With the rapidly changing landscape of rectal cancer treatment, it is becoming increasingly challenging for clinicians to interpret and synthesise the vast amount of high-quality evidence being generated. A core outcome set (COS) for clinical trials in rectal cancer would help address issues surrounding outcome selection and reporting. The purpose of this research project is to develop a COS to be used in research comparing different treatment paradigms in the management of rectal cancer.
This will be a mixed-methods project, including a systematic review, semi-structured interviews and a Delphi consensus process. The project was designed in accordance with the COMET (Core Outcome Measures in Effectiveness Trials) Handbook, which provides a framework for COS development based on existing evidence. A multidisciplinary Study Advisory Group, composed of rectal cancer providers, methodologists and patients, will oversee the project. A systematic review will be performed to identify an inclusive list of outcomes reported by researchers in previous rectal cancer trials. Outcomes will be collapsed into various core areas and domains according to the OMERACT Filter V.2.0. Semi-structured interviews with rectal cancer survivors and their partners/caregivers will help identify additional patient-centric outcomes not captured in the systematic review. Finally, after a final list of outcomes is generated, patients and healthcare professionals will be invited to participate in a Delphi process to develop the final COS.
The study has received full approval with the Research Ethics Committee at the Integrated Health and Social Services Network for West-Central Montreal (health network responsible for the Jewish General Hospital) (REC: 2025-4377) and the Institutional Review Board of the Mount Sinai School of Medicine (IRB: STUDY-25-00515). The results of this study will be presented at national and international meetings and a manuscript will be submitted for publication in a high-impact surgery and/or oncology peer-reviewed journal.
The study was registered in the COMET database in December 2023 (https://www.comet-initiative.org/Studies/Details/2941). The full systematic review protocol, along with the search strategy and inclusion/exclusion criteria, was registered online in September 2023 (researchregistry.com; reviewregistry1705).
Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a well-accepted treatment for advanced Parkinson’s disease (PD). Currently, programming of the DBS is done in a trial-and-error manner and it can take up to 12 months to reach optimal stimulation parameters. Technological advances in electrode design and implantable pulse generator capabilities lead to an almost infinite number of stimulation options. To explore the potential benefit of all these technological advances, a conventional trial-and-error approach is no longer sufficient. Consequently, there is a clear need for a more computational approach to programming DBS systems. This pilot study is a prospective trial to prove the feasibility of programming bilateral STN-DBS for PD in a computational fashion based on patient anatomy, electrode position and brain connectivity. In this study, we aim to assess the safety, practical feasibility and technical feasibility of a computational approach for programming newly implanted STN-DBS patients with PD. This computational approach will be based on a patient-specific DBS setting regarding sweet spots and structural connectivity of the STN. The results of this pilot study will be used to develop a computational approach for DBS programming to use in a future randomised clinical trial.
The iDBS trial will be a prospective randomised feasibility study carried out at the Radboud university medical center. A total of 24 patients with PD eligible for bilateral STN-DBS surgery implanted with Boston Scientific Cartesia leads will be included. Patients will be randomised to receive either (1) computational DBS programming (n=12) or (2) conventional DBS programming based on monopolar review (n=12). The primary endpoints are safety (occurrence of stimulation-induced side effects, duration of induced side effects (temporary or permanent), severity of the stimulation-induced side effects) and technical feasibility (time from surgery to DBS initiation, time from surgery to reaching optimal DBS stimulation settings) of the computational workflow.
Ethical approval for this study has been granted by the Medical Ethical Committee region Arnhem-Nijmegen, the Netherlands (2024–17453). This study will be conducted in accordance with the Declaration of Helsinki and all applicable European and Dutch law. All participants will have to provide written informed consent. Results of the study will be submitted for publication in peer-reviewed journals and conferences.
The study is registered in the OMON-registry (NL87334.091.24, NL-OMON57446).
Multivitamins and minerals (MVMs) are readily available dietary supplements that help prevent nutritional deficiencies and boost energy. This study examined the prescribing and consultation practices of healthcare professionals (HCPs) related to MVM supplements in Pakistan.
This cross-sectional study used a web-based structured questionnaire to collect data from HCPs from February 2021 to January 2022. The study link, which included a consent form and questionnaire, was circulated on social media platforms, and all individuals who provided consent and completed the forms were included in the study.
