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

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

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

Methods and analysis

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

Ethics and dissemination

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

FOLFOX-based transarterial infusion chemotherapy for unresectable colorectal cancer: protocol of an open-label, multicentre, randomised, controlled, phase II trial

Por: Wang · J. · Sun · Y. · Chen · L. · Wang · Z. · Li · K. · Guo · Y. · Yao · L. · Duan · L. · Liu · Q.
Introduction

Colorectal cancer (CRC) is the third leading cause of new cancer cases and the second leading cause of cancer-related deaths worldwide. Current therapeutic modalities for CRC include surgical resection, intravenous chemotherapy (IVC), radiotherapy, immunotherapy, targeted therapy and their combinations. As a mainstream systemic treatment for CRC, IVC leads to widespread drug distribution but relatively low intratumoural drug accumulation. Compared with IVC, transarterial infusion chemotherapy (TAIC) involves selective arterial catheterisation to deliver chemotherapeutic agents directly to the tumour feeding vessels. Hepatic tumours receive their blood supply predominantly through branches of the hepatic artery. Hepatic artery infusion chemotherapy (HAIC) yields significantly superior outcomes compared with IVC and is currently widely employed for the treatment of primary and secondary hepatic malignancies. HAIC in combination with IVC can offer long-term durable disease control in the clinical treatment of liver cancer compared with IVC. CRC is also predominantly grown through angiogenesis. Therefore, we raise the question whether sequential IVC administered after intensive TAIC achieves better clinical efficacy than IVC alone for the treatment of unresectable CRC (uCRC). However, no prospective clinical trials have been conducted to compare the efficacy of these two strategies. This prospective study was therefore designed to fill this clinical knowledge gap.

Methods and analysis

This is a prospective, multicentre, randomised, open-label clinical trial. The uCRC is defined as inability to achieve an R0 resection owing to locally advanced CRC with clinical T4 disease confirmed by MRI or CT and/or synchronous liver metastases. This study only includes microsatellite stable or proficient mismatch repair uCRC. A total of 50 eligible patients will be randomly assigned to either the IVC group or the TAIC group. Patients in the IVC group will receive FOLFOX (fluorouracil, leucovorin, oxaliplatin)-based IVC every 2 weeks for a total duration of 8 weeks. Patients in the TAIC group will receive FOLFOX-based TAIC at week 0 and week 4 and receive FOLFOX-based IVC at week 2 and week 6. For patients with colorectal liver metastases, cetuximab or bevacizumab will be administered according to the RAS and BRAF status and the primary tumour site. The primary endpoint is the objective response rate. This study is scheduled to commence on 10 January 2026, and complete follow-up on 31 December 2027. The first subject was enrolled on 20 March 2026. To date, one subject in the IVC group and six subjects in the TAIC group have been enrolled.

Ethics and dissemination

The present study protocol has been approved by the Medical Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences (ethical approval number 2025-268 KY). On completion of the study, data cleaning and analysis will be performed, and the results will be disseminated at academic conferences and in international peer-reviewed journals. This trial has been registered at ClinicalTrials.gov. The statistical analysis plan will be finalised and approved before the database lock. The final version is retained in the study documentation and will be made available to support the transparency and interpretation of the study results.

Trial registration number

NCT07333053.

Development and internal validation of an intrapartum caesarean risk prediction model to guide rural obstetric transfer decisions: a population-based study using BORN Ontario data

Por: Jolin-Dahel · K. · Hawken · S. · Bruce · L.
Objective

To develop and internally validate a clinical prediction model estimating the probability of emergency caesarean delivery among low-risk pregnancies using routinely available intrapartum variables. The model is intended to support clinicians in recommending transfer decisions in rural obstetric settings without onsite caesarean capacity.

Design

Retrospective cohort study with multivariable logistic regression and internal validation using bootstrap resampling.

Setting

Province-wide birth registry in Ontario, Canada.

Participants

Singleton, hospital births from low-risk pregnancies between 1 April 2012 and 31 March 2020, captured in the Better Outcomes Registry and Network Ontario. Exclusions included previous caesarean, major comorbidities and other high-risk conditions.

Primary outcome

Emergency caesarean delivery during labour.

