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Hoy — Diciembre 16th 2025Tus fuentes RSS

Ensuring racial inclusion in research: the role of research ethics committees and patient and public involvement and engagement

Por: Dube · A. · Ataiyero · Y. · Jones · S.
Introduction

Although the UK is a multicultural society, racially minoritised populations are often under-represented in healthcare research owing to the significant barriers to participation they experience.1 Under-representation of racially minoritised groups in research impacts the quality of evidence and applicability of findings to these groups. This, in part, explains why these communities are more likely to report poorer health and poorer experiences of using healthcare services than their White counterparts,2 given that their cultural and spiritual preferences are often ignored.3 This commentary will explore some of the persistent multifaceted barriers and the role of research ethics committees (RECs) in enabling inclusive healthcare research among racially minoritised communities, given their key responsibility in building public confidence, ensuring ethical conduct and safeguarding research participants. In addition, patient and public involvement and engagement (PPIE) can complement the roles of RECs in embracing diversity in healthcare...

Association between the continuum of maternal healthcare services and child immunisation in East Africa: a propensity score matching analysis

Por: Gebrehana · A. K. · Abrham Asnake · A. · Seifu · B. L. · Fente · B. M. · Bezie · M. M. · Asmare · Z. A. · Tsega · S. S. · Negussie · Y. M. · Asebe · H. A. · Melkam · M.
Objective

To assess the association between the maternal continuum of healthcare and child immunisation in East Africa using propensity score matching (PSM).

Design

Cross-sectional study using Demographic and Health Survey data.

Setting

This study was conducted in East African countries.

Participants

This study included a weighted sample of 13 488 women with children aged 12–23 months.

Outcome measure

Child immunisation was the outcome variable of this study.

Results

The PSM estimates indicate that the average treatment effect on the treated for complete child immunisation was 0.0583, meaning that children of mothers who received a complete maternal continuum of care had a 5.83% higher probability of being fully immunised compared with children of mothers with incomplete care. Expressed relative to the treated group’s mean, this corresponds to a 7.48% increase. Additionally, our results indicated that the population average treatment effect was 0.0629. This means that, on average, a complete continuum of maternal healthcare increases the probability of full child immunisation by approximately 6.29% across the entire population.

Conclusion

The study highlights that children whose mothers receive comprehensive maternal healthcare are more likely to complete their childhood immunisations. This finding underscores the need to integrate immunisation services into maternal healthcare programmes to enhance vaccination coverage and promote better child health. To maximise this connection, improving access to maternal healthcare, especially in underserved regions, is crucial, along with ensuring that immunisation is a regular part of maternal care.

Longitudinal analysis of an actor-partner interdependence model of recurrent fear and depressive symptoms in elderly patients and caregivers after postoperative adjacent vertebral refracture: a prospective longitudinal study in China

Por: Du · P. · Chen · Y. · Zhong · X. · Li · R.
Objective

This study aims to examine the longitudinal relationship between fear of disease recurrence and depressive symptoms in elderly patients who have experienced postoperative adjacent vertebral refractures, as well as in their spouses, using the actor-partner interdependence model (APIM) to assess both individual and mutual psychological influences.

Design

A prospective longitudinal study in China.

Participants

A total of 230 osteoporotic vertebral compression fractures (OVCF) and their spouses were selected by convenience sampling method.

Methods

Simplified fear disease Progression Scale and 9-item Patient Health Questionnaire were used at admission (T1), before discharge (T2) and 1 month after discharge (T3), respectively. Equivalence test and cross-lagged analysis of APIM were used for statistical examination.

Results

A total of 224 valid questionnaires were collected in this study, yielding an effective recovery rate of 97.31%. Across the measurement stages, both patients and their spouses exhibited a decreasing trend in scores for fear of disease recurrence and depressive symptoms. The subjective effect analysis revealed that, in elderly patients with postoperative adjacent vertebral refracture, fear of disease recurrence significantly and positively predicted depressive symptoms at the subsequent stage (T1->T2: β=0.18, T2->T3: β=0.17, pT2: β=0.16, T2->T3: β=0.17, pT2: β=0.21, T2->T3: β=0.20, pT2: β=0.20, pT3: β=0.18, pT2: β=0.21, T2->T3: β=0.20, pT2: β=0.17, T2->T3: β=0.16, all p

Conclusions

It is recommended that medical staff prioritise the assessment and management of fear of disease recurrence and depressive symptoms in elderly patients with OVCF and their spouses, and strategically leverage the mutual influence between them to minimise depressive symptom levels as much as possible.

