Objectives: Functional gastrointestinal disorders (FGIDs) are diagnosed on the basis of symptoms such as abdominal pain, bloating, and passage of hard stools. The process of creating a self-report diagnostic questionnaire involves the selection of symptom criteria and frequency thresholds by expert clinicians and scientists, followed by an authoring process handled by questionnaire developers. Once developed, the questionnaire undergoes further validation. Our objective with the ROME IV Diagnostic Questionnaire was to conduct the first step of the linguistic validation process-translatability evaluation-for several target languages. Methods: Translatability evaluation of the US English version of the ROME IV diagnostic questionnaire was performed by experienced PRO translators who were native speakers of each target language and resided in-country. Languages included: Arabic (Egypt), French (France), German (Germany), Hindi (India), Italian (Italy), Japanese (Japan), Korean (Korea), Russian (Russia), and Simplified Chinese (China). The project team assessed the instrument to identify potential linguistic and cultural issues. Results: A small number of linguistic and cultural concerns were identified during the translatability assessment-mainly idiomatic expressions and necessary clarifications of the concepts. Once all identified issues and suggested revisions were carefully reviewed by the developers (OP, WW), any changes likely to affect translation were incorporated into the final ROME IV. Changes were not incorporated if they accommodated only a single language or if they did not accurately represent the intent of the expert committees that developed the diagnostic criteria. Conclusions: The translatability of the ROME IV instrument into nine target languages was confirmed with minor changes made to the instrument. We will proceed with translating the ROME IV Diagnostic Questionnaire into more than 20 languages and then linguistically validating each translation using industrycompliant methodology. The ROME IV Diagnostic Questionnaire will then be used in multinational drug trials, epidemiological studies, and clinical practice.

Crane AL, Popielnicki A, Sperber AD, Drossman D, Palsson OS, Whitehead WE, et al. Translatability evaluation of the Rome IV diagnostic questionnaire for adults. Value in Health. 2016;19(7):A389.

http://dx.doi.org/10.1016/j.jval.2016.09.241