Effects of a multidisciplinary approach on the effectiveness of antiviral treatment for chronic hepatitis C.

UNLABELLED:  Background. Despite the introduction of direct antiviral agents, pegylated interferon remains the mainstay of treatment for chronic hepatitis C. However, pegylated interferon is associated with a high rate of severe adverse events and decreased quality of life. Specific interventions can improve adherence and effectiveness. We aimed to determine whether implementing a multidisciplinary approach improved outcomes in the treatment of chronic hepatitis C. MATERIAL AND METHODS: We analyzed consecutive patients treated with pegylated interferon plus ribavirin between August 2001 and December 2011. We compared patients treated before and after the implementation of a multidisciplinary approach in 2007. We compared the baseline demographic and clinical characteristics and laboratory findings between groups, and used bivariate logistic regression models to detect factors involved in attaining a sustained virological response, calculating the odds ratios with their respective 95% confidence intervals. To evaluate the effect of the multidisciplinary team, we fitted a multivariate logistic regression model to compare the sustained virological response after adjusting for unbalanced variables and predictive factors. RESULTS: We included 514 patients [228 (44.4%) in the pre-intervention cohort]. Age, viral genotype, previous treatment, aspartate transaminase, ferritin, and triglyceride were prognostic factors of sustained virological response. After adjusting for prognostic factors, sustained virological response was higher in the multidisciplinary cohort (58 vs. 48%, p = 0.038). Despite higher psychiatric comorbidity and age in the multidisciplinary cohort, we observed a trend toward a lower rate of treatment abandonment in this group (2.2 vs. 4.9%, p = 0.107). CONCLUSION: Multidisciplinary management of chronic hepatitis C improves outcomes.

A nurse-driven outpatient clinic for thiopurine-treated inflammatory bowel disease patients reduces physician visits and increases follow-up efficiency.

Patients on thiopurine therapy need frequent monitoring to prevent drug adverse events. To describe the structure and main results of a nurse-driven outpatient clinic (NDOC) program for the follow-up of patients receiving treatment with thiopurine immunosuppressants, we retrospectively reviewed patients' clinical charts on thiopurine drugs, azathioprine (AZA), and 6-mercaptopurine. We evaluated the efficacy of the NDOC by comparing the number of physician visits and the adequacy of laboratory controls for each patient before and after inclusion in the program. From January 2006 to December 2008, 179 patients were included. Of these, 102 had received thiopurines for at least 1 year before the start of the NDOC. Mean age was 42 ± 15 years; 83 were female. In all, 137 of the 179 patients (76%) had Crohn disease. AZA was the most frequent drug used (97%). Mean time of follow-up was 2.03 ± 0.9 years. Implementation of this program decreased the number of physician visits per year-from 4.6 ± 1.9 to 2.4 ± 1.3 (p < .001)-and the number of periods longer than 4 months without laboratory control (from 68% to 45%; p = .01). Leucopenia episodes and complications did not differ significantly before and after the start of the NDOC. Nurse-driven follow-up of these patients reduces physician visits while improving tightness of the follow-up.

[Spontaneous visits to the emergency service and hepatology day hospital by patients with liver cirrhosis]. / Análisis de las consultas espontáneas de enfermos cirróticos a urgencias y hospital de día de hepatología.

INTRODUCTION: Because of the current overload of emergency services, new units, such as day units, have had to be created. Liver cirrhosis (LC) is a chronic disease with frequent decompensations requiring medical attention. The aim of this study was to compare differences between emergency consultations in a hepatology day hospital (HDH) and in an emergency service (ES) among patients with LC. METHODS AND MATERIAL: We performed an observational prospective study. All patients with LC attending the HDH or ES from September 2007 to August 2008 were asked to complete a questionnaire. Demographic, clinical, and radiological variables were collected. RESULTS: There were 743 consultations, of which 62% involved the HDH. The mean age was 65±12 years, and the male/female ratio was 2:3. The most frequent diagnosis in the ES was hepatic encephalopathy (26.2% ES versus 6% HDH, p<0.001) followed by upper gastrointestinal hemorrhage (17.7% ES versus 0.6% HDH, p<0.001), while the most frequent diagnosis in the HDH was ascites (66.2% HDH versus 22.7% ES, p<0.001). The tests performed were as follows: blood analysis: 95% ES versus 60% HDH (p<0.01); radiology: 71% ES versus 11% HDH (p<0.01) and paracentesis: 51% ES versus 74% HDH (p<0.01). The mean length of stay in the ES was 21.3±121.5 hours compared with 3.3±2.4 hours in the HDH (p<0.001). A total of 53% of patients attended in the ES were hospitalized compared with 12% of those attended in the HDH (p<0.05). CONCLUSION: Patients with LC preferentially attend the HDH, where fewer tests are performed and the length of stay is shorter. The care provided in the HDH is appropriate and efficient.

