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Ayer — Abril 20th 2026BMJ Open

N-terminal proBNP adds prognostic value to high-sensitivity cardiac troponin I in elective thoracic surgery: an observational cohort study

Por: Alonso · M. · Popova · E. · De Miguel · M. · Garcia-Osuna · A. · Gonzalez-Tallada · A. · Ordonez-Llanos · J. · Jauregui · A. · Trujillo · J. C. · Martin Grande · A. · Martinez-Tellez · E. · Parera · A. · Planas · G. · Trujillo · L. · Butron · D. · Sola-Roca · J. · De Nadal · M.
Background

Perioperative myocardial injury (PMI) is a common complication following non-cardiac, particularly thoracic, surgery and is associated with increased cardiovascular risk. Although guidelines recommend cardiac biomarker monitoring to detect PMI, its implementation in routine clinical practice remains limited.

Objective

To evaluate the combined use of high-sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro-brain natriuretic peptide (NT-proBNP) in predicting major adverse cardiovascular events (MACE) following elective thoracic surgery, and to determine whether NT-proBNP provides incremental prognostic value beyond hs-cTnI alone.

Design

Multicentre observational cohort study.

Setting

Conducted between February 2021 and November 2023 in three Spanish tertiary hospitals.

Participants

Patients aged ≥45 years scheduled for elective thoracic surgery involving lung resection (pneumonectomy, lobectomy, bilobectomy or segmentectomy) under general anaesthesia. Exclusion criteria included urgent or non-thoracic surgery, active infection or sepsis and a history of severe heart failure (ejection fraction

Main outcome measures

Combined measurement of hs-cTnI and NT-proBNP at baseline (preoperatively) and at 24 and 48 hours postoperatively.

PMI was defined as hs-cTnI ≥45 ng/L at 24 and/or 48 hours or a ≥20% increase from baseline in patients with elevated preoperative concentrations.

Results

Among 475 patients, PMI occurred in 11.8%. PMI had higher rates of prior stroke (12.5% vs 2.9%; p=0.004), smoking history (85.7% vs 64.0%; p=0.001) and severe renal dysfunction (7.1% vs 0.7%; p=0.001), with similar Revised Cardiac Risk Index distribution. Patients with PMI also had greater postoperative elevations of hs-cTnI and NT-proBNP (p

Conclusions

Combined hs-cTnI and NT-proBNP assessment improves perioperative cardiovascular risk stratification beyond ischaemia.

Trial registration number

NCT04749212

Metformin use and the risk of incident osteoarthritis among individuals with diabetes: a register-based nested case-control study

Por: DellIsola · A. · Magnusson · K. · Turkiewicz · A. · Recenti · F. · Lohmander · S. · Englund · M. · Kiadaliri · A.
Objective

To evaluate the association between metformin use and incident osteoarthritis (OA) in people with diabetes and the impact of dosing.

Design

Nested case-control study within a cohort of >1.4 million individuals from Sweden.

Participants

Participants were aged 35–80 years in 2005, without diabetes or OA. We identified persons with incident diabetes between 2006 and 2016 and excluded those with OA before the diabetes diagnosis and those with an incident OA diagnosis within 3 years of the diabetes diagnosis. Cases were defined as individuals with incident OA before 2020 and were matched with up to four controls without OA in the same period, by sex, diabetes duration, birth year (±1 year) and date of diabetes diagnosis (±180 days) using incidence density sampling. Metformin use before the index date (OA diagnosis) was the main exposure. Secondary exposures were quartiles of total metformin use (defined daily doses (DDD)) and duration-adjusted use (DDD/day), reflecting average daily use. We estimated risk ratios with 95% CIs using conditional logistic regressions, adjusted for age at diabetes diagnosis, education, immigration status and comorbidities.

Primary outcome

Incident OA diagnosis in primary or specialist care (International Classification of Diseases codes M15–M19).

Results

We identified 4007 cases and 14 111 controls. Any metformin use was not associated with OA risk (risk ratio (RR) 1.02, 95% CI 0.93 to 1.12). Results for higher total use (0.98 (95% CI 0.86 to 1.11)) and duration-adjusted use (0.92 (95% CI 0.79 to 1.07)) showed no or inconclusive associations.

Conclusions

In individuals with incident diabetes and no prior OA, metformin was not linked to a lower risk of developing OA.

AnteayerBMJ Open

Methods of cervical ripening in induction of labour: an individual participant data network meta-analysis of randomised controlled trials (CIRCLE-NMA) study protocol

Por: Au · N. · Patabendige · M. · Libesman · S. · Wang · R. · Gurrin · L. C. · Mol · B. W. · Li · W. · the CIRCLE-NMA Collaborative · Haas · Galadanci · Zhang · Allotey · de Carvalho Pacagnella · Mundle · Grobman · Seidler · Karahalios · Hunter · Wang · Libesman · Chan · Jones · Tan · Li
Introduction

Induction of labour (IOL) is a commonly performed obstetric intervention, particularly when delivery is deemed more beneficial than continuing the pregnancy due to maternal or fetal indications. When the cervix is unfavourable for delivery, cervical ripening is performed prior to IOL. A wide variety of mechanical, pharmacological and combination methods are used, but the optimal approach balancing efficacy, safety and patient experience remains uncertain. Conventional aggregate data (AD) meta-analyses lack individual-level data, limiting exploration of patient-level factors for personalised medicine and do not address concerns about the trustworthiness of data presented in peer-reviewed randomised controlled trials (RCTs). This protocol describes an individual participant data (IPD) network meta-analysis (NMA) designed to evaluate and rank cervical ripening methods for IOL using only high quality, trustworthy data.

