Health in All Networks Simulator: mixed-methods protocol to test social network interventions for resilience, health and well-being of adults in Amsterdam

Background
Social networks are an important, although overlooked, component of community-based health promotion. Advances in social network research have highlighted different social network intervention (SNI) strategies to improve community-based health promotion. The aim of this project is to collaborate with community and policy stakeholders to explore how to best apply these SNI strategies to improve the resilience, health and well-being of adults in Amsterdam, and more broadly in the Netherlands.

Methods and analysis
To this end, we will collaboratively develop an intervention planning tool called the ‘Health in All Networks Simulator (HANS)’. This tool will be capable of virtually testing different SNI strategies and forecasting their possible impact on resilience, health and well-being. Taking a mixed-methods approach consisting of a combination of interviews, group model building workshops and agent-based modelling with members of two communities in Amsterdam and policy stakeholders, we will foster a shared learning process while ensuring ownership and relevance of HANS to ongoing community-based health promotion practice.

Ethics and dissemination
The research project has been approved by the research ethics committee of Wageningen University (approval numbers: 2024-039; 2024-226). HANS will be shared directly with stakeholders. The results will be made available to the public via open-access publications and conferences.

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Use of Meludia to evaluate the effect of music training in cochlear implant users: study protocol of a randomised controlled study

Introduction
Although most cochlear implant (CI) users achieve good speech understanding in quiet without visual cues, they may have limited speech understanding in noise and often have poor music perception. The present study was designed to investigate the degree to which the use of Meludia training can improve music perception, music enjoyment and speech understanding in paediatric and postlingually deafened adult CI users. The study also aims to assess the participants’ changes in cognitive skills (attention and memory) and quality of life.

Methods and analysis
This randomised controlled trial will randomise new CI users and experienced CI users older than 6 years who meet the inclusion criteria in a 1:1 ratio to either a musical training (MT) group or a non-MT (NMT) group. The NMT group will receive standard care that does not include MT. Participants in the MT group will practise with Meludia software for 4 weeks and later for 12 additional weeks. Outcomes will include scores in: ‘Listening Up’ exercises, the -Music-Related Quality of Life questionnaire, the Music Questionnaire for Paediatric Population, Disyllables in silence, Matrix test, Mini Mental State Examination, Performance IQ and the Wechsler intelligence scale for children and the Assessment of Quality of Life—8 Dimensions questionnaire. The NMT group will receive standard care that does not include MT.

Ethics and dissemination
On 16 October 2023, the study protocol was approved by the La Paz Hospital in Madrid (Spain). The findings of this study will be published in peer-reviewed publications and presented at appropriate conferences.

Trial registration number
NCT06540677.

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White Matter Hyperintensity Load Independent From the Stroke Lesion Is Associated With Chronic Aphasia Severity and Treatment Outcome

Stroke, Ahead of Print. BACKGROUND:Although many studies have suggested that white matter hyperintensity (WMH) severity predicts naming and aphasia severity in chronic poststroke aphasia, there are inconsistencies in the literature. WMHs are typically symmetrical in neurotypical controls, and measuring WMH in the contralateral hemisphere is likely the best option to estimate brain health independently from the stroke lesion and avoid measurement contamination from stroke-related gliosis. In this study, we aimed to clarify the discrepancies in the literature by testing whether WMH rating methods are related to clinical outcomes.METHODS:Ninety-five participants with chronic aphasia at least 12 months after their left-hemisphere stroke completed a baseline Western Aphasia Battery and the Philadelphia Naming Test. All participants then underwent 6 weeks of phonological and semantic naming treatments focused on improving lexical processing, and the Philadelphia Naming Test was readministered immediately following treatment. Using the Fazekas scale, WMH severity was independently rated on the whole brain and the right hemisphere only. Their relationship of WMH behavior was calculated by accounting for age, lesion volume, time poststroke, years of education, and sex.RESULTS:There were significant positive correlations between whole-brain and right-hemisphere ratings of WMH, but Wilcoxon signed-rank tests revealed that whole-brain ratings were consistently higher (whole brain M=3.337, right hemisphere M=2.899;P

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Replicating a COVID-19 study in a national England database to assess the generalisability of research with regional electronic health record data

Objectives
To assess the degree to which we can replicate a study between a regional and a national database of electronic health record data in the UK. The original study examined the risk factors associated with hospitalisation following COVID-19 infection in people with diabetes.