Interferon and the fear of needles: a case report.

The treatment of viral hepatitis C infection uses a combination of pegylated interferon and ribavirin. Psychological preparation of the patient is vital to ensure adherence to the treatment. In our center, the nurse prepares this treatment according to an established educative protocol; however, some patients have special needs that require individualized attention. One such situation observed by the nurse is that the patients frequently admit to the fear of needle puncture (the peginterferon treatment is administered subcutaneously) and are unable to inject themselves. We describe a representative case and the care plan to manage the patient's fear so that the patient acquires confidence in his or her ability to self-inject. This facilitates autonomy and coresponsibility for the treatment, and the nurse can develop care approaches to combat the patient's fear of needles.

[Use of intravenous iron infusion in a gastroenterology day hospital: Indications, dosage and adverse effects]. / Uso del hierro intravenoso en un hospital de día de aparato digestivo: indicaciones, dosificación y efectos adversos.

UNLABELLED: There are no data in the literature on the use of intravenous iron infusion in gastroenterology day hospitals. OBJECTIVE: To determine the indications, dosage and tolerance of intravenous iron infusion in outpatients attending a gastroenterology day hospital. MATERIAL AND METHODS: We retrospectively reviewed the medical records of patients who received intravenous iron infusion between August 2007 and July 2008. The indications, dosage, transfusion requirements, adverse effects and patients' clinical and laboratory data were recorded. RESULTS: During the study period, 111 patients (41% women, with a mean age of 63.8 ± 18 years) received intravenous iron infusions. The main causes of anemia indicating iron administration were portal hypertensive gastropathy (n=55), inflammatory bowel disease (n=22) and intestinal angiodysplasia (n=12). The patients received a total of 557 iron infusions with a mean dose of 1033 mg iron per patient. There were no adverse effects. Despite the treatment, 46 patients required transfusion. Iron and transfusion requirements and mortality were significantly higher in patients with liver cirrhosis than in the remainder of the study group. CONCLUSION: Intravenous iron therapy is frequently used in the gastroenterology day hospital. Most infusions were administered in patients with chronic iron loss. Patients with liver cirrhosis had the most severe anemia and underlying disease and the highest mortality.

Correction: Impact of treatment with direct-acting antivirals on anxiety and depression in chronic hepatitis C.

[This corrects the article DOI: 10.1371/journal.pone.0208112.].

Impact of treatment with direct-acting antivirals on anxiety and depression in chronic hepatitis C.

BACKGROUND AND AIM: Treatment of hepatitis C with direct-acting antiviral agents (DAA) has few side effects. Although pivotal studies suggested that DAA were safe in patients with psychiatric diseases who could not be treated with previous antiviral therapies, their effects on anxiety and depression have not yet been analysed in clinical practice. The aim of our study was to analyse anxiety and depression in the setting of DAA treatment in a clinical practice series. METHODS: All patients starting DAA treatment between November 1, 2014 and October 31, 2015 were eligible. Patients completed the Hospital Anxiety and Depression scale at different times during treatment. The results were plotted on line graphs and evaluated using a linear regression model with repeated measures. RESULTS: One hundred and forty-five patients were included (11% with major psychiatric disorders; 32% on psychiatric treatment). Sustained virologic response (SVR) was achieved in 97.3% of cases. Anxiety and depression measures did not differ between time points. No differences between patients on psychiatric treatment or with advanced fibrosis or cirrhosis were found at any time point analysed. CONCLUSION: DAA treatment had no impact on anxiety or depression during or after chronic hepatitis C infection treatment, even in high-risk patients with major psychiatric disorders.

