Cancer is the leading cause of death and morbidity among children and adolescents worldwide. Functionality-based interventions are relevant among children and adolescents with an oncological diagnosis, whence studies summarising evidence on this topic are needed. This systematic review will summarise evidence on the effect of interventions to improve functionality indicators among paediatric patients diagnosed with cancer.
This protocol will follow Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA)-Protocols reporting guidelines. The systematic review will be conducted according to the Cochrane Handbook and PRISMA 2020. Studies will be searched in MEDLINE (PubMed), Embase, Web of Science, CENTRAL, LILACS and PEDro. Additional searches will include Google Scholar, reference lists of included studies, relevant reviews and trial registries. Studies will be included if they implement a functionality-based intervention. They must evaluate effects among paediatric patients with an oncological diagnosis. Secondary outcomes will include health-related quality of life. There will be no limits to language or year of publication, and articles published in peer-reviewed journals will be accepted. Only randomised controlled trials will be included. Risk of bias will be assessed using the Cochrane Risk of Bias Tool 2. Two independent reviewers will select studies, extract data and assess risk of bias. A narrative synthesis and meta-analysis will be conducted if studies are clinically and methodologically homogeneous. Statistical heterogeneity will be assessed using Higgins’ inconsistency test (I²). Meta-analysis may estimate combined effects using random-effects and the inverse variance method. The R statistical software will be used. The certainty of evidence will be evaluated for each outcome using the Grading of Recommendations Assessment, Development and Evaluation system.
This study used data from previously published studies, thus waiving submission to an Ethics Committee. Scientific dissemination strategies will include publication in peer-reviewed journals, conference presentations and workshops for the public.
CRD42024462833.
Unplanned hospital readmissions within 30 days of discharge measure the quality of healthcare. This study aims to identify the characteristics of patients at higher risk of readmission.
Retrospective cohort study.
North-east Italy (Marca Trevigiana Local Health Authority).
The study examined a total of 39 467 index admissions from hospital discharges (SDO) in the 890 000-inhabitant area during 2022.
Readmission rates and 95% CIs were computed by risk factor, age and type of admission (surgical or medical). A logistic mixed-effects model was used to estimate readmission OR, adjusting for potential confounders.
A total of 2197 readmissions occurred within 30 days of the index admission, resulting in an overall rate of 30-day readmissions of 6.7% (CI 6.4% to 7.0%). The median time to readmission was 11 days (IQR 5 to 20). In the multivariate analysis, after adjusting for age and sex, the following clinical conditions were associated with a higher risk of readmission: alcohol-related disease (OR=2.06, CI 1.36 to 3.13), metastatic cancer (OR=1.98, CI 1.57 to 2.50), epilepsy (OR=1.93, CI 1.36 to 2.75), dialysis or end-stage kidney disease (OR=1.92, CI 1.39 to 2.66), chronic obstructive pulmonary disease (OR=1.88, CI 1.49 to 2.36), stoma (OR=1.72, CI 1.22 to 2.44), transplant (OR=1.62, CI 1.03 to 2.55), being bedridden (OR=1.57, CI 1.28 to 1.93), anaemia (OR=1.57, CI 1.35 to 1.83), urinary tract infection (OR=1.54, CI 1.30 to 1.83), pneumonia (OR=1.52, CI 1.31 to 1.75), dementia (OR=1.49, CI 1.24 to 1.79), diabetes (OR=1.37, CI 1.17 to 1.61) and transfusion (OR=1.34, CI 1.03 to 1.73).
Several chronic and acute conditions at index admission significantly increased the risk of readmission. Strengthening transitional care, outpatient services and palliative care could mitigate readmissions.
The study evaluated the feasibility and efficacy of a non-immersive virtual reality (VR) system on upper extremity (UE) recovery in ischaemic stroke patients in comparison to a conventional physiotherapy.
An open-label, parallel-group, randomised controlled trial randomly assigned the participants to two groups, VR intervention or conventional physiotherapy.
Two tertiary stroke care centres in South India participated in the study.
Sixty first-ever ischaemic stroke patients (1–6 months of stroke onset) having spasticity grades of 1 or 1+ as per Modified Ashworth scale and Brunnstrom recovery stages of 3, 4 or 5 in the UE were included in the intention-to-treat analysis.
High-intensity non-immersive VR-based comprehensive rehabilitation gaming system with a duration of 12 weeks (3 days/week) was compared with equally intensive conventional physiotherapy.
