Development of a health-related quality-of-life questionnaire for individuals with gastroesophageal reflux disease - A validation study

This study was conducted to test the psychometric properties of a newly dev eloped health-related quality-of-life (HRQoL) questionnaire. A total of 172 , symptomatic GERD patients completed a 57-item questionnaire (containing t he SF-12; symptom frequency/bothersomeness; problems related to activities, sleep, work disability; overall HRQoL; and treatment satisfaction) at base line, week 1 [retest (N = 25)], and week 4 [follow-up (N 100)]. Internal-co nsistency reliability was acceptable for most scales (range: 0.74-0.92). Te st-retest reliability was acceptable for most scales (ICC: 0.74-0.85). Cons truct validity was demonstrated based on observed correlations. Known-group s validity was upheld, as patients who experienced more symptom days and pa tients who reported higher pain reported worse HRQoL than those with less s ymptoms or less severe pain. When categorized according to change in pain s everity, Guyatt's statistic for the "improved" and "worse" groups demonstra ted responsiveness, although many of the scales for the "stable" group were also responsive. In conclusion, the HRQoL questionnaire was found to be re liable, valid, and responsive.