DISEASE-SPECIFIC QUALITY-OF-LIFE - THE GALLSTONE IMPACT CHECKLIST

Objective: To develop a disease-specific quality-of-life scale for sym ptomatic cholelithiasis for use in clinical trials, and to evaluate it s reliability, construct validity and responsiveness. Design: Question naire. Participants: Health care professionals, patients with symptoma tic cholelithiasis and their significant others. Interventions: A 114- item questionnaire was developed from open-ended questions completed b y the participants. Questions dealt with physical symptoms, activities of daily living, job performance, leisure activities, emotional facto rs, marital and sexual relations, support networks and financial situa tion. The questionnaire was administered by an interviewer to 50 subje cts booked for elective cholecystectomy: frequency-importance products were calculated for each of the 114 items. A final shortened scale (t he Gallstone Impact Checklist [GIC]) contained 41 items and was comple ted by patients with symptomatic cholelithiasis on two occasions, 4 to 6 weeks apart. Results: The checklist requires 10 to 15 minutes to co mplete. Reliability of the questionnaire and its four subscales was as sessed by Cronbach's alpha (overall questionnaire 0.88, pain 0.60, dys pepsia 0.73, emotional impact 0.78 and food and eating 0.84). Construc t validity was established by comparison of questionnaire subscales wi th global ratings of physical and emotional health. Among subjects who reported a difference in their symptoms attributed to gallstones, the re was a significant change in total GIC score and in each of the four subscales. Among patients who had undergone cholecystectomy, the abso lute value of the effect size was 1.63. Conclusions: The GIC has conte nt validity and appears to be a reliable, responsive measure of within -person change for subjects with symptomatic cholelithiasis.