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Ayer — Septiembre 16th 2026Tus fuentes RSS

Effects of Vacuum Compression Therapy on Healing of Chronic Lower Limb Ulcers: A Randomised Controlled Study

ABSTRACT

Chronic lower limb ulcers remain difficult to manage when unresponsive to conventional treatment. This study evaluated the clinical and physiological effects of vacuum compression therapy on wound healing and quality of life. Fifty patients with chronic lower limb ulcers were randomised to receive 12 sessions of vacuum compression therapy plus standard care or standard care alone over 4 weeks. Wound dimensions, exudate, pain intensity and quality of life were assessed at baseline and post-treatment. Estimated wound volume was calculated as length × width × depth. Tissue oxygenation was measured at the dorsum of the foot in the experimental group. The vacuum compression therapy group showed greater improvements in wound width, depth, volume and quality of life. Estimated wound volume decreased by 61% in the intervention group, whereas no statistically significant volume reduction was observed in controls. Local tissue oxygenation in the experimental group increased by 43%. Baseline wound size was associated with poorer quality of life. Vacuum compression therapy may enhance wound healing and quality of life in patients with chronic lower limb ulcers. Observed increases in local tissue oxygenation represent exploratory physiological findings within the treated cohort that warrant controlled comparative evaluation.

Trial Registration: ClinicalTrials.gov identifier: NCT07737184.

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Health system interventions to floods and heatwaves for maternal and child health services: a realist-informed systematic review protocol

Por: Debele · S. E. · Bozzani · F. M. · Mushinda-Musonda · G. · Kovats · S. · Bonnet · G. · Chama-Chiliba · C. M. · Foss · A. M. · da Silva · E. N. · Borghi · J.
Introduction

Floods and heatwaves are becoming more frequent and intense and can disrupt routine maternal and child health (MCH) services. Previous reviews have not systematically examined how context and mechanisms may shape adaptation outcomes. This realist-informed systematic review examines how, why and under what conditions interventions support access to, utilisation of and continuity of routine MCH services during flood and heat events.

Methods and analysis

The search strategy was developed by integrating terms from 17 related reviews, refined with the author team and checked by an experienced London School of Hygiene & Tropical Medicine librarian. The initial database search was conducted on 16 May 2025 and the search was updated on 30 April 2026. Eight databases were searched: Web of Science, Ovid MEDLINE, EMBASE, Global Health, EconLit, GreenFILE, CINAHL and ProQuest Environmental Science & Public Policy. Records published between January 2000 and April 2026 were eligible. Search results were imported into EndNote and deduplicated. Title-and-abstract screening and full-text assessment were conducted independently by two reviewers for the initial search and are ongoing for the updated search, with ASReview being used to prioritise records during title-and-abstract screening. Data extraction across the full review evidence base remains ongoing using a structured template covering study context, intervention characteristics, mechanisms, outcomes, costs and implementation conditions. Study settings will be classified by country income group, health system context and Köppen–Geiger climate zone to compare evidence across settings and, where appropriate, to identify possible climate analogues for exploratory, context-specific assessment. Climate-zone similarity will not be used to infer intervention transferability or future effectiveness. The synthesis will be guided by the WHO Climate-Resilient Health Systems framework, Meadows’ leverage-points framework and realist-informed C–M–O reasoning. Interventions will be grouped to identify where they operate within the health system and which health system components and vulnerabilities they address. Findings will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance.

Ethics and dissemination

Ethical approval is not required because the review uses published literature and does not involve human participants. The findings will be disseminated through a peer-reviewed systematic review publication. They will inform the design, improvement and scaling of interventions intended to maintain routine MCH services and strengthen health system resilience to floods and heatwaves across diverse settings.

Registration details

The review was not prospectively registered with PROSPERO.

Ebetsu Active Future Study (EAFS): cognitive function and physical and mental health in elderly residents of Ebetsu City, Japan - cohort profile

Por: Kagami-Katsuyama · H. · Ito · N. · Hazama · M. · Toya · N. · Wataya · T. · Satoh · K. · Toda · N. · Kinoshita · K. · Honma · N. · Nishibe · T. · Satoh · H. · Koshino · K. · Saito · S. · Chiba · F. · Hattori · H. · Ogata · A. · Tanaka · N. · Maeda-Yamamoto · M. · Kimoto · H. · Kim · M. · Kumano
Purpose

Ebetsu Active Future Study (EAFS) conducts comprehensive annual surveys of individuals who are independent in activities of daily living (ADLs) to track age-related physical and mental changes. These surveys include a variety of assessments such as cognitive function tests, physical function tests, blood tests, self-administered questionnaires about lifestyle and health, and interviews regarding medical and family history. In addition, serum, plasma and DNA samples from these assessments are stored at –80°C to facilitate future analyses and accommodate the potential addition of new measurement items. The purposes of this study are: (1) to identify potential blood-based biomarkers applicable to the detection of various types of mild cognitive impairment (MCI), (2) to explore diet-based strategies for preventing MCI and the progression of dementia, (3) to examine the relationship between urban characteristics, individual attributes and healthy life expectancy in Ebetsu City and (4) to return the research findings to the city.

