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Prospective accuracy study on an artificial intelligence-based ultrasound system for gestational age estimation among pregnant women in Ghana, Kenya and South Africa: protocol

Por: Swarray Deen · A. · McDougall · A. R. A. · Chemway · R. · Craik · R. · Jayaratnam · S. · Joseph · N. · Mahar · R. · Koye · D. · Nguyen · L. · Simpson · J. · Gwako · G. · Hadebe · R. L. · Nartey · E. T. · Minckas · N. · Gülmezoglu · A. M. · Vogel · J. P. · Osman · A. · PEARLS Collaborat
Background

Risk screening for pre-eclampsia relies on accurate gestational age assessment, but routine access to ultrasound-based gestational dating remains challenging in many low- and middle-income countries. As part of the formative work for the ‘Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening’ (PEARLS) platform, we aim to validate and implement an artificial intelligence (AI)-based algorithm for estimation of gestational age, using blind sweeps done with a handheld ultrasound device. This study protocol outlines the accuracy cohort for AI-based gestational age estimation in participating facilities in Ghana, Kenya and South Africa.

Methods and analysis

This multicountry prospective cohort study will recruit 969 pregnant women at 13 health facilities across Kenya, Ghana and South Africa. The eligible population is pregnant women presenting for antenatal visits from 11+0 to 13+6 weeks’ gestation. Eligible women will have a gestational age assessment by a trained sonographer using fetal biometry (reference standard), followed by gestational age estimation conducted by a trained midwife using the AI-based Intelligent Ultrasound ScanNav FetalCheck system (experimental). Both conventional and AI-based gestational age scans will be conducted with the General Electric VScan Air platform. Women will return for a second visit between 14+0 and 27+6 weeks’ gestation (week of visit is randomly selected) for an assessment with both conventional and AI-based ultrasound. The primary objective is to determine the accuracy and precision of gestational age estimation using an AI ultrasound system in first and second trimesters, as compared with gestational age estimation using crown-rump length measurement by conventional ultrasound in first trimester (11+0 to 13+6 weeks’).

Ethics and dissemination

This study has received or sought ethics approval from the following entities: Australia: University of Melbourne, Office of Research Ethics and Integrity (Reference Number: 2024–28489-49438-3) and the Alfred Hospital Ethics Committee (Reference: Project 727/23); Ghana: Ghana Health Service Ethics Review Committee (GHS-ERC Number 002/01/24); Kenya: Kenyatta National Hospital, University of Nairobi ERC (Ref: KNH-ERC/01/MISC/20); South Africa: University of Cape Town, Faculty of Health Science, Human Research Ethics Committee (HREC Ref: 138/2024). Key findings will be disseminated to research teams to inform future scale-up of AI-based pregnancy dating and pre-eclampsia risk screening. Findings from this pilot work will be published in peer-reviewed open-access journals, conferences and meetings to maximise reach of our findings.

Intermittent fasting and chronic pain: Protocol for a systematic review of randomised controlled trials

Por: Bruton · A. M. · Staab · C. · Gray · O. · Chua · W. R. · Alsakhita · N. · Goldenberg · J. · Roberts · J. L.
Introduction

Chronic pain is a leading public health problem, impacting over 1.5 billion people worldwide. Standard-of-care includes pharmaceutical medication, surgery and physical therapy, yet many patients experience continued symptoms. Investigation into lifestyle-based approaches such as dietary interventions has increased in recent years, including intermittent fasting, due to known impacts on inflammation and neurotransmitters.

Methods and analysis

This systematic review and meta-analysis will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The literature search will include the PubMed/MEDLINE, Embase (Ovid), Web of Science (Core Collection) and LILACS (VHL) databases. The Google Scholar, ClinicalTrials.gov, PROSPERO, Open Science Forum and MedRXiv platforms will also be searched. Randomised, controlled trials investigating the impact of intermittent fasting interventions in adult humans with any chronic pain condition will be included. The primary outcomes will be self-reported pain or function and the secondary outcome will be rescue medication use. Study screening, data extraction and risk of bias assessment will be conducted independently in duplicate. The Cochrane Risk of Bias-2 tool will be used to assess bias at the study level, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines will be used to assess bias at the outcome level. The meta-analysis will use random effects, with heterogeneity assessed using the I2 statistic. For studies that report rescue medication use, we will analyse the impact of intermittent fasting on pain or function, adjusting for rescue medication use, using established methods. Subgroup and sensitivity analyses will be conducted to explore heterogeneity.

Ethics and dissemination

As this project involves analysis of publicly available data, no ethical oversight was or is required. The results of this review will be disseminated by publication in a peer-reviewed journal.

PROSPERO registration number

CRD #420261395061.

Antibacterial consumption in four paediatric inpatient facilities in Sri Lanka in 2023: a cross-sectional descriptive study

Objective

To describe antibacterial consumption (ABC) in four paediatric inpatient facilities in Sri Lanka in 2023.

Design

Descriptive cross-sectional study, adapted from the WHO Global Antimicrobial Resistance and Use Surveillance System methodology.

Settings

Paediatric inpatient facilities in two tertiary and two secondary care government hospitals located across three provinces.

Data

Data on antibacterials for systemic use, J01 in the Anatomical Therapeutic Chemical (ATC) classification issued to these paediatric inpatient facilities in 2023 by their respective hospital pharmacies.

Outcome measures

(1) ABC at ATC third and fifth levels expressed as defined daily doses (DDDs)/100 admissions, (2) ABC as per WHO ‘Access, Watch and Reserve’ category, (3) choice of antibacterials within a class, (4) DU 75% for oral and parenteral dosage forms, (5) quality indicators such as amoxicillin index and broad:narrow spectrum ratio.

