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.

The Infant Gut Bacterial Study in Nigeria (INBUGS-NG) investigates how delivery mode, antibiotic exposure, feeding practices and environmental factors shape gut microbiome development and acquisition of antibiotic resistance genes (ARGs) during the first year of life in northern Nigeria.

Between February and July 2024, 90 mother–infant dyads were enrolled at a tertiary hospital in Kano city, Nigeria. This was a prospective longitudinal cohort with follow-ups at 10 scheduled time points: days 0, 1, 3, 5, 7, 14, 28, 90, 180 and 365. We also intensified stool sampling after infant antibiotic administration, enabling dense early-life sampling. To date, the cohort has contributed 480 infant stool samples, 232 maternal rectal swabs, 254 breast milk samples and 806 environmental samples (total 1772). In parallel, socio-demographic, clinical and cultural data were collected using Research Electronic Data Capture (REDCap) and household visit diaries.

Baseline data show that 84/90 mothers (93.3%) received postpartum antibiotics, and 26/90 infants (28.9%) received antibiotics within the first 3 months of life. Only 8% of infants were exclusively breastfed, with early water supplementation common. Caesarean deliveries accounted for 25% of births, and the mean gestational age was 38.5 weeks. Across the cohort, high retention was achieved, and the study has generated a unique long-read metagenomic resource from an African infant population, with analyses ongoing.

Shotgun long-read metagenomic sequencing (Oxford Nanopore) will enable strain-level and plasmid-level profiling of microbial communities and ARGs. Planned analyses include associations between early-life exposures and resistome dynamics, as well as cross-cohort comparisons with a parallel study in Pakistan. Follow-up will continue through 12 months.

Cardiovascular disease (CVD) risk remains high but unevenly distributed in patients with type 2 diabetes mellitus (T2DM). Current risk stratification strategies are far from optimal, leading to both undertreatment and overtreatment of patients. The STENO INTEN-CT trial aims to evaluate a strategy of improved CVD risk management by using cardiac CT (coronary artery calcification (CAC)) for stratification and tailoring of multifactorial cardiovascular treatment based on CAC score. We hypothesise that (1) intensified medical treatment will lower CVD event rates in high-risk patients (CAC≥100), and (2) less intensive multifactorial treatment is safe in very low-risk patients (CAC=0).

The Steno INTEN-CT trial is an investigator-initiated, pragmatic, open-label, event-driven randomised controlled trial including patients with T2DM without known CVD. All participants (expected n=7300) will be invited for a non-contrast coronary CT scan. After the scan, participants will be randomised to either standard treatment (blinded for CAC results) or CAC-based treatment. Participants in CAC-based treatment and their general practitioner (GP) will receive information on CAC and a recommendation of multifactorial treatment. High-risk participants in the interventional arm will be invited for one or more initial study visits to intensify treatment with a combination of sodium glucose co-transporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, high-dose lipid-lowering, antihypertensive and antithrombotic treatment. Very low-risk patients in the interventional arm will be recommended less intensive treatment targets. After initial study-related activities, all participants will continue to be taken care of by their GP guided by specific treatment recommendations. The primary outcome in the primary hierarchical analysis (the rate of the combined CVD endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for heart failure) will be monitored through national health registries. The trial is event-driven, but a median follow-up of 5 years is expected. Key secondary outcomes include patient-reported outcomes, quality-adjusted life years and healthcare costs.

The protocol V.1.9 is approved by the Research Ethics Committee and the Danish Medicines Agency and the Danish Data Protection Agency. The results of the study—positive, negative or neutral—will be published in peer-reviewed journals and through www.clinicaltrials.org.

NCT05700877.

Many pregnant women have a history of trauma, such as abuse or violence, which can significantly impact their mental and physical health. Discussing these experiences in maternity care presents an opportunity to support women, reduce stigma and connect them with resources. However, concerns persist about stigmatisation, re-traumatisation and unwarranted safeguarding referrals.

The objective of this study was to explore how trauma discussions should be approached in maternity care, drawing on the perspectives of women with lived experience, voluntary sector representatives and healthcare providers in the UK. Findings aim to inform the development of a future intervention.

