BACKGROUND: Although there is growing evidence of the association between gender and early diagnosis of preclinical Alzheimer's disease, little attention has been given to the enrolment ratio of men and women in clinical trials and data reporting. METHODS: This study aims to analyze gender differences in sociodemographic factors associated with the willingness to participate in clinical trials and undergo specific procedures in the context of an Alzheimer's disease prevention research cohort. 2544 cognitively unimpaired participants from the ALFA parent cohort (age 45-75 years) of the Barcelonaβeta Brain Research Center were contacted through a structured phone call to determine their willingness to participate in Alzheimer's disease clinical trials and undergo trial-related procedures (magnetic resonance imaging, lumbar puncture, positron emission tomography, and cognitive assessment). Sociodemographic data on education, occupational attainment, civil and caregiver status were gathered. Stepwise logistic regression models were performed in order to study the interaction between gender and sociodemographic factors in the willingness to participate in clinical trials and to undergo clinical trial-related procedures. RESULTS: 1,606 out of the 2,544 participants were women (63.1%). Women were significantly younger and had lower educational attainment compared with men. In addition, women were more likely to be caregivers, single and unemployed. Women showed a significantly lower willingness than men to participate in a clinical trial (p = 0.003) and to undergo a lumbar puncture (p < 0.001). Single women were less willing to participate in clinical trials than single men (p = 0.041). Regarding clinical trial-related procedures, women with higher years of education were significantly less willing to undergo a lumbar puncture (p = 0.031). CONCLUSION: We found gender differences regarding the sociodemographic factors that predict the willingness to participate in clinical trials and to undergo clinical trial-related procedures. Our results highlight the urgent need to design recruitment strategies accounting for gender-related factors, particularly those related to marital status and education.
- MeSH
- Alzheimerova nemoc * psychologie MeSH
- klinické zkoušky jako téma * psychologie MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- pohlavní dimorfismus MeSH
- senioři MeSH
- sexuální faktory MeSH
- stupeň vzdělání MeSH
- výběr pacientů MeSH
- zapojení pacienta psychologie statistika a číselné údaje MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Proposed in the early 1980s as a solution for managing complications of portal hypertension, the percutaneous creation of transjugular intrahepatic portosystemic shunt has consistently gained a central role. Increasingly lower complication rates have been observed thanks to improvements in both technologies and the skills of interventional radiologists. PURPOSE: This document is aimed at interventional radiologists and provides best practice recommendations for transjugular intrahepatic portosystemic shunt creation, describing patient selection, intraprocedural management and follow-up, in addition to recommendations in paediatric settings. METHODS: The CIRSE Standards of Practice Committee established a writing group consisting of seven European clinicians with recognised expertise in the creation of transjugular intrahepatic portosystemic shunt. The writing group reviewed the existing literature performing a pragmatic evidence search using PubMed to select relevant publications in the English language and involving human subjects, preferably published from 2009 to 2024. The final recommendations were developed by consensus. RESULTS: TIPS creation has an established role in the successful management of portal hypertension and its complications. This Standards of Practice document provides up-to-date recommendations for patient selection, materials, its safe performance, and follow-up with complications management.
- MeSH
- dítě MeSH
- intervenční radiologie * normy MeSH
- lidé MeSH
- portální hypertenze * chirurgie MeSH
- přehledová literatura jako téma MeSH
- transjugulární intrahepatální portosystémový zkrat * normy MeSH
- výběr pacientů MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- směrnice pro lékařskou praxi MeSH
PURPOSE OF REVIEW: This review critically evaluates the current state of bladder-sparing options in muscle-invasive bladder cancer (MIBC) and provides an overview of future directions in the field. RECENT FINDINGS: Bladder-sparing treatments have emerged as viable alternatives to radical cystectomy (RC) for selected patients with MIBC, especially in those who are unfit for RC or elect bladder preservation. Numerous studies have assessed the efficacy of trimodal therapy (TMT), with outcomes comparable to RC in a subgroup of well selected patients. Combining immunotherapy with conventional treatments in bladder-sparing approaches can yield promising outcomes. Current research is making significant progress in optimizing treatment protocols by exploring new combinations of systemic therapy agents, innovative drug delivery methods, and biomarker-based approaches. Furthermore, clinical markers of response are being tested to ensure adequate response assessment. SUMMARY: Bladder preservation promise to offer a viable alternative to RC for selected patients with MIBC with the potential to improve patient quality of life. Careful patient selection and ongoing research are essential to optimize patient selection, response assessment, and salvage strategies. As evidence continues to evolve, the role of bladder preservation in MIBC is likely to expand, providing patients with more treatment options tailored to their needs and preferences.
