by Lucy H. Eddy, Nat K. Merrick, Cara E. Staniforth, Jade L. Jukes, Liam J. B. Hill, Mark Mon-Williams, Farid Bardid, Rebecca Murray
BackgroundApproximately 5% of children are affected by a neurodevelopmental disorder of their sensorimotor skills. DSM-V and ICD-10, the two most widely used diagnostic systems, define this diagnostically as ‘Developmental Coordination Disorder’ (DCD) or ‘Specific Developmental Disorder of Motor Function’ (SDDMF), respectively. A diagnosis of DCD has been found to have a detrimental impact on a range of outcomes (e.g., health and education). It is therefore crucial that these children receive timely intervention. This is reliant, however, on effective assessment and support pathways. Research has shown there is great parental dissatisfaction, but there has been limited research exploring a clinical and education perspective. This study therefore aimed to understand barriers and facilitators for clinical and education practitioners in the pathway in a diverse district in the UK (Bradford).
MethodsSemi-structured interviews were completed with stakeholders across the pathway to identify barriers and facilitators to assessing, diagnosing, and supporting children with sensorimotor skill difficulties. Theoretical thematic analysis aligned to the Capability, Opportunity, Motivation model of Behaviour change (COM-B) was used to analyse the qualitative data.
ResultsInterviews revealed many barriers in the DCD pathway related to capability (confusing terminology, inconsistent knowledge, inappropriate referrals), opportunity (resource constraints, DCD being considered low priority, and disconnected services), and motivation (overlapping job roles, a desire to consider those with difficulties not eligible for a diagnosis). No facilitators were consistently identified across interviews.
ConclusionFamilies face multiple barriers to obtaining a diagnosis for their child through existing clinical pathways for assessment and support. These findings are unlikely to be unique to Bradford, due to international research highlighting these issues via parental interviews. These findings therefore may reflect challenges both nationally and internationally within DCD pathways. There is an urgent need for: (i) clear communication across different services (with consistency in terminology), and (ii) a more collaborative and integrated approach to assessment, diagnosis, and support in order to help these children thrive.
Postoperative pain is common after surgery, with a high incidence and risk of becoming chronic. Current multimodal analgesia has drawbacks, including limited efficacy from single agents and opioid side effects and addiction risk. These issues have led to opioid-sparing multimodal analgesia. Transcutaneous auricular vagus nerve stimulation (taVNS) is non-invasive and convenient. Studies have shown it can reduce postoperative pain, improve mood and lower adverse events. However, taVNS lacks a comprehensive evaluation and standardised protocols, so further research is needed to provide reliable evidence.
This study strictly adheres to the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. To identify suitable randomised controlled trials (RCTs), eight credible databases will be searched, including four English databases (Web of Science, PubMed, Cochrane Central Register of Controlled Trials, EMBASE) and four Chinese databases (China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Wanfang Database, Chinese Biomedical Literature Database). RevMan V.5.3 will be employed to integrate the retrieved data and conduct meta-analyses. The methodological quality of included RCTs will be evaluated using the Cochrane Risk of Bias Assessment 2.0 tool. Additionally, the Grading of Recommendations, Assessment, Development and Evaluation system will be applied to assess the strength and certainty of the evidence. We will also conduct publication bias analyses, sensitivity analyses and subgroup analyses.
No ethical review is required as no private or confidential patient data will be included. Results of this study will be disseminated through a peer-reviewed journal.
CRD420251207651.
Since the 1970s, telemedicine has transformed significantly, becoming a critical component of modern healthcare delivery. Over time, technological innovation has increasingly emphasised the integration of the human body with digital systems to develop non-invasive methods for monitoring physiological parameters. Among these technologies, wearable sensors demonstrate substantial potential for continuous patient monitoring. These devices can facilitate real-time data collection, enable more rapid clinical decision-making and promote active patient participation in health management. Such capabilities are particularly valuable in emergency contexts, including prehospital care provided by ambulance services and telephone triage systems. Despite the growing interest in wearable health technologies, their integration into emergency medical services (EMS) remains insufficiently explored and warrants further investigation. We aim to map current research, explore the use of wearables in EMS settings and identify gaps in knowledge regarding their use in EMS.
