The burden of Clostridium difficile infection between 2010 and 2013: trends and outcomes from an academic center in Eastern Europe

Modeling is now an essential ingredient in business process management and information systems development. The general usefulness of models in these areas is therefore generally accepted. It is also undisputed that the quality of the models has a significant impact on their usefulness. In the literature we can find any number of quality metrics, but hardly any study that investigates their relation with (perceived) usefulness and none that considers their relative impact on usefulness. We take a look at some of the most frequent quality dimensions and their relative impact on the perceived usefulness of models

Drug persistence and need for dose intensification to adalimumab therapy; the importance of therapeutic drug monitoring in inflammatory bowel diseases

Background: Therapeutic drug monitoring (TDM) aid therapeutic decision making in patients with inflammatory bowel disease (IBD) who lose response to anti-TNF therapy. Our aim was to evaluate the frequency and predictive factors of loss of response (LOR) to adalimumab using TDM in IBD patients. Methods: One hundred twelve IBD patients (with 214 TDM measurements, CD/UC 84/28, male/female 50/62, mean age CD/UC: 36/35years) were enrolled in this consecutive cohort from two referral centres in Hungary. Demographic data were comprehensively collected and harmonized monitoring strategy was applied. Previous and current therapy, laboratory data and clinical activity were recorded at the time of TDM. Patients were evaluated either at the time of suspected LOR or during follow-up. TDM measurements were determined by commercial ELISA (LISA TRACKER, Theradiag, France). Results: Among 112 IBD patients, LOR/drug persistence was 25.9%/74.1%. The cumulative ADA positivity (>10ng/mL) and low TL (<5.0μg/mL) was 12.1% and 17.8% after 1 year and 17.3% and 29.5% after 2 years of adalimumab therapy. Dose intensification was needed in 29.5% of the patients. Female gender and ADA positivity were associated with LOR (female gender: p<0.001, OR:7.8 CI 95%: 2.5-24.3, ADA positivity: p=0.007 OR:3.6 CI 95%: 1.4-9.5). Conclusions: ADA development, low TL and need for dose intensification were frequent during adalimumab therapy and support the selective use of TDM in IBD patients treated with adalimumab. ADA positivity and gender were predictors of LOR

Optimizing patient management in Crohn’s disease in a tertiary referral center: the impact of fast-track MRI on patient management and outcomes

Background& Aims: Rapid optimization of treatment algorithms and disease outcomes requires an objective measurement of disease activity in patients with Crohn's disease (CD). Our aim was to evaluate the impact of rapid-access to magnetic resonance imaging (MRI) on treatment optimization, clinical decision-making and outcomes for CD patients in a specialized tertiary care for inflammatory bowel disease (1BD) patients

Register for bivirkninger ved bruk av kosmetiske produkter 2008-2010

Meldingene som har kommet inn til bivirkningsregisteret viser at bivirkninger ved bruk av kosmetiske produkter utgjør et problem hos forbrukerne. I løpet av de to første årene mottok bivirkningsregisteret 96 meldinger. De fleste meldingene ble sendt inn av apotekfarmasøyter. Kun ni av meldingene kom fra leger og dette er et lavere antall enn forventet. De fleste meldingene omhandlet produkttyper som fuktighetskremer, renseprodukter, solkremer og produkter for hårfarging/bleking. De hyppigst rapporterte bivirkningene er eksem med ødem, blemmedannelse og/eller svie. Det er utført vurdering av årsakssammenhenger for 35 av meldingene som totalt omfatter 33 produkter. For 25 av de 35 meldingene ble det vurdert å være en meget sannsynlig eller sannsynlig sammenheng mellom bruken av produktet og de meldte bivirkningene. Vårt norske register for bivirkninger ved bruk av kosmetiske produkter har mottatt i underkant av 50 meldinger per år. I Nederland mottar de derimot rundt 100 meldinger per måned. Dette registeret har, i motsetning til det norske registeret hvor helsepersonell sender inn meldinger, en internettbasert rapporteringsløsning hvor forbrukerne selv rapporterer om sine bivirkninger. Det høye antallet meldinger til det nederlandske registeret tyder på at bivirkninger etter bruk av kosmetiske produkter forekommer relativt hyppig samtidig som det viser at det en stor grad av underrapportering til det norske registeret. Erfaringer fra de første to årene tyder på at dette skyldes at både forbrukerne og helsepersonell lar være å melde fra om bivirkninger til registeret. En mer komplett rapportering vil kunne gi et mer pålitelig bilde av situasjonen med hensyn til bivirkninger og potensielle problemprodukter. I tiden fremover vil derfor arbeidet med å øke meldefrekvensen være en prioritert oppgave

Decreasing trends in hospitalizations during anti-TNF therapy are associated with time to anti-TNF therapy: Results from two referral centres

