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Multicentre prospective trial of abbreviated MRI using gadoxetic acid versus CT for detection of late recurrent HCC (AMRICT): study protocol

Por: Park · H. J. · Lee · D. H. · Chang · W. · Kim · H. Y. · Kim · D. H. · Choi · W.-M. · Chung · S. W. · Choi · J. · Lee · D. · Shim · J. H. · Lee · H. C. · Lim · Y.-S. · Kim · S.-O. · Singal · A. G. · Kim · S. Y.
Introduction

Hepatocellular carcinoma (HCC) recurs in most patients after curative treatment. Late recurrence (>2 years after curative treatment) typically indicates de novo tumours in the residual liver. Although contrast-enhanced computed tomography (CECT) and MRI are widely used for post-treatment follow-up, they each have limitations including radiation exposure, high cost and limited access. The abbreviated MRI using gadoxetic acid versus multiphasic CECT for detection of late recurrent HCC after curative treatment (AMRICT) trial aims to compare gadoxetic acid-enhanced abbreviated MRI using hepatobiliary phase imaging (HBP-AMRI) and multiphasic CECT for detecting late recurrent HCC after curative treatment.

Methods and analysis

This prospective multicentre intra-individual comparison trial will enrol 455 participants who have undergone surgical resection or local ablation for HCC and remained recurrence-free for over 2 years. Each participant will undergo two imaging sessions at 6±2 month intervals, using both HBP-AMRI and multiphasic CECT. The primary endpoint is the detection rate of all-stage HCC. The secondary endpoints include the false referral rate of all-stage HCC and detection and false referral rates of Barcelona Clinic Liver Cancer stage 0–A HCC and of stage 0 HCC. Structured imaging protocols and quality assessments will be implemented for both modalities.

Ethics and dissemination

This study was approved by the Institutional Review Boards of the three participating institutions (approval number: 2023–1630 (Asan Medical Center), H-2407-146-1556 (Seoul National University Hospital) and B-2410-929-401 (Seoul National University Bundang Hospital)) and registered at ClinicalTrials.gov (NCT06537193). Findings will be disseminated through peer-reviewed journals, scientific meetings, public forums and guideline updates.

Trial registration number

ClinicalTrials.gov: NCT06537193. Participant enrolment began on 12 December 2024, and is ongoing.

Missed opportunities in methanol poisoning: a qualitative exploration of the socio-material practices of health professionals responding to acute methanol poisoning in Bangladesh

Por: Perkins · J. E. · Sorensen · J. B. · Islam · M. S. · Hovda · K. E. · Chowdhury · F. R. · Ghose · A. · Rahman · A. S. M. M. · Eddleston · M. · Street · A.
Objective

This study applied a socio-material practice lens to examine health professionals’ responses to methanol poisoning in Bangladesh and to compare these practices with established guidelines.

Design

This study employed a rapid ethnographic design.

Setting

Data were generated in primary-level, secondary-level and tertiary-level health facilities in six districts of western Bangladesh between September 2024 and May 2025.

Participants

We carried out semi-structured interviews with 50 health professionals with responsibilities for managing patients experiencing alcohol-related or poisoning-related conditions.

Results

Among health professionals, the meanings of methanol poisoning as a diagnostic category, its symptoms and treatments are obscured by moral concerns about alcohol. Materials, including antidotes, for managing methanol poisoning were scarce, and health professionals reported using readily available medical supplies for supportive treatment, though not specifically adapted for methanol poisoning. Health professionals’ care practices for responding to methanol poisoning were often structured by these meanings and materials, with guidelines remaining largely invisible.

Conclusions

Socio-material practices of health professionals in response to methanol poisoning in Bangladesh are characterised by missed opportunities. Improving responses requires shifting the meanings of methanol poisoning as a diagnostic category, ensuring that materials such as treatment guidelines and appropriate antidotes, such as ethanol and fomepizole, are available and supporting providers to enact care practices that reflect these guidelines.

Breastfeeding initiation and continuation among women on medicines: a systematic review and meta-analysis

Por: Nakijoba · R. · Musaazi · J. · Kyohaire · I. · Atuyambe · L. · Waitt · C. · Kiguba · R.
Objectives

Breastfeeding provides essential health benefits for infants and mothers, yet initiation and continuation can be influenced by maternal medication use. Uncertainty regarding medication safety may lead to early discontinuation or avoidance of necessary treatment. We conducted a systematic review and meta-analysis to estimate the prevalence of breastfeeding initiation and continuation at 6 months post partum among women using medications.

Design

Systematic review and meta-analysis using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

Data sources

PubMed, Web of Science, Academic Search Premier (EBSCO) and Google Scholar were searched up to 30 November 2024.

Eligibility criteria

For selecting studies: We included cohort, cross-sectional and observational studies reporting breastfeeding initiation at birth and continuation at 6 months post partum among women aged ≥18 years using medications during pregnancy or post partum. Studies reporting medication type and duration of breastfeeding were prioritised.

Data extraction and synthesis

Two independent reviewers screened, extracted and coded data using standardised methods. Risk of bias was assessed using validated tools. Pooled prevalence estimates were calculated using a random effects meta-analysis and meta-regression was performed to explore factors associated with breastfeeding outcomes. Findings were summarised in GRADE evidence profiles and synthesised qualitatively.

Results

Of 286 retrieved articles, 29 met the inclusion criteria and 28 were included in the meta-analysis. 14 (48%) were cohort studies reporting breastfeeding prevalence while using medications. The pooled prevalence of breastfeeding initiation among women on medication during pregnancy or post partum was 75.2% (95% CI 69.8% to 80.7%; range 14–98%), with high heterogeneity (I²=99.2%, p

Conclusion

Breastfeeding initiation among women using medications is generally high, but continuation declines substantially, particularly among women on psychotropic, opioid or antiepileptic drugs. HIV status, medication type, healthcare support and national guidelines influence breastfeeding outcomes. Targeted interventions, including provider education, medication-specific lactation guidance and supportive workplace policies, are essential to promote sustained breastfeeding among women using medications.

