FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Effects of Erbium:YAG laser combined with vaginal estriol therapy in postmenopausal women with Genitourinary Syndrome of Menopause: protocol for a randomised, double-blind, controlled trial

Introduction

Genitourinary syndrome of menopause (GSM) is a chronic, oestrogen-deficient condition that is frequently underdiagnosed and undertreated. Although low-dose vaginal estriol improves epithelial trophism and microbial balance, a substantial proportion of women report persistent symptoms. High-quality randomised evidence evaluating combined therapeutic strategies remains scarce. Energy-based modalities, including the erbium:YAG (Er:YAG) laser (=2940 nm), have been proposed as adjunctive treatments. This trial aims to assess the efficacy of Er:YAG laser therapy combined with vaginal estriol compared with estriol alone in postmenopausal women with GSM.

Methods and analysis

This is a single-centre, randomised, double-blind, controlled clinical trial. Postmenopausal women aged 45–70 years with vaginal pH ≥5.0 and at least one moderate GSM symptom (Visual Analogue Scale ≥4) will be eligible. Exclusion criteria include current systemic or local hormone therapy, previous vaginal energy-based treatment, abnormal cervical cytology and body mass index ≥35 kg/m2. All participants will receive vaginal estriol cream (0.5 mg per dose) daily for 14 days, followed by twice-weekly administration for 16 weeks. Participants will be randomised (1:1) to receive either estriol plus sham Er:YAG laser or estriol plus active Er:YAG laser. Three laser sessions will be delivered at approximately 4-week intervals. Assessments will occur at baseline, monthly during treatment and 4 months after the final session. The primary outcome is the Vulvovaginal Health Index, with the primary endpoint defined as the change from baseline to 4 months post-treatment, reflecting sustained effect. Secondary outcomes include GSM symptom severity, vaginal microbiome composition (16S rRNA sequencing), quality of life (Menopause Rating Scale) and sexual function (Female Sexual Function Index). Data will be analysed using repeated-measures analysis of variance or appropriate non-parametric tests, with significance set at p

Ethics and dissemination

Ethical approval has been obtained from the Human Research Ethics Committee of UNINOVE. Written informed consent will be obtained. Findings will be disseminated via peer-reviewed journals and scientific meetings.

Trial registration number

NCT06873971.

Socioeconomic burden of osteoarthritis in Sub-Saharan Africa and the determinants of healthcare inequities: a scoping review protocol

Introduction

Access to musculoskeletal healthcare services in Sub-Saharan Africa is inadequate. As osteoarthritis is the most prevalent chronic osteoarticular disease globally, it’s essential to understand its social and economic impact, as well as the determinants of inequities in access to healthcare services in Sub-Saharan Africa. The absence of systematised knowledge on this topic makes this review pertinent. However, due to data scarcity, assessing this burden is challenging. The objective of this scoping review is to map and summarise the available literature up to 2025 on the socioeconomic burden and health inequity determinants among the Sub-Saharan African population with osteoarthritis.

Methods and analysis

A predefined search strategy will be applied to MEDLINE (via PubMed), Embase, African Journals Online and African Index Medicus to incorporate articles relevant to adults diagnosed with osteoarthritis who are residents of sub-Saharan Africa. We will also include grey literature sources such as Google Scholar, Research Square, manuals, books, medical society websites, secondary databases, theses and dissertation repositories and conference proceedings. Study selection will be conducted in two stages by a pair of reviewers who will independently screen titles and abstracts according to the eligibility criteria, followed by a full-text review of the selected studies. The search period was from October 2025 to January 2026. Data extraction will be performed using a standardised charting form developed by the review team.

Ethics and dissemination

This scoping review maps evidence on OA-related socioeconomic impacts and healthcare inequities in Sub-Saharan Africa. As a secondary data analysis, ethical approval is not required. Findings will be disseminated via peer-reviewed journals and academic conferences to clinicians and policymakers.

HOTFy: randomised clinical trial for hyperbaric oxygen therapy in fibromyalgia

Background

Fibromyalgia is a polysymptomatic central sensitisation disorder characterised by widespread pain, fatigue, sleep disturbances and neuropsychiatric features. Hyperbaric oxygen therapy modulates neuroinflammation, mitochondrial function and neuroplasticity, thereby yielding analgesic and functional benefits.

Objective

Evaluate the efficacy and optimal timing of hyperbaric oxygen therapy as an adjunct to standard care for fibromyalgia.

Design, setting and participants

This single-centre, randomised, cross-over group, assessor-blinded clinical trial was conducted in the Department of Rheumatology at the University Hospital of the Federal University of Juiz de Fora, Juiz de Fora, Brazil, and adhered to Consolidated Standards of Reporting Trials (CONSORT) guidelines. Women (18–70 years) with a diagnosis of fibromyalgia for ≥2 years were randomised 1:1 to early hyperbaric oxygen therapy plus standard care or standard care alone (delayed group). Intention-to-treat (ITT) analysis was conducted with all 56 participants (mean age: 51.0±9.8 years; mean body mass index: 30.5±5.1 kg/m²).

