The objective of this study is to assess the extent to which palliative care content is integrated into occupational therapy education in Germany. In addition, the study will examine trainees’ and students’ knowledge, experiences and attitudes towards palliative care.

A cross-sectional quantitative survey study using a structured online questionnaire.

Institutions and universities across Germany that offer training in occupational therapy.

A total of 451 subjects completed the survey (89.4% female). Of these, 91.4% were trainees at vocational schools, while 8.6% were university students. The inclusion criteria stipulated that subjects must be enrolled in an occupational therapy programme in Germany at the time of data collection.

Not applicable.

The primary outcomes of the study were knowledge, educational experience and attitudes towards palliative care among occupational therapy trainees and students. Secondary outcomes encompassed practical experience with palliative care patients and expressed interest in further training.

A total of 451 occupational therapy trainees and students participated in the survey. The majority of participants (89.4%) were female and in training (91.4%). Although 90.8% had no previous medical training, 69.2% could define palliative care and 92.6% were familiar with the concept of a hospice. However, 68.1% of respondents reported that they had not received any teaching on palliative care as part of their occupational therapy training. A strong interest in further education in this area was expressed by 95.1%. Only 23.9% had practical experience with palliative clients, mainly in nursing homes.

A substantial discrepancy exists between the recognised importance of palliative care and its representation in occupational therapy education. The findings underline the necessity for a more robust and methodical incorporation of palliative care into occupational therapy curricula. This integration is crucial to ensure that trainees and students are adequately equipped with the theoretical knowledge and practical skills necessary to provide support to seriously ill and dying patients.

DRKS00033464.

The EPHOR-NIGHT cohort was established to investigate how night shift work influences biological pathways and chronic disease risk using a comprehensive working-life exposome approach, focusing on cardiometabolic, mental health, cognitive and biological ageing outcomes.

The cohort includes 937 workers aged 20–65 years (88% female), primarily from the healthcare sector (96%) in Spain, Sweden, Denmark and the Netherlands. Participants were categorised as permanent day (39%), permanent night (35%) or rotating/other shift workers (26%). Data collection included questionnaires, daily ecological momentary assessments, wearable sensors tracking light, physical activity, heart rate and environmental exposures and biological samples (blood collected once and saliva collected during five points across the day), with harmonised protocols across countries.

From the 937 participants contributing data to the cohort, 708 had complete information from questionnaires, sensors and blood and saliva, with subsets undergoing advanced biological analyses, including genomics, targeted and genome-wide DNA methylation, telomere length and mtDNA copy number, metabolomics, transcriptomics, proteomics, hormone profiling and inflammatory biomarkers and blood metals. Many reported prevalent chronic conditions, including anxiety (27%), depression (18%) and metabolic disturbances. Night shift and rotating shift workers had greater exposure to long shifts and more scheduled rest days compared with day workers. Sleep duration and quality were poorest among permanent night shift workers.

A 2-year follow-up was completed in June 2025, including the collection of additional biomarker data, psychosocial work environment data and data related to female sexual and reproductive health. Findings from the EPHOR-NIGHT study aim to inform prevention strategies and occupational health policies. Data will be made available to support broader research efforts on shift work and health.

Cisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect.

The SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m². Each subject will receive transtympanic STS injections in one ear, chosen by randomisation, before each cisplatin infusion. The contralateral ear serves as an internal control. The primary objective is efficacy (ie, clinically relevant benefit) of transtympanic STS injections against CIHL, defined as a difference in threshold shift of ≥10 decibels between baseline and 3 months after treatment in favour of the STS-treated ear. Secondary objectives include the difference in mean threshold shifts on frequencies essential for speech and extended high frequencies, as well as the difference between both ears in the gradation of hearing loss as defined by ototoxicity grading scales.

The medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals.

CTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.

Addressing physical inactivity is a promising dementia risk reduction strategy due to its direct benefits for brain health, and indirect benefits for other modifiable dementia risk factors. A potential limitation of previous interventions is that they often overlook how increasing physical activity affects other behaviours throughout the 24-hour day, such as sleep and sedentary behaviour, which are also important for brain health. Further, interventions are rarely tailored to the individual, considering their needs, preferences and constraints that may serve as barriers or facilitators to behaviour change. The current phase I randomised controlled trial, Small Steps, aims to investigate feasibility, acceptability and preliminary effectiveness of a personalised 24-hour time-use intervention to improve lifestyle and cognitive health in older adults.