Methods and analysis

We will identify eligible parallel-group RCTs enrolling pregnant women with a singleton, cephalic fetus at ≥34 weeks’ gestation requiring cervical ripening, through comprehensive searches of Ovid MEDLINE, Embase, Emcare, Scopus, Cochrane Pregnancy and Childbirth Register, WHO International Clinical Trials Registry Platform, clinicaltrials.gov and reference lists of prior reviews. The interventions we consider will be selected via Delphi consensus with international clinical experts. Eligible trial investigators will be invited to contribute de-identified IPD; AD will be used if IPD is unavailable. Trials will be assessed for trustworthiness using the Trustworthiness in RAndomised Clinical Trials checklist and the IPD Integrity Tool, with only eligible studies included in the primary analysis. All statistical analyses will follow a pre-specified statistical analysis plan (SAP) finalised before any analyses are conducted. A two-stage, contrast-based, frequentist IPD-NMA will compare cervical ripening methods for three co-primary outcomes: vaginal birth, composite adverse perinatal outcomes and composite adverse maternal outcomes. Subgroup analyses will assess effect modifiers (eg, parity, age and previous caesarean), with treatment rankings presented using the surface under the cumulative ranking curve and rank-heat plots. Sensitivity analyses will examine the impact of bias, missing data and population criteria.

Ethics and dissemination

This study has been approved by the Monash University Human Research Ethics Committee (No. 48189). IPD will be de-identified and securely transferred for storage on a Monash University-hosted shared network drive. Findings will be disseminated via peer-reviewed publications, conference abstracts and the Cervical Ripening for Induction of Labour Collaborative Evidence Network Meta-Analysis (CIRCLE-NMA) website (https://circlenma.com). Patient and public involvement will guide the communication and interpretation of results.

PROSPERO registration number

CRD420251077464.

Prevalence of presbyopia among social safety net beneficiaries with the cognitive, numeracy and dexterity skills required for smartphone use: a cross-sectional analysis of THRIFT RCT screening data from Kurigram, Bangladesh

Por: Aftab · I. B. · Chakma · T. · Pant · S. · Sigwadhi · L. N. · Shitol · S. A. · Rahman · H. M. M. · Alam · J. · Haque · E. · Chadalavada · H. P. · Murtaza · F. · Chan · V. F. · Little · J.-A. · Khanna · R. C. · MacKenzie · G. · Gudwin · E. · Lohfeld · L. · Clarke · M. · Shonchoy · A. · Congd
Objectives

To determine the prevalence of presbyopia and associated risk factors among Bangladeshi recipients of elderly social safety net payments who were not currently using mobile financial services (MFS) and demonstrated numeracy, dexterity and cognitive prerequisites for smartphone use during eligibility screening for the Transforming Households with Refraction and Innovative Financial Technology (THRIFT) trial. Accessing these payments requires use of online banking, as with a smartphone.

Design

Cross-sectional analysis of trial eligibility screening data.

Setting

Community-based screening conducted in two rural subdistricts in Kurigram District, Bangladesh.

Participants

Among 13 944 Old Age Allowance and Widows’ Allowance (WA) beneficiaries screened, 953 met trial eligibility criteria, including passing a smartphone readiness assessment and completing near vision examinations.

Primary and secondary outcome measures

Presbyopia, defined as binocular presenting near visual acuity of N6.3 or worse, correctable to at least N5 with near vision glasses and with distance vision of ≥6/12 in both eyes.

Results

Among 953 participants (mean age 61.4±7.2 years, 62.6% women), presbyopia prevalence was 62.6% (95% CI 59.5 to 65.7). Presbyopia was significantly positively associated with female gender (adjusted prevalence ratio (APR)=1.19, 95% CI 1.02 to 1.41) and receiving WA (APR=1.20, 95% CI 1.04 to 1.38) in multivariable analyses.

Conclusions

This study highlights a substantial burden of uncorrected presbyopia among a prescreened, randomised control trial-eligible subgroup of social safety net beneficiaries in rural Bangladesh, who were not currently using MFS but demonstrated cognitive and functional capacity to use mobile phones, potentially hampering their ability to carry out online banking. Delivery of reading glasses may improve digital financial access and facilitate broader financial inclusion, a hypothesis currently being tested in the parent THRIFT trial.

Trial registration number

NCT05510687.

Alarm fatigue among critical care unit and emergency room nurses: a multicentre cross-sectional study in Iran

Por: Abbaszadeh · S. M. · Poursaadat · N. · Sadeghian · A. · Karimi · N. · Zarei · R. · Dehghan Nayeri · N.
Objectives

To assess the level of alarm fatigue among intensive care unit (ICU), cardiac care unit (CCU) and emergency room (ER) nurses, identify associated demographic and occupational factors, determine the most frequent sources of alarms and evaluate nurses’ psychological reactions to alarms.

Design

A cross-sectional, descriptive–analytical study.

Setting

ICUs, CCUs and ERs of six public teaching hospitals affiliated with Tehran and Kashan Universities of Medical Sciences in Iran.

Participants

Using a multistage stratified random sampling method, 285 nurses were approached, of whom 260 completed and returned the questionnaires (response rate: 91%). Participants were registered nurses with at least a bachelor’s degree or higher and 3 months of experience in ICUs, CCUs or ERs.

Primary and secondary outcome measures

The primary outcome was the level of alarm fatigue measured using the validated Nurses’ Alarm Fatigue Questionnaire. Secondary outcomes included factors associated with alarm fatigue and nurses’ reported psychological responses to frequent alarms.

Results

The mean score of alarm fatigue was 26.4±7.9, indicating a moderate level. After adjusting for confounders and hospital-level clustering using multivariable mixed-effects regression, higher monthly income was significantly associated with lower alarm fatigue (β=–0.15, p=0.03), and nurses working rotational shifts reported significantly higher fatigue compared with those with fixed shifts (β=0.18, p=0.02). Other demographic and occupational factors were not significant. Reported psychological reactions to alarms included indifference (14%), irritability (18%) and anxiety/stress (15%).

Conclusions

ICU, CCU and ER nurses experience a moderate level of alarm fatigue, with income and shift type as independent associated factors. The association between income and alarm fatigue may reflect the role of financial stress as an additional job demand that compounds the burden of frequent alarms, particularly in contexts where low base salaries lead nurses to rely on overtime and multiple shifts. These findings underscore the need for targeted managerial and educational interventions, including shift schedule optimisation and attention to workload-related stressors, alongside alarm prioritisation strategies. Due to the cross-sectional design, causal inferences cannot be drawn.

