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

Overview of attention for article published in Patient related outcome measures, June 2016
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Title
Cultural adaptation: translatability assessment and linguistic validation of the patient-reported outcome instrument for irritable bowel syndrome with diarrhea
Published in
Patient related outcome measures, June 2016
DOI 10.2147/prom.s102647
Pubmed ID
Authors

Leticia Delgado-Herrera, Kathryn Lasch, Ana Popielnicki, Akito Nishida, Rob Arbuckle, Benjamin Banderas, Susan Zentner, Ingrid Gagainis, Bernhardt Zeiher

Abstract

Following 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. Translatability 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. Linguistic 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. The 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.

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Geographical breakdown

Country Count As %
Unknown 24 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 4 17%
Student > Ph. D. Student 3 13%
Researcher 3 13%
Student > Doctoral Student 2 8%
Student > Postgraduate 2 8%
Other 4 17%
Unknown 6 25%
Readers by discipline Count As %
Medicine and Dentistry 7 29%
Nursing and Health Professions 5 21%
Biochemistry, Genetics and Molecular Biology 1 4%
Linguistics 1 4%
Agricultural and Biological Sciences 1 4%
Other 1 4%
Unknown 8 33%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 23 June 2016.
All research outputs
#20,829,511
of 25,593,129 outputs
Outputs from Patient related outcome measures
#153
of 197 outputs
Outputs of similar age
#270,558
of 354,199 outputs
Outputs of similar age from Patient related outcome measures
#7
of 9 outputs
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