Conectar
To evaluate the cost-effectiveness of anti-vascular endothelial growth factor (VEGF) treatments for neovascular age-related macular degeneration (nAMD) using a value-based model that considers drug durability, dosing regimens and real-world administration strategies, including safe vial fractionation.
Model-based pharmacoeconomic analysis using data from randomised clinical trials and network meta-analyses. Analysis conducted from the payer perspective using cost data from the Spanish National Health System.
A model-based analysis compared five anti-VEGF agents—innovator and biosimilar ranibizumab, aflibercept 2 mg, brolucizumab and faricimab—across three dosing regimens: fixed, Pro Re Nata and Treat-and-Extend (TAE). Administration formats included single-use vials, prefilled syringes and vial fractionation (VF), with or without dead-space-free (DSF) syringes to minimise waste. The primary outcome was cost per optimal responder, defined as a patient gaining ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, with and without adverse events. Cost-effectiveness was evaluated using Number Needed to Treat (NNT), Net Efficacy Adjusted for Risk-NNT (adjusted for safety) and incremental cost-effectiveness ratios. Secondary outcomes included the number of treated patients and optimal responders achievable within a fixed 1 000 000 budget.
The most cost-effective strategy was aflibercept 2 mg under a TAE regimen using DSF VF, with a total cost of 6214 per patient and a cost per optimal responder of 27 155. Under a fixed budget of 1 000 000, this approach allowed treatment of 160 patients, yielding 36 optimal responders. Faricimab with DSF VF ranked second, with a total cost of 5847 and a cost per optimal responder of 28 652, treating 171 patients and achieving 34 responders. In contrast, single-use vials without VF led to substantially higher total costs (eg, 11 305 for aflibercept TAE) and lower treatment capacity (eg, 88 patients treated).
This model demonstrates that combining durable agents, extended dosing intervals and optimised delivery strategies (eg, prefilled syringes and DSF VF) can substantially improve the cost-effectiveness and sustainability of anti-VEGF therapy in public health systems.
To quantify the costs associated with a stepped model of depression care—Integrated Chronic Care Clinics-Depression Module (IC3D)—in rural Malawi.
Cross-sectional cost analysis.
Integrated chronic care clinics (n=14) throughout Neno District, Malawi.
The stepped model of depression care provided behavioural therapy (Problem Management Plus (PM+)) to adults (aged 18+) with moderate depression and joint PM+ and antidepressant therapy (ADT) to those with moderate-to-severe and severe depression. The model incorporated two cost-saving features: treatment was integrated into existing chronic care services within the health system, and PM+ was group-based rather than one-on-one.
We conducted time-driven activity-based costing to quantify the marginal economic cost of implementing PM+ and ADT, inclusive of training and supervision. We measured all costs in 2025 US dollars and quantified costs from a societal perspective—including human resources, infrastructure, equipment, consumables, indirect costs and opportunity costs.
The marginal cost of PM+ was $90 per patient treated for five sessions over 2 months, while ADT was $138 for eight sessions over 8 months. In both instances, human resources (45% from PM+, 52% for ADT) and consumables (30% for PM+, 31% for ADT) represented primary health system cost drivers. In the first year of implementation, 15 002 depression screenings were conducted, 724 adults were evaluated with a diagnostic tool and 398 adults subsequently received care: 263 received PM+ alone, 31 received ADT alone and 104 received both PM+ and ADT. The total cost of introducing operations throughout Neno District was $62 806.
These findings indicate that integrating depression care services into the Malawian health system is financially feasible and successfully reached many individuals with major depressive disorder.
Severe aorto-iliac steno-occlusive atherosclerotic disease is a major cause of morbidity and amputation in patients with peripheral arterial disease. While both open surgical and endovascular revascularisation are standard treatments in this patient group, there is no high-quality randomised evidence to determine which approach offers superior clinical and cost-effectiveness, leading to uncertainty and poor outcomes after intervention.
The EVOCC trial is a national, multicentre, parallel-group, superiority randomised controlled trial comparing open surgery to endovascular revascularisation in patients with symptomatic severe aorto-iliac occlusive disease. A total of 628 participants across 30 NHS sites in the UK will be randomised 1:1 to receive either open surgery or endovascular (minimally invasive) intervention. The primary outcome is amputation-free survival, defined as time to first event (major lower limb amputation or death). Secondary outcomes include mortality, cardiovascular events, hospital readmissions, re-interventions and quality-of-life measures. An internal pilot phase (10 sites, 6-month duration) will assess recruitment feasibility. A QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.
