Table 1. Reconciliation after two forward translations. US / English Items First Forward Korean Translation Second Forward Korean Translation Reconcil

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1 UROLOGICAL ONCOLOGY Korean Version of the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index (VCI): Translation and Linguistic Validation Myong Kim, 1 Hahn-Ey Lee, 1 Sung-Han Kim, 1 Sung Yong Cho, 2 Seong Jin Jeong, 3 Seung-June Oh, 1 Michael S. Cookson, 4 Ja Hyeon Ku 1 * Purpose: To develop a Korean version of the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index (VCI) from the original English version, with subsequent linguistic validationin Korean patients who underwent radical cystectomy with urinary diversion. Materials and Methods: Translation and linguistic validation were carriedout between January and May of 2013, which consisted of the following stages:(1) permission for translation;(2) forward translation;(3) reconciliation;(4) backward translation;(5) cognitived ebriefing and(6) final proof-reading. Results: During the forward translation phases,word ssuch as bother, spend time, support, coping and concern were adjusted to be more comprehensible to the target population. There conciled Korean version was accepted without certain objections because the original version and the backward translation were almost congruent exceptfor minor differences in a subset of questions. The translation was tested using 5 Korean-speaking subjects. The subjects took an average of 8.2 minutes to complete the questionnaire, without difficulty and found thequestionnaire clear andeasyto understand. The panel discussed each of the issues raised by subjects and most terms were judged by the panel as to not require further changes because the overall comprehension levels were relatively high and because the translated terms were accurately rendered in the target languages. Conclusion: This report has demonstrated that despite translation difficulties, the linguistic validation of the FACT-VCIin the Korean language was successful. The next step is to assess the psychometric properties of the Korean version of FACT-VCI. Keywords: cystectomy; psychometrics; quality of life; questionnaires; reproducibility of results; urinary bladder neoplasms; linguistics. INTRODUCTION Current awareness of the psychological and social sequelae of cancer is evident from the intensified clinical research on these problems. Because of its impact on sexual function and body image, radical cystectomy for bladder cancer is probably more traumatic than many other cancer operations. (1) Bladder cancer is the ninth most common malignancy in South Korea, and annual incidence rate is reaching 6.8 cases per 100,000 people. The 5-year relative survival of bladder cancer was 78.3% in South Korea, however about one thirds of whole patients eventually receive radical cystectomy. (2) However, the true impact of radical cystectomy with urinary diversion on distressing symptoms, quality of life and general well-being in survivors of bladder cancer remains controversial and requires further clinical investigation. Quality of life instruments assess general health perceptions, sense of overall well-being, and physical, emotional and social functions. Tools used to assess the quality of life in patients with bladder cancer include general instruments, cancer-specific instruments and instruments specific to bladder cancer. Although modules specific to bladder cancer have recently become available, they have not been tested as extensively as other general cancer instruments that are more applicable to a variety of cancer types. In addition, almost all clinical studies of the quality of life in patients with bladder cancer have used ad hoc questionnaires of untested validity and reliability. (3-7) In 2003, Cookson and colleagues (8) developed a new 1 Department of Urology, Seoul National University Hospital, Seoul,Korea. 2 Department of Urology, SMG-SNU Boramae Medical Center, Seoul, Korea. 3 Department of Urology, Seoul National University Bundang Hospital, Seongnam, Korea. 4 Department of Urology, University of Oklahoma, Oklahoma City, Oklahoma. *Correspondence: Department of Urology, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul , Korea. Tel: Fax: kuuro70@snu.ac.kr. Received February 2014 & Accepted July 2014 Vol 11. No 06 Nov-Dec

