Gallstone-related symptoms and quality-of-life in patients undergoing gallstone surgery - The Gothenburg Gallstone Questionnaire (GGQ24)

Abstract: Background: Patients with symptomatic gallstone disease can present with years of intermittent suffering or acute complicated disease. The only definitive cure is surgery. Registering both surgical and patient reported outcome measures may provide a more reliable platform to assess the impact of gallstone surgery and improved decision-making. Methods: Retrospective patient cohorts from the national quality registry for Gallstone Surgery and ERCP, Gallriks, served as study groups in paper I-IV. These groups were crosslinked with the National Patient Register, Statistics Sweden, Central Death Register and the Swedish Prescribed Drug Register to obtain valid and reliable data. Paper V is a prospective qualitative mixed methods design using guidelines for item-development from the International Society of Pharmoacoeconomics and Research (ISPOR) including focus group interviews, expert team reviews, cognitive debriefing, and other psychometric analyses. Results: The 36-Item Short Form health survey (SF36) proved to be a highly responsive tool for measuring HrQoL 6 months after surgery. Cholecystectomy gave a significant improvement in QoL (Paper I). Subgroups in the Swedish population with different socioeconomic variables did not show any difference in incidence or outcome of surgery. The presentation of the disease and the timing for surgery differed between the genders (Paper II). Patients over 80 years are associated with increased postoperative morbidity but may benefit substantially from surgical intervention. Laparoscopic approach was associated with significantly less mortality than open surgery or conversion, and lead to shorter hospital stay (Paper III). Perioperative myocardial infarction after gallstone surgery is more frequent among the elderly. A previous Non-ST Elevation Myocardial Infarction (NSTEMI) within 8 weeks prior to surgery was the most important predictor of a 30-day postoperative MI. The postoperative 30-day risk for MI was 52.8%. After 8 weeks it gradually reached the risk of the background population (Paper IV). 367 QoL statements were generated from focus groups. Following question reduction, statistical and psychometric evaluation, a disease-specific PROM formula was developed with 24 preoperative and 21 postoperative questions – The GGQ24 (Paper V). Conclusion: Gallriks and other Swedish national registers offer high quality data for research. Cholecystectomy does not differ in incidence or outcome in relation to socioeconomic subgroups in Sweden. Gallstone surgery can be performed safely in patients over 80 following careful preoperative selection. NSTEMI independently is the greatest risk factor of a 30-day postoperative MI following cholecystectomy. GGQ24 is a disease specific PROM-instrument that will contribute to decision-making and care of patients undergoing gallstone surgery.