A total of 524 HCPs participated in the study, with the majority being males, holding MBBS or Fellow of the College of Physicians and Surgeons qualifications, and working in urban settings. Findings revealed that HCPs prescribe MVMs for varied reasons. We assessed differences based on various factors like gender, education level, area of practice and specialty. Most of the differences observed were not statistically significant, except for a few related to area of practice and education level that were found significant. The primary conditions prompting MVM prescriptions included osteoporosis and bone pain (80% for vitamin D and calcium), fatigue and weakness (over 70% for iron) and numbness/tingling (more than half for folate and vitamin B12). Regarding biospecimen analysis before prescribing MVMs, 46% of HCPs required laboratory investigations before prescribing vitamin D and calcium and 60% for iron prescriptions. Common formulations prescribed include cholecalciferol for vitamin D deficiency (62%) and ferrous sulfate for iron deficiency (76%).
Our study findings highlight that the prescribing practices of MVMs by HCPs are primarily in line with the known physiological roles of these supplements. However, a few identified gaps in practices highlight the need for standardised guidelines to ensure patients’ health and well-being.
Induction of labour (IOL) is a commonly performed obstetric intervention, particularly when delivery is deemed more beneficial than continuing the pregnancy due to maternal or fetal indications. When the cervix is unfavourable for delivery, cervical ripening is performed prior to IOL. A wide variety of mechanical, pharmacological and combination methods are used, but the optimal approach balancing efficacy, safety and patient experience remains uncertain. Conventional aggregate data (AD) meta-analyses lack individual-level data, limiting exploration of patient-level factors for personalised medicine and do not address concerns about the trustworthiness of data presented in peer-reviewed randomised controlled trials (RCTs). This protocol describes an individual participant data (IPD) network meta-analysis (NMA) designed to evaluate and rank cervical ripening methods for IOL using only high quality, trustworthy data.
We will identify eligible parallel-group RCTs enrolling pregnant women with a singleton, cephalic fetus at ≥34 weeks’ gestation requiring cervical ripening, through comprehensive searches of Ovid MEDLINE, Embase, Emcare, Scopus, Cochrane Pregnancy and Childbirth Register, WHO International Clinical Trials Registry Platform, clinicaltrials.gov and reference lists of prior reviews. The interventions we consider will be selected via Delphi consensus with international clinical experts. Eligible trial investigators will be invited to contribute de-identified IPD; AD will be used if IPD is unavailable. Trials will be assessed for trustworthiness using the Trustworthiness in RAndomised Clinical Trials checklist and the IPD Integrity Tool, with only eligible studies included in the primary analysis. All statistical analyses will follow a pre-specified statistical analysis plan (SAP) finalised before any analyses are conducted. A two-stage, contrast-based, frequentist IPD-NMA will compare cervical ripening methods for three co-primary outcomes: vaginal birth, composite adverse perinatal outcomes and composite adverse maternal outcomes. Subgroup analyses will assess effect modifiers (eg, parity, age and previous caesarean), with treatment rankings presented using the surface under the cumulative ranking curve and rank-heat plots. Sensitivity analyses will examine the impact of bias, missing data and population criteria.
This study has been approved by the Monash University Human Research Ethics Committee (No. 48189). IPD will be de-identified and securely transferred for storage on a Monash University-hosted shared network drive. Findings will be disseminated via peer-reviewed publications, conference abstracts and the Cervical Ripening for Induction of Labour Collaborative Evidence Network Meta-Analysis (CIRCLE-NMA) website (https://circlenma.com). Patient and public involvement will guide the communication and interpretation of results.
CRD420251077464.
Anaemia is highly prevalent among the indigenous population globally. Several interventions have been used to prevent and manage nutritional anaemia, including dietary measures, health education, oral iron supplements, food fortification and intravenous iron therapy. This protocol describes a systematic review and meta-analysis to assess the effectiveness of interventions for the prevention and treatment of nutritional anaemia in indigenous populations worldwide.
The review will include randomised controlled trials, quasi-experimental studies and observational studies evaluating interventions, including but not limited to iron and folic acid supplementation, dietary modifications, food fortification, deworming and health education. A robust search strategy will be developed, and six electronic bibliographic databases and Google Scholar will be searched from 2000 to 2025. Two reviewers will independently screen the identified studies, extract data, conduct a critical appraisal and evaluate quality using the Joanna Briggs Institute tool. Based on the level of heterogeneity, a meta-analysis will be conducted using either a fixed-effect or random-effects model, with pooled estimates, and 95% CIs. The I2 statistic will be used to evaluate heterogeneity. When meta-analysis is not feasible, narrative synthesis will be conducted. The impact of the intervention type and delivery model will be investigated using subgroup analysis.
