Conectar
Risk screening for pre-eclampsia relies on accurate gestational age assessment, but routine access to ultrasound-based gestational dating remains challenging in many low- and middle-income countries. As part of the formative work for the ‘Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening’ (PEARLS) platform, we aim to validate and implement an artificial intelligence (AI)-based algorithm for estimation of gestational age, using blind sweeps done with a handheld ultrasound device. This study protocol outlines the accuracy cohort for AI-based gestational age estimation in participating facilities in Ghana, Kenya and South Africa.
This multicountry prospective cohort study will recruit 969 pregnant women at 13 health facilities across Kenya, Ghana and South Africa. The eligible population is pregnant women presenting for antenatal visits from 11+0 to 13+6 weeks’ gestation. Eligible women will have a gestational age assessment by a trained sonographer using fetal biometry (reference standard), followed by gestational age estimation conducted by a trained midwife using the AI-based Intelligent Ultrasound ScanNav FetalCheck system (experimental). Both conventional and AI-based gestational age scans will be conducted with the General Electric VScan Air platform. Women will return for a second visit between 14+0 and 27+6 weeks’ gestation (week of visit is randomly selected) for an assessment with both conventional and AI-based ultrasound. The primary objective is to determine the accuracy and precision of gestational age estimation using an AI ultrasound system in first and second trimesters, as compared with gestational age estimation using crown-rump length measurement by conventional ultrasound in first trimester (11+0 to 13+6 weeks’).
This study has received or sought ethics approval from the following entities: Australia: University of Melbourne, Office of Research Ethics and Integrity (Reference Number: 2024–28489-49438-3) and the Alfred Hospital Ethics Committee (Reference: Project 727/23); Ghana: Ghana Health Service Ethics Review Committee (GHS-ERC Number 002/01/24); Kenya: Kenyatta National Hospital, University of Nairobi ERC (Ref: KNH-ERC/01/MISC/20); South Africa: University of Cape Town, Faculty of Health Science, Human Research Ethics Committee (HREC Ref: 138/2024). Key findings will be disseminated to research teams to inform future scale-up of AI-based pregnancy dating and pre-eclampsia risk screening. Findings from this pilot work will be published in peer-reviewed open-access journals, conferences and meetings to maximise reach of our findings.
This study assessed the feasibility of both the delivery and evaluation of ‘enhanced’ (behaviourally informed) text message reminders containing links to existing co-designed resources supporting decision-making for people with severe mental illness (SMI) regarding attendance of cervical screening.
A pilot randomised controlled trial (RCT).
13 General Practice (GP) practices in London were recruited.
GP practices identified people with SMI aged 24–64 years who were overdue cervical screening. Target sample size was 120 participants (60 per arm) based on existing guidance for pilot trials.
In March 2025, participants were randomised (1:1) to receive either the enhanced (intervention) or the standard (control) SMS reminder.
18 weeks later, feasibility outcomes were collected (primary outcomes) and data analysis for a definitive RCT was rehearsed (secondary outcome).
Of the 150 participants across 13 GP practices that were randomised (n=75 per arm), 132 (88%) texts delivered (intervention n=64/75 (85%), control n=68/75 (91%)). 10 practices (76.9%) provided follow-up data for 102 participants (intervention n=50, control n=52). Five participants (intervention n=4, control n=1) attended screening within the trial period. Participant survey response rate was low (9/132 (7%), intervention n=5, control n=4). Both SMS messages were low cost, with the intervention SMS a 50% higher cost to deliver (7.5p vs 5p per SMS). Primary feasibility measures of recruitment rate of GP practices (27%), retention of GP practices (77%) and participants (100%), SMS delivery (88%) and data completeness (64%) indicated viability, although survey response rate (7%) did not.
Achieving adequate recruitment and retention, data completeness and comparable groups is viable with some amendments, although an alternative method is required to assess fidelity. Behaviourally informed SMS reminders are feasible to deliver to people with SMI, although it is uncertain if the extra resources are accessed and used. With changes to data collection, a definitive trial could be feasible. Given the low observed cervical screening attendance, additional intervention is needed for this group.
To synthesise existing evidence concerning the application of AI methods in detecting depression through behavioural cues among adults in healthcare and community settings.
