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☐ ☆ ✇ BMJ Open

Spatial distribution of HIV prevalence and associated factors in Guinea: retrospective cross-sectional study using Demographic and Health Surveys (DHS) data from 2012 and 2018

Por: Balde · I. · Toure · A. A. · Abbate · J. L. · Sow · A. · Sow · M. S. · Bangoura · S. T. · Hounmenou · C. G. · Sidibe · S. · Camara · A. · Delamou · A. · Ouattara · C. A. · Dieng · S. · Toure · A. — Marzo 19th 2026 at 15:12
Objectives

In Guinea, around 17 new cases of HIV occurred each day and it was responsible for 10 deaths a day in 2022. In addition to this burden, regional disparities have emerged over the years. This study aimed to describe and explain the uneven distribution of HIV infection in Guinea using spatial analysis.

Design

This is a retrospective cross-sectional secondary analysis using data from the 2012 and 2018 Guinea Demographic and Health Survey (DHS).

Setting

This study was conducted in Guinea.

Participants and methods

We conducted a secondary analysis of data from 300 and 400 enumeration areas, respectively, included in the 2012 and 2018 DHS Program for participants aged 15 to 49 who underwent HIV testing. Spatial analysis methods, including Moran I, interpolation and Kulldorff’s scan statistic, were applied to examine variation and identify high-risk spatial clusters of HIV prevalence rate. The potential relationship between HIV status and socio-demographic, biological, behavioural and socio-environmental explanatory variables was explored using logistic regression at individual level.

Results

In total, 7922 individuals in 2012 and 8539 in 2018 participated in the study. HIV prevalence rate in 2012 and 2018 was 1.9% and 1.5%, respectively. Across Guinea’s 33 prefectures, HIV prevalence rate varied from 0% to 3.9% in 2012 and from 0% to 3.5% in 2018. Spatial analysis identified four significant high-risk spatial clusters in 2012 and one high-risk cluster in 2018. The high-risk clusters in 2012 were in Kissidougou (relative risk (RR)=3.97; p value=0.037), Matam (RR=2.80; p value=0.019), Pita (RR=3.46; p value=0.035) and N’zerekore prefectures (RR=6.08; p value=0.027), the high-risk cluster in 2018 was located in Boffa prefecture (RR=3.95; p value=0.022). Factors significantly and positively associated with HIV infection in 2012 included age class 25–34 (aOR: 2.20; 95% CI 1.40 to 3.47), age class 35–49 (aOR: 2.43; 95% CI 1.51 to 3.92), number of HIV healthcare facilities>30 (aOR: 2.14; 95% CI 1.34 to 3.43). HIV infection was significantly lower in men (aOR: 0.52; 95% CI 0.35 to 0.77). In 2018, in addition to age groups 25–34 years (aOR=1.90; 95% CI 1.18 to 3.04) and 35–49 years (aOR=2.25; 95% CI 1.40 to 3.64), the Soussou ethnicity group (aOR=1.73; 95% CI 1.04 to 2.87) was also positively associated with HIV infection.

Conclusion

This study describes the spatial distribution of HIV prevalence rate and identified high-risk clusters in Guinea. In addition, risk factors associated with HIV status were identified. The information can help prioritise surveillance and response efforts to control HIV in Guinea.

☐ ☆ ✇ BMJ Open

Caring beyond the procedure: a qualitative study on thoracic surgery nurses perspectives on chronic illness experiences of individuals with myasthenia gravis undergoing thymectomy

Por: Missel · M. · Donsel · P. O. · Nielsen · T. F. · Secher · E. L. · Medeiros · E. B. Z. · Rude · K. · Hojgaard · J. L. S. · Viby · N.-E. · Birnbaum · S. · Andersen · L. K. · Petersen · R. H. · Witting · N. — Marzo 9th 2026 at 14:04
Objectives

To explore how thoracic surgical nurses perceive and respond to the chronic illness needs of individuals with myasthenia gravis undergoing thymectomy.

Methods

Data were collected through four focus group interviews using a semi-structured interview guide. The analysis followed a hermeneutic approach, identifying recurring themes through iterative interpretation and critical reflection. Nineteen thoracic surgical nurses from ward and postanaesthesia care unit settings participated, representing a diverse range of clinical experience. The study followed the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist for reporting the findings of this study.

Results

The analysis identified three overarching themes reflecting nurses’ experiences of caring for individuals with myasthenia gravis undergoing thymectomy. First, nurses described how the chronic aspects of the illness often ‘disappeared’ within the surgical care process, with attention focused mainly on procedural recovery, leaving patients’ broader illness needs unaddressed. Second, nurses experienced a dilemma between providing acute surgical care and responding to patients’ chronic illness understanding, highlighting uncertainty due to limited knowledge and lack of clear guidelines. Third, nurses emphasised the difficulty of managing the invisible and unpredictable symptoms of myasthenia gravis, which created a heightened need for vigilance but also uncertainty in symptom assessment and support. Across all themes, the findings suggest that surgical care practices may insufficiently recognise patients’ ongoing illness experiences, emphasising the need for greater knowledge, interdisciplinary collaboration and chronic illness-sensitive care approaches.

Conclusions

The study highlights the need for increased attention to chronic illness needs in surgical care, supporting interdisciplinary collaboration and tailored nursing practices that address the lived experiences of patients with chronic conditions.

