Translation and cross-cultural adaptation of the parental version of Type 1 Diabetes and Life (T1DAL): a US patient-reported outcome measurement into Danish following ISPOR guidelines.

Abstract

Transferability of questionnaires across languages and cultures requires a systematic process to preserve content integrity and ensure validity and reliability. The aim of this study was to translate, culturally adapt and face validate the US-developed patient-reported outcome (PRO) measure 'Type 1 Diabetes and Life' (T1DAL) for use in a Danish population of parents of children under the age of 11 years living with type 1 diabetes. The process followed the 10-step International Society for Pharmacoeconomics and Outcomes Research good practice principles for the translation and cultural adaptation of PRO measures, thereby establishing content validity and cross-cultural validity in accordance with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) recommendations. Following approval from the developer of the original questionnaire, two independent forward translations were conducted by bilingual native Danish speakers. These translations were then synthesised into a reconciled version, which were then back translated by two bilingual native English speakers. Discrepancies between the original and the reconciled versions were reviewed, leading to small linguistic and cultural adjustments. This process included discussions around the response categories on the Likert-scale and items reflecting the US healthcare context-particularly those related to insurance-dependent access, which are less relevant in Denmark.Cognitive debriefings regarding the updated Danish version with 12 parents resulted in a Danish version demonstrating strong semantic, conceptual and experiential equivalence. Additionally, minor linguistic and cultural adjustments were made to enhance clarity and contextual appropriateness. Cognitive debriefing confirmed the questionnaire's acceptability and comprehensibility across a diverse range of respondents. Applying ISPOR principles emphasised the importance of cultural adaptation that extends beyond linguistic translation to preserve the original questionnaire's integrity and meaningfulness and resulted in a conceptually equivalent and culturally adapted Danish version of the original T1DAL questionnaire, suitable for use in Danish clinical and research settings. H-25016032.