Patient-informed outpatient intervention to improve pregnancy outcomes through connections to social services: protocol for the BETTER randomised controlled trial

Introduction
A substantial portion of the 3.6 million births per year in the USA (approximately 25%–30%) occur in the context of adverse pregnancy outcomes (APOs), including preterm birth (PTB), hypertensive disorders of pregnancy (HDP) and small-for-gestational-age (SGA) birth. Black individuals have a 2–3-fold higher risk of APOs and a similarly increased risk of maternal morbidity and mortality compared with White individuals. Adverse social determinants of health (SDoH) are at the root of this disparity and contribute to it through multiple mechanisms. Maternal anaemia is an upstream factor associated with severe maternal morbidity, maternal mortality and other APOs and is also associated with adverse SDoH. Effectively and efficiently addressing social needs arising from adverse SDoH in the obstetric setting can be difficult due to varying patient preferences, resource accessibility and clinic workflows. The Better Birth Outcomes Through Technology, Education and Reporting (BETTER) intervention attempts to account for these barriers by encouraging patients to address social needs through motivational interviewing and by sending recurring text messages that provide links to multiple kinds of social service resources.

Methods and analysis
We will use a two-arm randomised controlled trial to evaluate the effects of providing patients with a motivational interviewing session and text messages with links to multiple resources to address their social needs compared with patients receiving usual care. We will recruit 550 pregnant individuals less than 21 weeks of gestation from two university prenatal clinics that primarily serve Medicaid-covered individuals in an urban city in the Midwestern USA. We will assess whether the intervention reduces the primary outcome of maternal anaemia measured as haemoglobin

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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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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 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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Randomised controlled trial to compare the efficacy of integrated cognitive-behavioural therapy (COPE-A) for substance use and traumatic stress among adolescents and young adults delivered via telehealth versus in person: trial protocol

Introduction
Emerging research indicates that integrated treatment of co-occurring post-traumatic stress disorder (PTSD) and substance use disorder can be effective among adolescents and young people. However, various barriers exist to young people accessing evidence-based treatments. Telehealth offers an opportunity to address these barriers and provide a scalable and accessible alternative to inperson treatment. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy, safety and cost-effectiveness of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents and young adults (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure – Adolescent and Young Adult version (COPE-A)) when delivered in person compared with via telehealth.

Methods and analysis
A two-arm, parallel group, single-blind, non-inferiority RCT with follow-up at 4 months and 12 months post study entry will be conducted in Sydney, Australia. Participants (170 adolescents and young adults aged 12–25 years) will be allocated to receive COPE-A either in person or via telehealth (allocation ratio 1:1) using minimisation. Project psychologists will administer treatment via both modes of delivery over a maximum of 16 sessions of 60–90 min. The primary outcome will be between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

Ethics and dissemination
This study has been approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee (2024/ETH01050). Research findings will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number
ACTRN12624000776505.

Protocol version
V.2.3, 20 March 2025.

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Development of a large Danish single-centre retro- and prospective transgender cohort using a web-based platform: a study protocol of a transgender cohort study

Introduction
Referrals for gender-affirming healthcare services have surged in recent decades, presumably driven by increased visibility, acceptance and reduced barriers to care. Despite these advances, transgender and gender-diverse individuals continue to face significant mental health challenges, including elevated rates of anxiety, depression as well as high prevalence of autistic traits. Gender-affirming hormonal treatment (GAHT) has been suggested to improve mental health and quality of life (QoL) among transgender individuals; however, the short- and long-term treatment effects of GAHT are not yet fully understood. Therefore, this study aims to establish a comprehensive cohort of transgender individuals at the Centre for Gender Identity (CGI), Aalborg University Hospital, Denmark, to enhance understanding and treatment outcomes.

Methods and analysis
The Transgender Cohort (TraCK) will recruit participants from February 14, 2024, with recruitment occurring continuously alongside yearly follow-up. This single-centre cohort study will include both retrospective and prospective data collection. Transgender individuals referred to CGI will be invited to participate in the study via the Danish digital mail system called e-Boks. Participants must provide informed consent and complete a baseline questionnaire. Data will be collected from self-reported questionnaires and medical records across multiple specialists. Self-reported questionnaires include WHO-Quality of Life BREF, Eating Disorders Examination Questionnaire, Autism Spectrum Quotient, Transgender Congruence Scale, and Gender Minority Stress and Resilience Measure. Medical records will provide information on demographics, mental health, physical health, and gender-affirming treatment details. Data will be managed using REDCap, ensuring compliance with GDPR and the National Data Protection Act.

Ethics and dissemination
While recognising the potential privacy risks associated with data collection, the study considers these outweighed by the benefits of advancing knowledge on gender diversity and the impacts of gender-affirming care. The North Jutland Region Ethics Committee reviewed the project, determining no formal approval was needed, but it was registered and approved (no. F2024-012) by the North Jutland Region. Findings will be disseminated through peer-reviewed journals, conferences, and accessible reports for participants.