Participants aged ≥65 years from Adelaide, South Australia will be recruited and randomised to either the Extended or Condensed programme. During the first 12 weeks, participants in the Extended programme will use a tailored website to set personalised weekly goals to move towards their ‘optimal’ 24-hour day for brain health, facilitated by weekly website ‘check-ins’ and weekly phone calls with a research staff member. Participants randomised to the Condensed programme will have access to the website educational resources only but will not undergo personalised goal setting or telephone calls. Following the introductory phase (first 12 weeks), phone calls will be gradually withdrawn for the Extended programme. Primary (feasibility and acceptability) and secondary outcomes (changes in time use, cognitive function and behaviour change metrics) will be assessed 12, 24 and 36 weeks after the beginning of the intervention.

Ethics approval has been obtained from the University of South Australia’s Human Research Ethics Committee (205989). Study findings will be disseminated through peer-reviewed journal articles, conference presentations, media releases and community engagement.

NCT06291909).

To examine chronic kidney disease (CKD) prevalence, incidence, prognosis, kidney function decline and associated risk factors among people with diabetes and/or hypertension.

Cross-sectional multicentre study.

14 primary care centres across Jakarta.

Adults (≥18 years) with diabetes and/or hypertension were included. Exclusion criteria were receiving kidney replacement therapy, language barrier, cognitive impairments, refusal to consent and pregnancy. Participants were grouped into three categories: hypertension only, diabetes only and both.

None.

Primary outcomes included CKD prevalence, incidence, number-needed-to-screen, KDIGO-based prognosis and annual kidney function decline. Secondary outcomes were risk factors for CKD, uncontrolled blood glucose, blood pressure and albuminuria.

A total of 1263 participants were enrolled: 51% had hypertension, 17.6% diabetes and 31.4% both. Mean age: 57.1±10.2 years, 72.2% female and 76% obese. Renin angiotensin aldosterone system inhibitors were prescribed in 32.3%, and only 1.2% used insulin despite a median glycated haemoglobin of 7.5% (IQR: 6.5–9.1). CKD prevalence was 14.8%, with an incidence rate of 9.1 per 100 person-years; number-needed-to-screen was 7. Based on KDIGO criteria, 48.9% were at moderate-to-very high risk of adverse outcomes. Baseline estimated glomerular filtration rate was 80.9 (SE=10.1), declining by 4.7 (SE=9.9) mL/min/1.73 m² annually. CKD incidence was higher with albuminuria (OR 3.6, p=0.007) in the combined group; older age (OR 4.5, p

CKD burden is high among people with diabetes and hypertension. Nearly half were at elevated risk despite preserved kidney function, highlighting the need for targeted early screening.

The rapidly growing population of older adults (individuals aged 65 years and older) presents a new set of challenges for healthcare providers in the emergency department (ED), given the prevalence of severe and life-threatening conditions among this group, such as chronic cancer, Alzheimer’s disease/dementia and congestive heart failure. ED encounters often represent a critical point in an older patient’s trajectory of care and can thus be an important opportunity for various interventions such as palliative care consultation. Therefore, identifying those who will benefit most from palliative care is of high importance, especially in determining the course of future treatment. Thus, we aim to conduct a systematic review assessing the efficacy of palliative care screening in the ED by assessing inpatient length of stay as the primary outcome and quality of life, percentage of hospitalisation and cost of care as secondary outcomes.

This study will use Ovid MEDLINE, Embase, EBSCO CINAHL, Web of Science and Cochrane as databases. The study population comprises adults aged 60 years and older, with no focus on any specific clinical specialty or disease. Patients who have not received palliative care screening will serve as the comparator. Only studies with an applicable comparator will be considered. Studies published from 1 January 2000 to 1 July 2025 will be included.

All articles will be reviewed independently and in duplicate, and every author will participate in the review, data abstraction and conflict resolution process.

Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations.

CRD42024562389.