Epidemiological investigation and patterns of antimicrobial use in multidrug-resistant bacteria at a tertiary hospital: a retrospective cohort study

Por: Wang · M. · Cao · Y. · Zhang · J.-H. · Ma · S.-N. · Wang · Y. · Miao · T. · Xiao · W. · Fu · Q.
Objective

To analyse trends and characteristics of multidrug-resistant (MDR) bacteria over the past 7 years, in relation to patterns of antimicrobial use, to inform rational antimicrobial use and strengthen hospital infection control measures.

Design

Retrospective cohort study.

Setting

A large teaching hospital in Tianjin, a major metropolitan city in northern China.

Participants

A total of 190 352 inpatients aged >18 years, admitted between 1 January 2017 and 31 December 2023, were included. Patients were eligible if they had complete clinical data and met the five quality control indicators for multidrug-resistant bacteria (QC-MRB), defined in the ‘Hospital Infection Surveillance Specifications’ (WS/T 312–2023). Patients with MDR infections before admission or those with duplicate results from multiple specimens were excluded.

Results

Statistical analysis revealed a detection rate of 12.11% for the five QC-MRB and an incidence rate of 0.20%. The findings also indicated an upward trend in the detection and incidence rates of carbapenem-resistant Enterobacteriaceae, despite a relatively stable rate of antimicrobial use over 7 years. A positive correlation was observed between the incidence of MDR bacteria and the intensity of antimicrobial use within the hospital setting.

Conclusions

The hospital’s bacterial data align with national trends. It established an interdisciplinary management framework for clinical data analysis and prediction of antimicrobial resistance. This approach enhances infection control measures and supports the rational use of antimicrobials.

Effects and safety of dapagliflozin in paediatric hereditary kidney disease: protocol for a multicentric, prospective, open and randomised crossover study (DAPA-PedHKD)

Por: Zhang · W. · Dou · Y. · Liu · J. · Liu · T. · Yan · W. · Shen · Q. · Xu · H. · Zhai · Y.
Introduction

Sodium-glucose cotransporter-2 inhibitors have demonstrated cardiorenal protective effects in adults with chronic kidney disease (CKD), but their efficacy and safety in paediatric CKD remain uncertain. Treatment for hereditary kidney disease in children is limited. This DAPA-PedHKD study aims to evaluate the effectiveness and safety of combining renin-angiotensin-aldosterone system inhibitors (RAASi) with dapagliflozin compare to RAASi alone in children with hereditary kidney disease accompanied by proteinuria.

Methods and analysis

DAPA-PedHKD is a multicentre, randomised, crossover, open-label clinical trial. Patients aged 6–18 years with hereditary kidney disease will be eligible. All patients must have received stable RAASi therapy for at least 4 weeks, with a baseline estimated glomerular filtration rate (eGFR) of ≥60 mL/min/1.73 m2, and either a 24-hour urinary protein level of >0.2 g or a urinary protein-to-creatinine ratio (UPCR) of >0.2 mg/mg. Participants will be randomised in a 1:1 ratio to receive either dapagliflozin in addition to standard RAASi therapy or RAASi therapy alone for 12 weeks. After a 4-week washout period with continued RAASi therapy, participants will crossover to the other treatment for another 12 weeks. Outcome assessments will be conducted at baseline and at weeks 2, 6, 12, 16, 18, 22 and 28. The primary outcome is the change in 24-hour urinary protein excretion from baseline to week 12. Secondary outcomes include changes in the UPCR, urinary albumin-to-creatinine ratio, serum albumin, eGFR, blood pressure and body weight from baseline to week 12. Neither participants nor investigators are blinded to treatment allocation, and placebo control is not used.

Ethics and dissemination

This study has been approved by the Ethics Committee of the Children’s Hospital of Fudan University and 11 local ethics committees. We will publish results in peer-reviewed journals and present at international conferences.

Trial registration number

NCT06890143.

High-dose intermittent theta burst stimulation targeting the individualised frontoparietal cognitive network for post-stroke cognitive impairment: protocol for a randomised sham-controlled trial in China

Por: Han · K. · Zhou · Y. · Huang · J. · Ren · J. · Lu · H. · Liao · X. · Zhu · Y. · Zhang · H. · Liu · H.
Introduction

Cognitive impairment is a common consequence after stroke. Intermittent theta burst stimulation (iTBS) has emerged as a promising cognitive therapy. However, traditional iTBS typically employs lower doses and one-size-fits-all stimulation targets, which may not fully capitalise on the potential of this therapy and warrants further evaluation for both efficacy and safety. This study aims to evaluate the efficacy and safety of high-dose iTBS targeting the individualised frontoparietal cognitive network (FCN) identified by precision functional neuroimaging for post-stroke cognitive impairment (PSCI).

