Cultural adaptation and validation of the Freiburg Life Quality Assessment - Wound Module to Brazilian Portuguese1

Objectives: to adapt the Freiburg Life Quality Assessment - Wound Module to Brazilian Portuguese and to measure its psychometric properties: reliability and validity. Method: the cultural adaptation was undertaken following the stages of translation, synthesis of the translations, back translation, committee of specialists, pre-test and focus group. A total of 200 patients participated in the study. These were recruited in Primary Care Centers, Family Health Strategy Centers, in a philanthropic hospital and in a teaching hospital. Reliability was assessed through internal consistency and stability. Validity was ascertained through the correlation of the instrument's values with those of the domains of the Ferrans and Powers Quality of Life Index - Wound Version and with the quality of life score of the visual analog scale. Results: the instrument presented adequate internal consistency (Cronbach alpha =0.86) and high stability in the test and retest (0.93). The validity presented correlations of moderate and significant magnitude (-0.24 to -0.48, p<0.0001). Conclusion: the results indicated that the adapted version presented reliable and valid psychometric measurements for the population with chronic wounds in the Brazilian culture.

The abbreviated version is known as the FLQA-Wk and aims to measure the quality of life of people with chronic wounds over the previous week. It is made up of 24 items, distributed in six domains: physical symptoms, daily life, social life, psychological wellbeing, treatment and satisfaction. It has been validated in three separate studies with individuals with acute and chronic wounds (9) .

Method
This is a study with a quantitative approach, of the methodological type, grounded in the theoretical reference of cultural adaptation and validation. It followed the stages recommended by international studies (10)(11)(12) .

The Procedure of Cultural Adaptation
First of all, the FLQA-Wk instrument was translated into Brazilian Portuguese by two independent translators. One nurse with knowledge in the area of wounds and of the study's objectives, and one professor of modern languages, participated in this phase. Each participant undertook one translation, totaling two independent versions (VT1 and VT2).
The analysis of the divergences between the versions was undertaken by the two translators, in conjunction with one of the researchers. Following this analysis, a version was developed for the back translation (VT12).
The back translation was undertaken by two translators whose native language was English and who had a good command of the Portuguese language.
Neither was informed of the study's concepts and objectives, and they undertook the translations independently (R1 and R2).
All the versions (VT1, VT2, VT12, R1 and R2) were sent to a committee of eight judges who undertook an analysis relating to the semantic, idiomatic, cultural and conceptual equivalencies.
The specialists were selected due to their knowledge about wounds, quality of life, or the translation of instruments.
The validity of the instrument's content was investigated through calculating the Content Validity Index (CVI). This test evaluates the level of agreement among the judges on specific aspects of the adapted questionnaire and of its items. The judges scored the items with values ranging from one to four. For the study, a level of agreement equal or superior to 0.8 was stipulated (13) .
Subsequently, a pretest was undertaken with 30 subjects (11) with chronic wounds of differing etiologies, attended in a wound treatment center. All were interviewed and were requested to talk about the difficulties found in answering the questionnaire.
As some interviewees showed doubts in interpreting some questions, the decision was made to hold a focus group, a technique used in similar studies, with the objective of adapting the instrument's content to the specific population (14)(15) .
A meeting was held with five patients with differing educational levels (two illiterates, two who had not finished their basic education, and one who had completed higher education). The focus group began with a description of the study and the importance of each individual's participation. The items of the questionnaire were presented separately, to make it easier for the participants to absorb the information.
The focus group was run with the participation of a moderator and two observers, following steps recommended in the literature: assembly, conduct of the group, and analysis of the data (16) .
With the authorization of those present, the entire process was recorded. The moderator was responsible for reading the questionnaire out loud and for the discussion, while the observers analyzed all the issues raised. Following the reading of each item, the participants were questioned regarding its interpretation. In accordance with what people said, associated with the nonverbal expressions indicating doubt, the item was discussed, with a vote being held In the analysis of the validity, the Spearman correlation coefficient was used. For this, the following classification was adopted: close to 0.30, considered satisfactory; between 0.30 and 0.5, moderate magnitude; and above 0.5, strong magnitude (19) . The level of significance adopted for the statistical tests was 5%, that is, p value <0.05.

