Enhancing the cross-cultural adaptation and validation process: linguistic and psychometric testing of the Brazilian-Portuguese version of a self-report measure for dry eye.

Objectives: To provide a reliable, validated, and culturally adapted instrument that may be used in monitoring dry eye in Brazilian patients and to discuss the strategies for the enhancement of the cross-cultural adaptation and validation process of a self-report measure for dry eye.

Methods: The cross-cultural adaptation process (CCAP) of the original Ocular Surface Disease Index (OSDI) into Brazilian-Portuguese was conducted using a 9-step guideline. The synthesis of translations was tested twice, for face and content validity, by different subjects (focus groups and cognitive interviews). The expert committee contributed on several steps, and back translations were based on the final rather than the prefinal version. For validation, the adapted version was applied in a prospective longitudinal study to 101 patients from the Dry Eye Clinic at the General Hospital of the University of São Paulo, Brazil. Simultaneously to the OSDI, patients answered the short form-36 health survey (SF-36) and the 25-item visual function questionnaire (VFQ-25) and underwent clinical evaluation. Internal consistency, test-retest reliability, and measure validity were assessed.

Results: Cronbach's alpha value of the cross-culturally adapted Brazilian-Portuguese version of the OSDI was 0.905, and the intraclass correlation coefficient was 0.801. There was a statistically significant difference between OSDI scores in patients with dry eye (41.15 ± 27.40) and without dry eye (17.88 ± 17.09). There was a negative association between OSDI and VFQ-25 total score (P < 0.01) and between the OSDI and five SF-36 domains. OSDI scores correlated positively with lissamine green and fluorescein staining scores (P < 0.001) and negatively with Schirmer test I and tear break-up time values (P < 0.001).

Conclusion: Although most of the reviewed guidelines on CCAP involve well-defined steps (translation, synthesis/reconciliation, back translation, expert committee review, pretesting), the proposed methodological steps have not been applied in a uniform way. The translation and adaptation process requires skill, knowledge, experience, and a considerable investment of time to maximize the attainment of semantic, idiomatic, experiential, and conceptual equivalence between the source and target questionnaires. A well-established guideline resulted in a culturally adapted Brazilian-Portuguese version of the OSDI, tested and validated on a sample of Brazilian population, and proved to be a valid and reliable instrument for assessing patients with dry eye syndrome in Brazil.