To determine the prevalence of undiagnosed hypertension and its risk factors among adults in rural Sidama Region, Ethiopia, using a two-step diagnostic method.

A community-based cross-sectional study was conducted from 1 April to 31 July 2024. Data were collected among adults aged 45 years and above using the World Health Organization STEPwise Approach to Surveillance questionnaire. The Demographic and Health Survey questionnaire was also used to collect data on household characteristics.

Selected rural kebeles of Shebedino district, Sidama, Ethiopia.

2875 adults aged ≥45 years identified via census.

Undiagnosed hypertension was defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg, in individuals with no history of the condition.

The prevalence of undiagnosed hypertension ranged from 7.7% (95% CI: 6.7% to 8.7%) to 14.3% (95% CI: 13.0% to 15.6%). The previously diagnosed hypertensive cases were found in 3.3% (95% CI: 2.7% to 4.1%). Female sex (AOR 2.02; 95% CI: 1.44 to 2.82), age ≥ 65 years (AOR 1.48; 95%CI: 1.01 to 2.15), and history of alcohol drinking and khat chewing (AOR 2.94; 95%CI: 1.52 to 5.66) were significantly associated with undiagnosed hypertension. Lack of awareness of salt-related health risks (AOR 3.14; 95% CI: 2.30 to 4.30) and no prior blood pressure measurement (AOR 5.60; 95% CI: 1.73 to 18.07) were also associated with undiagnosed hypertension.

Undiagnosed hypertension is common among adults aged ≥45 years in the rural Sidama Region. Female sex, older age, substance use, limited awareness of salt-related health risks, and lack of prior blood pressure measurement were the identified risk factors. Regular screening should be implemented to detect cases at an early stage.

The aims of this study were to explore how health visitors (HVs) and community health nurses (CHNs) assess unsettled baby behaviours, how their perceptions of these behaviours influence decisions about support offered, and how able they feel to deliver support to families of unsettled babies.

Qualitative semi-structured interviews were conducted, recorded and transcribed. Data were analysed using Reflexive Thematic Analysis.

Potential participants were invited nationally via social media and via Health Visiting Service managers from an NHS Trust. Interviews took place remotely.

17 HVs and 3 CHNs were purposively selected to include a wide range of perspectives.

Three themes were developed, (1) HVs’ perceptions of parents’ sense-making which explains how HVs/CHNs understand parents’ beliefs around unsettled babies; (2) care pathway which highlights the importance HVs place on creating emotional space for the baby, the parent and the health visitor within the pathway (containment); and (3) service delivery decline, which outlines the impact of funding cuts to the services on the HVs’ ability to provide support for families. Lastly, a new concept – the Tipping Point model - was created to holistically conceptualise the experiences of HVs providing support for unsettled babies in the UK.

Policy makers need to organise services to value and support the role of the health visiting team in ‘containment’. HVs identified a training need around assessing and advising about unsettled babies to place them in a stronger position to support families. Further research is needed into different models of support for families of unsettled babies from the wider primary care team and/or from digital services.

To identify predictors of treatment changes and to evaluate the effectiveness and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) initiating tofacitinib in a real-world setting.

The non-interventional study ESCALATE-RA included 1518 patients with RA from Germany. RA treatment, including all changes in therapy, was documented for 24 months starting from the initial intake of tofacitinib.

All patients started with tofacitinib therapy, either as monotherapy or in combination with methotrexate (MTX).

The impact of several factors of interest on the number and timing of treatment changes was assessed as primary outcome using Cox proportional hazards models. Further outcomes were tofacitinib drug survival and the use of follow-up disease-modifying antirheumatic drugs after first treatment change. We also assessed the effectiveness, concomitant glucocorticoid (GC) use, PROs (such as functional ability, patient satisfaction, pain and quality of life) and safety. Analyses were based on observed data.

