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.

Preoperative Assessment of Obstructive Sleep Apnea in Bariatric Patients Using Polysomnography or Polygraphy.

BACKGROUND: Preoperative assessment of obstructive sleep apnea (OSA) in patients scheduled for bariatric surgery can be performed by in-laboratory polysomnography (PSG) or by portable polygraphy (PP) at home. We aimed to evaluate the association between PSG/PP, OSA diagnosis, and implementation of continuous positive airway pressure (CPAP) therapy. METHODS: All patients who underwent bariatric surgery from 2015 to 2017 were retrospectively reviewed. Patients underwent preoperative PSG or PP, based on prevailing protocols or at the physician's discretion. Logistic regression analyses were performed to determine predictors of CPAP implementation. OSA-related postoperative complications were analyzed in both groups. RESULTS: During the study period, 1464 patients were included. OSA was diagnosed in 79% of 271 patients undergoing PSG, compared to 64% of 1193 patients undergoing PP (p < 0.001), with median apnea-hypopnea index (AHI) of 15.8 and 7.7, respectively. CPAP treatment was initiated in 52% and 27% of patients, respectively, p < 0.001. Predictors (with adjusted odds ratio) in multivariate regression analysis for CPAP implementation were as follows: male gender (5.15), BMI ≥ 50 (3.85), PSG test (2.74), hypertension (2.38), and age ≥ 50 (1.87). OSA-related complications did not differ between groups (p = 0.277). CONCLUSION: Both PSG and PP are feasible options for preoperative OSA assessment in bariatric patients. When PP is performed, some underdiagnosis may occur as cases of mild OSA may be missed. However, clinically relevant OSA is detected by both diagnostic tools. No difference in OSA-related complications was found. PP is a safe, less invasive option and can be considered as a suitable measure for OSA assessment in this population.

Cost-effectiveness of direct discharge from the emergency department of patients with simple stable injuries in the Netherlands.

BACKGROUND: Approximately one-third of musculoskeletal injuries are simple stable injuries (SSIs). Direct discharge (DD) from the emergency department (ED) of patients with SSIs reduces healthcare utilization, without compromising patient outcome and experience, when compared with "traditional" care with routine follow-up. This study aimed to determine the cost-effectiveness of DD compared with traditional care from a societal perspective. METHODS: Societal costs, including healthcare, work absenteeism, and travel costs, were calculated for patients with an SSI, 6 months before (pre-DD cohort) and after implementation of DD (DD cohort). The pre-DD cohort was treated according to local protocols. The DD cohort was treated using orthoses, discharge leaflet, smartphone application, and telephone helpline, without scheduling routine follow-up. Effect measures included generic health-related quality of life (HR-QoL; EuroQol Five-Dimensional Questionnaire); disease-specific HR-QoL (functional outcome, different validated questionnaires, converted to 0-100 scale); treatment satisfaction (Visual Analog Scale (VAS), 1-10); and pain (VAS, 1-10). All data were assessed using a 3-month postinjury survey and electronic patient records. Incremental cost-effectiveness ratios were calculated and uncertainty was assessed using bootstrapping techniques. RESULTS: Before DD, 144 of 348 participants completed the survey versus 153 of 371 patients thereafter. There were no statistically significant differences between the pre-DD cohort and the DD cohort for generic HR-QoL (0.03; 95% CI -0.01 to 0.08), disease-specific HR-QoL (4.4; 95% CI -1.1 to 9.9), pain (0.08; 95% CI -0.37 to 0.52) and treatment satisfaction (-0.16; 95% CI -0.53 to 0.21). Total societal costs were lowest in the DD cohort (-€822; 95% CI -€1719 to -€67), including healthcare costs (-€168; 95% CI -€205 to -€131) and absenteeism costs (-€645; 95% CI -€1535 to €100). The probability of DD being cost-effective was 0.98 at a willingness-to-pay of €0 for all effect measures, remaining high with increasing willingness-to-pay for generic HR-QoL, disease-specific HR-QoL, and pain, and decreasing with increasing willingness-to-pay for treatment satisfaction. DISCUSSION: DD from the ED of patients with SSI seems cost-effective from a societal perspective. Future studies should test generalizability in other healthcare systems and strengthen findings in larger injury-specific cohorts. LEVEL OF EVIDENCE: II.