Participants

From August to October 2023, EAFS invited Ebetsu residents to participate in the study. As a result, 1340 individuals applied and 1189 residents aged between 55 and 75 years who were independent in ADLs participated in the baseline survey for the first year.

Findings to date

EAFS initiated a follow-up of 1189 participants (38.9% male; 64.5±5.6 years) in the baseline year of 2023 and maintained a high follow-up rate of 98.5% by wave 3 (2025). The Montreal Cognitive Assessment-Japanese demonstrated that 53.6% of the participants had operational MCI. The proportion of participants with operational MCI increased with ageing. Regarding the APOE4 gene, which is associated with an increased risk of Alzheimer’s disease, 1.2% of the total population were homozygous carriers and 22.1% were heterozygous carriers.

Future plans

EAFS will conduct annual follow-up surveys until 2032. In addition to analysing data for each objective, we also plan to perform further analysis of the stored specimens.

Validation and psychometric properties of the Persian version of the Physician Self-Efficacy to Manage Emotional Challenges (P-PSMEC) scale among medical students: a methodological cross-sectional study

Por: Hamidkholgh · G. · Mirzaei · A. · Nemati-Vakilabad · R. · Yousefian · M. · Adiban · V.
Objectives

Translate and culturally adapt the Physician Self-Efficacy to Manage Emotional Challenges (PSMEC) scale into Persian, then assess the validity and reliability of the Persian version of the PSMEC (P-PSMEC) among medical students.

Design

Methodological cross-sectional study.

Setting

Ardabil University of Medical Sciences, Ardabil, Iran.

Participants

A convenience sample of 237 medical students participated in the study between July and December 2024.

Primary and secondary outcome measures

The main focus was on evaluating the psychometric performance of the 17-item P-PSMEC scale, particularly its intended five-factor structure, examined through confirmatory factor analysis (CFA). Secondary outcomes encompassed face validity, content validity, internal convergent validity, discriminant validity, internal consistency and test-retest reliability. Additionally, an ordinal CFA sensitivity analysis was performed using the weighted least squares mean-adjusted and variance-adjusted (WLSMV) estimator.

Results

The P-PSMEC showed acceptable face and content validity with a Scale Content Validity Index/AVE of 0.871. The main maximum likelihood-based CFA indicated good model fit: ²/df=1.415, root mean square error of approximation (RMSEA)=0.041, Comparative Fit Index (CFI)=0.984 and standardised root mean square residual (SRMR)=0.021. An ordinal CFA with WLSMV produced similar results: ²=168.234, df=109, RMSEA=0.048, CFI=0.981, Tucker-Lewis Index=0.976, SRMR=0.049, with standardised loadings between 0.52 and 0.89. Evidence for internal convergent validity was supported by average variance extracted (AVE) values above 0.50 and composite reliability values above 0.70. Heterotrait-Monotrait ratio values were below 0.85, and maximum shared variance was lower than AVE, indicating good discriminant validity. Internal consistency was high (Cronbach’s α=0.902), and test-retest reliability was also strong (intraclass correlation coefficient=0.901).

Conclusions

The P-PSMEC shows good validity and reliability for measuring self-efficacy in managing emotional challenges among Persian-speaking medical students. The results support the proposed five-factor structure, although additional multisite, longitudinal, external validation and measurement-invariance studies are necessary.

Human papillomavirus (HPV) and HPV vaccine awareness in Indigenous communities in Northwest Territories, Canada

by Afsaneh Omidimorad, Fariba Kolahdooz, Ghazal Kolahdooz, Adrian Wagg, Paul Veugelers, André Corriveau, Kami Kandola, Stephanie Irlbacher-Fox, Gina Ogilvie, Carolyn Gotay, Sangita Sharma

Objectives

Human papillomavirus (HPV) is a common sexually transmitted infection linked to several cancers, including cervical cancer, which ranks fourth in cancer incidence and mortality among women globally. Despite its significance, awareness of HPV and the HPV vaccine remains limited across many populations. This project assessed HPV and HPV vaccine awareness among Indigenous adults in Northwest Territories communities in Canada and explored factors influencing HPV vaccine utilization; such data have never been available or explored.

Methods

Using a community-based participatory research approach, quantitative and qualitative data were collected in 11 Indigenous communities in Northwest Territories. Indigenous adults aged 18 years and older were invited to complete a semi-structured questionnaire administered by trained local research assistants. Multiple logistic regression was used to examine potential associations among age, gender, education, and awareness of HPV and the HPV vaccine. A thematic analysis of qualitative data explored reasons for non-vaccination.

Results

Among the 221 participants (66.5% women; mean age 43.6 years (±13.9)), approximately half had heard of HPV, and fewer than one-third had heard of the HPV vaccine. Education emerged as a key factor, with individuals with lower educational attainment being significantly less aware of HPV (p < .000). Age (p < .033), gender (p < .019), and education (p < .004) predicted vaccine awareness, with women, individuals with higher education, and younger adults being more likely to have heard about the vaccine. Only 26.3% of participants aged up to 26 years had received the HPV vaccine. Qualitative data revealed that limited awareness and insufficient information about HPV and the vaccine are the main barriers to vaccination. Participants recommended enhancing vaccine promotion by raising awareness about the connection between HPV and cancer, as well as increasing educational efforts in schools and communities.