Results

Among 611 644 low-risk pregnancies, 66 482 (10.9%) resulted in emergency caesarean delivery. Key predictors included abnormal fetal health surveillance, nulliparity, gestational hypertension, polyhydramnios area under the receiver operating characteristic curve (AUC) and oxytocin augmentation. The optimism-corrected AUC was 0.86, indicating strong discrimination. Calibration was generally good, though the model underestimated caesarean risk in patients first admitted to level I hospitals.

Conclusions

This study presents a proof-of-concept prototype with strong discrimination, though calibration of the full model was suboptimal in level I hospitals, the intended setting for application. While not clinically deployable in its current form, the model lays the groundwork for a translational pathway that will require local recalibration, external validation and contextual adaptation before implementation. Threshold-based clinical utility (eg, positive/negative predictive value or net benefit) was not assessed and will be evaluated during external validation and local recalibration.

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

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

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

Methods and analysis

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

Ethics and dissemination

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

PROSPERO registration number

CRD #420261395061.

Efficacy and safety of mycophenolate mofetil in preventing relapse of IgG4-related disease with re-elevation of serum IgG4 level during maintenance therapy: a protocol for a multicentre, randomised, double-blind, placebo-controlled study in China

Por: Zhang · J. · Nie · Y. · Peng · L. · Fei · Y. · Liu · Y. · Dong · L. · Kong · X. · Fu · M. · Zhang · X. · Liu · C. · Chen · Y. · Li · M. · Zhou · J. · Zhang · W.
Introduction

IgG4-related disease is a chronic fibroinflammatory disease with multiorgan involvement. Glucocorticoids and/or immunosuppressants as well as rituximab are both first-line treatments in remission induction therapy. However, relapse is common during the maintenance period, particularly in patients with re-elevation of serum IgG4 level. This study aims to evaluate whether adding mycophenolate mofetil (MMF) during the maintenance phase for such patients can reduce the risk of disease flare.

Methods

This study is a multicentre, randomised, double-blind, placebo-controlled study. A total of 108 eligible patients with re-elevation of serum IgG4 level during maintenance therapy will be included in this study and randomised in a 1:1 ratio to receive add-on MMF 0.5 g one time per day or placebo for 52 weeks. The primary outcome is the proportion of patients experiencing relapse at week 52. Secondary outcomes include time-to-relapse, changes in disease activity and serum IgG4 level, stratified relapse rate according to the elevation level of IgG4. Analyses will follow the intention-to-treat principle.

Ethics and dissemination

The study has been approved by the Ethics Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (approval no. K3231). Written informed consent will be obtained from all participants before enrolment. Findings will be disseminated through peer-reviewed journals and conference presentations.

Trial registration number

NCT05974683.

Benefits of childhood vaccines in ecological studies focusing on Germany: a scoping review protocol

Por: Nolting · T. · Martin · D. D.
Introduction

General statements that vaccinations are among the most important preventive measures in medicine are common in public health guidance. While the efficacy of individual vaccines is well established through randomised controlled trials and observational studies, ecological studies at the population level can provide complementary insights into the relative historical contributions of different childhood vaccinations to reductions in morbidity and mortality. To date, there has been a lack of systematic reviews of such comparative studies, especially with a focus on Germany. The aim of this scoping review is to map the state of research on ecological studies that compare the relative contribution of different childhood vaccinations to reducing morbidity and mortality, with a focus on reported data from Germany in an international comparison. A more precise scientific and public communication about vaccinations strengthens confidence in evidence-based vaccination recommendations.

Methods and analysis

This scoping review follows the Joanna Briggs Institute methodology for scoping reviews. Reporting will be in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Extension for Scoping Reviews (PRISMA-ScR). A comprehensive search will be conducted in MEDLINE via PubMed, Embase via Elsevier, Web of Science, Scopus via Elsevier and Google Scholar, supplemented by grey literature sources. Studies will be selected and data charted by at least two independent reviewers using the Population/Concept/Context (PCC) framework. Results will be synthesised descriptively and presented thematically.