Mapping the evidence on anaemia across trimesters of pregnancy and risk of adverse birth outcomes in sub-Saharan Africa: a scoping review protocol

Por: Adjei-Gyamfi · S. · Zeng · I. · Aryee · P. A. · Mearns · G. J.
Introduction

Pregnancy-related anaemia significantly affects human development across life stages. In sub-Saharan Africa (SSA), country-specific epidemiological variations primarily driven by nutritional practices, socioeconomic factors and health-system disparities contribute to heterogeneity in prevalence, severity and adverse birth outcomes (ABOs). While anaemia and micronutrient deficiencies in pregnancy are well studied globally, comprehensive trimester-specific evidence and their associations with ABOs in SSA remain scarce. This review, therefore, examines the breadth and nature of existing evidence on these associations within SSA, thereby updating current knowledge and informing regionally tailored interventions and future research.

Methods and analysis

A scoping review methodology will be employed due to the limited volume of literature addressing the specific research questions and population. The review will follow the Joanna Briggs Institute (JBI) framework, applying the population-concept-context approach. Comprehensive searches will be conducted across CINAHL, MEDLINE, Cochrane Library, Scopus, Google Scholar, EBSCO Open Dissertations and relevant organisational websites. The planned search period will span from 1 January 2016 to 31 December 2025. Two reviewers will independently screen and extract data using JBI-adapted protocols within the Rayyan review platform. Any discrepancies will be resolved via discussion with the research team. Findings will be synthesised narratively through descriptive content analysis and visual mapping.

This review will include peer-reviewed studies and grey literature that investigate the associations between anaemia or deficiencies in iron, folate and vitamin B12 during pregnancy trimesters and ABOs in SSA. All relevant sources of evidence will be considered, regardless of study design or methodology, provided they report on women of reproductive age who experienced anaemia in any trimester and were subsequently identified with ABOs. Birth outcomes of interest include low birth weight, macrosomia, small or large for gestational age, preterm birth, post-term birth and stillbirth. Only sources published in English from 2016 onward will be included. The studies’ quality will be evaluated using Cochrane’s risk of bias assessment and mixed methods appraisal tools and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review.

Ethics and dissemination

This scoping review will not require ethical approval as it will synthesise published data and reports. It has been registered with the Open Science Framework. This review does not involve human participants. The final report will be submitted for publication in a peer-reviewed journal. The findings will be used to shape subsequent research, serving as a fundamental element of the evidence and knowledge mapping framework. As this study protocol was not reviewed by an ethics committee, the appropriate contact for research integrity matters is the Faculty of Health and Environmental Sciences, Auckland University of Technology.

Real-world changes in lipid-lowering therapy use and LDL-C goal attainment in high and very high cardiovascular risk patients in the UK: a secondary analysis of the European SANTORINI study 1-year follow-up

Por: Connolly · D. · Fuat · A. · McCormack · T. · Mcnally · D. · Garstang · J. · Ryan · J. · Reed · A. · Robinson · D. · Catapano · A. L. · Ray · K. K.
Objectives

This real-world study investigated the changes of lipid lowering therapy (LLT) usage in patients with high or very high cardiovascular (CV) risk in the UK and the group of all other European countries in the SANTORINI study up to 1 year from baseline and the impact this treatment had on the attainment of low-density lipoprotein cholesterol (LDL-C) risk-adjusted goals set by the National Institute for Health and Care Excellence (NICE) and those in the 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) dyslipidaemia guidelines.

Design

Secondary analysis of the SANTORINI dataset (an international, prospective, observational, non-interventional study (NCT04271280)).

Setting

Primary and secondary care centres in the UK and the group of other European countries (Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Sweden and Switzerland).

Participants

663 UK patients with high and very high CV risk were included in this analysis and 8502 from the group of other European countries. Of these, 380 UK patients and 6830 from the group of other European countries had LDL-C information available at baseline and 1-year follow-up.

Primary outcome measures

The primary objectives were to describe patients’ lipid management, LDL-C levels at 1-year follow-up and their attainment of 2023 NICE (≤2.0 mmol/L) and 2019 ESC/EAS LDL-C 2019 guideline-recommended LDL-C goals (

Results

Over the course of 1-year follow-up, the overall proportion of UK patients on no LLT reduced from 20.4% at baseline to 7.1%, similar to that observed in the group of other European countries (baseline–20.9%, 1 year–3.0%). The proportion of UK patients receiving LLT monotherapy increased from 74.8% at baseline to 84.9%, higher at both time points than that observed for the group of other European countries (baseline: 52.0%, 1 year: 55.0%). The use of any combination therapy increased slightly from baseline to 1 year in the UK overall cohort (4.9% vs 7.1%) and overall in the group of all other European countries, the cohort increased from baseline (27.1%) to 1 year (40.2%). Overall, mean (SD) LDL-C levels in the UK were 2.5 (1.2) mmol/L at baseline and 2.1 (1.0) mmol/L at 1 year and for the group of other European countries were 2.4 (1.2) mmol/L at baseline and 2.0 (0.9) mmol/L at 1 year. The overall proportions of UK patients achieving the UK NICE treatment goal and ESC/EAS 2019 guidelines at baseline versus 1-year follow-up were 40.3% vs 52.6% and 22.9% vs 32.9%, respectively; 21.1% and 30.9% of patients in the group of other European countries achieved the ESC/EAS 2019 guidelines at baseline and 1-year follow-up, respectively.

Conclusions

In this UK-focused analysis of the SANTORINI study, use of LLT increased modestly over 1 year, accompanied by a reduction in average LDL-C levels. However, mean LDL-C remained above the NICE goal, and attainment of both NICE and ESC/EAS LDL-C thresholds remained suboptimal. The findings highlight continued opportunities to optimise lipid management in UK clinical practice, including the potential for broader use of combination therapies.