Conclusions

Limited awareness of the HPV vaccine may contribute to low vaccination rates. Tailored and targeted interventions are crucial to increasing HPV vaccine utilization in Indigenous communities in Northwest Territories.

Hyperbaric Oxygen Therapy for Diabetic Foot Ulcers in Sub‐Saharan Africa: A Critical Review of Clinical Evidence, Health‐System Feasibility and Public Health Implications

ABSTRACT

Diabetic foot ulcers are an important cause of morbidity, amputation, disability and healthcare expenditure in sub-Saharan Africa, where limitations in preventive foot care, referral pathways, vascular services, multidisciplinary wound care and financial protection may contribute to poor outcomes. This critical narrative review evaluates the potential role of systemic hyperbaric oxygen therapy as an adjunct to standard diabetic foot ulcer care in sub-Saharan Africa by integrating evidence on clinical effectiveness and safety with health-system, economic, equity and implementation considerations. Evidence was drawn from clinical studies, systematic reviews, clinical guidelines, economic evaluations and literature relevant to diabetic foot care and health-system capacity in the region. Global evidence suggests that systemic hyperbaric oxygen therapy may improve wound healing in selected patients whose ulcers fail to heal with best standard care, but findings remain heterogeneous; evidence for reducing amputation is uncertain, and direct regional evidence is sparse. Implementation in sub-Saharan Africa would require reliable oxygen, electricity, trained staff, safe maintenance systems, multidisciplinary care, referral pathways, sustainable financing and feasible treatment completion. The therapy should therefore not be considered routine or first-line treatment. Where appropriate infrastructure exists, carefully monitored referral-centre pilots should assess clinical outcomes, safety, treatment completion, affordability, budget impact and equity before wider implementation.

Adherence to sexual and reproductive health programmes among migrant women residing in the Basque Country: protocol for a mixed-methods study on implementation and influencing factors

Por: Artieta Pinedo · I. · Mulas-Martin · M. J. · Paz-Pascual · C. · Espinosa Cifuentes · M. · Maquibar · A. · Estalella · I.
Introduction

The increased resources available to improve the population’s sexual and reproductive health do not always reach migrant women equally. This is relevant in a context where 26.6% of births in 2024 were to foreign-born mothers. The objective of this study is to analyse the adherence among the migrant population in the autonomous region of the Basque Country (Spain) to the established protocols for pregnancy, childbirth and postnatal care, as well as their use of health services. In addition, it aims to identify the barriers and facilitators that influence their access to and continuity of care.

Method

This mixed-methods study comprises two phases: (a) a population-based, descriptive, retrospective study using data from the routine monitoring of health programmes for women who gave birth during 2024 in the Basque Country. Variables related to the women’s characteristics, healthcare utilisation, and the course of pregnancy, childbirth and the postnatal period will be analysed. The analysis will include descriptive statistics, bivariate techniques and multivariate modelling; (b) a qualitative study using focus groups. At least five focus groups will be organised to ensure representation by continent and country of origin. These groups will explore experiences and perceived barriers related to the adaptation of sexual and reproductive health self-care practices to the healthcare system among migrant women. The sessions will be audio-recorded, transcribed verbatim, coded and categorised to develop a conceptual framework that will later be analysed with the text.

Ethics and dissemination

The study has been approved by the Basque Country Ethics Committee. Informed consent will be obtained from all participants for the collection of primary data, and participants may withdraw from the study at any time without consequence. Authorisation has also been granted by the Basque Health Service Directorate to access recorded data, which will be provided in anonymised form, ensuring that individuals cannot be reidentified. Findings will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.

Mapping the internationally reported evidence on physician-staffed helicopter transport in Japan: a scoping review

Por: Nakao · S. · Yokono · Y. · Shimazaki · J. · Iba · J. · Irisawa · T. · Oda · J.
Objectives

Japan’s physician-staffed helicopter emergency medical services (HEMS) are widely deployed but published evidence is heterogeneous across indications, outcomes and study designs. We aimed to map the internationally reported, English-language literature evaluating physician-staffed HEMS in Japan and to identify evidence gaps requiring further research.

Design

Scoping review was conducted using established methodological frameworks and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR).

Data sources

MEDLINE, Web of Science, CINAHL and the Cochrane Library, supplemented by backward and forward citation tracking.

Eligibility criteria

Original studies evaluating physician-staffed HEMS in Japan and reporting patient outcomes for any emergency condition published in English-language journals.

Methods

We conducted a systematic database search using terms related to physician-staffed HEMS in Japan. The original search (28 May 2024) was updated on 25 February 2026 using the same eligibility criteria. Two reviewers independently performed title/abstract screening followed by full-text screening to determine eligibility. We additionally performed backward and forward citation tracking of the included studies. We summarised characteristics of eligible studies descriptively using counts and proportions.

Results

The updated search identified 341 records, and citation tracking identified 16 further studies, yielding 76 included studies. Publications increased over time (2016–2020: 32.9%; 2021–2026: 52.6%). Most studies were single-centre observational (55.3%) or registry-based (39.5%), with few multi-centre studies (5.3%). Trauma was the most frequent study population (25.0%), and mortality the most common primary outcome (35.5%). First authors were university-affiliated in 88.2% of studies, 39.5% appeared in a single aeromedical journal, and no study compared physician-staffed with non-physician HEMS.

