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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Global prevalence of chronic kidney disease and associated risk factors in children and adolescents: protocol for a systematic review and meta-analysis

Introduction
While chronic kidney disease (CKD) is well characterised in adults, less is known about the prevalence of CKD in children and adolescents, where it is rare and associated with unique characteristics and implications for long-term health outcomes. This study protocol outlines a systematic review to assess the global prevalence of CKD in children and adolescents along with causes and associated risk factors. This is warranted to better characterise prevalence and to identify at-risk groups that would benefit from screening efforts. We will explore the risk and burden of CKD and its variations by sociodemographic characteristics (age group, race, sex/gender) and geographical regions (country, International Society of Nephrology region and income groups based on World Bank country classifications).

Methods and analysis
We will conduct a systematic review of studies reporting on the prevalence of CKD in children and adolescents following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 (PRISMA-P-2015) and the PRISMA 2020 methodological guidelines (PRISMA 2020). Searches will be undertaken in the following databases with the date range from 2000 to date: Ovid MEDLINE, Ovid Embase, CINAHL, Cochrane Library, ProQuest Dissertations & Theses Citation Index (via Clarivate), Web of Science Core Collection, Google Scholar and grey literature sites (registries, government reports) to identify studies that report on the prevalence of CKD in children and adolescents from ages 0 to 18. The primary outcome will be the global prevalence of CKD in children and adolescents. Secondary outcomes will include the causes of and risk factors for CKD, and examining differences and temporal trends in CKD prevalence across countries, geographical regions, income levels and sociodemographic characteristics.

Ethics and dissemination
No direct involvement with patient data will be used in this systematic review, as data will be obtained from previously published reports. Ethical approval is therefore not required. Our findings will be published in an open-access peer-reviewed journal and presented at scientific conferences.

PROSPERO registration number
CRD42024547467.

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Correlates of HIV-TB co-infection and mental health of adults living in countries across sub-Saharan Africa: systematic review and meta-analysis protocol

Introduction
HIV and tuberculosis (TB) are two of the most devastating disease conditions of public health concern globally. A co-infection of the two diseases poses serious health challenges to patients including mental health problems, ranging from mild to severe, with differing outcomes. This systematic review aims to assess the correlates of HIV-TB co-infection and mental health of adults living in sub-Saharan Africa.

Methods and analysis
We will conduct comprehensive database and non-database searches for studies (published and unpublished). We will search Google Scholar, PubMed, CINAHL, LILACS, JSTOR, Cochrane Library, SCOPUS, PsycINFO, HINARI and African Journals Online from inception to 31 May 2025, without restriction on language. We will also search the grey literature, including conference proceedings, preprint repositories, databases of dissertations, WHO and governmental databases. In the event where there is a need to contact experts and corresponding authors for further information, the review team will do so to enrich the content of the review. At least three reviewers will independently undertake study selection, data extraction and risk of bias assessment using validated tools. We will resolve discrepancies or disagreements through discussion. We will analyse dichotomous data as risk ratio, OR or proportion and continuous data as mean difference with their SD; all estimates will be presented with their 95% CI. Where applicable, we will determine SD from point estimates and the appropriate denominators assuming a binomial distribution. The magnitude of heterogeneity between the included studies will be assessed quantitatively using the index of heterogeneity (I2 statistic). The I2 values of 25%, 50% and 75% will be considered to represent low, moderate and significant heterogeneity. The significance of heterogeneity will be determined by the p value of the I2 statistic, and a p value of

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Unpacking the black box of interprofessional collaboration within healthcare networks: a scoping review

Introduction
Health systems are facing increasingly complex healthcare challenges, including system fragmentation, silos culture, lack of accountability, budgetary constraints and epidemiological transitions. Many governments adopted healthcare networks as a new strategy to address the complex healthcare challenges (eg, multidisciplinary care) by fostering effective clinical and interprofessional collaboration (IPC) across clinical pathways. Yet, limited evidence exists on how IPC is fostered within healthcare networks (ie, happening inside the structure of the network—including processes, systems, communication and practices).

Objectives
This review aims to identify the underlying processes and drivers for effective IPC within healthcare networks, as well as facilitators and barriers.

Design
We followed the scoping review guidance developed by the Joanna Briggs Institute and Preferred Reporting Items for Systematic Review and Meta-Analysis for Scoping Reviews reporting guidelines.

Data sources
We searched five databases (PubMed (Medline), Scopus, Web of Science, Research4Life and BDSP).