☐ ☆ ✇ BMJ Open

Alloplastic total temporomandibular joint (TMJ) replacement registry: a protocol for a prospective global multicentre observational cohort study

Por: Thor · A. · Bengtsson · M. · Dowgierd · K. · Epifanov · S. · Fichter · A. M. · Jelovac · D. · Korn · P. N. · Nilsson · J. L. · Pastore · G. · Rughubar · V. · Smolka · W. · Talvilahti · J. · Thiem · D. · Thieringer · F. · Ulmner · M. · Wolvius · E. B. · Zubillaga Rodriguez · I. · Kumar · V — Marzo 9th 2026 at 14:04
Introduction

Total alloplastic replacement of the temporomandibular joint (TMJ) is a viable treatment option for severe TMJ disorders (TMDs) unresponsive to conservative approaches, as well as for reconstruction of congenital or acquired TMJ defects. However, clinical data on indications, outcomes, complications and long-term effects remain limited, and no global registry currently exists. This study aims to address this gap by establishing an international registry to collect data from patients undergoing total alloplastic TMJ replacement systematically. The registry will document clinical indications and disease progression, explore relationships between treatments, outcomes and quality of life, identify predictors of favourable outcomes and inform future research.

Methods and analysis

This international, prospective, multicentre, observational registry will enrol approximately 200 patients with TMD requiring total alloplastic TMJ replacement, with follow-up lasting up to 5 years postoperatively. The data collected will include underlying disease, treatment details, functional outcomes, patient-reported outcomes and procedure-related adverse events. The registry will also monitor patients who decline surgery and record their reasons. All treatments will adhere to the standard of care at each participating centre.

Ethics and dissemination

Ethics approval was obtained from the responsible ethics committee (EC) at each participating site prior to TMJ surgery. All patients will be enrolled following an informed consent process approved by the relevant EC. Study results will be disseminated through peer-reviewed publications.

Approving ECs include: Krishnadevaraya College of Dental Sciences and Hospital EC, KCDS/Ethical Comm/54/2022–23; Ethikkommission Nordwest- und Zentralschweiz, 2019–02387; University of Belgrade School of Dental Medicine EC, 36/19; National Videnskabsetisk Komité, 2401881; University of KwaZulu-Natal Biomedical Research EC, BREC/00001592/2020; Etikprövningsmyndigheten, 2019–04477; Ethikkommission Medizinische Hochschule Hannover, 8660_BO_K_2019; Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig, 080/21-lk; Comité de Ética de la Investigación con Medicamentos Hospital Universitario 12 de Octubre, 19/392; Landesärztekammer Rheinland-Pfalz EC, 2025–18012-andere Forschung/nachberatend; Local Ethical Committee at National Medical and Surgical Centre named after NI Pirogoov, LEC meeting 5; Ethikkommission bei der LMU München, 19–589; Komisja Bioetyczna przy Warmiłsko-Mazurskiej Izbie Lekarskiej w Olsztynie, 12/2021; De Medisch Ethische Toetsings Commissie Erasmus MC, MEC-2019–0696 and Comissão Nacional de Ética em Pesquisa, 3.825.711.

Trial registration number

NCT03991728.

☐ ☆ ✇ BMJ Open

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. — Febrero 24th 2026 at 16:52
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.

☐ ☆ ✇ BMJ Open

Epidemiological investigation of perinatal depression among pregnant and postpartum women: findings from a cross-sectional survey in the Philippines

Por: Filoteo · J. A. · Maravilla · J. C. · Mamaat · J. E. · Flores · A. D. · Jumamil · A. N. · Cardenas · R. L. · Quijencio · W. · Bayani · M. A. · Santos · N. · Acena · J. L. · Alfonso · A. L. · Rivera · M. · Guarino · R. · Sarmiento · R. · Flenady · V. · Boyle · F. M. · Loughnan · S. A. · T — Febrero 18th 2026 at 14:51
Objective

This study investigated perinatal depressive symptoms among pregnant and postpartum Filipino women.

Design

Cross-sectional survey.

Setting

The Philippines.

Participants

Participants were recruited online and face-to-face from maternal care facilities.

Primary outcome measure

Perinatal depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS) score, with prevalence calculated based on ≥13 cut-off, indicating clinically significant symptoms of depression. Patterns of depressive symptoms were examined by demographics, perinatal time period and other obstetric information using adjusted regression coefficients (ab) and risk ratios (aRR).

Results

A total of 856 women participated in the study, comprising 356 pregnant and 500 postpartum women. EPDS scores were, on average, similar between pregnant (14.4) and postpartum women (14.1). Using the locally validated cut-off of ≥13 revealed that 69.1% of pregnant and 62.0% of postpartum women reported clinically significant depressive symptoms. Consistent EPDS scores and prevalence were observed across pregnancy trimesters and within 12 months postpartum and beyond. Women who received adequate prenatal care were less likely to experience antenatal (ab=–1.59, 95% CI –3.13 to –0.05) and postpartum (ab=–1.30, 95% CI –2.48 to –0.12) depressive symptoms. Postpartum EPDS scores and depressive symptom prevalence (EPDS score ≥13) were higher among 18–24-year olds (ab=1.96, 95% CI 0.30 to 3.61; aRR=1.23, 95% CI 1.03 to 1.47) and single mothers (ab=3.46, 95% CI 0.22 to 6.71; aRR=1.42, 95% CI 1.07 to 1.90), compared with older and married mothers, respectively.

Conclusions

At least 60% Filipino mothers experienced clinically significant perinatal depressive symptoms, which exceeds the established global average of 25%. Younger and single postpartum women were at greater risk, while pregnant and postpartum women who attended adequate prenatal visits were less likely to report depressive symptoms. Our study underscores the need for further research to uncover the true burden of poor perinatal mental health and calls for targeted early interventions and integrative public health strategies to support at-risk mothers, particularly those from socially disadvantaged backgrounds.

