Neck pain is a common issue among the working-age population, with a high recurrence rate and one of the highest healthcare costs globally. Exercise is proposed as one of the key components in managing this condition, and electrotherapy is established as a safe and proven analgesic measure. Telemedicine improves access to healthcare by removing geographical barriers and reducing costs, allowing consultations from any location and supporting the work-life balance of the patient.

The aim of this study is to compare the efficacy of e-Health versus a face-to-face programme in the therapeutic management of non-specific neck pain through exercise and analgesic electrotherapy.

A randomised clinical trial with 100 participants suffering from non-specific neck pain will be conducted. Participants will be evenly divided into two groups to receive analgesic electrotherapy combined with a cervical exercise programme delivered either via an e-Health programme or face-to-face programme. A total of 24 sessions will be administered over 8 weeks. Data collected will include demographic and clinical information, disability, pain intensity, fear of movement, sleep quality, catastrophising, quality of life and range of motion. Assessments will be conducted at the start of the study (baseline), at 8 weeks (post-treatment), and 2 months after completing the intervention (follow-up).

This protocol has been approved by the Andalusian Biomedical Research Ethics Coordinating Committee (SICEIA) with number register (SICEIA-2024-000820) on 25 September 2024. Findings will be disseminated through publications in peer-reviewed journals and presentations at international and national conferences.

ClinicalTrials.gov (NCT06842381).

Overmedication of off-label use of psychotropic medicines to address behaviours of concern in people with intellectual and developmental disabilities is a major public health concern. Disability support workers (DSWs) play a pivotal role in supporting adults with intellectual and developmental disabilities who are prescribed psychotropic medicines. Therefore, there is an urgent need to train DSWs to help understand the appropriate use of these medicines. This paper describes the protocol of a project that aims to develop such a programme.

A participatory action framework will underscore the programme and follow a Universal Design for Learning approach. It will be a co-production involving all stakeholders, including people with intellectual and developmental disabilities, their families, members of the disability workforce, healthcare professionals and educational designers. The programme will be developed using the following steps: (a) development of a consumer advisory committee and expert panel groups, (b) an online survey of learning needs analysis, (c) a rapid umbrella review of the relevant literature, (d) focus groups involving participants from different parts of Australia, (e) co-design events in four Australian cities, (f) field testing on 6–12 DSWs to determine any practical difficulties of implementing the programme, (g) a feasibility trial involving at least 1200 DSWs using a train-the-trainer model and online resources and (h) a mixed-method process evaluation using interviews of a purposive sample of trainees and online questionnaire survey.

Ethics approval will be sought at each stage of the co-design process. Each step of the project will include an academic language paper and Easy Read report developed. The training programme will be shared across Australia, with DSWs able to complete the project for free. We expect the training will help improve DSWs’ knowledge of appropriate psychotropic medicine prescribing in people with intellectual and developmental disabilities, confidence in effectively communicating with health professionals and using non-pharmacological approaches to support behaviours of concern, promote shared decision-making with clients, advocate for psychotropic medicine reviews by healthcare professionals, encourage positive interactions with people with intellectual and developmental disabilities and their families and self-reflection on their own behaviour and attitude can influence their client and behaviours of concern.

Using network analysis, which takes a holistic approach to health systems, we aimed to identify which psychosocial burden dimensions are the most central and, thus, critical to prioritising to improve the overall health of people with type 1 diabetes (PwT1D).

A cross-sectional network analysis.

We used data from participants attending 44 diabetes centres in France, who were enrolled in the SFDT1 cohort study between June 2020 and February 2024.

We included 1430 PwT1D (52% women, median age (IQR) 41 (31–52.8) years) who had completed questionnaires on diabetes burden.

The items from questionnaires on diabetes distress, fear of hypoglycaemia, quality of life, treatment burden and the impact of diabetes on education and work.

