Brazilian Journal of Pulmonology

ISSN (on-line): 1806-3756 | ISSN (printed): 1806-3713

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Current Issue: 2019 - Volume 45 - Number 4 (July/August)

ORIGINAL ARTICLE

Translation and cultural adaptation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module for quality of life assessment in patients with lung cancer in Brazil

Tradução e adaptação cultural do Quality of Life Questionnaire-Lung Cancer Module da European Organisation for Research and Treatment of Cancer para avaliação da qualidade de vida relacionada à saúde em pacientes com câncer de pulmão no Brasil

 

Ana Paula Ramos Marinho1; 2; a; Gracielle Fin3; 4; b; Antuani Rafael Baptistella3; c; Rudy José Nodari Júnior3; d; Magnus Benetti4; e

 

1. Departamento de Fisioterapia, Centro Universitário Unifacvest -
Lages (SC) Brasil.
2. Departamento de Fisioterapia, Universidade do Estado de
Santa Catarina -UDESC/CEFID -
Florianópolis (SC) Brasil.
3. Área das Ciências da Vida, Universidade do Oeste de Santa Catarina - Unoesc - Joaçaba (SC) Brasil.
4. Departamento de Educação Física, Universidade do Estado de Santa Catarina -UDESC/CEFID -
Florianópolis (SC) Brasil.
a. http://orcid.org/0000-0001-7469-1092
b. http://orcid.org/0000-0001-7860-4451
c. http://orcid.org/0000-0003-1708-9921
d. http://orcid.org/0000-0002-8375-657X
e. http://orcid.org/0000-0002-0079-255X
Submitted: 10 January 2018.
Accepted: 7 December 2018.
Study carried out in the Setor de Oncologia, Hospital Universitário Santa Terezinha, Joaçaba (SC) Brasil.

Correspondence to:
Ana Paula Ramos Marinho. Rua Manoel Thiago de Castro, 199, bloco A, sala 1601, Centro, CEP 88501-020, Lages, SC, Brasil.
Tel.: 55 49 3225-4114. E-mail: anaramos.fisio@gmail.com
Financial support: None.


 

Abstract

Objective: To translate the European Organisation for Research and Treatment of Cancer (EORTC) 29-item Quality of Life Questionnaire-Lung Cancer Module (QLQ-LC29, developed for the assessment of quality of life in patients with lung cancer) to Portuguese, conducting a pilot study of the Portuguese-language version and adapting it for use in Brazil. Methods: For the translation, cultural adaptation, and pilot testing of the QLQ-LC29, we followed the guidelines established by the EORTC. The translation (English → Portuguese) and back-translation (Portuguese → English) were both carried out by translators, working independently, who were native speakers of one language and fluent in the other. After review, a draft version was created for pilot testing in lung cancer patients in Brazil. Results: A total of 15 patients diagnosed with lung cancer completed the Portuguese-language version of the questionnaire. At the end of the process, we conducted a structured interview to identify any patient difficulty in understanding any of the questions. The final versions were sent to the EORTC and were approved. Conclusions: The Portuguese-language version of the EORTC QLQ-LC29 appears to be a useful, important, reliable questionnaire that is a valid tool for assessing quality of life in patients with lung cancer in Brazil.

 

Resumo

Objetivo: O objetivo deste estudo foi traduzir, adaptar culturalmente e realizar um ensaio piloto para criar a versão em português do Brasil do questionário da European Organisation for Research and Treatment of Cancer (EORTC) denominado Quality of Life Questionnaire-Lung Cancer (QLQ-LC29, lung module), desenvolvido para a avaliação da qualidade de vida em doentes com câncer de pulmão. Métodos: Foram seguidas as orientações da EORTC para a tradução, a adaptação cultural e a realização de um ensaio piloto do QLQ-LC29. Foi realizado o processo de tradução (inglês → português) e tradução reversa (português → inglês) por tra-dutores independentes nativos em um dos idiomas e fluentes no outro idioma. Após revisão, uma versão preliminar for criada para o ensaio piloto com pacientes no Brasil. Resultados: No total, 15 pacientes com diagnóstico de câncer de pulmão preencheram a versão em portu-guês do Brasil do questionário. No final, foi conduzida uma entrevista estruturada para identi-ficar qualquer dificuldade em alguma das perguntas. As versões finais foram enviadas para a EORTC e aprovadas. Conclusões: A versão em português do Brasil do EORTC QLQ-LC29 (lung module) é uma ferramenta útil, importante, fidedigna e válida para a aferição da qualidade de vida relacionada à saúde em pacientes com neoplasia pulmonar.

 

 

Keywords: Surveys and Questionnaires; Lung neoplasms; Quality of Life; Brazil; Translations.

 

Palavras-chave: Inquéritos e questionários; Neoplasia pulmonar; Qualidade de Vida; Brasil; Traduções.

