Conectar
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.
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.
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.
CRD #420261395061.
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.
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.
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.
To describe antibacterial consumption (ABC) in four paediatric inpatient facilities in Sri Lanka in 2023.
Descriptive cross-sectional study, adapted from the WHO Global Antimicrobial Resistance and Use Surveillance System methodology.
Paediatric inpatient facilities in two tertiary and two secondary care government hospitals located across three provinces.
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.
(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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
A pilot randomised controlled trial (RCT).
13 General Practice (GP) practices in London were recruited.
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.
In March 2025, participants were randomised (1:1) to receive either the enhanced (intervention) or the standard (control) SMS reminder.
18 weeks later, feasibility outcomes were collected (primary outcomes) and data analysis for a definitive RCT was rehearsed (secondary outcome).
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.
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.
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.
Engaging stakeholders through group model building (GMB) to elicit their knowledge to build a system dynamics (SD) simulation model for intervention strategy design.
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.
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).
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.
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.
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.
An exploratory qualitative study from a social constructionist perspective. The interviews were recorded, transcribed, categorised and analysed through thematic analysis.
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.
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.
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.
Floods and heatwaves are becoming more frequent and intense and can disrupt routine maternal and child health (MCH) services. Previous reviews have not systematically examined how context and mechanisms may shape adaptation outcomes. This realist-informed systematic review examines how, why and under what conditions interventions support access to, utilisation of and continuity of routine MCH services during flood and heat events.
The search strategy was developed by integrating terms from 17 related reviews, refined with the author team and checked by an experienced London School of Hygiene & Tropical Medicine librarian. The initial database search was conducted on 16 May 2025 and the search was updated on 30 April 2026. Eight databases were searched: Web of Science, Ovid MEDLINE, EMBASE, Global Health, EconLit, GreenFILE, CINAHL and ProQuest Environmental Science & Public Policy. Records published between January 2000 and April 2026 were eligible. Search results were imported into EndNote and deduplicated. Title-and-abstract screening and full-text assessment were conducted independently by two reviewers for the initial search and are ongoing for the updated search, with ASReview being used to prioritise records during title-and-abstract screening. Data extraction across the full review evidence base remains ongoing using a structured template covering study context, intervention characteristics, mechanisms, outcomes, costs and implementation conditions. Study settings will be classified by country income group, health system context and Köppen–Geiger climate zone to compare evidence across settings and, where appropriate, to identify possible climate analogues for exploratory, context-specific assessment. Climate-zone similarity will not be used to infer intervention transferability or future effectiveness. The synthesis will be guided by the WHO Climate-Resilient Health Systems framework, Meadows’ leverage-points framework and realist-informed C–M–O reasoning. Interventions will be grouped to identify where they operate within the health system and which health system components and vulnerabilities they address. Findings will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance.
Ethical approval is not required because the review uses published literature and does not involve human participants. The findings will be disseminated through a peer-reviewed systematic review publication. They will inform the design, improvement and scaling of interventions intended to maintain routine MCH services and strengthen health system resilience to floods and heatwaves across diverse settings.
The review was not prospectively registered with PROSPERO.
Whiplash-associated disorders (WADs) are the most common and costly consequence of road traffic injury (RTI). Providing early and effective treatment is a healthcare priority; however, current guideline-based care which focuses on education and physiotherapy-led exercise does not routinely address the psychosocial effects of trauma, and access to early integrated treatment is limited. This study aims to evaluate the feasibility of delivering and evaluating recovery, information, support and empowerment (RISE), a co-designed short message service-based intervention integrating psychosocial and exercise/activity support for individuals with acute whiplash injury who are at risk of poor recovery in a randomised feasibility trial. Secondary aims are to explore preliminary changes in candidate clinical outcomes and opportunities for intervention personalisation and future implementation.
This mixed-methods randomised controlled feasibility trial with a nested process evaluation will recruit 50 participants (
This trial is approved by the Townsville Hospital Human Research Ethics Committee (HREC/QTHS/121395) and ratified by the Human Research Ethics Committee at The University of Queensland, which is the study sponsor (2025/HE002491). Results will be published in peer-reviewed journals and presented at conferences and professional meetings.
ACTRN12626000506392; date registered: 23 April 2026; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=390706&isReview=true
To (1) systematically identify tools developed to assess and address the support needs of informal carers in palliative or end-of-life care and (2) examine the extent to which socially stratifying sample characteristics have been reported following tool use.
A systematic scoping review was conducted.
Medline, CINAHL, PsycINFO, ASSIA, ProQuest Central and Web of Science databases were searched from inception to May 2024 and again in May 2025. Primary studies using any methodology reporting the development and/or use of tools to assess informal carer support needs in end-of-life care were included. Consistent with scoping review methodology, we did not conduct a quality appraisal of included studies. We extracted tool characteristics, frequency of use and sample characteristics according to PROGRESS+.