Results

In 2023, total antibacterial (J01) consumption across the four paediatric inpatient facilities was 94.49 DDDs/100 admissions. Together, non-penicillin beta-lactams, penicillins and macrolides/lincosamides/streptogramins accounted for 90–98%. Co-amoxiclav was the most consumed antibacterial, and six agents (co-amoxiclav, cefotaxime, clarithromycin, azithromycin, cefuroxime and meropenem) collectively accounted for 70–90%. Aminoglycosides, tetracyclines, sulfonamides and trimethoprim, and quinolones contributed minimally. Access and Watch group antibacterials accounted for 34 and 65%. Quality indicators demonstrated disproportionately higher use of broad-spectrum and Watch group antibacterials.

Conclusion

High use of broad-spectrum and Watch-group antibacterials was observed across the four paediatric inpatient facilities. The findings highlight targets for antibacterial stewardship programmes and demonstrate the feasibility of ABC surveillance in Sri Lanka.

Continuous glucose monitoring in older inpatients with type 2 diabetes and cognitive impairment: an open single-arm feasibility study

Por: Donat Ergin · B. · Mattishent · K. · Minihane · A. M. · Holt · R. I. G. · Murphy · H. · Dhatariya · K. · Hornberger · M.
Background

Type 2 diabetes (T2DM) and cognitive impairment are common long-term chronic conditions affecting older people in hospital. Cognitive impairment can complicate glucose monitoring and lead to diabetes-related emergencies in T2DM. Traditionally, point of care test measurements of capillary blood glucose are conducted in-hospital for T2DM while continuous glucose monitoring (CGM) is not widely used.

Aim

To understand the feasibility, acceptability and tolerability of using CGM in older inpatients with T2DM and cognitive impairment.

Methods

32 older people (mean age=78.7±6.7 years) with comorbid T2DM and cognitive impairment (Abbreviated Mini-Mental Test ≤8/10 and Mini-Addenbrooke’s Cognitive Examination ≤22/30) were recruited within a tertiary care hospital in the UK. All participants were naive to CGM and were asked to wear blinded Dexcom G7 sensors for up to 10 days. Participants were asked about feasibility, acceptability and tolerability questions at the point of sensor removal.

Results

29 participants (96%) reported no pain during CGM fitting. All participants (100%) agreed that they did not notice wearing the sensor, and it did not affect their day-to-day hospital activities. All participants (100%) found it ‘very easy’ or ‘easy’ to have the sensor fitted and wearing it for 10 days, with 27 participants (90%) finding CGM convenient. 17 participants (57%) reported favourable perceptions of the subcutaneous sensor sensation.

Conclusion

CGM use in older inpatients with T2DM and cognitive impairment is highly feasible and acceptable for patients. Future studies and trials are now needed to evaluate the clinical use of CGM for glucose monitoring in hospitalised or community-dwelling older individuals with T2DM and cognitive impairment.

Health system interventions to floods and heatwaves for maternal and child health services: a realist-informed systematic review protocol

Por: Debele · S. E. · Bozzani · F. M. · Mushinda-Musonda · G. · Kovats · S. · Bonnet · G. · Chama-Chiliba · C. M. · Foss · A. M. · da Silva · E. N. · Borghi · J.
Introduction

Floods and heatwaves are becoming more frequent and intense and can disrupt routine maternal and child health (MCH) services. Previous reviews have not systematically examined how context and mechanisms may shape adaptation outcomes. This realist-informed systematic review examines how, why and under what conditions interventions support access to, utilisation of and continuity of routine MCH services during flood and heat events.

Methods and analysis

The search strategy was developed by integrating terms from 17 related reviews, refined with the author team and checked by an experienced London School of Hygiene & Tropical Medicine librarian. The initial database search was conducted on 16 May 2025 and the search was updated on 30 April 2026. Eight databases were searched: Web of Science, Ovid MEDLINE, EMBASE, Global Health, EconLit, GreenFILE, CINAHL and ProQuest Environmental Science & Public Policy. Records published between January 2000 and April 2026 were eligible. Search results were imported into EndNote and deduplicated. Title-and-abstract screening and full-text assessment were conducted independently by two reviewers for the initial search and are ongoing for the updated search, with ASReview being used to prioritise records during title-and-abstract screening. Data extraction across the full review evidence base remains ongoing using a structured template covering study context, intervention characteristics, mechanisms, outcomes, costs and implementation conditions. Study settings will be classified by country income group, health system context and Köppen–Geiger climate zone to compare evidence across settings and, where appropriate, to identify possible climate analogues for exploratory, context-specific assessment. Climate-zone similarity will not be used to infer intervention transferability or future effectiveness. The synthesis will be guided by the WHO Climate-Resilient Health Systems framework, Meadows’ leverage-points framework and realist-informed C–M–O reasoning. Interventions will be grouped to identify where they operate within the health system and which health system components and vulnerabilities they address. Findings will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance.

Ethics and dissemination

Ethical approval is not required because the review uses published literature and does not involve human participants. The findings will be disseminated through a peer-reviewed systematic review publication. They will inform the design, improvement and scaling of interventions intended to maintain routine MCH services and strengthen health system resilience to floods and heatwaves across diverse settings.

Registration details

The review was not prospectively registered with PROSPERO.

Health-related quality of life in patients with cancer in Lubumbashi/Democratic Republic of the Congo: a semi-structured qualitative and quantitative prospective cross-sectional study

Por: Pilz · M. J. · Giesinger · J. M. · Mutoke · S. · Kavira · G. · Kaseba · A. N. · Epule · N. · Kitenge · P. · Basema · M.-F. · Shabani · F. M. · Arraras · J. I. · Mitterlehner · S. B. · Hallsson · L. R. · Tambwe-A-Nkoy · A. M.
Objectives

Health-related quality of life (HRQoL) assessments are a cornerstone of outcome evaluations for patients with cancer. The aim of this project was to assess patients with cancer in Lubumbashi/Democratic Republic of the Congo and: (1) evaluate what constitutes a clinically important health problem, (2) evaluate HRQoL and (3) compare HRQoL to controls.

Design

Cross-sectional, prospective study.

Setting

Patient recruitment took place in 12 hospitals in Lubumbashi.