The trial has received ethical approval from a UK Research Ethics Committee (REC reference: 23/SW/0065; trial registration reference: ISRCTN14591444). Informed consent will be obtained from all participants.
The EVOCC trial is the first RCT assessing the clinical and cost-effectiveness of open vs endovascular revascularisation for severe aorto-iliac disease worldwide. The results will provide robust evidence to inform clinical practice and healthcare policies globally. Results will be disseminated via patient groups, online lay summaries, a trial website, social media, presentations in conferences, a formal scientific publication in a medical journal and direct communications with policymakers across borders.
Certain leading medical organisations are considering alternatives to the Body Mass Index (BMI) as a predictor of the risk for non-communicable chronic disease (NCD) or death. Our objective was to evaluate the associations between various measures of body fat and the risk of incident NCDs or mortality, independent of inflammation.
Population-based prospective cohort study (the UK Biobank cohort).
The UK.
Adults (aged between 40 and 69 years) were accrued between March 2006 and October 2010 and followed until December 2022. There were 500 107 participants: the median age was 58 years (IQR 50–63) at baseline, 45.6% were male and 94.7% were white.
BMI, waist-to-hip ratio (WHR), body fat percentage measured by bioimpedance analysis (BIA; fatBIA), C-reactive protein (CRP) and various other measures of body fat obtained by dual-energy X-ray absorptiometry (DXA; including visceral adipose tissue (VAT)) and magnetic resonance imaging (MRI).
All-cause death, cardiovascular disease (heart failure, hypertension, myocardial infarction, pulmonary embolism and stroke), cancers (breast, colorectal, endometrial, oesophageal, kidney, ovarian, pancreatic and prostate), diabetes, asthma, gallbladder disease, chronic back pain and osteoarthritis.
The 5th and 95th percentiles for measures of body fat were BMI 20.5 (considered ‘healthy’) and 37.0 kg/m2 (considered ‘unhealthy’), WHR 0.71 and 0.94 and BIA 24.8% and 47.6% in females, and BMI 22.0 (considered ‘healthy’) and 35.4 kg/m2 (considered ‘unhealthy’), WHR 0.83 and 1.05 and BIA 15.5% and 34.7% in males. BMI was strongly correlated to fatBIA (0.85 in females and 0.80 in males) but less so with WHR (0.46 in females and 0.59 in males). All measures of body fat were positively associated with the incidence of NCDs, but only WHR remained positively associated with death after full adjustment (HR 95th percentile vs 5th percentile (95% CI): BMI 0.80 (0.76 to 0.84), WHR 1.21 (1.16 to 1.28) and BIA 0.80 (0.76 to 0.84) in females; BMI 0.89 (0.85 to 0.93), WHR 1.19 (1.14 to 1.24) and BIA 0.89 (0.85 to 0.92) in males). Simpler models that adjusted for age, sex, CRP, WHR and either BMI or fatBIA gave similar results. Associations between body fat and the incidence of NCDs after accounting for the competing risk of death were also similar.
BMI was strongly correlated with fatBIA, but WHR and visceral adipose tissue percentage were less so. All measures of body fat were associated with the incidence of NCDs, but only WHR was independently associated with mortality. These findings support the hypothesis that body fat may be protective against death and that the excess risk associated with higher WHR may be mediated by something other than body fat.
HIV pre-exposure prophylaxis (PrEP) is an effective HIV prevention tool, reducing infection risk by up to 99% when used as prescribed. Despite its proven efficacy, PrEP uptake remains suboptimal, particularly among high-risk populations in Canada. Barriers to access and uptake, including stigma, financial constraints and healthcare accessibility, persist, highlighting the need for targeted interventions. The objective of this scoping review is to identify and map the extent and types of interventions, programmes, practices and policies aimed at increasing the acceptance, access, uptake and sustained use of HIV PrEP in Canada.
This review will use the Joanna Briggs Institute (JBI) Scoping Review methodology. Databases to be searched are MEDLINE, Embase, PsycINFO, Cochrane Library, CINAHL, Scopus and Web of Science from 2016 onwards. Two independent reviewers will screen studies, based on the inclusion criteria. The search results will be presented in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. Data will be extracted from relevant studies by two independent reviewers and summarised to inform future research and policy development. This review will include studies focusing on individuals in Canada who are eligible for or using PrEP for HIV prevention. The interventions considered will address the awareness, acceptance, access, uptake and sustained use of PrEP. Studies must be set within the Canadian context, considering geographic, cultural and systemic factors. Exclusions include studies conducted outside Canada or those not addressing HIV prevention interventions.