Design
A replication of a retrospective cohort study.

Setting
Observational electronic health record data from primary and secondary care sources in the UK. The original study used data from a large, urbanised region (Greater Manchester Care Record, Greater Manchester, UK—2.8 m patients). This replication study used a national database covering the whole of England, UK (NHS England’s Secure Data Environment service for England, accessed via the BHF Data Science Centre’s CVD-COVID-UK/COVID-IMPACT Consortium—54 m patients).

Participants
Individuals with a diagnosis of type 1 diabetes or type 2 diabetes prior to a positive COVID-19 test result. The matched controls (3:1) were individuals who had a positive COVID-19 test result, but who did not have a diagnosis of diabetes on the date of their positive COVID-19 test result. Matching was done on age at COVID-19 diagnosis, sex and approximate date of COVID-19 test.

Primary and secondary outcome measures
Hospitalisation within 28 days of a positive COVID-19 test.

Results
We found that many of the effect sizes did not show a statistically significant difference, but that some did. Where effect sizes were statistically significant in the regional study, then they remained significant in the national study and the effect size was the same direction and of similar magnitude.

Conclusions
There is some evidence that the findings from studies in smaller regional datasets can be extrapolated to a larger, national setting. However, there were some differences, and therefore replication studies remain an essential part of healthcare research.

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Association Between Real-World Actigraphy and Poststroke Motor Recovery

Stroke, Ahead of Print. BACKGROUND:Stroke is a leading cause of long-term disability, but advances for rehabilitation have lagged those for acute treatment. Large biological studies (eg, omics) may offer mechanistic insights for recovery but require collecting detailed recovery phenotypes at scale, for example, in thousands of people with minimal burden for participants and researchers. This study investigates the concurrent validity between remotely collected wearable sensor data and in-clinic assessments of motor recovery poststroke.METHODS:Utilizing a large, harmonized multisite dataset of adults at various stages of recovery poststroke, we analyzed cross-sectional (N=198; from 0 to >52 weeks) and longitudinal (N=98; from 0 to 26 weeks) changes in the use ratio, the Action Research Arm Test, and the Fugl-Meyer Assessment upper extremity subscale. The use ratio is the ratio of the time the paretic arm is active divided by the time the nonparetic arm is active.RESULTS:Our findings indicate strong concurrent validity of the use ratio, the Action Research Arm Test, and the Fugl-Meyer Assessment upper extremity subscale both cross-sectionally (differences between people) and longitudinally (changes within a person), for example,r=0.87 (95% CI, 0.80–0.91) at 0 to 6 weeks, declining tor=0.58 (95% CI, 0.39–0.72) at ≥52 weeks for correlations between use ratio and Action Research Arm Test.CONCLUSIONS:Although the use ratio strongly correlated with the Fugl-Meyer Assessment upper extremity subscale and Action Research Arm Test early after stroke, these correlations reduced with longer elapsed time poststroke. This decreasing correlation might be explained by the increasing influence that personal and environmental factors play as recovery progresses.

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Gap Years

To the Editor The rise in prevalence of gap years among applicants prior to medical school, as described in the Viewpoint by Dr Schwartzstein and Mr Marzouk, not only presents a trend but rather an evolution in how we, as future physicians, strive to meet the demands of an increasingly competitive application process to medical school. While we do not deny that the gap-year system may be flawed and possibly exacerbate inequities, for many students, especially collegiate athletes, it provides a unique opportunity. If taking 15 to 18 credit hours per semester was not enough, as athletes, we dedicated more than 40 hours per week to our respective sports, including meetings, practice, weight lifting, and treatment and recovery from injury. As former collegiate athletes, we utilized gap years as opportunities to strengthen our résumés, which, as a consequence of the time devoted to athletics, often lacked experiences in research and clinical work and were blemished by some grades or Medical College Admission Test scores. While many athletic programs attempt to mitigate the athletic and academic workload by providing tutors and academic advisers along with other resources, the difficulty of obtaining acceptance into medical school is at an all-time high. Competitive applications require more than just good grades and communication of the demands of a “full-time job” (our sport), which is sometimes perceived less favorably when compared with more traditional premedical activities.

