settings-based approach
Dotaz
Zobrazit nápovědu
BACKGROUND: Various explicit screening tools, developed mostly in central Europe and the USA, assist clinicians in optimizing medication use for older adults. The Turkish Inappropriate Medication use in oldEr adults (TIME) criteria set, primarily based on the STOPP/START criteria set, is a current explicit tool originally developed for Eastern Europe and subsequently validated for broader use in Central European settings. Reviewed every three months to align with the latest scientific literature, it is one of the most up-to-date tools available. The tool is accessible via a free mobile app and website platforms, ensuring convenience for clinicians and timely integration of updates as needed. Healthcare providers often prefer to use their native language in medical practice, highlighting the need for prescribing tools to be translated and adapted into multiple languages to promote optimal medication practices. OBJECTIVE: To describe the protocol for cross-cultural and language validation of the TIME criteria in various commonly used languages and to outline its protocol for clinical validation across different healthcare settings. METHODS: The TIME International Study Group comprised 24 geriatric pharmacotherapy experts from 12 countries. In selecting the framework for the study, we reviewed the steps and outcomes from previous research on cross-cultural adaptations and clinical validations of explicit tools. Assessment tools were selected based on both their validity in accurately addressing the relevant issues and their feasibility for practical implementation. The drafted methodology paper was circulated among the study group members for feedback and revisions leading to a final consensus. RESULTS: The research methodology consists of two phases. Cross-cultural adaptation/language validation phase follows the 8-step approach recommended by World Health Organization. This phase allows regions or countries to make modifications to existing criteria or introduce new adjustments based on local prescribing practices and available medications, as long as these adjustments are supported by current scientific evidence. The second phase involves the clinical validation, where participants will be randomized into two groups. The control group will receive standard care, while the intervention group will have their treatment evaluated by clinicians who will review the TIME criteria and consider its recommendations. A variety of patient outcomes (i.e., number of hospital admissions, quality of life, number of regular medications [including over the counter medications], geriatric syndromes and mortality) in different healthcare settings will be investigated. CONCLUSION: The outputs of this methodological report are expected to promote broader adoption of the TIME criteria. Studies building on this work are anticipated to enhance the identification and management of inappropriate medication use and contribute to improved patient outcomes.
INTRODUCTION: The histopathological classification for antineutrophil cytoplasmic autoantibody (ANCA)-associated glomerulonephritis (ANCA-GN) is a well-established tool to reflect the variety of patterns and severity of lesions that can occur in kidney biopsies. It was demonstrated previously that deep learning (DL) approaches can aid in identifying histopathological classes of kidney diseases; for example, of diabetic kidney disease. These models can potentially be used as decision support tools for kidney pathologists. Although they reach high prediction accuracies, their "black box" structure makes them nontransparent. Explainable (X) artificial intelligence (AI) techniques can be used to make the AI model decisions accessible for human experts. We have developed a DL-based model, which detects and classifies the glomerular lesions according to the Berden classification. METHODS: Kidney biopsy slides of 80 patients with ANCA-GN from 3 European centers, who underwent a diagnostic kidney biopsy between 1991 and 2011, were included. We also investigated the explainability of our model using Gradient-weighted Class Activation Mapping (Grad-CAM) heatmaps. These maps were analyzed by pathologists to compare the decision-making criteria of humans and the DL model and assess the impact of different training settings. RESULTS: The DL model shows a prediction accuracy of 93% for classifying lesions. The heatmaps from our trained DL models showed that the most predictive areas in the image correlated well with the areas deemed to be important by the pathologist. CONCLUSION: We present the first DL-based computational pipeline for classifying ANCA-GN kidney biopsies as per the Berden classification. XAI techniques helped us to make the decision-making criteria of the DL accessible for renal pathologists, potentially improving clinical decision-making.