☐ ☆ ✇ BMJ Open

Synthesising evidence on the association between the structure, function and quality components of social connection and quality of life for people with dementia: a scoping review protocol

Por: Liougas · M. P. · Campos · J. L. · Montanari · L. · Rabin · J. S. · McGilton · K. S. · Bethell · J. — Febrero 17th 2026 at 13:17
Introduction

Social connection describes how individuals connect, relate and interact with one another, and can affect quality of life (QoL) in persons with dementia. Much of the existing research on social connection does not explicitly differentiate social connection’s structure, function and quality components. Due to this, social connection is described using inconsistent terminology, making it unknown how each component is associated with health and well-being outcomes. However, for people with dementia, it is unknown which components of social connection are associated with QoL and whether factors such as gender and type of dementia influence these relationships. This scoping review will identify which components of social connection have been studied in relation to the QoL for people with dementia. This will address inconsistent definitions of social connection terminology and clarify what components of social connection are described and measured in the existing literature.

Methods and analysis

The six-stage scoping review framework developed by Arksey and O’Malley (2005), with updates from Levac et al (2010), will be used. In March 2025, a comprehensive literature search in the following databases will be conducted: MEDLINE ALL (Ovid), APA PsycInfo (Ovid), Embase Classic and Embase (Ovid), CINAHL Complete (EBSCOhost) and Scopus, from database inception. Studies will be included if they are observational studies reporting on an association between social connection and QoL in community-dwelling people with dementia. In Covidence, two reviewers will independently screen the titles and abstracts and review full-text articles based on the inclusion criteria. Data extraction will be carried out by one reviewer and cross-checked by another reviewer. A content analysis for scoping reviews will be used to analyse data and synthesise findings.

Ethics and dissemination

Ethical approval is not required. Dissemination activities will include peer-reviewed publications, academic presentations and lay summaries on professional websites and social media.

☐ ☆ ✇ BMJ Open

Development and validation of a machine learning model for prediction of 1-year mortality following ST-elevation myocardial infarction: a retrospective cohort study

Por: Sritharan · H. P. · Nguyen · H. · Ciofani · J. L. · Bhindi · R. · Allahwala · U. K. — Febrero 12th 2026 at 19:06
Objectives

To develop a machine learning (ML)-based risk prediction model for 1-year mortality in ST-elevation myocardial infarction (STEMI) patients undergoing primary or rescue percutaneous coronary intervention.

Design

Patient data, including demographic, clinical, biochemical, imaging and procedural details, were extracted from electronic medical records. Data were split into training (80%) and test (20%) sets. Eight supervised learning algorithms were evaluated: least absolute shrinkage and selection operator, ridge, Elastic Net (EN, decision tree, support vector machine, random forest, AdaBoost and gradient boosting. Feature selection was performed sequentially with subsets of the top 5/10/15/20/25/30 features. Model hyperparameters were optimised using fivefold cross-validation with area under the curve (AUC) as the scoring metric.

Setting

Single, tertiary Australian centre.

Participants

We analysed data from 1863 consecutive STEMI patients treated at a tertiary Australian centre from July 2010 to December 2019.

Outcome measures

The primary outcome was 1-year all-cause mortality.

Results

The 1-year mortality rate was 13.6% (n=254) in our cohort. The EN model with five key features (parsimonious model) demonstrated superior performance, achieving an AUC of 0.821, which was comparable to the full 30-variable model (AUC 0.821). Advanced age, pre-hospital cardiac arrest and management with balloon angioplasty alone were identified as predictors of increased mortality risk, while family history of premature coronary disease and higher left ventricular ejection fraction were associated with improved survival. To facilitate clinical implementation, we developed a user-friendly web application for individualised risk assessment.

Conclusion

Our ML model accurately predicts 1-year mortality in STEMI patients using only five clinical variables. This tool offers improved accuracy and ease of use compared with existing risk stratification methods, potentially enhancing patient stratification and guiding treatment decisions in STEMI management.

☐ ☆ ✇ BMJ Open

Feasibility of a mobile health intervention to motivate adolescent fitness and high-intensity exercise adherence (Motivating Adolescent Fitness (MOTAFIT)): protocol for a randomised controlled trial

Por: Koep · J. L. · Sansum · K. M. · Low · J. · Smith · K. J. · Cocks · M. · McManus · A. M. — Febrero 10th 2026 at 14:17
Introduction

Most adolescents fail to achieve recommended levels of vigorous-intensity physical activity, despite the established benefits for cardiorespiratory fitness and vascular health. Supervised interventions can be effective, but are resource-intensive and lack scalability. Mobile health (mHealth) technologies may provide a cost-effective and accessible approach to support structured, individualised training for adolescents. The Motivating Adolescent Fitness (MOTAFIT) trial will assess the feasibility and acceptability of an mHealth-supported exercise intervention for adolescents to inform the design of a definitive randomised controlled trial (RCT).

Methods and analysis

MOTAFIT is a three-arm feasibility RCT targeting 120 adolescents aged 13–16 years from the Okanagan Valley, British Columbia. Participants will be randomised (1:1:1) to: (1) MOTAFIT, (2) active control or (3) control group. The 12-week intervention targets ≥40 min/week of vigorous-intensity exercise (≥80% HRmax), co-designed with an exercise specialist and supported by mHealth technology. Primary outcomes for feasibility, including recruitment, retention, adherence, fidelity and acceptability, will be assessed as part of a process evaluation. Secondary measures (cardiorespiratory fitness, vascular health and blood pressure) will provide preliminary estimates to guide future sample size calculations.

