The Process of Translation and Linguistic Validation of the Functional Assessment of Cancer Therapy-Brain Quality of Life Instrument from English to Malayalam: The Challenges Faced

Brain tumors - The burden of disease

Brain tumors comprise roughly 1.8% of the total cancer burden globally and 1.9% in India. In 2012, the global incidence of primary central nervous system (CNS) tumors was 3.4 per 100,000, age-adjusted using the world standard population. The incidence rates in males were 3.9 per 100,000 and among females, 3.0 per 100,000. Thus, an estimated total of 256,123 individuals were diagnosed, including 139,608 males and 116,605 females. The incidence was higher in the developed nations (5.1 vs. 3.0 per 100, 000 population).[1]

According to unpublished data (hospital cancer registry)from our institute, CNS tumours comprised 3.4% of the total tumors in males and 3.1% in females. However, in the age group of 0–14 years, it was 18.3% and 25.8%, respectively. Again, in the 15–34 years’ age group, this was 11% and 8.3%. Thus, brain tumors occur more commonly in the younger patients in whom the quality of life (QoL) issues are of paramount importance.

Quality of life in neuro-oncology

The brain can harbor tumors that cover a wide spectrum from the truly benign, indolent tumors to one of the most malignant and aggressive ones. Even a tiny tumor in an eloquent area could be catastrophic as compared to a large tumor in a relatively noneloquent region. The most common symptoms include fatigue, headache and seizures followed by sleep disturbances, cognitive issues, focal neurologic deficits, and behavioral problems. Both surgery and radiation therapy that form the backbone of treatment add to the insult. Moreover, like in any other subsite of oncology, as the survival gets better with the availability of better treatment modalities, the QoL issues gain more prominence.

Quality of life assessment

There are no well-established tools to assess the QoL in neuro-oncology practice. Too short questionnaires may not yield much information, too long and complicated questionnaires lead to a lack of compliance. Finding the right instrument to measure QoL is probably a challenge in itself.[2]

The most commonly used questionnaires are the EORTC BN20 and the Functional Assessment of Cancer Therapy-Brain (FACT-BR),[3] although both may be difficult to use in the setting of recurrent tumors. The EORTC BN 20 looks more at the physical disabilities of patients while the FACT-BR is focused more on emotional and social aspects [Table 1]. Since it is not easy to pick up these subtle concerns in the routine clinic, we decided to explore the translation of FACT-BR.

Table 1 The FACT BR questionnaire

Functional Assessment of Cancer Therapy-Brain

The principles of test construction and evaluation have been utilized in the development of the FACT scale, and it has undergone thorough psychometric testing for validity and reliability.[4] FACT-BR was developed as a newly combined brain subscale questionnaire and checked for validation and reliability in 1995.[5]

It is a 23-item questionnaire with disease-specific questions pertaining to brain neoplasms,[6] usually used along with the core questionnaire that has 27 items. Patients rate all 5 items using a five-point Likert scale ranging from 4 “very much” to 0 “not at all.” The higher the ratings, the better the QoL. The FACT-BR can be filled out in a few minutes and is written at the 4^th grade reading level.

Indian scenario

Very modest work has been done on QoL issues in India, especially in neurooncology[7] primarily because we are a vast diverse nation and questionnaires developed in the West have little relevance in our context. This article outlines our experience in translating and validating the FACT-BR questionnaire into Malayalam[8] – the official language of Kerala which is spoken by nearly 38 million people, including in the union territories of Lakshadweep and Puducherry.

Process of translation and linguistic validation: Need for a culturally adapted tool

Each culture is unique due to economic, demographic, political, geographic, and sociologic differences. Thus, even linguistic and conceptual equivalence between questionnaires cannot guarantee the general applicability of results.

A number of outcome based assessment tools that are sensitive across cultures have been developed that help clinicians to better understand the factors that affect QoL and associated well-being. Many instruments have been translated, adapted, and validated in non-English-speaking people.[91011]

Translation methodology

The suitability of the instrument to the target language is mainly ensured by the process of translation. Local dialects, idioms, and subtle variations in which words and terms are used and meant in common parlance lead to qualitative issues as well. A comprehensive translation methodology helps avoid all conceptual or semantic concerns.

The cultural adaptation of a QoL questionnaire is achieved by: (1) Translation: To ensure the linguistic validity and (2) psychometric validation: To evaluate the psychometric properties. Both are complementary and mandatory to demonstrate the equivalence of the questionnaires.[7]

Conceptual match among the adapted versions is essential since minor deviations in the intended meaning would lead to changes in perception of the item.[12] The intent could be very well understood, but the perception may be different from the original source in English. Thus, linguistic nuances cause conceptual inequalities that may not get detected easily. This is especially likely to happen if there are significant cultural differences or differences in qualifying symptoms between both groups.[1113]

Functional Assessment of Chronic Illness Therapy translation system

Functional Assessment of Chronic Illness Therapy (FACIT) translation measurement system makes use of experts, both health care and language, to develop linguistically and culturally appropriate translations.[14] The protocol also includes a pilot testing to ensure that patients with dissimilar backgrounds but with similar symptoms understand the terms consistently.

We translated the FACT-BR QoL Questionnaire into Malayalam and then conducted a linguistic validation as per the FACIT Methodology. The purpose is to ensure that the concepts of the original English questionnaire is adequately captured by the Malayalam translation and is readily understood by patients with brain tumors in Kerala.