The network was highly stable (correlation stability coefficient=0.75). We observed nine domains within the network; ‘Loneliness, Worrying & Burnout’ was the most influential. We further grouped the domains into three distinct syndromes labelled ‘Diabetes Distress’, ‘Treatment Burden’ and ‘Impact of Diabetes on Life’. These syndromes reflect the most relevant pillars of the psychosocial burden in PwT1D.

We observed that ‘Loneliness, Worrying & Burnout’ is the most influential psychosocial burden network domain to prioritise for type 1 diabetes care. This new network-based approach opens the path to defining personalised interventions targeting the most critical burden parameters to expect the most significant overall beneficial impact on PwT1D’s health.

NCT04657783.

The global rise in the population aged over 65 has led to a corresponding increase in cognitive impairment diagnoses, with dementia as a predominant condition characterised by diverse aetiopathogenetic profiles. Behavioural and psychological symptoms of dementia (BPSD) encompass a range of psychiatric, behavioural and cognitive symptoms associated with cognitive impairment. BPSD significantly affects patients, caregivers and healthcare providers, often necessitating interventions like sedatives or physical restraints that may worsen patient outcomes. Emerging evidence underscores the need for innovative, non-pharmacological interventions to manage BPSD effectively.

The current study intends to investigate the feasibility and acceptability of customised, immersive virtual reality environments (iVRe) to reduce responsive behaviours among individuals with dementia. Building on prior findings demonstrating virtual reality (VR) potential in reducing anxiety and fostering positive emotional states, this pilot study assesses the feasibility, safety and user engagement of customised iVRe interventions.

A longitudinal, mixed-methods design will be employed, enrolling 20 elderly participants with varying levels of cognitive impairment from the APSP ‘Margherita Grazioli’ long-term care facility in Trento. Participants undergo three VR exposure sessions featuring tailored environments adjusted in real-time for visual and auditory preferences. Data collection integrates standardised self-report questionnaires, observational tools and clinical records. Measures include the Functional Assessment Staging Tool, Neuropsychiatric Inventory and Cohen-Mansfield Agitation Inventory, as well as tools assessing pain, anxiety and emotional states before, during and after VR sessions.

The study protocol has been approved by the Comitato Etico Territoriale della Provincia Autonoma di Trento per le Sperimentazioni Cliniche, Azienda Provinciale per i Servizi Sanitari—Trento, Italy (Rep. Int. 12090, 15 May 2025). All participants or their legal representatives will provide written informed consent prior to enrolment. Deidentified data will be securely stored on institutional servers at the Fondazione Bruno Kessler and the APSP ‘Margherita Grazioli’, curated in compliance with the General Data Protection Regulation, and retained for 3 years after study completion. Any data shared externally will be provided in fully anonymised form, and only for scientific purposes, subject to prior ethical and legal approval. Study findings will be disseminated through peer-reviewed publications, conference presentations and executive summaries shared with participating institutions and stakeholders.

NCT06693193.

Preoperative administration of tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirements in total hip arthroplasty (THA), but optimal dosing remains uncertain due to the narrow range of doses explored in prior studies. This study aims to define the dose–response of intravenous TXA in THA, focusing on perioperative haemoglobin drop to improve blood-sparing effect.

This monocentric, double-blind, placebo-controlled, parallel-group, dose-finding study will enrol 170 adults undergoing THA, aiming to randomise 150 patients. Participants will be allocated using a minimisation technique with a random component in equal proportions to receive either placebo or one of four intravenous TXA doses: 300 mg, 500 mg, 1000 mg or 3000 mg. Dose selection and sample size are based on a model-based meta-analysis that employed a maximum effect (Emax) model with a maximum effect of 40% and an ED50 (dose providing 50% of Emax) of 400 mg. The primary outcome will be the relative perioperative haemoglobin drop at postoperative day 3. Secondary outcomes include TXA exposure and perioperative fibrinolytic activity as measured by D-dimer levels. Only patients receiving the allocated study treatment will be analysed (modified intention-to-treat population). The dose–response relationship for the primary outcome will be analysed using non-linear mixed-effect models.

