Translation and Linguistic Validation of the Simplified Chinese Brain Cancer Patient-Reported Outcomes Evaluation System


 BackgroundThe Functional Assessment of Cancer Therapy Scale Brain Cancer-Specific Module (FACT-Br) was developed by a standard measurement theory and used to assess the symptoms, functions, and quality of life among brain cancer patients in English spoken countries. However, this instrument has not been translated into Chinese.ObjectiveThis study aimed to develop the Chinese version of the Functional Assessment of Cancer Therapy Scale Brain Cancer-Specific Module (C-FACT-Br).MethodsC-FACT-Br was translated following the standard Functional Assessment of Chronic Illness Therapy Translation (FACIT) methodology. Then, the cognitive briefing interviews were done to ensure the conceptual equivalence by probing 10 native Chinese-speaking brain cancer patients.ResultsThe translation was finished by bilingual teams with the help of the FACIT organization. All items in C-FACT-Br were understandable to patients, and they also gave some comments in adjusting items in scale.ConclusionsC-FACIT-Br items had the equivalence meaning, same structure, and harmonization with the English version. Brain cancer patients over 18 years old can understand the scale and express their symptoms, function, and quality of life by these measures.


Introduction
Brain cancer is a group of primary and secondary brain cancers, including glioma, meningioma, and metastatic brain tumors, etc [1,2]. Though it only comprises 2% of cancers, it still becomes an important health issue due to its high morbidity and mortality in children and teenagers [3]. Besides, the average percent of brain cancer disability-adjusted life years (DALYs) also sharply increase from 1990 to 2016, not only in China (0.44% to 0.53%) but also around the world (0.25% to 0.35%).
Health-related quality of life (HRQOL) is a medical concept developed in recent years that means an individual's or a group's perceived physical and mental health over time [4][5][6]. Recently, numerous researches have reported that the patients' HRQoL significantly decreased because of brain cancer [7,8]. The main reason is that different from other cancers, brain cancer can cause personality changes and cognitive decline because of its position [9][10][11]. Furthermore, the standard treatment modalitiesmaximal surgery, chemotherapy, and radiation through can increase overall survival, are reported relate to psychosocial distress and functional impairment [12,13]. Patients with brain cancer can also have a high prevalence of psychological diseases such as depression [14], post-traumatic stress disorder (PTSD) [15]and anxiety [16]. Thus, the brain cancer patient' HRQoL and its assessment instruments are gradually concerned by researchers.
To investigate the HRQoL of brain cancer patients, researchers have developed numerous evaluation tools [17]. One of them is the Functional Assessment of Cancer Therapy General Scale (FACT-G) and its brain cancer-specific module (FACT-Br) [18]. FACT-G is a 33-item general scale for evaluating patients received cancer treatment, which has been proved has a high reliability and validity among different population [19,20]. And FACT-Br is designed as a complement to provide additional specific questions pertaining to brain tumors and mainly focused on psychosocial condition evaluation [21]. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is also used in brain cancer patients' HRQoL evaluation, individually or with its brain module (called QLQ-BN 20) [22,23]. In the beginning, the aim of QLQ-BN was only developed for those brain cancer patients who receive chemotherapy or radiotherapy, but now, it is proved that this scale also has high reliability and validity when testing brain cancer patient without receiving treatment [24]. Besides, Patient-Reported Health Outcome Measurement Information System (PROMIS) and the MD Anderson Symptom Inventory [25] as well as their cancer or brain cancer-specific module are employed in the assessment of HRQoL of brain cancer patients, too [26][27][28].
However, although there are a number of scales can be used in brain cancer patient's HRQoL evaluation around the world, the assessment instruments in China is still limited. Nowadays, the standard Chinese version of the EORTC QLQ-C30 (version 3.0) is one of the most commonly used instruments in evaluating the HRQoL of adult brain cancer patients in China [13,28]. Recently, the Chinese version of EORTC QLQ-BN 20 was developed and proved had a high validation among patients with brain cancer [29]. Nevertheless, EORTC QLQ-BN 20 is mainly focused on function, symptoms and assessing the treatment outcome, there still lacks tools to evaluate brain cancer patients' psychosocial assessment [21]. Thus, we developed the Chinese version of FACT-Br in this study aimed to provide a psychosocial condition evaluation instrument for brain cancer patients.

