To explore how urinary (UI) and anal incontinence (AI) affect various aspects of quality of life (QoL) and the risk of depression 6 months postpartum, using patient-reported outcome measures (PROMs).

Prospective cohort study.

Women who gave birth between 2020 and 2022 within a local obstetric collaborative network in the Netherlands, including 13 midwifery practices, 5 maternity care organisations at the primary care level, and 1 secondary teaching hospital.

Prospectively collecting data by using the questionnaires of the International Consortium for Health Outcome Measures Pregnancy and Childbirth set at five moments during pregnancy and postpartum.

Associations between UI, AI, QoL and likelihood of depression based on PROMs collected from questionnaire 6 months postpartum.

Of the 663 women who completed the 6-month postpartum questionnaire, 79 women had severe UI, 71 had severe AI and 45 experienced both. These women reported significantly lower QoL as measured by PROMIS-10: 34 (IQR 30.5–38.5), 34 (IQR 30–39.5), and 32 (IQR 27–35), respectively, compared with a score of 37 (IQR 33–42) for the total population. Additionally, the positive rate for depression screening was notably higher among these groups, with rates of 6%, 10% and 18%, respectively, compared with 3% for the overall group.

In this observational cohort study, we found that severe UI and/or AI 6 months postpartum significantly impact QoL and increase the likelihood of depression, as indicated by PROMs. Our findings emphasise the importance of screening, evaluation and treatment of UI and/or AI to improve the QoL and reduce the risk of depressive disorders for postpartum women.

Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis, health outcomes have improved. This paper evaluates the health system costs and the health-related quality of life implications of these guidelines.

A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015.

Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months.

Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS) and the EuroQoL; healthcare costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life Years (QALYs) were calculated from the EQ-5D utility scores. Cost–utility analysis was performed using the NHS and Social Care perspective.

A total of 49 patients were included; 35 were treated within 48 hours, ‘early’ (median (IQR) 8.25 [3.7–20.5]) and 14 were treated after 48 hours ‘delayed’ (median (IQR) 93.9 [66.7–100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared with 4 (29%) in the delayed group. According to GOS, 10 (29%) had a good recovery in the early treatment group, but only 1 (7%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p

This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment.

To examine health and social service use pre- and post-cochlear implant in adults.

A retrospective cohort study.

All public and private hospitals in Australia.

A total of 3033 adults aged ≥18 years who received a cochlear implant in Australia between 1 January 2014 and 31 December 2018 were included. Participants were followed for 3 years pre-implant date and 3 years post-implant date or until death. Data were sourced from the Person Level Integrated Data Asset.

The study examined the (i) number of visits to general practitioners (GPs), specialists and audiologists; (ii) fee charged, benefit paid and out-of-pocket (OOP) expenses for health services; (iii) personal income; (iv) completion of higher education and post-high school vocational education and training and (v) number of government benefits and concession cards received.

The mean age of adults at cochlear implantation was 63.3 years (SD 16.1). Over the 3 years period before and after implantation, the mean number of GP visits remained stable (24.5 pre-implant vs 24.7 post-implant), specialist visits decreased (6.4 pre-implant vs 5.3 post-implant) and audiologist visits increased (1.7 pre-implant vs 6.6 post-implant). Higher GP visit rates were observed both pre- and post-implantation among females (RR 1.13 vs 1.14), older adults (RR 1.06 vs 1.15), individuals needing assistance with daily activities (RR 1.11 vs 1.12), individuals with chronic health conditions (RR 1.25 vs 1.34), with ≥6 RxRisk comorbidities (RR 2.35 vs 2.22) and adults residing in socio-economically disadvantaged areas (RR 1.64 vs 1.19). Mental health conditions were associated with increased specialist visits pre- and post-implantation (RR 2.57 vs 2.53), while employed individuals had higher specialist visit rates post-implantation (RR 1.58). Average OOP costs for health services decreased by 31.4% post-implant. Government benefits were higher pre-implant (55.6%) than post-implant (44.4%). Females and adults needing assistance with activities of daily living were more likely to seek government benefits.

