Study protocol using informatics to identify and recruit a cohort of older adults in Florida to develop teleneuropsychological norms

Introduction
The use of teleneuropsychology or neuropsychological remote assessment increased during and after the COVID-19 pandemic in 2020. Teleneuropsychology facilitates remote assessment for populations that do not have access to neuropsychological services as well as individuals who are vulnerable or have physical restrictions that would otherwise make it difficult for individuals to receive appropriate care. However, there are many instruments that are not validated or lack normative data for the overall population. Therefore, this study aims to develop normative data for a neuropsychological battery administered on telehealth with commonly used tools to identify cognitive performance in older adults.

Methods and analysis
The following study will use a previously informatics-generated list of participants who have a lower risk of developing Alzheimer’s disease and other related dementias. Participants will complete screening surveys related to cognitive and health status. They will also complete questionnaires related to sociodemographic information, depression, functionality and social determinants of health. Participants will undergo a teleneuropsychological battery examination via remote assessment. We estimate recruiting 500 participants to establish normative data.

Ethics and dissemination
The current protocol is approved by the University of Florida’s Institutional Review Board. Results will be analysed and disseminated in a research paper once sample number goals are completed.

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Electronic Informed Consent in MOST: An Acute Ischemic Stroke Clinical Trial

Stroke, Ahead of Print. BACKGROUND:Obtaining timely informed consent is a key barrier in acute ischemic stroke clinical trial recruitment. Electronic consent (eConsent) allows electronic delivery and documentation of the informed consent process, which may optimize recruitment. eConsent in acute ischemic stroke clinical trials, however, is limited and understudied. We conducted a post hoc analysis of eConsent adoption in MOST (Multi-Arm Optimization of Stroke Thrombolysis Trial), a phase III acute ischemic stroke clinical trial, and studied the impact on recruitment.METHODS:From October 10, 2019, to July 5, 2023, MOST enrolled 514 participants at 57 sites in the United States. Study databases were reviewed to determine informed consent modality for each participant: paper—in person, paper—remote, eConsent—in person, and eConsent—remote. Study sites could use paper consent or eConsent for each enrollment. eConsent adoption trends and participant demographic diversity were reported using descriptive statistics. We utilized χ2and Kruskal-Wallis tests to compare individual site enrollment, remote consent utilization, baseline neuroimaging-to-randomization times, data clarification requests, and reportable consent-related unanticipated events.RESULTS:eConsent was utilized for 173 (33.7%) of 514 participants. Of 57 sites, 32 (56.1%) utilized eConsent at least once: those sites had higher median enrollment over the course of the entire trial than non-eConsent sites (7.5 [interquartile range, 5–17] versus 3 [interquartile range, 2–4];P

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Impacts on quality of care following electronic health record implementation within a large Canadian community hospital: a qualitative study

Objective
This study aimed to describe how healthcare providers perceived the impacts of implementing and using an electronic health record (EHR) on quality, safety and person-centredness of care.

Design
A qualitative descriptive design using semistructured interviews.

Setting
In October 2020, a large Canadian community hospital implemented a new EHR system (Epic) across three sites, transitioning from a previously fragmented (combination of paper-based and electronic) system.

Participants
Sixty-two healthcare providers and clinical leaders.

Results
Participants shared their experiences regarding the impact of EHR implementation on quality of care, which were analysed into common themes including task efficiency, information management, patient interactions and patient safety. While the system significantly altered their routines and introduced new responsibilities like additional documentation requirements, it also facilitated adherence to clinical guidelines, improved information visibility and enhanced documentation, benefiting overall quality of care and patient safety. Participants reported that EHR implementation led to increased efficiency, freeing up time for patient care and improving communication with patients and other providers.

Conclusion
EHRs have the potential to improve quality of care and patient safety, but this depends on their perceived value and how well healthcare providers can integrate their various features into clinical routines.

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A protocol using mixed methods for the impact analysis of the implementation of the EMPOWER project: an eHealth intervention to promote mental health and well-being in European workplaces

Introduction
Mental health at the workplace has been identified as a major priority by the World Health Organization (WHO). Despite its significance, international studies examining the influence of digital mental health interventions on workplace implementation and outcomes are lacking. The European Platform to Promote Well-being and Health in the Workplace (EMPOWER) platform is an eHealth intervention consisting of a website and web-based app designed to guide employers and employees on the prevention of common health problems, reduce presenteeism and absenteeism in the workplace. The aim of this paper is to describe the rationale and methods that will be used to conduct a maxi impact analysis of the processes undertaken to develop and implement the EMPOWER platform in European workplaces using the Global Impact Analytics Framework (GIAF) methodology.

