PORTUGUESE TRANSLATION AND VALIDATION OF THE YQOL – FD (YOUTH QUALITY OF LIFE INSTRUMENT—FACIAL DIFFERENCES) FOR BRAZILIAN ADOLESCENTS WITH CRANIOFACIAL DEFORMITIES TRADUÇÃO E VALIDAÇÃO EM PORTUGUÊS DO YQOL – FD (YOUTH QUALITY OF LIFE INSTRUMENT – FACIAL DIFFERENCES) PARA ADOLESCENTES BRASILEIROS COM DEFORMIDADES CRANIOFACIAIS

The Youth Quality of Life—Facial Differences (YQOL-FD), validated in the United States in 2005, was developed at the University of Washington by the Seattle Quality of Life Group (SeaQol), to evaluate quality of life of adolescents with facial deformities. Because no Portuguese version exists, the measure was not viable in Brazil. This study aimed to obtain linguistic and psychometric validation of a version of the YQOL-FD in Portuguese. Twenty-five patients with cleft lip and palate and five without facial deformity participated in Traumatology and Maxillofacial Prosthesis Surgery Clinic, School of Dentistry, University of São Paulo. The linguistic validation of the YQOL-FD was carried out by a team consisting of the researcher, as project manager, two native Portuguese-speaking consultants fluent in English, and one native Englishspeaking consultant fluent in Portuguese. After translation and back-translation, a Portuguese version was obtained, which was applied in a pilot test (n = 10); after the final adjustments the Seattle Quality of Life Group approved the official version of the YQOL-FD in Portuguese. To obtain the psychometric validation, we requested the participation of 20 patients with cleft lip and palate who answered the questionnaire twice in a range of 7 to 15 days. The Cronbach’s alpha test was applied in the 48-item block, showing a high degree of internal consistency (0.949). The Wilcoxon Signal Post Test was applied to verify if the test and retest values were similar; the general agreement was 4/5 = 80%, indicating high reproducibility. It was concluded that the Portuguese version of the YQOL-FD is adequate for evaluating Quality of Life of Brazilian adolescents with craniofacial deformities.


INTRODUCTION
Quality of life is defined as an individual's perception of his or her position in life in the context of the culture and value system in which they live and in relation to their goals, expectations, standards, and concerns. Adolescents with a facial deformity may experience significant distress, but the ways to better solve this problem remain poorly studied (RIKLIN et al., 2019). It is a broad concept that expresses its subjectivity and multidimensionality and is a window through which one's own perceptions are evaluated (WHOQOL, 1995;BONOMI et al., 2000). Among the main objectives pursued in current clinical trials is the improvement of people's quality of life. In the research into new methodologies for treatment and prevention of diseases, the need to standardize their analysis emerged (NOBRE, 1995).
There are several methodological differences between studies about quality of life assessment among individuals with cleft lip and palate (QUEIROZ HERKRATH et al. 2015). Quality of life assessment during adolescence presents special challenges, including finding the most important and relevant domains, conceptualizing the thoughts and feelings of adolescents and indicating both "positive" and "negative" aspects of their lives, and measuring their self-perception with a valid and reliable instrument (PATRICK et al., 2002). Measuring instruments were needed to assess and compare the quality of life of groups of vulnerable adolescents, such as those with disabilities or special health needs, with that of the general adolescent population (PATRICK, 1997).
The use of a standard questionnaire and standardized assessment by a calibrated examiner is an indispensable factor for quality of life research (MONTES et al. 2019). When choosing an assessment instrument, it must be consider whether its components present idiomatic, semantic, cultural, and conceptual equivalents (GUILLEMIN et al., 1993). In the search for an instrument to evaluate the quality of life of adolescents with cleft lip and palate, the most appropriate one we found in the literature was the Youth Quality of Life Instrument-Facial Differences (YQOL-FD), developed by the Seattle Quality of Life Group (SeaQOL), Department of Health Services, University of Washington, which is a questionnaire designed and validated specifically for young patients with craniofacial deformities (EDWARDS et al., 2005). The YQOL-FD consists of 48 items, including questions and statements, related to perceptual and contextual aspects. The first part of the questionnaire contains 18 contextual questions and the second part consists of 30 items distributed in five domains which are: 1) Coping; 2) Negative self image; 3) Positive Consequences; 4) Negative Consequences; 5) Stigma. The YQOL-FD in its original version can be found at: http://www.seaqolgroup.org.
Each society has its own characteristics reflecting the national culture and differentiating it from others. Similarly, health problems are expressed differently across cultures. Thus, when proposing application of a health-related data collection or measurement tool, the criteria proposed in the literature should be observed, resulting in an instrument with simple, clear language and conceptual equivalence (CICONELLI et al., 1999). The process of linguistic validation of an instrument in another language is not a literal translation but the production of a translation that is conceptually equivalent to the original and culturally acceptable in the country where the translation will be used. It requires a systematic approach that takes the following steps: translation, back-translation, and cultural adaptation.
This study aimed to obtain an official version of the YQOL-FD questionnaire in Portuguese and to submit it to psychometric validation.