The feasibility outcome was the compliance with the treatment. The primary efficacy outcome was the improvement in the motor function assessed by the Fugl-Meyer assessment (FMA) and Wolf motor function test (WMFT). The secondary outcomes included the performance in activities of daily living by the Barthel index (BI) and the quality of life by the 36-item short form health survey (SF-36).
The treatment compliance was similar in two groups (p=0.19). Both groups improved in motor performance, activities of daily living and quality of life. However, there were no significant differences in the FMA (p=0.58), WMFT (functional ability scale, p=0.33; performance time, p=0.44), BI (p=0.84) and SF-36 (physical, p=0.87; mental, p=0.99) scores between the groups.
The non-immersive VR system was feasible, effective and safe; however, it was not found to be superior to conventional physiotherapy. The trial was stopped early and did not reach its proposed sample size and hence, the findings are to be interpreted cautiously.
Clinical trial registry India: CTRI/2021/11/038339 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTc1OTI=&Enc=&userName=CTRI/2021/11/038339).
To assess the prevalence and determinants of essential newborn care (ENC) practices among Ethiopian mothers using the 2023 Performance Monitoring for Action (PMA) dataset.
A cross-sectional analysis of the nationally representative 2023 PMA Ethiopia survey.
A total of 1933 mothers with complete data on ENC practices were included.
Ethiopia, using a multi-stage stratified cluster sample.
ENC, defined as the adoption of at least four of five WHO-recommended practices: immediate drying, delayed bathing, skin-to-skin contact, clean cord care and early initiation of breastfeeding.
Overall, 32.1% (95% CI 28.1% to 36.0%) of mothers practised at least four ENC components. Coverage was highest for immediate drying (95.4%) and delayed bathing (87.3%), but lower for skin-to-skin contact (53.6%) and clean cord care (64.5%). Health facility delivery showed a strong association with higher ENC practice (adjusted OR (AOR)=106.00; 95% CI 46.14 to 243.54). Mothers who were spouses, rather than household heads, had higher odds of practising ENC (AOR=2.88; 95% CI 1.20 to 6.89) and those mothers with parity two or three had higher odds of practising ENC compared with first-time mothers (AOR=2.00; 95% CI 1.33 to 3.02 and AOR=3.39; 95% CI 1.76 to 6.53, respectively). Lack of postnatal care attendance was negatively associated with ENC (AOR=0.56; 95% CI 0.37 to 0.85). Regional disparities were observed, with mothers in the Southern Nations, Nationalities and Peoples’ region being significantly less likely to practise ENC compared with those in Addis Ababa (AOR=0.31; 95% CI 0.15 to 0.64). All results are based on weighted data to ensure national representativeness.
The prevalence of ENC practices remains low in Ethiopia. Health facility delivery, maternal role in the household, parity and region of residence were significant predictors of ENC practice. Strengthening facility-based delivery, promoting maternal empowerment and addressing regional disparities are essential to improving newborn health outcomes in the country and achieving Sustainable Development Goal 3.
This study assessed the feasibility of implementing a phase 3 field-based clinical trial protocol to evaluate paediatric praziquantel (PED-PZQ) for the treatment of Schistosoma mansoni infection in children aged 3 months to 6 years in endemic areas of Brazil, focusing on operational aspects such as recruitment logistics, documentation management, investigational product handling and protocol adherence.
Pilot and feasibility study for a phase 3 clinical trial, comprising two components: a randomised, open-label, parallel-group, two-arm trial and a single-arm trial.
Conde, Bahia, Brazil, from December 2024 to January 2025.
Two trials aim to screen 5774 participants from three rural areas in Bahia and three in Sergipe, states in northeastern Brazil, and enrol 403 children eligible for either randomisation or allocation. Trial 1 will randomise (1:1 ratio) 240 children aged 4–6 years into the PED-PZQ treatment arm or the standard praziquantel (PZQ) 1. Trial 2 will enrol 163 children aged 3 months to 3 years, all receiving PED-PZQ. Both trials are open label. Eligible participants shall meet age criteria, test positive for S. mansoni and fulfil other inclusion criteria. In the first recruiting centre, Conde (Bahia), it was estimated that 650 participants would need to be screened for trial 1 and 552 for trial 2, assuming schistosomiasis prevalence of 5% and 4%, respectively. This pilot study reports on the first 60 participants enrolled.