- Publikační typ
- časopisecké články MeSH
AIM: To examine the organisational (i.e., perceived organisational support and psychologically safe environment) and individual (i.e., value, belief and norm) antecedents that strengthen healthcare workers' speaking-up behaviour in a developing economy. DESIGN: The study uses a cross-sectional design to gather the same data from healthcare workers within the Ashanti Region of Ghana. METHODS: The data collection happened between 15 June and 30 August 2023. A sample of 380 healthcare workers was selected from 20 facilities in the Ashanti Region of Ghana. A configurational approach, a fussy-set qualitative comparative analysis, was used to identify the configurations that caused high and low speaking-up behaviour among the study sample. RESULTS: The study results reveal that whereas four configurations generate high speaking-up behaviour, three configurations, by contrast, produce low speaking-up behaviour among healthcare workers. CONCLUSION: Results suggest that in so far as organisational support systems which take the form of a psychologically safe environment and perceived organisational support are vital in relaxing the hierarchical boundaries in a healthcare setting to improve healthcare workers' speaking-up behaviour, the individual value-based factors that take the form of values, beliefs and norms are indispensable as it provides the healthcare workers with the necessary inner drive to regard speaking-up behaviour on patient safety and care as a moral duty. IMPACT: Healthcare workers' speaking-up behaviour is better achieved when organisational support systems complement the individual norms, values and beliefs of the individual. REPORTING METHOD: Adhered to Strengthening Reporting of Observational Studies in Epidemiology guidelines. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.
- MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- organizační kultura * MeSH
- postoj zdravotnického personálu * MeSH
- průřezové studie MeSH
- zdravotnický personál * psychologie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Ghana MeSH
In vitro dissolution testing is commonly performed to ensure that oral solid dosage medicines are of high quality and will achieve their targeted in vivo performance. However, this testing is time and material consuming. Therefore, pharmaceutical companies have been developing predictive dissolution models (PDMs) for drug product release based on fast at- and/or on-line measurements, including real-time release testing of dissolution (RTRT-D). Recently, PDMs have seen acceptance by major regulatory bodies as release tests for the dissolution critical quality attribute. In this paper, several methodologies are described to develop and validate a fit-for-purpose model, then to implement it as a surrogate release test for dissolution. These approaches are further exemplified by real-life case studies, which demonstrate that PDMs for release are not only viable but more sustainable than in vitro dissolution testing and can significantly accelerate drug product release. The rise of continuous manufacturing within the pharmaceutical industry further favors the implementation of real-time release testing. Therefore, a steep uptake of PDMs for release is expected once this methodology is globally accepted. To that end, it is advantageous for global regulators and pharmaceutical innovators to coalesce around a harmonized set of expectations for development, validation, implementation, and lifecycle of PDMs as part of drug product release testing.
- MeSH
- aplikace orální MeSH
- farmaceutická chemie metody MeSH
- léčivé přípravky chemie aplikace a dávkování MeSH
- lidé MeSH
- příprava léků MeSH
- rozpustnost MeSH
- schvalování léčiv MeSH
- uvolňování léčiv * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Hepatectomies play a crucial role in the multidisciplinary management of primary and secondary liver malignancies but are associated with significant risks, including 30-day mortality, morbidity, prolonged hospitalization, and increased resource utilization. Optimizing perioperative care remains a challenge; however, enhanced recovery programs have shown improved patient outcomes. The EUPEMEN (EUropean PErioperative MEdical Networking) protocol focuses on improving the perioperative management of liver resections through the establishment of interdisciplinary principles based on practical experience and theoretical frameworks from five European countries. This paper outlines the core elements of the EUPEMEN protocol, emphasizing strategies to minimize surgical stress, optimize perioperative care, and enhance postoperative recovery. The protocol is systematically designed to reduce postoperative mortality and morbidity, shorten hospital stays, and improve patient outcomes. The EUPEMEN guidelines address inconsistencies in surgical practice across Europe and are structured for implementation in various healthcare environments. "The protocol's approach is designed to support improvements in perioperative care standards in liver resections and may serve as a practical and efficient tool for healthcare professionals, pending further clinical validation. The EUPEMEN protocol offers a standardized, evidence-based framework to enhance perioperative management in hepatectomies. By integrating multidisciplinary principles, the main target is to eliminate complications, improve surgical outcomes, and promote faster recovery. Its implementation across diverse clinical settings may contribute to advancing perioperative care standards for liver resections in Europe.
