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AnteayerInterdisciplinares

Self-directed arm-crank exercise to improve volitional control of the trunk in patients with subacute spinal cord injury: a multicentre, parallel-group, randomised controlled trial protocol

Por: Hidalgo Mas · M. d. R. · Kearney · J. · Middleton · V. · Chiu · C.-Y. · Duda · J. L. · Nightingale · T. E. · Martinez-Valdes · E. · Ahmed · Z. · Chiou · S.-Y.
Introduction

A spinal cord injury (SCI) disrupts synaptic connections between the corticospinal tract and motor neurons, impairing muscle control below the injury site. Many individuals with an SCI have impaired trunk control, affecting the performance of activities of daily living and quality of life. Work has shown improvements in trunk control after home-based, unsupervised arm-crank exercise training (ACET) in people with chronic motor-incomplete SCI. However, no studies have examined ACET’s impact on trunk control in individuals with subacute SCI. This study aims to investigate ACET’s effects on trunk control in adults with subacute incomplete SCI, and its mechanisms, and its long-term benefits on neuropathic pain, psychological well-being, physical activity levels and health-related quality of life.

Methods and analysis

This multicentre, parallel-group, randomised controlled trial will evaluate self-directed ACET in 60 individuals with subacute SCI (

Ethics and dissemination

This study was approved by The Health Research Authority and Health and Care Research Wales (22/NS/0054). Results will be published in peer-reviewed journals. Findings will be presented at National and International conferences for researchers and clinicians. Finally, results will be disseminated to the SCI community.

Trial registration number

ISRCTN17247972

Scope of practice of primary care nurses: a protocol for an umbrella review of international literature

Por: Lukewich · J. · Mathews · M. · Myles · S. · Dufour · E. · Asghari · S. · Rioux-Dubois · A. · Martin-Misener · R. · Halcomb · E. J. · Chiu · P. · Poitras · M.-E. · Leslie · K. · McGraw · M. · Ryan · D. · Curnew · D. · Meredith · L. · Morin · A. · Swab · M. · Braithwaite · S. · Macdonald · D.
Introduction

Primary care nurses (PCNs) are the second largest workforce in primary care and play a critical role in facilitating access to coordinated care and reducing health disparities. There is renewed interest in team-based primary care as a solution for health workforce challenges. Some team models enable PCNs (ie, nurse practitioners, registered nurses, licensed/registered practical nurses) to leverage one another’s expertise to work to optimal scope; the extent to which this happens depends on multiple context-dependent factors. We will conduct an umbrella review to synthesise and compare international knowledge syntheses focused on scope of practice enactment (ie., roles and activities) of PCNs in primary care.

Methods and analysis

We will conduct the umbrella review according to the Joanna Briggs Institute methodology, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines, and using the Nursing Care Organization Framework as guidance. We will search a wide range of scientific electronic databases and grey literature sources, and consider articles published in English and French by the Organization for Economic Cooperation and Development and designated key partner countries for inclusion, with no publication date limits. Two independent reviewers will screen titles, abstracts and full-text articles, and any disagreements will be resolved through discussion or by a third reviewer. We will use the Risk of Bias Assessment Tool for Systematic Reviews to assess the quality and risk of bias in the included systematic and scoping reviews.

Ethics and dissemination

Results will be presented in a PRISMA Scoping Review flow diagram. We will synthesise data from included studies in a detailed literature review table and develop visual aids to communicate the shared and unique roles and activities of PCN scope of practice. We will disseminate the results of the review through peer-reviewed publications and conferences related to this field. Ethics approval is not required.

Clinical and economic impact of cost-intensive vs non-cost-intensive antihypertensive therapies: a retrospective study using real-world data from Japan

Por: Yoshihara · H. · Maeda · N. · Tonoike · T. · Ohno · H. · Nishiuchi · S. · Igarashi · A.
Background

Hypertension is a major health challenge imposing substantial economic and health burdens worldwide. This study compared treatment outcomes and costs between cost-intensive and non-cost-intensive pharmacotherapies, defined by prescribing intervals and the type of drugs, using electronic health record (EHR) data from multiple healthcare facilities, focusing on the type of antihypertensive drug and prescribing patterns.

Design

A retrospective cohort study. A mixed-effects Cox proportional hazards model was used to investigate the association between cardiovascular events and healthcare resource use.

Setting

EHRs from 34 primary care facilities in Japan.

Participants

Patients prescribed either angiotensin receptor blockers (ARBs) alone or calcium channel blockers (CCBs) alone were included.

Results

During 6629 person-years of follow-up, 71 events were observed. Model diagnostics confirmed the proportional hazards assumption and substantial inter-clinic heterogeneity. The type of drug (ARBs or CCBs) had no statistically significant impact on the incidence of cardiovascular events (HR 0.999, 95% CI 0.603 to 1.655). Similarly, shorter prescribing intervals (less than 36 days) were not significantly associated with the outcome (HR 1.724, 95% CI 0.906 to 3.279). The mean annual medical cost per patient for the cost-intensive (ARB with short prescribing intervals) and non-cost-intensive (CCB with long prescribing intervals) groups was Japanese yen (JPY) 137 023 and JPY 85 911, respectively. Sensitivity analysis using different time windows yielded similar results, confirming the robustness of the findings.

