Endoscopic ultrasound (EUS)-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration with rapid onsite evaluation in pancreatic lesions: a multicenter randomized trial.

BACKGROUND: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the standard in the diagnosis of solid pancreatic lesions, in particular when combined with rapid onsite evaluation of cytopathology (ROSE). More recently, a fork-tip needle for core biopsy (FNB) has been shown to be associated with excellent diagnostic yield. EUS-FNB alone has however not been compared with EUS-FNA + ROSE in a large clinical trial. Our aim was to compare EUS-FNB alone to EUS-FNA + ROSE in solid pancreatic lesions. METHODS: A multicenter, non-inferiority, randomized controlled trial involving seven centers was performed. Solid pancreatic lesions referred for EUS were considered for inclusion. The primary end point was diagnostic accuracy. Secondary end points included sensitivity/specificity, mean number of needle passes, and cost. RESULTS: 235 patients were randomized: 115 EUS-FNB alone and 120 EUS-FNA + ROSE. Overall, 217 patients had malignant histology. The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA + ROSE at 92.2 % (95 %CI 86.6 %-96.9 %) and 93.3 % (95 %CI 88.8 %-97.9 %), respectively (P = 0.72). Diagnostic sensitivity for malignancy was 92.5 % (95 %CI 85.7 %-96.7 %) for EUS-FNB alone vs. 96.5 % (93.0 %-98.6 %) for EUS-FNA + ROSE (P = 0.46), while specificity was 100 % in both. Adequate histological yield was obtained in 87.5 % of the EUS-FNB samples. The mean (SD) number of needle passes and procedure time favored EUS-FNB alone (2.3 [0.6] passes vs. 3.0 [1.1] passes [P < 0.001]; and 19.3 [8.0] vs. 22.7 [10.8] minutes [P = 0.008]). EUS-FNB alone cost on average 45 US dollars more than EUS-FNA + ROSE. CONCLUSION: EUS-FNB alone is non-inferior to EUS-FNA + ROSE and is associated with fewer needle passes, shorter procedure time, and excellent histological yield at comparable cost.

Early cholangioscopy-assisted electrohydraulic lithotripsy in difficult biliary stones is cost-effective.

BACKGROUND AND AIMS: Single-operator cholangioscopy-assisted electrohydraulic lithotripsy (SOC-EHL) is effective and safe in difficult choledocholithiasis. The optimal timing of SOC-EHL use, however, in refractory stones has not been elucidated. The following aims to determine the most cost-effective timing of SOC-EHL introduction in the management of choledocholithiasis. METHODS: A cost-effectiveness model was developed assessing three strategies with a progressively delayed introduction of SOC-EHL. Probability estimates of patient pathways were obtained from a systematic review. The unit of effectiveness is complete ductal clearance without need for surgery. Cost is expressed in 2018 US dollars and stem from outpatient US databases. RESULTS: The three strategies achieved comparable ductal clearance rates ranging from 97.3% to 99.7%. The least expensive strategy is to perform SOC-EHL during the first endoscopic retrograde cholangiography pancreatography (ERCP) (SOC-1: 18,506$). The strategy of postponing the use of SOC-EHL to the third ERCP (SOC-3) is more expensive (US$18,895) but is 2% more effective. (0.9967). SOC-EHL during the second ERCP in the model (SOC-2) is the least cost-effective. Sensitivity analyses show altered conclusions according to the cost of SOC-EHL, effectiveness of conventional ERCP, and altered willingness-to-pay (WTP) thresholds with early SOC-1 being the most optimal approach below a WTP cut-off of US$20,295. CONCLUSIONS: Early utilization of SOC-EHL (SOC-1) in difficult choledocholithiasis may be the least costly strategy with an effectiveness approximating those achieved with a delayed approach where one or more conventional ERCP(s) are reattempted prior to SOC-EHL introduction.

Use of stents in patients undergoing chemotherapy for borderline resectable pancreatic cancer-causing biliary obstruction while awaiting surgery: A cost-effectiveness analysis.

