Clinical trials in oncology are important tools to identify and establish new effective drugs for cancer treatment. Since the development of the concept of precision oncology, a huge number of multi-centric biomarker-driven clinical trials have been performed and promoted by either academic institutions or pharmaceutical companies. In this scenario, the role of pathologists is essential in multiple aspects, with new challenges that should be addressed. In this position paper of the European Society of Pathology, the role of pathologists as contributors to the design of the clinical trial, as local collaborators, or as members of central review laboratories is discussed. Moreover, the paper emphasizes the important role of pathologists in guiding methods and criteria of tissue biomarker testing in the biomarker-driven clinical trials. The paper also addresses issues regarding quality control, training, and the possible role of digital pathology.

• MeSH
• klinické zkoušky jako téma * MeSH
• laboratorní medicína normy   metody   MeSH
• lidé MeSH
• nádorové biomarkery * analýza   MeSH
• nádory * patologie   farmakoterapie   MeSH
• patologové * MeSH
• společnosti lékařské MeSH
• výzkumný projekt normy   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• Geografické názvy
• Evropa MeSH

OBJECTIVES: Nonpharmacologic interventions (NPIs) constitute an important part of treatment for older adults, cover a broad and diverse range of interventions, and have advantages over pharmacologic interventions (eg, limited adverse side effects). However, an unambiguous definition of NPIs is still lacking. Defining NPIs may facilitate research on this topic and enhance comparability of results between studies, and might help to face the challenges of recognition, acceptation, funding, and implementation. Therefore, the aim of this review was to provide an overview and comparison of the definitions of NPIs used in the current literature on older adults. DESIGN: A systematic review was performed to provide an overview of the definitions of NPIs that are used in the current literature on older populations and to organize the characteristics involved in the definitions. SETTING AND PARTICIPANTS: People ≥60 years of age were included, not limited to a specific setting. METHODS: A systematic search was performed in the following 5 databases: PubMed, Embase, Clarivate Analytics/Web of Science Core Collection, Cumulative Index to Nursing and Allied Health Literature, and Wiley/Cochrane Library. The time frame within the databases was from inception to December 4, 2023. Review articles, editorials and consensus papers were included. RESULTS: We included 28 articles. We organized the definitions of NPI according to 4 different aspects: types of interventions involved, target population, goals the interventions addressed, and requirements of the interventions. Definitions in the current literature can generally be divided into 2 groups: NPIs described as not involving medication, and more elaborated multidomain definitions. Based on the results, we formulated criteria for types of interventions that can be considered an NPI. CONCLUSIONS AND IMPLICATIONS: Using current descriptions and characteristics, elements for a new definition for NPIs were proposed. To improve research in this field, consensus needs to be reached regarding elements covered by a definition of NPIs.

• MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• terapie * metody   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• systematický přehled MeSH

PURPOSE OF REVIEW: This review explores the design and endpoints of perioperative platforms in clinical trials for muscle-invasive bladder cancer (MIBC). RECENT FINDINGS: The choice of clinical trial design in perioperative platforms for MIBC must align with specific research objectives to ensure robust and meaningful outcomes. Novel designs in perioperative platforms for MIBC integrate bladder-sparing approaches. Primary endpoints such as pathological complete response and disease-free survival are highlighted for their role in expediting trial results in perioperative setting. Incorporating patient-reported outcomes is important to inform healthcare decision makers about the outcomes most meaningful to patients. Given the growing body of evidence, potential biomarkers, predictive and prognostic tools should be considered and implemented when designing trials in perioperative platforms for MIBC. SUMMARY: Effective perioperative platforms for MIBC trials are critical in enhancing patient outcomes. The careful selection and standardization of study designs and endpoints in the perioperative platform are essential for the successful implementation of new therapies and the advancement of personalized treatment approaches in MIBC.