This is a diagnostic accuracy systematic review.
This review included studies examining different AI methods in detecting depression among adults. Two independent reviewers screened, appraised and extracted data. Data were analysed by meta-analysis, narrative synthesis and subgroup analysis.
Published studies and grey literature were sought in 11 electronic databases. Hand search was conducted on reference lists and two journals.
In total, 30 studies were included in this review. Twenty of which demonstrated that AI models had the potential to detect depression. Speech and facial expression showed better sensitivity, reflecting the ability to detect people with depression. Text and movement had better specificity, indicating the ability to rule out non-depressed individuals. Heterogeneity was initially high. Less heterogeneity was observed within each modality subgroup.
This is the first systematic review examining AI models in detecting depression using all four behavioural cues: speech, texts, movement and facial expressions.
A collaborative effort among healthcare professionals can be initiated to develop an AI-assisted depression detection system in general healthcare or community settings.
It is challenging for general healthcare professionals to detect depressive symptoms among people in non-psychiatric settings. Our findings suggested the need for objective screening tools, such as an AI-assisted system, for screening depression. Therefore, people could receive accurate diagnosis and proper treatments for depression.
This review followed the PRISMA checklist.
No patients or public contribution.
To examine the feasibility of using a large language model (LLM) as a screening tool during structured literature reviews to facilitate evidence-based practice.
A proof-of-concept study.
This paper outlines an innovative method of abstract screening using ChatGPT and computer coding for large scale, effective and efficient abstract screening. The authors, new to ChatGPT and computer coding, used online education and ChatGPT to upskill. The method was empirically tested using 400 abstracts relating to public involvement in nursing education from four different databases (CINAHL, Scopus, ERIC and MEDLINE), using four versions of ChatGPT. Results were compared with a human nursing researcher and reported using the CONSORT 2010 extension for pilot and feasibility trials checklist.
ChatGPT-3.5 Turbo was most effective for rapid screening and had a broad inclusionary approach with a false-negative rate lower than the human researcher. More recent versions of ChatGPT-4, 4 Turbo, and 4 omni were less effective and had a higher number of false negatives compared to ChatGPT-3.5 Turbo and the human researcher. These more recent versions of ChatGPT did not appear to appreciate the nuance and complexities of concepts that underpin nursing practice.
LLMs can be useful in reducing the time nurses spend screening research abstracts without compromising on literature review quality, indicating the potential for expedited synthesis of research evidence to bridge the research–practice gap. However, the benefits of using LLMs can only be realised if nurses actively engage with LLMs, explore LLMs' capabilities to address complex nursing issues, and report on their findings.
Nurses need to engage with LLMs to explore their capabilities and suitability for nursing purposes.
No patient or public contribution.
Hospital-at-home (HaH) is becoming more widely available to children with cancer, providing care in a familiar environment while upholding medical safety and quality. Little is known, however, about how these children experience their parents' caregiving in the context of HaH, how they perceive and interpret parental roles, what they require in daily care, and how they communicate these needs.
Seven children aged 7 to 12 years undergoing home-based cancer treatment were interviewed using interpretative phenomenological analysis (IPA). These interviews, conducted via telephone, were open-ended and exploratory, allowing the children to express their experiences freely.
One major theme—‘the child's voice’—emerged, encompassing two interrelated sub-themes: (1) parental presence as a condition of care; and (2) the strategies children use to express their voice. Parental presence was described as essential for emotional security, predictability and meaning, serving as both a psychological anchor and a temporal organiser in the child's daily life. The children expressed their voice through multiple forms—verbal, gestural, symptom-focused or silent—revealing their active participation in care and their capacity to preserve relational and emotional continuity within the family setting.
Children with cancer perceive HaH as more than a transfer of hospital treatment; they experience it as a shared relational experience built on parental presence and mutual understanding. Recognising and supporting the child's voice in its various forms is vital for ensuring that HaH becomes not only a site for medical care but also a meaningful space for living.
Our findings highlight the need for healthcare teams to take into account the variety of children's voices and grant them a real place in HaH. They are not simply recipients of care, but also active participants in the care relationship, capable of expressing their needs, emotions, and expectations in their own way.
