ARBOR-Telehealth study: an examination of telerehabilitation to improve function and reduce opioid use in persons with chronic low back pain in rural communities – protocol of a pragmatic, individually randomised group treatment trial

Introduction
Chronic low back pain (LBP) imposes significant burden on patients, healthcare systems and society. Physical therapy is a cost-effective method for improving pain and disability; however, only a small number of patients (7–13%) with LBP ever receive physical therapy services. Patients report obstacles to accessing physical therapy, such as transportation, provider availability and missed work. Access is especially limited in rural communities, where approximately 40% fewer physical therapists are available per capita than in metropolitan regions. This lack of access likely contributes to the greater rates of LBP-related disability and opioid consumption in rural communities. Innovative methods for improving access to physical therapy for patients with chronic LBP are urgently needed; these can help address differences in health outcomes and mitigate opioid dependence for patients with chronic LBP living in rural communities. Telerehabilitation increases access to physical therapy, which can potentially improve health outcomes for these patients.

Methods and analysis
This prospective, individually randomised group treatment trial will involve primary care clinics serving rural communities on Maryland’s Eastern Shore. We will enroll 434 individuals with chronic LBP. Eligible patients will be randomised to either standardised education for back pain delivered via website or to a risk-informed telerehabilitation. Standardised education will be delivered via a study website containing information consistent with materials provided by primary care providers. Risk-informed telerehabilitation will be delivered by trained physical therapists using a web-based, video-enabled telehealth platform. The primary outcome is LBP-related disability. Secondary outcomes are opioid use, pain intensity, health-related quality of life and LBP-related healthcare use assessed using standard patient-reported outcome measures, participant self-report and medical chart abstraction. Implementation outcomes are acceptability, adoption, feasibility and fidelity of our treatment approach guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and assessed using surveys, semi-structured interviews and key performance metrics.

Ethics and dissemination
Ethics approval was obtained from the Johns Hopkins Medicine Institutional Review Boards (IRB), which serves as the single IRB for this trial. Upon completion, study data will be shared in compliance with National Institutes of Health guidelines.

Trial registration number
NCT06471920.

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Utilisation of point-of-care ultrasound by critical care nurses: a scoping review protocol

Introduction
Point-of-care ultrasound (POCUS) is considered an essential component of intensive care practice, enabling rapid assessment and diagnosis of various medical conditions. Critical care nurses (CCNs) have increasingly adopted this bedside technology, which has demonstrated to improve patient care and streamline workflows. This scoping review aims to map and present the contexts in which CCNs use POCUS, the content and structure of the training programmes undertaken and any reported impacts on patient outcomes.

Methods and analysis
This scoping review will be conducted in accordance with the Joanna Briggs Institute guidelines and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklists. We will search Medline, EBSCOhost CINAHL and Google Scholar for relevant studies published from 2015 to the present. Additionally, the reference lists of included studies will be manually checked for further relevant articles. All review steps will be carried out by at least two reviewers to ensure accuracy and reliability. Data charting will be performed narratively, detailing the study characteristics and findings pertinent to the review questions.

Ethics and dissemination
There is no ethics disclosure required for this review protocol, as the data will be sourced from previously published primary studies. The findings of this review will be published in a peer-reviewed journal and disseminated through presentations at both national and international conferences.

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Examining the challenges of people living alone with neurodegenerative conditions: a scoping review protocol

Introduction
People living alone with neurodegenerative conditions face unique difficulties in maintaining independence and accessing appropriate health and social care support. Consolidating current understanding regarding these unique difficulties would better inform health and social care services and enable more tailored and appropriate service delivery. The proposed scoping review will summarise evidence from studies that provide evidence about people with dementia, Parkinson’s disease, Huntington’s disease or motor neurone disease who live alone. This protocol sets out the processes that will be followed in the subsequent scoping review to ensure that a transparent, rigorous and reproducible approach is used to identify, select and synthesise relevant evidence.

Methods and analysis
This scoping review protocol uses well-established methodology outlined by the Preferred Reporting Items for Systematic review and Meta-Analysis and the Joanna Briggs Institute. Relevant publications will be searched using PubMed, Web of Science Core Collection, CINAHL and AgeLine via EBSCOhost and EMBASE, PsycInfo and Social Policy and Practice via Ovid. Grey literature will be searched via Google looking specifically for pdf documents. As there was no previous review on the topic, no date restrictions will be applied to the searches. Piloting of the search strategy provided an estimate of the number of titles likely to require title and abstract screening, which, along with prior experience from a similar review approach, informed the feasibility of the proposed strategy. For research publications, a two-stage screening approach will be undertaken. The first stage will involve screening titles and abstracts for relevant literature on people with neurodegenerative conditions living alone in the community. The second stage will involve full text screening of selected articles. For grey literature, the first 20 PDFs per website identified in Google will be downloaded and screened. Summary data will be extracted from publications selected for inclusion. Data synthesis will involve tabulating study characteristics and findings and preparing narrative summaries to identify commonalities, gaps and areas for future research.