Evaluating a novel recovery device in diabetic patients with knee osteoarthritis: protocol for a randomised controlled trial

Por: Matourypour · P. · Akbari · A. · Zakerimoghadam · M. · Arjmandi · R. · Dehghan · A. H. · Zarei · M. · Parvizi · A. · Parvizi · A.
Introduction

Knee osteoarthritis (KOA) is a prevalent degenerative joint disorder, often accompanied by comorbidities like type 2 diabetes mellitus (T2DM). These conditions have a significant impact on patients’ sleep quality and metabolic health. Current treatments for KOA primarily focus on symptom management, while innovative approaches targeting interconnected health outcomes remain underexplored. The lumbar knee recovery device, a non-invasive device patented in Iran, offers potential benefits by enhancing lumbar-knee synchronisation, improving blood circulation and optimising cellular metabolism. This randomised controlled trial (RCT) aims to evaluate the device’s effectiveness in improving sleep quality and regulating blood glucose levels in diabetic patients with KOA.

Methods and analysis

This RCT aims to evaluate the impact of using the lumbar knee recovery device (Kamarasa) on sleep quality, blood glucose levels, HbA1c (blood glucose control level over the past 90 days) and body mass index (BMI) in patients with T2DM and grade 1–3 KOA. The study will be conducted at the Orthopedic Clinic of Imam Khomeini Hospital, Tehran, and the Health and Wellness Clinic. Eligible participants will be randomly allocated into two groups: the intervention group (receiving 10 supervised sessions using the Recovery device over 3 months) and the control group (receiving standard KOA and diabetes care). A total of 37 participants will be included in each group. The primary outcome, sleep quality, will be assessed using the Pittsburgh Sleep Quality Index at baseline and 3 months post intervention. Secondary outcomes will include random blood glucose levels, which will be measured at 10 intervals during the study; BMI, measured at the start and end of the study and HbA1c, assessed at both baseline and post intervention. The Western Ontario and McMaster Universities Arthritis Index will be used to assess pain, stiffness and physical function, also at both baseline and 3 months. Appropriate statistical tests, including two-sample t-tests, ² tests, analysis of covariance or linear regression, will be performed based on the type of variables using SPSS V.23. Additionally, standardised intervention effect sizes will be calculated for each outcome.

Ethics and dissemination

Ethical approval for this study was obtained from the Research Ethics Committee of the School of Nursing and Midwifery at Tehran University of Medical Sciences with reference number (IR.TUMS.FNM.REC.1403.145). Additionally, the study protocol was registered with the IRCT under the identifier IRCT20191027045257N7 on 24 November 2024.

Trial registration number

Iranian Registry of Clinical Trials (IRCT20191027045257N7). This clinical trial was registered on 24 November 2024.

Logic model development through a feasibility RCT for a group-based weight management programme

Por: Sheaff · R. · Moghadam · S. · Hollands · L. · Hawkins · L. · Swancutt · D. · Lloyd · J. · Pinkney · J. · Tarrant · M.
Objectives

Clinical psychology interventions for reducing obesity have developed alongside pharmacological and surgical treatments, but usually as interventions for individual patients. Any healthcare intervention rests on a logic model: assumptions that through specific physical and social mechanisms, it will produce certain intended outcomes, provided that conducive background conditions (‘contexts’) exist. Using evidence from the feasibility trial preceding a full randomised controlled trial (RCT), this paper assesses the empirical validity of the initial logic model of a new group-based weight management intervention: PROGROUP, designed for patients with body mass index (BMI) ≥40 kg/m2 or ≥35 kg/m2 with comorbidities. We aimed to test whether:

  • PROGROUP’s programme components produce the intended outcomes at all, whatever their size and how.

  • The intervention can practicably be implemented (‘delivered’) as designed.

  • How the programme and delivery components affected each other.

  • Design

    Multimethod proof-of-concept study by means of realist evaluation of the initial PROGROUP logic model. We:

  • Elicited the logic model underlying the intervention design.

  • Compared these assumptions with data from a pre-RCT feasibility study in two English and one Welsh National Health Service (NHS) sites during 2021–2023.

  • Revised the logic model in light of the data, noting how much variation in delivery the programme components (therapeutic mechanisms) could tolerate.

  • Setting

    Specialised ambulatory mental health services in the English NHS.

    Participants

    Adults with severe obesity (BMI ≥40 kg/m2 or ≥35 kg/m2 with comorbidities).

    Intervention

    Group-building techniques to enhance group members’ adoption of evidence-based methods of behaviour change affecting their dietary behaviour and physical activity.

    Primary and secondary outcome measures

    Qualitative outcomes. What kinds of:

  • Mechanisms were established and triggered by the attempt to implement PROGROUP (secondary outcome, see objective 1 above).

  • Patient behaviours resulted and whether patients sustained them after the intervention ended (primary outcome; see objective 1 above); and what kinds of context affected that (objectives 2 and 3).

  • Quantitative measures not used.

    Results

    The initial logic model assumed that the following sequence of mechanisms would produce weight loss: referral from GP to specialist weight management services; further referral to PROGROUP; preparatory individual consultation; facilitated group sessions produce a group identity; group identity reinforces weight management capability and motivation; further individual consultations adjust for individual circumstances; behaviour change outside the treatment setting, producing weight loss. Contexts necessary for these mechanisms to work included: sufficient catchment population; group size, continuity and membership retention; suitable location; facilitator training; and practical support outside the treatment setting.

    Conclusions

    The findings suggested revisions to the logic model, but more in the delivery components and contextual assumptions than the core therapeutic mechanisms. There was scope to simplify the referral mechanisms. Different professions could implement the model. A realist evaluation of a pre-RCT feasibility study can be used to make the intervention’s logic model more securely evidence-based, serving as a proof-of-concept test for the intervention. It indicated the conditions under which such group psychological interventions might be more widely used.