No patient or public contribution.
Colorectal cancer patients with peritoneal metastases have a very poor prognosis. A minority of these patients is eligible for curative cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The peritoneal cancer index (PCI) is an important criterion to select patients for CRS-HIPEC. Due to challenges in peritoneal metastasis detection by imaging, the PCI is currently routinely assessed by invasive diagnostic laparoscopy in addition to CT and/or MRI. Yet, open-close procedures and early disease recurrence following CRS-HIPEC are common, indicating the need for better patient selection tools. Fibroblast activation protein (FAP)-targeted imaging has recently emerged as a promising strategy for visualising peritoneal disease. The aim of this study is to assess the potential value of FAP inhibitor positron emission tomography/CT (FAPI-PET/CT) as an alternative non-invasive tool for quantitative PCI assessment.
TROMPET is a prospective observational proof-of-concept study. A total of 25 colorectal cancer patients with suspected or verified peritoneal metastases who are eligible for CRS-HIPEC based on MRI will be included in this study. Patients younger than 18, pregnant and/or breastfeeding, with any contraindication(s) for MRI, PET, CT and/or CRS-HIPEC, and/or with a known additional malignancy within the past five years are excluded. Participants will receive [18F]AlF-FAPI-74 PET/CT prior to surgery. The primary objective is to determine the correlation between PCI scores determined by FAPI-PET/CT and ‘true’ PCI scores determined by histopathological analysis of all resected lesions. The secondary objectives include the correlations between PCI scores determined by FAPI-PET/CT, by MRI and during surgery, the potential of FAPI-PET/CT to detect extraperitoneal metastases, and molecular and immunohistochemical analysis of resected tissue to provide insight into the nature of FAPI-PET-positive lesions. The primary endpoint is all PCI scores determined by FAPI-PET and histopathology and their correlation on patient level. If this study shows that the PCI score can be accurately determined preoperatively by FAPI-PET/CT, it will form the basis for further developing FAPI-PET/CT as a quantitative, standardised, non-invasive diagnostic tool for selecting patients for CRS-HIPEC. Moreover, the ‘radiology-pathology’ setup of the study will allow us to characterise FAPI-PET-positive and PET-negative lesions in detail, providing further insight into the strengths and potential pitfalls of FAPI-PET/CT in the detection of peritoneal metastases from colorectal cancer.
This study is approved by the assigned Medical-Research-Ethics-Committee (METC NedMec) on 19-08-2024. All participants will provide written informed consent. Study results will be disseminated through (inter)national meetings and peer-reviewed publications.
2024-512301-16-01
The Veterans Affairs (VA) Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act expanded eligibility for community-based care particularly for Veterans facing geographic or capacity-related barriers. Patients with diabetic foot ulcers (DFU) require timely specialty management and are vulnerable to fragmented care, yet little is known about how the MISSION Act reshaped patterns of DFU-related specialty care within and outside the VA. We conducted a retrospective cohort study of Veterans aged 65 or older with a new DFU diagnosis in VA between 2016 and 2022. We identified DFU-related specialty encounters (podiatry, vascular surgery, infectious diseases and endocrinology) and categorised community encounters as VA-paid or Medicare-paid. We assessed annual trends in community specialty care and changes in the proportion and payer type of care before and after the MISSION Act. Among 76 398 patients, VA-paid community specialty care increased substantially following the MISSION Act, with larger relative growth among rural Veterans (rural: +119%; urban: +96%). In contrast, Medicare-paid DFU specialty care declined during the same period (rural: −12%; urban: −13%). Following the MISSION Act, reliance on VA-paid community specialty care increased markedly for Veterans with DFU, particularly in rural areas, while reliance on Medicare-paid care decreased.
Chronic back pain (CBP), defined as back pain persisting for more than 3 months, is highly prevalent and associated with substantial socioeconomic burden and impaired quality of life. Pain catastrophising is an important cognitive-affective factor in the maintenance of CBP and may fluctuate in daily life. Conventional treatment approaches often do not address these momentary dynamics. Just-in-time adaptive interventions (JITAIs) deliver tailored support at opportune moments based on time-varying information and may therefore complement existing treatments for CBP. In this study, ecological momentary assessment (EMA) is used to capture momentary pain-related states and guide the delivery of adaptive microinterventions. To our knowledge, no JITAI specifically targeting pain catastrophising in CBP has yet been evaluated in a randomised controlled trial.