This research will rely exclusively on previously published data and will not include human participants. Therefore, ethics approval is not required. For further clarification, please contact Stephen Hwang, Director, MAP Centre for Urban Health Solutions, Unity Health Toronto, at
The protocol has been registered with Open Science Framework at https://doi.org/10.17605/OSF.IO/C7S4Z.
To explore existing evidence for the provision of support for return to work (RTW) in long COVID (LC) patients and the barriers and facilitators to taking up this support.
A rapid review reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The study was preregistered in PROSPERO (ID: CRD42023478126).
Searches were completed in June 2024 across major databases including MEDLINE, Embase, PsycINFO, evidence-based medicine reviews, Web of Science and Google Scholar.
Included studies focused on people with LC (PwLC) symptoms lasting over 12 weeks and addressed either: (1) non-workplace- or workplace-based support for RTW and/or (2) barriers and facilitators to RTW in this population.
A quality assessment was conducted using the JBI Systematic Reviews critical appraisal tool. The data were summarised in tabular format and a narrative synthesis.
Twenty-five studies were included. While many studies demonstrated rigorous methodologies and low risk of bias levels, some had high and medium risk levels. Non-workplace-based support was mostly measured quantitatively and included interdisciplinary healthcare programmes, clinical interventions and rehabilitation programmes focusing on pacing and breathing strategies. Compensation and insurance schemes were important funders of these interventions.
Workplace-based support was mostly measured qualitatively. Barriers to the provision of support at organisational level included lack of understanding of LC symptoms, insufficient workplace guidance and educational gaps among managers. Individual barriers included threat of income loss, remote working and disconnection from the workplace. Facilitators for support included recognition and validation of LC and its symptoms, and eligibility for disability benefits associated with work.
RTW is an important outcome of health-related absence and should be systematically recorded in studies of PwLC. The heterogeneity and unpredictability of LC symptoms create challenges for supporting working age populations. Further research is crucial to better understand the specific RTW needs for PwLC and address potential barriers and facilitators to workplace-based support, particularly through interventions, organisational practices and employ-led policies that enable sustained RTW. Consistent guidelines on LC’s definition and disability status may facilitate the provision of support and the development of interventions.
CRD42023478126.
Worldwide, maternal mortality is mostly caused by avoidable or treatable health complications, despite the progress made in maternal health. High-quality care focuses on a standardised and patient-centred approach. In this light, care bundles, which are sets of evidence-based practices, were introduced to improve the quality of care and maternal outcomes. The existing reviews on care bundles focus on specific conditions, and there is, to our knowledge, no comprehensive systematic review on the effectiveness and evidence-based character of care bundles on multiple maternal outcomes. This systematic review aims to describe maternal care bundles on labour and birth, to assess their effectiveness on maternal outcomes and to evaluate the evidence-based character of their interventions.
This systematic review will include randomised controlled trials, quasi-randomised studies, cohort studies, case-control studies, controlled before-and-after studies and interrupted-time-series studies, starting from 2001, focused on labour and childbirth stages, addressing care bundles that include multiple conditions. The search strategy will include six electronic databases (PubMed, Cochrane Library, CINAHL, Embase, Scopus and Web of Science) used to retrieve relevant titles and abstracts based on a database-specific search strategy. Titles and abstracts will be independently screened by two reviewers, followed by a full-text eligibility assessment. Reviewers will also extract data based on this review’s objectives and outcomes. Analysis will be performed in three phases: descriptive analysis, evaluation of the evidence-based character of interventions and quantitative synthesis analysis.
Ethics approval is not needed. Dissemination will be performed through publication in peer-reviewed journals, conference presentations and informing policies and stakeholders by offering a structured overview of maternal care bundles on labour and childbirth.
PROSPERO 2025 CRD420251081127.
Intermittent physiological monitoring and early warning scores (EWS) are limited in their ability to detect deteriorating patients in a timely manner. Wearable physiological sensors allow continuous remote monitoring and may be more timely and accurate in the identification of those at risk, compared with manual collection. This study aims to determine if wearable physiological sensors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff.
