Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

ACTRN12623000598684p.

Cancer remains a major public health concern worldwide. Patient navigation, developed in the 1990s to address disparities in cancer outcomes, aims to guide patients through the complex healthcare system and improve access to timely, quality care. Despite its proven benefits, little is known about the implementation or impact of patient navigation programmes in African settings.

This scoping review aims to map the current evidence on components, procedures, outcomes and impact, as well as barriers and challenges to implementation of patient navigation programmes in cancer care across Africa.

This scoping review will follow Arksey and O’Malley’s scoping review framework, as further developed by Levac et al. A systematic search will be conducted across PubMed, African Journals Online and Google Scholar to identify relevant studies published from database inception to the date of the final search, using a combination of relevant keywords and MeSH terms. Eligible studies must be reported in English, have been carried out in Africa, involved patients diagnosed with cancer or navigating the cancer care continuum, and report on the description, implementation or evaluation of patient navigation programmes. Screening will be managed with Rayyan and carried out through a two-stage process: screening by titles and abstracts, then by full-text screening based on the prespecified inclusion and exclusion criteria. Data will be extracted into a structured Excel spreadsheet and synthesised using qualitative content analysis to identify programme characteristics, outcomes, barriers and implementation challenges.

This scoping review does not require ethical approval. Our findings will be published in a peer-reviewed, open-access journal on completion.

Sepsis and antibiotic resistance constitute a deadly synergy, causing the loss of millions of lives across the world, with their economic and developmental consequences posing a threat to global prosperity. Their impact is disproportionately felt in resource-limited settings and among vulnerable populations, especially children. A key challenge is prompt diagnosis and timely commencement of appropriate antibiotic therapies. These challenges are compounded in low-income and middle-income countries by a lack of comprehensive epidemiological data, with Nigeria being one such country for which it is lacking. Kaduna is the third largest state in Nigeria, with over 10 million inhabitants, of whom more than half are children under 14 years old. While bacterial sepsis and antimicrobial resistance (AMR) are recognised as a growing problem in the state, there are huge gaps in the current understanding of their aetiology. This project employs a cross-sectional design to investigate the clinical and haematological markers of paediatric sepsis, alongside determining the bacterial cause and prevalence of AMR at four high-turnover hospitals in Kaduna State, Nigeria. Further, whole-genome sequencing of isolated bacterial pathogens will be performed to determine the genetic features of resistance. This project represents the largest surveillance study of paediatric sepsis in Kaduna to date. Additionally, we aim to use the clinical, haematological, microbiological and genomic data to derive predictive models for sepsis causes, treatment strategies and patient outcomes.

This is a hospital-based, cross-sectional study that will recruit up to 461 children with bacterial sepsis who were admitted at the two teaching and two general hospitals in Kaduna State, Nigeria. Children presenting with features of fever, subnormal temperature and body weakness would be recruited into the study and have their blood samples collected. The blood samples will be used for culture, complete blood count, HIV and malaria testing. Accordingly, we will capture clinical presentation, haematological characteristics, causative pathogen from blood culture and patient outcomes. Nutritional status, known congenital immunosuppressive diseases, HIV infection and malaria infection will also be determined and documented. The bacterial isolates will be phenotypically characterised for AMR and genotypically following whole genome sequencing. Known and potential confounders to the outcomes of bacterial sepsis would be assessed in all participants, and adjustment for confounding would be performed using logistic regression and/or stratification±Mantel-Haenszel estimator where applicable.

Ethical approvals were granted by the University of Birmingham (ERN_2115-Jun2024), the Ahmadu Bello University Teaching Hospital (ABUTHZ/HREC/H45/2023), Barau Dikko Teaching Hospital, Kaduna (NHREC/30/11/21A) and the Kaduna State Ministry of Health (MOH/AD M/744/VOL.1/1110018). The study will be conducted using the international guidelines for good clinical practice and based on the principles of the Declaration of Helsinki. The results will be disseminated via oral and poster presentations in scientific conferences and published in peer-reviewed journal articles.

Amyotrophic lateral sclerosis (ALS) is a rapidly progressive, fatal motor neuron disease. Diagnostic delay severely impairs patient access to ALS multidisciplinary clinics, available disease-modifying medications and therapies that may prolong survival.