A total of 74 articles were included. From these, 24 unique tools were identified. Nine tools were used in ≥2 articles, while 15 were used only once. The most commonly used tools were the Carer Support Needs Assessment Tool (35 articles), the Family Inventory of Needs (6 articles), the Carer Alert Thermometer (5 articles) and the Spiritual Needs Inventory (4 articles). There was limited evaluation of tools beyond psychometric validation. There were substantial gaps in equity-informed caregiver sample reporting. While gender, age and country of participants were commonly reported, most other PROGRESS+characteristics were inconsistently or minimally reported.
While numerous tools exist to assess and address informal caregiver support needs, there is considerable variation in tool uptake, evaluation and the extent to which tools consider equity factors. There is a need for equity-informed tool development and clearer conceptualisation of caregiver needs, alongside efforts to evaluate tool implementation, impact and sustainability in palliative care settings.
Distressing sensory experiences (DSEs) are commonly reported by children and young people accessing Child and Adolescent Mental Health Services (CAMHS) in the UK. Despite their prevalence, evidence-based tailored interventions for this population are scarce. The ChUSE trial aims to address this gap by evaluating the feasibility and acceptability of a novel brief talking therapy for children aged 8–16 years and an accompanying parent coaching programme.
A single-blind, two-arm randomised controlled feasibility trial will be conducted across three National Health Service trusts in Greater Manchester, UK. Sixty young people under the care of CAMHS experiencing DSEs and their parents/caregivers will be randomised 1:1 to receive either treatment as usual (TAU) or TAU plus the ChUSE intervention. The intervention involves four child therapy sessions and three optional parent sessions. Primary feasibility outcomes include recruitment and retention rates, treatment adherence and intervention safety. Secondary objectives assess the feasibility of data collection procedures and gather qualitative insights into trial acceptability and the influence of the intervention on young people’s well-being.
The ChUSE Trial has received ethical approval through the Health Research Authority following review by the West Midlands – South Birmingham Research Ethics Committee specialising in paediatric research (ID 327343). The feasibility trial addresses a significant clinical gap in CAMHS provision and will also capture information as to current TAU practices, contributing novel data to guide future service provision as TAU is currently understood to be heterogeneous. The information gathered through this trial will inform the design of a definitive trial evaluating the clinical effectiveness and cost-consequences of an early, age-appropriate intervention for DSEs. Findings and translational outputs will be shared through scientific and public forums to reach a variety of audiences.
Mailed smoking and vaping cessation support provided through the Which Way? Quit Pack programme has demonstrated acceptability and preliminary effectiveness in delivering culturally grounded support. However, there is no evidence of the effectiveness of mailed cessation programmes for Aboriginal and Torres Strait Islander people when implemented on a national scale. Building on previous work, this study aims to evaluate both the implementation effectiveness and cost-effectiveness analysis of the Which Way? Quit Pack mailed smoking and vaping cessation intervention for Aboriginal and Torres Strait Islander people.
A national single-group hybrid type 2 effectiveness-implementation study with 2000 Aboriginal and/or Torres Strait Islander people who use cigarettes and/or e-cigarettes (vapes) daily, want to quit and are aged ≥18 years. Participants will receive access to a culturally tailored mailed quit pack that includes up to a 12-week supply of nicotine replacement therapy, phone-based behavioural counselling and access to an online support forum. Cessation outcomes including 7-day point prevalence abstinence, prolonged abstinence and quit rates will be evaluated at 3, 6 and 12 months. An intention-to-treat approach will be used for cessation outcomes, with participants lost to follow-up classified as smokers or vapers. Exploratory logistic regression analyses will examine factors associated with quitting, and causal machine learning methods will be used to explore variation in intervention effectiveness across participant subgroups. The Reach-Effectiveness-Adoption-Implementation-Maintenance framework will guide evaluation of implementation and effectiveness outcomes. Analysis measures include cessation and quit attempt rates, number of participants recruited, representativeness and intervention uptake. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) will guide the cost-effectiveness analysis.
This study is governed by Aboriginal and Torres Strait Islander leadership and community-controlled partnerships and is conducted in line with Indigenous data sovereignty and Indigenous research ethics principles. The study has also received approval from the following human research ethics committees: Aboriginal Health & Medical Research Council of NSW (2493/25), Aboriginal Health Committee South Australia (04-25-1209), the Western Australian Aboriginal Health (HREC1474), the Victorian Aboriginal Community Controlled Health Organisation (2025/HREC0061) and the University of Newcastle Human Research (H-2025-0311). Findings will be disseminated in forms determined, governed and endorsed by Aboriginal and Torres Strait Islander people and communities through the project Governance, including peer-reviewed publications, policy briefs, community-led knowledge translation activities and presentations at local, national and international conferences.
