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Investigating differences in the implementation and experience of the Enhanced Health in Care Homes Framework in England: a qualitative protocol for the Understanding Variation in Admissions from Care Homes (UVAC) study

Por: Marincowitz · C. · Zwerger · K. E. · Harrad-Hyde · F. · Garrett · H. · Lam · E. · Burton · J. · Reeve · J. · Mason · S. M. · Spilsbury · K. · Price · D. B. · Jacques · R. M. · Martin · G.
Introduction

Older people living in care homes are at increased risk of harm during acute hospital admissions. In England, care home residents have more than twice as many emergency department (ED) attendances as people of the same age living at home. Up to 40% of emergency hospital admissions of older care home residents may be avoidable with different models of care within their homes.

In 2023, National Health Service England introduced the updated Enhanced Health in Care Homes (EHCH) framework, a set of recommendations to support ‘joined up’ and enhanced care for people living in care homes. A stated aim of the framework is to reduce ED attendances and inpatient admissions of residents. There is limited available evidence regarding how implementation of the EHCH framework differs regionally and whether variation in implementation may impact on hospitalisations of care home residents.

Aims

We aim to explore regional differences in care elements developed from the EHCH framework and assess how these differences may contribute to variation in hospitalisations of care home residents over the age of 65.

Methods and analysis

This is a comparative qualitative case study of six care home-containing postcode districts in England embedded within three Integrated Care Boards (ICBs). ICBs are regional organisations responsible for commissioning healthcare services in England. Case study districts and ICBs were selected due to contrasting case-mix adjusted admission rates and other characteristics (eg, deprivation). Data will be collected through semistructured interviews. We will interview health and social care professionals who are responsible for commissioning, overseeing and delivering enhanced care in care homes, care home professionals, residents over the age of 65 and their family and friends. Interview data will be analysed through a framework approach, with comparisons drawn within cases, across cases and across ICBs. Through our analysis, we will characterise the EHCH framework care elements and identify differences in implementation that may cause variation in hospital admissions. We will also identify perceived appropriate, effective and replicable enhanced care models.

Patients and the public have informed the design of this study, and will advise the research practice, support the analysis of data and guide dissemination plans.

Ethics and dissemination

This study has received Social Care Research Ethics and Health Research Authority Approval (25/IEC08/0014). All participants will be required to provide informed consent. The findings will inform a national survey of ICBs to map appropriate and effective enhanced care in England. Findings will be shared with key stakeholders and academic audiences.

What is the diagnostic accuracy of contrast enema for Hirschsprung disease during COVID-19 service disruption in Vietnam? A retrospective study

Por: Tran · Q. A. · Pham · H. D. · Dang · T. T. · Nguyen · L. V. T. · Ly · D. B. · Nguyen · N. T. · Nguyen · H. V. · Nguyen · Q. T.
Objectives

To assess the diagnostic accuracy of contrast enema for Hirschsprung disease in children when preoperative rectal suction biopsy was unavailable and to examine age-related diagnostic performance and the utility of individual radiographic signs.

Design

Retrospective diagnostic accuracy study.

Setting

A high-volume tertiary paediatric surgical centre in Hanoi, Vietnam, during a period of COVID-19 related service disruption from May 2020 to October 2021.

Participants

354 consecutive children aged 0 to under 16 years who underwent contrast enema for suspected Hirschsprung disease. Final diagnosis was established by intraoperative frozen section and postoperative histopathology for operated patients and by clinical follow-up for non-operated patients.

Interventions

Not applicable.

Primary and secondary outcome measures

Primary outcome was diagnostic accuracy of contrast enema versus the reference standard, expressed as sensitivity, specificity, positive predictive value and negative predictive value with 95% CIs. Secondary outcomes were age-stratified accuracy and the performance of individual radiographic signs.

Results

Among 354 children, contrast enema yielded 131 true positives, 19 false positives, 20 false negatives and 184 true negatives. Overall sensitivity was 86.75% (95% CI 80.43 to 91.26), specificity 90.64% (95% CI 85.85 to 93.93), positive predictive value 87.33% (95% CI 81.06 to 91.74) and negative predictive value 90.20% (95% CI 85.34 to 93.56). Sensitivity was higher in children aged 1 month or less than in those older than 1 month, 96.00% vs 75.71%, whereas specificity was lower, 80.00% vs 97.67%. Of the individual radiographic signs, the inverted rectosigmoid index was the most sensitive, while the irregular mucosal pattern was the most specific.

Conclusions

Contrast enema showed moderate to high diagnostic accuracy for Hirschsprung disease in this biopsy-constrained setting and may be useful as a triage tool within a limited diagnostic pathway. However, its false negative rate indicates that it should not be used as a standalone rule-out test when histological confirmation is available.

Regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes: a systematic review with meta-analysis and trial sequential analysis

Por: Petersen · J. J. · Faltermeier · P. · Juul · S. · Kamp · C. B. · Sillassen · C. D. B. · Dos Santos · T. J. · Jakobsen · J. C.
Objectives

To assess the beneficial and harmful effects of regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes.

Design

Systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.

Data sources

CENTRAL, MEDLINE, Embase, LILACS and other sources from inception to 30 January 2026.

Study selection

Randomised clinical trials comparing regular human insulins versus rapid-acting insulin analogues (insulin aspart, lispro, glulisine) in children and adolescents with type 1 diabetes.