Stakeholder perspectives on transferability of a 12-week physical activity and sedentary behaviour intervention for ethnically diverse community dwelling older adults: a qualitative study

Por: Meghani · N. A. A. · Hudson · J. · Stratton · G. · Mullin · J.
Introduction

Numbers of ethnically diverse older adults are increasing in the UK. These individuals often have complex health problems that are exacerbated by language barriers (ie, limited English proficiency), acculturation experiences and socio-economic level. Further, this diverse group is also the most sedentary and least active subgroup in the wider population which raises major health issues. A number of interventions have been implemented to improve older adults’ physical activity and decrease their sedentary behaviour. Nevertheless, there is a lack of research examining how stakeholders’ perspectives can inform the transferability of interventions into the real-world particularly for ethnically diverse older adults. Therefore, the purpose of the current study was to explore the perspectives of stakeholders regarding the transferability of a 12-week intervention that aims to increase activity and decrease sedentary behaviour among ethnically diverse sedentary older adults.

Methods

A qualitative exploratory study employing reflexive thematic analysis was conducted using purposive sampling and in-depth interviews to recruit a diverse group of stakeholders representing varied professional roles, service delivery and organisational sectors related to older adults’ physical activity and well-being. The Population–Intervention–Environment–Transfer Model of Transferability (PIET-T) model served as a theoretical and conceptual framework for assessing the transferability of health interventions. Prior to the interview, the researcher explained the intervention study that was assessed in a prior feasibility study. This helped us identify stakeholder perspectives about potential challenges and practical considerations for transferring the intervention within existing policy and service frameworks. The primary researcher (NAAM) transcribed data from recorded interviews. Using reflexive thematic analysis, themes were generated from the data set and were interpreted using the PIET-T model.

Findings

The findings showed that different concepts of the PIET-T model influenced intervention transferability. The findings generated the following key themes: (1) User-centred and organisation supported programmes (Population), (2) intervention appropriateness and adaptations (Intervention), (3) organisational and system context (Environment) and (4) transferability and implementation factors (Transferability). Overall, the PIET-T model addresses key factors within each domain to facilitate the transferability of intervention.

Conclusion

Exploring diverse stakeholder perspectives was crucial for facilitating transferability and ensuring readiness for real-world implementation. Stakeholders suggested key modifications, including translated materials, adjusted duration, flexible digital delivery options and stronger collaboration with local organisations and healthcare systems to improve transferability among ethnically diverse older adults.

Epidemiological, entomological and community determinants of the 2021 yellow fever outbreak in Wa East District, Ghana: cross-sectional descriptive outbreak investigation

Por: Bessing · B. · Aabalekuu · S. · Bangniyel · J. · Alhassan · I. K. · Danquah · C. B.
Objective

To describe the epidemiology, ecological determinants and public-health response to a yellow-fever (YF) outbreak in Wa East District (WED), Ghana, and to identify operational gaps to strengthen surveillance and immunisation in high-risk rural settings.

Design

A cross-sectional descriptive outbreak investigation integrating epidemiological, entomological, vaccination-coverage and community knowledge assessments, conducted under Ghana’s Integrated Disease Surveillance and Response framework.

Setting

WED, located in the Upper West Region of Ghana, is an agrarian, forest-fringe area bordering the Mole National Park, characterised by limited access to health services and seasonal nomadic movements.

Participants

All suspected YF cases (N=57) reported between epidemiological weeks 41–46 of 2021; 50 community respondents interviewed for knowledge and awareness and 52 households inspected for entomological indices.

Main outcome measures

Demographic and clinical characteristics of cases, spatial–temporal distribution, vaccination coverage, Aedes vector indices, community knowledge and awareness levels and response interventions.

Results

A total of 57 suspected cases (33 males 24 females) were identified, of which 12 (21.1%) were laboratory-confirmed. The case-fatality ratio among confirmed cases was 33.3% (95% CI 9.7% to 65.1%). Most cases occurred in individuals aged 6–30 years and were clustered in the Ducie community. The epidemic curve, based on confirmed cases, showed a single focal wave between epidemiological weeks 41 and 46 of 2021, peaking in week 45 and declining thereafter following intensified outbreak response activities, particularly surveillance and risk communication. Routine YF vaccination coverage was 25% before the outbreak, increasing to 95% after the mass campaign. The district’s composite risk score was 83%, indicating very high transmission risk. Entomological indices (House Index=48.5%, CI=36.1%, Breteau Index=159.6) exceeded WHO thresholds, confirming intense Aedes proliferation. Community awareness was low, with only 22% recognising the viral cause, 16% identifying mosquitoes as vectors and 10% knowing that vaccination prevents YF.

Conclusions

The outbreak reflected the convergence of ecological vulnerability, low baseline immunity and poor community awareness. Sustained high routine immunisation, structured Aedes surveillance and continuous risk communication are essential to prevent recurrence and advance Ghana’s commitment to the WHO Eliminate Yellow Fever Epidemics strategy.

The world according to girls: a qualitative study of school, work and identity among adolescent girls and young women living with HIV in Ghana

Por: Bhagavathi · V. · Martyn-Dickens · C. · Owusu · S. A. · Nettey · G. K. · Bedele · J. · Sarfo · A. D. · Munyikwa · M. · Moyer · C. A. · Enimil · A. K. · Ratner · L.
Background

Adolescent girls and young women (AGYW) living with HIV in Ghana face multiple intersecting forms of marginalisation. Beyond the clinical management of HIV, little is known about how they construct meaning, navigate identity and imagine their futures within structural contexts shaped by stigma, gender inequity, economic precarity and colonial legacies.

Objective

To explore how AGYW living with HIV in Ghana understand and negotiate their social identities in work and school. We then aimed to understand how their lived experiences at school and work are shaped by broader systems of power.

