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Safety and efficacy of the Atalante exoskeleton in the rehabilitation of French patients with amyotrophic lateral sclerosis: a prospective, monocentric, open, uncontrolled, interventional protocol, EXALS

Por: Trad · G. · Lenglet · T. · Ledoux · I. · Querin · G. · Blancho · S. · Marchand-Pauvert · V. · Hogrel · J.-Y. · Pradat · P.-F.
Introduction

Robotic rehabilitation on locomotion is a new approach in amyotrophic lateral sclerosis (ALS) and previous studies showed its feasibility. In this study, we aim to evaluate safety, patient’s experience and efficacy of a gait training programme with the Atalante exoskeleton, compared with usual care, on walking ability, functional capacity and other symptoms associated with ALS.

Methods and analysis

EXALS is a monocentric, prospective, interventional, open trial. 20 slowly progressing patients with gait deficits will be recruited. The study is conducted in three phases, each lasting 6 weeks, following the ABA procedure. Phase B represents the intervention phase, during which patients practise their gait training at a rhythm of three sessions/week, as an add-on to usual care. In the two phases A, patients receive usual care with no additional treatment. An evaluation is planned before, in the middle and at the end of each phase. The primary outcome of the study is safety and tolerability of the Atalante exoskeleton. Secondary outcomes include: participants’ subjective impact and experience, attitude and motivation, efficacy and interactivity of the exoskeleton, walking ability, functional capacity, spasticity, balance, postural stability, lower limb muscle strength, quality of life, pain, fatigue, anxiety and depression. Statistical analyses will include descriptive methods for all variables and adverse events. Quantitative outcomes are analysed using repeated-measures ANOVA (analysis of variance) across the seven visits, with post hoc tests applied when appropriate. Nominal outcomes are evaluated using Cochran’s Q test with McNemar pairwise comparisons when significant. Associations between variables are examined using Spearman correlation coefficients. Missing data will be replaced using linear interpolation, and sensitivity analyses will be planned. Qualitative interview data are analysed using thematic analysis.

Ethics and dissemination

This study was approved by the French ethics committee CPP Nord-Ouest I (no. 23.02378.000201). Participant data are anonymised and securely stored in the laboratory’s database, accessible only to the research team. Results will be disseminated through peer-reviewed journals and conferences.

NCT06199284.

Rationale and design of the REMECHOQUE multicentre registry protocol: evaluating therapeutic trends in cardiogenic shock

Introduction

Cardiogenic shock (CS) is a complex syndrome characterised by primary cardiac dysfunction. Despite advances in therapeutic options such as mechanical cardiac support, it remains associated with high mortality. Although previous registries have described heterogeneous populations and outcomes across different centres, contemporary real-world data on management practices remain limited. This gap is particularly evident in low- and middle-income countries, where there is no robust registry that clearly defines the current state of CS management. Therefore, a multicentre registry is needed to better characterise current practices and outcomes. Our study aims to gain insight into current therapeutic trends in Mexico, a low- to middle-income country with a significant cardiovascular disease burden.

Methods and analysis

The Mexican Registry of Cardiogenic Shock is a quality initiative that aims to identify therapeutic trends, demographic characteristics and clinical presentations. It also aims to evaluate outcomes, including mortality and cognitive function at in-hospital and 1-year follow-ups, and to identify areas for improvement in the care process across the broad spectrum of CS.

Ethics and dissemination

Ethical approval for this multicentre study was obtained from the local research ethics committees of all participating institutions. The study results will be disseminated to all participating institutions in the form of summary reports and presentations on completion of the analysis.

Mitigating chronic respiratory disease through the lens of multimorbidity: the MARES mixed-methods study protocol

Por: Mendes · R. G. · Leonardi · N. T. · Castello-Simoes · V. · Kawakami · D. M. d. O. · Souza · J. V. R. · Schafauser-Segundo · N. S. · Simoes · R. P. · Pinto · F. G. · Araujo · G. H. G. · da Silva · M. M. C. · Moriguchi · C. S. · Franco · F. J. B. Z. · Pires Di Lorenzo · V. A. · Jor
Introduction

Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.

Objective

To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.

Methods and analysis

The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.

MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.

MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.

MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.

Ethics and dissemination

This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.

Trial registration number

NCT07050823/NCT07093021/NCT07134855.

Effectiveness of poliovirus environmental surveillance in Ghana: an indicator-based performance evaluation across seven regions, 2018-2022

Por: Obodai · E. · Asante Ntim · N. A. · Duker · E. O. · Gberbi · E. · Antwi · C. N. · Mensah · J. Y. · Odame · D. · Boakye · J. D. · Bimpong · S. A. · Agbotse · G. D. · Odoom · N. · Adams · P. L. · Acquah · N. K. · Dickson · A. E. · Odoom · C. · Achempem · K. K. · Baffoe-Nyarko · I. · Egbi
Objective

To evaluate the performance of Ghana’s environmental surveillance (ES) system for poliovirus (PV) detection from 2018 to 2022 using standardised indicators developed by the WHO and the US Centers for Disease Control and Prevention.

Design

A retrospective performance evaluation using 10 key indicators benchmarked against global targets for PV surveillance.