To investigate how patient and physician perspectives might be leveraged to promote timely ALS diagnosis, and how system-level barriers might be addressed to promote appropriate referral to ALS multidisciplinary care.

A qualitative study in Alberta, Canada, used human-centred design and interviews to map the diagnostic journeys of ALS patients and identify individual-level and system-level diagnostic barriers and opportunities.

30 semistructured interviews (10 patients; 20 physicians) were conducted. Data were inductively analysed with the aid of Miro board software. Patient and physician data were triangulated to identify key phases of the journey from symptom onset to confirmed ALS diagnosis and themes related to the diagnostic barriers and opportunities. Journey maps were created to visualise the diagnostic journey.

Patient journeys were comprised of five phases and commonly involved iterative cycles of referral and testing before an ALS diagnosis was confirmed. Four primary themes related to diagnostic barriers: difficulty recognising and responding effectively to early-stage ALS symptoms, absence of a single definitive diagnostic test, long wait times between referrals and clinical visits, and physician reluctance to pronounce an ALS diagnosis. Analysis indicated three approaches for improving diagnostic processes: increase ALS awareness; improve communication between referring physicians and physicians receiving referrals (consultants); and develop physician, diagnostic testing and multidisciplinary clinic referral forms that will guide symptom assessment and accurate referral.

Timely ALS diagnosis is challenging for patients navigating the frequently prolonged, circuitous diagnostic journey and physicians who struggle with referral pathways and the efficient diagnosis of this rare disease. Findings demonstrate the importance of increased ALS awareness and effective communication and response within referral pathways. Recommendations include strengthening the clinical approach of community-based physicians and supporting access and referral pathways. Current initiatives arising from this investigation seek to achieve meaningful change in timely referrals for progressive neurological diseases like ALS.

Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.

This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.

This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.

This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).

Medical oxygen supplementation is essential for treating severe illnesses and plays a critical role in managing life-threatening conditions, especially during the period of increased demand, such as the delta wave of COVID-19. The study aims to evaluate oxygen requirements and production to support effective capacity planning for future health crises.

Cross-sectional quantitative study. Data collection was carried out between 15 March and 19 December 2021.

The study used secondary data from Nepal’s Health Emergency Operation Centre. Regarding medical oxygen production, calculations included oxygen generated from both hospital-based oxygen plants and private companies, using their highest capacities for comparison. These production capacities were then assessed using three levels of efficiency (100%, 80% and 50%), revealing significant gaps when compared against the oxygen requirements of hospitalised COVID-19 patients, as guided by WHO recommendations. The results were communicated in terms of J-size cylinders, alongside average daily COVID-19 hospitalizations. Data was inputted and analysed using Microsoft Excel and presented in numbers and percentage.

The country’s oxygen demand relies largely on the production from private enterprises, with meeting approximately 85.2% of the total requirement. Optimal production ensures that national oxygen needs will be met. The analysis highlighted that at 80% operational efficiency, 90.8% of the hospital’s requirements could be fulfilled. However, if operational efficiency drops to 50%, the fulfilment rate diminishes to 56.7%. The differences in requirement and production of oxygen are consistent across the provinces; however, a huge disparity was notable in Karnali and Sudurpaschim.

Continuous assessment of production capacities in both hospital and private enterprises producing oxygen is necessary to plan and address the gaps.

To investigate whether quantitative retinal markers, derived from multimodal retinal imaging, are associated with increased risk of mortality among individuals with proliferative diabetic retinopathy (PDR), the most severe form of diabetic retinopathy.

Longitudinal retrospective cohort analysis.

This study was nested within the AlzEye cohort, which links longitudinal multimodal retinal imaging data routinely collected from a large tertiary ophthalmic institution in London, UK, with nationally held hospital admissions data across England.

A total of 675 individuals (1129 eyes) with PDR were included from the AlzEye cohort. Participants were aged ≥40 years (mean age 57.3 years, SD 10.3), and 410 (60.7%) were male.