‘Lack of efficacy’ (HR 3.30) and ‘intolerance’ (HR 4.43) leading to termination of tofacitinib were key factors favouring therapy changes. Higher patient satisfaction was significantly associated with a reduced likelihood of treatment changes (HR 0.82). Increasing GC doses were associated with a higher probability of step-up/switch changes (HR 1.21). The estimated tofacitinib drug survival was 48% at the end of study. Proportions of patients achieving low disease activity (both Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) 62%) and remission (SDAI 25%, CDAI 28%) increased from baseline under tofacitinib and were comparable between monotherapy and combination therapy with MTX. Mean concomitant GC dose decreased (2 mg/day). PROs indicated reduced pain and fatigue, while functional ability and quality of life improved. 63.9% of the patients experienced a treatment-emergent adverse event (AE), 8.8% a treatment-emergent AE of special interest and deaths occurred in 0.5%.

Key factors for therapy changes in patients with RA treated with tofacitinib were lack of efficacy and intolerance. Higher patient satisfaction was associated with a reduced probability of treatment changes, while increased GC doses led to a higher likelihood of step-ups/switches. Patients demonstrated a marked reduction in disease activity for up to 24 months, along with improvements in functional ability, pain and quality of life. Observed AEs were consistent with the known safety profile of tofacitinib.

NCT03387423.

Recent advances in treatment and care have improved survival rates for children and young adults with severe blood disorders such as sickle cell disease (SCD), transfusion-dependent beta-thalassaemia (TDT) and acute leukaemia. However, their quality of life and reproductive and psychosocial outcomes are not yet well studied. For SCD and TDT, robust survival data are mainly limited to North America. Thus, there is a need to fill these knowledge gaps to guide improvements in care, address unmet clinical needs and rigorously assess the efficacy of emerging novel therapies.

This is an observational population-based mixed-methods study of individuals diagnosed with SCD, TDT or acute leukaemia when under the age of 18 in England, involving a data linkage component and a patient-reported outcomes measures survey. Data linkage-eligible participants will be identified from national and regional databases, including the Hospital Episode Statistics, Yorkshire Specialist Register of Cancer in Children & Young People and the National Congenital Anomaly and Rare Diseases Registration Service. Data linkage will be processed within the NHS England and the University of Leeds’ secure, trusted research environments. Data will be accessed without consent under section 251 and approval by the confidentiality advisory group. It will assess survival rates for SCD and TDT as well as clinical, educational and mental health outcomes for SCD, TDT and acute leukaemia diagnosed in childhood.

Survey-eligible participants for SCD, TDT and acute leukaemia cohorts will be checked for their suitability to participate by the North of England clinical care teams. An NHS-approved survey provider will facilitate data checks with the NHS National Data Opt-Out Service. Consent is required for participation in the survey and for subsequent data linkage to existing databases. Surveys are conducted in various formats (online, paper and phone), with reminders sent after 21 days. The survey will assess quality of life and psychosocial and reproductive outcomes. Participants can withdraw at any time, and support is available via telephone helplines.

The study has received ethical and information governance approval from the Health Research Authority (Reference 24/YH/0186) and the Confidentiality Advisory Group (CAG 24/CAG/0138) to process identifiable data without consent. Study results will be available to patients, physicians, researchers, stakeholders and others through open-access publishing, results sharing via media platforms and presentations at conferences and meetings.

Fetal alcohol spectrum disorder (FASD) is a diagnostic term that describes the neurodevelopmental and physical effects resulting from prenatal exposure to alcohol. Individuals living with FASD can experience lifelong challenges, yet with a diagnosis and sufficient support for the individual and their whānau (families), people can live fulfilling lives. Currently, little is known of the prevalence and impact in Aotearoa, New Zealand (NZ). Our aim is to identify the prevalence and understand the needs of young people living with FASD and other neurodevelopmental disorders in Youth Justice (YJ) residences in Aotearoa, NZ. One study will investigate the prevalence of FASD in this setting. The outcomes of both studies may demonstrate barriers and enablers, as well as strengths and gaps in YJ services of Aotearoa, NZ. The outcomes of both studies may guide reinforcing of current best practices as well as highlight necessary and novel initiatives together providing best support for the children and adolescents and their whānau as well as staff across YJ residences.