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New Blood Test Shows Promise in Detecting Pancreatic Cancer

Pancreatic cancer is considered the third deadliest cancer in the US, resulting in more than 50 000 deaths each year, partially because tumors of the pancreas often go undetected until later stages. Although early-stage and localized pancreatic cancer has a much higher survival rate, there are no reliable US Food and Drug Administration–approved screening methods to detect tumors before they spread to the lymph nodes or other organs.

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Association between herpes simplex virus 1 and dementia: a systematic review protocol

Introduction
Herpes simplex virus 1 (HSV-1) infects approximately two-thirds of the global population under the age of 50 years. Although widely prevalent, the possible implications of HSV-1 in neurodegenerative diseases, especially dementia and Alzheimer’s disease, remain poorly understood. This review seeks to elucidate this association and explore the potential benefits of preventing or treating herpesvirus infections on dementia risk. The goal is to enhance our understanding of HSV-1’s potential role in dementia, which could inform the development of future therapeutic interventions for these conditions.

Methods and analysis
PubMed, Embase (Elsevier/Ovid), Web of Science, Scopus, Global Health, PsycInfo, Cochrane Library and Clinicaltrials.gov will be searched from the inception of each respective database. Studies that have HSV-1 as an exposure and dementia, or its subtypes, as a primary outcome will be included. Two researchers will independently screen titles, abstracts and full texts, with discrepancies resolved by a third researcher. Systematic data extraction from eligible studies will be performed using a standardised template. Risk of bias of individual studies will be assessed with the Cochrane Collaboration approach. We will assess the overall quality of cumulative evidence using the Grading of Recommendations, Assessment, Development and Evaluations criteria. Statistical analysis will employ a random effects model, and heterogeneity will be determined with Cochrane’s Q test and assessed using I2. Studies will be grouped by population subgroups and dementia subtypes when possible to explore nuances in results. We will consider performing meta-regression if heterogeneity remains after subgroup analyses. All statistical analyses will be conducted using Stata V.18 software (College Station, Texas, USA).

Ethics and dissemination
No ethical approval is required since data will be collected from existing studies. The review will be disseminated through peer-reviewed publication and at national and international conferences.

PROSPERO registration number
CRD42024516789.

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Protocol of the pilot study to test and evaluate the iCARE tool: a machine learning-based e-platform tool to make health prognoses and support decision-making for the care of older persons with complex chronic conditions

Introduction
The provision of optimal care for older adults with complex chronic conditions (CCCs) poses significant challenges due to the interplay of multiple medical, pharmacological, functional and psychosocial factors. To address these challenges, the I-CARE4OLD project, funded by the EU-Horizon 2020 programme, developed an advanced clinical decision support tool—the iCARE tool—leveraging large longitudinal data from millions of home care and nursing home recipients across eight countries. The tool uses machine learning techniques applied to data from interRAI assessments, enriched with registry data, to predict health trajectories and evaluate pharmacological and non-pharmacological interventions. This study aims to pilot the iCARE tool and assess its feasibility, usability and impact on clinical decision-making among healthcare professionals.

Methods and analysis
A minimum of 20 participants from each of the seven countries (Italy, Belgium, the Netherlands, Poland, Finland, Czechia and the USA) participated in the study. Participants were general practitioners, geriatricians and other medical specialists, nurses, physiotherapists and other healthcare providers involved in the care of older adults with CCC. The study design involved pre-surveys and post-surveys, tool testing with hypothetical patient cases and evaluations of predictions and treatment recommendations. Two pilot modalities—decision loop and non-decision loop—were implemented to assess the effect of the iCARE tool on clinical decisions. Descriptive statistics and bivariate and multivariate analysis will be conducted. All notes and text field data will be translated into English, and a thematic analysis will be performed. The pilot testing started in September 2024, and data collection ended in January 2025. At the time this protocol was submitted for publication, data collection was complete but data analysis had not yet begun.

