Translation and cultural adaptation of Aberdeen Varicose Veins Questionnaire

Background: Currently there is a growing interest in health assessment tools produced and validated throughout the world. Nevertheless, it is still inadequate the number of instruments that assess the impact of chronic venous disease in the life of its bearer. To use these measures it is necessary to accomplish the translation and cultural adaptation to the language in question. Objective: Translate to Portuguese and culturally adapted for the Brazilian population the Aberdeen Varicose Veins Questionnaire (AVVQ-Brazil). Methods: The process consisted of two translations and two back-translations performed by freelance translators, then the evaluation versions of the development of consensual version and commented pretest. Results: The patients in the pre-test were female, mean age 49.9 years, average response time of 7.73 minutes, which ranged from 4.55 minutes (minimum) to 10.13 minutes (maximum time). Education: 20% functional illiteracy and first and second complete degrees; 30% first incomplete degree, and 10% third complete degree. Clinical severity: 40% C3 and C6s, 10% C2 and C5, with five misunderstood terms in the application. Conclusion: The Portuguese version of the Aberdeen Varicose Veins Questionnaire has been translated and adapted for use in the Brazilian population, and can be used after further analysis of their clinimetric properties, which is underway.


Introduction
A large number of health assessment tools have been produced and validated in the entire world, providing more accuracy to individual and collective assessments of the states of health, which demonstrates marked improvement, occurred from the growing interest of the scientific and the health care communities in such issues 1 .
In order to use these health evaluation tools developed and applied in another language, it is necessary to carry out the cross-cultural equivalence, a process involving translation, cultural adaptation and validation of the proposed tool 2 .
The translation and cultural adaptation of health questionnaires published in other cultures are important in the international setting, as they provide the use of the tool in clinical practice and in research, greater accuracy in measuring health aspects related to the population in question, less effort, time and financial resources, comparison of results between different samples, as well as the performance of cross-cultural studies by using the same tool.This entire process turns the application into a more reliable, understandable tool, and part of the cultural aspects of the population under investigation 3 .
There are few tools for assessing venous diseases compared to those used to assess other diseases, and they are usually available in English, such as the Chronic Venous Insufficiency Questionnaire (CIVIQ) and the Venous Insufficiency Epidemiological and Economic Study (VEINES-QOL/Sym) 4 .
In the presence of chronic diseases, such as chronic venous disease (CVD), the subject loses some of his/her autonomy and independence, resulting in difficulties in performing their activities of daily living (ADLs), from limitations imposed by the disease that affect their quality of life 5,6 .
CVD is a vascular disease that affects 2 to 7% of the world population 7,8 .It is associated with high morbidity rates and causes significant socioeconomic impact 9 , therefore becoming a serious public health problem also due to its high prevalence 7,[10][11][12] .In 2000, it was the cause of 61,000 admissions to public and private hospitals in Brazil, causing the Brazilian Public Health System (SUS) to spend R$ 43 million in varicose vein operations in 2004 12 .
In addition to using generic measures, to assess the impact of venous disease in patients' lives it is important to use a specific measurement tool, sensitive to aspects related to the disease, focusing on its signs and symptoms, and evaluating important dimensions of quality of life that may be compromised 4,13 .
A disease-specific questionnaire was developed and validated in the United Kingdom and named the Aberdeen Varicose Veins Questionnaire (AVVQ) (Annex 1).Considered a specific scale of quality of life for the CVD and a disease severity measurement, its validity, consistency and reproducibility were regarded as good in its country of origin 4,[14][15][16] , and it has been used in several studies.An easy-to-manage, self-applicable tool composed of 13 items covering 3 dimensions: physical, socio-functional and psychological.It is interpreted by a score ranging from 0 to 100, where 0 represents no evidence of varicose veins and 100 represents the most serious problem associated with varicose veins 15,16 .
Given the little availability of specific assessment tools designed for evaluating CVD in Brazil and that data related to quality of life are important to the selection and interpretation of results in clinical trials of patients affected by the disease, the current s study is justified, with its aim of translating the AVVQ-Brazil into Brazilian Portuguese and culturally adapting it to the Brazilian population.