- MeSH
- hepatektomie * metody normy MeSH
- klinické protokoly MeSH
- lidé MeSH
- nádory jater chirurgie MeSH
- perioperační péče * metody normy MeSH
- pooperační komplikace prevence a kontrola MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Geografické názvy
- Evropa MeSH
Multiple sclerosis (MS) is characterized by a progressive worsening of disability over time. As many regulatory-cleared disease-modifying treatments aiming to slow down this progression are now available, a clear need has arisen for a personalized and data-driven approach to treatment optimization in order to more efficiently slow down disease progression and eventually, progressive disability worsening. This strongly depends on the availability of biomarkers that can detect and differentiate between the different forms of disease worsening, and on predictive models to estimate the disease trajectory for each patient under certain treatment conditions. To this end, we here describe a multicenter, retrospective, observational study, aimed at setting up a harmonized database to allow the development, training, optimization, and validation of such novel biomarkers and AI-based decision models. Additionally, the data will be used to develop the tools required to better monitor this progression and to generate further insights on disease worsening and progression, patient prognosis, treatment decisions and responses, and patient profiles of patients with MS.
- Publikační typ
- časopisecké články MeSH
Cílem studie bylo zjistit, zda je střídavý nácvik v prostředí běžné školy realizovatelný a zda u našeho výzkumného souboru, tvořeného školní třídou, povede ke vyšší míře retence dovedností ve srovnání s blokovým nácvikem. Studie vycházela z dosavadních výzkumů zaměřených na vliv kontextuální in- terference, avšak nově na tuto problematiku nahlížela z didaktického hlediska v kontextu standardního prostředí české školy. Výzkumného šetření se zúčastnilo 38 žáků šesté třídy základní školy. V rámci hodin tělesné výchovy byla zkoumána efektivita blokového a střídavého nácviku při osvojování tří specifických pohybových dovedností. Vybrané dovednosti byly pro účastníky nové, atraktivní a odpo- vídaly jejich úrovni obtížnosti. Nácvik probíhal ve dvou skupinách (dívky a chlapci) za rovnocenných podmínek, přičemž jedna dovednost byla nacvičována blokově a zbývající dvě střídavě. Každé doved- nosti bylo věnováno celkem 30 minut nácviku rozdělených do tří týdnů. Výsledky učení byly hodnoceny bezprostředně po skončení nácviku a následně po čtyřtýdenní pauze pomocí retenčního testu. Srovnání blokového a střídavého režimu nácviku pomocí Mann-Whitneyho U testu ukázalo, že střídavý nácvik byl u našeho souboru efektivnější metodou učení. Z řízených rozhovorů a pozorování vyplynulo, že střídavý nácvik kladl vyšší nároky na organizaci výuky, motivaci žáků a didaktické kompetence učitele. Celkově lze konstatovat, že střídavý nácvik je v podmínkách školní tělesné výchovy realizovatelný a z hlediska retence dovedností může být efektivnější než tradiční blokový přístup.
The aim of the study was to determine whether variable practice is feasible in a mainstream school setting and whether our research population, consisting of a school classroom, would lead to a higher rate of skill retention compared to block practice. The study was based on previous research focusing on the influence of contextual interference, but it took a new didactical perspective on this issue in the context of a standard Czech school environment. Thirty-eight sixth grade elementary school pupils participated in the research investigation. The effectiveness of block and variable drills in the acquisition of three specific movement skills was investigated in physical education classes. The selected skills were new and attractive to the participants and matched their level of difficulty. Training was conducted in two groups (girls and boys) under equivalent conditions, with one skill practiced in block and the remaining two skills practiced variably. Each skill received a total of 30 minutes of practice divided into three weeks. Learning outcomes were assessed immediately after the end of practice and then after a four-week break using a retention test. Comparison of block and variable practice mode using Mann-Whitney U test showed that variable practice was the more effective learning method for our sample. The guided interviews and observations showed that the variable training placed higher demands on the organisation of teaching, the motivation of the pupils and the didactic competence of the teacher. Overall, it can be concluded that variable practice is feasible in school physical education conditions and may be more effective than the traditional block approach in terms of skill retention.
