burns 39 (2013) 957–964
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Spanish transcultural adaptation of the Leuven Itch Scale Valentı´n Yuste *, Alberto Agullo´, Murilo Silva, Julio Delgado, Fernando Albin˜ana, Enrique Monclu´s Servicio de Cirugı´a Pla´stica, Reconstructiva y Grandes Quemados, Hospital Universitario Miguel Servet, Zaragoza, Spain
article info
abstract
Article history:
Itching is one of the most frequent symptoms, and most resistant to treatment, relating to
Accepted 13 November 2012
scar formation after burns. The Leuven Itch Scale is a questionnaire which has been validated for use in burns, analysing different clinical dimensions of pruritus. However,
Keywords:
until now there was no Spanish version available for use with Spanish-speaking patients. This article presents the process of the academic translation of the questionnaire in
Itch Pruritus (Mesh) Psychometrics (Mesh)
order to obtain a Spanish version, and the final version of the questionnaire. We followed a translation/back-translation methodology with a final pilot test on a sample of burn patients. The final result fills a major gap in the quality-of-life questionnaires available in Spanish. # 2012 Elsevier Ltd and ISBI. All rights reserved.
1.
Introduction
Beyond the threat to life and functions of the patient, burns and their scarring also present multiple associated effects, one of the most often observed being itching, which according to some series can affect up to 87% of burn patients [1]. Itching is defined as an unpleasant sensation which provokes a desire to scratch [2]. It is a debilitating sensation which interferes with sleep and everyday activities, and which can produce additional harm through scratching [3] and even damage areas with skin grafts, delaying the scarring process [1]. The aetiology of pruritus in burn patients is confusing and multifactorial [4]. In recent years there has been significant progress in clarifying the physiopathological mechanisms [5], and in the therapeutic realm. Multiple treatments exist for pruritus in burn patients, studying the use of antihistamines [6] or their association with gabapentin [7] and naltrexone [8]. A combined approach using agents which act centrally and peripherally seems to be the most effective way to treat itching due to burns, although there are no studies with a high level of evidence.
Given the prevalence and resistance to treatment of this symptom, its evaluation in burn patients is very important. However, the great majority of major burns units (95% in the UK [9]) do not routinely measure the pruritus of their patients. The instrument most used to evaluate pruritus is the Itch Man Scale [10], which is also available in Spanish. There are other instruments such as the 5-point descriptive scale [11] and the Visual Analogue Scale [12], which can evaluate it objectively by evaluating scratching activity. However, until recently there was no validated and consensus instrument for measuring burn patients available for use. The Leuven Itch Scale is a scale designed by the University of Leuven (Belgium) and validated for use in different pathologies such as burn injuries. In comparison with previously developed instruments, it deals with pruritus as a symptom, and evaluates its different aspects as such [13]. It measures the frequency, duration, severity, circumstances, treatment, consequences, sensory characteristics, distress and location of pruritus, giving a multidimensional picture of the symptom. It is an extremely useful instrument which can be used in clinical tests to evaluate pruritus treatments.
* Corresponding author at: Hospital Universitario Miguel Servet, Paseo de Isabel ‘La Cato´lica’, 1–3, 50009 Zaragoza, Spain. Tel.: +34 609852921. E-mail address:
[email protected] (V. Yuste). 0305-4179/$36.00 # 2012 Elsevier Ltd and ISBI. All rights reserved. http://dx.doi.org/10.1016/j.burns.2012.11.011
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burns 39 (2013) 957–964
The use of this instrument in the evaluation of patients who do not speak English, the language in which the questionnaire was designed, requires a transcultural adaptation of it, ensuring semantic, linguistic and cultural equivalence with the original instrument. This process requires a method which lets us obtain this equivalence between the original questionnaire and the adaptation [14]. In this article we present the process of academic translation and transcultural adaptation to the Spanish language of the LIS.
2.
Materials and methods
2.1.
Prior stages
Before beginning the translation process we contacted the University of Leuven (Belgium), which provided the English version of the questionnaire for our study group. Having obtained this version and the permission of the authors of the original questionnaire, we had an academic translation done of it. For carrying out the study, we obtained the approval of the Bioethics Committee of the Aragonese Institute of Health Sciences (Comite´ de Bioe´tica del Instituto Aragone´s de Ciencias de la Salud).