Ethics and dissemination
Ethical approvals were granted in each participating country before the start of the pilot. All participants gave informed consent to participate in the study. The results of the study will be published in peer-reviewed journals and disseminated during national and international scientific and professional conferences and meetings. Stakeholders will also be informed via the project website and social media, and through targeted methods such as webinars, factsheets and (feedback) workshops. The I-CARE4OLD consortium will strive to publish as much as possible open access, including analytical scripts. Databases will not become publicly available, but the data sets used and/or analysed as part of the project can be made available on reasonable request and with the permission of the I-CARE4OLD consortium.

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Influence of context on engagement with COVID-19 testing: a scoping review of barriers and facilitators to testing for healthcare workers, care homes and schools in the UK

Objective
The UK government’s response to the COVID-19 pandemic included a ‘test, trace and isolate’ strategy. Testing services for healthcare workers, care homes and schools accounted for the greatest spend and volume of tests. We reviewed relevant literature to identify common and unique barriers and facilitators to engaging with each of these testing services.

Design
Scoping review.

Search strategy
PubMed, Scopus and the WHO COVID-19 Research Database were searched for evidence published between 1 January 2020 and 7 November 2022. This was supplemented by evidence identified via free-text searches on Google Scholar and provided by the UK Health Security Agency (UKHSA).

Data extraction and synthesis
Data were extracted by a team of reviewers and synthesised thematically under the broad headings of perceptions, experiences, barriers and facilitators to engaging with the COVID-19 testing programme.

Results
This study included 40 sources, including 17 from projects that informed UKHSA’s decisions during the pandemic. Eight themes emerged and were used to categorise barriers and facilitators to engaging with the testing services for healthcare workers, care homes and schools: (1) perceived value, (2) trust in the tests and public bodies, (3) importance of infrastructure, (4) impact of media and social networks, (5) physical burden of the test, (6) perceived capability to undertake testing, (7) importance of relevant information and 8) consequences of testing.

Conclusions
Universal barriers and facilitators to engagement with the testing programme related to the core elements of each testing service, such as uncomfortable specimen collection and the influence of media and peers; these could be mitigated or leveraged to increase engagement across settings. However, the individuals involved, perceptions of value and available resources differed across services, leading to unique experiences between settings. Thus, consideration of context is crucial when designing and implementing a testing programme in response to a pandemic.

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Hypoxic Preconditioning Enhances the Potential of Mesenchymal Stem Cells to Treat Neonatal Hypoxic-Ischemic Brain Injury

Stroke, Ahead of Print. BACKGROUND:Neonatal hypoxic-ischemic (HI) brain injury is one of the leading causes of long-term neurological morbidity in newborns. Current treatment options for HI brain injury are limited, but mesenchymal stem cell (MSC) therapy is a promising strategy to boost neuroregeneration after injury. Optimization strategies to further enhance the potential of MSCs are under development. The current study aimed to test the potency of hypoxic preconditioning of MSCs to enhance the therapeutic efficacy in a mouse model of neonatal HI injury.METHODS:HI was induced on postnatal day 9 in C57Bl/6 mouse pups. MSCs were cultured under hypoxic (hypoxic-preconditioned MSCs [HP-MSCs], 1% O2) or normoxic-control (normoxic-preconditioned MSCs, 21% O2) conditions for 24 hours before use. At 10 days after HI, HP-MSCs, normoxic-preconditioned MSCs, or vehicle were intranasally administered. Gold nanoparticle–labeled MSCs were used to assess MSC migration 24 hours after intranasal administration. At 28 days post-HI, lesion size, sensorimotor outcome, and neuroinflammation were assessed by hematoxylin and eosin staining, cylinder rearing task, and IBA1 staining, respectively. In vitro, the effect of HP-MSCs was studied on transwell migration, neural stem cell differentiation and microglia activation, and the MSC intracellular proteomic content was profiled using quantitative LC-MS/ms.RESULTS:Intranasally administered HP-MSCs were superior to normoxic-preconditioned MSCs in reducing lesion size and sensorimotor impairments post-HI. Moreover, hypoxic preconditioning enhanced MSC migration in an in vitro set-up, and in vivo to the lesioned hemisphere after intranasal application. In addition, HP-MSCs enhanced neural stem cell differentiation into more complex neurons in vitro but had similar anti-inflammatory effects compared with normoxic-preconditioned MSCs. Lastly, hypoxic preconditioning led to elevated abundances of proteins in MSCs related to extracellular matrix remodeling.CONCLUSIONS:This study shows for the first time that hypoxic preconditioning enhanced the therapeutic efficacy of MSC therapy in a mouse model of neonatal HI brain injury by increasing the migratory and neuroregenerative capacity of MSCs.