Most patients receive behavioural healthcare (BH) in a primary care setting, yet much of the BH research was not developed to account for eventual implementation. Areas of research and intervention that are considered priorities to patients may be absent from our existing knowledge base. Engaging the community in the research process can facilitate translation and uptake. A key strategy for community engagement is to employ a Community Advisory Board (CAB). CABs can assist in a number of research processes, including guiding research questions to fit the priorities of the community and creating research materials that are tailored to the patient population and healthcare setting. There is variability in practices and reporting standards for CABs. The field would benefit from a summary of the state of the current literature on CAB utilisation for BH research in primary care. To fill this gap, we will conduct a scoping review to answer the question, ‘What is known about the use of CABs in behavioural health studies in primary care?’.

We will use the guidelines for scoping reviews outlined by Arksey and O’Malley: (1) identifying the research question; (2) identifying relevant studies; (3) study selection; (4) charting the data and (5) collating, summarising and reporting the results. Our reporting of the results will be guided by the Arnos and colleagues Toolkit for Project-Based Community Advisory Boards, a set of practical guidelines for employing a CAB. To this end, we will report on how well CABs currently employed in BH primary care research match existing guidelines and what gaps need to be filled by future research.

This review does not require ethics board approval, as no patient data will be collected. We will disseminate findings primarily through journal publications and conference presentations.

This scoping review protocol was registered on the Open Science Framework (https://osf.io/pa3rz/?view_only=31c558eb395a4a9482ee9c5b57ca1c4c)

Targeted biologic therapies have transformed outcomes for individuals with psoriasis, a common immune-mediated inflammatory skin disease. The widespread use of these highly effective treatments has led to a growing number of individuals with clear or nearly clear skin remaining on continuous, long-term treatment. Personalised strategies to minimise drug exposure may sustain long-term disease control while reducing treatment burden, associated risks and healthcare costs. This study aims to evaluate the feasibility of a definitive pragmatic effectiveness trial of two personalised dose minimisation strategies compared with continuous treatment (standard care) in adults with well-controlled psoriasis receiving the exemplar biologic risankizumab.

This is a multicentre, assessor-blind, parallel group, open-label randomised controlled feasibility trial in the UK, evaluating two personalised biologic dose minimisation strategies for psoriasis. 90 adults with both physician-assessed and patient-assessed clear or nearly clear skin on risankizumab monotherapy for ≥12 months will be randomised in a 1:1:1 ratio to (1) patient-led ‘as-needed’ treatment, where risankizumab is administered at the first sign of self-assessed psoriasis recurrence, (2) therapeutic drug monitoring-guided treatment, with personalised dosing intervals determined using a pharmacokinetic model or (3) continuous treatment as per standard care, for 12 months. Participants will be invited to submit self-reported outcomes and self-taken photographs every 3 months using a bespoke remote monitoring system (mySkin app) and will attend an in-person assessment at 12 months. They may also request additional patient-initiated follow-up appointments during the trial if needed. The primary outcome is the practicality and acceptability of the two personalised biologic dose minimisation strategies, assessed as a composite measure including recruitment and retention rates, adherence to the assigned strategies and acceptability to both patients and clinicians. The feasibility of collecting healthcare cost and resource utilisation data will also be evaluated to inform a future cost-effectiveness analysis. A nested qualitative study, involving semistructured interviews with patients and clinicians, will explore perspectives on the personalised biologic dose minimisation strategies. These findings will inform the design of a future definitive trial.

This study received ethical approval from the Seasonal Research Ethics Committee (reference 24/LO/0089). Results will be disseminated through scientific conferences, peer-reviewed publications and patient/public engagement events. Lay summaries and infographics will be codeveloped with patient partners to ensure the findings are accessible for the wider public.

ISRCTN17922845.

The COVID-19 pandemic has had a tremendous impact on daily lives globally, healthcare access and healthcare utilisation, especially for individuals who are traditionally underserved by the...

This study aimed to examine how older adults form beliefs about their memory and how these beliefs are influenced by their level of concern about dementia. Inaccurate beliefs and excessive worrying, indicative of erroneous metacognition, are associated with negative health outcomes. This research can help identify mitigation for these harmful effects.

Qualitative focus groups; thematic analysis.

Focus group discussion with healthy older adults hosted at a university in central London.

35 healthy older individuals (women=29) without any psychiatric or neurological diagnoses, over the age of 65 years (mean 75.31, SD: 6.15). 13 participants were identified as having a high level of worry about dementia and 22 as having low worry. Groups were matched for cognitive performance on the Telephone Mini Addenbrooke’s cognitive assessment (Tele-MACE).