The primary outcome was all-cause mortality. Quantitative retinal markers were derived from fundus photographs and optical coherence tomography using AutoMorph and Topcon Advanced Boundary Segmentation, respectively. We used unadjusted and adjusted Cox-proportional hazards models to estimate hazard ratios (HR) for the association between retinal features and time to death.

After adjusting for sociodemographic factors, each 1-SD decrease in arterial fractal dimension (HR: 1.54, 95% CI: 1.18 to 2.04), arterial vessel density (HR: 1.59, 95% CI: 1.15 to 2.17), arterial average width (HR: 1.35, 95% CI: 1.02 to 1.79), central retinal arteriolar equivalent (HR: 1.39, 95% CI: 1.05 to 1.82) and ganglion cell-inner plexiform layer (GC-IPL) thickness (HR: 1.61, 95% CI: 1.03 to 2.50) was associated with increased mortality risk. When also adjusting for hypertension, arterial fractal dimension (HR: 1.45, 95% CI: 1.08 to 1.92), arterial vessel density (HR: 1.47, 95% CI: 1.05 to 2.08) and GC-IPL thickness (HR: 1.56, 95% CI: 1.03 to 2.38) remained significantly associated with mortality.

Several quantitative retinal markers, relating to both microvascular morphology and retinal neural thickness, are associated with increased mortality among individuals with PDR. The role of retinal imaging in identifying those individuals with PDR most at risk of imminent life-threatening sequelae warrants further investigation.

Fostering well-being and positive mental states are major aims of many strategies for the promotion of public mental health. Such strategies become increasingly important since many people worldwide suffer from psychological distress and mental disorders, resulting in substantial individual and societal costs. Within the last years, there is a shift from strategies solely focusing on the reduction of mental distress to those also aiming at the promotion of positive mental states. Correlates, that is, psychosocial resources, of positive mental states may represent a starting point for those interventions. To date, a comprehensive systematic review on those correlates is still missing as well as knowledge on culture-related differences.

A systematic review and meta-analysis on the longitudinal link between psychosocial resources (eg, income, optimism, social support and community coherence) and hedonic and eudaimonic positive mental states (eg, life satisfaction, happiness and forward-looking attitude) will be conducted. Using Hofstede’s dimensions of culture and global metrics of Education, Industrialisation, Richness and Democratic values (EIRDness), we will examine culture-related moderators of these associations. The systematic review will be conducted following standards of the Cochrane Collaboration and will be reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyse guidelines. Literature searches for primary studies will be carried out across four databases (APA PsycNet, Embase, Scopus and the Web of Science Core Collection), including all publications up to 27 January 2025. Screening at the level of titles and abstracts will be performed with the help of artificial intelligence software (ASReview). Study quality will be assessed using an adapted version of the Newcastle Ottawa Scale. We will employ multilevel meta-analyses of correlation coefficients, with cultural variables being examined as moderators.

This systematic review does not require ethics approval, as it solely uses previously published data. Materials and data used for this review will be shared via open repositories (https://osf.io/2xkhs/). Results will be published in an international, peer-reviewed journal and presented at conferences including plain language summaries.

https://doi.org/10.17605/OSF.IO/K7X52

Using the community-based participatory research (CBPR) methodology, sustained peer group treatment has effectively improved medication adherence. Although many studies investigate the effectiveness of peer group therapy, there is a lack of evidence addressing the cost-effectiveness of CBPR models in low- and middle-income countries. This protocol outlines the methods for the economic evaluation of the PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hyperTEnsion (PARTICIPATE) trial to determine whether the CBPR approach to enhance medication adherence among patients with diabetes and/or hypertension is cost-effective in India.