Methods and analysis
We will undertake a mixed-methods analysis of the impact of the process of implementation in the two phases of implementation (initiation and maturity—the early implementation phase). The primary methodology that will be used for the analysis is the GIAF and toolkit. The GIAF toolkit includes a taxonomy (knowledge map), glossary and checklists to examine and rate the EMPOWER project across various domains of impact: planning, pre-engagement, readiness, usability, dissemination, adoption and uptake. Information will be collected from a range of sources through different methods and used to rate the EMPOWER platform (website and app) on each domain. For reliability and validity, four raters will independently rate the EMPOWER platform using the same information. The analysis will include qualitative and quantitative methods to rate on standardised ladders and scales in the GIAF toolkit. Analysis will include descriptive statistics and non-parametric tests where relevant. The information gained will be reviewed in a subgroup (per country) and group (three country) analysis for formative and key summative learnings. These key learnings will be synthesised to generate organisational learnings and insights for the EMPOWER consortium to improve future intervention implementation processes.

Ethics and dissemination
The impact analysis study protocol has been approved by the Research Ethics Committees of the University of Canberra (ID:202311841) and also the Fundació Sant Joan de Déu (PIC-39-20). The participating countries for the RCT (EMPOWER study) also obtained ethical approval through their respective ethical organisations in the participating countries. The impact analysis is registered with the Open Science Framework ID osf.io/eysc9. The EMPOWER project trial is registered at ClinicalTrial.gov with trial ID NCT04907604. The outcomes of the impact analysis study will be disseminated via conference presentations, peer-reviewed journals and key organisational learnings presented in relevant forums.

Trial registration number
NCT04907604.

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Faecal phageome transplantation alleviates intermittent intestinal inflammation in IBD and the timing of transplantation matters: a preclinical proof-of-concept study in mice

We read with interest the Rome Consensus paper on faecal microbiota transplantation (FMT) in IBD (a refractory disease with intermittent flare-ups and remissions of intestinal inflammation) by Lopetuso et al.1 It highlights modest efficacies of FMT in treating IBD and adverse event risks caused by bacteria transplantation, according to data from clinical trials.1 Hence, further refinement of FMT is warranted for IBD treatment.2 3 Our prior study found that FMT can simultaneously reconfigure the gut bacteriome and phageome in patients with Clostridioides difficile infection; however, the reconfiguration of phageome was associated more with a long-term intestinal inflammation amelioration, suggesting a prominent role for gut bacteriophages in combating intestinal pathologies.4–6 Our more recent studies discovered a critically perturbed gut phageome in the intestinal mucosa of patients with IBD.7 8 Surprisingly, the distortion…

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Incidence of Visuospatial Neglect in Acute Stroke: Assessment and Stroke Characteristics in an Unselected 1-Year Cohort

Stroke, Ahead of Print. BACKGROUND:The true incidence of visuospatial neglect, impaired attention toward contralesional space, remains unclear. Common variability sources are sensitivity differences of conventional assessments and the exclusion of patients with language, motor, and other cognitive impairments. We aimed to determine the incidence of visuospatial neglect in an unselected cohort of patients with acute stroke using video oculography during free visual exploration, a newly established assessment overcoming the aforementioned biases.METHODS:Single-center, prospective, observational cohort study. We screened every patient admitted to a representative Swiss stroke center over 1 year (n=626). Two hundred eighty-five patients were eligible (first-ever stroke within 72 hours), and 221 were included. The incidence of visuospatial neglect was determined with conventional paper-pencil assessments and video oculography during free visual exploration. Demographic, risk, and stroke-related factors, as well as stroke localization, were also considered. Feasibility and ability to detect visuospatial neglect of the assessments were evaluated.RESULTS:The overall incidence of visuospatial neglect was ≈38%: widely varying location-specifically: ≈61% and ≈22% for stroke in the right and left cerebral hemispheres, respectively, and ≈14% to ≈37% for some less commonly affected infratentorial areas or multifocal stroke. In hemispheric stroke, visuospatial neglect was most common when the middle (≈64% right and ≈21% left) and posterior (≈53% right and ≈25% left) cerebral artery territories were affected. Neglect patients had higher National Institutes of Health Stroke Scale scores, more commonly atrial fibrillation and thrombectomy, and less commonly an undetermined stroke cause. They were older, with ≈4% yearly increase in the odds of having visuospatial neglect. Video oculography during free visual exploration was administrable and detected visuospatial neglect more often than conventional paper-pencil assessments.CONCLUSIONS:The incidence of visuospatial neglect in an unselected cohort, using a highly sensitive assessment, is considerably higher than previously assumed and can also occur after less typically localized strokes. These results can enhance the awareness of visuospatial neglect in the acute setting, potentially facilitating earlier identification and therapy of this disabling disorder.

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Framework to guide the use of mathematical modelling in evidence-based policy decision-making

Introduction
The COVID-19 pandemic highlighted the significance of mathematical modelling in decision-making and the limited capacity in many low-income and middle-income countries (LMICs). Thus, we studied how modelling supported policy decision-making processes in LMICs during the pandemic (details in a separate paper).
We found that strong researcher–policymaker relationships and co-creation facilitated knowledge translation, while scepticism, political pressures and demand for quick outputs were barriers. We also noted that routine use of modelled evidence for decision-making requires sustained funding, capacity building for policy-facing modelling, robust data infrastructure and dedicated knowledge translation mechanisms.
These lessons helped us co-create a framework and policy roadmap for improving the routine use of modelling evidence in public health decision-making. This communication paper describes the framework components and provides an implementation approach and evidence for the recommendations. The components include (1) funding, (2) capacity building, (3) data infrastructure, (4) knowledge translation platforms and (5) a culture of evidence use.