These findings highlight the need for tailored healthcare and social support services to address the diverse needs of cochlear implant users, ensuring comprehensive care and support throughout their healthcare journey.

The emergency department (ED) often serves as a crucial pathway for cancer diagnosis. However, little is known about the management of patients with new suspected cancer diagnoses in the ED. The objective of this study was to explore emergency physicians’ experiences in managing patients with a newly suspected cancer diagnosis in the ED.

Between January and April 2024, we conducted a qualitative descriptive study. Interviews were conducted by trained research personnel using a semistructured interview guide. Interviews were conducted until thematic saturation was achieved. The interview transcripts were coded and thematic analysis was used to uncover key themes.

Emergency physicians practising in Ontario, Canada.

20 emergency physicians were interviewed. Four themes around the management of patients with new suspected cancer diagnoses in the ED were identified: (1) healthcare system-level factors that impact suspected cancer diagnosis through the ED, (2) institutional and provider-level challenges associated with managing patients with a suspected cancer diagnosis in the ED, (3) patient-level characteristics and experiences of receiving a cancer diagnosis in the ED and (4) the need for care coordination for patients with suspected cancer in the ED.

Physicians experienced several unique challenges in managing patients with a suspected cancer diagnosis in the ED. Overall, the findings of this study suggest these challenges often make the ED a difficult environment in which to deliver a suspected cancer diagnosis.

To seek consensus among global experts on concepts, measures and approaches to guide national and global action to address HIV-related stigma and formulate a call to action. This outlines priorities to unite actors in more effectively responding to and resourcing efforts to address HIV-related stigma.

An adapted Delphi consensus-building process using two rounds of online questionnaires.

Online questionnaires sent to a global expert panel.

50 global experts on HIV-related stigma and discrimination representing sectors including civil society, people living with HIV and key populations, research and academia, clinical practice, law, non-profit organisations, the United Nations, and policy and donor organisations.

The panel reached consensus on 55 points relating to the 12 broad themes extracted from the evidence base. These comprised the importance of addressing HIV-related stigma at scale; HIV-related stigma terms and definitions; Frameworks; Programming and approaches; Community leadership in HIV-related stigma-reduction implementation; Intersectional stigma and discrimination; Stigma and discrimination measures and assessment scales; Monitoring and evaluation; Stakeholder and community participation in monitoring and evaluation; Knowledge gaps and research needs; Funding and Commitment calls. From these, a consensus statement and call to action were formulated on priorities for strong political and financial commitments by all countries to reduce and mitigate HIV-related stigma and achieve global HIV targets adopted in 2021.

This study illustrated that global experts across sectors consider that action is needed to support the three critical enablers of the HIV response—society, systems and services—to ensure that HIV services are non-discriminatory and person-centred. The importance of attention and action to reduce stigma is critical in the current geopolitical and funding crisis affecting HIV and global health.

Excessive sedentary behaviour (SB) is highly prevalent among children and adolescents and young adults (AYAs) treated for cancer. Although SB is associated with adverse health outcomes in adults with cancer, little is known about SB in younger cancer patients and survivors. In this scoping review, we aim to summarise current literature on (1) the association between SB and clinical outcomes and (2) results of intervention trials to reduce SB, specifically in paediatric and AYA cancer patients and survivors.

The scoping review will follow the five stages described in the Arksey and O’Malley methodology framework. We will conduct a comprehensive search in five varied electronic databases (PubMed, Embase, Web of Science, CINAHL and SportDiscus) for original articles published in peer-reviewed journals since 1 January 2000, and search reference lists of identified articles and previous review articles. All original research article types will be considered (ie, cross-sectional, cohort, interventional trials). Two reviewers will independently screen all articles based on predetermined inclusion and exclusion criteria, including (1) more than half the sample at the time of study must have been children (0–14 years old) and/or adolescent and young adults (AYAs, 15–39-year old) who were being or had been previously treated for cancer and (2) reporting of SB. Data will be extracted as a descriptive and quantitative summary of each study’s key characteristics and results. Study-specific quality assessment will be performed using established tools. Results will be presented in evidence tables with an accompanying narrative summary.

