Costs Associated With Early Vascular and Biliary Complications in Liver-Transplanted Patients in a Hospital in Antioquia, Colombia 2019: A Case Series.

OBJECTIVES: Vascular and biliary complications associated with liver transplants involve high morbidity and mortality as well as cost overrun for health systems. Efforts to prioritize their prevention require not only clinical information but also information on costs that reflect the economic burden on health systems. The objective of this study was to describe cost overrun incurred from early vascular and biliary complications after liver transplant. METHODS: This cases series included liver transplant patients treated at the San Vicente Foundation University Hospital, Rionegro, Antioquia, from January 1, 2013, to December 31, 2018. All liver transplant patients treated during the above period were included; the absence of clinical records on the variables of interest was considered the exclusion criterion. A probabilistic analysis of patient cost was performed. Monte Carlo simulations as well as a 1-way sensitivity analysis per transplant cost component were performed. RESULTS: Records from 154 patients were assessed. The average patient age was 56.9 (SD 10.9) years; 42.9% of patients were women. Of all, 36.4% patients were classified as Child C, and the average Model for End-Stage Liver Disease score was 19.6. The average cost for patients without complications was $27 834.82, whereas that for patients with early vascular complications was $36 747.83 and for those with early biliary complications was $38 523.74. CONCLUSION: Early vascular and biliary complications after liver transplant increase healthcare costs, with the increase being significant in patients with biliary complications.

Cost and outcomes of open versus laparoscopic cholecystectomy in Mongolia.

BACKGROUND: Laparoscopic cholecystectomy (LC) is the standard of care for biliary disease in developed countries. LC in resource-limited countries is increasing. This prospective, observational study evaluates costs, outcomes, and quality of life (QoL) associated with laparoscopic versus open cholecystectomy (OC) in Mongolia. METHODS: Patient demographics, outcomes, and total payer and patient costs were elicited from a convenience sample of patients undergoing cholecystectomy at four urban and three rural hospitals (February 2016-January 2017). QoL was assessed preoperatively and postoperatively using the five-level EQ-5D instrument. Perioperative complications, surgical fees, and QoL scores were evaluated for LC versus OC. Multivariate regression models were generated to adjust for differences between these groups. RESULTS: Two hundred and fifteen cholecystectomies were included (LC 122, OC 93). LC patients were more likely to have attended college and have insurance. Preoperative symptoms were comparable between groups. Total complication rate was 21.8% (no difference between groups); LC patients had less superficial infections (0% versus 10.8%). Median hospital length of stay (HLOS) and days to return to work were shorter after LC. QoL improved after surgery for both groups. Mean total payer and patient costs were higher for LC, but not significant (P-value 0.126). After adjustment, LC had significantly less complications, shorter HLOS, fewer days to return to work, greater improvement in QoL scores, and no increase in cost. CONCLUSIONS: LC is safe and beneficial to patients with biliary disease in Mongolia, and cost effective from the patient's and payer's perspective. Although equipment costs for LC may be more expensive than OC, there are likely significant cost savings related to reduced HLOS, shorter time off work, fewer complications, and improved QoL.

Patient-provider relationships and health outcomes among hepatopancreatobiliary patients.

BACKGROUND: The patient-provider relationship (PPR) is an important element of health care delivery and may influence patient outcomes. The objective of the present study was to identify clinical predictors of PPR among patients with hepatopancreatobiliary (HPB) diseases and assess the association of PPR and health care utilization. MATERIALS AND METHODS: The Medical Expenditure Panel Survey database from 2008-2014 was used to identify adult patients with HPB diagnoses. A PPR score of "poor," "average," and "optimal" was calculated from the Consumer Assessment of Healthcare Providers and Systems Survey. Predictors of poor PPR and the association of PPR and health care utilization were assessed. RESULTS: Among 592 patients, PPR was optimal (210, 35.4%), average (270, 45.5%), or poor (114, 19.2%). Patients without insurance (36.3%) or with Medicaid (28.8%) were more likely to report poor PPR versus patients with private insurance (14.0%) or Medicare (15.4%) (P = 0.03). Poor (24.3%)- and low (21.5%)-income patients were more likely to report poor PPR versus middle (12.8%)- or high-income (14.0%) patients (P = 0.03). Poor mental health was also more common among patients with poor PPR (13.4%) versus average (5.4%) or optimal (3.7%) PPR (P = 0.02), and this association between poor PPR and poor mental health remained significant on multivariable analysis (odds ratio [OR] 2.43, 95% confidence interval [CI] 1.20-4.92). Poor PPR was associated with increased emergency room utilization on univariate (OR 2.50, 95% CI 1.21-5.14), but not multivariate (OR 2.18, 95% CI 0.92-5.15) analysis. CONCLUSIONS: Among patients with HPB diseases, PPR was associated with insurance type, socioeconomic status, and mental health scores. Patients reporting poor PPR were more likely to be high utilizers of the emergency room. Efforts to improve the PPR are needed and should be focused on these high-risk populations.