This is a prospective observational cohort study that will recruit adults undergoing major surgery in Benin, India, Ghana, Guatemala, Mexico, Nigeria, Rwanda and the UK. Participants will wear wearable physiological chest and limb sensors before, during and after surgery for up to 10 days or until discharge. In this ‘shadow-mode’ study, continuous physiological observations collected using the devices will not be made available to clinical teams. No changes in participant care will result. Standard of care clinical data will be collected contemporaneously. Continuous sensor data will be used to design algorithms to predict deterioration and specific complications in this population. Usability and feasibility testing, through focus groups, interviews and questionnaires, will be undertaken with healthcare professionals and people undergoing surgery.
Our stakeholder panel are directly involved in all aspects of this study, which will be conducted in accordance with the principles of the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) in addition to the principles of the ethics committee(s)/Institutional Review Boards (IRBs) who have reviewed and approved this study. Artificial intelligence (AI) prediction models will be reported in accordance with the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis+Artificial Intelligence (TRIPOD+AI) and Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI) reporting guidelines frameworks.
With the growing older population, ensuring effective, accessible nutritional support within primary care as a first line of medical care is becoming increasingly important. Nutritional counselling is a promising approach to enhancing health outcomes and independence among older adults. However, a stronger evidence base is needed to assess its true effect and inform clinical decisions. Additionally, food insecurity remains an under-recognised issue in this population and is often overlooked in primary care settings. This highlights the need for simple, practical methods to identify those at risk. This study aimed to assess the effectiveness of nutritional intervention provided to older people and determine which nutrients may indicate food insecurity in primary care settings in Tehran.
The study will be conducted in two phases. The first phase is a prospective cohort study (single cohort). The second phase is a cross-sectional study on older people who refer to primary care settings affiliated with the Tehran University of Medical Sciences. In the first phase, the effectiveness of nutritional interventions – including counselling and diet – is evaluated based on anthropometric indicators (weight, waist circumference, calf circumference, arm circumference and waist-to-height ratio), blood pressure and scores from the Mini Nutritional Assessment, health-related quality of life, dietary intake and physical activity. Assessments will be evaluated prospectively at the beginning of the study, after 3 months, and at the end of the study. In the second phase of the cross-sectional study, by examining dietary intake and food insecurity, we will identify the specific nutrient or food group that serves as an indicator of food insecurity in the diet of older individuals. Intakes below 50% and 75% of the recommended daily allowance will be analysed. Through sensitivity and specificity analysis, we will identify which nutrient or food group is strongly associated with food insecurity in older people.
This study received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICINE.REC.1402.474). Study findings will be disseminated through peer-reviewed journal articles, presentations at national and international conferences and meetings with the Iranian Ministry of Health, facility and community stakeholders.
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This analysis aimed to explore how local health system strategies and plans seek to tackle health and care inequalities and address national policies. Specifically, the analysis considered alignment with five national priority areas: restoring services inclusively, mitigating digital exclusion, ensuring the completeness and timeliness of datasets, accelerating preventative programmes and strengthening leadership and accountability. In addition, the analysis explored the extent to which systems are engaging with the Core20PLUS5 approach, which targets the most deprived 20% of the population (‘Core 20’) and population groups experiencing disproportionately poor access, outcomes or experiences of care (‘PLUS’).
Integrated Care Systems (ICSs) are statutory partnerships that bring together healthcare, social care, local government and wider system organisations to collaboratively address the root causes of ill health and health inequalities. We conducted a document analysis of available ICS strategies, 5-year plans and health inequalities plans published in England between 1 January 2022 and 31 July 2023. A total of 43 strategy documents, 38 5-year plans and 7 health inequalities plans were analysed. A data extraction framework was used to guide reviewers and independent quality assurance was completed to ensure internal validity, intrarater reliability, and reproducibility of the project.
The analysis highlighted good alignment with national healthcare inequalities policies and local approaches to tackling healthcare inequalities, with the majority of systems citing the Core20PLUS5 framework. There was notable variation between systems on the adoption of the framework with the children and young people’s framework being less widely considered than the adult’s framework. Across systems, equity-focused tools were widely used, and numerous systems had developed outcome frameworks to monitor progress. Leadership for health inequalities was strengthened with senior leadership roles being established to hold integrated care boards accountable for improving access, experiences and outcomes. However, competing priorities, particularly concerning implementations of new organisational models and multiple national priorities, were evident within the plans which may challenge progress on reducing health and healthcare inequalities.
