Cultural adaptation of Quality Of Care Through The Patient ’ s Eyes-QUOTE-HIV Adaptação cultural do Quality Of Care Through The Patient ’ s Eyes-QUOTE-HIV Adaptación cultural de Quality Of Care Through The Patient ’ s Eyes-QUOTE-HIV

Objective: to translate and adapt Quality of Care Through the Patient’s Eyes HIV (QUOTE-HIV) for the Brazilian population living with HIV/AIDS. Method: a methodological study, which followed the stages of translation, synthesis, back-translation, evaluation by the committee of experts and pre-test for cultural adaptation of the instrument. Results: the process of translation and cultural adaptation was considered adequate. Evaluation by the expert committee resulted in semantic, structural and grammatical adequacy of the evaluated items. 30 subjects considered the instrument to be easy to understand and suggested minor adjustments in some items. Conclusion: the Brazilian version of QUOTE-HIV has been adapted and validated in relation to its content. However, this is a study that precedes the process of evaluating the psychometric properties of the instrument, the results of which will be presented in a later publication. Descriptors: Translation; Validation Studies; HIV; Acquired Immunodefi ciency Syndrome; Nursing. RESUMO Objetivo: traduzir e adaptar o Quality of Care Through the Patient’s Eyes HIV (QUOTE-HIV) para população brasileira que vive com HIV/aids. Método: estudo do tipo metodológico, que seguiu as etapas de tradução, síntese, retrotradução, avaliação pelo comitê de especialistas e pré-teste para adaptação cultural do instrumento. Resultados: o processo de tradução e adaptação cultural foi considerado adequado. A avaliação pelo comitê de especialistas resultou em adequações semânticas, estruturais e gramaticais dos itens avaliados. Participaram do pré-teste 30 sujeitos que consideraram o instrumento de fácil compreensão e sugeriram pequenas adequações em alguns de seus itens. Conclusão: a versão brasileira do QUOTE-HIV encontra-se adaptada e validada em relação ao seu conteúdo. Contudo, este é um estudo que antecede o processo de avaliação das propriedades psicométricas do instrumento, cujos resultados serão apresentados em publicação posterior. Descritores: Tradução; Estudos de Validação; HIV; Síndrome de Imunodefi ciência Adquirida; Enfermagem. RESUMEN Objetivo: traducir y adaptar el Quality of Care Through the Patient’s Eyes HIV (QUOTE-HIV) para población brasileña que vive con HIV/sida. Método: estudio del tipo metodológico, que siguió las etapas de traducción, síntesis, retro traducción, evaluación por comité de especialistas y pre test para adaptación cultural del instrumento. Resultados: el proceso de traducción y adaptación cultural fue considerado adecuado. La evaluación por comité de especialistas resultó en adecuaciones semánticas, estructurales y gramaticales de los ítems evaluados. Participaron del pre test 30 sujetos que consideraron el instrumento de fácil comprensión y sugirieron pequeñas adecuaciones en algunos de sus ítems. Conclusión: la versión brasileña del QUOTE-HIV se encuentra adaptada y validada con relación a su contenido. Sin embargo, este es un estudio que antecede el proceso de evaluación de las propiedades psicométricas del instrumento, cuyos resultados serán presentados en publicaciones posterior. Descriptores: Traducción; Estudios de Validación; HIV; Síndrome de Inmunodefi ciencia Adquirida; Enfermería. Cultural adaptation of Quality Of Care Through The Patient’s Eyes -QUOTE-HIV Adaptação cultural do Quality Of Care Through The Patient’s Eyes -QUOTE-HIV Adaptación cultural de Quality Of Care Through The Patient’s Eyes QUOTE-HIV Tiago Cristiano de Lima E-mail: tiagolima@hc.unicamp.br CORRESPONDING AUTHOR


