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.

Approximately 1 in 13 Australian children have a neurodevelopmental disability. This project aims to assess the effectiveness and implementation of an online parenting support programme, Parenting Acceptance and Commitment Therapy (PACT) Online, for parents of children with neurodevelopmental disabilities for improving the parent–child relationship and parent and child outcomes.

This hybrid type 1 randomised controlled trial will focus on evaluating intervention effectiveness and understanding the context for implementation. The primary outcome is observed emotional availability within parent–child interactions assessed at postintervention (12 weeks postbaseline) with additional measurement at follow-up (6 months postbaseline). Secondary outcomes include (1) parent-reported emotional availability, (2) parental mindfulness, (3) parent mental health, (4) psychological flexibility, (5) adjustment to child’s disability, (6) health behaviour and (7) regulatory abilities as well as child outcomes of (1) mental health, (2) adaptive behaviour and (3) regulatory abilities. Evaluation of implementation will include an economic evaluation of costs and consequences, and an implementation analysis grounded in the consolidated framework for implementation research with a focus on contextual factors influencing implementation.

Ethical approval has been obtained from the University of Queensland Human Research Ethics Committee (023/HE000040). Dissemination of study outcomes will occur through the appropriate scientific channels. Long-term implementation will be grounded within the implementation analysis and occur in partnership with the partner organisations and consumer engagement panel. This will include releasing the PACT Online intervention as a massive open online course on the edX platform if support for intervention effectiveness and implementation is found.

ACTRN12623000612617; this trial has been registered with the Australian New Zealand Clinical Trials Registry.

Breast cancer is the most common form of cancer in women. A considerable number of women with breast cancer who have been treated with chemotherapy subsequently develop neurological symptoms such as concentration and memory difficulties (also known as ‘chemobrain’). Currently, there are no validated therapeutic approaches available to treat these symptoms. Cognitive training holds the potential to counteract cognitive impairment. Combining cognitive training with concurrent transcranial direct current stimulation (tDCS) could enhance and maintain the effects of this training, potentially providing a new approach to treat post-chemotherapy subjective cognitive impairment (PCSCI). With this study, we aim to investigate the effects of multi-session tDCS over the left dorsolateral prefrontal cortex in combination with cognitive training on cognition and quality of life in women with PCSCI.

The Neuromod-PCSCI trial is a monocentric, randomised, double-blind, placebo-controlled study. Fifty-two women with PCSCI after breast cancer therapy will receive a 3-week tDCS-assisted cognitive training with anodal tDCS over the left dorsolateral prefrontal cortex (target intervention), compared with cognitive training plus sham tDCS (control intervention). Cognitive training will consist of a letter updating task. Primary outcome will be the performance in an untrained task (n-back task) after training. In addition, feasibility, safety and tolerability, as well as quality of life and performance in additional untrained tasks will be investigated. A follow-up visit will be performed 1 month after intervention to assess possible long-term effects. In an exploratory approach, structural and functional MRI will be acquired before the intervention and at post-intervention to identify possible neural predictors for successful intervention.

Ethical approval was granted by the ethics committee of the University Medicine Greifswald (BB236/20). Results will be available through publications in peer-reviewed journals and presentations at national and international conferences.

ClinicalTrials.gov; NCT04817566, registered on 26 March 2021.

Recessive dystrophic epidermolysis bullosa (RDEB) is a severe genetic mucocutaneous fragility disorder characterised by chronic blistering, slow wound healing and increased risk of squamous cell carcinoma. Current management options are very limited.

This is a randomised (1:1), placebo-controlled, double-blinded crossover (A/B) trial with an internal phase I dose de-escalation (4+5 design) in the first 3 months and a 12-month continued treatment follow-on open-label study if 3-month outcome data from the crossover trial indicate safe and beneficial effects. RDEB is a rare condition, so we expect to recruit a maximum of 36 participants based on feasibility and not formal power considerations. Participants aged>6 months and x10⁶ cells/kg intravenous infusion of umbilical cord-derived mesenchymal stem cells or placebo at the start of each crossover period (day 0) and 14 days later. The dose will be de-escalated to 1–1.5x10⁶ cells/kg depending on observed toxicity. For the main crossover trial, the primary outcome is the change in disease severity as measured by the Epidermolysis Bullosa Disease Activity and Scarring Index at 3 months from day 0 infusion. Secondary outcomes measured at 3 and 6 months from day 0 infusion include changes in general clinical appearance of skin disease, pain and itch, and quality of life. Adverse events and serious adverse events will be monitored throughout the trial.

