Összefoglaló. Bevezetés: A perifériás verőérbetegség napjaink egyik világméretű népegészségügyi problémája, több mint 200 millió embert érint világszerte. A Peripheral Artery Disease Quality of Life (PADQOL) kérdőívet azzal a céllal fejlesztették ki, hogy a betegség fizikai tünetein kívül annak szubjektív betegségterhét, pszichoszociális és emocionális hatásait is vizsgálja. Célkitűzés: Az eredeti, angol nyelvű PADQOL betegségspecifikus, önkitöltős kérdőív magyar nyelvű, érvényes változatának kifejlesztése, annak fordítása, kultúrközi adaptációja és magyar nyelvi validálása. Módszerek: Az életminőség-kérdőív lingvisztikai validálása nemzetközi protokoll alapján történt: két szakfordító külön-külön lefordította a kérdőívet angol forrásnyelvről magyarra; egy harmadik szakfordító bevonásával elkészült a két verzió szintézise, majd azt két, angol anyanyelvű fordító visszafordította angol forrásnyelvre, amit konszenzusmegbeszélés követett. A „pre-final” magyar verzió érthetőségét 30, angiológiai járó és fekvő beteg bevonásával, kognitív interjúk lefolytatásával, pilotvizsgálat során teszteltük. A PADQOL kérdőív faktorstruktúrájának feltárásához faktoranalízist végeztünk, az alskálák megbízhatóságát, a tételek belső konzisztenciáját a Cronbach-alfa-együttható kiszámításával vizsgáltuk. Az elemzésekhez IBM SPSS 23.0 programcsomagot használtunk. Eredmények: A PADQOL nyelvi validálása jelentéstani, tapasztalati és idiomatikus ekvivalencia tekintetében nem jelentett nehézséget. A kognitív interjúk során egy kérdés esetén tapasztaltunk értelmezési nehézséget. A kérdőív „pre-final” verziója tartalmilag és nyelvileg könnyen érthető, kitöltése nem okoz nehézséget. Az egyes dimenziók Cronbach-α-értéke 0,624 és 0,887 között volt. A legrosszabb értéket a Félelem és bizonytalanság (score-átlag: 14,07) életminőség-dimenzió mutatta. Következtetés: Létrehoztuk a PADQOL kérdőív végső magyar verzióját, mely mérőeszköz alkalmas a nyelvi és kultúrközi adaptáció következő lépésének elvégzésére, nagyobb betegpopuláción történő pszichometriai és klinikometriai vizsgálat által a perifériás verőérbetegek életminőségének, szubjektív betegségterhének felmérését célzó validálásra. Orv Hetil. 2020; 161(51): 2153–2161. Summary. Introduction: Peripheral artery disease is one of the greatest, global public health concerns affecting more than 200 million people worldwide. The Peripheral Artery Disease Quality of Life questionnaire was developed to assess the subjective disease burden of peripheral artery disease, by focusing on psychosocial and emotional effects besides physical symptoms and functional limitations. Objective: To develop the valid Hungarian version of the original PADQOL via the standard linguistic validation and cross-cultural adaptation procedure. Methods: The linguistic validation was conducted according to an international protocol: two independent forward translations, a synthesis of the translations, back translations and consensus team review. The pilot-testing of the ’pre-final’ Hungarian version was conducted via cognitive interviews with 30 in- and outpatients attending the Department of Angiology. Factor analysis was performed, Cronbach-alpha values were calculated to establish the reliability of subscales and to determine the internal consistency if items. IBM SPSS 23.0 was used. Results: The linguistic validation of PADQOL into Hungarian posed no difficulties in terms of semantic, experiential and idiomatic equivalence. One item was found difficult to interpret during cognitive interviewing. The ‘pre-final’ version of the questionnaire was easy to understand and complete. Cronbach-alpha values of factors ranged between 0.624 and 0.887. The lowest value was that of factor 4: Fear and Uncertainty (mean score: 14.07). Conclusion: The linguistic validation of PADQOL into Hungarian was successful, the final Hungarian version is a tool that should reveal valuable insights with regard to subjective disease burden of patients living with peripheral artery disease subsequent to psychometric and clinicometric validation on a larger patient population. Orv Hetil. 2020; 161(51): 2153–2161.