The review concluded that while progress has been made in adopting national healthcare inequalities policies and steers, significant variation exists between systems, possibly reflecting local population needs and varying levels of maturity of the systems across England. The review highlights the need for further evaluations at both national and local levels, allowing for further development of the systems. Additionally, consistent and sustainable funding and more robust training for health inequalities leadership roles is needed to ensure equitable access, experience and outcomes.
Children with medical complexity (CMC) are a subset of children with special healthcare needs, defined by high healthcare utilisation, severe single or multisystem organ dysfunction, and in many cases, reliance on medical technology. In the emergency care setting, known challenges for this population include poor quality of care, avoidable admissions and high caregiver and provider burden. While experts and professional societies recommend emergency care planning tools to address these concerns, evidence to support effectiveness and implementation of such tools is lacking. Through a human-centred design approach, we recently engaged key partners to create and optimise an emergency care action plan (ECAP) for infants with medical complexity. Here, we describe the protocol for a pilot type 1 hybrid effectiveness-implementation randomised controlled trial (RCT) for infants with medical complexity aimed to evaluate ECAP effectiveness and implementation.
Infants with medical complexity and their caregivers will be randomly assigned to the intervention group (ECAP) or control group (standard care) in a pilot type 1 hybrid effectiveness-implementation RCT. The primary outcome is number of inpatient hospital days for infant participants. Additional effectiveness outcomes include perceived avoidance of emergency department (ED) visits, healthcare costs, caregiver stress and self-efficacy. Preliminary implementation outcomes include acceptability, feasibility, appropriateness and usability, as well as contextual barriers and facilitators to reach, adoption and implementation. Key partners, including caregivers of CMC and healthcare providers, will be engaged throughout the implementation of the ECAP and execution of the trial.
This study was approved by the University of Vermont Institutional Review Board (STUDY00002937). Findings will be disseminated through peer-reviewed publications, conference presentations, and focus groups and interviews with key stakeholders.
Suicide is a leading cause of preventable death worldwide. Evidence supports the impact of providing active contact for individuals who have attempted suicide. The current systematic review and meta-analyses aim to investigate the effects of suicide prevention strategies implemented through remote and synchronous technology-based interventions.
Systematic review, narrative synthesis and meta-analysis.
Electronic databases (PubMed, PsycINFO, Scopus and Web of Science) and grey literature sources (ClinicalTrials.gov and Google Scholar) were searched until December 2024.
Eligible articles assessed suicide prevention interventions for participants over 12 years with prior suicidal behaviour. Eligible study designs included randomised controlled trials and non-randomised clinical trials published in English or Spanish.
Screening, selection process, data extraction and risk of bias assessment were performed independently by two reviewers. Data on suicide-related factors and adherence to treatment were extracted. Meta-analyses were conducted to determine effect sizes (Hedges’ g) for suicidal ideation, risk ratios (RR) for suicide attempts and Peto odds ratios (OR) for suicide. Heterogeneity was assessed using the Cochrane’s Q test, tau2 statistic and I2 value. Publication bias was investigated employing funnel plots and Egger’s test.
A total of 28 studies, comprising 10 015 participants in the intervention group and 10 726 in the comparison group, were included in the systematic review and meta-analyses. Synchronous remote-based interventions were effective in preventing repeated suicide attempts at 1 month (RR 0.73, 95% CI 0.62 to 0.85, I2=0.0%, Q=0.70, tau2=0.00), 6 months (RR 0.56, 95% CI 0.34 to 0.95, I2=85.4%, Q=54.92, tau2=0.36) and 12 months (RR 0.68, 95% CI 0.49 to 0.96, I2=87.6%, Q=72.63, tau2=0.27). Additionally, these interventions were associated with a reduction in suicide-related deaths at 18 months (Peto OR 0.18, 95% CI 0.08 to 0.44, I2=0.0%, Q=0.03, tau2=0.00). Effects on suicidal ideation were not statistically significant at any time point (Hedges’ g –0.07 to –0.28, I2=0.0 to 69.3%, Q=1.16 to 7.38, tau2=0.00 to 0.14).
Synchronous remote-based interventions demonstrate a potential benefit in preventing suicide attempts and deaths by suicide and may serve as an adjunct to usual treatment; however, the effect on suicidal ideation appears limited. The observed heterogeneity warrants caution when interpreting these findings. Future research should prioritise methodological enhancements to improve the quality and consistency of evidence, as well as investigate the mediating processes underlying their effectiveness in reducing suicidal behaviour.