Ethics approval and consent to participate
The procedures in this study were approved by the School of Dentistry Ethics Committee, University of São Paulo, number 835.697 and all patients has signed the consent form.

Linguistic Validation
The first step was to translate and adapt the YQOL-FD into Portuguese. All internationally accepted standards were met. In addition, the guidance in the Language Validation Manual provided by the developers of the instrument, SeaQOL, were strictly followed.
The Linguistic Validation team indicated in the methodology of the SeaQOL Linguistic Validation Manual was constituted as follows: 1. Project Manager: responsible for overseeing the translation process and mediation to obtain the reconciled version. With the translation team already formed, we started the validation process.

Phase I: Direct translation
This phase can be summarized as the first pass from the original language (English) to the target language (Portuguese) by Consultants 1 and 2. Each translator independently produced an initial version. Then, comparing the two versions, we chose the best translation for each item to obtain the reconciled version. Thus, we obtained Version 1 in Portuguese.

Phase II: Back-translation
At this stage, Consultant 3, a native English language speaker, back-translated Version 1 into English. The researcher, as Project Manager, assisted by Consultant 3, compared the backtranslation with the original version of the YQOL-FD. All doubts were clarified regarding possible inaccuracies or even errors in translation as well as understanding, and the necessary corrections and modifications were made, leading to Version 2.
The "Translation Table" in the Linguistic Validation Manual provided by the developer was completed by the work team, including item-byitem discussion in detail. At present, a report has been drawn up presenting the consultants' qualifications and comments. This material (Table  and Report) has been submitted to the YQOL-FD development team for review and approval of this release.

Phase III: Cognitive analysis
Cognitive analysis is necessary to know if the translated version of the questionnaire is acceptable and easy to understand as well as if the language used is simple and appropriate for the population in which the questionnaire will be applied. Version 2 of the questionnaire was obtained after Phase II was applied in a "Pilot Test" with 10 participants between the ages of 14 and 18 years, 5 of whom had complete cleft lip and palate and 5 of whom had no facial deformity. The test was applied as an interview, during which participants were asked about any difficulty with understanding and problems with interpreting items addressed in the instrument; when necessary, alternative proposals for translation were suggested.
A report of the interviews was produced containing the number of participants, their ages, the time taken to complete the questionnaire, the difficulties encountered, and the solutions proposed. Finally, a third version of the questionnaire was produced. This version, called Version 3, was sent with this second report to the YQOL-FD development team for review and approval. After some minor adaptations and suggestions from the Seattle team, the official version of the YQOL-FD in Portuguese was approved. Total validation process was completed in 6 months.

YQOL-FD Psychometric Validation (Portuguese Version)
For this stage, 20 patients were selected from the Cleft Lip and Palate Outpatient Clinic of the Department of Maxillofacial Surgery, Prosthodontics and Traumatology, Dentistry School University of São Paulo. These patients with cleft lip and palate, had already undergone primary repair surgeries, were in the age range of 11 to 18 years, and were of both genders regardless of ethnicity. Prior to questionnaire application, all participants received guidance on the research purpose and notions about quality of life through a small explanatory speech. The adolescents were accommodated comfortably in an appropriate place and without distractions that could disrupt or interrupt responses. The 20 participants were asked to return in 7-15 days to respond again to the same questionnaire to compare the answers and, thus, test the reliability and reproducibility of the official Portuguese version of the YQOL-FD. Data from the 40 completed questionnaires were placed in the spreadsheet and then submitted to statistical analysis. The Cronbach's Alpha Statistical Test was used to verify the level of reliability in terms of the so-called "internal consistency" of the observed values. The Wilcoxon Signpost Test was used to verify that test and retest values are similar.
The complete sequence of the linguistic validation steps is presented in Figure 1 (GOES et al., 2013) to illustrate the process.

RESULTS
For the psychometric validation, the sample profile can be seen in table 1, which presents the group of 20 patients with cleft lip and palate who responded to the test and retest to evaluate the reliability and reproducibility of the Portuguese version. of the YQOL-FD.   The Wilcoxon Signpost Test (Table 3) was used to verify that test and retest values are similar (p > 0.050). Four of the five domains present "concordance" (similarity between the two moments of observation). Therefore, the general agreement is 4/5 = 0.8 = 80% for the domains.