Analyses

Data were analysed using meta-analysis and trial sequential analysis. Risk of bias was assessed using the Cochrane Risk of Bias tool, V.2, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Primary outcomes

Severe hypoglycaemia, ketoacidosis and serious adverse events.

Results

10 trials randomising 1107 participants were included. The certainty of evidence was very low mainly due to high risk of bias and small sample sizes. Meta-analysis showed no evidence of a difference between regular human insulins and rapid-acting insulin analogues on severe hypoglycaemia (risk ratio (RR) 1.28, 95% CI 0.81 to 2.03; I2=0.0%; p=0.2851; nine trials), ketoacidosis (RR 0.88, 95% CI 0.26 to 2.93; I2=0.0%; p=0.8593; two trials) and serious adverse events (RR 1.00, 95% CI 0.44 to 2.25; I2=0.0%; p=0.9958; two trials). Trial sequential analysis showed that all meta-analyses of primary outcomes were underpowered.

Conclusions

Current research shows no differential effects between regular human insulins and rapid-acting insulin analogues for children and adolescents with type 1 diabetes, but the evidence is very uncertain.

PROSPERO registration number

CRD42024508625.

How does prior infection and vaccination relate to the risk of incident SARS-CoV-2 infection/reinfection? A prospective cohort study among nine clinical sites in the USA, February 2021 to January 2023

Por: Judge · A. · Beidelman · E. T. · Allison · D. B. · Dickinson · S. · Gadde · K. M. · Golzarri Arroyo · L. · Ioannidis · J. P. · Macagno · A. L. · Macy · J. T. · Maki · K. C. · Perlman · S. · Ricciardi · M. J. · Rosenberg · M. · Ludema · C.
Objective

To estimate the relative effectiveness of vaccination (0, 1, 2, ≥3 doses) and prior infection, in combination, on risk of SARS-CoV-2 infection/reinfection.

Design

Prospective cohort study.

Participants

We recruited participants for the Aegis Study from nine clinics across five US states. Participants must have been 18 years or older, had a history of a positive PCR for SARS-CoV-2, SARS-CoV-2 antigen or antibody test for SARS-CoV-2 with documentation or had no suspected or documented prior SARS-CoV-2 infection, intended to remain in study area for the next 12 months, and had elevated risk of future SARS-CoV-2 exposure. Exclusion criteria included acute illness, contraindication to phlebotomy, use of immunosuppressants or receipt of systemic immunoglobulins.

Methods

We used extended Cox regression with robust standard errors to estimate the association between time-varying number of vaccine doses and baseline prior infection on risk of infection/reinfection among a prospective cohort of US adults between February 2021 and January 2023, accounting for censoring using inverse probability of censoring weights. Additionally, to quantify possible exposure misclassification of prior infection by comparing prior infection operationalised as (1) documented/self-reported prior infection and (2) documented/self-reported prior infection plus nucleocapsid antibody indication of prior infection.

Results

Of n=2178 who completed enrolment, n=1887 adults (63% female; 65% non-Latino White) contributed 366 905 days of observation. Participants contributed an average of 7.2 months of follow-up between February 2021 and January 2023. 28% (n=533) of individuals were infected or reinfected during the study period. Similar relative effectiveness was observed between the two different operationalisations of prior infection. After correction for prior infection status in the nearly 16% of those without study documentation of prior infection who had nucleocapsid antibody levels comparable to documented cases, relative to the unvaccinated with no prior infection, estimated effectiveness generally increased with increasing vaccine doses and prior infection (without prior infection: one (17%, 95% CI –31% to 47%), two (49%, 95% CI 31% to 63%), ≥three (71%, 95% CI 58% to 80%) vaccine doses; with prior infection: none (56%, 95% CI 30% to 72%), one (71%, 95% CI 42% to 86%), two (65%, 95% CI 49% to 76%), ≥three (80%, 95% CI 68% to 88%) vaccine doses). Pairwise comparisons at each vaccine dose (ref: no prior infection) revealed that prior infection provided additional protection, with stronger relationships for no and one dose (none: 56% (95% CI 30% to 72%), one: 66% (95% CI 28% to 84%), two: 31% (95% CI 7% to 49%), ≥three 31% (95% CI 0% to 53%)). There was a marked decrease in the protection offered by vaccination, prior infection, or both in the Omicron period versus pre-Omicron period.

Conclusion

In our real-world observational sample, vaccination (with two and ≥three vaccine doses of any Food and Drug Administration Emergency Use Authorization approved vaccine) and prior infection conferred benefits for protection against infection/reinfection. Re-classification of prior infection status based on antibody levels had little effect on results.

Randomised, sham-controlled, double-blinded, multicentre international trial to evaluate the efficacy of the Ventfree Respiratory Muscle Stimulator to assist ventilator weaning in critically ill patients: a study protocol of a randomised controlled trial

Por: McCaughey · E. J. · McLachlan · A. J. · Cai · J. · Cohen Freue · G. · Demoule · A. · Gotur · D. B. · Hill · N. S. · Dimatteo · C. · Oliva · S. P. · Patel · M. B. · Girard · T. D. · Heunks · L.
Introduction

Nearly half of patients who receive invasive mechanical ventilation for acute respiratory failure require over 4 days of ventilator support, each day of which is associated with increased morbidity, mortality and cost. Many of these patients develop expiratory muscle atrophy and weakness, which are linked to failed extubation and weaning. We seek to test the hypothesis that exhalation synchronised abdominal functional electrical stimulation reduces mechanical ventilation duration.

