Assessment of the PHQ-9 as a screening tool for depression in patients with chronic hepatitis C.

BACKGROUND AND OBJECTIVES: We examined the test characteristics of the PHQ-9, a new screening tool that has been validated in the general population but not amongst patients with hepatitis C virus (HCV). METHODS: The PHQ-9, CES-D and BDI-II questionnaires were administered to 129 consecutive patients with chronic HCV attending a specialty clinic between August 2005 and April 2006. RESULTS: Approximately 52% of participants reported symptoms suggesting depression. Prevalence of depression was 62% using the BDI-II, 75% per the PHQ-9 and 72% per the CES-D. We observed a strong correlation between the BDI-II, CES-D and PHQ-9 in patients on and off interferon. Scores on the three questionnaires were only moderately associated with symptoms reported by the patients. There was moderate agreement between the CES-D and BDI-II and slight agreement between both these questionnaires and the PHQ-9. Scores on the PHQ-9 correlated strongly with scores on the CES-D and BDI-II and moderately with patients' symptoms.

Cost-effectiveness of screening for hepatopulmonary syndrome in liver transplant candidates.

The hepatopulmonary syndrome (HPS) is present in 15-20% of patients with cirrhosis undergoing orthotopic liver transplantation (OLT) evaluation. Both preoperative and post-OLT mortality is increased in HPS patients particularly when hypoxemia is severe. Screening for HPS could enhance detection of OLT candidates with sufficient hypoxemia to merit higher priority for transplant and thereby decrease mortality. However, the cost-effectiveness of such an approach has not been assessed. Our objective was to perform a cost-effectiveness analysis from a third-party payer's perspective of screening for HPS in liver OLT candidates. The costs and outcomes of 3 different strategies were compared: (1) no screening, (2) screening patients with a validated dyspnea questionnaire, and (3) screening all patients with pulse oximetry. Arterial blood gas analyses and contrast echocardiography were performed in patients with dyspnea or a pulse oximetry (SpO(2)) < or =97% to define the presence of HPS. A Markov model was constructed simulating the natural history of cirrhosis in a cohort of patients 50 years old over a time horizon of their remaining life expectancy. Transition probabilities were obtained from published data available through Medline and U.S. vital statistics. Costs represented Medicare reimbursement data at our institution. Costs and health effects were discounted at a 3% annual rate. No screening was associated with a total cost of 291,898 dollars and a life expectancy of 11.131 years. Screening with pulse oximetry was associated with a cost of 299,719 dollars and a life expectancy of 12.27 years. Screening patients with the dyspnea-fatigue index was associated with a cost and life expectancy of 300,278 dollars and 12.28 years, respectively. The incremental cost-effectiveness ratio of screening with pulse oximetry (compared to no screening) was 6,867 dollars per life year gained, whereas that of the dyspnea-fatigue index (compared to pulse oximetry) was 55,900 dollars per life year gained. The cost-effectiveness of screening depended on the prevalence and severity of HPS, and the choice of screening strategy was dependent on the sensitivity of the screening modality. In conclusion, screening for HPS, especially with pulse oximetry, is a cost-effective strategy that improves survival in transplant candidates predominantly by targeting the transplant to the subgroup of patients most likely to benefit. The utility of screening depends on the prevalence and severity of HPS in the target population.

Economical and clinical outcomes of alternative treatment strategies in the management of common bile duct stones in the elderly: wait and see or surgery?

