Assessing the Effectiveness of metaHelper: A Randomized Controlled Trial of a Web Application for Statistical Transformations in Meta-Analysis.

Objective: To test whether the use of a web application (www.metaHelper.eu) can reduce errors and time needed for statistical transformations commonly performed for meta-analysis.

Improvements in Walking During Subacute Stroke Rehabilitation Translate to Physical Activity at the Chronic Stage: A Sub-Analysis From the Phys Stroke Trial.

Unlabelled: Stroke frequently results in mobility impairments, contributing to an increased cardiovascular risk. Despite efforts to promote physical activity, stroke survivors fail to meet recommended levels. This secondary analysis of the 'Physical Fitness in Patients with Subacute Stroke' (Phys-Stroke) trial analyzes physical activity at 6 months post-stroke, and examines the effect of gains in walking capacity during the subacute phase on physical activity in the chronic stage.

Hospital-Acquired Pressure Ulcers and Long-Term Motor Score Recovery in Patients With Acute Cervical Spinal Cord Injury.

Importance: Pressure ulcers (PUs) are (1) prevalent secondary complications after spinal cord injury (SCI), (2) present with elevated systemic inflammatory tone, and (3) may interfere with healing processes underlying neurological recovery (disrepair).

Objective: To investigate whether PUs acquired during initial hospitalization are associated with neurological and functional long-term outcome and survival after SCI.

Design, Setting, And Participants: Multicenter cohort study at 20 centers of the prospective SCI Model Systems (SCIMS) Database (Birmingham, AL).

Ethics practices associated with reusing health data: an assessment of patient registries.

Background: As routinely collected patient data have become increasingly accessible over the years, more attention has been directed at the ethics of using such data for research. Patient data is often available to researchers through patient registries that typically collect data of patients with a specific condition. While ethical guidelines for using patient data are presented frequently in the literature, it is currently unknown how patient registries implement the recommendations from these guidelines in practice and how they communicate their practices.

Establishing a telemedical supported trans-sectoral collaboration network from community support to emergency care for outpatient care recipients: study protocol of a prospective non-randomized complex intervention study with a pragmatic approach, Stay@Home - Treat@Home.

Background: Demographic changes in Germany are increasing the number of outpatient care recipients, who often resort to emergency care due to difficulties accessing timely outpatient medical care. Previous studies suggest that early detection and telemedical interventions could reduce unnecessary hospitalizations. The new form of healthcare aims to provide continuous, flexible healthcare for outpatient care recipients using digital technologies to detect health deteriorations and facilitate interventions at home.

Exploring influential components and indicators in hospital resilience assessment: a scoping review protocol.

Introduction: Hospitals are vital infrastructures that provide health services during emergencies and disasters. However, in recent years, disasters have led to hospital losses and interruptions in medical services. Consequently, the concept of resilience has garnered significant attention.

A facility for laboratory mice with a natural microbiome at Charité - Universitätsmedizin Berlin.

Mice with a natural microbiome are a promising research model for basic and applied science because of their closer resemblance to the human superorganism compared to mice born and raised under stringent hygiene conditions. Consequently, biomedical therapies developed and tested in “Wildling mice” hold great potential for successful translation into clinical applications. Over the past four years, scientists, veterinarians and institutional officials at Charité – Universitätsmedizin Berlin, supported by the University Hospital Erlangen, have designed a facility for Wildling mice and developed a conceptual framework for safe and ethical preclinical research involving mice with a natural microbiome.

Connecting the dots in neuroscience research: The future of evidence synthesis.

Making progress in neuroscience research involves learning from existing data. In this perspective piece, we explore the potential of a data-driven evidence ecosystem to connect all primary data streams, and synthesis efforts to inform evidence-based research and translational success from bench to bedside. To enable this transformation, we set out how we can produce evidence designed with evidence curation in mind.

Stroke patient and stakeholder engagement (SPSE): concepts, definitions, models, implementation strategies, indicators, and frameworks-a systematic scoping review.

Background: Involving stroke patients in clinical research through patient engagement aims to ensure that studies are patient-centered, and may help ensure they are feasible, ethical, and credible, ultimately leading to enhanced trust and communication between researchers and the patient community. In this study, we have conducted a scoping review to identify existing evidence and gaps in SPSE.

Methods: The five-step approach outlined by Arksey and O'Malley, in conjunction with the Preferred Reporting Items for Scoping Reviews (PRISMA-ScR) guidelines, provided the structure for this review.

Patient flow management in biological events: a scoping review.

Introduction: Biological Events affect large populations depending on transmission potential and propagation. A recent example of a biological event spreading globally is the COVID-19 pandemic, which has had severe effects on the economy, society, and even politics,in addition to its broad occurrence and fatalities. The aim of this scoping review was to look into patient flow management techniques and approaches used globally in biological incidents.

Impaired glucose metabolism and the risk of vascular events and mortality after ischemic stroke: A systematic review and meta-analysis.

Background: Diabetes mellitus (DM), prediabetes, and insulin resistance are highly prevalent in patients with ischemic stroke (IS). DM is associated with higher risk for poor outcomes after IS.

Objective: Investigate the risk of recurrent vascular events and mortality associated with impaired glucose metabolism compared to normoglycemia in patients with IS and transient ischemic attack (TIA).

Rethinking animal attrition in preclinical research: Expressing causal mechanisms of selection bias using directed acyclic graphs.

