Original article Transcultural adaptation of VEINES/QOL-Sym questionnaire: evaluation of quality of life and symptoms in chronic venous disease Adaptação transcultural do questionário VEINES/QOL-SYM: avaliação da qualidade de vida e sintomas na doença venosa crônica Regina Márcia Faria de Moura1, Gabriela Silva Gonçalves2, Túlio Pinho Navarro3, Raquel Rodrigues Britto4, Rosângela Correa Dias5 Abstract Objective: To adapt cross-culturally and to analyze the clinimetric properties of the VEINES-QOL⁄Sym, which is a specific questionnaire to evaluate the quality of life and symptoms in patients with chronic venous disease. Methods: The VEINES-QOL⁄Sym was adapted according to the recommended methodology and administered to 74 subjects (53,7±12,3 years-old) with chronic venous disease, who were assisted at the outpatient clinic. Results: The results showed a good internal consistency for VEINES-QOL (Cronbach’s alpha (α) = 0,88) and VEINES/Sym (α=0,84). The inter and intra-rater reliability evaluated by the Intraclass Correlation Coefficient ranged from 0,95-0,98 for VEINES-QOL and 0,76-0,79 for the VEINES/Sym. The intraclass correlation coefficient was calculated for each item and some of them showed values lower than the expected, deserving a revision. The correlations with SF-36 were significant (p<0.001); however, of moderate magnitude. Only the VEINES-QOL was capable to distinguish the subjects in two groups, according to the severity of chronic venous disease (p=0.02). Conclusion: The VEINES-QOL/Sym, Brazil-Portuguese version has presented good clinimetric properties and has shown to be applicable to the population. Keywords: Translation; psychometrics; questionnaires; venous failure; quality of life. Resumo Objetivo: Adaptar transculturalmente e analisar as propriedades clinimétricas do VEINES-QOL⁄Sym, um questionário específico para avaliar a qualidade de vida e os sintomas na doença venosa crônica. Métodos: O VEINES-QOL⁄Sym foi adaptado segundo metodologia recomendada e aplicado em 74 indivíduos (53,7±12,3 anos) com doença venosa crônica, assistidos ambulatorialmente. Resultados: Os resultados evidenciaram boa consistência interna do VEINES-QOL (alfa de Cronbach - α=0,88) e do VEINES/Sym (α=0,84). A confiabilidade inter e intra-examinadores avaliadas pelo coeficiente de correlação intraclasse variou de 0,95-0,98 para o VEINES-QOL e de 0,76-0,79 para o VEINES/Sym. O coeficiente de correlação intraclasse foi calculado para cada item e alguns apresentaram valores abaixo do esperado merecendo revisão. As correlações com SF-36 foram significativas (p<0,001), porém com moderada magnitude. Apenas o VEINES-QOL foi capaz de distinguir os indivíduos em dois grupos, de acordo com a gravidade da doença venosa crônica (p=0,02). Conclusões: O VEINES-QOL/Sym, versão português-Brasil, apresentou boas propriedades clinimétricas e demonstrou ser aplicável na população. Palavras-chave: Tradução; psicometria; questionários; insuficiência venosa; qualidade de vida. Professor of the Physical Therapy Course from Centro Universitário Newton Paiva; Doctorate degree in Sciences of Rehabilitation by the Federal University of Minas Gerais (UFMG, acronym in Portuguese), Belo Horizonte (MG), Brazil. Volunteer scholarship student at UFMG, Belo Horizonte (MG), Brazil. 3 Associate Professor at UFMG, Belo Horizonte (MG), Brazil. 4 Full Professor at UFMG, Belo Horizonte (MG), Brazil. 5 Full Professor at UFMG, Belo Horizonte (MG), Brazil. Received on: 16.09.10. Accepted on: 31.01.11 J Vasc Bras. 2011;10(1):17-25. 