Participants

Inclusion criteria were a secured diagnosis of cancer, aged 18 years and above, no serious cognitive impairments.

Primary and secondary outcome measures

(1) Semi-structured interviews with patients and healthcare professionals were conducted to investigate aspects of clinical importance. (2) The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was employed to quantitatively assess HRQoL; (3) an exploratory comparison of HRQoL data to Spanish controls, multinational reference data and the European general population data is performed.

Results

(1) 20 patients (x-age=55.0 years; 70.0% female) and 10 healthcare professionals were interviewed. Social isolation, need for help/care and worries were frequently mentioned aspects making a health problem clinically important. (2) 103 patients (x-age=54.0 years; 67.0% female) with various cancer types were assessed. The prevalence of clinically important problems ranged from 26.2 % for fatigue to 94.1% for financial problems. (3) Compared to matched Spanish controls (n=207), symptom burden was more pervasive (OR 1.18 for insomnia to 28.0 for financial problems) than functional health limitations (max. OR 2.12 for role function). While adjusting HRQoL scores for age, sex, comorbidities and treatment intention decreased effect sizes of score difference across countries for 14 out of 16 scales, statistically significant differences across countries (p<0.05) remained for ten scales even after adjusting for covariates.

Conclusion

Clinical characteristics, aspects of clinical importance and HRQoL profiles of patients with cancer in Lubumbashi were reported. Aspects of clinical importance were identified, whereas a high symptom burden was reported by patients with cancer in Lubumbashi. Enhancing symptom management in Lubumbashi may alleviate symptom burden of patients with cancer.

Dual antiplatelet therapy duration after percutaneous coronary intervention with contemporary drug-eluting stents: A systematic review and network meta-analysis of randomized trials

by Admire Hlupeni, Mehran Jalilzadehbinazar, Rayvlin J. Liceralde, Hussain A. M. Khan, Ravi Donepudi, Shilpkumar Arora

Background

Despite widespread adoption of abbreviated (<12 months) dual antiplatelet therapy (DAPT) strategies after percutaneous coronary intervention (PCI), the optimal threshold for DAPT abbreviation remains undefined.

Methods

We conducted a network meta-analysis of randomized controlled trials (RCTs) evaluating various abbreviated DAPT durations in patients undergoing PCI with contemporary drug-eluting stents (DES). We searched PubMed, Embase, and Scopus from January 2008 through March 21, 2026. The efficacy and safety outcomes were major adverse cardiovascular events (MACE) and major bleeding, respectively. Relative treatment effects were estimated using risk ratios (RR) with 95% confidence intervals (CI) using random-effects models. Treatment ranking was assessed using surface under the cumulative ranking curve (SUCRA). The study protocol was registered on PROSPERO (CRD420261349664).

Findings

Twenty-eight RCTs comprising 84,325 patients were included. Compared with 12-month DAPT, abbreviated strategies (1-, 3-, and 6-month) were not associated with a significant difference in MACE (1-month: RR 1.03 [95% CI 0.88–1.22]; 3-month: RR 0.95 [95% CI 0.82–1.10]; 6-month: RR 1.06 [95% CI 0.88–1.27]). In contrast, these shorter durations were associated with significantly reduced major bleeding (1-month: RR 0.59 [95% CI 0.42–0.82]; 3-month: RR 0.64 [95% CI 0.49–0.84]), with a consistent trend for 6-month DAPT (RR 0.68, 95% CI: 0.46–1.00). SUCRA rankings indicated that the 3-month DAPT strategy ranked highest for MACE (lowest ischemic risk); whereas the 1-month strategy ranked highest for major bleeding (lowest bleeding risk), followed by the 3-month strategy.

Conclusion

Shorter DAPT durations (1 & 3 months) were associated with reduced bleeding without evidence of increased ischemic risk compared with the conventional 12-month strategy. Among the abbreviated strategies, the 3-month regimen consistently demonstrated the most favorable overall profile across analyses, suggesting it may represent a pragmatic threshold for DAPT abbreviation. However, these findings should be interpreted cautiously given the absence of statistically significant differences in efficacy and the limitations inherent to study-level network meta-analysis.

Proton pump inhibitors in invasively ventilated patients with SARS-CoV-2: a substudy of the re-evaluating the inhibition of stress erosions trial

Por: Dennis · B. · Heels-Ansdell · D. · Ibrahim · Q. · Basmaji · J. · Thabane · L. · Guyatt · G. · Saunders · L. · Hand · L. · Loy · O. · Zytaruk · N. · Hardie · M. · Deane · A. M. · Marshall · J. C. · Arabi · Y. · Lauzier · F. · Dionne · J. C. · Burns · K. E. · Alhazzani · W. · Vazquez-Grande
Objectives

Observational studies suggest that acid suppression may worsen outcomes among patients infected with SARS-CoV-2. The objectives of this embedded substudy of a randomised controlled trial evaluating pantoprazole in mechanically ventilated patients were to (1) describe the clinical characteristics of critically ill patients with SARS-CoV-2, (2) compare clinical outcomes with a propensity-matched non-infected cohort and (3) assess whether pantoprazole’s treatment effects differed by SARS-CoV-2 infection status.

Design

A pre-planned substudy of the re-evaluating the inhibition of stress erosions (REVISE) trial, including a propensity-matched analysis of infected and non-infected patients comparing the effect of pantoprazole between patients with and without SARS-CoV-2.

Setting

68 intensive care units (ICUs) in eight countries.

Participants

From July 2019 to October 2023, 4821 eligible participants were enrolled in REVISE whether or not they had SARS-CoV-2 infection.

Primary and secondary outcome measures

Participants enrolled in REVISE with SARS-CoV-2 infection had additional data collection, including biomarkers, venous thromboembolism, SARS-CoV-2 therapies and tracheostomy timing. The primary outcomes were clinically important upper gastrointestinal bleeding and 90-day mortality. Secondary outcomes included ventilator-associated pneumonia, Clostridioides difficile infection, patient-important upper GI bleeding, renal replacement therapy, ICU and hospital mortality and duration of mechanical ventilation, ICU and hospital stay.