Setting

Seven regions across Ghana, participating in the national ES programme implemented under the Global Polio Eradication Initiative.

Surveillance coverage

Wastewater sampling was conducted at designated ES sites, supported by field collection teams and laboratory personnel responsible for sample acquisition, processing and reporting of PV detection results.

Outcome measures

Detection rates of PV and non-polio enteroviruses (NPEVs), timeliness of sample collection and reporting, data quality and system stability.

Results

A total of 738 wastewater samples were collected. The system demonstrated high sensitivity, detecting circulating vaccine-derived PV type 2 in 51 (6.9%) of samples, Sabin PV types 1 and 3 in 61 (9.5%) and 114 (17.8%), respectively, and NPEVs in 491 (66.5%) of samples. Over 80% of samples met the recommended 21-day collection-to-reporting time frame. Data quality exceeded the ≥80% threshold, and workflows remained stable throughout the evaluation period.

Conclusions

Ghana’s ES system for PV was found to be flexible, stable and effective in generating high-quality data for early detection and public health response. These findings underscore the system’s critical role in supporting polio eradication efforts and highlight its potential as a model for surveillance in similar settings.

Equity, Diversity and Inclusion in Nursing Educational Institutions: A Scoping Review

ABSTRACT

Aim

To present the current evidence on the nature and principles of Equity, Diversity and Inclusion (EDI) in Nursing Education Institutions (NEIs).

Method

Five databases (CINAHL, Medline, Scopus, ERIC and Educational Research Complete) and websites of Canadian nursing education institutions were searched for studies and grey literature on EDI. Information was analysed using the Diversio Diversity and Inclusion Survey (DDIS) framework to highlight the nature and principles of EDI in NEIs. A content analysis guided by a deductive approach informed the data synthesis.

Results

Eighty-eight studies (90 papers) published between 1999 and 2025 were included from 1301 identified articles in the database search. The websites of seven nursing institutions in Alberta, Canada, were examined. The review revealed facilitators, barriers and gaps. The results illustrated the presence and need for diversity, inclusion, equal opportunity and fairness, employing the DDIS framework across participant groups, curricula and contexts.

Conclusion

The literature on EDI in NEI is diverse and provides many facilitators, barriers, challenges and gaps. This review reveals the need for intervention and review studies to highlight specific practices that can lead to successful EDI implementation in NEIs.

Implications for Nursing

These results show that further research is required to refine the definition of EDI within the nursing academy. Evidence must be advanced to develop nursing theories, frameworks and methods specific to EDI implementation.

Impact

Promoting EDI is a vital goal for the nursing profession, and there is a need to understand how EDI behaves in NEIs. This review revealed facilitators, challenges, barriers, gaps and principles of EDI that exist within NEI in the literature. This data can support policy and practice change within NEIs and promote EDI within those organisations.

Reporting Method

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist was adhered to in this review.

Patient and Public Contribution

This study did not include patient or public involvement in its design, conduct, or reporting.

Randomised controlled community trial assessing efficacy of the AWACAN-ED public toolkit to improve cancer symptom awareness and intention to seek help in South Africa and Zimbabwe: study protocol

Por: Scott · S. · Lurgain · J. G. · Day · S. · Guzha · B. T. · Pazukhina · E. · Arendse · K. D. · Govender · S. · Chirenje · M. · Sills · V. A. · Harries · J. · Jacobs · R. · Moodley · J. · Walter · F. M.
Introduction

Despite the benefits of early diagnosis, most cancers in sub-Saharan African (SSA) countries are diagnosed at an advanced stage due to late presentation of symptoms, inadequate referral systems and poor diagnostic capacity. Health communication interventions have been used extensively in high-income countries to increase people’s awareness of cancer symptoms and encourage timely help-seeking. However, in SSA, there is still limited evidence on the effectiveness of these interventions and existing evaluations are mainly focused on communicable diseases rather than cancer.

Methods and analysis

A randomised, multisite, controlled community trial will evaluate a culturally tailored health infographic toolkit delivered in rural and urban settings in the Western Cape Province in South Africa and Harare and surrounding provinces in Zimbabwe. Participants will be randomised to receive one of three African aWAreness of CANcer and Early Diagnosis (AWACAN-ED) cancer awareness tools, coproduced with local communities, comprising health communication infographics with descriptions of breast, cervical and colorectal cancer symptoms plus messages to encourage consultation with primary care providers if symptoms occur, all presented in English and four local languages. We will recruit 144 participants in each of the three intervention groups (N=432). The primary outcome will be recall of symptoms and the secondary outcomes will be (1) intention to seek help, (2) emotional impact and (3) acceptability of the toolkit. Outcomes will be measured preintervention and at two points postintervention: after 15 min and 1 month.

Ethics and dissemination

Ethical approval was obtained in both participating countries, South Africa (148/2025) and Zimbabwe (363/2021). All participants will be required to provide written informed consent prior to participation. Findings will be disseminated through peer-reviewed publications, conference presentations and the AWACAN-ED programme website.

Trial registration number

PACTR202505475803308.

