Translation of the Convexity Assessment Guide into the Portuguese language

1Faculdade de Medicina de Rio Preto – Programa de Pós-Graduação em Enfermagem – São José do Rio Preto/SP – Brazil. 2Hollister do Brasil – Coordenação de Educação Clínica – São Paulo/SP – Brazil. 3Faculdade de Medicina de Rio Preto – Curso de Graduação em Enfermagem – Departamento de Enfermagem Geral – São José do Rio Preto/SP – Brazil. 4Universidade de São Paulo – Programa de Pós-Graduação em Gerenciamento em Enfermagem – São Paulo/SP – Brazil. 5Unimed São Jose do Rio Preto – Departamento de Enfermagem – Setor de Emergência – São José do Rio Preto/SP – Brazil. 6Grupo Empório Saúde – São José do Rio Preto/SP – Brazil. 7Unimed São Jose do Rio Preto – Departamento Unimed Lar – São José do Rio Preto/SP – Brazil. Correspondence author: Bruna Prini Rafaldini | Rua São Domingos, 978/101 – Vila Caiçara | ZIP Code: 11706-380 – Praia Grande/ SP | E-mail: brunaprini@yahoo.com.br Received: Aug 03 2018 | Accepted: Dec 15 2018 ABSTRACT Objectives: Translate the Convexity Assessment Guide into the Portuguese language and perform its semantic, linguistic, conceptual and cultural validation. Methods: Translation study, qualitative descriptive, following the recommended phases: translation, back translation, comparison of original and translated versions back to Portuguese, validation by national experts committee. Results: It was obtained 400 evaluations – 49 annulled and 351 valid – which represents the total used for the agreement analysis of the items. After the analysis, there were six discordant items, reviewed according to the experts’ suggestions, obtaining, then, a greater agreement of 90% in all items evaluated. Conclusion: There was a high level of agreement among the evaluator’s committee, ensuring the continuity of the study with the cross-cultural validation of the Convexity Guide for the Brazilian reality. This research promoted the translation of an instrument that assists in the clinical indication of collector devices for stomas. The validation of the translation into the Portuguese language was obtained, being this the fi rst phase of the process of cross-cultural validation.


INTRODUCTION
Currently, there is a gap in national research on the topic of translation or development of guidelines related to the use of convexity in stomas.However, this type of tool has been used e ciently in North America, as evidenced by international events such as the 2016 WOCN Society & CAET Joint Conference, Montreal, Canada 1 , and in 21st WCET Biennal Congress, Cape Town, South Africa 2 , in which relevant studies were presented regarding the development of tools to aid in the indication of collector equipment, such as the use of convexity.
In Brazil, studies on the use of convexity and standardization of this language are still few and have been developed, for the most part, such as case studies, experience reports and bibliographic reviews only published in the summary format in annals 3 .Research aimed at translating instruments from di erent areas of care and management aims to disseminate technologies to those who have not yet bene ted from the development of new diagnostics, therapeutics or tools that instrumentalize decision making.Studies such as these are widely used in health in Brazil, due to the scarcity of literature and, mainly, the complexity involved in the creation of valid national and international instruments 4,5 .e lack of instruments that aid in decision making regarding the collector equipment for intestinal stomas and intestinal habits in Brazil stimulates the search for tools already scienti cally proven and validated that, when translated in a judicious way and according to a methodological scope, can favor professionals and bene t the patients with a safe nursing care, based on scienti c evidence 6 .
With the increase in the life expectancy of the Brazilian population, it was identi ed a growth of new stomas and longevity of those who already live with this condition, making even more critical the necessity for specialized care and the development of innovative technologies 7 .

