Promoting smoking cessation and preventing relapse to tobacco use following a smoke-free mental health inpatient stay (SCEPTRE feasibility study): a multicentre randomised controlled feasibility study protocol

Introduction
Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health Trusts presently invest substantial effort and resources to implement smoke-free policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help those who smoke remain abstinent or quit smoking during their smoke-free inpatient stay and beyond. At present, little is known about how best to support patients to prevent their return to pre-admission smoking behaviours after discharge from a smoke-free mental health inpatient stay. We have developed an intervention which includes targeted resources to support smoking-related behaviour change in patients following discharge from a smoke-free mental health setting. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the SCEPTRE intervention, compared with usual care.

Methods and analysis
This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (≥18 years) admitted to an acute adult mental health inpatient setting who smoke tobacco on admission, or at any point during their inpatient stay. Consenting participants will be randomised to receive a 12-week intervention consisting of components aimed at promoting or maintaining positive smoking-related behaviour change following discharge from a smoke-free mental health inpatient setting or usual care. Data will be collected at baseline, 3 months and a second timepoint between 4 and 6 months post-randomisation. With 64 participants (32 in each group), the trial will allow a participation rate of 15% and completion rate of 80% to be estimated within a 95% CI of ±3% and ±10%, respectively. The analysis will be descriptive and follow a prespecified plan.

Ethics and dissemination
Ethics approval was obtained from the North West—Greater Manchester West Research Ethics Committee. We will share results widely through local, national and international academic, clinical and patient and public involvement networks. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: https://sceptreresearch.com/.

Trial registration number
ISRCTN77855199.

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Effect of prednisolone on live birth rate in women with unexplained recurrent pregnancy loss: a study protocol for a double-blind, placebo-controlled, multicentre, randomised controlled trial (PREMI-study)

Introduction
Recurrent pregnancy loss (RPL) is defined as the occurrence of two or more spontaneous pregnancy losses from the time of conception until 24 weeks of gestation. Currently, an underlying cause can be identified in only a minority of the losses. Potentially, an impaired maternal immune response targeting the semiallograft pregnancy may lead to miscarriage. While prior studies have explored the use of immune-suppressing corticosteroids to modulate the maternal immune system and hopefully improve pregnancy outcome, the absence of sufficiently powered randomised controlled trials (RCT) underscores the need for further research. The primary aim of this study is to evaluate if prednisolone administration in early pregnancy (20 mg daily for 6 weeks, then tapering doses for 2 weeks) in women with unexplained RPL leads to a higher live birth rate (LBR) in comparison to placebo. Additionally, the study assesses the tolerability, safety and the cost-effectiveness of this intervention. Finally, we will explore the effect of prednisolone in various subgroups (based on maternal age, number of previous pregnancy losses, presence of specific antibodies and pre-pregnancy endometrial immune cell level).

Methods and analysis
This ongoing multicentre, double-blind RCT will randomise 490 women with unexplained RPL and pregnancy

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Validation of salivary uric acid remote self-monitoring for early prediction of hypertensive disorders of pregnancy: study protocol for a prospective, observational, multicentre cohort study

Introduction
Hypertensive disorders of pregnancy (HDP), including gestational hypertension and pre-eclampsia, affect approximately 10% of pregnancies worldwide and contribute significantly to fetal and maternal morbidity and mortality. Early identification of HDP would facilitate targeted surveillance and personalised care in order to mitigate the severity of complications and improve pregnancy outcomes. Uric acid is a marker of oxidative stress, inflammation and endothelial dysfunction, and has been proposed as a predictor of hypertensive disease. Salurate is a salivary uric acid test that has the potential to identify pregnant women at risk of developing HDP several weeks before clinical manifestation.