Prevalence and factors associated with pre-diabetes and undiagnosed diabetes in Cambodia: cross-sectional study based on the World Health Survey Plus 2023

Por: Chhim · S. · Ku · G. V. · Kowal · P. · Te · V. · Sorithisey · M. · Ngor · C. · Walton · P. · Maung · K. T. · Ng · N. · Naidoo · N. · Por · I. · Klipstein-Grobusch · K. · Chhea · C. · Sopheab · H.
Objective

This study aimed to determine the prevalence and factors associated with pre-diabetes and undiagnosed type 2 diabetes (UDD) in Cambodia.

Design

This analysis used data from the WHO World Health Survey Plus, which was collected using a cross-sectional design with a GIS-based, three-stage sampling approach. Multiple logistic regression was used to identify key associated factors, based on a significance level of p

Setting

Data were collected from all 25 provinces in Cambodia between 12 March 2023 and 31 May 2023.

Participants

4427 individuals aged 18 years or older, residing in the selected household for at least 6 months in the past year.

Primary outcome measures

Pre-diabetes (Haemoglobin A1c (HbA1c) 5.7%–6.4%) and UDD (HbA1c≥6.5%), without prior knowledge of having type 2 diabetes (T2D).

Results

The weighted prevalences of pre-diabetes and UDD were 26.4% (95% CI 24.0% to 29.0%) and 9.3% (95% CI 7.9% to 11.0%). Pre-diabetes prevalence was higher in urban areas compared with rural areas (adjusted OR, aOR=1.2, 95% CI 1.0 to 1.4), males (aOR=1.7, 95% CI 1.3 to 2.3), individuals aged 40–49 (aOR=1.8, 95% CI 1.4 to 2.4), individuals aged 50+ years group (aOR=2.9, 95% CI 2.3 to 3.6) compared with the 18–39 years group, overweight individuals (aOR=1.7, 95% CI 1.4 to 2.0), obese (aOR=2.1, 95% CI 1.5 to 3.0) and those with elevated total triglycerides (aOR=1.3, 95% CI 1.1 to 1.5). Similar risk factors were identified for UDD, with the addition of hypertension (aOR=1.6, 95% CI 1.3 to 2.0) and high waist circumference (aOR=2.0, 95% CI 1.5 to 2.7).

Conclusions

The high prevalence of pre-diabetes and UDD in Cambodia is a pressing public health concern. Urgent and intensive interventions are needed to effectively prevent and manage T2D, particularly among urban residents, older persons and individuals with metabolic risk factors.

Does CMR improve aetiological sub-phenotyping beyond echocardiography in patients with elevated LV filling pressure? A prospective registry study (PREFER-CMR)

Por: Bana · A. · Li · R. · Mehmood · Z. · Rogers · C. · Grafton-Clarke · C. · Bali · T. · Hall · D. · Jamil · M. · Ramachenderam · L. · Dudhiya · U. · Spohr · H. · Underwood · V. · Girling · R. · Kasmai · B. · Nair · S. · Matthews · G. · Garg · P.
Objectives

To evaluate the incremental diagnostic value and sub-phenotyping capability of Cardiovascular Magnetic Resonance (CMR) compared with Transthoracic Echocardiography (TTE) in patients with elevated left ventricular filling pressure (LVFP).

Design

Prospective registry study. [Results from ClinicalTrials.gov ID NCT05114785]

Setting

A single NHS hospital in the UK.

Main outcome measures

The primary outcome was the rate of diagnostic discordance between TTE and CMR. Secondary outcomes included the characterisation of specific pathologies identified by CMR where TTE was normal, non-diagnostic or provided a non-specific diagnosis.

Results

CMR demonstrated diagnostic discordance with TTE in 74% (n=194) of cases. In patients with a normal TTE (n=54), CMR identified heart failure with preserved ejection fraction (HFpEF) in 46% (n=25) and ischaemic heart disease (IHD) in 19% (n=10). For non-diagnostic TTE cases (n=15), CMR detected HFpEF in 53.3% (n=8) and IHD in 26.7% (n=4). Among those with non-specific left ventricular hypertrophy on TTE (n=47), CMR revealed HFpEF in 45% (n=21) and hypertrophic cardiomyopathy in 34% (n=16).

Conclusions

CMR markedly improves diagnostic precision and sub-phenotyping in patients with elevated LVFP, identifying key conditions like HFpEF, IHD and specific cardiomyopathies that TTE frequently misses. These findings highlight CMR’s critical role as a complementary imaging tool for refining diagnoses and informing management strategies in cardiovascular conditions.

Nutritional knowledge, attitudes and practices and their determinants among pregnant women attending healthcare centres in southern Tehran

Por: Rajaeieh · G. · Bakhtiari · A. · Gholami · M. · Ghavidel · F. · Mostafavi · H. · Zabihi · M. · Mohamadi · E. · Olyaeemanesh · A. · Takian · A.
Objectives

To assess nutrition-related knowledge, attitudes and practices among pregnant women, and identify socioeconomic and healthcare determinants.

Design

A cross-sectional study on maternal nutrition during pregnancy.

Setting

Pregnant women attending primary healthcare centres in the south of Tehran from December 2022 to March 2024.

Participants

1535 pregnant women of all ages living in the south of Tehran (both Iranian and non-Iranian).