Methods

This qualitative study drew on semi-structured interviews with AGYW (ages 11–24, n=24) receiving HIV care in Kumasi, Ghana. Data were coded both inductively and deductively. Themes were interpreted through the Ghanaian context using intersectionality, Critical Disability Studies, spoiled identity theory and African feminist decolonial theory. The analysis was conducted iteratively and reflexively, with attention to positionality, gender and structural power dynamics.

Results

Seven major themes were identified: (1) social support; (2) concrete plans for the future; (3) unattainability of the future; (4) coping via detachment; (5) need for privacy and confidentiality; (6) role as an arbiter of HIV information; and (7) financial stress. Across these themes, AGYW described dynamic processes of identity negotiation, moral and emotional labour and structural constraint. HIV was rarely the sole barrier. Rather, it intersected with gender norms, family dynamics, age hierarchies, economic marginalisation and misinformation to shape participants’ social worlds. Some participants coped through detachment or concealment, while others reclaimed agency through caregiving roles, education or aspirational goals.

Conclusions

AGYW living with HIV in Ghana are not only navigating a chronic illness but also resisting a layered matrix of social and structural injustice. Their stories reveal both vulnerability and strategic agency. Interventions and policy must go beyond biomedical care to address stigma, provide confidential and affirming school and work environments, and offer structural supports for emotional, educational and economic well-being.

Do studies of interventions to improve laypeoples critical thinking about health choices assess potential harms? A systematic review

Por: Oxman · M. · Cusack · L. · Verdugo-Paiva · F. · Avila · C. · Pena · J. · Novillo · F. · Oxman · A. D. · Fretheim · A. · Melby-Lervag · M. · Nordheim · L.
Objectives

To make informed health choices, and avoid waste and unnecessary suffering, people need critical thinking skills. However, like health interventions, educational interventions can have adverse effects. In this systematic review, the objective was to assess the extent to which researchers have included potential adverse effects in studies of interventions intended to improve the critical thinking of laypeople about health choices.

Design

This study was a systematic review, in which we updated the search for an earlier systematic review of intended effects of relevant interventions. The earlier review did not address potential adverse effects. We did not update the analysis of intended effects.

Data sources

We searched Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, Epistemonikos, Medical Literature Analysis and Retrieval System Online (MEDLINE), Education Resources Information Center (ERIC) and Web of Science up to March 2025. In addition to studies from the original review and updated search, we included any additional studies included in a similar, even earlier review. Our unit of analysis was study report (eg, journal article).

Eligibility criteria

We included all studies from the original review. We applied the same inclusion criteria to the results of the updated search: the study included a comparison, the population was laypeople and the intervention was intended to improve understanding of ≥1 key concept for informed health choices.

Data extraction and synthesis

We extracted data about study design (randomised trial or other), participants (children, adolescents or adults), study setting (countries), main intervention (resources delivered to participants) and comparator (usual/no intervention or other). For the analysis, we extracted verbatim text describing any assessment of a potential adverse effect of the intervention. We conducted a narrative synthesis of the extracted data.

Results

We included 35 reports of quantitative studies (including multi-method and mixed-methods studies). Most often, the study was a randomised trial, the setting was a high-income country, the population included adults (including university students) and the intervention was school-based (including university). In one of the 35 reports, authors described assessing a potential adverse effect.

Conclusion

To our knowledge, this is the first systematic review assessing the extent to which researchers have assessed adverse effects of any category of educational interventions. Our review shows that researchers generally have not assessed potential adverse effects of interventions to improve critical thinking about health choices. Researchers should pay more attention to such effects, while policymakers and educators making decisions about implementing relevant interventions should consider the lack of evidence. The findings of this study suggest a need for research that facilitates assessing potential adverse effects of interventions to improve critical thinking about health choices.

Refining Trichomonas vaginalis treatment in women and men: protocol for an open-label randomised comparison of multi-dose oral metronidazole versus single-dose oral secnidazole

Por: Muzny · C. A. · Lillis · R. A. · Chavoustie · S. E. · Arbuckle · J. L. · Van Gerwen · O. T. · Sagoe · M. · Kandregula · A. R. · Srivastav · S. · Kissinger · P. J.
Introduction

Trichomonas vaginalis is estimated to be the most common non-viral sexually transmitted infection (STI) worldwide with 156 million new cases each year. In 2021, the United States Centres for Disease Control and Prevention (CDC) updated their STI Treatment Guidelines to recommend multi-dose oral metronidazole (MTZ) for all T. vaginalis-infected women. Although multi-dose oral MTZ 500 mg twice daily was found to be superior to single-dose 2 g oral MTZ in multiple trials in women, multi-dose oral MTZ still had unacceptably high rates of breakthrough infection (9%–11%) at test-of-cure. With approximately 156 million cases of T. vaginalis worldwide per year, over 17 million persons per year are estimated to be insufficiently treated with multi-dose oral MTZ. Moreover, past trials only included women, and single-dose 2 g oral MTZ remains the recommended treatment for men. Thus, there is a critical need to further refine T. vaginalis treatment in women and men. A single dose of 2 g of oral secnidazole (SEC), a next generation 5-nitroimidazole with a longer half-life than oral MTZ and improved tolerability, may be a good option. This study will examine the effectiveness of multi-dose oral MTZ versus single-dose oral SEC in both men and women infected with T. vaginalis.

