We investigated symptoms reported before and after heart failure (HF) diagnosis and their associations with 3-month hospitalisation and mortality.

To examine associations between symptoms recorded in primary care and short-term hospitalisation and mortality in HF patients.

Landmark analysis using Royston-Parmar survival models at baseline (diagnosis), 6 and 12 months post-diagnosis.

Primary care database (Clinical Practice Research Datalink) linked to hospital and mortality data (1998–2020).

Adults (>40 years) with a first HF diagnosis.

Shortness of breath, ankle swelling, oedema, fatigue, chest pain, depression and anxiety in the 3 months before diagnosis and at 6 and 12 months.

3-month all-cause hospitalisation and mortality; secondary outcomes included HF and non-cardiovascular hospitalisation.

Among 86 882 HF patients (62 742 and 54 555 surviving to 6 and 12 months, respectively), the magnitude of symptom risk varied by timepoint. Specifically, the symptoms with the strongest associations with adverse outcomes were: depression for all-cause hospitalisation at diagnosis (HR: 1.26; 95% CI 1.15 to 1.39) and 6 months (1.46; 1.25 to 1.70); ankle swelling for mortality (1.49; 1.14 to 1.94) at 6 months and SOB for HF hospitalisation (1.18; 1.12 to 1.26) at diagnosis and 12 months (1.99; 1.68 to 2.35).

Symptoms persisted and were more prominent at 6 and 12 months post-diagnosis than at diagnosis.

The objective of this study is to co-produce a care bundle for women with multiple long-term health conditions (MLTC) that could be pilot tested and implemented in UK maternity services.

Online co-production workshops each attended by 20–30 key interest holders.

United Kingdom, October 2023-February 2024.

Women with experience of pregnancy with MLTC, healthcare professionals and other interest holders involved in commissioning, planning and delivering care for pregnant women with MLTC.

This study followed a three-step process: (1) a consolidated list of key components of care for pregnant women with MLTC was created through secondary analysis of prior collected qualitative data; (2) the list of care components was explored during four co-production workshops; and (3) findings from (1) and (2) were synthesised to develop a maternity care bundle of 4–5 key care components for pregnant women with MLTC.

A maternity care bundle of five key care components for pregnant women with MLTC.

A list of 25 care components was refined to develop a proposed care bundle of five components. These were provisions of early and reliable medication advice and decision support; creation of a ‘goals of care summary’ accessible to women and the care team; provision of continuity of midwifery care throughout pregnancy and postnatal care; provision of a named care coordinator; and a formal postnatal handover of care from the multidisciplinary care team to the General Practitioner (GP) and secondary care team involving the woman.

This study coproduced an evidence-based care bundle for pregnant women with MLTC to enhance communication and ensure individualised care and support. Further collaborative work with women and professionals is required to refine, implement and evaluate its impact on outcomes.

All children in England should receive a health review at 2–21/2 years, with the Ages and Stages Questionnaire third edition (ASQ-3) used to collect public health surveillance data on child development. However, practitioners also value tools that assess individual children’s development—consistent with ASQ-3’s original purpose. Concerns about licensing costs and barriers to digitalisation have prompted interest in alternative tools to the ASQ-3 in England.

To inform policy, we conducted a rapid scoping review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines to identify tools that can measure or assess early child development.

Searched PubMed, PsycINFO and Web of Science from January 2012 to November 2022, with targeted search update November 2024.

We included English-language studies published after January 2012 that described or evaluated tools in English which could measure or assess early child development in children

We extracted key features and reliability, validity, sensitivity and specificity of tools which could feasibly be implemented at the 2–21/2-year review (eg, including multiple age versions and

We identified 112 unique publications describing 34 tools; six met our feasibility criteria for the 2–21/2-year review (reported in 53 studies). Only ASQ-3 and CREDI offer domain-specific scoring—a government priority. ASQ-3 moderately detects mild delays and performs better for severe delays in at-risk groups. Caregiver Reported Early Development Instruments (CREDI) was designed for public health surveillance, and we do not yet know how it performs for individual assessment.

ASQ-3 and CREDI are most promising for use at the 2–21/2-year review. However, we lack UK-based validation and norming studies, even for ASQ-3. Ultimately, careful implementation and integration into existing systems will determine a tool’s value for identifying developmental needs, supporting families and producing high quality data for public health surveillance.

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.

