of patients' input from the above interviews and the literature.

(IV)

A final draft of the prototype questionnaire will be presented to 4 patients, to evaluate whether the items in the questionnaire are understandable and relevant, and if there is anything we have overlooked, leading to a final version that will be tested before administration to patients in the quantitative phase.

PHASE TWO:

In the quantitative phase, a questionnaire will be designed to tap into body image concerns and be administered to patients extracted from the "Danish Pacemaker and ICD Register", (expected sample size 300-400 patients).

Collaborating researchers and departments

Department of Cardiology, Odense University Hospital and Department of Psychology, University of Southern Denmark

• Professor of Cardiac Psychology Susanne S. Pedersen, PhD

Department of Cardiology, Odense University Hospital

• Clinical Associate Professor, Consultant, MD, PhD Jens B. Johansen

Department of Cardiology, Linköping University Hospital, Sweden

• Professor, Heart Failure Nurse Specialist PhD, NFESC, FAAN Anna Strömberg

Publications associated with the project

Frydensberg VS, Johansen JB, Möller S, Strömberg A, Pedersen SS. Psychometric evaluation of the implantable cardioverter defibrillator body image concerns questionnaire (ICD-BICQ). J Cardiovasc Electrophysiol. 2021 Aug;32(8):2295-2311. doi: 10.1111/jce.15122. Epub 2021 Jun 14. PMID: 34091980.