Conclusion

The internationally reported, English-language literature on physician-staffed HEMS in Japan has expanded over time, but remains dominated by retrospective observational designs, is produced largely by university-affiliated authors, and is concentrated in a small number of journals. Prospective multi-centre evaluation, comparison with non-physician HEMS, functional and longer-term outcomes, and economic evaluation were absent from the identified literature.

Study protocol: Effect of inulin supplementation on gut microbiota in patients with oral lichen planus — A double-blind, randomised, placebo-controlled parallel-group trial

by Koki Nambu, Naoki Kaneko, Shiho Yokomizo, Hu Chen, Lijing Yan, Wang Shiyao, Ryusei Shizuma, Eiji Iwata, Yukiko Ohyama, Shohei Akagawa, Soichiro Ibaragi, Shintaro Kawano, Masafumi Moriyama

Oral lichen planus is a chronic inflammatory disease of the oral mucosa characterised by immune dysregulation, but its pathogenesis remains incompletely understood and no curative treatment has been established. Our previous work showed that patients with oral lichen planus exhibit gut dysbiosis, including reduced microbial diversity and depletion of butyrate-producing bacteria. Because butyrate promotes regulatory T-cell differentiation and supports immune homeostasis, targeting this dysbiosis may represent a microbiota-directed approach for immune modulation in oral lichen planus. This study aims to investigate the effects of inulin supplementation on the gut microbiota and related immune markers in patients with oral lichen planus. This multicentre, double-blind, randomised, placebo-controlled parallel-group trial will enrol 80 patients with oral lichen planus. Participants will be randomly assigned in a 1:1 ratio to receive either inulin (8 g/day) or a maltose placebo for 4 weeks, in addition to standard care. The primary outcome is the change in the relative abundance of prespecified butyrate-producing gut bacteria from baseline to the end of intervention at Week 6. Secondary outcomes include changes in gut microbiota diversity, salivary microbiota composition, faecal short-chain fatty acid concentrations, peripheral blood regulatory T-cell counts, blood test parameters, and clinical symptoms of oral lichen planus. Analyses will follow the intention-to-treat principle, and between-group differences will be assessed using appropriate statistical methods. This trial is designed to evaluate, in a randomised placebo-controlled setting, whether a microbiota-directed intervention can modify gut microbial profiles and related immune markers in patients with oral lichen planus. The findings are expected to clarify whether inulin supplementation can modify gut microbial profiles and related immunological markers in patients with oral lichen planus. Trial registration: UMIN Clinical Trials Registry (UMIN-CTR), UMIN000060840, registered on 1 April 2026 (https://rctportal.mhlw.go.jp/detail/um?trial_id=UMIN000060840#).

Multidrug resistance and carbapenemase producing <i>Enterobacteriaceae</i> isolated from clinical samples, Addis Ababa, Ethiopia: A cross-sectional study

by Yordanos Getachew, Tamirat Tamiru, Mekdelawit Fisseha, Sami Sebri, Tadesse Shume, Regasa Diriba, Kassu Desta

Background

Multidrug-resistant Enterobacteriaceae (MDRE) is among the leading causes of hospital-acquired infections, resulting in prolonged hospitalization, increased healthcare costs, and mortality. Carbapenem are often used as last-resort antibiotics; however, the emergence of carbapenemase-producing Enterobacteriaceae (CPE) has severely limited treatment options. In Ethiopia, data on their burden from routine diagnostic laboratory settings remain limited. This study assessed the prevalence of multidrug-resistant and carbapenemase-producing Enterobacteriaceae among clinical isolates in Addis Ababa.

Methods

A laboratory-based cross-sectional study was conducted from January 2, 2025, to April 2, 2025 on clinical specimens referred to Wudassie Advanced Medical Laboratory in Addis Ababa, Ethiopia. A total of 1105 clinical specimens collected through convenience sampling method were processed. Bacterial identification was performed using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) (EXS 3000, Zybio Inc., China). Antimicrobial susceptibility testing was conducted using the Kirby–Bauer disk diffusion method according to Clinical and Laboratory Standards Institute (CLSI 2024) guidelines. Carbapenemase production was confirmed using the modified Carbapenem Inactivation Method (mCIM). Data were analyzed using SPSS version 26.

Results

Of the 1105 clinical specimens, 288/1105 (26.1%) showed bacterial growth. Enterobacteriaceae accounted for 156/288 (54.2%) of the isolates. The most common isolates were Escherichia coli 89/156 (57.1%) and Klebsiella pneumoniae 47/156 (30.1%). Overall, 123/156 (78.8%) of Enterobacteriaceae were multidrug resistant. Carbapenem resistance was detected in 35/154 (22.7%) of isolates, and 30/154 (19.5%) were confirmed as carbapenemase producers. Klebsiella pneumoniae 24/30 (80%) was the predominant carbapenemase-producing organism. Most CPE isolates were recovered from urine specimens, followed by wound and sputum samples.

Conclusion

This study demonstrates a high prevalence of multidrug-resistant and carbapenemase-producing Enterobacteriaceae in Addis Ababa. The findings highlight the urgent need for strengthened antimicrobial stewardship programs, early detection strategies, and enhanced infection prevention and control measures in the private health facilities.

