Translation and Linguistic Validation of the Korean Version of the Treatment Satisfaction Visual Analogue Scale and the Overactive Bladder Satisfaction With Treatment Questionnaire
Article information
Abstract
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-SAT-q, which could be useful tools for evaluating treatment satisfaction in patients.
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 between 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 Korean-speaking 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 bothersome 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 significant differences between the wording of the sentences in the original and the back-translated versions.
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.
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-year-old 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 Korean-language 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.
Notes
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.