2 Table 1. Reconciliation after two forward translations. US / English Items First Forward Korean Translation Second Forward Korean Translation Reconciled Korean Version I have nausea 나는메스꺼움을느낀다나는구역질이나어지럼증이있다나는메스꺼움을느낀다 Because of my physical condition, I have trouble meeting the needs 내신체적상태때문에내가족의필 나의육체적상태때문에가정의필 내신체상태때문에내가족이필요로 of my family 요를채우는데어려움이있다 요에충족하지못하고있다 하는것들을충족시키는데어려움이있다 I am bothered by side effects 나는이치료의부작용때문에괴로움을느낀다 나는치료의부작용이신경쓰인다 나는치료부작용때문에불편하다 of treatment I am forced to spend time in bed 나는어쩔수없이침대에서시간을보내야만한다 나는침대에누워있는상태로시 나는어쩔수없이침대에서지내야만 간을보낼수밖에없다 한다 I get support from my friends 나는내친구들로부터지지를받는다 친구들이나를지지해준다 나는친구들로부터지지를받는 다 I am satisfied with family 나는내가족과내병에대해서이야 나의병에대하여가족들과의사소 나는가족과내병에대해서이야기하 communication about my illness 기하는것에만족한다 통하는것에만족한다 는것에만족한다 I feel close to my partner 나는내배우자 ( 또는나에게가장많은나는내동반자가 ( 혹은주로부양나는내동반자가 ( 혹은주로지지하 (or the person who is my main support) 지지가되는사람 ) 에게가깝게느낀다하는사람 ) 가깝게느껴진다는사람 ) 가깝게느낀다 Regardless of your current level of 귀하의현재성생활과무관하게다 현재성활동의정도에무관하여 귀하의현재성활동정도와무관하게 sexual activity, please answer the 음의질문에답해주세요 다음질문에답변해주십시오 다음의질문에답해주세요 following question. I am satisfied with how I am coping 나는내가내병을견디고있는것에만족한다 나의투병방식에대해서만족감 나는내병에대처하고있는방식에만 with my illness 을느낀다 족한다 I am able to work (include work at home) 나는일을할수있다. ( 집에서하는일포함 ) 나는일할수있다 ( 재택근무포함 ) 나는일 ( 집에서하는일포함 ) 을할수있다. I am able to enjoy life 나는내인생을즐길줄안다 나는인생을즐길수있다 나는삶을즐길수있다 Additional Concern 추가적인문제들추가적인영향요소추가적인문제들 I have to limit my sexual activity 나는내건강상태때문에내성생활을제한해야만한다 나의성생활을건강상태에따 나는내건강상태때문에성생활을제 because of my condition 라제한할수밖에없다 한해야만한다 questionnaire for patients treated with radical cystectomy and urinary diversion, the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index (VCI), on the basis of their clinical experiences. The questionnaire is a disease specific questionnaire that can objectively assess quality of life following radical cystectomy and urinary diversion, and has been shown to be clinically useful in validation studies. (9,10) A recent study has demonstrated that a simple 15-item summary score of FACT-VCI (VCI-15) is a gender-neutral, reliable and valid measure of condition-specific quality of life in patients who undergo radical cystectomy and urinary diversion. (11) However, it is not simple to translate a questionnaire written in one language into a version in another language; translated versions must reflect differences in the culture and custom of subjects who use a given language. The linguistic validation is the first step of the cultural adaptation of a questionnaire. (12) The objective of the present study was to develop a Korean version of the FACT-VCI from the original version, with subsequent linguistic validation among Korean patients who underwent radical cystectomy with urinary diversion. To our best knowledge, the current study is the first translation and linguistic validation of the FACT-VCI. MATERIALS AND METHODS Original FACT-VCI Questionnaire The questionnaire developed by Cookson and colleagues (8) was selected for this study. The original English version of the FACT-VCI consists of the 27-items FACT-G, divided into 4 subscales for physical, social/ family, emotional and functional well-being in addition to 17 radical cystectomy specific questions, which specifically relates to urinary, bowel and sexual function. ( 8) Each item is scored in a 5- point Likert scale (from 0 for not at all to 4 for very much ), with higher scores indicating better quality of life. Methodology This study was approved by the institutional review board at Seoul National University Hospital (Seoul, Korea; IRB No. H ). The purpose of translating this instrument was to obtain a translated version in the Korean language that is conceptually equivalent to the original, consistent across either of the two languages, and is easily understood by the subjects responding to the translated version, according to the standardized cultural adaptation process. (13) The previous Korean validation studies in urologic filed were also consulted. ( 14,15) The linguistic validation process took place under the guidance of a project leader of the panel. The following individuals were involved at various steps of this process: A panel of six Korean experts Two forward translators One backward translator One interviewer Translation and linguistic validation were carried out between January and May of 2013 and consisted of Urological Oncology 1962