Background and study aims Biliary stenting is indicated to relieve obstruction from borderline resectable pancreatic cancer while patients receive preoperative neoadjuvant therapy. We compared the cost-effectiveness of plastic versus metal biliary stenting in this setting. Methods A decision tree analysis compares two competing types of biliary stents (initially metal vs. initially plastic) to treat malignant distal biliary obstruction while receiving neoadjuvant therapy with different scenarios including possible complications as bridge till the patient undergoes curative surgical attempt. Using published information, effectiveness was chosen as the probability of successfully reaching a state of being ready for surgery once chemotherapy was completed. Costs (2018 US$) were based on national data. A third-party payer perspective was adopted, and sensitivity analyses were performed over a time-horizon of one year. Results Initially inserting a metal versus a plastic biliary stent was more efficacious with a higher probability of reaching the readiness for surgery endpoint (96 % vs. 85 %), on average 18 days earlier while also being less expensive (US$ 9,304 vs. US$ 11,538). Sensitivity analyses confirmed robustness of these results across varying probability assumptions of plausible ranges and remained a dominant strategy even when lowering the willingness-to-pay threshold to US$ 1,000. Conclusions Initial metal stenting to relieve malignant biliary obstruction from borderline resectable pancreatic cancer in patients undergoing neoadjuvant therapy prior to surgery is a dominant intervention in economic terms, when compared to initially inserting a plastic biliary stent as it results in a greater proportion of patients being fit for surgery earlier and at a lower cost.

Flexural and Shear Tests on Reinforced Concrete Bridge Deck Slab Segments with a Textile-Reinforced Concrete Strengthening Layer.

Many older bridges feature capacity deficiencies. This is mainly due to changes in code provisions which came along with stricter design rules and increasing traffic, leading to higher loads on the structure. To address capacity deficiencies of bridges, refined structural analyses with more detailed design approaches can be applied. If bridge assessment does not provide sufficient capacity, strengthening can be a pertinent solution to extend the bridge's service lifetime. For numerous cases, applying an extra layer of textile-reinforced concrete (TRC) can be a convenient method to achieve the required resistance. Here, carbon fibre-reinforced polymer reinforcement together with a high-performance mortar was used within the scope of developing a strengthening layer for bridge deck slabs, called SMART-DECK. Due to the high tensile strength of the carbon and its resistance to corrosion, a thin layer with high strength and low additional dead load can be realised. While the strengthening effect of TRC for slabs under flexural loading has already been investigated several times, the presented test programme also covered increase in shear capacity, which is the other crucial failure mode to be considered in design. A total of 14 large-scale tests on TRC-strengthened slab segments were tested under static and cyclic loading. The experimental study revealed high increases in capacity for both bending and shear failure.

Fictitious Rough Crack Model (FRCM): A Smeared Crack Modelling Approach to Account for Aggregate Interlock and Mixed Mode Fracture of Plain Concrete.

The intention of this paper is to clarify the mechanisms of mixed mode fracture and shear stress transfer in plain concrete. To capture these scarcely explored phenomena, a new mechanical formulation is proposed called the fictitious rough crack model (FRCM). The FRCM considers mode I deformations to control crack formation and residual tensile stress transfer, while mode II deformations are assumed to induce shear stress transfer along the crack surfaces and compressive normal stresses attributed to aggregate interlock. The fundamental idea of the FRCM is to combine these tension-softening and shear-transfer laws and to superimpose the emerging shear and normal stresses of both mechanisms in the crack. The paper illustrates the analytical development of the FRCM and its numerical implementation. Three well-known experimental benchmark problems (concrete panel test series by Nooru-Mohamed and by Hassanzadeh as well as aggregate interlock test series by Paulay and Loeber) are numerically addressed to test plausibility of FRCM results. The numerical implementation of the FRCM is capable of simulating the transition from mode-I fracture to mixed-mode fracture in the structural response and is also able to predict the crack path with reasonable agreement.

Use of Doppler Probe in Nonvariceal Upper-Gastrointestinal Bleeding Is Less Costly and More Effective Than Standard of Care.