Ethics and dissemination

No ethical approval is required as this is a secondary analysis of published data. The findings will be disseminated through publication in a peer-reviewed journal and as part of the first author’s doctoral thesis. The protocol is registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/4FH3X).

Barriers and facilitators to reducing sedentary behaviour in stroke survivors: a scoping review based on the theoretical domains framework

Por: Li · Y. · Yang · J. · Yang · Y. · Yang · L.
Objectives

To synthesise barriers and facilitators to reducing sedentary behaviour among stroke survivors and map them to the Theoretical Domains Framework (TDF).

Design

A scoping review conducted following Joanna Briggs Institute (JBI) methodology and reported in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis, Scoping Review extension (PRISMA-ScR) guidelines.

Data sources

Nine electronic databases (PubMed, CINAHL, MEDLINE, Embase, PsycINFO, Web of Science, Cochrane Library, CNKI and WanFang) were searched from inception to May 2025. Grey literature was identified through Google Scholar and ProQuest. Updated research was conducted in July 2026.

Eligibility criteria

Studies focusing on barriers and/or facilitators to sedentary behaviour among stroke survivors were included, with no restrictions on study design.

Data extraction and synthesis

Two reviewers independently screened studies, extracted data and mapped identified barriers and facilitators to the Theoretical Domains Framework. Frequencies of domains were calculated to summarise distribution patterns.

Results

49 studies were included. A total of 32 barriers and 17 facilitators were identified and mapped to 12 TDF domains. Barriers were reported more frequently than facilitators. The most frequently represented domains included Skills, Environmental Context and Resources, Beliefs about Capabilities, Beliefs about Consequences, Social Influences, Knowledge and Emotion. Common barriers included stroke-related physical and functional limitations, fatigue, inadequate knowledge, low self-efficacy, fear of falling, limited social support and environmental constraints. Key facilitators included sedentary behaviour education, higher self-efficacy, supportive social and physical environments, inpatient rehabilitation and behaviour change strategies that promoted more active lifestyles.

Conclusions

Barriers to reducing sedentary behaviour among stroke survivors include limited knowledge, low motivation, insufficient social support, negative emotions and beliefs and physical limitations. Facilitators include social support, positive beliefs and supportive environmental conditions. Future interventions should comprehensively address these multilevel factors to develop more tailored and feasible behaviour change strategies.

Registration number

This study was registered with the Open Science Framework website (osf.io/ma8qp).

Qualitative study to explore which components of home-based primary care may reduce emergency department visits among older adults

Por: Bring · H. · Bergqvist · M. · Gustafsson · L. L. · Modig · K. · Bastholm-Rahmner · P. · Schmidt-Mende · K.
Objective

Home-based primary care has been suggested to reduce emergency department visits among vulnerable older adults but how it should be organised to achieve this effect is unclear. This study aimed to increase the understanding of how older adults receiving home-based primary care and their family caregivers’ experience care during the period prior to an emergency department visit and to identify components of home-based primary care delivery that could help reduce such visits.

Design

Qualitative study using semi-structured interviews with older adults receiving home-based primary care who had recently visited the emergency department, along with their family caregivers. Interviews were analysed using inductive thematic analysis.

Setting

Interviews were conducted in the homes of informants receiving home-based primary care in Region Stockholm, Sweden, 2022–2023.

Participants

Fourteen adults aged ≥65 years receiving home-based primary care who had visited an emergency department within the past 3 months were interviewed; seven interviews also included a family member.

Results

An overarching theme, Trust as a prerequisite for timely emergency assessments in home-based primary care, describes how patient trust–in home-based primary care in general and in specific individual healthcare professionals–seems important in reducing emergency department visits, especially when patients experience symptoms of uncertain urgency or gradual onset. Four subthemes describe how primary care may build trust: through (1) access to care, (2) medical competence, (3) respect and relationship and (4) coordination and teamwork.

Conclusion

Trust in both home-based primary care in general and in individual healthcare professionals is crucial in reducing emergency department visits among older adults receiving home-based primary care. Trust may be strengthened by accessible and competent care, familiarity with both general practitioners and the responsible nurse and working as a collaborative team.