Measures

Pregnant women were systematically selected from primary healthcare centres. Data were collected via validated questionnaires and electronic health records. Statistical analyses included multivariate logistic regression (adjusted ORs (aORs) with 95% CIs) and generalised linear mixed models.

Results

The findings revealed that a majority of pregnant women (83.3%; 95% CI 81.2% to 85.3%) exhibited low levels of nutritional knowledge (scores below 12), whereas 14% demonstrated moderate knowledge (scores between 12 and 17), and only 2.7% (95% CI 1.9% to 3.8%) possessed high nutritional knowledge (scores above 18). In terms of attitudes, 36.9% of respondents expressed positive views toward nutrition, with higher education significantly associated with positive attitudes (aOR=1.8; 95% CI 1.3 to 2.5, comparing higher vs lower education levels). Dietary variety was consistently reported by 65.4% of participants, while 8.5% lacked dietary variety. Statistically significant associations were observed between educational attainment, socioeconomic status and nutrition-related practices (p

Conclusion

As a cross-sectional study, these findings highlight substantial gaps in nutrition knowledge among pregnant women in Tehran, with socioeconomic status and education playing crucial roles in shaping dietary behaviours. Improving nutritional education through healthcare interventions is essential for enhancing maternal and fetal health outcomes.

Protocol for the development of the WHO gestational weight gain charts

Por: Rangel Bousquet Carrilho · T. · Oladapo · O. T. · Hutcheon · J. A. · Gatica-Dominguez · G. · Rasmussen · K. M. · Flores-Urrutia · M. C. · Kumapley · R. · Tuncalp · O. · Bahya-Batinda · D. · Fayed · A. A. · Bogaerts · A. · Papageorghiou · A. T. · Munoz-Manrique · C. · Farias · D. R
Introduction

Gestational weight gain (GWG) is an important indicator of maternal nutrition to be monitored during pregnancy. However, there is no evidence-based tool that can be used to monitor it across all geographic locations and pre-pregnancy body mass index (BMI) categories. The WHO is undertaking a project to develop GWG charts by pre-pregnancy BMI category, and to identify GWG ranges associated with the lowest risks of adverse maternal and infant outcomes. This protocol describes all the steps that will be used to accomplish the development of these GWG charts.

Methods and analysis

This project will involve the analysis of individual participant data (researcher-collected or administrative). To identify eligible datasets with GWG data, a literature review will be conducted and a global call for data will be launched by the WHO. Eligible individual datasets obtained from multiple sources will be harmonised into a pooled database. The database will undergo steps of cleaning, data quality assessment and application of individual-level inclusion criteria. Heterogeneity of maternal weight and GWG will be assessed to verify the possibility of combining datasets from multiple sources and regions into a single database. Generalized Additive Models for Location, Scale and Shape will be applied for the construction of the centile curves. Diagnostic measures, internal and external validation procedures will also be performed.

Ethics and dissemination

This project will include an analysis of existing study de-identified data. To be included in the pooled database, each included study should have received ethics approvals from relevant committees. Manuscripts will be submitted to open-access journals and a WHO document will be published, including the GWG charts and cut-offs for application in antenatal care.

Protecting Nurses During Pregnancy: Cross‐Sectional Study of Workplace Exposures and Modifications

ABSTRACT

Aims

This study examined associations between pregnancy-related fear and stress, occupational exposures, and workplace modifications among pregnant registered nurses in the United States engaged in direct patient care.

Methods

A cross-sectional design was used with data collected via an online survey between November 2021 and April 2022. Participants (n = 358) were recruited through social media and listservs. Log-binomial regression models, adjusted for age and parity, estimated prevalence ratios and confidence intervals for associations between occupational exposures and workplace modifications with prevalence of pregnancy-related stress at work and fear of pregnancy or infant complications. Stress, a non-specific physical/psychosocial response to demands, and fear, an emotional response to perceived threat, functioned as distinct constructs.

Results

Emotional and physical environmental hazards were associated with increased prevalence of stress. Emotional and environmental hazards, as well as physical movement, administering antineoplastic medications, infectious disease transmission and scans, were associated with increased prevalence of fear. Each additional occupational exposure increased prevalence of stress by 4% and fear by 12%. Nurses also mitigated risks by implementing workplace modifications. Stress was associated with changing work schedules, while fear was statistically significantly associated with taking extra infection precautions and seeking assistance for CPR.

Conclusions

Findings highlight the need for interventions that address modifiable occupational hazards and improve access to modifications that reduce stress and fear among pregnant nurses.

Implications for the Profession

Strengthening workplace protections could reduce occupational stress, improve nurse retention and enhance patient care quality.

Impact

Pregnant nurses face significant occupational hazards, yet limited research has examined their psychosocial effects and mitigation strategies. This study identified key exposures associated with increased stress and fear and showed that workplace modifications varied by stress/fear levels and pregnancy trimester, informing policies to better protect pregnant nurses.

Reporting Method

Authors adhered to the STROBE checklist for cross-sectional studies.

Patient or Public Contributions

This study did not include patient or public involvement in its design, conduct or reporting.

