Symptoms associated with gastroesophageal reflux disease - Development of a questionnaire for use in clinical trials

Many persons who suffer from GERD report additional symptoms, e.g., chest p ain, dyspepsia, dysphagia, that are often not measured in clinical trials e ven though they may be distressing to the GERD sufferer. The primary goal o f this study was to develop and assess the psychometric characteristics of a new GERD symptom scale measuring frequency, severity, and distress. The G ERD Symptom Assessment Scale (GSAS) was administered To a sample of 169 GER D sufferers at baseline and two weeks. Internal consistency, construct vali dity, and test-retest reliability were assessed. Responsiveness was evaluat ed using clinical trial data assessing drug efficacy. Results: Internal con sistency was >0.80 for the symptom severity and distress scales. All three scales showed stability over two weeks (ICC >0.70). Both validity hypothese s were supported. Comparison of effect sizes showed the GSAS is sensitive t o changes in severity of symptoms. In conclusion, the GSAS is a reliable, v alid, and responsive measure of GERD symptoms.