Extensive consultation with Māori and Pacific Advisory groups, researchers and experts in FASD and justice settings, individuals living with FASD and YJ staff together informed the development of this study.

Children and adolescents (hereafter young people) aged 10 to 18 years and currently residing in YJ residences are eligible for participation and assessment for FASD through assenting and consenting to provide personal and social histories and completed physical and neuropsychological assessments. The comprehensive FASD histories, screening and assessment will be conducted by a neuropsychologist and paediatrician employing standardised assessment practices and instruments. The team will also collect information from health, education and care and protection records; from the young people themselves; and from their family and staff. The study will reference Whakakotahitanga, the newly released (2024) guidelines for screening and diagnosing FASD in Aotearoa, NZ while also acknowledging the differences imposed under constraints of funding research including, for example, time and money. An individualised report will be prepared for each young person and their whānau. Study data will be analysed with descriptive statistics as appropriate. Our findings will be considered by the Māori and Pasifika advisory groups for framing and culturally secure translation, disseminated with all participating young people, translated to YJ services and staff, government and community neurodiversity sectors. Outcomes will be made available through community hubs, conferences, reports and peer-reviewed journal publications.

The study has received ethical approval from the Southern Health and Disability Ethics Committee (2024 Full 20065). Locality ethical approval has been granted from Oranga Tamariki (Ministry of Children), and a privacy impact evaluation has been undertaken. The findings will be shared through peer-reviewed publication, local and national conferences and with key agencies including Oranga Tamariki.

Administering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO₂) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO₂ 90%–96%) compared with usual care.

The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO₂ 90%–96%) as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomisation. Secondary outcomes include the amount of supplemental oxygen administered and the proportion of time spent in hypoxaemia (SpO₂2 >96%). Specifying the protocol and statistical analysis plan before the conclusion of enrolment increases the rigour, reproducibility and interpretability of the trial. Enrolment began on 6 May 2024.

The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal.

NCT06374225.

The optimal strategy for induction of labour (IOL) in cases of prelabour rupture of membranes (PROM) with an unfavourable cervix is elusive. No study conducted in nulliparous women has shown any one induction method to be superior to any other. In this project, we seek to determine whether IOL with balloon catheter and oxytocin can (1) increase rate of delivery

We are conducting a multicentre, randomised, controlled, open-label therapeutic trial with two parallel arms on nulliparous women with unfavourable cervix showing PROM at term without spontaneous labour.

After 12 hours of PROM, women are randomly assigned to one of two study groups. One group is treated with a balloon catheter for 12 hours, with oxytocin administered after 6 hours. If the balloon is expelled earlier than 6 hours after insertion and the cervix is still unfavourable, another balloon is placed. The other group (control) is treated with 25 µg oral PGE1 every 2 hours until labour starts. After a maximum of eight administrations and a timelapse of 4 hours, if there are no effective uterine contractions, the induction is continued with oxytocin infusion and epidural analgesia if the patient requests it. A total of 520 women will be recruited in five university hospitals in France and randomised at a 1:1 ratio with stratification by study centre.

Main inclusion criteria are nulliparous women with gestational age ≥37 weeks, PROM without labour beyond 12 hours, unfavourable cervix (Bishop score

The hierarchical primary endpoints are: (1) Proportion of patients vaginally delivered

The RUBAPRO2 trial was approved by the French national agency for drug safety and committee for protection of persons involved in biomedical research on 15 September 2022. Informed written consent will be obtained from all participants.

NCT05568745.

To examine the self-reported adherence of ambulance nurses to acute chest pain guidelines and analyse how demographic and professional characteristics influence this adherence.

Cross-sectional study.

Regional ambulance service in southern Sweden (18 ambulance stations).

Ambulance nurses (registered and specialist nurses). Of the 397 ambulance nurses invited, 261 responded (65.7%) in 2023.

Descriptive statistics; independent-samples t-tests and ² tests for group comparisons; Pearson correlation; and stepwise linear regression to identify predictors of adherence.