The journey to healing: exploring travel challenges and associated costs for cancer care at a tertiary care centre in Puducherry, Southern India - a mixed methods study

Por: Devaraj · L. · Ayiraveetil · R. · Arikrishnan · K. · Sahu · S. K. · Ganesan · P. · Karunanithi · G. · Auroprem · S. P. · Srinivasan · T. S. · Thulasingam · M.
Objectives

This study aims to assess travel time, associated costs, challenges and factors influencing healthcare facility choices among persons with cancer in Southern India.

Design

An explanatory sequential mixed methods study.

Setting

The study was conducted in the cancer care outpatient department at a tertiary care centre in Puducherry, Southern India.

Participants

A total of 192 persons with cancer aged 18 to 65 years, diagnosed with breast, lip and oral cavity, cervical, lung or upper gastrointestinal cancers, and attending the cancer care centre between 2023 and 2024, were enrolled in the study through systematic random sampling. Additionally, 10 in-depth interviews were conducted using purposive sampling.

Results

Of the 192 participants, 89 (46.4%) belonged to a lower socioeconomic group, and 178 (92.7%) reported experiencing financial hardship while undergoing cancer treatment. The median travel time to a tertiary care centre was 4.3 hours (IQR: 2.07–7.3), with a median direct non-medical cost of Indian Rupees (INR) 453 (IQR: 200–987). Median expenditures for travel, food and accommodation were INR 200 (IQR: 123–400), INR 360 (IQR: 150–613) and INR 30 (IQR: 20–60), respectively, per single visit. A significant proportion of participants (n=146, 76%) were unaware of nearby cancer treatment centres and relied on peer recommendations when choosing their place of treatment. Key challenges identified included long-distance travel, financial burden due to high food and transportation costs and limited affordability for accommodation.

Conclusion

The study highlights that prolonged travel time and associated costs pose substantial financial strain on cancer-affected families. Enhancing awareness of available healthcare facilities, implementing patient-friendly travel and accommodation support systems and decentralising cancer care services can improve accessibility and mitigate both travel and financial burdens.

Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (SPEEDY): study protocol for a cluster randomised controlled trial with included health economic and process evaluations

Por: Shaw · L. · Allen · M. · Day · J. · Ford · G. A. · James · M. · McClelland · G. · McMeekin · P. · Mossop · H. · Pope · C. J. · Simmonds · R. L. · White · P. · Wilson · N. · Price · C. I.
Background

Outcome from large vessel occlusion stroke can be significantly improved by time-critical thrombectomy but treatment is only available in regional comprehensive stroke centres (CSCs). Many patients are first admitted to a local primary stroke centre (PSC) and require transfer to a CSC, which delays treatment and decreases the chance of a good outcome. Access to thrombectomy might be improved if eligible patients could be identified in the prehospital setting and selectively redirected to a CSC. This study is evaluating a new specialist prehospital redirection pathway intended to facilitate access to thrombectomy.

Methods and analysis

This study is a multicentre cluster randomised controlled trial with included health economic and process evaluations. Clusters are ambulance stations (or teams) which are work bases for ambulance practitioners. Intervention allocated ambulance practitioners use the Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (‘SPEEDY’) pathway which comprises initiation according to specific criteria followed by contact with CSC staff who undertake a remote assessment to select patients for direct CSC admission. Control allocated ambulance practitioners continue to provide standard care which comprises admission to a local PSC and transfer to a CSC for thrombectomy if required. A co-primary outcome of thrombectomy treatment rate and time from stroke symptom onset to thrombectomy treatment will evaluate the impact of the pathway. Secondary outcomes include key aspects of emergency care including prehospital/hospital time intervals, receipt of other treatments including thrombolysis, and performance characteristics of the pathway. A broad population of all ambulance practitioner suspected and confirmed stroke patients across participating regions is being enrolled with a consent waiver. Data about SPEEDY pathway delivery are captured onto a study case record form, but all other data are obtained from routine healthcare records. Powered on a ‘primary analysis population’ (ischaemic stroke patients with pathway initiation criteria), 894 participants will detect an 8.4% difference in rate and data from 564 thrombectomy procedures will detect a 30 minute difference in time to treatment. The full study population is estimated to be approximately 80 000. Regression modelling will be used to examine primary and secondary outcomes in several analysis populations. The economic analyses will include cost-effectiveness and cost–utility analyses, and calculation of willingness to pay at a range of accepted threshold values. The process evaluation involves semi-structured interviews with professionals and patient/family members to explore views and experiences about the SPEEDY pathway.

Ethics and dissemination

This study has ethical, Health Research Authority and participating NHS Trust approvals.

Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities.

Trial registration number

ISRCTN77453332.

Exploring the mechanisms of yoga-based cardiac rehabilitation in heart failure via assessment of endothelial function, genomics and arterial health (Yoga-EndOmics): a study protocol

Por: Shetty · V. V. · Patil · L. R. · Patil · S. G. · Aithal · K. · Oli · A. K. · Yenagi · V. A. · Kaulgud · R. S. · Dharne · M. · Chandra Sekaran · A. M. · Prabhakaran · D.
Introduction

Heart failure (HF) remains a major global health challenge, particularly in low-resource settings where access to comprehensive cardiac rehabilitation (CR) is limited. Yoga, a culturally contextualised mind-body intervention, holds promise as an adjunctive therapy in CR. The Yoga-EndOmics study aims to evaluate the effects of Yoga-based cardiac rehabilitation (Yoga-CaRe) on gene expression, endothelial function, vascular biomarkers and clinical outcomes in systolic HF, providing mechanistic insights into its potential integration into conventional cardiac rehabilitation.