Fatigue in out-patients with inflammatory bowel disease: Prevalence and predictive factors.

BACKGROUND AND AIM: Fatigue is a common and bothersome symptom in inflammatory bowel disease (IBD) patients. The study was aimed to determine the relationship of biological and psychological factors with IBD-related fatigue. METHODS: Consecutive clinically inactive IBD outpatients receiving immunosuppressants or biological drugs were enrolled between January and December 2013. Patients completed a Fatigue score (FACIT-F), various psychological, quality of life (IBDQ-9), and IBD activity scores. Biological parameters were assessed, including levels of interleukins (IL-5, IL-8 and IL-12) and micronutrients. RESULTS: We prospectively recruited 202 patients (28% ulcerative colitis and 72% Crohn's disease) for the study. Fatigue measured by FACIT-F score was prevalent in the studied population (54%, 96/177) and higher than in the general population. In the univariate analysis no relation was found between IL levels or micronutrient deficiencies and fatigue. Fatigue was significantly related to female sex, Crohn's disease, joint disorders, body mass index (BMI), psychological tests, thiopurine use, and anti-TNF treatment. All these variables were included in the multivariate analysis. Female sex (OR: 4.8), high BMI (OR:1.2) and higher depression rates (OR:1.2) were predictors of increased fatigue. High IBDQ-9 score (OR: 0.82) was significantly related to lower degrees of fatigue. CONCLUSION: Fatigue was prevalent in quiescent IBD patients with moderate-to-severe disease. It was associated with high levels of depression, low quality of life, and female sex. No association was found with the other biological and psychological factors evaluated.

Usefulness of indirect noninvasive methods in predicting progression to cirrhosis in chronic hepatitis C.

BACKGROUND AND AIMS: The ability of noninvasive methods to predict the development of cirrhosis has not been established. We evaluated the ability of three noninvasive methods [the Forns index, the aspartate aminotransferase-to-platelet ratio index (APRI), and the Non-Invasive Hepatitis-C-related Cirrhosis Early Detection (NIHCED) score] to determine the risk of developing cirrhosis in chronic hepatitis C. METHODS: Consecutive patients with chronic hepatitis C who had undergone liver biopsy between 1998 and 2004 were eligible. We used the three methods to evaluate patients at baseline and at follow-up (4-10 years later). When these methods yielded discordant or indeterminate results, a second liver biopsy was performed. Logistic regression models were fitted for each method to predict whether cirrhosis would appear and to predict long-term mortality from cirrhosis. RESULTS: We included 289 patients in our study. The mean scores at baseline and at follow-up, respectively, were as follows: Forns, 5.47 ± 1.95 and 6.56 ± 2.02; APRI, 1.1 ± 2.33 and 1.4 ± 1.53; and NIHCED, 7.79 ± 11.45 and 15.48 ± 15.28. The area under the receiver operating characteristic curve for predicting cirrhosis was 0.83 for Forns, 0.79 for APRI, and 0.76 for NIHCED. The sensitivity and specificity for predicting cirrhosis, respectively, were 75 and 71% for Forns (cutoff 4.7), 86 and 42% for APRI (cutoff 0.48), and 41 and 82% for NIHCED (cutoff 0). The area under the receiver operating characteristic curve for predicting mortality was 0.86 for Forns, 0.79 for APRI, and 0.84 for NIHCED. CONCLUSION: Indirect noninvasive markers could help identify patients with chronic hepatitis C at risk of progression to cirrhosis.

Delphi consensus statement: Quality Indicators for Inflammatory Bowel Disease Comprehensive Care Units.