Ethics approval is not required as only publicly available data will be analysed. Results will be published in a peer-reviewed journal and may be presented at a scientific conference.

The protocol is registered in Open Science Framework (https://osf.io/ua8z9).

Endovascular therapy is the main treatment for chronic limb-threatening ischaemia in the UK. Despite a restenosis risk of 50% over 2 years, reintervention rates are low, potentially resulting in preventable amputations. European guidelines recommend ultrasound surveillance to facilitate early treatment of restenosis. This study will investigate the use of duplex ultrasound after endo revascularisation (DUSTER). The aim is to assess the feasibility, acceptability and impact on clinical decision-making of a 1-year integrated ultrasound surveillance programme after lower limb endovascular therapy.

DUSTER is a mixed-methods study. Phase I is a three-site, feasibility, open-label, randomised controlled trial. The standard of care, the control arm, is standard clinical surveillance by a vascular specialist at 1, 6 and 12 months. The intervention arm will receive integrated ultrasound (ankle-brachial pressure index, toe pressure and duplex) plus standard clinical surveillance. Primary outcomes are rates of attendance and completion of ultrasound surveillance tests, as well as the percentage of participants undergoing reintervention for restenosis. Secondary outcomes are limb salvage, amputation-free survival, reasons for amputation, complications, serious adverse events and mortality.

Phase II comprises independent semistructured interviews with intervention arm participants. The interviews will explore barriers and facilitators to ultrasound surveillance and the effect of ultrasound surveillance on patients’ lives.

Phase III has two separate focus groups for participants and clinical stakeholders to identify which outcomes matter most in any subsequent large-scale effectiveness trials.

This research has been approved by a UK (West Midlands, Black Country) Research Ethics Committee (reference 24/WM/0232) and the Health Research Authority (IRAS 349192). Dissemination of results will be by the DUSTER co-investigators in peer-reviewed journals, to the National Institute for Health and Care Research and to a lay audience via the Mid and South Essex NHS Foundations Trust website.

NCT06702306.

There is high interest in long-acting injectable antiretroviral therapy (LAI-ART) among people with HIV (PWH), with many conveniences for uptake and persistence. However, both patients and clinicians have expressed important barriers to effective implementation, including concerns about frequent clinic visits and strain on clinic resources. Administration of LAI-ART by a trained layperson injector (such as family, friend or partner of the patient) can help mitigate some of these patient-identified and clinician-identified barriers. Alternative LAI-ART delivery methods have the potential to increase the PWH and layperson injector’s confidence, empowerment, convenience, privacy and self-management skills and ultimately facilitate LAI-ART uptake and persistence.

INVITE-Home (innovative administration of long-acting injectables for HIV treatment enhancement at home) will support the expansion of LAI-ART in non-clinical settings by developing, implementing and evaluating a comprehensive, theory-informed training to support the administration of LAI-ART by a trained layperson injector. First, INVITE-Home will design and develop an innovative, theory-based layperson injector training to improve acceptability and uptake of LAI-ART in home-based settings, grounded in qualitative evaluation of training barriers and needs of PWH, layperson injectors and clinicians to develop the training. In Aim 2, INVITE-Home will enhance understanding of home-based LAI-ART using the training, by examining implementation and effectiveness of home-based LAI-ART injections.

This study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board and the scientific staff of HIV Research Branch, Division of HIV Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, at the Centers for Disease Control and Prevention. Study staff will disseminate findings locally (eg, to partnering clinics, via the UCSF Center for AIDS Prevention Studies’ Community Engagement Core), statewide (eg, the California Department of Public Health’s Office of AIDS) and nationally at conferences related to HIV.

NCT06488846.

Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.

A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).

This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.

Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).