Semistructured interviews were conducted with women with trauma histories (experts by experience; n=4), representatives of voluntary sector organisations (n=7) and healthcare providers (n=12). Reflexive thematic analysis was used to analyse the data. A qualitative content analysis approach was employed, supported by a Patient and Public Involvement and Engagement group (named as the ‘Research Collective’ for this study) comprising experts by experience, maternity care professionals and voluntary sector practitioners. The group contributed to both study design and data analysis.

Five descriptive categories emerged: (1) Rationale for discussions—whether and why trauma should be addressed; (2) Professionals and settings—who should lead discussions and in what environment; (3) Timing considerations—when discussions should occur; (4) Communicating about trauma—strategies to sensitively explore prior trauma; and (5) Supporting care providers—training and emotional support needs. Participants highlighted both the benefits of trauma discussions and the practical, emotional and systemic challenges involved.

Trauma discussions in maternity care are complex but essential. Findings provide practical, UK-specific insights into timing, communication and staff support considerations, highlighting the need for culturally sensitive, co-designed approaches to facilitate safe and effective trauma-informed care.

People experiencing severe and multiple disadvantage (SMD: homelessness, substance use and criminal offending) have multiple intersecting unmet health and social care needs and high mortality rates, often due to street-drug overdose. Pilot randomised controlled trials (RCTs) suggest an integrated, holistic, collaborative outreach intervention (Pharmacy Homeless Outreach Engagement Non-medical Independent Prescribing Rx (PHOENIx)) involving generalist-trained pharmacists, nurses or General Practitioners accompanied by staff from third sector homeless organisations may improve outcomes, including reducing overdose.

Multicentre, parallel group, prospective RCT with parallel economic and process evaluation. Set in six areas of Scotland, UK, 378 adults with SMD will be recruited and randomised (stratified by setting and previous non-fatal overdoses) to PHOENIx intervention in addition to usual care (UC) or UC. Aiming to meet participants weekly for 9–15 months, PHOENIx teams assess and address health and social care needs while referring onwards as necessary, co-ordinating care with wider health and third sector teams. During a person-centred consultation, in the participants’ choice of venue, and taking account of the participant’s priorities, the NHS clinician may prescribe, de-prescribe and treat, for example, wound care, and refer to other health services as necessary. The third sector worker may help with welfare benefit applications, social prescribing or advocacy, for example, securing stable housing. Pairings of clinicians and third sector workers support the same participants. The primary outcome is time to first fatal/non-fatal street-drug overdose at nine months. Secondary endpoints include health-related quality of life, healthcare use and criminal justice encounters. A health economic evaluation will assess cost per quality adjusted life year of PHOENIx relative to standard care. A parallel qualitative process evaluation will explore the perceptions and experiences of PHOENIx, by participants, stakeholders and PHOENIx staff.

The primary and other time-to-event secondary outcomes will be analysed by Cox proportional hazards regression.

IRAS number 345246, approved 23/10/2024 by North of Scotland Research Ethics Service. Results will be shared with participants, third sector homelessness organisations, health and social care partnerships, then peer-reviewed journals and conferences worldwide, from the first quarter of 2027.

ISRCTN12234059 registered on 20/2/2025 (ISRCTN).

Testing rates for hepatitis C virus (HCV) of new prison entrants vary considerably between prisons, with particularly low rates in category B male remand prisons. Improvement in testing rates will require an understanding of the underlying reasons.

To investigate the rates and uptake of testing for HCV in new entrants to three category B prisons in England and to use an implementation science framework to analyse the facilitators and barriers to meeting national standards for HCV testing in a prison healthcare environment.

This mixed-methods non-interventional study collated three data sets: anti-HCV testing uptake in prisons, plus data on the prior location of each individual (transfer from another prison or community) and their length of stay; a questionnaire designed to identify reasons for decline of a test administered to people in prison (PIP) who refused testing; qualitative interviews with key stakeholders in the process of prison HCV testing, with analysis based on the Consolidated Framework for Implementation Research (CFIR) to enable identification of barriers and facilitators to testing.

This study was conducted in the East Midlands region of England.

Data were obtained from three category B male remand prisons.

