INJ Lee, et al. Linguistic Validation of TS-VAS and OAB-SAT-q INTRODUCTION Patient-reported outcomes (PROs) are important for assessing patients satis

Official Journal of Korean Continence Society / Korean Society of Urological Research / The Korean Children s Continence and Enuresis Society / The Korean Association of Urogenital Tract Infection and Inflammation pissn 2093-4777 eissn 2093-6931 einj.org Mobile Web NEUROUROLOGY JOURNAL INJINTERNATIONAL Original Article https://doi.org/10.5213/inj.1734992.496 pissn 2093-4777 eissn 2093-6931 Translation and Linguistic Validation of the Korean Version of the Treatment Satisfaction Visual Analogue Scale and the Overactive Bladder Satisfaction With Treatment Questionnaire Ha Na Lee 1, Ji Yun Chae 2, Hyo Serk Lee 3, Min Soo Choo 4, Min Gu Park 5, Seo Yeon Lee 6, Seung-June Oh 7, Sung Yong Cho 8 1 Department of Urology, Seoul Metropolitan Seonam Hospital, Seoul, Korea 2 Mizlove Female Urology Clinic, Seoul, Korea 3 Department of Urology, Cheil General Hospital & Women s Healthcare Center, Kwandong University College of Medicine, Seoul, Korea 4 Department of Urology, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea 5 Department of Urology, Inje University Seoul Paik Hospital, Seoul, Korea 6 Department of Urology, Myongji Hospital, Seonam University College of Medicine, Goyang, Korea 7 Department of Urology, Seoul National University Hospital, Seoul, Korea 8 Department of Urology, Seoul Metropolitan Government - Seoul National University Boramae Medical Center, Seoul, Korea Purpose: This study reports the development of the Korean Version of the Treatment Satisfaction Visual Analogue Scale (TS- VAS) and the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q) based on the original versions, with subsequent linguistic validation by Korean patients with overactive bladder receiving active treatment from a physician. Methods: Translation and linguistic validation were performed in 2016. The validation process included permission for translation, forward translation, reconciliation, backward translation, cognitive debriefing, and proofreading. The original versions of the TS-VAS and OAB-SAT-q were independently translated into Korean by 2 bilingual translators and were then reconciled into a single version. The third bilingual translator performed a backward translation of the reconciled version into English. A trained interviewer and 5 Korean-speaking patients with OAB carried out the cognitive debriefing. Results: During the forward translation process, the terms used in the 2 questionnaires were adjusted to use more appropriate expressions in the Korean language than were used in the original versions. During the backward translation process, no changes were made in terms of semantic equivalence. In the cognitive debriefing session, 5 patients were asked to fill in the answers within 8 minutes; most of them reported that the translated questions were clear and easy to understand. Conclusions: The present study presents successful linguistic validation of the Korean version of the TS-VAS and OAB-SATq, which could be useful tools for evaluating treatment satisfaction in patients. Keywords: Linguistics; Patient Satisfaction; Visual Analogue Scale; Overactive Bladder, Overactive Research Ethics: This study was approved by the Institutional Review Board of the Seoul Metropolitan Government - Seoul National University Boramae Medical Center (approval number: 26-2016-60). Conflict of Interest: MSC and SYC, members of the Editorial Board of INJ, are the fourth and corresponding authors of this article. However, they played no role whatsoever in the editorial evaluation of this article or the decision to publish it. No potential conflict of interest relevant to this article was reported. Corresponding author: Sung Yong Cho https://orcid.org/0000-0001-9271-6951 Department of Urology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul 07061, Korea E-mail: kmoretry@daum.net / Tel: +82-2-870-2394 / Fax: +82-2-870-3863 Submitted: September 14, 2017 / Accepted after revision: December 1, 2017 Copyright 2017 Korean Continence Society This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. www.einj.org