BACKGROUND: Common bile duct stones (CBDS) are especially prevalent in the elderly population. Although the standard of care for stone removal is endoscopic retrograde cholangiography with sphincterotomy (ERC-S), the clinician's decision to refer a patient for cholecystectomy after ERC-S depends on several factors including potential for future biliary symptoms and complications, morbidity and mortality related to cholecystectomy, and costs associated with referral for cholecystectomy versus conservative approach. Using decision analysis, we explored the economic implications of cholecystectomy versus expectant management following ERC-S in elderly patients with CBDS. MATERIALS AND METHOD: A decision tree was constructed with DATA 3.5 (Williamstown, MA) to estimate the costs and outcomes associated with two treatment strategies following ERC-S for CBDS in patients age 60 yr and older: (1) elective cholecystectomy, and (2) expectant management. Probabilities for potential complications and outcomes were derived from the medical literature and cost reflected Medicare reimbursement rates at our institution. The time horizon of the analysis was 2 yr. RESULTS: Elective cholecystectomy was associated with total costs of 5,259 dollars with 94.3% of the cohort alive (1.886 life-years) at 2 yr, whereas expectant management was associated with total costs of 1,173 dollars with 94.7% of the cohort alive (1.894 life-years). The results were sensitive to the probability of recurrent biliary symptoms in patients treated conservatively. Compared to elective cholecystectomy, expectant management became less effective and more expensive at a yearly probability of recurrent symptoms greater than 40% and 90%, respectively. CONCLUSIONS: In patients aged 60 and older, expectant management after ERC-S for CBDS is a reasonable approach, but the economic attractiveness of this strategy is highly dependent on the probability of recurrent symptoms.

Expandable metal biliary stents before pancreaticoduodenectomy for pancreatic cancer: a Monte-Carlo decision analysis.

BACKGROUND & AIMS: Endoscopic placement of plastic or self-expandable metal biliary stents (SEMS) relieves obstructive jaundice from pancreatic cancer. Short-length, distally placed SEMS do not preclude subsequent pancreaticoduodenectomy. We sought to determine whether SEMS placement in patients whose surgical status is uncertain is cost-effective for management of obstructive jaundice. METHODS: A Markov model was constructed to evaluate costs and outcomes associated with endoscopic biliary stenting for obstructive jaundice. Strategies evaluated were: (1) initial plastic stent with plastic stents for subsequent occlusions in nonsurgical candidates after staging (plastic followed-up by [f/u] plastic), (2) initial plastic with subsequent SEMS (plastic f/u metal), (3) initial short-length SEMS with subsequent plastic (metal f/u plastic), and (4) initial short-length SEMS with subsequent expandable metal stent (metal f/u metal). Published stent occlusion rates, ERCP complication rates and outcomes, cholangitis rates and outcomes, pancreatic cancer mortality rates, and Whipple complication rates were used. Costs were based on 2004 Medicare standard allowable charges and were accrued until all patients reached an absorbing health state (death or pancreaticoduodenectomy) or 24 cycles (24 mo) ended. RESULTS: Average costs per patient from Monte Carlo simulation were: (1) metal f/u metal, $19,935; (2) plastic f/u metal, 20,157 dollars; (3) metal f/u plastic, 20,871 dollars; and (4) plastic f/u plastic, 20,878 dollars. For initial plastic stents to be preferred over short-length metal stents, 70% or more of pancreatic cancers would need to be potentially resectable by pancreaticoduodenectomy. CONCLUSIONS: In patients undergoing ERCP before definitive cancer staging, short-length SEMS is the preferred initial cost-minimizing strategy.

A cost-minimization analysis of alternative strategies in diagnosing pancreatic cancer.

