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.

Physician Assessment and Feedback During Quality Circle to Reduce Low-Value Services in Outpatients: a Pre-Post Quality Improvement Study.

BACKGROUND: The impact of the Choosing Wisely (CW) campaign is debated as recommendations alone may not modify physician behavior. OBJECTIVE: The aim of this study was to assess whether behavioral interventions with physician assessment and feedback during quality circles (QCs) could reduce low-value services. DESIGN AND PARTICIPANTS: Pre-post quality improvement intervention with a parallel comparison group involving outpatients followed in a Swiss-managed care network, including 700 general physicians (GPs) and 150,000 adult patients. INTERVENTIONS: Interventions included performance feedback about low-value activities and comparison with peers during QCs. We assessed individual physician behavior and healthcare use from laboratory and insurance claims files between August 1, 2016, and October 31, 2018. MAIN MEASURES: Main outcomes were the change in prescription of three low-value services 6 months before and 6 months after each intervention: measurement of prostate-specific antigen (PSA) and prescription rates of proton pump inhibitors (PPIs) and statins. KEY RESULTS: Among primary care practices, a QC intervention with physician feedback and peer comparison resulted in lower rates of PPI prescription (pre-post mean prescriptions per GP 25.5 ± 23.7 vs 22.9 ± 21.4, p value<0.01; coefficient of variation (Cov) 93.0% vs 91.0%, p=0.49), PSA measurement (6.5 ± 8.7 vs 5.3 ± 6.9 tests per GP, p<0.01; Cov 133.5% vs 130.7%, p=0.84), as well as statins (6.1 ± 6.8 vs 5.6 ± 5.4 prescriptions per GP, p<0.01; Cov 111.5% vs 96.4%, p=0.21). Changes in prescription of low-value services among GPs who did not attend QCs were not statistically significant over this time period. CONCLUSION: Our results demonstrate a modest but statistically significant effect of QCs with educative feedback in reducing low-value services in outpatients with low impact on coefficient of variation. Limiting overuse in medicine is very challenging and dedicated discussion and real-time review of actionable data may help.

Development, Validation, and Comparative Assessment of an International Scoring System to Determine Risk of Upper Gastrointestinal Bleeding.

BACKGROUND & AIMS: The Glasgow-Blatchford score (GBS) and pre-endoscopy Rockall score (pRS) are used in determining prognoses of patients with acute upper gastrointestinal bleeding, but neither predicts outcomes of patients with a high level of accuracy. A scoring system is needed to identify patients at risk of adverse outcomes and patients at low risk of harm. METHODS: We pooled data from 5 data sets in Canada, the United Kingdom, and Australia on 12,711 patients with acute upper gastrointestinal bleeding. The GBS and pRS were calculated for each patient. We performed multivariable logistic regression modeling of data from 10,639 cases to develop the new scoring system Canada - United Kingdom - Adelaide (CANUKA). We performed area under the receiver operating characteristic analyses to test the ability of CANUKA to identify patients who died or had rebleeding within 30 days, surgical or radiologic intervention to control bleeding, need for therapeutic endoscopy, and transfusion-a poor outcome was defined as 1 or more of these outcomes. Patients at low risk of a poor outcome (safe for management as an outpatient) were identified based on lack of transfusion, rebleeding, therapeutic endoscopy, interventional radiology or surgery, or death. We validated in 2072 patients from a separate cohort compiled from 2 datasets. RESULTS: In the development data set there was no difference between GBS and pRS in identifying patients who died without 30 days of bleeding (area under the receiver operating characteristic curve [AUROC], 0.67; 95% CI, 0.62-0.72 for GBS; AUROC, 0.70; 95% CI, 0.66-0.74 for pRS; P = .21). The GBS was superior to the pRS in identifying patients with rebleeding, hemostatic interventions, and transfusions. In the validation data set, CANUKA had higher accuracy than the GBS in identifying patients who died within 30 days of bleeding (AUROC, 0.77 vs 0.74; P = .047), but there was no significant difference in the accuracy of these scoring systems in identifying patients who required hemostatic intervention. The GBS more accurately identified patients who required therapeutic endoscopy (AUROC, 0.78; 95% CI, 0.76-0.81 for GBS; AUROC, 0.77; 95% CI, 0.74-0.79 for CANUKA; P = .47). For patients classified as low-risk patients by CANUKA (score ≤1), 96.3% were safely discharged, whereas 16 patients with a GBS ≤1 had an adverse outcome (a 95.3% probability of safe discharge). CONCLUSIONS: In an international validation analysis of the GBS and pRS for patients with acute upper gastrointestinal bleeding, we found the GBS to more accurately identify those who later required hemostatic interventions and transfusions; the scoring systems identified 30-day mortality or rebleeding with equal levels of accuracy. We developed a scoring system (CANUKA) that had similar performance to the GBS in predicting patient outcomes and it more accurately identifies patients at low risk for adverse outcomes.