Questionnaire
FACT-Br is a 23-item scale usually used along with the FACT-G scale [18]. Patients can rate each item ranging from 0 "not at all" to 4 "very much" and the higher grades patients get, the higher HRQoL patients have [18]. Now, this questionnaire has been proved strong validity and reliability in testing psychosocial condition among both primary and secondary brain cancer patients [30,31].

Authorization
We get authorization from the Functional Assessment of Chronic Illness Therapy (FACIT) organization to translate the FACT-Br into simplified Chinese. Pre-training documents for translation including scoring & interpretation materials were available on the FACIT official website and item definitions were also provided by FACIT staff helped to clarify the meanings and concepts for translation. All the process of translation and the final Chinese vision of FACT-Br (C-FACT-Br) has been approved by the FACIT organization.

Procedures
The C-FACT-Br was developed according to the standard Functional Assessment of Chronic Illness Therapy (FACIT) methodology, which was known as a rigorous method in establishing the same meaning and measurement between different version through double-back-translation and advanced statistical methods [32]. The main steps of FACIT methodology are shown in Table 1.

Translation Process
Step 1: Forward translation The English version of FACT-Br was translated into Chinese by 2 independent native Chinese speakers, one is a professional translator and another is a health professional passed China Accreditation Test for Translators and Interpreters (Level 2).
Both translators are living in China now. Before translating, the definitions of each item were provided to two translators to help them familiar with the meaning of each item.
Step 2: Reconciliation A third independent native Chinese who is also a health professional reconciled the two forward translations finished in step 1. Translator checked both English and Chinese version of this scale and choose the better one based on the definition of item.
He could also make adjust or retranslate item to make sure finding the best way to convey the meaning of the item.
Step 3: Back-translation The reconciled was back-translated into English with simple language by a native English speaker who also had a fluent Chinese. During the back-translation, the translator was blind to anything related to the English version of scale to reduce bias.
This back-translation reflected the meaning of the Chinese version, which helped FACIT staff recognized the missing value or misunderstand.
Step 4: Comparing back-translation with source document The FACIT staff compared the back-translation with the English resource to make sure the Chinese translation had the equivalence meaning, same structure, and harmonization and then gave some comments about how to make further adjustments in this Chinese translation.
Step 5: Independent review Three native Chinese experts (one is a linguistic professor; another is a neurosurgeon and another is a professional translator) individually examined all documents in previous steps and the comments given by FACIT staff. And then chose the most appropriate translation for each item or adjust the translation based on item definitions, comments and idiomatic in Chinese. If necessary, three experts could offer alternate translations.
Step 6: Finalization process The results of independent review then back-translated into English by a native English speaker with fluent Chinese again. FACIT staff and language coordinator assessed this back-translation and produced the final scale.
Step 7: Testing of translation We investigated whether the brain cancer patients could understand the meaning of each item and respond to it based on the comprehension by cognitive debriefing interview. This step is a key strategy to make sure the conceptual equivalence between the English source and final scale. All brain cancer patients in this test recruited in Xiangya Hospital, Department of Neurosurgery and confirmed diagnosis through pathological biopsy. Patients who also had complications, psychiatric disease and disfunction were excluded for this study. All samples and their family members were told the aim of these interviews before they participated. Besides, each participant was signed informed consents.
Participants were asked to finish both C-FACT-Br and C-FACT-G scales (37 items in total) independently. Then the cognitive debriefing interviews were conducted by trained interviewer and recorded to make sure the accuracy of interview notes. All standard questions in interviews were offered by FACIT organization (Table 2).
Because the instructions and response choices in the FACT system are the same and have already tested before, we only interviewed patients' opinions about the overall assessment and opinions about each item. For overall assessment, participants were asked the difficulty of scale and their suggestions about these items. The questions for items aimed to explore whether participants can understand the meaning of each item.
Besides, the sociodemographic information also collected in this survey including sex, age, diagnosis, whether receiving any treatment and current activity level.
Step 8: Incorporating testing results After all interviews finished, the results were translated into English and sent to FACIT staff with the reply of scales. Then, the staff reviewed all of these comments and answers to decide whether the final scale needs further adjustment.

