INTRODUCTION
Overactive bladder (OAB) is a chronic disease that usually requires an antimuscarinic agent, which has shown poor adherence, poor efficacy, and frequent adverse effects within 3 months of use [
1,
2]. Patients becoming dissatisfied with their treatment is closely related to treatment failure. Therefore, health-related quality of life has been actively assessed, and the concept of patient-reported outcomes (PRO) has been introduced [
3]. Implementing PRO involves assessing patient satisfaction with treatment in clinics by examining individual medical needs, perceived benefits, and patients’ concerns and expectations. Patient satisfaction ultimately affects the decision of willingness to continue the treatment provided by the physicians or the clinic.
The Benefit, Satisfaction, and Willingness to Continue (BSW) questionnaire has been recently developed for patients with OAB to assess PRO [
4]. Patients are asked to provide their general impressions of benefit, satisfaction with treatment, and willingness to continue treatment, which are helpful to quantify the subjective relief of symptoms, impact on daily lives, and side effects. Patients can weigh the benefits and harms, and provide a global response to physicians. This could facilitate the physician-patient relationship and increase medication compliance for OAB.
Up to this point, a Korean version of the BSW was not available to patients. Therefore, authors of the present study developed a Korean version of the BSW questionnaire from the original, with subsequent linguistic validation in Korean patients with OAB who underwent active treatment by a physician.
MATERIALS AND METHODS
Original BSW Questionnaire
The BSW was developed by the Pfizer Corporation and is administered by physicians. It consists of 3 patient-rated global assessments of treatment benefit (little vs. much benefit), satisfaction with treatment (little vs. very satisfied and little vs. very dissatisfied), and willingness to continue treatment (little vs. very willing and little vs. very unwilling).
Translation and Linguistic Validation
This study was approved by the Institutional Review Board of Seoul National University Hospital (approval number: H-1305-033-487). The procedure was designed to obtain a translated Korean version of the questionnaire, which is conceptually equivalent to the original. The translation was appropriate according to the cultural adaptation and performed by the project leader of the panel. This panel consisted of three Korean experts (SJO, SYC, and SJJ) who performed a typical linguistic validation process.
Permission
Before the study commenced, the panel contacted the Pfizer Corporation and acquired permission to translate and use the BSW with the linguistic validation process.
Forward translation
The original version of the BSW was translated into the Korean language (ver. 1.0a and 1.0b) by 2 bilingual translators who do 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 (ver. 1.0a and 1.0b) were reconciled into a single version after several panel meetings (ver. 1.1). The panel discussed comprehension difficulties due to subtle differences in the nuance of selected words and phrases.
Backward translation
The reconciled version of the BSW in the Korean language (ver. 1.1) was sent to a third bilingual translator. This translator translated it backward into the English version, which was compared to the original English version of the BSW. After the third translator completed the backward translation, the panel discussed the discrepancies between the original and the backward-translated version of the BSW. Some changes were made in the reconciled BSW in the Korean language based on the outcomes of several discussions (ver. 1.2).
Cognitive debriefing
Next, version 1.2 of the questionnaire was evaluated by 5 Korean-speaking patients with OAB, who were asked whether or not there were any clarity problems, culturally inappropriate feelings, or difficulties in understanding. The panel chose a trained interviewer who performed a standardized in-depth interview with a small number of patients. The debriefing interviews involved paraphrasing each question of the questionnaire and indicating whether there was any difficulty understanding or any confusing terms. Then, the panel discussed the feedback from the 5 patients with OAB and agreed to a new version based on the issues raised (ver. 1.3).
Proofreading
Version 1.3 was proofread to check spelling, grammar, and format. Afterwards, the panel obtained the final version of the BSW in the Korean language (ver. 1.4).
RESULTS
Forward Translation and Reconciliation
As shown in
Table 1, the word ‘benefit’ in the title of the original version was translated into ‘hyogwa’ (efficacy or effect) and ‘chilyohyetaeg’ (treatment benefit) by the translators, which was finally reconciled into ‘chilyohyetaeg’ (treatment benefit). ‘Willingness’ in the title was translated into ‘uihyang’ and ‘uiji,’ which was reconciled into ‘uihyang.’ The panel thought that ‘uihyang’ gives the impression that patients are fairly happy about doing it and would do it if they were asked or required to do it more so than the word ‘uiji.’
Question 1, “Have you had any benefit from your treatment?” in the original version was directly translated into “Hyetaegeul badeun jeogi issseubnikka?” (Have you experienced any benefit?). However, the panel reconciled it into “Hyetaegeul badassseubnikka?” (Did you have any benefit?), because this sentence would be more natural and equal to the meaning of the original version based on cultural adaptation.
Question 2, “Taking all things into account” in the original version was translated into “modeun myeoneul golyeohaesseul ttae” (taking all angles of the question into account) because the term, ‘things’ has an expansive definition of ‘geot,’ (objects or stuff) ‘myeon,’ (aspects) etc. Therefore, the panel agreed to specify the meaning of ‘things.’
Question 3, “Would you be a little bit unwilling to continue treatment with this medication?” in the original version was translated into “Gwihaneun i yageulo chilyoleul jisoghago sipeun uihyangi yaggan eobsseubnikka?”. The panel discussed which would be more appropriate between “Uihyangi yaggan eobsseubnikka?” (unwilling to continue treatment?) and “Naekiji anhseubnikka?” (reluctant to continue treatment?). The latter is a more natural expression in the Korean language than the former in terms of conceptual equivalence. Therefore, the panel decided to choose the latter expression to convey the meaning exactly.
Backward Translation
As shown in
Table 2, the panel discussed the differences between “Have you had any benefit?” in the original version and “Did you have any benefit?” in the reconciled version. The panel did not think that there was a large difference in meaning between “Have you had any…?” and “Did you have any…?” in this particular case. Thus, the translated sentence was left as is to acquire idiomatic equivalence.
The 3 translators discussed the translated term ‘yaggan’ in the Korean language and ‘a little’ in the English language in terms of sematic equivalence. They agreed on the possible confusion that ‘yaggan’ would have both meanings of ‘a little’ and ‘somewhat.’ The panel finally decided not to change the term.
Cognitive Debriefing and Proofreading
The translation was tested by four patients with OAB who underwent medical therapy. Two patients were women and 2 were men, ranging in age from 30s to 70s. Their levels of education varied from illiterate to university graduate. Three were employed and the other was a housewife. All patients completed the answers within 5 minutes. Three reported that the translated questions were clear and easy to understand; however, one patient felt that the questions were a bit difficult to understand, and pointed out the awkward expression of the above-mentioned problem between “Uihyangi yaggan eobsseubnikka?” (unwilling to continue treatment?) and “Naekiji anhseubnikka?” (reluctant to continue treatment?). However, the panel decided not to change the expressions because the overall level of comprehension was high and the translated terms were accurate enough to convey the meaning of the original BSW version. The final conclusion of the questionnaire is shown in the
Fig. 1.
DISCUSSION
In general, OAB is diagnosed based on subjective symptoms, such as urgency, frequency, and/or nocturia. However, OAB is a chronic disease that requires long-term medication therapy, which is why the patient’s perspective is important. Persistence is particularly important in cases of long-term medication therapy, as patients’ satisfaction with the therapy is closely related to medication compliance.
Previous investigations have measured the severity of OAB symptoms and their impact on quality of life [
3,
5]. King’s Health Questionnaire [
6] and the OAB questionnaire [
7] are appropriate for evaluating bothersomeness caused by each symptom and its effect on daily quality of life. However, these questionnaires have too many questions for patients to fill in quickly in the outpatient department and they seem to be more appropriate for a clinical study instead of a daily practice. The Overactive Bladder Symptom Score has been developed recently, which is comprised of only 4 questions regarding frequency, nocturia, urgency, and urgency urinary incontinence [
8]. This is simple and easy to complete, however, it does not have any questions regarding bothersomeness or effects on daily life. Therefore, the authors of this study thought that these questionnaires are limited in directly evaluating perspectives on the medication therapy of patients with OAB. Previous studies showed that there was discrepancy between the severity of OAB symptoms and bothersomeness [
9]. Furthermore, long-term medication with anticholinergic agents showed poor compliance and persistence regardless of the type of the agents [
2]. Therefore, a direct evaluation of the patients’ perspective is needed to increase drug compliance and persistence.
The BSW questionnaire directly evaluates patients’ global assessment of treatment benefit, satisfaction with treatment and willingness to continue treatment [
4]. Because the results of the BSW seemed to be more directly related to treatment compliance and persistence than other previously reported questionnaires, the original version of the BSW questionnaire has been validated in other languages [
10]. Therefore, information from these studies would be helpful to domestic investigators for use of the Korean version of the BSW to assess treatment response, increase patients’ compliance, and determine a treatment plan for patients with OAB.
In conclusion, the present study carried out a successful linguistic validation of the BSW questionnaire. Further studies are needed to assess of the psychometric properties of the BSW.