INJ Lee, et al. Linguistic Validation of TS-VAS and OAB-SAT-q INTRODUCTION Patient-reported outcomes (PROs) are important for assessing patients satisfaction with the treatment they receive in clinics. PROs can help guide treatment with regard to the risks and benefits of an intervention in the course of treatment [1-3]. Therefore, it is important to develop a questionnaire that accurately represents PROs in order to facilitate decision-making about treatment. The Treatment Satisfaction Visual Analogue Scale (TS-VAS) and Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q) have been used for evaluating patients satisfaction with their treatment. The visual analogue scale (VAS) is a widely accepted method for measuring the effects of disease and medical interventions with special reference to quality of life (QoL) [4-6]. The OAB-SAT-q was developed based on a review of existing instruments for measuring treatment satisfaction, input from physicians experienced in treating overactive bladder (OAB), and patient feedback. To the best of our knowledge, no Korean versions of the TS- VAS and OAB-SAT-q were previously available. Therefore, we developed a Korean version based on the original versions, with subsequent linguistic validation in Korean patients with OAB who were receiving active treatment from a physician. MATERIALS AND METHODS Original TS-VAS and OAB-SAT-q The VAS was described for the first time in 1921 by Hayes and Patterson [7]. The VAS is a simple and frequently used method to evaluate variations in pain intensity [8]. The VAS for satisfaction is a simple and valid instrument to quantify a patient s satisfaction after a treatment [9], and consists of a 100-mm-long horizontal line, with 2 descriptors representing extremes of satisfaction at the beginning and at the end of the line. Patients rate their satisfaction by making a vertical mark on the 100- mm line. The measurement in millimeters is converted to the same number of points, ranging from 0 to 100 points. The OAB-SAT-q was developed as a way to evaluate the satisfaction of patients with OAB as part of the modular International Consultation on Incontinence Questionnaire [10]. The OAB-SAT-q is a disease-specific 11-item questionnaire designed to assess patients satisfaction with their treatment in the clinical setting. The OAB-SAT-q items include effectiveness, convenience, side effects, preference for treatment, willingness to undergo the treatment again, and an assessment of global satisfaction. The response options vary depending on the content of the question and are presented on 4-, 5-, and 6-point Likert scales with anchors, such as extremely dissatisfied to extremely satisfied and extremely bothersome to not at all bothersome [10]. Translation and Linguistic Validation This study was approved by the Institutional Review Board of the Seoul Metropolitan Government - Seoul National University Boramae Medical Center (approval number: 26-2016-60). The process was designed to obtain a translated Korean version of the questionnaire that would be conceptually equivalent to the original. The translation was appropriate in terms of cultural adaptation and was supervised by the project leader of the panel. The panel consisted of 7 Korean experts who performed a typical linguistic validation process. Permission Before the study commenced, the panel contacted the copyright holder and acquired permission to translate and use the TS- VAS and OAB-SAT-q after conducting the linguistic validation process. Forward Translation The original versions of the TS-VAS and OAB-SAT-q were translated into the Korean language (versions 1.0a and 1.0b) by 2 bilingual translators who did not have medical licenses. The translations were performed independently, and the translators were not permitted to contact each other during the translation process. Reconciliation by the Panel The independently translated versions in the Korean language (versions 1.0a and 1.0b) were reconciled into a single version after several panel meetings (version 1.1). The panel discussed comprehension difficulties due to subtle differences in the nuances of the selected words and phrases. Backward Translation The reconciled version of the TS-VAS and OAB-SAT-q in the Korean language (version 1.1) was sent to a third bilingual translator. This translator translated it backward into English, and the results were compared to the original English versions of the TS- VAS and OAB-SAT-q. After the third translator completed the backward translation, the panel discussed the discrepancies be- 310 www.einj.org