This scoping review will follow the Joanna Briggs Institute’s (JBI) methodology for scoping reviews. A systematic search of relevant databases (MEDLINE, EMBASE, Cochrane Library, CINAHL, ProQuest and Web of Science) will be conducted, from inception to March 2026. All types of study designs, including quantitative and qualitative studies, will be considered in this scoping review. The inclusion is limited to studies published in English. Two independent reviewers (RA and AA) will conduct a thorough screening of titles and abstracts against the predefined inclusion criteria. Studies that meet the inclusion criteria will be reviewed in full text. Quality and risk of bias will be assessed using the JBI’s critical appraisal tools for the relevant study types. The findings will be presented using diagrams or tables, supplemented by narrative summaries following the JBI guidelines.
Ethical approval is not required. The findings of this study will be disseminated via publication in a peer-reviewed journal.
Open Science Framework (10.17605/OSF.IO/MUEFX).
Healthcare utilisation (HU) is key to improving the health of residents in urban informal settlements. This study aimed to explore household-level factors influencing HU among informal settlement households in Freetown, Sierra Leone.
Cross-sectional survey.
Three informal settlements (Cockle Bay, Dwarzark and Moyiba) in Freetown, Sierra Leone.
Primary data from 4871 households were collected during the Health and Wellbeing survey conducted between April and May 2023, targeting households with adults aged 18 years and older.
The primary outcomes were households HU both within and outside informal settlements. Household-level predisposing and enabling explanatory variables were derived from Andersen’s Behavioural Model of HU.
Disability in households increases HU within settlements (especially in Dwarzark, 13% and Moyiba, 10%) but is less likely outside. Households engaged in income-generating activities are more likely to seek healthcare within settlements, but 12% less likely outside in Cockle Bay and Dwarzark. Food insecurity decreases HU within Dwarzark (9%) and increases HU outside by 174% in Moyiba. Longer water fetching times and water shortages were associated with higher HU (between 6% and 16%) within settlements, especially in Cockle Bay and Dwarzark. Clean water sources (eg, piped dwelling, bowser, surface, bottled) were consistently associated with higher HU both within and outside settlements. Shared sanitation facilities (such as shared toilets) were positively associated with HU both within and outside settlements, particularly in Dwarzark and Moyiba. Households with income from fishing, informal salaried work and bike riding showed higher HU both within and outside settlements, especially in Dwarzark and Moyiba.
We identified strong settlement-specific patterns of household-level factors that influence HU both within and outside Freetown’s informal settlements. These findings provide a foundation for developing targeted policies such as strengthening local services, addressing affordability and accessibility barriers and supporting vulnerable occupation groups.
Postoperative sleep disturbance (PSD) is a common complication following major surgery, occurring in 15%–72% of patients. PSD poses a significant threat to both postoperative recovery and long-term outcome, leading to elevated risks of cognitive decline, pain sensitivity and cardiovascular events in patients. The current pharmacological treatments for PSD are typically reactive, administered only after symptoms have manifested, highlighting a critical unmet need for effective prophylactic strategies during the perioperative period. Recently, an increasing number of studies have demonstrated the effect of esketamine on preventing PSD, but their findings are inconsistent. This protocol outlines a systematic review and meta-analysis to examine the effect of perioperative esketamine on the prevention of PSD.
A comprehensive search will be conducted in MEDLINE (via Ovid), EMBASE (via Ovid), the Cochrane Central Register of Controlled Trials (via Ovid), PubMed and Web of Science by two authors independently. The search terms will comprise indexed and free-text terms to encompass the concepts of esketamine and PSD. The primary outcome is the incidence of PSD at postoperative days 1, 3 and 7. Two authors will independently conduct study screening, data extraction and risk of bias assessment with the Cochrane Collaboration’s tool. RevMan V.5.4.1 and Stata V.17.0 software will be used to conduct the statistical analysis. Subgroup analysis, sensitivity analysis and assessment of publication bias will be performed to verify the strength of our conclusions. Finally, the Grading of Recommendations Assessment, Development and Evaluation approach will be used to recommend evidence quality.
Ethical approval is not required for this study. The findings will be presented at national or international conferences and submitted to a peer-reviewed journal.
CRD420251232636.