Interventions

Standardised care (education, exercise and pharmacotherapy) plus hyperbaric oxygen therapy was delivered at 2.3 atmospheres absolute for 90 min, five times per week, over 8 weeks (total 32–40 sessions). The early group received hyperbaric oxygen therapy during weeks 0–8, while the delayed group received it during weeks 8–16, following the same protocol.

Outcomes

Primary endpoints included the Fibromyalgia Impact Questionnaire-Brazilian Portuguese (FIQR-Br), the pain visual analogue scale (VAS) and the Symptoms Assessment Scale-40 (EAS-40) for psychopathology. Secondary endpoints included the 12-Item Short-Form Health Survey (SF-12) physical and mental components and adverse effects. Assessments were conducted at baseline, 8 weeks and 16 weeks, and analysed using a mixed-design 2x3 analysis of variance (group: early vs delayed; time: baseline, 8 weeks and 16 weeks) with Greenhouse-Geisser corrections as needed, followed by Bonferroni post hoc tests. Missing data were assessed using Little’s missing completely at random (MCAR), and considering the ITT analysis, the means imputed for missing data were estimated through expectation maximisation. Effect sizes were reported as partial ² and Cohen’s d with α=0.05.

Results

44 participants completed the study, and the overall withdrawal rate was 21.4% with no baseline between-group differences. Significant time effects were observed for all primary outcomes and the SF-12 outcome (pxtime interactions were significant for FIQR-Br, VAS, EAS-40 and SF-12 physical and mental (p≤0.02; interaction ² up to 0.23), indicating improvements during active hyperbaric oxygen therapy exposure. Compared with standard care alone over 8 weeks, combined treatment achieved greater gains: FIQR-Br, –31.1% vs –14.4%; VAS, –54.0% vs –33.5%; EAS-40, –28.4% vs –3.7%; SF-12 physical, +39.1% vs +14.8%; SF-12 mental, +57.4% vs +31.9%. Large within-group effect sizes were observed (eg, VAS d=2.5–2.7; FIQR-Br d=1.4–1.7). Efficacy was equivalent regardless of time started, and the benefits converged by the end of each hyperbaric oxygen therapy phase. After stopping hyperbaric oxygen therapy, the FIQR-Br and SF-12 mental component scores regressed towards standard care levels, whereas residual improvements persisted for up to 8 weeks in VAS, EAS-40 and SF-12 physical component scores. Adverse events were infrequent; one case of otalgia required extended management. Withdrawals were primarily due to non-compliance or intolerance to chamber confinement. No serious or unexpected safety concerns were reported.

Conclusions

Hyperbaric oxygen therapy, delivered under a standardised protocol, is an effective and well-tolerated adjunct to multimodal fibromyalgia care. Timing can be individualised: early initiation for rapid relief or stepped introduction after optimised usual care, with comparable overall efficacy. The durability of the benefit appears to be exposure dependent, and maintenance or booster schedules merit further evaluation.

Trial registration number

RBR-6prps8g.

Association between physical fitness and anthropometric indicators according to area of residence in Chilean adolescents: a cross-sectional study

Background

Research has yielded contradictory results regarding differences in physical fitness and cardiometabolic risk between children and adolescents living in rural and urban areas.

Objectives

The present study aimed to analyse the moderating role of area of residence on the association of physical fitness and anthropometric parameters in Chilean adolescents.

Design and setting

Cross-sectional analysis of a nationally representative school-based sample from Chile.

Participants and measures

A total of 7,833 adolescents with an average age of 15.8±0.7 years participated in both rural (n=759) and urban (n=7,074) settings. Physical fitness tests were evaluated using the Assessing Levels of Physical Activity and Fitness (ALPHA-Fitness) battery and anthropometric variables such as body mass index (BMI), waist circumference (WC) and waist-to-height ratio (WHtR). Generalised linear models with Gaussian distributions were constructed to estimate moderation models, with anthropometric-related variables as dependent variables, physical fitness variables as independent variables and area of residence as a moderator. Moderation analyses were conducted to examine whether the area of residence influences the association between physical fitness and anthropometric indicators (WC, WHtR and BMI).

Results

In all models, place of residence did not moderate the potential associations between physical fitness and anthropometric indicators; for example, cardiorespiratory fitness with WC (B=0.13, 95% CI 0.05 to 0.31; 0=0.160), WHtR (B=0.08, 95% CI –0.03 to 0.20; p=0.143) or BMI (B=0.08, 95% CI –0.03 to 0.20; p=0.207).

Conclusions

These findings suggest the associations between physical fitness and anthropometric outcomes do not differ significantly between rural and urban adolescents.

Clinical Trials in Central Venous Access Devices: An Evidence and Gap Map

ABSTRACT

Aims

To systematically map the landscape of central venous access device research from 2014 to 2024, identifying critical gaps in evidence that may impact nursing practice and patient outcomes across the full device lifecycle from selection through to removal.

Design

This review was conducted in accordance with the Guidance for producing a Campbell evidence and gap map and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Data Sources

PubMed, Cumulative Index to Nursing and Allied Health Literature Complete, Scopus, and Cochrane Central Register of Controlled Trials were systematically searched with additional hand-searching of reference lists from included reviews.