Translation results
The translation processes were done strictly followed the FACIT translation methodology. Most items in the final translation were consistent with English resources except three of them made little changes. The first one was "I am able to drive a vehicle (my car, truck, etc.)", because it was important to demonstrate "a vehicle" in singular form. However, there was not any single or plural form in Chinese, thus we achieved an acceptable agreement, just said "vehicle". "I have trouble feeling sensations in my arms, hands or legs" and "I have weakness in my arms or legs" also had the same problems, after discussion, we translated "legs", "hands" and "arms" into "腿部", "手 部" and "胳臂", which usually used similar as plural form in English.

Cognitive debriefing interview results
This cognitive debriefing interviews were conducted during Dec. 8 th , 2019 to Dec. 12 th , 2019 and recruited 10 brain cancer patients (Table 3). Among them, 70% were male, and 40% were between 25 and 44 years old. All patients were diagnosed as brain cancer and received treatment before interviewing. 40% of patients evaluated themselves required bed rest for more than half of waking day and only 20% of patients thought they did not have any symptoms.
During these interviews, most participates could finish the final translation individually except one's hands could not move after surgery. However, patients whose current activity level less than 3 rd (60%) could respond to each item at a consistent speed, while others spent an average one more minute longer than that in good current activity level. Besides, brain cancer patients rarely confused or corrected the given answers. The results also indicated all items were understandable and clear. But participants still gave some comments for this final scale and the first one was one patient thought the questions "I have had seizures (convulsions)" and "I am afraid of having a seizure (convulsions)" let her think unpleasant experience and suggested to delete it. Furthermore, another two patients considered the item "I am able to drive a vehicle (my car, truck, etc.)" was not suitable in China because not many people drive after receiving brain cancer treatment and youth as well as elderly were seldom drive by themselves. Considering the aim of this scale, after discussion, we decided to keep these items.

Discussion
In this study, we described the procedure of translating the Chinese version of Chinese and English has been reported a lot. In this study, we made little adjustment for word order based on Chinese grammar after translation, for example, "I am bothered by the change in my personality" was translation as "My personality changing makes me feel bothered". We also changed words according to expressive habits, for instance, "arms, hands or legs" in Item 19 should be translated as "双臂, 双手或双腿" [two arms, hands or legs]. While considering normal expression, we translated it into "手臂, 手部及腿部" [two arms, hands or legs]. In short, the final translation was developed by premeditating words, word order, expression habits as well as understandability.
A common recommendation is that, to ensure the new version retains its conceptual equivalence, pretesting is necessary after finishing the process of translation [33,34]. Both qualitative and quantities method can be used in pretesting, such as cognitive debriefing interview [34], retrospective debriefing, internal consistency analysis [32], differential item functioning analysis [35], etc. To identify potential problems among items, we did the cognitive debriefing interviews followed the standard questions provided by FACIT staff. Interview results indicated that the age and education level of patients did not affect the comprehension of this scale. However, patients' cognitive condition influenced patients' answer speed. Because of cultural differences, brain cancer patients offered unique insights into some items, for example, they thought "I am afraid of having a seizure (convulsions)" could let them recollect unpleasant memories and then feel upset.

Implications for practice
The study described the translation procedure of C-FACT-Br and provided evidence that it was conceptually equivalent to the English source. Based on this study, the validity and reliability of C-FACT-Br can be tested in future research. C-FACT-Br then may become a new patient-reported health outcome measurement instrument used in evaluating the psychosocial condition of Chinese brain cancer patients. Also, a cross-countries comparison can be done with this scale.

Limitation
Although we followed FACIT methodology cautiously, there still some limitations in this study. First, we only did a qualitative method -cognitive debriefing interview to evaluate the conceptual equivalence and understandability of this final translation.
However, it is not enough to prove the validity and reliability of C-FACT-Br. Thus, future research should be done. Second, two items were suggested to delete, and one was recommended to adjust during the interviews because of Chinese culture. But it may reduce the validity of this scale if we delete it. So, these three items may need further adjust after the evaluation of validity and reliability. Finally, even though there were not any comments about adding symptoms related items in this scale, after assessing more patients, maybe some new items should be subjoined in it because finding new symptoms related to brain cancer.

Conclusion
The study is the first attempt to develop the C-FACT-Br. The cognitive debriefing interview and FACIT methodology guarantee C-FACT-Br has equivalence meaning, same structure, and harmonization with the English sources. Brain cancer patients over