Assessing symptom improvement in patients with postural orthostatic tachycardia syndrome (POTS) following a 16-week structured exercise programme: a protocol for a randomised cross-over trial in a clinical outpatient setting

Introduction
Exercise training is recommended as a complementary treatment in postural orthostatic tachycardia syndrome (POTS) according to international guidelines. However, less is known regarding how exercise training could successfully be implemented in clinical practice in patients with POTS. Thus, in the current study, we aim to assess the effect of a 16-week tailored exercise training programme in POTS.

Methods and analysis
A total of 200 patients diagnosed with POTS will be recruited. The study will be conducted as a randomised cross-over study. POTS symptoms will be evaluated using the Malmö POTS Symptom Score, Orthostatic Hypotension Questionnaire and 36-item Short Form Health Survey. Haemodynamic parameters will be evaluated by orthostatic tests and maximum working capacity evaluated by bicycle exercise test. Symptoms, haemodynamic parameters and exercise capacity will be assessed before and after a 16-week training programme.

Ethics and dissemination
The study was approved by the Swedish ethical review authority (2022-03186-01) and all procedures will be performed in accordance with the Helsinki Declaration. Results will be made available to patients with POTS, healthcare professionals, the funders and other researchers in publicly available (open access) medical journals.

Trial registration details
NCT05554107, registered on 26 September 2022.

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Understanding preconception care: a scoping review of knowledge, attitudes and practices among reproductive age individuals, healthcare workers and stakeholders in low- and middle-income countries

Objectives
This scoping review aims to map existing evidence on knowledge, attitudes and practices (KAP) and barriers to preconception care in low- and middle-income countries. The primary objective is to identify key gaps and research priorities to guide future efforts to improve maternal and child health.

Design
This review followed Arksey and O’Malley’s scoping review framework, with a comprehensive search across Medline, EMBASE, CINAHL and Scopus from inception to May 2025. Eligible studies included original research on preconception care (PCC), KAP in low- and middle-income countries (LMICs) without date restrictions. Two independent reviewers conducted screening in Covidence. Findings were presented in graphical, tabular and narrative formats, adhering to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols Extension for Scoping Reviews (PRISMA-ScR) standard.

Setting
The review focused on PCC studies conducted in LMICs across various healthcare settings, emphasising primary and secondary levels of care. The geographical scope was global but limited to LMICs as defined by World Bank criteria.

Result
A total of 62 studies were included in the review. Of these, 42 employed quantitative methods, 18 used qualitative approaches and 2 used a mixed-methods design. Regarding focus areas, 25 studies assessed knowledge, 14 assessed practices, 12 studies assessed KAP comprehensively and 10 assessed attitudes. Participants were mainly women of reproductive age (44 studies), with only five studies including men. Among healthcare providers, KAP varied, with midwives being the most frequently studied group. Stakeholders such as policymakers were notably under-represented. Identified barriers included limited training, cultural beliefs and inadequate policies. Facilitators highlighted were targeted education, spousal support and policy advocacy, emphasising the need for gender-sensitive and systemic interventions.

Conclusion
LMICs face complex challenges in utilising PCC, influenced by socioeconomic, cultural, and healthcare system factors. To address these challenges, nuanced approaches incorporating intersectional perspectives and practical qualitative methodologies are essential for improving couples’ and child health outcomes.

Trial registration number
The study protocol was registered in the Open Science Framework (OSF) on December 23, 2022, with DOI: 10.17605/OSF.IO/H3MK6.

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Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China

Objectives
Azvudine and Paxlovid are the primary antiviral agents for the management of COVID-19. However, there is currently insufficient evidence regarding the effectiveness and safety of these drugs in treating COVID-19 patients with pre-existing hypertension. The objective of this study was to assess their effectiveness and safety among those patients in a real-world context.

Design
Retrospective cohort study.

Setting
Electronic medical record data of COVID-19 patients with pre-existing hypertension were extracted from nine hospitals in Henan Province from 5 December 2022 to 31 January 2023.

Participants
Following 2:1 propensity score matching (PSM), 996 individuals who received treatment with azvudine and 498 individuals who received treatment with Paxlovid were included in the analysis.

Primary and secondary outcome measures
The primary outcome was all-cause death and the secondary outcome was the composite disease progression.

Results
Following adherence to the inclusion and exclusion criteria and 2:1 PSM, 996 individuals were included in the azvudine group and 498 in the Paxlovid group. The Cox regression analysis revealed that the azvudine group had a significantly lower risk of all-cause death compared with the Paxlovid group (HR 0.64, 95% CI 0.455 to 0.911, p=0.013). However, there was no statistically significant difference in composite disease progression between the two groups (HR 0.93, 95% CI 0.711 to 1.229, p=0.629). Subgroup analysis indicated that, compared with Paxlovid, patients with moderate disease receiving azvudine treatment exhibited a significantly reduced risk of composite disease progression (HR 0.46, 95% CI 0.24 to 0.89). The safety analysis showed that the azvudine group had fewer adverse events.