Methods

We systematically reviewed literature published between 2014 and 2024, mapping 710 studies on central venous access device interventions and outcomes. Studies were categorised by design, population, setting, device characteristics, intervention types, and outcomes. Evidence was evaluated using the National Health and Medical Research Council levels of evidence framework.

Results

Of 710 included studies, 89 were systematic reviews and 621 primary studies, of which 41.1% (n = 292) were randomised controlled trials. Research was primarily conducted in high-income countries (n = 405, 65.2%) and focused on adults (n = 370, 59.6%) in hospital inpatient settings (n = 588, 94.7%). Catheter insertion and infection prevention dominated the evidence base, while device selection and removal procedures were less studied. Infection outcomes were extensively reported (bloodstream infection: n = 455, 13.6% of 3349 outcomes), while patient-reported outcomes (n = 218, 6.5%) and cost (n = 60, 1.8%) were underrepresented.

Conclusions

This review reveals that central venous access device research is predominantly focused on insertion and infection prevention while other key parts of nursing practice are under-supported.

Implications for the Profession and/or Patient Care

Future nursing research should address these gaps to improve evidence-based care across diverse populations and healthcare contexts, particularly focusing on understudied device types, settings, and vulnerable populations.

Reporting Method

This review was conducted and reported in accordance with the Guidance for producing a Campbell evidence and gap map.

Patient or Public Contribution

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

Recommendations for Arterial Blood Gas Collection in Intensive Care: Scoping Review

ABSTRACT

Objectives

To map and synthesise the main recommendations for arterial blood gas (ABG) collection in intensive care units (ICUs).

Design

A scoping review was conducted according to the PRISMA-ScR Checklist, supported with The PAGER framework and guided by the Joanna Briggs Institute methodology to ensure methodological rigour and analytical comprehensiveness.

Methods

Data collection was conducted from February to April 2024. The data sources included: Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library, PubMed Central, Scientific Electronic Library Online (SciELO), Web of Science (WoS), SCOPUS, Science Direct, Virtual Health Library (VHL), Excerpta Medica database (Embase), CAPES Thesis and Dissertation Catalogue, Brazilian Digital Library of Theses and Dissertations (BDTD), Scientific Open Access Repository of Portugal (RCAAP), Theses Canada and the Oswaldo Cruz Foundation (Fiocruz) repository.

Results

Key findings recommend the radial artery as the preferred puncture site, an insertion angle of 30° to 45°, the use of 1 or 3 mL syringes and 20G or 23G gauge needles. Transport and storage at room temperature are advised. Cryoanalgesia and subcutaneous analgesia methods were found to be effective for pain management.

Conclusion

The review highlights the best practices for arterial blood gas collection in critical care. The synthesized evidence strengthens clinical practice, informs guidelines for intensive care nursing and promotes safer, higher-quality care for critically ill patients.

Implications for the Profession and/or Patient Care

The evidence-based recommendations identified can enhance nursing care related to arterial blood gas collection. Adherence to these practices promotes safer, more humanised and evidence-based care during the procedure.

Reporting Method

The report of this study followed the PRISMA-ScR Checklist.

Patient or Public Contribution

There was no patient or public involvement in this scoping review.

Mapping the direct and indirect costs of patient and public involvement (PPI) in stroke and aphasia research: a scoping review protocol

Por: Charalambous · M. · Kountouri · A. · Kola · E. · Claudia De Souza · A.
Introduction

Patient and public involvement (PPI) is increasingly embedded in stroke and aphasia participatory research, enhancing relevance and inclusivity. While the benefits of PPI are well-documented, the costs, both direct (eg, honoraria, travel, accessibility materials) and indirect (eg, time, administrative burden, emotional labour), remain poorly reported. This scoping review aims to (1) identify and categorise direct and indirect costs of PPI in stroke research, (2) examine how these costs are defined, reported or implied, (3) map cost-related barriers and facilitators and (4) expose evidence gaps to inform the Mapping the Economic and Social Tangible and Emotional Resources of Patient and Public Involvement (MASTER-PPI) framework.

Methods and analysis

Following the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines, we will search Medline, PUBMED, Embase, CINAHL, APA PsycINFO, Scopus and Web of Science, as well as grey literature (NIHR INVOLVE, Horizon Europe, non-governmental organisation (NGO) reports). Eligible studies include those reporting or implying direct or indirect costs of PPI in stroke research. Two reviewers will independently screen and extract data, which will be synthesised descriptively and thematically. Findings will be aligned with the MASTER-PPI framework.

Ethics and dissemination

Ethical approval is not required. The findings will be disseminated through peer-reviewed journal publications, conference presentations, social media posts in lay language and policy briefs tailored for NGOs and funders.

Registration

This protocol is registered with the Open Science Framework (OSF) (https://doi.org/10.17605/OSF.IO/VM9ZU).