Eligibility criteria
We included peer-reviewed articles published between 2010–2024 in French or English that addressed IPC within healthcare networks.

Data extractions and synthesis
Data charting included the general characteristics of included studies, IPC characteristics, barriers and facilitators and implications for policy and practice. Thematic analysis was guided by the levels of IPC at individual, professional, interactional and organisational levels.

Results
29 studies were included in this review. Most scholars from the included studies indicated that IPC is a complex, socially stratified process that includes four levels: individual, interactional, professional role and organisational characteristics. The main barriers were poor communication, lack of shared knowledge and decision-making, hierarchy and power imbalances. Key facilitators included clarifying roles, building formal structures for IPC, enhancing communication and promoting interprofessional education and training.

Conclusion
Promoting IPC necessitates systemic interventions that target multiple levels, including the individual, interactional, professional and organisational dimensions. Additional research is needed to understand how to foster effective IPC and develop strategies to ensure high-quality patient care.

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Considerations of Intraoperative Transesophageal Echocardiography During Adult Cardiac Surgery: A Scientific Statement From the American Heart Association

Circulation, Ahead of Print. Intraoperative transesophageal echocardiography is used with increasing frequency in cardiac surgery for monitoring and diagnostic purposes. Recent data have shown the impact of improved outcomes in patients undergoing cardiac surgery and the use of intraoperative transesophageal echocardiography in managing complex surgical decisions. However, specialty society recommendations have not been updated to reflect these trends. This scientific statement reviews the state-of-the-art practice of intraoperative echocardiography, summarizes the association of the use of intraoperative transesophageal echocardiography with enhanced outcomes, and provides specific perioperative and procedural transesophageal echocardiography considerations in the cardiac surgical population.

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Arm Based on LEg blood pressures (ABLE-BP): can systolic ankle blood pressure measurements predict systolic arm blood pressure? An individual participant data meta-analysis from the INTERPRESS-IPD Collaboration

Objectives
To determine associations between arm and ankle systolic blood pressures (SBPs), develop and validate a multivariable model predicting arm SBP from ankle SBP, and investigate associations between ankle SBP, cardiovascular disease and mortality.

Design
Ankle-arm SBP differences were examined in two-stage individual participant data (IPD) meta-analyses using multivariable hierarchical linear regression models. Models were used to derive and validate a prediction model for arm SBP based on ankle SBP. Model performance was assessed using area under the receiver operating characteristic (AUROC) curve analyses. Prognostic associations of ankle SBP with outcomes were examined using Cox proportional hazards models.

Data sources
Searches identified cohorts for the Inter-arm Blood Pressure Difference IPD (INTERPRESS-IPD) Collaboration from Medline, Old Medline, Medline in process, Embase and CINAHL databases from inception until January 2017; unpublished data were also sought. Required primary outcomes were all-cause mortality, cardiovascular mortality, and/or fatal and non-fatal cardiovascular events.

Eligibility criteria
Prospective studies from community, primary care or general clinic settings, without language restriction, that recorded SBP in both arms were eligible. Adults aged ≥18 years with SBP measured in all four limbs, in a supine position, were included in the current analyses. People with peripheral artery disease were excluded.

Data extraction and synthesis
Anonymised datasets were individually cleaned and then combined into a single dataset for the INTERPRESS-IPD Collaboration.

Results
The current dataset included 33 710 participants from 14 studies; mean age 58 years, 45% female, mean baseline arm blood pressure 138/80 (SD: 20/12) mm Hg. Mean ankle SBP was 12.0 mm Hg (95% CI 8.8 to 15.2) higher than arm SBP. The multivariable model predicting arm SBP from ankle SBP demonstrated excellent performance (AUROC curves, sensitivities and specificities were >0.82, 0.80 and 0.82, respectively, at all BP thresholds from 130 to 160 mm Hg). Model performance was superior to existing arithmetic formulae.
Ankle SBP was neither associated with all-cause nor cardiovascular mortality (HR 1.000 (0.997 to 1.002; p=0.682) and 1.001 (0.996 to 1.005; p=0.840), respectively). However, lower-reading ankle SBP was associated with fatal or non-fatal cardiovascular events (HR 1.005 (1.002 to 1.007; p

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Clinical effect of ePRO-based symptom monitoring and management on improving survival outcomes in patients with advanced cancer: a single-centre, prospective, randomised controlled trial protocol

Introduction
Symptom management is crucial in cancer care, yet patient symptoms are often overlooked in routine care. There is some evidence that electronic symptom monitoring and management can improve patients’ physical function, symptom control, quality of life and survival outcomes. However, the evidence of the impact on survival outcomes in patients with advanced cancer is still limited and debated. This study aims to conduct a prospective randomised controlled trial by a professional symptom management team to monitor and manage symptoms in advanced cancer patients via an electronic information systems for patient-reported outcomes (ePRO) system (WeChat mini-program) and to verify its effectiveness on improving overall survival.