Methods
The research project was approved by the Ethics Committee of Universidade Estadual de Ciências da Saúde de Alagoas (Uncisal), protocol 835, according to the National Health Council guidelines as written in the resolution 196/96 on research with human beings.This cross-sectional, analytical cohort study was carried out in Maceió (AL, Brazil).
The nonprobability convenience sampling technique was used.Subjects were selected at the Physical Therapy outpatient clinics of Uncisal, where a program of assistance of patients with venous insufficiency is developed.Patients participating in other assistance programs from Uncisal were also included in the sample, such as those developed in community, at the Health Center, and at the Tropical Diseases Hospital.Patients were interviewed and selected according to the inclusion and exclusion criteria.
Patients from both genres and age ≥30 with CVD were included in the analysis, as their condition was confirmed by a vascular surgeon based on CEAP classification (1 to 6).
CEAP classification is a system that was proposed in 1995 based in clinical presentation, etiology, anatomy and pathophysiology of venous disease, and has been widely used to classify the clinical presentation of CVD and to measure changes in severity 9 .Telangiectasies and/or reticular veins are classified as C 1 , varicose veins as C 2 , edema as C 3 , hyperpigmentation and lipodermathosclerosis as C 4 , healed ulcer as C 5 , and active ulcer as C 6 .
Patients younger than 30 years were excluded from the sample, as well as those who had cognitive alterations, who refused to sign the informed consent form, who had specific associated conditions (arterial and lymphatic), and those who could not speak or understand Portuguese.
Primary variables of the study were the translation and cross-cultural adaptation of the questionnaire, while secondary variables were CEAP classifications.As complementary data, we analyzed schooling degree and genre of patients.Statistical analysis was descriptive and based on frequencies.
The translation into Brazilian Portuguese and cultural adaptation of AVVQ were performed in accordance to international criteria that has been applied to other assessment tools that were already validated and published in Portuguese 17 .

Translation and cross-cultural adaptation methods
The process of linguistic equivalence was initiated by contacting the authors of the original AVVQ in order to define their concepts and ask for authorization to use it in our study.
An independent translation of the questionnaire was made from English into Portuguese by two bilingual translators, thus originating versions 1 and 2 (V1 and V2).Afterwards, a consensus meeting defined the V1,2, which was translated by two other translators who had English as they first language and were not acquainted with the questionnaire.Therefore, the re-translated versions R1 and R2 were generated and, following, a consensual version named R1,2.
All versions were submitted to analysis by a committee of professionals and researchers of the field and one translation expert to review all procedures and get to a consensual pre-final version (F1).After that, some terms had to be modified aiming at a better understanding by patients.Then, the pre-final version of the questionnaire was obtained and applied to patients (Table 1).
The next step was to contact the authors of the original questionnaire in order to to approve it and, if necessary, discuss the resulting Portuguese version's equivalence and the Brazilian population habits related to it.
The V1 version was then applied to ten patients with CVD, and the possible difficulties related to the text and time required to fill it were investigated.The translation was again assessed according to the results, and an updated and modified final version (F2) was obtained.
When applying the questionnaire, the researchers explained the objectives of the study to patients and, when they agreed to participate, they signed the informed consent form.

Results
There was no sample deviation.Ten female patients (100%) were recruited for the pre-test, with mean age of 49.9 years.As to schooling, two of them were functionally illiterate (20%), three had not finished elementary school (30%), and two had finished it (20%); two had finished high school (20%), and only one had been to college (10%) (Table 2).For the illiterate, the questionnaire was read aloud by the researcher, who complied with the instruction by the original authors based on an interview script that previewed a way of putting questions without interfering in the interviewee' answer.
The mean time to answer the questionnaire was 7.73 minutes, ranging from 4.55 to 10.13 minutes (Table 3), measured by a chronometer used by the researcher.Five term of the questionnaire was misunderstood by patients (Table 1).

