ABC | Volume 114, Nº5, May 2020

Original Article Silva et al. Florida Shock Anxiety Scale Arq Bras Cardiol. 2020; 114(5):764-772 ICD patients live with the expectation that, at any moment, the device will deliver shock therapies to interrupt ventricular arrhythmias resulting from their heart disease. Thus, although they recognize the benefits of the treatment, some patients may present with anxiety, depression, mood disorders, post-traumatic stress disorder, as well as fear that the device will not operate in crucial situations. 9-14 On the other hand, ICD implantation has been reported to provide the patient with a great sense of safety, considering the device’s capacity to interrupt unexpected episodes of potentially fatal ventricular arrhythmias. 10-14 In face of the concern about the deleterious effects of ICD on psychosocial adaptation, an scale was specifically developed to assess the level of anxiety related to the presence of ICD and to the shocks delivered by the device, for use both in clinical practice and in the context of scientific research. 15,16 The Florida Shock Anxiety Scale (FSAS) quickly achieved wide international acceptance, and has been translated and validated in several countries (Netherlands, 17 Denmark, 18 Poland, 19 China, 20 Norway, 21 Turkey 22 ), with consistent results. Objectives The purpose of the present study was to assess the psychometric properties of the Brazilian version of the FSAS for ICD patients. Methods Study design This study was conducted in a high-complexity cardiology hospital and it was approved by that hospital’s Committee of Ethics in Research. All subjects signed a free and informed consent form. Study location and ethical aspects This was a psychometric study of cross-cultural adaptation and validation of the FSAS. The Florida Shock Anxiety Scale (FSAS) The FSAS was developed in 2006 in the United States to provide a quantitative measure of ICD shock-related anxiety. The instrument consists of 10 items, with five response options (“not at all”,”rarely”,”some of the time”,”most of the time”,”all the time”), corresponding to a 5-point Likert scale. 15,16 Questions are related to patients’ fear or anxiety caused by the expectation that the device may deliver shock therapies and to the behavioral changes (not engaging in physical exercise or in sexual activity, or not getting angry or upset, for instance) to avoid the occurrence of ICD therapies. The FSAS total score is determined by the sum of all items, with a maximum score of 50 points. The higher the score, the higher the anxiety level. The items receiving three points or more should be considered the most critical aspects. 17,18 The instrument can be self-administered or administered by interview. Stage 1 – Translation and cross-cultural adaptation of the instrument The cross-cultural adaptation process of the FSAS followed international guidelines and included five stages: (1) Translation by two independent translators; (2) Synthesis of the translations; (3) Back-translation; (4) Harmonization of the translations by the expert committee; (5) Pretest with the target population; (6) Pretest review and final translation. 23-25 The expert committee was composed by professionals of the area of artificial cardiac stimulation and by nurses. The translation of the original instrument into Portuguese was performed by two independent Brazilian translators, proficient both in the Portuguese and English languages. In this stage, the translations produced by the two independent translators (T 1 and T 2 ) were reconciled into one version (T 1 - 2 ), after discussion with the expert committee. Working from the final version and blind to the original version, two bilingual teachers carried out the back- translations (RT 1 and RT 2 ). The aim of this stage was to measure the semantic and idiomatic consistency of the translations produced in the first stage. Finally, a new meeting was held with the expert committee to review all the cross-cultural adaptation process and undertake the harmonization across versions, thus obtaining the pre-final version of the instrument (Figure 1). The pretest version was administered in a convenience sample of 20 ICD patients, aged between 18 and 80 years, All patients were recruited during an outpatient cardiovascular clinic appointment, and were at least 6 months postimplant. The pretest was conducted to identify and correct possible translation problems. Following self-completion of the instrument, a clarifying interview was held to verify the existence of irrelevant or hardly understandable items, as well as to measure the understanding of each item of the instrument. It was established that the translation would be reviewed or reformulated if less than 80% of the participants were able to understand the items. Stage 2 – construct validation of the FSAS The final Portuguese version of the FSAS was administered to a convenience sample of 151 participants with the following characteristics: (1) adults, aged between 18 and 80 years, of both sexes and with any education level; (2) ICD implanted for more than 6 months; (3) capable of understanding and answering the questionnaire used in the study; (4) having agreed to participate in the study by signing the informed consent form. We did not include in the study patients presenting at least one of the following situations: (1) indication for cardiac transplantation; (2) ongoing pregnancy; (3) malignant neoplasia. Patients were selected consecutively, during outpatient care or by visits to the inpatient unit of our institution. Individuals who met the eligibility criteria were invited to answer the FSAS questionnaire. At the same time, demographic, clinical and ICD data were collected by using electronic case report forms developed in REDCap (26) (Research Electronic Data Capture) hosted at the hospital’s server. 765