CRD42021275044.
Type 1 diabetes (T1D) demands self-management skills, knowledge and confidence to prevent medical complications. Adolescents living with T1D have distinct developmental challenges resulting in a worsening in glycaemic stability, irregular care and an increased risk for complications all while transitioning to adult healthcare. Age-specific online platforms could facilitate transition by fostering self-management education and support. The Support online self-guided training platform has been shown to increase the confidence of adults with T1D in managing their glycaemia. We aim to test the effectiveness of Support-t (ie, adapted for youth), compared with usual care, in improving haemoglobin A1c (HbA1c) and to understand the context of its implementation.
We will conduct a multisite, assessor-blinded, randomised controlled, parallel group, two-arm, superiority trial, evaluating effectiveness and implementation of Support-t versus usual care in 200 adolescents (14–16 years old) living with T1D. The active arm will have an 18-month access to Support-t, and their healthcare team will be trained on the platform’s content. The control arm will receive usual care. The primary outcome is HbA1c at 18 months. Secondary outcomes include self-efficacy for diabetes self-management, transition readiness, diabetes-specific quality of life, diabetes distress, continuous glucose monitoring metrics, number of severe hypoglycaemic events, diabetic ketoacidosis, T1D-related emergency department visits and hospitalisations as well as engagement and satisfaction. A subgroup of participants in the active arm and of healthcare providers will be interviewed assessing barriers, facilitators, engagement and fidelity of the intervention. Primary analysis will be by intention-to-treat. The difference in mean HbA1c at 18 months (with a 95% CI) will be calculated between both arms. A cost-effectiveness analysis is also planned.
December 8, 2024 version of the protocol was approved by the McGill University Health Centre Research Ethics Board (MP-37-2024-9734). Results will be disseminated through peer-reviewed publications and patient-partners’ network.
ClinicalTrials.gov (NCT05910840).
The prevalence of pulmonary nodules (PNs) has been rising in China, but PN patients’ perceptions towards the management remain underexplored. This study aimed to investigate the knowledge, attitudes and behaviours (KAB) regarding PN management among Chinese patients.
A cross-sectional study was conducted to evaluate the KAB scores using a self-designed questionnaire.
The study included 519 PN patients (275 males, aged 41.07±19.47) diagnosed at Wenzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medicine University between November 2022 and January 2023. Participants completed a self-designed questionnaire assessing their KAB regarding PN management.
The primary outcomes included mean scores for KAB, with secondary outcomes examining correlations and associations with demographic factors.
The mean KAB scores were 4.24±2.93 (range: 0–10), 17.97±4.88 (range: 0–32) and 31.30±11.98 (range: 0–52). Pearson’s correlation analysis revealed a weakly positive correlation between knowledge and behaviour (r=0.248, p
PN patients demonstrate insufficient knowledge and moderate attitudes and behaviours regarding PN management. These findings highlight the need for targeted educational interventions to improve understanding among PN patients.
Dental caries is the most common oral disease worldwide, affecting up to 90% of children globally. It can lead to pain, infection and impaired quality of life. Early prevention is a key strategy for reducing the prevalence of dental caries in young children. Valid and reliable diagnostic or prognostic tools that enable accurate individualised prediction of current or future dental caries are essential for facilitating personalised caries prevention and early intervention. However, no efficacious tools currently exist in early childhood—the optimal period for disease prevention. We aim to develop and validate diagnostic and prognostic prediction tools for dental caries in young children, using a combination of environmental, physical, behavioural and biological early life data.
Data sources include two prospective studies, with a total sample size of approximately 600 children. These cohorts have collected detailed demographic, antenatal, perinatal and postnatal data from medical records and parent-completed questionnaires and biological samples including a dental plaque swab. Candidate predictor variables will include sociodemographic characteristics, health history, behavioural and microbiological characteristics. The outcome variable will be the presence, incidence or severity of dental caries diagnosed using the International Caries Detection and Assessment System. Statistical and machine learning approaches will be used for selection of predictor variables and model development. Internal validation will be conducted using resampling methods (i.e., bootstrapping) and nested cross-validation. Model performance will be evaluated using standard performance metrics such as accuracy, discrimination and calibration. Where feasible, external validation will be performed in an independent cohort. Model development and reporting will be guided by the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) statement and the Prediction model Risk Of Bias Assessment Tool (PROBAST) guidelines.
