Translation and cross-cultural adaptation of an instrument designed for the assessment of quality of life in orthognatic patients

Contact address: Adriana Monteiro de Araújo Av. Almirante Barroso, 28 – Souza – Belém/PA, Brazil CEP: 66613-020 – E-mail: ortodontia.adriana@gmail.com 1 Specialist in Orthodontics, Rio de Janeiro State University (UERJ). 2 Specialist in Orthodontics, Rio de Janeiro State University (UERJ). MSc and PhD in Dentistry. Associate Professor of Orthodontics at Rio de Janeiro State University (UERJ). 3 PhD in Collective Health/Epidemiology, Institute of Social Medicine (IMS) / UERJ, 2003. Associate Professor, Department of Preventive and Community Dentistry at College of Dentistry, Rio de Janeiro State University (UERJ). 4 Specialist in Orthodontics, Rio de Janeiro State University (UERJ). Master’s degree student at Rio de Janeiro State University (UERJ). Introduction: The Orthognathic Quality of Life Questionnaire (OQLQ) was developed in 2000 and validated in 2002, aiming at assessing the impact and the benefits of orthosurgical treatment on patients’ quality of life. Objective: Cross-culturally translate into Brazilian Portuguese and back-translate into English a quality of life instrument, assuring maintenance of its properties. Methods: At first, equivalence of concepts and items was discussed by a group of specialists who scrutinized all questionnaire items. Additionally, four patients in need of orthosurgical treatment were interviewed by means of the focus group methodology. Relevance of the questionnaire items was assured prior to its translation which was carried out by two translators who worked independently. Both translations were tested in 20 patients and then consolidated. The consolidated questionnaire version was back-translated into English by two translators who worked independently, and the consolidated back-translation was assessed by the authors of the original questionnaire as well as by the researchers. Results: The OQLQ was translated into Brazilian Portuguese. This translation was tested in a pilot study comprising 12 patients, aged between 16 and 34 years old. Conclusion: The OQLQ Brazilian Portuguese translation proves to be an appropriate instrument to access the impact of dentofacial deformities on the quality of life of patients in the Brazilian public health system and who are in need of orthosurgical treatment.


INTRODUCTION
Health-related quality of life (HRQL) among patients with malocclusions and severe dentofacial deformities may be affected in various ways.They may experience functional limitations, emotional problems and social difficulties, even to the extent of considering life less satisfactory. 1,2In cases in which improper skeletal relationships cannot be compensated by means of using orthodontic therapy only, orthognathic surgery proves to be an alternative for treating dentofacial deformities, as it provides more stable correction and better esthetic results. 3atients' request for orthodontic treatment is based on their complaints about appearance and other psychological and social factors. 4Patient's perception of their dentofacial deformity should be the main factor inluencing their decision on whether or not to have orthosurgical treatment. 3The success of this type of treatment and the alterations in HRQL that it may produce depend on proper patient selection. 5he Orthognathic Quality of Life Questionnaire (OQLQ) was developed in the United Kingdom, in 2000, aiming to assess the success of orthosurgical treatment in terms of its efect on HRQL, from the patient's point of view. 6The OQLQ consists of 22 questions, divided into 4 domains: 8 questions regarding social aspects of deformity, 5 questions regarding facial esthetics, 5 questions regarding oral functions, and 4 questions regarding awareness of facial deformity.The answers are given using a 4-point rating scale in order to measure to what extent the condition described in each question bothers the patient (1= "bothers you a little"; 4 = "bothers you a lot").In 2002, the validity and responsiveness of the questionnaire were demonstrated.To the validation process, the OQLQ was correlated to other HRQL impact assessment measures, and responsiveness was tested by means of comparing the scores that patients obtained on the OQLQ before and ater treatment.The results proved the questionnaire to be useful both in clinical practice and in research projects. 7The OQLQ has already been adapted to other cultures 8,9 and used in many countries to assess the impact of dentofacial deformities and the efects of orthosurgical treatment on quality of life in cross-sectional 5,10 and longitudinal 11,12 studies.
Many patients in need of orthosurgical treatment appeal for the public health system and for university health services.However, since this treatment is expensive, complicated and lengthy, not everyone can be immediately assisted in the public health system and university facilities.As a result, priorities must be set, and the OQLQ has proved to be a useful instrument for healthcare professionals to establish those priorities.
The purpose of this article is to describe the process of adapting the OQLQ questionnaire into Brazilian Portuguese in order to make it suitable to be used in Brazilian public and university dental services.