Lee, et al. Linguistic Validation of TS-VAS and OAB-SAT-q INJ tween the original and the backward-translated versions of the TS-VAS and OAB-SAT-q. Some changes were made in the reconciled TS-VAS and OAB-SAT-q in the Korean language based on the outcomes of several discussions (version 1.2). Cognitive Debriefing Version 1.2 of the questionnaires was evaluated by 5 Koreanspeaking patients with OAB, who were asked whether there were any clarity issues, culturally inappropriate expressions, or difficulties in understanding the questions. The panel chose a trained interviewer who conducted a standardized in-depth interview of a small number of patients. The debriefing interviews involved paraphrasing each question of the questionnaire and indicating whether the participants had any trouble understanding the question or felt that any terms were confusing. Subsequently, the panel discussed the feedback from the 5 patients with OAB and agreed upon a new version based on the issues raised (version 1.3). Proofreading Version 1.3 was proofread to check spelling, grammar, and formatting. This resulted in the final version of the TS-VAS and OAB-SAT-q in the Korean language (version 1.4). RESULTS Forward Translation and Reconciliation As shown in Table 1, the word satisfied in the title of the original version of the TS-VAS was translated as manjok ( satisfaction ) by the 2 translators. As shown in Table 2, the 11 questions of the OAB-SAT-q were translated into Korean. Question 1, How satisfied or dissatisfied are you with the way the treatment relieves your symptoms? in the original version was directly translated as jeungsangeul wanhwasikineundeisseoseo manjok hogeun bulmanjok hasimnikka? The phrase How satisfied or dissatisfied are you with the treatment? was repeated in questions 1-3. Question 2, How satisfied or dissatisfied are you with the amount of time it takes the treatment to start working? in the original version was translated as chiryohyogwaga natananeundekkaji geollineun sigane manjok hogeun bulmanjok hasimnikka? Question 3, How satisfied or dissatisfied are you with the effectiveness of the treatment, compared to what you expected? in the original version, was translated as gidaehaetdeon dae bihayeo chiryoui hyogwae eoneujeongdo manjok hogeun bulmanjok hasimnikka? The phrase compared to what you expected was translated as gidaehaetdeon geonmankeumebihae ( compared to your expectation ) in translation 1, and as yesanghaetdeon geotboda ( than you expected ) in translation 2. The panel reconciled it as gidaehaetdeon dae bihayeo ( expected compared to ). Question 4, How convenient or inconvenient is it to take the treatment as instructed? in the original version, was directly translated as eoneujeongdo pyeolli hogeun bulpyeonhasyeotseumnikka? The word convenient was translated as yongi ( easy ) and pyeonhada ( comfortable ) in translations 1 and 2, respectively. The panel reconciled it as pyeolli ( convenient ). The word extremely was finally translated as jigeuki rather than wanjeon ( complete ) and aju ( very ). Question 5, How often did you experience side effects from your treatment? in the original version, was directly translated as eolmana jaju chiryo bujagyongeul gyeongheom hasyeotseumnikka? This question was translated in nearly the same way by both translators. Question 6, How bother- Table 1. Reconciliation after 2 forward translations of Treatment Satisfaction Visual Analogue Scale US English item EXAMPLE OF TREATMENT SATISFACTION VISUAL ANALOGUE SCALE Please place a vertical mark on the line to indicate your answer to the question below Are you satisfied with your treatment? First forward Korean translation 치료만족시각상사척도예시 다음과같은질문을답하기위해해당선에수직선을표기하십시오. Second forward Korean translation 예 ) 치료만족도시각상사척도 선위에세로선을표시하여다음질문에답변하시기바랍니다. Reconciled forward Korean translation 다음질문을답하기위해선위에세로선을표기해주시기바랍니다. 귀하의치료에만족하십니까? 귀하께서는치료에만족하십니까? 귀하는치료에만족하십니까? No, not at all 전혀그렇지않음 아니요, 절대만족하지않습니다. 아니요, 전혀그렇지않음 Yes, completely 완전히만족함 네, 전적으로만족합니다. 네, 전적으로만족함 www.einj.org 311

INJ Lee, et al. Linguistic Validation of TS-VAS and OAB-SAT-q Table 2. Reconciliation after 2 forward translations of Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q) US English item OAB-SAT-q First forward Korean translation (Translation 1) 과민성방광치료만족도설문조사확인 ( 인증 ) Second forward Korean translation (Translation 2) Instructions 설명설명서지시사항 Please think about how satisfied you have been with the treatment you have received in the study. The questions below will ask you to rate how satisfied or dissatisfied you are with your treatment for overactive bladder. T hinking about the past four weeks, check one box for each item that best reflects your treatment experience. 1. How satisfied or dissatisfied are you with the way the treatment relieves your symptoms? 2. How satisfied or dissatisfied are you with the amount of time it takes the treatment to start working? 3. How satisfied or dissatisfied are you with the effectiveness of the treatment, compared to what you expected? 