Methods and analysis

This is a prospective, double-blind, sham-controlled, parallel-group randomised controlled trial. 60 eligible participants with PSCI will be randomly assigned (1:1) to an active iTBS or a sham-controlled group. The active group will receive high-dose iTBS (3600 pulses/day) at 80% resting motor threshold targeting the left individualised FCN, guided by a real-time neuronavigation system. The sham group will follow identical procedures using a sham coil. Both groups will also undergo conventional computerised cognitive training. The intervention will be administered on workdays over a period of 3 weeks, totalling 15 workdays. The primary outcome is the change in Montreal Cognitive Assessment scores from baseline to immediately post-treatment. Secondary outcomes include long-term change in global cognition, activities of daily living and specific cognitive domains (assessed by a comprehensive neuropsychological battery covering memory, attention, executive function and language), as well as mood. Assessments occur at baseline, post-treatment and 3-month follow-up. Safety outcomes, specifically the number of adverse events related to iTBS, will be monitored and recorded throughout the trial.

Ethics and dissemination

This study has been approved by the Medical Ethics Committee of the China Rehabilitation Research Center. The results of this study will be published in peer-reviewed scientific journals and disseminated at academic conferences.

Trial registration number

NCT05953415.

Impact of atherosclerotic cardiovascular disease on mortality in ICU sepsis patients: a retrospective MIMIC-IV cohort study

Por: Chang · Y.-C. · Su · M.-I. · Hu · W.-P. · Liao · E.-C.
Objective

Evaluation of the impact of atherosclerotic cardiovascular disease (ASCVD), particularly polyvascular disease, on 30-day and 365-day mortality among intensive care unit (ICU) patients diagnosed with sepsis.

Design

Retrospective cohort study.

Setting

This study was conducted using data from the Medical Information Mart for Intensive Care IV, a publicly available critical care database from a tertiary care hospital in the US.

Participants

A total of 7895 adult ICU patients with sepsis were included between 2008 and 2022. Among them, 3314 (41.97%) had ASCVD, defined by International Classification of Diseases (ICD) codes for coronary artery disease, peripheral artery disease or stroke.

Outcome measures

The primary outcomes were all-cause mortality at 30 and 365 days following ICU admission.

Result

ASCVD patients with a greater number of disease beds tend to be male, older, have lower body mass index, heart rates, mean blood pressure, respiratory rate and temperature, compared with non-ASCVD patients. Before propensity-score matching, patients with ASCVD (3314) had significantly higher 30-day (29.21% vs 24.14%, p

Conclusion

Integrated management of sepsis and ASCVD—using targeted interventions such as tailored pharmacotherapy and risk factor modification—may reduce mortality and morbidity in this high-risk population.

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Developing policy on sugar-sweetened beverages for children and adolescents in China: a qualitative study of stakeholder views and perceptions

Por: Suo · Y. · Zang · J. · Wang · J. · Shen · Q. · Long · Q.
Objective

To explore stakeholder perceptions on sugar-sweetened beverage (SSB) policies for Chinese children and adolescents and facilitators and challenges for policy implementation.

Design

This study followed the sector governance analysis framework, which included three steps: context analysis, mapping stakeholders and stakeholder analysis. Context analysis comprised policy and literature reviews of existing domestic and international measures, complemented by expert consultation to clarify the policy context and identify relevant stakeholders. Guided by these insights, we mapped stakeholders for key informant interviews, in-depth interviews and focus group discussions to explore stakeholders’ perceptions of SSB policies. Qualitative data were collected and analysed through a thematic analysis approach.

Setting

Shanghai and Chongqing, China, July to August 2022.

Participants

37 stakeholders including policymakers, nutrition experts, industry and consumers (primary caregivers of children and adolescents aged 6–17 years).

Results

Context and stakeholder analyses indicated rising SSB consumption among Chinese youth since 2000. Qualitative interviews reflected the absence of national policies due to inadequate policymaker awareness. Although policymakers and nutrition experts supported SSB policies, consumers were worried about their personal choices being affected and the industry feared innovation challenges and profit loss. Multiple stakeholders mentioned that a comprehensive national standard is lacking, which is needed to facilitate national policy roll-out. An initial focus on health education is suggested to raise awareness among policymakers and consumers to foster a supportive environment for SSB policy development.

Conclusions

Although SSB intake is rising among Chinese children, policymakers’ insufficient awareness and the lack of national standards hinder SSB policy development and implementation. Strategies that raise health knowledge and awareness among policymakers and consumers should be prioritised for now to assist future introduction of SSB standards and related policies.

Buccal fat applied to transoral robotic lateral oropharyngectomy defects to lessen radical tonsillectomy pain (BOLT): a single-centre, phase II, parallel, randomised control trial study protocol

Por: Xie · M. · de Almeida · J. · Goldstein · D. · Martino · R. · Liu · Y. F. · Allen · B. · Xu · W. · Hueniken · K. · Yao · C. M.
Introduction

Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

Methods and analysis

This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

Ethics and dissemination

The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

Trial registration number

NCT06965738.