Conclusion

No apparent reduction in cardiovascular events associated with the use of ARBs or shorter prescribing intervals was observed despite the elevated cost caused by intensive pharmacotherapy and frequent clinic visits.

Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial

Por: Lin · Y.-N. · Hsu · S.-P. · Kang · J.-H. · Liou · T.-H. · Han · D.-S. · Ni · P. · Chiu · V. · Rodakowski · J. · Chang · F.-H.
Introduction

Stroke is a leading cause of death and disability worldwide. Stroke survivors and their caregivers often face profound social isolation and various participation restrictions, resulting in frustration and adverse health outcomes. Dyad-focused interventions, which address both survivor and caregiver needs, are essential during the transition process. However, few interventions equally prioritise the outcomes of both survivors and caregivers. This study aims to evaluate the efficacy of a newly developed dyad-focused strategy training intervention in enhancing participation among stroke survivors and their caregivers.

Methods and analysis

This study employs a single-blind, parallel-group randomised controlled trial with allocation concealment and assessor blinding. We aim to enrol 138 stroke survivor-caregiver dyads, randomly assigned in a 1:1 ratio to either the experimental intervention group or the control group. Both groups will receive their usual rehabilitation plus 45–60 min sessions of the intervention twice weekly for a total of 12 sessions. Outcome measures, including the Participation Measure-3 Domains, 4 Dimensions, General Self-Efficacy Scale and Activity Measure for Post-Acute Care, will be collected at baseline, post-intervention and at 3-month, 6-month and 12-month follow-ups. Data will be analysed using multiple linear regression and mixed-effects regression models. Qualitative indepth interviews with participants, caregivers and therapists will be conducted post intervention, transcribed and thematically analysed.

Ethics and dissemination

Ethics approval was obtained from the Ethics Committee of Taipei Medical University (approval number: N202203083), National Taiwan University Hospital (approval number: 202207096RINA) and Taipei Tzu Chi Hospital (approval number: 11 M-107). Findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals.

Trial registration number

NCT05571150; Preresults.

Clinical predictors of flare and drug-free remission in rheumatoid arthritis: preliminary results from the prospective BIO-FLARE experimental medicine study

Por: Rayner · F. · Hiu · S. · Melville · A. · Bigirumurame · T. · Anderson · A. · Dyke · B. · Kerrigan · S. · McGucken · A. · Prichard · J. · Shahrokhabadi · M. S. · Hilkens · C. M. U. · Buckley · C. D. · McInnes · I. B. · Ng · W.-F. · Goodyear · C. · Teare · D. · Filer · A. · Siebert · S. · Ra
Objectives

Huge advances in rheumatoid arthritis (RA) treatment mean an increasing number of patients now achieve disease remission. However, long-term treatments can carry side effects and associated financial costs. In addition, some patients still experience painful and debilitating disease flares, the mechanisms of which are poorly understood. High rates of flare and a lack of effective prediction tools can limit attempts at treatment withdrawal. The BIOlogical Factors that Limit sustAined Remission in rhEumatoid arthritis (BIO-FLARE) experimental medicine study was designed to study flare and remission immunobiology. Here, we present the clinical outcomes and predictors of drug-free remission and flare, and develop a prediction model to estimate flare risk.

Design, setting and participants

BIO-FLARE was a multicentre, prospective, single-arm, open-label experimental medicine study conducted across seven National Health Service Trusts in the UK. Participants had established RA in clinical remission (disease activity score in 28 joints with C reactive protein (DAS28-CRP)

Interventions

The intervention was disease-modifying anti-rheumatic drug cessation, followed by observation for 24 weeks or until flare, with clinical and immune monitoring.

Outcome measures

The primary outcome measure was the proportion of participants experiencing a confirmed flare, defined as DAS28-CRP≥3.2 or DAS28-CRP≥2.4 twice within 2 weeks, and time to flare. Exploratory predictive modelling was also performed using multivariable Cox regression to understand risk factors for flare.

Results

121 participants were recruited between September 2018 and December 2020. Flare rate by week 24 was 52.3% (95% CI 43.0 to 61.7), with a median (IQR) time to flare of 63 (41–96) days. Female sex, baseline methotrexate use, anti-citrullinated peptide antibody level and rheumatoid factor level were associated with flare. An exploratory prediction model incorporating these variables allowed estimation of flare risk, with acceptable classification (C index 0.709) and good calibration performance.

Conclusion

The rate of flare was approximately 50%. Several baseline clinical parameters were associated with flare. The BIO-FLARE study design provides a robust experimental medicine model for studying flare and remission immunobiology.

Trial registration number

ISRCTN registry 16371380

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