INTRODUCTION
Acquired Immunodeficiency Syndrome (AIDS), caused by the Human Immunodeficiency Virus (HIV), stands out among infectious diseases due to the great magnitude and extent of harm it causes (1) .
According to data from the Joint United Nations Program on HIV/AIDS (UNAIDS), in 2014 there were a total of 36.9 million people living with HIV in the world.That same year, two million people were infected with the virus and 1.2 million died from HIV/AIDS-related illnesses.In Brazil, from the first cases identified up until June 2015, a total of 798,366 HIV/AIDS cases have been reported.In the last five years, the country has registered an average of 40,600 new cases of the disease per year (2)(3) .
From the beginning of the epidemic to the present day, the disease has progressed in a complex, chronic and controllable way.The quality of life of people infected with the virus has improved considerably, thanks to the set of procedures available for their treatment (highly effective antiretroviral therapy, medicines for prophylaxis of opportunistic diseases, routine immunizations, periodic medical examinations and consultations, and health programs) (4)(5) .However, maintaining the quality of care provided and guaranteeing patients' adherence to care programs will continue to be a challenge for health professionals.Thus, systematically evaluating the quality of care provided for people living with HIV/AIDS (PLWHA) is essential for the development of good practices and the maintenance of satisfactory results that have already been achieved (6)(7) .
Quality in health can be defined as the degree of compliance with quality standards established according to norms and protocols that organize actions and practices, as well as current technical and scientific knowledge, respecting culturally accepted values and considering, also, the attendance to health needs perceived expectations of users and their families, as well as the response to technically defined needs (8) .
Patients' perspectives on health services include their needs, opinions, perceptions and individual experiences that require responses from these services to users.Thus, the quality of health care, from the perspective of the patient, can be defined as the degree to which health services meet the needs of their users, considering the multi-dimensionalities that guarantee such quality, namely courtesy, information, autonomy, competence, continuity of care, costs and accessibility to services (9) .
The importance of incorporating the perspective of patients in the elaboration, evaluation and adequacy of health programs has been discussed extensively (10)(11)(12)(13) Nevertheless, it has been observed in practice that there is a lack of instruments that contemplate such concern, especially when one considers the quality of care provided by health professionals to specific groups of individuals, such as PLWHA or have specificities related to their health condition that need to be addressed.In 2003, a group of studies from the University of Amsterdam, Department of General Practice of the Clinical Methods & Public Health Division proposed an instrument (11) to evaluate the quality of care provided to PLWHA from their perspectives: "Quality of Care Through the Patient's Eyes -HIV" (QUOTE-HIV).This is a questionnaire published in the English language, which is self-reported and consists of three independent instruments that evaluate the specialist doctor in HIV/AIDS, the general practitioner and the nurse, the latter of these being chosen for the development of the present study.
The instrument that evaluates the care provided by nurses consists of 23 items answered in two stages.In the first, the user is asked about the importance he or she attaches to each item, and in the second, their evaluation of how the actions specified in each item are being performed by the health professionals.These items are distributed in three domains, and the data evaluation can consider each item individually or the score obtained in each domain through specific formulas (14) .
Inter-item Correlation Analysis, Reliability Testing and Factor Analysis were used to test the internal consistency and reliability of the instrument, which demonstrated good validity and reliability with an internal consistency ≥ 0.80 (Cronbach's Alpha).
Although there is no knowledge of a translation and cultural adaptation of QUOTE-HIV into other languages and cultures, it is a relevant tool for evaluating the care provided to PLWHA, and is a reference for the elaboration of studies on the theme (15)(16)(17)(18) .
Considering the inexistence of instruments with this purpose in the country and the importance of systematically evaluating the care provided to Brazilian PLWHA, it was decided to translate and adapt the QUOTE-HIV to Brazilian Portuguese.

OBJECTIVE
To translate and culturally adapt the Quality of Care Through the Patient's Eyes -HIV (QUOTE-HIV) instrument for use in Brazil.

Ethical aspects
Authorization to carry out the research was requested and obtained from the author of QUOTE -HIV, Dr. Christine F Hekkink, and the Ethics in Research Committee of the Faculty of Medical Sciences of the State University of Campinas.The HIV/AIDS patients were invited to participate in the study and, after clarifying its objectives, they expressed their consent and signed the Informed Consent Term.

Design, place of study and period
A methodological type study was performed, characterized by processes of development and evaluation of data collection instruments (19) .
In order to guarantee quality in the process and equivalence between the translated and adapted version with the original version of the instrument, the stages of translation, synthesis, back-translation, evaluation by the expert committee and pre-test were followed, as recommended in the literature (20 -21) for the process of cultural adaptation of QUOTE-HIV.
The pre-test was applied at a reference center for HIV/AIDS located in a teaching hospital in the interior of the state of São Paulo, in May and June, 2015.

Sample and inclusion criteria
Thirty patients diagnosed with HIV/AIDS undergoing outpatient care for at least one year participated in the pre-test at the HIV/AIDS reference center.The sample size followed recommendations in the literature (21) for cultural adaptation studies.
Inclusion criteria for this stage were: a) to be a carrier of the HIV virus; b) under specialized HIV/AIDS outpatient care for at least one year; c) age 18 years or over; d) present conditions to understand and respond to the instrument.