- MeSH
- dítě MeSH
- lidé MeSH
- motorické dovednosti * MeSH
- pohybová aktivita fyziologie MeSH
- psychomotorický výkon fyziologie MeSH
- retence (psychologie) MeSH
- tělesná výchova * metody MeSH
- učení MeSH
- vyučovací postupy metody výchova MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- klinická studie MeSH
BACKGROUND: Effective diabetes management requires a multimodal approach involving lifestyle changes, pharmacological treatment, and continuous patient education. Self-management demands can be overwhelming for patients, leading to lowered motivation, poor adherence, and compromised therapeutic outcomes. In this context, digital health apps are emerging as vital tools to provide personalized support and enhance diabetes management and clinical outcomes. OBJECTIVE: This study evaluated the impact of the digital health application Vitadio on glycemic control in patients with type 2 diabetes mellitus (T2DM). Secondary objectives included evaluating its effects on cardiometabolic parameters (weight, BMI, waist circumference, blood pressure, and heart rate) and self-reported measures of diabetes distress and self-management. METHODS: In this 6-month, 2-arm, multicenter, unblinded randomized controlled trial, patients aged 18 years or older diagnosed with T2DM were randomly assigned (1:1) to an intervention group (IG) receiving standard diabetes care reinforced by the digital health app Vitadio or to a control group (CG) provided solely with standard diabetes care. Vitadio provided a mobile-based self-management support tool featuring educational modules, motivational messages, peer support, personalized goal setting, and health monitoring. The personal consultant was available in the app to provide technical support for app-related issues. The primary outcome, assessed in the intention-to-treat population, was a change in glycated hemoglobin (HbA1c) levels at 6 months. Secondary outcomes included changes in cardiometabolic measures and self-reported outcomes. Data were collected in 2 study centers: diabetologist practice in Dessau-Roßlau and the University of Dresden. RESULTS: Between November 2022 and June 2023, a total of 276 patients were screened for eligibility, with 149 randomized to in intervention group (IG; n=73) and a control group (CG; n=76). The majority of participants were male (91/149, 61%). The dropout rate at month 6 was 19% (121/149). While both groups achieved significant HbA1c reduction at 6 months (IG: mean -0.8, SD 0.9%, P<.001; CG: mean -0.3, SD 0.7%, P=.001), the primary confirmatory analysis revealed statistically significant advantage of the IG (adjusted mean difference: -0.53%, SD 0.15, 95% CI -0.24 to -0.82; P<.001; effect size [Cohen d]=0.67, 95% CI 0.33-1). Significant between-group differences in favor of the IG were also observed for weight loss (P=.002), BMI (P=.001) and systolic blood pressure (P<.03). In addition, Vitadio users experienced greater reduction in diabetes-related distress (P<.03) and obtained more pronounced improvements in self-care practices in the areas of general diet (P<.001), specific diet (P<.03), and exercise (P<.03). CONCLUSIONS: This trial provides evidence for the superior efficacy of Vitadio in lowering the HbA1c levels in T2DM patients compared to standard care. In addition, Vitadio contributed to improvements in cardiometabolic health, reduced diabetes-related distress, and enhanced self-management, highlighting its potential as an accessible digital tool for comprehensive diabetes management. TRIAL REGISTRATION: German Clinical Trials Registry DRKS00027405; https://drks.de/search/de/trial/DRKS00027405.