BACKGROUND & AIMS: Upper gastrointestinal bleeding is a common emergency and rebleeding is associated with an increased risk of death. Proper assessment of high-risk lesions and appropriate endoscopic hemostasis are required for the best outcomes. The endoscopic Doppler probe examination (DPE) allows for a more complete assessment of the stigmata of hemorrhage, providing better evaluation of the need for endoscopic hemostasis and determination of its completeness. We aimed to evaluate whether use of the DPE provides an additional advantage in cost and effectiveness compared with traditional endoscopic visual assessment (TEA) of high-risk stigmata in patients with nonvariceal upper gastrointestinal bleeding. METHODS: We drew a decision tree representing the choice between DPE and TEA approaches for patients undergoing an index endoscopy for active nonvariceal upper gastrointestinal bleeding. Clinical probabilities were retrieved from randomized controlled trial data. Costs were expressed in 2017 US dollars. A third-party payer perspective was adopted. We performed deterministic and probabilistic sensitivity analyses. The adopted time horizon was 30 days after the index endoscopy. RESULTS: We found that DPE is a dominant strategy over the TEA, in that DPE is more efficacious (92.6% of patients avoiding rebleeding vs 78.6% for TEA) and less expensive ($8502 vs $9104 for TEA). The economic dominance of DPE over TEA was robust to sensitivity analyses across all assumptions of the model when varied among ranges spanning 30% of their respective baseline values. CONCLUSIONS: In a cost-effectiveness analysis, we found DPE to be an economically dominant strategy to TEA (the traditional approach) in the management of high-risk lesions in patients with nonvariceal upper gastrointestinal bleeding. DPE was less costly and more effective.

Plastic stents are more cost-effective than lumen-apposing metal stents in management of pancreatic pseudocysts.

BACKGROUND AND STUDY AIMS: Endoscopic ultrasound-guided drainage is an effective and accepted primary modality for management of pancreatic pseudocyst (PP). A lumen-apposing metal stent (LAMS) has recently been developed specifically for drainage of pancreatic fluid collections which may be superior to using traditional plastic stents (PS) but is more expensive. Because use of a stent involves a risk of unplanned endoscopy, percutaneous drainage (PCD) and surgery, their costs should also be included in the comparison and a cost-effectiveness analysis of LAMS and PS should therefore be performed. PATIENTS AND METHODS: A decision tree was developed assessing both endoscopic drainage strategies for patients with PP: LAMS and PS over a 6-month time horizon. For each strategy, inpatients received a stent and were followed for subsequent need for direct further interventions or adverse events leading to unplanned endoscopy, PCD, surgery, or successful endoscopic drainage using probabilities obtained from the literature. The unit of effectiveness was successful endoscopic drainage without need for PCD or surgery. Sensitivity analyses were performed. RESULTS: Success rates were 93.9 % for LAMS and 96.96 % for PS. Respective costs per successful drainage were US $ 18,129 (LAMS) and US $ 10,403 (PS). The LAMS strategy was thus characterized as dominated by the PS approach because it was costlier and less effective than PS. Both deterministic and probabilistic sensitivity analyses confirmed the robustness of these findings. CONCLUSION: Use of LAMS is not less effective and more costly than PS in management of patients with PP. As such, PS should be preferred over LAMS as initial management of these patients.

Cost-effectiveness analysis comparing lumen-apposing metal stents with plastic stents in the management of pancreatic walled-off necrosis.

BACKGROUND AND AIMS: EUS-guided transmural drainage is effective in the management of pancreatic walled-off necrosis (WON). A lumen-apposing metal stent (LAMS) has recently been developed specifically for the drainage of pancreatic fluid collections that shows promising results. However, no cost-effectiveness data have been published in comparison with endoscopic drainage with traditional plastic stents (PSs). Our aim here was to compare the cost-effectiveness of LAMSs to PSs in the management of WON. METHODS: A decision tree was developed to assess both LAMSs and PSs over a 6-month time horizon. For each strategy, after the insertion of the respective stents, patients were followed for subsequent need for direct endoscopic necrosectomy, adverse events requiring unplanned endoscopy, percutaneous drainage (PCD), or surgery using probabilities obtained from the literature. The unit of effectiveness was defined as successful endoscopic drainage without the need for PCD or surgery. Costs in 2016 U.S.$ were based on inpatient institutional costs. Sensitivity analyses were performed. An a priori willingness-to-pay threshold of U.S.$50,000 was established. RESULTS: LAMSs were found to be more efficacious than PSs, with 92% and 84%, respectively, of the patients achieving successful endoscopic drainage of WON. LAMSs, however, were more costly: the average cost per patient of U.S.$20,029 compared with U.S.$15,941 for PSs. The incremental cost-effectiveness ratio favored LAMSs at U.S.$49,214 per additional patient successfully treated. Sensitivity analyses confirmed the robustness of the results. CONCLUSION: LAMSs are more effective but also more costly than PSs in managing WON. Data from high-quality, adequately controlled, prospective, randomized trials are needed to confirm our findings.