Multidrug-resistant tuberculosis (MDR-TB) is an urgent public health challenge in Namibia, with profound socioeconomic consequences. The high burden of both tuberculosis and HIV complicates treatment and underscores the need for optimised drug therapies. Precision medicine, which leverages patient-specific genetic and molecular information, offers promise for improving MDR-TB outcomes. However, its effective application relies on population-specific data, particularly understanding how individuals metabolise tuberculosis drugs and how genetic diversity drives variability in treatment response. Currently, no pharmacokinetic (PK) or pharmacogenetic (PG) data on TB treatment exist for Namibian populations. This gap is particularly concerning, given the country’s genetic diversity, environmental factors and comorbidities that may uniquely influence drug metabolism. This study aims to generate PK and PG data to inform dose optimisation and support personalised treatment strategies for MDR-TB in Namibia. The findings will contribute to improved patient care and inform health system strengthening based on locally relevant evidence.
This cross-sectional study will consist of 100 Namibian participants with matched human DNA and PK data of MDR-TB cases receiving isoniazid, clofazimine, bedaquiline and the fluoroquinolones (levofloxacin or moxifloxacin). PK sampling will be divided as follows: 30 individuals will undergo intensive PK sampling, while the remaining (n=70) will undergo sparse PK sampling. DNA will be extracted at Stellenbosch University (SU), and samples will be genotyped using the H3Africa microarray. Sequences will be aligned to the human reference genome, hg38 (GRCh38p13), using the freely available Burrows-Wheeler Aligner. A subset of the samples (n=20–30) will undergo whole genome sequencing (WGS) to verify imputation results and identify novel genetic variants potentially affecting PK in this population.
Quality control and variant call format file generation will be performed using the Genome Analysis Toolkit best practices (V.3.5). Intensive and sparse PK data will be pooled for the development of a population PK (popPK) model using a non-linear mixed-effects modelling approach. The popPK model will characterise the relationship between TB drug dose and exposure, including quantifying covariates, including genetic variation, explaining PK variability, providing a foundation for dose optimisation and personalised treatment strategies.
Ethics approval was obtained from the University of Namibia Human Research Ethics Committee for Health (Ref. SOM18/2024), the Ministry of Health and Social Services (Ref. 22/4/2/3), the SU Health Research Ethics Committee (Ref. N21/11/136) and the University of Cape Town Human Research Ethics Committee (Ref. 500/2022).
Losses of functional reserve across multiple physiological systems have been identified in frail patients, yet the exact aetiology of frailty remains unclear. Although strongly associated with chronological age, frailty often develops at a younger age in patients with organ failure. Frailty is prevalent in patients with kidney failure; however, individuals experience improvements in physical frailty measures following kidney transplantation. This makes younger patients with kidney failure a unique population for studying both the accelerated onset of frailty and its reversal. This research project aims to test the hypothesis that frailty secondary to organ failure and age-related frailty are associated with similar molecular and physiological measures.
This longitudinal study will recruit 150 patients in three groups. Group A (kidney transplant recipients aged ≥40 years; n=50) and Group B (patients aged ≥40 years active on the kidney transplant waitlist; n=50) will comprise younger adults with frailty from organ failure. Group C (adults aged ≥65 years (or ≥55 years for Aboriginal and Torres Strait Islander patients); n=50) will comprise older community dwellers. The primary outcome is the Frailty Index (FI). Secondary outcomes include the change in FI over time, and at baseline when considering various clinical metadata, immune parameters, kidney function and nutrition intake which will be measured at baseline and 12-month time points. Longitudinal changes in frailty will be analysed using linear mixed models with multiple testing corrections for false discovery rates.
Endocrine profiles and metabolomics, measures of immune function and microcirculatory dysfunction, will be measured by liquid chromatography-mass spectrometry and/or gas chromatography-mass spectrometry. The gut microbiome will be sequenced via shotgun metagenomics (Illumina NextSeq500, 150 bp paired-end, 3Gbp/sample). Circulating cell-free DNA/mitochondrial DNA will be quantified through droplet digital PCR. Microcirculation will be assessed via sublingual dark field videomicroscopy with glycocalyx markers measured by ELISA.
This study will be conducted with all stipulations of this protocol, and the conditions of the ethics committee approval. Ethical principles have their origin in the Declaration of Helsinki, all Australian and local regulations and in the spirit of the standard of Good Clinical Practice (as defined by the International Conference on Harmonisation). Organs/tissues will be sourced ethically and will not be sourced from executed prisoners or prisoners of conscience or other vulnerable groups.