The primary outcome of this pilot study is the feasibility of implementing the research protocol in a real-world field setting, focusing on key aspects such as study documentation challenges, participant safety, investigational medicinal product custody chain and protocol adherence. In addition to providing preliminary data on the parasitological cure rate, secondary outcomes include the prevalence of S. mansoni infection and the reduction in S. mansoni egg count (Kato-Katz method). Furthermore, the occurrence and severity of drug-related adverse events are monitored from drug administration to day 21 post-treatment, alongside changes in renal, hepatic and cardiac functions assessed through biochemical markers.
A total of 60 participants were recruited, and 55 provided stool samples for screening. The pilot phase demonstrated the feasibility of implementing the clinical protocol under field conditions, with successful completion of all planned procedures and minimal protocol deviations. Operational challenges were identified mainly in documentation processes, participant recruitment and investigational product management and were addressed through preventive and corrective quality assurance actions. The experience also highlighted logistical and infrastructural barriers typical of field-based trials in remote endemic areas, which informed adjustments for the subsequent phase 3 study. Preliminary parasitological results indicated an overall S. mansoni prevalence of 9.1% (5/55), with 21% in trial 1 and 2.8% in trial 2. All infected participants met the eligibility criteria, received treatment and completed follow-up. Four achieved a parasitological cure, and one case of treatment failure was observed (trial 1, PZQ group). Two mild adverse events (diarrhoea) were reported, with no serious complications or clinically significant changes in biochemical parameters.
This pilot study demonstrated the feasibility of implementing a field-based phase 3 clinical trial protocol for PED-PZQ in endemic areas of Brazil. The findings confirm that the protocol can be successfully applied in primary care settings, despite operational challenges related to recruitment, logistics and documentation. The study also provided preliminary evidence supporting the safety and effectiveness of the paediatric formulation and highlighted the need to revise prevalence assumptions to improve future screening strategies. Overall, the experience offers valuable insights to guide the large-scale phase 3 trial and supports the incorporation of PED-PZQ into national schistosomiasis control policies.
Brazilian Clinical Trials Registry; RBR-86kcy37.
Mobile health (mHealth) technologies have become increasingly popular for monitoring mental health symptoms and lifestyle behaviours, and are largely reported to be feasible and acceptable to users. However, to date, the efficacy of such technologies to improve perinatal mental health outcomes has been mixed. Within the perinatal context, much of this work has been done in the context of postpartum depression, stemming from electronic health records as well as cohort studies. There is, however, a dearth of studies focusing on depression in pregnancy, and machine learning-based clinical decision support systems remain underexplored. The HappyMums application has been developed to meet this need, and its use across Europe will be tested in this study.
A total of 1000 pregnant people currently suffering from, or at risk of, antenatal depression will be recruited across six countries. All participants will be between 13 and 28 weeks’ gestation and will be given access to the new purposefully developed HappyMums mobile application, to use from enrolment until 2 months postpartum. The application leverages passively collected data from smartphone sensors relating to physical activity and behaviour, as well as requiring active engagement from the user to complete mental health questionnaires and ‘game-like’ activities. Digital data types will be combined with traditional mental health measurement methods, such as standardised questionnaires and interviews, to develop novel predictive models capable of identifying mental health trajectories in women at risk of developing antenatal depression and to test the app’s utility for use as personalised risk prediction and depression identification tool. The primary outcome of this study is to determine what proportion of users will continue to use the mobile application and engage with its tasks and activities at least weekly, while secondary exploratory outcomes include assessing usability of the app and testing the predictive ability of a novel machine learning-based model. These outcomes will, for the first time, be assessed by integrating active as well as passive data.
Ethical approval has been granted by local research ethics committees in each recruiting centre. At King’s College London (leading the clinical study), the study was reviewed by the East of England—Essex Research Ethics Committee and granted favourable opinion (REC reference 24/EE/0129). All other sites collecting participant data have the study approved for local delivery. Findings relating to the primary and secondary outcomes will be submitted for publication in open access, peer-reviewed journals, as well as presentations at conferences as symposia or posters. Findings will be made available to a non-specialist audience through open access digital mental health magazines and promotion on social media.