Participants were assigned to a focus group depending on their level of worry about dementia. During focus groups, a vignette prompted discussion around lifespan changes in memory and how this affected concerns around memory. This allowed investigation of the differences in beliefs about memory.

Thematic analysis revealed two key themes. First, older adults appear to base their definition of ‘normality’ of their own memory on comparisons. These comparisons were between themselves and others and between themselves now and their own past self. Despite similar strategies to define ‘normality’, those with high dementia worry had stricter definitions of what they determined as normal. The second theme described narratives around the ‘self’ and the ‘other’. There was a difference between those with high versus low worry; those with high worry had a strong focus on the ‘self’, while those with low dementia worry focused on ‘others’.

Comparison is a common metacognitive strategy used in forming beliefs about memory. Targeting the use of comparison is potentially valuable in interventions aiming to alleviate older adults’ memory concerns. Addressing self-focused thinking, for example, with cognitive behavioural therapy, could improve harmful levels of high worry.

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

A cross-sectional mixed methods online survey.

Primary care in England.

120 clinical pharmacists with experience in conducting SMRs in primary care.

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

In Bangladesh, evidence on the long-term trajectory of adolescents' sexual and reproductive health (SRH) remains limited, largely due to the lack of longitudinal data to assess the changes over time. To address this gap, the Advancing Sexual and Reproductive Health and Rights (AdSEARCH) project of International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) set up an adolescent cohort study aimed at documenting changes in SRH knowledge, attitudes and practices, and identifying the factors affecting these changes. This article presents the baseline sociodemographic and SRH characteristics of this cohort as a pathway for future analyses.

This cohort study included 2713 adolescents from the Baliakandi Health and Demographic Surveillance System run by icddr,b. The cohort covered three age groups from girls and boys, giving a total of five cohorts: girls aged 12, 14 and 16 years; and boys aged 14 and 16 years. A total of seven rounds of data had been collected at 4-month intervals over 2-years follow-up period.

The majority of adolescents were attending school (90%), and school dropouts were higher among boys. Around 17% of the respondents were involved in income-generating activities, which were mostly boys. Among girls, the mean age of menarche was 12.2 years. Overall, 6% of adolescents had major depressive disorder, with prevalence increasing with age. Gender differences were evident regarding knowledge about conception and contraception. Egalitarian attitudes towards social norms and gender roles were found higher among girls (52%) compared to boys (11%). The majority of adolescents reported experiencing social/verbal bullying (43%), followed by physical violence (38%) and cyberbullying (4%).

This article presents the baseline findings only. A series of papers is in the pipeline for submission to different peer-reviewed journals. The findings from this study will be used to support data-driven policy formulation for future adolescent health programmes.

Gestational diabetes mellitus (GDM) is an emerging public health concern in low and middle-income countries, including Nigeria, because of the associated pregnancy complications, increased healthcare costs and long-term health sequelae among women of reproductive age and their offspring. We determined the cumulative incidence, risk factors and pregnancy outcomes of GDM in Ibadan, Nigeria.

Prospective cohort study.

Ibadan, Southwest Nigeria.

721 pregnant women from the Ibadan Pregnancy Cohort Study participated in the one-step 75 g-oral glucose tolerance test at 24–28 weeks’ gestation.

The primary outcome of the study is the cumulative incidence of GDM. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups criteria. Secondary outcomes were pregnancy outcomes, which included modes of delivery (CS, spontaneous vaginal delivery), macrosomia (birth weight ≥4.0 kg), gestational age at delivery and birth asphyxia. The risk factors (exposures) examined included sociodemographic, obstetric, clinical, behavioural and lifestyle factors. Bivariate and multivariate Log-binomial regression models were used to identify the independent risk factors of GDM (adjusted for maternal age ≥35 years, income, maternal body mass index, history of pregnancy loss and congenital anomaly) and the associated pregnancy outcomes of GDM (adjusted for maternal age, income and maternal body mass index). Adjusted relative risk (aRR) and 95% CI, used to assess the strength of associations, were reported.