Methods and analysis

This pivotal superiority trial will be performed in up to 30 intensive care units (ICUs) in the USA, France, the Netherlands and Australia. Adults (≥22 years old) who have been mechanically ventilated for 24–96 hours and are expected to remain ventilated for another 24+ hours are potentially eligible. We will recruit participants until 150 successful liberations from mechanical ventilation occur. To achieve this, we estimate that a maximum of 272 participants will be randomised in a 1:1 ratio to receive 30 min of active exhalation synchronised abdominal functional electrical stimulation (vs sham). The intervention will be applied using the VentFree Respiratory Muscle Stimulator two times per day, a minimum of 5 days per week, for a maximum of 28 days or until ICU discharge. The primary outcome is time from first intervention to successful liberation from mechanical ventilation. Secondary outcomes include cough peak flow (CPF) and maximum expiratory pressure (MEP) at 24 hours post-extubation, hospital and ICU length of stay, reintubations, complications, ICU readmissions, 90-day mortality and quality of life. The participant, clinical team and outcome assessor are blinded to group allocation. A positive outcome has the potential to improve patient-centred outcomes in ICUs.

Ethics and dissemination

This study was approved by local ethics institutions in the USA, Australia, France and the Netherlands. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. The results will be disseminated through peer-reviewed journal publications, conference presentations and clinicaltrials.gov updates. Individual country-level approvals are as follows:

France:

  • Ethics committee: Comité de Protection des Personnes Ile-de-France X.

  • Reference numbers: CPP 27-2024; RCB 2024-A00559-38.

  • Initial approval date: 14 May 2024.

  • Australia:

  • Ethics committee: South Eastern Sydney Local Health District Human Research Ethics Committee.

  • Reference number: 2022/ETH02724.

  • Initial approval date: 21 March 2023.

  • Netherlands:

  • Ethics committee: Medisch Ethische Toetsings Commissie Erasmus MC.

  • Reference numbers: MEC-2023-0364; NL84195.000.23.

  • Initial approval date: 30 April 2024.

  • USA:

  • Ethics committee: WCG IRB.

  • IRB tracking number: 20214073.

  • Initial approval date: 13 March 2023.

  • All participating sites are currently approved and operating under protocol version 09 or later.

    Trial registration number

    NCT05759013. Registered 8 March 2023.

    Development and acceptability of a patient decision aid for people with degenerative cervical myelopathy: an international mixed-methods study

    Por: Gamble · A. R. · Anderson · D. B. · McKay · M. J. · Davies · B. · Macpherson · S. · Van Gelder · J. · Hoffmann · T. · McCaffery · K. · Stevens · S. X. · Ammendolia · C. · Chauhan · R. V. · Zipser · C. M. · Boerger · T. F. · Tetreault · L. A. · Fehlings · M. G. · Dustan · E. · Nugent · C
    Objectives

    To develop and user-test a patient decision aid for people diagnosed with degenerative cervical myelopathy and who are considering surgery.

    Design

    Mixed-methods study describing the development of a patient decision aid.

    Setting

    A draft decision aid was developed by a multidisciplinary steering group (including study authors with degenerative cervical myelopathy, health professionals and researchers) informed by the best available evidence, authorship consensus and existing patient decision aids.

    Participants

    Patient-participants and health professional-participants who manage people with degenerative cervical myelopathy were recruited through social media and the steering group’s research and practice network. Quantitative questionnaires were used to gather baseline data, descriptive feedback, refine the decision aid and assess its acceptability. Qualitative semi-structured interviews were conducted online to gather feedback on the decision aid and were analysed using reflexive thematic analysis.

    Results

    We conducted 32 interviews: 19 patient-participants and 13 health professional-participants who manage people with degenerative cervical myelopathy (neurosurgeons, neurologists, physiotherapists, orthopaedic surgeons, general practitioners, rehabilitation and pain specialists and consultant occupational physicians and chiropractors). Participants were from 10 countries (Australia, Canada, Cyprus, Germany, Ireland, New Zealand, Sweden, Switzerland, United Kingdom and USA). Most participants rated the decision aid’s acceptability as good-to-excellent and agreed with most aspects of the decision aid (eg, defining degenerative cervical myelopathy, management recommendations, potential benefits and harms, questions to consider asking a health professional).

    Conclusion

    Our patient decision aid was rated as an acceptable tool by both health professional-participants who treat degenerative cervical myelopathy and patient-participants with lived experience of degenerative cervical myelopathy. This decision aid can be used by clinicians and people with degenerative cervical myelopathy to help with shared decision making following a diagnosis of degenerative cervical myelopathy. A study testing the potential benefits of this decision aid in a clinical setting is recommended.