Ethics approval was received by the Metro South Health Research Ethics Committee (HREC/2023/QMS/95392) and ratified by the University of Queensland.
Results will be disseminated through peer-reviewed publications, academic conferences, participant newsletters and health organisation collaboration.
To identify the factors associated with low psychological resilience among university students in the Grand Est region of France at the end of the first national COVID-19 lockdown.
A cross-sectional online survey was conducted (May 2020) among students at the University of Lorraine using the LimeSurvey platform and institutional mailing lists.
Higher education setting in north-eastern France, involving students from the University of Lorraine (multicampus public university) and Sciences Po Nancy, a political science institute in the same region.
A total of 3708 students fully completed the online questionnaire, including the Brief Resilience Scale (BRS), resulting in an estimated response rate of 7.1%. All students enrolled at the University of Lorraine and Sciences Po Nancy during the 2019–2020 academic year were eligible to participate.
The primary outcome was psychological resilience, measured using the BRS. Secondary measures included perceived social support assessed with the Multidimensional Scale of Perceived Social Support, quality of interpersonal relationships evaluated using the Quality of Interpersonal Relationships Scale (Échelle de la Qualité des Relations Interpersonnelles, EQRI) and frequency of positive and negative thoughts measured with the Thermometer of Thoughts Tool. Factors associated with low resilience were analysed using bivariable and multivariable logistic regression.
Among 3708 students included in the sample, corresponding to a response rate of approximately 7.1%, 50.6% had normal resilience, while 37.3% reported low resilience. Female gender (OR=2.1, 95% CI: 1.8 to 2.6) and low social support (OR=1.7, 95% CI: 1.1 to 2.6) were the factors associated most strongly with low resilience. Negative thoughts (OR=1.4, 95% CI: 1.4 to 1.5), lower quality of relationships with people in general (OR=1.5, 95% CI: 1.3 to 1.8) and studying arts, humanities or languages (OR=1.4, 95% CI: 1.0 to 1.8) were identified as factors associated with low resilience. Increased age (OR=0.9, 95% CI: 0.9 to 1.0) and flat sharing (OR=0.6, 95% CI: 0.4 to 0.9) were inversely associated with low resilience levels.
Resilience seems to be impacted primarily by internal and micro-environmental factors. Consolidating levels of individual resilience of at-risk populations by acting on these factors could be the key to improving their mental health.
To explore patients’ perceptions of managing adverse events (AEs) from anticancer drugs for gynaecological cancer, focusing on AEs they want to avoid, views on dose adjustments and communication with healthcare professionals.
Observational study using a web-based questionnaire.
Women in Japan who had received chemotherapy for endometrial or ovarian/fallopian tube cancer were enrolled. Healthcare professionals, including obstetrics and gynaecology physicians, nurses and pharmacists, who administered chemotherapy to these patients, were also enrolled.
AEs that patients wished to avoid or found distressing; varied perceptions of AEs before and after treatment; discrepancies in the communication of AEs between patients and healthcare professionals; administration time and intervals between hospital visits patients found distressing; patient awareness of dose adjustment (reduction, interruption or discontinuation) to suppress AEs.
Participants comprised 153 physicians, 166 nurses, 154 pharmacists and 154 patients. Nausea/vomiting (28.6%), alopecia (18.2%) and peripheral neuropathy (9.1%) were the most distressing AEs overall. Physicians rated nausea/vomiting lower (15.4%) and alopecia higher (38.2%) than patients, while pharmacists emphasised peripheral neuropathy (25.7%). Many patients found AEs, including peripheral neuropathy (53/99), fatigue (52/105) and alopecia (46/120), to be more severe than expected. Communication patterns revealed that 49.4% of patients reported all symptoms, even uncertain ones, but younger patients tended to communicate fewer symptoms. Physicians (54.2%), nurses (92.2%) and pharmacists (85.7%) preferred full disclosure of symptoms. While 28.6% of patients wished to avoid dose reductions because of fears of disease progression, 18.2% preferred dose reduction or discontinuation when AEs became intolerable. Drug administration times and visit intervals influenced patient distress. Treatment administration of over 3 hours (19.5%) and visits occurring more frequently than once every 3 weeks (27.3%) were the most distressing.