PRELUCA is a randomised, intervention, non-inferiority study designed to use real-time, longitudinal circulating tumour DNA (ctDNA) measurements to evaluate the efficacy of immunotherapy in patients with advanced non-small cell lung cancer (NSCLC). The primary outcome is overall survival between the two groups: the standard of care group (computer tomography scan evaluation) and intervention group (ctDNA evaluation).
The inclusion and exclusion criteria align with European Society for Medical Oncology treatment guidelines and permit broad inclusion of NSCLC patients, ensuring ‘real-world’ representativeness. The study uses a tumour-informed method, using baseline next generation sequencing analyses to design patient-specific droplet digital PCR assays, which are run with collected blood samples 1 week prior to the intended treatment, enabling real-time evaluation via ctDNA Response Evaluation Criteria in Solid Tumours.
Inclusion began in July 2023 and patients are now being actively included in five locations across Denmark. Approval by The Committee on Health Research Ethics of Region Zealand was gained on 4 May 2023.
Group A Streptococcus (Strep A) causes a wide spectrum of diseases, ranging from pharyngitis and impetigo to severe invasive infections and immune-mediated conditions such as acute rheumatic fever, rheumatic heart disease and acute post-streptococcal glomerulonephritis. Contemporary data on the global burden of Strep A diseases are lacking. The proposed study aims to use administrative data from numerous jurisdictions to estimate age-specific incidence or prevalence of Strep A diseases, with an emphasis on severe clinical endpoints. Depending on the availability of data, a secondary objective will be to estimate the economic burden of Strep A diseases.
This population-based descriptive study will use routine health data obtained from different low-income and middle-income and high-income countries through international research collaborations to estimate the country-level and global burden of Strep A diseases. Data will be primarily obtained and collated from hospital or national health laboratory databases for individuals across all age groups, along with emergency department, primary care and microbiological datasets where available. Strep A disease endpoints will be identified using International Classification of Diseases 10th Revision or other relevant coding systems and microbiological diagnosis. Age-specific incidence and prevalence rates will be computed using population denominators, and country-level age-adjusted rates will be applied to standard global reference populations to estimate the number of cases globally.
Ethical approval to conduct this study was obtained from the Human Research Ethics Committee at the University of Western Australia (reference: #2024/ET000401) and governance approval was obtained from The Kids Research Institute Australia. The findings from this study will be published in peer-reviewed journals and presented at Strep A Vaccine Global Consortium collaborative meetings.
Concentration of care and collaborations between hospitals increasingly reorganise oncological care into Comprehensive Cancer Networks (CCNs), aiming to improve care outcomes and reduce costs. This study aims to evaluate the effect of four CCNs on healthcare cost and outcomes for patients with colon or pancreatic cancer.
We performed a retrospective cohort study based on claims data in the Netherlands. Data included patient characteristics, health insurance claims and healthcare activities. All costs were indexed to Euro 2023. We performed propensity score matching per CCN and applied regression models with a difference-in-difference design, adjusting for non-linear trends before the start of a CCN.
The study was conducted within the Dutch healthcare system, analysing claims data representative of hospital-based cancer care.
A total of 92 309 patients with colon cancer and 25 630 patients with pancreatic cancer were included. Patients were identified through health insurance claims between January 2013 and June 2021.
Implementation of four CCNs, which included structured collaboration between healthcare organisations. Follow-up duration was 2 years post-diagnosis.
Primary outcomes included 2-year oncological healthcare costs and 2-year mortality rate. Secondary outcomes involved care process indicators: referral rates and double diagnostics (an identical diagnostic activity performed within 4 weeks after referral to a secondary hospital).
For colon cancer, one CCN showed a significant decrease in 2-year oncological costs (–1899). One CCN showed a significant decrease in referrals (–3.6%) and one a significant increase (+4.4%). No significant effect on 2-year mortality and double diagnostic activities was found. For pancreatic cancer, one CCN showed a significant decrease in 2-year oncological costs (–3747) and one CCN showed a significant increase in double diagnostic activities (+8.6%). No significant effect on referrals and 2-year mortality was found.
CCNs do not consistently reduce costs or affect referral patterns or redundant diagnostics. No impact on mortality was found. Additional insights into determinants of CCN success are required before broad implementation is warranted.
Timely publication of preregistered study outcomes is not self-evident. Discrepancies can lead to significant research waste.
To assess timely (within 7 years) and consistent publication of preregistered primary outcomes and associated factors of total knee arthroplasty (TKA) studies registered between 2000 and 2017 over time.