    Trial registration number

    ISRCTN22088800.

    Evaluation of non-ophthalmologist-led and offline AI-assisted models for diabetic retinopathy screening in India: a pragmatic diagnostic accuracy study

    Por: Chauhan · A. · Vale · L. · Kankaria · A. · Tigari · B. · Kumar · S. · Yadav · M. · Kumar · L. · Kaur · G. · Bhadada · S. K. · Gupta · V. · Duggal · M.
    Objectives

    To assess and compare the diagnostic accuracy of non-ophthalmologist-led diabetic retinopathy screening (DRS) at health and wellness centres (HWCs) and offline artificial intelligence (AI)-assisted community-based screening, using specialist grading as the reference standard in India.

    Design, settings and participants

    Pragmatic diagnostic accuracy study in primary healthcare settings. The settings included HWCs and community-based screening sites in rural Block Boothgarh, Mohali District, Punjab, India. A total of 600 people with diabetes aged ≥30 years were enrolled across three screening models: (1) non-ophthalmologist-led DRS at the HWC, (2) AI-assisted smartphone-based DRS in the community and (3) standard referral-based care. Retinal images were captured using non-mydriatic fundus cameras and independently graded by two masked human graders; a senior retina specialist resolved any disagreements. The AI was assessed for its ability to detect diabetic retinopathy (DR) and referable diabetic retinopathy (RDR). Diagnostic performance metrics were reported.

    Results

    The non-ophthalmologist-led model demonstrated 86.4% sensitivity (95% CI 65.1% to 97.1%) and 94.3% specificity (95% CI 88.5% to 97.7%) for DR detection, with an ungradability rate of 8%. For RDR, sensitivity reached 95.8% (95% CI 78.9% to 99.9%) and specificity was 93.1% (95% CI 88.0% to 96.5%). The offline AI-assisted model achieved 93.3% sensitivity (95% CI 68.1% to 99.8%) and 85.1% specificity (95% CI 76.9% to 91.2%) for RDR, but with a higher ungradability rate (38%), mainly due to cataracts and poor image quality. Both approaches effectively identified referable cases; however, the non-ophthalmologist-led model demonstrated greater accuracy and operational feasibility.

    Conclusions

    This study demonstrates that non-ophthalmologist-led DRS at HWCs can enhance access to primary care. Offline AI-enabled screening demonstrates potential for community use but is currently limited by image quality and binary classification outputs. Integrating both approaches may strengthen DRS coverage in resource-limited settings.

    Clinical trials registry of India

    CTRI/2022/10/046283.

    Changes in the prevalence of adolescent tobacco use and its associated factors in Indonesia: analysis of repeated cross-sectional survey 2009-2019

    Por: Suryadarma · A. Y. · Saputro · S. A. · Isnuwardana · R. · Destiwi · M. · Bassey · P. E. · Martini · S. · Sebayang · S. K.
    Background

    Adolescent tobacco use (ATU) is a global public health concern, causing significant morbidity and premature death. This study aimed to assess trends in the prevalence of ATU in Indonesia between 2009 and 2019 and to identify factors contributing to the observed changes.

    Methods

    This study performed secondary data analysis of three consecutive waves (2009, 2014, and 2019) of the Indonesian Global Youth Tobacco Survey (IGYTS). Weighted prevalence estimates and complex survey data analysed using multivariate logistic regression were established across the three-wave surveys. A pooled IGYTS data set was explored to determine the risk factors of the ATU. A multivariate decomposition analysis (MDA) was used to determine factors contributing to the prevalence change in male adolescents over the last two surveys.

    Results

    The prevalence of ATUs was 21.1% (38.2% in males; 6.4% in females), 18.6% (32.7% in males; 3.9% in females) and 19.8% (36.8% in males; 3.5% in females) for the three consecutive surveys, respectively. Being older adolescents, male, exposed to SHS (secondhand smoke) at home, tobacco industry promotion, not knowledgeable of the dangers of tobacco smoke and SHS, and against banning smoking in public places were associated with ATU consistently across the surveys. In addition, inadequate anti-cigarette media and not being knowledgeable of the difficulty of quitting smoking were also identified as risk factors in the pooled data. MDA showed that 88.94% of the explained change was due to differences in the composition of explanatory variables between the last two surveys.

    Conclusions

    This study suggests that social influence and tobacco industry promotion significantly impact ATU in Indonesia. Governments should emphasise these factors in their tobacco control interventions.

    Protocol for an open-label, randomised, controlled trial to evaluate the efficacy and safety of sotatercept add-on therapy compared with pulmonary vasodilator-based standard of care for pulmonary vasodilator-resistant pulmonary arterial hypertension assoc

    Por: Yoshida · K. · Hosokawa · K. · Hiraide · T. · Akagi · S. · Ejiri · K. · Taniguchi · Y. · Adachi · S. · Inami · T. · Nakanishi · N. · Kataoka · M. · Satoh · T. · Tatebe · S. · Shinke · T. · Tomita · H. · Akazawa · Y. · Higaki · T. · Tagawa · K. · Ishikita · A. · Asakawa · S. · Abe · K.
    Introduction

    Eisenmenger syndrome and pulmonary arterial hypertension (PAH) due to unrepaired congenital shunts, including atrial septal defect (ASD), ventricular septal defect (VSD) and patent ductus arteriosus (PDA), remain life-threatening conditions despite advances in congenital heart disease (CHD) care. In this population, vasodilator-based therapies effective in other forms of PAH have shown limited benefit, and no disease-modifying treatment has been established. Sotatercept, an activin-signalling inhibitor, improved exercise capacity and haemodynamics in phase 2/3 PAH trials; however, patients with unrepaired CHD, including Eisenmenger syndrome, were excluded. The efficacy and safety of sotatercept in this population remain unknown.