DISCUSSION
There is virtually universal consensus on the evaluation of the quality of life in individuals with facial deformities as a means of assessing the efficacy of a therapeutic protocol (PATRICK et al., 2007;RAPOSO DO AMARAL et al., 2011;KLASSEN et al., 2012). Quality of life is measured using general or specific health questionnaires for specific pathologies, but they are almost always developed in the English language, and their use in countries with other languages requires rigorous translation and revalidation. KORTELAINEN et al. (2016), conducted a comparative study for validation of the Child Perception Questionnaire (CPQ11-14), and concluded that the oral health-related quality of life of Finnish children with CLP was considerably poorer than that of their peers in all dimensions, especially social welfare. It is important to emphasize that there is a significant number of protocols proposed by different reference centers for the rehabilitation of patients with craniofacial deformities, particularly those with orofacial clefts. Although a standard treatment is established, the quality of life of these patients and their families is affected (ZERAATKAR et al., 2018). The presence of cleft lip and/or palate negatively affected the healthrelated quality of life, mainly on psychosocial dimensions (QUEIROZ HERKRATH et al., 2015).
In making this review, it was difficult to find really effective instruments to measure the quality of life of individuals with craniofacial deformities. Many questionnaires were created and transcribed in different publications, and, although their diversity is significant, it was very difficult to find one that comprehensively covers orofacial clefts. KLASSEN et al. (2012) identified 28 different questionnaires applied to measure the results from the perspective of the patients or their parents; however, almost all of these instruments were used only once.
The YQOL-FD, instrument developed at the Department of Health Services of the University of Washington (PATRICK et al., 2007) it was the most appropriate for application in patients with cleft lip and palate because items were dedicated exclusively to facial deformities, and, since it has elements specifically designed for adolescents and young adults, it can allow a relevant study of the treatment protocol used; in this age group, they are in the final stage of rehabilitation.
To obtain linguistic validation of the YQOL-FD for Portuguese, patients with clefts were selected in the metropolitan region of São Paulo that had equivalent socioeconomic and cultural levels. Brazil is a country with an extensive territorial area with significant cultural and social diversity, but this does not characterize a bias of this work, whose objective was to seek a language that was faithful to the original.
When selecting the sample, decided that patients with isolated clefts of the palate would not be interviewed because they did not present facial differences, and the YQOL-FD instrument has as weak point of not considering functional alterations such as speech, voice quality, hearing, and chewing (RAPOSO DO AMARAL et al., 2011;ECKSTEIN et al., 2011). However, Klassen et al. (2012 emphasize that the YQOL-FD instrument was developed to study the quality of life of adolescents with a wide range of craniofacial malformations and not to cover the specific problems of the population with cleft lip and palate.
It was decided not to include the isolated clefts of the lip because they are the least severe, and many patients with cleft lip have almost imperceptible scars, which could also intervene in the domain scores and constitute a bias of this work.
The validation process was not easy and required a significant amount of time to complete, which can be seen in the description of the methodology. For linguistic validation, difficulties were observed in understanding some items; these were responsible for small changes in the text to facilitate participants' understanding. For example, the question "How often do you have your picture taken?" has been replaced with "How often do you take photos that you appear in?".
After the Portuguese version was accepted by the developers of the YQOL-FD, and to complement the validation process, this study aimed to evaluate the reliability and reproducibility of the instrument in its different domains.
The statistical tests showed results similar to those found by PATRICK et al. (2007). The Cronbach's alpha test for internal consistency of the YQOL-FD, whose results are shown in Table 2, presented the coefficient of 0.949, which surpasses that presented in the reference study, demonstrating high consistency since it exceeds 0.70. The same occurred in the reproducibility test, which presented, in the individual item evaluation, 93.73% agreement between test and retest behaviors, and, when grouped in domains, the value was 80% (Table 3), showing high reproducibility, it can be consider high concordances when this ratio is above 2/3 (66.67%). For the YQOL-FD (english version), the Cronbach alpha test and I.C.C (Intraclass correlation coefficient) were used., applied within the five domains and presented results as follow: 1). Cronbach's Alpha: between 71% and 90%; 2). I.C.C.: between 80% and 91% (PATRICK et al. 2007).
Adolescence is a phase where facial appearance and attractiveness are very important for self-esteem and psychosocial well-being, which is why this instrument is considered very valuable, however for small cleft lip and palate rehabilitation centers this instrument ends up being limiting in obtaining a significant sample, as it excludes patients outside this age group.