ACTRN12626000459325.
Non-communicable diseases (NCDs) are major contributors to morbidity and mortality in Thailand, yet the effectiveness of lifestyle counselling within routine practice is underexplored. This rapid realist review examined how, for whom and under what circumstances lifestyle counselling supports behaviour change among Thai adults.
Rapid realist review following guidance from the Realist and Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES).
Lifestyle counselling and health-coaching interventions for NCD prevention and management delivered in Thai primary care, community settings or digitally supported programmes.
Six international and Thai databases (Scopus, Google Scholar, ProQuest, PubMed, EMBASE (Ovid) and ThaiJo) were searched for studies published between 2005 and 2025.
Empirical studies involving adults (≥18 years) in Thailand that described lifestyle counselling or coaching interventions for NCD-related prevention or management and reported outcomes.
Data were extracted to identify contexts (C), mechanisms (M), outcomes (O) and equity considerations. These were synthesised into context–mechanism–outcome configurations (CMOCs) and helped to form programme theories.
16 studies were included. 19 explanatory configurations were identified across six mechanisms: self-efficacy, social support, motivation, accountability, emotional resilience and relevance and engagement. These mechanisms and programme theories (PTs) were supported by family-centred education, routine self-monitoring with feedback, culturally or literacy-tailored materials and brief stress-regulation strategies. Barriers included low health and digital literacy, conflicting norms, short programme duration and rural workforce constraints. Facilitators included plain-language materials, low-tech or hybrid follow-up, co-designed dietary strategies and task-sharing with village health volunteers and family members.
This rapid realist review identified six PTs, suggesting that the operation of lifestyle counselling interventions for non-communicable diseases in Thailand may be influenced by cultural norms, family and community support, village health volunteers and health service capacity. The findings highlight the potential importance of sustained follow-up, cultural and literacy tailoring and accessible modes of delivery in supporting behaviour change and self-management across different contexts. These PTs provide insight into how lifestyle counselling may operate in Thailand and may inform future research and the refinement of lifestyle counselling interventions.
The optimal timing for direct oral anticoagulants (DOACs) initiation after acute ischaemic stroke in patients with atrial fibrillation (AF) remains unclear, particularly in those undergoing endovascular thrombectomy (EVT), who are at higher risk of both haemorrhagic transformation and early embolic recurrence. Patients undergoing thrombectomy have been under-represented in previous randomised trials, resulting in limited evidence for guiding management in this high-risk population. The TIMERS trial aims to evaluate the efficacy and safety of early versus delayed initiation of DOACs therapy after EVT in patients with large vessel occlusion stroke and AF.
This is a multicentre, prospective, randomised, open-label trial with a blinded outcome assessment. In total, 438 patients with acute ischaemic stroke and AF treated with EVT will be enrolled in this study. Patients will be randomised in a 1:1 ratio within 72 hours after stroke onset to early initiation (≤4 days) or delayed initiation (5–14 days). The primary outcome is a composite of recurrent ischaemic stroke, symptomatic intracranial haemorrhage or all-cause death within 90 days. Secondary outcomes include individual components of the primary endpoint, venous thromboembolism, systemic embolism, myocardial infarction, functional outcome (modified Rankin Scale), health-related quality of life (EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)) and major extracranial bleeding events.
The study is approved by the Ethics Committee of Xuanwu Hospital of Capital Medical University, the ethics approval document number is (2025)259-001. The trial findings will be disseminated through peer-reviewed publications and presentations at scientific conferences.
Frailty is a multidimensional syndrome of reduced physiological reserve and heightened vulnerability to stressors. Frailty is common among older adults and linked to adverse outcomes including disability, hospitalisation and death. Infections are common in older populations and remain a major cause of morbidity and death. Although it has been suggested that infections influence frailty development and progression (via inflammatory and functional mechanisms), evidence from longitudinal studies is inconsistent. Therefore, we aim to assess longitudinal associations between infections and frailty in adults.
We will conduct a systematic review of observational cohort and case-control studies examining associations between infections and frailty in adults. We will search MEDLINE, Embase and Global Health from 2001 to February 2026 without language restrictions. Two reviewers will independently screen titles and abstracts and subsequently assess full texts for eligibility. Data will be extracted using a standardised data extraction form. Risk of bias will be assessed using a customised domain-based tool based on the Risk Of Bias In Non-randomised Studies of Exposures (ROBINS-E) framework. We will initially narratively synthesise our findings. Where studies are sufficiently homogeneous, we will undertake random effects meta-analysis. We will assess the certainty of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
Ethical approval is not required for a systematic review. Results of the review will be published in a peer-reviewed journal and disseminated through conferences.
CRD420261299590.