A within-trial cost-effectiveness analysis (CEA) from a societal perspective will be conducted alongside a multicentre cluster randomised controlled trial to identify, measure and evaluate the key resource and outcome impacts of a CBPR model compared with usual care aimed at improving medication adherence in adult rural Indian patients with diabetes and/or hypertension. The CEA will provide results in terms of the cost per improvement in medication adherence score, and a cost-utility analysis (CUA) will express the findings as the cost per disability-adjusted life year (DALY) or quality-adjusted life year (QALY) gained. Intervention costs and effects will be projected for the population of Indian adults with diabetes and/or hypertension who are on medication, analysed over the cohort’s lifetime. Results from the modelled CUA will detail incremental costs, costs per death averted and costs per DALY averted/QALY gained for the interventions relative to the comparator. Incremental cost-effectiveness ratios will be computed by dividing the cost difference between the intervention and comparator by the difference in benefits. Health economic evaluation methods, including a lifetime horizon, a 3% discount rate for costs and benefits and a societal perspective, will be followed. The effects of sampling uncertainty on estimated incremental costs and effectiveness parameters, as well as the influence of methodological assumptions (such as the discount rate and study perspective), will be examined through both deterministic and probabilistic sensitivity analyses. Relevant differences in costs, outcomes or cost-effectiveness disparities among subgroups of patients with varying baseline characteristics will also be reported. Results will be illustrated using cost-effectiveness acceptability curves across a range of willingness-to-pay thresholds. Modelled CUA will broaden the target population and time frame to offer decision-makers insights into the cost-effectiveness of the CBPR approach for enhancing medication adherence. Furthermore, a return on investment analysis will be performed to express benefits in monetary terms relative to investments made, allowing for a comprehensive expression of both costs and the full spectrum of intervention benefits in monetary units.

The Institutional Ethics Committee of Sri Aurobindo Medical College and PGI, Indore, provided ethics approval. The results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal and disseminated through reports to Indian Council of Medical Research and conference presentations.

Clinical Trial Registry of India (CTRI) CTRI/2024/01/061939.

The transition from paediatric to adult healthcare marks a pivotal period for chronically ill adolescents, as they transition from a highly supportive and family-oriented environment to an adult-oriented and a more individual-oriented healthcare system that places a greater emphasis on personal responsibility and independence. Parents, given their firsthand experience managing their child’s healthcare, play a central role in ensuring a smooth and successful transition, yet their perspectives on the barriers and facilitators of this complex process remain vastly underexplored. This scoping review aims to assess and provide comprehensive insights into parents’ perceptions of the successes and challenges during their adolescents’ transition from paediatric to adult healthcare.

This scoping review is led by patient partners and will be guided by the Peters et al and the Joanna Briggs Institute guidelines for scoping reviews. The preliminary search strategy will be developed and calibrated in Ovid MEDLINE and will be subsequently replicated in the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsychInfo, Embase, Web of Science and Sociological Abstracts from inception through 18 December 2024, including all types of studies. Grey literature sources recommended by patient partners and clinical and qualitative research experts will also be included. Two reviewers will independently perform the title and abstract review of all studies against the predefined inclusion and exclusion criteria, followed by the full-text review of included studies. The reference list of all included studies will also be screened to maximise the retrieval of relevant sources. Data will be extracted and analysed quantitatively and qualitatively, with the study procedural and reporting format following Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines.

This scoping review, through the broad and systematic mapping of existing literature, aims to provide a foundation for developing targeted support systems, strategies and interventions to address the unique needs and barriers faced by parents and caregivers of chronically ill adolescents during this critical transition to adult care.

Endovascular aortic aneurysm repair (EVAR) requires long-term surveillance to detect and treat postoperative complications. However, prediction models to optimise follow-up strategies are still lacking. The primary objective of this study is to develop predictive models of post-operative outcomes following elective EVAR using Artificial Intelligence (AI)-driven analysis. The secondary objective is to investigate morphological aortic changes following EVAR.

This international, multicentre, observational study will retrospectively include 500 patients who underwent elective EVAR. Primary outcomes are EVAR postoperative complications including deaths, re-interventions, endoleaks, limb occlusion and stent-graft migration occurring within 1 year and at mid-term follow-up (1 to 3 years). Secondary outcomes are aortic anatomical changes. Morphological changes following EVAR will be analysed and compared based on preoperative and postoperative CT angiography (CTA) images (within 1 to 12 months, and at the last follow-up) using the AI-based software PRAEVAorta 2 (Nurea). Deep learning algorithms will be applied to stratify the risk of postoperative outcomes into low or high-risk categories. The training and testing dataset will be respectively composed of 70% and 30% of the cohort.