An observational study.
ClinicalTrials.Gov, MEDLINE, Embase, Cochrane Library, Web of Science, PubMed and Google Scholar.
Registered TKA trials at ClinicalTrials.Gov between 2000 and 2017.
ClinicalTrials.Gov’s required and optional data elements for registering a study and the preregistered and published primary outcome, defined as the outcome stated in the primary outcome field on ClinicalTrials.Gov. We used descriptive statistics, Kaplan-Meier curves and Cox regression analyses.
1352 registered TKA (1072 interventional; 280 observational) studies were included, with 967 (811 interventional; 156 observational) unique references. Regarding the publication of preregistered primary outcomes within 7 years, the results for interventional trials were 0% (2000), which increased to 59.6% (2017). Observational studies were timely published in 0% (2000) and 37.5% (2017). Interventional trials and observational studies not funded by industry were more likely to have timely and consistent publication of their primary outcomes. Drug intervention trials were more likely to be timely and consistently published than procedure-focused trials. Phase 3 interventional trials were more likely, while phase 1 trials were less likely to be consistently published on time.
Despite ongoing efforts to improve publication rates, over a third of interventional trials remain unpublished within 7 years. For observational studies, the rate is even lower, with only two-fifths published on time, contributing to significant research waste.
CRD42021246599.
Population ageing is a global phenomenon that has resulted in an increase in the number of patients with chronic diseases and geriatric syndromes. Frailty, sarcopenia and neurocognitive disorders are among the most prevalent conditions affecting older adults and have a direct effect on their quality of life, and can impact the burden and budgets of health systems. Recently, the oral microbiome has gained attention as it may be a factor that potentially influences the onset and progression of these syndromes. However, this is still a new line of research that has not been deeply explored. This scoping review protocol aims to explore how the oral microbiome may be associated with the onset of prevalent geriatric syndromes, frailty, sarcopenia and neurocognitive disorders, providing a picture of the current evidence and potential gaps for future research.
The scoping review will follow the Johanna Briggs Institute (JBI) methodology and will be reported accordit to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines (PRISMA-ScR). Searches will be conducted in Medline, Embase, Cochrane Central, CINAHL, LILACS and Epistemonikos from inception to December 2025. Independent reviewers will perform the study selection and data extraction. A descriptive analysis of information will be conducted, highlighting oral microorganisms associated with these syndromes and emerging trends in the evidence. Original research studies in any language will be included. We will include randomised controlled trials, cohort studies, case–control studies and other relevant designs if they investigate the oral microbiome and its relation to geriatric syndromes in adults aged 65 or older, regardless of geographic location or setting.
Ethics approval is not required.
Antimicrobial resistance (AMR) is a critical public health issue in Bangladesh, exacerbated by the widespread practice of non-prescribed antibiotic dispensing. This study seeks to assess their knowledge and attitudes, particularly how these factors influence non-prescribed antibiotic dispensing practices in Bangladesh.
A total of 287 pharmacy staff across four regions of Bangladesh were included in the study. Data were collected using a structured questionnaire assessing knowledge, attitudes and practices regarding non-prescribed antibiotic dispensing.
The study found that 92.4% of respondents dispensed antibiotics without prescriptions. The practice was significantly more prevalent among those with poor knowledge (99.28% in below-average vs 86.09% in above-average knowledge groups, p
These findings highlight knowledge and attitude towards antibiotic dispensing play a vital role where weak regulation, education and economic incentives further worsen the situation. Urgent interventions, including improved pharmacist training, prescription monitoring and public awareness campaigns, are essential to reduce non-prescribed antibiotic dispensing and align practices with Bangladesh’s National Action Plan on AMR.
Bangladesh is facing a growing obesity epidemic; however, evidence on sex-specific patterns and socioeconomic determinants is limited.
We aimed to investigate sex differences in obesity prevalence and to assess how socioeconomic and demographic factors influence obesity risk among adult men and women.
We analysed data from the Bangladesh Demographic and Health Survey 2022. Prevalence of obesity (body mass index ≥25.0 kg/m²) among men and women was estimated by sociodemographic characteristics. Two multinomial logistic regression models were fitted: first, to quantify sex-specific odds of obesity with socio-demographic variables as interaction terms for effect modification; and second, adjusted sex-stratified models to assess determinants of obesity separately in men and women.