Risk and benefit for targeted therapy agents in paediatric phase I trials in oncology: a systematic review and meta-analysis protocol

Por: Ostrowska · J. · Strzebonska · K. · Waligora · M.
Introduction

Paediatric phase I oncology trials establish safe dosing and provide preliminary efficacy data for investigational anti-cancer agents in children. The aim of the proposed systematic review is to identify the risk and benefit ratio for targeted therapy agents in paediatric Phase I trials in oncology.

Methods and analysis

We will search Embase and PubMed for paediatric Phase I cancer trials published from 2 March 2015 to 30 June 2026. Eligible studies are dose-escalation trials enrolling participants under 21 years with solid or haematological malignancies, testing targeted therapy agents. We will measure two co-primary outcomes: (1) risk—proportion of participants experiencing drug-related adverse events of grade 3, 4 or 5; and (2) benefit—objective response rate. Where data permit, proportions will be pooled using random-effects meta-analysis.

Ethics and dissemination

This study will use publicly available data; therefore, ethics committee approval is not required. Results from the systematic review will be published in a peer-reviewed journal and presented at relevant conferences.

PROSPERO registration number

CRD420261408673.

Are study design characteristics in single-arm trials comparable with those of their objective performance criteria or performance goals? A scoping review

Por: Wang · H. · Chai · Q. · Jin · F. · Feng · Y. · Cao · R. · Liu · Z. · Li · X. · Luo · M. · Tao · L. · Fei · Y.
Objectives

Single-arm trials (SATs) with objective performance criteria (OPCs) or performance goals (PGs) are increasingly used for regulatory approval of medical devices and other interventions. However, the comparability of study design characteristics between SAT and their external comparator sources remains unclear. This scoping review aimed to evaluate the comparability of study design characteristics between SATs and their matched OPC/PG sources.

Design

Scoping review.

Data sources

PubMed, Embase, the Cochrane Library and four Chinese databases—China National Knowledge Infrastructure, Wanfang Data, CQVIP and SinoMed—were searched from inception to 30 April 2026.

Eligibility criteria

We included SATs that used one or more OPCs or PGs as external comparators to evaluate safety and/or effectiveness endpoints and reported specific numerical values of OPCs or PGs.

Data extraction and synthesis

Two reviewers independently screened the retrieved records and extracted data using a standardised form. For each included SAT, we retrieved the cited OPC/PG sources and extracted study design characteristics data (age, sex, health conditions, outcome definitions and measurement time points) for comparison. Age and sex were compared using summary t-tests and ² tests; health conditions were assessed by two clinicians based on eligibility criteria and baseline characteristics. Results were stratified by OPC versus PG.

Results

A total of 1243 records were identified, and 133 SATs were included. Most studies used PGs (84, 63.2%); 34 (25.6%) claimed to use OPCs, and 15 (11.3%) could not be classified. Of the 60 age comparisons available from 41 studies, 30 showed statistically significant differences; of the 82 sex comparisons available from 59 studies, 60 showed significant differences. Health conditions, outcome definitions and time points were assessed descriptively in a subset of studies, and discrepancies were also observed.

Conclusion

Suboptimal comparability of study design characteristics was observed between SATs and their OPC/PG sources, which might influence the treatment effect estimates. Greater attention to the comparability of study design characteristics in SATs with OPC/PGs may improve the validity of evidence.

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

Objective

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

Design

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

Settings

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

Data

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

Outcome measures

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

Results

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

Conclusion

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

Brain and behavioural responses to food viewing in women during pregnancy and their relationship with metabolic health: study protocol for the FOODY Play Study - a prospective observational study

Por: Trevino Montemayor · M. · Hamam-Mechkour · A. · Eisler · J. J. · Murray · M. M. · Spierer · L. · Schenk · S. · Halter · R. J. · Toepel · U. · Horsch · A. · Retsa · C. · Arhab · A. · Quansah · D. Y. · Puder · J. J.
Introduction

During pregnancy, physiological and psychological factors influence eating behaviour and food preferences. Food cravings are common in pregnancy and contribute to excessive gestational weight gain (GWG). Excessive GWG is present across all body mass index (BMI) categories and is associated with adverse outcomes. Outside of pregnancy, highly palatable food cues activate brain regions involved in reward and attention, which may influence eating behaviour and behavioural responses. However, brain and behavioural responses to food cues across pregnancy, and their association with psychological and metabolic factors, remain poorly understood. This study aims to investigate spatiotemporal brain responses to visual food cues across individuals with different BMI categories and their associations with behavioural, psychological and metabolic outcomes during pregnancy.