Latent profile analysis of rotation stress and associated factors among nurses undergoing standardised training in China: a cross-sectional study

Por: Peng · Y. · Yan · W. · Yuan · L. · Xie · C. · Feng · H. · Jiang · H.
Objectives

This study aimed to identify potential categories of rotation stress among nurses undergoing standardised training and to explore the relevant factors associated with each profile.

Design

Cross-sectional study.

Setting

Data were collected in November 2024 from three hospitals in Zunyi City, Guizhou Province, China.

Participants

Nurses undergoing standardised training were recruited for this study.

Methods

Convenience sampling method was used to recruit standardised training nurses in November 2024 from three hospitals in Zunyi City, Guizhou Province. The survey instruments used included demographic characteristics questionnaire, the Nursing Job Rotation Stress Scale and the Maslach Burnout Inventory. Latent profile analysis method was used to analyse rotation stress characteristics of nurses during standardised training. Additionally, logistic regression was performed to identify the factors influencing different characteristics.

Results

A total of 493 nurses completed the questionnaires, of which 453 were valid, resulting in a validity rate of 91.88%. Rotation stress was classified into two profiles: ‘Low Emotional Response–Stress Adaptation Group’ (21.5%) and ‘High Emotional Response–Stress Distress Group’ (78.5%). Univariate analysis showed that highest degree (2=11.389, p=0.001), monthly night shifts (2=33.913, p2=20.858, p2=12.319, p2=35.754, p2=15.357, p=0.002) significantly influenced the two subgroups. Multivariable regression analysis revealed significant associations of monthly night shifts, pretraining work experience, training duration and burnout level (p

Conclusions

Nurses undergoing standardised training exhibit two distinct rotation stress profiles. Monthly night shifts, pretraining work experience, training duration and burnout are significant factors. Nursing managers should implement targeted interventions such as mindfulness, laughter therapy and emotional freedom techniques to mitigate stress and thereby enhance the quality of standardised training.

Is there a role for anticoagulation with dabigatran in S. aureus bacteremia? Protocol for the adjunctive treatment domain of the Staphylococcus aureus Network Adaptive Platform (SNAP) randomised controlled trial

Por: McDonald · E. G. · Cheng · M. P. · Davis · J. S. · Goodman · A. L. · Lawler · P. R. · Marsh · J. · Mertz · D. · Paul · M. · Rodriguez-Bano · J. · Siegal · D. M. · Tong · S. Y. · Walls · G. · Lee · T. C. · The SNAP Global Trial Steering Committee · Bonten · Daneman · van Hal · Heriot
Introduction

Many patients receive oral anticoagulation for reduced stroke risk in atrial fibrillation or as treatment or prevention of venous thromboembolism. Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication. Dabigatran, an oral direct thrombin inhibitor, is similarly approved. In vitro and animal model evidence suggests that dabigatran also has direct effects on Staphylococcus aureus virulence and infection. Observational data have shown that dabigatran users are less likely to develop S. aureus bacteremia (SAB), and a small randomised controlled trial showed that dabigatran has anti-S. aureus effects when compared with low molecular weight heparins during bloodstream infection. We seek to answer whether dabigatran is superior to the oral FXaIs in achieving better SAB outcomes among patients who independently require oral anticoagulation. We report the intervention-specific protocol, embedded in an adaptive platform trial.

Methods and analysis

The S. aureus Network Adaptive Platform (SNAP) trial [NCT05137119] is a pragmatic, randomised, multicentre adaptive platform trial that compares different SAB therapies for 90-day mortality rates. For this intervention (‘Dabi-SNAP’), patients receiving therapy with an oral FXaI will be randomised to continue as usual or to change to dabigatran as of the next scheduled dose. All subjects will receive standard of care antibiotics and/or antibiotics allocated through other active domains in the platform. As the choice of anticoagulant may not demonstrate large differences in mortality, a ranked composite of death and adverse outcomes (Desirability of Outcome Ranking, or DOOR) was chosen as the primary outcome.

Ethics and dissemination

The study is conditionally approved by the research ethics board of the McGill University Health Centre: identifier 2025-10900. Trial results will be published open access in a peer-reviewed journal and presented at a global infectious disease conference. The trial is registered at clinicaltrials.gov with the identifier NCT06650501.

Trial registration number

NCT0665050.