귀하가실험에참여하며받은치료에대해얼마나만족했는지를생각해보십시오. 아래의질문들은귀하의과민성방광치료에대한만족 ( 또는불만족 ) 정도를평가하기위한항목들입니다. 지난 4 주동안귀하의치료경험을가장정확하게반영하는칸을항목별로표시하여주십시오. 귀하께서는이연구에서받으신치료에어느정도만족하시는지생각해보시기바랍니다. 하기질문들에귀하의과민성방광치료만족도를평가하여주시기바랍니다. 귀하께서는지난 4 주를생각하시어귀하의치료경험을가장잘묘사하는항목을선택하여주시기바랍니다. 1. 귀하가받는치료의증상 1. 귀하께서는치료가증상완완화효과에얼마나만족화하는데있어서어느정도혹은불만족하십니까? 만족혹은불만족하신가요? 2. 치료가작용하기까지걸리 2. 귀하께서는치료하시는데는시간에얼마나만족혹기여되는시간에있어서어은불만족하십니까? 느정도만족혹은불만족하신가요? 3. 귀하가기대했던것만큼에 3. 귀하께서는치료효과에대비해치료의효과에얼마나해서예상했던것보다어만족혹은불만족하십니까? 느정도만족혹은불만족하신가요? Reconciled forward Korean translation 과민성방광치료만족도설문지 귀하는이번연구에서받은치료에어느정도만족하는지생각해보시기바랍니다. 아래의질문들은귀하가과민성방광치료에어느정도만족또는불만족하는지를평가할것입니다. 지난 4 주동안, 귀하의치료경험을가장정확하게반영하는칸을항목별로표시하여주십시오. 1. 치료가귀하의증상을완화시키는데있어서어느정도만족혹은불만족하십니까? 2. 치료효과가나타나는데까지걸리는시간에어느정도만족혹은불만족하십니까? 3. 귀하가기대했던바에비하여치료효과에어느정도만족혹은불만족하십니까? Extremely dissatisfied 완전불만족 아주매우불만족스럽다 지극히불만족 Very dissatisfied 매우만족 아주불만족스럽다 매우불만족 Dissatisfied 불만족 불만족스럽다 불만족 Satisfied 만족 만족스럽다 만족 Very satisfied 매우만족 아주만족스럽다 매우만족 Extremely satisfied 완전만족 아주매우만족스럽다 지극히만족 4. How convenient or inconvenient is it to take the treatment as instructed? 4. 설명지에명시된대로치료를받는것이얼마나용이혹은불편하십니까? 4. 설명서대로치료를받으시는것이어느정도편하시거나불편하신가요? 4. 귀하가치료를받는데어느정도편리혹은불편하셨습니까? Extremely inconvenient 완전불편함 아주매우불편하다 지극히불편함 Very inconvenient 매우불편함 아주불편하다 매우불편함 Inconvenient 불편함 불편하다 불편함 Convenient 용이함 편하다 편리함 Very convenient 매우용이함 아주편하다 매우편리함 Extremely convenient 완전용이함 아주매우편하다 지극히편리함 5. How often did you experience side effects from your treatment? 5. 귀하는얼마나자주치료에 5. 귀하께서는얼마나자주치의한부작용을경험하셨습료부작용을경험하시나요? 니까? Never 부작용경험없음 한번도없다 전혀없음 A little of the time 매우가끔 거의없다 거의없음 5. 귀하는얼마나자주치료부작용을경험하셨습니까? (Continued to the next page) 312 www.einj.org

Lee, et al. Linguistic Validation of TS-VAS and OAB-SAT-q INJ Table 2. Continued US English item First forward Korean translation (Translation 1) Second forward Korean translation (Translation 2) Some of the time 가끔가끔있다가끔있음 Reconciled forward Korean translation A good bit of time 자주그런적이여러번있다상당히있음 Most of time 매우자주경험함거의있다매우자주있음 All of the time 항상항상있다항상있음 6. How bothersome are the side effects of the treatment you take to treat your overactive bladder? 6. 귀하의과민성방광치료에의한부작용이얼마나불편하십니까? 6. 과민성방광을치료하는데있어서부작용이귀하께어느정도의불편함을주나요? 6. 귀하는과민성방광치료를받는데있어서 ( 치료 ) 부작용이얼마나불편하십니까? Extremely bothersome 완전히불편함 아주매우불편하다 지극히불편함 Very bothersome 매우불편함 많이불편하다 매우불편함 Somewhat bothersome 적당히불편함 어느정도불편하다 다소불편함 A little bothersome 약간불편함 조금불편하다 약간불편함 Not at all bothersome 전혀불편하지않음 전혀불편하지않다 전혀불편하지않음 7. To what degree have side effects affected your overall satisfaction with the treatment? 7. 부작용이귀하의전반적인 7. 부작용이귀하의전체적인 7. 귀하의전반적인치료만 치료만족도에얼마나영향을미쳤습니까? 치료법만족도에어느정도의영향을주었나요? 족도에부작용이얼마나영향을미쳤습니까? A great deal 매우많이 상당히많이주었습니다 상당히많이 Quite a bit 상당히 / 적당히 상당히주었습니다 꽤많이 Somewhat 약간적게 어느정도주었습니다 다소 Minimally 매우적게 최소주었습니다 극히일부분 Not at all 전혀영향없음 전혀주지않았습니다 전혀영향없음 8. Do you prefer the treatment that you received since entering this study to the treatment you received before the study? Never been treated before for overactive bladder Definitely prefer my previous treatment Slight preference for my previous treatment Slight preference for the treatment I am receiving now Definitely prefer the treatment I am receiving now 9. Would you be willing to use the same treatment for your bladder problem that you have received since entering this study? 8. 귀하가실험참가후에받으신치료를실험참가전에받으신치료보다선호하십니까? 과민성방광치료를받아본적이없음 실험참가전에받은치료를확실하게선호함실험참가전에받은치료를약간선호함실험참가후에받은치료를약간선호함실험참가후에받은치료를확실하게선호함 9. 귀하의방광문제를치료하기위해실험참가후에받으신거와동일한치료를받기를원하십니까? Definitely would not use the same treatment again 확실히같은치료를받고싶지않음 Might not use the same treatment again 같은치료를다시선택하지않을수도있음 8. 귀하께서는이번연구에서받으신치료법을이전에받으셨던치료법보다더선호하십니까? 이번연구이전에과민성방광치료를받은이력이전혀없습니다분명히이번연구이전에받은치료법을선호합니다이번연구이전에받은치료법을조금더선호합니다이번연구의치료법을조금더선호합니다분명히이번연구의치료법을선호합니다 9. 귀하께서는방광문제치료방법으로이번연구에서받으신치료법과동일한치료법을사용하시겠습니까? 절대로동일한치료법을사용하지않을것이다아마도동일한치료법을사용하지않을것이다 8. 귀하는이전에받았던치료방법보다이번연구에서받은치료방법을더선호하십니까? 과민성방광치료를받아본적이없음 이전에받은치료를분명히선호함이전에받은치료를약간선호함이번연구의치료방법을약간선호함이번연구의치료방법을분명히선호함 9. 귀하는방광문제를치료하기위해이번연구에서받은치료방법과동일한치료를받을의향이있으십니까? 동일한치료방법을분명히받지않을것임동일한치료방법을아마도받지않을것임 (Continued to the next page) www.einj.org 313