Prevalence of and factors associated with pain-related disabilities among First Nations people living off-reserve in Canada in 2017: a secondary analysis of data from the 2017 Aboriginal Peoples Survey

Por: DeSouza · A. · Cancelliere · C. · Hogg-Johnson · S. · Sheppard · A. J. · Taylor · D. · Ward · J. L. · Radyk · R. · Maher · J. · Garner · J. · Lynds · R. · Cote · P.
Objectives

To determine the prevalence and factors associated with pain-related disabilities among First Nations people living off-reserve in Canada in 2017.

Design and setting

Secondary analysis of the 2017 Aboriginal Peoples Survey, a cross-sectional survey of individuals living in private dwellings throughout Canada.

Participants

First Nations people living off-reserve aged 15 years and older (n=9115; weighted n=482 066).

Outcome measure

Pain-related disabilities, defined as pain-related activity limitations lasting ≥6 months.

Results

Overall, 22.1% (95% CI 20.9% to 23.4%) of First Nations people living off-reserve reported pain-related disabilities. Prevalence was higher among females (26.1%; 95% CI (24.3% to 28.0%)), increased with age (34.3%; 95% CI (30.3% to 38.5%) among those 45 to 54 years) and was similar across geographic areas (ranging from 21.0%; 95% CI (18.3% to 23.9%) to 22.5%; 95% CI (20.8% to 24.2%)). Pain-related disabilities increased with the number of coexisting disabilities (96.2%; 95% CI (94.3% to 97.5%) among those with >3 disabilities) and was highest among those reporting physical disabilities (ranging from 88.2%; 95% CI (85.6% to 90.4%) for those with mobility disabilities to 91.0%; 95% CI (88.6% to 92.9%) for those with disability related to flexibility). Regression models suggested that individuals with unmet basic needs, housing dissatisfaction, unmet healthcare needs, a history of mental health consultations, part-time or no employment, chronic conditions, residential school attendance or a low sense of belonging were more likely to report pain-related disabilities.

Conclusions

Pain-related disabilities are common among First Nations people living off-reserve, and their aetiology may be multifactorial. Continued collaboration with Indigenous partners is required to contextualise findings and to inform culturally responsive clinical and rehabilitation strategies.

Persistence of the hepatic benefits of high-intensity interval training (HIIT) during detraining despite body weight regain in mice

by Renata dos Santos Guarnieri, Guilherme Sá de Oliveira, Kaylaine Marques Ferreira, Aline Penna-de-Carvalho, Vanessa Souza-Mello, Sandra Barbosa-da-Silva

High-intensity interval training (HIIT) is an effective intervention for improving metabolic health and mitigating metabolic dysfunction-associated steatotic liver disease (MASLD). Nonetheless, the stability of these benefits throughout detraining periods and upon weight regain remains inadequately characterized. This study aimed to evaluate whether hepatic improvements induced by HIIT are sustained during detraining, even after body weight regain. Eighty male C57BL/6 mice were fed either a control (10% fat) or a high-fat (HF) diet (50% fat) for 12 weeks. Following this period, the animals were allocated to groups subjected to continuous HIIT or intermittent training cycles (each lasting 3 weeks). The outcomes assessed included body mass (BM), glucose tolerance, lipid profiles, liver enzyme levels (aspartate aminotransferase and alanine aminotransferase), hepatic steatosis, and the expression profiles of genes associated with lipogenesis (Srebf1, Mlxpl, and Fas), β-oxidation (Ppara and Cpt1a), and endoplasmic reticulum (ER) stress (Atf4, Ddit3, and Gadd45). Compared with the sedentary HF-NT condition, continuous HIIT reduced BM and improved glucose tolerance. Intermittent training (HF-TNT, HF-NTN) preserved metabolic benefits and reduced triglyceride and cholesterol levels. Notably, hepatic steatosis was significantly alleviated in all training groups but persisted even after detraining. Additionally, HIIT downregulated the expression of lipogenic genes and upregulated the expression of genes involved in β-oxidation. The levels of markers indicating ER stress were attenuated by HIIT, with a sustained reduction during periods of detraining. HIIT-induced metabolic and hepatic improvements persist partially during detraining, despite weight regain. These findings underscore the therapeutic value of continued or periodically repeated physical training in mitigating the adverse effects of an HF diet and preventing the progression of metabolic disorders such as MASLD.

Social determinants of health and risk of lower extremity amputation in patients with peripheral artery disease in Canada: protocol for a systematic review and meta-analysis

Por: Chowdhury · A. · Sheikh · F. · Azab · S. M. · de Souza · R. J. · Banfield · L. · Balakrishnan · N. · Anand · S. S.
Introduction

Peripheral artery disease (PAD) affected approximately 800 000 Canadians aged 25 years or older in 2015 and it poses a substantial risk of lower extremity amputation (LEA). While clinical risk factors for amputation are well-established, the impact of social determinants of health (SDoH) on amputation risk remains unclear, particularly in a Canadian context.

Objectives

This systematic review aims to: (1) synthesise evidence on the associations between multilevel SDoH domains and LEA (both major and/or minor) risk in Canadian PAD patients including intersectional effects of race and ethnicity with another SDoH domain, and (2) evaluate the statistical methodologies used in the researched literature to inform future study design and analysis approaches.