Animal attrition in preclinical experiments can introduce bias in the estimation of causal treatment effects, as the treatment-outcome association in surviving animals may not represent the causal effect of interest. This can compromise the internal validity of the study despite randomization at the outset. Directed Acyclic Graphs (DAGs) are useful tools to transparently visualize assumptions about the causal structure underlying observed data.

Perfusion parameter map generation from TOF-MRA in stroke using generative adversarial networks.

Purpose: To generate perfusion parameter maps from Time-of-flight magnetic resonance angiography (TOF-MRA) images using artificial intelligence to provide an alternative to traditional perfusion imaging techniques.

Materials And Methods: This retrospective study included a total of 272 patients with cerebrovascular diseases; 200 with acute stroke (from 2010 to 2018), and 72 with steno-occlusive disease (from 2011 to 2014). For each patient the TOF MRA image and the corresponding Dynamic susceptibility contrast magnetic resonance imaging (DSC-MRI) were retrieved from the datasets.

Strength of statistical evidence for the efficacy of cancer drugs: a Bayesian reanalysis of randomized trials supporting Food and Drug Administration approval.

Objectives: To quantify the strength of statistical evidence of randomized controlled trials (RCTs) for novel cancer drugs approved by the Food and Drug Administration in the last 2 decades.

Study Design And Setting: We used data on overall survival (OS), progression-free survival, and tumor response for novel cancer drugs approved for the first time by the Food and Drug Administration between January 2000 and December 2020. We assessed strength of statistical evidence by calculating Bayes factors (BFs) for all available endpoints, and we pooled evidence using Bayesian fixed-effect meta-analysis for indications approved based on 2 RCTs.

Informing pandemic management in Germany with trustworthy living evidence syntheses and guideline development: lessons learned from the COVID-19 evidence ecosystem.

Objectives: We present the 'COVID-19 evidence ecosystem' (CEOsys) as a German network to inform pandemic management and to support clinical and public health decision-making. We discuss challenges faced when organizing the ecosystem and derive lessons learned for similar networks acting during pandemics or health-related crises.

Study Design And Setting: Bringing together 18 university hospitals and additional institutions, CEOsys key activities included research prioritization, conducting living systematic reviews (LSRs), supporting evidence-based (living) guidelines, knowledge translation (KT), detecting research gaps, and deriving recommendations, backed by technical infrastructure and capacity building.

The Impact of Multi-Institution Datasets on the Generalizability of Machine Learning Prediction Models in the ICU.

Objectives: To evaluate the transferability of deep learning (DL) models for the early detection of adverse events to previously unseen hospitals.

Design: Retrospective observational cohort study utilizing harmonized intensive care data from four public datasets.

Setting: ICUs across Europe and the United States.

Calcitonin treatment for osteoarthritis and rheumatoid arthritis - a systematic review and meta-analysis of preclinical data.

Purpose: The aim of this study was to investigate the efficacy of calcitonin (CT) in animal models of experimental osteoarthritis (OA) and rheumatoid arthritis (RA), as new stabilized CT formulations are currently being introduced.

Methods: A comprehensive and systemic literature search was conducted in PubMed/MEDLINE and Embase databases to identify articles with original data on CT treatment of preclinical OA and RA. Methodological quality was assessed using the Systematic Review Centre for Laboratory Animal Experimentation's risk of bias tool for animal intervention studies.

Automated detection of early signs of irreversible ischemic change on CTA source images in patients with large vessel occlusion.

Purpose: To create and validate an automated pipeline for detection of early signs of irreversible ischemic change from admission CTA in patients with large vessel occlusion (LVO) stroke.

Methods: We retrospectively included 368 patients for training and 143 for external validation. All patients had anterior circulation LVO stroke, endovascular therapy with successful reperfusion, and follow-up diffusion-weighted imaging (DWI).

Workflow for detecting biomedical articles with underlying open and restricted-access datasets.

To monitor the sharing of research data through repositories is increasingly of interest to institutions and funders, as well as from a meta-research perspective. Automated screening tools exist, but they are based on either narrow or vague definitions of open data. Where manual validation has been performed, it was based on a small article sample.

The unmet promise of trustworthy AI in healthcare: why we fail at clinical translation.

Artificial intelligence (AI) has the potential to revolutionize healthcare, for example via decision support systems, computer vision approaches, or AI-based prevention tools. Initial results from AI applications in healthcare show promise but are rarely translated into clinical practice successfully and ethically. This occurs despite an abundance of "Trustworthy AI" guidelines.

Informed consent and trial prioritization for clinical studies during the COVID-19 pandemic. Stakeholder experiences and viewpoints.

Background: Very little is known about the practice-oriented challenges and potential response strategies for effective and efficient translation of informed consent and study prioritization in times of a pandemic. This stakeholder interview study aimed to identify the full spectrum of challenges and potential response strategies for informed consent and study prioritization in a pandemic setting.

Methods: We performed semi-structured interviews with German stakeholders involved in clinical research during the COVID-19 pandemic.

[Nationally standardized broad consent in practice: initial experiences, current developments, and critical assessment].

Background: The digitalization in the healthcare sector promises a secondary use of patient data in the sense of a learning healthcare system. For this, the Medical Informatics Initiative's (MII) Consent Working Group has created an ethical and legal basis with standardized consent documents. This paper describes the systematically monitored introduction of these documents at the MII sites.