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Print version ISSN 1677-5449
J. vasc. bras. vol.11 no.2 Porto Alegre Apr./June 2012
Translation and cultural adaptation of Charing Cross Venous Ulcer Questionnaire*
Renata Cardoso CoutoI; Flávia de Jesus LealI; Guilherme Benjamin Brandão PittaII; Rita de Cássia B. BezerraIII; Walmir S. S. SegundoIII; Tatiana de Mendonça PortoIV
I Post-graduate student (Master's degree) at Universidade Federal de São Paulo (UNIFESP) - São Paulo (SP), Brazil; Assistant professor at UNCISAL - Maceió (AL), Brazil.
II PhD in cardiovascular surgery from UNIFESP, São Paulo (SP), Brazil; Adjunct Professor at UNCISAL - Maceió (AL), Brazil.
III Physical Therapy student at the Estácio/Faculdade de Alagoas - Maceió (AL), Brasil.
IV Nurse at Hospital Antonio Targino - Campina Grande (PB), Brazil; Nurse at the Infant Intensive Therapy Unit of Hospital Regional de Trauma de Campina Grande - Campina Grande (PB), Brazil. Nurse at CICATRIZA - Clínica de Enfermagem Especializada em Curativos - Campina Grande (PB), Brazil.
Background: The translation and cultural adaptation are steps that will allow an instrument created in a particular language and culture might be used in another cultural context. The Charing Cross Venous Ulcer Questionnaire (CCVUQ) is a quality of life questionnaire in English for patients with venous ulcers that need to be translated and culturally adapted to be used in Brazil.
Objective: To translate and culturally adapt to the Brazilian the CCVUQ.
Methods: The process consisted of two translations and two back translations performed by freelance translators, evaluation of versions, followed by the development of consensus version and pre-test commented.
Results: In the process of translating some words and expressions were changed in its literal aspect. Pre-test evaluation indicated changes were needed for better understanding of the respondent. The average time to respond to the questionnaire was 5 minutes and 23 seconds.
Conclusion: The Portuguese version of the Charing Cross Venous Ulcer Questionnaire was translated and adapted for use in Brazilian population.
Keywords: questionnaires; translating; cross-cultural comparison.
The Charing Cross Venous Ulcer Questionnaire (CCVUQ), in a recent systematic review, was considered to be the most specific instrument to measure the impact of venous ulcers on the quality of life of patients1. It presents good psychometric properties, besides being short, simple and with a quick application time2, thus being rated as excellent and promising3.
The original version of the Questionnaire presented good reliability, high correlation (r=0.55, p<0.001) with eight SF-36 domains, and good sensitivity to changes over time in patients with venous ulcers4-6.
To adjust an instrument previously created, such as CCVUQ, to a new language, population and culture, it is necessary to implement cross-cultural equivalence, which consists of several steps, the first ones being translation and cultural adaptation7.
This process is mainly intended to maintain the validity of the original instrument content, in such a way that the local version may provide measurements similar to those obtained with the original instrument8.
In Brazil, the lack of valid and reliable methods for this assessment has imposed barriers when it comes to new treatments for diseases such as chronic venous ulcer, which causes great social and economic impact and affects the quality of life of patients9.
In order to properly analyze the impact of an intervention on a chronic disease such as venous ulcer, one should use a generic questionnaire related to specific measures of health scales4.
Given the need for specific tools to assess new methods of treatment for venous ulcers and because a specific and relevant instrument that measures the quality of life in this disease has already been created, the present study is justified, with the objective of translating the CCVUQ into Portuguese and adapting it to the Brazilian population.
This research project was approved by the Ethics Committee , protocol No. 836, in compliance with the rules of the National Health Council (CNS) based on Resolution No. 196/96 on research involving human beings.
This is a cross-sectional study on the translation and cultural adaptation of a questionnaire whose data were subjected to quantitative analysis of frequency, and to qualitative analysis.