Methods and analysis
This is a prospective, multicentre, observational, cohort study with health economics evaluation. Women aged 16 and above, with a viable singleton pregnancy at 1:300 will be eligible for recruitment. Participants will perform weekly remote salivary uric acid testing from enrolment until the conclusion of pregnancy and upload results of colourimetric paper tests via a smartphone application. We will validate a predictive algorithm that analyses colour data from several consecutive samples to detect patterns that predict whether HDP is likely to occur. The primary outcome is test performance for the prediction of HDP. Secondary outcomes include adherence to sampling and test performance for predicting gestational diabetes, stillbirth and fetal growth restriction. Data on pregnancy outcomes will be collected from the medical notes, compared with the predictions made by the algorithm and subjected to statistical analysis.

Ethics and dissemination
Approval has been obtained from Cambridge East Research Ethics Committee (REC reference 24/EE/0123), Medicines and Healthcare products Regulatory Agency (CI/2024/0038/GB) and Health Research Authority (IRAS ID 337290). Results of the study will be published in peer-reviewed journals and presented at national and international conferences.

Trial registration number
ISRCTN17992452.

Protocol version
4, 4 July 2024.

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Cohort profile: Mother and Infant Metabolome and Microbiome (MIMM) study, a prospective cohort study of mothers and infants in Boston, Massachusetts

Purpose
Breastfeeding is beneficial to the health of both the mother and infant. Despite recommendations to breastfeed by organisations including the WHO and the American Academy of Pediatrics, rates of breastfeeding remain below public health goals. The Mother and Infant Metabolome and Microbiome (MIMM) study is a prospective cohort study of healthy mother-term infant dyads designed to comprehensively assess the perinatal, maternal, neonatal and infant factors that are associated with breastfeeding outcomes and human milk composition.

Participants
MIMM participants were recruited from two medical centres in Boston, Massachusetts, from 2019 to 2023 and are followed for 2 years. Dyads were included if the mother delivered a singleton infant at ≥37 weeks’ gestation, was discharged home

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Validation of urinary biomarkers for accurate diagnosis of urinary tract infections in older adults across primary care, hospitals and long-term care facilities in the Netherlands and UK (UTI-GOLD): a multicentre observational study protocol

Introduction
Urinary tract infections (UTIs) are highly prevalent and pose a significant burden among older adults. Accurate diagnosis in this population is challenging due to the high prevalence of pre-existing lower urinary tract symptoms, inability to express symptoms and asymptomatic bacteriuria. Current diagnostic tests are unreliable, often resulting in over- and underdiagnosis. A previous pilot study proposed a higher cut-off for pyuria and identified five promising biomarkers for the diagnosis of UTIs in older adults. The UTI-GOLD study aims to validate these five new biomarkers and the higher leucocyte cut-off as a diagnostic tool for UTIs in older people in a real-world setting.

Methods and analysis
Between August 2024 and December 2027, an observational multicentre diagnostic accuracy study is being conducted across primary, secondary and tertiary healthcare facilities in the Netherlands and the UK. Adults ≥65 years with a suspected UTI will be considered eligible. Patients with pre-existing decision-making incapacity or an indwelling catheter will be excluded. UTI will be defined according to an international consensus-based reference standard. Biomarkers will be measured by liquid chromatography-mass spectrometry (neutrophil gelatinase-associated lipocalin, tissue inhibitor of metalloproteinase 2 and CXC motif chemokine ligand 9) and enzyme-linked immunosorbent assay (interleukin 6 and azurocidin). Pyuria will be quantified by automated microscopy and/or flow cytometry. Diagnostic accuracy measures will be calculated using the receiver operating characteristic curves, and sensitivity, specificity, likelihood ratios and predictive values will be reported for optimal cut-offs.

Ethics and dissemination
The protocol was reviewed by the local Leiden University Medical Center research committee, who declared on 15 April 2024 that the medical research involving human subject act (Dutch abbreviation: WMO) does not apply to the current study (reference number nWMODIV2_2024025). The study also received approval from the NHS Research Ethics Committee in the UK (reference number 24/LO/0649).
The study findings will be published in a peer-reviewed journal, presented at academic congresses and shared with healthcare providers.

Trial registration number
The study was registered at clinicaltrial.gov on the 24 September 2024 with registration number: NCT06610721.