INJ Lee, et al. Linguistic Validation of TS-VAS and OAB-SAT-q Table 2. Continued US English item Might use the same treatment again Definitely would use the same treatment again 10. Would you recommend this treatment to others with overactive bladder? First forward Korean translation (Translation 1) 같은치료를다시선택할수도있음확실히같은치료를다시받고싶음 10. 귀하가받고계신치료를다른과민성방광환자들에게추천하시겠습니까? Second forward Korean translation (Translation 2) 아마도동일한치료법을사용할것이다분명히동일한치료법을사용할것이다 10. 귀하께서는다른분에게과민성방광치료방법으로이치료법을추천하시겠습니까? Reconciled forward Korean translation 동일한치료방법을받을수도있음동일한치료방법을분명히받을것임 10. 귀하는다른분에게과민성방광치료방법으로이치료방법을추천하시겠습니까? Definitely would not recommend 추천하지않을것이확실함 절대로추천하지않을것이다 절대로추천하지않을것임 Might not recommend 추천하지않을수도있음 아마도추천하지않을것이다 아마도추천하지않을것임 Might recommend 추천할수도있음 아마도추천할것이다 추천할수도있음 Definitely would recommend 추천할것이확실함 분명히추천할것이다 분명히추천할것임 11. Overall, how satisfied or dissatisfied are you with this treatment? 11. 전반적으로귀하는귀하의 11. 전체적으로이치료법에 11. 전반적으로귀하의치 치료에얼마나만족혹은불만족하십니까? 대해어느정도만족혹은불만족하십니까? 료에얼마나만족혹은불만족하십니까? Extremely dissatisfied 완전불만족 아주매우불만족스럽다 지극히불만족 Very dissatisfied 매우불만족 아주불만족스럽다 매우불만족 Dissatisfied 불만족 불만족스럽다 불만족 Satisfied 만족 만족스럽다 만족 Very satisfied 매우만족 아주만족스럽다 매우만족 Extremely satisfied 완전만족 아주매우만족스럽다 지극히만족 some are the side effects of the treatment you take to treat your overactive bladder? in the original version, was translated as gwihaneun gwaminseong banggwang chiryoreul banneundeisseoseo chiryobujagyongi eolmana bulpyeonhasimnikka? The responses included phrases such as extremely bothersome, very bothersome, somewhat bothersome, a little bothersome, and not at all bothersome, which were translated as follows after the panel discussed the translation possibilities: jigeuki bulpyeonham, maeu bulpyeonham, daso bulpyeonham, yakgan bulpyeonham, and jeonhyeo bulpyeonhaji aneum, respectively. Question 7, To what degree have side effects affected your overall satisfaction with treatment? in the original version, was directly translated as jeonbanjeogin chiryo manjokdoe bujagyongi eolmana yeonghyangeul michyeotseumnikka? The translation of this question did not meaningfully differ between the 2 translators. Question 8, Do you prefer the treatment that you received since entering this study to the treatment you received before the study? in the original version, was directly translated as ibeon yeongueseobadeun chiryobangbeobeul deo seonhohasimnikka? Question 9, Would you be willing to use the same treatment for your bladder problem that you have received since entering this study? in the original version, was directly translated as dongilhan chiryoreul badeul uihyangi isseusimnikka? ( Would you be willing to use the same treatment? ) The panel discussed and reconciled the 2 different translated sentences into the final question, and included uihyang ( willing ). Question 10, Would you recommend this treatment to others with overactive bladder? in the original version, was directly translated as ichiryobangbeobeul chucheon hasigetseumnikka? ( Would you recommend this treatment to others? ). Question 11, Overall, how satisfied or dissatisfied are you with this treatment? in the original version, was directly translated as jeonbanjeogeuro gwihaui chiryoeeol manamanjok hogeun bulmanjokasimnikka? The panel attempted to choose sentences that preserved the exact meaning of the English phrases, and reconciled the 2 translated versions to provide more natural expressions in the Korean language, within the framework of conceptual equivalence. The panel chose the final forward-translated versions on this basis. Backward Translation As shown in Table 3, the panel agreed that there were no signif- 314 www.einj.org

Lee, et al. Linguistic Validation of TS-VAS and OAB-SAT-q INJ Table 3. Backward translation Original Forward translation Back translation TS-VAS Please place a vertical mark on the line to indicate your answer to the question below 치료만족도시각적척도 다음질문을답하기위해선위에세로선을표기해주시기바랍니다. I n order to answer the following question, please indicate a vertical line on the line Are you satisfied with your treatment? 귀하는치료에만족하십니까? Are you satisfied with your treatment? No, not at all 아니요, 전혀그렇지않음 No, I do not feel satisfied at all. Yes, completely 네, 전적으로만족함 Yes, I am fully satisfied. OAB-SAT-q 과민성방광치료만족도설문지 The satisfaction of overactive bladder treatment Instructions: 지시사항 : Explanation/Description: P lease think about how satisfied you have been 귀하는이번연구에서받은치료에어느정도만 with the treatment you have received in the 족하는지생각해보시기바랍니다. study. The questions below will ask you to rate how satisfied or dissatisfied you are with your treat- 도만족또는불만족하는지를평가할것입니다. 아래의질문들은귀하가과민성방광치료에어느정 ment for overactive bladder. P lease think how satisfied you are with treatment you have received during this investigation T he questions below will evaluate either how satisfied or dissatisfied you were with the overactive bladder treatment Thinking about the past four weeks, check one 지난 4주동안, 귀하의치료경험을가장정확하 Please indicate the box that best describes your box for each item that best reflects your treatment experience. each 게반영하는칸을항목별로표시하여주십시오. treatment experience during the past 4 weeks in category 1. How satisfied or dissatisfied are you with the way the treatment relieves your symptoms? 