Burden of Crohn's disease: economics and quality of life aspects in Italy.

BACKGROUND: This was a prospective observational study designed to evaluate direct and indirect costs and quality of life for patients with Crohn's disease in Italy from the perspectives of the National Health System and of society. METHODS: A total of 162 male and female subjects aged 18-70 years with Crohn's disease in the active phase and a Crohn's Disease Activity Index score ≥150 were included in the study. Subjects were recruited from 25 Italian centers on a consecutive basis. The study consisted of four visits undertaken every 6 months with a follow-up period of 18 months. The study started on September 1, 2006 and was completed on April 12, 2010. Multivariate analyses were carried out on demographic characteristics, treatment costs based on the prescribed daily dose, resource use and other cost parameters, and changes in quality of life using the EQ5D questionnaire. RESULTS: Cost of illness per subject with Crohn's disease in Italy was estimated to be €15,521 per year, with direct costs representing 76% of total costs. Nonhealth care costs and loss of productivity accounted for 24% of total costs. Societal costs during the first months of enrolment were higher compared with costs in the final months of the study. Quality of life measured by the EQ-5D was 0.558 initially and then increased to 0.739, with a mean value of 0.677 during the enrolment period. The cost of illness was not correlated with age or gender. CONCLUSION: The cost of illness was correlated with quality of life; Crohn's disease had a negative impact on subjects' quality of life, and higher costs corresponded to a lower quality of life as measured with the EQ5D. Drug treatment may improve quality of life and reduce hospitalization costs. Our results appear to be in line with the results of other international cost-of-illness studies.

Appropriateness of the indication for colonoscopy: is the endoscopist the 'gold standard'?

BACKGROUND: The appropriate selection of patients for colonoscopy is crucial for an efficient use of endoscopy. The role of endoscopist in filtering out inappropriate referrals is largely unknown. METHODS: A multicentre, prospective study was performed in which consecutive patients referred for colonoscopy during a 1-month period were enrolled. Before colonoscopy, the endoscopist assessed appropriateness of the endoscopic referral without directly consulting official guidelines, also collecting clinical and demographic variables. Appropriateness of the indication was eventually assessed by a group of experts based on the American Society for Gastrointestinal Endoscopy guidelines, representing the gold standard. Outcomes of the study were the inappropriateness rate and the main related causes, as well as the concordance rate between the endoscopists and the experts. A multivariate analysis was performed to identify predictors of inappropriateness. RESULTS: One thousand seven hundred ninety-nine patients were enrolled in 20 centres, of which 1489 outpatients were included in the final analysis. According to the American Society for Gastrointestinal Endoscopy guidelines, 432 referrals were inappropriate, corresponding to an inappropriateness rate of 29%. At multivariate analysis, prescription of a repeated colonoscopy (≥2 colonoscopies in the same patient) was strongly associated with the inappropriateness of the indication (odds ratio: 8.8; 95% confidence interval: 6.2, 12.7). Postpolypectomy or post-colorectal cancer surveillance accounted for 77% of the inappropriate control procedures. A 79% concordance rate between endoscopist and expert assessment was found. Among the 317 discordant cases, postpolypectomy or post-colorectal cancer surveillance accounted for 51% of the cases, the endoscopists mistakenly classifying it as appropriate in 55% to 61% of the inappropriate cases. CONCLUSIONS: Inappropriateness in outpatient colonoscopy referrals remains high, surveillance procedures representing the most frequent source of inappropriateness.

Kaposi sarcoma of the stomach: a case report.

A 60-year-old man presented with persistent dysphagia and weight loss of 2-months duration. An upper GI endoscopy revealed mycotic oesophagitis and chronic gastritis with two ulcers of the gastric body and antrum. Repeat endoscopy was performed after medical treatment failed, and histological examination on new biopsy samples led to a diagnosis of Kaposi sarcoma of the stomach. HIV infection was not known at this time; however, the patient was tested after the diagnosis of Kaposi sarcoma was made and found to be HIV positive. An adequate biopsy sampling was required for histological diagnosis and the use of immunohistochemical markers, especially human herpesvirus 8 (HHV8) antibodies, supplied valid diagnostic support. This case underlines the importance of an accurate evaluation of vascular proliferation in gastrointestinal biopsies even in patients without clinical evidence of HIV-related pathology.

Peginterferon alpha-2a and ribavirin versus peginterferon alpha-2a monotherapy in early virological responders and peginterferon alpha-2a and ribavirin versus peginterferon alpha-2a, ribavirin and amantadine triple therapy in early virological nonresponders: the SMIEC II trial in naïve patients with chronic hepatitis C.

OBJECTIVE: The objective of this study was to compare the efficacy of anti-hepatitis C virus (anti-HCV) treatment schedules on the basis of an early virological response (EVR), defined as undetectable serum HCV-RNA (<50 IU/ml) after a 12-week induction course of peginterferon alpha-2a (PEG-IFN) 180 mcg/week. METHODS: A total of 210 interferon-naïve patients (69% male; median age, 42 years) with histologically proven chronic hepatitis C infection (genotype 1: 62%) received PEG-IFN 180 mcg/week for 12 weeks. Patients with EVR (58%) were randomized to continue PEG-IFN monotherapy (n=64) or to add ribavirin (RBV), 800 mg/day (n=57), for 36 additional weeks. Patients without EVR (42%) were randomized to add RBV (n=42), or RBV plus amantadine, 200 mg/day (n=47), for 36 additional weeks. Sustained virological response (SVR, undetectable HCV-RNA 24 weeks after treatment completion) was compared among treatment groups. RESULTS: Patients with EVR: SVR rate was 60.3% in the PEG-IFN group versus 67.2% in the PEG-IFN+RBV group (NS). In genotypes 2/3, SVR rates were 66.7 versus 73.1% (NS); in genotypes 1/4, SVR rates were 51.6 versus 61.3%, respectively (NS). Patients without EVR: SVR was 16.7% in the PEG-IFN+RBV group versus 31.9% in the triple therapy group (P=0.07). In patients with genotypes 1/4, SVR rates were 9.4 versus 29.7% (P=0.041). CONCLUSION: In genotypes 1/4 patients without EVR, triple therapy results in higher SVR rates than standard dual therapy. This study confirms that addition of amantadine is beneficial in early-recognized 'difficult-to-treat' patients.