Methods and analysis

This is a prospective observational cohort study conducted at the Lausanne University Hospital, Switzerland. 94 pregnant individuals (47 healthy normal weight and 47 with overweight/obesity) will be assessed at 12–16 and 31–36 weeks of gestational age from November 2024 to September 2026. Data collected for the primary outcomes include electroencephalography-based brain responses to validated visual food cues varying in fat and carbohydrate content, behavioural responses to the same cues using a gamified smartphone Go/NoGo task. Secondary validated outcomes include heart rate variability (Actiheart), body composition (InBody S10), glycated haemoglobin (Afinion), cardiorespiratory fitness (The Chester step test), snack intake, eating behaviour (Intuitive Eating Scale-2, Three-Factor Eating Questionnaire-Revised), food cravings (Food Craving Questionnaire-state), mood and depressive symptoms (Edinburgh Postnatal Depression Scale). Statistical analyses include group comparisons, longitudinal analyses and regression models adjusted for potential sociodemographic/medical confounders.

Ethics and dissemination

All participants will provide written informed consent. The Human Research Ethics Committee of the Canton de Vaud approved the study protocol (CER-VD 2023-01462). Findings will be disseminated through peer-reviewed publications, (inter)national conferences and shared with healthcare professionals and stakeholders to inform strategies for improving maternal health.

Tranexamic acid to prevent anastomotic leak after rectal cancer surgery: protocol for a feasibility trial with embedded mechanistic analysis of the microbiome

Por: Helliwell · J. A. · Chilton · C. H. · Bestall · J. · Kirby · A. · Quirke · P. · Wood · H. M. · Stocken · D. D. · Jayne · D.
Introduction

Anastomotic leak is a major complication after anterior resection for rectal cancer, with reported rates of 10–15%. Recent evidence implicates the gut microbiome, where specific bacteria colonise the anastomotic site and secrete collagenase that weakens healing tissue. Preclinical studies demonstrate that tranexamic acid can inhibit this process when delivered rectally into the bowel lumen. This protocol outlines a feasibility trial of rectally administered tranexamic acid delivered via rectal catheter to the anastomotic site after anterior resection, accompanied by embedded microbiome and qualitative substudies.

Methods and analysis

This is an open-label, single-centre, randomised controlled feasibility trial. 45 patients undergoing anterior resection for rectal or sigmoid cancer will be randomised 2:1 to receive tranexamic acid or sterile water, administered intraoperatively and on postoperative days 1–3 via a rectal catheter. Feasibility outcomes include assessment of recruitment, intervention adherence, protocol compliance and safety. Exploratory clinical outcomes include anastomotic leak and other postoperative complications. A mandatory microbiome substudy will characterise changes in microbial composition and bacterial collagenase activity, providing mechanistic insight into treatment response. An optional qualitative substudy will explore acceptability of the intervention from the perspectives of patients and healthcare professionals.

Ethics and dissemination

The protocol was approved by the North West Liverpool Central Research Ethics Committee and the Medicines and Healthcare products Regulatory Agency on 30 October 2024 (24/NW/0254). Recruitment commenced on 7 January 2025 following receipt of site-specific approvals. Feasibility, mechanistic and qualitative findings will be disseminated through peer-reviewed publications, academic conferences and stakeholder engagement activities. The results will inform progression to a definitive phase III trial and shape key elements of study design.

Trial registration number

ISRCTN13727659.