A literature-based cost analysis of tissue plasminogen activator for prevention of biliary stricture in donation after circulatory death liver transplantation.

INTRODUCTION: This study sought to approximate the cost-effectiveness of tPA utilization for prevention of biliary strictures (PTBS) in donation after circulatory death liver transplantation (DCD-LT). METHODS: Previously-reported PTBS rates in DCD-LT with and without tPA were used to calculate the number needed to treat (NNT) for prevention of one PTBS. The incremental cost of PTBS was then used to determine the cost effectiveness of tPA for prevention of PTBS. RESULTS: The incidence of PTBS in the setting of tPA administration was 20%, while incidence in patients without tPA use was 43% (p < 0.001). Meta-analysis demonstrated a risk reduction of 15.7%, which translated into a NNT of 6.4. Cost associated with treating 6.4 patients was $50,353. Based on an incremental cost of $81,888 associated with PTBS management, use of tPA in DCD-LT protocols was estimated to save $31,528 per PTBS prevented. CONCLUSION: Utilization of tPA in DCD-LT protocols represents one possible cost-effective strategy for prevention of PTBS in DCD-LT.

Practice Patterns for Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography for Patients With Choledocholithiasis.

BACKGROUND & AIMS: Cholecystectomy (CCY) after an episode of choledocholithiasis requiring endoscopic retrograde cholangiopancreatography (ERCP) with stone extraction reduces recurrent biliary events compared to expectant management. We studied practice patterns for performance of CCY after ERCP for choledocholithiasis using data from 3 large states and evaluated the effects of delaying CCY. METHODS: We conducted a retrospective cohort study using the ambulatory surgery, inpatient, and emergency department databases from the states of California (years 2009-2011), New York (2011-2013), and Florida (2012-2014). We collected data from 4516 patients hospitalized with choledocholithiasis who underwent ERCP. We compared outcomes of patients who underwent CCY at index admission (early CCY), elective CCY within 60 days of discharge (delayed CCY), or did not undergo CCY (no CCY), calculating rate of recurrent biliary events (defined as an emergency department visit or unplanned hospitalization due to symptomatic cholelithiasis, cholecystitis, choledocholithiasis, cholangitis, or biliary pancreatitis), mortality, and cost by CCY cohort. We also evaluated risk factors for not undergoing CCY. The primary outcome measure was the rate of recurrent biliary events in the 365 days after discharge from index admission. RESULTS: Of the patients who underwent ERCP for choledocholithiasis, 41.2% underwent early CCY, 10.9% underwent delayed CCY, and 48.0% underwent no CCY. Early CCY reduced relative risk of recurrent biliary events within 60 days by 92%, compared with delayed or no CCY (P < .001). After 60 days following discharge from index admission, patients with early CCY had an 87% lower risk of recurrent biliary events than patients with no CCY (P < .001) and patients with delayed CCY had an 88% lower risk of recurrent biliary events than patients with no CCY (P < .001). A strategy of delayed CCY performed on an outpatient basis was least costly. Performance of early CCY was inversely associated with low facility volume. Hispanic race, Asian race, Medicaid insurance, and no insurance associated inversely with performance of delayed CCY. CONCLUSIONS: In a retrospective analysis of >4500 patients hospitalized with choledocholithiasis, we found that CCY was not performed after ERCP for almost half of the cases. Although early and delayed CCY equally reduce the risk of subsequent recurrent biliary events, patients are at 10-fold higher risk of recurrent biliary event while waiting for a delayed CCY compared with patients who underwent early CCY. Delayed CCY is a cost-effective strategy that must be balanced against the risk of loss to follow-up, particularly among patients who are ethnic minorities or have little or no health insurance.

Readmissions due to acute biliary edematous pancreatitis in patients without cholecystectomy.

