Social determinants of health (SDOH) factors are known to influence patient outcomes, but their effect on sepsis remains insufficiently studied. This research aims to investigate the relationship between SDOH factors and sepsis outcomes, highlighting opportunities to reduce health disparities and enhance patient care.

Retrospective study.

Level I trauma centre in Baton Rouge, Louisiana, USA.

Patients with sepsis aged 18–89 years. Patients discharged or transferred to hospice were excluded to prevent bias and misinterpretation of the findings.

Social Vulnerability Index (SVI), the Gini Index and the average distance to the nearest urgent care, emergency department and clinic.

In-hospital mortality, 30-day readmission and hospital length of stay (LOS).

² tests, Mann-Whitney U tests and Cox regression.

Distance from urgent care is significantly associated with mortality (4.14 vs 3.24 miles, p

Mortality and LOS are closely linked to proximity to urgent care, while high SVI is notably associated with longer LOS. These findings highlight the significant impact of SDOH factors on sepsis outcomes and underscore the need for targeted interventions to address disparities in healthcare access and contextual health practices.

Opioid use disorder (OUD) is a chronic and severe psychiatric condition defined by a level of opioid use which significantly impairs interpersonal and social functioning. In the biopsychosocial model of addiction, research has shown that psychiatric, sociological and neurobiological factors individually affect OUD severity. However, how these factors interact in the determination of OUD severity remains poorly understood.

The Epigenetic Bonds of Opioid Use Profiles are a multidisciplinary project whose primary objective is to characterise psychiatric and social factors of OUD in a large cohort of patients. The secondary objectives are, first, to correlate psychosocial severity with blood-derived epigenetic biomarkers to provide a deeper understanding of determinants of OUD and, second, to examine over a 2 year follow-up the correlation between the evolution of OUD and psychosocial severity with epigenetic biomarkers at inclusion. An additional objective is to analyse the impact of drug consumption rooms on access to care for most severely affected patients with OUD. In total, 300 opioid users will be recruited at supervised injection sites in Strasbourg and Paris and at addiction care centres in Strasbourg and Lyon to explore four psychiatric (substance use disorders beyond opioids, depression, anxiety, post-traumatic stress disorder) and five social (social support and status, traumatic experiences, housing, imprisonment, access to care) factors. Opioid users will be followed for 24 months and reassessed for psychosocial factors at 3, 6, 12, 18 and 24 months. Opioid consumption will be measured in all subjects using questionnaires, complemented by toxicological screenings (mass spectrometry). Finally, DNA methylation and gene expression will be characterised in capillary blood using next-generation sequencing. Mixed models will be used to model the primary and secondary outcomes.

This ongoing study was approved by the French Ethics Committee ‘Sud Méditerranée III’ of University Hospital of Nîmes (approval 2023–2024, protocol IDRCB number 2022-A02477-36) and authorised by the French Data Protection Authority (authorisation decision DR-2023–277 in December 2023). Results will be presented in international and national conferences and published in peer-reviewed international journals.

NCT06021548.

Targeted biologic therapies have transformed outcomes for individuals with psoriasis, a common immune-mediated inflammatory skin disease. The widespread use of these highly effective treatments has led to a growing number of individuals with clear or nearly clear skin remaining on continuous, long-term treatment. Personalised strategies to minimise drug exposure may sustain long-term disease control while reducing treatment burden, associated risks and healthcare costs. This study aims to evaluate the feasibility of a definitive pragmatic effectiveness trial of two personalised dose minimisation strategies compared with continuous treatment (standard care) in adults with well-controlled psoriasis receiving the exemplar biologic risankizumab.

This is a multicentre, assessor-blind, parallel group, open-label randomised controlled feasibility trial in the UK, evaluating two personalised biologic dose minimisation strategies for psoriasis. 90 adults with both physician-assessed and patient-assessed clear or nearly clear skin on risankizumab monotherapy for ≥12 months will be randomised in a 1:1:1 ratio to (1) patient-led ‘as-needed’ treatment, where risankizumab is administered at the first sign of self-assessed psoriasis recurrence, (2) therapeutic drug monitoring-guided treatment, with personalised dosing intervals determined using a pharmacokinetic model or (3) continuous treatment as per standard care, for 12 months. Participants will be invited to submit self-reported outcomes and self-taken photographs every 3 months using a bespoke remote monitoring system (mySkin app) and will attend an in-person assessment at 12 months. They may also request additional patient-initiated follow-up appointments during the trial if needed. The primary outcome is the practicality and acceptability of the two personalised biologic dose minimisation strategies, assessed as a composite measure including recruitment and retention rates, adherence to the assigned strategies and acceptability to both patients and clinicians. The feasibility of collecting healthcare cost and resource utilisation data will also be evaluated to inform a future cost-effectiveness analysis. A nested qualitative study, involving semistructured interviews with patients and clinicians, will explore perspectives on the personalised biologic dose minimisation strategies. These findings will inform the design of a future definitive trial.