PROspective Prostate Cancer Infrastructure: study protocol for the ProPCI 'trials within cohorts study

Por: Wissing · R. O. · van Elst · T. · Sedelaar · M. · Smeenk · R. J. · van den Berg · P. · van Dodewaard-de Jong · J. M. · Lont · A. P. · Hendriks · M. P. · Luijendijk-de Bruin · D. · van de Luijtgaarden · A. C. M. · Roelofs · L. A. J. · Vis · A. N. · Hoekstra · R. J. · Bloemendal · H
Introduction

The diagnostic and therapeutic landscape for high-risk localised prostate cancer and synchronous metastatic hormone-sensitive prostate cancer (mHSPC) is rapidly evolving, driven by advances in imaging, risk stratification and systemic therapies, including the advent of precision medicine. High-quality real-world data integrating clinical, imaging, molecular, quality-of-life information and outcome data remain scarce. The PROspective Prostate Cancer Infrastructure (ProPCI) is a nationwide, multicentre observational cohort designed to collect comprehensive longitudinal data and biomaterials to support real-world evidence generation, facilitate biomarker discovery and enable future cohort multiple randomised controlled trials (cmRCTs).

Methods and analysis

ProPCI includes adult men with high-risk localised prostate cancer or synchronous mHSPC across hospitals in the Netherlands. Clinical data are extracted from electronic health records using a standardised protocol and linked to national registries and healthcare use datasets. Patient-reported outcome measures are collected at baseline and regular intervals using validated instruments. Serial blood samples are biobanked for circulating tumour DNA and other molecular analyses. Outcomes include diagnostic and treatment patterns, Prostate-specific antigen kinetics, time to castration-resistant prostate cancer, radiological and clinical progression, health-related quality of life trajectories and healthcare use, including expenditure and exploratory biomarker associations. Statistical methods include descriptive analyses, time-to-event models, mixed-effects models and biomarker-outcome correlates.

Ethics and dissemination

Ethical approval has been obtained from the Committee on Research Involving Human Subjects (CMO) of Radboudumc. Written informed consent will be obtained from every participating patient and covers: (1) extraction and linkage of clinical, imaging, pathology and registry data, (2) future contact for potential cmRCT participation; and optional components (3) quality-of-life questionnaires, (4) collection of additional blood samples and (5) use of biomaterials for genomic testing. Results will be disseminated through peer-reviewed publications.

Trial registration number

NCT07560748.

Behaviourally informed text message reminders to increase cervical screening attendance in people with severe mental illness: the OPTIMISE pilot randomised controlled trial

Por: Nichol · B. · Bryant · A. · Hall · L. · von Wagner · C. · Barley · E. · Grimani · A. · Oliver · E. · Osborn · D. · Vale · L. · Vlaev · I. · Graham · F.
Objectives

This study assessed the feasibility of both the delivery and evaluation of ‘enhanced’ (behaviourally informed) text message reminders containing links to existing co-designed resources supporting decision-making for people with severe mental illness (SMI) regarding attendance of cervical screening.

Design

A pilot randomised controlled trial (RCT).

Setting

13 General Practice (GP) practices in London were recruited.

Participants

GP practices identified people with SMI aged 24–64 years who were overdue cervical screening. Target sample size was 120 participants (60 per arm) based on existing guidance for pilot trials.

Intervention

In March 2025, participants were randomised (1:1) to receive either the enhanced (intervention) or the standard (control) SMS reminder.

Primary and secondary outcome measures

18 weeks later, feasibility outcomes were collected (primary outcomes) and data analysis for a definitive RCT was rehearsed (secondary outcome).

Results

Of the 150 participants across 13 GP practices that were randomised (n=75 per arm), 132 (88%) texts delivered (intervention n=64/75 (85%), control n=68/75 (91%)). 10 practices (76.9%) provided follow-up data for 102 participants (intervention n=50, control n=52). Five participants (intervention n=4, control n=1) attended screening within the trial period. Participant survey response rate was low (9/132 (7%), intervention n=5, control n=4). Both SMS messages were low cost, with the intervention SMS a 50% higher cost to deliver (7.5p vs 5p per SMS). Primary feasibility measures of recruitment rate of GP practices (27%), retention of GP practices (77%) and participants (100%), SMS delivery (88%) and data completeness (64%) indicated viability, although survey response rate (7%) did not.

Conclusions

Achieving adequate recruitment and retention, data completeness and comparable groups is viable with some amendments, although an alternative method is required to assess fidelity. Behaviourally informed SMS reminders are feasible to deliver to people with SMI, although it is uncertain if the extra resources are accessed and used. With changes to data collection, a definitive trial could be feasible. Given the low observed cervical screening attendance, additional intervention is needed for this group.