Primary outcome measures: This descriptive study sought to understand factors that influence anti-HCV test uptake in three English remand prisons. The selected prisons serve a combined population of 2.3 million and have the capacity to accommodate a total of 2030 prisoners. The testing rates within 4 weeks of arrival in the three prisons over a 12-month study period (March 2022–March 2023) were 17.2%, 28.3% and 42.5%. PIP were more likely to be tested if they arrived from the community compared with interprison transfer (39.13% vs 29.5%). Testing uptake rates increased with length of prison stay (12.4%, 33.6% and 40.7% for stays of 0–7, 15–21 and >28 days, respectively). The most common reasons for not accepting a test were a lack of interest and not wanting to be retested. 13 semistructured interviews revealed 21 barriers and 9 facilitators to testing, summarised in 5 overarching themes: misunderstanding of the concept of opt-out testing; nurses not meeting performance targets due to competing priorities; prison regime hampering healthcare delivery; absence of a specifically appointed co-ordinator who is held to account; incentivising nurses to test and PIP to accept testing.

The rates of testing for HCV in three category B male remand prisons were far below national standards. Key recommendations to improve testing rates, based on the CFIR analysis are (1) to appoint a dedicated senior healthcare staff member who combines responsibility, accountability and authority to proactively oversee testing and ongoing referral processes; (2) to reintroduce an education programme for prison healthcare teams to teach about HCV, cirrhosis and how to deliver ‘opt-out’ conversations and respond to typical responses and (3) to adopt more widely the strategy already shown to be successful in increasing test uptake by the Hepatitis C Trust HITT programme and offer simple incentives.

The aim of this study is to identify and analyse research priorities across the osteopathic profession internationally, to determine how different interested parties conceptualise research importance and to examine how contextual factors influence research prioritisation.

A mixed methods sequential exploratory design combining an umbrella review, a thematic analysis, an expert consensus agreement and an international cross-sectional survey was used to define, validate and evaluate research priorities.

An international online survey, available in nine languages, was distributed through professional osteopathic organisations and network worldwide, a patient representative organisation and social media.

2229 respondents including patients (7.4%), practitioners (42.1%), students (17.4%), educators (13.5%), researchers (5.0%) and policy makers (4.3%) from across 42 countries.

Primary outcomes were interested party’s conceptualisation of research importance and validation of the priorities in Research for Osteopathic Care (PROCare) framework. Secondary outcomes included current research priorities across interested parties groups and influence of contextual factors on prioritisation.

Three distinct approaches to priority-setting emerged: conservative (42.9%), sceptic (20.2%) and enthusiast (36.9%). Organising research priorities as a construct built from domains and subdomains was shown to be internally valid (Cronbach’s α=0.911). ‘Patient safety’ (nominated by 82% of relevant countries) and ‘physical activities and mobility’ (51.0%) were the most prioritised subdomains. ‘Digital health’ ranked lowest (28th of 28 subdomains). Significant geographic variations were observed mainly for the overall importance to most research domains. Strong consensus emerged around core priorities including patient safety, physical activity promotion and understanding treatment mechanisms.

The PROCare framework provides a validated structure for evaluating osteopathic research priorities across diverse interested parties. While geographic variations exist in priority emphasis, fundamental agreement on key research domains suggests potential for internationally coordinated research strategies. Future work should focus on developing mechanisms to ensure balanced representation of conservative, sceptic and enthusiast perspectives in research planning.

Despite the potential benefits of physiotherapy and physical activity, awareness remains limited among patients with sequela and healthcare professionals. This study aims to explore Danish physiotherapists’ (PTs) perspectives on barriers, facilitators and potential solutions to improve the care of sequelae after cancer in physiotherapy clinics.

This qualitative study used semi-structured interviews with Danish PTs, following a published research protocol and the Criteria for Reporting Qualitative Research checklist. Danish-speaking PTs working in private clinics in Denmark were eligible to participate and were selected via purposive sampling. Online interviews with PTs were conducted in June and July 2022.

A phenomenological approach was employed for data collection and thematic analysis, allowing researchers to set aside preconceptions. Preunderstandings were stated and revisited post-analysis for validation. The interview guide was developed and validated through discussions and pilot testing. A patient panel provided feedback on the interview guide. Interviews were conducted by a trained and experienced PT and transcribed using a standardised key.