Conclusions
Among COVID-19 patients with pre-existing hypertension, the effectiveness of azvudine is not inferior to Paxlovid in reducing all-cause death and composite disease progression, with fewer adverse events.

Trial registration number
NCT06349655.

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Exploring the social dimensions of AI integration in healthcare: a qualitative study of stakeholder views on challenges and opportunities

Objectives
This study aimed to investigate the opportunities and challenges associated with integrating artificial intelligence (AI) in healthcare by exploring the perspectives of various stakeholders. The objective was to provide a nuanced understanding of stakeholder views to address concerns and promote the acceptance and successful integration of AI technologies in medical practice.

Design
This exploratory qualitative study used semi-structured interviews. Data were analysed using a combination of deductive and inductive coding, followed by content analysis to identify and develop categories.

Setting
This study was conducted in Tübingen, Germany, within the framework of the TüKITZMed project (Tübingen AI Training Center for Medicine), between August 2022 and March 2023.

Participants
A total of 38 stakeholders participated, including 6 lecturers, 9 clinicians, 10 healthcare students, 6 AI experts and 7 institutional stakeholders. Inclusion criteria included professionals involved in or affected by AI in healthcare, while exclusion criteria comprised individuals without relevant experience.

Interventions
Not applicable.

Outcome measures
The main outcome was the identification of thematic categories capturing stakeholders’ perceptions, expectations and concerns regarding the integration of AI in healthcare.

Results
The analysis identified two main thematic categories: two main categories encompassing a total of 14 subcategories: (1) perceived opportunities of AI in medicine, including aspects of increased efficiency, reduced workload and improved patient safety and (2) perceived challenges of AI in medicine, such as its impact on medical decision-making and concerns about dependence on technology. These themes reflect diverse perspectives and insights across stakeholder groups.

Conclusions
Diverse stakeholder perspectives offer valuable insights into the anticipated effects of AI in healthcare. Understanding these perspectives can support decision-makers in designing context-sensitive AI strategies and identifying areas for further professional and institutional development. Future research should monitor how these attitudes evolve in response to technological progress and real-world implementation.

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Effectiveness of Kushal Maa, a group-based mhealth interactive education and social support intervention for maternal and neonatal health outcomes: study protocol for a multisite randomised controlled trial in India

Introduction
Perinatal care continuity across the full continuum is essential for optimising maternal and infant health; however, a stark gap occurs post partum, with less than one half of Indian mothers receiving postpartum care due to significant logistical and sociocultural barriers, particularly for periurban and rural residents. To overcome these barriers and reduce women’s postpartum isolation, our international team of maternal and infant health clinicians and researchers developed and pilot-tested a culturally-tailored mobile interactive education and support group intervention, Kushal Maa (‘informed-mother’), confirming feasibility and acceptability and preliminary effectiveness. The current study seeks to estimate the effectiveness of the Kushal Maa intervention compared with standard care on maternal and neonatal health-related behaviours and health, characterise the mechanisms of intervention impact and evaluate the cost-effectiveness of the Kushal Maa intervention in improving postpartum maternal and neonatal health compared with the standard of care.

Methods and analysis
We will conduct a prospective, parallel block-randomised controlled trial with a 1:1 allocation ratio among 2100 pregnant women across three geographically diverse Indian states. Inclusion criteria for women: aged 18+years of age at enrolment, in the last trimester of pregnancy (30–33 weeks of gestation), with any parity, carrying single or multiple gestation (1-2), with knowledge of site-specific local language and had access to a mobile phone. Participants will be block-randomised in groups of 15. Intervention participants will receive 28 tailored education and support sessions weekly via audio/video conference facilitated by trained moderators (four prenatal and 24 weekly postpartum sessions through 6 months) and will be engaged in WhatsApp groups for health education videos and peer discussion via text chat. Control participants receive the standard of care. Data will be collected at four points: 30–33 weeks of pregnancy (enrolment), 6 weeks, 3 months and 6 months postpartum (endline). Investigators, outcome assessors and data analysts will be blinded to group allocation. Primary outcomes will be measured at 6 weeks, 3 months and 6 months post partum and include: postpartum depression (using Edinburgh Postnatal Depression Scale), exclusive breastfeeding and met need for postpartum family planning. Secondary outcomes include other maternal and child health knowledge, outcomes and maternal and newborn healthcare use indicators. We will use intention-to-treat analysis. Mixed-effects models will account for clustering due to the group-oriented delivery of the intervention and repeated measures.

