Chagas disease affects millions of individuals across Latin America and imposes a substantial economic burden on healthcare systems, particularly in rural and underserved regions. Chronic Chagasic cardiomyopathy remains one of the leading causes of heart failure-related mortality in endemic countries. Tissue inhibitor of metalloproteinases-1 (TIMP-1) has emerged as a potential biomarker of myocardial fibrosis in cardiomyopathies. This study was designed to investigate the association between TIMP-1 and myocardial fibrosis in chronic Chagas disease and to assess its potential as an early biomarker of fibrotic remodelling.

Bottom of form: The PTICH trial is a single-centre, prospective observational cohort study conducted at a government reference clinic in Pernambuco, Brazil. The study aims to enrol 210 adults with Chagas heart disease: 140 without ventricular dysfunction (left ventricular ejection fraction (LVEF) ≥52% in women and ≥54% in men) and 70 with ventricular dysfunction (LVEF

The Research Ethics Committee (REC) of Chagas disease and heart failure outpatient clinic—PROCAPE approved the PTICH trial (CAAE number: 65746322.8.1001.5192). Written informed consent has been obtained from all participants enrolled to date, and data handling is in compliance with applicable privacy and data protection regulations. Study findings will be disseminated through targeted outreach to civil society, the scientific community, healthcare professionals and Brazilian Unified Health System (SUS) policymakers; school-based science communication activities conducted in collaboration with state education departments (potentially including oral health educational materials); policy briefs and targeted reports for public health managers; technical meetings and institutional presentations; a plain-language summary published on the institutional website; and submissions to peer-reviewed journals and presentations at academic and health policy conferences.

RBR-3dcrj98.

Exercise therapy is the most recommended treatment for chronic low back pain (LBP), with evidence supporting modest effects, likely due to the heterogeneity of patient presentations. Evidence suggests that matching individuals to the most appropriate exercise type could improve outcomes. Systematic reviews also emphasise that effective exercise interventions should be patient centred, target paraspinal muscle health and be of sufficient duration. This study addresses these gaps using a targeted care approach to identify a homogenous sample that is more likely to respond to our interventions. The inclusion of a sample with predominant nociceptive pain profile will be performed with the integration of the Pain and Disability Drivers Management Model (PDDM) and the Lumbar Spine Instability Questionnaire (LSIQ). The primary aim of this two-arm randomised controlled trial is to compare the effectiveness of motor control plus isolated lumbar extension exercises (MC+ILEX, arm 1) to free-weight resistance training (arm 2) in reducing LBP-related disability. Secondary aims include examining whether changes in multifidus composition mediate disability improvements comparing intervention effects on muscle size and quality, strength, mobility, pain, quality of life, sleep, physical activity and satisfaction; exploring baseline LSIQ scores and sex/gender as moderators of treatment response; and investigating participants’ perceptions and experiences of exercise therapy.

A total of 106 participants will be recruited through primary and secondary care and randomised (1:1) to receive either MC+ILEX or free-weight resistance training. Both groups will complete 48 exercise sessions over 16 weeks. The primary outcome will be disability at 16 weeks, measured by the Oswestry Disability Index. Secondary outcomes include multifidus muscle composition and size, lumbar and gluteal muscle strength, hip range of motion, pain, physical and mental function, satisfaction and recovery, health-related quality of life, sleep quality and physical activity levels. Linear mixed-effects models will be used to assess primary and secondary outcomes. Regression analyses will explore whether baseline LSIQ scores moderate treatment effects on multifidus composition and other outcomes. A subsample of participants will undergo semistructured interviews before and after the intervention to explore their illness perceptions, illness mindsets, perceptions of exercise therapy, as well as their experiences and satisfaction with the two exercise interventions. Reflexive thematic analysis will be used to analyse qualitative data.

This study received ethics approval from the Central Ethics Research Committee of the Quebec Minister of Health and Social Services (CCER-25-26-14). Results will be submitted to peer-reviewed journals and scientific meetings.

ISRCTN14864451.

Streptococcus pneumoniae serotype 3 (SPN3) remains a significant contributor to invasive pneumococcal disease globally, despite its inclusion in widely administered vaccines. The next generation of pneumococcal vaccines may confer better protection against this serotype, reducing disease burden. We describe an ethically approved protocol for a double-blind randomised controlled trial assessing the impact of VAXNEUVANCE (15-valent pneumococcal conjugated vaccine (PCV15)) and 0.9% saline (placebo) on the acquisition, density and duration of SPN3 carriage using a controlled human infection model.

Healthy adults aged 18–50 years will be randomised 1:1 to receive PCV15 or placebo. Participants will be considered enrolled on the trial at vaccination. One month following vaccination, all participants will be intranasally inoculated with SPN3. Following inoculation, participants will be followed up on days 2, 7, 14 and 28 to monitor safety, SPN3 colonisation status, density and duration, as well as immune responses. The primary endpoint of the study is to assess the rate of SPN3 acquisition between vaccinated and unvaccinated participants defined by classical microbiological methods. Secondary endpoints will determine the density and duration of SPN3 colonisation and compare the immune responses between study groups. An exploratory cohort of 5 participants will be asked to consent to a nasal biopsy procedure during a screening visit and a second nasal biopsy 28 days after PCV15 vaccination. This cohort will only receive PCV15 and will not be challenged. Through this exploratory cohort, we will explore gene expression changes induced by PCV15 vaccination and their visualisation (spatial location) within the nasal tissue.