AIMS: Analyzing the readmission of patients with acute biliary edematous pancreatitis (ABEP) without cholecystectomy despite a previous episode of mild acute gallstone pancreatitis or lithiasic cholecystitis. Calculating the health costs associated with the non-performance of cholecystectomy. MATERIAL AND METHODS: Prospective observational study conducted at a tertiary hospital from July to November 2014. The study has consecutively included inpatients suffering from ABEP who: a) had suffered a previous episode of mild acute gallstone pancreatitis or cholecystitis at least 2 weeks before readmission; and b) had not undergone cholecystectomy despite the lack of contraindications. RESULTS: During the research period, 9 patients (7 females and 2 males) with a mean age of 65.3 years (standard deviation [SD] 19.2) were readmitted. The median number of days between the previous episode of ABEP or cholecystitis and the readmission was 114 days (interquartile range [IQR] 111.0). Reported median overall length of hospital stay was 10 days (IQR = 2.0). Patients underwent a mean of 2.8 (SD = 1.2) ultrasound scans, 1.3 (SD = 0.9) abdominal and pelvic CT, 0.8 (SD = 1.0) MRCP and 0.2 (SD = 0.4) ERCP. The mean cost per patient for each readmission, including hospital stay (143.0 €/day), Emergency Service (332.31 €) and tests performed was 2,381.70 €/patient. CONCLUSIONS: Not performing a cholecystectomy within two weeks after a first episode of mild ABEP or cholecystitis contributes to patient readmission due to recurrent pancreatitis, resulting in avoidable treatment costs.

Single-incision laparoscopic surgery for biliary tract disease.

Single-incision laparoscopic surgery (SILS), or laparoendoscopic single-site surgery, has been employed in various fields to minimize traumatic effects over the last two decades. Single-incision laparoscopic cholecystectomy (SILC) has been the most frequently studied SILS to date. Hundreds of studies on SILC have failed to present conclusive results. Most randomized controlled trials (RCTs) have been small in scale and have been conducted under ideal operative conditions. The role of SILC in complicated scenarios remains uncertain. As common bile duct exploration (CBDE) methods have been used for more than one hundred years, laparoscopic CBDE (LCBDE) has emerged as an effective, demanding, and infrequent technique employed during the laparoscopic era. Likewise, laparoscopic biliary-enteric anastomosis is difficult to carry out, with only a few studies have been published on the approach. The application of SILS to CBDE and biliary-enteric anastomosis is extremely rare, and such innovative procedures are only carried out by a number of specialized groups across the globe. Herein we present a thorough and detailed analysis of SILC in terms of operative techniques, training and learning curves, safety and efficacy levels, recovery trends, and costs by reviewing RCTs conducted over the past three years and two recently updated meta-analyses. All existing literature on single-incision LCBDE and single-incision laparoscopic hepaticojejunostomy has been reviewed to describe these two demanding techniques.

Understanding drivers of hospital charge variation for episodes of care among patients undergoing hepatopancreatobiliary surgery.

BACKGROUND: Understanding factors associated with variation in hospital charges may help identify means to increase savings. The aim of the present study was to define potential variation in hospital charges associated with hepatopancreatobiliary(HPB) surgery. METHODS: Patients who underwent an HPB procedure between 2009-2013 were identified. Total hospital charges were tabulated for room and board, surgical/anaesthesia services, medications, laboratory/radiology services and other miscellaneous charges. RESULTS: Approximately 2545 patients underwent either a pancreas (66.8%) or liver/biliary (33.2%) resection. The mean total charges for all patients were $42,357 ± 33,745 (pancreas: $46,352 ± 34,932 versus the liver: $34,303 ± 29,639; P < 0.001). Morbidity (pancreas, range: 7-18%; liver, range: 9-18%) and observed:expected (O:E) length of stay (LOS)(pancreas, range: 0.67-1.64; liver, range: 1.06-3.35) varied among providers (both P < 0.001). While a peri-operative complication resulted in increased total hospital charges (complication: $66,401 ± 55,124 versus no complication: $39,668 ± 29,250; P < 0.001), total charges remained variable even among patients who did not experience a complication (P < 0.001). Surgeons within the lowest quartile of O:E LOS had lower total charges ($33 879 ± $27 398) versus surgeons in the highest quartile ($49,498 ± 40 971) (P < 0.001). Surgeons with the highest O:E LOS had higher across-the-board charges (operating room, highest quartile: $10,514 ± $4496 versus lowest quartile: $7842 ± $3706; medication, highest quartile: $1796 ± $3799 versus lowest quartile: $925 ± $2211; radiology, highest quartile: $2494 ± $4683 versus lowest quartile: $1424 ± $3247; P = 0.001; laboratory, highest quartile: $4236 ± $5991 versus lowest quartile: $3028 ± $3804; all P < 0.001). CONCLUSIONS: After accounting for in-hospital complications, the total mean hospital charges for HPB surgery remained variable by case type and provider. While the variation in charges was associated with LOS, provider-level differences in across-the-board charges were also noted.