1. 치료가귀하의증상을완화시키는데있어서어느정도만족혹은불만족하십니까? 2. How satisfied or dissatisfied are you with the 2. 치료효과가나타나는데까지걸리는시간에 amount of time it takes the treatment to start 어느정도만족혹은불만족하십니까? working? 3. How satisfied or dissatisfied are you with the 3. 귀하가기대했던바에비하여치료효과에어 effectiveness of the treatment, compared to 느정도만족혹은불만족하십니까? what you expected? 1. How satisfied or dissatisfied are you with treatment relieving your symptoms? 2. How satisfied or dissatisfied are you with the time that it takes to show the effect of the treatment 3. Compared to your expectations, how satisfied or dissatisfied are you with the effect of the treatment? Extremely dissatisfied 지극히불만족 Extremely dissatisfied Very dissatisfied 매우불만족 Very dissatisfied Dissatisfied 불만족 Dissatisfied Satisfied 만족 Satisfied Very satisfied 매우만족 Very satisfied Extremely satisfied 지극히만족 Fully Satisfied 4. How convenient or inconvenient is it to take the treatment as instructed? 4. 귀하가치료를받는데어느정도편리혹은불편하셨습니까? 4. How comfortable or uncomfortable are you with receiving treatments the way you have been explained Extremely inconvenient 지극히불편함 Extremely uncomfortable Very inconvenient 매우불편함 Very uncomfortable Inconvenient 불편함 Uncomfortable Convenient 편리함 Convenient Very convenient 매우편리함 Very convenient Extremely convenient 지극히편리함 Exceptionally convenient 5. How often did you experience side effects from your treatment? 5. 귀하는얼마나자주치료부작용을경험하셨습니까? Never 전혀없음 Never A little of the time 거의없음 Seldom/rarely 5. How often have you experienced the side effects (of the treatment)? (Continued to the next page) www.einj.org 315

INJ Lee, et al. Linguistic Validation of TS-VAS and OAB-SAT-q Table 3. Continued Original Forward translation Back translation Some of the time 가끔있음 Occasionally A good bit of time 상당히있음 Quite often Most of time 매우자주있음 Very often All of the time 항상있음 All of the time 6. How bothersome are the side effects of the 6. 귀하는과민성방광치료를받는데있어서 ( 치 treatment you take to treat your overactive 료 ) 부작용이얼마나불편하십니까? bladder? 7. To what degree have side effects affected your overall satisfaction with treatment? 7. 귀하의전반적인치료만족도에부작용이얼마나영향을미쳤습니까? 6. How uncomfortable are you with the side effects from/when receiving the overactive bladder treatment 7. To what extent did the side effects influence the overall satisfaction of the treatment A great deal 상당히많이 To a very large extent Quite a bit 꽤많이 To a large extent Somewhat 다소 To some extent Minimally 극히일부분 To a very small extent Not at all 전혀영향없음 No influence at all 8. Do you prefer the treatment that you received 8. 귀하는이전에받았던치료방법보다이번연구 8. Do you prefer this treatment (method) rather since entering this study to the treatment you received before the study? 에서받은치료방법을더선호하십니까? than the previous treatment (method)? 9. Would you be willing to use the same treatment for your bladder problem that you have received since entering this study? 10. Would you recommend this treatment to others with overactive bladder? 11. Overall, how satisfied or dissatisfied are you with this treatment? 9. 귀하는방광문제를치료하기위해이번연구 9. Do you have any intentions to receive the 에서받은치료방법과동일한치료를받을의 same type/method of treatment as the previous one to treat the bladder 향이있으십니까? problems? 10. 귀하는다른분에게과민성방광치료방법으로이치료방법을추천하시겠습니까? 11. 전반적으로귀하의치료에얼마나만족혹은불만족하십니까? 10. Would you recommend this overactive bladder treatment (method) to other people? 11. How satisfied or dissatisfied are you with your treatment overall? TS-VAS, Treatment Satisfaction Visual Analogue Scale; OAB-SAT-q, Overactive Bladder Satisfaction with Treatment Questionnaire. icant differences between the wording of the sentences in the original and the back-translated versions. 치료만족도시각적척도 (TS-VAS) 다음질문을답하기위해선위에세로선을표기해주시기바랍니다. 귀하는치료에만족하십니까? 아니요, 전혀그렇지않음. 네, 전적으로만족함. Fig. 1. Korean version of the Treatment Satisfaction Visual Analogue Scale (TS-VAS). Cognitive Debriefing and Proofreading The translation was tested by 5 patients with OAB (3 men and 2 women; age range, 30 70 years) who underwent medical therapy. Their levels of education varied from being a high school graduate to a university graduate. All patients completed the questionnaires within 8 minutes. One patient reported being unsure about the marking position on the line of TS-VAS. He suggested that vertical lines on the long horizontal line of TS- VAS could help patients understand the scale and mark their responses. The panel accepted his proposal and added 10 vertical lines indicating 0 to 10 points. Three patients reported that the translated questions were clear and easy to understand; however, 2 patients felt that the questions were a bit difficult to understand owing to the excessively long structure of the questions. The panel discussed these opinions that were articulated during the cognitive debriefing process, and the final versions of the questionnaires are shown in Figs. 1 and 2. 316 www.einj.org