The cumulative incidence of GDM was 20.7%, 95% CI (17.9% to 23.9%). The mean time for the diagnosis of GDM is 25.4±1.42 weeks of gestation. After adjusting for other variables, maternal age ≥35 years: (aRR: 1.48). 95% CI (1.07 to 1.97) p=0.016), maternal obesity (aRR: 1.85, 95% CI (1.26 to 2.30) p=0.002) and a previous history of congenital anomaly (aRR: 2.83, 95% CI (1.97 to 4.07) p

The cumulative incidence of GDM is high among pregnant women in Ibadan. Maternal age ≥35 years, maternal obesity and a history of congenital anomaly were significant independent risk factors for GDM. These factors should be targeted for public health interventions, including lifestyle modification among pregnant women with obesity and early screening and diagnosis of GDM.

The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.

A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.

This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.

CRD42023452537.

Canadian guidelines recommend HIV testing for individuals being evaluated for syphilis. Our objective was to examine three aspects of HIV testing (ie, if an HIV test occurred, the timing of the HIV test in relation to the syphilis test and the proportion with a positive HIV test result) among syphilis tests between 2017 and 2022 from individuals with no evidence of a previous HIV diagnosis.

This study is a retrospective analysis of comprehensive laboratory testing data from Ontario’s provincial public health laboratory.

Direct fluorescent antibody (DFA) and serological non-prenatal syphilis tests were conducted from 1 January 2017 to 31 December 2022, from individuals aged ≥15 years with no evidence of a previous HIV diagnosis (n=3 001 058 total tests). Positive syphilis tests were categorised using the rapid plasma reagin (RPR) titre as ‘current’ (DFA+/RPR≥1:8) or ‘historical’ (RPR

The number and proportion of syphilis tests with a corresponding HIV test on the same day or within 7, 28, 90 or 180 days, and, among those with an HIV test within 28 days, the number and proportion with an HIV-positive test result.

From 2017 to 2022, 1 516 726 and 1 484 332 syphilis tests among males and females, respectively, were included in the analysis. Individuals with a positive syphilis result were less likely to be tested for HIV within 28 days of their syphilis test compared with those with a negative syphilis test result (74.7% vs 91.1% in males, 97.5% CI (–0.17 to –0.16); 65.2% vs 92.4% in females, 97.5% CI (–0.28 to –0.26)). Males with ‘current’ positive syphilis test results were less likely than males with ‘historical’ positive syphilis results to be tested for HIV within 28 days (69.1% vs 76.6%, 97.5% CI (–0.084 to –0.066)); this was not true in females (67.1% vs 64.4%, 97.5% CI (0.0062 to 0.049)). Males overall and males with ‘current’ syphilis were more likely to be diagnosed as HIV-positive (p

Most individuals who tested for syphilis at Public Health Ontario were also tested for HIV; however, those who tested positive for syphilis were less likely to be tested, representing an opportunity for enhanced HIV testing. Ensuring that individuals with syphilis are tested for HIV may help identify previously undiagnosed individuals living with HIV.

Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain ‘at risk’ individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.

The ‘Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility’ trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24/NE/0147; ISRCTN61751241). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (‘Rinvoq’, 30 mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the ‘Quintet Recruitment Intervention’, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13/50/17; Research Ethics Commitee reference: 16/LO/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.

This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24/NE/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.

ISRCTN61751241.

Tuberculosis (TB) remains the leading cause of infectious disease deaths, particularly among people living with HIV (PWH). Despite being preventable, TB preventive therapy (TPT) uptake is low in high-burden regions like South Africa, where new guidelines have expanded TPT eligibility and introduced shorter, more effective regimens like 3 months of weekly rifapentine and isoniazid (3HP). As differentiated service delivery models for HIV care have proven effective, there is increasing recognition that decentralising TPT delivery may improve coverage and completion. This study explores whether a community-based TPT delivery strategy can enhance uptake and completion of TPT compared with traditional clinic-based services.

We will conduct a household-randomised, non-blinded, controlled trial. Persons eligible for TPT will be recruited from the TB TRIAGE+Trial study, a community-based household TB screening study. Households containing at least one person eligible for TPT will be randomised 1:1 to either community-based TPT or standard-of-care clinic referral for TPT. At enrolment, all participants will be provided with a 2-week supply of TPT in the community. Participants randomised to the community arm will receive the entire course of TPT in a single dispense (12 weeks of 3HP or 6 months of isoniazid, if 3HP is contraindicated). Clinic-arm participants will be referred to their local clinic for the remainder of their course of TPT and will collect TPT refills on the clinic-determined schedule. Our primary outcome is the proportion of participants who complete a course of TPT. Secondary outcomes include overall adherence to TPT, predictors of adherence with TPT, participant satisfaction with the assigned TPT delivery method and adverse events.