Using Hemospray Improves the Cost-effectiveness Ratio in the Management of Upper Gastrointestinal Nonvariceal Bleeding.

GOALS: We compared the cost-effectiveness of traditional recommended endoscopic hemostatic therapies and Hemospray alone or in combination when treating nonvariceal upper gastrointestinal bleeding (NVUGIB). BACKGROUND: Hemospray (TC-325) is a novel endoscopic hemostatic powder, achieving hemostasis through adherence to actively bleeding biological surfaces. STUDY: A decision tree of patients with NVUGIB assessed 4 possible treatment strategies: traditional therapy alone (T), Hemospray alone (H), traditional therapy completed by Hemospray if needed (T+H), or Hemospray completed by traditional therapy if needed (H+T). Using published probabilities, effectiveness was the likelihood of avoiding rebleeding over 30 days. Costs in 2014 US$ were based on the US National Inpatient Sample. A third-party payer perspective was adopted. Sensitivity and subgroup analyses were performed. RESULTS: For all patients, T+H was more efficacious (97% avoiding rebleeding) and less expensive (average cost per patient of US$9150) than all other approaches. The second most cost-effective approach was H+T (5.57% less effective and US$635 more per patient). Sensitivity analyses showed T+H followed by a strategy of H+T remained more cost-effective than H or T alone when varying all probability assumptions across plausible ranges. Subgroup analysis showed that the inclusion of H (especially alone) was least adapted for ulcers and was more cost-effective when treating lesions at low risk of delayed rebleeding. CONCLUSIONS: Hemospray improves the effectiveness of traditional hemostasis, being less costly in most NVUGIB patient populations. A Hemospray first approach is most cost-effective for nonulcer bleeding lesions at low risk of delayed hemorrhage.

Strengthening of Existing Bridge Structures for Shear and Bending with Carbon Textile-Reinforced Mortar.

Increasing traffic loads and changes in code provisions lead to deficits in shear and flexural capacity of many existing highway bridges. Therefore, a large number of structures are expected to require refurbishment and strengthening in the future. This projection is based on the current condition of many older road bridges. Different strengthening methods for bridges exist to extend their service life, all having specific advantages and disadvantages. By applying a thin layer of carbon textile-reinforced mortar (CTRM) to bridge deck slabs and the webs of pre-stressed concrete bridges, the fatigue and ultimate strength of these members can be increased significantly. The CTRM layer is a combination of a corrosion resistant carbon fiber reinforced polymer (CFRP) fabric and an efficient mortar. In this paper, the strengthening method and the experimental results obtained at RWTH Aachen University are presented.

Timing or Dosing of Intravenous Proton Pump Inhibitors in Acute Upper Gastrointestinal Bleeding Has Low Impact on Costs.