3 Table 2. Backward translation. Original Items Forward Translation (reconciled) Backward Translation I have nausea 나는메스꺼움을느낀다 I feel nauseous I feel close to my partner 나는내동반자가 ( 혹은주로지지하는사람 ) 가깝게느껴진다 I feel close to my companion (or the person who is my main support) (or my primary supporter) I am forced to spend time in bed 나는어쩔수없이침대에서지내야만한다 I cannot help but stay in bed I feel nervous 나는불안감을느낀다 I feel a sense of uneasiness seven stages. A schematic overview of a typical linguistic validation process is illustrated in Figure. In brief, one corresponding author (JHK) contacted the author of the original version (MSC) to obtain permission for the translation of the English version of the FACT-VCI by . All there translators (two forward and one backward) were bilingual but did not own the medical license of the Korean Medical Association. Two translations of the original version into the Korean language were performed independently by two different translators according to the instructions for forward translation supplied by the corresponding author (Korean versions 1.0a and 1.0b, respectively). The two translations were compared and reconciled into the Korean language version after two meetings of a panel consisting of the aforementioned translators and the authors (Korean version 1.1). To ensure that the Korean language version is faithful to the original version, particularly at the conceptual level, the version 1.1 was given to a third translator who was versed in the two languages (English and Korean) to formulate the questionnaire back into English. This backward-translated English version was subsequently compared to the original questionnaire by the panel. The discrepancies between the original English questionnaire and back-translated version led to subsequent changes to the reconciled translated version in the Korean language. This resulted in the production of a second Korean version and a report explaining the translation decisions (Korean version 1.2). Standardized interviews were conducted by a trained interviewer and completion of patient-reported outcome. The Korean version 1.2 questionnaire was presented to five Korean-speaking subjects who hand been treated with radical cystectomy and urinary diversion, to test the clarity, cultural adequacy, and the linguistic understanding of each item and the appropriateness of the translated questions. The debriefing interviews consisted of subjects paraphrasing each item and indicating any difficult or confusing terms to the interviewer. This feedback from the five subjects was analyzed, and the panel agreed on resolutions for each issue raised (Korean version 1.3). The third version was proofread to check for spelling, grammar, and formatting, which corresponds with changes made for the final version (Korean version 1.4) (Appendix). RESULTS Some of the terms in the original English version were replaced with Korean expressions, which include bother, spend time, support, coping and concern. During the forward translation phases, some of the words and phrases were adjusted to be more comprehensible to the target population (Table 1). The problems that arose during the translation of questionnaire can be divided into the three categories: Sematic equivalence: There were multiple meanings to a given word or a phrase. This included changing the term my condition as this expression connote broader interpretations in the Korean language. Thus, my condition was replaced with my health condition. Similarly, the word, partner has many meanings in Korean, in which the word can refer to party, couple, friend, member, and spouse. Therefore, the word partner was replaced by spouse in order to convey the original meaning in the English version. Idiomatic equivalence: Often the English word did Table 3. Resolution of subject comprehension problems during cognitive debriefing interviews. Original Items Translation (reconciled) Comprehension Issue of Subjects Resolution I have a lack of energy. 