1 2 18 J Vasc Bras 2011, Vol. 10, Nº 1 Introduction Technological and scientific advances in contemporary society have made it possible to diagnose and treat diseases more efficiently, increasing life expectancy and exposing the population to the risk of developing chronic degenerative diseases1. Amongst chronic diseases that affect adults, chronic venous disease (CVD) is relevant, being defined as a dysfunction in the venous system of lower limbs resulting from venous hypertension, which is caused by valve incompetence and/or obstruction of the venous flow2. Clinical manifestations of CVD are qualified based on etiologic, clinical, anatomical and pathological classifications (Clinical manifestations, Etiologic factors, Anatomic distribution of disease, and Pathophysiologic findings – CEAP). According to this classification, clinical signs are categorized into seven groups: C0 – nonvisible and nonpalpable signs of venous disease; C1 – telangiectasias or reticular veins; C2 – varicose veins; C3 – edema; C4 – changes in the skin and subcutaneous tissue (4a – pigmentation or eczema and 4b – lipodermatosclerosis or white atrophy); C5 – changes in the skin with healed ulcer; and C6 – changes in the skin with active ulcer3. Such clinical manifestations, that may or may not be associated with symptoms such as pain, cramps, itch and sensation of heavy legs and burning, are often related to limitations in daily activities and functional performance, not to mention psychological alterations and changes in perception of one´s health status. Due to such consequences, several authors have emphasized the importance of including quality of life (QOL) evaluation when approaching patients with CVD4-7. According to the World Health Organization Quality of Life Group (WHOQOL Group), QOL is defined as the individual’s perception of his/her position in life in the context of the cultural and value systems in which one lives, and in relation with personal objectives, expectations, patterns and concerns8. This is a broad and complex concept which involves physical health, psychological state, level of independence, social relations, personal beliefs and the relation with social environment 9-11. Venous Insufficiency Epidemiological and Economic Study (VEINES) is a multicenter study that aimed to evaluate clinical results, QOL, costs and use of health services by individuals with CVD12. Because there are few specific questionnaires that analyze QOL of patients with CVD, and most of the existing ones neglect the evaluation of functional, psychological and social impact of the disease, the authors have developed a particular instrument to assess Transcultural Adaptation of VEINES/QOL-Sym - Moura RMF et al. QOL in CVD, the Venous Insufficiency Epidemiological and Economic Study – Quality of life/Symptom (VEINESQOL/Sym). The format of the items, its content and answer scale were based on the Medical Outcomes Study Shortform 36 (SF-36), which is a generic instrument to evaluate QOL. VEINES-QOL/Sym was validated in four countries (Canada, Belgium, France and Italy) and has versions in English, French, Canadian French and Italian4,12. The original version of VEINES-QOL/Sym consists of a self-applicable questionnaire with 26 items: ten are related to symptoms (questions 1 and 7); nine to the development of daily life activities (questions 4, 5, and 6); one to the time of the day when symptoms become more intense (question 2); one considers changes that have occurred within the last year and are related to the disease (question 3); and five refer to psychological impact (question 8). The time considered for questions related to symptoms, limitations in daily life, and psychological impact covers the last four weeks4. VEINES-QOL/Sym produces two scores – VEINESQOL, that estimates the impact of CVD on QOL, and VEINES-Sym, which is related to symptoms resulting from CVD. In order to calculate the total score of VEINES-QOL, 25 items included in questions 1, 3, 4, 5, 6, 7 and 8 of the questionnaire must be taken into account. Question 2 is related to the time of the day when symptoms are more intense, and, therefore, should not be used to calculate the score, serving only descriptive purposes4. The score produced by VEINES-Sym includes ten items (questions 1 and 7), out of which nine are related to the following symptoms: heavy legs, sore legs, swelling, night cramps, heat or burning sensation, restless legs, throbbing, itching and numbness. Such symptoms are assessed by a five-point Likert scale according to their frequency. The other item, question 7, is related to pain in the legs and is evaluated as to its intensity by a six-point Likert scale4. Firstly, to calculate VEINES-QOL and VEINES-Sym scores, it is necessary