Young-onset stroke in the UAE: A single-centre retrospective analysis of risk factors and outcomes

by Sobia Siddiq, Saryia Adra, Kamel A. Samara, Batool Aldaher, Mohamad Emad Aldeen Mahfouz, Nour Sakan, Fathima Musfira, Roomiyah Riyaz Assadi, Ahlam Mohamed Almarzooqi, Hiba Jawdat Barqawi, Eman Abu-Gharbieh

Background

Young-onset stroke represents a growing public health concern, yet data from the United Arab Emirates (UAE) remain limited. This study aimed to examine the risk factors and clinical outcomes associated with young-onset stroke in the UAE.

Methods

A retrospective chart review was conducted on 419 patients aged below 50 years who were admitted at Al Qassimi Hospital, Sharjah, UAE, with a diagnosis of stroke between 2016 and 2022. Data on demographics, comorbidities, stroke subtype, management, and outcomes were collected and analyzed using Python-based statistical libraries.

Results

The study population comprised predominantly of male individuals (78.28%), with most patients originating from South Asia (63.96%) and the Middle East and North Africa region (19.33%). Ischemic stroke was the most common subtype (50.12%), followed by intracerebral hemorrhage (27.21%) and non-traumatic subarachnoid hemorrhage (22.67%). Hypertension (45.45%) and diabetes mellitus (24.42%) were the most prevalent comorbidities. Only 0.24% of patients underwent mechanical thrombectomy, and 9.41% received intravenous thrombolysis. The overall mortality rate was 12.68%, with coronary artery disease significantly associated with death (p  Conclusions

Young-onset stroke in the UAE is characterized by a high burden of modifiable cardiovascular risk factors, particularly hypertension and diabetes mellitus. Targeted preventive strategies and region-specific research are essential to reduce disease burden and improve patient outcomes.

Knowledge and attitude regarding the risks of teenage pregnancy among adolescent girls at selected secondary schools in Lira city, Uganda: a cross-sectional study

Por: Winfred · A. · Nakaziba · R.
Background, hypothesis and aim

Teenage pregnancy remains a major public health challenge in Uganda, with Northern Uganda accounting for approximately 25% of the national burden. Inadequate knowledge on reproductive health among adolescents predisposes them to early childbearing, thereby increasing the risk of adverse outcomes for both the mother and the infant. This study aimed to assess the knowledge and attitudes regarding the risks associated with teenage pregnancy among adolescent girls at selected secondary schools in Lira City to determine whether these factors contribute to the persistently high rates of teenage pregnancy in the region.

Design

A cross-sectional study design was employed using quantitative data collected through structured questionnaires. Data analysis was conducted at both univariate and bivariate levels using SPSS V.26. The 2 test was applied to assess associations, and p≤0.05 indicated statistical significance.

Setting

The study was conducted in selected secondary schools located in Lira City, Northern Uganda.

Participants

The study was conducted among 384 adolescent girls aged 18–19 years, recruited from three secondary schools in Lira City.

Primary and secondary outcome measures

The primary outcome measures included participants’ socio-demographic characteristics as well as their knowledge and attitude towards the risk of teenage pregnancy. Secondary outcomes comprised the levels of knowledge and attitude and the factors associated with these outcomes.

Results

The majority of participants (67.2%) demonstrated adequate knowledge regarding the risks of teenage pregnancy, whereas 76.3% exhibited negative attitudes towards teenage pregnancy, perceiving it as inappropriate. The participants’ class level and family type were significantly associated with both knowledge and attitude (p

Conclusion

Adolescent girls in secondary schools in Lira City demonstrated adequate knowledge of the risks associated with teenage pregnancy and generally held negative attitudes towards it. Families, schools and the general community should actively monitor and mentor adolescents within their care to limit the occurrence of teenage pregnancy. Moreover, further research is warranted to explore the underlying factors contributing to the persistently high rates of teenage pregnancy in the region, despite this level of awareness and the negative attitudes.

Multicentre, double-blind, randomised, placebo-controlled study on the prophylactic use of naldemedine for opioid-induced nausea and vomiting in patients with cancer (POSEIDON study): a protocol paper

Por: Ishihara · Y. · Ohira · M. · Hokabe · M. · Yoshino · S. · Iwashita · K. · Takahashi · K. · Tomita · N. · Uneno · Y. · Kataoka · S. · Kurihashi · T. · Satomi · E. · Hamano · J. · Higashibata · T. · Kosugi · K. · Hirakawa · M. · Kajiura · S. · Ogihara · S. · Kida · M. · Morita · T. · Koretaka
Introduction

Opioid-induced nausea and vomiting (OINV) in patients with cancer imposes a substantial clinical burden and may compromise adherence to opioid therapy. Naldemedine, a peripheral μ-opioid receptor antagonist, is currently approved for the treatment of opioid-induced constipation. Recent evidence suggests similar benefits for the treatment of OINV. This study aims to evaluate the preventive effect of naldemedine on OINV in patients with cancer pain initiating opioid analgesics.