This pragmatic, two-arm randomised controlled trial will compare a JITAI with enhanced treatment as usual (TAU+). A total of 100 participants will be recruited to obtain an evaluable sample of 86 participants. Eligible participants are adults with CBP persisting for more than 3 months and an average pain intensity over the previous week of at least 3 on a 0–10 Numerical Rating Scale. Participants in the intervention group will receive app-based, adaptive microinterventions, such as relaxation exercises and physical activities triggered by EMA responses on pain catastrophising and pain intensity. Participants in the TAU+ group complete the same EMA assessments but will not receive adaptive micro-interventions. The primary outcome is reduction in pain catastrophising, assessed with the Pain Catastrophizing Scale. Secondary outcomes include pain intensity, pain interference, pain behaviour, pain quality, physical functioning, anxiety, depression, fatigue, sleep disturbance, social participation, fear-avoidance beliefs, pain-related self-efficacy and treatment satisfaction. Primary and secondary outcomes will be analysed using between-group comparisons according to the intention-to-treat principle. Exploratory analyses will examine proximal, short-term effects of microinterventions using dynamic structural equation modelling. Assessments will be conducted at baseline before randomisation (T0), mid-treatment 2 weeks after intervention start (T1), end of treatment 4 weeks after intervention start (T2) and at 3 months (T3) and 6 months (T4) after end of treatment.
This study has been approved by the Ethics Committee of the Charité Universitätsmedizin Berlin (approval number: EA4/207/21, 18 October 2021). Results will be submitted for publication in peer-reviewed journals and presented at conferences.
DRKS00028494.
To describe all nursing home staff members' confidence in engaging in complex clinical communication with residents and family carers, and to explore factors affecting their attitudes.
A convergent mixed-methods study used questionnaires (n = 288) and 15 group-based discussions involving 278 professionals across nine nursing homes between April and May 2025. Quantitative data were analysed descriptively, and qualitative data underwent inductive thematic analysis. Findings from the two strands were compared and integrated to develop mixed-methods inferences, with qualitative data given priority to confirm, expand or contrast the survey results.
Staff members reported limited confidence in sustaining complex clinical communication, mainly because of uncertainty in responding to family carers' questions, difficulty managing emotional reactions, lack of training and unclear role responsibility. Qualitative findings identified barriers at the facility (chronic understaffing, limited physician presence, structural limitations), team (hierarchical asymmetries, limited information sharing, intraprofessional conflicts) and resident/family levels (sensory/cognitive impairments, unrealistic expectations, distrust, role confusion, intra-family conflict). Integrated findings showed convergent and divergent patterns. Qualitative data added information on communicative and relational challenges with residents/families, understaffing-driven system barriers and structural limitations. Questionnaires suggested good leadership relationship and group cohesiveness, but group discussions revealed interprofessional and intraprofessional conflicts.
Limited confidence in complex clinical communication was linked to interacting barriers at the organizational, team and resident/family levels. Effective improvement requires combining education that builds communication skills and strategies for emotionally intense conversation, protected time and spaces, team and organizational initiatives that strengthen wellbeing and collaboration, and strategies that support residents' involvement, foster family trust, and reduce unrealistic expectations and role confusion.
Findings highlight the factors that undermine professionals' confidence in sustaining complex clinical communication in nursing homes, and offer targets that policymakers, nursing home managers and educators should consider to strengthen staff-resident/family interactions.
Mixed methods reporting checklist.
None.
by Yaniga Swaengdee, Sararas Khongwirotphan, Jaravee Lasode, Phakakarn Kuecharoen, Phathayphout Phetvilay, Thitithep Limvorapitak, Anapat Sanpavat, Sira Sriswasdi, Piyaporn Boonsirikamchai, Yothin Rakvongthai
ObjectiveAccurately assessing residual disease after neoadjuvant chemoradiotherapy (nCRT) in locally advanced rectal cancer (LARC) remains challenging. Residual extramural venous invasion (EMVI) and perirectal lymph node (PLN) metastasis indicate adverse outcomes, but treatment-related changes obscure their detection on post-treatment MRI. This study developed MRI-based radiomics models to predict residual EMVI and PLN metastasis using post-nCRT restaging MRI.