to take the following steps: to recodify questions 3, 6 and 7 (inversion of score values); to calculate the mean and standard deviation of each item; to standardize each item in a Z-score with mean zero and standard deviation of one; and to calculate the individual’s score minus the mean of the question divided by the standard deviation. Total score is calculated as to the mean of Z-scores of the items involved. The final score is transformed so that it presents a mean of 50 and a standard deviation of 10, multiplying the total score by 10 and adding 50 to the result. If less than 50% of the 25 items included in VEINES-QOL score are answered, final score will not be calculated, and Transcultural Adaptation of VEINES/QOL-Sym - Moura RMF et al. the answer will be considered as absent. Likewise, if less than 50% of the 10 items are answered, the VEINES/Sym score will not be calculated. For both VEINES-QOL and VEINE-Sym, higher scores indicate better outcomes4,13. In its original version, the instrument presents good clinimetric proprieties, besides an objective, not onerous methodology, applicable in most settings, which completes conventional clinical evaluation4. QOL questionnaires are based on the sociocultural reality of the country of origin, and their application in populations with different sociocultural characteristics requires a judicious translation and the analysis of whether or not it is necessary to make cultural adaptations14-17. The original version of the VEINES-QOL/Sym questionnaire was developed in English, and, in order to apply it in other populations, besides translation, it is important to verify the need for transcultural adjustments aiming at the target population and to evaluate clinimetric properties. Mere literal translation of the instrument is not enough to apply it in other languages16,17. The purpose of the present study was to translate and culturally adapt VEINES-QOL/Sym, besides analyzing clinimetric proprieties of its Brazilian Portuguese version. Methodology Cross-sectional methodological study approved by the Research Ethics Committee of Hospital Municipal Odilon Behrens (Opinion 83/2006). The participants signed the informed consent form. Procedures Following recommendation by Beaton et al.16, VEINESQOL/Sym was initially translated to Brazilian Portuguese from the semantic, idiomatic, cultural, and conceptual point of view by two bilingual translators whose mother tongue was Portuguese. A synthesis of both translated versions were made during a meeting with the translators, aiming to achieve a single final version. From this moment on, the back translation was performed independently by two other qualified professionals, living in Brazil, whose mother tongue was English (language of the original instrument)16. A committee of expert judges, comprising professionals who were fluent in both languages and had knowledge about the subject, was assembled to produce the final version. The committee discussed linguistic and idiomatic equivalence between the translated, both back-translated and original versions, and found no need to eliminate any item. However, the inclusion of the activity “going to J Vasc Bras 2011, Vol. 10, Nº 1 19 church” in the examples of item “d”, question 4, was considered to be necessary. The committee also suggested to add the information “I can’t find a position for my legs” to the item “restless legs”. Another modification recommended by the committee was that the instrument should be applied by means of interviews, instead of being self-applicable, as in the original version. Such recommendation was suggested due to the fact that part of the assessed population might be illiterate or semi-illiterate. After the final version of the instrument had been approved by the committee, the proof technique recommended by Beaton et al.16 was performed with the use of VEINESQOL/Sym, Brazilian Portuguese version, on 30 adults from the general community who had been diagnosed with CVD and presented no cognitive changes that might interfere with the understanding of the questionnaire. Since there were no problems or doubts related to the