This study highlights discrepancies in AE perceptions and communication between patients and healthcare professionals, emphasising the need for tailored communication strategies and shared decision-making to improve cancer treatment experiences and outcomes.
jRCT1040220088, Japan Registry of Clinical Trials (jRCT).
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.
Osteoporosis (OP) is a systemic skeletal disorder that increases fragility and susceptibility to fractures. Despite the availability of teriparatide for the treatment of patients with acute fractures with better efficacy, its long-term daily injection and high cost limit its broader use among a wider patient population, especially for those living in low- and middle-income countries. This study aims to evaluate the efficacy of a novel sequential treatment with teriparatide daily for 6 months followed by denosumab every 6 months for another 18 months, in comparison with denosumab monotherapy every 6 months for 24 months, in reducing the risk of fractures in patients with newly diagnosed osteoporotic fractures. The study will also explore the possible difference between two sequential treatments (shifting to denosumab treatment at 6 or 12 months) in their effect on increasing bone mineral density (BMD).
This study is designed as a multicentre, open-label, randomised controlled trial among 2478 patients with newly diagnosed osteoporotic fractures from 58 hospitals across China. Participants will be randomly assigned in a 10:10:1 ratio to three treatment groups: 24 months of denosumab monotherapy, early sequential treatment (teriparatide for 6 months followed by denosumab for 18 months) and late sequential treatment (teriparatide for 12 months followed by denosumab for 12 months). The primary outcome is the incidence of vertebral fractures over 24 months of treatment. Secondary outcomes include changes in BMD at the lumbar spine, total hip and femoral neck, changes in bone turnover markers (β-carboxy-terminal telopeptide of type 1 collagen and procollagen type 1 N-terminal propeptide), treatment adherence and cost-effectiveness. Follow-up assessments are scheduled at 3, 6, 9, 12, 18 and 24 months post-randomisation for primary and secondary outcomes, and biannually afterwards for the primary outcome.
The study protocol has been registered on ClinicalTrials.gov and has received ethical approval from the Peking Union Medical College Hospital Medical Science Research Ethics Committee (1-22PJ939). The findings will be disseminated through peer-reviewed scientific journals.
Peritoneal dialysis (PD) is a widely used renal replacement therapy for chronic kidney disease patients, yet malnutrition remains a common complication linked to poor outcomes. Nearly 40% of PD patients in China are malnourished, with serum albumin levels below 35 g/L. Amino acid-based peritoneal dialysis solutions (AA-PDS), which replace glucose with amino acids as the osmotic agent, have been used globally for decades to improve nutrition and reduce peritoneal damage, but they were introduced to mainland China only in 2022. This study aims to evaluate the efficacy and safety of AA-PDS in improving nutritional status and clinical outcomes among malnourished PD patients in mainland China, providing a potential new therapeutic option for this population.
This multicentre, open-label, prospective, parallel-controlled study will enrol patients with end-stage kidney disease who were stable on PD for more than 3 months. A total of 500 eligible patients will be divided into the intervention group undergoing PD once every morning using 2.0 L of amino acid (15) PD solution and the control group using conventional PD solution (lactate) in a 4:1 ratio based on their willingness and clinical needs. Our primary outcome is serum albumin, while other nutritional indicators, including serum prealbumin, serum transferrin, total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and ultrafiltration volumes are considered secondary outcomes. Information such as demographics, clinical and biochemical characteristics, examination indicators, anthropometry measurements and Subjective Global Assessment scores will be collected at baseline, 1 month, 3 month and 6 month follow-up. Statistical analysis will be conducted using SAS V.9.4 or higher versions. All statistical tests are conducted through the two-tailed test, and a p value≤0.05 will be considered statistically significant. The description of quantitative indicators will be used in calculating the number of cases, mean, SD, median and IQR method. The classification indicators will be used to describe the number of cases and percentages (frequency and frequency rate).
This multicentre study obtained ethical approval from the lead ethics committee at the First Affiliated Hospital of Zhejiang Chinese Medical University (approval no.: 2024-KLS-379-02). Additionally, each participating site provided local ethical approval or a formal waiver, as required by their institutional policies. The results will be reported in a peer-reviewed journal and a relevant academic conference.
ChiCTR2400090896.