North East—York Research Ethics Committee approved the protocol (ref: 21/NE/0016) on 16 March 2021. Findings will be published in peer-reviewed scientific journals, presented at relevant national and international conferences, and an open-access final report submitted to the funder.

ISRCTN14409785. Protocol V. 8.0, 14 November 2022.

Stillbirth and second trimester miscarriage have wide-reaching consequences for women, their partners and their families. There is currently little community-based care provision within the National Health Service for women and partners who have had a stillbirth or second trimester miscarriage. There is a research gap in the evidence to guide best practice. This review will seek to understand how, when and where this care is best delivered.

The aim of this review is to identify the key elements of community-based care following a stillbirth or second trimester miscarriage. As this is a complex intervention, a realist approach will be used to establish for whom, how, when and where this care is best delivered. An initial programme theory will be constructed which will be tested against the available evidence and refined. A wide range of evidence including qualitative, quantitative, mixed-methods and experiential knowledge will be identified through secondary sources, extracted and synthesised to develop and refine the programme theory.

This review will not require ethical approval as it does not involve primary data collection. The findings will be submitted for open-access publication to a peer-reviewed journal and disseminated to stakeholders.

CRD42024587365.

Vast empirical evidence highlights the importance of early identification, diagnosis and support for autistic children. Caregivers of autistic children often experience high levels of psychological distress; hence there is a need for parallel child and caregiver support. Autism New Zealand’s Let’s Play programme is a caregiver-mediated, community-based programme based on the principles of developmental and relational interventions (henceforth, developmental). Developmental interventions are evidence-based supports designed to enhance children’s learning within the context of developmentally appropriate, naturalistic settings (eg, everyday routines, play). We aim to evaluate the effects of the Let’s Play programme on autistic children’s engagement and caregiver stress.

This study will be a single-blind (rater) randomised controlled trial with two parallel arms: immediate programme access (intervention) versus a waitlist control. Participants will be 64 caregivers of children aged 0–5 years with diagnosed or suspected autism, allowing for 20% attrition, based on power calculations. The Let’s Play programme will be delivered over 9 weeks using a combination of small group workshops and in-home coaching. Primary outcome variables include child engagement and caregiver stress. Caregivers will complete measures at three time points (baseline, immediately post-programme and at the 6-month follow-up), and effectiveness will be analysed using generalised estimating equation models and intention-to-treat and per protocol analyses.

This trial was approved by Aotearoa New Zealand Ministry of Health’s Health and Disability Ethics Committee (2022 FULL 13041). Findings will be communicated nationally and internationally via conferences, journal publications and stakeholder groups (eg, service providers for autistic children). Results will be shared regardless of magnitude or direction of effect.

ACTRN12622001139763.

To establish the prevalence of clinically significant chronic obstructive pulmonary disease (COPD) and relevant characteristics in individuals with a significant smoking history who are hospitalised for acute myocardial infarction (MI).

Cross-sectional study.

Hospital inpatients at 8 European centres (7 in Sweden, 1 in the UK).

518 men or women (302 in Sweden, 216 in the UK) hospitalised for acute MI, aged 40 years or older, with a smoking history of at least 10 pack-years.

The primary outcome was prevalence of detected significant COPD (Global Initiative for Chronic Obstructive Lung Disease stages 2–4), defined as a ratio of forced expiratory volume in 1 and 6 s (FEV₁/FEV₆) 1

The prevalence of significant COPD was 91/518 (18% (95% CI 14 to 21)) with no difference between the countries. Of those with detected significant COPD, 69 (76%) had no previous COPD diagnosis. A CAT score >10 was found in 65%, and a blood eosinophil count of ≥100/mm³ and ≥300/mm³ was found in 76% and 20%, respectively. Inhaled corticosteroids were used by 15% of the patients.

In a cohort of patients hospitalised for acute MI in Sweden and the UK, one in five patients with a history of smoking was found to have significant COPD based on microspirometry. Symptom burden was high and treatment rates with ICS low. Among those diagnosed with COPD, three out of four had not been previously diagnosed with COPD.