Ethics and dissemination
This study has been approved by the Health Ministry Screening Committee, Government of India and approved by ethics boards at the Post-Graduate Institute for Medical Education and Research, Chandigarh (Ref:001208, IEC-06/2022–2471), Maharashtra University of Health Sciences (Ref: MUHS/EC/06/2024), Sangath (Ref: AB_2022_81) and the University of California, San Francisco (Ref: 21–35730). All research activities will be performed in accordance with the Declaration of Helsinki. On completion, findings will be disseminated to stakeholders through diverse strategies. Results will be published in academic journals and presented at conferences.

Trial registration number
ClinicalTrials.gov: NCT05268588 Clinical Trials Registry – India: CTRI/2022/07/043889.

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How did staffing strategies change amid COVID-19 and post pandemic? A qualitative study

Objectives and design
A qualitative study was undertaken to explore the nature of staffing strategies from the perspectives of nursing, medicine and health disciplines employed in a hospital setting.

Setting
Interviews were conducted in six hospitals in Canada between November 2022 and September 2023.

Results
118 healthcare professionals and leaders who experienced changes in staffing strategies participated in this study. Three themes emerged to describe new or adaptive staffing strategies: (1) valuing new roles and teams; (2) being redeployed; and (3) enhancing coverage.

Conclusions
Our study elucidates the staffing strategies that were employed during the COVID-19 pandemic that included creating new and adapting existing roles and teams; redeploying healthcare professionals; and enhancing coverage. Study findings can be used to guide leaders to use a proactive systematic approach to staffing models that includes adaptable and flexible staffing models within local contexts.

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Cross-sectional study of the rates of military sexual trauma (MST) and associations with adverse mental health outcomes among UK female ex-service personnel: a study protocol

Introduction
This study investigates the rates of military sexual trauma (MST) and its associations with adverse mental health among a sample of UK female ex-service personnel who served during the Iraq/Afghanistan eras.

Methods and analysis
Female ex-service personnel, who participated in the fourth phase (Phase 4) of the King’s Centre for Military Health Research (KCMHR) Health and Well-being Cohort Study (2022–2023) and consented to be recontacted for follow-up studies (n=295), are being invited to participate in an online questionnaire between July 2024 and February 2025. The questionnaire contains surveys and questions related to experiences of sexual harassment and sexual assault during and outside of military service, disordered eating and broader female health issues. While the questionnaire relates to several female health topics, this study focuses on the surveys related to experiences of sexual trauma and eating disorders. Sociodemographic variables and some health variables, including post-traumatic stress disorder (PTSD), complex PTSD, common mental disorders, alcohol misuse, physical somatisation and social support, will be extracted from participants’ pre-existing data collected in Phase 4 of the KCMHR Cohort Study. Analyses will assess rates of MST, and hierarchical multiple logistic regressions will investigate associated health impacts. Rates and ORs, employing 95% CIs, will be reported.

Ethics and dissemination
This study has been granted full ethical approval by the King’s College London Research Ethics Committee (Ref: HR/DP-23/24–39040). Participants provide informed consent before participating and have access to a signposting booklet containing contact details for a range of support services. A risk protocol is in place, which outlines the procedure to be undertaken if a participant contacts the research team in distress. Findings will form part of a PhD thesis and will be further disseminated through peer-reviewed publication and dissemination with veteran mental health services and charities, and relevant government departments.

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Wearable device monitoring of HIV health in the face of climate change and weather exposures: protocol for a mixed-methods study

Introduction
Climate change and HIV are interconnected epidemics that increase vulnerability in people living with HIV (PLWH), particularly in sub-Saharan Africa. Despite their public health significance, research on the synergistic effects of these epidemics on the health of PLWH is limited. The advancement of non-invasive wearable technology offers an opportunity to leverage objective health data for large-scale research, addressing this knowledge gap. This study will examine the impact of weather events on distinct health variables of PLWH within the Siaya Health and Demographic Surveillance System (HDSS) in rural Kenya.

Methods and analysis
Over a period of 6 months, we continuously monitored health parameters of a total of 200 participants including heart rate, activity and sleep, using consumer-grade wearable devices. We will correlate these health data with real-time weather parameters (ambient temperature, wet bulb globe temperature, precipitation level) from five weather stations within the HDSS area and compare between HIV-positive participants and an HIV-negative control group. Additionally, a convergent mixed-methods approach will explore participants’ perceptions of the impact of weather events on their health and personal experiences. The study aims to inform future research on the complex relationship between HIV and weather events, which are projected to increase in frequency in this region due to climate change and provide valuable insights for policymakers to develop effective measures to protect this vulnerable population amid the growing climate crisis.

Ethics and dissemination
This study has been approved by the Research Ethics Committees at Kenya Medical Research Institute, Nairobi (approved on 23 October 2023; SERU 4826) and Heidelberg University Hospital, Germany (approved on 14 February 2023; S-824/2022). Written informed consent was obtained from all participants prior to enrolment, with data anonymised and handled according to Kenyan and German data protection regulations. Research findings will be disseminated through peer-reviewed publications and presented at scientific conferences.

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