Enteric fever, primarily caused by Salmonella enterica Typhi and Salmonella enterica Paratyphi A (SPA), is endemic mainly in South Asia, disproportionately affecting school-age children. Although typhoid conjugate vaccines (TCVs) are effective and implemented in many countries, no licensed vaccine exists against paratyphoid A. Bivalent vaccines targeting both S. Typhi and SPA may address this gap. Although field efficacy trials are not considered feasible, controlled human infection models (CHIMs) offer an alternative pathway for evaluating vaccine efficacy. This will be the first efficacy study of a bivalent vaccine against typhoid and paratyphoid A using a paratyphoid CHIM.

This is a phase II multicentre, double-blind, randomised controlled trial assessing the efficacy and immunogenicity of a bivalent conjugate vaccine candidate, Serum Institute of India Typhoid Conjugate Vaccine (Bivalent) (SII-TCV(B)), against SPA using a CHIM in healthy UK adults aged 18–55 years. A total of 192 participants will be randomised 1:1 to receive either SII-TCV(B) or a licensed Vi-polysaccharide typhoid vaccine (Vi-PS). All participants will be orally challenged with S. Paratyphi A (strain NVGH308) 28 days postvaccination. Participants will be monitored closely for 14 days and treated at 14 days postchallenge or promptly on diagnosis, according to prespecified criteria. The primary objective is to evaluate vaccine efficacy of SII-TCV(B) against paratyphoid infection using a CHIM. The coprimary immunogenicity objective is to assess non-inferiority of the typhoid IgG response compared with a licensed Vi-PS control.

The study has received ethical approval from the Berkshire Research Ethics Committee (24/SC/0309) and regulatory approval from the UK Medicines and Healthcare products Regulatory Agency. Results will be disseminated via peer-reviewed publications and scientific meetings.

ISRCTN65855590.

To examine how patients and family members decide whether to accept a highly invasive intervention (aortic valve replacement (AVR)) when their condition (aortic stenosis (AS)) is asymptomatic and its course uncertain.

Nested, longitudinal, qualitative substudy of an ongoing randomised controlled trial (RCT) (NCT04204915) testing early intervention (EI) versus watchful waiting (WW) in patients with asymptomatic severe AS.

Six select UK sites of the RCT.

Select participants of the RCT, their next-of-kin and some who declined RCT participation.

73 interviews were conducted, with 41 participants.

Few knew much about AS before diagnosis. Uncertainty and the need for reliable information regarding symptoms and progress was a significant problem.

While some expressed unease at a major intervention for an asymptomatic condition, there were no outright objections to the idea.

Those who declined participation in the RCT did so for personal reasons, for example, their home circumstances did not permit the required period of recovery or they felt too old to risk intervention.

Reasons for accepting early intervention included the belief that the condition was serious and likely to deteriorate, and so better to have the intervention before such deterioration, as well as avoiding long waiting lists. Trusting clinicians’ judgement played a part in some decisions. Patients also wanted choice in the type of intervention received.

The longitudinal interviews (n=32) showed satisfaction in the early intervention group despite some problems in the the early recovery phase, especially for those undergoing surgical AVR.

Where evidence supports major intervention for an asymptomatic condition, patients are likely to accept the offer, although personal circumstances play an important role in decision-making. Where a condition is not well known to the public, such as AS, patients rely on clinicians and other resources to help decide. Liaison with patient groups in developing shared decision-making resources may help with complex decisions.

NCT04204915

Early screening for autism spectrum disorder (ASD) can enhance educational and health outcomes for affected children. This narrative systematic review explores school-based screening tools used around the world to identify children with ASD and explore the differences across socio-demographic groups.

Systematic review of electronic databases (EMBASE, MEDLINE, PsycINFO, Cochrane and Scopus) in October 2024 of papers published between 2011 and 2024.

Mainstream school-based settings globally.

Children aged 4–16 years old attending mainstream school.

School-based screening tools for ASD, including all types of informant and format of tools reported in eligible studies.

Primary outcomes included prevalence of screen positives, sensitivity and specificity of the screening tools. Secondary outcomes included participants’ sex, socioeconomic status and ethnicity, and the relation of this to the primary outcomes.

Of 7765 eligible articles, 14 studies were included in this review. We identified eight different school-based ASD screening tools. Study populations ranged from 103 to 16 556 children, with sensitivity and specificity varying by screening tool used, age group, setting and ASD prevalence. The percentage of children screening positive for ASD ranged from 0.7% to 8.5%. Studies were conducted in Europe (n=6), Western Pacific (n=4), the Americas (n=3) and Eastern Mediterranean (n=1) regions. No studies explicitly explored accuracy or validity outcomes based on ethnicity or socioeconomic status. Half of the 14 studies (n=7) reported the sensitivity and specificity of the screening tools; sensitivity ranged from 58% to 94% and specificity from 61% to 100%. There was insufficient evidence to recommend any single ASD screening tool.