This study received ethical approval from the Seasonal Research Ethics Committee (reference 24/LO/0089). Results will be disseminated through scientific conferences, peer-reviewed publications and patient/public engagement events. Lay summaries and infographics will be codeveloped with patient partners to ensure the findings are accessible for the wider public.

ISRCTN17922845.

Smoking and vaping are especially prevalent among people with experience of psychosis (EoP), potentially increasing their toxicant exposure. Switching from tobacco smoking to vaping e-cigarettes reduces exposure to tobacco-related toxicants and likely associated diseases. We compared levels of nicotine and tobacco-related toxicant exposure among people with versus without EoP.

Cross-sectional study, secondary data analysis of Wave 5 (2018) of the Population Assessment of Tobacco and Health Study.

Data collection took place in the USA at the home of participants.

Data were from 5750 adults (aged >18 years) with and without EoP who smoked, vaped, did both or did neither. EoP was defined as ever being told by a health professional that you have schizophrenia, schizoaffective disorder, psychosis, a psychotic illness or psychotic episode.

Levels of urinary toxicants: nicotine metabolites, metals, volatile organic compounds (VOCs) and tobacco-specific nitrosamines (TSNAs) among people with and without EoP. Analyses were adjusted for demographics, cannabis use and past 30-day smoking/vaping status, and were repeated after stratifying by smoking /vaping status.

Of the 5750 participants, 6.3% (n=361) reported EoP, and 93.7% reported no EoP. Levels of nicotine and TSNA metabolites, cadmium, uranium and some VOCs were significantly higher among participants with EoP compared with those without. However, when smoking, vaping and cannabis use were taken into account, the associations of EoP with nicotine and TSNA metabolites, and most of the VOCs, were attenuated and no longer significant.

Participants with EoP are exposed to more nicotine and tobacco-related toxicants than those without EoP, likely largely due to the high prevalence of smoking, vaping and cannabis use among this population.

Nicotine vaping is common among children and youth, and even more so among those with mental health concerns. Identifying and managing nicotine vaping in child and youth mental health treatment settings is key to addressing this modifiable risk factor for poorer physical and mental health in young people. Recommendations exist for screening, assessment and treatment of youth vaping; however, it remains unclear whether current practices in child and youth mental health programmes align with recommended standards.

An explanatory sequential mixed methods design with three stages will be employed. In the first stage, a cross-sectional survey will be distributed to all eligible Canadian hospitals to identify practices in assessment and treatment of nicotine vaping within their child and youth mental health and addictions programmes. This survey will also assess barriers and facilitators for the uptake of the 2021 Canadian Paediatric Society recommendations on management of youth vaping. Semi-structured focus groups and interviews will be conducted in stage two, with clinicians, managers, youth and caregivers. Qualitative data will be analysed using a reflexive thematic approach. In stage three, findings and proposed behaviour change interventions will be reviewed at a knowledge mobilisation meeting with the goal of developing a national knowledge mobilisation plan to improve assessment and treatment of youth vaping in hospital-based mental health and addictions programmes.

This study has received ethics approval from the Research Ethics Board at the Children’s Hospital of Eastern Ontario (Protocol #25/19X). Participants will provide informed consent prior to participating. Results will be published in peer-reviewed journals and presented at scientific conferences. Summaries will be provided to the funders of the study and to participating hospitals.

The aim of the study was to evaluate the healthcare costs and effects of a remote person-centred care (PCC) add-on intervention compared with usual care for people with chronic heart failure (CHF) and/or chronic obstructive pulmonary Disease (COPD) from a societal perspective.

A cost-effectiveness analysis (CEA) based on the results from a randomised controlled trial.

The study was conducted from August 2017 until June 2021 within nine primary care centres across Western Sweden.

Participants in the study had a diagnosis of COPD (J43.0, J44.0–J44.9) and/or CHF (I50.0–I50.9).

224 patients were randomly allocated to the study groups. After two withdrawals, the final intention-to-treat analysis included 110 participants in the intervention group and 112 in the control group.

Both the intervention and control group received usual care through their primary care centres. In addition, the intervention group participated in a remote PCC add-on intervention consisting of a digital platform and structured telephone support.

Incremental cost-effectiveness ratio using direct healthcare costs, productivity loss and prescription drug costs, compared with health effects measured using the EuroQoL questionnaire (EQ-5D-3L) over a 2-year time horizon.

The intervention group had lower healthcare utilisation in inpatient care, specialised outpatient care and reduced productivity loss. The CEA showed incremental effects of 0.0469 quality-adjusted life years and incremental costs of SEK –68 533 (Swedish crowns). The PCC alternative was both more effective and resulted in lower healthcare costs compared with usual care, that is, PCC was dominant.

The results of this CEA demonstrated that a remote PCC add-on intervention for people with COPD and/or CHF had lower healthcare costs and higher health-related quality of life compared with usual care.

NCT03183817 ClinicalTrials.gov.

Frequent use of emergency departments (EDs) places a considerable burden on healthcare systems. Although frequent attenders are known to have complex physical, mental health and social needs, national-level evidence on their characteristics and patterns of attendance remains limited. This study aimed to provide a comprehensive, population-level description of frequent ED attendance in England, with a focus on age-based subgroups.

Retrospective cohort study.

EDs in England via the Hospital Episode Statistics and the Emergency Care Dataset data linked with primary care prescribing and mortality data, between March 2016 and March 2021.

The dataset received from National Health Service Digital contained approximately 150 million ED attendances by 30 million adult (>18 years) patients over the time period April 2016 to March 2021. A random sample of 5 million people was used for this analysis.

The primary outcome was the number of attendances in each financial year by frequent attenders compared with the remaining patients, split by age bands. Patients were classified as frequent attenders if they had ≥5 or ≥10 ED attendances within a rolling 12-month period. Secondary outcomes included demographic, diagnostic and prescribing characteristics, as well as the number of different ED sites visited.

A Gaussian mixture model was used to identify age-based subgroups. Descriptive statistics were used to summarise key features; 95% CIs were reported where applicable. Among 3.91 million unique adult ED attenders, there were 8.7 million attendances. Of these, 222 160 individuals (5.7%) had ≥5 attendances in a year, accounting for 12.6% of total attendances. A trimodal age distribution was identified, with three distinct peaks corresponding to ages 18–34, 35–64 and 65+. Frequent attenders were more likely to live in deprived areas and have a history of psychotropic or analgesic prescribing. Mental health diagnoses and polypharmacy were particularly common in the younger and middle-aged groups. Multisite attendance was uncommon, with over 80% of frequent attenders using only one ED site annually.

This national analysis reveals a trimodal age pattern among frequent ED attenders, with differing clinical and socio-demographic profiles across age groups. These findings highlight the need for age-tailored approaches to managing high-intensity ED use and inform targeted service development.

To describe the usage patterns of patients and healthcare professionals (HCPs) using a person-centred telehealth and e-health intervention.

An exploratory, descriptive, observational study embedded in the "Person-centred care at a distance (PROTECT)" randomised controlled trial (ClinicalTrials.gov: NCT03183817) as part of a process evaluation. Data on intervention use and time spent on the intervention were collected. Descriptive statistics were calculated.

Participants were recruited from nine public primary healthcare facilities located in various areas of Gothenburg, Sweden.

110 patients participating in the intervention group in the PROTECT trial were included. Participants were diagnosed with chronic heart failure (CHF, n=42), chronic obstructive pulmonary disease (COPD, n=56) or both (n=12). They were 33–93 years old (mean 71 years).

A secondary outcome report on resource use.

The 6-month-long intervention was performed as an add-on to standard care and comprised person-centred telephone support and access to a digital platform. Per-protocol use included co-creation of a health plan via the telephone and use of the digital platform at least once. Forms of use were tailored to the preferences and needs of the patients.

Most intervention activities took place in the first 3 months of the intervention. Most patients used a combination of phone and digital support, spending most of their time using the digital platform. Overall, patients and HCPs spent 6 and 2.5 hours/patient using the intervention, respectively. Of this time, 1.5 hours involved synchronous communication through phone calls, with health-plan calls averaging 77 min.

The intervention usage patterns of patients and HCPs differed. Despite HCPs being accessible when required, patients dedicated most of their time to self-care practices. Based on time distribution data, 15 full-time HCPs could potentially co-create, document and follow-up on health plans for 10 000 patients under study conditions.

ClinicalTrials.gov: NCT03183817.