This systematic review has been registered with PROSPERO. Ethical approval is not required as the study does not collect primary data from participants. The findings will be communicated via peer-reviewed journal articles and presentations at national and international conferences.
CRD420251120554.
All physicians will experience challenging history taking encounters, where communication is impaired and negatively impacts the diagnostic process. The aims of this systematic review were to (1) undertake a meta-analysis of the frequency of challenging encounters; (2) collate adverse outcomes of challenging encounters; (3) identify underlying causes of challenging encounters; (4) identify strategies to deal with different challenges; and (5) align these strategies with our published phenomenological framework of history taking challenges.
This was a systematic review and meta-analysis of prevalence data adhering to the Preferred Reporting Items for Systematic reviews and Meta-Analyses and the Meta-analyses of Observational Studies in Epidemiology guidelines.
A literature search in MEDLINE, Embase and Cochrane databases was performed on 12 July 2020, and updated on 4 August 2025, focusing on challenging history taking encounters in any clinical setting.
Articles reporting on the frequency, adverse outcomes, causative factors or strategies used to address challenges in the history taking process in any clinical area of medicine.
Factors associated with challenging history encounters (causative or consequential) were categorised using inductive coding and referenced to a phenomenological framework. Meta-analysis was used to estimate the prevalence of history taking encounters using a restricted maximum likelihood model with 2 and I2 as tests for heterogeneity and funnel plot with Egger’s test for publication bias.
73 articles were included in the analysis. The overall prevalence of challenging history taking encounters was 19.5% (95% CI 14.2% to 24.7%). Adverse outcomes of patient dissatisfaction (level 1 evidence) and diagnostic uncertainty (level 3 evidence) were identified. Factors associated with (n=22) and strategies to mitigate challenging encounters (n=13) were categorised. Correlation of factors and strategies with a phenomenological approach created a framework to assist novice history takers in approaching such circumstances.
Challenging history taking encounters are common. Little is known of the relative importance of factors associated with challenging history taking encounters or the impact of suggested strategies. Many of the suggested strategies to facilitate meaningful communication in these situations involve a departure from standard history taking. More research is required to better define the nature of challenges encountered in history taking with a view to develop better educational models for trainee physicians.
The Trauma Recovery Center (TRC) is an evidence-based model of care designed to meet the needs of underserved survivors of violent crime through the provision of comprehensive mental health and psychosocial services. Originally developed in the USA, the TRC model has been adopted by 53 hospitals and outpatient settings nationwide. Its demonstrated effectiveness supports its potential for international scale-up, particularly in countries seeking to improve their responses to interpersonal violence and trauma. While the core principles of the model remain universally consistent, there is a striking paucity of synthesised evidence on implementation barriers and enablers, necessary to guide effective scale-up and adaptation across diverse systems of care. The objective of this scoping review is to identify and map barriers and facilitators that influence implementation of the TRC model of care.
The scoping review was initiated in May 2025 and is expected to be completed in May 2026. The review will be conducted following the Joanna Briggs Institute methodology for scoping reviews. Results will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews. The initial PubMed search was conducted in June 2025. The finalised search strategy will subsequently be applied to PubMed, Embase, PsycINFO, CINAHL and Scopus databases. A two-stage screening process using Covidence software will be used to determine study eligibility. To be included, studies will be required to have examined implementation-related barriers or facilitators associated with at least one core element of the TRC model or analogous psychosocial support programmes within the context of comprehensive, trauma-informed care for survivors of violent crime. Studies conducted within the USA and published in English between 2001 and 2026 will be included.
All studies will be independently assessed for eligibility. Data will be extracted and mapped using the Consolidated Framework for Implementation Research (CFIR). Extracted data will be analysed and synthesised narratively across the five CFIR domains, accompanied by summary tables that describe how the findings relate to the review objective. Existing knowledge gaps will be identified and discussed.
Ethics approval is not required for this scoping review. Experts from the National Alliance of Trauma Recovery Centers (NATRC) will be engaged to provide feedback on the study findings and support the dissemination of results. Dissemination activities will include peer-reviewed publications and presentations at academic conferences and professional events, such as NATRC’s technical assistance and learning community training sessions.