Ethics and dissemination
Ethical approval is not required for this review, as the information included is in the public domain and people with lived experience are consultees rather than research participants. Consultation with people with lived experience, stakeholders and experts linked with the National Institute for Health and Care Research Policy Research Unit in Dementia and Neurodegeneration University of Exeter will help to ensure the relevance and applicability of findings. Dissemination will include a policy report and peer-reviewed publications aimed at informing policy, practice and improving support services for people living alone with neurodegenerative conditions.

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Effectiveness of cognitive stimulation for individuals with mild cognitive impairment: a systematic review and meta-analysis

Objective
Cognitive stimulation (CS) is a non-pharmacological intervention aimed at enhancing cognitive function. However, the effectiveness of CS in individuals diagnosed with mild cognitive impairment (MCI) remains inconclusive. Therefore, this study aimed to assess the effectiveness of CS in improving cognitive function, psychological well-being, instrumental activities of daily living (IADL) and quality of life (QoL) in individuals with MCI, based on randomised controlled trials (RCTs).

Design
Systematic review and meta-analysis.

Data sources
Six English databases were systematically searched, including PubMed, Web of Science, Embase, Cumulative Index to Nursing and Allied Health Literature, American Psychological Association PsycInfo and Academic Search Premier.

Eligibility criteria
RCTs about CS for individuals with MCI, published between January 2003 and December 2024.

Data extraction and synthesis
Data were extracted and assessed using the revised Cochrane risk of bias tool for randomised trials by independent researchers. The meta-analysis was conducted using the standardised mean difference (SMD) and 95% CIs of the included studies.

Results
The meta-analysis included five eligible studies for the primary outcomes of cognitive function and three eligible studies for the secondary outcomes of psychological wellness. In the pooled samples, the CS intervention had a significant effect on cognitive function (SMD=0.63, 95% CI 0.25 to 1.01; p=0.001) and depression symptoms (SMD=–0.29, 95% CI –0.55 to –0.03; p=0.03) in individuals with MCI. However, no significant improvements in anxiety symptoms were identified after the CS intervention (SMD=–0.05; 95% CI –0.31 to 0.21; p=0.71).

Conclusion
The CS intervention can effectively improve cognitive function and alleviate depression symptoms. Although a meta-analysis was not conducted for IADL and QoL due to the limited number of included studies, positive trends in enhancing IADL performance and augmenting QoL were observed in individuals with MCI. However, due to the scarcity of relevant studies in this research field, more comprehensive RCTs are warranted to provide a better understanding of the potential benefits of CS and to guide its clinical application in the future.

PROSPERO registration number
CRD42023494685.

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Effectiveness of the BioFire FilmArray for the rapid detection of bloodstream infection in haematological patients with febrile neutropenia (the ONFIRE study): study protocol of a prospective, multicentre observational study at three reference university hospitals in Spain

Introduction
Bloodstream infection (BSI) due to multidrug-resistant Gram-negative bacilli is a serious global health problem that has a profound impact on severely immunosuppressed neutropenic haematological patients. Prompt institution of appropriate antimicrobial therapy is crucial for improving outcomes in these patients, and in an era of multidrug resistance, antimicrobial stewardship programmes are mandatory. Blood cultures, the current gold standard for the diagnosis of BSI, present two main drawbacks: the prolonged time to results and their low sensitivity, especially if the patient has received antimicrobial treatment before blood extraction. The aim of this study is to determine whether a molecular technique, the BioFire FilmArray Blood Culture Identification 2 (BCID2) panel, achieves higher sensitivity and specificity than conventional blood cultures for the microbiological diagnosis of BSI in haematological patients with febrile neutropenia.

Methods and analysis
This multicentre, prospective, observational study will be conducted at three reference university hospitals in Spain. The population will comprise haematological patients scheduled to undergo diagnostic blood cultures as standard care for the microbiological diagnosis of the febrile neutropenia episode. The BioFire FilmArray panel will be performed in patients with positive blood cultures at the time of blood culture positivity and in patients with negative blood cultures at 48 hours of incubation. The primary endpoint will be the sensitivity and specificity of the BioFire FilmArray BCID2 panel compared with conventional blood cultures. The secondary endpoints will be this same comparison in the subgroup of patients with recent (

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Perinatal outcomes for infants exposed to systemic cancer treatment during gestation: a systematic review and meta-analysis

Objectives
The incidence of cancer diagnosed during pregnancy is increasing, but data relating to perinatal outcomes for infants exposed to systemic cancer treatment in utero remain limited. This systematic review and meta-analysis aimed to synthesise evidence from the available literature to investigate whether perinatal outcomes for babies born to women with gestational cancer differ based on whether they are exposed to systemic cancer treatment in utero.

