Cultural adaptation: translatability assessment and linguistic validation of the patient-reported outcome instrument for irritable bowel syndrome with diarrhea

Abstract

Background and objectiveFollowing a 2009 US Food and Drug Administration guidance, a new patient-reported outcome (PRO) instrument was developed to support end points in multinational clinical trials assessing irritable bowel syndrome with diarrhea (IBS-D) symptom severity. Our objective was to assess the translatability of the IBS-D PRO instrument into ten languages, and subsequently perform a cultural adaptation/linguistic validation of the questionnaire into Japanese and US Spanish.Materials and methodsTranslatability assessments of the US English version of the IBS-D PRO were performed by experienced PRO translators who were native speakers of each target language and currently residing in target-language countries. Languages were Chinese (People’s Republic of China), Dutch (the Netherlands), French (Belgium), German (Germany), Japanese (Japan), Polish (Poland), Portuguese (Brazil), Russian (Russia), Spanish (Mexico), and Spanish (US). The project team assessed the instrument to identify potential linguistic and/or cultural adaptation issues. After the issues identified were resolved, the instrument was translated into Spanish (US) and Japanese through a process of two forward translations, one reconciled translation, and one backward translation. The project team reviewed the translated versions before the instruments were evaluated by cognitive debriefing interviews with samples of five Spanish (US) and five Japanese IBS-D patients.ResultsLinguistic and cultural adaptation concerns identified during the translatability assessment required minor revisions, mainly the presentation of dates/times and word structure. During the cognitive debriefing interviews, two of five Spanish respondents misunderstood the term “bowel movement” to mean only diarrhea in the Spanish version. Consequently, the term was changed from “movimiento intestinal” to “evacuaciones”. None of the Japanese respondents identified issues with the Japanese version.ConclusionThe translatability of the IBS-D PRO instrument into ten target languages was confirmed, with only minor changes made to the translations of the instrument. The translation and linguistic validation into Spanish (US) and Japanese provide evidence that this instrument can be used in multinational trials and clinical settings.

Diarrhea-predominant irritable bowel syndrome: creation of an electronic version of a patient-reported outcome instrument by conversion from a pen-and-paper version and evaluation of their equivalence

“…It has undergone both qualitative assessments of content validity and quantitative assessments of its psychometric properties. 5 – 7 The pen-and-paper version of the instrument is shown in Figures 1 and 2 .…”

“…The IBS-D PRO instrument, which comprises two questionnaires – the IBS-D Daily Symptom Diary and the IBS-D Symptom Event Log (Astellas Pharma Global Development, Inc., Northbrook, IL) was developed for use within clinical trials and real-world settings; 4 its ability to be translated into ten languages has been confirmed. 5 The primary goal of this study was to support the migration of the IBS-D PRO instrument from its pen-and-paper-based version to an electronic mobile version by testing the conceptual equivalence of the two formats and the usability of the mobile application for subjects with IBS-D.…”

Exploration of “Zhang” in functional gastrointestinal disorders: A cross‐cultural challenge in Chinese clinical setting

“…Non‐English speakers may not perceive the nuances in English words, and some regional terms may not have equivalent English words 14 . The Rome Foundation Working Team has suggested that culturally adapted questionnaires or other instruments would be of great help in describing a true picture of FGIDs in different cultural regions 14,15 . Studies have indicated diagnostic dilemmas in Asian patients with irritable bowel syndrome (IBS) derived from different cultural perceptions of symptoms 16‐18 .…”

“…14 The Rome Foundation Working Team has suggested that culturally adapted questionnaires or other instruments would be of great help in describing a true picture of FGIDs in different cultural regions. 14,15 Studies have indicated diagnostic dilemmas in Asian patients with irritable bowel syndrome (IBS) derived from different cultural perceptions of symptoms. [16][17][18] For instance, a single Mandarin word or phrase could contain one or several symptom patterns.…”

Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures

“…A PubMed search using “translatability,” “assessment,” “review,” or “assurance” as key words retrieved only eight papers [ 10 – 17 ]. In seven of them [ 11 – 17 ], it is assumed that TA offers original and qualitative knowledge on the cross-cultural relevance of concepts, a type of information not provided by psychometric results. Only one paper out of the eight retrieved (Conway et al [ 10 ]) has documented its value and how it is performed.…”