Study Protocol
In the first stage, the instrument was translated from English into Brazilian Portuguese by two independent translators, one of which a bilingual health professional, whose mother tongue is Brazilian Portuguese.Only one of the translators was informed of the objectives of the instrument and related concepts.From this stage, two independent versions of the instrument, T1 and T2, resulted, which was then analyzed by a third translator from the health area, who, together with the authors, prepared the synthesis-version of the translations (T12), which constituted the second stage in the cultural adaptation process for the instrument.
In the third stage, two independent translators, both fluent in Portuguese and having the same mother tongue as the instrument's native language, performed the translation of the synthesis version into English again, generating two back-translated versions of the instrument, BT1 and BT2.These translators were not informed of the objectives and concepts related to the instrument.
The fourth stage in the methodological procedure consisted in the evaluation of the instrument by an expert committee which aimed to consolidate all versions of translation and to obtain a consensus between the translated version to Brazilian Portuguese and the original version in addition to evaluating the validity of content.A professional with experience in methodological research, a linguist and three health professionals participated in this committee, one with experience in direct assistance to PLWHA and two teachers from public universities with teaching, research experience and that has worked with PLWHA.For this evaluation, each member of the expert committee received all the translated versions, the synthesis, the original instrument and specific instructions for analysis of the semantic, idiomatic, cultural and conceptual equivalences.This resulted in the pre-final version of QUOTE-HIV, used in the final stage of the process of cultural adaptation, i.e. the pre-test.
This stage aimed at evaluating the comprehension, clarity of the items and the response time.The participants answered the questionnaire and then were asked about possible issues during its completion and degree of difficulty to understand the items.The instrument response time was measured by recording the start time and the completion time.The data were collected individually, in a reserved place and in the presence of the researcher.

Analysis of the results
The results were analyzed by the expert committee in two stages: one quantitative and the other qualitative in nature (22) .
In the quantitative analysis, the individual evaluation of each item by the committee members was tabulated, and the Content Validity Index (CVI) (22)(23) was used to calculate the degree of agreement between the evaluations.An agreement rate of 100% for the items in the instrument was considered to be satisfactory.Lower values would imply mandatory adjustments to the item under consideration.
Regarding the qualitative analysis, during the consensus meeting, committee members suggested modifications to ensure equivalence with the original instrument.This required two meetings, lasting approximately three hours each, to obtain the pre-final version of the QUOTE-HIV used in the pre-test.
The results from the pre-test are presented in a descriptive way.

RESULTS
All stages proposed by the literature for cultural adaptation of instruments were satisfactorily completed: translation, synthesis, back-translation, expert committee analysis and pre-test.
In the quantitative evaluation of the content validity performed by the committee, semantic, idiomatic, cultural and conceptual equivalence between the original instrument and the translations and back-translations were observed.Chart 1 presents the CVI values found for the items of the instrument at each stage of its application.
Although most of the items received a score of CVI = 1, suggesting the questions should remain unchanged, the consensus meeting with the committee members found there was a need, on all items, for grammatical changes, inversion of word order in the sentences, replacement of some terms by synonyms and change of certain terms such as "Specialized nurse in HIV/AIDS" for "Nursing Team".These modifications aimed to facilitate the understanding of items by the population to be studied.The changes made are shown in Chart 2.
The introductory text of the instrument, as well as its layout, was also modified by the committee during the consensus meeting, in order to facilitate its understanding by the respondents.After changes, the pre-final version of the instrument was pre-tested.Thirty patients participated in this stage, with a diagnosis of HIV/AIDS in outpatient follow-up for at least one year in a reference center for HIV/AIDS.The mean age of respondents was 42 years, of which 19 (63%) were male and 11 (37%) were female.There was an educational level of on average 9 full years of study.The pre-test occurred in private with the researcher.After applying the instrument, the participants were asked about possible issues during their completion and degree of difficulty to understand the items.The average time for completing the questionnaire was 20 minutes.

Chart 1 -Content Validity Index for the items in the Brazilian version of QUOTE-HIV
Respondents reported ease in understanding the items in the questionnaire and did not indicate a need to modify them, except item 5 of the instrument.Item 5 refers to the question, "How important is it that the nursing team is open to discuss euthanasia", for which three subjects stated they did not understand the meaning of the word "euthanasia" and four considered this question unnecessary because they were interested in talking about "life" and not "death".
At this point, the experts were consulted again and, in consensus, it was decided to maintain the item as it was written, since it was not possible to suggest any word or term that could replace the word euthanasia without changing its semantic and conceptual structure.The experts suggested waiting for the evaluation of the psychometric properties of the questionnaire to decide on the maintenance or exclusion of this item.