Methods and analysis

We will systematically search MEDLINE, Embase, EmCare, Global Health, Cumulative Index to Nursing and Allied Health Literature and Web of Science for studies examining SDoH and LEA in Canadian patients with PAD (including chronic limb-threatening ischaemia which is a severe form of PAD). Date limits for each database will be from inception through December 2025. SDoH will be categorised using a modified Healthy People 2030 SDoH framework under six domains: economic stability, education, food, neighbourhood and physical environment, healthcare system and community and social context. Two reviewers will independently screen titles, abstracts and full texts, with discrepancies resolved by a third reviewer. Data will be extracted on study characteristics, SDoH measures, outcomes and statistical methods. Risk of bias will be assessed using RoB 2 for randomised trials, ROBINS-I for non-randomised studies of interventions and ROBINS-E for studies investigating exposures. A narrative synthesis, and where data permit, a Bayesian hierarchical meta-analysis using both effect size and contingency table approaches will be conducted. Statistical heterogeneity will be explored through subgroup analyses and meta-regression, examining study design, SDoH measurement approaches and population characteristics.

Ethics and dissemination

As a systematic review and meta-analysis, ethics approval is not required. For institutional oversight, we provide the contact of Dr Sonia Anand (Associate Vice-President, Global Health, McMaster University; anands@mcmaster.ca). Results will be reported following PRISMA guidelines and disseminated through a peer-reviewed publication.

PROSPERO registration number

CRD420251115759.

Feasibility of a phase 3 partially randomised clinical trial to assess the safety and efficacy of paediatric praziquantel for schistosomiasis treatment in children aged 3 months to 6 years in endemic regions of Brazil: a pilot study

Objective

This study assessed the feasibility of implementing a phase 3 field-based clinical trial protocol to evaluate paediatric praziquantel (PED-PZQ) for the treatment of Schistosoma mansoni infection in children aged 3 months to 6 years in endemic areas of Brazil, focusing on operational aspects such as recruitment logistics, documentation management, investigational product handling and protocol adherence.

Design

Pilot and feasibility study for a phase 3 clinical trial, comprising two components: a randomised, open-label, parallel-group, two-arm trial and a single-arm trial.

Setting

Conde, Bahia, Brazil, from December 2024 to January 2025.

Participants

Two trials aim to screen 5774 participants from three rural areas in Bahia and three in Sergipe, states in northeastern Brazil, and enrol 403 children eligible for either randomisation or allocation. Trial 1 will randomise (1:1 ratio) 240 children aged 4–6 years into the PED-PZQ treatment arm or the standard praziquantel (PZQ) 1. Trial 2 will enrol 163 children aged 3 months to 3 years, all receiving PED-PZQ. Both trials are open label. Eligible participants shall meet age criteria, test positive for S. mansoni and fulfil other inclusion criteria. In the first recruiting centre, Conde (Bahia), it was estimated that 650 participants would need to be screened for trial 1 and 552 for trial 2, assuming schistosomiasis prevalence of 5% and 4%, respectively. This pilot study reports on the first 60 participants enrolled.

Primary and secondary outcome measures

The primary outcome of this pilot study is the feasibility of implementing the research protocol in a real-world field setting, focusing on key aspects such as study documentation challenges, participant safety, investigational medicinal product custody chain and protocol adherence. In addition to providing preliminary data on the parasitological cure rate, secondary outcomes include the prevalence of S. mansoni infection and the reduction in S. mansoni egg count (Kato-Katz method). Furthermore, the occurrence and severity of drug-related adverse events are monitored from drug administration to day 21 post-treatment, alongside changes in renal, hepatic and cardiac functions assessed through biochemical markers.

Results

A total of 60 participants were recruited, and 55 provided stool samples for screening. The pilot phase demonstrated the feasibility of implementing the clinical protocol under field conditions, with successful completion of all planned procedures and minimal protocol deviations. Operational challenges were identified mainly in documentation processes, participant recruitment and investigational product management and were addressed through preventive and corrective quality assurance actions. The experience also highlighted logistical and infrastructural barriers typical of field-based trials in remote endemic areas, which informed adjustments for the subsequent phase 3 study. Preliminary parasitological results indicated an overall S. mansoni prevalence of 9.1% (5/55), with 21% in trial 1 and 2.8% in trial 2. All infected participants met the eligibility criteria, received treatment and completed follow-up. Four achieved a parasitological cure, and one case of treatment failure was observed (trial 1, PZQ group). Two mild adverse events (diarrhoea) were reported, with no serious complications or clinically significant changes in biochemical parameters.

Conclusions

This pilot study demonstrated the feasibility of implementing a field-based phase 3 clinical trial protocol for PED-PZQ in endemic areas of Brazil. The findings confirm that the protocol can be successfully applied in primary care settings, despite operational challenges related to recruitment, logistics and documentation. The study also provided preliminary evidence supporting the safety and effectiveness of the paediatric formulation and highlighted the need to revise prevalence assumptions to improve future screening strategies. Overall, the experience offers valuable insights to guide the large-scale phase 3 trial and supports the incorporation of PED-PZQ into national schistosomiasis control policies.