Translation of Functional Assessment of Cancer Therapy-Brain

The entire process of translation of the FACT-BR into Malayalam was done according to the FACIT translation methodology[615] which is somewhat complex. It requires two forward translations from English to Malayalam by two translators working independently from one another, a reconciliation of the two forward translations provided by a third translator, a back-translation into English performed by a fourth translator, a review/finalization by a fifth translator (a Malayalam speaking health care expert), proofreading and then testing on a small cohort of patients who are familiar with both languages and who complete the test version of the questionnaire and then answer questions from a cognitive debriefing script that was prepared by the FACIT team.

During the initial translation, a grammatically correct translation of the meaning of each question was the priority and not translating each word. This was reviewed by the FACIT team and then by a group of bilingual health care experts to ensure a harmonized translation. The participants were then chosen from among patients receiving treatment for brain tumors at the authors’ institution. Cognitive debriefing interviews were used to test the translated questionnaire. A trained interviewer carried out a standardized process following a participant's review, and completion of a patient reported outcome tool.

Linguistic validation

As per the FACIT validation methodology, ten participants were recruited from among the patients undergoing treatment for brain tumors. Participants were eligible if Malayalam was their first language, could understand and use English well, and had a brain tumor that had not impaired their cognitive ability. They also had to be 18 years or older and Eastern Cooperative Oncology Group Performance Status 2 or above and able to provide a written informed consent. Details collected include the age, gender, educational qualification, diagnosis, and functional performance status [Table 2].

Table 2 Patient characteristics

Procedure

The participants were first screened to ensure that their mental status was satisfactory and that they could communicate well in both languages. A field tester (medical social worker) supervised the process, and then the subjects completed the FACT-BR in both English and Malayalam. Later, each person underwent the cognitive debriefing interview to ensure that none of the terms used was difficult to understand, offensive, or irrelevant. The interviewer aimed to assess both the individual and cultural relevance and the participants’ total understanding of the item, and also to check whether any of the translations were poorly phrased.

The interview began with this text that was read out: “A questionnaire for brain tumor patients is being tested. We would like to know if it can be readily understood. Were there any items which were difficult to understand? Would you please tell me which items were difficult to understand and why they were difficult? Furthermore, could you suggest a better way to phrase these items?”

The interviewer decided whether the paraphrasing of the items was correct and recorded any issues with the understanding or suggested wording changes on a data collection form.

The debriefing results were evaluated by the original translator, back translators, language coordinator, and the survey research expert. There were multiple harmonized translations of problem words/sentences with new back translations that were reviewed by the survey research expert. The final forward and backward translations were created once all the issues were resolved [Figure 1].

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Figure 1

Functional Assessment of Cancer Therapy-Brain Martin Marietta Materials (original)

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Participants

The age ranged from 19 to 68 years, with a mean age of 41.2 years. There were 4 males and 6 females and most had benign brain tumors [Table 2]. The level of education ranged from Pre- to postgraduation. We had two bright young people as participants – an engineer and a speech therapist; also a senior pediatrician and a newspaper editor. The rest of the participants were doing clerical jobs.

Translation

The whole process of translation was fraught with small and large hurdles– from small technical issues to the gaps in sociocultural norms. The sub item BR 7, due to the lack of an exact equivalent word, had issues that persisted up to the validation phase. BR 3 and BR 19 were other items where the approximate words had to be substituted.

Cognitive debriefing

During the process of linguistic validation, we tried to ensure that the desired intent was communicated by the translated items using the “Patient Interview Form” provided by FACIT. The debriefing process exposed the confusion due to the double negative used in subitem Br 7 (“I feel independent”). Five patients provided comments consistent with their answer choices on the questionnaire. The other five seemed to give good explanations, but their response choice of 0 or 1 was not a match with that explanation. These same five patients gave an accurate explanation for the question “What does the term “independent” mean in this item?” The answers ranged from “not dependent” to “not expecting help.” This showed that the participants understood the meaning correctly, but the question seemed to have derailed due to the double negative. Hence, after multiple rounds of discussions, it was decided to change the phrase to “I feel I am self-sufficient” that is nearer in meaning and less confusing.

Overall, the participants found the Malayalam FACT-BR easy to complete, relevant, and definitely appropriate. The postquestionnaire debriefing interviews confirmed that except for BR 7, the translations were well understood and conceptually equivalent to the original English one.

Translation - Challenges

The test of the quality of translation was the process of establishing semantic and content equivalence. Apart from sociocultural implications (driving a vehicle), many English words are commonly integrated into everyday speech. This difficulty has been already noted by translators working with other tools of health-related QoL (HR-QoL).[17]

The sub item BR-7 posed the most difficult problem since there is no equivalent Malayalam term for independence in a person. We finally had to settle for a double negative that was, however, proved to be too complicated to understand during the validation phase.

The word “frustrated” in subitem BR-3 was another difficult item, for which semantic equivalence could not be achieved. “Arms, hands and legs” in BR-19 and 20 were shortened to “arms and legs” which is a more common usage in Malayalam.

The Malayalam words for “difficulty,” “trouble” and “problem” are used interchangeably in the day today conversation. For the purpose of this translation, we decided to be consistent and substituted the words used in FACT-general version. There were also issues with using the noun form of a word in place of a verb.

One major worry we had was that the questionnaire may remind the patient of unpleasant problems. However, we finally decided that venting their emotions would help the patient face their issues better and also make our bond stronger. We were indeed proved right.

Study limitations

Apart from the literary issues per se, the most important limitation was probably that we included patients with all kinds of brain tumors. However, this was also a good opportunity to test the questionnaire among different kinds of participants from the ones that have indolent tumors like pituitary adenoma, where the patient has a very positive outlook to ones like recurrent glioma that have a dismal outcome.

The small number of ten participants was adequate according to the FACIT organization. All participants had a preserved cognition and were familiar with both languages.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.