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Experiences of adopting remote technologies for blood pressure control among women with pre-eclampsia and healthcare providers: a systematic review of qualitative studies

Introduction
Pre-eclampsia is a harmful and potentially life-threatening condition affecting maternal health and fetal well-being. In response to the need for timely and continuous monitoring, remote health technologies have been implemented for blood pressure control among this group over the last decades. The purpose of this study is to synthesise qualitative evidence on the experiences of adopting remote technologies for blood pressure control among women with pre-eclampsia and their healthcare providers.

Methods
Peer-reviewed publications published in English from January 2013 to March 2023 were searched using seven electronic databases: PubMed, Nursing & Allied Health Premium (ProQuest), Scopus, ScienceDirect, Taylor & Francis Online, Google Scholar and EBSCO Open Dissertations. The findings were subjected to meta-synthesis using the Joanna Briggs Institute meta-aggregation approach, whereby credible and unequivocal findings supported by participant quotations were extracted, grouped into categories and then integrated into synthesised findings through consensus among reviewers. A total of 4827 studies were identified in the initial database search. Twelve eligible studies were included in the meta-synthesis.

Results
Among 12 studies, five synthesised findings were elicited from women’s experiences with remote monitoring, including reassurance and increased self-confidence in health, a sense of autonomy, enhanced awareness of their health, acceptability and satisfaction with telehealth and reduced anxiety and stress. Providers’ perspectives on telehealth were presented in four synthesised findings: increasing value for oneself and work, strengthening knowledge and skills on pre-eclampsia, improving quality of care and concerns about technology challenges.

Conclusion
Healthcare providers reported professional growth and improved care delivery, though technical challenges persist. These findings support the integration of remote monitoring into maternal healthcare.

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Perceptions of chemoprevention among individuals at high risk of oral cancer: qualitative study within the UK-based SAVER trial

Objectives
Clinical trials are needed to advance interventions such as chemoprevention that have potential to reduce the risk of malignant transformation in individuals with oral potentially malignant disorders. We explored the perspectives of those screened or invited to join an early phase clinical trial (the SAVER trial: Sodium valproate for the epigenetic reprogramming of high-risk oral epithelial dysplasia). Our objectives were to inform the SAVER trial while it was ongoing and to provide insights for future trials and chemoprevention therapy development more broadly.

Design
Qualitative study involving audio-recorded, semistructured interviews. Analysis of transcribed interviews drew on thematic approaches.

Setting
Five UK-based sites involved in SAVER.

Participants
Purposive sample of individuals (n=20) with suspected or diagnosed oral epithelial dysplasia (OED) who were approached about SAVER.

Results
Most interviewees readily accepted that OED warranted preventive treatment and were positive about the potential of chemoprevention. However, they were often concerned about the side effects of the trial medication, and together with a dislike of biopsies and a perception that the trial might disadvantage treatment, these concerns made some hesitant to participate in SAVER. Interviewees indicated that the communication of staff influenced their understanding and experience of the trial and identified several opportunities for enhancing these aspects.

Conclusions
In indicating that individuals at risk of malignant transformation are accepting of chemoprevention in principle, our findings are supportive of future research on chemoprevention for this group. The findings also draw attention to the crucial role of communication in recruitment to chemoprevention trials. We provide recommendations to support staff during recruitment and enhance individuals’ experience of the trial.

Trial registration number
ISRCTN12448611; Pre-results.

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Evolution of medical students tolerance for uncertainty throughout their curriculum: a systematic mixed studies review protocol

Introduction
Understanding how uncertainty tolerance (UT) evolves in medical students is crucial to identify training needs and implement effective interventions. However, the dynamic nature of UT and the mechanisms behind its changes over time remain poorly understood. This systematic review aims to map the development of UT in medical students across the course of their training by synthesising the available evidence. We will adopt a systematic mixed studies review approach to provide an integrative synthesis of both quantitative and qualitative data, offering a comprehensive overview of UT temporal evolution.

