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lable at ScienceDirect Journal of Tissue Viability xxx (2016) 1e6 Contents lists avai Journal of Tissue Viability journal homepage: www.elsevier .com/locate/ j tv Translation and cross-cultural adaptation of the Cardiff Wound Impact Schedule to Brazilian Portuguese Fabiana da Silva Augusto a, *, Leila Blanes b, Denise Nicodemo c, Lydia Masako Ferreira d a Graduate Program in Translational Surgery, Federal University of S~ao Paulo (UNIFESP), S~ao Paulo, Brazil b Graduate Program in Translational Surgery and Professional Master's Degree Program, UNIFESP, S~ao Paulo, Brazil c S~ao Paulo State University, UNESP, S~ao Paulo, Brazil d Division of Plastic Surgery, Department of Surgery, UNIFESP, S~ao Paulo, Brazil a r t i c l e i n f o Article history: Received 21 April 2016 Received in revised form 7 November 2016 Accepted 9 December 2016 Keywords: Quality of life Wounds and injuries Validation studies Reproducibility of results Evaluation * Corresponding author. Division of Plastic Surgery Barros 715, 4� andar, CEP 04024-002, S~ao Paulo, SP, B E-mail address: fabianasaugusto@gmail.com (F.S. A http://dx.doi.org/10.1016/j.jtv.2016.12.002 0965-206X/© 2016 Tissue Viability Society. Published Please cite this article in press as: Augusto Brazilian Portuguese, Journal of Tissue Viab a b s t r a c t Aim: To translate into Brazilian Portuguese and cross-culturally adapt the Cardiff Wound Impact Schedule, a specific measure of health-related quality of life (HRQoL) for patients with chronic wounds. Chronic wounds have a relevant impact on the HRQoL of patients. However, there are few instruments cross-culturally adapted and validated in Brazil to assess HRQoL in patients with wounds. Methods: A descriptive cross-sectional study was conducted following six steps: (1) translation of the original instrument into Brazilian-Portuguese by two independent translators; (2) construction of a consensus version based on both translations; (3) two independent back-translations into English of the consensus version; (4) review by an expert committee and construction of the pre-final version; (5) testing of the pre-final version on patients with chronic wounds; and (6) construction of the final version. The psychometric properties of the instrument were tested on 30 patients with chronic wounds of the lower limb; 76.7% were men, 70.0% had traumatic wounds, and 43.3% had the wound for more than 1 year. Participants were recruited from an outpatient wound care clinic in S~ao Paulo, Brazil. Results: The final version approved by the expert committee was well understood by all patients who participate in the study and had satisfactory face validity, content validity, and internal consistency, with Cronbach's alpha coefficients ranging from 0.681 to 0.920. Conclusion: The cross-culturally adapted Brazilian-Portuguese version of the instrument showed satis- factory face and content validity, good internal consistency, and was named Cardiff Wound Impact Schedule-Federal University of S~ao Paulo School of Medicine or CWIS-UNIFESP/EPM. © 2016 Tissue Viability Society. Published by Elsevier Ltd. All rights reserved. 1. Introduction Wounds may be direct or indirect consequences of various diseases and affect people of all ages. Wound healing involves a number of complex, biological and anatomical processes, which in favourable clinical condition, can occur in an acceptable period of time [1]. In the case of chronic wounds, the treatment may be quite complex, leading to significant social and economic impact [2]. Chronic wounds affect about 6 million people in the United States for an estimated annual cost of treatment of US$25 billion [3]. This condition also causes changes in the quality of life of these patients. Studies on quality of life in people with chronic wounds have , UNIFESP, Rua Napole~ao de razil. ugusto). by Elsevier Ltd. All rights reserved FdS, et al., Translation and ility (2016), http://dx.doi.org/ helped researchers gain a better understanding of the challenges of having a wound, adaptive strategies used by patients, and factors related to their quality of life. The presence of a wound has a negative impact on the quality of life of this population [4e8], because wounds are commonly associated with pain, exudate, foul odour, impaired mobility, sleep problems, difficulty in