Ethics and dissemination

The study has received approval from the University of British Columbia Clinical Research Ethics Board (H22-03183) and the University of Victoria Human Research Ethics Board. Parental consent and adolescent assent will be obtained prior to participation. Findings will be disseminated via peer-reviewed publications, conferences and community engagement.

Trial registration number

NCT06409793.

☐ ☆ ✇ BMJ Open

Connecting families--randomised controlled trial of poverty screening and financial support navigation for families of young children in primary care: an internal pilot study informed protocol

Por: Bayoumi · I. · Parkin · P. C. · Tabassum · F. · Johnson · C. · Sherwood · M. · Mitchell · M. · Birken · C. S. · Bloch · G. · Carsley · S. · Cole · M. · Green · M. · Keown-Stoneman · C. D. G. · Maguire · J. L. · Purkey · E. · van den Heuvel · M. · Weir · S. · Wong · P. · Borkhoff · C. M. — Febrero 6th 2026 at 14:29
Introduction

Poverty can have profound negative impacts on parent, child and family health. Primary care providers are in a unique position to address child poverty. Some team-based models have integrated community support workers (CSWs) for social service system navigation assistance. The overall aim of this study is to rigorously test a poverty reduction intervention (navigation of financial supports) embedded in primary care. The primary objective is to compare parenting stress between CSW-supported, structured review of financial supports and social system navigation (intervention) and receipt of written summary of local resources (usual care).

Methods and analysis

This is a multisite pragmatic superiority randomised controlled trial with a 1:1 allocation to the CSW-supported social system navigation versus no navigation. Parent–child dyads (80 parents of children aged Do you ever have difficulty making ends meet at the end of the month?’) will be recruited during a scheduled health supervision visit from primary care practices in Kingston, Ontario. Intervention group participants will have a structured review of financial supports with a trained CSW and will meet up to 6 times over 6 months. Outcomes are measured at baseline, 6 months and 12 months after randomisation. The primary outcome is the Parenting Stress Index Fourth Edition Short Form (PSI-4-SF) total score at 6 months. Secondary outcomes include household income, food insecurity, parent mental health (depression and anxiety) and child health. An internal pilot study was used to obtain more reliable estimates of the SD of PSI-4-SF at 6 months to recalculate the sample size (if needed) and assess randomisation and completion rates. Qualitative interviews conducted 9 months after enrolment explore parent experiences with the CSW intervention.

Ethics and dissemination

Research ethics approval by Queen’s University Health Sciences REB. Results will be shared with the College of Family Physicians of Canada, the Ontario SPOR SUPPORT Unit and academic forums.

Trial registration number

Connecting Families (Registered 12 October 2021 at www.clinicaltrials.gov; NCT05091957).

☐ ☆ ✇ BMJ Open

Effectiveness of protein supplementation combined with resistance training to counteract disproportional fat-free mass loss following metabolic bariatric surgery: rationale and design of the ENRICHED randomised controlled trial

Por: de Roos · B. M. · Yeh · L.-L. Y. · van den Hooff · P. S. · Nuijten · M. A. H. · Twisk · J. W. R. · Liem · R. S. L. · van Acker · G. J. D. · Severens · J. L. · Kambic · T. · Serlie · M. J. M. · Monpellier · V. M. · Eijsvogels · T. M. H. · Hopman · M. T. E. · Karregat · J. H. M. — Diciembre 30th 2025 at 05:33
Introduction

Metabolic bariatric surgery (MBS) can lead to substantial fat-free mass loss (FFML) due to malnutrition, decreased protein intake and insufficient physical activity. Disproportional FFML has been associated with an increased risk for adverse health outcomes. Resistance training (RT) combined with protein intake contributes to maintenance and increase of fat-free mass (FFM) in healthy individuals. However, it is unclear whether RT and protein supplementation can prevent FFML after MBS.

Methods and analysis

In the EffectiveNess of pRotein supplementatIon Combined witH resistance Exercise training to counteract Disproportional fat-free mass loss following metabolic bariatric surgery (ENRICHED) randomised controlled trial, 400 patients scheduled to undergo MBS will be randomised in a 1:1 ratio to the ENRICHED perioperative care programme (intervention group) or the standard perioperative care programme of the Dutch Obesity Clinic (control group). The study is currently recruiting participants at two centres in the Netherlands: Nieuwegein and Amsterdam. The postoperative standard programme consists of 13 group sessions spread over a period of 18 months. As part of the ENRICHED programme, RT and protein supplementation will be added 3 weeks after MBS. Additional whole-body RT consists of home-based training sessions two to three times a week, and supervised RT sessions of 45–60 min once weekly, performed at 60–75% of one-repetition maximum (1-RM). Protein supplementation will start by adding 20 g of whey protein to the daily intake. The supplementation will be gradually increased with 20 g every 4 weeks until a total of 60 g whey protein a day is reached. After 12 weeks of protein supplementation, the focus shifts towards incorporating protein-rich food products into the daily dietary intake. The primary endpoint is the prevalence of disproportional FFM loss, defined as FFML/total weight loss ≥30%, at 3 months post-MBS. Secondary endpoints are differences in body composition, muscle strength and function, cardiorespiratory fitness, (cardio)metabolic health, health-related quality of life, gastrointestinal discomfort, cost-effectiveness of the intervention and treatment satisfaction. Outcomes will be assessed preoperatively and at 3, 6 and 12 months postoperatively.

Ethics and dissemination

The study protocol V.2.0 was approved by the Medical Research Ethics Committee Oost-Nederland (NL-OMON57119) on 9 April 2025. All participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations. Insights gained in this study will provide evidence for a patient-tailored intervention that could be implemented in clinical practice.