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.

Assessment of a Colonoscopy Triage Sheet for Use in a Province-Wide Population-Based Colorectal Screening Program.

Background and Aims. A colonoscopy triage sheet (CTS) integrating 6 hierarchical scheduling priorities based on indications for screening, surveillance, or symptoms was designed for colonoscopy referral. We compared CTS priority ratings by referring physicians and endoscopists, assessing yields. Methods. Retrospective study of consecutive patients. Data were collected on demographics, CTS and endoscopist priority ratings, and endoscopic findings. Weighted kappa values measured interrater agreement on priority assignment. Predictors of agreement and lesions were identified using multivariable analysis. Results. Among 1230 patients (60.3 years, 52.5% female), clinically significant lesions included tumors (1.1%), polyps per patient ≥ 10 mm (7.6%), and ileocolitis (4.6%). Moderate agreement was found between referring physician and endoscopist on all 6 priorities (weighted kappa 0.55 (0.51; 0.59)). P4 and P5 ratings predicted increased agreement (range of OR for P4: 2.47-4.57; P5: 1.58-2.93). Predictors of clinically significant findings were male gender (OR 1.44, 1.03-2.03) and P1/P2 priorities that were significantly superior to P3 (OR = 2.14; 1.04-4.43), P4 (OR = 2.90; 1.35-6.23), and P5 (OR = 4.30; 2.08-8.88). Conclusion. Priority-assignment agreement is moderate and highest for less urgent ratings. Predictors of clinically significant findings validate the hierarchal priority scheme. Broader validation and physician education are needed.

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.

Current status of core and advanced adult gastrointestinal endoscopy training in Canada: Survey of existing accredited programs.

OBJECTIVE: To determine the current status of core and advanced adult gastroenterology training in Canada. METHODS: A survey consisting of 20 questions pertaining to core and advanced endoscopy training was circulated to 14 accredited adult gastroenterology residency program directors. For continuous variables, median and range were analyzed; for categorical variables, percentage and associated 95% CIs were analyzed. RESULTS: All 14 programs responded to the survey. The median number of core trainees was six (range four to 16). The median (range) procedural volumes for gastroscopy, colonoscopy, percutaneous endoscopic gastrostomy and sigmoidoscopy, respectively, were 400 (150 to 1000), 325 (200 to 1500), 15 (zero to 250) and 60 (25 to 300). Eleven of 13 (84.6%) programs used endoscopy simulators in their curriculum. Eight of 14 programs (57%) provided a structured advanced endoscopy training fellowship. The majority (88%) offered training of combined endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasonography. The median number of positions offered yearly for advanced endoscopy fellowship was one (range one to three). The median (range) procedural volumes for ERCP, endoscopic ultrasonography and endoscopic mucosal resection, respectively, were 325 (200 to 750), 250 (80 to 400) and 20 (10 to 63). None of the current programs offered training in endoscopic submucosal dissection or natural orifice transluminal endoscopic surgery. CONCLUSION: Most accredited adult Canadian gastroenterology programs met the minimal procedural requirements recommended by the Canadian Association of Gastroenterology during core training. However, a more heterogeneous experience has been observed for advanced training. Additional studies would be required to validate and standardize evaluation tools used during gastroenterology curricula.

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.

Conflicts of interest ethics: silencing expertise in the development of international clinical practice guidelines.