Translation of the Convexity Assessment Guide into the Portuguese language
People with stomas may experience complications related to them in di erent periods of their lives and, despite the development of surgical techniques, complication rates still remain between 25 and 59% of patients in the rst three postoperative months 8 .
One of the most frequently diagnosed complications is dermatitis related to the contact of the e uent with the skin, and the most used resource for the prevention of peristomal dermatitis is the use of a collector device that ts perfectly to the abdominal contours and that maintains a comfortable and safe adherence between the device and the skin.In several situations, the convexity is used to maintain this attachment of the adhesive barrier with the abdominal anatomy, allowing complete adhesion of the equipment with the skin, avoiding detachment and early leakage of the collector device 9 .
In 2012, international researchers classi ed convexity as the curvature of the skin barrier that meets the peristomal skin.e terminology and convexity characteristics were classi ed according to depth, pro le, tension, construction and exibility.e depth may be shallow (less than 1.5 mm), moderate (1.5 mm to 6.3 mm) and deep (above 6.3 mm), depending on the slope and gradient pro le, , its soft or rm exibility, its tension that is related to low or high amont of tension and peripheral or central location.e convexity can be integrated to the barrier already in its construction or customized, according to the necessity, adding accessories, like plane rings or convex, helping in the adaptation of the equipment and preventing peristomal complications 9 .
The management of complications requires a multidisciplinary e ort, but especially of the nurse who uses the available devices in the market; however, the evaluation guides to aid in the indication of di erent types of devices are scarce 9 .e costs involved in nursing care may be extremely high, especially in cases of peristomal complications, leading to a 75% increase in expenses 8,10 , values that indicate the necessity for improvements in health policies, aiming the promotion of quality reduction of losses for health services.However, these advances in the area of public and private health are materialized through scienti c evidence that encourages managers with concrete and systematized data, allowing the planning and budget management conscious that allows the specialized assistance and the provision of personal collector equipment for this population group.
Some studies related to the management of complicated stomas and also the in uence of medications on e uent consistency and characteristics indicate convexity in situations such as retracted stomas, skin folds, use of chemotherapy, accid abdomen, frequent e uent leaks or even when the durability of the equipment does not reach that expected by the user.It is these complex occurrences that have a direct impact on the lives of those living with the stoma, as well as posing great challenges for health professionals and services 11 .
In this context, the experience in specialized care

OBJECTIVES
Translate the Convexity Assessment Guide into the Portuguese language.Perform the semantic, linguistic, conceptual and cultural validation of the Convexity Guide.

METHODS
It is a methodological study of translation, qualitative descriptive, whose methodological procedures followed were the phases announced for this methodology:

Adapting the Convexity Assessment Guide to the Portuguese language
e translation of the Convexity Assessment Guide was realized in three stages: translation, back translation and validation of the translation by the committee of experts.
Only these stages were adopted because the convexity is still little studied in Brazil, requiring a greater general understanding about the theme to broaden the translation process for transcultural validation of the guide.
Step Step 2. Back-translation Step 3. Validation of the translation by the expert committee e VP4 was submitted as a semantic and linguistic agreement evaluation tool to a group of 10 stomatherapists nurses to verify the level of agreement with the issues described.For the study of translation, even if the methodological phase in which the group participated didn´t required English language knowledge, 40% of its participants stated that they had knowledge in basic English, 40% intermediate and 20% advanced.This heterogeneity of the group promotes a technical language with a range of understanding across diverse cultures and confers the national character to the validation of the instrument.
The semantic evaluation of the content refers to the analysis of the meaning of each sentence and if the sentences match the speci c reality in the stomatherapy.
e Likert scale 13 was used with scores from 1 to 5, in which 1 represents "strongly disagree", 2 "disagree", 3 "not agree or disagree", 4 "agree" and 5 "strongly agree" to classify semantic agreement and linguistics of the items.
e acceptable level of agreement to validate each item was at least 90% among stomal therapist's opinions.
In cases in which the score represented some

RESULTS
In its original version, the introductory theoretical part was translated from English into Portuguese and submitted to the analysis of the trio of specialist nurses Translation of the Convexity Assessment Guide into the Portuguese language with extensive clinical experience in the area of assistance to the person with the stoma, being two stomal therapists and a master in nursing and specialist in education, all uent in English.A degree of agreement of 100% was obtained in the translations of the key characteristics for the evaluation of the stomas proposed by the guide (Table 1).e guide then presents the evaluation form with 40 sentences/items submitted to the three-step translation process.In this phase, the quartet of specialists also realized the inclusion of the item "confection of the stoma" in the VP3, referring to the stomas in the handle or terminal stomas, an item that did not exist in VI1, in order to perform cultural and conceptual validation.In the classi cation of the 40 items, 400 evaluations were obtained.After applying the exclusion criteria, 49 evaluations were canceled, leaving 351 valid classi cations that represented the total used for the concordance analysis of each item (Figure 1).
For the classification of each item, the collector instrument followed the division of themes proposed by the original guide containing the following sessions: Patient identi cation; Evaluation of stoma -for terminal and/or in loop stoma; Distal stoma evaluation -only for the loop stoma; Peristomal evaluation -for all types of stomas; and Result of the evaluation.After agreement analysis of each of the 40 items, only six presented agreement less than 90% between responses, an item with 89% agreement in the Patient Identi cation session, Table 1.Description of some characteristics for evaluation of the stomas according to the Convexity Assessment Guide. in which case one item was included by the evaluating committee, two items in the stoma assessment session -for terminal and/or in handle stoma, with 87 and 89%, three items of the session Result of the evaluation presented ratings of 87% for one item and 89% for the other two (Table 2).