Trial registration number

ISRCTN12558681.

Engaging community to co-design a multilevel intervention to reduce lung cancer disparities in persistent poverty tracts in California through group model building and simulation

Por: Lee · C. Y. J. · Waller · A. · Winn · L. · Hill · C. · Wood · E. H. · Ramos · O. F. E. · Conlon · K. C. · Darmstadt · G. L. · Patel · M. I.
Objectives

This study examined social determinants and structural barriers to lung cancer outcomes in Kern and Fresno counties, California, and co-developed a multilevel intervention strategy informed by community perspectives.

Design

Engaging stakeholders through group model building (GMB) to elicit their knowledge to build a system dynamics (SD) simulation model for intervention strategy design.

Setting and participants

We identified and trained four community members from two community-based organisations in Central Valley, California, to help recruit GMB participants. 14 community members representing patient advocacy organisations, cancer survivors, clinicians, caregivers, public health professionals, medical interpreters, housing, agriculture, sanitation, healthcare payer organisations and local policymaking sectors were recruited.

Procedures

The GMB protocol consisted of two in-person and four virtual workshops from 22 August to 11 November 2024. The SD simulation model was built with iSee System’s Stella Architect SD modelling software (V.4.0).

Results

The 181 variables suggested by the GMB workshop participants were categorised into 3 themes and 13 subthemes, which shaped the system boundary and model structure. 7 of the 16 intervention scenarios tested showed a cumulative reduction in the at-risk population and increases in screening, diagnoses, treatment and cancer-free survival. Participants selected a multilevel strategy focused on expanding public health and insurance education and advocating for air pollution-related screening within existing protocols.

Conclusion

Community engagement is essential for understanding lung cancer disparities and designing practical multilevel interventions. Scenario testing enables informed planning to improve long-term population health outcomes.

International collaboration to develop a dental implant standard set: study protocol for a multicentre prospective cohort study for the validation of a core outcome set

Por: Chin · M. · Pijpe · J. · Blanco · J. · Cune · M. · Wolvius · E. · Kragt · L.
Introduction

Dental implants are a widely accepted solution for tooth replacement, but standardised outcome assessment, particularly patient-reported outcomes, remains limited. Moreover, international variability in implantology practices underscores the need for consistent and comprehensive evaluation tools. This study aims to develop and validate the DEntal implaNt Set (DENS), a standardised tool to capture clinician and patient perspectives on peri-implant health and restorative treatment outcomes.

Methods and analysis

This prospective multicentre cohort study aims to include 1000 patients aged 18–75 years from 30 dental practices in the Netherlands and Spain. The DENS was developed by an international multidisciplinary team through structured iterative working sessions, grounded in the mandatory outcome domains of the Implant Dentistry Core Outcome Set and Measurement (ID-COSM) framework and informed by expert consultation with the ID-COSM authors. Patient-reported outcome measure (PROM) items were adapted from validated instruments and subjected to forward-backward translation into Dutch, English and Spanish. Data are collected at six time points from pre-implant placement to 12-month follow-up. Clinical outcomes and PROMs are assessed via the digital. Descriptive analyses and psychometric testing of the DENS instrument are planned at the end of the data collection phase.

Ethics and dissemination

Ethical approval was granted by committees in the Netherlands (Erasmus University Medical Center: MEC-2023-0688; Anna Hospital Eindhoven: 2024.076; Anna Hospital Geldrop: MEC-24.008; St. Antonius Hospital: R&D/Z24.070/DENS; University Medical Center Groningen: METc 2024/389) and Spain (CEI-SL 2024/122). Participants provide informed consent, and no procedures exceed standard clinical care. All data are pseudo-anonymised. Findings will be shared through publications, conferences and professional networks. The DENS tool will be made available for clinical practice and research purposes to promote standardised, evidence-based practice in implant dentistry.

Trial registration number

NCT07337057.