- MeSH
- cystektomie * metody MeSH
- imunoterapie metody MeSH
- invazivní růst nádoru * MeSH
- léčba šetřící orgány * metody MeSH
- lidé MeSH
- močový měchýř chirurgie patologie MeSH
- nádory močového měchýře * terapie patologie chirurgie MeSH
- výběr pacientů MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
BACKGROUND AND OBJECTIVE: There has been a recent surge in the development of agents for bacillus Calmette-Guérin-unresponsive (BCG-U) non-muscle-invasive bladder cancer (NMIBC). Critical assessment of these agents and practical recommendations for optimal selection of patients and therapies are urgently needed, especially in the absence of randomized trials on bladder-sparing treatment (BST) options. METHODS: A global committee of bladder cancer experts was assembled to develop recommendations on BST for BCG-U NMIBC. Working groups reviewed the literature and developed draft recommendations, which were then voted on by International Bladder Cancer Group (IBCG) members using a modified Delphi process. During a live meeting in August 2023, voting results and supporting evidence were presented, and recommendations were refined on the basis of meeting discussions. Final recommendations achieved >75% agreement during the meeting, and some were further refined via web conferences and e-mail discussions. KEY FINDINGS AND LIMITATIONS: There is currently no single optimal agent for patients with BCG-U disease who seek to avoid radical cystectomy (RC). BST selection should be personalized, taking into account individual patient characteristics and preferences, tumor attributes, and efficacy/toxicity data for the agents available. For patients with BCG-U carcinoma in situ (CIS), gemcitabine/docetaxel (GEM/DOCE), nadofaragene firadenovec (NFF), and nogapendekin alfa inbakicept-pmln (NAI) + BCG are recommended; because of its systemic toxicity, pembrolizumab should only be offered after other options are exhausted. For patients with BCG-U papillary-only tumors, GEM/DOCE, NFF, NAI + BCG, single-agent chemotherapy, hyperthermic mitomycin C, and pembrolizumab are recommended. Given the modest efficacy of available options, clinical trial participation is encouraged. For unapproved agents with reported data, IBCG recommendations await the final results of pivotal trials. CONCLUSIONS AND CLINICAL IMPLICATIONS: The IBCG consensus recommendations provide practical guidance on BST for BCG-U NMIBC.
- MeSH
- adjuvancia imunologická terapeutické užití MeSH
- BCG vakcína * terapeutické užití MeSH
- cystektomie MeSH
- invazivní růst nádoru * MeSH
- léčba šetřící orgány * MeSH
- lidé MeSH
- nádory močového měchýře neinvadující svalovinu MeSH
- nádory močového měchýře * farmakoterapie patologie MeSH
- výběr pacientů * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- směrnice pro lékařskou praxi MeSH
V průběhu čtyřiceti let vývoje se transplantace pankreatu stala v České republice běžnou léčebnou metodou, která je zvláště vhodná pro pacienty současně podstupující transplantaci ledviny z důvodu dlouho trvajícího diabetu 1. typu. Oproti samostatné transplantaci ledviny zlepšuje kvalitu života i dlouhodobé přežití. Vede k téměř úplné normalizaci glykemií bez potřeby injekčního inzulinu a bez rizika hypoglykemií. Jako samostatný výkon suverénně léčí syndrom porušeného vnímání hypoglykemie u osob, u nichž edukace a použití dostupných technických prostředků nebyly dostatečně efektivní. V současné době existuje v České republice komplexní program, který dovoluje využít nabídku pankreatů od zemřelých dárců a různým typům příjemců s diabetem 1. a výjimečně i 2. typu poskytnout efektivní a relativně bezpečnou náhradu nefunkčních beta buněk s přihlédnutím k jejich celkovému zdravotnímu stavu, operačnímu riziku a také jejich volbě. Popisujeme dlouhodobé zkušenosti s transplantační léčbou diabetu v IKEM, na které se podílí odborníci z řad transplantačních chirurgů, diabetologů, nefrologů, imunologů a dalších specialistů.