Antimicrobial resistance (AMR) and plastic pollution are converging global crises that threaten both human health and environmental sustainability. Despite the growing recognition of these challenges, few legislative and policy frameworks acknowledge the complex interplay between antibiotic misuse and environmental plastic contamination. This protocol seeks to bridge that gap by critically examining policies in Europe and the Philippines, focusing on those that target antibiotic misuse and plastic pollution in human and animal health.
Document analysis will be employed to systematically review relevant legislative and policy frameworks. We will retrieve laws, regulations and policy documents from official databases, government websites and other sources using broad inclusion criteria. The extraction process and analysis will be guided by the READ (Ready, Extract, Analyse, Distill) approach which will ensure a thorough examination of how these documents address the dual challenges of AMR and plastic pollution. Particular attention will be paid to identifying policy gaps, overlaps and synergies that may affect the overall effectiveness and coherence of current governmental responses.
This policy review has been granted exemption from ethical review by the Research Institute for Tropical Medicine (RITM-IRB No. 2024-35), Philippines. The results are expected to provide a robust evidence base to inform the development of integrated policies at the nexus of global public health and environmental sustainability. Findings will be disseminated at academic conferences and peer-reviewed publications and to key stakeholders within European, Philippine, and international organisations.
The detailed protocol is pre-registered and openly available on the Open Science Framework (https://osf.io/3tkn2/overview).
Diabetic foot is an infection, ulceration or destruction of the tissue of the foot of a person diagnosed with diabetes mellitus (DM). Diabetic foot ulcer (DFU) is a major and preventable complication of DM. Adequate knowledge and foot self-care practices are crucial to reduce the risk of DFU complications, particularly in resource-limited healthcare settings.
To assess the knowledge and practices related to foot self-care and associated factors among individuals diagnosed with diabetes attending diabetic clinics at all base hospitals in Colombo District, Sri Lanka.
An analytical cross-sectional study was conducted among 423 individuals diagnosed with diabetes attending the diabetic clinic at all three base hospitals in Colombo district, from January 2023 to March 2024 (study period). Participants were selected by using a systematic random sampling. Data were collected using a validated and pre-tested interviewer-administered questionnaire. Descriptive and inferential analyses were performed using Statistical Packages for Social Sciences V.26 software. Associations were examined using 2 tests, independent sample t-tests and one-way ANOVA (Analysis of Variance), with a p value
The majority of the participants were females (71.2%). Among the participants, 33.8% of them had a poor level of knowledge regarding foot self-care. Knowledge level was significantly associated with the participants’ family history of diabetes and the hospital where they attended the clinic (p
Nearly one-third of participants demonstrated poor knowledge of foot self-care, despite over half exhibiting satisfactory foot-care practices. This gap highlights the need for targeted education to boost awareness and promote consistent foot care, which is a key step in preventing diabetic foot complications and improving long-term outcomes for individuals diagnosed with diabetes.
To explore perceived barriers to adhering to a healthy lifestyle among older people living in a Sri Lankan setting.
Qualitative thematic analysis of in-depth interviews among older people.
The study was conducted in Kalutara district, Sri Lanka.
In total, 28 older people aged between 60 years and 74 years were interviewed.
Six major themes were identified following the analysis. They were named as lack of knowledge, financial difficulties, poor health status, domestic constraints, cultural norms and changing the living environment. Lack of knowledge emerged through two subthemes, namely lack of information and lack of services. Domestic constraints were derived from family commitments and domestic conflicts, while cultural norms came via beliefs and customs. Poor health status emerged through three subthemes, namely disabilities, diseases and polypharmacy, while changing the living environment emerged via adaptation and urbanisation.
This study provides evidence of real-life perceptions on why older people do not adhere to a healthy lifestyle. Barriers are multifaceted and complex, yet those dimensions need to be considered heavily while developing lifestyle programmes to get maximum benefit for the older people.
Treatment with bevacizumab achieves both tumour stabilisation or regression and preservation or improvement of hearing. However, the efficacy of bevacizumab varies between patients and within patients. Side effects due to bevacizumab treatment are also common. It would be of value to predict therapeutic response prior to initiating therapy to prevent unnecessary exposure in patients unlikely to benefit.