DISCUSSION
The process of translation and cultural adaptation of QUOTE-HIV for use in Brazil was carried out in a systematized manner and followed all the stages recommended for cultural adaptation of measurement instruments.The use of an internationally standardized method for the cultural adaptation process of the instrument allows its use in diverse populations in the country and the reproducibility of results (24) .
In the search for equivalence between the original version of the instrument and the Brazilian version, the semantic, idiomatic, cultural and conceptual equivalences were evaluated through a committee composed of five specialists.In order for the concordance rate among the members of this committee to be considered acceptable, the CVI should be higher than 0.80 (23) .In both stages for applying the questionnaire, Importance and Performance, a concordance rate of over 80% was obtained for most items.
However, at the consensus meeting among experts, it was found that all items of the instrument were modified to ensure consistency and cohesion of the issues and enable better understanding on the part of the respondents.It should be noted that two face-to-face meetings were necessary with the committee members to finalize the pre-test version of the questionnaire, which can be justified by the number of items evaluated and the complexity of the discussions in the quest for consensus in the final formulation of the questions.
The presence of a professional linguist and a methodologist in the committee of judges allowed a refinement of the items regarding the semantic and idiomatic aspects of the sentences.The participation of professionals with assistance and research experience with PLWHA also proved to be fundamental to ensure the cultural and conceptual adequacy of the items.Thus, grammatical changes were made together with inversion of word order in the sentence, substitution of some terms for synonyms and the term "Nursing Specialist in HIV/AIDS" was replaced by "Nursing Team".The latter change took into account the context of nursing care in health services in Brazil and the Netherlands, which differs substantially.In the Netherlands, those who provide nursing care to people living with HIV/AIDS are nurses specialized in HIV/AIDS, while in Brazil the nursing care is performed by teams usually composed of nurses and nursing technicians, both providing direct care to the users.
For a successful translation, cultural equivalence is important so that the terms used in the instrument are consistent with the reality experienced by the target population in its cultural context.If a term is outside the context or the experience of that population, then it must be modified (21) .
In the pre-test of the instrument, performed with 30 patients, there was good acceptance and easy comprehension by the respondents, except for item 5 of the questionnaire, which inquired about euthanasia, since the term was not understood by the subjects, while others considered it an irrelevant and unnecessary question.It should be noted that, from the Brazilian cultural perspective, questions regarding euthanasia are not yet part of discussions involving health professionals and patients, nor the nursing team (25) , in addition the legal implications are not well defined.Although authorized in a number of countries, such as the Netherlands, where the instrument was developed and validated, euthanasia in Brazil is criminalized by the Penal Code, and although there are discussions and varied opinions on the subject, many conceive such a prohibition as a violation of the right to choose over life and death.
When consulted regarding this item, the committee of experts suggested waiting for the evaluation of the psychometric properties of the instrument to decide for its maintenance or exclusion.
The results demonstrate that the Brazilian version of QUOTE-HIV presented good understanding and comprehension among respondents.The evaluation of its psychometric Cultural adaptation of Quality Of Care Through The Patient's Eyes -QUOTE-HIV Lima TC, Freitas MIP.
properties is underway and, after this process, the instrument will be available for use in Brazil.

Limitations of the study
A limitation that should be considered is that the validity of a measuring instrument is not a fixed property and therefore may vary according to the circumstances, population and purpose of the research.Thus, an instrument that is valid for one set of situations may not have the same validity in different circumstances; therefore, its psychometric characteristics must always be tested.

Contributions to Nursing
The availability of HIV-QUOTE in Brazil may allow the evaluation of nursing care provided to PLWHA, considering the importance that the individual attributes to each action of care and the performance of the professional in its execution.This evaluation, from the perspective of the patient, makes it possible to obtain important information for the planning of Nursing care, in order to meet the needs of these subjects, while providing for active participation of the patient in their care.

CONCLUSION
The procedures for culturally adapting and validating content of QUOTE-HIV have been successfully completed, as recommended in the literature.After evaluation by the committee of experts, the semantic, idiomatic, cultural and conceptual equivalences between the translated version and the original version of the instrument were achieved.However, this is a study that precedes the process of evaluation of the psychometric properties of the questionnaire, the results of which are currently being investigated and will presented later in order to enable its use in Brazil.