writing or clarity of the items and answers, the version prepared by the judge committee was maintained16 (Appendix 1). VEINES-QOL/Sym Application, Brazilian Portuguese version Individuals diagnosed with CVD were selected regardless of gender, age or stage of the disease. They attended the vascular surgery clinic of a public health system hospital during the period of the research. Those who presented with the following diagnoses were excluded: chronic renal insufficiency; decompensated congestive heart failure; chronic obstructive pulmonary disease; lumbar radiculopathy; lower limb peripheral arterial disease (ankle-brachial index lower than 0.9); osteoarthritis in the lower limb joints, cognitive deficits or speech disorders that might interfere in the participation. Individuals were informed about the objectives of the research and invited to sign the informed consent form. Afterwards, they went through an interview to collect sociodemographic and clinical data. In order to characterize the clinical signs of CVD, the CEAP classification was used. Lower limbs were examined by visual inspection, always by the same trained examiner, with patients in the orthostatic position. In case both lower limbs were compromised, the one with the highest CEAP score was considered. Members classified as 4a (pigmentation or eczema) and 4b (lipodermatosclerosis or white atrophy) were gathered in the same group (Class 4)3. VEINES-QOL/Sym questionnaires, Brazilian Portuguese version, and SF-3618 were administered in the interview format, performed by two trained examiners who followed standard instructions. 20 J Vasc Bras 2011, Vol. 10, Nº 1 Transcultural Adaptation of VEINES/QOL-Sym - Moura RMF et al. Clinimetric Property Analysis Results The reliability of VEINES-QOL/Sym, Brazilian Portuguese version, was evaluated by analyzing the internal consistence and the inter and intraexaminers reliability. Internal consistency refers to the extension in which items that comprise certain scale measure the same construct14,19. It was analyzed by Cronbach alpha (α), and α values were considered as acceptable between 0.70 and 0.9019. Intra and interexaminers reliability was assessed through the application of the questionnaire by two previously trained examiners on 12 participants, in two different moments, with a seven to ten day interval between the two interviews. In the first moment, the individual was analyzed by examiner A and, in the second moment, the evaluation was repeated by examiner A, and also applied by examiner B. Intraclass correlation coefficient (ICC) was used to investigate intra and interexaminers reliability19. Convergent validity indicates that one scale’s measurements are correlated to another scale that evaluates the same construct, or a similar one. It was assessed by the correlation analysis (Pearson correlation) between the VEINES-QOL/Sym scores, Brazilian Portuguese, and those from the SF-36 questionnaire18. Such questionnaire is made of 36 questions, divided in eight domains: four are related to physical health (functional capacity, physical aspect, pain and general health state); and four related to mental health (vitality, social and emotional aspects and mental health). The final score varies from 0 to 100, and the higher the score, the better the individual’s perception of his or her QOL. The mean score of domains related to physical health represented the physical health component (PHC) score, and the mean score of domains related to mental health represented the mental health component (MHC) score18. The validity of known groups indicates the capacity of the instrument to distinguish individuals who present different characteristics. By means of a t test for independent samples, VEINES-QOL and VEINES/Sym means were compared in two groups, according to CEAP classification. One group was formed by CEAP 1, 2 and 3 participants (less clinically compromised regarding CVD), and the other one was formed by CEAP 4, 5 and 6 participants (more clinically compromised regarding CVD)19. Data were expressed in mean±standard deviation, minimum and maximum values, in percentage. Statistically