We aim to recruit 25 patients with NF2-related schwannomatosis (NF2) with bilateral vestibular schwannomas. Patients will receive an intravenous injection of 37 MBq [89Zr]bevacizumab followed by positron emission tomography (PET)/CT imaging 4 days later. After clinical evaluation at baseline, patients undergo bevacizumab treatment and are followed up at 3 and 6 months. The primary objective is to examine associations between pretreatment [89Zr]bevacizumab uptake on PET/CT and changes in multiple hearing outcomes and radiological characteristics of the target tumour following treatment. Secondary outcome measures include vestibular functioning, patient reported outcome measures, cranial nerve functionality, peripheral neurology, non-target schwannoma response and renal function. Given the explorative nature of the study, associations between PET-derived metrics and clinical and radiological outcomes will be examined without formal hypothesis testing, using generalised estimating equations to account for within-patient correlation. Pairwise associations will be summarised in an association matrix with multiplicity addressed using an all-resolutions inference approach, and findings will be considered hypothesis generating.
This study was submitted via the Clinical Trials Information System reviewed and approved by the Medical Research Ethics Committee Leiden–The Hague–Delft Delft. The study findings will be disseminated through publication in peer-reviewed scientific journals and by presentation at national and international conferences.
The trial is registered at ClinicalTrials.gov Protocol Registration and Results System under the registration ID: NCT05685836.
Quality collaboratives improve quality of care at the hospital and collaborative levels, but less is understood about how such efforts affect patient-level disparities. This study evaluated how a quality improvement (QI) effort (increasing multiarterial grafting during coronary artery bypass grafting (CABG)) translated into populations which historically receive lower-quality care (females and patients of low socioeconomic status).
Retrospective cohort study.
All non-federal hospitals in the state of Michigan that perform cardiac surgery and participate in a statewide collaborative database (n=33).
Patients undergoing first-time, isolated CABG receiving at least two bypass grafts from 2011 to 2022 were identified.
Association of sex and socioeconomic status with multiarterial grafting was evaluated across the study period. The distressed community index (DCI), a socioeconomic ranking (0—not distressed, 100—severely distressed), was matched to the patient’s zip code. Hierarchical regression modelling was performed to associate DCI and sex with multiarterial grafting, incorporating patient factors and hospital and surgeon effects. A sex-surgery year and DCI-surgery year interaction term was performed to assess the change in the rate of multiarterial grafting.
A total of 40 322 patients underwent CABG at 33 centres with a median age of 66 years and 24% were female. The rate of multiarterial grafting was 15%, although lower among females (10% vs 17%) and the highest (vs lowest) DCI quartile (14% vs 18%). After risk adjustment, females were less likely to receive multiarterial grafting (ORadj 0.51 (95% CI 0.45 to 0.58), padj 0.35 per 10-point increase (95% CI 0.24 to 0.51), p0.05).
Despite a large overall increase in multiarterial grafting due to QI efforts, females and patients with low socioeconomic status had lower rates of multiarterial grafting. QI efforts should be evaluated both overall and among patients who historically receive lower quality care to improve quality and equity.
To determine the prevalence of presbyopia and associated risk factors among Bangladeshi recipients of elderly social safety net payments who were not currently using mobile financial services (MFS) and demonstrated numeracy, dexterity and cognitive prerequisites for smartphone use during eligibility screening for the Transforming Households with Refraction and Innovative Financial Technology (THRIFT) trial. Accessing these payments requires use of online banking, as with a smartphone.
Cross-sectional analysis of trial eligibility screening data.
Community-based screening conducted in two rural subdistricts in Kurigram District, Bangladesh.
Among 13 944 Old Age Allowance and Widows’ Allowance (WA) beneficiaries screened, 953 met trial eligibility criteria, including passing a smartphone readiness assessment and completing near vision examinations.
Presbyopia, defined as binocular presenting near visual acuity of N6.3 or worse, correctable to at least N5 with near vision glasses and with distance vision of ≥6/12 in both eyes.
Among 953 participants (mean age 61.4±7.2 years, 62.6% women), presbyopia prevalence was 62.6% (95% CI 59.5 to 65.7). Presbyopia was significantly positively associated with female gender (adjusted prevalence ratio (APR)=1.19, 95% CI 1.02 to 1.41) and receiving WA (APR=1.20, 95% CI 1.04 to 1.38) in multivariable analyses.
