Cost-effectiveness of ursodeoxycholic acid in preventing new-onset symptomatic gallstone disease after Roux-en-Y gastric bypass surgery.

BACKGROUND: The aim was to evaluate the cost-effectiveness and cost-utility of ursodeoxycholic acid (UDCA) prophylaxis for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass (RYGB) in patients without gallstones before surgery. METHODS: Data from a multicentre, double-blind, randomized placebo-controlled superiority trial were used. Patients scheduled for laparoscopic RYGB or sleeve gastrectomy were randomized to receive 900 mg UDCA or placebo for 6 months. Indicated by the clinical report, prophylactic prescription of UDCA was evaluated economically against placebo from a healthcare and societal perspective for the subgroup of patients without gallstones before surgery who underwent RYGB. Volumes and costs of in-hospital care, out-of-hospital care, out-of-pocket expenses, and productivity loss were assessed. Main outcomes were the costs per patient free from symptomatic gallstone disease and the costs per quality-adjusted life-year (QALY). RESULTS: Patients receiving UDCA prophylaxis were more likely to remain free from symptomatic gallstone disease (relative risk 1.06, 95 per cent c.i. 1.02 to 1.11; P = 0.002) compared with patients in the placebo group. The gain in QALYs, corrected for a baseline difference in health utility, was 0.047 (95 per cent bias-corrected and accelerated (Bca) c.i. 0.007 to 0.088) higher (P = 0.022). Differences in costs were -€356 (95 per cent Bca c.i. €-1573 to 761) from a healthcare perspective and -€1392 (-3807 to 917) from a societal perspective including out-of-pocket expenses and productivity loss, both statistically non-significant, in favour of UDCA prophylaxis. The probability of UDCA prophylaxis being cost-effective was at least 0.872. CONCLUSION: UDCA prophylaxis after RYGB in patients without gallstones before surgery was cost-effective.

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: study protocol for a randomized controlled trial (UPGRADE trial).

BACKGROUND: The number of bariatric interventions for morbid obesity is increasing worldwide. Rapid weight loss is a major risk factor for gallstone development. Approximately 11 % of patients who underwent Roux-en-Y gastric bypass develop symptomatic gallstone disease. Gallstone disease can lead to severe complications and often requires hospitalization and surgery. Ursodeoxycholic acid (UDCA) prevents the formation of gallstones after bariatric surgery. However, randomized controlled trials with symptomatic gallstone disease as primary endpoint have not been conducted. Currently, major guidelines make no definite statement about postoperative UDCA prophylaxis and most bariatric centers do not prescribe UDCA. METHODS: A randomized, placebo-controlled, double-blind multicenter trial will be performed for which 980 patients will be included. The study population consists of consecutive patients scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy in three bariatric centers in the Netherlands. Patients will undergo a preoperative ultrasound and randomization will be stratified for pre-existing gallstones and for type of surgery. The intervention group will receive UDCA 900 mg once daily for six months. The placebo group will receive similar-looking placebo tablets. The primary endpoint is symptomatic gallstone disease after 24 months, defined as admission or hospital visit for symptomatic gallstone disease. Secondary endpoints consist of the development of gallstones on ultrasound at 24 months, number of cholecystectomies, side-effects of UDCA and quality of life. Furthermore, cost-effectiveness, cost-utility and budget impact analyses will be performed. DISCUSSION: The UPGRADE trial will answer the question whether UDCA reduces the incidence of symptomatic gallstone disease after Roux-en-Y gastric bypass or sleeve gastrectomy. Furthermore it will determine if treatment with UDCA is cost-effective. TRIAL REGISTRATION: Netherlands Trial Register (trialregister.nl) 6135 . Date registered: 21-Nov-2016.

Socioeconomic Differences in Parenting Strategies to Prevent Adolescent Smoking: A Case Study from the Netherlands.

PURPOSE: This study aimed to identify possible socioeconomic differences in the use of anti-smoking parenting strategies. METHODS: In 2012, survey data of adolescents (N = 225) aged 13 to 17 years and their mothers (N = 122) and fathers (N = 105) were collected in Haarlem, the Netherlands. Questions on smoking behaviour and eleven anti-smoking parenting strategies were answered by adolescents, mothers and fathers. School tracks of adolescents and educational level of parents were measured as indicators of socioeconomic position. Linear multilevel regression analyses were applied to study the association between socioeconomic position (SEP) and standardised scores of anti-smoking strategies. Analyses were controlled for age, sex and smoking by parents and adolescents. RESULTS: We found no consistent socioeconomic differences in the use of anti-smoking parenting strategies. There were no statistically significant differences in relation to parental educational level or when using adolescent reports on parenting practices. However, when using parental reports, a few strategies varied significantly according to adolescent educational track. Adolescents in higher educational tracks were more likely to have no-smoking rules in the home (standardised regression coefficient (ß) = 0.20, 95 % confidence interval (CI): 0.03; 0.37, p = 0.022) and more likely to have a no-smoking agreement (ß = 0.17, 95 % CI: 0.00; 0.34, p = 0.048). However, they were less likely to frequently communicate about smoking with their parents (ß = -0.25, 95 % CI: -0.41; -0.08, p = 0.004). CONCLUSION: In this specific population, there was no consistent support for the hypothesis that anti-smoking parenting strategies contribute to socioeconomic inequalities in adolescent smoking. Parental factors that are more likely to contribute to these inequalities include parental smoking and parenting styles.