Cultural adaptation and content validity of ISTAP Skin Tear Classification for Portuguese in Brazil

1Universidade de São Paulo – Faculdade de Medicina – Instituto do Coração do Hospital das Clínicas – São Paulo/SP – Brazil. 2Universidade de São Paulo – Escola de Enfermagem – São Paulo/SP – Brazil. 3Western University – Scholl of Physical Therapy – Advanced Health Care Practice Program – Ontario – Canada. 4National Pressure Ulcer Advisory Panel – Washington, DC – USA. 5Universidade de São Paulo – Escola de Enfermagem – Departamento de Enfermagem Médico-Cirúrgica – São Paulo/SP – Brazil. Corresponding author: Cinthia Viana Bandeira da Silva | Rua Sebastião Dias, 38 | ZIP Code: 02976-050 – São Paulo/SP – Brazil | E-mail: bandeira.cinthia@gmail.com Received: Mar. 07 2018 | Accepted: Jun. 28 2018 ABSTRACT Objective: To translate and culturally adapt the International Skin Tear Advisory Panel (ISTAP) Skin Tear Classification into the Portuguese language in Brazil and test the content validity of the adapted version. Methods: The cultural adaption comprised three phases: translation, evaluation by committee of judges composed of five stomatherapists (confirming the instrument content validity) and back-translation. Results: Two Brazilian Portuguese versions of the instrument were obtained after translation and analyzed by the committee, disagreements arose over several health related terms. This generated low values of the content validity index. However, the content validity was confirmed after discussion of discrepancies between the authors and some members of the judges’ committee, as well as with one of the authors of the original instrument, Dr. Kimberly LeBlanc, who also testified that validity when approving the back-translations of the adapted version to Brazilian Portuguese. Conclusion: The culturally adapted version of the ISTAP Skin Tear Classification is considered to have been obtained, with its content validity also attested. At that moment, the tests for inter and intraobserver reliability and concurrent validity are in the finalization phase, after which the instrument adapted and validated for Brazil will be made available.


INTRODUCTION
Skin tears (ST) are traumatic wounds that occur primarily in the extremities and in the elderly, caused by shear, friction and/or brute force, resulting in the separation of the layers of skin.This separation may be of partial thickness when the dermis and epidermis separate, or of full thickness, when the dermis, epidermis and underlying structure are separated from each other 1,2 .
It is already known that some factors alter the healing process and these also present as risk factors for the appearance of ST, such as: extremes of age, especially the elderly older than 85 years; women and caucasians; impaired nutritional status; use of drugs such as immunosuppresives, antiinflammatory agents and anticoagulants, the last often causing the appearance of ecchymoses; smoking; loss of sensation; dependency for activities of daily living; impaired mobility; and current disease state 1,3 .
There is much debate surrounding the nomenclature and methods for describing and documenting STs.Payne and Martin 4,5 published seminal work in 1990 when they developed the Payne-Martin Classification System for Skin Tears.Although no measured properties tested, the system was and still is widely used 6 .Since that time two distinct international groups have proposed new classification systems,

METHODS
This is a methodological study with a quantitative approach on the cultural adaptation of the ISTAP Skin Tear Classification based on the proposal of Beaton et al. 9 .equivalences between the translated and original versions 9 .

The invitation and authorization for ISTAP
Each judge proceeded to the analysis using Likert scale (1 to 4), respectively: totally disagree, disagree, agree and totally agree.In addition to this analysis, the members of the committee were asked to suggest changes to suit and improve the wording of the items in order to better adjust the translations made to the health area.The agreement between the judges' answers was analyzed through the content validity index (CVI) obtained by the proportion of items that received scores 3 or 4 by the judges 10

Committee of judges´analyses
The mean CVI was 0.66, when calculated according to the mean proportions (Table 1).
The translations with higher values of CVI (0.To obtain the T3 version, at the end of this phase, the judges' suggestions were considered and it was established that the term lesão would be standardized throughout the instrument, rather than the word ferida.
The suggestions of the judges were similar in all aspects of the instrument, the differences being characterized only with regard to synonymy, verb tenses and prepositions, that is, grammatical differences.

