INTERNATIONAL ADAPTATION AND LINGUISTIC VALIDATION OF NASH-CHECK, A NOVEL PATIENT-REPORTED OUTCOME MEASURE FOR PATIENTS WITH NONALCOHOLIC STEATOHEPATITIS
Author(s)
Doward L1, Balp MM2, Poepsel T3, Twiss J4, Brass C5, Cai J5, Cryer D6, Sanyal AJ7, Anstee QM8
1RTI-Health Solutions, Manchester, UK, 2Novartis Pharma AG, Basel, Switzerland, 3RWS Life Sciences, Chicago, CT, USA, 4RTI-Health Solutions, Manchester, LAN, UK, 5Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 6Global Liver Institute, Washington, DC, USA, 7Virginia Commonwealth University, Richmond, VA, USA, 8Newcastle University, Newcastle-Upon-Tyne, UK
OBJECTIVES: NASH-CHECK is a recently developed, disease-specific, patient-reported outcome measure (PROM) to assess symptoms and health-related quality of life in patients with nonalcoholic steatohepatitis (NASH). NASH-CHECK was originally developed in US English. This study reports on the large-scale adaptation of NASH-CHECK for use in 39 additional languages. METHODS: The methods used to adapt NASH-CHECK adhered to published International Society for Pharmacoeconomics and Outcomes Research guidelines and Food and Drug Administration requirements for PROMs to support labelling claims. The adaptation procedure involved: two independent forward translations, back translation, and reconciliation of the translations. Each language adaptation then underwent in-country cognitive debriefing (CD) to evaluate content validity with 5 patients with NASH who were native speakers of the target language. RESULTS: NASH-CHECK was adapted into 39 languages for 29 countries in Europe, Asia, Australia, North America, and South America. The CD sample (N=195; 5 per language) was 49% female, with an average age of 49 years (standard deviation [SD] = 12.6; range = 21-86), and average length of education of 12 years (SD = 3.7), with at least 2 patients from each language having fewer than 12 years of education. The adaptation of NASH-CHECK into the new languages was successful with no significant issues identified. The CD interviews in each country showed that the comprehension rate for all items across all languages was 98%. Following the CD interviews, some minor changes were made to the translations to improve grammar or localise wording for greater conceptual understanding. Overall, CD results demonstrate that patients in all countries found NASH-CHECK to be clear, comprehensive, and relevant with no missing areas of importance. CONCLUSIONS: NASH-CHECK has been successfully adapted into 39 new languages according to regulatory standards. The new language adaptations of NASH-CHECK significantly improve the suitability of the instrument for use in multinational clinical trials.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
PGI52
Disease
Gastrointestinal Disorders