Method and analysis
The protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We will conduct searches in Embase, Medline, Cumulative Index to Nursing and Allied Health Literature, ERIC, Cochrane Library and PsycINFO, from inception to July 2026. We will manually search the references of included studies and track citations through Google Scholar to identify additional eligible studies. Two reviewers will independently extract data from each eligible study using a pre-piloted Microsoft Excel data extraction form. A thematic synthesis will be employed to develop analytic themes from the existing literature, generating new concepts and explanatory hypotheses. Study quality will be evaluated using the QuADS score.

Ethics and dissemination
Ethical approval is not necessary for this systematic review, as no primary data will be collected. The protocol for this review has been registered with the International Prospective Register of Systematic Reviews PROSPERO: CRD42024591340.

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What matters to you? Improving the adoption of shared decision-making for birth planning in women with chronic hypertension: a multicentre multiple methods study

Objective
To explore the role of shared decision-making (SDM) in the implementation of evidence-based practice in women with chronic hypertension planning birth and investigate the barriers and the facilitators in the provision of antenatal care.

Methods
A multimethod multisite approach was used including case-note review (n=55) and structured observations (n=18) to assess the provision of third trimester antenatal care. The barriers and facilitators to implementation were identified from semistructured qualitative interviews with healthcare professionals (n=13) and pregnant women (n=14) using inductive thematic analysis. The findings were integrated and evaluated using the ‘Three Talk Model of Shared Decision-making’.

Setting and participants
Pregnant women with chronic hypertension, some with superimposed pre-eclampsia and their principal carers at three National Health Service hospital trusts.

Results
Healthcare professionals delivering care to pregnant women with high blood pressure were aligned with most communication practices (set out in the Calgary-Cambridge communication guide). Pregnant women with hypertension who described being engaged in shared decisions about birth developed a trusting relationship with their maternity team. Despite frequent caesarean section birth (52%) and early term birth (median gestation at delivery 38 weeks (IQR1 37 weeks, IQR3 39 weeks) identified by case-note review; integrated data (observations, case-note review and qualitative interviews) found pregnant women with high blood pressure were not regularly provided with personalised information based on what they would find helpful, encouraged to share their own thoughts or offered choice in relation to timing or mode of birth. Uncertainty regarding the evidence around optimal timing of birth was the main barrier identified by professionals. Facilitators included training for professionals in SDM, midwife-led antenatal classes for high-risk women and multiprofessional clinics.

Conclusions
Strategies to promote more widespread adoption of SDM are likely to improve the experiences of women with high blood pressure making decisions about childbirth.

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Experiences of postnatal contraceptive care during the COVID-19 pandemic: a multimethods cross-sectional study

Objectives
This study aimed to examine the impact of the first COVID-19 lockdown period on access to postnatal contraception (PNC) and wider postnatal care and to explore the experiences of PNC care within the North East and North Cumbria (NENC) Integrated Care System (ICS) during the same period.

Design
This study reports a subanalysis of the NENC Postnatal Contraception (PoCo) study, an online survey of a convenience sample of women in the NENC ICS who completed pregnancies between 2019 and 2023.

Setting
Women who completed pregnancies between 2019 and 2023 in the NENC ICS.

Participants
Out of the total 2509 eligible participants who completed the PoCo survey, women who delivered in April–June 2020, April–June 2021 and April–June 2022 were included within this subanalysis, resulting in 457 eligible survey responses. There were no additional exclusion criteria.

Primary and secondary outcome measures
Primary outcome measures were PNC uptake and number of healthcare professional contacts during the postnatal period. Secondary outcome measures were self-reported experiences of PNC care.

Results
Women who delivered in April–June 2020 had fewer postnatal contacts than women who delivered in subsequent non-lockdown cohorts and were less likely to be offered PNC prior to discharge. There were no significant differences in relation to PNC uptake. In qualitative analyses, several women who delivered in 2020 highlighted COVID-19 as a factor perceived to be associated with poor postnatal care. Across all three groups, experiences of PNC care were diverse; feeling pressured to accept PNC was frequently reported.