• MeSH
• cystektomie metody   škodlivé účinky   MeSH
• invazivní růst nádoru * MeSH
• klinické zkoušky jako téma MeSH
• lidé MeSH
• nádory močového měchýře * chirurgie   patologie   terapie   mortalita   MeSH
• perioperační péče metody   normy   MeSH
• stanovení cílového parametru MeSH
• výsledek terapie MeSH
• výzkumný projekt MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

OBJECTIVE: This scoping review aims to identify, catalogue, and characterize previously reported tools, techniques, methods, and processes that have been recommended or used by evidence synthesizers to detect fraudulent or erroneous data and mitigate its impact. INTRODUCTION: Decision-making for policy and practice should always be underpinned by the best available evidence-typically peer-reviewed scientific literature. Evidence synthesis literature should be collated and organized using the appropriate evidence synthesis methodology, best exemplified by the role systematic reviews play in evidence-based health care. However, with the rise of "predatory journals," fraudulent or erroneous data may be invading this literature, which may negatively affect evidence syntheses that use this data. This, in turn, may compromise decision-making processes. INCLUSION CRITERIA: This review will include peer-reviewed articles, commentaries, books, and editorials that describe at least 1 tool, technique, method, or process with the explicit purpose of identifying or mitigating the impact of fraudulent or erroneous data for any evidence synthesis, in any topic area. Manuals, handbooks, and guidance from major organizations, universities, and libraries will also be considered. METHODS: This review will be conducted using the JBI methodology for scoping reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Databases and relevant organizational websites will be searched for eligible studies. Title and abstract, and, subsequently, full-text screening will be conducted in duplicate. Data from identified full texts will be extracted using a pre-determined checklist, while the findings will be summarized descriptively and presented in tables. REVIEW REGISTRATION: Open Science Framework https://osf.io/u8yrn.

• MeSH
• lidé MeSH
• podvod prevence a kontrola   MeSH
• systematický přehled jako téma MeSH
• vědecký podvod * MeSH
• výzkumný projekt normy   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

INTRODUCTION: The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) may be as high as 38% in the adult population with potential serious complications, multiple comorbidities and a high socioeconomic burden. However, there is a general lack of awareness and knowledge about MASLD and its progressive stages (metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis). Therefore, MASLD is still far underdiagnosed. The 'Global Research Initiative for Patient Screening on MASH' (GRIPonMASH) consortium focuses on this unmet public health need. GRIPonMASH will help (primary) healthcare providers to implement a patient care pathway, as recommended by multiple scientific societies, to identify patients at risk of severe MASLD and to raise awareness. Furthermore, GRIPonMASH will contribute to a better understanding of the pathophysiology of MASLD and improved identification of diagnostic and prognostic markers to detect individuals at risk. METHODS: This is a prospective multicentre observational study in which 10 000 high-risk patients (type 2 diabetes mellitus, obesity, metabolic syndrome or hypertension) will be screened in 10 European countries using at least two non-invasive tests (Fibrosis-4 index and FibroScan). Blood samples and liver biopsy material will be collected and biobanked, and multiomics analyses will be conducted. ETHICS AND DISSEMINATION: The study will be conducted in compliance with this protocol and applicable national and international regulatory requirements. The study initiation package is submitted at the local level. The study protocol has been approved by local medical ethical committees in all 10 participating countries. Results will be made public and published in scientific, peer-reviewed, international journals and at international conferences. REGISTRATION DETAILS: NCT05651724, registration date: 15 Dec 2022.

• MeSH
• diabetes mellitus 2. typu komplikace   MeSH
• jaterní cirhóza diagnóza   MeSH
• lidé MeSH
• metabolický syndrom komplikace   MeSH
• multicentrické studie jako téma MeSH
• nealkoholová steatóza jater * diagnóza   MeSH
• plošný screening * metody   MeSH
• prospektivní studie MeSH
• výzkumný projekt MeSH
• ztučnělá játra * diagnóza   epidemiologie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• protokol klinické studie MeSH

Díky novým technologiím a vyššímu důrazu kladenému na bezpečnostní profil léčiv dochází k postupnému zlepšování lékových forem, což je také případ inhalačního kortikosteroidu beklometason dipropionátu, kdy jeho extra-fine formulace vede vklinické praxi ke snížení jeho nominální dávky až 2,5krát. Článek podrobněji popisuje dopady této transformace vefixních kombinovaných přípravcích, tj. depozici extra-fine částic vcentrální i periferní části plic, nižší systémovou expozici a v neposlední řadě taky pozitivní vliv u skupiny pacientů s astmatem, CHOPN a snížení rizika výskytu pneumonie.