Methods and analysis

This is a multi-centred open-label effectiveness trial comparing oral multi-dose MTZ (500 mg twice daily for 7 days) to 2 g of single-dose oral SEC. This trial aims to enrol 1200 T. vaginalis-infected women and men aged 18 years and older at four clinical sites: the University of Alabama at Birmingham (UAB) Sexual Health Clinic and the UAB Gynaecology Clinics in Birmingham, AL, LSU-CrescentCare Sexual Health Centre (LSUHSC-NO) in New Orleans, LA, and HealthCare Clinical Data, Inc. in Miami, FL. Those who are pregnant/lactating, have been treated with a 5-nitroimidazole within the last 28 days, used intra-vaginal boric acid or any other intra-vaginal treatment for T. vaginalis within the last 14 days, have a history of a type 1 hypersensitivity reaction to 5-nitroimidazoles, are taking phenytoin and/or warfarin, use any medications which may alter the metabolism of oral MTZ, or have previously been enrolled will be excluded from the study. Participants will be randomised in a 1:1 fashion to either multi-dose oral MTZ or single-dose oral SEC. A test-of-cure (TOC) visit will be performed 4 weeks after completion of treatment (window 1 week before and 2 weeks after scheduled TOC visit).

Ethics and dissemination

This protocol is approved through a single Institutional Review Board (IRB) mechanism by the Tulane Human Research Protection Programme (Protocol # 2024–101 SPHTM). External relying sites are the UAB IRB (including both the UAB Sexual Health Research Clinic and Gynaecology Clinics; Protocol ID IRB-300012617), the LSUHSC-NO IRB (LSU-CrescentCare Sexual Health Centre; Protocol ID 6979) and the Advarra IRB (Healthcare Clinical Data Inc; Protocol ID Pro00085531). This study is also approved for referral purposes only by the Research Review Committee at the Jefferson County Department of Health (JCDH) Sexual Health Clinic in Birmingham, AL (JCDH Research Number 2024–03). Study findings will be presented in scientific conferences and peer-reviewed journals, shared with treatment advisory boards, as well as disseminated to providers and patients in communities of interest. The study Data Safety and Monitoring Board (DSMB) will meet twice a year to review patient safety data and study progress and provide recommendations on the study’s continuation or modification.

Trial registration number

NCT06261840.

Facilitators and barriers to the practice of intermittent auscultation fetal monitoring in UK maternity services: a qualitative study using the Consolidated Framework for Implementation Research (CFIR)

Por: MacLellan · J. · Ade · M. · Douthwaite · M. · Fitzsimons · B. · Joash · K. · Mulla · S. · Sanders · J. · Kenyon · S. · Pope · C. J. · Rowe · R.
Objectives

To explore barriers and facilitators to midwifery practice of intermittent auscultation according to national guidance in the UK.

Design

Multisite ethnographic study using observations of practice, semistructured interviews and informal conversations. Framework analysis using the Consolidated Framework for Implementation Research (CFIR).

Setting

11 maternity units across seven NHS maternity services in England and Wales in 2024.

Participants

Midwives and other maternity care professionals involved in fetal monitoring during labour.

Intervention

‘Intermittent auscultation’ (IA), or listening to the fetal heart rate at regular intervals, to monitor fetal well-being during active labour.

Outcome measures

Not applicable.

Results

IA monitoring was frequently observed to be marginalised due to national and local pressures. IA is a complex skill that requires expertise and practice to develop and maintain. However, lack of a robust evidence base for IA methods is a further barrier to implementation. The study uncovered examples of facilitators that include: leadership engagement, access to knowledge and information supported in mentorship programmes and peer support models. These features created micro-environments where IA was valued, supported and integrated into care.

Conclusions

Our study highlights the significant impact of multilevel factors on the implementation of IA within UK maternity care. However, when organisational readiness, strong leadership engagement and supportive conditions are present, IA can be delivered in accordance with guidance. These findings underscore the need to align policy, infrastructure and organisational culture to sustain evidence-based, woman-centred practices such as IA.

Model-based economic evaluation of non-pharmacological interventions for fatigue in patients with long-term medical conditions in the UK

Por: Mon-Yee · M. · Burton · C. · Leaviss · J. · Forsyth · J. E. · Daly · G. · Davis · S.
Background

Persistent fatigue is a frequent symptom in chronic medical conditions. Systematic reviews of non-pharmacological interventions for fatigue have identified interventions that are effective at reducing fatigue, but there is limited published evidence on the cost-effectiveness of these interventions.

Objective

To identify non-pharmacological fatigue interventions that have the potential to be cost-effective in patients with long-term medical conditions.

Design

Decision analytic modelling with intervention costs estimated from staff time and quality-of-life outcomes mapped from a systematic review and network meta-analysis of fatigue outcomes.

Setting

UK National Health Service (NHS).

Participants

People with persistent fatigue associated with a chronic medical condition.

Interventions

Non-pharmacological fatigue interventions versus usual care.

Primary and secondary outcome measures

Net monetary benefit from a UK NHS and Personal Social Services perspective; quality-adjusted life years (QALYs) gained; intervention costs valued at 2022/23 prices; costs and benefits discounted at 3.5% per annum.

Results

In the base-case analysis, expected costs from the probabilistic analysis for individual and group interventions were: £267 and £157 for physical activity promotion, £810 and £485 for cognitive behavioural therapy (CBT)-Fatigue and £462 and £214 for mindfulness. The expected QALYs gained were similar for mindfulness and physical activity promotion (0.061 and 0.060, respectively), but lower for CBT-Fatigue (0.045). All interventions provided positive incremental net monetary benefit (INMB) versus usual care when valuing a QALY at £20 000. However, since group interventions are less costly than individual ones, and we assumed equivalent clinical benefit, they are expected to provide greater INMB. These findings remained robust across different scenarios, except for CBT-Fatigue (individual), which had negative INMB in some scenarios.

Conclusions

There remains uncertainty regarding which intervention is most cost-effective due to limitations in the underlying evidence base. Future research is recommended to compare the cost-effectiveness of these interventions across a broad population with different chronic conditions.