BACKGROUND: Several modalities currently exist for tissue confirmation of suspected pancreatic cancer prior to therapy. Since there is a paucity of cost-minimization studies comparing these different biopsy modalities, we analyzed costs and examined effectiveness of four alternative strategies for diagnosing pancreatic cancer. METHODS: A decision analysis model of patients with suspected pancreatic cancer was constructed. We analyzed costs, failure rate, testing characteristics, and complication rates of four commonly employed diagnostic modalities: 1) computerized tomography or ultrasound-guided fine-needle aspiration (CT/US-FNA), 2) endoscopic retrograde cholangiopancreatography with brushings (ERCP-B), 3) Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA), and 4) laparoscopic surgical biopsy. If the first attempt with a particular modality failed, a different modality was employed to identify the most preferable secondary biopsy strategy. RESULTS: This analysis identifies EUS-FNA as the preferred initial modality for the diagnosis of pancreatic cancer. Resultant expected costs and strategies in decreasing optimality include: 1) EUS-FNA (1,405 dollars), 2) ERCP-B (1,432 dollars), 3) CT/US-FNA (3,682 dollars), and 4) surgery (17,711 dollars). If a patient presents with obstructive jaundice, decision analysis modeling resulted in a total expected costs of 1,970 dollars if ERCP-B is successful at the time of biliary stent placement. Additional analyses to identify the preferred follow-up modality after a failed alternative method showed that EUS-FNA is the preferred secondary modality if any of the other three modalities failed first, in both the setting of and absence of obstructive jaundice. One- and two-way sensitivity analysis of the variables shows unchanged results over an acceptable range. CONCLUSIONS: This cost-minimization study illustrates that EUS-FNA is the best initial and the preferred secondary alternative method for the diagnosis of suspected pancreatic cancer. In addition to local expertise and availability, costs and diagnostic yield should be considered when choosing an optimal diagnostic strategy.

Re-examination of the cost-effectiveness of surgical versus medical therapy in patients with gastroesophageal reflux disease: the value of long-term data collection.

OBJECTIVES: For patients with reflux esophagitis, long-term therapeutic options include proton pump inhibitor (PPI) therapy and/or antireflux surgery. An earlier cost-effectiveness analysis concluded that at 5 yr, medical therapy was less expensive but similarly effective to fundoplication, but the results were sensitive to estimates on quality of life and long-term medication usage, which were derived from "expert opinion." Recently, data from randomized controlled trials addressing these variables have become available. We have incorporated these new data into a revised Markov model to examine the cost-effectiveness of surgical versus medical therapy in patients with severe reflux esophagitis. METHODS: A Markov simulation model was constructed using specialized software (DATA PRO 4.0, Williamstown, MA). Total expected costs and quality-adjusted life-years were calculated for long-term medical therapy and for laparoscopic Nissen fundoplication. Probabilities were obtained from the medical literature using Medline. Procedural and hospitalization costs used were the average Medicare reimbursements at our institution. Medication costs were the average wholesale price. The analysis was extended over a 10-yr time horizon at a discount rate of 3%. RESULTS: The discounted analysis shows that medical therapy is associated with total costs of 8,798 dollars and 4.59 quality-adjusted life-years, whereas the surgical strategy is more expensive (10,475 dollars) and less effective (4.55 quality-adjusted life-years). The results were robust to most one-way sensitivity analyses. CONCLUSIONS: Long-term medical therapy with proton pump inhibitors is the preferred strategy for patients with gastroesophageal reflux disease and severe esophagitis. Our study highlights the importance of using primary, patient-derived data rather than expert opinion.

Cost implications of administering intravenous proton pump inhibitors to all patients presenting to the emergency department with peptic ulcer bleeding.

OBJECTIVES: Administering proton pump inhibitors (PPI) intravenously (iv) after endoscopic treatment of bleeding peptic ulcers reduces the incidence of rebleeding, the need for operative procedures, and hospitalizations. We assessed the cost implications of iv PPI initiated in all patients presenting to the emergency department (ED) with signs of upper gastrointestinal (UGI) bleeding. METHODS: From a third-party payer perspective with a time horizon of 60 days, we built a decision analytic model comparing standard endoscopic therapy to a strategy in which all patients presenting to the ED with UGI bleeding would start iv PPI before endoscopy. After endoscopy, only those with peptic ulcers would be kept on iv PPI added to standard therapy. Probabilities of health events were extracted from published literature. Resource utilization profiles and costs (iv PPI, hospital stay for medical and operative procedures, and professional fees) were based on Medicare reimbursement data from a large hospital in Alabama. All costs were expressed in 2000 US dollars. Uncertainty was investigated through one-way sensitivity analyses and probabilistic analyses using Monte Carlo simulations. RESULTS: In a hypothetical group of 1000 individuals, routine use of iv PPI prevented 40 rebleeds, 9 surgical procedures, and 223 hospital days, and led to incremental savings of dollars 920 per subject. Probabilistic sensitivity analyses indicated that the strategy of using iv PPI was likely to be dominant even when accounting for uncertainty. CONCLUSIONS: Based on available evidence, routine administration of iv PPI to all persons presenting with UGI bleeding represents good value for money and merits consideration as standard hospital policy.

