Translation, validation and cross-cultural adaptation of two specific questionnaires for the assessment of outcomes reported by implantable cardioverter-defibrillator recipients

Abstract

Currently there is sufficient evidence to support the effectiveness of implantable cardioverter-defibrillator (ICD) in the prevention of sudden cardiac death. The impact of ICD on the quality of life has also been explored in several studies, however, to date, this issue has not been fully clarified, mainly due to the great heterogeneity of the available studies and the lack of specific questionnaires for ICD patients. Objective: To perform the translation and cross-cultural adaptation of two specific questionnaires: "Florida Shock Anxiety Scale" (FSAS) and "Florida Patient Acceptance Scale" (FPAS) into Brazilian Portuguese language for evaluation of implantable cardioverter defibrillator (ICD) recipients. Methods: The study has two parts: Part 1 - Translation and cross-cultural adaptation of two specific questionnaires for the assessment of outcomes reported by ICD recipients according to international guidelines; Part 2 - Evaluation of patient reported outcomes in two moments: inclusion and 6-months after the first evaluation. Will be considered eligible for the study, adults with the following characteristics: (1) ICD implanted for more than 6 months; (2) Possibility of attending the InCor-HCFMUSP to carry out the study evaluations; (3) Ability to understand and answer the questionnaires; (4) Accept to participate in the study by signing the informed consent. The sample will consist of 150 patients who will be consecutively selected during outpatient care or by visits to the inpatient unit of our institution. To evaluate patient reported outcomes the following questionnaires will be used: SF-36, Beck Anxiety Inventory, Beck Depression Inventory II, FSAS, FPAS and Visual Analogue Scale for assessment of pain caused by ICD shocks. The psychometric properties evaluation of FSAS and FPAS questionnaires will involve reliability analysis (test-retest technique, interobserver reliability and internal consistency), content and construct validity and responsiveness. All data collection forms will be developed in RED Cap system (Research Electronic Data Capture) hosted on the server of our institution. Statistical analysis will used intraclass correlation coefficient and the Bland-Altman method to evaluate the intraobserver reproducibility (test-retest) and inter-observer, the Cronbach's alpha coefficient for internal consistency of FSAS and FPAS questionnaires and Spearman and Pearson coefficients to evaluate the correlation between the scores of FSAS and FPAS with the scores of other questionnaires used in the study.