Methods and analysis

This multicentre, double-blind, randomised, placebo-controlled, parallel-group comparison trial will be conducted across 20 hospitals and clinics in Japan. An estimated 120 patients with cancer scheduled to initiate opioid analgesic therapy will be recruited and randomly assigned (1:1) to receive either naldemedine or placebo on day 1 (visit 1). From days 1 to 7, patients will receive blinded study medication concurrently with opioid analgesics and will be followed for 8 days. The primary endpoint will be the proportion of patients achieving a complete response (CR) on day 5, defined as no vomiting and no use of rescue antiemetics for up to 120 hours after initiation of opioid analgesics. Key secondary endpoints will include the proportion of patients achieving CR on days 1, 2, 3 and 7; changes in Numerical Rating Scale scores from baseline; duration of nausea; proportion of patients who experience vomiting; proportion of patients using rescue antiemetics and frequency of rescue antiemetic use. Additionally, the incidence of adverse events and serious adverse events will be recorded throughout the observation period.

Ethics and dissemination

This study has been reviewed and approved by the Hattori Clinic Certified Review Board (approval number: CRB3180027). Written informed consent will be obtained from all participating patients before study commencement. The results of the study will be presented at academic conferences in Japan or overseas and submitted for publication in a peer-reviewed journal.

Trial registration number

NCT07038551 and jRCTs031250128.

Implementing and evaluating Adaptive Mentorship Networks to strengthen primary care in Canada: protocol for a mixed-methods implementation science study

Por: Radhakrishnan · A. · Beselt · L. J. · King · A. C. · van Allen · Z. · Archibald · D. · Maniate · J. · Hickcox · S. · Rangel · C. · Rash · J. A.
Introduction

Canada’s health workforce crisis is placing sustained pressure on primary care, particularly in the management of chronic pain, mental health conditions and substance use disorders. Mentoring is a compelling response to workforce, educational and well-being challenges in healthcare, and Adaptive Mentorship Networks (AMNs) have emerged in Canada as an interprofessional model to strengthen provider capacity, psychological safety and compassionate care. Despite widespread interest and demonstrable effectiveness, the determinants that influence successful implementation, spread, adaptation and sustainability of AMNs remain insufficiently understood.

Methods and analysis

This 3-year mixed-methods protocol will evaluate implementation of 11 AMNs that are established or in development across Canada. The study will focus on two complementary levels: (1) implementation of AMNs within healthcare ecosystems; and (2) capabilities, opportunities and motivations that contribute to adaptive mentorship between mentors and mentees. The overarching approach to understand the determinants of successful implementation and behavioural influences on adaptive mentorship uses implementation science and systems thinking methodologies to support a pan-Canadian Learning Health System. Work will proceed in three phases. Phase I will explore determinants of implementation (phase Ia) and behavioural influences on adaptive mentorship (phase Ib) through document review, interviews, systems mapping and readiness assessment. Phase II will use a Learning Alliance to identify, select and operationalise fit-for-purpose implementation strategies. Phase III will co-develop AMN-specific logic models and evaluate the feasibility, acceptability and initial utility of selected strategies. The study will be guided by the Active Implementation Framework, the Consolidated Framework for Implementation Research, the Consolidated Framework for Sustainability Constructs, the Capabilities, Opportunities and Motivation for Behaviour model, the Theoretical Domains Framework and the Health Equity Implementation Framework. Outputs from phase Ia will provide a compendium of determinants critical for the implementation of mentorship networks within healthcare arranged by stage of implementation, and the activities that current networks have taken to influence such determinants. Outputs from phase Ib will identify the capabilities, opportunities and motivations deemed critical for facilitating engagement in the act of clinical mentorship. Phase II will identify a contextualised understanding of strategies that are optimally suited to influence critical determinants of implementing AMNs and engaging in clinical mentorship. Our outputs from phases I and II will be pilot tested with each AMN and inform the development of site-specific logic models and a cross-site implementation blueprint that will be evaluated in phase III. This protocol advances a systems-informed approach to implementing AMNs across diverse Canadian health systems, with implications for mentorship-enabled workforce development.

Ethics and dissemination

Ethics approval has been obtained from the Bruyère Health Research Ethics Board (M16-25-001 and M16-25-002) and the Newfoundland and Labrador Health Research Ethics Board (Ref# 2025.047). Participants provide informed consent prior to participating in study interviews acknowledging potential risks and benefits to participation. Findings will be mobilised through integrated knowledge mobilisation with participating AMNs, members of the Learning Alliance, policy and practice partners, conference presentations, publications, AI-enabled knowledge sharing tools and plain-language resources.

VIR-SAAF: a study protocol for a national decentralised randomised controlled trial of home-based sleep apnoea screening in patients with atrial fibrillation in Denmark

Por: Hashiba · M. · Linz · D. · Frandsen · R. · Jennum · P. · Grove · E. L. · Gantzhorn · E. · Al-Ansary · L. · Nielsen · S. K. · Al-Alak · A. · Bille · J. · Fuglsang · M. · Tang · L. H. · Korshoj · M. · Risom · S. S. · Lamberts · M.
Background

Obstructive sleep apnoea (OSA) is a common and modifiable risk factor for atrial fibrillation (AF), yet it remains frequently unrecognised and undertreated. Despite guideline recommendations to consider OSA screening, no consensus exists on optimal strategies. The VIR-SAAF (VIRtual national study with home Sleep Apnea investigation in patients with Atrial Fibrillation) trial investigates whether home-based OSA screening and referral for potential treatment improve quality of life, physical activity and AF-related outcomes compared with standard care.