significant difference was considered when α<5%19. Statistical Package for the Social Sciences (SPSS), version 16.0 for Windows® was used. Seventy-four subjects with mean age of 53.7±12.3 were assessed; 70.3% were women. All participants presented with some degree of venous compromise, 48.7% belonging to CEAP 5 and 6 class. Clinical and sociodemographic data are represented in Table 1. Results showed adequate internal consistency for VEINES-QOL (α=0.88) and VEINES/Sym (α=0.84), and also an adequate interexaminers (VEINES-QOL - ICC: 0.95 and VEINES/Sym - ICC: 0.76) and intraexaminers (VEINES-QOL - ICC: 0.98 and VEINES/Sym - ICC: 0.79) reliability. When ICC was separately evaluated, few items (1-8, 2, 3, 4-a and 5-c) presented values below 0.5 (Table 2). Correlation analysis between VEINES-QOL and VEINE/Sym scores with PHC and MHC of SF-36 showed Table 1 – Sociodemographic and clinical data Variables n Gender Male 22 Female 52 Age (years) Mean±SD (minimum-maximum) 53.70±12.36 (26-82) Education (years of study) Without schooling 4 Between 1 and 7 years 46 8 or more 24 Family Income Less than BRL 496.00 33 From BRL 497.00 to 1.064.00 30 From BRL 1.065.00 to BRL 2.943.00 11 Disease Duration (years) Mean±SD (minimum-maximum) 16.65±12.33 (1-50) CEAP Classification 1 3 2 6 3 10 4 19 5 19 6 17 Associated diseases SAH 27 SAH + another disease 10 None 34 Others 3 Family History of CVD Yes 52 No 11 Did not have an answer 11 % 30 70 5.4 62.2 32.4 44 41 15 4.1 8.0 13.5 25.7 25.7 23 36.5 13.5 45.9 4.1 70.2 14.9 14.9 SD: standard deviation; SAH: systemic arterial hypertension; CVD: chronic venous disease. Transcultural Adaptation of VEINES/QOL-Sym - Moura RMF et al. J Vasc Bras 2011, Vol. 10, Nº 1 21 moderate values of Pearson’s correlation coefficient (r)19, as demonstrated in Table 3. There was statistical significance for all evaluated correlations (p<0.001). Significant differences were found between groups CEAP 1, 2 and 3 and CEAP 4, 5 and 6 just for VEINESQOL score (p=0.02). For VEINES/Sym, p-value was 0.50. For both VEINES-QOL and VEINES/Sym, scores decreased as the severity of CVD increased, representing a decline in QOL, with aggravation of CVD. However, only the score produced by VEINES-QOL could distinguish QOL in a statistically significant manner between groups CEAP 1, 2 and 3 and CEAP 4, 5 and 6. Time spent to apply VEINES-QOL/Sym, Brazilian Portuguese version, in the studied population was about ten minutes. Table 2 – Inter and intraexaminer reliability of VEINES-QOL/Sym, Brazilian Portuguese version It was not necessary to make important adaptations in the original structure of the items in VEINES-QOL/Sym, because they were fully applicable to the Brazilian culture. Due to the high illiteracy rates in our population and in order to standardize the application, the interview format was adopted, differently from the original version (selfapplicable)4. The most frequent ways to administer such QOL questionnaires are self-application and interview8,9. Wu et al.20 have investigated whether or not there would be a difference in the scores of QOL instruments administered with interviews or self-application, in a sample of HIV positive patients, and no significant difference was observed20. Cronbach α values regarding the internal consistency analysis VEINES-QOL, α=0.88, and VEINES-Sym, α=0.84, were high, indicating that the scales present adequate internal consistency. These results are similar to those found in the original version of VEINES-QOL, α=0.91, and VEINES-Sym, α=0.874, and in other studies that also have evaluated such propriety, VEINES-QOL, α=0.91, and VEINES-Sym, α=0.8813, and VEINES-QOL, α=0.91, and VEINES-Sym, α=0.8821. Intra and interexaminers reliabilities were found to be adequate for the VEINES-QOL and VEINES-Sym total score, which assures that the instrument is effective to achieve trustworthy results. Results have showed higher intraexaminer than interexaminer reliability, concerning the total score as well as each item. This is in accordance with previous studies, which have also evaluated the instrument’s reliability4,13,21. When evaluating the items of the scales