Cultural adaptation
Cultural adaptation is a complex process, and with different methods recommended by the literature. In this study, this process followed the following phases: translation, synthesis of the translations, back translation, committee of specialists, pre-test and focus group (12) .
During the procedures of translation, synthesis of translation and back translation, complications did not occur. In the evaluation by the committee of specialists, taking into account that the rate of agreement between these was to be >0.80, the results indicated that the items were appropriate.   (Table 1).

Characteristics of the study's subjects
Rocha EA, Alexandre NMC, Silva JV.

Psychometric properties
The adapted instrument (FLQA-Wk) presented a total Cronbach alpha of 0.86 (Table 2). The convergent validity appears with negative or inverse correlations, as the score of the FLQA-Wk indicates that the higher the score, the worse the quality of life, while in the score of the FPQLI-WV, the scoring is inverse: the higher the score, the better the quality of life.
The correlations were of moderate and significant magnitudes between the values of the adapted instrument with those of the domains of the FPQLI-WV and with the Visual Analog Scale (Table 3).

Discussion
The subjects' characteristics were similar to those found in Brazilian and international publications, the same being observed in the study on the development of, and in the validation of, the Brazilian FPQLI-WV questionnaire (5,8) .
The sociodemographic data showed that 55.2% of the interviewees were female, with a mean age of 59.2 years; 47.7% were married, and the educational level of 60.4% was below basic education. Regarding the clinical characteristics of the wound, it was ascertained that 50.1% were of venous etiology, with a mean of 1.5 wounds per patient and mean duration of 51.1 months (5) .
The data suggest that elderly women have a higher probability of developing chronic wounds, and that a low educational level is present in this population. This last characteristic seems to have hindered the application of the questionnaire, which underwent certain modifications in order to facilitate its understanding.
In one study undertaken in Germany, with 198 individuals with wounds of a venous origin, an internal consistency for the FLQA-Wk of 0.87 was obtained (9) .
The stability of the questionnaire adapted to Portuguese presented an intraclass correlation coefficient value of 0.93, which can be considered excellent (18) .
In one randomized study, which consisted of the measurement of the quality of life of patients with Rocha EA, Alexandre NMC, Silva JV.
venous ulcers, receiving treatment with keratinocyte transplants and with local compression, a test-retest value of 0.69 was observed, which can be considered to be of moderate magnitude (9) .
It is worth emphasizing that, in the present study, the interval of the application of the instrument was of seven days, as it was considered that, after this period, with chronic and acute wounds (5) .
The FPQLI-WV was shown to be an instrument capable of measuring the quality of life of patients with chronic wounds and diabetic foot, making it possible for the nurse to provide quality interventions, with a view to assessing not only the wound, but also the individual as a whole (5,21) .
The study on the construction and validation of the FPQLI-WV presented reliability and validity which were adequate for assessing general quality of life, the health, and the psychological and spiritual aspects of individuals with acute or chronic wounds (5) , conferring on the FLQA-Wk the capacity to measure the quality of life of patients with chronic wounds.
In relation to the correlation of the FLQA-Wk total score with the quality of life score of the visual analog scale, the value obtained was considered to be of moderate magnitude (-0.38) and significant.
The same correlation was undertaken in three separate studies with the original instrument, with values being found of: -0.38 (p=0.001), -0.67 (p=0.001) and -0.61 (p=0.001), considered to be of moderate and strong magnitude (9) .
In this way, it is hoped that the cultural adaptation of the Freiburg Life Quality Assessment-Wound module allows the attendance to these patients to be undertaken in a holistic way, also taking into account their quality of life, and contributing to quality care (22) .
It is emphasized that the original version was developed to be self-applied or to be answered through

Conclusions
The cultural adaptation of the Freiburg Life Quality Assessment-Wound module was undertaken following the international methodology, resulting in a reliable version. In the data collection procedure, the instrument was revealed to be easy to understand and apply.
The questionnaire also presented satisfactory internal consistency and temporal stability. In relation to its validity, the adapted FLQA-Wk questionnaire