This study highlights a substantial burden of uncorrected presbyopia among a prescreened, randomised control trial-eligible subgroup of social safety net beneficiaries in rural Bangladesh, who were not currently using MFS but demonstrated cognitive and functional capacity to use mobile phones, potentially hampering their ability to carry out online banking. Delivery of reading glasses may improve digital financial access and facilitate broader financial inclusion, a hypothesis currently being tested in the parent THRIFT trial.
The FirstCPR cluster randomised trial delivered multimodal basic life support (BLS) learning opportunities to community organisations. An a priori process evaluation examined intervention implementation, including participation, reach, uptake and member engagement.
The study used a multimethod process evaluation. Data were collected via semistructured interviews, focus group discussions, participant surveys, study records, web analytics and in-field observations. These sources captured participation patterns and implementation measures (delivery, reach, uptake and engagement: opt-in to digital messages and attendance at training sessions), as well as reasons for refusals and withdrawals. Qualitative data were analysed thematically and organised using the UK Medical Research Council process-evaluation framework. Qualitative and quantitative data were analysed separately and subsequently interpreted collectively to contextualise implementation patterns and identify barriers and enablers that influenced trial successes and failures.
Intervention uptake and engagement varied significantly across organisations, with greater success observed in social and faith-based groups. Of the 82 intervention clusters, 78 (95%) received intervention materials; 74 (90%) engaged in at least one activity and 15 (18%) engaged in all activities. Participation was primarily driven by the organisation’s leadership interest and support in providing BLS training to members, and by the time available to facilitate intervention activities. The presence of a dedicated liaison/champion emerged as the most critical enabler of member engagement and implementation. Feedback recommended concise, simple and culturally tailored modules, with practical components delivered in shorter, convenient sessions. Intervention delivery was affected by contextual challenges, including COVID-19 disruptions that limited in-field recruitment and group activities.
Process evaluation can strengthen community-based interventions by identifying mechanisms and contextual factors that shape implementation and engagement. Partnering with social and faith-based organisations may be an effective approach to disseminating educational programmes such as life-saving skills to lay communities. Minimising research burden and ensuring organisational leadership support may improve participation while brief, practical and culturally tailored training may enhance engagement.
ACTRN12621000367842.
To assess whether the Marburg Heart Score (MHS) and INTERCHEST score may improve telephone triage of chest pain by providing better diagnostic discrimination compared with the triage protocol from the Netherlands Triage Standard (NTS).
Prospective diagnostic accuracy study.
Large regional out-of-hours primary care (OOH-PC) facility in Alkmaar, the Netherlands.
A total of 1254 eligible patients contacted the OOH-PC facility (median age 56.0 years, 57.9% female) between December 2022 and May 2023. The study was completed and verbal informed consent obtained in 280 (22.3%) patients.
Triage assistants asked study questions in addition to the NTS protocol to complete the MHS and INTERCHEST score.
Discrimination (C-statistics) and diagnostic test properties (eg, sensitivity/specificity) were used; the reference standard was the occurrence of a major event (ie, composite of all-cause mortality, and urgent cardiovascular and non-cardiovascular conditions) or acute coronary syndrome (ACS) within 6 weeks.
A major event occurred in 36 patients (12.9%), including 13 (4.6%) ACS cases. For predicting major events, the MHS and INTERCHEST scores showed C-statistics of 0.67 (95% CI 0.57 to 0.77) and 0.64 (95% CI 0.54 to 0.74), respectively, compared with 0.62 (95% CI 0.53 to 0.71) for the NTS protocol. For ACS, C-statistics were 0.62 (95% CI 0.45 to 0.79), 0.59 (95% CI 0.43 to 0.75), and 0.62 (95% CI 0.49 to 0.75) for MHS, INTERCHEST and NTS, respectively. Regarding test characteristics, the MHS and INTERCHEST score showed higher point estimates for specificity (27.9% and 26.6%) vs the NTS (19.7%), but at the expense of lower sensitivity (88.9% and 86.1% versus 97.2%) for major events. For ACS, a similar pattern was observed (specificity 26.2% and 25.5% vs 18.4; sensitivity 84.6% and 84.6% vs 100.0%).
Simple clinical decision rules (MHS and INTERCHEST) have comparable, modest discriminative ability and diagnostic properties compared with the current protocol for telephone triage of acute chest pain in Dutch OOH-PC.
Netherlands Trial Register (TRACE – NL-OMON20102).