나는에너지가부족하다 Energy (1) Translated term is identical to original English term. No change necessary. I have nausea. 나는메스꺼움을느낀다 Nausea (1) Translated term is conceptually equivalent to original English term. No change necessary. Because of my physical condition, 내신체상태때문에내가족이필요로하 Trouble meeting the needs Translated terms are conceptually equivalent to I have trouble meeting the needs 는것들을충족시키는데어려움이있다 of my family (1) original English terms. No change necessary. of my family. I am forced to spend time in bed. 나는어쩔수없이침대에서지내야만한다 In bed (2) Change made from 침대에서 to 누워서. I have control of my bowels. 나는배변활동을조절할수있다 Bowels (1) Conceptual issue in original English. No change necessary. I have trouble controlling my urine. 나는소변을조절하는데문제가있다 Controlling my urine (1) Translated term is identical to original English term. No change necessary. Vol 11. No 06 Nov-Dec

4 신체적건강전혀아님아님어느정도꽤많이아주많이 GP1 나는에너지가부족하다 GP2 나는메스꺼움을느낀다 GP3 내신체상태때문에내가족이필요로하는 것들을충족시키는데어려움이있다 GP4 나는통증이있다 GP5 나는치료부작용때문에불편하다 GP6 나는아프다고느낀다 GP7 나는어쩔수없이누워서지내야만한다 사회적 / 가족적건강전혀아님약간어느정도꽤많이아주많이 GS1 나는친구들과가깝게느낀다 GS1 나는가족으로부터정서적인지 지를받는다. GS3 나는친구들로부터지지를받는다 GS4 가족은나의병을받아들였다 GS5 나는가족과내병에대해서이야기 하는것에만족한다. GS6 나는내동반자가 ( 혹은주로지지 하는사람 ) 가깝게느껴진다. Q1 귀하의현재성활동정도와무관하게다음의질문에답해주세요. 만약답하고싶지않다면, 이네모 ( ) 에표시해주시고다음부분으로넘어가주세요. GS7 나는나의성생활에만족한다 지난 7 일동안각각의내용들이귀하에게얼마나적합하였는지를각문항마다동그라미를한개만쳐주세요. 정서적건강전혀아님약간어느정도꽤많이아주많이 GE1 나는슬픔을느낀다 GE2 나는내병에대처하고있는방식에만 족한다. GE3 나는내병과싸우면서희망을 잃어가고있다. GE4 나는불안감을느낀다 GE5 나는죽는것이걱정된다 GE6 나의상태가악화될까걱정된다 기능적건강 전혀아님 약간 어느정도 꽤많이 아주많이 GF1 나는일 ( 집에서하는일포함 ) 을할수있다. GF2 내일 ( 집에서하는일포함 ) 에성취감을 느낀다. GF3 나는삶을즐길수있다 GF4 나는내병을받아들였다 GF5 나는잘잔다 GF6 나는즐거움을위해주로하는활동들을즐기고있다 GF7 나는현재내삶의질에만족한다 지난 7 일동안각각의내용들이귀하에게얼마나적합하였는지를각문항마다동그라미를한개만쳐주세요. 추가적인문제들전혀아님약간어느정도꽤많이아주많이 C2 나의체중이줄고있다 C3 나는배변활동을조절할수있다 C3 나는설사를한다 C6 나는식욕이좋다 C7 나는내외모에만족한다 BL1 나는소변을조절하는데문제가있다 ITU7 내건강상태때문에밤에잠을깬다 ITU6 나는내건강상태때문에당혹스럽다 C9 내소변상태를관리하는것이어렵다 ITU3 나는내건강상태때문에사회적활동을 제한해야만한다. ITU4 나는내건강상태때문에신체적활동을제한해야만한다 ITU5 나는내건강상태때문에성생활을 ITU1 Appendix. Korean version of the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index. 아래내용은귀하와같은병을앓았던다른환자들이중요하다고이야기한목록입니다. 지난 7 일동안각각의내용들이귀하에게얼마나적합하였는지를각문항마다동그라미를한개만쳐주세요. 제한해야만한다 나는친구들과나의건강상태에대해 의논하는것이편하다 VC1 나는나의소변상태에만족한다 ITU2 나는화장실과멀리떨어져있는것이두렵다 BL4 나는섹스에관심이있다 BL3 ( 남성만해당 ) 나는발기가되고그상태를 유지할수있다. Urological Oncology 1964

5 Figure. The standard linguistic validation algorithm. not have quite the same conceptual meaning in the Korean language. For example, the question, I have control of my bowels was translated into I have control of my defecation. The question, I have to limit my sexual activity because of my condition was translated to I have to limit my sex life because of my health condition for a more natural expression. The item, Caring for my urinary condition is difficult, was translated into Managing my urinary condition is difficult, because of the possibility of difficulty in understanding of the expression caring for in the Korean language. Conceptual equivalence: Some words hold different conceptual meaning between cultures. For instance, the meaning of Because of my physical condition, I have trouble meeting the needs of my family would differ between cultures because the word family could potentially mean immediate family or family including extended relatives. The reconciled Korean version (version 1.1) was accepted without strong objections because the original version and the backward translation were almost congruent except for the questions listed in Table 2. Despite these differences, the meanings of respective items between both versions were judged to be almost identical. The translation was tested using 5 subjects. The mean age was 67 years (range 55 to 73), and all subjects were male. The length of education ranged from 6 to 14 years, with a mean of 9.2 years. Four subjects had fewer than 12 years of education. The respondents completed the questionnaire