Eastern and Western mindfulness: investigating a potential mediating role of self-regulation

The present study examined the hypothesis that self-regulation of attention would be the core mechanism that ties together two dominant conceptualizations of mindfulness: (1) an eastern style more associated with influential figures such as Dr. Jon Kabat-Zinn, and (2) a western style pioneered by Dr. Ellen Langer. Dispositional mindfulness (defined as a trait rather than a momentary state of being) of eastern and western styles as well as self-regulation were measured using self-reported questionnaires: FFMQ, LMS and SRS. A large sample of participants (N=208), mostly female university non-meditator students, completed the respective scales online. Selfregulation of attention was correlated with both kinds of dispositional mindfulness. A partial mediation effect of self-regulation of attention on eastern and western mindfulness mode was revealed using the regression- based methods described by Baron and Kenny (1986) and the Sobel-Goodman analyses. Implications and areas of future research are discussed.Master of Arts (MA) in Psycholog

The Burden of Inflammatory Bowel Disease in Europe.

AbstractInflammatory bowel diseases (IBD) are chronic disabling gastrointestinal disorders impacting every aspect of the affected individual's life and account for substantial costs to the health care system and society. New epidemiological data suggest that the incidence and prevalence of the diseases are increasing and medical therapy and disease management have changed significantly in the last decade. An estimated 2.5–3million people in Europe are affected by IBD, with a direct healthcare cost of 4.6–5.6bn Euros/year. Therefore, the aim of this review is to describe the burden of IBD in Europe by discussing the latest epidemiological data, the disease course and risk for surgery and hospitalization, mortality and cancer risks, as well as the economic aspects, patients' disability and work impairment

Biosimilars in Inflammatory Bowel Disease: Facts and Fears of Extrapolation

Biologic drugs such as infliximab and other anti–tumor necrosis factor monoclonal antibodies have transformed the treatment of immune-mediated inflammatory conditions such as Crohn’s disease and ulcerative colitis (collectively known as inflammatory bowel disease [IBD]). However, the complex manufacturing processes involved in producing these drugs mean their use in clinical practice is expensive. Recent or impending expiration of patents for several biologics has led to development of biosimilar versions of these drugs, with the aim of providing substantial cost savings and increased accessibility to treatment. Biosimilars undergo an expedited regulatory process. This involves proving structural, functional, and biological biosimilarity to the reference product (RP). It is also expected that clinical equivalency/comparability will be demonstrated in a clinical trial in one (or more) sensitive population. Once these requirements are fulfilled, extrapolation of biosimilar approval to other indications for which the RP is approved is permitted without the need for further clinical trials, as long as this is scientifically justifiable. However, such justification requires that the mechanism(s) of action of the RP in question should be similar across indications and also comparable between the RP and the biosimilar in the clinically tested population(s). Likewise, the pharmacokinetics, immunogenicity, and safety of the RP should be similar across indications and comparable between the RP and biosimilar in the clinically tested population(s). To date, most anti–tumor necrosis factor biosimilars have been tested in trials recruiting patients with rheumatoid arthritis. Concerns have been raised regarding extrapolation of clinical data obtained in rheumatologic populations to IBD indications. In this review, we discuss the issues surrounding indication extrapolation, with a focus on extrapolation to IBD

Management of Patients With Crohn's Disease and Ulcerative Colitis During the Coronavirus Disease-2019 Pandemic: Results of an International Meeting

The International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) is the only global organization devoted to the study of and management of the inflammatory bowel diseases (IBDs), namely, Crohn?s disease and ulcerative colitis. Membership is composed of physician-scientists who have established expertise in these diseases. The organization hosts an annual meeting and a number of working groups addressing issues of the epidemiology of IBD, diet and nutrition, and the development and use of treatments for IBD. There are currently 89 members of IOIBD representing 26 different countries. The organization has taken particular interest in the coronavirus disease-2019 (COVID-19) pandemic and how it may affect the IBD patient population. This document summarizes the results of 2 recent virtual meetings of the group and subsequent expert guidance for patients and providers

Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

Necessity of phenotypic classification of inflammatory bowel disease.

Inflammatory bowel diseases (IBD) are classically divided in Crohn's disease (CD) and ulcerative colitis (UC). However, these two entities are still heterogeneous and a further classification in subphenotypes is necessary. Clinical subphenotypes are easy to use, do not necessitate complicated tests and can already give very important information for the management of the patients. In CD, clinical subphenotypes are based on age at diagnosis, disease location and disease behaviour. Age at diagnosis allows to differentiating paediatric CD, classical young adult onset and more seldom CD of the elderly. These categories are associated with a different risk of development of complications and disabling disease and may have partly different pathophysiology. The classification on disease behaviour, including stricturin, penetrating or uncomplicated disease may have an impact on reponse to medical treatment and need for surgery. Finally the classification based on location is particularly relevant since it has been associated with different types of complications. Particularly ileal disease has been associated with the risk of surgery and colonic (particularly rectal) disease, with the risk of perianal disease. In UC, the classification in subphenotypes is essentially based on disease location, distinguishing proctitis, left-sided colitis and extensive colitis. This subclassification also has a very significant clinical relevance since extensive colitis has been associated with and increased risk of colon cancer, colectomy and even in some studies, mortality