performing functional activities, impaired body image, low self-esteem, social isolation, and changes in mood [4,5,7e14]. Various generic and specific questionnaires are available worldwide to assess health-related quality of life (HRQoL) in pa- tients with wounds, including in people with venous ulcers, wounds caused by diabetic complications, burns, chronic wounds, and pressure ulcers [15e26]. Several studies have addressed the quality of life of patients with wounds in Brazil, but there are few specific tools validated in Brazilian Portuguese [25e32]. The Cardiff Wound Impact Schedule (CWIS) is a British . cross-cultural adaptation of the Cardiff Wound Impact Schedule to 10.1016/j.jtv.2016.12.002 mailto:fabianasaugusto@gmail.com www.sciencedirect.com/science/journal/0965206X www.elsevier.com/locate/jtv http://dx.doi.org/10.1016/j.jtv.2016.12.002 http://dx.doi.org/10.1016/j.jtv.2016.12.002 http://dx.doi.org/10.1016/j.jtv.2016.12.002 Abbreviations CVI Content Validity Index CWIS Cardiff Wound Impact Schedule CWIS-UNIFESP/EPM Cardiff Wound Impact Schedule-Federal University of S~ao Paulo School of Medicine CXVUQ Charing Cross Venous Ulcer Questionnaire HRQoL Health-related quality of life MMSE Mini-Mental State Examination SPSS Statistical Package for the Social Sciences VAS Visual analog scale F.S. Augusto et al. / Journal of Tissue Viability xxx (2016) 1e62 questionnaire used worldwide to assess HRQoL in patients with wounds. It is available in several languages, including French, German, American English, European Portuguese, Swedish, and Chinese [20,33e36]. The work presented here is the first of three stages necessary for the development of an instrument for use in a different culture and language. The second and third stages involve tests of construct validity, criterion-related validity, and reproduc- ibility (test-retest reliability) of the instrument. The aim of this study was to translate, cross-culturally adapt the CWIS to Brazilian Portuguese and assess face and content validity and internal consistency of the instrument for assessing HRQoL in patients with chronic wounds on the legs. Translation 2 Original Translation 1 Version 1 Back-translation 1 Expert Committee Version 2 Back-translation 2 2. Materials and methods This clinical, primary, observational, cross-sectional study approved by the Institutional Research Ethics Committee (approval no. 02143/08) was conducted between 2014 and 2015 in a university-affiliated outpatient wound care clinic in S~ao Paulo, Brazil. The present study was performed after the authors of the original version of the CWIS [20], represented by Dr Patricia Price, granted permission to translate, cross-culturally adapt and validate the instrument to Brazilian Portuguese. Written informed consent was obtained from all patients prior to their inclusion in the study; anonymity was assured. The size of the sample was determined based on the guidelines of Beaton et al. [37], which recommend a sample size ranging from 30 to 40 patients from the target population. A non-probability, convenience sample of 30 patients with chronic wounds of the lower limb who met study criteria were selected for the study. Inclusion criteria were age of 18 and over, having awound of the lower limb for 12 weeks or more, and agreeing to participate in the study. Patients who had cognitive impairment according to the Mini- Mental State Examination (MMSE), any type of cancer or burn injury, and those without physical conditions to answer the ques- tions were not included in the study [38,39]. Four instruments were used for data collection: (1) the MMSE to detect cognitive impairment, (2) a questionnaireassessing socio- demographic and clinical characteristics of patients, (3) a visual analogue scale (VAS) for pain assessment, and (4) the CWIS. The questionnaires were administered as a structured interview by the same investigator. Assessment N = 30 Final Version Fig. 1. Translation and cross-cultural adaptation steps according to Beaton et al. [37]. 