Methods and analysis
This is a single-centre, prospective, open-labelled, randomised, parallel-controlled clinical trial targeting patients with advanced cancer. We plan to recruit 940 patients using a stratified block randomisation method based on different tumour types. The control group will receive a symptom management self-care manual (both electronic and paper versions). Similarly, the intervention group will receive the same manual and education while also received symptom management by the hospital’s specialised symptom management team through the ePRO system. The primary outcome is comparison of overall survival between groups at the 24-month follow-up. Secondary outcomes will include quality of life, psychological status and incidence of adverse events.

Ethics and dissemination
The study protocol and related documents received approval from the Ethics Committee of Peking University Cancer Hospital (IRB) in December 2023 (2023YJZ99). Ethical approval will be obtained before implementing any major study revisions in the future. The results of this study will be disseminated through academic seminars, peer-reviewed publications and academic conferences.

Trial registration number
ChiCTR2400081247.

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ARBOR-Telehealth study: an examination of telerehabilitation to improve function and reduce opioid use in persons with chronic low back pain in rural communities – protocol of a pragmatic, individually randomised group treatment trial

Introduction
Chronic low back pain (LBP) imposes significant burden on patients, healthcare systems and society. Physical therapy is a cost-effective method for improving pain and disability; however, only a small number of patients (7–13%) with LBP ever receive physical therapy services. Patients report obstacles to accessing physical therapy, such as transportation, provider availability and missed work. Access is especially limited in rural communities, where approximately 40% fewer physical therapists are available per capita than in metropolitan regions. This lack of access likely contributes to the greater rates of LBP-related disability and opioid consumption in rural communities. Innovative methods for improving access to physical therapy for patients with chronic LBP are urgently needed; these can help address differences in health outcomes and mitigate opioid dependence for patients with chronic LBP living in rural communities. Telerehabilitation increases access to physical therapy, which can potentially improve health outcomes for these patients.

Methods and analysis
This prospective, individually randomised group treatment trial will involve primary care clinics serving rural communities on Maryland’s Eastern Shore. We will enroll 434 individuals with chronic LBP. Eligible patients will be randomised to either standardised education for back pain delivered via website or to a risk-informed telerehabilitation. Standardised education will be delivered via a study website containing information consistent with materials provided by primary care providers. Risk-informed telerehabilitation will be delivered by trained physical therapists using a web-based, video-enabled telehealth platform. The primary outcome is LBP-related disability. Secondary outcomes are opioid use, pain intensity, health-related quality of life and LBP-related healthcare use assessed using standard patient-reported outcome measures, participant self-report and medical chart abstraction. Implementation outcomes are acceptability, adoption, feasibility and fidelity of our treatment approach guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and assessed using surveys, semi-structured interviews and key performance metrics.

Ethics and dissemination
Ethics approval was obtained from the Johns Hopkins Medicine Institutional Review Boards (IRB), which serves as the single IRB for this trial. Upon completion, study data will be shared in compliance with National Institutes of Health guidelines.

Trial registration number
NCT06471920.

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Economic burden of hypertension in Iran: a prevalence-based cost of illness study

Objectives
Hypertension is one of the silent diseases and is the major cause of many chronic conditions. The treatment services for hypertension and its cardiovascular complications impose high costs on society and the health system. However, in LMCs, there is not enough evidence-based information about the costs of high blood pressure. This study aims to assess the economic burden of hypertension in Iran in 2020.

Design
A prevalence-based cost of illness study.

Setting
Data on hypertension and selected diseases, including their prevalence, incidence, mortality risk and death counts, were sourced from literature reviews, the Global Burden of Disease (GDP) and the Non-Communicable Diseases Research Centre. Cost estimates were derived from health insurance data, surveys, research studies and treatment protocols. Additional data, such as population, employment rates, household activity rates, wage rates and GDP per capita, were obtained from the Statistical Centre of Iran and the World Bank.