Protocol of a multicentre, prospective cohort study that evaluates cost-effectiveness of two perioperative care strategies for potential obstructive sleep apnoea in morbidly obese patients undergoing bariatric surgery.

INTRODUCTION: Despite the high prevalence of obstructive sleep apnoea (OSA) in obese patients undergoing bariatric surgery, OSA is undiagnosed in the majority of patients and thus untreated. While untreated OSA is associated with an increased risk of preoperative and postoperative complications, no evidence-based guidelines on perioperative care for these patients are available. The aim of the POPCORN study (Post-Operative Pulse oximetry without OSA sCreening vs perioperative continuous positive airway pressure (CPAP) treatment following OSA scReeNing by polygraphy (PG)) is to evaluate which perioperative strategy is the most cost-effective for obese patients undergoing bariatric surgery without a history of OSA. METHODS AND ANALYSIS: In this multicentre observational cohort study, data from 1380 patients who will undergo bariatric surgery will be collected. Patients will receive either postoperative care with pulse oximetry monitoring and supplemental oxygen during the first postoperative night, or care that includes preoperative PG and CPAP treatment in case of moderate or severe OSA. Local protocols for perioperative care in each participating hospital will determine into which cohort a patient is placed. The primary outcome is cost-effectiveness, which will be calculated by comparing all healthcare costs with the quality-adjusted life-years (QALYs, calculated using EQ-5D questionnaires). Secondary outcomes are mortality, complications within 30 days after surgery, readmissions, reoperations, length of stay, weight loss, generic quality of life (QOL), OSA-specific QOL, OSA symptoms and CPAP adherence. Patients will receive questionnaires before surgery and 1, 3, 6 and 12 months after surgery to report QALYs and other patient-reported outcomes. ETHICS AND DISSEMINATION: Approval from the Medical Research Ethics Committees United was granted in accordance with the Dutch law for Medical Research Involving Human Subjects Act (WMO) (reference number W17.050). Results will be submitted for publication in peer-reviewed journals and presented at (inter)national conferences. TRIAL REGISTRATION NUMBER: NTR6991.

Mandatory imaging in the work-up of children suspected of having appendicitis reduces the rate of unnecessary surgeries.

OBJECTIVE: In children, the diagnosis "acute appendicitis" is difficult. In 2010, a new Dutch appendicitis guideline was published with the goal to reduce the negative appendectomy rate. The guideline recommended mandatory imaging (ultrasound first and CT or MRI when inconclusive) before surgery. This study examines whether the negative appendectomy rate in children has declined after the implementation of the guideline and if the number of ionising imaging procedures increased. METHODS: In this cohort study, all consecutive patients aged 17 or younger, with the suspicion of appendicitis were included. Patients were divided into two groups. Those who presented between 2006 and 2010 (before the implementation) and those between 2011 and 2016 (after implementation). RESULTS: In total, 748 children were enrolled, of which 363 children were seen before and 385 children after implementation of the guideline. Before implementation, 46% of the children with acute appendicitis underwent preoperative ultrasound compared with 95% in the post implementation group, p < 0.001. Any imaging was performed in 51% and 100%, respectively, p < 0.001. The percentage of negative appendectomy before implementation was 13% and 2.7% after implementation, p < 0.001. There was no significant increase in the number of CT scans before and after the implementation of the guideline, 3.6% versus 6.0%, respectively, p = 0.126. There was no increase in direct medical costs. CONCLUSIONS: Mandatory preoperative imaging in children with the suspicion of acute appendicitis results in a significant decrease in negative appendectomies with no increase in the number of CT scans and without a substantial increase in costs.

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.