    Accelerating diagnosis of degenerative cervical myelopathy through improved education: a mixed-methods study protocol from Myelopathy.org RECODE-DCM to define stakeholders, knowledge requirements and an optimal intervention strategy

    Por: Veremu · M. · Deakin · N. · Chauhan · R. V. · Lantz · J. M. · Toumbas · G. · Tabrah · J. · Kumar · V. · Zipser · C. M. · Plener · J. · Ammendolia · C. · Anderson · D. B. · dos Santos Rubio · E. J. · Tetreault · L. · Parnaik · R. · Rodrigues-Pinto · R. · Ongwen · O. M. · Sarewitz · E. · S
    Introduction

    Outcomes for degenerative cervical myelopathy (DCM) patients are limited by delayed and missed diagnoses, driven in part by poor professional awareness. Despite DCM being the most common cause of adult spinal cord injury, it remains under-recognised and undertaught in clinical education. Lessons from other common pathology like stroke and acute myocardial infarction highlight the potential of education to improve early diagnosis. This study will develop a professional education strategy to improve early DCM diagnosis. It will define key audiences and identify an effective delivery method, laying the groundwork for a sustained, targeted intervention.

    Methods and analysis

    The study aims to define who needs to know about DCM, what they need to know and how they can learn it. This will be carried out in three phases: phase 1—who and what: to establish the target population and to define core competencies for the educational intervention; phase 2—how: to create and review the educational intervention; phase 3—evaluation: to test whether the framework is an improvement to existing strategies.

    Ethics and dissemination

    Ethical approval is in place from the University of Cambridge (HBREC.2024.24). Results from the study will be disseminated through scientific publication, conference presentation, blog posts and podcasts.

    PROSPERO registration number

    CRD42023461838

    Dissemination of study results to participants in mental health research: a meta-research review of studies published in high-impact psychiatry journals

    Por: Pierson · G. · Nassar · E.-L. · Adams · C. · Boruff · J. · Nordlund · J. · Hu · S. · Rice · D. B. · Thombs-Vite · M. · Co · N. · Cook · V. · Thombs · B. D.
    Objectives

    We surveyed authors of publications in high-impact psychiatry journals to assess the (1) proportion that disseminated results to study participants or others with lived experience, and, among those who disseminated, (2) methods (eg, email) and (3) tools (eg, plain-language summary) used.

    Design

    Meta-research review.

    Data source

    PubMed search on 14 December 2022 and emails to study authors for information on dissemination.

    Eligibility criteria

    Eligible studies collected primary human data and were published in psychiatry journals with 2021 impact factor ≥10.

    Data extraction and synthesis

    Study information was extracted by one investigator and validated by a second investigator, with conflicts resolved by consensus, with a third investigator consulted as necessary. We emailed authors approximately 2 years post-publication to ensure sufficient time had passed to share results. We estimated the proportion of authors that may have disseminated results to participants or others with lived experience, assuming that non-respondents (1) did not disseminate, (2) were half as likely to disseminate as respondents or (3) disseminated in the same proportion as respondents.

    Results

    Of 141 studies, 94 (67%) authors responded. Among respondents, 21 (22%) reported disseminating to study participants, and an additional 9 (10%) reported disseminating lay materials to people with lived experience (total of 30 studies, 32%). Overall, we estimated that 15% (95% CI 10% to 22%) to 23% (95% CI 17% to 30%) of authors may have disseminated results directly to study participants and 21% (95% CI 15% to 29%) to 32% (95% CI 25% to 40%) to participants or others with lived experience. Among the 30 that reported disseminating, the most common methods were sending mail or emails to study participants (17 studies, 57%) and posting on social media (15 studies, 50%). The most common tools were plain-language summaries (22 studies, 73%) and webinars or other meetings (15 studies, 50%).

    Conclusions

    Dissemination of results to participants in mental health research is uncommon. Funding agencies, ethics committees, journals and academic institutions should support dissemination.

    Association between weather, air quality and asthma-related emergency department visits: a retrospective time-series study in Singapore

    Por: Toh · M. R. · Wen · X. · Ng · G. X. Z. · Fun · A. Q. R. · Youxin · P. · Fong · L. · Wu · J. T. · Ong · M. · Matchar · D. B. · Tan · N. C. · Loo · C. M. · Sheikh · A. · Koh · M. S. · Lam · S. W.
    Objectives

    To evaluate the association between asthma-related emergency department (ED) visits and weather, air quality, monsoons, haze and cultural festivals in Singapore.

    Design

    Retrospective cohort study.

    Setting

    A public healthcare cluster that covers 20% of the nation’s adult asthma population.

    Participants

    2617 adult patients accounting for 5337 asthma ED visits between 2016 and 2024.

    Primary and secondary outcome measures

    Temperature, rainfall, wet bulb temperature (WBT), wind speed and Pollution Standards Index (PSI) were correlated with asthma ED counts at 0–7 day lags. Associations between ED visits and monsoons, transboundary haze and cultural festivals were evaluated using one-way analysis of variance. Weekly seasonal ARIMA models with exogenous regressors were fitted, incorporating PSI as a covariate and adjusting for demographic, clinical and socioeconomic factors.