Lee, et al. Linguistic Validation of TS-VAS and OAB-SAT-q INJ 과민성방광치료만족도설문지 지시사항 : 귀하는이번연구에서받은치료에어느정도만족하는지생각해보시기바랍니다. 아래의질문들은귀하가과민성방광치료에어느정도만족또는불만족하는지를평가할것입니다. 지난 4 주동안, 귀하의치료경험을가장정확하게반영하는칸을항목별로표시하여주십시오. 1. 치료가귀하의증상을완화시키는데있어서어느정도만족혹은불만족하십니까? 2. 치료효과가나타나는데까지걸리는시간에어느정도만족혹은불만족하십니까? 3. 귀하가기대했던바에비하여치료효과에어느정도만족혹은불만족하십니까? 4. 귀하가치료를받는데어느정도편리혹은불편하셨습니까? 5. 귀하는얼마나자주치료부작용을경험하셨습니까? 6. 귀하는과민성방광치료를받는데있어서 ( 치료 ) 부작용이얼마나불편하십니까? 7. 귀하의전반적인치료만족도에부작용이얼마나영향을미쳤습니까? 8. 귀하는이전에받았던치료방법보다이번연구에서받은치료방법을더선호하십니까? 9. 귀하는방광문제를치료하기위해이번연구에서받은치료방법과동일한치료를받을의향이있으십니까? 10. 귀하는다른분에게과민성방광치료방법으로이치료방법을추천하시겠습니까? 11. 전반적으로귀하의치료에얼마나만족혹은불만족하십니까? 지극히불만족 매우불만족 불만족 만족 매우만족 지극히만족 1 2 3 4 5 6 1 2 3 4 5 6 1 2 3 4 5 6 지극히불편함 매우불편함 불편함 편리함 매우편리함 지극히편리함 1 2 3 4 5 6 전혀없음 거의없음 가끔있음 상당히있음 매우자주있음 항상있음 0 1 2 3 4 5 전혀없음 ' 이면 8번문항으로가세요 지극히불편함 매우불편함 다소불편함 약간불편함 전혀불편하지 않음 1 2 3 4 5 상당히많이 꽤많이 다소 극히일부분 전혀영향없음 과민성방광치료를받아본적이없음 1 2 3 4 5 이전에받은치료를분명히선호함 이전에받은치료를약간선호함 이번연구의치료방법을약간선호함 이번연구의치료방법을분명히선호함 0 1 2 3 4 동일한치료방법을분명히받지않을것임 동일한치료방법을아마도받지않을것임 동일한치료방법을받을수도있음 동일한치료방법을분명히받을것임 1 2 3 4 절대로추천하지않을것임 아마도추천하지않을것임 추천할수도있음 분명히추천할것임 1 2 3 4 지극히불만족 매우불만족 불만족 만족 매우만족 지극히만족 1 2 3 4 5 6 Fig. 2. Korean Version of the Overactive Bladder Satisfaction with Treatment Questionnaire for patients with overactive bladder. www.einj.org 317

INJ Lee, et al. Linguistic Validation of TS-VAS and OAB-SAT-q DISCUSSION This study presented the first linguistic validation of the TS- VAS and OAB-SAT-q, which are used to evaluate patients satisfaction with their treatment. Linguistic validation is the process of investigating the reliability, conceptual equivalence, and content validity of translations of PRO measures. According to the universal translation methodology, the process of validation consists of permission for translation, forward translation, reconciliation, back-translation, cognitive debriefing, and proofreading [11]. Forward translations were performed simultaneously by 2 separate bilingual speakers. One was a 19-year-old Korean woman who had lived in Phuket, Thailand for 17 years. The other was a 24-yearold Korean man who had lived in the state of Maryland in the USA for 4.5 years, before becoming a university student majoring in Business Administration at Korea University. The forward translators in the present study were experienced bilingual speakers who were involved in the forward translation process for other questionnaires. Subsequently, reconciliation was performed to resolve discrepancies between the 2 forward translations. The reconciler altered the forward translations to make them suitable, or offered new forward translations, if necessary. The back-translation of the reconciled version involved another bilingual speaker who was fluent in the Korean and English languages, but was not involved in the previous steps of the forward translation process. Cognitive debriefing interviews were performed to gather data on the patients interpretation of the translation. This process ensured that the meaning intended by the developer was retained in translation and was also understood by the patients in the same way [11]. The authors performed the validation process according to this universal process of translation validation. The VAS is a valid and reliable measure for rating pain, and is widely accepted as a way to quantitatively evaluate QoL [12]. In adults, it has been observed to be a responsive and valid tool for measuring satisfaction, feelings, and emotional function [8,13-15]. VAS-based questionnaires could be a useful tool for assessing satisfaction specific to treatment with any medication [8]. The TS-VAS, which is widely used to evaluate patient satisfaction, reflects a patient s subjective perceptions or opinions regarding the treatment experience [8]. OAB is a condition that negatively effects patients well-being, and is a chronic disease that requires long-term medical therapy. Patient satisfaction is an important issue when determining whether to continue a drug for the treatment of OAB. Therefore, it is important for physicians to evaluate patient satisfaction. Previous investigators have used King s Health Questionnaire [16], the OAB questionnaire [17], the Overactive Bladder Symptoms Score [18] and Benefit, Satisfaction, and Willingness to Continue questionnaires to evaluate the severity of the symptoms of OAB, their effect on QoL, and patients