Participants and methods
A prevalence-based cost of illness study was used to estimate the economic burden of hypertension. The focus was on the most significant diseases associated with high blood pressure, including coronary heart disease, ischaemic stroke, haemorrhagic stroke and the direct costs of hypertension. Subsequently, the total number of patients was multiplied by the average cost per patient for each disease. To calculate the average cost, inpatient and outpatient, direct non-medical and indirect costs of diseases were estimated and multiplied by a population-attributed fraction of high blood pressure. Direct costs (hospitalisation and outpatient costs and direct non-medical costs) of hypertension were calculated using the bottom-up approach, and the human capital approach was used to calculate indirect costs.

Results
According to the results of the study, the total economic burden of hypertension was $ purchasing power parity (PPP) 12 848.22 million, of which the share of direct medical, non-medical and indirect costs of hypertension were $ PPP 7245.13 million (56.4%), $ PPP 1173.42 million (9.1%) and $ PPP 4429.68 million (34.5%), respectively. The total economic burden of high blood pressure was equal to 23% of the total economic burden of four chronic diseases.

Conclusion
The economic burden of high blood pressure in the country is very high and significant, and it was equivalent to about 1% of the country’s gross domestic product in 2020, which shows the necessity of preventive interventions.

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British Society of Gastroenterology practice guidance on the management of acute and chronic gastrointestinal symptoms and complications as a result of treatment for cancer

Background
Survival rates after a diagnosis of cancer are improving. Poorly managed gastrointestinal (GI) side effects can interfere with delivery of curative cancer treatment. Long-term physical side effects of cancer therapy impinge on quality of life in up to 25% of those treated for cancer, and GI side effects are the most common and troublesome.

Aim
To provide comprehensive, practical guidance on the management of acute and chronic luminal gastrointestinal symptoms arising during and after treatment for cancer

Methods
A multidisciplinary expert group including patients treated for cancer, divided into working parties to identify, and synthesise recommendations for the optimal assessment, diagnosis and appropriate interventions for luminal GI side effects of systemic and local cancer therapies. Recommendations were developed using the principles of the BMJ AGREE II reporting.

Results
103 recommendations were agreed. The importance of the patient perspective and what can be done to support patients are emphasised. Key physiological principles underlying the development of GI toxicity arising from cancer therapy are outlined. Individual symptoms or symptom clusters are poor at distinguishing the underlying cause(s), and investigations are required if empirical therapy does not lead rapidly to significant benefits. Patients frequently have multiple GI causes for symptoms; all need to be diagnosed and optimally treated to achieve resolution. Investigations and management approaches now known to be ineffective or of questionable benefit are highlighted.

Conclusions
The physical, emotional and financial costs to individuals, their families and society from cancer therapy can be considerable. Identifying and signposting affected patients who require specialist services is the role of all clinicians. Progress in the treatment of cancer increasingly means that patients require expert, multidisciplinary supportive care providing effective and safe treatment at every stage of the cancer journey. Development of such expertise should be prioritised as should the education of health professionals and the public in what, when and how acute and chronic gastrointestinal symptoms and complications should be managed.

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Is the green mark really recyclable?

I read the paper by López-Muñoz et al1 on ‘Life cycle assessment of routinely used endoscopic instruments and simple intervention to reduce our environmental impact’ with great interest. The green mark setting for parts that do not come into contact with the endoscope’s operating channel is a very simple and convenient method that can be carried out on site, and it was shown that the environmental impact of the equipment could be greatly reduced by recycling. However, as we read the paper, two questions came to mind. First, there is a possibility that the risk of nosocomial contamination was underestimated. There is insufficient evidence to show that the separation of equipment using the green mark system meets infection control standards. To evaluate the safety of the method and the risk of the nosocomial contamination of the biopsy forceps that are recycled, we conducted a simple bacteriological evaluation…

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Effects of a remote therapeutic education programme involving peers and health professionals on physical activity in patients with coronary heart disease undergoing phase 3 cardiac rehabilitation: protocol for a single-centre randomised controlled trial

Introduction
Maintaining a satisfactory level of physical activity (PA) after cardiovascular rehabilitation in patients with coronary heart disease (CHD) is an important public health issue. However, more than half of patients do not maintain recommended levels of PA in the long term. There is growing interest in the use of cognitive-behavioural interventions that actively involve both health professionals and patients in education and research settings. We hypothesise that a personalised therapeutic education programme (PTEP) delivered by peers in collaboration with health professionals may help patients with CHD maintain appropriate levels of PA after participation in a cardiovascular rehabilitation programme (CRP).