Thanks to advancements and increased emphasis on the safety profile of medications, there is a gradual improvement in the development of pharmaceutical forms. One such change has been implemented in the inhaled corticosteroid beclomethasone dipropionate, resulting in a 2.5× reduction in its nominal clinical dose. The article provides a detailed description of the effects of this transformation in fixed combination preparations, i.e., the deposition of extra-fine particles in both the central and peripheral parts of the lungs, lower systemic exposure, and, last but not least, the positive impact on patients with asthma, COPD, and a reduced risk of pneumonia.

• MeSH
• aplikace inhalační MeSH
• beklomethason * aplikace a dávkování   farmakologie   terapeutické užití   MeSH
• bronchiální astma * farmakoterapie   MeSH
• chronická obstrukční plicní nemoc * farmakoterapie   MeSH
• fixní kombinace léků MeSH
• formoterol fumarát aplikace a dávkování   farmakologie   terapeutické užití   MeSH
• lidé MeSH
• pneumonie prevence a kontrola   MeSH
• randomizované kontrolované studie jako téma MeSH
• Check Tag
• lidé MeSH

JBI has long held the view that an inclusive approach to the conceptualization of what counts as evidence is important to the evidence-based movement. JBI's approach for appraising textual evidence had encompassed all forms of text (narrative, opinion, and policy), with one general tool used to guide critical appraisal. The proliferation of textual evidence and increase in textual evidence reviews demonstrate the need to reconceptualize JBI's methodological approach to critically appraising textual evidence. The objective of this paper is to outline the updated methodological approach to systematic reviews of textual evidence, especially in relation to the development of 3 separate critical appraisal tools for narrative, expert opinion, and policy text. Using an adapted Delphi approach, the JBI Textual Evidence Methodology Group convened over several rounds of meetings and discussions with international experts to reach consensus on the reconceptualization of critical appraisal tools for textual evidence sources. Strategies to effectively interrogate the legitimacy and authenticity of sources were found to be dependent upon the type of textual evidence under review. Therefore, 3 separate critical appraisal tools for narrative, expert opinion, and policy text were developed. This paper provides an overview of the development of 3 separate critical appraisal tools, highlighting the complex nature of textual evidence data sources.

• MeSH
• delfská metoda MeSH
• lidé MeSH
• medicína založená na důkazech * metody   MeSH
• periodika jako téma MeSH
• přehledová literatura jako téma MeSH
• redakční směrnice MeSH
• systematický přehled jako téma MeSH
• vyprávění MeSH
• výzkumný projekt MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

Potřeba simplifikace (deintenzifikace) intenzifikovaného inzulínového režimu (IIR) je u pacientů s diabetes mellitus 2. typu důsledkem častého zahajování této terapie v minulosti, kdy nebyly k dispozici jiné alternativy. Deintenzifikace je v současné době umožněna dostupností fixních kombinací bazálního inzulinu a agonistů receptoru glukagonu podobného peptidu 1 (giukagon-iike peptide 1, GLP-1) (iGlarLixi, IDegLira). Studie IDEAL prokázala, že deintenzifikace IIR přechodem na iGlarLixi je u pacientů s diabetes mellitus 2. typu účinnou a bezpečnou možností simplifikace terapie, která poskytuje porovnatelnou glykemickou kompenzaci, benefity redukce tělesné hmotnosti, snížení množství inzulinových injekcí a celkové denní dávky inzulínu, zlepšení hodnot při kontinuálním monitorování glykemie (continuous glucose monitoring, CGM), a to bez zvýšeného rizika hypoglykemie a s vyšší spokojeností pacientů s léčbou.

The need for simplification (deintensification) of multiple daily injections (MDI) regimen in people with type 2 diabetes is a consequence of its frequent use in the past when no other relevant options were available. At present, this has become possible due to the availability of new medications and formulations, such as the fixed ratio combinations of basal insulin analogues and glucagon-like peptide 1 (GLP-1) receptor agonists (iGlarLixi, IDegLira). The IDEAL randomised controlled trial showed that insulin therapy deintensification from MDI regimen into once-daily administered iGlarLixi is an efficient and safe treatment option for people with type 2 diabetes that provides comparable glycaemic control with the benefits of reduction of body weight, total daily dose of insulin, number of insulin injections, lower proportion of visits as which hypoglycaemia was reported and increased patients’ satisfaction with the treatment.