ASD screening tools vary widely across the globe, with limited standardisation. Evidence is lacking on how ethnicity and socioeconomic status affect their effectiveness in schools. Given the dearth of scientific evidence in this field, collaboration among educators, researchers and policymakers is needed to establish the evidence base for universal screening, identify optimal tools, coordinate their use and ensure their validation for specific populations.

We conducted a pilot randomised controlled trial (the PHaCT study), including a process evaluation to assess the acceptability of a housing-led Critical Time Intervention (CTI) for prison leavers and the use of a trial design. This paper presents the process evaluation findings.

To explore the acceptability of both the intervention and the trial design to participants and those delivering the intervention, and to assess whether the intervention was delivered with fidelity.

A process evaluation following Medical Research Council guidelines. Data collection included semi-structured interviews with participants and CTI caseworkers and observations of intervention delivery. A thematic analysis of interviews and observations was conducted to understand the intervention’s implementation and contextual factors as well as the trial process acceptability.

Participants for the pilot trial were recruited from three prisons in England and Wales where the intervention was being delivered.

While 28 out of 34 trial participants consented to interviews, only one was completed. Seven caseworkers were interviewed.

A housing-led CTI to support people leaving prison at risk of homelessness, involving phased, time-limited support from caseworkers, starting prerelease and continuing postrelease, to help secure stable housing and build independence, without directly providing housing.

The intervention’s acceptability was primarily reflected through the positive feedback and success stories shared by CTI caseworkers, as well as observational data indicating high acceptance among service users. The trial design’s acceptability was challenged by concerns about randomisation and equipoise, with staff viewing randomisation as unethical due to limited support for vulnerable populations. The fidelity to the CTI intervention housing-led approach was adhered to as best as possible; stable housing was prioritised for service users before addressing other needs. Despite these efforts, both sites encountered significant challenges due to limited housing availability and complex systems for securing social housing, particularly for single men leaving prison.

This wider study faced significant challenges which impacted the process evaluation. Despite these issues, the evaluation provides important insights into the challenges of conducting trials on interventions for people leaving prison. The challenges experienced should inform future study designs with similar populations and in similar settings.

ISRCTN46969988.

To determine whether a full-scale randomised control trial (RCT) assessing the efficacy and cost-effectiveness of a housing led Critical Time Intervention (CTI) is feasible and acceptable.

Pilot parallel two-arm individual level RCT, including process evaluation and embedded exploratory health economic evaluation.

Four prisons for men across England and Wales, UK.

Men leaving prison at risk of homelessness and intervention delivery staff.

CTI has four components: (1) pre-engagement phase: assessing the needs of the client and implementing a plan pre-discharge; (2) transition to community: forming relationships and goal setting; (3) try out: encouraging problem-solving and managing practical issues and (4) transfer of care: developing long-term goals and transferring responsibilities to community providers.

Progression criteria: recruitment, retention, acceptability of the processes (CTI and trial method) and fidelity of intervention delivery. We also assessed the completeness of primary, secondary and exploratory outcome measures and estimated intervention costs.

The recruitment progression criterion was met, with 92% (34/37) of approached individuals consenting to participate (target: 50%). However, the overall recruitment target of 80 was not achieved, and retention was low, only 18% (6/34) provided follow-up data, well below the 60% threshold. Retention was hindered by systemic challenges, including changes to prison release policies and reduced probation support. While the CTI model was acceptable to staff and service users, the trial design, particularly randomisation, was not. Intervention fidelity met the progression criteria. Baseline data collection for health economics and resource use was feasible, and intervention costs were estimated.

This pilot trial identified significant challenges to conducting a full-scale RCT of CTI in this context, particularly around retention, trial acceptability and systemic instability. While CTI remains a promising model, a traditional RCT design may not be viable in this setting without substantial structural and ethical adaptations.

ISRCTN46969988.

Patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) are considered to have a symptomatic venous thromboembolism (VTE) risk of 1.0%–1.5% despite thromboprophylaxis. Fast-track treatment protocols have substantially lowered the VTE risk in most patients. Hence, the majority of patients may be unnecessarily exposed to the burden and risk of thromboprophylaxis. On the contrary, there are still patients with a high VTE risk who develop VTE despite thromboprophylaxis. Thus, tailored thromboprophylaxis treatment may potentially reduce both VTE and bleeding risk.