Triple-drug therapy with Goreisan, tranexamic acid and carbazochrome sodium sulfonate hydrate to prevent recurrence after chronic subdural haematoma surgery: a multicentre, randomised, controlled trial protocol

Por: Negishi · H. · Hirata · K. · Aiyama · H. · Fujita · K. · Komatsu · Y. · Kato · N. · Shibata · Y. · Tsuda · K. · Yamazaki · T. · Sato · M. · Watanabe · S. · Sugii · N. · Konishi · T. · Mathis · B. J. · Ohigashi · T. · Endo · M. · Ishikawa · E. · Matsumaru · Y. · The Triple Study Investigato
Introduction

Chronic subdural haematoma (CSDH) is a common neurosurgical condition in older adults, with a recurrence rate of approximately 7.1–13% after burr-hole drainage. Although surgical adjuncts such as subdural drains and middle meningeal artery embolisation may reduce recurrence, these are not suitable for all patients. Pharmacological strategies, including tranexamic acid, Goreisan and carbazochrome sodium sulfonate hydrate, have shown potential, but high-level evidence remains lacking. A prior retrospective study suggested that a triple oral regimen combining these agents may reduce recurrence. This randomised controlled trial aims to evaluate its efficacy and safety.

Methods and analysis

This is a prospective, multicentre, open-label, randomised controlled trial conducted across six hospitals in Ibaraki, Japan. A total of 180 patients undergoing first-time burr-hole surgery for CSDH will be randomised 1:1 to receive either triple therapy (Goreisan 7.5 g/day, carbazochrome sodium sulfonate hydrate 90 mg/day and tranexamic acid 750 mg/day for up to 90 days) or standard postoperative care. The primary outcome is recurrence requiring reoperation within 90 days. Secondary outcomes include time to recurrence and haematoma volume reduction on serial CT imaging. All analyses will follow the intention-to-treat principle, using logistic regression, Cox proportional hazards models and mixed-effects models.

Ethics and dissemination

Written, informed consent will be obtained from all participants at each participating hospital by trained staff from that hospital. The trial protocol has been approved by the ethics committee of the University of Tsukuba Hospital (approval no. TCRB23-025) and the Institutional Review Boards of all participating centres. Study findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. A summary of the results will also be provided to participating institutions and made publicly available in accordance with the BMJ Open data sharing policy.

Trial registration number

jRCTs031240007.

Preoperative anaemia and its impact on immediate surgical outcomes in elderly patients: a multicentre prospective cohort study in Ethiopia

Por: Wubet · H. B. · Gobezie · N. Z. · Deress · G. M. · Mekuriaw · B. Y. · Abuhay · A. G. · Afework · W. A. · Siyoum · T. M. · Gedefaw · G. D. · Abate · A. T. · Demissie · B. · Demtie · D. G. · Asmare · T. B.
Objective

To assess how preoperative anaemia affects surgical outcomes in elderly patients within a resource-limited setting.

Design

Prospective cohort study.

Setting

Two comprehensive specialised hospitals in Ethiopia.

Participants

Participants consisted of 224 patients aged 65 years and older who underwent surgery between 1 December 2024 and 29 March 2025.

Primary and secondary outcome measures

Perioperative blood transfusions were the primary outcome. Secondary outcomes included intensive care unit (ICU) admission, risk of postoperative complications, prolonged hospitalisation, poor recovery quality and in-hospital mortality.

Results

The anaemic group required transfusions of three or more units more frequently than the non-anaemic group (10.5% vs 2.6%; absolute risk difference 8.0%). Their perioperative transfusion rates were significantly higher (42.3% vs 18.4%; p

Conclusion and recommendation

Preoperative anaemia significantly increases the risk of transfusion, poor recovery, ICU admission, prolonged hospitalisation and in-hospital mortality in older patients who underwent surgery. In resource-limited settings, improving perioperative outcomes should prioritise the early detection and treatment of anaemia.

DIVINE-pilot trial: a phase 2 multicentre, randomised pilot trial of pharmacotherapy and physical activity monitoring conducted in women with recent gestational diabetes and increased risk of type 2 diabetes recruited from tertiary referral hospitals in A

Por: Chen · A. X.-N. · Lee · V. Y. · Donges · K. · Giancas · C. · Angell · B. · Parmenter · B. · Barrett · H. L. · Henry · A. · Patel · A. · Arnott · C.
Introduction

Women who develop gestational diabetes mellitus (GDM) have a 60% lifetime risk of developing type 2 diabetes mellitus (T2D), which is already elevated within the first decade following childbirth. Despite the impact of lifestyle interventions to reduce long-term T2D risk in women with previous GDM, successful implementation of lifestyle interventions remains a barrier. Metformin is recommended for adults at increased risk of developing T2D; however, there is limited evidence of tolerability in the early postpartum period. Glucagon-like peptide 1 receptor agonists (GLP-1 RA) are effective at improving glycaemic status and body weight. However, GLP-1 RA have not been evaluated in the postpartum population. Finally, physical activity monitors may support behaviour changes related to physical activity to reduce long-term risk of T2D but are yet to be studied following GDM.