Overall, 30% of our participants had obesity, with women more affected than men (36% vs 20%; adjusted OR (aOR) 2.75, 95% CI 2.53 to 3.00). Interaction analyses showed attenuation of the female-male difference among those with higher education (interaction aOR 0.57, 95% CI 0.43 to 0.74), richest quintile (interaction aOR 0.63, 95% CI 0.47 to 0.83) and urban residence (interaction aOR 0.81, 95% CI 0.68 to 0.96). Obesity was positively associated with age, education, wealth and urban residence, with stronger effects in men, except for higher education (interaction aOR 0.65, 95% CI 0.47 to 0.89), richest quintile (interaction aOR 0.72, 95% CI 0.54 to 0.98) and urban residence (interaction aOR 0.84, 95% CI 0.70 to 0.98).
Obesity disproportionately affected women, although association with socio-demographic factors was stronger in men. Targeted sex-specific interventions that address socioeconomic and contextual determinants are needed to mitigate obesity burden in Bangladesh.
The term ‘culture of care’ began to be used following the Francis Report in the UK in 2013. This concept involves three dimensions: personal care, leadership care and co-worker care. Personal care focuses on employees’ attitudes and behaviours. Co-worker care relates to a sense of community, and leadership care relates to how employees perceive leaders and managers as caring individuals dedicated to ensuring the well-being of others. Previous studies investigating culture assessment tools used in the healthcare system reported that although organisations are increasingly using culture assessment instruments, there is a focus on assessing safety and quality cultures rather than on caring perspectives. This scoping review aims to map existing studies related to the assessment of culture of care.
This scoping review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews. The search strategy will include four indexed databases (PubMed, EMBASE, Cochrane Library and Latin American and Caribbean Literature in Health Sciences) and additional sources not retrieved with the adopted search strategy. The search strategy will be constructed using the controlled vocabulary in Health Sciences Descriptors, Medical Subject Headings and Emtree. Relevant articles in all languages, without restrictions related to date of publication, will be considered eligible for inclusion. Two independent researchers will select articles based on the inclusion criteria, and a third author will be consulted to establish consensus, if necessary. Data extraction will involve a form with information on the study characteristics, methodological issues and main results from the evidence sources. The extracted data will be analysed using descriptive and content analysis.
Ethics approval is not required, as this review will use data from publicly available bibliographic sources. The results will be disseminated through publications in scientific journals and presentation of the evidence to interested parties.
The protocol was registered in the Open Science Framework (DOI: 10.17605/OSF.IO/U9Q53).
About 30% of depressed patients suffer from a protracted course in which the disorder continues to cause significant burden despite treatment efforts. While originally developed for relapse prevention, mindfulness-based cognitive therapy (MBCT) has increasingly been investigated in depressed patients with such ‘difficult-to-treat’ courses. This is a protocol for an individual participant data (IPD) meta-analysis aiming to determine efficacy and potential moderators of MBCT treatment effects in this group based on evidence from randomised controlled trials.
Systematic searches in PubMed, Web of Science, Scopus, PsycINFO, EMBASE and the Cochrane Controlled Trials Register for randomised controlled trials were completed on 17 June 2024. Authors of identified studies have contributed IPD, and data extractions have been completed. An update search will be conducted immediately before the start of data analyses. We will investigate the following outcomes: (a) self-reported and observer-reported severity of depression symptomatology, (b) remission and (c) clinically meaningful improvement and deterioration. One-stage and two-stage IPD-MA will be conducted with one-stage models using the observed IPD from all studies simultaneously as the primary approach. One-stage IPD models will include stratified study intercepts and error terms as well as random effects to capture between-study heterogeneity. Moderator analyses will test treatment-covariate interactions for both individual patient-level and study-level characteristics.
The results will inform understanding of the use of MBCT in patients with current ‘difficult-to-treat’ depression and will contribute to arguments in favour of or against implementing MBCT as a treatment for this group. They will be published in a peer-reviewed journal and made available to stakeholders in accessible formats. No local ethical review was necessary following consultation with the Ethics and Governance Board of the University of Surrey. Guidance on patient data storage and management will be adhered to throughout.
CRD42022332039.
