Assessment of quality of life in patients with gastro-esophageal reflux: development and validation of a specific questionnaire.

Quality of life is frequently impaired in patients with gastro-esophageal reflux. The aim of this study was the validation of a new specific quality of life questionnaire in patients with gastro-esophageal reflux. Methods - A questionnaire was generated as follows: a) item generation with patients. b) item reduction, c) psychometric validation and comparison to a reference questionnaire (SF36) in patients with symptomatic gastro-esophageal reflux, d) assessment of reproductibility. and e) responsiveness over time. Results. - The primary questionnaire was made of 104 items. Two hundred twenty three patients were enrolled. 38 items were selected in 7 dimensions. One item was deleted following a new analysis conducted in 349 patients. Cronbach coefficient ranged from 0.84 to 0.91 for the specific questionnaire and from 0.78 to 0.90 for the SF36 questionnaire. Dimensions of specific questionnaire and SF36 were correlated. Quality of life was more impaired in patients with more frequent symptoms. Severity of endoscopic lesions was partly correlated with impaired quality-of-life. Reproducibility and responsiveness over time were correct. The final valid questionnaire was made of 37 items in 7 dimensions. Conclusion. - This work is the first validation of a specific questionnaire in French which has the ability to measure quality of life in patients with gastro-esophageal reflux. The use of this questionnaire during therapeutic trials might allow to be more accurate in assessment of treatment efficacy.