satisfaction with their treatment [19]. The OAB-SAT-q is a useful assessment tool for evaluating satisfaction among patients receiving treatment for OAB [10]. The OAB-SAT-q was developed by identifying concepts that are important for treatment satisfaction among patients with OAB. The questionnaire was developed and refined based on a review of existing instruments measuring treatment satisfaction, input from physicians experienced in treating OAB, and patient feedback [10]. Therefore, the findings of the current study will be helpful to domestic investigators, who will use the Korean version of the TS-VAS and OAB-SAT-q to assess treatment satisfaction and response among patients. A limitation of this study is that it did not include a reliability analysis, which would enhance the strength of the association between the scores obtained from the English- and Koreanlanguage versions. However, the content of the original questionnaires was not modified, and a reliability test can be considered for psychometric validation in the future. In conclusion, the present study reports the successful linguistic validation of the TS-VAS and OAB-SAT-q. Our results can help provide reliable PROs to physicians in Korea. REFERENCES 1. Golin CE, DiMatteo MR, Gelberg L. The role of patient participation in the doctor visit. Implications for adherence to diabetes care. Diabetes Care 1996;19:1153-64. 2. Katz JN. Patient preferences and health disparities. JAMA 2001; 286:1506-9. 3. Owens DK. Spine update. Patient preferences and the development of practice guidelines. Spine (Phila Pa 1976) 1998;23:1073-9. 4. Stach-Lempinen B, Kujansuu E, Laippala P, Metsänoja R. Visual analogue scale, urinary incontinence severity score and 15 D--psychometric testing of three different health-related quality-of-life instruments for urinary incontinent women. Scand J Urol Nephrol 2001;35:476-83. 5. Ohnhaus EE, Adler R. Methodological problems in the measure- 318 www.einj.org

Lee, et al. Linguistic Validation of TS-VAS and OAB-SAT-q INJ ment of pain: a comparison between the verbal rating scale and the visual analogue scale. Pain 1975;1:379-84. 6. Abdel-Fattah M, Ramsay I, Barrington JW. A simple visual analogue scale to assess the quality of life in women with urinary incontinence. Eur J Obstet Gynecol Reprod Biol 2007;133:86-9. 7. Hayes MH, Patterson DG. Experimental development of the graphic rating method. Psychol Bull 1921;18:98-9. 8. Chapman CR, Casey KL, Dubner R, Foley KM, Gracely RH, Reading AE. Pain measurement: an overview. Pain 1985;22:1-31. 9. Brokelman RB, Haverkamp D, van Loon C, Hol A, van Kampen A, Veth R. The validation of the visual analogue scale for patient satisfaction after total hip arthroplasty. Eur Orthop Traumatol 2012;3: 101-5. 10. Margolis MK, Fox KM, Cerulli A, Ariely R, Kahler KH, Coyne KS. Psychometric validation of the overactive bladder satisfaction with treatment questionnaire (OAB-SAT-q). Neurourol Urodyn 2009; 28:416-22. 11. Eremenco SL, Cella D, Arnold BJ. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Eval Health Prof 2005;28:212-32. 12. Stinson JN, Kavanagh T, Yamada J, Gill N, Stevens B. Systematic review of the psychometric properties, interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents. Pain 2006;125:143-57. 13. Guyatt GH, Townsend M, Berman LB, Keller JL. A comparison of Likert and visual analogue scales for measuring change in function. J Chronic Dis 1987;40:1129-33. 14. Jaeschke R, Singer J, Guyatt GH. A comparison of seven-point and visual analogue scales. Data from a randomized trial. Control Clin Trials 1990;11:43-51. 15. Singer AJ, Thode HC Jr. Determination of the minimal clinically significant difference on a patient visual analog satisfaction scale. Acad Emerg Med 1998;5:1007-11. 16. Margolis MK, Vats V, Coyne KS, Kelleher C. Establishing the content validity of the King s Health Questionnaire in men and women with overactive bladder in the US. Patient 2011;4:177-87. 17. Oh SJ, Son H, Kim SW, Lee KS, Choo MS, Kim SO, et al. Psychometric properties of the Korean Version of the Overactive Bladder Questionnaire (OAB-q) in a Korean population. Int Neurourol J 2012;16:77-85. 18. Homma Y, Yoshida M, Seki N, Yokoyama O, Kakizaki H, Gotoh M, et al. Symptom assessment tool for overactive bladder syndrome: overactive bladder symptom score. Urology 2006;68:318-23. 19. Pleil AM, Coyne KS, Reese PR, Jumadilova Z, Rovner ES, Kelleher CJ. The validation of patient-rated global assessments of treatment benefit, satisfaction, and willingness to continue--the BSW. Value Health 2005;8 Suppl 1:S25-34. www.einj.org 319