Evaluation of stomas Evaluation of the peristomal region
e items in disagreement received six suggestions for adequacy of each sentence for the Portuguese language, aiming at the technical language.ese proposals were analyzed by the author and by the group of E2 nurses and, after discussion and pertinence, were realized the adjustments, reaching the levels of the agreement required for the validation of the translation.

DISCUSSION
e process of translation and validation of instruments for the Portuguese language has been widely used in Brazil in several sectors of the health area, due to the complexity involved in the elaboration and validation of an instrument, a situation that is complicated when it is aimed at the area of stomatherapy 6 . is specialty began its expansion in the 1990s, with the creation of the Brazilian Association of Stomatherapy (SOBEST), an entity that supports Brazilian stomatherapists , promoting events, courses, and the development of scienti c knowledge in the area 15 .
e predominantly female group of stomatherapists participating in the research -10% (one) man and 90% (nine) women -is in agreement with the research related to gender among nursing professionals in Brazil and, consequently, in stomatherapy, since the nurse profession is historically female 15 .
As to familiarity with the stoma care , the group was highly involved with technical, care and management care, since 90% work directly in the area. is characteristic is similar to that demonstrated in studies of out-of-state undergraduates in the countryside of Sao Paulo, in which 93.3% of postgraduate students already worked in the area before entering the course 15 .ese data demonstrate the interest of this class in transforming their practical and empirical knowledge into scienti c and assertive, even this behavior was also identi ed at all stages of this research.
e fact that there are few items in disagreement, only 17.5% of all items evaluated, shows that the language used is in accordance with the one used regularly, but disagreements represent an important point of discussion, since the speci c language in stomatherapy comes still Translation of the Convexity Assessment Guide into the Portuguese language evolving in a timid manner, with some studies suggesting the standardization of language and systematization of pre-and-postoperative care 4,9,16 .
By choice of the rst trio of nurses (E1), the necessity to identify, in the instrument itself, the type of preparation of the stoma, whether terminal or in the handle, was identi ed.Because it is a guide that should be used by specialist and non-specialist nurses, it should contain all the priority information, as added and validated by the expert committee.Even though they were among the items in disagreement, the suggestions were extremely valid and approved by the group, since a recent study con rms that several factors associated with the confection of the stoma may lead to the development of peristomal complications 16 .
Disagreements and discomforts related to the "e uent type" item were widely discussed, due to the importance of characterizing and measuring e uent volume, since the main complication presented by people with a stoma, peristomal dermatitis, can be caused by the direct contact of the e uent with the skin 8 . is type of lesion is classi ed as a peristomal lesion associated with moisture, by a consensus of 2013 17 .Just as the characterization of the e uent becomes important for the choice of the ideal equipment for the patient, the identi cation of the stoma opening is crucial, since its position directs the ow of the e uent can if decentralized or in a telescope, facilitate the in ltration of the e uent below the adhesive barrier of the collector bag 18.During the validation, it was suggested by 20% of the participants that the word "score", of English origin, be replaced by "result", precisely because it is a national application guide and in the Portuguese language.Although the word "score" is widely used in Brazil, the suggestions were accepted and validated by the group 19 .Study of instrument translation in the orthopedic area maintained the original use of the word score only adapting to the Portuguese language "score", being evident the freedom of choice and validation of the term used for each class of professionals; in this sense, the use of the term "result", validated with 90% agreement, was accepted.
e last two items in disagreement also presented similar suggestions.Due to the similarity between the phrases, the suggestion of the expert committee was accepted, since it was the annotation and indication of several "products" related to the care of the stoma, encompassing the "equipment " collector and other accessories that help in the best adjustment to the stoma, not just the equipment 20 .A recent study with North American stomal therapist nurses has identi ed that the main product choices for the management of peristomal complications involve collector equipment with a convex base between other accessories 21 .These indications corroborate the choice of terminology adopted in the nal version of the guide.An adequate indication of the equipment, the attendance of a stomatherapist nurse and family support are essential for the development of self-care 22 since the most common peristomal skin complication is a result of e uent contact with the skin caused by the lack of adequate adjustment the type of barrier with the skin and stoma type 23 .e guarantee of the health of the peristomal skin promotes quality of life to the one who lives with the stoma 23 .

Limitations of the study
e main limitations of the study occurred during the literature review due to the scarcity of national scienti c production regarding the use of convexity in the stomas and the di culty in recruiting stomal therapist nurses with advanced knowledge and uency in the English language.

