OBJECTIVES

: The Chronic Kidney Disease and Anaemia Questionnaire (CKDAQ) is a 22-item GSK-developed PRO instrument to assess the association with quality of life of patients with chronic kidney disease and anaemia. This questionnaire went through linguistic validation into 71 languages, of which 30 were Asia-Pacific languages. The objective is to identify the challenges raised in performing linguistic validation in these languages; focusing on terminology specific to kidney disease and anaemia, grammatical structure, format, style and register.

METHODS

: In-country review (ICR), back translation review (BTR) and cognitive debriefing review (CDR) grids were analysed. The CDR grid was based on feedback from 5 participants with chronic kidney disease for each of the 30 languages; 150 participants in total. The translation changes were placed into 5 categories: terminology, grammar, formatting, style and register.

RESULTS

: Following the analysis, across the 30 languages, 83% required changes related to at least one of the 5 categories during ICR/BTR or CDR stage with an average of 2.5 changes implemented for each language.

BTR/ICR analysis indicated that 57% required updates based on terminology difficulties, either due to lack of equivalent terms or due to level of complexity with 23% of languages providing alternative terms for ‘distressed’ such as ‘anguished’ or ‘upset’.

CDR analysis showed that 50% involved terminology changes to increase understanding, 7% required grammatical updates, 33% made stylistic changes for the same reason and 10% altered formatting to conform to the target culture. One expression that proved problematic for multiple languages was ‘shortness of breath’ which was altered to linguistic variations of ‘breathing difficulties’ for 20% of the languages.

CONCLUSIONS

: This analysis demonstrates the necessity for a full linguistic validation process involving back translation review and cognitive debriefing to ensure cultural and conceptual equivalence to subsequently ensure accurate PRO data in Asia-Pacific countries.