Cost-effectiveness of the evaluation of a suspicious biliary stricture.

BACKGROUND: Biliary stricture without mass presents diagnostic and therapeutic challenges because the poor sensitivity of the available tests and significant mortality and cost with operation. METHODS: A decision model was developed to analyze costs and survival for 1) investigation first with endoscopic ultrasound (EUS) and fine needle aspiration, 2) investigation first with endoscopic retrograde cholangiopancreatography (ERCP) and brushing, or 3) surgery on every patient. The average age of someone with a biliary stricture was found to be 62-y-old and the rate of cancer was 55%. Incremental cost-effectiveness ratios (ICER) were calculated based on the change in quality adjusted life years (QALYs) and costs (US$) between the different options, with a threshold of $150,000 to determine the most cost-effective strategy. One-way, two-way, and probabilistic-sensitivity analysis were performed to validate the model. RESULTS: ERCP results in 9.05 QALYs and a cost of $34,685.11 for a cost-effectiveness ratio of $3832.33. EUS results in an incremental increase in 0.13 QALYs and $2773.69 for an ICER of $20,840.28 per QALY gained. Surgery resulted in a decrease of 1.37 QALYs and increased cost of $14,323.94 (ICER-$10,490.53). These trends remained within most sensitivity analyses; however, ERCP and EUS were dependent on the test sensitivity. CONCLUSIONS: In patients with a biliary stricture with no mass, the most cost-effective strategy is to investigate the patient before operation. The choice between EUS and ERCP should be institutionally dependent, with EUS being more cost-effective in our base case analysis.

Burden of digestive diseases in Portugal: trends in hospitalizations between 2000 and 2010.

OBJECTIVE: Data on the burden of gastrointestinal diseases are incomplete, particularly in Southern European countries. The aim of this study was to estimate the burden of digestive diseases in Portugal. PATIENTS AND METHODS: This was a retrospective observational study based on the national hospitalizations database that identified all consecutive episodes with a first diagnosis of a digestive disease between 2000 and 2010 using ICD-9-CM codes. Comparative analyses were carried out to assess hospitalization trends of major indicators over time and across regions. RESULTS: More than 75,000 deaths attributable to digestive diseases were observed, representing 16% of the overall in-hospital mortality. Over half of these (59%) were premature deaths (in patients <75 years of age). Biliary tract disease was the most common digestive disorder leading to hospitalization (249,817 episodes, 5210 episodes of acute stone-related cholecystitis in 2010, with an 11% increase compared with 2000). Gastric cancer was responsible for the highest number of in-hospital deaths (10,278) and alcohol-related liver disorders accounted for the highest in-hospital premature deaths (7572). Both costs and the in-hospital mortality rate for major digestive diseases showed a significant positive relation with progression of time (ß=0.195, P<0.001); however, when adjusted for age, this was not significant. Significant positive associations were found between age and in-hospital mortality (odds ratio=1.032, P<0.001) and between costs and in-hospital mortality (odds ratio=1.054, P<0.001). CONCLUSION: In Portugal, digestive diseases represent a major burden, with evidence of an increasing trend. An ageing population contributes strongly towards this increase, placing further demands on healthcare organizations. Diseases such as gastric cancer, biliary tract disease and alcohol-related liver disorders may require particular attention.

Clinical outcomes and costs associated with in-hospital biliary complications after liver transplantation: a cross-sectional analysis.