Clinical research in emergency and critical care is vital, but recruitment and consent are complex. Research may be conducted without prior consent when patients are critically ill, and interventions are time critical. Some patients may die before research participation can be discussed with relatives, leaving the bereaved unaware of their involvement. This study explored potential communication strategies for informing bereaved relatives when a patient has died following enrolment into an emergency or critical care study without prior consent.
A mixed-methods study using a telephone survey and semi-structured interviews conducted simultaneously. The survey was conducted within a National Health Service Trust in North West England with relatives of deceased study participants. Semi-structured interviews were conducted with bereaved relatives and research and clinical staff across the UK, and medical examiner (ME)/ME officers based in England and Wales. Quantitative data were analysed descriptively, and qualitative data were analysed using reflexive thematic analysis. Data were synthesised using a constant comparison approach.
11 bereaved relatives completed the survey. 53 individuals (21 research and clinical staff, 18 relatives and 14 MEs/officers) participated in semi-structured interviews.
Although many trials do not include a process for notifying bereaved relatives about research participation, most relatives valued the opportunity to learn about their family member’s participation, emphasising the importance of transparency and trust. However, some raised concerns over the potential burden of automatic disclosure by the ME service. Offering bereaved relatives the option to receive sensitively worded information about research involvement at an appropriate time, soon after death, was recommended.
Bereaved relatives should have the choice to be informed about research participation without prior consent. Our findings support the need for transparent and sensitive communication and will contribute to future guidance for the design and conduct of adult emergency and critical care studies.
Acute pain following pulmonary surgery can affect the recovery process of patients. The use of intrathecal morphine (ITM) injections offers a long-lasting analgesic effect, but its clinical application remains controversial. This study aims to investigate the impact of combining bupivacaine with ITM injections on the quality of postoperative recovery in patients who have undergone pulmonary surgery.
This multicentre, randomised, double-blind, controlled trial will enrol 254 patients undergoing elective lung surgery, who will be randomly assigned in a 1:1 ratio to either group IT (receiving an intrathecal injection of 3 mg bupivacaine and 0.25 mg morphine before general anaesthesia induction) or the control group (C group). The primary outcome includes postoperative recovery quality on day 1 (quality of recovery, QoR-15), with secondary outcomes encompassing postoperative recovery quality on days 2 and 3 (QoR-15), pain scores within 72 hours postoperatively, analgesic rescue, intraoperative haemodynamic parameters, opioid consumption, postoperative adverse reactions, recovery metrics, complications, chronic pain incidence and sleep quality.
The results will be disseminated through peer-reviewed publications. This study protocol (V.2.0, 30 October 2024) involves human participants and has been approved by the Ethics Committee of Affiliated Hospital of Yangzhou University (number 2024-08-02-2), Taicang Hospital Affiliated to Soochow University (number 2025 SR-041) and Yichang Central People’s Hospital (number 2024-513-02). Each individual who agrees to participate in the research will provide written informed consent after the objectives and procedures of this study are explained to them.
ChiCTR2400092935. Registered on 26 November 2024.
Artificial intelligence (AI) is rapidly evolving, offering an expanding suite of capabilities that go beyond the traditional focus on prediction and classification. Generative AI (GenAI) and agentic AI could create transformative practices to support real-world evidence (RWE) generation for health research by streamlining studies, accelerating insights and improving decision-making. However, there is no published overview available describing the range of applications in RWE generation. This review aims to describe where and how genAI and agentic AI are applied across the domains of healthcare research tasks for RWE generation. Additionally, to map applications by tasks and methods across the product lifecycle continuum, and to identify emerging gaps and opportunities.
This Living Scoping Review (LSR) will include studies reporting an application and/or evaluation of genAI or agentic AI applied to one or more RWE generation research tasks. Searches will be conducted in Embase, MEDLINE and additional sources (eg, grey literature). Citations will be independently screened by two human senior reviewers for a substantive training dataset and a commercially available screening algorithm (Robot Screener) will complete screening with a human reviewer. The LSR will include reports of studies (primary or reviews) describing and/or evaluating the application of any genAI model for RWE generation in healthcare, in English, published from 1 January 2025 to the date of search. Data will be extracted from all studies included in the LSR by one independent senior reviewer using a piloted template, with 10% quality check by a second senior reviewer. Descriptive statistics will be used to summarise the applications of genAI per RWE research task, and the results of genAI evaluations. Thematic analysis will be used to describe genAI application patterns, trends, gaps and opportunities. The LSR protocol and reports will be updated annually, and findings will be published on a publicly available website (eg, ISPE—the International Society for Pharmacoepidemiology).