Past studies show a mixed relationship between the Global Health Security (GHS) Index and COVID-19 pandemic health outcomes. Some recent work that suggested higher GHS Index scores are associated with better mortality outcomes has been criticised on methodological grounds. There remains scope for improved analyses of these relationships, including of island nations and macroeconomic pandemic outcomes. We aimed to determine the relationship between GHS Index scores and COVID-19 pandemic excess mortality 2020–2021 and macroeconomic pandemic outcomes.
Cross-sectional, multivariable regression design (controlling for per capita gross domestic product (GDP) and political corruption), comparing island and non-island jurisdictions.
194 jurisdictions with 2019 GHS Index scores.
Age-standardised cumulative excess mortality 2020–2021, GDP per capita growth 2019–2020 and 2020–2021.
The GHS Index predicted better health outcomes in terms of age-standardised excess mortality through 2020–2021 in non-island jurisdictions (β=–0.046, p=0.00068, adj R2=0.48), but not in island jurisdictions (β=0.012, p=0.734). For a starting age-standardised excess mortality of 100 per 100 000, a +10-point rise in overall GHS Index score predicts a 26.7 per 100 000 reduction in age-standardised mortality. We found no robust evidence that a higher GHS Index predicted higher year-on-year GDP per capita growth through 2019–2020 or 2020–2021.
The GHS Index demonstrated clear associations with favourable health outcomes of non-island jurisdictions through the COVID-19 pandemic, supporting its use to guide pandemic preparedness investments. Contrasting findings for islands suggest the need to enhance how the Index measures border biosecurity capacities and capabilities, including the ability to support the exclusion/elimination strategies that successfully protected islands during the COVID-19 pandemic.
Childhood cancer survivors (CCSs) experience educational disruptions during and following treatment, yet robust, longitudinal evidence on educational performance remains limited. We will investigate differences in educational outcomes between CCSs and non-cancer peers during primary and secondary school. We will also explore how sociodemographic factors and age at diagnosis contribute to potential differences in General Certificate of Secondary Education (GCSE) examinations, a critical indicator of future academic and employment prospects.
We will use the Education and Child Health Insights from Linked Data (ECHILD) to capture linked health and education data for children born in National Health Service (NHS)-funded hospitals in England. We will generate birth cohorts spanning September 1997 to August 2015 (estimated sample size: ~10 million), formed of pupils expected to have undertaken national curriculum assessments between academic years 2004/2005 and 2021/2022 including Key Stage (KS) 1, 2 and 4, corresponding to ages 7, 11 and 16 respectively. Cancer diagnosis will be identified from inpatient hospital records, using International Classification of Diseases, 10th Revision codes (ICD-10). We will investigate differences between CCS and their non-cancer peers in terms of their sociodemographic characteristics and describe trends in educational performances at all KSs, recorded Special Educational Needs and Disabilities (SEND) and school absences. Differences in KS4 (GCSE) performances between CCS and non-cancer peers will be quantified, according to and accounting for geographic region, sex, deprivation, ethnicity and birth characteristics. To assess whether cancer diagnosis disrupts academic trajectories, we will restrict analysis to those with KS2 attainment data and investigate KS4 performance. We will finally explore the influence of age at diagnosis on educational performance at KS4.
Ethics approval was granted by NHS Health Research Authority Research Ethics Committee (20/EE/0180). Findings will be shared with academics, policymakers, children and families affected by childhood cancer, and published in journals. Code/metadata will be shared on ECHILD GitHub repository.
Radioembolisation (RE) is gaining traction as a robust treatment option for patients with hepatocellular cancer (HCC) across all cancer stages. RE allows the delivery of targeted high-dose radiation directly to tumours, with relative sparing of the surrounding liver tissue. Traditionally, radiation has been delivered using 90Yttrium ([90Y]Y)-labelled microspheres, either glass or resin. The success of RE is dependent on the dose delivered to the tumour. When using [90Y]Y microspheres, dose prediction is calculated through a 99mTechnitium ([99mTc]Tc)-macroaggregated albumin (MAA) scan, which allows the calculation of the dose to be administered to the tumour. However, [99mTc]Tc-MAA is not a true surrogate of [90Y]Y microspheres, and this will impact on the final dose delivered. [166Ho]Ho, like [90Y]Y, is a beta emitter but unlike [90Y]Y also emits gamma-radiation, allowing for quantitative nuclear imaging. The primary aim of this pilot study was to investigate the safety and efficacy of dosimetry-based individualised 166Holmium ([166Ho]Ho-RE) in patients with HCC.