This protocol has been reviewed by the sponsor, funder and external peer reviewers. The study is approved by the NHS Research and Ethics Committee (Reference: 24/SC/0388) and by the Medicines and Healthcare Products Regulatory Agency (Reference: CTA 21584/0485/001-0001).

NCT06731374 – ISRCTN91656864.

This study aimed to describe the epidemiology, outcomes and costs of four immune-mediated inflammatory rheumatic diseases (IMIRDs)—systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)—in Brazil’s public and private healthcare systems from 2018 to 2022.

Retrospective observational study.

The study was conducted across hospital and outpatient levels of care in Brazil, based on nationwide data representing the public (Department of Informatics of the Unified Health System—DATASUS) and private (National Supplementary Health Agency—ANS) healthcare sectors.

The study analysed data from four distinct systems: 609 427 patients from the public Outpatient Information System (SIA), 32 119 patients from the public Hospital Information System (SIH), 19 083 deaths from the public Mortality Information System (SIM) and 11 846 hospitalisations from the private healthcare system (ANS).

RA had the highest incidence, ranging from 19.9 to 24.9 per 100 000, while SLE remained stable (6.3–6.7 per 100 000). Prevalence increased for all diseases: RA rose from 95.7 to 136.8, SLE from 23.4 to 38.9, AS from 15.0 to 23.6 and PsA from 10.8 to 17.4 per 100 000. SLE had the highest hospitalisation (7.2%) and lethality rates (8.7%), along with the highest average outpatient cost (US$440.9 per patient). In the private system, RA and SLE accounted for the most hospitalisations (36.3% each). SLE had the highest proportion of emergency hospitalisations (70.5%), while PsA had the highest proportion of elective hospitalisations (61.8%).

RA had the highest prevalence and incidence rates among the studied IMIRDs, while SLE was associated with the highest lethality, outpatient costs and emergency hospitalisations. The rising prevalence of these diseases highlights their growing burden on Brazil’s healthcare systems.

NCT06698900.

Osteoarthritis (OA) is a degenerative and progressive joint condition causing pain and disability. Physical exercise is recognised as the most effective intervention since individuals with this condition often experience muscle weakness, balance deficits and chronic pain. Additionally, knee osteoarthritis (KOA) is associated with central sensitisation, contributing to chronic pain conditions. Transcranial Direct Current Stimulation (tDCS), a non-invasive neuromodulation technique, has been employed to induce changes in pain perception by altering cortical excitability, potentially reducing chronic pain.

This is a protocol for a randomised controlled trial. Participants will be allocated to two groups: G1 (active tDCS combined with exercise) and G2 (sham tDCS combined with exercise). The intervention protocol will last for 5 weeks, with two sessions per week on non-consecutive days. Pain intensity will be assessed as the primary outcome using the Numeric Rating Scale (NRS). The sample size was calculated based on a minimum clinically important difference of 3 points on the NRS between groups, with a statistical power of 80% and a significance level of 5%. Secondary outcomes will include physical function and global perceived change.

This protocol was approved by the Research Ethics Committee of the Trairi School of Health Sciences, Federal University of Rio Grande do Norte (Approval Number: 6.801.827), and it is in accordance with the Declaration of Helsinki for human research. Results will be published in peer-reviewed journals and presented at scientific events. This trial is registered in the Brazilian Clinical Trials Registry.

Brazilian Clinical Trials Registry (RBR-5pb2g33).

Hospitalisation is one of the most stressful life events for older adults, particularly for those who are pre-frail or frail. Multi-component community-based interventions have the potential to address the complex needs of older adults post-acute care admission. While some available interventions have been developed with end-user engagement, fully involving older people who are pre-frail or frail in the design of interventions has been less common. Multi-component community-based interventions that address the needs of older adults and their care partners with potential implementation barriers informed by healthcare providers, community partners and health system decision makers are needed. This protocol paper describes the planned process of co-designing for older patients discharged into the community, a Post-Acute Care Intervention for Frailty using Information and Communication technology.

The development of a complex multi-component frailty intervention which meets older people’s needs involves several concurrent tasks and methodologies, each informed by co-design and conducted with consideration to eventual implementation. These tasks include: (1) establishing a Research Advisory Board, (2) assessing the feasibility and validity of using hospital administrative data to identify frail or pre-frail older adults and their needs, (3) conducting a needs assessment of patients returning to the community, (4) mapping community assets to identify existing programmes and services to help tailor the intervention, (5) co-designing a multicomponent frailty intervention, (6) selecting study outcome measures and (7) selecting and tailoring a digital health patient portal to support intervention delivery, data capture and communication.

Each task requiring ethics approval will be submitted to the Hamilton Integrated Research Ethics Board at McMaster University. Results will be disseminated through peer-reviewed journal articles, conferences and networks of relevant knowledge users who have the capacity to promote dissemination of the results. A toolkit will be developed to help researchers and healthcare providers replicate the methodology for other populations.