Results

Of the eligible trial cohort, 11.9% (540/4550) had SARS-CoV-2; 532 patients had additional SARS-CoV-2-specific data collection. Of these 532 patients, 87.8% received COVID-19-directed treatments—(dexamethasone 75.2%), 11.7% developed pulmonary embolism and 9.2% developed deep-vein thrombosis. After propensity matching, SARS-CoV-2 infection was not associated with clinically important upper gastrointestinal bleeding (adjusted HR 0.78, 95% CI 0.40 to 1.50) but was associated with significantly higher ICU, hospital and 90-day mortality, as well as longer duration of ventilation and ICU and hospital length of stay. The effect of pantoprazole on clinically important upper GI bleeding and 90-day mortality was consistent regardless of SARS-CoV-2 status.

Conclusions

SARS-CoV-2 infection was associated with higher mortality and longer duration of mechanical ventilation, ICU and hospital stays, without an increased risk of clinically important upper gastrointestinal bleeding. Pantoprazole reduced clinically important upper gastrointestinal bleeding without adversely affecting other outcomes.

Trial registration number

REVISE trial (NCT03374800), SARS-CoV-2 cohort study (NCT05715567).

Evaluating temporal associations between executive functioning, stress and physical activity among adolescents at risk for type 2 diabetes: protocol for an ecological momentary assessment study

Por: Gutierrez-Colina · A. M. · Neiser · A. · Aichele · S. · Velasco · P. · B Goldschmidt · A. · Lavender · J. M. · Dailey · R. · Sanchez · N. · Kelsey · M. M. · Shomaker · L. B.
Introduction

Adolescent-onset type 2 diabetes (T2D) has increased in prevalence in recent decades. However, the efficacy of preventative interventions targeting health behaviours is limited, and key developmental factors that may influence effectiveness, such as executive functioning (EF) and stress, are often overlooked. Within-person fluctuations in EF and stress are linked to the adoption and maintenance of physical activity, a critical component of T2D prevention, yet little is known about the between- and within-person temporal variability of these constructs or their relationship with physical activity in adolescents at risk for T2D. Ecological momentary assessment (EMA) is ideal to capture these processes in real-time to inform intervention development and personalisation.

Methods and analyses

We will enrol a subset of participants from a larger intervention study involving assigned-female-at-birth adolescents aged 12–17 years, with elevated depression symptoms (CES-D≥21) and T2D risk (BMI≥85th percentile) and diabetes family history. Prior to the intervention, a minimum of 50 participants will complete a 7-day EMA protocol consisting of repeated daily gamified EF assessments and brief surveys about EF, stress and physical activity. Participants will simultaneously wear an activity monitor to provide objective measures of physical activity. Recruitment began in Spring 2024 and is ongoing. Multilevel models will be used to separate between- and within-person variability and to estimate short-term lagged within-person associations between EF/stress and subsequent physical activity across 15–60 min windows. Primary analyses are planned for Winter 2026.

Ethics and dissemination

The Colorado Multiple Institutional Review Board approved this study (COMIRB#22-0180). Findings will be disseminated in peer-reviewed journals and conference presentations.

Trial registration number

NCT05543083.

Cohort profile: the Entebbe Mother and Baby Study (EMaBS)

Por: Webb · E. L. · Walusimbi · B. · Komata · R. · Elliott · A. M. · The EMaBS Study Team
Purpose

The Entebbe Mother and Baby Study (EMaBS) was established in 2001 to test the hypothesis that treating helminth infections during pregnancy and early childhood could improve children’s responses to Bacillus Calmette-Guérin (BCG) and other vaccines given in infancy and influence immune responses to other infectious pathogens. Follow-up was subsequently extended to address further research questions and continue to the present day.

Participants

Two thousand five hundred and seven pregnant women were recruited when attending antenatal services at Entebbe General Hospital, Uganda; 2345 resulting live-born children were enrolled into the EMaBS birth cohort.

Findings to date

Initial results from EMaBS showed that treating helminths in pregnancy and early childhood was safe and that treatment with albendazole reduced anaemia in mothers with heavy hookworm infections. Maternal anthelminthic treatment had small effects on infant response to tetanus immunisation, but no effect, either beneficial or detrimental on the occurrence of infectious diseases in childhood. However, treatment of helminths during pregnancy resulted in increased rates of eczema in early childhood, although this was not sustained to nine years. Subsequent work in early adolescence found that postnatal weight gain was important in the developmental programming of blood pressure in this population and current and early-life malaria modified blood pressure and lipid levels. We also showed that variation in host genes significantly shapes antibody responses to multiple childhood vaccines, highlighting genetics as a key determinant of vaccine performance.

Future plans

Cohort ‘children’ are currently aged 19–22 years, and future plans focus on investigating longer term effects of early-life and childhood exposures. A new round of data collection is ongoing with the aim of determining the impact of early-life exposures on adult non-communicable disease risk. Work determining whether frequent childhood infections lead to specific epigenetic changes implicated in later disease development is also underway.

Registration

The EMaBS began as a randomised controlled trial (ISRCTN32849447). Two further randomised controlled trials have been nested within the cohort: TB042 (NCT03681860) and POPVAC C (ISRCTN10482904).

Protocol for the DECIDE+ trial: a quasi-experimental hybrid effectiveness-implementation study of social support and CVD self-management through community health workers in Philadelphia

Por: Bonett · S. · Alvarez · C. · Clemmons · A. · Thomas · G. · Villarruel · A. M. · Tan · A. S. L. · Lipman · T. H. · Glanz · K. · Bauermeister · J.
Background

Cardiovascular disease (CVD) is the leading cause of death in the USA, with significant disparities affecting racial/ethnic minority populations particularly in Philadelphia. Although effective self-management can improve outcomes for those with CVD risk factors, social and economic barriers often impede implementation of recommended health behaviours in underserved communities. This study aims to (1) determine the effectiveness of the Decision-making Education for Choices in Diabetes Everyday (DECIDE)+ intervention in improving CVD self-management skills among Philadelphia residents with CVD risk factors and unmet social needs compared with standard community health worker (CHW) engagement and (2) assess the reach, adoption, fidelity and maintenance of DECIDE+.