Effectiveness of an online interval group therapy for children with developmental language disorders: protocol for a randomised controlled intervention study

Por: Heiland · A. · Siemons-Lühring · D. · Speckemeier · C. · Klaar · L. · Treger · P. · Sonntag · K. · Scharpenberg · M. · Tücke · J. · Neusser · S. · Brannath · W. · Mathmann · P. · Voss · T. · Neumann · A. · Rieger · T. · Heiming-Al Yosef · J. · Hesping · A. · Kanaan · O. · Weber · M.
Introduction

With a prevalence of around 7.6%, developmental language disorders (DLDs) without comorbidities are among the most common and most frequently treated childhood disorders. Standard DLD therapy in Germany consists of individual therapy sessions once per week within speech–language therapy practices. In reality, these sessions only take place every 10–14 days on average. Online therapy may be beneficial but is not yet standard practice in Germany. Although DLD group therapy has been proven to be effective, it is rarely undertaken in Germany. The aim of this study is to compare the effectiveness of online DLD therapy for small groups of children with standard one-to-one therapy.

Methods and analysis

The effectiveness of two treatment settings is evaluated in 212 children with moderate-to-severe DLD (ages 3 years to 6 years 11 months) in the multicentre, block randomised controlled trial (RCT) THErapy ONline. Five centres in Germany participate. Children are randomly assigned to the intervention group (online interval-intensive therapy, IG1, n=106) or the control group (extensive standard in-person therapy, IG2, n=106). A speech and language assessment is conducted at baseline (study entry, T0), 12 months (T1) and 18 months (T2) after therapy start. The co-primary outcome parameters are the speech and language test scores of phonological speech sound production, expressive vocabulary, grammar production and language comprehension at T1. The secondary outcome parameters comprise two composite speech and language test scores at T1 and T2, including phonological working memory scores and the individual scores of the aforementioned tests at T2, as well as process evaluation parameters (time expenditure, resource utilisation, such as salary costs of speech–language therapists, additional costs of the online therapy, adherence to appointments and therapy acceptance).

Ethics and dissemination

This study has been approved by the Institutional Ethics Review Board of Westphalia-Lippe (2022-282 f-S). Parents provide written informed consent. Findings will be disseminated through presentations, peer-reviewed journals and conferences.

Trial registration number

DRKS00030068

Cost-effectiveness modelling of early lead extraction for cardiac implantable electronic device infections in the United Kingdom

Por: Rinaldi · A. · Howell · S. · Verma · S. · Youn · J.-H. · Uehlin · A. · Vanden Baviere · H.
Objectives

To evaluate the cost-effectiveness of early lead extraction (≤7 days post-admission) compared with delayed (>7 days) or no extraction for cardiac implantable electronic device (CIED) infections in the UK using a decision-analytic model from the NHS perspective.

Design

A decision-tree model was constructed to simulate clinical and economic outcomes in adult patients with systemic or pocket CIED infections.

Setting

Secondary care hospital setting within the UK NHS.

Participants

A simulated cohort of adult patients with systemic or pocket CIED infections. Model inputs were sourced from published literature and NHS cost data (2023 £).

Interventions

Early lead extraction (≤7 days after diagnosis/admission) compared with delayed extraction (>7 days) or no extraction.

Primary and secondary outcome measures

Adverse events avoided and total healthcare costs over a 1-year time horizon; deterministic and probabilistic sensitivity analyses were conducted to assess model robustness.

Results

Early extraction was both clinically and economically superior to delayed or no extraction. For systemic infections, early extraction reduced costs by £123 056 and avoided 9.0 adverse events per 100 patients, with mortality falling from 20.0 to 7.5 per 100 patients. In pocket infections, early extraction lowered costs by £104 904 and avoided 8.4 adverse events per 100 patients, with mortality decreasing from 12.4 to 0.9 per 100 patients. Sensitivity analyses confirmed the robustness of these findings, with antibiotic failure rates being the most influential parameter.

Conclusions

Early lead extraction for CIED infections is a cost-effective, dominant strategy in the UK, reducing mortality, adverse events and overall costs. These results strongly support guideline recommendations for prompt extraction and highlight the need for improved adherence to evidence-based management of CIED infections.

Glycemia Range and Offspring Weight and adiposity in response To Human milk (GROWTH) study: protocol for an observational cohort designed to study lactational programming

Por: Josefson · J. L. · Gregg · B. · Sen · S. · Rajakumar · K. · McGowan · E. C. · Andrei · A.-C. · Arend · A. B. · Rick · A.-M. · Marshall · E. · Caal · K. · Robinson · D. T.
Introduction

Maternal human milk feedings continue an offspring’s exposure to the programming stimuli of maternal metabolism during the postnatal period. While considerable research focuses on associations between in utero environments and offspring metabolic disease, few studies have been able to specifically measure how human milk composition modifies programming of children’s growth in conjunction with comprehensive measures of maternal glycaemia during pregnancy.

Methods and analysis

The Glycemia Range and Offspring Weight and adiposity in response To Human milk (GROWTH) Study is a longitudinal cohort enrolling women with a singleton pregnancy who (1) undergo serial testing of glycaemia during pregnancy and (2) are intending to provide their breast milk through direct breastfeeding or pumped milk as the primary nutrition for their infant. Enrolment started in October 2023 and is expected to be completed in December 2026. Key procedures include virtual lactation support visits, serial human milk sampling at three time points, maternal and infant blood sampling, serial maternal and child anthropometric measurements and diet assessment. After delivery, mother–child dyads are followed until children turn 2 years of age. The primary exposure variable is maternal glycaemia obtained from a fasting, 3 hour 100 g oral glucose tolerance test performed at 24–28 weeks of gestation, and the primary outcome measure is the composite of human milk linoleic and docosahexaenoic acid concentrations in milk samples collected at 1 month postpartum.

Ethics and dissemination

Lurie Children’s Hospital Institutional Review Board (IRB) provides central oversight of the GROWTH Study in conjunction with each participating centre’s IRB. The GROWTH Study data has the potential to inform perinatal health and future research in lactation and human milk science by providing comprehensive measures of human milk composition and early childhood growth and body composition parameters impacted by maternal metabolism in pregnancy.