separately, ICC values for questions 1-8, 2, 3, 4-a and 5-c remained below 0.5 for intraexaminers and interexaminers reliability (except for question 3, in the intraexaminer reliability evaluation). In the future, such questions must be reviewed in the attempt to verify the reasons for the instability of the mentioned indicators and improve the general quality of the instrument. SF-36 is commonly used in research involving QOL evaluation in CVD5,6,7,11,22. Despite the fact that generic instruments, like SF-36, reflect the impact of diseases on general health aspects and have the advantage to allow the Items Q 1-1 Q 1-2 Q 1-3 Q 1-4 Q 1-5 Q 1-6 Q 1-7 Q 1-8 Q 1-9 Q2 Q3 Q 4a Q 4b Q 4c Q 4d Q 5a Q 5b Q 5c Q 5d Q6 Q7 Q 8a Q 8b Q 8c Q 8d Q 8e VEINES-QOL VEINES/Sym Interexaminer reliability ICC 0.78 0.61 0.91 0.53 0.75 1.00 0.89 0.29 0.55 0.25 0.45 0.42 0.80 0.85 0.65 1.00 0.65 0.00 0.65 0.92 0.83 0.79 0.83 0.54 0.94 0.67 0.95 0.76 Intraexaminer reliability ICC 0.91 0.65 0.95 0.67 0.89 1.00 0.92 0.37 0.69 0.27 0.68 0.44 0.88 0.86 0.68 1.00 0.78 0.00 0.78 0.96 0.98 0.86 0.92 0.71 0.96 0.87 0.98 0.79 ICC: intraclass correlation coefficient. Table 3 – Analysis of VEINES-QOL/Sym convergent validity in the Brazilian Portuguese version SF-36 PHC SF-36 MHC Pearson’s correlation coefficient (r) VEINES-QOL VEINES/Sym r=0.65 r=0.51 r=0.52 r=0.49 PHC: physical health component; MHC: mental health component. Discussion 22 J Vasc Bras 2011, Vol. 10, Nº 1 comparison between individuals with different illnesses, they are also less sensitive to explore specific effects of the disease on QOL9,10. The current recommendation to assess QOL as a primary outcome is to use a specific instrument associated to a generic one8-10. Results of the correlation analysis between VEINESQOL/Sym and SF-36 presented r values around 0.519. Considering that both questionnaires measure similar constructs and that one is specific and the other is generic, moderate magnitude correlations are expected. If r values were very high (close to 1.0), it could mean that both are redundant; in case r values were very low, it could mean there is no evidence that the scales were measuring similar constructs13. The r value was higher between VEINES-QOL and PHC (r=0.65) than between VEINES-QOL and MHC (r=0.52). This can be explained by the fact that VEINESQOL presents more questions related to physical and functional aspects. Similar results were observed in previous studies that evaluated VEINES-QOL/Sym clinimetric properties4,13,22. The mean scores produced by VEINES-QOL were significantly lower (p=0.02) for subjects of group CEAP 4, 5 and 6 comparing to groups CEAP 1, 2 and 3, which demonstrates that VEINES-QOL was capable of detecting differences related to QOL in both groups with different clinical characteristics. Several authors have demonstrated the existing direct relation between the severity of CVD and QOL, especially regarding physical and functional aspects4,7,11,22. Reduction of VEINES/Sym score with the aggravation of the disease was observed; however, there was no statistical significance (p=0.50). Studies that evaluated the relation of symptoms and the severity of CVD demonstrated that even in the presence of telangiectasias and reticular veins, symptoms such as throbbing, heat sensation in the legs and pain may be present without generating physical and functional limitation in the same proportion as in more advanced stages of the disease. This may explain why VEINES/Sym did not distinguish the groups7,22. Conclusion VEINES-QOL/Sym, Brazilian Portuguese version, proved to be an adequate instrument from the semantic and linguistic points of view, with satisfactory clinimetric properties and easy to apply. It should be emphasized the need for further analyses related to reliability is noteworthy, especially in reference to the items that presented ICC values below 0.50. This instrument may contribute to the development of further research and to a better understanding of the QOL aspects mostly affected by CVD. Transcultural Adaptation of VEINES/QOL-Sym - Moura RMF et al. References 1. Martins LM, França, APD, Kimura M. Qualidade de vida de pessoas com doença crônica. Rev. Latino-am. Enfermagem. 