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Case Report: Successful Implementation of Integrative Cognitive Remediation for Early Psychosis.Many individuals demonstrate functionally relevant impairment in neurocognition as well as social cognition early on in the course of their psychotic disorder. There is robust evidence supporting cognitive remediation as an effective treatment of cognitive dysfunction in schizophrenia. Increasingly it is accepted that earlier treatment is associated with better outcome and that it is important to systematically assess and treat cognitive dysfunction before the cognitive and functional disabilities are fully realized. However, the clinical availability of these interventions remains sparse. As we move forward with implementing evidence-based interventions into multi-component treatment for early psychosis, it is important to reflect on experience as well as evidence. This case report aims to describe the implementation of an integrative cognitive remediation program in coordinated specialty care (CSC) for early psychosis in Iceland and investigate whether the intervention is sustainable in a CSC setting. Data on the number of patients treated, facilitators trained, groups conducted, and funding was used to assess the sustainability. The results show that since initial implementation in 2016, the intervention has been routinely available as part of standard care, with over 100 patients having received the treatment. The report discusses key factors in the successful implementation of the program. Keywords: compensatory cognitive training; functional outcome; rehabilitation; schizophrenia; social cognition and interaction training.
The Expiry of Humira Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures.Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80-90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 - €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.
Acute upper gastrointestinal bleeding: a population-based, five-year follow-up study.Objective: Data on long-term rebleeding risk and mortality in acute upper gastrointestinal bleeding (AUGIB) patients are scarce and comparison to controls are lacking. Aimsof the study were to assess long-term prognosis of AUGIB patients and compare to controls. Methods: A population-based retrospective case-control study conducted at the National University Hospital of Iceland and included all patients who underwent endoscopy in 2010-2011. AUGIB was defined as haematemesis or coffee ground vomiting leading to hospitalization or occurring in a hospitalized patient. Controls underwent endoscopy in 2010-2011, matched for sex/age. Rebleeding was defined as AUGIB >14 days up to five years after index bleeding. Results: Overall, 303 patients had AUGIB, mean age 67 (±18), controls66 years (±19), females, 51 and 46%, respectively. The five-year rebleeding rate for AUGIB patients was 13% (95%CI 9-17%), higher than the rate of bleeding events in controls, 3% (95%CI 1-5%; log-rank <0.001), hazard ratio (HR) 6.0 (95%CI 2.4-15) when correcting for comorbidities, NSAID's, PPI's and antithrombotics. The mortality of AUGIB patients at end of follow-up was higher when compared to controls, 39% (95%CI 49-33%) vs. 26% (95%CI 30-21%), log-rank <0.001, comorbidity-adjusted HR 1.4 (1.1-1.9). A subanalysis of non-variceal AUGIB yielded similar results in regard to rebleeding and mortality rates. Conclusions: AUGIB patients were at 6-fold risk of rebleeding compared to bleeding events in controls at five years of follow-up. Five-year mortality was higher in AUGIB patients when compared to controls even when correcting for age and comorbidities, suggesting that an episode of AUGIB indicates serious frailty. Keywords: GI-bleeding;; mortality;; outcome;; prognosis;; rebleeding; survival;.
Inflammatory hallmarks of lesser prominence in psoriatic arthritis patients starting biologics: a Nordic population-based cohort study.Objectives: To assess secular trends in baseline characteristics of PsA patients initiating their first or subsequent biologic DMARD (bDMARD) therapy and to explore prescription patterns and treatment rates of bDMARDs from 2006 to 2017 in the Nordic countries. Methods: PsA patients registered in the Nordic rheumatology registries initiating any treatment with bDMARDs were identified. The bDMARDs were grouped as original TNF inhibitor [TNFi; adalimumab (ADA), etanercept (ETN) and infliximab (IFX)]; certolizumab pegol (CZP) and golimumab (GOL); biosimilars and ustekinumab, based on the date of release. Baseline characteristics were compared for the five countries, supplemented by secular trends with R2 calculations and point prevalence of bDMARD treatment. Results: A total of 18 089 patients were identified (Denmark, 4361; Iceland, 449; Norway, 1948; Finland, 1069; Sweden, 10 262). A total of 54% of the patients were female, 34.3% of patients initiated an original TNFi, 8% CZP and GOL, 7.5% biosimilars and 0.3% ustekinumab as a first-line bDMARD. Subsequent bDMARDs were 25.2% original TNFi, 9% CZP and GOL, 12% biosimilars and 2.1% ustekinumab. From 2015 through 2017 there was a rapid uptake of biosimilars. The total of first-line bDMARD initiators with lower disease activity increased from 2006 to 2017, where an R2 close to 1 showed a strong association. Conclusion: Across the Nordic countries, the number of prescribed bDMARDs increased from 2006 to 2017, indicating a previously unmet need for bDMARDs in the PsA population. In recent years, PsA patients have initiated bDMARDs with lower disease activity compared with previous years, suggesting that bDMARDs are initiated in patients with a less active inflammatory phenotype. Keywords: bDMARDs; international collaborations; prescription patterns; psoriatic arthritis; secular trends of inflammatory hallmarks.
Nasal symptoms increase the risk of snoring and snoring increases the risk of nasal symptoms. A longitudinal population study.Purpose: Humans have a preference for nasal breathing during sleep. This 10-year prospective study aimed to determine if nasal symptoms can predict snoring and also if snoring can predict development of nasal symptoms. The hypothesis proposed is that nasal symptoms affect the risk of snoring 10 years later, whereas snoring does not increase the risk of developing nasal symptoms. Methods: In the cohort study, Respiratory Health in Northern Europe (RHINE), a random population from Denmark, Estonia, Iceland, Norway, and Sweden, born between 1945 and 1973, was investigated by postal questionnaires in 1999-2001 (RHINE II, baseline) and in 2010-2012 (RHINE III, follow-up). The study population consisted of the participants who had answered questions on nasal symptoms such as nasal obstruction, discharge, and sneezing, and also snoring both at baseline and at follow-up (n = 10,112). Results: Nasal symptoms were frequent, reported by 48% of the entire population at baseline, with snoring reported by 24%. Nasal symptoms at baseline increased the risk of snoring at follow-up (adj. OR 1.38; 95% CI 1.22-1.58) after adjusting for age, sex, BMI change between baseline and follow-up, and smoking status. Snoring at baseline was associated with an increased risk of developing nasal symptoms at follow-up (adj. OR 1.22; 95% CI 1.02-1.47). Conclusion: Nasal symptoms are independent risk factors for development of snoring 10 years later, and surprisingly, snoring is a risk factor for the development of nasal symptoms. Keywords: Epidemiology; Nasal obstruction; Sleep; Snoring.