The study protocol was approved by the French ethics committee (Institutional Review Board Sud Méditerranée V) and the French National Agency for the Safety of Medicines and Health Products (ANSM). Results will be disseminated at conferences and published in peer-reviewed journals.

CTIS 2022-502532-38-01; NCT03822793.

Giant cell arteritis (GCA) is a vision-threatening systemic vasculitis for which no universally accessible diagnostic tool exists. Optic nerve sheath diameter (ONSD), measurable via ultrasound, has emerged as a promising, non-invasive biomarker of cranial GCA. The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis (SONIC-GCA) aims to validate ONSD ultrasound as a diagnostic and monitoring tool in GCA.

SONIC-GCA is a prospective, multicentre study enrolling patients referred for the evaluation of suspected GCA. A total of 285 participants will undergo optic nerve sheath ultrasound and digital retinal funduscopy, followed by a standardised GCA assessment. All participants will be followed for a minimum of 6 months, at which time an external adjudication committee will confirm the diagnosis of GCA. Those diagnosed with GCA will be followed for 2 years, with repeated optic nerve sheath ultrasound and digital retinal funduscopy at months 3, 6, 12, 18, 24 and at relapse, if applicable.

The primary outcome is the diagnostic accuracy of ONSD to detect GCA, which will be evaluated using receiver operating characteristic curve analysis, with adjudicated GCA status serving as the reference standard. Secondary outcomes will address several complementary domains: its value for relapse monitoring will be assessed through time-dependent Cox proportional hazards models, examining whether baseline or longitudinal ONSD predicts relapse risk; intraobserver and interobserver reliability will be determined using intraclass correlation coefficients, providing quantitative estimates of measurement reproducibility; and its association with retinal findings will be evaluated by correlating ONSD measurements with ocular imaging and clinical retinal outcomes. Together, these analyses will comprehensively determine the diagnostic, prognostic and operational utility of ONSD in GCA.

The study has been peer-reviewed by the scientific committee and approved by the CIUSSS du Nord-de-l’Île-de-Montréal Research Ethics Board. Each participating site will obtain local ethics approval prior to enrolment. All participants will provide informed consent. Results will be disseminated through peer-reviewed publications, conference presentations and webinars.

NCT05749094.

To develop and compare algorithms for identifying gestational diabetes mellitus (GDM) across European electronic healthcare databases and evaluate their impact on the estimated prevalence.

Multi-national cohort study using routinely collected electronic healthcare data

National and regional databases in five European countries (Norway, Finland, Italy, Spain and France), in primary and/or secondary care.

Pregnancy cohorts resulting in stillbirths or live births between 2009 and 2020, comprising 602 897 pregnancies in Norway, 507 904 in Finland, 374 009 in Italy, 193 495 in Spain and 116 762 in France.

The primary outcome was the prevalence of GDM identified using six algorithms: (1) Only diagnosis; (2) Diagnosis or prescription; (3) Two diagnoses or prescriptions (2DxRx); (4) Diagnosis including unspecified diabetes in pregnancy or prescription (DxRx broad); (5) Diagnosis excluding pre-existing diabetes in pregnancy or prescription; (6) Registration of GDM in a birth registry (BR).

The strictest algorithm (2DxRx) resulted in the lowest GDM prevalence, while the broadest (DxRx broad) resulted in the highest, except in France where it was BR. In the Nordic countries, GDM prevalence varied only slightly by algorithm; greater variations were observed in other countries. The prevalence ranged from 3.5% (95% CI: 3.5% to 3.5%) to 4.6% (95% CI: 4.5% to 4.7%) in Norway; 12.1% (95% CI: 12.0% to 12.2%) to 15.8% (95% CI: 15.7% to 15.9%) in Finland, where prevalence was much higher than elsewhere. The prevalence ranged from 1.3% (95% CI: 1.3% to 1.3%) to 5.4% (95% CI: 5.3% to 5.5%) in Italy; 1.6% (95% CI: 1.5% to 1.7%) to 6.2% (95% CI: 6.1% to 6.3%) in Spain; and 1.7% (95% CI: 1.6% to 1.8%) to 5.8% (95% CI: 5.7% to 5.9%) in France.

