Korean Version of the Patient Perception of Study Medication Questionnaire: Translation and Linguistic Validation
Article information
Abstract
Purpose
The patient perception of study medication (PPSM) questionnaire consists of 12 questions designed to quantify patient satisfaction with the efficacy of study treatment by focusing on specific changes that patients experience during the study period. This study aimed to develop a Korean version of the PPSM questionnaire.
Methods
The linguistic validation process consisted of obtaining permission for translation, forward translation, reconciliation, backward translation, cognitive debriefing, and proofreading. Two independent bilingual translators translated the original version of the questionnaire, and a panel discussed and combined the 2 versions. Another independent translator performed backward translation of the reconciled version, after which 15 patients underwent the cognitive debriefing.
Results
The 12 questions and 4 response scales of the PPSM questionnaire were forward translated into 2 Korean versions. The terms were adjusted to conceptually equivalent expressions in Korean. After backward translation, the panel made minor changes to the forward translations for brevity and better readability. No difficulties were experienced during cognitive debriefing by 15 patients, and all items were reported to be generally easy to understand.
Conclusions
The Korean version of the PPSM questionnaire has been successfully translated and validated. The questionnaire is appropriate for assessing symptom satisfaction in patients that undergo benign prostatic hyperplasia pharmacotherapy.
INTRODUCTION
Physiologically, with increasing age, the prostate enlarges and can obstruct the prostatic urethra and induce a functional decline of the urethral sphincter. Benign prostatic hyperplasia (BPH) is one of the most common benign neoplasms in the elderly male population, with symptoms reported in approximately half of men by 60 years of age [1,2]. Lower urinary tract symptoms (LUTS) such as frequency, incontinence, urgency, and nocturia are due to a combination of BPH and the anatomical and physiological responses of the bladder to urinary outflow obstruction [3]. Moreover, the progression of BPH with LUTS increases the risk of acute urinary retention (AUR) and decreases maximum urinary flow rate, which ultimately leads to a reduction in patient quality-of-life [4].
Various patient-reported outcome (PRO) questionnaires have been developed to address the increasing need for disease-specific and validated means to measure PROs to objectively analyze and assess BPH with LUTS. In the clinical spectrum of BPH, patient outcome measures such as Boyarsky Score [5], International Prostate Symptom Score (IPSS) [6], and BPH Impact Index (BII) [7] are standard assessment tools. However, these questionnaires show limited efficacy for evaluating treatment satisfaction in patients with BPH. Treatment satisfaction, which includes evaluation of the treatment process and patient outcomes, is rapidly gaining importance in clinical trials and disease-management programs [8,9]. However, the rarity of questionnaires or clinical studies that focus on treatment satisfaction in patients with BPH indicates a need to develop a valid, reliable treatment satisfaction assessment or questionnaire.
The Patient Perception of Study Medication (PPSM) questionnaire was developed to evaluate the satisfaction levels of BPH treatments in clinical studies to provide additional insight to clinical practice [10]. The PPSM questionnaire consists of items on the approval levels of the patient for study medication and the patient’s final decision after weighing the side effects against the therapeutic advantages and the voluntary compliance in continued administration of the medication [10]. The PPSM questionnaire has been verified to be clinically relevant in several clinical trials [10,11]. The objective of this study was to translate the English version of the PPSM questionnaire into Korean, along with consequent linguistic validation in the Korean BPH patient population.
MATERIALS AND METHODS
Original PPSM Questionnaire
The PPSM questionnaire was developed by GlaxoSmithKline (GSK) for use in the CombAT (Combination of Avodart and Tamsulosin) trial to determine whether questions addressing satisfaction with individual symptoms provided additional useful information on patient satisfaction with BPH pharmacotherapy (Supplementary materials 1-3). The questionnaire consists of 12 questions designed to quantify patient satisfaction with the effect of the study treatment by focusing on specific changes experienced by patients during the study period. The PPSM questionnaire focuses on 4 areas: control of urinary symptoms (2 items), strength of urinary stream (2 items), 2 aspects of pain with urination (2 items each), effect on usual activities (2 items), and a single item about overall satisfaction. The final item asks whether the respondent would request a prescription of the study medication.