Ethical approval is not required due to use of previously published data. Planned dissemination includes peer-reviewed publication, presentation and short summaries.
Adults living with chronic conditions may need to access health programmes to mitigate health-related challenges that persist long after discharge from the hospital. Community physical activity programmes represent critical opportunities for health promotion and chronic disease self-management that can extend beyond hospital-based services. However, navigating the healthcare system and connecting to much-needed physical activity programmes can be challenging due to fragmentation of the health and social care system, especially for those who are transitioning between different healthcare providers, settings, stages of recovery and funding sources (eg, public, private). Patient navigation services can assist with this fragmentation by providing tailored support to individuals with chronic conditions. However, our understanding of patient navigation services in Canada is limited. This rapid review seeks to explore the landscape of patient navigation services supporting Canadians with chronic conditions in connecting to physical activity programmes in the community.
The rapid review will follow the recommendations published by Garritty et al in 2024. Integrated Knowledge Translation will be employed to facilitate meaningful engagement of people with lived experience of chronic conditions throughout the entire research process. Studies published in English that examine patient navigation services in physical activity for community-dwelling Canadians with chronic conditions will be included. Ovid MEDLINE, Embase, Emcare, CINAHL and Google Canada will be searched for articles published from 1990 to May 2025 to identify the characteristics, strengths and limitations, and prioritised features of patient navigation services for community physical activity programmes. The Mixed Methods Appraisal Tool will be used to assess the quality of included studies.
This protocol is a rapid review of published literature and does not require ethical approval. Review findings will be disseminated to various key interest groups through publications, presentations, infographics, social media posts and/or videos.
To investigate the associations of oxidative balance score (OBS) with all-cause mortality, cardiovascular mortality and cardiovascular disease (CVD) incidence in two large, population-based cohorts.
Cohort study and cross-sectional study were used.
The US National Health and Nutrition Examination Survey (NHANES) and the UK Biobank.
A total of 33 566 adults from NHANES (1998–2018) and 55 760 adults from the UK Biobank were included.
All-cause mortality, cardiovascular mortality and CVD. Mortality outcomes were ascertained through national death registries. Prevalent CVD was identified in NHANES through questionnaire, and incident CVD events were identified in the UK Biobank using linked hospital admission and death registry data.
Higher OBS was consistently associated with lower all-cause and cardiovascular mortality in both cohorts. In NHANES, participants in the highest OBS quartile (Q4) had a 39% lower risk of all-cause mortality (adjusted HR: 0.61, 95% CI 0.52 to 0.72) and a 45% lower risk of cardiovascular mortality (adjusted HR: 0.55, 95% CI 0.41 to 0.74) compared with those in Q1. Similarly, in the UK Biobank, Q4 was associated with an 18% lower risk of all-cause mortality (adjusted HR: 0.82, 95% CI 0.74 to 0.91) and a 41% lower risk of cardiovascular mortality (adjusted HR: 0.59, 95% CI 0.4 to 0.87). In NHANES, Q4 was associated with lower odds of prevalent CVD (adjusted OR: 0.56, 95% CI 0.46 to 0.67), whereas in the UK Biobank, Q4 was associated with a 19% lower risk of incident CVD during follow-up (adjusted HR: 0.81, 95% CI 0.74 to 0.9). Subgroup analyses in NHANES indicated heterogeneity by ethnicity and socioeconomic status, whereas associations in the UK Biobank followed an L-shaped pattern with a flattening of estimated risk at moderate OBS levels.
Higher OBS was associated with more favourable mortality and cardiovascular outcomes. These findings indicate that OBS is a composite indicator associated with cardiovascular health at the population level.
To estimate tuberculosis (TB) incidence trends in the high-altitude Xizang, China, and to explore the key intervention strategies on achieving the WHO 2030 TB control target.
We developed a susceptible–exposed–infectious–recovered transmission model using routinely reported TB surveillance data from 2004 to 2022. Scenario-based simulations were conducted to project future TB incidence under alternative intervention strategies. Model assumptions are as follows: (1) a stable population, (2) lifelong vaccine-induced immunity, (3) infectiousness of active TB cases, (4) relapse risk after recovery and (5) homogeneous mixing within the population.