Materials and methodsIn this retrospective study, 219 patients with LARC who completed nCRT and underwent post-treatment MRI for restaging prior to surgery were included. Radiomic features were extracted from manually segmented regions of interest encompassing the primary tumor and mesorectal fat on high-resolution T2-weighted images using PyRadiomics. Logistic regression (LR), support vector machine (SVM), and random forest (RF) models were developed to predict pathological EMVI and PLN status. Model performance was assessed using repeated 5-fold cross-validation, with the area under the receiver operating characteristic curve (AUC) as the primary evaluation metric. Differences in model performance were compared using DeLong test.
ResultsFor EMVI prediction, the combined tumor and mesorectal fat radiomics model achieved the highest AUC of 0.797 ± 0.073 using the LR model. For PLN prediction, the combined model also demonstrated superior performance, achieving an AUC of 0.824 ± 0.073. Models incorporating both tumor and mesorectal fat features consistently outperformed single-region models.
ConclusionMRI-based radiomics models using post-nCRT restaging images could predict residual EMVI and PLN metastasis in LARC. Incorporating mesorectal fat features improved model performance, suggesting that information from the surrounding mesorectal compartment may be useful for post-treatment risk assessment.
PREVENT 1 is a nationwide, prospective Swedish infant cohort established to characterise gut microbiome development during the first 2 years of life and to relate microbial trajectories to feeding, infections, growth and everyday well-being. The study integrates repeated infant stool sampling with shotgun metagenomics analysis with aligned parental questionnaires, stool photographs and infant cry recordings collected at three approximately 3-month intervals for each infant.
Families were recruited nationwide in Sweden from September 2023 through targeted digital channels. Eligible participants were term-born infants residing in Sweden and aged
Retention was high, with 248 families completing at least one follow-up questionnaire at Phase 2 and 243 at Phase 3. For stool samples, 250 infants provided at least two samples and 241 provided all three. At enrolment, 42.3% of infants were older than 7 months, 73.9% had weight-for-length z-scores in the normal range and exclusive breastfeeding at 4 months was reported for 58.9%.
Three-phase sample and questionnaire data collection was completed in December 2024. Future analyses will examine microbiome features, resistome profiles and functional pathways in relation to antibiotic exposure, feeding, growth and infant health outcomes. Subject to ethical approval and participant consent, follow-up may include further stool collection and Swedish register linkage.
Home care services face increasing challenges driven by population ageing, ageing-in-place policies, growing complexity of care needs among home care recipients and shortages of qualified personnel. These developments underscore the need to better use the available workforce and its competencies. Workforce composition refers to the skill mix and organisational structures of home care services, including professional backgrounds, team configurations and work scheduling practices. Competence utilisation refers to how effectively health personnel apply their skills and qualifications in service delivery. This scoping review aims to map existing knowledge on how workforce composition and professional skill sets influence (1) the organisation of tasks, roles and responsibilities and (2) competence utilisation in home care services. By examining the relationship between workforce organisation and competence use, the review seeks to identify factors that support or constrain the optimal use of workforce competence in home care services.
This scoping review will be conducted according to the Arksey and O’Malley methodological framework as refined by Levac. The review process will be guided by the Joanna Briggs Institute methodology for scoping reviews. The review has been conducted between April and August 2026. The literature search will be conducted on MEDLINE, EBSCOhost CINAHL, Scopus, ProQuest and Embase to include peer-reviewed primary research studies published in scientific journals. The search will also be supplemented by Google Scholar to identify additional and grey literature in order to improve search coverage. The search strategy has been developed with support from an experienced university librarian. Using the Population–Concept–Context (PCC) framework, inclusion criteria are: (1) employees in home care services, (2) workforce organisation and competence utilisation and (3) municipal or district-based home care services. Exclusion criteria are: (1) volunteers or staff without care responsibilities, (2) studies focusing only on patient outcomes without addressing competence or workforce structure and (3) institutional or hospital-based settings. An online platform will be used to share search results and perform record screenings by two reviewers independently to enhance accuracy and reliability. Data from included sources will be charted and synthesised narratively, supported by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews flow diagram (PRISMA-ScR).