Towards an integrated model for dengue management: a scoping review

Por: Salehi · M. · Mousa Farkhani · E. · Moghri · J. · Ghasemian · A. · Tabatabaee · S. S. · Hooshmand · E.
Objective

To systematically identify and synthesise dengue management strategies, levels of implementation, management dimensions, key challenges and proposed solutions across health systems worldwide.

Design

A scoping review following the Arksey and O’Malley framework and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.

Data sources

PubMed, Scopus, Web of Science, Embase and the Cochrane Library were searched for studies published between January 2003 and December 2024. Reference lists of included studies were also manually screened.

Eligibility criteria

English-language, peer-reviewed articles and reviews focusing on dengue management strategies, challenges and solutions at any health system level were included. Studies without full-text access or outside the scope of dengue management were excluded.

Data extraction and synthesis

Two reviewers independently screened studies and extracted data using a structured form. Extracted data were charted and synthesised using an inductive thematic approach to identify core strategy domains, implementation levels, challenges and solutions.

Results

Of 4822 records identified, 34 studies met the eligibility criteria. Dengue management strategies were categorised into six domains: vector and environmental control; surveillance and early warning systems; vaccination; enhancement of diagnostic and treatment services; community participation and education; and governance with intersectoral coordination. Implementation occurred at community, municipal, national, regional and international levels. Key challenges were grouped into five domains: structural and resource-related; sociocultural; governance and policy; scientific and technological; and climate- and urbanisation-related factors.

Conclusions

Global dengue management is increasingly adopting integrated, multi-sectoral approaches. Effective dengue control requires strengthening health system infrastructure, institutionalising community engagement and leveraging scientific and technological innovations. Sustained political commitment, stable financing mechanisms and coordinated governance across sectors are essential for resilient and sustainable dengue control.

Comparison of immunity-boosting regimens for COVID-19 upon initiation of immunosuppressive therapy (CIRCUIT): study protocol for a randomised, controlled clinical trial

Por: Carey · D. L. · Ahlenstiel · G. · Brilot · F. · Brown · D. A. · Bull · R. · Crowther · H. · Cunningham · A. · Davenport · M. P. · Diamond · P. · Hamad · N. · Johnston · A. · Kelleher · A. D. · Lee · F. J. · Matthews · G. V. · Petoumenos · K. · Quichua · G. C. · Swaminathan · S. · Trotman
Introduction

Immunosuppression is associated with an increased risk of delayed SARS-CoV-2 viral clearance, severe COVID-19 and related death. This heterogeneous group of affected patients includes but is not limited to those with a haematological malignancy, people on immunosuppressive therapy for the treatment of autoimmune/inflammatory diseases and those following bone marrow transplantation (BMT). Immunosuppression is associated with decreased rates of anti-spike IgG seroconversion following COVID-19 vaccination. While clinical guidelines have been established to guide vaccination pre-splenectomy and post-BMT, there are limited data to guide timing of COVID-19 or other booster vaccines in adults commencing new or intensified moderate to severe immunosuppression. The comparison of immunity-boosting regimens for COVID-19 upon initiation of immunosuppressive therapy (CIRCUIT) study was designed to address this knowledge gap. CIRCUIT investigates whether administration of a third (or subsequent) COVID-19 booster vaccine ≤2 weeks prior to immunosuppression provides greater anti-spike IgG-mediated immunity than a booster given 24 weeks after new or intensified immunosuppression, that is, week 24 timepoint (Group 1; n=280). Additionally, the research will investigate whether giving a fourth post-BMT COVID-19 booster vaccine at 9 months post-transplant provides greater anti-spike IgG-mediated immunity than a booster given 15 months post-transplant (Group 2; n=40).

Methods and analysis

The CIRCUIT study is an open-label, multicentre randomised clinical trial. Participants will be randomised 1:1 to receive either an additional COVID-19 booster ≤2 weeks pre-immunosuppression and a diphtheria/tetanus toxoids (DT) booster at 24 weeks following new or intensified immunosuppression (week 24 timepoint) or receive a DT booster ≤2 weeks pre-immunosuppression and an additional COVID-19 booster at week 24 (Group 1). Group 2 participants who underwent autologous or allogenic BMT in the last 9 months will be randomised 1:1 to either receive a fourth post-BMT COVID-19 booster at 9 or 15 months post-transplant. The primary outcome will be the integrated time-weighted area under the curve anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months from a SARS-CoV-2 booster as assessed by a high-throughput SARS-CoV-2 NAb platform assay. Key secondary outcomes of the CIRCUIT randomised control trial will include safety and generation of SARS-CoV-2 antigen specific T and B cell responses.

Ethics and dissemination

The research protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee on 25 August 2022 (Ref no. 2022/PID00782 – 20022/ETH0069). Study results will be published in peer-reviewed medical journals and presented at local and international conferences. All findings regardless of the outcome will be reported.

Trial registration number

NCT05415267.

Rehabilitation intervention to improve Recovery after an Episode of Delirium in adults over 65 years (RecoverED): a multicentre, single-arm feasibility study in NHS acute hospitals in the UK

Por: Allan · L. · Um · J. · OConnell · A. · Raghuraman · S. · Bingham · A. · Laberick · A. · Chandler · K. · Connors · J. · Mahmoud · A. · Hawton · A. · Goodwin · E. · Morgan-Trimmer · S. · Goodwin · V. A. · Ukoumunne · O. C. · Jackson · T. A. · Richardson · S. J. · Collier · L. · Glasby · J.
Objectives

To test a theory-informed, person-centred rehabilitation intervention for older adults following a hospital admission complicated by delirium, developed in line with the Medical Research Council framework for complex interventions, to determine whether: (a) the intervention is acceptable to individuals with delirium and (b) a definitive trial and parallel economic evaluation of the intervention are feasible.

Design

Multicentre, single-arm feasibility study.

Participants

19 patient (aged >65 years old) and carer pairs were recruited from six National Health Service acute hospitals across the UK.