    Methods and analysis

    The SuMILE trial is a prospective, exploratory, multicentre, open-label, randomised, controlled trial conducted at 11 Japanese tertiary centres. 36 adults with vasodilator-resistant PAH due to unrepaired ASD, VSD or PDA, including Eisenmenger syndrome, will be randomised 2:1 to sotatercept add-on therapy plus vasodilator-based PAH therapy versus vasodilator-based PAH therapy alone. Sotatercept will be administered subcutaneously every 3 weeks in accordance with label-approved dose-modification rules for haemoglobin and platelet changes. The primary endpoint is the change in 6-min walk distance from baseline to week 24. Key clinical events will be independently adjudicated. Secondary endpoints include all-cause mortality or lung transplantation; pulmonary hypertension-related hospitalisation or initiation of parenteral prostacyclin and changes in WHO functional class, N-terminal pro-brain natriuretic peptide and emPHasis-10. Exploratory endpoints include genotype, right heart catheterisation and cardiac MRI parameters. The primary analysis will use ANCOVA, adjusting for baseline 6-min walk distance and randomisation stratum in the intention-to-treat population.

    Ethics and dissemination

    The protocol has been reviewed and approved by the certified central review board (Kyushu University Hospital Clinical Ethics Review Board) and participating institutions. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, scientific conferences and trial registries.

    Trial registration number

    Japan Registry of Clinical Trials no. 1071250069; ClinicalTrials.gov NCT07356778. Protocol version and date: V.1.3; 23 October 2025

    Promoting CHANGE cluster randomised controlled trial to improve food outlet healthiness in Australian sport and recreation facilities: protocol

    Por: Lalchandani · N. · Romaniuk · H. · Cameron · A. · Orellana · L. · Ananthapavan · J. · Peeters · A. · Backman · B. · Adam · M. · Allender · S. · Nguyen · P. · Sacks · G. · Brimblecombe · J. K. · McMahon · E. · Blake · M.
    Introduction

    Food retail outlets in sports and recreation facilities often fail to support healthy eating, despite aligning with healthy lifestyles and goals of local governments (LGs) that often own or manage them. LGs face barriers to implementing facility changes including inadequate staffing, training and incentives. The Promoting CHANGE initiative was co-designed to support LGs in improving and sustaining healthier food and drink offerings in these settings.

    Methods and analysis

    A 3-year, type 2 effectiveness-implementation hybrid cluster randomised controlled trial will evaluate the Promoting CHANGE capacity-building and support package in three Intervention and four Control LGs in Victoria, Australia (August 2023–July 2026). The co-designed initiative includes human resource support, training, tools, technical assistance, community-of-practice groups, feedback based on food outlet audit and sales data and small grant incentives. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) evaluation framework, the trial’s co-primary outcomes are the percentage of least healthiest food and drinks (1) displayed (implementation) and (2) sold weekly (effectiveness). Key secondary outcomes are effectiveness (sales and revenue); facility-level adoption, implementation, maintenance of healthy changes; cost-effectiveness (within-trial modelled economic evaluation). Findings will provide evidence of the initiative’s effectiveness and scalability, informing recommendations for advancing healthier food environments in over 6000 community-based food outlets across 500 Australian LGs, with implications globally.

    Ethics and dissemination

    This study has received approval from the Deakin University Human Research Ethics Committee (reference number HEAG-H 92_2023). The results will be published in scientific peer-reviewed journals along with plain language summaries for participants.

    Trial registration number

    ACTRN12621001120864.

    'We just give the phone so they stay quiet: a qualitative exploration of screen time practices among caregivers of children younger than 5 years in south India

    Por: Varadarajan · S. · Govindarajan Venguidesvarane · A. · Rajamohan · M. · Krupa · M. · Ramaswamy · K. N.
    Objective

    To explore the perceptions, challenges and strategies of caregivers in managing screen time among children younger than 5 years in the urban and rural areas of Tamil Nadu, India.

    Design

    Qualitative study using focus group discussions (FGDs).

    Setting

    Rural Health and Training Centre in Vayalanallur, Thiruvallur district and Urban Health and Training Centre, Thiruvanmyur in Chennai district, Tamil Nadu, India.

    Participants

    54 caregivers (27 rural, 27 urban, 46 mothers, 6 grandmothers, 2 fathers) of children younger than 5 years whose screen time exceeded WHO age-specific recommendations participated. Six FGDs were conducted, each with 8–10 participants.

    Methods

    FGDs were conducted in familiar community locations near the participants’ homes to ensure comfort and accessibility. The audio recordings were transcribed verbatim in Tamil and translated into English and analysed using inductive thematic analysis. Coding was manually performed by two independent researchers.

    Results

    Six major themes emerged: (1) circumstances leading to screen exposure, (2) perceived advantages, (3) perceived disadvantages, (4) challenges in reducing screen time, (5) methods adopted to reduce screen time and (6) strategies for sustaining reduction. Safety concerns, lack of play space and the need to manage household chores were commonly cited reasons for screen use. Although most caregivers were aware of the potential harms, screens were often used to feed or pacify children. Emotional resistance from children, inconsistent family norms and grandparents’ screen use were common barriers. Caregivers employed strategies, such as limiting access, engaging in outdoor play and enrolling children in structured activities. Urban–rural differences were minimal, and thematic saturation was achieved after six FGDs.

    Conclusions

    Caregivers face multiple, structural and family level challenges in managing screen time among young children. Awareness and interventions need to be tailored to address family dynamics, caregiver fatigue and lack of alternatives. Health providers, community workers and policymakers should collaborate to offer structured support, promote screen-free engagement and ensure child-friendly spaces in urban and rural communities.

    Petit volunteer protocol for loneliness alleviation in community-dwelling older adults in Japan: a randomised controlled trial

    Por: Tomida · K. · Shimoda · T. · Nakajima · C. · Kawakami · A. · Shimada · H.
    Introduction

    Older adult loneliness is associated with depression, disability and higher mortality rates. As a public health concern, it contributes to increased medical and nursing care costs. Several intervention studies have been conducted to reduce loneliness; however, no universally effective method has been established. We hypothesise that if older adults use their physical abilities to perform petit volunteering, their feelings of loneliness would likely be reduced. This trial aims to investigate the benefits of using petit volunteers for loneliness alleviation (PetitVOLA) application as a sustainable programme to prevent loneliness through the creation of an Ikigai-based volunteer system.