• Klíčová slova
• Suliqua, Xultophy,
• MeSH
• agonisté receptoru pro glukagonu podobný peptid 1 farmakologie   terapeutické užití   MeSH
• diabetes mellitus 2. typu * diagnóza   farmakoterapie   MeSH
• fixní kombinace léků MeSH
• hyperglykemie krev   prevence a kontrola   MeSH
• hypoglykemika farmakologie   terapeutické užití   MeSH
• inzulin * aplikace a dávkování   farmakologie   klasifikace   terapeutické užití   MeSH
• klinická studie jako téma MeSH
• lidé MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• práce podpořená grantem MeSH
• přehledy MeSH

The circular economy of animal by-products rich in collagen focuses on converting collagen into peptides with a defined molecular weight. Collagen hydrolysates prepared by biotechnological methods from chicken gizzards, deer tendons, and Cyprinus carpio skeletons can be an alternative source of collagen for cosmetic products that traditionally use bovine or porcine collagen hydrolysates. Collagen hydrolysates were characterized by antioxidant activity, surface tension, solution contact angle, and other parameters (dry weight, ash content, and solution clarity). Furthermore, the vibrational characterization of functional groups and their molecular weight was performed using the GPC-RID method. Subsequently, emulsion and gel cosmetic matrices were prepared with 0.5% and 1.5% collagen hydrolysates. Microbiological stability, organoleptic properties, and viscosity were investigated. Verification of the biophysical parameters of the topical formulations was performed in vivo on a group of volunteers by measuring skin hydration and pH and determining trans-epidermal water loss. Fish collagen hydrolysate was the most suitable for cosmetic applications in the parameters investigated. Moreover, it also effectively reduces wrinkles in the periorbital region when used in a gel matrix.

• MeSH
• antioxidancia chemie   farmakologie   MeSH
• aplikace lokální MeSH
• kapři metabolismus   MeSH
• kolagen * chemie   MeSH
• kosmetické přípravky * chemie   MeSH
• kur domácí MeSH
• kůže metabolismus   účinky léků   MeSH
• lidé MeSH
• proteinové hydrolyzáty * chemie   farmakologie   MeSH
• stárnutí kůže účinky léků   MeSH
• viskozita MeSH
• vysoká zvěř MeSH
• zvířata MeSH
• Check Tag
• lidé MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH

Dual reporters encoding two distinct proteins within the same mRNA have had a crucial role in identifying and characterizing unconventional mechanisms of eukaryotic translation. These mechanisms include initiation via internal ribosomal entry sites (IRESs), ribosomal frameshifting, stop codon readthrough and reinitiation. This design enables the expression of one reporter to be influenced by the specific mechanism under investigation, while the other reporter serves as an internal control. However, challenges arise when intervening test sequences are placed between these two reporters. Such sequences can inadvertently impact the expression or function of either reporter, independent of translation-related changes, potentially biasing the results. These effects may occur due to cryptic regulatory elements inducing or affecting transcription initiation, splicing, polyadenylation and antisense transcription as well as unpredictable effects of the translated test sequences on the stability and activity of the reporters. Unfortunately, these unintended effects may lead to misinterpretation of data and the publication of incorrect conclusions in the scientific literature. To address this issue and to assist the scientific community in accurately interpreting dual-reporter experiments, we have developed comprehensive guidelines. These guidelines cover experimental design, interpretation and the minimal requirements for reporting results. They are designed to aid researchers conducting these experiments as well as reviewers, editors and other investigators who seek to evaluate published data.

• MeSH
• Eukaryota genetika   MeSH
• lidé MeSH
• messenger RNA genetika   metabolismus   MeSH
• proteosyntéza genetika   MeSH
• reportérové geny * MeSH
• směrnice jako téma MeSH
• výzkumný projekt normy   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH