Environmental enteropathy (EE) is a syndrome affecting the gut characterised by villus blunting, reduced nutrient absorption and microbial translocation in children and adults experiencing a high burden of enteric infection due to inadequate access to clean water and sanitation.

We will conduct coordinated randomised controlled trials in six countries to determine if supplementation with indispensable amino acids (IAAs) can improve intestinal barrier dysfunction in six geographically diverse populations of 18–36 months old children with stunting or severe stunting. All trials will measure the same primary outcomes while secondary outcomes will be measured on a per-trial basis using standardised protocols across the project. The primary endpoint will be change in gut permeability as assessed by the lactulose/rhamnose ratio. Secondary endpoints include changes in amino acid and carbohydrate absorption using novel, isotope tracer tests. Other prespecified outcome measures include changes in EE biomarkers and child weight. IAA supplementation will be given daily for 28 days and evaluation of the major endpoints will be at baseline and after 28 days of supplementation.

Ethical approval will be obtained from the Research Ethics Committee at each participating site. Caregivers will provide written informed consent for each participant. Findings will be disseminated through peer-reviewed journals, conference presentations and face-to-face meetings with participant caregivers.

CTRI: CTRI/2024/06/069187 (India); ClinicalTrials.gov (NCT06617130, Malawi; NCT06676215, Philippines and NCT07256028, Morocco); Ongoing (Zambia); Ongoing (Morocco); PACTR: (PACTR202311714091884, Ghana).

Research on psychosocial interventions for dementia demonstrates increased rigour and robustness. However, if we are to influence practice, beyond results from randomised controlled trials, a variety of types and sources of evidence is needed. The Medical Research Council (MRC) framework offers a valuable guide for developing, evaluating and implementing complex interventions, to facilitate integration of research into practice. There is limited knowledge of how researchers design, evaluate and implement psychosocial intervention studies in dementia, using the MRC framework. This scoping review aims to: (1) identify the methodological and methods trends, use and gaps in the development, evaluation and implementation of psychosocial interventions for dementia, and (2) determine if and how the MRC six core elements were considered and applied in studies.

Six databases (Ovid MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, Cochrane Library) will be searched for studies published from 2015 (when MRC process guidance was published) to 2025. Identified deduplicated citations will be imported into Covidence software, where up to 40% of title/abstracts will be double screened by independent reviewers. ASReview will be used to rank articles by relevance, with a stopping criterion of 250 consecutive irrelevant articles. Full texts will be reviewed by a single reviewer and those excluded will be checked by a second reviewer. Data extraction will include study aim/objective (ie, to develop/adapt; test feasibility/pilot; evaluate; implement); methodology and methods applied; information on which MRC six core elements were considered (yes/no), and if so, how they were addressed (ie, qualitative details). A narrative synthesis, alongside graphical representations (eg, table/bar charts/histograms), will be used to synthesise findings on methodologies and methods mapped onto the MRC framework.

This secondary analysis scoping review does not require ethics approval. Results will be disseminated through peer-reviewed publication(s), seminars, webinars, conferences, postgraduate dementia programmes, blogs, commissioner briefings and social media. The findings will provide a state-of-the-art overview of current practices; advance methods/methodology such as informing a Delphi consensus study on appropriate research approaches; and guide researchers in application of the MRC framework to widen the scope of dementia care evidence for practice improvements.

Submitted to Open Science Framework https://doi.org/10.17605/OSF.IO/S56NQ.

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.

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.

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.

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

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.

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

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).

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.

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 (

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.

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.

To identify key factors influencing the implementation of technology-enabled virtual wards (VWs), also known as hospital at home, drawing on the qualitative accounts of stakeholders involved in implementation, using the updated Consolidated Framework for Implementation Research (CFIR) as a guiding analytical framework.

Qualitative semi-structured interviews with implementation leads. All interviews were conducted online, using MS Teams or Zoom, between January–June 2024, and audio-recorded with consent. Audio-recordings were transcribed, anonymised and exported to NVivo V.12 Pro software for data management. The updated CFIR was used to guide thematic analysis of interview data.

Adult VW services in one regional health and social care system in North West England, UK.

Service implementation leads from 11 hospital sites providing adult VW services. Job titles and roles varied across sites and included both operational and clinical service leads.

20 interviews were conducted with 22 participants. Four implementation themes were identified: (1) complexity and adaptability: the ability to adapt the service to local conditions was valued by leads, but also contributed to wide variation in operational, clinical, workforce and digital components of VW models; (2) resource and infrastructure: workforce capacity was identified as a key implementation challenge along with information technology system capability and interoperability; (3) performance demands: leads were concerned that an excessive focus on bed numbers and occupancy levels, without accounting for patient acuity, could negatively affect implementation, straining the service and staff capacity; and (4) readiness for change: organisational and professional readiness for change was considered crucial for increasing referrals and enabling successful implementation, yet leads reported that the level of behavioural and cultural change required had been underestimated.

Implementation of a national VWs programme has resulted in wide service variation in one UK region, which raises questions about service equity and poses challenges for wider programme evaluation. Despite this variation, common factors found to help or hinder implementation have been identified. This study provides greater understanding of the factors that influence the implementation of VW services and outlines actionable insights to help refine VW strategies. These insights can support future planning and sustainability of technology-enabled inpatient-level care at home more widely.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

Inadequate emergence is a common postoperative complication in elderly patients following major abdominal surgery. This study was designed to determine its incidence, identify associated risk factors and characterise its clinical subtypes within this high-risk cohort.

This prospective single-centre cohort study was conducted at a comprehensive specialised tertiary care hospital in Northwest Ethiopia. Consecutive patients aged 65 years and older scheduled for elective major abdominal surgery under general anaesthesia were enrolled.

The primary outcome was the proportion of patients experiencing inadequate emergence.

A total of 388 patients were analysed. Inadequate emergence occurred in 21.9% of participants (95% CI 14.3% to 31.6%), with hypoactive emergence observed in 10.7% and emergence delirium in 11.2%. Multivariable logistic regression identified several independent predictors, including advanced age (adjusted OR (AOR)=1.9; 95% CI 1.5 to 8.2), preoperative anxiety (AOR=2.7; 95% CI 1.2 to 7.2), prolonged preoperative fasting (AOR=2.1; 95% CI 1.8 to 9.1), non-ketofol-based induction (AOR=3.4; 95% CI 1.6 to 6.3), absence of abdominal field block (AOR=4.2; 95% CI 4.0 to 9.6), substantial intraoperative blood loss (>1000 mL; AOR=1.9; 95% CI 1.2 to 7.6), postoperative nausea and vomiting requiring antiemetics (AOR=2.2; 95% CI 2.1 to 7.1) and presence of an indwelling urinary catheter (AOR=2.4; 95% CI 1.8 to 7.9).

Inadequate emergence occurred in approximately one in five elderly patients undergoing elective major abdominal surgery. Independent predictors included advanced age, major intraoperative blood loss, postoperative nausea/vomiting requiring antiemetics, non-ketofol-based induction, preoperative anxiety, absence of abdominal field block, presence of an indwelling urinary catheter and prolonged preoperative fasting.

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.

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).

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.

DRKS00030068

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.

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.

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.

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).

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.

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.

NCT05415267.

To assess adherence to retinal screening recommendations and its associated factors among patients with diabetes receiving follow-up care at public hospitals in Ethiopia.

A cross-sectional, institution-based study was conducted at public hospitals in Addis Ababa from 27 February to 27 March 2023.

Five of the fourteen public hospitals in Addis Ababa were selected for this study.

A systematic random sample of 405 adult patients with diabetes mellitus (receiving follow-up care at public hospitals in Addis Ababa was selected.

Bivariate and multivariate logistic regression analyses were conducted to assess statistical associations. Statistical significance between the outcome variable and independent variables was determined at a p value of less than 0.05 and a 95% CI.

223 participants (55.1%) adhered to the recommended retinal screening guidelines. Factors significantly associated with adherence to retinal screening recommendations included being an urban resident (adjusted OR (AOR)=2.783; 95% CI 1.022 to 7.583), lack of formal education (AOR=0.242; 95% CI 0.100 to 0.589) and poor knowledge regarding diabetic retinopathy (AOR=0.281; 95% CI 0.171 to 0.462).

Slightly more than half (55%) of the participants in this study adhered to the recommended retinal screening guidelines. Urban residence, higher educational attainment and good knowledge of diabetic retinopathy were significant predictors of adherence to retinal screening recommendations. Healthcare professionals should take a more proactive role in educating patients with diabetes about diabetic retinopathy and the importance of retinal screening, with particular emphasis on rural residents and individuals without formal education.

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.

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.

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.

CRD420251183954.

Malaria remains a serious public health issue, and sub-Saharan Africa (SSA) is still disproportionately burdened with the disease. Efficient disease tracking in both public and private healthcare points is required to consolidate elimination efforts. Considerable amounts of malaria cases in the private sector, especially community pharmacies, are not captured into routine surveillance systems. This scoping review aims to systematically collate the existing evidence on the facilitators and barriers to malaria surveillance in community pharmacies (CPs) and over-the-counter medicine sellers (OTCMS) in SSA.

We will retrieve all relevant studies (published and completed but unpublished) through searches in PubMed, CINAHL, Scopus, Web of Science and Hinari from inception to 15 June 2026. Searches will be conducted without language restrictions; however, full-text inclusion will be limited to English-language publications due to resource constraints. Titles and abstracts of non-English articles will be thoroughly screened using online-assisted translation tools such as Google Translate to assess their potential eligibility. Potentially relevant non-English studies will be documented and reported in the appendices to allow for an evaluation of possible language bias, in accordance with Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) reporting guidelines. All the articles retrieved from the searches will be collated and deduplicated using EndNote. The deduplicated studies will then be screened and selected. Two reviewers will independently screen studies using a study selection flow chart developed from the pre-specified eligibility criteria. The data synthesis for this scoping review will be conducted using a narrative synthesis approach. The extracted data will be organised into a structured format, categorising information based on study characteristics, malaria surveillance activities, facilitators and barriers.

Formal ethical approval is not required as the review uses publicly available data. Findings will be published in an open-access peer-reviewed journal, presented at relevant conferences and disseminated through policy briefs and infographics to the WHO, national malaria programmes and pharmacy councils.

Open Science Framework (registration link: https://osf.io/udwpn/overview?view_only=6e42bea8abb94f9cbc535b161ea329a6).

Sepsis is a global health priority with nearly 50 million cases annually. Cardiovascular dysfunction is common, frequently manifesting as hypotension that persists despite fluid resuscitation. Most affected patients require the use of intravenous (IV) vasoactive agents, typically necessitating intensive care unit (ICU)-level monitoring, invasive interventions and contributing substantially to healthcare costs. Midodrine, an oral alpha-1 agonist approved for orthostatic hypotension, has increasingly been used off-label as a vasopressor-sparing (reducing IV vasopressor use) strategy in sepsis, despite limited and inconsistent evidence. This pragmatic, randomised, open-label trial evaluates the efficacy and safety of midodrine in patients with sepsis-associated hypotension. We hypothesise that, compared with standard care, midodrine administration will reduce the duration of IV vasopressor use.

A total of 308 adult patients with sepsis-associated hypotension will be enrolled (154 per arm). The intervention group will, in addition to standard of care, receive enteral midodrine 10 mg three times daily. Outcomes will be ascertained pragmatically via electronic health record-based data retrieval and adjudicated by research coordinators blinded to treatment assignment. The primary outcome is time alive and off IV vasopressors in the first 28 days (in hours) after randomisation. Secondary outcomes include cumulative vasopressor exposure; use and duration of central venous access; cumulative fluid balance over the first 48 hours and up to 7 days of ICU stay; ICU and hospital length of stay; and ICU-, hospital-, and organ support-free days through day 28. Safety outcomes include adverse events potentially attributable to midodrine during hospitalisation including acute kidney injury. Primary analyses will follow an intention-to-treat framework, including all randomised participants according to their assigned treatment groups. Primary and secondary outcomes will be compared using a van Elteren test stratified by randomisation factors. A predefined secondary Bayesian analysis of the primary outcome will provide complementary estimates of treatment effect. Safety outcomes will be summarised descriptively without formal between-arm hypothesis testing.

The Mayo Clinic Institutional Review Board approved this protocol and required written informed consent from all participants (IRB# 24–0 00 121). Findings will be disseminated through peer-reviewed publications and international conference presentations.

NCT06319248.

Data on long-term outcomes after surgical repair of pulmonary valve stenosis are limited. This study evaluated survival, clinical outcomes and quality of life (QoL) after surgery during childhood.

Single centre, longitudinal cohort study evaluating consecutive patients with pulmonary valve stenosis who underwent surgical repair between 1968–1980 and were evaluated every decade since 1990.

Of the original cohort of 89 operated patients, 11 died (12%), including 2 who died within 30 days postsurgery (2%), and 7 (8%) were lost to follow-up. Survival at 50 years follow-up was 87%, which was not significantly different from the GDP. Of the remaining 71 survivors, 32 refrained earlier from participating in this cohort study, leaving 39 eligible, of whom 34 (87%) participated again (50% male, median age 48 years) with a median follow-up of 45 (range 40–52) years. Event-free survival was 50%, with supraventricular tachycardia (14%) and reintervention (13%) being the most frequent events, although less frequently in the last 10 years. At last follow-up, biventricular function was preserved in most patients. Reduced right and left ventricular ejection fraction (EF) was found in 33% and 13%, respectively. Exercise capacity and maximum rate of oxygen consumption were mildly impaired in 14% and 32% of patients. Patients who underwent an infundibulectomy during initial surgery were significantly more likely to undergo reintervention (HR=8.32, p=0.003). Patient-reported QoL scores remained stable over time and consistently exceeded those of the age-matched GDP.

Fifty-year survival after surgery for pulmonary valve stenosis was excellent and comparable to the GDP. Most patients maintained preserved ventricular function, functional capacity and excellent QoL. Routine lifelong follow-up may not be necessary for all patients, but should be considered for those who underwent an infundibulectomy or have residual lesions.

Obesity is a global public health issue, with its effects a particular issue in Kuwait. Advances in pharmaceutical treatment (eg, glucagon-like peptide-1s) offer an effective solution, with the magnitude of weight lost something to celebrate. However, this level of weight loss also results in dramatic reductions in lean mass, reflecting loss of muscle mass and muscle strength which can predispose people to sarcopenia. This is a particular issue in people with type 2 diabetes in Kuwait, where the prevalence of muscle weakness is extremely high. Solutions to mitigate this loss of muscle mass and strength are needed, with a pragmatic resistance exercise intervention and increasing dietary protein intake having potential. This trial aims to determine whether resistance exercise and/or protein intake can preserve muscle mass and improve physical function in people with obesity initiating semaglutide/tirzepatide therapy.

This single-centre, 6-month, randomised controlled trial at Dasman Diabetes Institute will enrol 232 adults with obesity, randomised (1:1:1:1) to control, resistance exercise, protein supplementation or combined resistance exercise and protein in conjunction with semaglutide or tirzepatide therapy. Resistance exercise will be home-based and involve three sessions per week, progressing from one to three sets targeting major muscle groups. Protein supplementation will target 1.6 g/kg/day via dietary adjustment and protein products. Assessments at baseline and 6 months will include MRI measured quadriceps cross-sectional area (primary outcome), plus measures of secondary outcomes of MRI measured liver fat content and stiffness and intramuscular fat, body composition (dual energy X-ray absorptiometry), strength, physical function, dietary assessment, physical activity levels, sleep patterns, quality of life, glycaemic control and metabolic biomarkers.

The study has received ethical approval from the Dasman Diabetes Institute Ethical Review Committee (HR-RA-2025-01, 19 February 2025) and is registered at ClinicalTrials.gov (NCT06885736, 26 June 2025). Written informed consent will be obtained from all participants, with no financial compensation provided. Data will be reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines, ensuring participant anonymity. Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences.

NCT06885736.

Patient and public involvement (PPI) in research is increasingly recognised for its potential to enhance feasibility, improve relevance and foster collaboration at different stages of a study. Reporting guidelines such as GRIPP2 (Guidance for Reporting Involvement of Patients and the Public) have been developed to help improve completeness and transparency in PPI reporting. This meta-research project aims to assess the impact of the GRIPP2 reporting guidelines through citation and alternative metrics, analysing its uptake or adoption across authors, institutions, journals and countries, as well as its practical application in reporting PPI within diverse research designs.

This protocol for a meta-research project consists of two studies. In Study 1, we will conduct a search across Web of Science, Scopus and Google Scholar to identify all publications citing the GRIPP2 guidelines (planned for July 2026 using forward citation analysis). Retrieved records will undergo standardised processing and structured de-duplication to ensure each citing article is represented once. Following de-duplication, data from unique citations—including title, publication year, journal, subject category, keywords, document type, citations, authors’ names, institutional affiliations, country and funding sources—will be collected. Citation counts, alternative metrics (eg, mentions in policy documents, news media) and knowledge production patterns across authors, institutions, journals and countries will be analysed to assess GRIPP2’s impact and uptake of the guidelines. Descriptive analyses will be conducted (including the number of papers, citations, authors, countries, journals, keywords, funding, field distribution and main collaboration metrics). Network analyses will be carried out to study the structure of collaborations. In Study 2, we will evaluate a random sample of 300 research articles citing GRIPP2, including randomised trials (n=100), systematic reviews with meta-analyses (n=100) and health economic evaluations (n=100). If an insufficient number of citing studies are available within these categories, we will include additional study types identified in Study 1 (eg, study protocols, observational studies, mixed-methods or qualitative research studies and other types of reviews). Reporting and PPI practices in each article will be extracted by at least two researchers using a standardised data extraction form. Information on general, methodological and PPI items will be analysed and reported, stratified by study design (eg, randomised trials vs systematic reviews vs health economic evaluations).

Due to the nature of the proposed study, no ethical approval will be required. All data will be deposited in a cross-disciplinary public repository. It is anticipated the study findings could be relevant to a variety of audiences. Study findings will be disseminated at scientific conferences and published in peer-reviewed journals.

Open Science Framework: https://osf.io/et85d

Nearly half of patients who receive invasive mechanical ventilation for acute respiratory failure require over 4 days of ventilator support, each day of which is associated with increased morbidity, mortality and cost. Many of these patients develop expiratory muscle atrophy and weakness, which are linked to failed extubation and weaning. We seek to test the hypothesis that exhalation synchronised abdominal functional electrical stimulation reduces mechanical ventilation duration.

This pivotal superiority trial will be performed in up to 30 intensive care units (ICUs) in the USA, France, the Netherlands and Australia. Adults (≥22 years old) who have been mechanically ventilated for 24–96 hours and are expected to remain ventilated for another 24+ hours are potentially eligible. We will recruit participants until 150 successful liberations from mechanical ventilation occur. To achieve this, we estimate that a maximum of 272 participants will be randomised in a 1:1 ratio to receive 30 min of active exhalation synchronised abdominal functional electrical stimulation (vs sham). The intervention will be applied using the VentFree Respiratory Muscle Stimulator two times per day, a minimum of 5 days per week, for a maximum of 28 days or until ICU discharge. The primary outcome is time from first intervention to successful liberation from mechanical ventilation. Secondary outcomes include cough peak flow (CPF) and maximum expiratory pressure (MEP) at 24 hours post-extubation, hospital and ICU length of stay, reintubations, complications, ICU readmissions, 90-day mortality and quality of life. The participant, clinical team and outcome assessor are blinded to group allocation. A positive outcome has the potential to improve patient-centred outcomes in ICUs.

This study was approved by local ethics institutions in the USA, Australia, France and the Netherlands. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. The results will be disseminated through peer-reviewed journal publications, conference presentations and clinicaltrials.gov updates. Individual country-level approvals are as follows:

France:

Australia:

Netherlands:

USA:

All participating sites are currently approved and operating under protocol version 09 or later.

NCT05759013. Registered 8 March 2023.

Despite the rapid increase in the proportion of unmarried women in the Chinese population, little is known about their sexual and reproductive health (SRH) and well-being. The aim of this survey is to collect data on SRH knowledge and needs, past care-seeking experiences, fertility goals and attitudes towards fertility technology among unmarried women in four megacities in China where singlehood is prominent among women of reproductive age.

This multi-centre cross-sectional survey, Survey of Unmarried women on Reproductive health and Fertility (SURF), aims to recruit 6000 eligible women, with 1500 from each study site. Eligibility criteria include: (1) women; (2) aged 25–40 years; (3) currently unmarried (never married, divorced or widowed); and (4) reside in Beijing, Shanghai, Shenzhen or Guangzhou metropolitan areas. Quota sampling is used to ensure the age strata in the final sample correspond to the age distribution from the latest Chinese census. Data are currently being collected through referral recruitment and a self-administered questionnaire available on the mobile devices and computers of participants.

SURF has been approved by the Biomedical Ethics Committee of Peking University (institutional review board (IRB) number: IRB00001052-24040). Each participant receives comprehensive information about the objectives, procedure and data handling of the survey before proceeding to the questionnaire. Participants are also provided with the contact information of the principal investigator in case they have questions regarding the survey. Written informed consent is obtained before data collection starts. Participation is anonymous and no personal identifiers are collected. Findings from this survey will be disseminated through peer-reviewed journals and at scientific conferences.