Trial registration number

NCT07156552.

☐ ☆ ✇ BMJ Open

Study protocol for the investigator-initiated Danish pragmatic randomised STENO INTEN-CT trial: does screening and intervention for subclinical coronary artery disease in type 2 diabetes reduce cardiovascular events?

Por: Funck · K. L. · Borregaard · B. · Egstrup · K. · Fredslund · E. K. · Hansen · T. W. · Kallestrup · P. · Olsen · M. H. · Reventlow · S. · Rossing · P. · Sandbaek · A. · Sondergaard · J. · Thomsen · J. L. · Vestergaard · P. · Poulsen · P. L. · Diederichsen · A. — Diciembre 16th 2025 at 05:04
Introduction

Cardiovascular disease (CVD) risk remains high but unevenly distributed in patients with type 2 diabetes mellitus (T2DM). Current risk stratification strategies are far from optimal, leading to both undertreatment and overtreatment of patients. The STENO INTEN-CT trial aims to evaluate a strategy of improved CVD risk management by using cardiac CT (coronary artery calcification (CAC)) for stratification and tailoring of multifactorial cardiovascular treatment based on CAC score. We hypothesise that (1) intensified medical treatment will lower CVD event rates in high-risk patients (CAC≥100), and (2) less intensive multifactorial treatment is safe in very low-risk patients (CAC=0).

Methods and analysis

The Steno INTEN-CT trial is an investigator-initiated, pragmatic, open-label, event-driven randomised controlled trial including patients with T2DM without known CVD. All participants (expected n=7300) will be invited for a non-contrast coronary CT scan. After the scan, participants will be randomised to either standard treatment (blinded for CAC results) or CAC-based treatment. Participants in CAC-based treatment and their general practitioner (GP) will receive information on CAC and a recommendation of multifactorial treatment. High-risk participants in the interventional arm will be invited for one or more initial study visits to intensify treatment with a combination of sodium glucose co-transporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, high-dose lipid-lowering, antihypertensive and antithrombotic treatment. Very low-risk patients in the interventional arm will be recommended less intensive treatment targets. After initial study-related activities, all participants will continue to be taken care of by their GP guided by specific treatment recommendations. The primary outcome in the primary hierarchical analysis (the rate of the combined CVD endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for heart failure) will be monitored through national health registries. The trial is event-driven, but a median follow-up of 5 years is expected. Key secondary outcomes include patient-reported outcomes, quality-adjusted life years and healthcare costs.

Ethics and dissemination

The protocol V.1.9 is approved by the Research Ethics Committee and the Danish Medicines Agency and the Danish Data Protection Agency. The results of the study—positive, negative or neutral—will be published in peer-reviewed journals and through www.clinicaltrials.org.

Trial registration number

NCT05700877.

☐ ☆ ✇ BMJ Open

Barriers and facilitators to performing benign paroxysmal positional vertigo manoeuvres among primary care physicians in Barcelona: a qualitative study

Por: Rullan-Rabassa · A. · G Abietar · D. · Rando-Matos · Y. · Ballve-Moreno · J. L. · Daryanani-Nawalrai · S. · Hernandez-Mendez · P. · Rozenek · M. A. · Santolalla-De Pedro · A. · Torrecilla-Sanchez · R. · Peguero-Rodriguez · E. — Diciembre 9th 2025 at 08:31
Objective

To explore the barriers and facilitators in adherence to the guidelines in the management of benign paroxysmal positional vertigo from the perspective of primary care physicians.

Design

Qualitative study using focus groups.

Setting

L’Hospitalet del Llobregat (Barcelona), Spain.

Study design

Qualitative study using focus groups. Structured 90 min focus groups were conducted until data saturation was reached. Each session included a moderator and an observer from the research team. Sessions were transcribed and thematically analysed by three independent researchers.

Participants

Purposeful sampling was used to form four groups of 4–10 participants, selected by sex, age, years of experience and primary care team (PCT). Participants were recruited between January and February 2023.

Results

A total of 34 family physicians belonging to four PCTs participated in the study. The main barriers identified were a lack of time, negative initial experiences, a fear of harming patients (especially older adults), difficulty in nystagmus visualisation and challenges in managing patient expectations, as many preferred medication over physical manoeuvres. Facilitators included potential time savings from effective early management, the value of initial practical training with periodic refreshers, access to expert consultants for case discussions and the availability of digital tools, such as tutorials, videos and aids for nystagmus interpretation.

Conclusion

Health systems should invest in protected time for history-taking and physical examination, and in regular, updated training for primary care professionals. This could improve vertigo management and reduce unnecessary investigations and medications, ultimately benefiting both patients and the healthcare system.

☐ ☆ ✇ BMJ Open

Development of a case definition for polycystic ovary syndrome using administrative health data: a validation study

Por: Salem · J. N. · Vettese · R. · Yamamoto · J. M. · Koshy · S. · Harrison · T. · Stephenson · N. · Ronksley · P. E. · Metcalfe · A. · Brennand · E. A. · Benham · J. L. — Noviembre 12th 2025 at 10:55
Objectives

To develop and validate a polycystic ovary syndrome (PCOS) case definition using administrative health data sources.

Design

A validation study.

Setting

Secondary care centre outpatient gynaecology clinic in Calgary, Alberta, Canada.