15 eligible participants will be recruited to receive [166Ho]Ho-RE. The primary objective is to establish the toxicity profile of dosimetry-based individualised [166Ho]Ho-RE. The secondary objective is to assess efficacy as measured by modified Response Evaluation Criteria in Solid Tumours (mRECIST) and Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria. Additional exploratory objectives include quality of life assessment and identification of a radiomic signature of response. The results from this study will be combined with the prospective iHEPAR study to form a larger analysis.
The study has received approval from the East Midlands—Nottingham 1 Research Ethics Committee—approval number 23/EM/0239. The study will be performed in compliance with the Declaration of Helsinki and the principles of Good Clinical Practice. Signed informed consent will be obtained from each patient before study entry. The results will be disseminated through publication in a peer-reviewed scientific journal.
Clinicaltrials.gov NCT06302400.
To explore the challenges and opportunities in clinical skills teaching and learning among faculty, final-year medical students and patients at a private medical university in Pakistan, within the context of a low- and middle-income country (LMIC) medical education system.
An exploratory descriptive qualitative design using inductive thematic analysis utilising in-depth interviews and focus group discussions, framed within a metaphorical lens.
A single private-sector tertiary care teaching hospital and affiliated undergraduate medical college in an urban setting in Pakistan.
A total of 48 participants were included in the study: 12 clinical faculty members representing various disciplines and levels of experience, 16 final-year medical students and 10 house officers and 10 patients from adult inpatient wards. Participants were purposively selected to ensure maximum variation in perspectives.
Six key metaphorical themes emerged, each reflecting both the challenges and opportunities within the clinical learning journey: (1) The Safety Harness—simulation as an opportunity for structured, risk-free skill development, yet limited by authenticity; (2) The Underwater Life—the irreplaceable but unpredictable nature of bedside learning in fostering empathy and communication; (3) The Stormy Seas—systemic and cultural barriers such as patient availability, gender constraints and limited faculty resources; (4) The Ship—students navigating self-development amid evolving expectations, digital distractions and shifting motivations; (5) The Engine Room Tools—balancing diverse teaching modalities while seeking optimal time distribution between simulation and bedside learning; and (6) The Guiding Compass—the pivotal role of clinical teachers as mentors and professional exemplars. Triangulated perspectives revealed that while structured simulation and bedside experiences complement one another, significant institutional, ethical and pedagogical challenges persist, many amplified by the realities of resource-limited LMIC settings.
This study underscores the complexities of clinical teaching and learning in an LMIC context, highlighting the need for a balanced, context-sensitive model that integrates simulation with authentic bedside exposure, supported by mentorship and reflective practice. Addressing structural and faculty-related barriers is essential to advancing equitable, patient-centred clinical education in resource-constrained environments.
The utility of brain MRI in dementia diagnosis offers critical insights into structural brain changes, such as hippocampal and thalamic atrophy, which are hallmark features of Alzheimer’s disease and Alzheimer’s disease-related dementias . However, its use, especially in low- and middle-income countries (LMICs), is affected by limited accessibility. This protocol outlines a systematic review and meta-analysis to assess the diagnostic utility, feasibility and challenges of integrating brain MRI for dementia diagnosis in LMICs.
The review follows Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols with a priori eligibility criteria and is registered in PROSPERO. Searches (from inception to September 2025) will be run in MEDLINE/PubMed, EMBASE, Web of Science and PsycINFO, with supplementary bibliography screening. Adults ≥50 years in LMIC settings undergoing brain MRI for dementia evaluation will be eligible. Data will be synthesised narratively and, where appropriate, via random-effects meta-analysis with planned subgroup analyses by MRI approach (qualitative vs quantitative), magnet strength, sequence availability and reference standard. Screening and data extraction are planned for 1 November to 30 December 2025.
Ethical approval was obtained from the Makerere University School of Medicine Research and Ethics Committee (Mak-SOMREC; Ref Mak-SOMREC-2022-337). For verification, contact the SOMREC Administrator at rresearch9@gmail.com. Departmental contact: Dr Geoffrey Erem, Head, Department of Radiology, Makerere University College of Health Sciences (dreremgeoffrey@gmail.com). Only published data will be used, with no new patient contact. Findings will be disseminated via peer-reviewed publication, conference presentations and policy briefs (and, where feasible, mainstream media) to inform clinical practice and training in LMICs.
CRD42024510241.