Back-translation
There were no difficulties reported by translators at this stage.There were small differences between the back-translated and the original versions, but without any changes in meanings or content.To finalize the version adapted by the researchers, only the definition of ST type 1 generated a new discussion with the original author.
Dr. LeBlanc commented on the difference in content that, in the adapted version, included a more detailed explanation on the form of ST type 1 coverage, in both cases: linear injury and cutaneous flap.Considering that only the edge approach is possible to "cover" the injury in case of linear rupture and that the repositioning of the flap is only possible when it exists, the researchers considered it important to detail such an explanation  As for the evaluation of translations by committee of judges, very low CVI levels were obtained (mean CVI: 0.66), much below the cutoff value (0.9) 10,13 , which could be interpreted as absence of content validity, to

Recommendations and limitations
The ISTAP has been working with wound care specialists in all continents aiming to disseminate its classification system and other prevention and treatment protocols and to achieve a standardized language regarding ST, which would A limitation of this manusrcipt is that as the result of time constraints and workloads, the study cannot be published in its entirity at this time.This manuscript represents the translation and cultural adaptation of the ISTAP ST Classification system.Phase two which is aimed at exploring the validity and reliability of the system in clincial practice.
In order to provide an adapted, reliable and valid instrument for use in the country, some measurement properties will be analyzed after the end of data collection (inter and intraobserver reliability and concurrent criterion validity).
both based on Payne-Martin's first initiative: The Skin Tear Audit Research (STAR) Skin Tear Classification System 2 was developed Australia in 2007, and International Skin Tear Advisory Panel (ISTAP) 1 developed the ISTAP Skin Tear Classification System in 2011.

Figure 1 .
photos, again without referring to the classification system, Skin Tear Classification cultural adaptation and validation for Brazilians was made by Dr. Kimberly LeBlanc, coordinator of the international ISTAP committee, to Prof. Dr. Vera Lucia C. G. Santos.The Research Ethics Committee of Nursing School of Sao Paulo University (EEUSP) approved the project (66513517.7.0000.5392/2017/CEPEEUSP) as well as the Heart Institute (InCor) of the Clinicals Hospital of Medical School of the University of São Paulo , where the data collection was performed to evaluate the measurement properties of the adapted version of the instrument.Participating nurses and patients were included in the study sample only after consent and anonymity were guaranteed.Although the present study relates only to the stage of cultural adaptation of ISTAP Skin Tear Classification to Portuguese in Brazil, the project was approved as a whole in the instances described previously.The study was developed as a conclusion work of the Nursing Residency Program in Cardiopneumology of High Complexity of EEUSP-InCor.The adaptation process included three stages: translation, judging by committee of judges (in which content validity was also tested) and back-translation.First, the ISTAP Skin Tear Classification was translated by two Brazilian translators, fluent in English: a lay person in the health area, without knowledge of the research project, and a nurse aware of the study´s aims 9 .The translations were named, respectively, T1 and T2.Both classified each item of the instrument as to the degree of difficulty in the translation process (0 to 10).The two translations were then analyzed by a committee of judges composed of five Brazilian specialized nurses in stomatherapy, fluent in English, experts in the treatment of patients with wounds and with knowledge of the concepts of the instrument.The judges' committee is a fundamental part of achieving the cultural equivalence of the translated instrument and its evaluation is aimed at analyzing the semantic (grammatical correspondence and meaning of words), idiomatic (substitution of specific colloquial expressions, rarely translatable, by equivalent terms), cultural (coherence between the terms used and the culture of the population to which the instrument is intended) and conceptual (if the translated terms reflect the same original concepts)

- 13 :
Content validity indicates to what extent the instrumenthas an appropriate sample of items to measure the particular construct and adequately cover its domain.It is increasingly common to use a group of independent experts to evaluate the content validity of new instruments.The CVI indicates the extent to which the opinions of the experts are congruent, by measuring the proportion or percentage of judges who agree on the aspects and items of the instrument.Besides analyzing the items, it allows analyzing the instrument as a whole.The excellence level of the content validity is achieved with an CVI of 0.90[10][11][12][13] .Based on the judges' answers, a single version was established by the researchers who discussed the discrepancies Cultural adaptation and content validity of ISTAP Skin Tear Classification for Portuguese in Brazil with some of the committee members and with one of the authors of the original instrument, Dr. LeBlanc.The resulting version was then forwarded to back-translation, also performed by two translators, both lay in health care and who had English as their native language.Both backtranslated versions were forwarded to Dr LeBlanc in order to confirm the equivalence between the original and the Brazilian adapted version.The data were grouped into Excel spreadsheets and analyzed through the Statistical Package for Social Sciences Program (SPSS) version 22.0.

Two
Brazilian Portuguese versions of the instrument were obtained (T1 and T2).For the lay translator in the health area (T1), both the title and the definition of the first type of injury presented higher degrees of difficulty to be translated (classified as 8), justified by lack of knowledge in the health area.Already the translator who knew the objective of the study (T2) mentioned difficulty only when translating the term tear.The two versions still showed slight differences as to the translations of the terms flap and wound bed: flap was translated as aba and borda and wound bed as leito and base da ferida.