Trial registration number

Brazilian Clinical Trials Registry; RBR-86kcy37.

Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol

Por: Kanaan · R. · Duncan · R. · Mihalopoulos · C. · Braat · S. · OBrien · T. J. · Velakoulis · D. · Kwan · P. · Mulder · R. T. · Cook · M. · Mullen · S. · Mayne · D. · Oliver · G. · Eleftheriadis · D. · Ameen · O. · Chatterton · M. L. · DSouza · W. · Nicolo · J.-P. · Perucca · P. · Winton-Brow
Introduction

Functional seizures (FS) are events that resemble epileptic seizures, but are not attributed to brain pathology and are instead thought to be due to psychological factors. A small, multisite, open-label, single-arm, pilot trial of a breathing intervention known as breathing control training (BCT) found it to be safe and effective in reducing seizure frequency in FS. We propose a protocol for a study to confirm these results.

Methods and analysis

A 24-week, multicentre, individually-randomised, assessor-blinded, two-arm, parallel-group efficacy and acceptability trial of BCT versus control (Befriending) in 220 participants ≥16 years of age with FS. Eligible participants will be randomly allocated to receive two sessions of either BCT or Befriending over a 4-week period. Sessions will be delivered by a respiratory physiotherapist at a clinical care site or via telehealth. They will complete assessments prior to commencing treatment and at 4, 12 and 24 weeks after their initial session of BCT/Befriending. The trial will be conducted alongside treatment as usual. An economic evaluation including cost-utility and cost-effectiveness analyses will be carried out from health sector and societal perspectives.

Ethics and dissemination

The study has been approved by The Austin Health Human Research Ethics Committee (HREC/84335/Austin-2022) and the New Zealand Central Health and Disability Ethics Committee (2022 FULL 12324). Findings will be reported to trial participants and consumers; presented at local, national and international conferences; and disseminated by a peer-reviewed scientific journal.

Burnout Syndrome Predictors in Nursing Professionals During and After the COVID‐19 Pandemic: A Prospective Cohort

ABSTRACT

Aim

To analyse predictors of burnout in nursing professionals during and after the COVID-19 pandemic.

Design

Cohort study.

Method

A two-phase study conducted during the COVID-19 pandemic's peak (2020) and post-vaccination period (2022). Data from nursing professionals of four hospitals in southern Brazil included sociodemographic, occupational, lifestyle, and health variables, and Maslach Burnout Inventory responses. Multivariate logistic and linear regression analyses were used to identify independent predictors of burnout syndrome. The study was approved by the Research Ethics Committee (approval no. 4.152.027).

Results

A sample of 163 participants were assessed at two distinct time points. In 2020, 9.2% of nursing professionals experienced burnout syndrome, decreasing slightly to 7.4% in 2022. As for the burnout dimensions, emotional exhaustion was reported by 27% of professionals in 2020 and 26.4% in 2022. Depersonalisation affected 28.2% during the pandemic and 25.2% afterward. Low professional accomplishment was identified in 29.4% of professionals in 2020, increasing to 30.1% in 2022. Distinct predictors were identified for overall burnout and its specific dimensions. The main predictors included: perceiving a mental health impact from the pandemic, previous mental health issues, recent medical leave, and working directly with COVID-19 patients.

Conclusions

Burnout syndrome remained stable post-pandemic. Key predictors were identified, highlighting the need for preventive mental health interventions.

Relevance for Clinical Practice

Identifying predictors of burnout in nursing professionals supports the development of targeted interventions to protect mental health, improve job satisfaction, and enhance the quality of patient care during and after health crises.

Impacts

This study fills a gap in post-pandemic research by identifying predictors of burnout in nursing professionals. It supports the development of policies and interventions to protect mental health and improve working conditions in Brazilian hospitals.

Reporting Method

STROBE guidelines for cohort studies.

Patient or Public Contribution

Participants contributed only through data collection.

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.

Decision Trees for Managing Impaired Physical Mobility in Multiple Trauma Patients

ABSTRACT

Aim

To develop and validate decision trees using conditional probabilities to identify the predictors of mortality and morbidity deterioration in trauma patients.

Design

A quasi-experimental longitudinal study conducted at a Level 1 Trauma Center in São Paulo, Brazil.

Method

The study analysed 201 patient records using standardised nursing documentation (NANDA International and Nursing Outcomes Classification). Decision trees were constructed using the chi-squared automatic interaction detection (CHAID) algorithm and validated through K-fold cross-validation to ensure model reliability.

Results

Decision trees identified key predictors of survival and mobility deterioration. Patients who did not require (NOC 0414) Cardiopulmonary Status but required (NOC 0210) Transfer Performance had a 97.4% survival rate. Conversely, those requiring (NOC 0414) Cardiopulmonary Status had a 25% risk of worsening mobility, compared to 9% for those who did not. K-fold cross-validation confirmed the model's predictive accuracy, reinforcing the robustness of the decision tree approach (Value).