BACKGROUND AND AIMS: While it is commonly accepted that Inflammatory bowel disease (IBD) Comprehensive Care Units (ICCUs) facilitate the delivery of quality care to Crohn's disease and ulcerative colitis patients, it remains unclear how an ICCU should be defined or evaluated. The aim of the present study was to develop a comprehensive set of Quality Indicators (QIs) of structure, process, and outcomes for defining and evaluating an ICCU. METHODS: A Delphi consensus-based approach with a standardized three-step process was used to identify a core set of QIs. The process included an exhaustive search using complementary approaches to identify potential QIs, and two Delphi voting rounds to select the QIs defining the core requirements for an ICCU. RESULTS: The consensus selected a core set of 56 QIs (12 structure, 20 process and 24 outcome). Structure and process QIs highlighted the need for multidisciplinary management and continuity of care. The minimal IBD team should include an IBD nurse, gastroenterologists, radiologists, surgeons, endoscopists and stoma management specialists. ICCUs should be able to provide both outpatient and inpatient care and admission should not break the continuity of care. Outcome QIs focused on the adequate prophylaxis of disease complication and drug adverse events, the need to monitor appropriateness of treatment and the need to reinforce patient autonomy by providing adequate information and facilitating the patients' participation in their own care. CONCLUSIONS: The present Delphi consensus identified a set of core QIs that may be useful for evaluating and certifying ICCUs.

Cost-minimization analysis favours intravenous ferric carboxymaltose over ferric sucrose for the ambulatory treatment of severe iron deficiency.

OBJECTIVE: Intravenous iron is widely used to treat iron deficiency in day-care units. Ferric carboxymaltose (FCM) allows administration of larger iron doses than iron sucrose (IS) in each infusion (1000 mg vs. 200 mg). As FCM reduces the number of infusions required but is more expensive, we performed a cost-minimization analysis to compare the cost impact of the two drugs. MATERIALS AND METHODS: The number of infusions and the iron dose of 111 consecutive patients who received intravenous iron at a gastrointestinal diseases day-care unit from 8/2007 to 7/2008 were retrospectively obtained. Costs of intravenous iron drugs were obtained from the Spanish regulatory agencies. The accounting department of the Hospital determined hospital direct and indirect costs for outpatient iron infusion. Non-hospital direct costs were calculated on the basis of patient interviews. In the pharmacoeconomic model, base case mean costs per patient were calculated for administering 1000 mg of iron per infusion using FCM or 200 mg using IS. Sensitivity analysis and Monte Carlo simulation were performed. RESULTS: Under baseline assumptions, the estimated cost of iron infusion per patient and year was €304 for IS and €274 for FCM, a difference of €30 in favour of FCM. Adding non-hospital direct costs to the model increased the difference to €67 (€354 for IS vs. €287 for FCM). A Monte Carlo simulation taking into account non-hospital direct costs favoured the use of FCM in 97% of simulations. CONCLUSION: In this pharmacoeconomic analysis, FCM infusion reduced the costs of iron infusion at a gastrointestinal day-care unit.

Evaluation of four different fecal tests for determination of cure after Helicobacter pylori treatment.

BACKGROUND: Data evaluating the monoclonal tests for determination of cure after Helicobacter pylori treatment are scarce. GOALS: This study was aimed to evaluate the usefulness of 4 stool tests-2 new RAPID monoclonal immunochromatographic tests (RAPID Hp StAR, DakoCytomation, Cambridge, UK and ImmunoCard STAT! HpSA, Meridian Diagnostics, Cincinnati, OH) a monoclonal EIA test (Amplified IDEIA Hp StAR, DakoCytomation, Cambridge, UK), and a polyclonal EIA test (Premier Platinum HpSA, Meridian Diagnostics, Cincinnati, OH)-to confirm cure of H. pylori infection after eradication treatment. STUDY: Ninety-seven patients who underwent eradication treatment were included. Cure of H. pylori infection was determined using 2 consecutive reference tests. Fecal tests were performed according to the specifications of the manufacturer. Sensitivity, specificity, and positive and negative predictive values were calculated. RESULTS: After H. pylori eradication, the RAPID Hp StAR test has a sensitivity of 73% for detecting persistent infection, a specificity of 96% to 98%, a positive predictive value of 73% to 80% and a negative predictive value of 96%. For ImmunoCard STAT! HpSA the corresponding values were 91%, 97%, 77%, and 99%, for Amplified IDEIA Hp StAR 73%, 97%, 73%, and 97%, and for Premier Platinum HpSA 91%, 79%, 35%, and 98%. CONCLUSIONS: All tests except Premier Platinum HpSA were highly accurate confirming eradication after treatment.