Methods and analysis
We designed a prospective randomised controlled trial (the P-HEART-NER study) conducted jointly by health professionals and patients as experts or peers. The primary objective is to assess the impact of PTEP on objective levels of moderate to vigorous PA—measured by accelerometers—6 months after cessation of CRP. The secondary objectives are (1) to assess the impact of the intervention on light PA and sedentary time (also measured by accelerometry), (2) to evaluate changes in cardiovascular health indicators, including blood pressure, waist circumference and lipid profile, (3) to assess changes in motivation towards PA (using the Motivation Scale Towards Health-Oriented Physical Activity), PA self-efficacy (measured by the Exercise Confidence Survey) and quality of life (EQ-5D-5L). Patients will be enrolled at the end of a 4-week phase 2 CRP after a myocardial infarction. The intervention will consist of two teleconsultations and a group workshop at 2, 4 and 5 months, respectively, each jointly delivered by a peer and a health professional. The peers who will deliver the intervention will be patients who have participated in a phase 2 CRP with good compliance and who will be trained in motivational enhancement and cognitive behavioural therapies by health professionals and expert patients. The control group will not complete the PTEP.

Ethics and dissemination
Ethical approval was granted by the French regional ethics committee CPP Ile de France (Ref CPPIDF1-2023-DI36-Cat2). All participants will sign a written informed consent form. The results will be presented at conferences and published in peer-reviewed journals.

Trial registration number
NCT05927363.

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Spatial and spatio-temporal analysis for malaria hotspot identification: a scoping review protocol

Introduction
Malaria hotspots have been the focus of public health managers during the last two decades because of the potential elimination gains that can be obtained by targeting them. Advances in spatial technologies in the 20th century such as geographic information systems, remotely sensed satellite data on climate and ecology, and statistical methods for spatial cluster detection have enhanced our ability to map fine-scale patterns of malaria transmission. This led to the diversification of analytical approaches and a lack of consensus on methods and standardised indicators for malaria hotspot detection, raising challenges for comparing and synthesising findings across different studies. This review aims to fill this gap by identifying and summarising all publicly available peer-reviewed articles on spatial and spatio-temporal analytical approaches used to detect malaria hotspots while highlighting research gaps.

Methods
This scoping review will follow the Joanna Briggs Institute Framework. A comprehensive search will be conducted in PubMed, Medline, Web of Science, Scopus and Embase using keywords related to malaria, hotspots and detection. Retrieved articles published between 1 January 2000 and 31 December 2024 in English or French will be uploaded to Covidence for screening. Empirical studies that apply spatial or spatio-temporal analytical methods to detect malaria hotspots will be included. Studies will be excluded if they rely solely on geographical visualisation without formal spatial analysis. Data extraction will be performed by two independent reviewers, with disagreements resolved by discussion. Data will be summarised using descriptive statistics and thematic analysis.

Ethics and dissemination
This scoping review will involve the secondary analysis of published literature on malaria hotspot analysis; therefore, ethics approval is not required. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews checklist will be used to ensure transparency and methodological rigour in reporting. The findings will be disseminated through publication in a peer-reviewed journal and presented at scientific conferences via abstracts, oral or poster presentations.

Trial egistration number
This review has been registered on the Open Science Framework under the DOI: https://doi.org/10.17605/OSF.IO/C8KUN.

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Understanding stakeholders perceptions of the impact of extractive industries on adolescent health and well-being in Mozambique: a qualitative study

Objectives
Adolescent health is critical for achieving Sustainable Development Goal 3, ‘health for all at all ages’. In sub-Saharan Africa (SSA), mining projects hold promise for social and economic development. Yet, the extent to which the health and well-being of adolescents are impacted by industrial mining is poorly understood. In this paper, we aim to investigate how adolescent health and well-being is perceived by key informants and caregivers in communities that have been affected by industrial mining projects in Mozambique.

Design and settings
A qualitative study was implemented from May–July 2022 in two rural districts in Mozambique’s northern and central regions. Both districts have large industrial mining projects: a coal mine in Moatize district and a mineral sands mine in Moma district.

Participants
A total of 21 key informant interviews (KIIs) were conducted with a range of stakeholders, including health professionals and civil society and private sector representatives. In addition, four focus group discussions (FGDs) were conducted with adolescents’ caregivers.

