Evaluation of the GERD Impact Scale, an international, validated patient questionnaire, in daily practice. Results of the ALEGRIA study.

BACKGROUND AND STUDY AIMS: Gastroesophageal reflux disease (GERD) is a common chronic disease that is primarily diagnosed based on symptom severity and frequency. This study gathered epidemiological data in a population of GERD patients and evaluated the added-value of the GERD Impact Scale (GIS), a novel, validated patient questionnaire, as a tool for initial and long-term patient management. PATIENTS AND METHODS: This observational study recruited patients (296 study centers) with symptomatic GERD and a history of erosive, or reflux, esophagitis. Symptoms were assessed by GIS and physician-subject interview and recorded at baseline (visit 1), at 4-6 weeks (visit 2) and 8-14 weeks (visit 3); also recorded at each visit was the physician's assessment of GERD severity and treatment changes. Analyses were performed on an intent-to-treat basis. RESULTS: Subjects (n = 1919; mean age, 55 years) were 54% female. Lifestyle characteristics included stress (approximately 70% of subjects), mean daily consumption of five cups of caffeine-containing beverages (approximately 70%), alcohol consumption of approximately nine units per week (approximately 50%) and smoking/ex-smoker (41%). Proton pump inhibitors were prescribed in 99% of cases: mainly esomeprazole (82%), with a median dose of 40 mg. Prescribed therapy was changed (mainly dosage levels) between visits in approximately 60% of subjects. The severity of GERD symptoms and GIS scores decreased substantially throughout the study. Mean GIS scores correlated positively with increasing GERD severity and clinical judgment at all visits. Physicians reported that the GIS helped them define the appropriate treatment for the patient and to evaluate the patient's response to treatment in 81% of cases. CONCLUSIONS: This study demonstrates the added-value and usefulness of the patient self-assessment GIS as a management tool for GERD.