Intervention

Home-based rehabilitation programme designed to support recovery after hospital discharge, addressing cognitive, physical, physiological and psychosocial needs. Delivered by a trained team of occupational therapists, physiotherapists and rehabilitation support workers, the intervention included a comprehensive home assessment, collaborative goal setting, up to 10 personalised sessions over 12 weeks and the use of a recovery record to guide progress, education and psychosocial support.

Outcome measures

Examined aspects of feasibility including eligibility, recruitment, data collection, attrition, acceptability of the rehabilitation intervention and potential to calculate cost-effectiveness.

Results

In total, 419 patients were identified as having delirium and 36 met the full eligibility. 19 patient and carer pairs agreed to participate in the study (consent rate 53%; 95% CI 35% to 70%) with 13 participants going on to start the intervention (68%; 95% CI 43% to 87%) and 10 participants completing final follow-up (53%; 95% CI 29% to 76%). Baseline assessments were conducted either during hospitalisation or postdischarge, with initial assessments occurring a mean of 18 days (SD=13.0) postdischarge, and 77% completed within 14 days. Participants completed a mean of eight sessions (SD=2.9). 19 participants completed the primary outcome at baseline, while 10 participants completed it at 6-month follow-up. The economic evaluation indicated a total cost of £1249.29 per participant, covering assessments, intervention sessions and training costs.

Conclusions

The intervention showed feasibility among older adults recovering from delirium, as evidenced by the trial processes for participants who entered the study. However, recruitment challenges indicate a need for better strategies and further research through a definitive randomised controlled trial to demonstrate the effectiveness and cost-effectiveness of the intervention.

Trial registration number

ISRCTN15676570

Parental-based prevention interventions to reduce suicidal-related behaviours in adolescents: protocol for a systematic review and meta-analysis

Por: Nunez · D. · Salas · F. · Gaete · J. · Meza · D. · Andaur · J.
Introduction

Effectiveness of prevention programmes to reduce suicidal-related behaviours among adolescents could improve when systematically involve interventions for parents/caregivers to enhance family functioning and parental skills. We aim to systematically review parental or family-based family prevention interventions and meta-analyse its effectiveness, as evidence on this topic has not been recently and systematically synthesised.

Methods and analysis

We will conduct a systematic review and meta-analysis of randomised controlled trials of parent-based prevention interventions to reduce suicidal-related behaviours in adolescents aged 10–19 years. Studies involving a comparison group, postintervention and/or follow-up assessments of suicidal ideation, self-harm, suicidal attempts, psychopathology, emotional regulation and behavioural and functional outcomes will be reviewed. The CINAHL, CENTRAL, PubMed, Scopus and Web of Science (WOS) databases were searched, without time limits, for eligible studies in English or Spanish, and with results available. Databases were searched from November 2025 to March 2026. The study selection process, the data extraction and the critical evaluation—with the Cochrane risk-of-bias tool—of included studies will be conducted independently and in duplicate by teams of reviewers, with the assistance of a third party, until reaching a high degree of agreement. If substantial heterogeneity is observed (I2>75%), we will use a narrative synthesis of the study results. If feasible, we will conduct a quality effects model for the statistical synthesis of results. If sufficient data are available, we will assess potential sources of heterogeneity. Doi plots, the Rosenthal’s N test and Egger’s Z test will be used to assess publication bias. The Grades of Recommendation, Assessment, Development and Evaluation approach will be used to assess the confidence in the evidence reviewed.

Ethics and dissemination

Results are expected to be published in a peer-reviewed journal in the field of adolescent and/or youth mental health. This study will be conducted using published data and does not involve human participants directly. Therefore, it is exempt from ethical review. Therefore, it is exempt from ethical review.

PROSPERO registration number

CRD420251183954.

Participatory priority setting of research questions for improving hospital care of adults with childhood-onset intellectual disabilities (PRISMA): a study protocol for a mixed-methods study

Por: Scheffel · A. · Fritsch · T. · Arnold · S. · Asam · T. · Bettenhausen · B. · Dengler · B. · einsmehr · V. · Spielmann · J. · Weidmann · A. · Winterholler · M. · Prodinger · B.
Introduction

Persons with childhood-onset intellectual or complex disabilities have an elevated probability of encountering delayed or erroneous diagnoses during hospital treatment. It is imperative to consider the possibility that mistreatment may worsen their health. Persons with intellectual disabilities face numerous challenges in accessing and using healthcare. These challenges include structural and communication barriers, as well as a dearth of competencies among health professionals in interacting with persons with intellectual disabilities. Nevertheless, there is a paucity of studies that analyse the challenges faced by persons with intellectual disabilities in hospital and even fewer that involve persons with intellectual disabilities in the research process. Therefore, the objective of the study described in this protocol is to identify the salient research questions for improving hospital care of adults with childhood-onset intellectual disabilities by collecting and prioritising the different perspectives of patients, caregivers and clinicians.

Methods and analysis

The study design is based on the Priority Setting Partnership procedure of the James Lind Alliance, encompassing four steps to identify and prioritise issues with patients, caregivers and clinicians. Initially, problems and issues pertinent to those affected are collated using an open online questionnaire and subsequently clustered into topics. In the second step, the topics are transformed into potential research questions and reviewed by available scientific literature. Subsequently, research questions that cannot yet be answered by current literature are prioritised by participants in a second online questionnaire. Finally, the 25 questions rated most relevant are to be discussed in a one-day workshop with participants reflective of all target groups. The salient 10 research questions are to be determined using nominal group technique.

Ethics and dissemination

The study has received a positive ethics vote from the Ethics Committee at the Ludwig Maximilian University of Munich in accordance with the Declaration of Helsinki on 21 March 2025 (reference 25-0106). This study’s findings will be shared in academic conferences and published in scientific peer-reviewed journals.

Trial registration number

DRKS00037347.

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