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

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

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

Aim

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

Methods

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

Results

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

Conclusion

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

Association between lifestyle risk factors and presenteeism among Chinese primary care physicians: a cross-sectional study

Por: Jia · X. · Gu · Z. · Wang · J. · Xi · X.
Objectives

This study aimed to examine whether lifestyle risk factors were associated with reporting any presenteeism and among primary care physicians (PCPs) who reported presenteeism, with the degree of productivity impairment.

Design

Cross-sectional study.

Setting

Primary healthcare institutions across all 31 provincial-level administrative regions of mainland China.

Participants

PCPs were eligible if they were aged ≥18 years, had worked in a primary healthcare institution for at least 1 year and provided written informed consent. Participants were recruited using multistage sampling with convenience sampling at the area, institution and physician levels. Of the 1500 questionnaires distributed, 1214 were returned, yielding a response rate of 80.9%. Following data quality screening, 338 questionnaires were excluded, leaving 876 physicians for analysis.

Primary and secondary outcome measures

Presenteeism was assessed using the Work Productivity and Activity Impairment Questionnaire: General Health version. Lifestyle risk factors (irregular diet, insufficient leisure-time physical activity (LTPA), poor sleep quality, smoking and drinking) were assessed using a structured questionnaire.

Results

Among the 876 PCPs included in the analysis, 417 (47.6%) reported presenteeism. Insufficient LTPA and poor sleep quality were associated with higher odds of reporting presenteeism (adjusted OR (aOR) 1.65, 95% CI 1.20 to 2.28; and aOR 1.59, 95% CI 1.12 to 2.26, respectively). Among PCPs reporting presenteeism, poor sleep quality was associated with a 3.85-percentage-point higher presenteeism score (average marginal effect 3.85, 95% CI 0.32 to 7.38). Smoking was associated overall with the degree of presenteeism (p=0.003), with category-specific estimates differing in direction. No clear associations were observed for irregular diet or drinking.

Conclusions

Poor sleep quality was associated with both the presence and degree of presenteeism, whereas insufficient LTPA was associated primarily with its presence. Sleep quality and LTPA may warrant further investigation as potentially modifiable factors associated with presenteeism among PCPs.

Intercultural interpreters perspectives on the provision of sexual and reproductive healthcare to Eritrean and Somali forced immigrant women in Switzerland: a qualitative exploration

Por: Zepro · N. B. · Erhardt · R. M. · Abongomera · C. · Paris · D. H. · Bohlius · J. · Chernet · A. · Merten · S.
Objectives

This study aimed to explore and synthesise interpreters’ perspectives on the provision of sexual and reproductive health (SRH) care to Eritrean and Somali migrant women in Switzerland, and to identify and analyse the professional and ethical challenges they encounter in this context.

Design

An exploratory qualitative study from a social constructionist perspective. The interviews were recorded, transcribed, categorised and analysed through thematic analysis.

Setting and participants

The study was conducted in the canton of Basel-Stadt, northwestern Switzerland. We have purposively selected 10 Eritrean and Somali intercultural interpreters serving as crucial intermediaries in assisting immigrant women to access SRH services.

Results

Our analysis of the interpreters’ perspectives revealed three key thematic areas that they identified as central challenges for their Eritrean and Somali immigrant women: (1) perceived limited health literacy among patients, (2) sociocultural barriers that interpreters observed hindering patient provider communication and (3) structural difficulties that interpreters reported their patients faced in navigating the Swiss healthcare system. These challenges have now persisted for a long time, and research findings and recommendations do not appear to have changed practices. For example, while abortion services are fully covered by Swiss health insurance, contraceptive methods often require out-of-pocket payments. This financial disparity may discourage appropriate use of SRH services among immigrant women. The lack of culturally competent care and the limited availability of funding for intercultural interpreters were among important bottlenecks identified.

Conclusions

This study explored interpreters’ perspectives on the provision of SRH care to Eritrean and Somali immigrant women in Switzerland. Despite the outstanding Swiss healthcare system, a majority of Eritrean and Somali refugee women struggle to benefit from SRH services due to limited health literacy, language barriers and challenges in navigating the Swiss healthcare system. Partnerships and integration of community entities, such as the Swisso-Kalmo association for Somali women and different Eritrean communities, could contribute via facilitating entry points for access to SRH healthcare.

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