INTRODUCTION: In-hospital biliary complications (BCs) after liver transplantation (LT) are reported in up to 20 % of patients and contribute to poor outcomes and increased costs. Existing single-center outcome and cost analyses studies are limited in scope. METHODS: This is a cross-sectional analysis of national data involving 7,967 patients transplanted between 2011 and 2012 with the primary aim of determining the association between BCs and clinical outcomes and costs. Age, race, diagnosis, and severity of illness are associated with the development of BCs. RESULTS: BCs develop in 14.6 % of LT recipients and have substantial implications for perioperative outcomes, including length of hospital and ICU stay (27.9 vs 19.6 mean days, p < 0.001 and 12.0 vs 8.3 mean days, p < 0.001, respectively), in-hospital morbidity (39 vs 27 %, p < 0.001), 30-day readmissions (14.8 vs 11.2 %, p < 0.001), and in-hospital mortality (5.8 vs 4.0 %, p < 0.001). BCs contributed to a mean increase in in-hospital costs of $36,212 (p < 0.001), due to increases in accommodations ($9,539, p < 0.001), surgical services ($3,988, p < 0.001), and pharmacy services ($8,445, p < 0.001). DISCUSSION: BCs are a predominant etiology for in-hospital morbidity and mortality, while contributing significantly to the high cost of LT. Efforts should be focused on understanding salient and modifiable risk factors, while developing innovative strategies to reduce BCs.

National assessment of early biliary complications after liver transplantation: economic implications.

BACKGROUND: Despite improvement in surgical technique and medical management of liver transplant recipients, biliary complications remain a frequent cause of posttransplant morbidity and graft loss. Biliary complications require potentially expensive interventions including radiologic procedures and surgical revisions. METHODS: A national data set linking transplant registry and Medicare claims data for 12,803 liver transplant recipients was developed to capture information on complications, treatments, and associated direct medical costs up to 3 years after transplantation. RESULTS: Biliary complications were more common in recipients of donation after cardiac death compared to donation after brain death allografts (23% vs. 19% P<0.001). Among donation after brain death recipients, biliary complications were associated with $54,699 (95% confidence interval [CI], $49,102 to $60,295) of incremental spending in the first year after transplantation and $7,327 in years 2 and 3 (95% CI, $4,419-$10,236). Biliary complications in donation after cardiac death recipients independently increased spending by $94,093 (95% CI, $64,643-$124,542) in the first year and $12,012 (95% CI, $-1,991 to $26,016) in years 2 and 3. CONCLUSION: This national study of biliary complications demonstrates the significant economic impact of this common perioperative complication and suggests a potential target for quality of care improvements.

Prospective randomized trial using cost-utility analysis of early versus delayed laparoscopic cholecystectomy for acute gallbladder disease.

BACKGROUND: This randomized controlled trial compared the cost-utility of early laparoscopic cholecystectomy with that for conventional management of newly diagnosed acute gallbladder disease. METHODS: Adults admitted to hospital with a first episode of biliary colic or acute cholecystitis were randomized to an early intervention group (36 patients, operation within 72 h of admission) or a conventional group (36, elective cholecystectomy 3 months later). Costs were measured from a National Health Service and societal perspective. Quality-adjusted life year (QALY) gains were calculated 1 month after surgery. RESULTS: The mean(s.d.) total costs of care were pound 5911(2445) for the early group and pound 6132(3244) for the conventional group (P = 0.928), Mean(s.d.) societal costs were pound 1322(1402) and pound 1461(1532) for the early and conventional groups respectively (P = 0.732). Visual analogue scale scores of health were 72.94 versus 84.63 (P = 0.012) and the mean(s.d.) QALY gain was 0.85(0.26) versus 0.93(0.13) respectively (P = 0.262). The incremental cost per additional QALY gained favoured conventional management at a cost of pound 3810 per QALY gained. CONCLUSION: In this pragmatic trial, the cost-utilities of both the early and conventional approaches were similar, but the incremental cost per additional QALY gained favoured conventional management.

Outcomes following cholecystectomy in pregnant and nonpregnant women.