Methods and analysis

VIR-SAAF is a national, investigator-initiated, decentralised randomised clinical trial enrolling adults with paroxysmal or persistent AF across Denmark. Participants are randomised 2:1 to home-based screening for OSA or to no screening. The trial is conducted entirely remotely using a purpose-built mobile application that supports electronic consent, digital questionnaires, rhythm monitoring, activity tracking and real-time communication with investigators. This design allows all study procedures, including device delivery, data collection and follow-up, to be completed without in-person visits, enabling large-scale participation across geographical regions. The primary outcome is the between-group difference in change from baseline to 18 weeks in quality of life, assessed using the Atrial Fibrillation Effect on QualiTy-of-life questionnaire. VIR-SAAF is the first randomised trial to evaluate OSA screening itself as an intervention in AF. The fully decentralised design will generate novel evidence on whether systematic home-based OSA screening can improve patient-centred outcomes.

Ethics and dissemination

The study has been approved by the Danish National Committee on Health Research Ethics (approval number: 2402591). All participants provide electronic informed consent prior to enrolment. Results will be disseminated through peer-reviewed publications and presentations at national and international scientific conferences.

Trial registration number

NCT06618417.

Feasibility and acceptability of lay counsellor-delivered single-session therapy: a pragmatic mixed-methods pilot cohort study protocol

Por: Shava · B. K. · Dambi · J. · Mushonga · R. H. · Takaona · T. · Dzapasi · L. · Mashunye · T. · Mukoki · C. M. · Tumbare · E. · Verhey · R. · Chibanda · D.
Introduction

Common mental disorders (CMDs) are endemic globally. The availability of evidence-based mental health interventions has grown rapidly, with many services focused on psychotherapy. Most psychotherapies require multiple sessions, resulting in lengthy waiting times due to limited provider availability. These delays can lead to higher morbidity, poorer adherence and less favourable outcomes.

Recent research indicates that single-session therapy (SST) can be as effective as multi-session approaches and offers cost savings. This pragmatic, prospective mixed-methods pilot cohort study assesses the uptake, feasibility, acceptability, appropriateness and preliminary clinical effectiveness of SST in individuals receiving the Friendship Bench intervention. The Friendship Bench is a task-shifting mental health intervention for individuals with low to moderate symptoms of CMDs.

Methods and analysis

We will conduct a pragmatic, prospective, mixed-methods pilot interventional cohort study involving 350 first-time clients of the Friendship Bench intervention in Harare and surrounding periurban areas. We will primarily explore the intervention’s feasibility, uptake, appropriateness and acceptability including the feasibility of a larger follow-up clinical trial. Secondary outcomes include changes in CMDs severity, depression and anxiety symptoms, social connectedness, functional status, hope, resilience, health-related quality of life and therapeutic alliance. Participants will be followed for 6 weeks, with data collected at baseline and at 2, 4 and 6 weeks postintervention time points. A qualitative component will explore participants’ perspectives and experiences with SST. Quantitative data will be analysed using descriptive statistics, bivariate analysis, Cox proportional hazards models and generalised mixed models with maximum likelihood estimation. Qualitative data will be analysed thematically.

Dissemination and ethics

Ethical approval was granted by the Medical Research Council of Zimbabwe. Findings from this study will contribute to the evidence base for SST in the management of CMDs and may inform mental health service delivery in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations, social media platforms and policy briefs.

Clinical trial registration

PACTR202605687485459

Extreme heat and cause-specific risk of hospital admission in the adult population in England: a case time series analysis

Por: Flower · G. · Cole · R. · Libardi · A. D. L. C. · Mieiro · L. · Quint · J. K. · Gasparrini · A. · Masselot · P.
Objectives

This study investigated the impact of heat on the risk of hospital admission due to a range of health conditions in England.

Design

We used records of over 4 million hospital admissions in the summer months between 2008 and 2019, to construct daily time series of admissions in 32 837 census areas. Coupled with high-resolution environmental data, we conducted a case time-series analysis using distributed-lag non-linear models to measure the lagged relationship between summertime temperature and risk of admission for a broad set of health conditions. We derived the relative risks of admission at the 99th compared with the 50th temperature percentile to understand the effect of extreme heat in each locality.

Setting

The adult population of England (aged 18 years and older).

Outcome measures

Unplanned National Health Service (NHS) in-patient hospital admissions for cardiovascular, respiratory, genitourinary, metabolic and infectious diseases, along with their subcategories.

Results

These conditions contributed more than 3.7 million admissions, of which over 1.5 million (42%) were for those aged 75 years and over. More than 80% of admissions were for respiratory, cardiovascular or genitourinary illness, which collectively contributed 3.1 million hospital admissions. There was clear evidence of an increased risk of hospital admission for many conditions, including acute renal failure (1.37, 95% CI 1.32 to 1.42), metabolic disorders (1.28, 95% CI 1.24 to 1.32), infectious and parasitic diseases (1.06, 95% CI 1.04 to 1.08), pneumonia (1.07, 95% CI 1.05 to 1.09) and chronic obstructive pulmonary disease (1.08, 95% CI 1.05 to 1.10). The evidence was less clear for asthma and diabetes, while there were negative associations for many cardiovascular conditions. There was a clear age gradient in heat-related admissions, with older people facing the greatest risk of admission.