OBJECTIVES: High-dose intravenous proton pump inhibitors (PPIs) post endoscopy are recommended in non-variceal upper gastrointestinal bleeding (UGIB), as they improve outcomes of patients with high-risk lesions. Determine the budget impact of using different PPI regimens in treating non-variceal UGIB, including pre- and post-endoscopic use, continuous infusion (high dose), and intermittent bolus (twice daily) dosing. METHODS: A budget impact analysis using a decision model informed with data from the literature adopting a US third party payer's perspective with a 30-day time horizon was used to determine the total cost per patient (US$2014) presenting with acute UGIB. The base-case employing high-dose pre- and post-endoscopic IV PPI was compared with using only post-endoscopic PPI. For each, continuous or intermittent dosing regimens were assessed with associated incremental costs. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: The overall cost per patient is $11,399 when high-dose IV PPIs are initiated before endoscopy. The incremental costs are all inferior in alternate-case scenarios: $106 less if only post-endoscopic high-dose IVs are used; with intermittent IV bolus dosing, the savings are $223 if used both pre and post endoscopy and $191 if only administered post endoscopy. Subgroup analysis suggests cost savings in patients with clean-base ulcers who are discharged early after endoscopy. Results are robust to sensitivity analysis. CONCLUSIONS: The incremental costs of using different IV PPI regimens are modest compared with total per patient costs.

Comparison Costs of ERCP and MRCP in Patients with Suspected Biliary Obstruction Based on a Randomized Trial.

BACKGROUND: The optimal management of patients with suspected biliary obstruction remains unclear, and includes the possible performance of magnetic resonance cholangiopancreatography (MRCP) and endoscopic retrograde cholangiopancreatography (ERCP). OBJECTIVES: To complete a cost analysis based on a medical effectiveness randomized trial comparing an ERCP-first approach with an MRCP-first approach in patients with suspected bile duct obstruction. METHODS: The management strategies were based on a medical effectiveness trial of 257 patients over a 12-month follow-up period. Direct and indirect costs were included, adopting a societal perspective. The cost values are expressed in 2012 Canadian dollars. RESULTS: Total per-patient direct costs were Can$3547 for ERCP-first patients and Can$4013 for MRCP-first patients. Corresponding indirect costs were Can$732 and Can$694, respectively. Causes for differences in direct costs included a more frequent second procedure and a greater mean number of hospital days over the year in patients of the MRCP-first group. In contrast, it is the ERCP-first patients whose indirect costs were greater, principally due to more time away from activities of daily living. Choosing an ERCP-first strategy rather than an MRCP-first strategy saved on average Can$428 per patient over the 12-month follow-up duration; however, there existed a large amount of overlap when varying total cost estimates across a sensitivity analysis range based on observed resources utilization. CONCLUSIONS: This cost analysis suggests only a small difference in total costs, favoring the ERCP-first group, and is principally attributable to procedures and hospitalizations with little impact from indirect cost measurements.

Partially covered self-expandable metal stents versus polyethylene stents for malignant biliary obstruction: a cost-effectiveness analysis.

UNLABELLED: BACKGROUND/ OBJECTIVE: Partially covered self-expandable metal stents (SEMS) and polyethylene stents (PES) are both commonly used in the palliation of malignant biliary obstruction. Although SEMS are significantly more expensive, they are more efficacious than PES. Accordingly, a cost-effectiveness analysis was performed. METHODS: A cost-effectiveness analysis compared the approach of initial placement of PES versus SEMS for the study population. Patients with malignant biliary obstruction underwent an endoscopic retrograde cholangiopancreatography to insert the initial stent. If the insertion failed, a percutaneous transhepatic cholangiogram was performed. If stent occlusion occurred, a PES was inserted at repeat endoscopic retrograde cholangiopancreatography, either in an outpatient setting or after admission to hospital if cholangitis was present. A third-party payer perspective was adopted. Effectiveness was expressed as the likelihood of no occlusion over the one-year adopted time horizon. Probabilities were based on a contemporary randomized clinical trial, and costs were issued from national references. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: A PES-first strategy was both more expensive and less efficacious than an SEMS-first approach. The mean per-patient costs were US$6,701 for initial SEMS and US$20,671 for initial PES, which were associated with effectiveness probabilities of 65.6% and 13.9%, respectively. Sensitivity analyses confirmed the robustness of these results. CONCLUSION: At the time of initial endoscopic drainage for patients with malignant biliary obstruction undergoing palliative stenting, an initial SEMS insertion approach was both more effective and less costly than a PES-first strategy.

Cost-effectiveness analysis: stress ulcer bleeding prophylaxis with proton pump inhibitors, H2 receptor antagonists.