within the average of 8.2 minutes, without difficulty, and reported the questionnaire to be clear and easy to understand. The panel discussed each of the issues raised by subjects to decide whether changes to the translation were needed. Items that were subsequently changes by the panel were considered resolved issues (Table 3). However, most terms were judged by the panel as not requiring changes because overall comprehension levels were relatively high and because the translated terms were accurately rendered in the target language. DISCUSSION The concept of quality of life can be defined as the extent to which the usual or expected physical, emotional, and social well- being is affected by a medical condition or its treatment. ( 16) Having accurate baseline and post-treatment data is essential in evaluating the quality of life of patients and subsequently determining the effectiveness of management. ( 17) Measuring quality of life might be challenging for physicians as it may take a long time during the overall assessment of their patients. Validated quality of life questionnaires are important tools to assess outcomes after surgery and help overcome this obstacle. In addition, the use of validated and standardized tools will allow comparison of outcomes across different studies and in meta-analyses. (18) Radical cystectomy with urinary diversion is considered to be the most effective local treatment for invasive bladder cancer. Quality of life after radical cystectomy may be affected by diversion type, body image, urinary function, and sexual function. Although generic quality of life measures provide valuable information, they may not be sufficiently sensitive to detect cystectomy- or diversion-specific changes. The development of bladder cancer-specific instruments has been essential in detecting differences in urinary, bowel, sexual, and body image outcomes in bladder cancer survivors. Some condition-specific measures have been used to measure health-related quality of life in bladder cancer patients. (19-21) However, only FACT-VCI and the Bladder Cancer Index (BCI) are reliable and validated disease-specific measures with known psychometric properties. (8,22) Between the two, the FACT-VCI has been found to have adequate internal consistency (Cronbach s α > 0.7). (8) Interclass correlation for the first and second administration of the FACT-VCI was 0.79, which verifies the stability of the score derived from serial administrations of this questionnaire by the same respondent. (8) Convergent validity was investigated by correlating the FACT- VCI with the generic RAND 36- Item Health Survey (SF-36) (r = 0.81). (8) Differences in quality of life cannot simply be attributed to the disease process, when comparing culturally diverse populations. (23) Cultural adaptation is the first step when validating instrument in new language. In general, translation of a questionnaire into a version in another language is not straightf orward, and differences in cultures and customs associated with each language have to be considered during the translation process. Therefore, the availability of high- quality translation is of vital importance to guarantee a successful implementation in the target language and to assure the international comparability of the data. (24) Consequently, detailed guidelines and appropriate documentation of each step of translation processes have been proposed. (25,26) In this study, we have presented the Korean version of the FACT-VCI by gaining permission of use from the original authors and verifying the appropriateness and reliability of the questionnaire in order for it to be officially used for patients in South Korea. We found that Korean subjects understood the translated questionnaire, Vol 11. No 06 Nov-Dec