    Results

    Asthma ED visits were positively correlated with PSI (lag 0: r=0.142; 95% CI 0.107 to 0.178) and inversely correlated with rainfall (lag 3: r=–0.062; 95% CI –0.099 to –0.026) and WBT (lag 1: r=–0.067; 95% CI –0.104 to –0.031). Wind speed (lag 2: r=–0.049; 95% CI –0.086 to –0.013) and ambient temperature (lag 6: r=–0.045; 95% CI –0.081 to –0.008) showed weaker inverse associations. Mean PSI was higher during haze (82.67 vs 51.46, p

    Conclusions

    PSI–ED association peaked on the same day of exposure but was no longer significant after adjusting for demographic and clinical factors. Pollution-linked festivals, transboundary haze and the Northeast monsoon were associated with increased asthma ED visits

    Effects of glucagon-like peptide-1 analogues on hard binary outcomes for patients at increased risk of cardiovascular events: a protocol for a systematic review with network meta-analysis and Trial Sequential Analysis

    Por: Sillassen · C. D. B. · Faltermeier · P. · Petersen · J. J. · Kamp · C. B. · Grand · J. · Dominguez · H. · Frolich · A. · Gaede · P. H. · Gluud · C. · Mathiesen · O. · Jakobsen · J. C.
    Background

    Cardiovascular diseases, overweight, type 2 diabetes and chronic kidney disease increase the risk of cardiovascular events.

    Glucagon-like peptide-1 analogues are recommended by the European Society of Cardiology and the American College of Cardiology to lower the risk of death and progression of cardiovascular disease in patients with cardiovascular disease and type 2 diabetes. Semaglutide, tirzepatide and liraglutide are approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of type 2 diabetes mellitus and overweight. CagriSema is currently not approved, but several phase III trials are ongoing.

    No previous systematic review has investigated the effects of semaglutide, tirzepatide, CagriSema and liraglutide, which may not be disease-specific, on hard binary outcomes for all trial populations at increased risk of cardiovascular events.

    Methods and analyses

    We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Latin American and Caribbean Health Sciences Literature, Science Citation Index Expanded, Conference Proceedings Citation Index—Science) and clinical trial registries from their inception and onwards to identify relevant randomised trials. We expect to perform the literature search in December 2025. Two review authors will independently extract data and assess the risk of bias. We will include randomised trials assessing the effects of semaglutide, tirzepatide, CagriSema and/or liraglutide in participants with an increased risk of cardiovascular events. The primary outcome will be all-cause mortality. Secondary outcomes will be myocardial infarction, stroke and all-cause hospitalisation. Data will be synthesised by aggregate data meta-analyses, Trial Sequential Analyses and network meta-analysis, risk of bias will be assessed with Cochrane Risk of Bias tool V. 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations and the Confidence in Network Meta-Analysis approach.

    Ethics and dissemination

    This protocol does not present any results. Findings of this systematic review will be published in international peer-reviewed scientific journals.

    PROSPERO registration number

    CRD42024623312.

    Exploring the influence of psychosociocultural factors on substance use among adolescent expectant mothers in Bolgatanga municipality: a qualitative study

    Por: Abagye · N. · Daliri · D. B. · Deegbe · D. A. · Adjorlolo · S. · Afaya · A.
    Background

    Substance use among adolescent expectant mothers is a significant public health concern due to its adverse effects on both maternal and fetal health. Despite this, there is limited evidence regarding the patterns and factors influencing substance use among pregnant adolescents in Ghana.

    Objective

    This study aimed to explore the psycho-social and cultural factors that influence substance use among adolescent expectant mothers attending the antenatal clinic at the Upper East Regional Hospital in the Bolgatanga municipality.

    Design

    A qualitative, descriptive exploratory design was employed. 17 adolescent expectant mothers were purposively recruited and interviewed using a researcher-developed semistructured guide. Interviews were audio-recorded, transcribed verbatim and analysed using a six-step thematic analysis guided by a deductive approach. The study was underpinned by the socioecological model, which allowed for the exploration of knowledge, social and cultural factors influencing substance use during pregnancy.

    Setting and participants

    The study was conducted at the antenatal clinic of the Upper East Regional Hospital in Bolgatanga and involved adolescent expectant mothers attending the clinic.

    Results

    Analysis revealed three major themes: knowledge of substance use, social factors and cultural factors influencing substance use. Participants demonstrated understanding of substance use, including its definition, causes and potential consequences. Social influences, particularly peer pressure and family dynamics, were reported as motivating factors for substance use. Cultural factors, including local beliefs, practices and community attitudes, also played a significant role in shaping substance use behaviours among these adolescents.

    Conclusion

    The findings indicate that while adolescent expectant mothers possess knowledge about the risks and consequences of substance use during pregnancy, many continue to engage in such behaviours. Peer and family influences, alongside cultural beliefs and community attitudes, were identified as key drivers of substance use. These results highlight the need for targeted, culturally sensitive substance use education and intervention programmes within antenatal clinics and the broader community to support adolescent mothers in reducing substance use during pregnancy.

    Intraoperative nursing workload and associated factors: a cross-sectional analysis from two Brazilian hospital surgical units

    Por: Constante · E. C. · Poveda · V. d. B. · Oliveira · R. A.
    Objective

    To estimate the workload of the nursing team and its associated factors during the intraoperative period for adult patients undergoing elective and urgent/emergency surgeries.

    Design

    Cross-sectional study.

    Setting

    Surgical units of two hospitals in Brazil.

    Data sources and sample size

    We prospectively assessed the workload using the National Aeronautics and Space Administration – Task Load Index (NASA-TLX) score and analysed the electronic medical records of patients who agreed to participate in the study, from November 2023 to February 2024. We included data from 116 nursing professionals and 402 surgeries.