Online interviews with 12 PTs were conducted. Five themes were identified: being aware of important physiotherapy competencies, PTs’ basic education and specialisation, patients’ resources, healthcare system and organisation, and sharing knowledge regarding sequelae from cancer and potential treatments. PTs emphasised the need for specialised competencies, emotional resilience and life experience. Patients experienced financial and psychosocial barriers, while systemic issues and poor communication hindered care. PTs suggested public lists of specialised providers and broader dissemination of knowledge to reduce stigma and improve access.

PTs identify clinical and systemic challenges requiring specialisation, improved collaboration and increased awareness to enhance rehabilitation and quality of life for cancer survivors.

Fathers of preterm infants wish to be actively involved and attentive in caring for their children. The positive impacts of paternal caregiving on preterm infants’ cognitive and social development have been recognised. Awareness of the need to support fathers during early parenthood is increasing, but fathers may feel excluded when their infants are in the neonatal intensive care unit. Here, we present the protocol for a study involving the development and national implementation of a complex intervention supporting first-time fathers of preterm infants in early parenthood.

The study adheres to the Medical Research Council framework for complex interventions. A multicentre, prospective, non-blinded, quasi-experimental design will be applied to evaluate the effect of a clinical and technology-based intervention targeting both nurses and the fathers. Outcomes from participants enrolled during the control (2023–2024) and intervention (2025–2026) periods, comprising 295 fathers and their partners, will be compared. Effects on parental confidence, stress, depression and mood and family and reflective functioning as well as infants’ emotional and social development will be assessed. A comprehensive process evaluation will be applied using both qualitative and quantitative methods.

The study has been registered at Clinicaltrials.org [no. NCT0 6 116 747 (The SUPPORTED study – First-time Fathers of Preterm Infants), approved on 3 November 2023]. The Danish Data Protection Agency has approved the study (P-2022–792). The findings will be disseminated through peer-reviewed publications.

NCT06116747.

Despite an increasing use of screens among preschool children and evidence suggesting potential adverse effects, there is a paucity of longitudinal research that aims to disentangle the multifaceted components of screen use and their unique associations with development. We present a protocol for a large-scale national longitudinal study with repeated measurements in Danish preschool children, with the aim of investigating the cross-sectional and cross-lagged longitudinal associations between screen use and psychological outcomes.

The Digital Child Study is a national prospective observational cohort of Danish preschool children. Baseline parent-report data collection commenced in 2024 via online questionnaires, and in total will include three time points over 1 year: baseline (age 4 years), and follow-ups at 6 and 12 months (ages 4.5 and 5 years). Participants were divided into two waves based on birth dates, starting in March and September 2024. Recruitment targeted parents and primary caregivers of all Danish children born between specific dates in 2020. Of 30 235 children whose parents were sent invitations, baseline questionnaire data were available for 11 690 (39%).

Children’s screen use was measured by detailed information of amount, content and timing of children’s screen use, and the broader context, incorporating parental mediation strategies, attitudes, motivations and practices. Cognitive and socioemotional developmental outcomes were measured using validated tools such as the Strengths and Difficulties Questionnaire, the Nordic Five-to-Fifteen parent questionnaire and the Behaviour Rating Inventory of Executive Function—Preschool Version. Questionnaire data will be linked to national social and health registries to enable long-term follow-up. Statistical analyses will include longitudinal modelling to explore associations between screen use and developmental outcomes, with sensitivity analyses for robustness. The study’s large sample size provides high statistical power to detect meaningful effects.

The study adheres to ethical research guidelines, ensuring voluntary participation, confidentiality and compliance with data protection laws, with approvals from relevant authorities. Findings will be disseminated through peer-reviewed publications, conferences and plain-language summaries to engage stakeholders and the broader community.

There are more than 10 million deaf or hard of hearing people in the UK. While the deaf and hard of hearing population is heterogeneous, many of those with profound hearing loss are part of deaf communities (UK estimate around 120 000) which are defined minority communities. Many members of deaf communities are sign language users. Studies have shown that health behaviour and knowledge and health-related attitudes and beliefs are suboptimal among deaf and hard of hearing individuals, with reasons not well understood. This qualitative study aimed to explore the effectiveness of delivery of public health messages to sign language users and the potential methods of delivering public health messages beyond direct translation.