Methods and analysis

This is a prospective, randomised, open-label, blinded-endpoint (PROBE) mechanistic trial enrolling 78 patients with HF with reduced ejection fraction (HFrEF). Participants will be randomised in a 1:1 ratio to receive either a structured Yoga-CaRe intervention or enhanced standard care for 3 months. The Yoga-CaRe group will attend 20 supervised sessions with guided home practice involving tailored asanas, pranayama and meditation. Primary outcomes are changes in endothelial-dependent flow-mediated dilation (FMD) and functional exercise capacity at 3 months. Secondary outcomes include changes in arterial compliance and stiffness, circulating biomarkers of endothelial dysfunction, oxidative stress and inflammation, and immediate changes in global gene expression profiles in peripheral blood mononuclear cells following the Yoga-CaRe intervention. Data will be analysed using analysis of covariance (ANCOVA) for between-group comparisons and significant analysis of microarray (SAM) for global gene expression profiles.

Ethics and dissemination

The study has received ethical clearance from the Institutional Ethics Committee of the SDM College of Medical Sciences and Hospital, India (SDMIEC/2025/1072) and is registered with the Clinical Trials Registry of India. Findings will be disseminated through peer-reviewed journals, scientific conferences and stakeholder engagement platforms to inform future integrative strategies in HF management.

Trial registration number

CTRI/2023/12/060758

Investigating the effect of transcranial magnetic stimulation combined with active sensory training on upper limb motor recovery after stroke: protocol for a randomised, sham-controlled, single-centre trial

Por: Jiang · Y. · first authorship · Zhu · G. · first authorship · Huo · C. · Wu · J. · Li · W. · Mao · M. · Hu · F. · Xia · J. · Xu · D.
Introduction

Transcranial magnetic stimulation (TMS) and upper extremity manipulation training have demonstrated clinical effectiveness in stroke rehabilitation. Post-stroke, the affected cerebral cortex often shows reduced excitability, which can limit the optimal outcomes of conventional manual training. To address this, we developed a new upper limb training method integrating TMS with active sensory training (AST) to enhance the fine motor ability in the upper limbs following stroke, potentially improving overall rehabilitation efficacy. However, the clinical effectiveness of this approach remains unclear. Importantly, we demonstrated the efficacy of the new rehabilitation strategy by using TMS in conjunction with AST in patients experiencing upper limb motor dysfunction after stroke.

Methods and analysis

This single-centre, single-blind, sham stimulation, randomised controlled clinical trial investigated the efficacy of AST combined with TMS in patients with stroke and upper limb motor dysfunction post-stroke (1–24 months post-onset) at Brunnstrom stages III–V. Upper limb motor function was evaluated before and 2 weeks after the intervention. The primary outcome was the Action Research Arm Test result, and the secondary indicators included results on the Fugl–Meyer Assessment Upper Extremity Scale, Modified Barthel Index, Semmes–Weinstein Monofilament, Erasmus MC revised Nottingham Sensory Assessment Scale, Embodied Sense of Self Scale (stroke version), functional near-infrared spectroscopy and neuroelectrophysiology. Between-group differences were analysed using independent t-tests, and within-group differences were examined with paired t-tests, with statistical significance set at p

Ethics and dissemination

This study was approved by the Ethics Committee of the Second Rehabilitation Hospital of Shanghai for ethical application (Approval number: 2024-34-01). Written informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed journals and presentations at local and international conferences.

Trial registration number

ChiCTR2500097067.

Global, regional and national burden of glaucoma from 1990 to 2021 and projections to 2050: a retrospective cross-sectional study

Por: Peng · Y. · Han · L. · Jiang · Q. · Liu · J. · Liu · X. · Jiang · G. · Li · Z. · Qin · S. · Zhuo · Y. · Su · W.
Objectives

This study assessed the global burden of glaucoma using data from the Global Burden of Disease (GBD) 2021 study. The analysis of epidemiological trends aimed to inform future public health prevention strategies.

Design

Retrospective cross-sectional study.

Participants

None.

Methods

Analysis of 1990–2021 GBD data on glaucoma prevalence, disability-adjusted life years (DALYs), age-standardised prevalence rates (ASPR), and age-standardised DALY rates (ASDR). Estimated annual percentage changes (EAPC) were calculated, Joinpoint regression identified trend changes, and Autoregressive Integrated Moving Average (ARIMA) modelling projected the burden for the year 2050.