Methods and analysis

Using a type 1 hybrid effectiveness-implementation design, this quasi-experimental study will compare outcomes between participants who enrol in the DECIDE+ group (n=250) or receive standard CHW services (n=250). DECIDE+ combines a structured nine-session problem-solving programme for chronic disease management with ongoing CHW support addressing social needs. Both groups will be randomly assigned to either monthly or biweekly CHW follow-up to examine the impact of contact frequency on health behaviour outcomes. Primary outcomes include CVD self-management skills measured by the Self-care of Chronic Illness Inventory. Implementation outcomes will be assessed through a mixed-methods approach including structured interviews with CHWs and analysis of programme-level data.

Ethics and dissemination

This study was approved by the University of Pennsylvania Institutional Review Board (Protocol #856216). Written informed consent is obtained from all participants prior to enrolment. This pragmatic trial addresses cardiovascular health disparities by simultaneously enhancing problem-solving skills for chronic disease management and addressing social and environmental barriers to effective self-management. The study will provide valuable insights into the effectiveness of multilevel CHW-delivered interventions and optimal implementation strategies in real-world community settings. Findings will be disseminated through peer-reviewed publications and scientific conference presentations.

Trial registration number

NCT06732102.

NHS healthcare worker experiences of moral injury: a follow-up qualitative study in England using reflexive thematic analysis

Por: Higginbottom · E. · Stoeck · F. · Stevelink · S. · Hegarty · S. · Raine · R. · Rafferty · A. M. · Greenberg · N. · Wessely · S. · Rahman · H. · Lamb · D.
Background

Moral injuries (MIs) may result from individuals being exposed to potentially morally injurious events (PMIEs). PMIEs have been a feature of work within much of the National Health Service (NHS) for many years, and the understanding of MI is now more commonplace, having been highlighted during the COVID-19 pandemic; however, understanding of how such events affect workers over the long term is lacking.

Objective

To understand the development of healthcare workers’ (HCWs) experiences of PMIEs over a period of 3 years.

Design and participants

We carried out follow-up semistructured qualitative interviews with 15 NHS staff who were previously interviewed on the same topic in 2021. All interviews were recorded, transcribed and analysed using reflexive thematic analysis following an inductive approach.

Results

Three main themes and six subthemes were identified: (1) internal context and subjective experiences, (1.i) control in a rigid system, (1.ii) psychosocial dynamics, (2) external context and the moral cost of culture, (2.i) organisational culture, (2.ii) sources of MI, (3) responses to PMIEs, (3.i) maladaptive responses, (3.ii) adaptive responses. Key issues identified included perceptions of insufficient control over their work and work environment, low psychological safety and perceived misunderstanding of the value of their work from patients and colleagues, leading to a challenging organisational culture. We found that in the 3 years between the interviews many staff reported developing ‘secondary’ feelings of betrayal as a result of perceived ongoing governmental neglect of recognition for HCWs’ sacrifices during the pandemic and a lack of acknowledgement of governmental mistakes made in the acute period.

Conclusion

Findings show an interplay between individual and organisational factors that HCWs faced while working in the NHS, underlining the need for wide-ranging intervention strategies. Since the HCWs’ original interviews in 2021, a secondary betrayal has developed, emphasising the need for interventions that can restore trust in the system.

Global research priorities for back pain, neck pain and osteoarthritis: a scoping review

Por: Young · J. J. · Pedersen · J. R. · King · L. K. · Zywiel · M. · Perruccio · A. V. · Chandran · V. · Rampersaud · Y. R. · Hawker · G. · Briggs · A. M. · Hartvigsen · J. · Koes · B.
Objectives

The primary aim of this scoping review was to synthesise published research priorities for back pain, neck pain and osteoarthritis. The secondary aim was to compare these research priorities to the priority areas identified in the Global Strategy to Improve Musculoskeletal Health.

Design

Scoping review conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews.

Data sources

Literature searches were performed in MEDLINE, EMBASE and the James Lind Alliance Priority Setting Partnership database from inception to March 2025.

Eligibility criteria

Peer-reviewed studies reporting the development of a prioritised ranking of research topics related to back pain, neck pain or osteoarthritis were included.

Data synthesis

Included research priority sets were described. All research priorities for back pain, neck pain and osteoarthritis were presented. Research priorities were categorised according to priority areas identified in the Global Strategy to Improve Musculoskeletal Health.

Results

15 studies from 3721 citations and three from the James Lind Alliance were included. Eight priority sets related to back and/or neck pain identified 155 research priorities. 15 priority sets related to osteoarthritis identified 206 research priorities. Most priority sets (69.6%) included patients in the development process, but only 17.4% included policymakers. Just three priority sets included participants from outside Europe, North America or Australia.

Most priorities were in the clinical and basic science research priority area (73.1%) followed by the health policy and systems research priority area (14.1%), health economics research priority area (4.7%), public health research priority area (4.4%), epidemiological and population health research priority area (1.9%) and the other priority area (1.7%).

Conclusions

The majority of published back pain, neck pain and osteoarthritis research priorities fall within clinical and basic science and were developed in high income countries. Given the known high population burden of musculoskeletal conditions, a broader approach to research beyond clinical and basic science is likely required to achieve population-level health benefits. Future initiatives should include all relevant members of the global musculoskeletal health community, including from low- and middle-income countries, to help ensure the development of broad-based research priorities that address all research domains required to improve back and neck pain and osteoarthritis health globally.