Peripheral artery disease (PAD) is a progressive atherosclerotic disease significantly impacting functional status and health-related quality of life (HRQoL). This study aimed to investigate HRQoL among PAD patients in Hungary using the validated Hungarian version of the PADQoL questionnaire. Patients with symptomatic PAD were consecutively recruited from the Department of Angiology, Clinical Center, University of Pécs, Hungary. Demographics, risk factors, and comorbidities were registered. Disease severity was measured by Fontaine and WIFI stages. Descriptive statistical analysis, Chi-square test, and non-parametric tests were performed (p < 0.05). Overall, 129 patients (mean age 67.6 ± 11.9 years, men 51.9%) participated in our study. The Hungarian PADQoL demonstrated good internal consistency (α range: 0.745–0.910). Factors on intimate and social relationships gave the best (89.15 ± 20.91; 63.17 ± 26.05) and sexual function (28.64 ± 27.42), and limitations in physical functioning (24.68 ± 11.40) the worst scores. PAD had a significant negative impact on the social relationships of patients aged 21–54 years (51.6 ± 25.4). Fontaine stage IV patients experienced significantly lower HRQoL due to fear and uncertainty (46.3 ± 20.9) and limited physical functioning (33.2 ± 24.8). The Hungarian PADQoL identified central aspects of HRQoL. Advanced PAD was found to impact several areas of HRQoL, primarily physical functioning and psycho-social well-being, drawing attention to the importance of early diagnosis and management.
Objectives: The Kansas City Cardiomyopathy Questionnaire (KCCQ) has been widely used to measure heart failure (HF) patients' perception of their health status, symptoms, physical and social function and quality of life. However, as a disease specific measure, the KCCQ is not designed to estimate health-state utilities, precluding its use in cost-effectiveness research. This study used data from the COAPT trial to map KCCQ scores to the SF-6D utility index. Methods: Data were obtained from the COAPT trial-a prospective, randomized controlled trial of transcatheter mitral valve repair vs. standard care in 614 patients with HF and secondary mitral regurgitation. Patients completed the SF-36 and the KCCQ at baseline and at 1, 6, 12, and 24 months. We calculated SF-6D utility scores and KCCQ overall summary (KCCQ-OS) scores for both the full and short form (KCCQ-12) for each subject. Using mixed linear models with random effects for subjects, we regressed SF-6D utility scores on the KCCQ-OS and the KCCQ-12, testing for age and sex effects. Model fit was evaluated using conditional AIC, R 2 and correlation. Results: Both the KCCQ-OS and the KCCQ-12 score were closely correlated with SF-6D derived health utility (correlation of 0.76 and 0.77 for the KCCQ-OS and KCCQ-12). Model testing revealed a conditional R 2 of 0.71 for the model using the KCCQ-OS and 0.73 for the KCCQ-12. The addition of age and gender to the models had negligible impact on the results. Based on these data, the final mapping equations were 0.44 + 0.0035*(KCCQ-OS) and 0.45 + 0.0034*(KCCQ-12). Conclusions: The KCCQ-OS and the KCCQ-12 are excellent predictors of health state utility in patients with HF, as compared with the SF-6D utility estimates. Further studies are needed to validate these predictive models in other heart failure populations.
Objectives: The Kansas City Cardiomyopathy Questionnaire (KCCQ) has been widely used to measure heart failure (HF) patients' perception of their health status, symptoms, physical and social function and quality of life. However, as a disease specific measure, the KCCQ is not designed to estimate health-state utilities, precluding its use in cost-effectiveness research. This study used data from the COAPT trial to map KCCQ scores to the SF-6D utility index. Methods: Data were obtained from the COAPT trial-a prospective, randomized controlled trial of transcatheter mitral valve repair vs. standard care in 614 patients with HF and secondary mitral regurgitation. Patients completed the SF-36 and the KCCQ at baseline and at 1, 6, 12, and 24 months. We calculated SF-6D utility scores and KCCQ overall summary (KCCQ-OS) scores for both the full and short form (KCCQ-12) for each subject. Using mixed linear models with random effects for subjects, we regressed SF-6D utility scores on the KCCQ-OS and the KCCQ-12, testing for age and sex effects. Model fit was evaluated using conditional AIC, R 2 and correlation. Results: Both the KCCQ-OS and the KCCQ-12 score were closely correlated with SF-6D derived health utility (correlation of 0.76 and 0.77 for the KCCQ-OS and KCCQ-12). Model testing revealed a conditional R 2 of 0.71 for the model using the KCCQ-OS and 0.73 for the KCCQ-12. The addition of age and gender to the models had negligible impact on the results. Based on these data, the final mapping equations were 0.44 + 0.0035*(KCCQ-OS) and 0.45 + 0.0034*(KCCQ-12). Conclusions: The KCCQ-OS and the KCCQ-12 are excellent predictors of health state utility in patients with HF, as compared with the SF-6D utility estimates. Further studies are needed to validate these predictive models in other heart failure populations.
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