Screening for hepatocellular carcinoma in patients with hepatitis C cirrhosis: a cost-utility analysis.

OBJECTIVES: Screening for hepatocellular carcinoma (HCC) is advocated in cirrhotic patients to optimize early detection and treatment. However, the cost-effectiveness is not well defined. Our objective was to perform a cost-utility analysis from a third-party payer's perspective of no screening, alpha-fetoprotein (AFP) concentration measurement alone, abdominal ultrasound (US) and AFP, abdominal three-phase CT and AFP, and abdominal magnetic resonance imaging (MRI) and AFP. METHODS: A Markov model was constructed simulating the natural history of hepatitis C-related cirrhosis in a cohort of patients age 50 yr over a time horizon of their remaining life expectancy. Transition probabilities were obtained from published data and U.S. vital statistics. Costs represented Medicare reimbursement data. Costs and health effects were discounted at a 3% annual rate. RESULTS: Screening with ultrasonography and AFP concentration measurement was associated with an incremental cost-utility ratio of 26,689 US dollars per quality-adjusted life year, whereas screening with abdominal three-phase CT and AFP concentration measurement was associated with an incremental cost-utility ratio of 25,232 US dollars per quality-adjusted life year compared with no screening. Compared with three-phase CT and AFP, magnetic resonance and AFP imaging costs 118,000 US dollars per quality-adjusted life year. Sensitivity analysis demonstrated that the results are most sensitive to the annual incidence of HCC, proportion of tumors amenable to treatment, and to transplant candidacy, whereas the choice of screening strategy is most sensitive to the test characteristics and cost. CONCLUSIONS: Screening for HCC with CT is a cost-effective strategy in transplant-eligible patients with cirrhosis secondary to chronic hepatitis C viral (HCV) infection, comparable with other commonly accepted screening interventions such as mammography and colonoscopy.

Screening for hepatocellular carcinoma: why, when, how?

Hepatocellular carcinoma (HCC) is a major public health concern in many areas of the world, and its incidence is increasing in the United States and other countries. Screening for HCC in patients with cirrhosis has been advocated to identify those with small lesions who would benefit from transplantation or surgical resection. Despite these recommendations, several issues regarding screening remain controversial. No randomized, controlled trials have confirmed that surveillance for HCC reduces disease-specific mortality. In addition, the most appropriate screening test and optimal screening interval have not yet been defined. Clearly, these unresolved questions have a major impact on the cost-effectiveness of a screening program either at the population or the clinic level. A few studies, however, have suggested that screening may be cost-effective because a minor survival benefit could result in a cost that is acceptable to decision makers.

Hepatitis A and considerations regarding the cost-effectiveness of vaccination programs.

Hepatitis A vaccines have demonstrated a high degree of immunogenicity and an excellent safety profile. Immunization of certain populations and patient subgroups is recommended according to specific epidemiological and clinical factors, such as a greater likelihood of acquisition of infection or concerns regarding the risk of development of fulminant hepatitis and death. Therefore, the economic implications of routine and/or targeted vaccination programs in the general population and high-risk individuals have been examined. In this manuscript, the available data from the literature regarding the cost-effectiveness of hepatitis vaccination programs in healthy individuals and in those with chronic liver disease are reviewed.

Cost-effectiveness of screening, surveillance, and primary prophylaxis strategies for esophageal varices.