Primary: adherence to the prehospital acute chest pain guideline, measured with the 5-item Self-Reported Adherence scale (5–25). Secondary: medication-specific adherence; guideline-access sources.

A cross-sectional study involving 261 ambulance nurses from 18 ambulance stations in southern Sweden. Adherence to acute chest pain guidelines was assessed using a validated instrument. Data collected in autumn 2023 were analysed using descriptive and inferential statistics, including stepwise linear regression analysis.

The study revealed an average self-reported adherence score of 19.2 out of 25 for acute chest pain guidelines. Mobile applications were the most commonly used source for accessing acute chest pain guidelines, while ambulance managers were the least used. Notably, older and more experienced ambulance nurses reported higher adherence scores. Additionally, a positive attitude towards the guidelines was correlated with higher adherence. Prioritisation of guidelines and age were predictors of adherence. In contrast, other demographic variables, such as sex and specialist nursing education, were not found to be associated with adherence.

The study indicates that self-reported adherence to acute chest pain guidelines among ambulance nurses is influenced by how highly they prioritise these guidelines and by their attitudes towards them, as well as their age and professional experience. Enhancing educational programmes and digital resources, particularly for younger and less experienced nurses, may improve adherence and patient outcomes in prehospital settings.

Earlier heart failure (HF) diagnosis in the community could allow timely treatment initiation and prevent unnecessary hospitalisation, but identifying those at risk remains challenging. We aimed to summarise the performance of risk prediction models for a new diagnosis of HF.

Systematic review of multivariable incident HF risk prediction models in the community setting.

MEDLINE and Embase were searched from inception to 9 November 2023.

Observational, community-based studies reporting prediction model performance for incident HF within a 5-year time horizon.

Two reviewers independently screened and extracted data. Where possible, C-statistics (or area under the receiver operating characteristic curve) with 95% CIs were extracted. Risk of bias was assessed using the Prediction model Risk Of Bias ASsessment Tool and certainty of evidence by the Grading of Recommendations, Assessment, Development and Evaluation.

Eighteen studies described 45 prediction models, 27 used traditional statistical methods and 18 applied machine learning. Most (39/45) demonstrated acceptable discrimination (C-statistic >0.70). Overall, C-statistics ranged from 0.675 to 0.954, typically with narrow 95% CIs. External validation was performed for 31 models, but only two—the modified PCP-HF models for white men and women—were validated in three cohorts, the highest among all the models. Exploratory random-effects meta-analysis of these models showed pooled C-statistics of 0.82 (95% CI 0.82 to 0.82) for men and 0.85 (95% CI 0.82 to 0.88) for women, indicating excellent discrimination but more heterogenous performance among women. Model performance was at high risk of bias due to unreported or inappropriate handling of missing data, and the certainty of evidence was very low.

Risk prediction models for a new diagnosis of HF in the community performed well, but were at high risk of bias and lacked external validation. Future model development requires appropriate data sources, robust handling of missing data, external validation and clinical testing to assess their impact on earlier HF diagnosis and outcomes.

CRD42022347120.

Despite the benefits of early diagnosis, most cancers in sub-Saharan African (SSA) countries are diagnosed at an advanced stage due to late presentation of symptoms, inadequate referral systems and poor diagnostic capacity. Health communication interventions have been used extensively in high-income countries to increase people’s awareness of cancer symptoms and encourage timely help-seeking. However, in SSA, there is still limited evidence on the effectiveness of these interventions and existing evaluations are mainly focused on communicable diseases rather than cancer.

A randomised, multisite, controlled community trial will evaluate a culturally tailored health infographic toolkit delivered in rural and urban settings in the Western Cape Province in South Africa and Harare and surrounding provinces in Zimbabwe. Participants will be randomised to receive one of three African aWAreness of CANcer and Early Diagnosis (AWACAN-ED) cancer awareness tools, coproduced with local communities, comprising health communication infographics with descriptions of breast, cervical and colorectal cancer symptoms plus messages to encourage consultation with primary care providers if symptoms occur, all presented in English and four local languages. We will recruit 144 participants in each of the three intervention groups (N=432). The primary outcome will be recall of symptoms and the secondary outcomes will be (1) intention to seek help, (2) emotional impact and (3) acceptability of the toolkit. Outcomes will be measured preintervention and at two points postintervention: after 15 min and 1 month.