Design
A systematic review was conducted according to PRISMA-P guidelines. We extracted raw data from the eligible studies to calculate ORs and 95% CIs for perinatal outcomes reported in the included studies.

Data sources
A comprehensive search of Medline, Embase, Cochrane Library and CINAHL databases identified studies published between January 2001 and May 2025.

Eligibility criteria
Studies were eligible for inclusion in the review that reported on both a study group (women with gestational cancer who received systemic therapy during pregnancy) and a comparison group (women with gestational cancer who did not receive systemic therapy during pregnancy).

Data extraction and synthesis
Two independent reviewers extracted data. Perinatal outcomes included spontaneous abortion, pregnancy termination, intrauterine growth restrictions (IUGR), stillbirth, intrauterine foetal death, neonatal mortality, preterm birth (

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Prevalence and types of errors in the electronic health record: protocol for a mixed systematic review

Introduction
In countries with access to the electronic health record (EHR), both patients and healthcare professionals have reported finding errors in the EHR, so-called EHRrors. These can range from simple typos to more serious cases of missing or incorrect health information. Despite their potential detrimental effect, the evidence on EHRrors has not been systematically analysed. It is unknown how common EHRrors are or how they impact patients and healthcare professionals.

Methods and analysis
A mixed systematic review will be carried out to address the research gap. We will search PubMed, Web of Science and CINAHL for studies published since 2000, which report original research data on patient-identified and healthcare professional-identified EHRrors. We will analyse (1) the prevalence of EHRrors, (2) the types of EHRrors and (3) their impact on care. Quantitative and qualitative findings will be synthesised following the Joanna Briggs Institute Framework for Mixed Systematic Reviews. Identified studies will be critically appraised for meta-biases and risk of bias in individual studies. The confidence in the emerging evidence will be further assessed through the Grading of Recommendations Assessment, Development and Evaluation approach. Findings will be contextualised and interpreted involving an international team of patient representatives and practising healthcare professionals.

Ethics and dissemination
The study will not involve collection or analysis of individual patient data; thus, ethical approval is not required. Results will be published in a peer-reviewed publication and further disseminated through scientific events and educational materials.

PROSPERO registration number
CRD42024622849.

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Protocol for the development of a transdiagnostic core outcome set for mental health disorders in adults: the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative

Introduction
Mental health problems are important causes of disability and economic costs worldwide. Randomised clinical trials examining the treatment of mental health disorders measure heterogeneous outcomes, causing difficulties in data synthesis, interpretation and translation into clinical practice. The aim of the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative is to develop an overarching, transdiagnostic research-based and consensus-based core outcome set for adult mental health disorders.

Methods and analysis
The development of the PIO-Psych transdiagnostic core outcome set will include three phases: (1) a systematic scoping review of the literature to develop the initial list of outcomes for the Delphi study; (2) a Delphi study in three rounds including people with lived experience of mental health disorders and their relatives, clinicians, researchers and others (administrators, mental healthcare policymakers, philosophers); (3) a hybrid consensus meeting to agree on the final overarching, transdiagnostic core outcome set and corresponding time points of assessment of each outcome.

Ethics and dissemination
Ethical approval is not applicable to this study according to the Research Ethics Committee of the Capital Region of Denmark, as it is not an interventional study. All data will be reported anonymously, and it will not be possible to identify study participants. Results will be disseminated via stakeholder and research networks and peer-reviewed publications.

Trial registration details
The PIO-Psych Initiative was pre-registered with COMET (Core Outcome Measures for Effectiveness Trials) on 17 May 2024 (https://www.comet-initiative.org/Studies/Details/3125).

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[Articles] Music therapy for the treatment of anxiety: a systematic review with multilevel meta-analyses

The findings suggest that music therapy, particularly receptive methods or combinations of receptive and active approaches, offer effective, flexible, and scalable interventions for reducing anxiety symptoms, offering psychological benefits that enhance patient autonomy and quality of life, though its impact on physiological outcomes and long-term effects requires further research.