Sexual and gender minority (SGM) individuals remain underrepresented across several medical specialties and leadership positions. Training environments in medical school and residency may shape specialty choice and career development for SGM individuals through experiences of discrimination and pressures related to identity disclosure. The literature remains fragmented across stages of training and specialties, limiting understanding of how these factors collectively shape physician workforce composition. We aim to investigate and synthesise the existing literature examining the association between SGM identity and specialty choice, career trajectory and physician workforce outcomes among medical trainees and physicians.
This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guideline, and the final review will be reported in accordance with PRISMA 2020. A comprehensive search was conducted in Ovid MEDLINE, Ovid Embase, Ovid APA PsycInfo and Web of Science Core Collection from database inception to March 2026. Eligible studies will include primary empirical research examining SGM medical trainees or physicians. Two reviewers will independently screen studies, extract data and assess risk of bias using design-specific tools: the Critical Appraisal Skills Programme checklist, Newcastle-Ottawa Scale and Mixed Methods Appraisal Tool. Outcomes will include specialty choice, career trajectory, workforce representation, training environment, identity disclosure, discrimination, mentorship and professional well-being. Given anticipated heterogeneity, findings will be synthesised using a structured narrative and thematic approach. At initial protocol submission, the literature search had been completed; study screening had not yet commenced.
Ethics approval is not required as this systematic review will use data from previously published studies and will not involve human participants or collection of individual-level data. Findings will be disseminated through peer-reviewed publication and presentations at scientific conferences.
CRD420261347745.
Parkinson’s disease (PD) is the second most common neurodegenerative disorder, its principal symptom being deterioration of motor function. Current treatment options are limited to symptom management but there is evidence that physical activity can provide motor benefits. More recently there is evidence to suggest that rhythmic auditory stimulation may improve gait and balance in PD. Sparky Samba is a community initiative in South Wales, UK, founded by a person living with PD. Sessions incorporate the following samba rhythms from a trained facilitator and are held weekly in a community setting.
The Sparky Samba trial is a multi-site, non-blinded, randomised controlled feasibility trial of Sparky Samba compared with activity as usual. A total of 60 people with PD will be randomised 1:1 to take part in a local Sparky Samba group for 12 weeks or continue their normal activities for the same length of time. The primary outcome is feasibility defined by recruitment, retention, data completeness and intervention adherence. Secondary outcomes relating to motor function, cognition, well-being and self-efficacy will also be assessed at baseline and at 12 weeks. Additionally, we will conduct a process evaluation to understand contextual mechanisms surrounding Sparky Samba. This will be achieved through qualitative interviews and structured participant questionnaires following individual trial completion and through structured questionnaires with intervention delivery staff, supplemented with qualitative interviews.
Feasibility outcomes will be assessed according to pre-defined criteria. For secondary outcomes, means and standard deviations (or medians and IQRs) will be calculated by arm, alongside 95% CIs for change from baseline to 12-week follow-up. Qualitative data will be subject to thematic analysis using NVivo software.
This study received a favourable ethical opinion from the North of Scotland Research Ethics Committee in April 2025 (REC reference 25/NS/0037). Study results will be disseminated through the peer-review literature, the ISRCTN registry and directly to participants, which will be facilitated by the study’s public and patient involvement steering group.
There are currently no colorectal cancer (CRC) screening recommendations specifically outlined for people with HIV (PWH). Screening measures used for people without HIV (PWoH) have been previously discussed as sufficient for use among PWH, despite observations of higher CRC prevalence and CRC reportedly appearing at earlier ages among PWH in comparison to PWoH. Machine learning (ML) methods are regarded as robust approaches that may enhance predictive performance, particularly in the context of complex or high-dimensional data. This study aims to develop an ensemble ML model to predict CRC risk in PWH using comprehensive nationwide datasets. The model’s predictive performance will be evaluated and compared with a baseline Cox proportional regression model. The better-performing method will be implemented to develop a CRC risk prediction model with the aim of personalising screening recommendations for PWH.
The study population will include all PWH and PWoH born between 1940 and 2008, aged 18 or older and living in Sweden sometime between 1983 and 2024. The study population will be linked to six nationwide demographic and healthcare registers. Follow-up will continue until the first incident of CRC, emigration or death. The outcome of interest is CRC. PWH will be matched to negative controls 1:10. A Cox regression analysis will be completed first, and the results will be used as a baseline comparison to the ensemble ML results. A range of ML methods will be used to develop the ensemble model using stacking.
This study has ethical approval from the Regional Ethical Committee in Sweden (Dnr: 2024-04185-02, 2024-06783-02, 2023-00191-01, 2022-02897-02, 2022-05624-01, 2018/11-31/2). Given that the study is retrospective and register-based, using only pseudonymised data, there are minimal physical, psychological or privacy risks to included individuals. All results will be presented at the population level with no possibility of identification. The results of this study will be submitted for publication in a peer-reviewed journal.
FreshRSS 