The scoping review will not require ethics approval, as all data will be obtained from publicly available literature. The review authors will adhere to principles of honesty and transparency throughout the data extraction and reporting processes and enhance the trustworthiness of the synthesised findings. Findings will be submitted for publication in a peer-reviewed journal and disseminated through presentations at relevant conferences.
To examine the association between institutional reporting and support structures and the reporting behaviour, perceived support and satisfaction with the handling of sexual harassment among medical students in Germany.
Cross-sectional multi-method study combining a nationwide student survey with a structured survey of medical school deaneries and a structured documentary analysis of publicly available institutional information.
All medical faculties offering a full undergraduate medical curriculum in Germany.
A total of 5681 medical students from 44 faculties participated in an anonymous online survey (77.8% women). Additionally, 34 of 42 medical faculties (81.0%) responded to a structured questionnaire regarding institutional support and reporting structures. Publicly accessible documents and faculty websites were analysed using a structured documentary analysis.
Primary outcomes included (1) availability and visibility of reporting structures, (2) reporting of sexual harassment and (3) satisfaction with the reporting process. Secondary outcomes included perceived accessibility of reporting pathways, awareness of support structures, psychosocial support and perceived institutional consequences. Associations between student-reported outcomes, deanery responses and institutional characteristics were examined using multiple logistic and linear regression analyses.
Most medical faculties (88.2%) indicated the presence of a dedicated advisory service for medical students. However, only a minority provided online reporting forms (29.4%) or chat-based options (8.8%). Institutional guidelines were available at almost all (97.6%) faculties. 44.2% of students reported having experienced sexual harassment during medical training, but only 12.7% of affected students reported an incident. Nearly half of the affected students (48.5%) indicated that they did not know where or how to report. Reporting behaviour was strongly associated with the perceived psychological burden (OR 3.48; 95% CI 1.67 to 7.27), and secondarily with prior non-medical vocational experience or later stage of study. Satisfaction with the reporting process and willingness to report again in the future were positively associated with perceived consequences (β=0.49; p
Most medical faculties provide counselling and reporting services, yet students, particularly those affected, often do not perceive them as visible, accessible or effective. We propose four additional strategies for medical faculties: (1) Awareness and Competence-Building, (2) Visibility and Active Communication, (3) Psychosocial Support as a Core Function and (4) Transparent Processes and Feedback. Transparent processes, clear communication of consequences and accessible psychosocial support are key to increasing trust and reporting willingness. Faculties should therefore ensure low-threshold access to advisory services, actively communicate reporting pathways, raise awareness and systematically monitor the effectiveness of institutional responses. Future research should evaluate whether implementing and strengthening these measures improves student satisfaction, institutional trust and ultimately contributes to reducing sexual harassment in medical education.
Cardiovascular disease is a leading cause of death worldwide, of which coronary artery disease is the most common form. Sudden cardiac death (SCD) is a serious complication following acute myocardial infarction (MI), accounting for the highest percentage of all deaths in this population. Currently implantable cardioverter-defibrillators (ICDs) provide an acceptable method of primary prevention of SCD. However, the current literature is heterogeneous with regard to studies evaluating the benefits of ICDs for the primary prevention of SCD after MI, particularly relating to the timing of ICD implantation, risk stratification of patients for ICD implant selection and reporting non-rhythmic deaths after ICD implantation.
A meta-analysis will be performed to estimate the pooled effect size of randomised controlled trials (RCTs) examining the relationship between prophylactic transvenous ICD (TV-ICD) implantation and other medical therapies for primary prevention of SCD after MI. A comprehensive literature search and review will be performed using electronic medical databases including Scopus, Ovid MEDLINE, EMBASE (Ovid Platform), Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, ProQuest (Health and Medicine) and CINAHL (EBSCO) from January 1980 to June 2025. The literature search will be limited to peer-reviewed original studies carried out in human subjects and published in English. Type of study design will be limited to RCTs. The systematic review and meta-analysis will be developed according to the Joanna Briggs Institute Manual for Evidence Synthesis (2024 edition) and conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020 guidelines. Data analysis will be performed according to a structured and predetermined analysis plan. The primary outcome of the study will be all-cause-mortality, for which Hazard Ratios (HRs) will be reported as a measure of effect with 95% CI. Based on data availability, subgroup analysis will be carried out. The effect sizes will be reported based on a random effects model.