2.1. The instrument CWIS is a specific self-report instrument with 47 items assessing HRQoL in patients with chronic wounds. The items are grouped into Please cite this article in press as: Augusto FdS, et al., Translation and Brazilian Portuguese, Journal of Tissue Viability (2016), http://dx.doi.org/ three scales. Scale 1 assesses demographic and clinical character- istics of patients. Scale 2 measures the impact of the wound on lifestyle and is divided into three domains: well-being (7 items), physical symptoms and daily living (24 items), and social life (14 items). The items are rated on a 5-point Likert-type scale to mea- sure the frequency or intensity of each response. Scale 3 proposes a self-assessment of HRQoL and has two items rated from 1 to 10. All three scales are then transformed onto a 0e100 scale, where a high score indicates a positive rating of HRQoL. There is no single overall score for the CWIS and no cut-off values [20]. The tool was translated and adapted to the Brazilian culture based on the guidelines of Beaton et al. [37], according to the following steps: (1) translation of the original questionnaire into Brazilian-Portuguese by two independent translators; (2) con- struction of a consensus version based on both translations; (3) back-translation of the consensus version into English by two different independent translators; (4) review by an expert com- mittee and construction of the pre-final version; (5) testing of the pre-final version on patients with chronic wounds; and (6) con- struction of the final version of the instrument (Fig. 1). The translators were native Brazilian-Portuguese speakers. Only one of the translators who performed the forward translation was experienced in translating specialized texts containing the tech- nical terminology used in the questionnaire, whereas the other translators did not have such experience [37]. Six experts with extensive experience in the management of patients with wounds and scientific research participated in the expert committee. A document containing the text of the original questionnaire and forward translations was provided to the expert committee, who evaluated the understanding of the items. The experts considered semantic, idiomatic, cultural and conceptual equivalences in the construction of a pre-final version, which was obtained by combining elements from both translations [30]. The expert committee also assessed face and content validity of the instrument. Face validity, which evaluates whether the instrument appears to measure what it was designed to measure [40], was assessed by the experts based on the answers given by the 30 participants and their own clinical experience in the management of patients with wounds combined with their knowledge of the concept of quality of life. The expert committee evaluated whether patients were able to understand the purpose of the instrument and its measurement procedure. The minimum level of agreement among experts and cross-cultural adaptation of the Cardiff Wound Impact Schedule to 10.1016/j.jtv.2016.12.002 Table 1 Sociodemographic and clinical characteristics of patients. Variables Subjects N % Gender Men 23 76.7 Women 7 23.3 Age group (years) 21e39 11 36.7 40e59 12 40.0 60e79 7 23.3 Ethnicity Not Caucasian 23 76.7 Caucasian 7 23.3 Religion Catholic 19 63.3 Other 9 30 Not informed 2 6.7 Practice of religion Yes 19 63.3 No 9 30 Not informed 2 6.7 Marital status With a partner 15 50.0 Without a partner 15 50.0 Education level Illiterate 2 6.6 Primary education 9 30.0 High school education 14 46.7 College degree 5 16.7 Household Live alone 5 16.7 Live with others 25 83.3 Employment status Unemployed 5 16.7 Employed 2 6.6 Retired/retired on disability 23 76.7 Type of wound Traumatic 21 70.0 Non-traumatic 9 30.0 Wound duration (months) � 6 13 43.3 7e12 4 13.4 > 12 13 43.3 Wound size (cm2) < 25 19 63.3 25e50 7 23.3 > 100 4 13.4 Amount of exudate Scant 8 26.6 Small 14 46.7 Moderate 5 16.7 Large 3 10.0 Presence of odour F.S. Augusto et al. / Journal of Tissue Viability xxx (2016) 1e6 3 researchers was set at 80%. Content validity is defined by the degree to which each item of a measuring instrument is relevant to and representative of the target construct [41,42]. Content validity was measured by calcu- lating the content validity index (CVI), using ratings of item rele- vance and clarity by content experts [43]. Members of the expert committee rated each item of the instrument as: (1) “not impor- tant”, (2) “slightly important”, (3) “important”, and (4) “very important.” Items rated “1” or “2” were revised by experts and researchers, according to principles of equivalence and their clinical experience, and could be removed from the instrument