    Results

    Among the procedures analysed, the median raw NASA-TLX score in cardiac surgery was significantly higher (60.8; IQR 40.0–72.5 points) compared with the others. We observed that in the generalised linear model procedures over minutes presented around 25% greater workload compared with 120 min surgeries (1.252; 95% CI 1.1018 to 1.549) and patients classified as American Society of Anesthesiologists (ASA) physical status classification (ASA) III and IV exhibited approximately 24% higher workload compared with those classified as ASA I (1.241; 95% CI 1.003 to 1.550).

    Conclusions

    Surgical length and ASA physical status influence the workload. Thus, we suggest that surgical unit leaders give special attention to long-term surgical procedures and patient severity on perioperative workload when dimensioning nursing staff.

    Feasibility of implementing a non-invasive self-sampling method for saliva specimens that can be used for the diagnosis of respiratory infections among paediatric patients in the Tshwane District, South Africa: a study protocol

    Por: Nxele · S. · Dlangalala · T. · Gxekwa · N. V. · Ramatsokotla · S. · Musekiwa · A. · Kgatle · M. M. · Hatchett · D. B. · Shin · A. · Tu · W.-c. · Robertson · I. H. · Su · X. · Berthier · E. · Thongpang · S. · Theberge · A. B. · Mashamba-Thompson · T. P.
    Introduction

    Effective community-based disease management is essential for public health. In low- and middle-income countries, sustainable strategies for timely diagnosis and treatment are a research priority. This study aims to assess the feasibility of a non-invasive saliva self-sampling method, paired with digitally linked molecular point-of-care diagnostics, for detecting respiratory infections among paediatric patients in the Tshwane District, South Africa.

    Methods and analysis

    A field study will be conducted at Steve Biko Academic Hospital to compare saliva collection using the CandyCollect lollipop device and standard mouth swabs. The spiral groove of the lollipop device captures pathogens, which are stored in DNA/RNA preservation media and later analysed using quantitative PCR and commercially available rapid antigen tests. The multiplex respiratory pathogen panel, based on TaqMan real-time PCR technology, targets key paediatric pathogens including Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, respiratory syncytial virus (RSV) and influenza A/B. Nucleic acids will be extracted using standard viral extraction kits and analysed following manufacturer protocols. Internal controls will be included in each qPCR run, and samples with CT values below defined thresholds will be considered positive. Rapid antigen tests will detect common pathogens such as influenza A/B, RSV and SARS-CoV-2 for comparative analysis. User experience and acceptability will be assessed via child-friendly and caregiver surveys following sample collection. The study will be implemented in two phases: diagnostic performance evaluation and user feedback assessment. The protocol is aligned with the Standard Protocol Items: Recommendations for Interventional Trials 2013 checklist.

    Ethics and dissemination

    Ethical approval has been granted by the University of Pretoria (509/2023) and the Gauteng Department of Health (GP_202406_032). The study is registered in the Pan African Clinical Trial Registry (PACTR202411743094783). Findings will be disseminated through peer-reviewed journals, conferences and stakeholder briefings. The study complies with South Africa’s Protection of Personal Information Act. Data collection is scheduled from November 2024 to February 2025, with project completion expected within 1 year.

    Trial registration number

    Pan African Clinical Trial Registry (PACTR202411743094783).

    Patterns of follow-up testing of abnormal eGFR and UACR for the detection of chronic kidney disease in Australian primary care: analysis of a national general practice dataset

    Por: Li · A. K. · Kotwal · S. · Wallace · H. · Ketema · D. B. · Wick · J. · Neuen · B. L. · Falster · M. O. · Lin · J. · Pearson · S.-A. · Peiris · D. · Jardine · M. J. · Woodward · M. · Chalmers · J. · Ronksley · P. E. · Jun · M.
    Objective

    To evaluate the patterns of abnormal estimated glomerular filtration rate (eGFR) and urine albumin–creatinine ratio (UACR) follow-up testing for the detection of chronic kidney disease (CKD) in Australian general practices.

    Design

    Retrospective, population-based observational study.

    Setting and participants

    2 717 966 adults who visited a MedicineInsight participating general practice between 1 January 2012 and 31 December 2020, had ≥1 serum creatinine measurement (with or without a UACR measurement) and did not have CKD at baseline.

    Main outcome measure

    ‘Guideline-concordant follow-up’ was defined as having a record of a repeat eGFR or UACR testing (assessed separately) within 6 months following the abnormal (eGFR2; UACR≥2.5 mg/mmol in males, ≥3.5 mg/mmol in females) incident result. Multivariable logistic regression was used to identify patient factors associated with receiving appropriate follow-up testing.

    Results

    A total of 220 841 and 114 889 patients with an abnormal incident eGFR and UACR result, respectively, were identified. Nearly half (45.0%) of the patients with an abnormal eGFR result and over two-thirds (69.7%) of the patients with an abnormal UACR result did not have a follow-up test within 6 months. Patient factors associated with a higher likelihood of follow-up eGFR testing included indicators of poorer baseline health and greater CKD risk, such as comorbid diabetes (adjusted OR 1.36, 95% CI 1.32 to 1.40) or more severe incident eGFR (adjusted ORs for eGFR categories 30–44, 15–29 and

    Conclusions

    In this large, population-based study, we observed substantial gaps in the follow-up of abnormal eGFR and UACR for the detection of CKD in primary care settings. Effective strategies to optimise follow-up testing for CKD detection are needed.