Registration details
This study is registered with the North Jutland Region (no. F2024-012). Recruitment and data collection began on February 14, 2024, and will continue alongside yearly follow-up. Keywords Transgender individuals, transgender and gender-diverse, transgender cohort, transgender health, transgender research, cohort study, gender-affirming care.

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Impact of Venous CONgestion on Organ Function and Outcomes in Sepsis (ICON-Sepsis): a prospective observational cohort study protocol

Introduction
Sepsis is a common condition with significant morbidity, mortality and annual costs of care in the billions of dollars. Despite innumerable studies on the causes of, and therapies for, sepsis, the mortality rate has not changed substantially in the last 20 years. Treatments remain generic, with current guidelines recommending the same approach for all patients, regardless of the litany of differences that exist at baseline. Moreover, the blanket administration of 30 cc/kg of intravenous fluid (IVF) to all patients is recognised as being directly harmful to some. Patient-level heterogeneity in prior sepsis trials is recognised as a substantial contributor to all these problems, yet no prior investigation has attempted to identify volume-informed septic phenotypes, a necessary first step towards precision care.

Methods and analysis
Predicated on prior studies demonstrating detectability of organ-level congestion, we hypothesise that central venous hypertension (1) is deleterious to the function of the lungs, liver, kidneys and vascular endothelium; (2) is worsened by cardiac dysfunction and IVF administration; and (3) contributes to adverse organ-specific and overall outcomes. Beginning in the emergency department, cardiac function will be assessed with echocardiography while congestion in the lungs and kidneys will be assessed using previously validated sonographic markers of congestion. Biomarkers for each organ will be collected concurrently, thereby increasing the fidelity of our phenotypic profiles by pairing indicators of macroscopic and microscopic stress and dysfunction. Data will also be collected at 24 hours and 7 days (or discharge, whichever comes first) after presentation. Classical and machine learning approaches will be used to analyse our large data stream and develop a rule-based system to identify distinct subpopulations of patients with sepsis who have greater risk/likelihood of both organ-specific and overall adverse outcomes.

Ethics and dissemination
This project has been approved by the Wayne State University Institutional Review Board, with patient enrolment beginning in April 2024. Findings will be reported and disseminated via conference presentations and open-access publications.

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Continuous heart rate variability monitoring–understanding patterns of stress and recovery and their relationship with self-reported burnout, resilience and well-being in doctors: a protocol for a sequential explanatory mixed-methods study

Introduction
The medical profession is facing an unprecedented crisis. Reasons for this are complex and multifactorial; however, rising rates of burnout will undoubtedly contribute to problems with recruitment and retention. Chronic workplace stress, whereby there are insufficient resources available to meet the demands doctors face, is a contributor to burnout. There are a wide variety of available self-report measures for stress, with heart rate variability (HRV) shown to be a biomarker of stress and recovery in doctors. We aim to triangulate continuous HRV measurements with validated self-report measures and qualitative data to better understand the patterns of stress and recovery.

Methods and analysis
This study has a sequential explanatory mixed-methods design. Participants will be recruited from multiple sites within National Health Service (NHS) Grampian. Initially, participants will complete a suite of validated scales, including the Maslach Burnout Inventory for Medical Personnel, the Resilience Scale for Adults and the Interpersonal, Community, Occupational, Physical, Psychological (ICOPPE) well-being scale. Following this, participants will undertake seven consecutive days of ecological momentary assessment of real-time demands, resources and fatigue, alongside 7 days of continuous ambulatory assessment of HRV via Firstbeat Bodyguard 3 chest-worn monitors. Participants will be provided with a summary report following their study period. If 40 participants are recruited within the recruitment timeframe, multilevel modelling will be used to analyse data; otherwise, N-of-1 statistical techniques will be used. Following initial analysis of the quantitative data, participants of interest will be invited to take part in semistructured interviews, which will be thematically analysed and presented alongside the quantitative data.

Ethics and dissemination
This study was approved by the University of Aberdeen, School of Medicine, Medical Sciences and Nutrition ethics review board (ref. 3389193) and the NHS Grampian research and development team. Results will be disseminated in international peer-reviewed journals.

Trial registration number
NCT06721312.

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GI highlights from the literature

Basic scienceSensing pain in the gut: new insights into enterochromaffin cells Touhara K, Rossen N, Deng F et al Topological segregation of stress sensors along the gut crypt-villus axis. Nature 2025; 640(8059): 732-742. doi: 10.1038/s41586-024-08581-9. The gut barrier is monitored by enterochromaffin (EC) cells, epithelial sensory enteroendocrine cells which release serotonin in response to stimuli. TRPA1 (transient receptor potential cation channel, subfamily A, member 1—also known as the wasabi receptor), which detects electrophilic irritants, is present in the crypts. TRPM2 (transient receptor potential cation channel, subfamily M, member 2), which measures oxidative stress, is in the villi. The EC-pain circuit is not well understood. Touhara et al used a new mouse model to study this. Serotonin receptors were labelled in a way that fluorescence intensity increased after serotonin release. Tonic (low-level) serotonin release was observed in crypts where TRPA1 was expressed. This activated metabotropic 5-HT4 (5-hydroxytryptamine receptor…

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