The study protocol is designed to ensure that the sponsor and the investigators comply with the principles of the Declaration of Helsinki and the ICH E6 good clinical practice guideline. The study has been approved by the ethics committee of the University Hospital of Patras (Patras, Greece) under the number 492/05.12.2024. The results of the study will be presented at relevant national and international conferences and submitted for publication to peer-review journals.

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.

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.

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.

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

Outpatient parenteral antimicrobial therapy (OPAT) is an innovative approach to manage infections that require extended courses of intravenous antibiotics by enabling patients to receive treatment in an outpatient setting. In Malaysia, there has yet to be a systematic evaluation of the OPAT service. This study aims to describe the safety, clinical indications and treatment outcomes of the OPAT service in Malaysia, assess patients’ satisfaction and experiences and determine the facilitators and barriers associated with the provision of the OPAT service in Malaysia.

A mixed-methods approach combining qualitative and quantitative methods will be employed for a comprehensive understanding of the provision of the OPAT service in Malaysian public hospitals. The study consists of four distinct parts: systematic review, retrospective cohort analysis of clinical outcomes, patients’ satisfaction survey and focus group discussions on providers’ experiences. A longitudinal analysis of the clinical outcomes (treatment success/failure, infection cure, adverse events, readmission and mortality) of the OPAT patients’ cohort will be conducted using descriptive and conclusive statistics, in addition to rates of patients’ satisfaction and evaluation of providers’ experiences.

This study is registered in the National Medical Research Register (NMRR ID-24-00941-2C8) and approved by the Medical Research and Ethics Committee, Ministry of Health Malaysia (Ref: 24-00941-2C8). Written informed consent will be obtained from all participants. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

The WHO’s Integrated Management of Childhood Illness (IMCI) in young infants

We will create a dataset that integrates data from population-based studies globally with similar designs that have examined the presence of signs of PSBI identified by frontline health workers throughout the young infant period (days 0 to

All prior studies incorporated into our pooled analysis were approved by the independent local ethics committee/institutional review board (IRB) at each study site in each country, and all study participants provided informed consent. This project was approved by the Stanford University School of Medicine IRB protocol 74456. Study findings will be disseminated through publications in peer-reviewed journals, WHO documents, and presentations at maternal and child health meetings.

Treating modifiable risk factors of dementia may prevent or delay dementia cases by up to 40%. The ‘Strategic Multimodal Intervention in at-risk Elderly Indians for Prevention of Dementia (SMRUTHI INDIA)’ study will be conducted to establish a trial-ready cohort of elderly Indians who are at high risk of developing dementia.

The main aim of the study is to create and study a cohort of individuals at high risk of dementia in rural India, where we can do multiple intervention trials. The study uses the ‘Cohort Multiple Randomised Controlled Trial’ (cmRCT) design, which combines a cohort study with in-built provisions to do multiple randomised controlled trials. A large rural cohort of size 10 000 (four zones of India, through established Indian Council of Medical Research - Model Rural Health Research Units) will be followed systematically with yearly neuropsychological evaluation for 5 years (the current funding supports first 3000 participants). The study also proposes to design a multimodal ‘care bundle’ for the prevention of dementia, which is culturally tailored and context-specific to the Indian population. This intervention will undergo testing for feasibility in the hospital setting at the central coordinating site through a pilot randomised controlled trial (6 months, 30 participants). In parallel, the care bundle will be culturally and linguistically adapted and pilot-tested in 20 participants in each zone. The final curated care bundle (first intervention that is planned) will then be tested for efficacy in phase 2 of the SMRUTHI INDIA cmRCT cohort.

The study has received ethical clearance at the central coordinating site and at each of the four clinical sites by the Institute Research Committee of each site. The outcomes of the study will be disseminated to various target audiences, including research participants, general public, scientific community and policy makers through national and international conferences and events, social media, various community engagement activities and publication in peer-reviewed journals.

The study protocol is registered in the Clinical Trial Registry of India (CTRI/2024/01/061172).