During 40 years of development, pancreas transplantation has become a common treatment method in the Czech Republic, which is particularly suitable for patients undergoing simultaneous kidney transplantation due to long-standing type 1 diabetes. Compared to kidney transplantation alone, it improves quality of life and long-term survival. It leads to almost complete normalisation of glycaemia without the need for insulin injections and without the risk of hypoglycaemia. As a stand-alone procedure, it sovereigny treats the syndrome of impaired hypoglycaemia perception in people for whom education and the use of available technical means have not been sufficiently effective. Currently, there is a comprehensive program in the Czech Republic that allows to use the supply of pancreases from deceased donors and to provide various types of recipients with type 1 and, exceptionally, type 2 diabetes with an effective and relatively safe replacement of non-functioning beta cells, taking into account their overall health status, surgical risk and also their choice. We describe the long-term experience with transplantation treatment of diabetes at IKEM, involving experts from transplant surgeons, diabetologists, nephrologists, immunologists and other specialists.
- Klíčová slova
- IKEM,
- MeSH
- diabetes mellitus 1. typu chirurgie MeSH
- doba přežití bez progrese choroby MeSH
- lidé MeSH
- přežívání štěpu imunologie MeSH
- transplantace slinivky břišní * dějiny metody MeSH
- týmová péče o pacienty MeSH
- výběr pacientů MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
BACKGROUND: The extent to which differences in results from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) and Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial (ROCKET) atrial fibrillation (AF)-the landmark trials for the approval of apixaban and rivaroxaban, respectively, for non-valvular AF-were influenced by differences in their protocols is debated. The potential influence of selection criteria on trial results was assessed by emulating these trials in data from the Global Anticoagulant Registry in the Field (GARFIELD)-AF registry. METHODS: Vitamin K antagonist (VKA) and non-vitamin K oral antagonist (NOAC) users from GARFIELD-AF were selected according to eligibility for the original ARISTOTLE or ROCKET AF trials. A propensity score overlap weighted Cox model was used to emulate trial randomisation between treatment groups. Adjusted HRs for stroke or systemic embolism (SE) within 2 years of enrolment were calculated for each NOAC versus VKA. RESULTS: Among patients on apixaban, rivaroxaban and VKA, 2570, 3560 and 8005 were eligible for ARISTOTLE, respectively, and 1612, 2005 and 4368, respectively, for ROCKET AF. When selecting for ARISTOTLE criteria, apixaban users had significantly lower stroke/SE risk versus VKA (HR 0.57; 95% CI 0.34 to 0.94) while no reduction was observed with rivaroxaban (HR 0.98; 95% CI 0.68 to 1.40). When selecting for ROCKET AF criteria, safety and efficacy versus VKA were similar across the NOACs. CONCLUSION: Apixaban and rivaroxaban showed similar results versus VKA in high-risk patients selected according to ROCKET AF criteria, whereas differences emerged when selecting for the more inclusive ARISTOTLE criteria. Our results highlight the importance of trial selection criteria in interpreting trial results and underline the problems faced in comparing treatments across rather than within clinical trials.
- MeSH
- antikoagulancia terapeutické užití MeSH
- aplikace orální MeSH
- cévní mozková příhoda * prevence a kontrola etiologie MeSH
- fibrilace síní * farmakoterapie komplikace MeSH
- hodnocení rizik metody MeSH
- inhibitory faktoru Xa * terapeutické užití aplikace a dávkování MeSH
- lidé MeSH
- pyrazoly * terapeutické užití MeSH
- pyridony * terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- randomizované kontrolované studie jako téma metody MeSH
- registrace MeSH
- rivaroxaban * aplikace a dávkování terapeutické užití MeSH
- rizikové faktory MeSH
- senioři MeSH
- vitamin K antagonisté a inhibitory MeSH
- výběr pacientů * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
PURPOSE OF REVIEW: This article offers an overview of recent randomized controlled trials (RCTs) testing the efficacy of veno-arterial extracorporeal membrane oxygenation (VA ECMO) and microaxial flow pump (mAFP) in treating cardiogenic shock, including findings from the DanGer shock trial. It summarizes the clinical implications and limitations of these studies and key decision-making considerations for cardiogenic shock device use. RECENT FINDINGS: Despite important limitations in all published RCTs, the routine use of VA ECMO for acute myocardial infarction related cardiogenic shock did not demonstrate benefit and should be reserved for selected patients with extreme forms of cardiogenic shock. Conversely, mAFP (Impella CP) appears promising for cardiogenic shock due to ST elevation myocardial infarction. A stepwise approach - initial mAFP use for cardiogenic shock with left ventricular failure, supplemented by VA ECMO if mAFP is inadequate or if severe right ventricular failure is present - may be preferable, but requires validation through RCTs. High complication rates in device arms underscore the need for careful patient selection, preventive strategies, education for centers and operators, and further research. SUMMARY: Recent trials offer insights into mechanical circulatory support in cardiogenic shock, but their real-world applicability is limited. Despite potential benefits, the use of VA ECMO and mAFP is associated with significant complication rates, emphasizing the need for personalized use.