    Methods and analysis

    We intend to conduct a randomised controlled trial with a 3-month intervention period to verify the effectiveness of the PetitVOLA programme (sample size, 126 participants; power, 0.8; significance level, 0.05). The primary outcome is loneliness, which we will measure using the UCLA Loneliness Scale (V.3). Secondary outcomes include social isolation (assessed via multicomponent objective criteria), life satisfaction, physical function (gait speed and grip strength), cognitive function, psychological status and lifestyle, each assessed with validated instruments (eg, Mini-Mental State Examination, Geriatric Depression Scale-15 and the Active Mobility Index). The main analysis uses an intention-to-treat approach, while a full analysis set and a per-protocol set are included for sub-analyses.

    Ethics and dissemination

    The trial was approved by the Human Research Ethics Committee of the National Center for Geriatrics and Gerontology, Japan (approval No. 1794). The results of this trial will be disseminated through peer-reviewed journals, conference presentations and reports to the participating community.

    Trial registration number

    UMIN000056649.

    Developing consensus definitions and methods for non-visually impairing eye conditions for population-based eye surveys in Nigeria: a Delphi study

    Por: Aghaji · A. · Okoye · O. · Nwachukwu · N. Z. · Ezegwui · I. · Okoye · O. · Umeh · R. · Gilbert · C. E. · The Nigeria National Non-Visually Impairing Conditions Study Group · Ada · Onochie · Nkiru · Ifeoma · Obiekwe · Rich · Clare · Lawan · Emem · Ebere · Dupe · Korede · Feyi · Kayo
    Objective

    To establish consensus definitions for non-visually impairing eye conditions (NVICs) and their methods of assessments to provide standards for use in population-based eye surveys.

    Design

    A literature review of NVICs in sub-Saharan Africa, a questionnaire of inquiry based on the literature review developed by an expert panel and a modified Delphi exercise with three iterative rounds with eye health experts.

    Setting

    Eye health academia and community eye health in Nigeria.

    Participants

    Nigerian ophthalmologists, including subspecialists experienced in population-based eye health surveys.

    Main outcome measures

    Definitions and statements where at least 70% of the respondents agreed or strongly agreed.

    Results

    Forty-two ophthalmologists practising in Nigeria with experience in conducting population-based eye health surveys were invited to take part in the Delphi exercise. There were three rounds with response rates of 39/42 (92.9%) in round 1, (94.9%) in round 2 and 100% in round 3. Consensus for NVICs to be included in population-based eye surveys, their definitions and methods for assessment was reached by the third round.

    Conclusions

    We propose case definitions for NVICs to be assessed in population-based eye surveys through a modified Delphi approach with an expert panel of ophthalmologists from across Nigeria. These case definitions will allow for standardisation of NVICs in population-based eye surveys to assess the prevalence and magnitude of the different types of NVICs for planning purposes. Further studies are needed to validate these case definitions and inform their evolution.

    Spatial distribution and multilevel analysis of factors associated with healthcare access barriers among women of reproductive age in Somalia: insights from the 2020 Somalia Demographic and Health Survey

    Por: Aw-Ali · Y. D. · Abdikarim · H. · Abdilleh · M. M. · Hassan Muse · A. · Nadarajah · S.
    Objective

    This study aimed to address the spatial distribution and multilevel analysis of healthcare access barriers among women of reproductive age in Somalia.

    Study setting, design and analysis

    The study was conducted across Somalia, an East African country facing significant spatial disparities in healthcare access. A cross-sectional study design was employed, using data from the 2020 Somali Demographic and Health Survey (SDHS). The data were analysed using both multilevel logistic regression and spatial analysis. To pinpoint barriers and identify statistically significant spatial clusters, the data were analysed using multilevel logistic regression in Stata V.17 and spatial analysis in R Studio (V.4.4.1), respectively.

    Participants

    The study population consisted of a weighted sample of 5118 women of reproductive age (15–49 years) from the SDHS.

    Results

    Spatial analysis revealed significant regional heterogeneity, with high-prevalence areas concentrated in the northern region of Togdheer and a south-central cluster encompassing Galguduud, Hiiraan and Bakool. Multilevel analysis presented that women in the Bay region had nearly 10 times (AOR: 9.62) the risk of facing healthcare access barriers. While women in the highest quintile of wealth (AOR 0.21), those in higher education (AOR 0.30), those aged 45–49 (AOR 0.49) and not currently working (AOR 0.46) were significantly less likely to report access barriers.

    Conclusion and recommendations

    Healthcare access barriers in Somalia are driven by a complex interplay of socioeconomic factors, specifically maternal age, education, employment and household wealth, and profound geographical disparities. Access barriers are not uniform but are geographically clustered in the south-central regions (Bay, Bakool, Hiiraan) and Togdheer in the northern region. Policy efforts must prioritise infrastructure investment in these identified high-burden hotspots while simultaneously dismantling systemic inequalities through the expansion of female education and financial protection schemes. This data-driven approach offers a definitive roadmap for decision-makers to equitably allocate resources and ensure that the most vulnerable populations are not left behind.