Contributions to the nursing area
This study promotes the first scientific evidence in stomatherapy points to a lack of scienti c research that supports clinical and managerial decisions.us, the interest for this research emerged from the absence of tools that support the decision-making of the nurse in the care of the person with the stoma and in the election of the ideal collector equipment for each patient in each moment of its life.erefore, the translation of the Convexity Assessment Guide into the Brazilian Portuguese language becomes important as a rst step towards the development of a validated instrument for the Brazilian reality, since the convexity is not yet studied in depth in Brazil.
1. Translation e guide, in its original English version (VI1), was translated by two independent translators, originating two versions in Portuguese (VP1) and (VP2); then, were compared by three specialist nurses and uent in the English language (E1) (two stomatherapists and a nursing master), compiling VP1 and VP2 and generating the rst full version in Portuguese (VP3).
was sent to two translators/teachers in English and Portuguese, not informed of the research objective, to perform the reverse translation of the guide, and VP3 was translated from Portuguese to English, generating the English version 2 (VI2) and the English version 3 (VI3).Next, a group of four stomatherapists nurses with masters and/or doctorate in the area (E2) compared the two reverse translations (VI2 and VI3) with the original version (VI1), in order to adapt in terms of semantics, concept and Brazilian culture, thus generating the Portuguese version 4 (VP4).

disagreement (score 1 ,
2 or 3), the nurse indicated a suggestion of change to the item.Portuguese version 5 (VP5) was the result of suggested changes and all validated items with the agreement of at least 90%14 between the group.To check the cultural and conceptual characteristics, some items could be included or removed from the instrument.e statistical treatment of the data was done through the program Windows Excel 2010 with analysis of the levels of agreement, using percentages based on the total of the valid answers.Exclusion criteria were used in the validation phase, such as indications of changes related to other aspects, blank responses, indications of esthetics changes and/or unrelated to semantic, linguistic, cultural and conceptual evaluation.After applying this lter, the statistical treatment had its total based only on valid data, with the nulls being subtracted from the general total.e numbers will be displayed with two decimal places and in percentage in the form of tables and gures.

e
evaluation form consists of 40 phrases/evaluation items referring to the identification of the patient's pro le, type of stoma, e uent characteristics, stoma, and abdominal anatomy , as well as identi cation of some peristomal complications.e form included elds for annotation of the concordance levels of each sentence.e process of translation of evaluation form from the original version VI1 to the rst Portuguese language versions VP1 and VP2 did not show signi cant differences among the translators, is then evaluated by the trio of nurses, generating agreement above 90%; thus, the VP1 and VP2 versions were consolidated in the third Portuguese version, the VP3.ere were no signi cant di erences between the two other translators for the two Portuguese-to-English translations of the VP3 version and were analyzed by the same trio of nurses from the rst stage, with a nurse doctor and specialist in skin care, being also uent in English.e group did not identify discrepancies between translations, compiling VI2 and VI3 and validating VP3.

For the semantic and
linguistic validation process, a group of 10 nurses was composed of nine women from di erent regions of Brazil, 30% of the countryside of Sao Paulo, 30% of the city of São Paulo, 20% of the state of Minas Gerais, 10% of the state of Parana and 10% of the state of Bahia.As for academic training, nine are specialists in stomatherapy and one specialist in health education, 50% masters and 20% doctors.e professionals were selected and invited to participate in the research for their professional performance, attendance to patients with stomas and knowledge on the subject, and to work in regions with large numbers of people with stomas.With regard to familiarity, all nurses attend patients with stomas in their work routine, with 60% working in outpatient clinics specialized in stomatherapy with an average of 35 visits per week, 10% in a hospital unit specialized in stomatherapy, 30% in professional education and patients.

Figure 1 .
Figure 1.Graphical representation of the degrees of agreement quantifi cation of the semantic validation instrument (n = 400).
related to the translation of instruments that aid in the clinical indication of collector devices for elimination stomas.e validation of the translation of the Convexity Assessment Guide into the Portuguese language was obtained through this research.CONCLUSIONIn this phase of translation, semantic, linguistic, conceptual and cultural validation of the Convexity Guide, there was a high level of agreement of the evaluator's committee, ensuring continuity of the study with the cross-cultural validation of the Convexity Guide for the Brazilian reality.
is study was supported by Hollister do Brasil and Hollister Incorporated.

Table 2 .
Presentation of the results of the validation of the items in disagreement.São Jose do Rio Preto/SP, 2017.