Qualitative study, using a phenomenological research approach and using interviews and focus groups. Interviews and focus groups were conducted initially between January and March 2019 and again between September and October 2022. Groups were held where logistically possible. The sessions followed a topic guide developed following review of the literature and discussion with the research team and with patient and public involvement input and pilot testing, but allowed for deviation for discussion depending on the responses given. Interviews took place in either British Sign Language (BSL) or English, depending on the language preference of the participants. Transcripts were analysed using thematic analysis.

Deaf community and associated stakeholders in Northern Ireland.

Participants were recruited from members of the deaf community and associated stakeholders across Northern Ireland and sampled purposively to ensure variation in age, sex, language, profession, educational level and region.

There were 16 one-to-one interviews and 5 focus groups held, in total involving 28 participants; 23 females and 5 males. 13 participants used BSL and 15 used English. Ages ranged from 23 to 77 years old. Participants included deaf community members (all BSL users and four English users) and key stakeholders involved in sign language and Healthcare. Interview duration ranged from 21 to 82 min. A number of themes were identified from the transcript analysis. These were broadly categorised into (1) current levels of awareness of public health messages, (2) barriers to accessing public health messages and (3) suggestions for facilitating improvement.

Participants reflected that, as with any heterogeneous population, levels of awareness of public health messages vary widely across Deaf communities. Overall levels of awareness were felt to be generally low and certainly much lower when compared with the hearing population. Particular difficulties were noted with regard to mental health, more abstract health-related concepts and preventative health measures. Participants identified not only communication barriers but also systemic, cultural and attitudinal barriers as contributing to this. Suggested next steps involve implementing legislative reforms to address systemic barriers, conducting awareness training to tackle attitudinal barriers, and launching culturally appropriate public health campaigns, all of which should be deaf-led to ensure the expertise and lived experiences of Deaf people guide the process.

For patients with perihilar cholangiocarcinoma (pCCA), surgical resection remains the sole treatment modality that can potentially result in cure. Unfortunately, the majority of patients present with unresectable tumours or are excluded from surgical treatment due to complications like cholangitis affecting their performance status. In the Netherlands, recommended first-line treatment for patients with unresectable pCCA is palliative chemotherapy with gemcitabine and cisplatin. This regimen yields an estimated median overall survival (OS) of 11.7–15.2 months, highlighting the urgent need for novel treatment options. The STRONG I trial, a phase I study in patients with unresectable pCCA, was completed in 2020. Its aim was to assess the feasibility and toxicity profile of adding stereotactic body radiation therapy (SBRT) to chemotherapy. SBRT, delivered in 15 fractions of 4.0 Gray (Gy), was considered to be feasible and safe, with no dose-limiting toxicity being observed. The 1-year local tumour control rate was 80% and the 1-year OS rate 100%, with maintenance of quality of life (QoL). These results encouraged us to initiate the STRONG II trial, aiming to investigate the efficacy of adding SBRT to chemotherapy in a larger patient cohort.

STRONG II is a single-arm, multicentre phase II study. Patients with non-metastatic unresectable pCCA (T1-4, N0-2) are eligible. A total of 30 patients will be enrolled in six academic centres in the Netherlands and two in Belgium. SBRT will be delivered in 15 fractions of 4.0–4.5 Gy. The primary endpoint is local tumour control, defined by Response Evaluation Criteria in Solid Tumours (RECIST) V.1.1. Secondary endpoints include toxicity, biliary stent-related events, progression-free survival, OS and QoL using the EuroQoL five-dimensional, five-level (EQ-5D-5L) questionnaire, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) and the EORTC Biliary Module (QLQ-BIL21). In addition, we will explore the predictive value of the peripheral immunological status (immune-related proteins and serum functional immunological status assay) and its dynamics in determining survival outcomes. For this explorative translational study, two blood samples will be collected, one before the start of chemotherapy and another after completing chemotherapy.

Approval of the study was obtained on 5 June 2024 by the Medical Ethics Review Committee of Erasmus Medical Center Rotterdam, the Netherlands (ID: NL86210.078.24). The anticipated time frame for patient enrolment is July 2024 to December 2027. The main study findings will be published in peer-reviewed medical journals, and presented at national and international conferences.

NCT06493734 (ClinicalTrials.gov).