    Association between smartphone screen time and fast food intake among adolescents: a cross-sectional survey

    Por: Kim · D. B. · Kim · S. Y. · Yun · I. · Park · E.-C. · Jang · S.-Y.
    Objective

    Despite growing concerns regarding the impact of smartphone use on adolescents' lifestyle, there is a notable lack of studies utilising national data to explore how smartphone use influences eating habits in this age group. We aimed to investigate the association between smartphone screen time and fast food intake using representative data from Korean adolescents.

    Design

    Cross-sectional survey.

    Setting

    This cross-sectional analysis used data from the 2017 Korean Youth Risk Behavior Web-based Survey (KYRBS). We used Poisson regression to directly estimate prevalence ratios (PRs) rather than using logistic regression as odds ratios (ORs) tend to overestimate PRs when the outcome is common. Smartphone screen time was categorised into four groups based on the daily time spent using smartphones:

    Participants

    Data from 39 753 individuals were included.

    Primary outcome measures

    The primary outcome was the frequency of fast food intake, assessed via a self-reported survey that asked: "In the past 7 days, how often did you eat fast food such as pizza, hamburgers, fried chicken, or drink carbonated beverages?". Participants were categorised into two groups based on their median intake: infrequent (≤2 times/week) and frequent (≥3 times/week).

    Results

    Among 39 753 adolescents, 19 273 reported frequent fast food intake (10 162 (51.9%) boys, 9111 (45.1%) girls), while 20 480 reported infrequent intake (9409 (48.1%) boys, 11 071 (54.9%) girls). The probabilities that adolescents who used smartphones for 6 hours daily would have frequent fast food intake were 1.29 times (95% CI: 1.28 to 1.30) among boys, and 1.43 times (95% CI: 1.42 to 1.44) higher among girls, compared with adolescents who used smartphones for 2 hours daily.

    Conclusion

    The association between prolonged smartphone screen time and frequent fast food intake in adolescents suggests the need for targeted interventions addressing digital media use to promote healthier eating behaviors.

    Antipsychotics for Parkinsons disease: a protocol for a systematic review with network meta-analysis and trial sequential analysis

    Por: Petersen · J. J. · Kamp · C. B. · Juul · S. · Bjerg · J. L. · Sillassen · C. D. B. · Faltermeier · P. · Salvesen · L. · Hejl · A.-M. · Bech · S. · Lokkegaard · A. · Jakobsen · J. C.
    Introduction

    Parkinson’s disease is a neurological disease with a rising incidence and prevalence. Patients with Parkinson’s disease may receive antipsychotics, for example, due to Parkinson’s disease psychosis. Parkinson’s disease psychosis is characterised by visual hallucinations and other psychotic symptoms. To date, no systematic review has evaluated the effects of antipsychotics in patients with Parkinson’s disease. Therefore, this review aims to assess the beneficial and harmful effects of antipsychotics for Parkinson’s disease.

    Methods and analysis

    This is a protocol for a systematic review. A search specialist will perform a search in major medical databases (eg, MEDLINE (Medical Literature Analysis and Retrieval System Online), EMBASE (Excerpta Medica database), CENTRAL (Cochrane Central Register of Controlled Trials)) and clinical trial registries. Published and unpublished randomised clinical trials comparing antipsychotics to any control (placebo, standard care or other antipsychotics) in patients with Parkinson’s disease will be included. Two review authors will independently extract data and conduct risk of bias assessments with the Cochrane Risk of Bias tool—V.2. Primary outcomes will be all-cause mortality, serious adverse events and significant falls. Secondary outcomes will be hospitalisations, non-serious adverse events, Unified Parkinson’s Disease Rating Scale total score and psychotic symptoms using any valid symptom scale. Data will be synthesised by aggregate meta-analysis, trial sequential analysis and network meta-analysis. Several subgroup analyses are planned. An eight-step procedure will be used to assess if the thresholds for clinical significance are crossed, and the certainty of the evidence will be assessed by GRADE (Grading of Recommendations Assessment, Development and Evaluations) and CiNeMA (Confidence in Network Meta-Analysis) approach.

    Ethics and dissemination

    This protocol does not include results, and ethics approval is not required for the project. The findings from the systematic review will be published in international peer-reviewed scientific journals.

    PROSPERO registration number

    PROSPERO ID: CRD42025633985. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD42025633985.

    Cardiovascular effects of incretin-based drugs in patients with and without a history of heart failure: a protocol for a systematic review, meta-analysis and trial sequential analysis of randomised controlled trials

    Por: El-Sheikh · M. · Sillassen · C. D. B. · Wisborg · F. D. · Hove · J. D. · Dirksen · C. · Lee · M. M. Y. · Jakobsen · J. C. · Grand · J.
    Background

    Incretin-based drugs, including glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RAs, are increasingly used in the management of type 2 diabetes mellitus and obesity. While these agents have shown cardiovascular benefits, their effects on both cardiovascular outcomes and cardiac structure and function remain uncertain—particularly in patients with and without a history of heart failure (HF).