Results

Globally, the number of prevalent glaucoma cases increased from 4 072 106.59 (95% uncertainty interval (UI) 3 489 888.7 to 4 752 867.3) in 1990 to 7 587 672.9 (95% UI 6 522 906 to 8 917 725.4) in 2021. Concurrently, DALYs increased from 467 600.4 (95% UI 323 490.5 to 648 641.6) in 1990 to 759 900.2 (95% UI 530 942.9 to 1 049 127.2) in 2021. In contrast, the ASPR and ASDR declined to 90.1 per 100 000 population (95% UI 77.8 to 105.5) and 9.1 per 100 000 population (95% UI 6.3 to 12.5) in 2021, respectively. During the COVID-19 pandemic period (2019–2021), the slowest growth rates in crude case numbers and overall disease burden were observed, accompanied by the most pronounced decline in annual percentage change of ASPR. The highest estimates for both case counts and DALYs were identified in the 70–74 age group, with males demonstrating higher prevalence rates than females. Furthermore, regions with lower Sociodemographic Index (SDI) values bore a disproportionately higher burden of glaucoma.

Conclusion

These findings underscore the need to strengthen early screening and treatment of glaucoma, particularly in ageing populations, male groups and low SDI regions. We urge cautious interpretation of COVID-19 related data and vigilance against potential post-pandemic surges in burden. Critical strategies include enhanced screening and intervention for high-risk groups, targeted prevention measures and integration of ophthalmic care into public health emergency frameworks to alleviate the disease burden.

Research on Eating and Adolescent Lifestyle (REAL) 2.0: 15-year follow-up study of eating disorders and weight-related trajectories, mental health and substance use health from early adolescence to early adulthood--a Canadian cohort profile

Por: Obeid · N. · Buchholz · A. · Bradley · A. H. · Mistry · N. · Vaillancourt · T. · Colman · I. · Tasca · G. A. · Corace · K. · Maras · D. · Goldfield · G.
Purpose

Few studies have examined how psychosocial risk and protective factors in adolescence shape mental health outcomes and other multimorbid conditions in adulthood, particularly among Canadian youth. The Research on Eating and Adolescent Lifestyle (REAL) 2.0 study was a 15-year follow-up cohort study designed to investigate how early etiological factors, including body image and disordered eating symptoms in adolescence, contribute to the development of eating, weight-related concerns, mental health and substance use health problems in early adulthood. In this paper, we describe the REAL 2.0 cohort’s demographic and clinical characteristics alongside an overview of the study procedures, laying the groundwork for collaboration on future learnings with this unique data.

Participants

The cross-sectional REAL study initially surveyed middle and high school students from 2004 to 2010 (n=3043) across 43 schools in the Ottawa, Canada region. Of those, respondents in grade 7 or 9 (n=1197 from 25 of the 43 original schools) were asked to participate in a longitudinal arm of the study that consisted of yearly follow-ups. From the longitudinal cohort, there were 278 participants (29.1% male; Mage=28.6) from those who consented to be re-contacted (n=912), who completed the REAL 2.0 survey electronically (30.4%), providing comprehensive data on demographic, clinical, eating and weight-related behaviour, psychological, social, environmental and substance use health factors in adulthood.

Findings to date

9.4% of REAL 2.0 participants met DSM-5 criteria for an eating disorder, while 17.6% met criteria for disordered eating. Moderate to severe anxiety was reported by 28% of participants, while 21.6% experienced moderate to severe depressive symptoms. Regarding substance use, 16.9% engaged in hazardous drinking, 16.9% used cannabis daily or almost daily, and 4.3% reported daily tobacco use.

Future plans

REAL 2.0 has the potential to answer multiple research questions about several mental health outcomes, but its priority focus is to answer questions related to risk and protective factors of multimorbidity in adulthood. Additionally, profiling work, linked to health service utilisation data for systems planning work and predictive modelling studies are secondary goals. By leveraging the Health Data Nexus (HDN) platform, we welcome collaboration with interested researchers who would like to utilise the breadth of data both in adolescence and adulthood to answer other pertinent aetiological questions in mental health and substance use health outcomes. Future plans to conduct additional follow-ups remain feasible.

UNIversity students LIFEstyle behaviours and Mental health cohort (UNILIFE-M): study protocol of a multicentre, prospective cohort study

Por: Schuch · F. B. · Waclawoscky · A. · Tornquist · D. · Oyeyemi · A. L. · Sadarangani · K. P. · Takano · K. · Teychenne · M. · Balanza-Martinez · V. · ONeil · A. · Romain · A. J. · McGrath · A. · Alselmi · A. · Andrade-Lima · A. · Zanetti · A. C. G. · Trompetero-Gonzalez · A.-C. · Heiss
Introduction

Students enrolling in higher education often adopt lifestyles linked to worse mental health, potentially contributing to the peak age onset of mental health problems in early adulthood. However, extensive research is limited by focusing on single lifestyle behaviours, including single time points, within limited cultural contexts, and focusing on a limited set of mental health symptoms.

Methods and analysis

The UNIversity students’ LIFEstyle behaviours and Mental health cohort (UNILIFE-M) is a prospective worldwide cohort study aiming to investigate the associations between students’ lifestyle behaviours and mental health symptoms during their college years. The UNILIFE-M will gather self-reported data through an online survey on mental health symptoms (ie, depression, anxiety, mania, sleep problems, substance abuse, inattention/hyperactivity and obsessive/compulsive thoughts/behaviours) and lifestyle behaviours (ie, diet, physical activity, substance use, stress management, social support, restorative sleep, environment and sedentary behaviour) over 3.5 years. Participants of 69 universities from 28 countries (300 per site) will be assessed at university admission in the 2023 and/or the 2024 academic year and followed up for 1, 2 and 3.5 years.