Vaccination against SARS-CoV-2 was a crucial public health measure during the COVID-19 pandemic. Among the multiple strategies developed to increase vaccine uptake, governments often employed vaccine mandates. However, little evidence exists globally about the impact of these mandates and their subsequent removal on vaccine uptake, including in Australia, France, Italy and the USA. The aim of this study is to provide a protocol to evaluate and quantify the impact of COVID-19 vaccine mandates and removals on vaccine uptake in these countries, with a specific focus on comparing Australian policies with those from Europe and the USA. Actualising the work outlined in this protocol will help to provide policy and technical guidance for future pandemic preparedness and routine immunisation programmes.

This protocol outlines a retrospective study using existing data sources including Australian Immunisation Register-Person Level Integrated Data Asset for Australia and publicly available data for France, Italy and California (USA). Causal inference methods such as interrupted time series, regression discontinuity design, difference-in-differences, matching and synthetic control will be employed to assess the estimated effects of vaccine mandates and removals on vaccine uptake.

The University of Newcastle’s human research ethics committee has approved the study (reference number: H-2024-0160). Peer-reviewed papers will be submitted, and results will be presented at public health, immunisation and health economic conferences nationally and internationally. A lay summary will be published on the MandEval website.

Fertility therapies are becoming an increasingly common option for conception, but there is little knowledge on the interactions of assisted reproductive technology (ARTs) and stroke in women, and its use among women with a history of stroke. This scoping review aims to examine the current state of knowledge and identify the knowledge gaps regarding: (1) the stroke risk with use of fertility therapy and (2) the safety of fertility therapy among stroke survivors, to help guide future research and clinical practice.

The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist for scoping reviews was followed.

MEDLINE (Ovid), Cochrane Central Registry of Controlled Trials (Ovid), EMBASE (Ovid), Medline, ClinicalTrials.gov and International Clinical Trials Registry Platform were searched through 20 June 2023.

All observational studies pertaining to use of fertility and stroke in humans over the age of 18 were included in this review.

Title and abstract and subsequent full-text review were performed by two independent reviewers in duplicate. A narrative synthesis of final articles for data abstraction is presented.

10 studies met inclusion criteria. The only meta-analysis that was included could not estimate the risk of stroke among all individuals undergoing fertility therapy due to lack of high-quality prospective cohort studies. There was only one prospective cohort that examined pregnancy among stroke survivors. Among the 32 pregnancies, one was conceived through in vitro fertilisation (IVF), although the details regarding stroke type, time since stroke, medications and IVF protocol were not specified. Therefore, the safety and effectiveness of ART among stroke survivors is currently unknown.

In this comprehensive review of existing fertility therapy science and stroke risk, we identify a large knowledge gap and a major scientific need for a systematic approach and prospective studies to better inform the risk of stroke during fertility therapy, especially among stroke survivors. Understanding this risk and developing treatment strategies serves to better inform women and healthcare providers as more women with a history of stroke seek and contemplate fertility therapy.

DOI 10.17605/OSF.IO/PHQ4X

To provide expert consensus recommendations to support health systems in England to improve prioritisation and implementation of cardiovascular and renal risk-based type 2 diabetes (T2D) care, achieving quality improvement in line with the National Institute for Health and Care Excellence (NICE) NG28 guideline.

A two-round modified Delphi panel was conducted.

Participants represented health system leadership from a cross-section of integrated care systems across England. Delphi panel statements were relevant to both primary and secondary care.

A panel of 28 participants took part in the Delphi panel (10.7% drop-off rate between rounds). Statement development was guided by a separate committee of 11 topic experts, forming the Implementing NICE NG28 by harnessing Opportunities for adVanced integrated cAre Transformation and Excellence (INNOVATE)-28 Working Group.