To evaluate the associations between anthropometric indices and components of metabolic syndrome (MetS), including blood pressure, fasting blood sugar (FBS), triglycerides, high-density lipoprotein cholesterol and waist circumference (WC) in Iranian adults.

Cross-sectional analysis of baseline data from a population-based cohort.

Fasa adults’ cohort study, a rural community-based cohort in Fars province, Iran.

A total of 1550 adults aged 35–70 years with MetS, identified from among 10 118 cohort participants using the National Cholesterol Education Programme Adult Treatment Programme III criteria.

The anthropometric indices include abdominal volume index (AVI), a body shape index (ABSI), atherogenic index of plasma (AIP), body roundness index (BRI), body adiposity index (BAI), conicity index, ponderal index and visceral adiposity index (VAI).

Participants (56.1% female) with a mean age of 49.8±9.5 years. AVI was significantly associated with systolic blood pressure (SBP) (β=0.010, p

Anthropometric indices, including VAI, AIP, BAI, BRI and AVI, exhibit significant associations with key components of MetS in Iranian adults, particularly blood pressure, glycaemic markers and central adiposity. Among these, BAI showed the strongest correlation with MetS parameters, while ABSI displayed the weakest.

Suicide poses a significant global health challenge in low- and middle-income countries and is a leading cause of death worldwide. Although global suicide rates have decreased by 36% between 2000 and 2019, the decline in Africa has not been as substantial. Suicide surveillance data, particularly from pesticide ingestion, is lacking.

This scoping review aimed to identify pesticide suicide surveillance methods currently used in African countries and to assess their viability for improving reporting of pesticide suicide deaths.

A scoping review was conducted using a five-stage methodological framework across several databases.

Peer-reviewed articles published in English that investigated (a) pesticide poisoning and (b) suicide in humans only and specific to the African continent.

MEDLINE (via PubMed), Scopus (with substantial Embase content), Web of Science Core Collection, Biological Abstracts, SciELO (on Web of Science platform), Academic Search Premier, Africa-Wide Information, Biological and Agricultural Index, CINAHL, Health Source Nursing/Academic, APA PsycInfo and General Science (EBSCOhost platform). The search was performed in January 2022, and the review of the results took place from February to May 2022.

All authors developed and tested the data extraction tool. The charting framework remained dynamic, continuously updated as reviewers gained a deeper understanding of the studies included. Four independent reviewers charted the data to ensure inter-rater reliability. To address discrepancies, a sample of eligible articles was cross-rated by the reviewers.

We identified 110 relevant studies describing eight different surveillance systems, conducted in 30 different African countries. Of these studies, 50.1% (56/110) reported on the number of pesticide suicides (totalling 1554); however, 49% (54/110) did not differentiate the cause of death further than either a poisoning death or a suicide, making it difficult to determine if pesticides were involved in the death or if the death was an intentional poisoning case. The surveillance systems identified included health facility records (hospital admissions data), poison control centre (PCC) data, forensic/mortuary data (including police reports), media reports, surveys/interviews with patient/family, case reports, systematic/literature reviews and civil registration and vital statistics (CRVS) data. Hospital admissions data was the most frequently used surveillance system (61/110, 55.5%).

The number of studies and surveillance methods found was higher than anticipated. While this is a positive sign, several areas of improvement were identified for pesticide suicide surveillance in Africa. These included improving reporting of the specific pesticides (including the active ingredient) linked to suicide cases for improving policy (since this is required for pesticide regulation) and making use of more than one surveillance system to enhance surveillance of pesticide suicides, allowing for under-used sources, such as PCCs, to be used more effectively in pesticide suicide surveillance. Finally, although a comparison of these surveillance methods outside of Africa was not directly possible for each surveillance system due to a lack of similar high-quality reviews, we did refer to publications where similar pesticide suicide surveillance systems were discussed.

The aims of this study were (1) To investigate the availability of NHS funded in vitro fertilisation (IVF) treatment for individuals affected by Mayer-Rokitansky-Küster-Hauser syndrome (MRKH) from all Integrated Care Boards (ICBs) across England and (2) To assess the ethical implications of piecemeal funding for those with MRKH.

This was a mixed-methods study containing both quantitative and qualitative data. We filed freedom of information (FOI) act requests on 01/06/2023 for all 42 ICBs across England via secure email.

The study focused on England.

All 42 ICBs across England were contacted.

The FOI requests asked for information concerning the provision of funded IVF for uterine factor infertility, and if this included individuals with MRKH. Where assistance was available, we recorded what it comprised along the IVF cycle. If IVF was not offered, we recorded the rationale provided by the ICB.