Stage 1: Forward translation First, we held a meeting to analyse the questionnaire and the possible conceptual questions which might arise. Once the different concepts were clarified, two bilingual translators whose native language was Spanish carried out two forward translations of the Leuven Itch Scale into Spanish, creating versions T1 and T2. Stage 2: Synthesis After obtaining these versions, a meeting was held to reach a consensus between the translators and the work group. Translations T1 and T2 were analysed, using this phase to correct conceptual discrepancies between the two versions. This enabled both versions to be synthesised as a single translation, T12. Stage 3: Back-translation We carried out a back-translation to assess and check the quality of the Spanish translation. Two independent translators, whose native language was English and who were not aware of the purpose of the study, carried out two independent back-translations of the consensus version T12 to English, generating versions BT1 and BT2. Stage 4: Expert committee review
2.2.
Adaptation process
The English version of the ‘‘Leuven Itch Scale’’ was adapted to Castilian (Spanish) following the methodology published by Beaton et al. [14]. These steps were followed (Fig. 1):
A committee was formed, surgeons, two researchers and consolidate all the versions develop a pre-final version Spanish.
consisting of two plastic two translators, in order to of the questionnaire and of the questionnaire in
Fig. 1 – Stages of the transcultural adaptation process followed during the study.
burns 39 (2013) 957–964
The committee analysed all the versions of the questionnaire created during the study (T1, T2, T12, BT1 and BT2), the original questionnaire, and the written reports of each earlier stage. The source and back-translated questionnaires were compared in search of equivalencies and discrepancies between the versions. In this last case, consensus decisions were taken to obtain a definitive questionnaire. The entire process was documented in writing. Stage 5: Pretesting The fifth step in the academic translation was to carry out a pilot test on the target audience. In our case, the test was administered to 20 burn patients at the Major Burns Unit (Unidad de Grandes Quemados) of Hospital Universitario Miguel Servet, both hospitalised and out-patients. The patients were randomly selected from the non-dependent adults whose native language was Spanish and who could read, to ensure different social and cultural registers were included. Potential participants were informed of the characteristics and aims of the study. Their informed consent was later requested, so that the participants would be eligible to take part in the study. The selected patients were asked to fill in the questionnaire. At the same time, through a personal interview, the patients were tested on how well they had understood the different items. Finally, we asked them to point out any items which they considered could be confusing, and make any suggestions they wanted. A record was kept of the entire process in order to carry out a later analysis of the results obtained during pretesting. Stage 6: Report Finally, proofreading was carried out to ensure there were no spelling mistakes in the final version. This final version was sent to the original authors at the University of Leuven, together with all written reports for their approval.
3.
Results
Stages 1 and 2: After obtaining the two translations (T1 and T2), the committee consisting of the two translators and the researchers did not find notable differences between both translations in almost all the items. The only differences found were in the translation of question 9, finding that the translations of ‘‘A prickling sensation’’ and ‘‘A stinging sensation’’ to Spanish were confusing and interchangeable. Finally, the committee opted as a consensus to translate them as ‘‘Sensacio´n de pinchazos’’ and ‘‘Sensacio´n de picadura’’ respectively, following the examples given in the original questionnaire. Stages 3 and 4: A comparison of the English version of the questionnaire and the back-translations (BT1 and BT2) few notable discrepancies were found: In item 1 a disagreement was found between the English version (‘‘1 to a few times. . .’’) and the back-translation (‘‘1 to several times. . .’’) so it was decided to correct the Spanish translation to fit the original better, replacing ‘‘varias’’ with ‘‘algunas’’.
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A disagreement was found in item 5, where the expression ‘‘how bad’’ appeared in the original questionnaire, and ‘‘how intense’’ in the back-translation. It was decided not to change the translation, as these concepts are similar in Spanish. Item 9 was analysed with care, as it had demonstrated several problems during the translation process. The backtranslation of this item was practically identical to the original, and was therefore not changed. The expert committee revised the discrepancies mentioned above and approved the corrections. After the analysis and corrections, the committee drew up a pre-final version of the questionnaire. Stage 5: The questionnaire was given to 20 patients: 12 men and 8 women. The average age of the sample was 54.8 11.19 years. The patients had suffered burns between 4 weeks and 9 months after administration of the questionnaire. 4 of the patients had not experienced pruritus of any kind in the month before receiving the questionnaire. The results obtained after the analysis of the questionnaires are summarised below (scores range between 0 and 100, where 0 is the lowest score and 100 the highest score): a. Frequency: An average score of 48.75 was obtained for the questions on the frequency of the pruritus. b. Duration: An average score of 28.125 was obtained for the duration of the pruritus. c. Severity: An average score of 36.812 was obtained for the severity of the pruritus. d. Distress: An average score of 28.56 was obtained for the distress produced by the pruritus. e. Consequences: An average score of 12.63 was obtained for the consequences produced by the pruritus. f. Location: The average body surface affected was 5 of the total body surface. The average results are shown in Fig. 2. The standard deviations obtained are not shown, as the data do not follow a normal distribution. After answering the questionnaire, the patients showed they had understood it properly in a personal interview. While the great majority of the sample had no problem answering the questions and found the language used clear and comprehensible, the evidence indicated that some of the
Fig. 2 – Average results obtained during the pilot test.