Primary care is facing multiple crises, including an increase in health misinformation. Digital health messaging by primary care providers has been shown to reach a diverse patient population. With the uptake of Generative Artificial Intelligence (GenAI) usage in healthcare, there is an important opportunity to rapidly create messages that are tailored to different populations and conditions. However, thoroughly assessing artificial intelligence (AI)-generated content is essential, as GenAI raises concerns regarding its accuracy, understandability, actionability and bias perpetuation. We aim to investigate whether digital health messages created by GenAI are evaluated as non-inferior compared with those created by human experts.
The AI-CARE (AI to Create Accessible and Reliable patient Education materials) study is a double-blind, crossover, non-inferiority randomised controlled trial. Data collection began on 30 May 2025, and is expected to be completed at the end of May 2026. Over 12 months, 192 messages on 48 topics will be written: half by primary care and public health experts and half by a GenAI tool (OpenAI’s ChatGPT). Review Panels composed of 24 primary care providers and 24 patients will evaluate these messages using an Evaluation Grid developed to assess the messages’ quality of information, adaptation to the target audience, relevance and usefulness, and readiness to be shared with patients. Evaluations will be completed via online REDCap (Research Electronic Data Capture) surveys and the order in which the 192 messages appear will be randomised and will vary between individuals. Participants and analysts will be blinded to the generation source. The primary outcome will be the Clarity and Understandability score.
The Research Ethics Boards of the Hôpital Montfort (24-25-11-038) and the University of Ottawa (S-12-24-11153) formally approved this study in December 2024. Reported data will be grouped and anonymised for dissemination in peer-reviewed scientific journals and conferences.
Non-communicable diseases, particularly cardiovascular diseases (CVDs), have become major contributors to morbidity and mortality in sub-Saharan Africa (SSA) and are projected to surpass infectious diseases as the leading cause of death among adults by 2030. Although CVDs have traditionally been associated with older age and obesity, adverse cardiovascular phenotypes are increasingly being observed in younger and leaner individuals in SSA. This pattern suggests that pathways to CVD risk in SSA may differ from those described in high-income countries. Early-life infectious exposures, undernutrition and socio-demographic conditions common in many SSA settings have been proposed as potential risk factors. Still, empirical evidence linking these exposures to cardiovascular risk in early adulthood remains limited due to a scarcity of long-running birth cohorts in the region.
This protocol describes a new round of data collection nested within the Entebbe Mother and Baby Study (EMaBS), a population-based Ugandan birth cohort established originally as a clinical trial (ISRCTN32849447) between 2003 and 2006 with prospective follow-up from pregnancy through adolescence. All participants currently under follow-up will be invited to participate at approximately 21 years of age. Primary outcomes are physiological determinants of CVD measured in early adulthood, including blood pressure, blood lipid levels, body mass index, body composition and markers of glucose metabolism. Secondary outcomes include behavioural CVD risk factors (diet, physical inactivity, alcohol use and tobacco use) and qualitative measures of CVD knowledge and risk perception. Key exposures of interest include prospectively collected early-life and childhood infectious exposures (malaria and helminth infections), markers of growth and undernutrition, micronutrient status, inflammatory markers, socio-demographic factors and selected genetic variants. Quantitative analyses will use multivariable regression and causal modelling approaches and will be complemented by qualitative interviews and focus group discussions.
The study protocol has been reviewed and approved by the Uganda Virus Research Institute Research and Ethics Committee (UVRI REC Ref: GC/127/35), the Uganda National Council for Science and Technology (UNCST Ref: MV625), and the London School of Hygiene & Tropical Medicine Research Ethics Committee (LSHTM Ethics Ref: 8811). Written informed consent will be obtained from all participants before study activities. Study findings will be shared and discussed with participants and community stakeholders through established engagement platforms. Results will be disseminated to the scientific community through peer-reviewed publications and conference presentations, and data will be made available to other researchers via established data-sharing platforms. We will engage policymakers at the district, national and international levels to facilitate the translation of findings into policy-relevant outputs.
Chronic postsurgical pain (CPSP) after hip arthroplasty is a major complication that affects patients’ long-term quality of life. However, reliable tools for the individualised prediction of CPSP risk after hip arthroplasty are lacking. This study aims to develop and validate a nomogram model to predict CPSP risk in patients undergoing hip arthroplasty.