In this multinational study, GDM prevalence ranged from 1.3% to 15.8% depending on the algorithm and database. Nordic countries showed smaller differences in prevalence between algorithms, while the other countries showed larger variations, likely due to differences in coding practices, healthcare systems and database coverage.

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) entails substantial morbidity and mortality, yet no epidemiologic evidence exists on its outcomes in Mexico. This study assessed national hospitalisations (2005–2022) and mortality (2000–2022) related to AAV using data from the General Board of Health Information.

Retrospective, population-based time-trend analysis on administrative health data.

Mexico’s national hospital discharge and mortality registries, covering 1 January 2000 through 31 December 2022.

All individuals aged ≥ 15 years with a primary or secondary International Classification of Diseases, 10th revision, diagnosis of AAV recorded during hospitalisation or on death certificates nationwide.

The study’s primary outcomes were the age-standardised hospitalisation and mortality rates for AAV (expressed per 100 000 population, overall and by sex), with temporal trends in both rates quantified using Joinpoint regression to calculate annual percent change (APC) and average APC (AAPC).

We identified 2804 hospitalisations and 599 deaths. Females accounted for 49.7% of hospitalisations, while males represented 48.7% of deaths. Although the overall age-standardised hospitalisation rate (ASHR) and mortality rate (ASMR) AAPCs were not statistically significant, relevant trends emerged. From 2010 to 2022, ASHR declined significantly (APC: –5.2%; 95% CI –9.7, –0.5; p=0.03), whereas mortality rates remained stable from 2000 to 2022 (AAPC: +3%; 95% CI –4.6, 11.3; p=0.45). Nevertheless, mortality increased among males (APC: +6.4%; 95% CI 0.9, 12.2; p=0.02) and individuals over 45 years (APC: +8.6%; 95% CI 1.7, 16.0; p=0.02) from 2008 onwards.

Overall, these findings indicate no major changes in national rates but reveal a decline in hospitalisations since 2010 and a rise in mortality for specific subgroups since 2008. Targeted interventions, particularly for older adults and men, appear warranted to address this evolving disease burden. Future research should explore underlying risk factors and evaluate tailored strategies to improve clinical outcomes in AAV across Mexico.

Head and neck cancer (HNC) accounts for over 4% of global cancer incidence, yet the oncological treatment induces several sequelae such as oral dysfunction, cervical and shoulder impairments or pain that are not well addressed. Thus, survivors of HNC (sHNC) perceive a decrease in their quality of life (QoL). This study protocol aims to investigate the effects of manual therapy (MT) to determine the effectiveness and safety on oral opening, swallow function and upper quarter mobility, cervical muscle strength, pain, functionality and QoL of sHNC.

A randomised controlled trial will include 70 sHNC over 18 years of age and will be divided into two groups. Intervention will last for 6 weeks with a total of 18 sessions, including MT targeting mastication and head and neck muscles. The control group will receive motor control exercises. The main outcomes will be oral opening and swallow function. An intention-to-treat analysis will be performed to evaluate the effectiveness of the intervention, which will be further determined with the calculation of effect sizes expressed in Cohen’s d.

The study was approved by the Ethics Committee of the Universidad de La Frontera (File 001_24) according to the Helsinki Declaration for Biomedical Research. All participants will provide informed consent. Study results will be published in open access peer-reviewed journals and may be shared at relevant meetings and research meetings.

This trial was registered with ClinicalTrials.gov on 28 November 2023 (code: NCT06148077).

A relationship between long-term metformin use and vitamin B12 deficiency has been long discussed in the literature. Nonetheless, prior to 2022, there was no official guidance. In June 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) published advice, stating that low vitamin B12 is now considered to be a common side effect. It advises checking levels in patients with symptoms of B12 deficiency, as well as monitoring those at risk of B12 deficiency.