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Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial

Introduction
Insomnia is prevalent in psychiatric populations and may contribute to maintain and exacerbate psychiatric symptoms. Cognitive behavioural therapy for insomnia (CBTi) is the treatment of choice also for insomnia comorbid to psychiatric illness. However, patients are rarely offered CBTi in psychiatric outpatient clinics. The aim of this randomised controlled trial is to investigate whether CBTi delivered in groups in a psychiatric outpatient clinic is superior to treatment as usual (TAU).

Methods and analysis
In the Sleep in Psychiatric Care trial, 60 patients with moderate to severe psychiatric illness who meet the criteria for insomnia disorder will be recruited from an outpatient psychiatric clinic in Norway. The patients will be randomised (1:1) either to group-based CBTi (Sleep School Wake Up for Insomnia; SSWU-I) or to a wait list (WL) while they are all receiving TAU for their psychiatric disorder. SSWU-I will comprise five bi-weekly sessions, each lasting 120 min, hence the treatment period is 8 weeks. Assessment will be conducted at baseline (T1) and after 8 weeks (T2). The primary outcome will be self-rated insomnia symptoms using the Insomnia Severity Index and the Bergen Insomnia Scale. Secondary outcomes include measures of symptoms of dysfunctional beliefs and attitudes about sleep, depression, anxiety, fatigue, problems with work and social adjustment and well-being. Mixed model analyses will be conducted to test the hypotheses.

Ethics and dissemination
Ethical approval has been granted by the Regional Committee for Medical and Health Research Ethics, in Western Norway (REK 2020/66304). Findings will be published in peer-reviewed journals and presented at research conferences and in relevant media. The results may document the need for specific sleep-directed treatments in psychiatric clinics as a way of treating insomnia disorder as well as to alleviate psychiatric symptoms.

Trial registration number
NCT04463498.

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Digital health intervention to optimise heart failure management after hospital discharge in Brazil (OPT-HF): a randomised clinical trial protocol

Introduction
Guideline-directed medical therapy (GDMT) for heart failure (HF) reduces adverse events, but is underused. Global barriers to GDMT optimisation include low frequency of visits, clinician inertia and poor patient knowledge, which may be mitigated by digital health interventions (DHI). In Brazil, low digital literacy and reduced access to technology may compromise these potential DHI’s beneficial effects. Our objective is to develop and test the effectiveness of a DHI to optimise GDMT in patients recently hospitalised for HF in the Brazilian public health system (Sistema Único de Saúde (SUS)).

Methods and analysis
This is a randomised, controlled, multicentre, parallel-group, clinical trial in which 154 patients being discharged from an HF-related hospitalisation will be randomised. Inclusion criteria are ≥18 years of age, reduced ejection fraction HF (EF

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QbTest for ADHD assessment and medication management: a mixed-methods systematic review of impact on clinical outcomes and patient, carer and clinician experiences

Objectives
To explore patient, carer and clinician experiences of the QbTest and its impact on patient outcomes for attention deficit hyperactivity disorder (ADHD) diagnosis and medication management.

Design
Mixed-methods systematic review.

Data sources
MEDLINE, EMBASE, PsycINFO, CINAHL, ClinicalTrials.gov and WHO ICTRP (from inception to September 2024).

Study selection
Primary studies, of any design, that evaluated any version of the QbTest (QbMini

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