The DISTINCT (inDividual, targeted thrombosIS prophylaxis versus the standard ‘one-size-fits-all’ approach in patients undergoing Total hIp or total kNee replaCemenT) trial is a national, multicentre, randomised, multiarm, open-label trial. The main objective is to study whether tailored thromboprophylaxis reduces the occurrence of symptomatic VTE (primary outcome) and major bleeding (primary safety outcome) within 90 days after THA/TKA in comparison with standard thromboprophylaxis. Patients with a low, intermediate or high predicted VTE risk (based on the Thrombosis Risk Prediction following total hip and knee arthroplasty score (TRiP(plasty) score)) will be included in the DISTINCT-1, DISTINCT-2 or DISTINCT-3 studies, respectively. In the DISTINCT-1 trial, 3478 patients will be randomly allocated to receive either in-hospital thromboprophylaxis or standard prophylaxis. In the DISTINCT-2 cohort study, 2500 patients will receive standard prophylaxis. In the DISTINCT-3 trial, 4100 patients will be randomly allocated to receive either 6 weeks of high-dose thromboprophylaxis or standard prophylaxis. Standard prophylaxis consists of a low dose of any approved thromboprophylactic agent for 4 weeks. We hypothesise that (1) the efficacy of in-hospital only thromboprophylaxis is non-inferior in preventing VTE and equally safe compared with standard prophylaxis in patients with a low VTE risk (DISTINCT-1) and (2) prolonged high-dose thromboprophylaxis is superior in preventing VTE as compared with standard prophylaxis in patients with a high VTE risk (DISTINCT-3). Patients with intermediate VTE risk will be observed to evaluate VTE and bleeding rates (DISTINCT-2).

The protocol has been approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft, EU-trial-number 2023-510186-98. Study results will be disseminated through peer-reviewed journals and during international conferences.

NCT06581965.

Aboriginal people in the Kimberley are concerned that scientific research, government Inquiries and Royal Commissions are not adequately informing policy and service design. In this protocol paper, we outline our proposed scoping review to identify and provide a broad overview of scientific literature regarding the health, well-being, mental health, disability, education and social outcomes of children and adolescents living in the Kimberley region of Western Australia and the recommendations that came from them.

This scoping review is guided by Arksey and O’Malley’s (2005) methodological framework. We will conduct a comprehensive search across multiple databases using several search engines. Inclusion criteria were established to inform the selection of papers to be included in the review. After de-duplication, all titles and abstracts will be reviewed, followed by full-text screening. A second reviewer will independently screen 20% of the titles, abstracts and full texts. Two reviewers will discuss discrepancies, and a third reviewer will resolve any disagreements that may arise. We will use a data extraction template in Covidence to systematically extract relevant data.

This scoping review does not require ethics approval, as we are investigating the breadth of existing literature regarding the outcomes of children and adolescents in the Kimberley, Western Australia. The scoping review results will be published in peer-reviewed journal(s) and shared with relevant policymakers to help inform future policies and service improvements and designs in the region.

Healthcare settings are experiencing profound changes that make them increasingly complex and demanding environments, particularly for nurses. Against this backdrop are the numerous phenomena of violence in healthcare settings, which are a worrying reflection of the growing problem of aggression in society. Institutions maintain a constant focus on the phenomenon while trying to counter it; however, workplace aggression is still on the rise.

Workplace violence (WPV) potentially leads to lower quality of care and increased costs; it also exposes nurses to burnout, turnover and intention to leave the profession.

The purpose of this scoping review is to explore the physical and psychological consequences on nurses who are victims of WPV and to identify possible correlations with burnout, turnover and intention to leave the workforce.

This scoping review will follow the methodology proposed by Arksey and O’Malley, also incorporating recommendations from the Joanna Briggs Institute Handbook for Scoping Review. A literature search will be conducted in PubMed, CINAHL, PsycInfo, Web of Science and Scopus. Grey literature sources including Google Scholar and ProQuest Dissertations & Theses will also be consulted. Data will be summarised in descriptive form and categorised according to the identified outcome variables, following an inductive approach. The results will be presented following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.

The review will include studies published from January 2020 to March 2025.

This scoping review represents the preliminary phase of a larger project aimed at developing support strategies for nurses who are victims of violence.

This scoping review protocol has been registered in the Open Science Framework (https://osf.io/785qd/?view_only=21952c15efd14b34a9931f07121bf935). No ethical opinion is required, as the review does not involve direct involvement of human subjects.

The findings will be disseminated through peer-reviewed publications and presentations at national and international conferences and workshops dedicated to workplace safety and nursing. In addition, the results will be shared with healthcare managers and stakeholders to inform context-specific strategies and support interventions within care settings.