OBJECTIVES: Proton pump inhibitors (PPIs) and H2-receptor antagonists (H2RAs) present varying pharmacological efficacy in preventing stress ulcer bleeding (SUB) in intensive care units. The literature also reports disparate rates of ventilator-assisted pneumonia (VAP) as side effects of these treatments. We compared the cost-effectiveness of these two prophylactic pharmacological options. METHODS: We constructed a decision tree with a 60-day time horizon for patients at high risk for developing SUB, receiving either PPIs or H2RAs. For each treatment strategy, patients could be in one of three states of health: SUB, VAP, or no complication. Contemporary, clinically relevant probabilities were obtained from a broad literature search. Costs were estimated by using a representative US countrywide database. A third-party payer perspective was adopted. Cost-effectiveness and univariate and multivariate sensitivity analyses were performed. RESULTS: Probabilities of SUB and VAP were 1.3% and 10.3% for PPIs versus 6.6% and 10.3% for H2RAs, respectively. Lengths of stay and per diem costs were 24 days and US $2764 for SUB, 42 days and US $3310 for VAP, and 14 days and US $2993 for patients without complications. Average costs per no complication were US $58,700 for PPIs and US $63,920 for H2RAs. The H2RA strategy was dominated by PPIs. Sensitivity analysis showed that these findings were sensitive to VAP rates but PPIs remain cost-effective. The acceptability curve shows the stability of the probabilistic results according to varying willingness-to-pay values. CONCLUSION: PPI prophylaxis is the most efficient prophylactic strategy in patients at high risk of developing SUB when compared with using H2RAs.

Randomized trial in malignant biliary obstruction: plastic vs partially covered metal stents.

AIM: To compare efficacy and complications of partially covered self-expandable metal stent (pcSEMS) to plastic stent (PS) in patients treated for malignant, infrahilar biliary obstruction. METHODS: Multicenter prospective randomized clinical trial with treatment allocation to a pcWallstent(®) (SEMS) or a 10 French PS. Palliative patients aged ≥ 18, for infrahilar malignant biliary obstruction and a Karnofsky performance scale index > 60% from 6 participating North American university centers. Primary endpoint was time to stent failure, with secondary outcomes of death, adverse events, Karnofsky performance score and short-form-36 scale administered on a three-monthly basis for up to 2 years. Survival analyses were performed for stent failure and death, with Cox proportional hazards regression models to determine significant predictive characteristics. RESULTS: Eighty-five patients were accrued over 37 mo, 42 were randomized to the SEMS group and 83 patients were available for analyses. Time to stent failure was 385.3 ± 52.5 d in the SEMS and 153.3 ± 19.8 d in the PS group, P = 0.006. Time to death did not differ between groups (192.3 ± 23.4 d for SEMS vs 211.5 ± 28.0 d for PS, P = 0.70). The only significant predictor was treatment allocation, relating to the time to stent failure (P = 0.01). Amongst other measured outcomes, only cholangitis differed, being more common in the PS group (4.9% vs 24.5%, P = 0.029). The small number of patients in follow-up limits longitudinal assessments of performance and quality of life. From an initially planned 120 patients, only 85 patients were recruited. CONCLUSION: Partially covered SEMS result in a longer duration till stent failure without increased complication rates, yet without accompanying measurable benefits in survival, performance, or quality of life.

Cost effectiveness of high-dose intravenous esomeprazole for peptic ulcer bleeding.