 

 

INTRODUCTION

Over the past 100 years, lung cancer has changed from a rare disease to a real global problem. Scientific and clinical efforts to improve outcomes have led to a better understanding not only of the etiology of lung cancer but also of the histological and molecular characteristics of individual lung tumors.(1)

Lung cancer is the most commonly diagnosed cancer (11.6% of all cancer cases) and the leading cause of cancer death (18.4% of all cancer deaths) worldwide; its prevalence is increasing among women and has surpassed that of breast cancer in 28 countries.(2) In Brazil, lung cancer is considered the most deadly type of cancer among men and women. A total of 18,740 and 12,530 new cases of lung cancer are estimated among men and women, respectively, for each year of the 2018-2019 biennium. This corresponds to an estimated risk of 18.16 new cases per 100,000 men and an estimated risk of 11.81 new cases per 100,000 women, lung cancer being the second most common type of cancer in Brazil.(3)

Although lung cancer is predominantly caused by tobacco smoke, approximately 25% of all lung cancers worldwide are not attributable to this etiology.(4) Other etiologies include environmental exposure to smoke, radiation, or smoke from burning wood; occupational exposures; oncogenic viruses; genetic alterations; and changes in sex hormone levels.(4,5)

The concept of quality of life (QoL) is broad, subjective, and encompasses four main domains: physical well-being; psychological well-being; social well-being; and occupational well-being.(6,7) In cancer patients, QoL care and attention to QoL are even greater, because QoL can not only be a predictor of morbidity and mortality but can also serve as a parameter for evaluating treatment course and response.(7)

Several generic QoL scales are used in Brazil and worldwide; however, it is important that the instrument chosen for use be as specific as possible so that it can provide information as accurately as possible. With this in mind, the European Organisation for Research and Treatment of Cancer (EORTC) developed a variety of instruments to assess QoL in patients with cancer.(8) The core questionnaire is the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30), which includes five functional scales, three symptom scales, and a global health and QoL scale.(9) However, the use of the EORTC QLQ-C30 prompted the need for instruments that could assess the specificity and particularities of each type of cancer more specifically, which resulted in a multitude of modules for different types of cancer. (10) One of these modules is known as the 29-item QLQ-Lung Cancer Module (QLQ-LC29), the objective of which is to assess QoL in patients with lung cancer.(11,12) The EORTC QLQ-LC29 was developed as an update to the previous lung cancer module, the EORTC QLQ-LC13, because of important advances in lung cancer treatment and in QoL assessment.(11)

The objective of the present study was to translate the original English-language version of the EORTC QLQ-LC29 to Portuguese, adapting it for use in Brazil, in order to provide an appropriate tool for assessing QoL in patients with lung cancer in the country.

METHODS

This was a methodological study whose objective was to translate and culturally adapt the QLQ-LC29, which is a module for specifically assessing QoL in patients with lung cancer. The final version has 29 items and refers to a specific time period (i.e., "during the past week"). Patients also have the opportunity to report whether there were symptoms or problems that were not covered by the questionnaire, but were relevant for them during the past week. Each item is scored on a 4-point scale (Not at All; A Little; Quite a Bit; and Very Much).

Translation procedure

The translation was made along with the cultural adaptation and the pilot testing authorized by the EORTC Quality of Life Department and carried out in accordance with the EORTC translation procedure.(13)

The original English-language version was translated by two translators, working independently, who were native speakers of Portuguese and fluent in English. Subsequently, a reconciled translation was made on the basis of the two translations, that is, a third person analyzed the two translations to achieve the best possible version by choosing one of the two translations or by combining them on the basis of their similarities, wording, etc. The next step was to translate the reconciled version back into English, which was done by two translators who were native speakers of or fluent in English. The result of these steps (forward translation, reconciliation, and backward translation with comments) was put into a translation report that was reviewed by the EORTC translation unit. In the review of the report, all suggestions and corrections were analyzed and discussed. Once the discussion reached a consensus, the translation could undergo linguistic validation (pilot testing).

Pilot testing

Pilot testing, in accordance with the EORTC translation procedure,(13) includes a group of 10 to 15 patients, who are invited to complete the questionnaire. After completion of the questionnaire, a structured interview focusing on each item, one by one, is conducted to investigate whether participants would report any difficulty answering the questions and whether they found any item to be confusing, upsetting, or offensive, or to contain difficult vocabulary. All of the participants' comments should be pooled and summarized in a pilot-testing report, which should be sent for review to the EORTC translation unit. Once all comments have been analyzed and discussed, the EORTC translation unit prepares the final version of the translation and closes the project.

Participants

This was a convenience sample in which patients were randomly recruited from the Oncology Department of the Santa Terezinha University Hospital, located in the city of Joaçaba, Brazil. Patient status was determined from the medical records, and only patients with a diagnosis of lung cancer were considered study participants.

Inability to understand or complete the questionnaire was considered an exclusion criterion. There were no restrictions regarding gender, age, or level of education. All participating patients were receiving cancer treatment and were approached at the time of their medical visit. It should be highlighted that the EORTC procedures for questionnaire translation do not stipulate a single time point during the course of the disease for patient assessment, this time point (diagnosis, treatment, or control) being random. The study was approved by the Human Research Ethics Committee of the Universidade do Oeste de Santa Catarina and the Santa Terezinha University Hospital (Protocol no. 2.286.701 of September 20, 2017).