Responses were received from all 42 ICBs across England. Seven stated that they would fund IVF and cryopreservation of embryos to women with MRKH and other absolute uterine factor infertility diagnoses (NHS Humber and North Yorkshire, NHS Dorset, NHS Devon, NHS Cornwall and Isles of Scilly, NHS Buckinghamshire, Oxford and Berkshire, NHS South Yorkshire and NHS West Yorkshire). However, the number of cycles, the length of cryopreservation and whether they would fund embryo transfer into a surrogate differed between ICBs.

Of the remainder, three (NHS Leicester, Leicestershire and Rutland, NHS Greater Manchester and NHS Hampshire and Isle of Wight) described some provision of fertility preservation (cryopreservation of oocytes or embryos) for women with uterine factor infertility, two of whom suggested their policy may include women with MRKH (NHS Greater Manchester and NHS Hampshire and Isle of Wight). Two ICBs (NHS Gloucester and NHS Bedford, Luton and Milton Keynes) explained that individual funding applications would be considered when made by clinicians on the patient’s behalf, but no information was provided on how many times requests had been made and granted. The remaining 30 ICBs explained that no part of a surrogacy pregnancy would be funded, owing to concerns around commercial surrogacy, which is illegal in the UK.

This work has revealed that only a small proportion of ICBs (7/42, 17%) treat women with MRKH like any other woman applying for NHS fertility treatment. The study revealed that decisions by ICBs not to fund IVF treatments based on concerns about commercial surrogacy create significant inequities. It unfairly penalises individuals with MRKH who require surrogacy as part of their fertility treatment. These individuals face a unique set of reproductive challenges, and denying them access to NHS-funded IVF treatments exacerbates existing inequalities. Furthermore, if individuals with MRKH accept that the expenses of the surrogate will be met by them rather than the ICB, it is unjustifiable to deny them the IVF component of the treatment if they meet all the other criteria for eligibility. Moreover, the fact that some ICBs do fund IVF for individuals with MRKH indicates that legal concerns regarding surrogacy are unfounded and inconsistently applied. This discrepancy highlights the need for a standardised approach that ensures equitable access to fertility treatments across all regions.

Assessment of Different NEoplasias in the adneXa (ADNEX) and Risk of Malignancy Index (RMI) are models that estimate the risk of malignancy in ovarian masses based on clinical and ultrasound information. The aim is to perform a meta-analysis of studies that compared the performance of the two models in the same patients (‘head-to-head comparison’).

Systematic review and meta-analysis.

Systematic literature search from publication of ADNEX model (15/10/2014) up to 31/07/2024 in Embase, Web of Science, Scopus, Medline (via PubMed) and EuropePMC.

We included all studies that externally validated the performance of ADNEX (with or without CA125) and RMI on the same data.

Two independent reviewers extracted data using a standardised extraction sheet. We assessed risk of bias using PROBAST. We performed random effects meta-analysis of the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and clinical utility (net benefit, relative utility and probability of being useful in a hypothetical new centre) at thresholds commonly used clinically (10% risk of malignancy for ADNEX, 200 for RMI).

We included 11 studies comprising 8271 tumours. Most studies were at high risk of bias. The summary AUC to distinguish benign from malignant tumours in operated patients for ADNEX with CA125 was 0.92 (95% CI 0.90 to 0.94) and for RMI it was 0.85 (0.81 to 0.89). Sensitivity and specificity for ADNEX with CA125 were 0.93 (0.90 to 0.96) and 0.77 (0.71 to 0.81) and for RMI, they were 0.61 (0.56 to 0.67) and 0.92 (0.89 to 0.94). The probability of the test being useful in a hypothetical new centre in operated patients was 96% for ADNEX with CA125 and 15% for RMI at the selected thresholds.

ADNEX has better discrimination and clinical utility than RMI.

Major depressive disorder (MDD) is among the most common psychiatric disorders in children and adolescents. While previous meta-analyses have synthesised evidence on the efficacy and acceptability of newer-generation antidepressants in this population, specific adverse events (AEs) remain poorly characterised. This is of high clinical importance, as AEs are burdensome for patients, can reduce treatment adherence and lead to discontinuation. Here, we present a protocol for a network meta-analysis designed to evaluate the specific AE profile and comparative tolerability of newer-generation antidepressants in children and adolescents with MDD.