1996;4:5-18. 2. Porter MJ, Moneta GL. Reporting standards in venous disease: An update. International Consensus Committee on Chronic Venous Disease. J Vasc Surg. 1995; 21:635-45. 3. Eklöf B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, Meissner MH, Moneta GL, Myers K, Padberg FT, Perrin M, Ruckley CV, Smith PC, Wakefield TW; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: Consensus statement. J Vasc Surg. 2004;40: 1248-52. 4. Lamping DL, Schroter S, Kurz X, Kahn SR, Abenhaim L. Evaluation of outcomes in chronic venous disorders of leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. J Vasc Surg. 2003;37(2):410-9. 5. van Korlaar I, Vossen C, Rosendaal F, Cameron L, Bovil E, Kaptein A. Quality of life in venous disease. Thromb Haemost. 2003;90(1): 27-35. 6. Lamping DL. Measuring health-related quality of life in venous diseases: practical and scientific considerations. Angiology. 1997;48(1):51-7. 7. Kurz X, Lamping DL, Kahn SR, Baccaglini U, Zuccarelli F, Spreafico G, Abenhaim L; VEINES Study Group. Do varicose veins affect quality of life? Results of an international population-based study. J Vasc Surg. 2001;34(4):641-8. 8. WHOQOL GROUP. The World Health Organization quality of life assessment (WHOQOL): position paper from the World Health Organization. Soc Sci Med. 1995;41(10):1403-9. 9. Seidl EMF, Zannon CMLC. Qualidade de vida e saúde: aspectos conceituais e metodológicos. Cad Saúde Pública. 2004;20:580- 8. 10. Ciconelli RM. Medidas de avaliação de qualidade de vida. Rev Bras Reumatol. 2003;43:9-13. 11. Kaplan RM, Criqui M, Denenberg JO, Bergan J, Fronek A. Quality of life in patients with chronic venous disease San Diego population study. J Vasc Surg. 2003;37(5):1047-53. 12. Abenhaim L, Kurz X. The VEINES Study (VEnous INsufficiency Epidemiologic and Economic Study): An International Cohort Study on Chronic Venous Disorders of the leg. Angiology. 1997;48(1):59-66. 13. Kahn SR, Lamping DL, Ducruet T, Arsenault L, Miron MJ, Roussin A, Desmarais S, Joyal F, Kassis J, Solymoss S, Desjardins L, Johri M, Shrier I; VETO Study investigators. VEINES-QOL/Sym questionnaire was a reliable and valid disease-specific quality of life measure for deep venous thrombosis. J Clin Epidemiol. 2006;59(10): 1049-56. 14. Gadotti IC, Vieira ER, Magee DJ. Importance and clarification of measurement properties in rehabilitation. Rev Bras Fisioter. 2006;10 (2):137-46. 15. Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993;46(12):1417-32. 16. Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine. 2000;35(24):3186-91. Transcultural Adaptation of VEINES/QOL-Sym - Moura RMF et al. 17. Maher CG, Latimer J, Costa LOP. The relevance of cross-cultural adaptation and clinimetrics for physical therapy instruments. Rev Bras Fisioter. 2007;11(4):245-52. 18. Ciconelli RM, Ferraz MB, Santos W, Meinão I, Quaresma MR. Tradução para a língua portuguesa e validação do questionário genérico de avaliação de qualidade de vida SF-36 (Brasil SF-36). Rev Bras Reumatol. 1999;39:143-50. 19. Portney LG, Watkins MP. Foundations of clinical research applications to practice. 3ª ed. New Jersey: Pearson Prentice Hall; 2008. 20. Wu AW, Hays RD, Kelly S, Malitz F, Bozzette SA. Applications of the Medical Outcomes Study health-related quality of life measures in HIV/AIDS. Qual Life Res. 1997;6(6):531-54. 21. Eden T, Garrat AM, Klow NE, Sandset PM. Assessing burden of illness following acute deep vein thrombosis: data quality, reliability and validity of the Norwegian version of VEINES-QOL/Sym, a disease-specific questionnaire. Scand J Caring Sci. 2009;23(2): 369-74. J Vasc Bras 2011, Vol. 10, Nº 1 23 22. Kahn SR, M’lan CE, Lamping DL, Kurz X, Bérard A, Abenhaim LA; VEINES Study Group. Relationship between clinical classification of chronic venous disease and patient-reported quality of life: Results from an international cohort study. J Vasc Surg. 2004;39(4):823-8. Correspondence Regina Márcia Faria de Moura Rua Nascimento Gurgel, 21/1.503 – Gutierrez Zip Code 30441-170 – Belo Horizonte (MG), Brazil E-mail: [email protected] Authors’ contributions: Study conception and design: RMFM, RCD, RRB Data analysis and interpretation: RMFM, RCD, RRB, TPN Data collection: RMFM, TPN, GSG Writing: RMFM, RCD, GSG Critical analysis: RMFM, RCD, RRB, TPN, GSG Final text approval*: RMFM, RCD, RRB, TPN, GSG Statistical Analysis: RMFM, RCD Overall responsibility: RMFM, RCD *All authors have read and approved the final version submitted to J Vasc Bras. 24 J Vasc Bras 2011, Vol. 10, Nº 1 Transcultural Adaptation of VEINES/QOL-Sym - Moura RMF et al. Apêndice 1 – VEINES-QQL/Sym questionnaire, English version. This questionnaire includes questions about your general health and leg condition, as well as questions about your life and activities. This will take about ten minutes to be completed. Your answers are confidential. Below, you will find some questions about opinion on your legs. This information will help yhe follow-up on how you feel and how well you are capable of performing your daily activities. 1. During the past 4 weeks, how often have you had any of the following leg problems? (check one box on each line) Several times About once Less than once Every day a week a week a week 1. Heavy legs 1 2 3 4 2. Aching legs 1 2 3 4 3. Swelling 1 2 3 4 4. Night cramps 1 2 3 4 5. Heat or burning sensation 1 2 3 4 6. Restless legs 1 2 3 4 7. Throbbing 1 2 3 4 8. Itching 1 2 3 4 9. Tingling sensation 1 2 3 4 (e.g.pins and needles) 2. At what time of day is your leg problem most intense ? (check one) 1. On waking 2. At mid-day 3. At the end of the day Never 5 5 5 5 5 5 5 5 5 4. During the nigh 5. At any time of day 6. Never 3. Compared to one year ago, how would you rate your leg problem in general now? (check one) 1. Much better now than one year ago 4. Somewhat worse now than one year ago 2. Somewhat better now than one year ago 5. Much worse now than one year ago 3. About the same now as one year ago 6. I did not have any leg problem last year 4. The following items are about activities that you might do in a typical day. Does your leg problem now limit you in these activities? If so, how much ? (Check one box on each line) I do not work YES, limited a lot YES, limited a little NO, not limited at all a. Daily activities at work 0 1 2 2 3 b. Daily activities at home (e.g. housework, ironing, doing odd jobs 1 2 3 3 repairs around the house, gardening, etc...) c. Social or leisure activities in which you are standing for long 1 2 3 3 periods (e.g. parties, weddings, taking public transportation, shopping, etc...) d. Social or leisure activities in which you are sitting for long periods 1 2 3 3 (e.g. going to the cinema or the theater, travelling, etc...) 5. During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your leg problem? (check one box on each line) YES NO a. Cut down the amount of time you spent on work or other activities 1 2 b. Accomplished less than you would like 1 2 c. Were limited in the kind of work or other activities 1 2 d. Had difficulty performing the work or other activities (for example, it took extra effort) 1 2 6. During the past 4 weeks, to what extent has your leg problem interfered with your normal social activities with family, friends, neighbors or groups? (check one) 1. Not at all 4. Quite a bit 2. Slightly 5. Extremely 3. Moderatel 7. How much leg pain have you had during the past 4 weeks? (check one) 1. None 2. Very mild 3. Mild 4. Moderate 5. Severe 6. Very severe Transcultural Adaptation of VEINES/QOL-Sym - Moura RMF et al. J Vasc Bras 2011, Vol. 10, Nº 1 25 8. These questions are about how you feel and how things have been with you during the past 4 weeks as a result of your leg problem. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4 weeks All of Most of A good Some of A little None of (check one box on each line) the time the time bit of the time the time of the time the time a. Have you felt concerned about 1 2 3 4 5 6 the appearance of your leg(s)? b. Have you felt irritable ? 1 2 3 4 5 6 c. Have you felt a burden to your 1 2 3 4 5 6 family or friends ? d. Have you been worried about 1 2 3 4 5 6 bumping into things? e. Has the appearance of your leg(s) 1 2 3 4 5 6 influenced your choice of clothing ?