In total, 84% (n=32/38) statements reached consensus across both Delphi rounds. There was agreement that health systems need to prioritise prevention of cardiovascular and renal complications in T2D, particularly for those at ‘high’ or at ‘rising’ cardiovascular and renal risk. Consensus was also reached that quality improvement should be incentivised based on local population needs, with investment into digital systems and supporting roles to aid this. Panellists further agreed that investment should be channelled into community-led resources to reinforce a preventative approach and help to ensure people living with T2D receive care in the most appropriate setting. Finally, collaboration between health and social care, health innovation networks and industry partners was highlighted as an opportunity to leverage support for the delivery of risk-based T2D care.

The recommendations from this Delphi panel are intended to support health systems to consistently implement the NG28 guideline and facilitate quality improvement to deliver equitable T2D care and mitigate cardiovascular and renal risk. By being innovative and bold with commissioning and ways of working, and leveraging partnerships, health system leaders can enact the transformational and sustainable change needed to improve outcomes for people living with T2D, tackle healthcare inequalities and optimise system resilience.

The aim of this study was to explore the features of high-quality rural health student placements from the perspective of university staff involved in designing, delivering and evaluating these programmes.

A sequential explanatory mixed methods design was employed, integrating quantitative survey data with qualitative interview findings to provide a comprehensive understanding of the research question.

The study was conducted online and sampled staff from universities across Australia, focusing on rural health student placements. The study involved 121 university staff members who participated in the survey, with 10 of these participants also taking part in follow-up qualitative interviews.

Quantitative data were collected using an online survey distributed to university staff involved in designing, delivering and evaluating rural health student placements. The survey included Likert scale, open-ended and demographic questions, and a preliminary analysis was used to write the interview questions. Qualitative data were gathered through semi-structured interviews, which were transcribed and analysed using the Framework approach. The quantitative and qualitative results were integrated to produce a narrative summary of findings.

Key features identified as essential for high-quality rural health placements included safe and affordable accommodation, financial support and personal safety. High-quality supervision, cultural awareness training and opportunities for interprofessional education were also highlighted. The qualitative findings provided depth to the quantitative data, emphasising the importance of structuring learning within a continuum of education and fostering connections through co-location and community engagement.

This study identifies fundamental features of high-quality rural health placements in Australia, including accommodation, student safety, supervision and cultural responsiveness training. These findings can inform the design, delivery and evaluation of rural health student placements, contributing to the quality of these programmes as an efficacious learning experience.

Around 80% of the world’s smokers live in lower-middle income countries and smoking rates in China, Philippines and Indonesia are very high. Evidence suggests that most people begin smoking or become habitual smokers before reaching adulthood. This highlights the need for a smoking prevention intervention focused on young people. ASSIST (A Stop Smoking In Schools Trial) is a ‘peer-led’, school-based smoking prevention intervention, shown to be effective in the UK. The aim of the study is to assess the feasibility of conducting a full-scale effectiveness evaluation of an adapted version of the ASSIST intervention in China, Indonesia or the Philippines. However, due to issues with obtaining relevant approvals, China was removed from the trial with the approval of the funder and Trial Steering Committee, and the study will only be completed in Indonesia and the Philippines.

A feasibility mixed-methods cluster randomised controlled trial in 10 schools (six intervention, four control) in each of the two countries. Participants will be students aged c13–14 in mainstream (‘lower secondary’) schools. In addition to their usual education on smoking, intervention schools will receive the ASSIST intervention which is based on ‘diffusion of innovation’ theory, with new norms and behaviours promoted through: (1) peer modelling by locally influential individuals; and (2) information disseminated by them through their social networks. Control schools will continue with their usual education around smoking prevention.

The key outcome of the study is whether prespecified progression criteria relating to recruitment, retention, acceptability and feasibility have been met in order to progress to a larger cluster randomised controlled effectiveness trial in one or more of the countries. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery, exposure to and reach of the intervention. The feasibility of trial processes including outcome measurement will be assessed. An economic evaluation will estimate the costs of the ASSIST intervention. Statistical analyses will focus on feasibility criteria, and qualitative data will be analysed using a framework approach. Outcomes assessed will include self-reported smoking behaviour (own and that of friends and family); vaping and other forms of nicotine use; smoking-related attitudes and knowledge; smoking norms; self-esteem; self-efficacy; (all at baseline and 7 month follow-up) and exhaled carbon monoxide concentration (at follow-up only).