if consid- ered irrelevant [37,41]. Items rated “3” and “4” were used for determining the CVI (Equation (1)) [43]. The minimum level of agreement among experts and researchers was set at 80% (CVI � 0.80) [44]. CVI ¼ Number of items rated “3” þ Number of items rated “4” Total number of items (1) The pre-final version was tested in patients with chronic wounds of the lower limb who met study criteria. During the application of the adapted instrument, each patient was probed about what he or she thought was meant by each questionnaire item and the chosen response, and was asked to suggest any changes he or she considered necessary to improve the under- standing of the items and response choices. The patients were also asked to rate the items for relevance according to the same 1e4 scale used by the experts. The comments of the patients were evaluated by the expert committee together with the authors of the study, and the final Brazilian-Portuguese version was obtained by consensus. The final version was then back-translated into English and sent to Dr Price for approval by the original authors. The internal consistency of all items of the cross-culturally adapted instrument was measured using the Cronbach's alpha co- efficient. Cronbach's alpha indicates the degree to which a set of items measures a single construct, determining the internal con- sistency or average correlation of items in a survey instrument and estimating its reliability [45,46]. It ranges from 0 to 1, with higher values indicating greater consistency among items of a scale or subscale. Cronbach's alpha values over 0.70 are considered acceptable [45]. Data were entered into an Excel spreadsheet (Microsoft Cor- poration, Redwood, WA, USA) and analysed using the IBM Statis- tical Package for the Social Sciences (IBM SPSS Statistics) 20.0 for Windows (IBM Corp., Armonk, NY, USA). Absent 23 76.7 Slight 4 13.3 Moderate 2 6.7 Strong 1 3.3 3. Results The pre-final version of the instrument was tested in 30 patients with chronic wounds of the lower limb, of whom 23 (76.7%) were men, the mean age was 47.7 years (range, 21e77), 15 (50.0%) pa- tients had a partner, 14 (46.7%) had high school education, and 23 (76.7%) were retired or receiving a government benefit at the time of interview. Among the patients, 21 (70.0%) had traumatic wounds, 13 (43.3%) had the wound for more than 1 year, 19 (63.3%) had wounds of less than 25 cm2; 14 (46.7%) showed small amount of wound exudate, and the wound of 23 (76.7%) patients had no strong odour (Table 1). The mean VAS pain scores was 2.74 ± 3.48 (range, 0e10), cor- responding to a mild pain; 12 (40.0%) patients reported no pain (VAS score¼ 0) and 13 (46.6%) were using analgesics regularly or as needed. During the analysis of semantic, idiomatic, experiential and conceptual equivalence, the word ‘schedule’ in the name of the Please cite this article in press as:Augusto FdS, et al., Translation and Brazilian Portuguese, Journal of Tissue Viability (2016), http://dx.doi.org/ instrument was translated as ‘questionnaire’, because, for Brazil- ians, theword ‘schedule’ has a time connotation (e.g., time schedule or timetable). The original instrument uses an ‘(s)’ to indicate possible plural forms after a few singular nouns, as in the example ‘I feel anxious about my wound(s)’. Initially, this was maintained in the translated version of the instrument, including the possible inflections of nouns, pronouns, adjectives, and articles related to grammatical gender and declensional classes, according to Brazil- ian Portuguese [e.g., ‘Eu me sinto preocupado(a) com a(s) minha(s) ferida(s)’]. However, such additions may hinder the reading and contribute little to an understanding of the item content. Thus, all markers of plural, gender and declensional classes were removed and the final translation of the above example was ‘Eu me sinto cross-cultural adaptation of the Cardiff Wound Impact Schedule to 10.1016/j.jtv.2016.12.002 F.S. Augusto et al. / Journal of Tissue Viability xxx (2016) 1e64 preocupado com a minha ferida’. In addition, when the sentence ‘To what extent do you agree/disagree with the following statements?’ was literally translated into Brazilian Portuguese (i.e., ‘At�e que ponto você concorda/discorda com as seguintes afirmaç~oes?’), the patients had difficulty during the pretesting to understand that the subse- quent items were related to their own feelings and not to the opinion of a health professional. So, the sentence was replaced with ‘To what extent the following statements are consistent with what you feel’. Also, the categorical response options of the Likert-type scale related to the physical symptoms, daily living, and social life domains were initially translated as ‘no/not applicable’, ‘rarely’, ‘sometimes’, ‘often’, and ‘always’. However, the patients understood that there were two questions to be answered in a single item, the first being if the symptom/situation had occurred, and the second being how often the symptom/situation occurred in last week. Thus, the word ‘yes’was added before positive response options, as follows: ‘no/not applicable’, ‘yes, rarely’, ‘yes, sometimes’, ‘yes, often’, ‘yes, always’. The participants had a good understanding of the adapted instrument, had few questions and made few sug- gestions about items and form filling, which were all addressed by the expert committee. There was no need for deletion of items. Face validity achieved 100% consensus among the expert com- mittee, who concluded that the instrument assesses HRQoL in people with chronic wounds satisfactorily addressing relevant factors that underlie the problem. As for content validity, the 47 items of the adapted instrument were assessed by the 6 members of the expert committee, for a total of 282 evaluations, of which 271 (96%) were rated as “very important” (n ¼ 206; 73%) or “important” (n ¼ 65; 23%). Thus, CVI for the adapted instrument was 0.96. The overall Cronbach's alpha for the instrument was 0.920, corresponding to an excellent internal consistency, and ranged from 0.681 to 0.846 for the domains, as seen in Table 2. The back-translated version was approved by Dr Price after few adjustments, such as the replacement of the word ‘disappointed’ with ‘upset’ in the item 2 of the well-being domain (i.e., I feel upset with the time to healing of my wound). The cross-culturally adapted CWIS preserved the main features of the original instrument in English. The final cross-culturally adapted, Brazilian-Portuguese version of the CWIS for assessing HRQoL in patients with wounds was then named Cardiff Wound Impact Schedule-Federal University of Sao Paulo/School of Medi- cine (CWIS-UNIFESP/EPM). 4. Discussion The concept of HRQoL involves aspects of quality of life that are affected or influenced by changes in health [47]. Despite its subjectivity, researchers recognize that HRQOL provides a more accurate measure of the impact of a disease on the patient than the evaluation of strictly clinical results, such as estimates of mortality rates [47]. The assessment of patient HRQoL, especially when using disease-specific instruments, may contribute to the development of management strategies and interventions for improving quality of care for the target population. Table 2 Cronbach's alpha coefficient values for the Brazilian version of the Cardiff Wound Impact Schedule (CWIS-UNIFESP/EPM). CWIS domains Cronbach's alpha coefficient Well-being 0.681 Physical symptoms and daily living 0.786 Social life 0.846 Overall Cronbach's alpha (CWIS-UNIFESP/EPM) 0.920 Please cite this article in press as: Augusto FdS, et al., Translation and Brazilian Portuguese, Journal of Tissue Viability (2016), http://dx.doi.org/ Several studies have been conducted over the years evaluating the impact of wounds on quality of life. The Charing Cross Venous Ulcer Questionnaire (CXVUQ) was one of the first validated specific measures of quality of live for patients with wounds [15]. Currently, there are many wound-specific measures of quality of life world- wide [15e32], but few are available in Brazilian-Portuguese [27e32], resulting in a small number of investigations on this topic in our country. The cross-cultural adaptation of an already developed instru- ment has the advantage of producing a measure whose results can be compared with those of international studies. In addition, it is less expensive and requires less time to create a tool with indicators already internationally validated. However, the cross-cultural adaptation of a quality-of-life measure also requires a rigorous research before the validation of the resulting instrument [37,48e50]. Every culture sees the world in a unique way and this view is reflected in its language. This