The sampling method was non-probabilistic, by convenience, in public services of assistance to patients with venous ulcers in the city of Maceió (AL). The subject should meet the inclusion criteria, such as being patient with open venous ulcer for longer than two weeks, had the diagnosis of a vascular CEAP 6 class chronic venous insufficiency made by a vascular surgeon or angiologist, to be clinically stable during 15 days preceding the survey, as well as in the 15 days following the interview with the investigator. Respondents could be of both sexes, age between 35 and 65 years (in the pilot study, there was a preference for selecting patients with higher prevalence of venous ulcers and, coincidentally, at the study sites, there were no subjects under 18 years with ulcers). Subjects with cognitive alterations and/or could not understand Portuguese were excluded from the study.
The translations into Portuguese and the cultural adaptation of CCVUQ were based on the criteria defined and recommended internationally, applied in some instruments that has already been validated and published in Portuguese10,11.
The primary variables were translation and cultural adaptation, and the secondary variables were time taken to answer the questionnaire, CEAP classification, ulcer size, and additional data such as gender, age, educational level, time of ulcer occurrence, and activities of daily living.
Method of translation and cultural adaptation
Prior to the study, we obtained the written authorization of the author of the questionnaire to the procedure of translation and cultural adaptation.
Initially, an independent translation of the CCVUQ English version into Portuguese was performed by two bilingual translators, resulting in versions V1 and V2. Then a consensus version, V12, was originated in a meeting, being back translated by two other English native speaker translators who had no prior knowledge of the Questionnaire. Versions R1 and R2 were generated, followed by a back-translated consensual version, R12.
All versions (V1, V2, V12, R1, R2, R12) were analyzed by a committee of professionals and researchers in the field of translation. This committee evaluated the versions as to semantic, idiomatic, conceptual and cultural equivalence. In a further meeting, the committee discussed and proposed the Portuguese pre-final version (F1) of the questionnaire for pretest.
The F1 version was then applied as pre-trial to ten patients with venous ulcers, and possible doubts and difficulties in relation to the text were investigated. The respondents were asked about (1) the understanding of the questionnaire (yes or no), (2) understanding of what each item meant, (3) suggestion of changes in case of items that were not understood by them.
The items mentioned as "not understood" by over 10% of the sample was changed.
The time required to complete the questionnaire was also analyzed, so the translation was reviewed based on the results and, if necessary, modified and updated, originating a final version (F2).
The F2 version was back translated and sent to the author of the original questionnaire for approval and questioning as to semantic and cultural changes that could have altered the purpose and context of the final questionnaire.
In the initial process of translation and back translation, the committee of professionals suggested changes in the literal meaning of some words in order to form simpler expressions more easily understood by the Brazilian population (Table 1).
Subsequently, the F1 version was applied to ten subjects who were asked about doubts and difficulties in the understanding of the questionnaire. Table 2 shows the item mentioned as "not understood" by 20% of the sample.
The sample selected for the pretest had a mean age of 56.2 years, was comprised of 100% of females, and the mean ulcer size was 3.25 cmÂ². In total, 80% of the subjects were away from their work activities, thus performing only household tasks. As to schooling level, 10% of them were illiterate, 60% were functionally illiterate, 20% had not finished primary education, and 10% had completed high school.
Regarding the time of ulcer occurrence, the data collected show that 50% of the sample presented venous ulcer for more than a year, while 20% had been suffering from venous ulcer for a month, 20% from one to six months, and 10% for six months to a year.
From the total number of individuals, 30% of the sample answered the questionnaire, while 70% had the questionnaire read by somebody related to the study without interfering in the response, as suggested by the author of the original version.
The average time of answering the questionnaire was 5 minutes and 23 seconds.
No facts that could determine sample deviation were observed.
Not many tools for evaluating quality of life in specific diseases are available in Brazil, so translation and standardization of tools such as the CCVUQ are required.
When performing inadequate translation and cultural adaptation, the results obtained may be biased and erroneous12. In order to minimize errors, the methodology used in this study follows internationally accepted models10.