BACKGROUND: It is unclear whether global experts with financial conflicts of interest (FCOIs) should be included in, be excluded from, or have a limited role in developing international clinical practice guidelines (CPGs). Optimal management of FCOIs to ensure independent, expert CPGs remains ethically contested. OBJECTIVE: To manage FCOIs and examine whether an ethics framework with discussion recusal by experts with FCOIs affects deliberations and voting on a CPG. DESIGN: Development of an ethics framework grounded on transparency and proportional management of COIs, including self-recusal, evaluation of the effect on COIs and CPG process by quantification of voting on recommendations, and qualitative assessment of experts' ethics dialogue. SETTING: International consensus meeting to formulate a CPG in gastroenterology. PARTICIPANTS: 34 experts from 15 countries. MEASUREMENTS: Counting the votes of experts with and without declared FCOIs and qualitative assessment of ethics discussions. RESULTS: 62% of experts reported at least 1 FCOI. Eight out of 21 recommendations presented potential FCOIs. Experts with conflicts recused themselves from discussing 6 of the 8 recommendations, leaving a majority of nonconflicted discussants (median, 22; range, 19 to 26) for the 6 recommendations. Recusals did not affect voting outcomes but may have diluted the richness of the discussions. Ethics dialogue revealed accord on transparency but underscored challenges to proportional management of COIs beyond basic disclosure. Concerns about bias, COI definitions, expertise, and integrity express important international ethics questions. LIMITATION: Small participant numbers and application of the framework to only 1 meeting of 1 CPG. CONCLUSION: An ethics framework may help to identify and manage COIs and catalyze both ethics dialogue and innovative COI standards that seek to balance impartiality and expertise for trusted CPGs. Optimal balancing remains contested. Recommendations include frameworks, interdisciplinary analysis, and international policy initiatives to better manage COIs in the CPG process. PRIMARY FUNDING SOURCE: Canadian Association of Gastroenterology; European Association for Gastroenterology and Endoscopy; Asian Pacific Society of Digestive Endoscopy; and Institute of Diabetes, Metabolism, and Nutrition of the Canadian Institutes of Health Research.

The importance of process issues as predictors of time to endoscopy in patients with acute upper-GI bleeding using the RUGBE data.

BACKGROUND: Early endoscopy has been shown to improve outcomes and optimize cost-effectiveness in nonvariceal upper-GI bleeding (NVUGIB). However, there is little information regarding clinical and process determinants that affect the time from onset of bleeding to performance of the endoscopy. OBJECTIVE: The aim of this study was to identify factors that predict time to endoscopy in patients with new onset NVUGIB. DESIGN: Linear regression models were constructed with time between triage (outpatients) or onset of bleeding (inpatients) and the performance of endoscopy. SETTING: The RUGBE is a nationwide, multicenter database collected for the purpose of obtaining descriptive data on patients with NVUGIB. PATIENTS: The study population consisted of 1500 patients (89.6%) who underwent gastroscopy within 48 hours. RESULTS: Median time to endoscopy was 12 hours (95% CI 11.0, 13.0). Endoscopy after working hours (regression coefficient [beta] -3.52; 95% CI -5.47, -1.58), availability of an endoscopy nurse on-call for the procedure (beta -2.48; 95% CI -3.83, -1.14), and admission to a hospital unit were associated with a shorter interval to endoscopy. In contrast, the presence of chest pain (beta 3.65; 95% CI 1.64, 5.67) or dyspnea (beta 2.79; 95% CI 1.10, 4.48), absence of gross blood on rectal examination (beta 2.20; 95% CI 0.69, 3.71), and inpatient status at onset of bleeding (beta 14.6; 95% CI 8.70, 20.4) were independent predictors of a delayed endoscopy. Subgroup analysis showed that actual time intervals as well as independent predictors of time until endoscopy differed between inpatients and outpatients. LIMITATIONS: Retrospective analysis. CONCLUSIONS: The timing of endoscopy in patients with NVUGIB is dependent on both clinical and process parameters, which differ between inpatient and outpatient settings. They bear implications with regards to shaping practice and deciding on resource allocation in order to facilitate an early endoscopy, which is currently recommended for improved patient outcomes.