Despite efforts to promote evidence-based practice, there is still a gap in the translation of research findings into policies and clinical practice. The above research has been shared widely in the academic and specialist diabetes literature over a prolonged period. The purpose of the scoping review is to explore what evidence is available regarding clinicians’ awareness of the association between metformin use and vitamin B12 deficiency in patients with type 2 diabetes mellitus, how this evidence is implemented into frontline clinical practice and what screening processes are recommended or exist.

This is a protocol for a scoping review to be guided by the Joanna Briggs Institute (JBI) methodology for scoping reviews 20. The databases to be searched will include MEDLINE (accessed via PubMed), British Nursing Index, Google Scholar, Cochrane, Embase, Web of Science and Cumulative Index to Nursing and Allied Health Literature (CINAHL) (accessed via EBSCO), alongside searching for grey literature such as Electronic Theses Online Service (EThOS), DART European and Kings College London Research Portal. Titles and abstracts of articles will be reviewed by the authors. If articles are representative of the inclusion criteria, the articles will go through a full-text review by the authors. The results of the search and study inclusion/exclusion process will be reported and presented in a Preferred Reporting Items for Systematic Reviews and Meta-analyses flow diagram. Data will be extracted from papers, using the recommended JBI data extraction tool. The search will commence in August 2025, and the review is expected to be completed by November 2025.

The search will commence in August 2025, and the review is expected to be completed by November 2025.

As this is a scoping review protocol that did not involve any human participants, human data or human tissue, no ethical approval was required. Our dissemination strategy includes peer review publication, presentation at conferences and with relevant stakeholders.

SARS-CoV-2 infection provides protection against reinfection and severe COVID-19 disease; however, this protective effect may diminish over time. We assessed waning of natural immunity conferred by previous infection against severe disease and symptomatic reinfection in Brazil and Scotland.

We undertook a test-negative design study and nested case–control analysis to estimate waning of natural immunity against severe COVID-19 outcomes and symptomatic reinfection using national linked datasets. We used logistic regression to estimate ORs with 95% CIs. A stratified analysis assessed immunity during the Omicron dominant period in Brazil.

We included data from the adult populations of Brazil and Scotland from 1 June 2020 to 30 April 2022.

Severe COVID-19 was defined as hospitalisation or death. Reinfection was defined as reverse-transcriptase PCR or rapid antigen test confirmed at least 120 days after primary infection.

From Brazil, we included 30 881 873 tests and 1 301 665 severe COVID-19 outcomes, and from Scotland, we included 1 520 201 tests and 7988 severe COVID-19 outcomes. Against severe outcomes, sustained protection was observed for at least 12 months after primary SARS-CoV-2 infection with little evidence of waning: 12 months postprimary infection: Brazil OR 0.12 (95% CI 0.10 to 0.14), Scotland OR 0.03 (95% CI 0.02 to 0.04). For symptomatic reinfection, Brazilian data demonstrated evidence of waning in the 12 months following primary infection, although some residual protection remained beyond 12 months: 12 months postprimary infection: OR 0.42 (95% CI 0.40 to 0.43). The greatest reduction in risk of SARS-CoV-2 infection was in individuals with hybrid immunity (history of previous infection and vaccination), with sustained protection against severe outcomes at 12 months postprimary infection. During the Omicron dominant period in Brazil, odds of symptomatic reinfection were higher and increased more quickly over time when compared with the overall study period, although protection against severe outcomes was sustained at 12 months postprimary infection (whole study: OR 0.12 (95% CI 0.10 to 0.14); Omicron phase: OR 0.15 (95% CI 0.12 to 0.19)).

Cross-national analyses demonstrate sustained protection against severe COVID-19 disease for at least 12 months following natural SARS-CoV-2 infection, with vaccination further enhancing protection. Protection against symptomatic reinfection was lower with evidence of waning, but there remained a protective effect beyond 12 months from primary infection.