uniqueness permeates all aspects of life, including the way in which patients see their health and its effects on their physical well-being [33]. A valid translation of a measure is not achieved by the literal translation of terms, but by expressing complex concepts of a foreign culture [33]. In this study, some terms have been adapted to the Brazilian culture, such as the replacement of the word ‘schedule’ with ‘questionnaire’, similarly to previous cross-cultural adaptations to French and German, in which the name of the CWIS was translated as ‘Cardiff Wound Impact Questionnaire’ [33]. With regard to the psychometric analysis, face validity is a relevant measure that determines whether the instrument mea- sures what it was designed to measure [40]. The expert committee established by consensus that the Brazilian version of the CWIS had face validity for measuring HRQoL in patients with chronic wounds. Similarly, a previous study on the cross-cultural adaptation and validation of the CWIS to Swedish also found that the final version of the instrument had face validity after testing it in patients with chronic wounds [35]. The CWIS-UNIFESP/EPM has also good con- tent validity, according to the ratings of experts and patients with chronic wounds of the lower limb. This is in agreement with the findings for the original instrument, as well as for other versions of this measure [20,35,36]. In this study, the overall Cronbach's alpha was 0.920, indicating an excellent internal consistency for the in- strument; the Cronbach's alpha was acceptable for the well-being domain (alpha ¼ 0.681) and good for both the physical symptoms and daily living (alpha ¼ 0.746) and social life (alpha ¼ 0.846) do- mains. These results are similar to those of the original instrument (alpha range, 0.770e0.960), and those obtained in validation studies of the CWIS conducted in Canada (alpha range, 0.562e0.809), Sweden (alpha range, 0.690e0.920), and China (alpha range, 0.789e0.915) [20,35,36,51]. However, the validation study conducted in Portugal showed a Cronbach's alpha ranging from 0.805 to 0.956, indicating good to excellent internal consis- tency forall domains [34]. In this study, only the validation tests (i.e., face validity, content validity and internal consistency) directly related to the cross- cultural adaptation of the questionnaire to Brazilian Portuguese were performed. Additional studies will be conducted to test other psychometric properties of the CWIS-UNIFESP/EPM, including construct validity, criterion-related validity, and test-retest reli- ability (reproducibility). The study was conducted only in patients with chronic wounds on the legs. This is a limitation on the generalization of the results. Further studies are necessary to test the performance of the CWIS- UNIFESP/EPM in patients with different types of wounds. The use of quality of life as an indicator of treatment response in health care is an international trend that can also be applied to the Brazilian reality. Although there are still few studies evaluating cross-cultural adaptation of the Cardiff Wound Impact Schedule to 10.1016/j.jtv.2016.12.002 F.S. Augusto et al. / Journal of Tissue Viability xxx (2016) 1e6 5 quality of life in patients with wounds in Brazil, the practical application of assessment results (especially those obtained with specific tools) contributes to the implementation of interventions and evaluation of their effectiveness in improving quality of life among patients with wounds. 5. Conclusion The cross-culturally adapted Brazilian-Portuguese version of the instrument showed satisfactory face and content validity, good internal consistency, and was named Cardiff Wound Impact Schedule-Federal University of S~ao Paulo School of Medicine or CWIS-UNIFESP/EPM. Conflicts of interest statement The authors have no conflicts of interest, financial interest or commercial association with any of the subject matter or products mentioned in the manuscript. Funding There was no external funding for this study. References [1] Lazarus GS, Cooper DM, Knighton DR, Percoraro RE, Rodeheaver G, Robson MC. 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Introduction 2. Materials and methods 2.1. The instrument 3. Results 4. Discussion 5. Conclusion Conflicts of interest statement Funding References
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