Peptic ulcer bleeding (PUB) is a serious and sometimes fatal condition. The outcome of PUB strongly depends on the risk of rebleeding. A recent multinational placebo-controlled clinical trial (ClinicalTrials.gov identifier: NCT00251979) showed that high-dose intravenous (IV) esomeprazole, when administered after successful endoscopic haemostasis in patients with PUB, is effective in preventing rebleeding. From a policy perspective it is important to assess the cost efficacy of this benefit so as to enable clinicians and payers to make an informed decision regarding the management of PUB. Using a decision-tree model, we compared the cost efficacy of high-dose IV esomeprazole versus an approach of no-IV proton pump inhibitor for prevention of rebleeding in patients with PUB. The model adopted a 30-day time horizon and the perspective of third-party payers in the USA and Europe. The main efficacy variable was the number of averted rebleedings. Healthcare resource utilization costs (physician fees, hospitalizations, surgeries, pharmacotherapies) relevant for the management of PUB were also determined. Data for unit costs (prices) were primarily taken from official governmental sources, and data for other model assumptions were retrieved from the original clinical trial and the literature. After successful endoscopic haemostasis, patients received either high-dose IV esomeprazole (80 mg infusion over 30 min, then 8 mg/hour for 71.5 hours) or no-IV esomeprazole treatment, with both groups receiving oral esomeprazole 40 mg once daily from days 4 to 30. Rebleed rates at 30 days were 7.7% and 13.6%, respectively, for the high-dose IV esomeprazole and no-IV esomeprazole treatment groups (equating to a number needed to treat of 17 in order to prevent one additional patient from rebleeding). In the US setting, the average cost per patient for the high-dose IV esomeprazole strategy was $US14 290 compared with $US14 239 for the no-IV esomeprazole strategy (year 2007 values). For the European setting, Sweden and Spain were used as examples. In the Swedish setting the corresponding respective figures were Swedish kronor (SEK)67 862 ($US9220 at average 2006 interbank exchange rates) and SEK67 807 ($US9212) [year 2006 values]. Incremental cost-effectiveness ratios were $US866 and SEK938 ($US127), respectively, per averted rebleed when using IV esomeprazole. For the Spanish setting, the high-dose IV esomeprazole strategy was dominant (more effective and less costly than the no-IV esomeprazole strategy) [year 2008 values]. All results appeared robust to univariate/threshold sensitivity analysis, with high-dose IV esomeprazole becoming dominant with small variations in assumptions in the US and Swedish settings, while remaining a dominant approach in the Spanish scenario across a broad range of values. Sensitivity variables with prespecified ranges included lengths of stay and per diem assumptions, rebleeding rates and, in some cases, professional fees. In patients with PUB, high-dose IV esomeprazole after successful endoscopic haemostasis appears to improve outcomes at a modest increase in costs relative to a no-IV esomeprazole strategy from the US and Swedish third-party payer perspective. Whereas, in the Spanish setting, the high-dose IV esomeprazole strategy appeared dominant, being more effective and less costly.

The Stretta procedure versus proton pump inhibitors and laparoscopic Nissen fundoplication in the management of gastroesophageal reflux disease: a cost-effectiveness analysis.

BACKGROUND: The Stretta procedure is an endoscopic therapy for gastroesophageal reflux disease. OBJECTIVE: To evaluate the cost-effectiveness of the Stretta procedure and that of competing strategies in the long-term management of gastroesophageal reflux disease. METHODS: A Markov model was designed to estimate costs and health outcomes in Canadian patients with gastroesophageal reflux disease over five years, from a Ministry of Health perspective. Strategies included the use of daily proton pump inhibitors (PPIs), laparoscopic Nissen fundoplication (LNF) and the Stretta procedure. Probabilities and utilities were derived from the literature. Costs are expressed in 2006 Canadian dollars. Units of effectiveness were symptom-free months (SFMs) and quality-adjusted life years (QALYs), using a five-year time horizon. RESULTS: In the analysis that used SFMs, the strategy using PPIs exhibited the lowest costs ($40 per SFM) and the greatest number of SFMs, thus dominating both the LNF and Stretta systems. But the cost-effectiveness analysis using QALYs as the measure of effectiveness showed that PPIs presented the lowest cost-effectiveness ratio, while both the LNF and Stretta strategies were associated with very high incremental costs (approximately $353,000 and $393,000, respectively) to achieve an additional QALY. However, the PPI strategy did not dominate the two other strategies, which were associated with better effectiveness. CONCLUSIONS: If SFMs are used as the measure of effectiveness, PPIs dominate the Stretta and LNF strategies. However, if QALYs are used, the PPIs still present the lowest cost and LNF gives the best effectiveness. Regardless of the units of effectiveness or utility used in the present cost analysis, an approach of prescribing PPIs appears to be the preferred strategy.

The costs of colonoscopy in a Canadian hospital using a microcosting approach.