Ethical approval
This research was approved by the Institutional Review Board of Pedro Ernesto University Hospital at Rio de Janeiro State University (CEP/HUPE Registration: 2705/2010.CAAE: 0150.0.228.000-10).Patients who stated their acceptance in writing by means of an Informed Consent Form were the only ones allowed to participate in the research.

Adaptation of the questionnaire Equivalence of concepts and items
Before starting the translation and back-translation processes, which intended to achieve semantic equivalence between the Brazilian version of the OQLQ and the original instrument; suitability of the conceptual model used to develop the questionnaire and relevance of the items of which it is comprised were evaluated within the context of Brazilian culture. 13These aspects were analyzed by a team of specialists (TS) consisted of two orthodontists, one postgraduate student in Orthodontics and a dentist with experience in developing and adapting quality of life instruments.Every item in the original English version was carefully read and discussed.Aterwards, four patients in need of orthosurgical treatment were interviewed at the UERJ Orthodontics Clinic.The interviews were videotaped so that they could be analyzed later.The goal was to identify the terms used by the patients themselves to describe how their dentofacial deformities interfered with their quality of life and, in particular, verify how the interviewees referred to the problems raised in the questionnaire and which were considered by the specialists involved in the previous phase as potentially diicult to explain in Portuguese.The videos were analyzed by the postgraduate student in Orthodontics, who also took into consider-original article Araújo AM, Miguel JAM, Gava ECB, Oliveira BH ation the patient's feelings, attitudes and motivation in relation to the problems discussed in the questionnaire.

Semantic equivalence
The OQLQ Brazilian adaptation process followed the guidelines proposed by Guillemin et al, 14 Ruperto et al. 15 and Tubert-Jeannin et al. 16

Translation
The questionnaire was translated into Portuguese by two Brazilians who worked independently, whose mother tongue is Portuguese and who are proicient in English.The goals of the questionnaire were explained to both translators (T1 and T2), who were advised to use terms employed by the target population in daily life, allowing the questionnaire to be easily understood by patients in the public health system.

Preliminary test of the translated questionnaires
A preliminary test of the questionnaire was carried out with 20 orthognathic patients recruited at the UERJ Orthodontics Clinic; 10 patients answered T1 questionnaire while the other 10 answered T2 questionnaire.The aim was to assess, from the interviewees' point of view, whether the questions on the questionnaire represented the impact of dentofacial deformities on their quality of life.In addition, the meaning of several words and expressions used in the questionnaire was questioned in order to determine whether or not they were being understood.Interviewees were also asked about the need for replacing any words or expressions.

Questionnaire consolidation
The specialists discussed both translations of the questionnaire based not only on the results obtained from the interviews, which were conducted with members of the target population during the preliminary test, but also from the analyses of the previously recorded videos.Aterwards, they determined how the questionnaire items would be written and how the intensity of patient's' discomfort towards the problems included on the questionnaire would be assessed.Thereater, three other patients with dentofacial deformities were interviewed and videotaped in order to test their comprehension of the statements and questions in the consolidated version.Ater those interviews, the consolidated version of the translations was inalized.

Back-translation
The OQLQ questionnaire was back-translated into English by two translators (B1 and B2) who worked independently.Although their native language is English, they are proicient in Portuguese.In contrast to the irst translators, the back -translators were not told about the objectives and concepts involved in the questionnaire in order to avoid any bias.They discussed the discrepancies in their results and carried out the consolidated version of the back-translation.

Translations and back-translations review
The consolidated versions of the OQLQ translations and back-translations were sent to the authors of  Translation and cross-cultural adaptation of an instrument designed for the assessment of quality of life in orthognatic patients original article ists as well as the information obtained from the interviews, and concluded that it would be appropriate to keep all the items from the original questionnaire.

Semantic equivalence
Table 1 shows the items from the original English OQLQ questionnaire, the results derived from the translations and from consolidation of the questionnaire, as well as the results derived from the consolidated version back-translation.

Translation
Both translations proved to be similar, with little discrepancy related to speciic terminology (Table 1).