This study has ethical and governance approval from The Royal Children’s Hospital Melbourne Human Research Ethics Committee (HREC/111803/RCHM-2024). Results of this study will be published in peer-reviewed journals and presented at scientific conferences.
Infant2Child: ACTRN12622000205730—pre-results; MisBair: NCT01906853—post results.
Diabetes affects ~10% of the world’s population and is rising. Treatment costs in the UK are ~15% of the NHS budget. Diabetes-related complications can be lowered through better evidence-based clinician management and patient self-management. MyWay intelligence quotient (MWIQ) is an electronic platform that will provide clinical decision support around the diagnosis and treatment of patients with diabetes. This study evaluates the safety and clinical performance (clinical appropriateness/applicability, clinical impact and clinical usability) of MWIQ.
The system will be implemented in real time in four to seven general practitioner (GP) practices. Clinicians with diabetes expertise will be recruited as validators, who will inspect records to ensure system robustness before use, and up to 14 healthcare professionals will use and evaluate the system.
Quantitative and qualitative analyses will be triangulated to assess the MWIQ system. Assessment of clinical outcomes will be made using pseudonymised routinely collected clinical data, including adherence to quality performance indicators, diabetes diagnosis, diabetes investigations (eg, genetic testing), HbA1c, blood pressure, body mass index, cholesterol and foot risk score for the diabetes population concerned. Clinical and validator participants will also submit a weekly questionnaire, and these, along with interviews, which are scheduled during the testing process, will be analysed to provide data on the utility, safety and usability of the system.
This study was approved, 08/01/2024, by the North of Scotland Research Ethics Committee (REC), IRAS project ID: 305267, REC, reference 23/NS/0134. The study has gained confidentiality advisory group (CAG) support (reference: 24/CAG/0002), medicines and healthcare products regulatory agency (MHRA) and health research authority (27/08/2024) approvals.
Findings will be reported to (1) The funding body, (2) The participating GP practices, (3) The study PPIE group, (4) The MHRA to support a submission for recognition as a class 2 CE/UKCA marked device, (5) Presented at local, national and international conferences and (6) Disseminated by peer-reviewed publications.
Photobiomodulation therapy (PBMT), particularly when combined with a static magnetic field (PBMT-sMF), is a promising non-pharmacological approach for managing musculoskeletal disorders. However, high-quality evidence for its efficacy in lateral epicondylitis remains limited.
The study aims to investigate the effectiveness of PBMT-sMF vs placebo in reducing pain, improving function and modulating inflammatory markers in individuals with lateral epicondylitis.
Multicentre, randomised, triple-blinded, placebo-controlled trial.
Three outpatient physiotherapy clinics in Brazil.
50 adults (18–50 years) with unilateral lateral epicondylitis and baseline pain ≥50 on the visual analogue scale (VAS).
Participants received either active PBMT-sMF (n=25) or placebo (n=25), 2 times per week for 3 weeks. PBMT-sMF involved multi-wavelength irradiation at 4 epicondyle sites (60 s; 27.1 J/site). The placebo group underwent the same procedure without active irradiation.
The primary outcome was degree of pain rating (VAS). Secondary outcomes included forearm disability (Patient-Rated Tennis Elbow Evaluation, PRTEE), grip strength, serum tumour necrosis factor-alpha (TNF-α) levels and treatment satisfaction. Assessments were conducted at baseline, post-treatment (3 weeks) and at 4-week follow-up.
PBMT-sMF yielded a higher responder rate (defined as the proportion of participants achieving at least a 30% reduction in pain intensity relative to baseline) than placebo (72% vs 40%, p=0.045), with a clinically and statistically significant between-group difference. Compared with placebo, the PBMT-sMF group showed significantly greater reductions in pain intensity both at the end of treatment (51.4±19.8 vs 36.9±22.6; p=0.0223) and at follow-up (37.4±24.1 vs 20.3±21.2; p=0.0049). TNF-α levels also decreased significantly in the PBMT-sMF group compared with placebo at both time points (p
PBMT-sMF significantly reduced pain intensity and TNF-α levels, suggesting an anti-inflammatory mechanism. Although functional outcomes were not improved, PBMT-sMF may be a valuable short-term, non-invasive option for lateral epicondylitis pain management.
NCT04829734 on ClinicalTrials.gov
The present study aimed to develop and psychometrically validate a culturally sensitive instrument, the women’s empowerment in dealing with intimate partner violence (WED-IPV) scale, in Iran.