BACKGROUND: This study is the first population-based measurement of outcomes after cholecystectomy during pregnancy. METHODS: We identified all pregnant women who underwent cholecystectomy in the Healthcare Cost and Utilization Project-Nationwide Inpatient Sample, 1996-2006. Outcomes were fetal, maternal, and surgical complications, length of stay (LOS), and hospital cost. Pregnant and nonpregnant women were compared to examine the effects of pregnancy on laparoscopic cholecystectomy outcomes. RESULTS: A total of 9,714 pregnant women underwent cholecystectomy (laparoscopic, 89%). Maternal and fetal complication rates were 4.3% and 5.8%, respectively. Pregnant women who underwent laparoscopic cholecystectomy compared to pregnant women who underwent open procedures had higher rates of surgical (19% vs 10%), maternal (9% vs 4%), and fetal (11% vs 5%) complications; longer LOS (6 vs 4 days); and higher cost ($13,198 vs $9,229), all P < .0001. High-volume surgeons were associated with lower rates of surgical (10% vs 13%; P < .05), maternal (1% vs 14%), and fetal (4% vs 10%) complications; shorter LOS (4 vs 5 days); and lower cost ($8,365 vs $10,350), all P < .0001. Patients with Medicaid coverage were associated with higher rates of surgical complications (13% vs 9%), longer LOS (4.3 vs 3.7 days), and higher cost ($10,403 vs $9,037), all P < .0001. On multivariable analysis, these factors remained independent predictors of outcome. Pregnancy was associated with longer LOS and higher cost. CONCLUSION: Complications of cholecystectomy during pregnancy are significant, with disparities based on modifiable variables.

The cost of ignoring acute cholecystectomy.

INTRODUCTION: Biliary symptoms whilst awaiting elective cholecystectomy are common, resulting in hospital admission, further investigation and increased hospital costs. Immediate cholecystectomy during the first admission is safe and effective, even when performed laparoscopically, but acute laparoscopic cholecystectomy has only recently become increasingly commonplace in the UK. This study was designed to quantify this problem in our hospital and its cost implications. PATIENTS AND METHODS: The case notes of all patients undergoing laparoscopic cholecystectomy in our hospital between January 2004 and June 2005 were examined for details of hospital admissions with biliary symptoms or complications whilst waiting for elective cholecystectomy. Additional bed occupancy and radiological investigations were recorded and these costs to the trust calculated. We compared the potential tariff income to the hospital trust for the actual management of these patients and if a policy of acute laparoscopic cholecystectomy on first admission were in place. RESULTS: In the 18-month study period, 259 patients (202 females) underwent laparoscopic cholecystectomy. Of these, 147 presented as out-patients and only 11% required hospital admission because of biliary symptoms whilst waiting for elective surgery. There were 112 patients who initially presented acutely and were managed conservatively. Twenty-four patients were re-admitted 37 times, which utilised 231 hospital bed-days and repeat investigations costing over 40,000 pounds. There would have been a marginal increase in tariff income if a policy of acute laparoscopic cholecystectomy had been in place. CONCLUSIONS: Adoption of a policy of acute laparoscopic cholecystectomy on the index admission would result in substantial cost savings to the trust, reduce elective cholecystectomy waiting times and increase tariff income.

Cost-effectiveness of endoscopic ultrasonography, magnetic resonance cholangiopancreatography and endoscopic retrograde cholangiopancreatography in patients suspected of pancreaticobiliary disease.

BACKGROUND: It is not known whether initial endoscopic ultrasonography (EUS) or magnetic resonance cholangiopancreatography (MRCP) is more cost effective than endoscopic retrograde cholangiopancreatography (ERCP). METHODS: A cost-effectiveness analysis of EUS, MRCP and ERCP was performed on 163 patients. The effectiveness of an investigation was defined as the percentage of patients with no need for further evaluation after the investigation in question had been performed. Costs were assumed from the budget-holder's point of view. RESULTS: MRCP, EUS and ERCP had a total accuracy of 0.91, 0.93 and 0.92, respectively. Eighty-four (52%) patients needed endoscopic therapy in combination with ERCP, giving an effectiveness of MRCP, EUS, and ERCP of 0.44, 0.45 and 0.92, respectively. The cost-effectiveness of MRCP, EUS, and ERCP was 6622, 7353 and 4246 Danish Kroner (DKK) per fully investigated and treated patient (1 DKK=0.14 EUR). CONCLUSION: Within a patient population with a probability of therapeutic ERCP in 50% of the patients, ERCP was the most cost-effective strategy.

Making cost-effectiveness analyses clinically relevant: the effect of provider expertise and biliary disease prevalence on the economic comparison of alternative diagnostic strategies.