The trial has been approved by the University of Glasgow College of Medical, Veterinary and Life Sciences (MVLS) Ethics Committee (ref: 200210204), the De La Salle University Research Ethics Review Committee (ref: 2023-012C) and the Medical and Health Research Ethics Committee (MHREC); Faculty of Medicine, Public Health and Nursing; Universitas Gadjah Mada (ref: KE/FK/1205/EC/2022). The trial is sponsored by the University of Glasgow (Head of Research Regulation and Compliance—debra.stuart@glasgow.ac.uk). The sponsor will not have input in data collection, management, analysis and interpretation; write up and submissions for publication.

The study findings will be disseminated through peer-reviewed publications in expert journals and conference presentations and targeted communications to schools, policymakers and the public.

ISRCTN99140476.

Young people (YP) whose parents have depression are at elevated risk for developing depression themselves and could benefit from preventive interventions. However, when parents are in a depressive episode, this reduces the effects of psychological interventions for depression in YP. Moreover, parental depression is often managed suboptimally in usual care. There is, therefore, a case for identifying and optimising parental depression treatment to enhance the effectiveness of psychological preventive interventions for depression in YP.

This is a randomised controlled trial (Skills for adolescent WELLbeing) to determine the effectiveness of a cognitive behavioural therapy (CBT) intervention compared with usual care in increasing the time to a major depressive episode in YP by 9-month follow-up (primary outcome). The intervention offers a 12-week treatment-optimisation phase for parents depressed at study entry, followed by randomisation of the young person to a small group manualised online CBT programme facilitated by a therapist. YP allocated to the intervention will receive eight weekly sessions plus three monthly continuation sessions. Secondary outcomes include the number of depression-free weeks, mental health symptoms and functioning. Mechanisms of intervention action will be assessed with mediation analysis of quantitative data and thematic analysis of qualitative interviews. Participants (parents/carers with depression and their children aged 13–19 years) will be identified through existing cohorts of adults with depression, from primary care through health boards in Wales and England, UK, schools and advertising including via social media.

The trial has received ethical approval from Wales NHS Research Ethics Committee (REC) 5, the Health Research Authority and Health and Care Research Wales (IRAS 305331; REC 22/WA/0254). This manuscript is based on V.5.7 of the protocol (17 January 2025). Findings will be disseminated in peer-reviewed journals and conferences. Reports and social media messages will be used to disseminate findings to the wider public.

ISRCTN13924193 (date registered: 15 March 2023).

It is unclear whether routine testing of women for group B streptococcus (GBS) colonisation either in late pregnancy or during labour reduces early-onset neonatal sepsis, compared with a risk factor-based strategy.

Cluster randomised trial.

320 000 women from up to 80 hospital maternity units.

Sites will be randomised 1:1 to a routine testing strategy or the risk factor-based strategy, using a web-based minimisation algorithm. A second-level randomisation allocates routine testing sites to either antenatal enriched culture medium testing or intrapartum rapid testing. Intrapartum antibiotic prophylaxis will be offered if a test is positive for GBS, or if a maternal risk factor for early-onset GBS infection in her baby is identified before or during labour. Economic and acceptability evaluations will be embedded within the trial design.

The primary outcome is all-cause early (

The trial received a favourable opinion from Derby Research Ethics Committee on 16 September 2019 (19/EM/0253). The allocated testing strategy will be adopted as standard clinical practice by the site. Women in the routine testing sites will give verbal consent for the test. The trial will use routinely collected data retrieved from National Health Service databases, supplemented with limited participant-level collection of process outcomes. Individual written consent will not be sought. The trial results, and parallel economic, qualitative, implementation and methodological results, will be published in the journal Health Technology Assessment.

ISRCTN49639731.

