| کلیدواژههای انگلیسی مقاله |
Vasovagal syncope, Questionnaires, Quality of life, Cross-cultural comparison, What&,rsquo s Known Vasovagal syncope is a common form of reflex syncope that significantly impacts quality of life. Several tools to assess its clinical and psychosocial effects have been developed and validated in various languages. What&,rsquo s New This study established the first valid and reliable Persian version of the syncope functional status questionnaire (SFSQ). This instrument could aid in better understanding the needs of Persian-speaking patients with vasovagal syncope. IntroductionSyncope is a clinical syndrome involving the cardiovascular and nervous systems. It is characterized by a sudden, transient, and complete loss of consciousness, followed by spontaneous and full recovery. 1, , 2, Among the various etiologies of syncope, the most prevalent is neurally mediated or reflex syncope&,mdash particularly vasovagal syncope (VVS). This contrasts with the less common but potentially life-threatening cardiac syncope. VVS is characterized by a transient loss of consciousness resulting from a sudden drop in heart rate and blood pressure, typically triggered by prolonged standing, emotional stress, or pain. Although VVS is generally benign and self-limiting, its recurrent and unpredictable nature can significantly impact a patient&,rsquo s quality of life (QoL). The absence of symptoms between episodes often complicates diagnosis, posing challenges for both patients and physicians. Extensive research has been conducted to better understand the underlying mechanisms of VVS, including its pathophysiology, which involves reduced venous return and cardiac output, leading to activation of the vasovagal reflex. Despite its benign prognosis, the burden of recurrent episodes warrants further investigation into its physiological basis and clinical presentation. 3, , 4, Among healthy individuals, approximately 35% will experience at least one syncope episode in their lifetime. These episodes can significantly impact an individual&,rsquo s QoL, and several studies have established a clear relationship between syncope and a decline in overall QoL. 5, - 7, The relationship between syncope and diminished QoL and mental health is direct. This evidence highlighted the significant burden of syncope and underscored the necessity for further research in this area. 6, - 8, Many studies assessing the QoL in patients with cardiovascular diseases utilize the Short Form 36 (SF-36) questionnaire. 3, , 4, , 7, The SF-36 is an internationally recognized tool designed to measure physical, mental, and emotional health across eight distinct domains. 9, Among the specific questionnaires focusing on syncope, the syncope functional status questionnaire (SFSQ) evaluates both the physical and psychological dimensions of the condition and its consequences. This specialized tool consists of 11 yes/no questions that assess the quality of daily life, along with three eight-point Likert-scale questions measuring fear and worry. The impairment score was calculated by dividing the number of areas in which syncope interferes with the patient&,rsquo s life (ranging from 0-11) by the total number of areas applicable to a patient&,rsquo s life, multiplied by 100. This score ranges from 0 to 100, with higher scores representing greater interference. The three Likert-scale questions are linearly converted to a 0-100 scale and averaged to calculate the fear&,ndash worry score, also scaled from 0 to 100, where higher scores indicate more fear and worry. A syncope dysfunction score (SDS) is then calculated as the mean of the impairment score and the fear&,ndash worry score. 10, , 11, The SFSQ has been extensively used in various studies to evaluate QoL in patients with syncope, and its reliability and validity are well established in both English-speaking and non-English-speaking populations. 12, - 14, Using a disease-specific tool enables more precise assessment of treatment outcomes and disease severity. Therefore, developing a culturally adapted Persian version of the SFSQ is crucial for improving the understanding and management of syncope in Persian-speaking patients. 14, - 16, While the SFSQ has been validated in other languages, the methodologies used for translation and the psychometric outcomes of those adaptations were often not detailed. The development of a Persian version of the SFSQ, with established validity and reliability, is essential for standardizing national studies and aligning them with international research in the field of syncope. Therefore, the objective of this study was to evaluate the reliability and validity of the Persian version of the SFSQ in patients presenting with syncope.Materials and Methods Translation and Cross-cultural Adaptation This study was conducted following approval from the Local Ethics Committee of Tehran University of Medical Sciences (Tehran, Iran) (code, IR.TUMS.IKHC.REC.1399.262). Written informed consent was obtained from all participants. The research involved a systematic process, including forward and backward translation of the original questionnaire, multiple expert reviews, and pilot testing with cognitive debriefing. These procedures were employed to ensure semantic, conceptual, and cultural equivalence between the original English version and the Persian adaptation (figure 1,). The Persian version of the questionnaire and its English back-translation are provided in Supplementary files 1 and 2,, respectively.Figure 1. The diagram depicts the step-by-step process of translation methodology. Step 1, Forward Translation The original English questionnaire was independently translated into Persian by two translators. They were instructed to use straightforward language that conveyed the original meaning, rather than adhering to a literal, word-for-word translation. One translator was a physician familiar with the concepts addressed in the questionnaire, while the other was a professional translator without a medical background, ensuring an unbiased perspective. Step 2, Synthesis of the Translations The two translated versions were compared, and any discrepancies were discussed in detail. This collaborative process resulted in a single, unified Persian translation of the questionnaire. Step 3, Back Translation The synthesized Persian version was independently translated back into English by two native Persian speakers fluent in English, both of whom had lived in English-speaking countries for a long time. They were blinded to the original English questionnaire and had no prior knowledge of the concepts being assessed to ensure an unbiased back-translation. Step 4, Compare Back Translation to Source and Expert Review A committee comprising an epidemiologist, a cardiologist, a cardiac electrophysiology specialist, an interventional cardiology specialist, a psychiatrist, a sports medicine specialist, and two translators compared the back translation with the