Preliminary test of the translated questionnaires and consolidation of the questionnaire
Conducting the preliminary test corroborated the need for a better evaluation of the questions, such as the understanding of the words: "self-conscious", "staring at me" and "lack conidence".
Ten patients (ive from T1 and ive from T2), meaning 50% of the interviewees, did not report any doubts about the questions and were able to answer them without any assistance.As for the other 10 patients, eight of them (four from T1 and four from T2) reported doubts about the word "self-conscious" (Items 1 and 14); one patient (T1) did not know the meaning of "jaw"; three patients (T1) did not ind the term "to stare" (Items 12 and 13) to be very clear; two patients (T2) reported doubts about the term "lack conidence" (Item 18); and three patients (T1) reported doubts about Item 22: "Comments about my appearance really upset me, even when I know that people are only joking".Some patients suggested using words such as "evaluate" instead of "analyze" (Items 8 and 9 -T1); "notice" instead of "stare" (Items 12 and 13 -T1); "gaze" instead of "stare" (Items 12 and 13 -T1) "compare" instead of "gaze" (Items 12 and 13 -T2); "get to know" instead of "meet" (Item 16 -T2); "irritate, upset or not be good for", to replace "hurt" (Item 22 -T1); and "image" instead of "appearance" (Items 14, 17, 20 and 22 -T1).
Based on the results of the preliminary test and the interviews, the decisions made by the team of specialists about the form and content of the consolidated questionnaire originated the consolidated translated questionnaire, shown in Table 1.
the original questionnaire by e-mail for their evaluation.Ater receiving the results of this evaluation, the team of specialists (TS) met again to compare the original version of the OQLQ questionnaire with the back-translated version, taking into consideration the authors' opinions of the original questionnaire.

Developing the final questionnaire
Based on the results of the preceding phase, the specialists proposed a inal version of the questionnaire which was written in Brazilian Portuguese and intended to be used in a pilot study, aiming at assessing other types of equivalence as well.

Pilot study
The pilot study was conducted at the clinic of the graduate program in Orthodontics at UERJ and involved 12 patients (9 male and 3 female) with an average age of 25 years.All patients involved in the research presented malocclusions with skeletal discrepancies.Two researchers involved in the project conducted the pilot test and were present during the application of the 12 questionnaires in order to ensure standardization of the method used to explain the questionnaire to the target public.Should patients have any doubts about the questions, the researchers were advised not to inluence their answers.The purpose of this pilot study was to test all the phases of later studies aimed at evaluating the psychometric properties of the instrument.

Equivalence of concepts and items
When the team of specialists assessed the suitability of the conceptual model, as well as the relevance of the questionnaire items in the context of Brazilian culture, they highlighted some words that could have created doubts in the process of translation into Brazilian Portuguese, namely: "self-conscious" (Items 1 and 14), "jaw" (Item 6), "studying" (Items 8 and 9), "oten stare at" (Items 12 and 13), "lack conidence" (Item 18), "get depressed" (Item 20), "staring at me" (Item 21) and "upset me" (Item 22).
Analysis of the recorded interviews carried out with the four patients, demonstrated that the words considered hard to translate were in fact well understood.The group responsible for the research project discussed the results of the analyses carried out by the team of special-  Translation and cross-cultural adaptation of an instrument designed for the assessment of quality of life in orthognatic patients original article

Back-translation
The translators suggested a change in the irst part of the wording of the questionnaire.However, the group responsible for the study claimed that this would result in a substantial change in comparison to the original questionnaire.The translators also found the expression "facial pains" to be very generic, given that in the Brazilian context more speciic terms such as headache, pain behind the eyes, etc. would be used.In addition, they thought that the word "depressed" might be too strong a translation of "deprimido", and suggested other words in English, such as "dejected" or "down".

Translations and back-translations review
The consolidation of the back-translations was evaluated by the main author of the original study.She commented that in the wording of the questionnaire, the term "intensely" seemed extreme and exaggerated.The author also suggested replacing "as to" with "about" in Item 1, and commented that, in Item 22, the word "anger" was not equivalent to the original questionnaire, and that it would be appropriate to keep the idea of "upset".

Developing the final questionnaire
A inal version of the OQLQ questionnaire, written in Brazilian Portuguese was, thus, obtained to be tested in terms of its validity and reliability (Fig 2).

Pilot study
12 (100%) interviewees took part in the pilot study, 9 of which (75%) were male and 3 (25%) female, with age ranging from 16 to 34 years old, with an average age of 25.According to the Criteria of Brazilian Economic Classiication, the study population belonged to social classes A (n=6; 49.99%) and B (n=6; 49.99%).
The pilot study corroborated the need for a subsequent evaluation study of the psychometric properties of the instrument.The average time for the interviews varied from 15 to 25 minutes.