This prospective observational cohort study will consecutively recruit 300 patients undergoing primary hip arthroplasty at the Department of Orthopaedics and Joints, Nanping First Hospital Affiliated with Fujian Medical University. The primary outcome is CPSP assessed at 3 months postoperatively (Visual Analogue Scale score ≥4). Candidate predictor variables have been identified based on literature review and clinical expertise, and include demographics, comorbidities, preoperative pain, psychological status and surgical and perioperative management. The dataset will be randomly split into development and internal validation sets in a 7:3 ratio. We will employ Least Absolute Shrinkage and Selection Operator regression to select variables and will use multivariable logistic regression to build the final prediction model. Internal validation will be performed using bootstrap resampling (1000 repetitions). The model’s discrimination, calibration and clinical utility will be assessed using the C-statistic (area under the curve), calibration plots and decision curve analysis, respectively. The final model will be presented as a nomogram.
The study protocol has been approved by the Ethics Committee of Nanping First Hospital (Approval No: NPSY202412034). All participants will provide written informed consent. The results will be submitted for publication in a peer-reviewed academic journal.
ChiCTR2500107193; https://www.chictr.org.cn/showproj.html?proj=282634.
While adverse childhood experiences (ACEs) have been consistently linked to poorer cognitive outcomes in later life, far less is known about ACEs’ contribution to dementia and cognitive ageing risk in low-income and middle-income countries (LMICs), despite their growing and disproportionate share of global Alzheimer’s disease and related dementias (ADRD) burden. This study aimed to systematically review existing evidence on the association between individual ACEs and cognitive outcomes among adults aged 40 years and older in LMIC settings.
Systematic review and narrative synthesis.
We searched Medline, Embase, PsycINFO and CINAHL from the inception of each database to January 2026.
Observational studies examining the association between individual ACEs and cognitive outcomes among adults aged 40 and older in LMICs.
Two reviewers independently screened each record, assessed risk of bias using the Joanna Briggs Institute critical appraisal tool and extracted data. Results were illustrated using descriptive forest plots and a narrative synthesis.
Our systematic review included 14 studies, primarily from upper-middle-income countries, that assessed the relationship between individual ACEs and cognitive impairment (n=4) and function (n=10). 10 studies reported significant associations between ACEs and poorer cognitive function and increased risk of cognitive impairment. No study assessed the association between ACEs and ADRD. Parental death, neglect and mental health issues in the family showed consistent associations with cognitive outcomes, whereas experiencing hunger and poor health in childhood showed inconsistent associations.
Our review corroborated evidence from high-income countries that exposure to ACEs is associated with a long-term risk of poorer cognitive outcomes among older populations in LMICs. However, the available literature remains limited, with most studies originating from upper-middle-income countries, few examining cognitive impairment and none assessing ADRD. These findings underscore substantial gaps in knowledge and highlight the need for research across diverse LMIC settings to clarify the role of broader psychosocial and contextual childhood experiences in shaping cognitive ageing and dementia risk.
CRD42024501816.
To assess the effect of three educational interventions on self-management behaviours among individuals at risk of diabetes in Burkina Faso, Comoros and Mali, using cluster analysis to identify distinct respondent profiles.
Single-arm before–after longitudinal study with 6-month follow-up.
Community screening initiatives and antenatal clinics in Burkina Faso, Comoros and Mali.
540 adults at risk of diabetes (body mass index ≥25 kg/m² and/or family history of diabetes and/or impaired fasting glucose ≥1.10 g/L; mean age 38.2 years, 69% female) recruited through community screening initiatives and antenatal clinics in Burkina Faso, Comoros and Mali.
Three educational interventions: (1) social media video broadcasting, (2) peer educator outreach and (3) gestational diabetes education at antenatal clinics.
Changes in domain-specific Health Education Impact Questionnaire scores over 6 months assessed using Cohen’s d effect sizes.
Of the 540 initial participants, 528 responded to the follow-up survey 6 months later. Cluster analysis revealed two distinct self-management profiles: cluster 1 showed significant improvement in only two domains, self-monitoring (d=0.35, p=0.006) and skill acquisition (d=0.30, p=0.020), indicating limited but focused gains. In contrast, cluster 2 suggested significant progress in seven out of eight domains, including large gains in positive engagement in life (d=0.74, p
Distinct self-management profiles among diabetes-risk populations revealed critical heterogeneity that demands tailored, context-specific public health strategies to effectively address diverse needs and optimise prevention efforts.