- MeSH
- klinické zkoušky jako téma * MeSH
- kurikulum MeSH
- lidé MeSH
- výběr pacientů MeSH
- výzkumní pracovníci výchova MeSH
- zdraví - znalosti, postoje, praxe MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- dopisy MeSH
- úvodníky MeSH
Transplantace jater je více než 40 let považována za standardní léčebnou metodu pacientů s život ohrožujícím jaterním onemocněním. V počátečním období byla indikována především u pacientů s jasně infaustní prognózou. Delší přežívání příjemců díky zlepšení chirurgické techniky, intenzivní péče a imunosuprese vedlo k cílení na nemocné s perspektivou dlouhodobého přežití, tedy k odklonu od onkologických indikací k pacientům s cirhózami. Narůstající nepoměr mezi potřebou transplantace a počtem dárcovských orgánů přinesl nutnost přísnějšího výběru, do kterého krom ryze medicinských úvah přicházejí i etické otázky ohledně rovného přístupu k transplantaci a nutnosti docílit s omezenými zdroji co největší transplantační benefit pro co nejširší okruh příjemců. Do vývoje indikací zasáhly jak změny v epidemiologii jaterních nemocí, tak i pokroky v jejich léčbě. Došlo k významnému poklesu zastoupení dříve dominantní virové hepatitidy C. Celosvětově pak narůstá počet pacientů transplantovaných pro nealkoholovou steatohepatitidu i alkoholovou jaterní cirhózu. Velký vývoj byl v poslední dekádě zaznamenán v oblasti nádorových onemocnění jater, především u indikací hepatocelulárního karcinomu, který v současnosti představuje v mnoha programech nejčastější indikaci. Přibližně jednu dekádu se transplantace jater standardně provádí pro hilový cholangiocelulární karcinom a omezeně pro neresekovatelné jaterní metastázy kolorektálního karcinomu. Uvedené indikace těsně souvisejí s dynamikou lokální čekací listiny.
Liver transplantation has been considered the standard treatment method for patients with life-threatening liver disease for more than 40 years. In the initial period, it was mainly indicated for patients with a clearly unfavorable prognosis. Longer survival of recipients was thanks to the improvement in surgical techniques, intensive care, and immunosuppression leading to the targeting of patients with the perspective of long-term survival, i.e. shift away from oncological indications to patients with cirrhosis. The growing disparity between the need for transplantation and the number of donor organs has brought about the necessity of a stricter selection, which, in addition to purely medical considerations, also includes ethical issues of equal access to transplantation and the need to achieve the greatest possible transplant benefit for the widest possible range of recipients while utilizing limited resources. Changes in the epidemiology of liver diseases as well as advances in their treatment affected the development of indications. There has been a significant decrease in the representation of previously dominant viral hepatitis C. Worldwide, the number of patients transplanted for non-alcoholic steatohepatitis and alcoholic liver cirrhosis is increasing. Great development has been noted in the last decade in the field of liver cancer, especially for the indications of hepatocellular carcinoma, which is currently the most common indication in many programs. For about a decade, liver transplantation has been performed standardly for hilar cholangiocellular carcinoma and experimentally for unresectable liver metastases of colorectal cancer. These indications are closely related to the dynamics of the local waiting list.
- MeSH
- lidé MeSH
- nádory jater patologie terapie MeSH
- nealkoholová steatóza jater patologie terapie MeSH
- transplantace jater * MeSH
- výběr pacientů MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- přehledy MeSH