Permission
The corresponding author contacted GSK to request permission to translate and utilize a Korean version of the PPSM questionnaire and was responsible for the overall study process.
Translation and Linguistic Validation
Translation and validation were performed between September and December 2020. The overall study procedure was conceptually similar to previous studies designed to translate non-Korean questionnaires into Korean versions [12,13]. The linguistic validation consisted of forward translation, reconciliation, backward translation, cognitive debriefing, and proofreading.
Forward Translation
Two bilingual translators who were blinded to the individual translation process independently translated the original version of the PPSM questionnaire into Korean (versions 1.0A and 1.0B). During the process, each translator provided comments and feedback on translation difficulties and various translational options. The IPSS and the Overactive Bladder Symptom Score questionnaires were provided as a reference in unifying medical terminologies regarding voiding symptoms.
Reconciliation
A panel of 5 urologists and 3 physician assistant nurses reviewed versions 1.0A and 1.0B and integrated the differences between the 2 versions to create a single new version (ver. 1.1).
Backward Translation
Version 1.1 was back translated into English by a third independent editor from an English proofreading and editing service. The panel compared the back-translated version with the original version, and alternative translation options were discussed. Discordant phrases were reviewed and revised (ver. 1.2).
Cognitive Debriefing
The questionnaire (ver. 1.2) was administered to 15 Koreanspeaking patients older than 50 years with different educational backgrounds after informed consent. On completion of the questionnaire, survey interviews were performed by a single certified clinical research coordinator to receive feedback on whether and why there were difficulties in understanding the questions. An opportunity was given to patients to provide alternative phrasing options for better readability and understanding. Based on the interview results, the panel reconvened to discuss and agree on a new version (ver. 1.3).
Proofreading
The final Korean version of the PPSM questionnaire was proofread by the panel for errors in spelling and format.
RESULTS
Forward Translation and Reconciliation
The translated 12 questions and 4 response scales of the PPSM questionnaire are presented in Table 1. The “PPSM questionnaire” was translated without disagreement by both translators as yeonguyagmule daehan insig seolmunji.
Grid for the first forward Korean translation and reconciliation of the patient perception of study medication questionnaire
In question 1, “how has control of your urinary problems changed” was translated as baenyojeungsang-eun eolmana jal jojeoldoego issseubnikka (well controlled) and baenyojeungsang-eun eolmana hojeondoeeossseubnikka (improved). “Baenyo” was considered a formal term in the Korean language, and the panel suggested that the usage of “sobyeon” which is a more common Korean term for “urination” would be better approach considering the various education levels of the patient population. Although cognitive feedback showed no difficulties in understanding the question, the panel agreed to the translation usage of sobyeon-eul bol ttaeui bulpyeonham instead of baenyojeungsang for urinary problems.
In question 3, “strength of your urinary stream” was translated to sobyeon julgi (stream) and sobyeon segi (strength). The panel agreed on sobyeon julgi in accordance with the terminology used in the Korean version of the IPSS questionnaire.
In question 9, “how has the way your urinary problems interfere with your ability to go about your usual activities” was translated to ilsangsaenghwal-e yeonghyang-eul juneun jeongdoga eotteohge dallajyeossseubnikka (degree of interference) and ilsangsaenghwal-e michineun yeonghyang-eun eotteohge dallajyeossseubnikka (interference). However, feedback results from the translation showed that “interfere” was not directly mentioned in the Korean translation. The option of “jijang” in as a direct substitute for “interfere” in the Korean version was considered, and question 9 was edited to sobyeon jeungsang-eulo inhae jijangbaddeon ilsangsaenghwal-eun eotteohge dallajyeossseubnikka. The panel discussed differences and agreed on the latter translation considering its brevity and better readability.
The response scale for questions 1, 3, and 9, “much improved; improved; somewhat improved; no change; somewhat worse; worse; much worse/much less control” was translated by both translators without discordance to maeu joh-ajyeossda; joh-ajyeossda; yaggan joh-ajyeossda; byeonhwa-eobsda; yaggan nappajyeossda; maeu nappajyeossda/maeu jojeol-i eolyeobda, respectively.