DISCUSSION
A translated instrument must be able to achieve in the target culture the same efect it has in its original context.Lack of cross-cultural equivalence hinders the validity of the collected information, making it impossible to properly use the instrument to study the concept that it aims to study. 17In order to achieve the desired efect, we carried out a careful process of translation into Brazilian Portuguese and back-translation into English of the OQLQ questionnaire and, before having a inal version of the instrument, the diferent versions of the original article Araújo AM, Miguel JAM, Gava ECB, Oliveira BH questionnaire in Portuguese were subjected to evaluation by specialists in the ield as well as tests carried out by patients.In addition, the authors of the original questionnaire were consulted.This strategy allowed us to cross-check the specialists' opinions on how the items in the questionnaire were written against the perceptions of the population to which the instrument is actually intended to be applied, thus, enabling the identification of expressions that are more suitable for proper understanding of the questions in the instrument without altering the ideas and concepts underlying the questions in the original instrument.
In comparing the original of the OQLQ questionnaire to the consolidated version of the back-translations, we were able to verify that they were similar and that the small differences found had arisen from changes considered necessary during the phase of assessing semantic equivalence, due to suggestions made by the specialists or the patients.Those changes were maintained since they were considered important for the clarity of the questionnaire translated into Portuguese.
We also found that it was necessary to change the format of the questionnaire, as had occurred in the study carried out by Bock et al, 8 whereby the scale with the degrees of discomfort was added below each question so that patients would not have to go back to the text of the questionnaire before answering each question.
Given that the patients were at least 16 years old and demonstrated no difficulties during the interviews and the preliminary test, we decided to let patients complete the questionnaire themselves during the pilot study, as had been suggested by the authors of the original instrument in English. 6,7Nevertheless, we must emphasize that although patients were recruited at a clinic in the public health system, all of them belonged to the A and B socioeconomic classes, which may not reflect socioeconomic and educational levels of those patients in need for orthosurgical treatment who normally use public dental services.
Additionally, it is important to highlight the fact that there has been a recent publication of a research describing the psychometric properties of the OQLQ Brazilian version. 9That study involved a convenience sample comprised of 25 patients selected in the states of Santa Catarina and Rio Grande do Sul and pro-vides information about the internal consistency and structural validity of the Brazilian questionnaire.That publication was discovered after the process of data collection and analysis had already been completed.Because of that, we contacted the author of the original questionnaire and she encouraged us to continue with the present study.The previously published study used an adaptation methodology which was different from the one used in the present study.In addition, it focused on the equivalence of measurement between the translated questionnaire and the original, without providing any details on how the translated questionnaire was obtained, taking into account: the number of translations and backtranslations done, patient participation in the process of identifying the most suitable words for the Brazilian context, contributions made by the authors of the original instrument in English to the final version of the instrument, socioeconomic characteristics of the participants, among others.We, thus, believe that the present study can be considered original, since it offers to dentists and researchers a contribution that is different from the one provided by the aforementioned study.In addition, one must take into account the fact that Brazil is a country of continental dimensions with a broad cultural diversity, which means that questionnaires adapted, validated and reliable to be used with certain populations may not have the same effectiveness when used with other groups. 18he questionnaire produced in the present study was used with patients from a public hospital in Rio de Janeiro, in order to assess its reliability and validity.The results are being analyzed and will be presented in a future publication.

CONCLUSION
Despite being hard work and time-consuming, the process of achieving semantic equivalence in the cross-cultural adaptation of the OQLQ, used with populations that appeal for public health services in Brazil, was developed on a solid conceptual base and with a carefully defined methodology.Such process allowed us to produce a valuable instrument for assessing the quality of life of Brazilian orthognathic patients, aiming to compare the effects of dentofacial deformities and orthosurgical treatment on Brazilians and on people from other countries and cultures.
which comprised six stages (Fig 1): (i) translation; (ii) preliminary testing of the translated questionnaires; (iii) consolidation of the questionnaire; (iv) back-translation; (v) review of the translations and back-translations; and (vi) development of a synthesized questionnaire.

Figure 1 -
Figure 1 -Methodology used to achieve semantic equivalence in the process of translating the Orthognathic Quality of Life Questionnaire (OQLQ) into Portuguese.

Figure 2 -
Figure 2 -Consolidated version of the Orthognathic Quality of Life Questionnaire (OQLQ) in Brazilian Portuguese, for testing.

Table 1 -
The OQLQ translations into Brazilian Portuguese, their consolidated version and back-translation.