    Targeting Vascular Inflammation In Patients with Community-Acquired Pneumonia (TIN-CAP): protocol for a multicentre, randomised, double-blind, placebo-controlled trial

    Por: Stotts · C. · Corrales-Medina · V. F. · deKemp · R. A. · Wells · G. A. · Beanlands · R. · Raggi · P. · Ferrara · G. · Sligl · W. · A Connelly · K. · Paul · N. · Brouwers · M. · Contreras-Dominguez · V. · Yadav · K. · Torres · C. · Tavoosi · A. · Wiefels · C. · Kirpalani · A. · Romsa · J.
    Introduction

    Inflammation plays a central role in atherosclerosis development and subsequent cardiovascular complications, including heart attack and stroke. Patients with inflammatory conditions such as community-acquired pneumonia (CAP) present with an elevated risk of cardiovascular events, which is likely driven by unresolved systemic inflammation. Targeting this heightened inflammatory burden may present a novel therapeutic strategy to attenuate heart attack risk in CAP survivors. Icosapent ethyl (IPE), an omega-3 fatty acid, demonstrates both pro-resolving and cardioprotective properties. The Targeting Vascular Inflammation In Patients with CAP (TIN-CAP) trial aims to evaluate the efficacy of IPE in mitigating vascular inflammation in CAP survivors.

    Methods and analysis

    TIN-CAP is a multicentre, randomised, double-blind, placebo-controlled trial. Eligible adults diagnosed with CAP in hospital or the emergency department will complete baseline assessments within 14 days of diagnosis including 18F-fluorodeoxyglucose (FDG) positron emission tomography/CT angiography, bloodwork and quality of life evaluation (EuroQol – 5 Dimensions (EQ-5D)). Participants will then be randomised 1:1 to receive IPE (4 g/day) or placebo for 6 months. Follow-up visits will occur at 30 days (bloodwork and EQ-5D only) and 6 months. The primary endpoint is the change in FDG uptake in the ascending aorta from baseline to 6 months between IPE and placebo groups. Secondary endpoints include FDG uptake in the bone marrow, spleen, lungs and other vasculature, in addition to major adverse cardiac events and quality of life assessments. An initial lead-in cohort of 18 patients will be enrolled to assess recruitment, imaging feasibility and IPE tolerability prior to full trial enrolment. These patients will remain blinded and will be included in the final analysis (Vanguard design).

    Ethics and dissemination

    The TIN-CAP trial has been approved provincially by the Clinical Trials Ontario Research Ethics Board (approval number: 5045). Participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations.

    Trial registration number

    NCT06710080.

    Hepatitis B virus infection and its determinants among pregnant women in Ethiopia: protocol for umbrella review of systematic review and meta-analysis 2025

    Por: Bekele · M. · Oche · W. O. · Geltore · T. E. · Sileshi · E. · Hadaro · T. S. · Alano · B. A. · Abera · W.
    Introduction

    Among the five hepatitis viruses, the hepatitis B virus (HBV) is a major cause of serious acute and chronic liver infections worldwide. The major public health impact of HBV infection arises from chronic liver disease, including cirrhosis and hepatocellular carcinoma, which predominantly affects young and middle-aged adults of both sexes. Therefore, preventive interventions focusing on mothers and infants are critical due to vertical and early childhood transmission dynamics.

    HBV prevalence largely varies among pregnant women in Ethiopia because of multiple interrelated factors. This umbrella review will consolidate all existing systematic reviews and create a more reliable picture of HBV infection and its determinants among pregnant women in Ethiopia.

    Methods and analysis

    This umbrella review will be conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses reporting standards. The review will focus on identifying and integrating evidence from eligible systematic reviews and meta-analyses, with methodological quality appraised using the MeaSurement Tool to Assess systematic Reviews instrument. A comprehensive literature search strategy will be developed using relevant Medical Subject Headings alongside free-text keywords. Electronic searches will be conducted in PubMed/MEDLINE, African Journals Online, Web of Science, Scopus and Google Scholar. Statistical heterogeneity among the included reviews will be quantified using the I² statistic. Data management and meta-analytic procedures will be performed using STATA version 17, and effect estimates will be presented with corresponding 95% CIs to determine statistical precision.

    Ethics and dissemination

    This review uses only published or publicly available data, so ethics approval is not required. Findings will be disseminated via peer-reviewed publications, conference presentations and shared with policymakers, healthcare partners, clinicians and patients to inform policy, enhance education and guide future research.

    PROSPERO registration number

    PROSPERO (CRD420251118982).

    ReFIT study (reversing frailty in transplantation): protocol for a longitudinal study to assess clinical and biomedical changes in frailty through kidney transplantation

    Por: Payne · T. · Shaw · A. · Hanjani · L. S. · Homes · R. · Giddens · F. · Ravuri · H. G. · Yap · C. X. · Walsh · J. · Kumar · V. · Garton · F. C. · Rhee · H. · Huang · A. · Francis · R. S. · Reid · N. · McAdams-DeMarco · M. · Gordon · E. · Midwinter · M. · Hubbard · R.
    Introduction

    Losses of functional reserve across multiple physiological systems have been identified in frail patients, yet the exact aetiology of frailty remains unclear. Although strongly associated with chronological age, frailty often develops at a younger age in patients with organ failure. Frailty is prevalent in patients with kidney failure; however, individuals experience improvements in physical frailty measures following kidney transplantation. This makes younger patients with kidney failure a unique population for studying both the accelerated onset of frailty and its reversal. This research project aims to test the hypothesis that frailty secondary to organ failure and age-related frailty are associated with similar molecular and physiological measures.

    Methods and analysis

    This longitudinal study will recruit 150 patients in three groups. Group A (kidney transplant recipients aged ≥40 years; n=50) and Group B (patients aged ≥40 years active on the kidney transplant waitlist; n=50) will comprise younger adults with frailty from organ failure. Group C (adults aged ≥65 years (or ≥55 years for Aboriginal and Torres Strait Islander patients); n=50) will comprise older community dwellers. The primary outcome is the Frailty Index (FI). Secondary outcomes include the change in FI over time, and at baseline when considering various clinical metadata, immune parameters, kidney function and nutrition intake which will be measured at baseline and 12-month time points. Longitudinal changes in frailty will be analysed using linear mixed models with multiple testing corrections for false discovery rates.

    Endocrine profiles and metabolomics, measures of immune function and microcirculatory dysfunction, will be measured by liquid chromatography-mass spectrometry and/or gas chromatography-mass spectrometry. The gut microbiome will be sequenced via shotgun metagenomics (Illumina NextSeq500, 150 bp paired-end, 3Gbp/sample). Circulating cell-free DNA/mitochondrial DNA will be quantified through droplet digital PCR. Microcirculation will be assessed via sublingual dark field videomicroscopy with glycocalyx markers measured by ELISA.