In questions 2, 4, and 6, “how satisfied are you” was translated to eolmana manjoghasibnikka (how much satisfied) and manjogdoneun eoneu jeongdoibnikka (degree of satisfaction). The panel agreed on eolmana manjoghasibnikka as it is a more familiar and communicative expression in the Korean language. Translations and agreements regarding “the effect of the study medication on control of your urinary problems” in question 2 and “strength of your urinary stream” in question 4 followed the same principle as in questions 1 and 3.
In question 8, “on your pain during urination” was translated to baenyo jung tongjeung (pain during urination) and baenyo tongjeung (urination pain). The panel agreed on sobyeon-eul bol ttae to maintain the nuance of the question.
In question 10, “the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems,” was translated to baenyojeungsang-e uihan jijang-eobs-i ilsangjeog-in saenghwal-eul hage haejuneun yeonghyang (ability) and baenyojeungsang-eulo uihan jijang eobs-i ilsangjeog-in saenghwal-eul ganeunghage haejuneun yeonghyang (ability to make it possible). Again, the panel agreed on sobyeon instead of baenyo to maintain the nuance of the question. As a result, the panel discussed and decided on sobyeon jeungsang-eulo inhan jijang-eobs-i ilsangjeog-in hwaldong-eul ganeunghage haejuneun due to better readability.
In question 11, “overall, how satisfied are you with the study medication and its effects on your urinary problems,” was translated by both translators without discordance to jeonbanjeog-eulo yeongu yagmulgwa baenyojeungsang-e michineun yeonghyang-e daehae eolmana manjoghasibnikka. However, the panel again agreed on sobyeonjeungsang instead of baenyojeungsang.
The response scale for questions 2, 4, 6, 8, 10, and 11, “very satisfied; satisfied; somewhat satisfied; neutral (neither satisfied nor dissatisfied); somewhat dissatisfied; dissatisfied; very dissatisfied,” was translated without discordance to maeu manjogseuleobda; manjogseuleobda; yaggan manjogseuleobda; junglib (manjogdo bulmanjogdo anim); yaggan bulmanjogseuleobda; bulmanjogseuleobda; maeu bulmanjogseuleobda.
In questions 5 and 7, “pain prior to urinating” and “pain during urination” was translated to baenyo jeon tongjeung (pain during urination) and to baenyo si tongjeung (pain at urination), respectively. Again, “pain prior to urinating” and “pain during urination” were respectively translated into “sobyun bogee jeon tongjeung” and “sobyun-eul bol ttaeui tongjeung.” The translations were based on the same principle as in questions 6 and 8.
In the response scale for questions 5 and 7, “less pain” and “more pain” were translated to deol apeuda (less pain) and tongjeung-gyeong-gam (pain reduction), and deo apeuda (more pain) and tongjeungjeung-ga (pain escalation), respectively. The panel agreed on tongjeung-gyeong-gam and tongjeung-jeung-ga for brevity.
In question 12, “would you ask your doctor for the medication you received in this study” and the response scale, “yes; no; not sure,” were translated by both translators without discordance to i yeongueseo bad-eusin yagmul-eul uisa-ege yocheong hasigessseubnikka and ne; aniyo; moleugessda, respectively.
Backward Translation and Second Reconciliation
An independent editor from an English proofreading and editing service performed backward translation of the Korean ver. 1.1 (Table 2). In question 9, “interfere” was backward translated to “influence.” In the reconciled version (ver. 1.1), “interfere” was translated into Korean, “yeonghyang.” In English, interfere and influence has different meanings. The panels concluded that there were no proper Korean words to represent “interfere” based on the context used in the question. However, after a group panel discussion, the usage of “jijang” as a direct substitute for “interfere” was suggested. Considering the expressions used in the Korean version of the IPSS questionnaire, the panels agreed that this modification was necessary and increased literary fluency.
Grid for the backward translation of the patient perception of study medication questionnaire
In questions 1, 3, 5, 7, and 9, there were discordances in sentence structure involving subject, verb, and object. The panel agreed on the reconciled version for better readability in the Korean language. Otherwise, backward translation of the reconciled version was accepted by all panel members without significant objection.