BACKGROUND: Colonoscopy has become accepted as one of the most effective methods of screening patients for colorectal cancer, and is used to remove the majority of colonic adenomas. OBJECTIVE: Because of the paucity of such estimates in the literature and the significant number of candidates for this procedure, the present study was performed to estimate the direct hospital costs of both diagnostic and therapeutic (polypectomy) colonoscopy. METHODS: A microcosting methodology was used to itemize the costs of colonoscopy. Variable and fixed costs were divided into labour, supplies, equipment and overhead costs. A third-party payer perspective was adopted. All costs are expressed in 2007 Canadian dollars. RESULTS: The cost of a diagnostic colonoscopy was $157 and the cost of a therapeutic colonoscopy was $199. Overhead costs represented approximately 30% of these amounts. When physician fees were added, these costs rose to $352 and $467, respectively. CONCLUSION: Because the overhead costs represent a large proportion of the total costs, allocation methods for these costs should be improved to allow for a more precise determination of the total costs of a colonoscopy. These estimates are useful when analyzing the cost-effectiveness of a strategy that uses colonoscopy when screening for colorectal cancer.

Cost-effectiveness of proton-pump inhibition before endoscopy in upper gastrointestinal bleeding.

BACKGROUND & AIMS: Randomized trials suggest high-dose proton-pump inhibitors (PPIs) administered before gastroscopy in suspected upper gastrointestinal bleeding downstage bleeding ulcer stigmata. We assessed the cost-effectiveness of this approach. METHODS: A decision model compared high-dose IVPPI initiated while awaiting endoscopy with IVPPI administration on the basis of endoscopic findings. IVPPIs were given to all patients undergoing endoscopic hemostasis for 72 hours thereafter. Once the IV regimen was completed or for patients with low-risk endoscopic lesions, an oral daily PPI was given for the remainder of the time horizon (30 days after endoscopy). The unit of effectiveness was the proportion of patients without rebleeding, representing the denominator of the cost-effectiveness ratio (cost per no rebleeding). Probabilities and costs were derived from the literature and national databases. RESULTS: IVPPIs before endoscopy were both slightly more costly and effective than after gastroscopy in the U.S. and Canadian settings, with cost-effectiveness ratios of US$5048 versus $4933 and CAN$6064 versus $6025 and incremental costs of US$45,673 and CAN$19,832 to prevent one additional rebleeding episode, respectively. Sensitivity analyses showed robust results in the US In Canada, intravenous proton-pump inhibitors (IVPPIs) before endoscopy became more effective and less costly (dominant strategy) when the uncomplicated stay for high-risk patients increased above 6 days or that of low-risk patients decreased below 3 days. CONCLUSIONS: With conservative estimates and high-quality data, IVPPIs given before endoscopy are slightly more effective and costly than no administration. In Canada, this approach becomes dominant as the duration of hospitalization for high-risk ulcer patients increases or that of low-risk ulcer patients decreases.

Estimates of costs of hospital stay for variceal and nonvariceal upper gastrointestinal bleeding in the United States.

OBJECTIVES: Variceal (VUGIB) and nonvariceal (NVUGIB) upper gastrointestinal bleeding are prevalent causes of hospitalization. Cost estimates are needed to determine the impact of their contemporary treatments (endoscopic hemostasis and high-dose proton pump inhibition). We determined the costs of upper gastrointestinal bleeding with or without complications (rebleeding). METHODS: Charges and length of stay (LOS) were obtained from the United States Nation-wide Inpatient Sample. We defined NVUGIB using Diagnosis Related Groups, and VUGIB using International Classification of Diseases, Ninth Revision, Clinical Modification codes. RESULTS: Hospitalization costs with and without complications were $5632 and $3402 for NVUGIB, and $23,207 and $6612 for VUGIB, respectively; similarly, mean LOS were 4.4 and 2.7 days, and 15.2 and 3.8 days. CONCLUSION: We present hospitalization costs and LOS for VUGIB and NVUGIB with and without complications. The reliability of our estimates rests with the size and the national representativeness of the databases used, and should prove helpful for cost analyses for UGIB requiring updated national estimates.