    Methods and analysis

    We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index-Science (CPCI-S)), as well as clinical trial registries from their inception and onwards to identify relevant randomised trials. The literature search is scheduled for July 2025. Two review authors will independently extract data and assess risk of bias. We will include randomised controlled trials assessing the effects of cagrilintide/semaglutide, liraglutide, semaglutide and tirzepatide in patients with and without a history of HF. The primary outcome will be cardiovascular mortality. Secondary outcomes will include HF hospitalisation, myocardial infarction, stroke, heart rate, systolic blood pressure, N-terminal pro B-type natriuretic peptide, left ventricular ejection fraction, left ventricular end-diastolic volume and left ventricular end-systolic volume. Data will be synthesised by aggregate data meta-analyses and trial sequential analysis. Risk of bias will be assessed with the Cochrane Risk of Bias tool, version 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations (GRADE).

    Ethics and dissemination

    As this study is a systematic review based on secondary analysis of published data, ethical approval is not required. Findings will be published in international peer-reviewed scientific journals.

    PROSPERO registration number

    CRD420251003374.

    Transcranial direct current stimulation combined with physical exercise in knee osteoarthritis: a protocol for a randomised controlled clinical trial

    Por: Lima · V. B. · Silva · C. A. M. · Silva · S. G. D. d. · Macedo · L. d. B. · de Souza · M. C. · Lins · C. A. d. A. · de Souza · C. G.
    Introduction

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

    Methods and analysis

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

    Ethics and dissemination

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

    Trial registration number

    Brazilian Clinical Trials Registry (RBR-5pb2g33).

    Quality of care for people with chronic kidney disease: a systematic review and meta-analysis

    Por: Ketema · D. B. · Wallace · H. · Hailu · W. · Badve · S. V. · Ronksley · P. · Neuen · B. L. · Pecoits-Filho · R. · Gallagher · M. · Kotwal · S. · Perkovic · V. · Joshi · R. · Jun · M.
    Objectives

    Guideline-based strategies to prevent chronic kidney disease (CKD) progression and complications are available, yet their implementation in clinical practice is uncertain. We aimed to synthesise the available evidence on the concordance of CKD care with clinical guidelines to identify gaps and inform future CKD care.

    Design

    Systematic review and meta-analysis.

    Data sources, participants, and outcomes

    We systematically searched MEDLINE (OVID), EMBASE (OVID) and CINAHL (EBSCOhost) (to 18 July 2025) for observational studies of adults with CKD reporting data on the quality of CKD care. We assessed data on quality indicators of CKD care across domains that related to patient monitoring (glomerular filtration rate and albuminuria), medications use (ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), statins) and treatment targets (blood pressure (BP) and HbA1c). Pooled estimates (95% CI) of the percentage of patients who met the quality indicators for CKD care were estimated using random effects model.

    Results

    59 studies across 24 countries, including a total of 3 003 641 patients with CKD, were included. Across studies, 81.3% (95% CI: 75% to 87.6%) of patients received eGFR monitoring, 47.4% (95% CI: 40.0% to 54.7%) had albuminuria testing, and 90% (95% CI: 84.3% to 95.9%) had BP measured. ACEIs/ARBs were prescribed among 56.7% (95% CI: 51.5% to 62%), and statins among 56.6% (95% CI: 48.9% to 64.3%) of patients. BP (systolic BP ≤140/90 mm Hg) and HbA1c (

    Conclusions

    Current evidence shows substantial variation in CKD care quality globally. Guideline-concordant care varied according to quality measures and across patient groups, with gaps in indicators like albuminuria testing. These findings underscore the need for effective quality improvement strategies to address gaps in CKD care, including increased albuminuria testing for risk stratification, together with systematic measures for monitoring care quality.

    PROSPERO registration number

    CRD42023391749.

    The Economic and societal burden associated with drug-resistant epilepsy in the Netherlands: an AIM@EPILEPSY burden-of-disease study protocol

    Por: Elabbasy · D. · Evers · S. · Majoie · M. H. J. M. · Schijns · O. E. M. G. · MRabet · L. · van Kranen-Mastenbroek · V. H. J. M. · Eekers · D. B. P. · Houben · R. · Hendriks · M. · Colon · A. · van Mastrigt · G. A. P. G.
    Background

    Living with epilepsy, especially drug-resistant epilepsy (DRE), imposes several challenges for people diagnosed with the condition. These challenges include the physical and mental implications of epilepsy on both caregivers and patients with epilepsy. For the more than 120 000 individuals living with this neurological disorder in the Netherlands, along with their families, daily activities become hazardous, limited and costly, significantly affecting their health-related quality of life (HRQoL). As data on the burden of epilepsy in the Netherlands are lacking, studies attempting to capture the impact of epilepsy on individuals, caregivers and society are needed to enhance understanding and help address the burden of epileptic seizures.

    Methods and analysis

    The study is part of the AIM@EPILEPSY project. The project aims to develop a planning suite enabling cost-saving, minimally invasive treatment for epilepsy. By surveying 330 people with epilepsy and an anticipated sample of 150–200 informal caregivers across the Netherlands, using standardised questionnaires focusing on associated societal costs and the impact on HRQoL, this bottom-up, prevalence-based prospective study aims to understand the societal burden of DRE in the Netherlands. The data will be collected at 0, 3, 6 and 12 months of follow-up. The study results will describe the economic impact of epilepsy, focusing on cost-of-illness () and HRQoL (utilities) in the Netherlands.

    Ethics and dissemination 

    The proposed study was approved by the Maastricht University Medical Ethics Review Committee (Approval reference: FHML-REC/2024/067/Amendment/2024_16). The result of the study is planned to be published in a peer-reviewed journal and presented at international and local scientific conferences.

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