Ethics and dissemination

The study was first approved at a national level in Brazil (CAE:63025822.8.1001.5346). Study sites outside Brazil obtained additional ethics approval from their institutions using the main approval. Results from the UNILIFE-M cohort will be disseminated through scientific publications, presentations at scientific meetings, press releases, the general media and social media.

Telehealth-delivered exercise and nutrition intervention to improve outcomes in patients with early stage non-small cell lung cancer: protocol for the multicentre STARLighT phase II (neoadjuvant) and phase III (adjuvant) trial

Por: Avancini · A. · Giannarelli · D. · Ugel · S. · Mafficini · A. · Fiorini · P. · Scaglione · I. · Adamoli · G. · Borsati · A. · Belluomini · L. · Eccher · S. · Trestini · I. · Tregnago · D. · Sposito · M. · Insolda · J. · Schena · F. · Scarpa · A. · Derosa · L. · Milella · M. · Novello · S.
Introduction

In early stage non-small cell lung cancer (NSCLC), recurrence is frequent despite surgery and systemic treatments. Observational studies suggest that physical exercise and nutrition could improve outcomes, such as survival and treatment tolerance; however, solid evidence is lacking. The STARLighT trial aims to assess the effects of a telehealth-delivered combined exercise and nutrition intervention on clinical, biological and patient-reported outcomes in early stage NSCLC.

Methods and analysis

STARLighT is a multicentre master protocol study conducted in Italy, comprising two cohorts of patients affected by early stage NSCLC (stages IB–IIIA) epidermal growth factor receptor and anaplastic lymphoma kinase wild type. Cohort A will include 46 patients with resectable NSCLC receiving neoadjuvant treatment and will exploit a single-arm phase II design. Cohort B will enrol 268 patients undergoing adjuvant treatment (including as a part of a perioperative strategy) and proposes a randomised controlled phase III design. Patients in Cohort A and those allocated to the interventional arm in Cohort B will receive a tailored telehealth-delivered exercise and nutritional intervention. The control group will receive the usual care plus educational material. For cohort A, two coprimary endpoints are set: pathological complete response and quality of life, whereas the primary endpoint for cohort B is 2-year disease-free survival. Secondary and exploratory endpoints include a series of clinical (eg, overall survival and safety), biological (immune–inflammatory markers, gut microbiota and transcriptomics) and patient-reported outcomes (eg, sleep habits, physical activity, anxiety and depression and distress) evaluations.

Ethics and dissemination

The study is approved by the Ethics Committee of the University of Verona (Prot. No. 33979) and registered on ClinicalTrials.gov (NCT07042724). Findings will be disseminated through peer-reviewed journals, scientific meetings, public forums and guideline updates.

Trial registration number

Clinicaltrial.gov: NCT07042724.

International perspective on healthcare provider gender bias in musculoskeletal pain management: a scoping review

Por: Wilford · K. F. · Mena-Iturriaga · M. J. · Vugrin · M. · Wainer · M. · Seeber · G. H.
Objective

Musculoskeletal pain is a global issue affecting millions of individuals. Healthcare provider gender bias (HCP-GB) in pain management or treatment may have implications. This study aimed to systematically (1) identify and map the scientific and grey literature as it relates to HCP-GB in the assessment, diagnosis and management of musculoskeletal pain, and (2) identify current gaps that necessitate further research.

Design

This scoping review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR).

Data sources

The following databases were searched: PubMed (National Library of Medicine), Embase (Elsevier), Scopus (Elsevier), CINAHL Complete (Ovid), Academic Search Complete (EBSCOhost), Pre-Prints Database (National Library of Medicine) and Rehabilitation Reference Center from inception to August 2022 and updated in May 2025. Relevant grey literature was identified.

Eligibility criteria for selecting articles

All screening was performed by two reviewers during title/abstract screening and full-text screening stages. Articles published in English, Spanish and German were included if they involved participants with musculoskeletal pain and examined HCP-GB as the dependent variable.

Data extraction and synthesis

Two reviewers independently extracted data from the bibliometric, study characteristics and pain science variables. Results were descriptively mapped, and the frequency of concepts, population and characteristics was narratively reported.

Results

21 full-text articles were included. All articles were published in North America and Europe. A total of 3694 healthcare providers from various specialty areas were examined. A majority of studies (57.1%; n=12) measured HCP-GB using written case vignettes, 33.3% (n=7) used case vignettes plus virtual human pictures/videos, and 9.5% (n=2) used real patients. The influence of patients’ sex in HCP pain assessment was reported in 28.5% (n=6) of the articles, while 42.9% (n=9) reported gender bias regarding HCP non-pharmacological treatment recommendations. Male patients were more likely to receive exercise recommendations for back pain and laboratory testing, whereas female patients received more psychological treatment recommendations and counselling from their HCP.

Conclusions

While there appears to be inconsistent use of the terms sex and gender, the literature informing this review suggests an existence of gender bias in the management of patients with musculoskeletal pain. Future research should be more purposeful in the use of sex/gender-related terms and consider exploring the impact of implicit bias training to rectify potential gender biases present in HCP.

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