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questions needed certain clarifications. These clarifications were mostly related to completing all the questions. In item 1, two of the patients answered the sub-section ‘‘ Porque´ no ha tenido picor/no ha vuelto a tener picor?’’ (Why have you not had an itch/again?) without having answered ‘‘Never’’ to the previous question. This led to a clarification in the definitive questionnaire that this question should only be answered if the option ‘‘Never’’ had previously been selected. In item 8 a tendency was found to leave blank the symptoms which had not been experienced at any time, rather than answering with option ‘‘a’’ (‘‘Never’’). This led to the clarification that all sections should be answered. In item 11, initially some patients (4) marked the areas where they experienced itching with crosses rather than shading the whole area. This led to a specific clarification in this item on the need to shade completely the area where they experienced itching. There were no problems in the answers to the remaining items. Stage 6: The original authors of the questionnaire approved the Spanish version. The final result after grammar corrections is shown in Appendix A. ?
4.
Discussion
Pruritus is an extremely serious problem for burn patients. However, it is remarkable that until now, no questionnaire was available in Spanish specifically adapted to burn patients. The purpose of this study was to create a Spanish translation of the Leuven Itch Scale for use with burn patients. During the adaptation process, less debate arose than would be expected in a process of this type, as most of the items were simple concepts and easy to translate. The bulk of the discussion centred on specific terms and adjectives, with little impact on the equivalence of the questionnaire and the results obtained. Stage 5 of the process, the pilot study, showed optimal comprehension of the questionnaire. The queries regarding filling in the questionnaire had practically no impact on calculating its results, except for Item 11, on the body surface with itching. In this case the problem was easily solved by emphasising the need to shade all of the surface. To summarise, the corrections made were minor and did not change the main thrust of the questionnaire.
It should be borne in mind that the purpose of the study was the adaptation of the questionnaire, and thus the sample used is not enough to obtain data which can be extrapolated to the Spanish burn population. The averages obtained illustrate the magnitude of the problem (80% prevalence of pruritus in our sample, with an average severity according to the questionnaire of 36.812). This is relevant because the data obtained are comparable with those obtained in a longitudinal study in burn patients using the Leuven Itch Scale [15]. This shows that our version of the scale is able to accurately assess the profile of itch in burn patients. For this reason we believe the use of the questionnaire is desirable in order to carry out an epidemiological study of the distribution of pruritus in our population of burn patients. Thus, given that the translation of the questionnaire has been validated for burn patients, it may be useful to test and validate it for other pruriginous conditions. Our academic translation process has created an instrument which can measure different dimensions of pruritus in the Spanish-speaking population. To conclude, the Leuven Scale is an innovative instrument for evaluating pruriginous conditions, and specifically, pruritus as a secondary effect of burns. We have produced a Spanish translation of the Leuven Itch Scale which is conceptually equivalent to the English version and comprehensible for our population of burn patients, thanks to the academic translation methodology used. This questionnaire fills a major gap in the quality-of-life questionnaires available in Spanish. This will permit a deeper understanding of the epidemiological distribution of pruritus in the Spanish population of burn patients, and provides a tool for the study of new therapies for the treatment of itching, and for the individual evaluation of the pruritus of burn patients, highlighting a symptom which despite its frequency and impact, is often ignored by the doctors responsible for their treatment.
Conflict of interests There is no conflict of interests.
Ethics This work has been approved by the Bioethics Committee of the Aragonese Institute of Health Sciences (Instituto Aragone´s de Ciencias de la Salud, IACS).
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Appendix A
961
962
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963
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