Results
Through the combined results from the KIIs and FGDs, four main health concerns affecting adolescents in mining areas were identified: sexually transmitted infections, respiratory tract infections, diarrhoeal diseases and malaria. Mining activities were perceived to exacerbate negative health effects and contribute to poor health outcomes among adolescents. Although mining companies invested in public infrastructure, most participants did not perceive this investment as a positive contribution to the health and well-being of adolescents.

Conclusion
Our study sheds light on the multifaceted challenges perceived by stakeholders that adolescents residing in mining communities in Mozambique face. Insufficient priority is given to effective interventions that specifically target adolescent health in the two study mining areas. In order to leave no one behind, as stipulated by the sustainable development agenda, more emphasis should be placed on the role and responsibility of mining companies in adequately addressing adolescents’ unique health needs in mining settings in SSA.

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Impact of an educational physiotherapy-yoga intervention on perceived stress in women treated with brachytherapy for cervical cancer: a randomised controlled mixed study protocol (KYOCOL)

Introduction
Cervical cancer is a major global health issue. The standard treatment for locally advanced disease involves radiochemotherapy followed by uterovaginal brachytherapy (UBT). UBT requires several days of hospitalisation and strict bed rest. UBT often induces pain, anxiety, stress, distress and a decline in physical capacity during and after treatment. Previous research suggests that non-pharmacological interventions, such as yoga, may help alleviate these issues. However, few studies have specifically evaluated their effectiveness in reducing stress during UBT. Furthermore, patient education has been shown to facilitate autonomous practice and to improve patient empowerment. This study aims to evaluate the impact of the KYOCOL protocol, which integrates both a physiotherapy-yoga intervention and an educational programme, on perceived stress and its correlates in patients undergoing UBT.

Methods and analysis
KYOCOL is an ongoing randomised, prospective trial carried out in three French comprehensive cancer centres, using a quantitative approach complemented by a qualitative component. Eighty patients are planned to be randomised (1:1) into a control arm (standard care) or an intervention arm. In the intervention arm, patients will be educated and supervised by a trained physiotherapist in a physiotherapy-yoga programme and will then perform daily autonomous sessions during UBT and for up to 15 days post-treatment. The primary objective is to assess the impact of the KYOCOL intervention compared with standard care during UBT, on perceived stress 15 days post-UBT, using the 10-item Perceived Stress Scale. Secondary objectives include evaluating the safety of the intervention, its effects on stress, pain and fatigue during UBT, and patient adherence to the programme. Qualitative analyses based on semistructured interview surveys will be conducted to gather valuable information and analyse in depth patients’ experiences with the intervention and UBT.

Ethics and dissemination
This study was approved by the French ethics committee (Comité de Protection des Personnes Ouest V, reference number 2023-A01491-44) on 22 February 2024 and will be carried out in accordance with the good clinical practice guidelines and the Declaration of Helsinki. The results will be shared with patients and healthcare professionals and published in a peer-reviewed journal.

Trial registration number
NCT06263283.

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Timing of mechanical ventilation and its association with in-hospital outcomes in patients with cardiogenic shock following ST-elevation myocardial infarction: a multicentre observational study

Objective
To evaluate the association between the timing of invasive mechanical ventilation (MV) initiation and clinical outcomes in patients with cardiogenic shock (CS) secondary to ST-elevation myocardial infarction (STEMI).

Design
Retrospective analysis of a multicentre registry.

Setting
Data were obtained from the Gulf-Cardiogenic Shock registry, which includes hospitals across six countries in the Middle East.

Participants
1117 patients diagnosed with STEMI and CS. Of these, 672 (60%) required MV and were included in this analysis.

Primary and secondary outcome measures
The primary outcome was in-hospital mortality. Secondary outcomes included comparisons of baseline characteristics, Society of Coronary Angiogram and Intervention (SCAI) shock stage, and clinical parameters among groups based on time to MV.

Results
Participants were categorised by time from shock diagnosis to MV: early (≤15 min), intermediate (30 min) and late (≥60 min). Median times were 15 min (IQR 10–20), 30 min (IQR 25–35) and 60 min (IQR 45–70), respectively. Baseline characteristics were comparable across groups. Increased delay in MV was associated with a higher mortality risk during the first 60 min post-diagnosis, beyond which the risk plateaued. Delayed MV was an independent predictor of in-hospital mortality (OR 2.14, 95% CI 1.36 to 3.38, p

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