Cognitive Debriefing
The translated PPSM questionnaire was administered to 15 Korean-speaking male patients who routinely underwent followup in the urology department due to BPH. The median age was 62.5 years (57.0–67.8 years), and the level of education ranged from high school to university degrees. All patients completed the questionnaire within 6 minutes and stated that all items were generally easy to understand. The final version is presented in Fig. 1.
Final Korean version of the patient perception of study medication questionnaire.
DISCUSSION
Patient satisfaction is being recognized as a prerequisite to successful outcomes of medical treatment. The 12-item PPSM questionnaire is intended to quantify overall patient satisfaction with the study medication by focusing on specific changes that the patient perceives during the given study period [10]. Our translation and linguistic validation of the PPSM questionnaire support its feasibility as a useful clinical measurement modality for assessing Korean patients with BPH who are undergoing pharmaceutical treatment.
The Korean version of the PPSM questionnaire was translated as closely as possible to the original English version. The translation and validation processes of this study involved complex planning and validation. During the initial forward translation phase, various sections and items of the questionnaire were translated differently in versions 1.0A and 1.0B. Although English and Korean languages have similar sentence structures and share words that convey the same meaning, the variation in expression of context and nuances results in discrepancies in the exact wording of the translation. Alterations in translations between the 2 translators were noted. In the forward translation stage, discrepancies between the 2 translators included the following terms: “urinary control” in question 1, “urinary stream” in question 3, and “interfere” in question 9, while slight differences were noted in the translation of “satisfaction” in items 2, 4, and 8.
After analyzing the backward translation through a panel discussion during the reconciliation phase, the discrepancies between version 1.0A and 1.0B were reduced in the reconciled Korean translation of the PPSM. The panels concluded that there were no substitute Korean words to represent “interfere” in the proper context used in the English version. The terminology in the Korean version of the IPSS questionnaire was used as a reference, and the panel agreed that paraphrasing “interfere” into “influence” was adequate for the questionnaire [14].
Measuring patient satisfaction with medication from the perspective of the patient based on experience and willingness to ask the physician for continued treatment provides valuable clinical information. The importance of assessing PROs, along with objective clinical parameters, is recognized by the U.S. Food and Drug Administration (FDA) [15] and recommended in various clinical practice guidelines for managing BPH patients [16,17]. Subjective outcome measures such as BII are extensively used to assess the efficacy of interventions for BPH with LUTS [7]. However, the relationships between the change in outcome scores and patient perception and satisfaction with change have not been well studied [18]. Therefore, the main objective of our study was to implement a questionnaire that includes relevant items and domains that are necessary for assessing treatment satisfaction in the Korean population. After translation and reconciliation of the original PPSM questionnaire, the Korean version was verified for validity and suitability for usage in the clinical setting. However, the differences in English and Korean expressions had to be adjusted based on cultural context and language nuances, and appropriate modifications were made to improve the implied nuances and relevance suitable to Korean culture. Another limitation of the study was the small number of participants in the study population; therefore, the need for future larger-scale studies is warranted to assess and confirm the reliability and validity of the Korean version. Nevertheless, this study suggests that the Korean translation version of the PPSM questionnaire is a relevant work tool that can be used in the clinical field to evaluate patients with BPH with LUTS.
Based on the results and patient feedback, this study suggests that the Korean translation version of the PPSM questionnaire is a relevant tool that can be used in the clinic to evaluate patients with BPH and LUTS.
SUPPLEMENTARY MATERIALS
Supplementary materials 1-3 can be found via https://doi.org/10.5213/inj.2040476.238.
Supplementary Material 1.
Interview Form
Supplementary Material 2.
Patient Perception of Study Medication
Supplementary material 3.
Cognitive debriefing
Notes
Funding Support
This study was supported by a research grant of the National Research Foundation of Korea (2020R1F1A1073833).
Research Ethics
This study was approved by the Institutional Review Board of Gangnam Severance Hospital (2017-0615-002).
Conflict of Interest
No potential conflict of interest relevant to this article was reported.
AUTHOR CONTRIBUTION STATEMENT
·Conceptualization: KCK
·Data curation: KSL, HKA, JWY
·Formal analysis: TJK
·Funding acquisition: KCK
·Methodology: TJK, KCK
·Project administration: KCK
·Visualization: KCK
·Writing-original draft: TJK, KCK
·Writing-review & editing: TJK, KCK