8 and 1 )
are related to the instrument title (ISTAP Skin Tear Classification) and type 1 (without skin loss).All other translations obtained suggestions for the adequacy of the translated terms.The word flap generated significant disagreement between judges and translators on all items in which they appeared, reducing CVI values.The incorrect translation of this term led the judges to suggest the use of the terminology retalho cutâneo instead of aba or borda, indicated in the translations.Another important item of discussion was the definition of ST type 1 (CVI: 0.4), which includes two ST subtypes (linear rupture and cutaneous flap -both without loss of cutaneous tissue or skin) and, therefore, leads to two different forms of "covering" the injury (linear or flap tear that can be repositioned to cover the wound bed).In this case, the main researchers chose to discuss the content of the definition with some of the committee members, with the non lay translator, as well as with Dr. LeBlanc.The discussions resulted in a definition that included two forms of coverage from the subtype (linear or flap): reaproximação de bordas or reposicionamento do retalho, respectively.
This article consists of the report of the first stage of a larger study, developed during the High Complexity Cardiopneumology Nursing Residency Program of EEUSP-InCor, aimed at cultural adaptation and validation of the ISTAP Skin Tear Classification, according to the Beaton et al. methodology 9 , classical in the academic environment.Since the instrument translation phase, some problems have been encountered with some terms that have already presented difficulties in a previous study of cultural adaptation and validation of STAR Skin Tear Classification System 7 , also developed by one of the researchers of the present study.The term skin tear or directly the word tear required in-depth study on the laws of mechanics to better understand the etiology of the injury and establishment of the term lesão por fricção 8 maintained herein.
immediate criticism.However, these results originate from the inadequate translation of the term flap that appears in the definitions of the three ST types.The final version was established after extensive discussion among the researchers, some members of the judges' committee and the original author, as the literature indicates in case of low CVI10,11 .The standardization of the terms retalho cutâneo and leito da lesão, respectively, for flap and wound bed, was due to its current use in the literature specialized in dermatology, plastic surgery and stomatherapy.As evidenced by Neto14 , the cutaneous flap is composed of a mobilized tissue attached to its vascular pedicle to maintain its irrigation.Irrigation of the skin occurs through superficial branches originating from the superficial fascia.Besides these, and as described in the Results section, the definition of type 1 -without skin loss -generated a great discussion, since it is the only type of injury that covers two subtypes.In order to avoid its inaccuracy, the discussions resulted in the detailing of its contents, approved by all, including by the original author, who could observe that in the back-translations.Thus, the content validity of the final Brazilian Portuguese version of the ISTAP Skin Tear Classification was confirmed.Until now, only one group in Denmark has performed the translation and validation of the ISTAP Skin Tear Classification System, following the same methodology used in the original study.The English to Danish translation was performed by two groups with four nurses specialized in dermatology, being later analyzed and mixed for final version by two of the authors of the adaptation.Then, this version was sent to back-translation, performed by two translators, a lay in the area and a nurse with knowledge of the study's objective.The adapted version was then submitted to a validation process similar to the original one.The 30 original photos belonging to ISTAP were applied to 270 professionals, nurses (n = 241) and physicians (n = 29).The level of agreement presented was moderate for both groups (Fleiss Kappa = 0.464 and 0.443, respectively), a result that resembles those obtained in the original study 15 .Although the other measuring properties of the instrument have not yet been analyzed in the Brazilian Portuguese adapted version, comparisons with the original and the Danish studies become difficult as methods used in both are different from those adopted here.
facilitate the recovery of the problem and comparison of the results obtained around the world.In addition, the Panel is adjusting and reviewing the ST nomenclature.Performing cultural adaptation and validation of the classification system are the best way to standardize the language and spread that across countries.Except for Denmark, the first country to adapt and validate the ISTAP Classification System, only Sweden, Czech Republic, Quebec (French Canadian), Brazil and Chile are in the process of adaptation and validation of the instrument.In parallel, the Panel attempts Cultural adaptation and content validity of ISTAP Skin Tear Classification for Portuguese in Brazil to introduce the term "skin tear" into the International Statistical Classification of Diseases and Related Health Problems (ICD) and Medical Subject Headings (MeSH).

Table 1 .
Content validity index (CVI) of translated versions of the instrument to Brazilian Portuguese.São Paulo.SP.Brazil.2017.