Real-world evidence on antibiotic use among privately insured beneficiaries in Saudi Arabia: a retrospective analysis of claims data

Por: Alghamdi · S. · Aljuffali · I. A. · AlDammas · A. M. · Abu Alhamayel · N. · Jumaah · M. · Bechwati · M. · Barhoun · J. · Alshahrani · S. M. · Alagil · N.
Objectives

Inappropriate and broad-spectrum antibiotic use contributes to antimicrobial resistance (AMR) and higher healthcare costs. In Saudi Arabia, despite ongoing antimicrobial stewardship efforts, comprehensive real-world evidence on antibiotic prescribing patterns remains limited. This study aimed to evaluate antibiotic prescribing among insured (Daman) beneficiaries in Saudi Arabia and benchmark against international standards.

Design

Retrospective analysis of deidentified health insurance claims from the National Platform for Health and Insurance Exchange Services (NPHIES), covering 1 November 2023–31 October 2024.

Setting

Antibiotic prescriptions were identified within claims and linked to diagnostic codes using the International Classification of Diseases, Tenth Revision, Australian Modification (ICD-10-AM) to determine clinical indications for use.

Participants

Among 4.02 million claimants, 8.3 million antibiotic prescriptions were identified.

Primary and secondary outcome measures

Antibiotic claims were mapped to the Saudi Food and Drug Authority (SFDA) drug list. Hospital antibiotic consumption was expressed as defined daily doses (DDD) per 100 patient-days for five selected inpatient antibiotics, whereas overall antibiotic consumption (in both community and hospital settings) was expressed as DDD per 1000 insured persons per day. Treatment duration, prescriber specialty and patient demographics were measured. Appropriateness of antimicrobial prescribing for respiratory tract infections was assessed using Healthcare Effectiveness Data and Information Set (HEDIS) metrics.

Results

Age-stratified and sex-stratified antibiotic prescription rates showed disproportionately high use in male infants (509.6 prescriptions per 1000) and older males (641.9 prescriptions per 1000). General practitioners accounted for 80% of prescriptions. Broad-spectrum beta-lactams, particularly amoxicillin–clavulanate, predominated. Overall antibiotic consumption was 11.63 DDD per 1000 insured persons per day, comparable to European Surveillance of Antimicrobial Consumption Network (ESAC-Net) outpatient benchmarks. Mean treatment durations ranged 8–14 days, exceeding global stewardship recommendations. HEDIS indicators revealed overprescribing, particularly for upper respiratory tract infections.

Conclusions

This is the first claim-based analysis of antibiotic prescribing patterns among Daman beneficiaries in Saudi Arabia. Decision support systems, artificial intelligence-driven audits and targeted education could optimise prescribing, reduce AMR and inform policy.

Consensus definition and classification of neglected fractures and dislocations: protocol for an international modified Delphi study

Por: Haile · A. M. · Seyoum · F. B. · Mekasha · T. Y.
Introduction

Neglected fractures and dislocations are a common and clinically important problem in low- and middle-income countries, often attributed to limited access to timely orthopaedic care, financial barriers, referral delays and prior non-formal treatment. Despite their clinical significance, no standardised definition or classification exists. Reported time thresholds, defining criteria and classification approaches vary substantially across and even within anatomical regions, injury types and practice settings, limiting clinical communication, research comparability and burden estimation. This study aims to develop an expert consensus-based definition and classification system for neglected fractures and dislocations, focusing on identifying a common denominator applicable across various anatomical regions and injury types, using a modified Delphi methodology.

Methods and analysis

A three-round, international, online modified Delphi study will be conducted involving purposively selected experts representing diverse geographical regions, subspecialties and practice settings, with approximately 200 experts invited to achieve a final panel of 20–30 participants. Questionnaire development was informed by a concurrent scoping review of the literature. Round 1 will explore the definitional elements and scope of the term as applied in orthopaedic practice, including the relative importance of temporal, biological, clinical and treatment-related factors that are often used to describe this entity, whether neglected fractures and dislocations are best conceptualised as a binary entity or a graded clinical spectrum, and whether defining criteria should vary across anatomical regions or different injury contexts. Round 2 will refine and present unresolved concepts and evaluate anatomic-specific operationalisation, including specific time thresholds and characteristic clinical and biological features. Round 3 will seek final consensus on the proposed definition and classification, including clarity, acceptability and perceived clinical usability. Consensus will be predefined as ≥70% agreement (7–9 on a 9-point Likert scale), with strong consensus defined as ≥80%. Free-text responses will undergo directed thematic content analysis. The study will be designed, conducted and reported in accordance with the Conducting and REporting of DElphi Studies (CREDES) checklist.

Ethics and dissemination

Ethical approval has been obtained from the Addis Ababa University Institutional Review Board (reference: 007/26/Ortho). Findings will be disseminated through a peer-reviewed publication and presentations at scientific meetings.

Trial registration details

https://osf.io/jx4ew/overview?view_only=5bcabab130964c90ba0d2d1f17b8f247

Real-world treatment patterns and adherence among privately insured patients with type 2 diabetes in Saudi Arabia: a retrospective cohort study using national claims data

Por: Alghamdi · S. · Aljuffali · I. A. · AlDammas · A. M. · Abu Alhamayel · N. · Jumaah · M. · Matni · M. · Barhoun · J. · Alshahrani · S. M. · Alagil · N.
Objectives

Type 2 diabetes mellitus (T2DM) imposes clinical and economic burdens worldwide, with the Kingdom of Saudi Arabia (KSA) reporting among the highest prevalence rates in the Middle East and North Africa (MENA) region. Despite national diabetes initiatives under Vision 2030 and recent guideline implementation, evidence on T2DM management among privately insured beneficiaries remains limited. This study aimed to provide one of the first real-world assessments of antidiabetic treatment patterns, therapy modifications, medication adherence and guideline-recommended glycaemic monitoring among privately insured patients with T2DM in KSA.

Design

Longitudinal retrospective cohort study.

Setting

A national claims-based analysis was conducted using the National Platform for Health Information Exchange Services (NPHIES), covering privately insured beneficiaries across KSA. The study period spanned from 1 September 2022 to 31 December 2024.