Ethical approval was obtained in both participating countries, South Africa (148/2025) and Zimbabwe (363/2021). All participants will be required to provide written informed consent prior to participation. Findings will be disseminated through peer-reviewed publications, conference presentations and the AWACAN-ED programme website.

PACTR202505475803308.

Visual Hallucinations (VHs) (seeing things that others do not, or visions) are a common feature of psychosis, causing significant distress and disability. Services rarely ask about these important experiences, and crucially there are no proven beneficial psychological treatments. There are at least two key challenges faced when treating VHs. First, people report not knowing why they see things others don’t, which leads them to feel alone and different from others. Second, they feel they cannot trust their own eyes to tell what is real or not, which can lead to fears they will be hurt or harmed by the VH, or even if they know the experience is not real, they may fear that they are losing their mind, or that they are not able to control or manage their experiences. For these reasons, they may struggle to put skills and strategies into practice when in the presence of the VH. Consequently, we have developed a novel treatment that addresses these core issues. First, we have a psycho-education and coping strategies package called Visual Unusual Sensory Experiences (VUSE) that uses the best aspects of digital technology (animations, videos) to explain why people have VHs and provides normalising information to help the person to feel less alone. It introduces coping strategies that are then tested in Virtual Reality sessions (VR for Visions VRV) where a representation of the visual experience is provided, enabling the person to safely develop skills and gain a sense of mastery and empowerment. We now plan to test this approach in a proof-of-concept study to help determine if this will help people use these skills in the real world and so help reduce distress, improve functioning and quality of life. We will address uncertainties in the feasibility of developing and delivering this treatment and inform its future use in a larger trial.

The study is a single arm feasibility trial (n=16) evaluating VUSE+VRV and treatment as usual. The study is recruiting people with psychosis and distressing VHs in one NHS Trust and uses independent but non-blind research assistants to undertake assessments before, during and after treatment (at baseline, 6, 12 week) and at follow-up (16 weeks). Quantitative information on recruitment rates, adherence and completion of outcome assessments (VHs, other psychiatric symptoms, quality of life and perceived recovery) will be collected. Qualitative interviews will capture service-users’ experience of therapy. Analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention.

The trial has received NHS Ethical and Health Research Authority approval (25/EM/0077). Informed consent will be obtained from all participants. Findings will be disseminated directly to participants, and services as well as through open access peer-reviewed publication(s).

ISRCTN11350954.

While paediatric cardiac arrest is a rare event, consequences for the patients are significant with a considerable risk of morbidity, disability and mortality. The risk of cardiac arrest is substantially increased in children with congenital heart disease. Nevertheless, there is a lack of data concerning this population. To close this knowledge gap, this multicentre, prospective, open registry aims to implement a standardised structure for data collection and follow-up of paediatric cardiac arrests associated with heart diseases in Germany.

All paediatric patients who experience a cardiac arrest and receive at least 2 minutes of cardiopulmonary resuscitation are invited to participate in this registry. The dataset comprises demographical, clinical, resuscitation and outcome data, collected in accordance with the Utstein guidelines. Neurological assessments, cognitive and motor tests are conducted at fixed intervals. Additionally, patient-reported outcome measures will be surveyed. Primary outcomes are survival to discharge and neurodevelopmental outcome after discharge and 2 years. The data are pseudonymised prior to submission to an online REDCap database, which is centrally hosted on a server located in Leipzig, Germany.

This study follows the Declaration of Helsinki and received ethical approval from the Ethics Committee in Leipzig. Registry results will allow us to understand the epidemiology, guideline adherence, risk factors and will be presented at conferences and submitted to a peer-reviewed journal for publication.

NCT05373498.