Methods and analysis

This will be a multicentre, randomised, open-label interventional pilot study. Using a 2x2 factorial design, we will examine the feasibility and acceptability of a pharmacotherapy intervention and a physical activity intervention in women with previous GDM at increased risk of developing T2D. Participants will be recruited from tertiary referral hospitals in Australia and will be randomised to receive either metformin alone or in combination with a GLP-1 RA and subsequently randomised to either a physical activity intervention involving activity monitor use, or usual care for 6 months, followed by a 6-month follow-up period. Primary feasibility outcomes include the acceptability and safety of the metformin and GLP-1 RA as measured through pill and injection counts, acceptability questionnaire and adverse events.

Ethics and dissemination

This trial is registered with the Australian and New Zealand Clinical Trials Registry (Registration Number: ACTRN12624001253594). This trial has received ethics approval from the South Eastern Sydney Local Health District Human Research Ethics Committee (Approval Number: 2024/ETH00042, protocol version v1.1, 28/02/2025).

Trial registration number

Australian and New Zealand Clinical Trials Registry, Registration Number: ACTRN12624001253594.

Impact of COVID-19 on the detection of tuberculosis in Guangdong, China based on the autoregressive integrated moving average model: a time-series study

Por: Wang · R. · Zhou · F. · Shi · G. · Liu · Y. · Bian · Y. · Wu · H. · Zou · G.
Objective

China has continued to improve tuberculosis (TB) control in the past decade; however, the sudden outbreak of COVID-19 hindered this progress. As a province with a large population and frequent international exchanges, Guangdong has been seriously affected by COVID-19. This study aimed to understand the effect of COVID-19 on TB detection in Guangdong based on the autoregressive integrated moving average (ARIMA) model.

Design

Time-series study.

Setting

Guangdong, China.

Outcome measures

We used the ARIMA model to quantify the effect of COVID-19 by comparing reported cases during the COVID-19 pandemic with predicted cases under a counterfactual scenario of no COVID-19 pandemic. After model evaluation, we chose ARIMA (0,1,2)(0,1,1)12 as the prediction model. We also highlighted that there were three emergency response periods in which the responses and public responses to COVID-19 varied.

Results

During the pandemic period, the average annual TB notification rate was 57.95/100 000, which decreased by 27.97% compared with the pre-pandemic period. Although it decreased by 6.17% on average annually in the pre-pandemic period, it decreased by 14.92% in 2020 as compared with 2019, but only decreased by 0.34% in 2021 as compared with 2020. The results of the ARIMA model showed that the number of reported cases in 2020 decreased by 6.62% compared with that of the predicted cases, but this decreased by 0.42% only in 2021. The most seriously affected period was the second-level emergency response period in 2020, when the relative difference between reported and predicted cases reached the peak (–16.43%). The least affected period was the third-level emergency response period of 2021, the reported cases recovered and exceeded the predicted cases, with a gap of 0.77%.

Conclusions

TB detection in Guangdong had generally declined during the COVID-19 pandemic, which might be related to the movement restrictions, diverted resources and patients’ concerns. This decline would lead to the delay or even interruption of diagnosis and treatment, which would cause the regression of TB control. To improve TB detection, it is important for stakeholders to take consorted effort during public health emergencies.

Exercise-focused wellness interventions for middle-aged adults: a scoping review

Por: Park · J. · Lee · H. · Lee · S. · Kim · Y.
Objectives

Middle-aged adults face multifaceted physical and psychosocial challenges that impact their overall wellness. Exercise has become a key component of wellness interventions due to its positive impacts on physical and psychosocial health. However, the understanding of exercise-focused wellness interventions for this age group remains limited. Therefore, this scoping review aimed to identify and map the existing literature on exercise-focused wellness interventions for middle-aged adults and to summarise their characteristics and reported outcomes.

Design

Scoping review.

Data sources

Six databases, including PubMed, EMBASE, CINAHL, Cochrane Library, Web of Science and PsycInfo, were initially searched on 29 July 2024, and the search was updated on 12 October 2025, with no restrictions on publication date. The reference lists of articles selected in the database search were also screened for further relevant studies.

Eligibility criteria

We included interventional studies, specifically randomised controlled trials (RCTs) and quasi-experimental designs, that examined exercise-focused wellness interventions for middle-aged adults.

Data extraction and synthesis

Two independent reviewers extracted data on study characteristics and intervention details and outcomes, and assessed the risk of bias. Any discrepancies were resolved by a third reviewer.