6 although a number of minor changes were made in an effort to improve the clarity and cultural appropriateness. This overall high comprehension rate and lack of significant unresolved comprehension issues demonstrated a high level of linguistic validity. Potential limitations of the study included the small sample size and an imperfectly stratified subject pool in terms of level of education. Psychometric validation of the translation produced may be a useful next step for verifying the cross-cultural validity of the translated questionnaire. (27,28) CONCLUSION This report has demonstrated that despite the translation difficulties, the linguistic validation of the FACT-VCI in Korean language was successful. We found that the translation was understood well by Korean-speaking subjects. The Korean version of the FACT-VCI questionnaire can be used as a tool for evaluating quality of life in patients who underwent radical cystectomy with urinary diversion and is expected to be useful in clinical research. The next step is to assess the psychometric properties of the Korean version of FACT-VCI. ACKNOWLEDGEMENTS This study was supported by grant no from SNUH research fund. Yu Kyoung Lee, Ha Young Kim, Yu Jin Lee, and Se Ra Park assisted with the development of the Korean version of FACT-VCI. CONFLICT OF INTEREST None declared. REFERENCES 1. Månsson A, Månsson W. When the bladder is gone: quality of life following different types of urinary diversion. World J Urol. 1999;17: The Korea Central Cancer registry. Annual report of cancer statistics in Korea in Gyeonggi-do, Republic of Korea: National Cancer Center; p Gotoh M, Mizutani K, Furukawa T, Kinukawa T, Ono Y, Ohshima S. Quality of micturition in male patients with orthotopic neobladder replacement. World J Urol. 2000;18: Fujisawa M, Isotani S, Gotoh A, Okada H, Araka wa S, Kamidono S. Health- related quality of life with orthotopic neobladder versus ileal conduit according to the SF-36 survey. Urology. 2000;55: Miyake H, Nakamura I, Eto H, et al. An evaluation of quality of life in patients who underwent orthotopic bladder replacement after cystectomy: comparison of ileal neobladder versus colon neobladder. Urol Int. 2002;69: Yoneda T, Igawa M, Shiina H, Shigeno K, Urakami S. Postoperative morbidity, functional results and quality of life of patients following orthotopic neobladder reconstruction. Int J Urol. 2003;10: Henningsohn L, Wijkström H, Steven K, et al. Relative importance of sources of symptom-induced distress in urinary bladder cancer survivors. Eur Urol. 2003;43: Cookson MS, Dutta SC, Chang SS, Clark T, Smith JA Jr, Wells N. Health related quality of life in patients treated with radical cystectomy and urinary diversion for urothelial carcinoma of the bladder: development and validation of a new disease specific questionnaire. J Urol. 2003;170: Large MC, Katz MH, Shikanov S, Eggener SE, Steinberg GD. Orthotopic neobladder versus Indiana pouch in women: a comparison of health related quality of life outcomes. J Urol. 2010;183: Vakalopoulos I, Dimitriadis G, Anastasiadis A, Gkotsos G, Radopoulos D. Does intubated uretero-ureterocutaneostomy provide better health-related quality of life than orthotopic neobladder in patients after radical cystectomy for invasive bladder cancer? Int Urol Nephrol. 2011;43: Morgan TM, Barocas DA, Penson DF, et al. Lymph node yield at radical cystectomy predicts mortality in node-negative and not node-positive patients. Urology. 2012;80: Acquadro C, Kopp Z, Coyne KS, et al. Translating overactive bladder questionnaires in 14 languages. Urology. 2006;67: Acquadro C, Conway K, Hareendran A, Aaronson N; European Regulatory Issues and Quality of Life Assessment (ERIQA) Group. Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials. Value Health. 2008;11: Chung KJ, Kim JJ, Lim SH, Kim TH, Han DH, Lee SW. Development and Validation of the Korean Version of Expanded Prostate Cancer Index Composite: Questionnaire Assessing Health-Related Quality of Life after Prostate Cancer Treatment. Korean J Urol. 2010;51: Min KS, Kim YH, Kim JM, Shin KL, Hong JY, Kim ME. Development of a Korean Version of the Urinary Tract Infection Symptoms Assessment Questionnaire. Korean J Urol. 2009;50: Cella DF. Quality of life: concepts and definition. J Pain Symptom Manage. 1994;9: Ikeda Y, Saku M, Kawanaka H, Nonaka M, Yoshida K. Features of second primary cancer in patients with gastric cancer. Oncology. Urological Oncology 1966

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