Key arguments
Our framework integrates the supply (modellers) and demand (policymakers) sides and contextual factors that enable change. It is designed to be generic and disease-agnostic for any policy decision-making that modelling could support. It is not a decision-making tool but a guiding framework to help build capacity for evidence-based policy decision-making. The target audience is modellers and policymakers, but it could include other partners and implementers in public health decision-making.

Conclusion
The framework was created through engagements with policymakers and researchers and reflects their real-life experiences during the COVID-19 pandemic. Its purpose is to guide stakeholders, especially in lower-resourced settings, in building modelling capacity, prioritising efforts and creating an enabling environment for using models as part of the evidence base to inform public health decision-making. To validate its robustness and impact, further work is needed to implement and evaluate this framework in diverse settings.

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DIAMONDS–a diabetes self-management intervention for people with severe mental illness: protocol for an individually randomised controlled multicentre trial

Introduction
Type 2 diabetes mellitus (T2DM) is two to three times more common in people with severe mental illness (SMI) than in the general population. Supporting self-management in diabetes is fundamental to improving clinical outcomes. The DIAMONDS trial aims to evaluate the clinical and cost effectiveness of a novel, codesigned, supported diabetes self-management programme for people with T2DM and SMI.

Methods and analysis
This multicentre, two-armed, parallel, individually randomised controlled trial will be conducted in National Health Service mental health trusts across England. We will recruit 380 participants (≥18 years old) with a diagnosis of SMI (schizophrenia, bipolar disorder, schizoaffective disorder, psychosis and severe depression) and T2DM. Eligible and consenting participants will be randomised to the DIAMONDS intervention or treatment as usual. The intervention group will receive one-to-one sessions with a trained DIAMONDS Coach for six months. These sessions will focus on goal setting, action planning and diabetes self-management education, supported by a paper-based workbook and an optional digital application. Individuals allocated to the control group will continue to receive usual care and may be offered National Institute for Health and Care Excellence-recommended generic diabetes self-management education programmes in line with usual practice. The primary outcome is the difference in glycated haemoglobin (HbA1c) between both groups at 12 months postrandomisation. The secondary outcomes include measures of physical and mental health, diabetes complications and physical activity. Economic and process evaluations will also be performed. Outcomes will be collected at baseline and at six and 12 month post-randomisation.

Ethics and dissemination
This study received ethics approval by the West of Scotland Research Ethics Committee 3 (22/WS/0117). Findings will be published in peer-reviewed, academic and professional journals. We will also be producing plain language summaries, infographics and audio summaries on the website, as well as attending conferences and dissemination events. A summary of the results will be distributed to all participants and other relevant stakeholders, and we will use social media channels, websites and knowledge exchange events to communicate our findings beyond academic audiences.

Trial registration number
ISRCTN22275538.

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DIAMONDS–a diabetes self-management intervention for people with severe mental illness: protocol for an individually randomised controlled multicentre trial

Introduction
Type 2 diabetes mellitus (T2DM) is two to three times more common in people with severe mental illness (SMI) than in the general population. Supporting self-management in diabetes is fundamental to improving clinical outcomes. The DIAMONDS trial aims to evaluate the clinical and cost effectiveness of a novel, codesigned, supported diabetes self-management programme for people with T2DM and SMI.

Methods and analysis
This multicentre, two-armed, parallel, individually randomised controlled trial will be conducted in National Health Service mental health trusts across England. We will recruit 380 participants (≥18 years old) with a diagnosis of SMI (schizophrenia, bipolar disorder, schizoaffective disorder, psychosis and severe depression) and T2DM. Eligible and consenting participants will be randomised to the DIAMONDS intervention or treatment as usual. The intervention group will receive one-to-one sessions with a trained DIAMONDS Coach for six months. These sessions will focus on goal setting, action planning and diabetes self-management education, supported by a paper-based workbook and an optional digital application. Individuals allocated to the control group will continue to receive usual care and may be offered National Institute for Health and Care Excellence-recommended generic diabetes self-management education programmes in line with usual practice. The primary outcome is the difference in glycated haemoglobin (HbA1c) between both groups at 12 months postrandomisation. The secondary outcomes include measures of physical and mental health, diabetes complications and physical activity. Economic and process evaluations will also be performed. Outcomes will be collected at baseline and at six and 12 month post-randomisation.

Ethics and dissemination
This study received ethics approval by the West of Scotland Research Ethics Committee 3 (22/WS/0117). Findings will be published in peer-reviewed, academic and professional journals. We will also be producing plain language summaries, infographics and audio summaries on the website, as well as attending conferences and dissemination events. A summary of the results will be distributed to all participants and other relevant stakeholders, and we will use social media channels, websites and knowledge exchange events to communicate our findings beyond academic audiences.

Trial registration number
ISRCTN22275538.

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