A mixed-methods research study to collect and analyse quantitative and qualitative data.
Social emergency centres, healthcare centres and psychotherapy clinics in three Iranian metropolises.
The participants were 31 married women in the qualitative phase and 420 in the quantitative phase.
The primary outcome was the validation of the WED-IPV scale, including the assessment of face, content, construct validity and the assessment of internal consistency through Cronbach’s alpha, test–retest reliability through intraclass correlation coefficients (ICC) and stability of the factor structure. Secondary outcomes included the assessment of WED-IPV indicators in women using values obtained from levels specified according to the Interval of SD from the Mean formula for each indicator and total empowerment.
The scale development process refined the initial 72 items down to 28 key items through expert review and validity testing. Exploratory factor analysis identified five factors: self-esteem, attitude, self-efficacy, access to support resources and economic empowerment that explained 65.72% of the variance. The scale showed excellent reliability (Cronbach’s α=0.97; ICC=0.95) and valid associations with related measures. Analysis of completed questionnaires of 412 women revealed that a significant portion scored low or moderate in each domain: 41% in self-esteem, 35% in self-efficacy, 39% in attitude, 47% in access to support and 45% in economic empowerment.
The WED-IPV scale is a psychometrically robust, reliable and valid instrument for assessing women’s empowerment concerning IPV in Iranian contexts. Its brevity and user-friendly design facilitate routine application in primary and secondary care settings. Future research should explore cross-cultural validation and predictive validity in longitudinal studies to inform targeted interventions and policy formulation.
Squamous cell carcinoma and multiple actinic keratoses caused by solar ultraviolet radiation (UVR) are among the most frequently recognised occupational diseases in Germany. Employees who regularly work outdoors, for example, in the construction industry, agriculture, forestry and gardening, are at a higher risk of developing occupational skin cancer. However, sun-safety behaviour in outdoor workers is currently insufficient. Therefore, this study aims to investigate the effectiveness of an intervention to increase sunscreen use among outdoor workers.
In this non-randomised, controlled intervention study, 234 outdoor workers from different companies in industries with outdoor working activities based in Germany will be included. The study population, aged 18 years and above, has to be intensively exposed to solar UVR of regularly 1 hour or more per day. The intervention group will receive a sunscreen package as well as health education. The control group follows the practice in their companies (‘treatment-as-usual’). At the beginning of the study, after 3 months and at the end of the study (after 6 months), both groups filled in different questionnaires. In addition, stratum corneum (SC) samples will be collected at the beginning and after 3 months. The primary outcome—increase in the frequency of sunscreen use during work and in leisure time—will be assessed from data on self-reported sunscreen use. The secondary outcomes include sun protection behaviour, knowledge about sun protection and skin cancer, and acceptance of the provided sunscreens. Further secondary outcomes include internal UV dose and UV-related immune response, determined by the levels of SC biomarkers. Data will be analysed using both descriptive and inferential methods.
The study protocol followed the principles of the Declaration of Helsinki (2013) and was approved by the Ethics Committee of Osnabrück University, Germany (reference Ethik-37/2024). Study results will be disseminated through peer-reviewed publications and conference presentations.
DRKS00035178.
To evaluate temporal trends in the epidemiology of hip osteoarthritis (OA) in the USA from 1990 to 2019, with stratification by sex and geographic region.
Cross-sectional time-series analysis using secondary data from the Global Burden of Disease (GBD) study.
US population-based analysis, stratified by the four US Census Bureau regions: Northeast, Midwest, South and West.
De-identified, aggregate population-level data representing all adults in the USA from 1990 to 2019, drawn from the GBD database.
Age-standardised rates per 100 000 population for years lived with disability (YLDs), prevalence and incidence of hip OA. Outcomes were stratified by sex and region. Statistical significance was defined as p
Between 1990 and 2019, hip OA in the USA increased by 23.91% in YLDs, 24.67% in prevalence and 25.22% in incidence. In 2019, the mean YLDs were 28.30 in women versus 25.48 in men; prevalence was 49.55 versus 41.08; and incidence was 919.29 versus 818.10 (all p
There has been a substantial rise in the burden of hip OA in the USA over the past three decades. Women and residents of the Northeastern USA are disproportionately affected. These findings underscore the need for targeted public health strategies that account for geographic and sex-based disparities in hip OA burden.
FreshRSS 