Results

A total of 15 studies were included in the review, of which 9 were RCTs and 6 were quasi-experimental studies. Most interventions targeted middle-aged women and were implemented in community settings. Exercise was often combined with diet and stress management. The majority of the interventions lasted for 3 months with weekly sessions. Additionally, various delivery modes were employed, including face-to-face, online, individual and group-based approaches. Outcome variables were categorised into exercise and physical activity, dietary intake, anthropometry and body composition, cardiovascular health, biochemical markers, menopausal symptoms, psychosocial health and wellness. Only one study assessed wellness as an outcome of the intervention. Across the included studies, improvements were commonly reported for physical and psychosocial health, whereas changes in biochemical markers were limited.

Conclusions

Exercise-focused wellness interventions for middle-aged adults encompass varied content and outcome variables, contributing to improvements in physical, psychological and social dimensions of health. Delivery modes are diverse, demonstrating flexibility and adaptability for tailored interventions. There is a need to develop a validated, midlife-specific measurement tool that reflects the multidimensional nature of wellness. Moreover, exercise-focused interventions tailored for middle-aged men, particularly in workplace settings, should be developed.

Effects of aquatic exercise on arterial stiffness and endothelial function in adults: A systematic review and meta-analyses

by Emily Dunlap, Yanbing Zhou, Manny M.Y. Kwok, Billy C.L. So, Hirofumi Tanaka

Objective

To evaluate the effects of aquatic exercise compared with non-exercise controls and land-based exercise on arterial stiffness and endothelial function.

Design

Systematic review and meta-analyses of randomized controlled trials assessed using the Cochrane risk-of-bias tool and Grading of Recommendations Assessment, Development and Evaluation.

Data sources

PubMed/MEDLINE, CINAHL Plus, SPORTDiscus, and reference lists, searched from database inception to April 16, 2025.

Eligibility criteria

Studies evaluating chronic aquatic exercise (multi-session interventions) compared with land-based exercise or non-exercise comparison groups in adults, measuring arterial stiffness via pulse wave velocity (PWV) or endothelial function via flow-mediated dilation (FMD).

Results

This review includes 18 randomized controlled trials with 845 participants (mean age 65 ± 7 years). Studies compared aquatic exercise with non-exercise controls (8 studies), land-based exercise (6 studies), or both (4 studies). Exercise sessions averaged 50 minutes, 3 times weekly for 11 weeks. Most studies (17 out of 18) implemented moderate-to-vigorous intensity protocols. Aquatic exercise resulted in improvements in arterial stiffness compared with non-exercise controls (7 studies; SMD = –2.37, 95% CI: –4.46 to –0.29; I2 = 98%: low certainty), with most evidence reflecting systemic and peripheral PWV. Changes in arterial stiffness did not differ from those observed after land-based exercise (6 studies; SMD = –0.07, 95% CI: –0.34 to 0.20; I2 = 0%, moderate certainty). For endothelial function, aquatic exercise may improve outcomes versus non-exercise controls (6 studies; SMD = 0.91, 95% CI: 0.39 to 1.43; I2 = 68%; low certainty) and may lead to greater improvements than land-based exercise (7 studies; SMD = 0.55, 95% CI: 0.05 to 1.06; I2 = 75%; low certainty).

Conclusion

Aquatic exercise improves systemic and peripheral arterial stiffness as well as endothelial function compared with non-exercising controls. Changes in arterial stiffness do not differ from those observed after land-based exercise. Aquatic exercise may provide greater improvement in endothelial function than land-based exercise, though this is supported by low-certainty evidence, and substantial heterogeneity limits confidence in the generalizability of this finding.

PROSPERO registration

CRD42025642087.

Drug-related pressure ulcers in hospitalised patients: a multicentre retrospective study in Japan identifying high-risk medications and patient characteristics

Por: Mizokami · F. · Kinoshita · T. · Sekine · Y. · Miyagawa · T. · Toriumi · M. · Ooka · K. · Nakashima · A. · Fukuda · K. · Sadaoka · M. · Ishii · H. · Kadowaki · H. · Iikura · K. · Fujimoto · S. · Yamanouchi · T. · Shiraishi · Y. · Ozaki · T. · Tatebe · H. · Fuse · T. · Ikushima · S. · Higashi
Objectives

To characterise patient and medication-related patterns observed in drug-related pressure ulcers (DRPUs) and provide descriptive findings that may support future consensus-building.

Design

Multicentre retrospective observational study.

Setting

20 hospitals across Japan participated in the study with hospital pharmacists specialised in PU care.

Participants

A total of 1113 hospitalised patients with existing PUs were included and classified into three groups (definite, probable and no-possibility of DRPUs) based on predefined criteria.

Primary and secondary outcome measures

The primary outcome was the description of medication-related characteristics observed in each DRPU classification group, including polypharmacy, initiation of new medications and dose adjustments. Secondary outcomes included differences in ulcer characteristics and functional status across DRPU categories.