This systematic review and meta-analysis will evaluate and provide primary evidence for the effectiveness of prophylactic implantation of TV-ICDs on all-cause mortality in patients who experienced MI, aiming for primary prevention of SCD after MI. The primary prevention of SCD after MI is an important goal to reduce community incidence of out-of-hospital cardiac arrests, improving patient survival rates and their quality of life after MI. Out-of-hospital cardiac arrests currently have a survival rate of less than 10% and could result in long-lasting neurological damage in those who survive.
CRD42023456995.
Language development is a key determinant of academic achievement and psychosocial outcome. Due to the therapeutic hypothermia procedure, 75% of children diagnosed with moderate to severe neonatal encephalopathy (E) survive without serious neurological sequelae. Several studies have already revealed the overall cognitive deficits of these infants; however, their long-term language developmental specificities and their attendant neonatal risk markers remain under-investigated.
In our single-centre prospective cohort study (n128), we will include only those children with perinatal asphyxia who meet the stepwise criteria of the Total Body Hypothermia (TOBY) study and who survive NE without functional motor deficits and moderate/severe overall cognitive deficits at the second-year follow-up examination. The NE survivors included and cared for in the Level III Neonatal Intensive Care Unit of the Pediatric Center, Semmelweis University, Budapest, Hungary, were born between 2017 and 2022. Clinical, laboratory, electrographic and neuroimaging data will be extracted from their medical records and will be evaluated retrospectively. Patients will be followed up to assess overall cognitive and language development between 4 and 8 years. The association between neonatal biomarkers and developmental language disorder (DLD) will be analysed with binary logistic regression models. Machine learning techniques will be used to develop predictive models for DLD. For modelling the longitudinal changes between early (2 years) and later (4–8 years) cognitive and language status, mixed effects models will be applied.
The protocol was approved by the National Centre for Public Health and Pharmacy (NNGYK/24844-9/2025) on 21 May 2025. Results of this study will be disseminated through multiple channels. We will publish the findings in international peer-reviewed scientific journals and present them at national and international conferences.
Language and communication difficulties are common across a range of dementias including primary progressive aphasia (PPA). Better Conversations with PPA (BCPPA) is a co-designed communication partner training intervention that aims to improve the experience of conversations for a person with communication difficulties. An NHS-based pilot study of face-to-face BCPPA demonstrated positive outcomes but also raised questions about when and where this intervention should be delivered (at diagnosis or later; face to face and/or remotely), how to best measure the effectiveness of the intervention in line with participant’s priorities and whether BCPPA might be acceptable and useful to people with a range of dementia types. We also had questions about the possible economic implications of BCPPA. In preparation for a future full effectiveness study, the present study will address the following questions:
What is the optimal schedule and dosage of BCPPA versus treatment as usual?
What are the eligibility criteria for the BCPPA intervention? Is remote delivery of BCPPA acceptable to people with PPA and other dementias? Can the BCPPA be delivered remotely as intended? Do planned outcome measures show sensitivity to change pre-/post-/3 months post BCPPA? What are the barriers and facilitators to implementation of BCPPA in an NHS setting? What is the most appropriate perspective of analysis and way of measuring costs and outcomes in a future cost-effectiveness analysis of BCPPA versus usual care?
In line with Medical Research Council guidance on development and management of complex interventions, Skivington et al, 2021 this protocol paper describes a phase II mixed-methods process evaluation and health economic study. This protocol for a randomised controlled pilot feasibility study compares the BCPPA communication partner training intervention with a deferred entry group for people with PPA and other rare dementias and their communication partners. Participants will be recruited at diagnosis and review appointments from two NHS trusts. Participants who have completed a repeated baseline measure will be randomised to either the BCPPA intervention or a deferred entry group. The intervention will be delivered remotely, via teletherapy, over 4–6 weeks depending on goal achievement. The deferred entry group will receive the intervention after a 6-week waiting period, and all participants will be assessed immediately post intervention and again at 3 months post intervention. Outcome measures have been selected in line with the current recommendations for a core outcome set for PPA and to address questions of implementation and health economic evaluation. Qualitative and quantitative analysis methods will be used to explore the data.