Statistical analysis

Once the interviews were completed, all data were compiled and analyzed using simple descriptive statistics. Understandability was assessed using a Likert scale preceded by the question, "Did you understand what was asked?"-0: I did not understand anything; 1: I understood only a little; 2: I somewhat understood it; 3: I understood almost everything, but I have some questions; 4: I understood almost everything; and 5: I understood it perfectly well, and I have no questions. (14) The internal consistency of the scale was calculated with Cronbach's alpha coefficient. All statistical analyses were performed with the IBM SPSS Statistics software package, version 20.0 (IBM Corporation, Armonk, NY, USA).

RESULTS

Fifteen patients participated in the present study, 8 of whom were female. The mean age was 61 ± 5.2 years. Thirteen patients (86.7%) had attended only elementary school, and 2 patients (13.3%) had completed high school.

All patients completed the questionnaire in less than 25 minutes, in a designated area within the hospital. Once pilot testing was completed, the comments from patients were analyzed. No difficulties in answering the questions were reported, and none of the items were found to be confusing, upsetting, or offensive, or to contain difficult vocabulary. Therefore, no changes were made to the final version approved by the EORTC translation unit. The Portuguese-language version of the QLQ-LC29 was approved. The steps are described in Table 1.







The understandability of the instrument was good, with a mean of 5.0 points (maximum value of 5.0), and most questions were fully understood (Table 2). The internal consistency of the scale was calculated with Cronbach's alpha coefficient, and an alpha value of 0.94 was found.



The full version of the instrument cannot be published in the present study for copyright reasons. The final version of the instrument can be purchased by consulting the EORTC.

DISCUSSION

This study presents data regarding the translation of the EORTC QLQ-LC29 to Portuguese in Brazil and regarding the cultural adaptation and pilot testing of this Portuguese-language version. This is the first such version, and was authorized and audited by the EORTC, which oversaw all the steps in creating this Portuguese-language version.

The importance of making the EORTC QLQ-LC29 available to scientists and clinicians in the field of oncology is immeasurable, since lung cancer is the most common cancer and is the one with the highest mortality rates and the lowest 5-year survival rates,(3-5) and therefore it is important that patient QoL be a variable taken into account.(6,8) Through the use of a disease-specific tool such as the EORTC QLQ-LC29, it is possible not only to predict patient prognosis or patient morbidity and mortality, but also to inform decisions regarding treatment, especially because the questionnaire provides information about patient clinical status in various domains.(6,11,12,15)

The measurement properties of the original English-language version of the EORTC QLQ-LC29 were evaluated and verified at the time of its creation in a multicenter study.(11) Because the EORTC QLQ-LC29 is a recent module, this is its first translated version, and therefore data are lacking for a comparison between our results and those of other studies. It is expected that, as soon as the original English-language version of the EORTC QLQ-LC29 is widely disseminated, various researchers from different countries and speaking different languages will translate and adapt this module in order to make this disease-specific tool available for assessing QoL in patients with lung cancer.(11)

For each new translation, a series of cultural changes and adaptations are made in order to develop a version specific to a given population and its characteristics. (16,17) This specificity justifies the need for translations and cultural adaptations, considering that a given topic can elicit different answers and different effects because of cultural differences.(10)

We acknowledge that our study may have some limitations, such as the size of the pilot-testing sample, which was intentionally selected; however, sampling was carried out in accordance with the EORTC recommendations.(13,18) Despite being small, the sample was sufficient to validate the translated version according to the EORTC recommendations. Data collection with a larger sample would make it possible to perform more complex analyses, including analysis of measurement properties, in accordance with parameters used internationally.(18)


After completion of all the steps described in the present study and analysis of the results, our data suggest that the present Portuguese-language version of the EORTC QLQ-LC29 is suitable for use by scientists and clinicians in Brazil.

REFERENCES

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4. Kawaguchi T, Ando M, Ito N, Isa SI, Tamiya A, Shimizu S, et al. Rationale and design of the Japan molecular epidemiology for lung cancer study. Clin Lung Cancer. 2013;14(5):596-600. https://doi.org/10.1016/j.cllc.2013.03.001
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10. Relvas-Silva M, Silva RA, Dinis-Ribeiro M. Portuguese Version of the EORTC QLQ-OES18 and QLQ-OG25 for Health-Related Quality of Life Assessment. Acta Med Port. 2017;30(1):47-52. https://doi.org/10.20344/amp.7499
11. Koller M. Update of the EORTC questionnaire for assessing quality of life in patients with lung cancer: Introducing the new EORTC QLQ-LC29. J Clin Oncol. 2016;34(15_suppl):e18096.
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17. Scott NW, Fayers PM, Aaronson NK, Bottomley A, de Graeff A, Groenvold M, et al. The relationship between overall quality of life and its subdimensions was influenced by culture: analysis of an international database. J Clin Epidemiol. 2008;61(8):788-95. https://doi.org/10.1016/j.jclinepi.2007.08.015
18. Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, et al. Quality criteria were proposed for measurement properties of health status ques-tionnaires. J Clin Epidemiol. 2007;60(1):34-42. https://doi.org/10.1016/j.jclinepi.2006.03.012

 

 


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