Seven prefectures of Xizang Autonomous Region on the Tibetan Plateau, China.
An estimated population of approximately 3 million individuals residing in Xizang.
We assessed the epidemiological impact of four interventions implemented independently: increasing vaccine efficacy rate, reducing transmission rates of susceptible individuals, decreasing progression rate from latent TB infection to active disease and reducing relapse rate among successfully treated patients, compared with continuation of current control measures.
The estimated basic reproduction number (R0 ) for TB in Xizang was 0.39 (95% CI 0.21 to 0.71) in the absence of additional interventions, which was the highest among all regions of China. Model simulations indicated that all four evaluated interventions were each likely to reduce TB incidence, but only reducing the latent-to-active TB progression had a substantial effect. A 50% reduction in the progression rate was predicted to lower TB incidence from 66.56 (62.00–70.11) to 40.54 (37.15–43.77) cases per 100 000 population, meeting the WHO 2030 TB control target.
Targeted management of individuals with latent TB infection should be strengthened to substantially reduce TB transmission in high-altitude areas.
The mental health impacts of COVID-19 on frontline healthcare workers have been reported globally; however, there is limited evidence from low-income countries such as Ethiopia. We reviewed the literature to understand how COVID-19 impacted the mental health of frontline healthcare workers, including the associated risk and protective factors.
A scoping review of peer-reviewed research was conducted between 2020–2025 to explore the mental health and well-being of frontline healthcare workers in Ethiopia during COVID-19. The process adhered to the guidelines for data extraction outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Our search identified 35 studies, of which 29 studies were included in the final synthesis.
Three online databases, PubMed, Web of Science and PsycInfo, were systematically searched for data.
Studies were considered for inclusion in the review if they focused on mental health conditions and psychosocial well-being among healthcare workers during COVID-19 in Ethiopia. Studies were only included if published in English and excluded if they were conference abstracts, case studies, reviews, commentaries, contained incomplete data or lacked variables of interest.
Data extraction was conducted manually by two reviewers by using a data extraction sheet created in Excel.
Most frontline healthcare workers experienced symptoms of insomnia, psychological distress, stress, anxiety, post-traumatic stress disorder and depression during COVID-19. Female frontline healthcare workers, nurses, midwives and laboratory technicians reported higher rates of adverse mental health outcomes. Our results found that being married, living together with a spouse and having a high educational level were risk factors for adverse mental health outcomes.
The mental health and well-being of frontline healthcare workers is at risk during a global health crisis; however, there is a limited understanding of how to protect the mental health of frontline healthcare workers in low-income countries, such as Ethiopia, at such a critical time. Additional research is needed to better inform mental health preparedness interventions for frontline healthcare workers in these contexts, particularly given predictions of another pandemic occurring within the next decade.
The use of bone-anchored prostheses (BAPs) has greatly increased quality of life for lower limb amputees. However, the long-term frequency of skeletal fractures and the need for arthroplasty surgery in the lower extremities following BAP use is scarce.
The current study aimed to investigate the frequency of fractures and arthroplasties in the lower limb after BAP surgery with the Osseointegrated Prosthesis for the Rehabilitation of Amputees (OPRA) system.
Retrospective cohort study using the OPRA database and medical record review for data collection.
A single-centre study at a tertiary hospital.
All patients with a transfemoral BAP (OPRA system) who underwent surgery between 1999 and 2019, and had completed at least 2 years of follow-up were included in the study. Patients with bilateral transfemoral amputations were excluded. A total of 100 patients were included.
The primary outcome measure was to identify patients who had a fracture or had undergone arthroplasty surgery in the lower extremities after BAP surgery.
Of the 100 patients included, 16 patients (16%) had an event in their lower limb. 11 patients (11%) had a fracture, all of the femur, and six patients (6%) underwent arthroplasty surgery due to osteoarthritis. Long-term prosthetic use was not affected by the occurrence of an event.
Patients with BAP may be at a higher risk for femur fractures and arthroplasty surgery than the general population. Although encouraging that prosthetic usage is not affected after a fracture or arthroplasty surgery, prospective studies on larger cohorts and control groups need to be conducted.