Clinical trials evaluating the management of acute exacerbations of COPD assess heterogeneous outcomes, often omitting those that are clinically relevant or more important to patients. We have developed a core outcome set, a consensus-based minimum set of important outcomes that we recommend are evaluated in all future clinical trials on exacerbations management, to improve their quality and comparability. COPD exacerbations outcomes were identified through methodological systematic reviews and qualitative interviews with 86 patients from 11 countries globally. The most critical outcomes were prioritized for inclusion in the core outcome set through a two-round Delphi survey that was completed by 1,063 participants (256 patients, 488 health professionals and 319 clinical academics) from 88 countries in 5 continents. Two global, multi-stakeholder, virtual consensus meetings were conducted to (i) finalize the core outcome set and (ii) prioritize a single measurement instrument to be used for evaluating each of the prioritized outcomes. Consensus was informed by rigorous methodological systematic reviews. The views of patients with COPD were accounted for in all stages of the project. Survival, treatment success, breathlessness, quality of life, activities of daily living, need for higher level of care, arterial blood gases, disease progression, future exacerbations and hospital admissions, treatment safety and adherence were all included in the core outcome set. Focused methodological research was recommended to further validate and optimize some of the selected measurement instruments. The panel did not consider the prioritized set of outcomes and associated measurement instruments burdensome for patients and health professionals to use.

A sensitive and specific tool for identifying lower respiratory tract involvement in COVID-19.

Randomised controlled trials (RCTs) on the management of COPD exacerbations evaluate heterogeneous outcomes, often omitting those that are clinically important and patient relevant. This limits their usability and comparability. A core outcome set (COS) is a consensus-based minimum set of clinically important outcomes that should be evaluated in all RCTs in specific areas of health care. We present the study protocol of the COS-AECOPD ERS Task Force, aiming to develop a COS for COPD exacerbation management, that could remedy these limitations.For the development of this COS we follow standard methodology recommended by the COMET initiative. A comprehensive list of outcomes is assembled through a methodological systematic review of the outcomes reported in relevant RCTs. Qualitative research with patients with COPD will also be conducted, aiming to identify additional outcomes that may be important to patients, but are not currently addressed in clinical research studies. Prioritisation of the core outcomes will be facilitated through an extensive, multi-stakeholder Delphi survey with a global reach. Selection will be finalised in an international, multi-stakeholder meeting. For every core outcome, we will recommend a specific measurement instrument and standardised time points for evaluation. Selection of instruments will be based on evidence-informed consensus.Our work will improve the quality, usability and comparability of future RCTs on the management of COPD exacerbations and, ultimately, the care of patients with COPD. Multi-stakeholder engagement and societal support by the European Respiratory Society will raise awareness and promote implementation of the COS.

The aim is to evaluate the effectiveness of complex therapy with the inclusion of the drug Saccharomyces boulardii in patients with non-alcoholic steatohepatitis (NASH) and intestinal dysfunction. Material and methods. An open prospective comparative study of the effectiveness of complex therapy of intestinal dysfunction in patients with non-alcoholic steatohepatitis was carried out. The study included two groups of 36 patients with NASH with symptoms of intestinal dysfunction, established intestinal dysbiosis, structural changes in the mucous membrane of the colon. Results and discussion. It was found that the complex therapy of intestinal dysfunction with the inclusion of the drug Saccharomyces boulardii against the background of NASH reduces the frequency of abdominal pain associated with the intestines, normalizes stool, reduces the degree of dysbiosis, promotes epithelialization of microerosions, and reduces the frequency of neutrophilic infiltration of the colon mucosa. Conclusion. The results of the study indicate the effectiveness of complex therapy with the addition of Saccharomyces boulardii in patients with NASH and intestinal dysfunction

Purpose of the study: to establish the clinical and diagnostic signifi cance of structural and functional changes in the colon in NAFLD against the background of obesity, type 2 diabetes, arterial hypertension.Materials and methods: 138 patients with NAFLD and intestinal pathology, 36 patients without intestinal dysfunction were examined. The clinical and endoscopic features of lesions of the colon mucosa in patients with NAFLD were studied, taking into account the underlying pathology (obesity, type 2 diabetes, arterial hypertension). Changes in intestinal microbiocenosis were revealed in patients with NAFLD, depending on the underlying pathology. The morphometric parameters of the expression of colonocytes immunopositive to the vascular endothelial growth factor, as well as to leptin, were studied in comparison with the clinical and endoscopic features of the colon and liver, and the presence of a background disease.Results: It has been established that the background diseases in NAFLD — type 2 diabetes and obesity — make a certain contribution to the structural and functional changes in the colon. In turn, changes in the intestinal microbiota in NAFLD against the background of obesity, type 2 diabetes lead to aggravation of dyslipidemia, glycemia with the progression of chronic systemic infl ammation and fi brosis in the liver.