Background: Hospitalization is an important outcome measure and a major driver of costs in patients with inflammatory bowel disease. We analysed medical and surgical hospitalization rates and predictors of hospitalization before and during anti-TNF therapy. Methods: Data from 194 consecutive patients were analysed retrospectively (males, 45.4%, median age at diagnosis, 24.0 years, infliximab/adalimumab: 144/50) in whom anti-TNF therapy was started after January 1, 2008. Total follow-up was 1874 patient-years and 474 patient-years with anti-TNF exposure. Results: Hospitalization rates hospitalization decreased only in Crohn's disease (odds ratio: 0.59, 95% confidence interval: 0.51-0.70, median 2-years' anti-TNF exposure) with a same trend for surgical interventions (. p=. 0.07), but not in ulcerative colitis. Need for hospitalization decreased in Crohn's disease with early (within 3-years from diagnosis, p=. 0.016 by McNemar test), but not late anti-TNF exposure. At logistic regression analysis complicated disease behaviour (. p=. 0.03), concomitant azathioprine (. p=. 0.02) use, but not anti-TNF type, gender, perianal disease or previous surgeries were associated with the risk of hospitalization during anti-TNF therapy. Conclusion: Hospitalization rate decreased significantly in patients with Crohn's disease but not ulcerative colitis after the introduction of anti-TNF therapy and was associated with time to therapy. Complicated disease phenotype and concomitant azathioprine use were additional factors defining the risk of hospitalization

Decreasing trends in hospitalizations during anti-TNF therapy are associated with time to anti-TNF therapy: Results from two referral centres

The purpose of this study is to give an insight into how school children in year six, in Sweden, value and view grades. In Sweden, currently there are many debates on whether schools should have grading systems and if so, in which school year they should be introduced. In the present study seven children (3 boys and 4 girls), attending year six, were divided into two focus groups; that were simultaneously conducted. In the focus groups, the children discussed their views, values and their experiences in regard to grades. The results discerned from the two focus groups were that the seven participating school children felt that there was value and merit in receiving grades because they gained a better understanding of their own academic performance based on the grades they received. Additionally, however, the children acknowledged that they also do experience negative emotional effects from receiving grades, such as stress and the de-evaluation of their capabilities in comparison to their schoolmates. Nevertheless, the participating children perceived that grades were necessary and believed that the grading system should begin to be enforced in either year four, or year five, for the most optimal effect

Prediction of short- And medium-term efficacy of biosimilar infliximab therapy. Do trough levels and antidrug antibody levels or clinical and biochemical markers play the more important role?

Background and Aims: Biosimilar infliximab CT-P13 received European Medicines Agency [EMA] approval in June 2013 for all indications of the originator product. In the present study, we aimed to evaluate the predictors of short- and medium-term clinical outcome in patients treated with the biosimilar infliximab at the participating inflammatory bowel disease [IBD] centres in Hungary. Methods: Demographic data were collected and a harmonised monitoring strategy was applied. Clinical and biochemical activities were evaluated at Weeks 14, 30, and 54. Trough level [TL] and anti-drug antibody [ADA] concentrations were measured by enzyme-linked immunosorbent assay [ELISA] [LT-005, Theradiag, France] at baseline at 14, 30 and 54 weeks and in two centres at Weeks 2 and 6. Results: A total of 291 consecutive IBD patients (184 Crohn's disease [CD] and 107 ulcerative colitis [UC]) were included. In UC, TLs at Week 2 predicted both clinical response and remission at Weeks 14 and 30 (clinical response/remission at Week 14: area under the curve [AUC] = 0.81, p < 0.001, cut-off: 11.5 μg/ml/AUC = 0.79, p < 0.001, cut-off: 15.3μg/ml; clinical response/remission at Week 30: AUC = 0.79, p = 0.002, cut-off: 11.5 μg/ml/AUC = 0.74, p = 0.006, cut-off: 14.5 μg/ml), whereas ADA positivity at Week 14 was inversely associated with clinical response at Week 30 [58.3% vs 84.8%,p = 0.04]. Previous anti-tumour necrosis factor [TNF] exposure was inversely associated with short-term clinical remission [Week 2: 18.8% vs 47.8%, p = 0.03, at Week 6: 38.9% vs 69.7%, p = 0.013, at Week 14: 37.5% vs 2.5%, p = 0.06]. In CD, TLs at Week 2 predicted short-term [Week 14 response/remission, AUCTLweek2= 0.715-0.721, p = 0.05/0.005] but not medium-term clinical efficacy. In addition, early ADA status by Week 14 [p = 0.04-0.05 for Weeks 14 and 30], early clinical response [p < 0.001 for Weeks 30/54] and normal C-reactive protein [CRP] at Week 14 [p = 0.005-0.0001] and previous anti-TNF exposure [p = 0.03-0.0001 for Weeks 14, 30, and 54] were associated with shortand medium-term clinical response and remission. Conclusions: In UC, early TLs were predictive for short- and medium-term clinical efficacy, whereas in CD, Week 2 TLs were associated only with short-term clinical outcomes