Participants

3951 electronic health records of women aged 18–45 years who presented to a gynaecology clinic in Calgary, Canada, between January 2014 and December 2019 were reviewed. We identified 180 patients with PCOS using the Rotterdam criteria. Participants were excluded if they were biologically male, pregnant at the time of the consultation, did not meet the date criteria or if their consultation note was missing. The chart data were connected to the Practitioner Claims and the Discharge Abstract Database by personal health number.

Primary and secondary outcome measures

Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of 68 case definitions for PCOS were estimated. Case definition performance was graded.

Results

Of the 68 case definitions tested, none had high validity. The best performing case definitions were: (1) ≥3 instances of International Classification of Diseases-9 code 256.4 (polycystic ovaries) with exclusion codes (sensitivity 23.89%, specificity 99.59%, PPV 74.14%, NPV 96.35%) and (2) 626.X (irregular menstruation), 704.1 (hirsutism) and ≥3 instances of code 256.4 with exclusion codes (sensitivity 2.78%, specificity 99.97%, PPV 83.33%, NPV 95.40%).

Conclusions

We identified several case definitions for PCOS of moderate validity with high PPV (>70%) for case ascertainment in PCOS research in jurisdictions with similar administrative health data. These case definitions are limited by low sensitivity, which should be considered when interpreting research findings.

☐ ☆ ✇ BMJ Open

Time-varying predictors of e-cigarette and cigarette use trajectories from adolescence to emerging adulthood: a longitudinal analysis of US youth in the PATH Study, 2013-2020

Por: Stanton · C. A. · Tang · Z. · Sharma · E. · Anesetti-Rothermel · A. · Marshall · D. · Park-Lee · E. · Silveira · M. L. · Xiao · H. · Deng · L. · Lagasse · L. · Rass · O. · Lee · R. · Valverde · R. · Blanco · C. · Kimmel · H. L. · Compton · W. M. · Hyland · A. J. · Pearson · J. L. — Noviembre 4th 2025 at 13:13
Objective

To examine the longitudinal impact of time-varying factors on US youth’s trajectories of initiation and use of e-cigarettes and cigarettes during the transition from adolescence to young adulthood.

Design

Longitudinal.

Setting

Nationally representative US survey, the Population Assessment of Tobacco and Health (PATH) Study.

Participants

2682 US youth (aged 16–17) at wave (W)1 of the PATH Study across six waves (2013–2020) into young adulthood (aged 22–23).

Primary and secondary outcome measures

Unweighted longitudinal latent class analyses identified trajectory classes of e-cigarette and cigarette use, separately. Nationally representative weighted multinomial logistic regression analyses examined time-varying harm perceptions, substance use problems and tobacco product first tried as predictors of these trajectory classes.

Results

Five e-cigarette classes (2013–2020; 41.5% Persistent Never Use, 12.6% W5 Initiation, 19.9% W3 Initiation, 15.2% Prior Initiation, 10.8% High Frequency Past 30-Day (P30D) Use) and five cigarette classes (2013–2019; 58.6% Persistent Never Use, 11.5% W4 Initiation, 10.9% W2 Initiation, 9.6% Prior Initiation, 9.5% High Frequency P30D Use) were identified. Time-varying harm perceptions and substance use problems were associated with trajectories of initiation and use for both products. Cigarettes, cigarillos, other combustibles and any smokeless tobacco as first product tried were associated with e-cigarette initiation and/or progression to high frequency use. E-cigarettes and hookah as first product tried were associated with later cigarette initiation. High Frequency P30D Cigarette Use was less likely if the first product tried was e-cigarettes, cigarillos, hookah or any smokeless tobacco product.

Conclusions

Results reinforce the need for identification and intervention of early substance use among younger adolescents and targeted public health messaging to address changing harm perceptions and prevent initiation among older adolescents.

☐ ☆ ✇ BMJ Open

Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial: protocol for a batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness-implementation trial

Por: Prendergast · N. T. · Kahn · J. M. · Angus · D. C. · Argote · L. · Barnes · B. · Chang · C.-C. H. · Graff · S. · Hess · D. R. · Onyemekwu · C. A. · Rak · K. J. · Russell · J. L. · Seaman · J. B. · Toth · K. M. · Girard · T. D. — Octubre 23rd 2025 at 09:28
Introduction

Many patients who are extubated after receiving mechanical ventilation for acute respiratory failure experience extubation failure (ie, require reintubation hours to days after extubation). High-quality evidence shows that extubating patients directly to non-invasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC), rather than conventional low-flow oxygen, can prevent extubation failure. These guideline-recommended interventions, however, require care coordination involving multiple intensive care unit (ICU) team members and are infrequently used. Interprofessional education (IPE), which teaches members of multiple professions together, could effectively address this implementation gap in complex, team-based, critical care settings, particularly when paired with a customisable protocol.

Methods and analysis

This batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness–implementation trial will test three hypotheses: (1) when compared with traditional online education (OE), IPE increases implementation of preventive postextubation respiratory support, (2) the benefits of IPE are increased when paired with a clinical protocol and (3) preventive postextubation NIV for high-risk patients and preventive postextubation HFNC for low-risk patients reduce in-hospital mortality when compared with conventional postextubation oxygen therapy. The trial will recruit 24 clusters made up of one or more ICUs that care for at least 100 mechanically ventilated patients per year in a large multihospital health system in the USA. All clusters will receive OE, IPE and a clinical protocol, with timing determined by randomisation. We will also randomise half of the clusters to education promoting postextubation NIV for patients at high risk of extubation failure and preventive, postextubation HFNC for patients at lower risk, whereas the other half will be randomised to education promoting postextubation HFNC for all eligible patients. We will include all patients who are invasively mechanically ventilated for at least 24 hours. The primary implementation endpoint is the rate of use of postextubation NIV or HFNC among eligible participants. The primary clinical endpoint is in-hospital mortality truncated at 60 days from intubation.