Conclusion

Decision trees demonstrated strong predictive capabilities for mobility outcomes and mortality risk, offering a structured, data-driven framework for clinical decision-making. These findings underscore the importance of early mobilisation, tailored rehabilitation interventions and assistive devices in improving patient recovery. This study is among the first to apply decision trees in this context, highlighting its novelty and potential to enhance trauma critical care practices.

Implications for the Profession and/or Patient Care

This study highlights the potential of decision trees, a supervised machine learning method, in nursing practice by providing clear, evidence-based guidance for clinical decision-making. By enabling early identification of high-risk patients, decision trees facilitate timely interventions, reduce complications and support personalised rehabilitation strategies that enhance patient safety and recovery.

Impact

This research addresses the challenge of improving outcomes for critically ill and trauma patients with impaired mobility by identifying effective strategies for early mobilisation and rehabilitation. The integration of artificial intelligence-driven decision trees strengthens evidence-based nursing practice, enhances patient education and informs scalable interventions that reduce trauma-related complications. These findings have implications for healthcare providers, rehabilitation specialists and policymakers seeking to optimise trauma care and improve long-term patient outcomes.

Patient or Public Contribution

Patients provided authorisation for the collection of their clinical data from medical records during hospitalisation.

Individual and Institutional Factors Associated With Urinary Incontinence Among Nursing Home Residents: A Multilevel Analysis

ABSTRACT

Aims

(1) To analyse individual and institutional-level factors associated with urinary incontinence in older adults living in nursing homes; (2) to estimate the prevalence of urinary, faecal and double incontinence in nursing home residents.

Design

Cross-sectional study.

Methods

Residents aged 65+ living in 22 nursing homes in Catalonia (Spain) were included. Descriptive, bivariate, and multilevel analyses were performed.

Results

The final sample comprised 452 residents (75.9% female, mean age of 87.0 years). The prevalence of urinary, faecal and double incontinence was 77.5%, 46.1% and 45.7%, respectively. Urinary incontinence was statistically significantly associated with neurological conditions, moderate cognitive impairment, moderate dementia, severe cognitive impairment, very severe cognitive impairment and age.

Conclusion

Approximately three out of four nursing home residents suffered from urinary incontinence and almost half of the sample from faecal or double incontinence. Individual-level factors (cognition, neurological conditions and age) played a more important role than institutional-level factors for urinary incontinence.

Implications for the Profession and Patient Care

The findings of this study highlight the importance of individual-level interventions to prevent and manage urinary incontinence in nursing homes.

Impact

In Catalonian nursing homes, individual factors such as cognitive impairment and neurological conditions were more strongly associated with urinary incontinence than institutional factors. This has implications for improving care provided to older adults, particularly those with dementia and neurological conditions.

Reporting Method

STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines.

Patient or Public Contribution

Nursing home residents were not involved in this study.

Aetiological clustering of newly diagnosed type 2 diabetes using machine learning: a retrospective cross-sectional study in Dubai, UAE

Por: Dsouza · S. M. · Sulaiman · F. · Abdul · F. · Mulla · F. · Ahmed · F. S. · AlSharhan · M. · AlOlama · A. · Ali · N. · Abdulaziz · A. · Rafie · A. M. · Alnuaimi · S. · Goswami · N. · Khamis · A. H. · Bayoumi · R. A. L.
Objectives

Type 2 diabetes (T2D) is a complex disease with a heterogeneous clinical presentation. Recently, five distinct clusters of T2D have been identified in the Emirati population of long-standing T2D with complications. This study aimed to validate these clusters in newly diagnosed T2D patients without any complications and determine whether severe and mild phenotypes are detectable early in the disease course.

Design

Retrospective, cross-sectional, non-interventional study.

Setting

Primary healthcare centres in Dubai, UAE.

Participants

A total of 451 adults, including both Emiratis and expatriates, diagnosed with T2D in the last 5 years and without T2D-related complications at the time of visit, were enrolled. Patients with complications, incomplete clinical data or higher duration of T2D were excluded from the study.

Outcome measures

Identification of distinct T2D clusters using machine learning-based clustering analysis. Five clinical variables: age at diagnosis, body mass index, glycated haemoglobin, fasting serum insulin and fasting blood glucose served as predictors. Overlap between clusters was assessed via the Silhouette Index and Bayesian probability.

Results

Five clusters were identified, replicating prior findings: severe insulin-resistant diabetes (SIRD), severe insulin-deficient diabetes (SIDD), mild age-related diabetes (MARD), mild obesity-related diabetes (MOD) and mild early-onset diabetes (MEOD). As confirmed by a Silhouette Index and Bayesian probability of 1, 55.43% of the patients showed cluster-exclusiveness, while 44.56% of the cohort showed overlap between clusters. The highest overlap was recorded for mild forms of T2D in the order MOD>MARD>MEOD.

Conclusions

The study confirms that both severe and mild T2D phenotypes are present in newly diagnosed, complication-free patients, supporting the applicability of cluster-based classification early in disease. These results highlight the potential for personalised treatment strategies to optimise management and prevent complications. Future studies should investigate longitudinal outcomes and therapeutic response across clusters.

