OBJECTIVES

Linguistic Validation (LV) is conducted to confirm that a patient-reported outcomes (PRO) questionnaire is acceptable for use in the target language and location, and is understood by patients. The objective of this study was to translate and linguistically validate the Endometriosis Treatment Satisfaction Questionnaire (ETSQ) in French (Canada), Spanish (U.S.) and Spanish (Puerto Rico) with endometriosis patients. The ETSQ measures patient-reported satisfaction with the impact of treatment on endometriosis pain, dysmenorrhea, dyspareunia, bleeding, tolerability, and treatment satisfaction.

METHODS

The ETSQ was translated twice, harmonized once, and back translated once into French (Canada), Spanish (U.S.), and Spanish (Puerto Rico) per ISPOR Task Force guidelines for the translation and cultural adaptation process for patient-reported outcomes measures. Harmonized translations were reviewed by in-country consultants. English back translations were reviewed by project managers and survey research analysts. Adaptations to the translations were made as needed. Harmonized translations underwent cognitive interviews with 5 endometriosis patients per language (total n = 15). Linguists implemented revisions after cognitive interviews as needed, and final proofreading of the translations was completed.

RESULTS

Subjects were aged 21-57 years, with an average age of 38.7 years and standard deviation (SD) of 10.8 years. Subjects had 4-20 years of formal education, with an average of 12.9 years and SD of 4.8 years. One hundred percent of the translated questionnaire items were understood by all subjects. As a result of cognitive debriefing, 1 recurring revision was made to the ETSQ translations (for Spanish (Puerto Rico)) to improve conceptual clarity and cultural appropriateness.

CONCLUSIONS

The ETSQ was translated and linguistically validated into 3 languages. ETSQ can be used to provide valid evaluation of satisfaction with endometriosis treatment for patients speaking French (Canada), Spanish (U.S.) and Spanish (Puerto Rico).