original English source. They assessed the coherence and fidelity of the back translation, identifying and discussing any discrepancies until a consensus was reached on necessary modifications. This process yielded the pre-final version of the Persian questionnaire. Step 5, Pilot Study of the Pre-Final Version Fifty patients with syncope participated in a pilot study to assess their comprehension of the questionnaire. Each participant completed the SFSQ independently. Subsequently, the interviewer reviewed each item and response with the participant to initiate a discussion. At the conclusion of the interview, patients were asked to identify any difficult-to-understand words or phrases and to share their overall impressions.To assess content validity, a separate panel of eight experts individually reviewed each item using the content validity index (CVI). The final version of the Persian questionnaire was approved by this expert committee.Face validity was assessed by calculating a misunderstanding index for each item. Participants first shared their interpretation of each question&,rsquo s meaning. The percentage of individuals whose interpretations contradicted the question&,rsquo s intended purpose was calculated and recorded as the misunderstanding index. Based on previous studies, a rate of less than 20% was considered acceptable. 10, , 17, Any item with an index exceeding 20% would have required wording modifications. Data Collection Procedure Study participants were patients diagnosed with VVS following a comprehensive evaluation by a cardiac electrophysiologist, which included history-taking, physical examination, and a 12-lead electrocardiogram. If the diagnosis remained uncertain, additional evaluation was performed at the physician&,rsquo s discretion. Eligible individuals were aged 18 to 60 with a confirmed VVS history. Participants were required to have experienced at least two syncope episodes in the preceding year and to be literate in Persian. 12, , 13, Exclusion Criteria Participants were excluded from the study based on the following criteria, A history of structural heart disease (including coronary artery disease, valvular disorders, cardiomyopathy, or heart failure), abnormal baseline electrocardiogram results, the presence of arrhythmias, or the use of any cardiac devices, any diagnosed psychiatric disorder or epilepsy, or the experience of any syncope episodes during the test-retest interval.To sample size for assessing the questionnaire&,rsquo s readability was determined using STATA software (version 17, StataCorp LLC, College Station, TX, USA). Based on an expected proportion (P1) of 0.80, a 95% confidence interval, a specified width of 0.20, and two replicates, the required sample size was calculated to be 50 participants. This ensures adequate precision for evaluating the readability of the Persian version of the questionnaire.Based on the aforementioned criteria, 50 eligible patients were selected from those referred to the Cardiovascular Clinic of Imam Khomeini Hospital Complex (IKHC) between October 2022 and January 2023. To assess test-retest reliability, these 50 participants were asked to complete the questionnaire for a second time after a one-week interval. Statistical Analysis All analyses were conducted using SPSS software (version 26, SPSS Inc., Chicago, Illinois, USA). Quantitative and categorical variables were reported as mean&,plusmn SD and frequency (percentage), respectively. Test-retest reliability was assessed using the intra-class correlation coefficient (ICC) with a one-way random effects model for each item. Internal consistency for each aspect of the questionnaire was evaluated using Cronbach&,rsquo s alpha, with a value greater than 0.7 considered acceptable.The CVI for each item was determined based on ratings from the panel of experts. Experts rated each item on a three-point scale of relevance (1=useful and necessary, 2=not useful but necessary, and 3=unnecessary). Based on previous studies, the level of agreement must exceed the probability of chance occurrence. For a committee of eight members, the required agreement ratio was set at 0.75. Consequently, a CVI above this threshold was deemed acceptable for our evaluation. 14, Convergent validity was assessed by analyzing the relationship between the dimensions of the SFSQ and the corresponding domains of the SF-36 questionnaire, whose validity and reliability were established. The Pearson correlation coefficient was used for this analysis. The SF-36 is a 36-item questionnaire designed to assess QoL in the general population and among individuals with various medical conditions (figure 2,). Figure 2. The method of reliability and validity assessment is illustrated.Results Demographic Information The study included 50 patients, of whom 26 (52%) were women, and 24 (48%) were men. The mean age of the participants was 26.5&,plusmn 5.5 years. Test-Retest Reliability Results Test-retest reliability was calculated for each item. The mean kappa for all 11 yes/no questions, assessed over an 8-day interval, demonstrated good reliability. The kappa values for questions 12, 13, and 14 were 0.976, 0.975, and 0.927, respectively. As shown in table 1,, all items exhibited strong to excellent reliability. The overall Cronbach&,rsquo s alpha coefficient for the 14-item questionnaire was 0.84, indicating good internal consistency. Item numberItemKappa1Interfering with my life or routine12Preventing or causing me to avoid driving a vehicle13Reducing the amount of walking I do each day14Interfering with my use of public transportation (buses, trains, etc.)15Interfering with my performing errands (grocery shopping, housekeeping)16Interfering with my physical activities (entertainment, sports)17Affecting my ability to work at my job18Affecting my relations with my spouse /boyfriend /girlfriend19Affecting my relationship with my family110Affecting my relationships with my friends111Affecting my sexual functioning112How much do you worry about your episodes?0.97613How much do you fear a typical episode coming on?0.97514How does worry about an episode affect your daily life?0.927P&,lt 0.05 was considered statistically significant. |
| نویسندگان مقاله |
Shayan MirShafiee |
Department of Cardiology, School of Medicine, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
Somayyeh Moradi |
Department of Cardiology, School of Medicine, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
Ali Mehrakizadeh |
Department of Cardiology, School of Medicine, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
Reza Mazaheri |
Department of Sports and Exercise Medicine, Sports Cardiology Section, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran
Masih Tajdini |
Division of Cardiology, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA
Reza Mollazadeh |
Department of Cardiology, School of Medicine, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
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