RATIONALE AND OBJECTIVES: This study was performed to assess the incremental cost-effectiveness of initial magnetic resonance cholangiopancreatography (MRCP) and initial endoscopic ultrasonography (EUS) compared with initial endoscopic retrograde cholangiopancreatography (ERCP) and to evaluate the effect of MRCP provider expertise on the relative cost-effectiveness of the three methods. MATERIALS AND METHODS: Thirty patients with suspected biliary disease and referred for ERCP were prospectively evaluated with EUS, MRCP, or ERCP within 24 hours of referral, according to institutional review board-approved protocol. Performance characteristics were measured for EUS and MRCP, with ERCP as the reference standard. A decision analysis compared the clinical and economic effects of three diagnostic strategies (ERCP, EUS followed by ERCP [EUS-ERCP], and MRCP followed by ERCP [MRCP-ERCP]) using prospective EUS and MRCP test characteristics and Medicare reimbursements. The added costs per additional correct diagnosis and per additional false-positive finding averted and the rates and costs of ERCP-related complications were calculated for EUS-ERCP and MRCP-ERCP. Two additional MRCP readers reviewed MRCP data to evaluate interobserver variability and estimate provider expertise. Additional economic analyses incorporated these estimates. RESULTS: Compared with initial ERCP, EUS-ERCP demonstrated 72% of biliary abnormalities and reduced ERCP-related complications by 60%; the corresponding percentages for MRCP-ERCP were 48% and 40%. Initial EUS and initial MRCP decreased the number of ERCP procedures performed by 69% and 49%, respectively. Each correct diagnosis made with ERCP that would not have been made with initial EUS or initial MRCP cost an additional 4,875 dollars or 2,580 dollars, respectively. Each false-positive diagnosis averted with initial ERCP that would have been made with EUS-ERCP or MRCP-ERCP cost an additional 9,750 dollars or 1,548 dollars, respectively. The decision model was most sensitive to disease prevalence. As provider expertise increased, the additional cost of an additional correct diagnosis increased for ERCP compared with MRCP-ERCP, with disease prevalence accentuating provider effects. CONCLUSION: Initial EUS and initial MRCP are less costly than initial ERCP, but provider expertise, biliary disease prevalence, and procedural costs influence incremental cost-effectiveness.

Funding, disease area, and internal validity of hepatobiliary randomized clinical trials.

OBJECTIVE: The aim of this study was to assess whether funding and the disease area are related to the internal validity of hepatobiliary randomized clinical trials. METHODS: We gathered data on funding, disease area, methodological quality (randomization and double blinding), and sample size from 616 hepatobiliary randomized clinical trials published from 1985 to 1996 in 12 MEDLINE indexed journals. RESULTS: The internal validity (methodological quality and sample size) of trials funded by profit or nonprofit organizations was not significantly different. Compared with these trials, trials without funding were significantly less likely to report adequate generation of the allocation sequence (55% vs 41%, p = 0.001) and to be double blind (42% vs 25%, p < 0.001), but the proportion with adequate allocation concealment and the sample size were not significantly different. The trials covered 12 disease areas. The proportion of funded trials did not differ significantly in different disease areas. The disease area was significantly associated with the proportion of trials with adequate generation of the allocation sequence (p < 0.001), allocation concealment (p = 0.003), and double blinding (p < 0.001) as well as the sample size (p < 0.001). This association was not explained by the proportion of trials with funding. CONCLUSIONS: External funding was significantly associated with adequate methodological quality, but not with the sample size. Irrespective of funding, the disease area was significantly associated with the methodological quality and sample size. Accordingly, external funding and the disease area are significant predictors of the internal validity of hepatobiliary randomized clinical trials.

MR and ultrasound in screening of patients with suspected biliary tract disease.

PURPOSE: The diagnostic value and cost-efficiency of MR imaging were compared with US before endoscopic retrograde cholangiopancreatography (ERCP) in patients with clinically suspected biliary tract disease. MATERIAL AND METHODS: In a prospective study of 219 patients, 85 were examined with both MR and US before ERCP. RESULTS: To find the correct diagnosis in the jaundiced patients the sensitivity of US, MR and ERCP was 53%, 93%, and 89%, respectively. In the patients with abdominal upper quadrant pain and normal serum bilirubin, the sensitivity of US, MR and ERCP was 50%, 100% and 70%, respectively. Examination with MR costs four times more than US. Screening with US and supplemental MR in non-diagnostic cases would cost 80% of the total amount compared to screening with MR only. CONCLUSION: MR had a higher sensitivity than US for diagnosing biliary tract disease and MR was superior to US in visualising stones in the common bile duct and in diagnosing the cause of cholestasis. However, screening with US and supplemental MR in non-diagnostic cases is at present most cost-effective. With increased accessibility and slightly lower costs, MR will probably replace US as screening method in patients with suspected biliary tract disease.