Conclusions
While the first COVID-19 lockdown appears to have had a significant impact on women’s experiences of postnatal care, this did not result in a substantive decrease in PNC provision, likely reflecting pre-existing shortcomings. These women and families may benefit from additional support postpandemic to mitigate the potential life course implications of restricted support in the postpartum period, and policy-makers and healthcare providers should continue to explore innovative and patient-centred approaches to improving PNC provision. Future research should continue to evaluate the longer-term impacts of these changes in non-pandemic contexts.

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Trends in high remnant cholesterol level and its risk factors among US adults using NHANES data from 1999 to 2020: a serial cross-sectional study

Objectives
To describe the trends in high remnant cholesterol (HRC) prevalence and identify its risk factors.

Design
A serial cross-sectional study.

Setting
Data from the National Health and Nutrition Examination Survey (NHANES) 1999–2020 were analysed.

Participants
A total of 24 658 adults aged ≥18 years with fasting total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) measured were included.

Outcome measure
Serum TC was measured using an enzymatic method. HDL-C and TG were quantified using photometry. Low-density lipoprotein cholesterol (LDL-C) was estimated by using the Sampson formula. Remnant cholesterol (RC) was defined as TC–HDL-C–LDL-C. HRC was defined as RC≥0.78 mmol/L.

Results
The multivariable-adjusted survey-weighted HRC prevalence decreased from 26.6% (1999–2002) to 13.7% (2015–2020) with a 5.4% reduction per year (plinear-trend

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Epidemiological association of the COVID-19 pandemic on Mycoplasma pneumoniae infections in children in Tianjin, China: a single-centre retrospective study (2017-2024)

Objective
To investigate the epidemiological characteristics and temporal-spatial distribution of Mycoplasma pneumoniae (MP) infections among paediatric inpatients with respiratory tract infections in Tianjin, China, across three distinct phases: pre-pandemic (2017–2019), pandemic (2020–2022) and post-pandemic (2023–2024). The primary hypothesis is that the COVID-19 pandemic altered the epidemiology of MP infections in children.

Design
Retrospective, single-centre study.

Setting
Secondary care paediatric hospital in a metropolitan area.

Participants
A total of 60 213 paediatric patients hospitalised with respiratory infections between January 2017 and December 2024 were included. The study population consisted of children aged 0–18 years, with a male-to-female ratio of 1.22:1.00. Selection criteria included children admitted with a diagnosis of respiratory infection, while those with incomplete clinical data or non-respiratory infections were excluded.

Primary and secondary outcome measures
The primary outcome was the overall positive detection rate of MP-RNA. Secondary outcomes included annual and seasonal variations in MP-RNA detection rates, differences by sex and age group, and the impact of the COVID-19 pandemic on MP epidemiology. All statistical methods, including those used to control for confounding, involved the use of ² tests for comparing positive rates between groups.

Results
The overall positive detection rate of MP-RNA among children hospitalised for respiratory infections during the study period was 36.58% (22 023/60 213). The annual MP-RNA-positive detection rates from 2017 to 2024 were as follows: 50.74% (411/810) in 2017, 36.28% (1150/3170) in 2018, 27.41% (1459/5323) in 2019, 10.18% (222/2181) in 2020, 11.42% (928/8129) in 2021, 13.27% (579/4364) in 2022, 28.97% (3064/10575) in 2023 and 55.38% (14 210/25 661) in 2024. The highest annual positivity rate was observed in 2024 (55.38%, 14 210/25 661), while the lowest rate occurred in 2020 (10.18%, 222/2181). Statistical analysis revealed significant differences in MP-RNA detection rates across different years (²=8331.511, p

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Association Between Adenoma Detection Rate and Prevalent Colorectal Cancer Detection Rate in a National Colonoscopy Registry Subtitle: Association Between Adenoma and Colorectal Cancer Detection

While the adenoma detection rate (ADR) is associated with post-colonoscopy colorectal cancer (PCCRC) risk, it is unknown to what extent this reflects missed colorectal cancer (CRC) versus missed pre-cancerous lesions. We evaluated the association between physician ADR and prevalent CRC detection during colonoscopy.

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