Conclusions

These findings highlight the widespread effect of extreme heat across a range of health conditions, in addition to mortality, and have implications for public health planning in our changing climate.

ENding HIV transmission to infants by Generating Evidence to optimise prevention and care for pregnant and postpartum Adolescent Girls and young women with HIV in Tanzania (ENGAGE): study protocol for a mixed-methods research project

Por: Lyatuu · G. W. · Larsson · E. C. · Siril · H. · Mbunda · T. · Urrio · R. F. · Machumi · L. · Machangu · D. · Unkels · R. · Mauka · W. I. · Mahande · M. J. · Simba · B. · Festo · C. · Mganga · A. · Mfaume · R. S. · Laizer · S. · Rutatinisibwa · H. · Kibao · A. · Muhode · P. · Njau · P. · Maok
Introduction

Sub-Saharan Africa (SSA), including Tanzania, is double-burdened with high rates of teenage pregnancy and new HIV infections among adolescent girls and young women (AGYW) aged 15–24 years. Moreover, pregnant AGYW living with HIV in SSA have poorer adherence and retention on HIV treatment and elevated risks of vertical HIV transmission to their infants, as compared with older women. This paper describes the methods for the ENGAGE project, aiming to investigate and optimise healthcare for prevention of vertical HIV transmission (commonly prevention of mother-to-child transmission (PMTCT)) for AGYW living with HIV in Tanzania.

Methods and analysis

ENGAGE uses a mixed-methods design to co-create and prototype an intervention package for pregnant/postpartum AGYW living with HIV through three phases in three Tanzanian regions. Phase 1 characterises the problem by investigating care engagement and outcomes in a cohort of N=10 147 AGYW receiving PMTCT services in routine healthcare. Phase 2 uses qualitative interviews to understand the social-structural drivers of care engagement from the perspective of AGYW, healthcare providers and community stakeholders and an evidence review of potential solutions. In phase 3, we will use findings from phase 1 and 2 to co-create (together with AGYW and healthcare providers) an intervention package to optimise PMTCT care for most at-risk AGYW. The co-creation will be done through an intervention development action cycle, where ideas are presented, feedback sought and refinements made iteratively via several workshops over about 6 months. The resulting co-created intervention package will be prototyped at selected facilities/communities and refined into a final version, ready for piloting for feasibility, acceptability and preliminary effect in a later phase. This protocol focuses on the co-creation phase 3 and its preceding phases 1 and 2.

Ethics and dissemination

ENGAGE has received ethical approval from the Tanzania National Health Research Ethics Committee (NIMR/HQ/R.8a/Vol.IX/4637), and the Swedish Ethical Review Authority (2024-05745-01) for analysis of data in Sweden. Findings will be disseminated to AGYW, healthcare providers, community stakeholders, health officials, researchers, policy makers and the wider local and global scientific community.

Developing general practitioner and consumer supports for genomics in Australian primary care: a mixed-methods protocol

Por: Long · J. C. · Archibald · A. D. · Lamprell · K. · Dawson-McClaren · B. · Kraan · C. · Springer · A. · Dive · L. · Newson · A. J. · Watts · G. · Holmes · I. · Cutler · H. · Jeet · V. · Trainer · A. · Best · S. · Delatycki · M. · Kirk · E. P. · Laing · N. · Ferrie · M. · Freeman · L. · Willco
Introduction

This project will establish a nationally consistent and ethically defensible approach to embed genomic testing in Australian primary care. Many non-genetic health professionals (eg, general practitioners (GPs) and other specialists) have limited experience with such testing. Current tests—both subsidised and consumer-paid—target a range of genes and conditions, making appropriate selection challenging. A structured implementation approach is therefore crucial. We will develop, test, refine and evaluate internationally relevant tools to support GPs and consumers in using genomics effectively.

Methods and analysis

Aims of the project are to (1) develop, implement and evaluate key supports for GPs offering tests through three interventions: primary health point-of-care resources, a practical guide to dealing with ethical issues affecting clinicians and established recommendations for a national approach for genetic counsellors to support GPs providing genetic testing; (2) develop and evaluate consumer resources and plan the implementation strategies; (3) evaluate real-world utilisation and equity of access to genetic testing in primary care using linked Medicare and population data.

This project will focus on two genomic applications recently made available in Australia on the universal insurance scheme (Medicare): a reproductive genetic carrier screen (an example of the role of genetics in reproductive testing) and genetic testing for familial hypercholesterolaemia (an example of a condition-specific test). Both tests can be complex for GPs to understand and explain to consumers and have potential implications beyond the purpose of the test (eg, personal health implications for carriers and results are also relevant to genetic relatives). Developing a robust clinical pathway and process for these tests will prepare GPs for future more complex applications of clinical genomics. The study will take place from January 2024 to December 2026.

Ethics and dissemination

Ethical approval for this work has been received from the Macquarie University Human Research Ethics Committee (Ref: 520241849560183) and the Royal Children’s Hospital Research Ethics and Governance (HREC/112451). Findings will be disseminated via publications, conferences and engagement with primary care networks and policymakers.

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