The PREgnancy Care Integrating translational Science, Everywhere Network was established to investigate specific placental disorders (pregnancy hypertension, preterm birth, fetal growth restriction and stillbirth) in sub-Saharan Africa. We created a repository of clinical and social data with associated biological samples from pregnant and non-pregnant women. Alongside this, local infrastructure and expertise in the field of maternal and child health research were enhanced.

Pregnant women were recruited in participating health facilities in The Gambia, Kenya and Mozambique at their first antenatal visit or at the time a placental disorder was diagnosed (Kenya and The Gambia only). Follow-up study visits were conducted in the third trimester, delivery and 6 weeks to 6 months postpartum. To elucidate the difference between pregnancy and non-pregnancy biology in these settings, non-pregnant nulliparous and parous women, aged 16–49 years, were recruited opportunistically primarily from family planning clinics in Kenya and Mozambique, and randomly through the Health and Demographic Surveillance System in The Gambia. Non-pregnant participants only had one study visit. Biological samples were processed rapidly and locally, stored initially in liquid nitrogen and then at –80°C, and details entered into an OpenSpecimen database linked to their social determinants and clinical research data.

A total of 6932 pregnant and 1825 non-pregnant women were recruited to the study, providing a repository of clinical and social data and a biorepository of 482 448 samples. To date, baseline descriptive analysis of the cohort has been undertaken, as well as a substudy on the prevalence of COVID-19 in the cohort.

Analysis of data and samples will include an analysis of biomarker and social and physical determinants of health and how these interact in a systemic approach to understanding the origins of common placental disorders. The data from non-pregnant women will provide control data for comparison with the data from normal and complicated pregnancies. Findings will be disseminated to local stakeholders and communities through meetings and ongoing community engagement and globally by publication and presentations at scientific meetings.

Chest pain is a major cause of emergency ambulance calls, often linked to acute myocardial infarction (AMI), a critical condition requiring immediate hospitalisation. Current diagnostic methods, such as history taking and ECG, have limitations, especially for non-ST-elevation myocardial infarction. High-sensitivity cardiac troponin (cTn) assays are more diagnostically sensitive, but the downside is that it needs hospital-based testing, which can delay diagnosis and the necessary treatment protocol. Point-of-care cTn testing, on the other hand, is much faster and done nearer to the patient; hence, it may fundamentally change the prehospital care pathway in terms of diagnostic accuracy, clinical utility and related safety.

To present a protocol for a systematic review and meta-analysis that will assess the diagnostic accuracy, clinical utility and safety of point of care (POC) troponin tests, with or without clinical decision aids, for ruling out AMI in adults presenting with cardiac chest pain to emergency ambulance services in prehospital settings.

This protocol follows BMJ guidelines and adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 reporting standards. It is registered with PROSPERO (ID: CRD42024533117). A comprehensive search strategy will identify relevant studies in MEDLINE, EMBASE and CINAHL, focusing on literature from 2000 onwards. Eligibility criteria include adults with chest pain suspected of AMI, excluding those with ST-elevation myocardial infarction. The primary target is type 1 AMI, with secondary outcomes including major adverse cardiac events at 30 days. Risk of bias assessment will be performed using tools such as Quality Assessment of Diagnostic Accuracy Studies version 2, Risk of Bias 2, and Risk of Bias in Non-randomised Studies of Interventions, while the quality of the economic evaluations will be appraised using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Data items extracted will include patient demographics, test characteristics and outcomes. Where possible, meta-analyses will be conducted by fitting hierarchical models for diagnostic accuracy and random effects models for clinical and cost-effectiveness estimates. Subgroup analyses are proposed to quantify the effect of variables such as gender, ethnicity and type of troponin assay on the estimated parameters.

Ethical approval is not required. The results will be published in a peer-reviewed journal and presented at international conferences.

This protocol is registered with PROSPERO, the International Prospective Register of Systematic Reviews, under the ID CRD42024533117. Any future amendments will be updated in the PROSPERO record.