Predictors of pain and cartilage damage in patellofemoral joint osteoarthritis: stair descent knee kinematics and kinetics

Por: Hammond · E. · Johnson · J. · Haley · T. · Lee · J. · Bucknor · M. D. · Akkaya · Z. · Kreutzinger · V. · Jiang · F. · Pedoia · V. · Majumdar · S. · Souza · R. B.
Objective

To identify gait biomechanical characteristics associated with pain and cartilage damage in individuals with patellofemoral joint osteoarthritis (PFJ OA) during a stair descent activity.

Design

Cross-sectional observational study.

Setting

University-based motion analysis laboratory and musculoskeletal imaging centre.

Participants

83 participants entered the study; 66 participants (41 female, 25 male) completed all components required for this analysis. Participants were recruited via electronic health records following clinical knee MRI. Inclusion criteria included MRI-confirmed patellofemoral cartilage lesions using Whole Organ MRI Score (WORMS) gradings (WORMS >1), pain during stair ambulation, body mass index (BMI) ≤35 and informed consent. Exclusion criteria were tibiofemoral abnormalities (WORMS >1), prior knee trauma, gait-altering conditions, MRI contraindications or pregnancy.

Primary and secondary outcome measures

Primary outcomes included knee joint kinematics and during stair descent, assessed during three-dimensional motion capture, patient-reported outcomes from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire and WORMS gradings to assess severity of cartilage abnormalities. Regression analyses were performed to examine correlations of biomechanics, age and BMI with pain and cartilage damage. Analyses were also performed on male and female participants separately.

Results

Significant associations were found between biomechanical characteristics and KOOS scores (pain, symptoms and patellofemoral) as well as cartilage damage. For the whole cohort, greater knee flexion at late stance was linked to worse KOOS scores (β=0.53 to 0.71, p

Conclusions

Altered knee biomechanics during stair descent are linked to worse knee pain, function and cartilage damage in PFJ OA, with sex-specific differences emphasising the need for individualised interventions to address movement abnormalities.

Social Representations of Bedside Milk Expression Among Mothers of Preterm Newborns in Neonatal Intensive Care Units

ABSTRACT

Aim

To understand the social representations of bedside milk expression (BME) among mothers of preterm newborns in neonatal intensive care units (NICUs).

Design

Qualitative descriptive study.

Methods

The study was conducted from July to August 2024 in two NICUs of a referral maternity hospital in Fortaleza, Brazil. Nineteen mothers of hospitalised premature newborns participated. Semi-structured interviews were conducted and subjected to thematic content analysis.

Results

Mothers perceived BME as a meaningful act of protection and bonding, though some were unfamiliar with the practice. Emotional ambivalence was common, shaped by prior breastfeeding experiences and the context of prematurity. Discomfort related to privacy and shared spaces was noted. Support from healthcare professionals was essential to promote understanding and adherence.

Conclusion

Social representations of BME are shaped by emotional, social and institutional experiences. Anchored in prior breastfeeding experiences and cultural meanings of maternal care, the practice is objectified through both gestures of affection and tangible barriers.

Implications for the Profession and/or Patient Care

Healthcare professionals, particularly nurses, should receive training to support mothers in BME. Structural improvements, privacy and emotional support are essential for fostering maternal autonomy and confidence.

Impact

This study highlights the barriers to BME, emphasising the role of healthcare support and the need for better infrastructure, privacy and training to enhance maternal confidence and breastfeeding.

Reporting Method

The study followed the Consolidated Criteria for Reporting Qualitative Research checklist.

Patient or Public Contribution

None.

What Does This Paper Contribute to the Wider Global Clinical Community?

This paper highlights the pivotal role of healthcare professional support in overcoming barriers to BME and promoting breastfeeding practices.

What Already Is Known?

Fresh breast milk is considered the gold standard for reducing complications and improving survival in preterm infants. BME is recommended as an effective strategy to ensure the availability of fresh breast milk. Mothers' social representations of this practice remain underexplored within the neonatal intensive care context.

What This Paper Adds?

Explores mothers' social representations of BME in NICUs, addressing a significant gap in qualitative research. Reveals how emotional, social and institutional factors shape mothers' perceptions, motivations and challenges related to BME. Highlights the need for targeted professional support, improved infrastructure and privacy to enhance maternal autonomy and adherence to milk expression practices.

Implications for Practice

Healthcare professionals, particularly nurses, should receive specialised training to provide technical guidance and emotional support, enhancing mothers' confidence and autonomy in BME. Improving infrastructure and ensuring privacy in NICUs are crucial to creating supportive environments that facilitate milk expression and strengthen maternal–infant bonding. Institutional policies should integrate maternal-centred strategies to support breastfeeding continuity and promote humanised neonatal care.

Factors influencing HPV vaccine acceptance in immunosuppressed patient populations: a protocol for a systematic review

Introduction

The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.

Methods and analysis

A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.

Ethics and dissemination

This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023452537.

❌