Participants

Eligible participants were privately insured individuals aged ≥15 years with a diagnosis of T2DM, defined as having at least one medical claim of T2DM (International Classification of Diseases, 10th Revision, Australian Modification code E11) and continuous insurance enrolment for a minimum of 12 months (including ≥180 days pre-index and ≥180 days post-index). The index date was defined as the earliest observed antidiabetic prescription within the study window. A total of 187 797 patients met the inclusion criteria and were included in the final analysis.

Primary and secondary outcome measures

The primary outcomes were antidiabetic real-world treatment patterns and therapy modifications, including treatment escalation, switching, early discontinuation and medication adherence. Secondary outcomes included guideline-recommended laboratory testing of glycaemic control for haemoglobin A1c (HbA1c), plasma glucose tests and oral glucose tolerance test. Claims were linked to the Council of Health Insurance’s internal product dictionary using the NPHIES product/service code to retrieve the standardised product name and activity type. Data extraction used Structured Query Language-based queries and Python transformation.

Results

Patients had a mean age of 53.7 years, while T2DM rates reached 47.4 per 1000 insured men and 43.8 per 1000 insured women. Combination therapy accounted for 29.4% of initial treatment regimens among eligible patients with T2DM. Biguanide monotherapy users exhibited switching and escalation rates of 9% and 7%, respectively, while 35% of sulfonylurea users exhibited escalation. Treatment discontinuation was observed in 22% of users of combination therapies, 22% of SGLT2 inhibitor users and 19% of sulfonylurea users. The medication possession ratio was 0.87 for insulin users. Regarding laboratory monitoring, 61% of patients had at least one glycaemic test 6 months prior to therapy initiation. Laboratory testing reached 73% following therapy initiation.

Conclusion

The Saudi experience suggests that integrated national claims platforms, supported by standardised coding and e-prescribing, can play a critical role in advancing real-world evidence generation and informing diabetes management strategies in KSA and across MENA health systems.

Cluster randomised feasibility trial of PRISM: the PRimary Care Individual Social Norms MSK Data Dashboard to support first contact physiotherapy management of musculoskeletal patients in primary care

Por: Dunphy · E. · Marston · L. · Hunter · R. · Hill · J. C. · Downey · A. M. · Forsyth · S. · Nwankwo · C. · Nazareth · I.
Introduction

Musculoskeletal (MSK) conditions affect over 20 million people in the UK and account for one in seven General Practitioner (GP) consultations. To address capacity challenges, First Contact Physiotherapists (FCPs) now manage MSK patients in primary care. However, FCPs working in isolation from physiotherapy teams exhibit broad variation in decision-making that could pose risks to care quality. PRimary Care Individual Social Norms MSK Data Dashboard (PRISM) is a clinician-facing behaviour change digital dashboard that provides individualised social norms feedback such as, ‘you are in the top 10% of those referring to secondary care’ or ‘in the bottom 10% of those referring to social prescribing’. It aims to nudge FCPs towards evidence-based norms, including more effective and cost-efficient treatments, thereby reducing unwarranted variation in care and improving patient outcomes. Social norms interventions have been shown to positively influence clinician behaviour, but their application in MSK services remains unexplored.

Aim

To determine the feasibility of evaluating PRISM’s effectiveness and cost-effectiveness in a future clinical trial.

Methods and analysis

A pragmatic feasibility cluster randomised controlled trial will be conducted across four UK primary care sites with FCP services. Sites will be allocated 1:1 to intervention (PRISM dashboard, guidebook and structured clinical supervision) or control (usual care). Data on clinical decision-making will be collected monthly and anonymised for dashboard generation and compared to an existing dataset of over a million FCP consultations. Patients seen by FCPs will be invited to provide patient-reported outcome measures and experience measures. Feasibility outcomes include recruitment and retention of sites, FCPs and patients; dashboard engagement and completeness of data collection.

The primary outcome is recruitment feasibility. Secondary outcomes include retention, dashboard usage, patient-rated outcome measure/experience measure (patient-rated outcome measures/patient-rated experience measures) completion and supervision engagement. Descriptive analyses will summarise feasibility metrics and missing data. Health economic and carbon reduction data collection will also be assessed for future trial planning.

Ethics

IRAS number 361 359. REC reference: 25/EM/0256, Approved: 10 December 2025 based on PRISM Protocol V.9. Dated 25 November 2025.

Trial registration number

NCT07112508.

Dissemination

Findings from the PRISM feasibility trial will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagement. Results will also be shared with participating sites, patient and public involvement representatives and professional bodies such as the Chartered Society of Physiotherapy to inform clinical practice and policy. Additionally, lay summaries will be produced for patients and the public and digital channels will be used to maximise reach.

Diaphragmatic speckle-tracking ultrasound for predicting successful liberation from mechanical ventilation: a systematic review and meta-analysis protocol

Por: Simari Neto · O. · de Jesus · M. S. · de Oliveira · D. Q. · Imoto · A. M. · Amorim · F. F.
Introduction

Ventilator-induced diaphragmatic dysfunction is increasingly recognised as an important complication of prolonged mechanical ventilation (MV) and a major contributor to difficult weaning and extubation failure. Although bedside diaphragmatic ultrasound has emerged as a useful tool for assessing diaphragm function, conventional indices such as diaphragm excursion and thickening fraction may be influenced by ventilatory mechanics and patient effort. Speckle-tracking ultrasound (STU), a deformation-based technique adapted from echocardiography, allows assessment of diaphragmatic strain and strain rate and may provide a more accurate evaluation of diaphragmatic contractility. However, the predictive utility of diaphragmatic STU for successful liberation from MV remains uncertain. This study aims to systematically review the available evidence on the predictive performance of diaphragmatic speckle-tracking ultrasound for successful weaning from MV in adult patients.