Ethics and dissemination

This study was approved by the institutional review board of the University of Pittsburgh and an independent data safety monitoring board. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. We will disseminate results to participating healthcare providers, through publication in a peer-reviewed medical journal and via presentations at international conferences.

Trial registration number

NCT05523479.

☐ ☆ ✇ BMJ Open

Prehabilitation of frail elderly PAtients undergoing majoR surgEry at HOME (PREPARE-HOME): a superiority parallel-group randomised controlled trial protocol evaluating smart wearable enhanced prehabilitation versus usual care

Por: Leong · Y. H. · Tay · V. Y. J. · Yang · X. · Tan · C. J. · Au-Yong · P.-S. · Sim · J. L. X. · Ng · R. R. G. · Ong · M. E. H. · Tan · B. P. Y. · Abdullah · H. R. · Ke · Y. — Octubre 23rd 2025 at 09:28
Introduction

Frailty is a key predictor of adverse surgical outcomes in older adults, contributing to increased postoperative complications, prolonged hospitalisation and delayed recovery. Prehabilitation—targeting improvements in physical function before surgery—can mitigate these risks. However, traditional programmes often face low adherence due to logistical barriers. Integrating smart wearable devices into tele-supervised, home-based prehabilitation may enhance adherence, engagement and clinical outcomes.

This trial protocol describes the PREhabilitation of frail elderly PAtients undergoing majoR surgEry at HOME study with the objective to evaluate the effectiveness of a wearable-enhanced, tele-supervised prehabilitation programme (swSEP) versus standard care (unsupervised prehabilitation, uSEP) on improving preoperative functional capacity and postoperative outcomes in frail older adults undergoing major elective surgery.

Methods and analysis

This single-centre, prospective, randomised controlled trial will enrol 190 patients aged ≥65 years scheduled for major elective, non-cardiac surgery at Singapore General Hospital. Participants with frailty (Edmonton Frail Scale ≥6) will be randomised 1:1 to either the swSEP group (tele-supervised exercise with Fitbit Inspire 3 monitoring) or the uSEP group (standard physiotherapy education, exercise booklet and inspiratory muscle training if maximal inspiratory pressure 2O). The primary outcome is change in 6 min walk test distance from baseline to 1–3 days presurgery. Secondary outcomes include 30 s sit-to-stand test, handgrip strength, postoperative complications (per American College of Surgeons National Surgical Quality Improvement Program), hospital length of stay, readmissions, five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) and adherence. Data will be analysed using t-tests, analysis of covariance, logistic regression and Cox models, with stratification by baseline nutritional status.

Ethics and dissemination

Approved by the SingHealth Institutional Review Board (CIRB Ref: 2024/2242). Trial registered on ClinicalTrials.gov (NCT06633614). Results will be disseminated via peer-reviewed publications and academic conferences. Contact: irb@singhealth.com.sg

Trial registration number

ClinicalTrials.gov Identifier: NCT06633614

☐ ☆ ✇ BMJ Open

The leishmaniases in Kenya: a scoping review sub-analysis of diagnostics

Por: OBrien · K. · Grifferty · G. · Shirley · H. · George · S. · Binkley · A. · Orriols · A. M. · Espinola Coombs · P. · Williams · A. L. · Wong · M. G. · Roe · S. · Wallace · F. · Tschoepe · K. · Hirsch · J. L. · Wamai · R. — Octubre 13th 2025 at 16:51
Objectives

Leishmaniasis poses a significant public health problem in Kenya, where effective case management and treatment rely on accurate diagnosis. This review aims to summarise the research landscape on leishmaniasis diagnostics in Kenya and identify gaps.

Design

This scoping review expands a previously published scoping review on leishmaniasis in Kenya to further analyse studies focusing on diagnostics. The field of diagnostics was chosen because of recent pushes for novel tools and because of the role timely diagnosis plays in disease elimination. A comprehensive search of PubMed, Embase via Embase.com, Web of Science Core Collection, the Cochrane Library, ClinicalTrials.gov, WHO ICTRP and the Pan African Clinical Trials Registry was conducted, covering studies up to 5 January 2024.

Results

After dual, blind screening with conflict resolution by a third reviewer, 41 studies were included in the review. These studies examined a range of diagnostic tools; however most were assessed in one or few studies, and none evaluated real-time PCR. Additional gaps in the research landscape include a lack of diagnostics for cutaneous leishmaniasis and post-kala-azar dermal leishmaniasis in Kenya, outdated literature surrounding the Direct Agglutination Test and randomised trials for any diagnostic tool.

Conclusions

Future research should focus on solidifying the validity and reliability of diagnostic tools in the Kenyan context and updating previous work.

☐ ☆ ✇ BMJ Open

Leishmaniases in Kenya: a scoping review subanalysis of vectors

Por: OBrien · K. · Grifferty · G. · Shirley · H. · Wanjiku · C. · Binkley · A. · Williams · A. L. · Espinola Coombs · P. · Wong · M. G. · Roe · S. · Wallace · F. · Tschoepe · K. · Orriols · A. M. · Hirsch · J. L. · Wamai · R. — Octubre 13th 2025 at 16:51
Objectives

Vector control is imperative for eliminating leishmaniasis as a public health problem in Kenya. As elimination efforts expand in East Africa, it is crucial to understand the current research landscape. To address that need and identify gaps, a scoping review was conducted to characterise the landscape of leishmaniasis vector research in Kenya.