The translation and cultural adaptation procedures used were considered to be satisfactory. The committee of professionals meeting allowed a discussion over the questionnaire with respect to goals, ways of filling and adapting the Questionnaire for an easy understanding and quick filling. The questions were adapted to achieve cultural and semantic equivalence.
This process was necessary and showed a good applicability of the questionnaire, with an average application time of 5 minutes and 23 seconds, confirming the process of cultural adaptation of CCVUQ to Spanish2, which considered the instrument as containing simple questions, with a time of administration of not more than ten minutes. This fact had already been reported in the Chinese version of the Questionnaire13, which did not exceed ten minutes for its filling even when applied to an elderly population.
In the analysis of translation, some possible answers such as "never," "not often," "often" and "occasionally" were modified from the original version after the analysis by the professional committee. The same happened in another study of questionnaire validation, in which "true" and "false" were replaced by "yes" or "no"14. However, the cultural adaptations of CCVUQ to Chinese13 and Spanish2 populations did not reveal the need for changes in response options, so they were deemed appropriate based on the literal translation of the original version.
In the present study, the committee of professionals also decided to modify expressions that were not suited to the habits of the majority of population, such as "doing household chores", "gardening", "hobbies". This procedure was similar to that performed in another study14 in which some terms were replaced, confirming the results of CCVUQ cultural adaptation in Spain2, which required modifications in six sentences to achieve cultural equivalence.
By applying the version established by the committee of professionals to ten individuals, it was necessary to change a single word considered to be not understood by 20% of the sample (for example: strained personal relationships), demonstrating compliance with the criteria established in other studies that determined a maximum of 15% of the sample possibly presenting difficulties in understanding15 or misunderstanding12 the questions.
In a study conducted with patients with venous ulcers, Abbade and Lastória9 found a mean age of 57 years, inasmuch as 35% were retired and 16.1% were out of work due to the ulcer.
Data referring to samples of the aforementioned studies are consistent with the sample used in the pretest of this survey, in which a relatively adult population (mean age of 56.2 years) was also away from their work activities.
It's important to mention, however, that the population to whom the original questionnaire was applied had a mean age of 76 years, a predominantly elderly population4.
The predominance of venous ulcer among female patients is well known9, which resembles the study of validation of the original questionnaire4, as well as the sample pre-test of this research.
The pre-test showed that the questionnaire is properly translated and adapted to Brazilian reality. However, it is worth pointing out that the sample was composed of adults with low education level and, although the author mentions that this questionnaire can be applied individually, we found that, in our culture, its application to individuals with low education should be assisted.
It is important to emphasize the need for clinimetric tests with a more diverse population so that the CCVUQ can be used to measure the quality of life of patients with venous ulcer in the Brazilian population.
The process of translation and cultural adaptation to the Brazilian population of the Charing Cross Venous Ulcer Questionnaire followed the recommended steps and was successful. Therefore, the Brazilian version of CCVUQ is currently available.
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Correspondence Submitted on: 13.08.11. Author's contributions
Renata Cardoso Couto
Rua Walberdson Ferreira, 42 - Feitosa
CEP 57042-295 - Maceió (AL), Brazil
Accepted on: 02.01.12.
Financial support: none.
Conflict of interest: nothing to declare.
Conception and design: RCC, FJL, GBBP
Analysis and interpretation: RCC, FJL, GBBP
Data collection: RCBB, WSSS
Writing the article: RCC, FJL
Critical revision of the article: TMP
Final approval of the article*: RCC, FJL, GBBP, TMP, RCBB, WSSS
Statistical analysis: RCC, FJL
Overall responsibility: RCC, FJL, GBBP
Study carried out at the Universidade Estadual de Ciências da Saúde de Alagoas (UNCISAL) - Maceió (AL), Brazil.
*All authors have read and approved the final version submitted to J Vasc Bras.
Submitted on: 13.08.11.