OBJECTIVE: Screening for varices is recommended in patients with cirrhosis to institute primary prophylaxis to prevent variceal bleeding. Our aim was to compare the cost-effectiveness of four strategies, including no screening/no prophylaxis, universal screening and primary prophylaxis with beta-blockers, universal screening and primary prophylaxis with variceal ligation, and universal institution of primary prophylaxis with beta-blockers without screening. METHODS: We constructed a Markov simulation model in two hypothetical cohorts of 50-yr-old patients with cirrhosis (one compensated and one decompensated), who were followed for 5 yr. Transition probabilities were derived from the medical literature, and costs reflected Medicare reimbursement rates at our institution. RESULTS: In patients with compensated cirrhosis, screening and primary prophylaxis with beta-blockers is associated with an incremental cost-effectiveness ratio of $3605 per year of life saved. The results were most sensitive to the prevalence of varices and risk of variceal bleeding. In patients with decompensated liver disease, primary prophylaxis without screening was associated with an incremental cost-effectiveness ratio of $1154 per year of life saved. The results were most sensitive to the cost of beta-blockers and endoscopy. CONCLUSIONS: Screening for varices is an affordable strategy in compensated liver disease, whereas universal primary prophylaxis with beta-blockers is cost-effective in decompensated patients.

Biliary stents in malignant obstructive jaundice due to pancreatic carcinoma: a cost-effectiveness analysis.

OBJECTIVES: Obstructive jaundice frequently complicates pancreatic carcinoma and is associated with complications such as malabsorption, coagulopathy, progressive hepatocellular dysfunction, and cholangitis in addition to disabling pruritus, which greatly interferes with terminal patients' quality of life. Endoscopic placement of biliary stents decreases the risk of these complications and is considered the procedure of choice for palliation for patients with unresectable tumors. We used decision analysis with Markov modeling to compare the cost-effectivenesses of plastic stents and metal stents in patients with unresectable pancreatic carcinoma. METHODS: A model of the natural history of unresectable pancreatic carcinoma was constructed using probabilities derived from the literature. Cost estimates were obtained from Medicare reimbursement rates and supplemented by the literature. Two strategies were evaluated: 1) initial endoscopic plastic stent placement and 2) initial endoscopic metal stent placement. We compared total costs and performed cost-effectiveness analysis in these strategies. The outcome measures were quality-adjusted life months. Sensitivity analyses were performed on selected variables. RESULTS: Our baseline analysis showed that initial plastic stent placement was associated with a total cost of $13,879/patient and 1.799 quality-adjusted life months. Initial placement of a metal stent cost $13,466/patient and conferred 1.832 quality-adjusted life months. Among the variables examined, expected patient survival was demonstrated by sensitivity analyses to have the most influence on the results of the model. CONCLUSION: Initial endoscopic placement of a metal stent is a cost-saving strategy compared to initial plastic stent placement, particularly in patients expected to survive longer than 6 months.

The cost-effectiveness of hepatitis A vaccination in patients with chronic hepatitis C viral infection in the United States.

OBJECTIVE: Hepatitis A vaccination is recommended for patients with chronic hepatitis C. Our aim was to analyze the cost-effectiveness of hepatitis A vaccination in these patients. The specific strategies evaluated were: no vaccination, targeted vaccination, and universal vaccination. METHODS: Clinical estimates were based on published data. Costs estimates were based on published data and institutional Medicare reimbursement rates. Health-related quality-of-life weights were derived from published data and expert estimates. The target population consisted of patients 45 yr of age with chronic hepatitis C followed every 6 months until death. We adopted a societal perspective. RESULTS: Compared with no vaccination, targeted vaccination was associated with an incremental cost-effectiveness ratio of $51,000 per quality-adjusted life-year. The incremental cost-effectiveness ratio of universal vaccination compared with targeted vaccination was $3,900,000 per quality-adjusted life-year. The results were particularly sensitive to the incidence of hepatitis A, probability of fulminant hepatic failure, and costs of hepatitis A antibody screening and vaccination. CONCLUSIONS: Targeted vaccination for hepatitis A in patients with chronic hepatitis C may be a cost-effective strategy to decrease the morbidity and mortality associated with hepatitis A superinfection. Universal vaccination is not a cost-effective alternative to targeted vaccination in this target population.