Development and validation of a simple and multifaceted instrument,GERD-TEST,for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms

摘要

AIM To evaluate the psychometric properties of a newly developed questionnaire,known as the gastroesophageal reflux and dyspepsia therapeutic efficacy and satisfaction test(GERD-TEST),in patients with GERD.METHODS Japanese patients with predominant GERD symptoms recruited according to the Montreal definition were treated for 4 wk using a standard dose of proton pump inhibitor(PPI). The GERD-TEST and the Medical Outcome Study Short Form-8 Health Survey(SF-8) were administered at baseline and after 4 wk of treatment. The GERD-TEST contains three domains: the severity of GERD and functional dyspepsia(FD) symptoms(5 items),the level of dissatisfaction with daily life(DS)(4 items),and the therapeutic efficacy as assessed by the patients and medication compliance(4 items).RESULTS A total of 290 patients were eligible at baseline; 198 of these patients completed 4 wk of PPI therapy. The internal consistency reliability as evaluated using the Cronbach's α values for the GERD,FD and DS subscales ranged from 0.75 to 0.82. The scores for the GERD,FD and DS items/subscales were significantly correlated with the physical and mental component summary scores of the SF-8. After 4 wk of PPI treatment,the scores for the GERD items/subscales were greatly reduced,ranging in value from 1.51 to 1.87 and with a large effect size(P < 0.0001,Cohen's d; 1.29-1.63). Statistically significant differences in the changes in the scores for the GERD items/subscales were observed between treatment responders and non-responders(P < 0.0001).CONCLUSION The GERD-TEST has a good reliability,a good convergent and concurrent validity,and is responsive to the effects of treatment. The GERD-TEST is a simple,easy to understand,and multifaceted PRO instrument applicable to both clinical trials and the primary care of GERD patients.