Results

The definite group (n=128, 11.5%) showed a significantly higher prevalence of polypharmacy (83.6% vs 71.1% in the no-possibility group, p

Conclusions

Medication-related characteristics such as polypharmacy, initiation of new medications, dose modifications and use of antipsychotics were more frequently observed in the definite DRPU group. These descriptive findings may help characterise the clinical patterns of DRPUs and may inform future hypothesis generation.

Impact assessment of neonatal care interventions on regional neonatal care capacity: a simulation study based on clinical data in the Netherlands

Por: Wagenaar · J. H. L. · Dietz · A. · Huang · Y. · Reiss · I. K. M. · Been · J. V. · Spaan · J. · Kornelisse · R. F. · Taal · H. R. · Hinrichs-Krapels · S.
Objective

To analyse the impact of selected neonatal care interventions on regional care capacity.

Design

Discrete event simulation modelling based on clinical data.

Setting

Neonatal care in the southwest of the Netherlands, consisting of one tertiary-level neonatal intensive care unit (NICU), four hospitals with high-care neonatal (HCN) wards and six with medium-care neonatal (MCN) wards.

Participants

44 461 neonates admitted to at least one hospital within the specified region or admitted outside of the region but with a residential address inside the region between 2016 and 2021.

Interventions

The impact of three interventions was simulated: (1) home-based phototherapy for hyperbilirubinaemia, (2) oral antibiotic switch for culture-negative early onset infection and (3) changing tertiary-level NICU admission guidelines.

Main outcome measure

Regional neonatal capacity defined as: (1) occupancy per ward level, (2) required operational beds per ward level to provide care to all inside region patients at maximum 85% occupancy, (3) proportion rejected, defined as outside region transfers due to no capacity to provide local care and (4) the weekly rejections in relation to occupancy to provide a combined analysis.

Results

In the current situation, with many operational beds closed due to nurse shortages, occupancy was extremely high at the NICU and HCNs (respectively 91.7% (95% CI 91.4 to 92.0) and 98.1% (95% CI 98.0 to 98.2)). The number of required beds exceeded available beds, resulting in >20% rejections for both NICU and HCN patients. Although the three interventions individually demonstrated effect on capacity, clinical impact was marginal. In combination, NICU occupancy was reduced below the 85% government recommendation at the cost of an increased burden for HCNs, highlighting the need for redistribution to MCNs.

Conclusion

Our model confirmed the severity of current neonatal capacity strain and demonstrated the potential impact of three interventions on regional capacity. The model showed to be a low-cost and easy-to-use method for regional capacity impact assessment and could provide the basis for making informed decisions for other interventions and future scenarios, supporting data-driven neonatal capacity planning and policy development.

Effect of transcutaneous auricular vagus nerve stimulation on perioperative psychological symptoms in patients undergoing elective thoracoscopic pneumonectomy under general anaesthesia: study protocol for a single-centre, prospective, randomised, double-b

Por: Sun · Z. · Wang · Y. · Chen · J. · Lin · Y. · Ma · T. · Zhou · M. · Li · P. · Liu · J. · Zhao · W. · Xiong · X. · Tan · W. · Tao · M. · Cao · J.-L. · Liu · H.
Introduction

Perioperative psychological symptoms are prevalent among patients undergoing lung surgery and can contribute to adverse clinical outcomes. Pharmacological interventions for these symptoms have inherent limitations. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising non-invasive therapeutic approach. This study aims to evaluate the efficacy of taVNS in managing perioperative psychological symptoms in patients undergoing elective thoracoscopic pneumonectomy under general anaesthesia.

Methods and analysis

This single-centre, prospective, randomised, double-blind, controlled trial will enrol 176 patients scheduled for elective thoracoscopic lung resection. Participants will be randomly allocated to either the active taVNS or the sham taVNS groups in a 1:1 ratio. Both groups will receive 30 min active or sham stimulation sessions at four time points: (1) the afternoon prior to surgery, (2) the morning of the surgery, (3) following extubation and (4) the first afternoon postsurgery. The primary outcome is the incidence of perioperative anxiety, assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale. Secondary outcomes include depression scores, stress index, sleep quality, pain scores, incidence of postoperative delirium, fatigue, cough symptoms and postoperative recovery quality, all evaluated through validated assessment tools. Analyses will be conducted using intention-to-treat and per-protocol populations.

Ethics and dissemination

The Ethics Committee of Affiliated Hospital of Xuzhou Medical University granted approval for the study with approval number: XYFY2024-KL444-01. Dissemination will be via national anaesthesia conferences and publication in the peer-reviewed literature.

Trial registration number

ChiCTR2400090542.

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