Methods

This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and is registered in the PROSPERO database. A comprehensive search will be conducted in MEDLINE (via PubMed), Embase, Scopus, Web of Science, LILACS/BVS and CENTRAL without restrictions on language or publication date. Observational studies and clinical trials evaluating diaphragmatic speckle-tracking ultrasound during the weaning process in adults receiving invasive MV for more than 24 hours will be eligible. Two reviewers will independently select studies, extract data and assess the risk of bias using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool for diagnostic and predictive accuracy studies and the Cochrane Risk of Bias 2 tool for randomised trials. When feasible, meta-analysis will be conducted using Review Manager software. The certainty of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE)approach.

Ethics and dissemination

Ethics approval is not applicable for this study since no original data will be collected. The results will be disseminated through peer-reviewed publication and conference presentations.

Prospero registration number

CRD420261338352.

Quality of antenatal care services in Sudan public health facilities: a cross-sectional study

Por: Mohammed · Y. I. A. · Hemmeda · L. · Ahmed · A. S. · Elgadi · A. · Elawad · S. · Abdelraheem · E. M. H. · Omer · L. M. · Esmaeel · M. A. M. · Al Fanob · R. M. · Dafaallah · R. · Mohamed Ahmed · K. A. H. · Fadlalmoula · G. A. A. G. A.
Objectives

To understand pregnant women’s perception of the quality of antenatal care (ANC) services in terms of service provision and experience in Sudan, a country with one of the highest rates of maternal deaths worldwide.

Design

A cross-sectional facility-based study.

Setting

Public primary healthcare centres in Khartoum state, Sudan.

Participants

473 pregnant women attending ANC visits. Data were collected through face-to-face interviews using a standardised questionnaire.

Primary outcome measures

The perceived quality of ANC services assessed across two continuous domains: service provision score and care experience score.

Results

The mean score for service provision was 19.96±3.03 out of 56. The great majority of the participants did not have their height or weight measured at any ANC visits 85% and 64.5%, respectively. About 87.1% and 82.5% of the participants, respectively, had blood and urine tests during each ANC visit. However, only 52.6% of the women reported receiving tetanus injections. The percentage of women receiving ultrasound examination at each visit was 88.4%. The mean score of care experience was 58.68±8.22 out of 84. Three-quarters of the women (74%) understood the purpose of the tests performed. The majority felt free to ask questions (87.3%). But only half and a third of the women were told about the signs of pregnancy complications and where to go in case any complications occurred, respectively. In linear regression, being married and older age had significant positive effects on women’s perception of care provision (p=0.004 and p=0.003, respectively). Regarding the experience of care, older age affected care experience positively (p=0.038), while rural residency (p=0.044), being illiterate (p

Conclusion

Women’s perception of the quality of ANC in terms of service provision and care experience was below average. Several factors were associated with their negative perceptions. These factors need to be further investigated and addressed to improve the quality of ANC provided.

Pooled prevalence of maternal continuum of care dropout and associated factors among mothers in 41 low-income and middle-income countries: a multi-country cross-sectional study after the Sustainable Development Goals

Por: Bitewa · M. D. · Getachew · M. S. · Kassie · T. D. · Getnet · M. · Lakew · A. M.
Objectives

This study aimed to assess the pooled proportion of dropout from the maternal continuum of care (CoC) and its associated factors in low-income and middle-income countries (LMICs).

Study design

Cross-sectional study using nationally representative demographic and health survey (DHS) data.

Setting

41 LMICs with DHS data available after the establishment of the Sustainable Development Goals from 2016 to 2024 were included. A total of 217 083 (weighted 213 474) women were included. Using Stata V.17.0, a multilevel binary logistic regression analysis was performed to examine the factors associated with dropout from the CoC. The adjusted ORs (AORs) with 95% CIs were calculated, and p

Participants

Women of reproductive age (15 to 49 years) who had at least one live birth within 2 years preceding the survey.

Primary outcome

Dropout from the CoC was the primary outcome of this study, defined as initiating antenatal care but failing to receive skilled birth attendance and/or postnatal care.

Results

The pooled proportion of CoC dropout was 50% (95% CI 45 to 56%), with significant heterogeneity, which ranges from 19% in Albania to 85% in Ethiopia. Factors associated with higher odds of dropout were multiparity (AOR=1.30, 95% CI 1.26 to 1.34), grand multiparity (AOR=1.70, 95% CI 1.62 to 1.78), delayed first ANC (AOR=2.87, 95% CI 2.79 to 2.95), regions compared with the North Africa/West Asia/Europe region; SSA (AOR=2.65, 95% CI 2.34 to 3.00), Central Asia (AOR=1.78, 95% CI 1.40 to 2.26), South and Southeast Asia (AOR=2.43, 95% CI 2.14 to 2.75), Oceania (AOR=2.41, 95% CI 1.98 to 2.94), Latin America and the Caribbean (AOR=8.47, 95% CI 6.81 to 10.54), distance from health facility (AOR=1.15, 95% CI 1.12 to 1.18), getting permission (AOR=1.27, 95% CI 1.23 to 1.32), pregnancy intention (AOR=0.76, 95% CI 0.73 to 0.78) and rural residence (AOR=1.57, 95% CI 1.51 to 1.64), primary education (AOR=0.83, 95% CI 0.80 to 0.86), secondary education (AOR=0.60, 95% CI 0.58 to 0.62), higher education (AOR=0.43, 95% CI 0.41 to 0.46), middle wealth index (AOR=0.80, 95% CI 0.77 to 0.83), rich wealth index (AOR=0.65, 95% CI 0.63 to 0.68), media exposure (AOR=0.70, 95% CI 0.69 to 0.72), women aged between 20 and 34 (AOR=0.76, 95% CI 0.72 to 0.79) and age ≥35 years (AOR=0.60, 95% CI 0.56 to 0.63) were associated with lower odds of dropout.

Conclusions

This study found a 50% dropout from CoC in LMICs with considerable heterogeneity. Factors identified as contributing to reducing dropout rates include improving women’s education, increasing media exposure, enhancing women’s decision-making power, ensuring better access to healthcare facilities, particularly in remote areas, and reducing adolescent pregnancies. To achieve Sustainable Development Goal 3 for maternal and child health by 2030, a coordinated, multi-level strategy is required.

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