Ethical approval for this study was granted by the Health Research Authority for England and Wales IRAS (Project ID: 341322 REC REF 24-NI-0123). Results from this study will be published in peer-reviewed journal articles and shared with participants and patient and public involvement advisors in accessible formats.
Atrial fibrillation (AF), a common arrhythmia, is associated with impaired quality of life and increased stroke risk and mortality. Clinical guidelines recommend leveraging digital technologies to support patient education and AF self-management. Conversational artificial intelligence (AI) technologies may support patient engagement with self-management by enabling human-like conversations. This study aims to evaluate the effectiveness of a conversational AI intervention (Conversational artificial intelligence HeAlth supporT in Atrial Fibrillation Self-Management (CHAT-AF-S)) in improving quality of life in patients with AF.
CHAT-AF-S is a 3-month randomised controlled trial with 1:1 allocation and embedded process evaluation. We will randomise 480 adults (aged 18 years and older) with documented AF to the CHAT-AF-S intervention or usual care. Primary outcome is the Atrial Fibrillation Effect on QualiTy-of-life overall score. We will follow the intention-to-treat principles and data analysts will be blinded. Intervention participants will be invited to complete a user experience survey and take part in an interview to explore the feasibility, acceptability, perceived use and barriers and enablers to implementing the intervention. Qualitative data will be analysed thematically.
Ethics approval was obtained from the Western Sydney Local Health District Human Ethics Research Committee (2023/ETH00765). Written and informed consent will be obtained from all study participants before commencing any study procedures. Results will be disseminated via peer-reviewed publications and presentations at international conferences.
Australian New Zealand Clinical Trials Registry (registration number: ACTRN12623000850673).
Cancer is the most common cause of disease-related mortality in children, highlighting the urgent need for improved care in this population. It is estimated that >15% of children diagnosed with cancer harbour a germline pathogenic variant in a cancer predisposition gene which confers an increased risk to develop cancer. There are over 100 genes associated with cancer predisposition syndromes (CPSs) and greater availability and acceptability of genetic testing in the last decade has facilitated their recognition in childhood. However, individually, each of these CPSs is rare, impeding robust research and advancement of clinical care. Once a specific CPS is diagnosed, current recommendations for clinical care are based primarily on expert consensus with a ’one size fits all’ approach to management. Detailed knowledge of genotype-phenotype associations and the impact of genetic modifiers is lacking, and due to strong ascertainment bias of children already diagnosed with cancer predominantly being tested for a CPS, the true cancer risk is likely overestimated.
The Childhood Cancer Predisposition Study (CCPS) is a multi-centre registry and biorepository for children and adolescents aged 0–21 years with a clinical or molecularly confirmed CPS and their family members (NCT04511806). The study objectives are to characterise the natural history of each CPS, correlate the natural history phenotype with CPS genotype, evaluate the efficacy of standard surveillance strategies and allow future investigation into the feasibility and effectiveness of novel surveillance strategies. The principal study question is whether adherence to recommended tumour surveillance guidelines is associated with earlier detection of tumours and/or improved survival. We will also address what barriers exist that prevent adherence to surveillance guidelines. Data collected from primary subjects includes detail about the CPS, genomic data, cancer history and family cancer history, as well as information about tumour surveillance. Required biospecimen collection includes germline DNA samples, with optional collection of serial blood and stool samples. Planned enrolment is 1050 primary subjects.
CCPS was reviewed and approved by a central IRB (WCG IRB 2020P002450) and the Research Ethics Board at The Hospital for Sick Children in Toronto (1000072286). Written informed consent is obtained from all participants. Data and specimens are available to qualified investigators by request to address specific research questions through a standardised research application process. In addition, de-identified data are available through the Pediatric Cancer Data Commons for exploration. Analysed data will be disseminated in peer-reviewed publications and at conferences including meetings inclusive of patient and family advocacy groups.
FreshRSS 