Molar incisor hypomineralisation (MIH) is a qualitative developmental defect of the enamel with a complex, multifactorial nature and a significant genetic component. Individuals with MIH have a compromised stomatognathic system manifested by muscle hyperactivity under postural and dynamic conditions. However, there is a gap in knowledge on the specific functional abnormalities that these individuals experience. Early identification and intervention, with a focus on the prevention of orofacial dysfunctions and deviations in facial growth and development, are aspects of the utmost importance. Therefore, the aim of the proposed study is to perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH. The secondary objective is to assess whether dentin hypersensitivity and the severity of MIH lesions are associated with alterations in orofacial functions.

Assessments will be performed using the Nordic Orofacial Test-Screening (NOT-S). Descriptive analyses will characterise the sample. The Shapiro-Wilk test will assess normality. For normally distributed data, analysis of variance and Tukey’s post hoc test will be used. For non-normal data, the Mann-Whitney U test will be applied. The 2 test will analyse categorical variables and compare NOT-S domains between groups. Potential confounders (eg, age, sex, socioeconomic status) will be controlled through stratification or as covariates. Logistic and Poisson regressions will model associations for categorical and count-based outcomes, respectively. Statistical significance will be set at p

This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 83969924.2.0000.5511; approval date: 22 November 2024). Participants will agree to take part in the study by signing an informed consent form. The findings will be published in a peer-reviewed journal. The collected data will be available on request.

NCT06692257.

Sleep disordered breathing is a chronic condition often requiring patient commitment to positive airway pressure (PAP) therapy. Understanding the lived experience of PAP therapy users is crucial for clinicians to support successful treatment and identify research priorities. There is a lack of evidence in this area, and published data predominantly explore the negative experiences of PAP. This study aims to explore the lived experiences of patients using PAP therapy.

This study employs a phenomenological approach, appropriate for researching human experiences where there is little existing research. Heideggerian theory underpins the research, recognising that the researcher’s beliefs influence meaning, allowing for rich analysis of the lived experience.

Participants will be recruited from a randomised controlled trial investigating the medium-term clinical impact of customised interfaces for patients requiring PAP therapy. Purposive sampling will be used to seek representation from various demographics, with a maximum of 30 participants.

Data collection will be via 1:1 semistructured interviews. Data will be analysed using Braun and Clarke’s six-phase reflexive thematic analysis. Data will be analysed inductively through an interpretivism lens. Data will be managed with computer-assisted qualitative data analysis software.

This protocol has been approved by the Hampshire B Research Ethics Committee (REC reference: 22/SC/0405). Results will be disseminated to healthcare professionals and patients through conferences, open-access journals, newsletters, the study webpage, infographics, animations, social media and healthcare awards. Tracy’s eight ‘big tent’ criteria for excellent qualitative research are comprehensive and encompassing, and this protocol has aimed to meet the criteria. The Consolidated Criteria for Reporting Qualitative Research has also been used. The findings of this study will contribute to a more holistic understanding of the lived experience of PAP therapy users, informing clinical practice and future research.

ISRCTN74082423.

The objective of the Chinese Neonatal Follow-Up Network (CHNFUN) is to establish a standardised follow-up protocol for the assessment of high-risk preterm infants, and collaborative research aimed at improving early intervention and neurodevelopmental outcomes for preterm infants with gestational age less than 32 weeks in China. The CHNFUN is the first national neonatal follow-up network and has the largest geographically representative cohort from neonatal intensive care units (NICUs) in China.

A survey of neonatal follow-up clinics participating in CHNFUN was used to inform the development of a standardised protocol for the assessment of high-risk preterm infants in China. Training in the use of assessment tools and data collection was provided to all participating centres. Individual-level neurodevelopmental outcomes data from participating neonatal follow-up clinics will be collected at corrected age, 40 weeks, 3–4 months, 12 months, 18–24 months, 3 years and 6 years of age, using a unique database developed by the CHNFUN and linked to NICU outcomes data in the CHNN Database. Data will be prospectively collected on an ongoing basis from all surviving infants born at

This study was approved by the ethics review board of Children’s Hospital of Fudan University (#CHFU 2022-112), which was recognised by all participating hospitals. Waiver of consent was granted at all sites. Only non-identifiable patient-level data will be transmitted, and only aggregate data will be reported in CHNFUN reports and publications.