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Automated Vessel Occlusion Software in Acute Ischemic Stroke: Pearls and Pitfalls

Stroke, Ahead of Print. Software programs leveraging artificial intelligence to detect vessel occlusions are now widely available to aid in stroke triage. Given their proprietary use, there is a surprising lack of information regarding how the software works, who is using the software, and their performance in an unbiased real-world setting. In this educational review of automated vessel occlusion software, we discuss emerging evidence of their utility, underlying algorithms, real-world diagnostic performance, and limitations. The intended audience includes specialists in stroke care in neurology, emergency medicine, radiology, and neurosurgery. Practical tips for onboarding and utilization of this technology are provided based on the multidisciplinary experience of the authorship team.

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Impact of Venous CONgestion on Organ Function and Outcomes in Sepsis (ICON-Sepsis): a prospective observational cohort study protocol

Introduction
Sepsis is a common condition with significant morbidity, mortality and annual costs of care in the billions of dollars. Despite innumerable studies on the causes of, and therapies for, sepsis, the mortality rate has not changed substantially in the last 20 years. Treatments remain generic, with current guidelines recommending the same approach for all patients, regardless of the litany of differences that exist at baseline. Moreover, the blanket administration of 30 cc/kg of intravenous fluid (IVF) to all patients is recognised as being directly harmful to some. Patient-level heterogeneity in prior sepsis trials is recognised as a substantial contributor to all these problems, yet no prior investigation has attempted to identify volume-informed septic phenotypes, a necessary first step towards precision care.

Methods and analysis
Predicated on prior studies demonstrating detectability of organ-level congestion, we hypothesise that central venous hypertension (1) is deleterious to the function of the lungs, liver, kidneys and vascular endothelium; (2) is worsened by cardiac dysfunction and IVF administration; and (3) contributes to adverse organ-specific and overall outcomes. Beginning in the emergency department, cardiac function will be assessed with echocardiography while congestion in the lungs and kidneys will be assessed using previously validated sonographic markers of congestion. Biomarkers for each organ will be collected concurrently, thereby increasing the fidelity of our phenotypic profiles by pairing indicators of macroscopic and microscopic stress and dysfunction. Data will also be collected at 24 hours and 7 days (or discharge, whichever comes first) after presentation. Classical and machine learning approaches will be used to analyse our large data stream and develop a rule-based system to identify distinct subpopulations of patients with sepsis who have greater risk/likelihood of both organ-specific and overall adverse outcomes.

Ethics and dissemination
This project has been approved by the Wayne State University Institutional Review Board, with patient enrolment beginning in April 2024. Findings will be reported and disseminated via conference presentations and open-access publications.

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Population pharmacokinetics and pharmacodynamics of two dosing regimens of antenatal corticosteroids: protocol for a prospective nested study in a randomised controlled trial

Introduction
Antenatal corticosteroid (ACS) regimens have remained unchanged since the initial trials in 1972, with the optimal regimen still undetermined. The WHO ACTION (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns)-III trial is a three-arm individually randomised double-blind trial evaluating the efficacy and safety of two different ACS dosing regimens (currently used and lower-dose ACS regimens vs placebo) in women with a high probability of having a late preterm birth. This study protocol nested within this trial aims to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) effects of two different ACS dosing regimens in pregnant women in the late preterm period (34–36 weeks) to help inform an optimal dosing regimen.

Methods and analysis
The study will be conducted in two of the five countries participating in the WHO ACTION-III trial—India (Delhi, Belagavi) and Nigeria (Ibadan and Ile-Ife). We will use a population PK approach using sparse sampling to study the PK effects of the two ACS regimens, that is, 6 mg dexamethasone phosphate (DEXp) or 2 mg betamethasone phosphate (BETp), administered intramuscularly every 12 hours for a maximum of four doses or till birth, whichever is earlier, compared with placebo. We will also ascertain the fetal–maternal ratio of DEXp and BETp at birth.
Maternal venous blood samples will be collected at 0, 1–4 hours, 8–12 hours after the first dose, and at 24–36 hours, 48–60 hours, 72–96 hours after the last dose, and immediately after birth, along with cord blood. Concentrations of DEXp and BETp will be measured at set time points using a validated liquid chromatography mass spectroscopy assay. PD parameters measured will include total and differential white blood cell count (by automated analysers using electrical impedance), plasma glucose (hexokinase method) and serum cortisol (using a validated electrochemiluminescence immunoassay), at predefined time points. PK models will be developed for each drug using non-linear mixed effects methods. Optimal dosing will be investigated using Monte Carlo simulations.

Ethics and dissemination
The study has been approved by the WHO Ethics Review Committee and the site-specific ethics committees of the participating leading institutions. Written informed consent will be obtained from all participants. The study results will be published in a peer-reviewed journal and presented at scientific conferences.

Trial registration number
ISRCTN11434567.

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