- MeSH
- diabetes mellitus 2. typu * krev terapie MeSH
- dospělí MeSH
- glykovaný hemoglobin analýza MeSH
- lidé středního věku MeSH
- lidé MeSH
- mobilní aplikace * MeSH
- péče o sebe MeSH
- self-management MeSH
- senioři MeSH
- telemedicína MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Liver glycogen storage disorders (GSDs) are rare inherited disorders of carbohydrate metabolism that are clinically characterized by hepatomegaly and fasting intolerance. This group of disorders comprises GSD Ia and Ib as well as the so-called ketotic GSDs including GSD III, VI, IX, XI and 0a. Although clinical practice guidelines exist for most GSD subtypes, diagnostics, treatment and monitoring differ significantly among metabolic centres. The aim of this study was to gain insight into current clinical practice for liver GSDs. METHODS: An international web-based survey was performed among health care professionals involved in the care of individuals with liver GSDs. RESULTS: Sixty-seven respondents from 28 different countries caring for approximately 2650 liver GSD patients completed the survey. While the diagnostic approach was generally consistent, significant differences among metabolic centres are still observed with respect to monitoring parameters and treatment approaches. Reasons for these differences are local availability of management tools and treatment options, the rarity of the different GSD subtypes, the experiences of health care professionals, and the existence of extreme phenotypes. CONCLUSION: The development of a standard set of outcomes for patients with liver GSDs is warranted as a reference for both daily care and the evaluation of safety and efficacy of future therapies. For various parameters that serve as valuable outcome measures, tools and target values should be better defined.
- MeSH
- glykogenóza * terapie diagnóza MeSH
- játra metabolismus patologie MeSH
- lidé MeSH
- management nemoci MeSH
- nemoci jater * terapie diagnóza MeSH
- průzkumy a dotazníky MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Flow cytometry immunophenotyping is critical for the diagnostic classification of mature/peripheral B-cell neoplasms/B-cell chronic lymphoproliferative disorders (B-CLPD). Quantitative driven classification approaches applied to multiparameter flow cytometry immunophenotypic data can be used to extract maximum information from a multidimensional space created by individual parameters (e.g., immunophenotypic markers), for highly accurate and automated classification of individual patient (sample) data. Here, we developed and compared five diagnostic classification algorithms, based on a large set of EuroFlow multicentric flow cytometry data files from a cohort 659 B-CLPD patients. These included automatic population separators based on Principal Component Analysis (PCA), Canonical Variate Analysis (CVA), Neighbourhood Component Analysis (NCA), Support Vector Machine algorithms (SVM) and a variant of the CA(Canonical Analysis) algorithm, in which the number of SDs (Standard Deviations) varied for each of the comparisons of different pairs of diseases (CA-vSD). All five classification approaches are based on direct prospective interrogation of individual B-CLPD patients against the EuroFlow flow cytometry B-CLPD database composed of tumor B-cells of 659 individual patients stained in an identical way and classified a priori by the World Health Organization (WHO) criteria into nine diagnostic categories. Each classification approach was evaluated in parallel in terms of accuracy (% properly classified cases), precision (multiple or single diagnosis/case) and coverage (% cases with a proposed diagnosis). Overall, average rates of correct diagnosis (for the nine B-CLPD diagnostic entities) of between 58.9 % and 90.6 % were obtained with the five algorithms, with variable percentages of cases being either misclassified (4.1 %-14.0 %) or unclassifiable (0.3 %-37.0 %). Automatic population separators based on CA, SVM and PCA showed a high average level of correctness (90.6 %, 86.8 %, and 86.0 %, respectively). Nevertheless, this was at the expense of proposing a considerable number of multiple diagnoses for a significant proportion of the test cases (54.5 %, 53.5 %, and 49.6 %, respectively). The CA-vSD algorithm generated the smaller average misclassification rate (4.1 %), but with 37.0 % of cases for which no diagnosis was proposed. In contrast, the NCA algorithm left only 2.7 % of cases without an associated diagnosis but misclassified 14.0 %. Among correctly classified cases (83.3 % of total), 91.2 % had a single proposed diagnosis, 8.6 % had two possible diagnoses, and 0.2 % had three. We demonstrate that the proposed AI algorithms provide an acceptable level of accuracy for the diagnostic classification of B-CLPD patients and, in general, surpass other algorithms reported in the literature.
- MeSH
- algoritmy MeSH
- B-lymfocyty * patologie MeSH
- imunofenotypizace * metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- lymfoproliferativní nemoci * diagnóza klasifikace MeSH
- průtoková cytometrie * metody MeSH
- senioři MeSH
- support vector machine MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