Analysis of factors predicting survival in patients with hepatocellular carcinoma treated with percutaneous laser ablation.

BACKGROUND/AIMS: The factors which predict the long-term outcome in patients with hepatocellular carcinoma who are treated with percutaneous laser ablation (PLA) are not well established. METHODS: We prospectively analyzed treatment and survival parameters of 148 cirrhotic patients with nonsurgical hepatocellular carcinoma who had undergone PLA at a single institution during an 11-year period. RESULTS: Single tumors were seen in 129 of 148 (87%) patients, and 2-3 nodules were seen in 19 (13%) patients, for a total of 169 tumors. The median overall time survival was 39 months (95% confidence interval [CI], 30-47 months). The 1-, 2-, 3-, 4-, and 5-year cumulative survival rates were 89, 75, 52, 43, and 27%, respectively. From multiple regression analysis, the independent predictors of survival were found to be tumor grading (P=0.002; risk ratio [RR] 0.37, 95% CI 0.20-0.70), bilirubin levels < or =2.5mg/dl (P=0.014; RR 1.58, 95% CI 1.09-2.28), and the achievement of complete tumor ablation (P=0.020; RR 0.53, 95% CI 0.31-0.90). An initial complete tumor ablation was the only factor associated with longer survival in patients with Child-Turcotte-Pugh class A cirrhosis (P=0.012; hazard ratio [HR] 0.48, 95% CI 0.23-1.03). CONCLUSIONS: A complete tumor ablation results in improved survival in all patients with nonsurgical hepatocellular carcinoma. Ideal candidates for PLA are those with a well-differentiated histology, and normal bilirubin levels.

Percutaneous laser ablation in the treatment of hepatocellular carcinoma with small tumors: analysis of factors affecting the achievement of tumor necrosis.

PURPOSE: To identify the factors that affect the achievement of tumor necrosis with percutaneous laser ablation (PLA) in patients with hepatocellular carcinoma (HCC) and tumor size no larger than 4.0 cm. MATERIALS AND METHODS: Ultrasound-guided biopsy results were retrospectively studied in 99 lesions (range, 0.5-4.0 cm; mean, 2.7 cm) from 82 patients (44 men, 38 women; age range, 50-80 years; median, 68 y) who had undergone PLA. RESULTS: Complete tumor ablation was obtained in 90 lesions (90.9%). Of the nine cases in which complete tumor necrosis was not achieved, six had tumors located in sites that did not allow the optimal placement of fibers, and five of these had a tumor diameter greater than 3 cm. Early discontinuation of PLA as a result of decompensation of liver cirrhosis was the reason for not achieving a complete tumor ablation in three other cases. There was a clear relationship between the energy delivered and the volume of necrosis achieved (r = 0.56; P < .001) regardless of the initial size of HCC tumors. The number of illuminations required, and consequently the amount of energy delivered, was also affected by tumor location. In fact, lesions adjacent to large vessels (> or = 3 mm) required a greater number of illuminations than the other lesions to achieve complete ablation (2.9 +/- 1.4 vs 2.3 +/- 0.9; P = .043). The eight cases with undifferentiated histology required more illuminations than the cases with other histologic types (3.4 +/- 0.9 vs 2.2 +/- 0.9; P < .001). However, these cases were located in sites that did not allow the optimal placement of fibers, therefore requiring multiple treatments. CONCLUSION: PLA is a highly effective treatment in HCC with a tumor size of 4.0 cm or smaller. In this setting, two variables, tumor size and tumor location, affect the achievement of complete tumor ablation and the number of treatments required to obtain tumor necrosis.

Helicobacter pylori eradication in the management of patients with idiopathic thrombocytopenic purpura.

PURPOSE: To investigate the relation between Helicobacter pylori infection and the clinical features of idiopathic thrombocytopenic purpura (ITP), and to examine the effects of H. pylori eradication on platelet counts. METHODS: A(13)C urea breath test for H. pylori infection was performed in a cohort of 137 consecutive patients with ITP. Patients who tested positive received standard eradication therapy if their platelet count was <50 x 10(9)/L or if they had symptoms of dyspepsia. RESULTS: H. pylori infection was detected in 64 patients (47%), and was not associated with dyspepsia or other clinical or laboratory features. Eradication therapy was successfully administered to 52 patients. Platelet responses were observed in 17 (33%) of these patients, which lasted for more than 1 year in 11 patients. Duration of ITP was shorter among responders than nonresponders. Only one response was observed among patients with severe thrombocytopenia (platelet count <30 x 10(9)/L). CONCLUSION: The prevalence of H. pylori infection in patients with ITP is similar to that found in the general population. Infection is not associated with distinctive features of the disease. H. pylori eradication may improve the platelet counts in adults in whom the ITP is of recent onset and in those with less severe degrees of thrombocytopenia, but was not effective in patients with chronic severe ITP.