    Ethics and dissemination

    This study will be conducted with all stipulations of this protocol, and the conditions of the ethics committee approval. Ethical principles have their origin in the Declaration of Helsinki, all Australian and local regulations and in the spirit of the standard of Good Clinical Practice (as defined by the International Conference on Harmonisation). Organs/tissues will be sourced ethically and will not be sourced from executed prisoners or prisoners of conscience or other vulnerable groups.

    Ethics approval was received by the Metro South Health Research Ethics Committee (HREC/2023/QMS/95392) and ratified by the University of Queensland.

    Results will be disseminated through peer-reviewed publications, academic conferences, participant newsletters and health organisation collaboration.

    Disparities in adverse event perception between patients and healthcare providers in gynaecologic anticancer therapy: results from an observational web-based study in Japan

    Por: Hashimoto · H. · Soejima · A. · Nishimura · Y. · Ike · A. · Sugawara · M. · Shimada · M. · Abe · M.
    Objective

    To explore patients’ perceptions of managing adverse events (AEs) from anticancer drugs for gynaecological cancer, focusing on AEs they want to avoid, views on dose adjustments and communication with healthcare professionals.

    Design

    Observational study using a web-based questionnaire.

    Participants

    Women in Japan who had received chemotherapy for endometrial or ovarian/fallopian tube cancer were enrolled. Healthcare professionals, including obstetrics and gynaecology physicians, nurses and pharmacists, who administered chemotherapy to these patients, were also enrolled.

    Outcome measures

    AEs that patients wished to avoid or found distressing; varied perceptions of AEs before and after treatment; discrepancies in the communication of AEs between patients and healthcare professionals; administration time and intervals between hospital visits patients found distressing; patient awareness of dose adjustment (reduction, interruption or discontinuation) to suppress AEs.

    Results

    Participants comprised 153 physicians, 166 nurses, 154 pharmacists and 154 patients. Nausea/vomiting (28.6%), alopecia (18.2%) and peripheral neuropathy (9.1%) were the most distressing AEs overall. Physicians rated nausea/vomiting lower (15.4%) and alopecia higher (38.2%) than patients, while pharmacists emphasised peripheral neuropathy (25.7%). Many patients found AEs, including peripheral neuropathy (53/99), fatigue (52/105) and alopecia (46/120), to be more severe than expected. Communication patterns revealed that 49.4% of patients reported all symptoms, even uncertain ones, but younger patients tended to communicate fewer symptoms. Physicians (54.2%), nurses (92.2%) and pharmacists (85.7%) preferred full disclosure of symptoms. While 28.6% of patients wished to avoid dose reductions because of fears of disease progression, 18.2% preferred dose reduction or discontinuation when AEs became intolerable. Drug administration times and visit intervals influenced patient distress. Treatment administration of over 3 hours (19.5%) and visits occurring more frequently than once every 3 weeks (27.3%) were the most distressing.

    Conclusions

    This study highlights discrepancies in AE perceptions and communication between patients and healthcare professionals, emphasising the need for tailored communication strategies and shared decision-making to improve cancer treatment experiences and outcomes.

    Trial registration number

    jRCT1040220088, Japan Registry of Clinical Trials (jRCT).

    Identifying innovative models of urgent care in rural coastal areas in England: the Elevate study - a mixed-methods protocol

    Por: Lampard · P. · Adamson · J. · Anderson · H. · Ballantine · L. · Bell · F. · Benger · J. R. · Blakey · R. L. · Dickinson · P. · Dykes · S. · Gaughan · J. · Maitland-Knibb · S. · Mensah · D. · Ransome · Z. A. · Richardson · G. · Santos · R. · Sheridan · R. · Sivey · P. · Smith · E. · Song · W
    Introduction

    Urgent and emergency care (UEC) systems in England face unprecedented pressures, with record accident and emergency attendances, persistent breaches of ambulance response targets and poorer outcomes for time-sensitive conditions. National UEC recovery plans have introduced multiple innovations—such as same-day emergency care, virtual wards and specialty hubs—to manage these pressures and improve patient flow. Rural coastal areas are particularly vulnerable to excessive demand due to higher levels of deprivation, older populations with complex health needs, seasonal surges that generate unpredictable demand and challenges in attracting and retaining staff. Following the Chief Medical Officer’s 2021 Annual Report, funding research and developing bespoke solutions to manage UEC demand and address geographical disparities has been recognised as a national priority. The Elevate study responds to this priority by identifying and evaluating innovative models of UEC in rural coastal communities in England.

    Methods and analysis

    The Elevate study is a 30-month, mixed-methods evaluation that comprises three interlinked work packages: (1) National service mapping—outlining provision of innovative models of UEC in rural coastal areas of England. This will be developed through document review and interviews with regional and national service leaders. (2) Quantitative analysis—quasiexperimental and longitudinal approaches will use National Health Service (NHS) England’s Emergency Care Data Set and linked routine NHS datasets to evaluate the impact of UEC models on health and process outcomes. Standard and bespoke metrics will be developed and used to assess performance. (3) Qualitative case studies—up to 12 case studies of UEC models in rural coastal communities. Interviews with patients and staff and non-participant observation will explore how and why different UEC models influence patient experience, clinical outcomes, resource use and the workforce. Findings will be integrated using the Consolidated Framework for Implementation Research to identify components of UEC models that are effective, scalable and sensitive to local context,

    Ethics and dissemination

    Ethical approval for qualitative components was granted by the North of Scotland Research Ethics Committee (25/NS/0099). Dissemination will include peer-reviewed publications, policy briefs, creative media and community engagement activities to ensure findings are communicated inclusively and effectively to policymakers, health and social care practitioners and the public.

    Trial registration number

    Research Registry (researchregistry11126).

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