Discussion
The translation and cultural adaptation of a questionnaire is a complex process for, many times, a word that best defines a concept in English, for instance, may have a different meaning in other countries, such as Brazil.Therefore, the production of such a tool for assessment requires standardization of the criteria to be applied, as reported in literature 18 and according to which our study was carried out.
AVVQ had not hitherto been translated into Portuguese or been through a cross-cultural adaptation.There was only a recently available Dutch version 19 .There has been little rigor as to the use of assessment tools originally developed in foreign languages.Informal translation is not uncommon, as well as the alteration of content and number of items of the tool, and the absence of linguistic adaptation to the population-target which all compromise the quality of information 20 .
In our study, we initially tried to perform semantic equivalence, that is, to modify terms from the original in order to achieve literal correspondence, so readers in the target-language are able to fully understand it in the pretest.After pre-test, the misunderstood terms are modified only if at least 10% of the sample claimed not understanding them.It confirms the idea that in a country with heterogeneous cultural roots, such as Brazil, the proposal of using typical colloquial terms which are easily accepted and understood deserve attention.In order to achieve a successful cultural adaptation, linguistic changes must be performed aiming at the cultural context and lifestyle of the Brazilian population 20 .
The analysis of the translations versions by the committee of experts was of great value, for they were acquainted with the issue, which made the process of equivalence between the original and the target-language easier.According to Beaton et al. 17 , the function of this committee is to consolidate all versions of the questionnaire and to develop the pre-final version.
The study was performed with 10 patients, because the pre-final version should be normalized between 30 to 40 individuals 17 .However, current publications do not include this number, as a range of procedures have been described [21][22][23][24][25][26][27] .
The literature recommends the use of two of more translators, once various more than one text allow the identification of possible mistakes in translation 17,18,20 .In our study two translators confronted and discussed in order to obtain a consensual version, though no discrepancies were observed between versions of AVVQ.
The time to answer The AVVQ has an estimated application time of 5 minutes 15 , which approximates the mean time to answer in our study (7.33 minutes), thus confirming that this assessment tool is feasible.The question that took the longest to be answered was the first, which involved a drawing in which the patient should indicate the spot of their varicose veins, because of a difficulty in perceiving their condition.Despite that, most patients were capable of answering it without problems, as it happened in the original study in which the AVVQ was developed 15 .
Despite the fact that the sample was diverse as to schooling and age, few questions and terms were misunderstood such as questions 7, 8 and 9 and the terms "purple discoloration", "eczema", "skin ulceration", "wound" and "tick one box" (Table 1).Therefore, it was clear that most participants understood the situations described in the items.The number of participants was a limitation of our study (n=10), as also reported in other papers 3 , but the small sample issue was compensated by the diversification that allowed the discussion of the questionnaire feasibility in all levels of the Brazilian population.
Further studies on the cultural adaptation of assessment tools originally written in other languages are needed, as well as the evaluation of the psychometric measures of such tools 20 .The final version of the AVVQ (Annex 2) must now have its clinimetric properties assessed by a study that is being conducted.

Conclusion
The Brazilian Portuguese version of AVVQ is now available and culturally adapted to the Brazilian population.

Table 1 .
Data related to the understanding of the Aberdeen Varicose Veins Questionnaire.

Table 2 .
Demographic characteristics of the pilot study sample.

Table 3 .
Time taken to answer the questionnaire.Original version of Aberdeen Varicose Veins Questionnaire.
Moderate ankle swelling (eg.causing you to sit with your feet up whenever possible) Severe ankle swelling (eg.causing you difficulty putting on your shoes) 2. In the last two weeks, for how many days did your varicose veins cause you pain or ache?(Please tick one box for each leg)

Legs viewed from front Legs viewed from back
Does the appearance of your varicose veins cause you concern?(Please tick one box) No Yes, their appearance causes me slight concern Yes, their appearance causes me moderate concern Yes, their appearance causes me a great deal of concern 9. Do you have a skin ulcer associated with your varicose veins?Do you have a rash or eczema in the area of your ankle?(Please tick one box for each leg) R Leg L Leg No Yes, but it does not require any treatment from a doctor or district nurse Yes, and it requires treatment from my doctor or district nurse 7. Do you have purple discoloration caused by tiny blood vessels in the skin, in association with your varicose veins?(Please tick one box for each leg) R Leg L Leg No Yes 6.In the last two weeks, have you had any itching in association with your varicose veins?(Please tick one box for each leg) R Leg L Leg No Yes, but only above the knee Yes, but only below the knee Both above and below the knee 5.In the last two weeks, have you worn support stockings or tights?(Please tick one box for each leg) R Leg L Leg No Yes, those I bought myself without a doctor' s prescription Yes, those my doctor prescribed for me which I wear occasionally Yes, those my doctor prescribed for me which I wear every day 1. Please draw in your varicose veins in the diagram(s) below:-YOUR VARICOSE VEINS 13.During the last two weeks, have your varicose veins interfered with your leisure activities (including sport, hobbies and social life)?(Please tick one box) No Yes, my enjoyment has suffered to a slight extent Yes, my enjoyment has suffered to a moderate extent Yes, my veins have prevented me taking part in any leisure activities