The study and its tools were approved by the Human Sciences Research Councils Research Ethics Committee (approval number: 2/25/10/23), based in Pretoria, Gauteng, South Africa, as well as the University of Washington Institutional Review Board (Study 00018448). Study findings will be shared through the community advisory group and local stakeholder meetings, relevant international and local meetings/conferences and peer-reviewed publications.

NCT06214910. Date and version: 3.0, 30 July 2024.

In the UK, each year, approximately 2250 babies are stillborn, and there are an additional 1150 neonatal deaths. The death of a baby before or shortly after birth is a profoundly distressing experience for women and their families and is invariably followed by a period of grief. Most women who have experienced the loss of a baby will embark on another pregnancy, usually within a year. Parents need specialist support from doctors and midwives in a future pregnancy to reduce the risk of pregnancy complications and meet care and support needs. The Rainbow Clinic aims to meet these needs and was first established in 2013 at Saint Mary’s Hospital, Manchester. Initial studies have shown that this model of care improves pregnancy outcomes, decreases anxiety levels and is associated with a strong social return on investment. The Tommy’s National Rainbow Clinic Study aims to evaluate the care provided within this new model, to examine women’s experiences of care and identify areas of improvement and measure the impact on pregnancy outcomes for mothers and babies.

This is a prospective cohort study, measuring a range of maternal and neonatal outcomes following care in Rainbow Clinic. The primary outcome measure is the frequency of stillbirth in the subsequent pregnancy. Measures of maternal well-being include maternal anxiety and psychological symptoms (assessed using Generalised Anxiety Disorder 2-item screening tool (GAD-2), the Cambridge Worry Scale and the Edinburgh Postnatal Depression Scale). Women’s experiences of attending Rainbow Clinic will be recorded on a standardised patient experience tool. Data will be collected on resource use, including the number of appointments with health professionals and the number of ultrasound scans performed. Up to 2000 participants are expected to be enrolled in this study.

This study was given a favourable ethical opinion by the South Central—Hampshire B Research Ethics Committee (Reference 20/SC/0180). The results will be presented at international conferences and published in peer-reviewed open-access journals. Information from this study will inform the development and evaluation of models of specialist antenatal care for pregnancies after stillbirth and neonatal death.

The study is registered with the clinicaltrials.gov under the registration number NCT04393259.

Around 75 000 people suffer from hip fractures yearly in the United Kingdom (UK) leading to significant mortality and morbidity. Although mortality has dropped from 8% to 5% between 2013 and 2023 after hip fractures, those undergoing surgery for hip fractures have a 30-day readmission rate which has remained stagnant at around 11% over the same decade in the UK.

This study protocol describes a mixed-methods investigation (The ARTHUR Study—avoiding readmission after hip fracture) which aims to understand and offer solutions to prevent avoidable 30-day readmission after hip fracture surgery. The study will focus on two hospitals in acute and community settings in a large urban and ethnically diverse city in the UK.

We describe two work packages.

Work Package One (WP1) involves analysis of 5 year’s worth of routinely collected health data provided by PIONEER, a Health Data Research UK data hub in Acute Care for our local population. Work Package Two (WP2) will involve semistructured interviews with patients, carers or family members as well as non-participant observations of hospital processes to understand systems-based issues related to readmissions after hip fracture surgery. Although recruitment may be an issue, our timeline for recruitment reflects this. We also aim to recruit a diverse population, which has often been under-represented in studies into hip fractures and aim to explore relevant interventions which can be widely generalisable.

This protocol was submitted via IRAS: 330074 and obtained UK NHS REC approval via the West Midlands Coventry and Warwickshire Research Ethics Committee (REC 23/WM/0242) on 25 January 2024. The results of this study will be published in relevant scientific journals and presented at orthopaedic, fragility fracture and geriatric specialty conferences and scientific meetings. A lay summary of the findings will be publicly available on the HRA website.