Development of a Health-Related Quality-of-Life Questionnaire for Individuals with Gastroesophageal Reflux Disease (A Validation Study)

This study was conducted to test thepsychometric properties of a newly developedhealthrelated quality-of-life (HRQoL) questionnaire. Atotal of 172 symptomatic GERD patients completed a57-item questionnaire (containing the SF-12; symptomfrequency/bothersomeness; problems related toactivities, sleep, work disability; overall HRQoL; andtreatment satisfaction) at baseline, week 1 [retest (N= 25)], and week 4 [follow-up (N = 100)]. Internal-consistencyreliability was acceptable for most scales (range:0.74-0.92). Test-retest reliability was acceptable formost scales (ICC: 0.74-0.85). Construct validity was demonstrated based on observedcorrelations. Known-groups validity was upheld, aspatients who experienced more symptom days and patientswho reported higher pain reported worse HRQoL than thosewith less symptoms or less severe pain. Whencategorized according to change in pain severity,Guyatt's statistic for the "improved" and“worse” groups demonstrated responsiveness,although many of the scales for the “stable”group were also responsive. In conclusion, the HRQoLquestionnaire was found to be reliable, valid, andresponsive.