Design

Building on a previously published scoping review by this team, we updated database searches in PubMed, Embase via Embase.com, Web of Science Core Collection, the Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) and the Pan African Clinical Trials Registry to incorporate literature up to 4 January 2024 and focused on vector-related papers. Studies classified as ‘prevention’ in the original scoping review were included due to overlapping definitions.

Results

A total of 95 studies were included in the analysis. Although a wide range of sandfly species have been documented, most of the research is outdated, having taken place 20–40 years ago. Existing studies are mostly epidemiological with little focus on basic and clinical research. There are also no studies on post-kala-azar dermal leishmaniasis despite its potential contribution to the disease transmission cycle. The geographical scope of the research is largely limited to traditional transmission foci with little attention to new disease hotspots such as North Eastern Kenya.

Conclusions

These research gaps need to be addressed to better inform the country’s leishmaniasis prevention and vector control strategy.

☐ ☆ ✇ BMJ Open

Understanding the complexity of living with, and managing, secretions in motor neuron disease/amyotrophic lateral sclerosis (MND/ALS/ALS): protocol for a complex intervention systematic review

Por: Barry · C. · Farquhar · M. · Hawkes · M. · Massey · C. · Cross · J. L. — Octubre 10th 2025 at 11:24
Introduction

Motor neuron disease/amyotrophic lateral sclerosis (MND/ALS/ALS) is an incurable disease which leads to muscle weakness that worsens over time. MND/ALS is highly heterogeneous in its presentation, with many people experiencing a rapidly progressive trajectory of symptoms. Many people living with MND/ALS (plwMND/ALS) experience a combination of flaccidity and spasticity of the muscles involved in speech, swallowing, breathing and coughing. This makes it challenging to deal with the saliva and mucous (‘secretions") produced by the body. Failure to manage these problems effectively can lead to accumulation and aspiration of secretions, which may cause pneumonia and respiratory insufficiency. Knowing the best way to treat this problem is a challenge. Systematic reviews report substantive ongoing uncertainty regarding secretions management (SM). Little is known about the comparative effectiveness of secretion management interventions, their impact on quality of life and acceptability for plwMND/ALS and their unpaid/family.

Methods and analysis

A complex intervention systematic review of SM for plwMND/ALS and/or their carers will be conducted using an iterative logic model approach, designed in accordance with the principles and guidance laid out in a series of articles published by the Agency for Healthcare Research and Quality on complex intervention reviews . Eight electronic databases will be searched for publications between 1996 and present: Ovid Embase, EBSCO CINAHL, EBSCO Academic Search Ultimate, Scopus, EBSCO PsycInfo, Ovid MEDLINE and the Social Sciences Citation Index. This will be supplemented by hand searching of reference lists of included studies. Two reviewers will independently screen the results for potentially eligible studies using AS Review Lab (a semi-automated machine learning tool). Study selection, data extraction and risk of bias assessment, using Gough’s Weight of Evidence Framework, will be independently performed by two reviewers. A framework thematic synthesis approach will be employed to analyse and report quantitative and qualitative data. The reporting will be conducted in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Complex Intervention Extension Statement and Checklist.

Ethics and dissemination

This review will involve the secondary analysis of published information; therefore, ethical approvals are not required. Dissemination will be via presentation at scientific meetings, presentations to MND/ALS support groups and publications in peer-reviewed journals.

PROSPERO registration number

CRD42025102364.

☐ ☆ ✇ BMJ Open

Perceived Social Risk Scale: development and validation in relation to social status and depression in the UK

Por: Newton · J. · Andrews · J. L. — Octubre 9th 2025 at 10:17
Objective

To develop and validate the Perceived Social Risk Scale (PSRS) for assessing perceptions of socially risky behaviours, and to validate it against existing psychological measures such as perceived social status and depressive symptoms in a UK sample of older adolescents and adults.

Design

A cross-sectional study involving exploratory and confirmatory factor analyses.

Setting

Participants were recruited from the Cardiff University’s Department of Psychology participant pool (students completing studies for course credit) and Prolific Academic (a crowdsourcing platform for research volunteers). Data collection occurred between 17 February and 6 May 2024.

Participants

A total of 640 UK participants, including both men and women, aged 18-65.

Main outcome measures

We measured the internal consistency of the PSRS, test-retest reliability and validity against measures including rejection sensitivity, perceived social status, depressive symptoms and resistance to peer influence. Moderation analyses examined the role of perceived social status, age and a sense of belonging in the relationship between PSRS scores and depressive symptoms.

Results

The PSRS showed excellent internal consistency (α=0.96) and good test-retest reliability (Intraclass Correlation Coefficient (ICC)=0.70). Perceptions of social risks significantly declined with age (r=–0.20, p) and factor analyses confirmed that the PSRS differentiates among four distinct but related social risk constructs: authenticity and integrity (α=0.91), social assertiveness (α=0.72), reservedness (α=0.83) and social non-conformity (α=0.72). For evidence of convergent validity, higher PSRS scores were associated with increased sensitivity to social rejection (r=0.23, p elevated depressive symptoms (r=0.13, p=0.012) and negatively correlated with resistance to peer influence (r=–0.13, p=0.013). Local perceived social status significantly moderated the relationship between PSRS scores and depressive symptoms (β=0.005, SE=0.002, t=2.36, p=0.019). A general sense of belonging did not moderate this relationship.

Conclusions

Our results confirm that social risk is not a uniform construct but is instead multidimensional. The PSRS offers a reliable and valid tool for assessing multidimensional social risk-taking, with strong internal consistency and test–retest reliability. The interaction between depression and local perceived social status highlights the importance of perceived status on social risk perception.

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