The planned study will include double-blind randomised controlled trials that compared one active drug with another and/or placebo for the acute treatment of MDD in children and adolescents. The following antidepressants will be considered: agomelatine, alaproclate, bupropion, citalopram, desvenlafaxine, duloxetine, edivoxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, vilazodone and vortioxetine. The primary outcomes will include the number of patients experiencing at least one AE, specific non-serious AEs, serious AEs (eg, suicidal ideation) and AEs leading to treatment discontinuation. Published and unpublished studies will be retrieved through a systematic search in the following databases: PubMed, Embase, Cochrane Library (including the Cochrane Central Register of Controlled Trials), Web of Science Core Collection, PsycInfo and regulatory agencies’ registries. Study selection and data extraction will be performed independently by two reviewers. For each outcome, a network meta-analysis will be performed to synthesise all evidence. Consistency will be assessed through local and global methods, and the confidence in the evidence will be evaluated using the Confidence in Network Meta-Analysis web application. All analyses will be conducted in the R software.

The planned review does not require ethical approval. The findings will be published in a peer-reviewed journal and may be presented at international conferences.

CRD420251011399.

The goal of this study is to assess the safety, feasibility and clinical outcomes of prophylactic fibrinogen administration in paediatric scoliosis surgery.

Prospective, two-arm, randomised, double-blind pilot trial.

Single-centre study conducted at a tertiary care hospital specialising in scoliosis surgery.

32 children undergoing scoliosis surgery entered and completed the study. The inclusion criteria were elective scoliosis surgery, age

Participants were randomised 1:1 to a standard group, receiving standard blood and coagulation management, or a fibrinogen group, receiving a single prophylactic dose of fibrinogen concentrate in addition to standard care.

Safety, the primary objective, was assessed according to adverse events, serious adverse events and other safety parameters. Secondary objectives included feasibility and clinical outcomes.

In the fibrinogen group, 101 adverse events across 19 types were observed, whereas in the standard group, 95 adverse events across 21 types (p>0.9999) and one serious adverse event were observed. No adverse events of special interest or deaths occurred in either group. Blood loss did not significantly differ between the fibrinogen (1021.88 mL (SD 473.63)) and standard (859.38 mL (SD 713.03)) groups (p=0.1677). The mean length of hospital stay was 8.88 (SD 0.81) days in the fibrinogen group and 9.25 (SD 1.88) days in the standard group (p=0.9210). No statistically significant differences in the use of blood transfusions, blood derivatives, crystalloids or colloids were observed between groups.

This study demonstrates that the prophylactic administration of fibrinogen during scoliosis surgery in children is feasible and appears to be safe. Due to the limited sample size, no conclusions can be drawn regarding the efficacy of pre-emptive fibrinogen administration on clinical outcomes. However, the results provide valuable data to inform sample size calculation for a future full-scale randomised controlled trial.

CliniacalTrials.gov NCT05391412.

Severe aorto-iliac steno-occlusive atherosclerotic disease is a major cause of morbidity and amputation in patients with peripheral arterial disease. While both open surgical and endovascular revascularisation are standard treatments in this patient group, there is no high-quality randomised evidence to determine which approach offers superior clinical and cost-effectiveness, leading to uncertainty and poor outcomes after intervention.

The EVOCC trial is a national, multicentre, parallel-group, superiority randomised controlled trial comparing open surgery to endovascular revascularisation in patients with symptomatic severe aorto-iliac occlusive disease. A total of 628 participants across 30 NHS sites in the UK will be randomised 1:1 to receive either open surgery or endovascular (minimally invasive) intervention. The primary outcome is amputation-free survival, defined as time to first event (major lower limb amputation or death). Secondary outcomes include mortality, cardiovascular events, hospital readmissions, re-interventions and quality-of-life measures. An internal pilot phase (10 sites, 6-month duration) will assess recruitment feasibility. A QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.

The trial has received ethical approval from a UK Research Ethics Committee (REC reference: 23/SW/0065; trial registration reference: ISRCTN14591444). Informed consent will be obtained from all participants.

The EVOCC trial is the first RCT assessing the clinical and cost-effectiveness of open vs endovascular revascularisation for severe aorto-iliac disease worldwide. The results will provide robust evidence to inform clinical practice and healthcare policies globally. Results will be disseminated via patient groups, online lay summaries, a trial website, social media, presentations in conferences, a formal scientific publication in a medical journal and direct communications with policymakers across borders.

ISRCTN14591444.

Sepsis-related myocardial injury is common in sepsis patients and has been repeatedly associated with poor patient outcomes. While experimental animal studies suggest that direct and indirect myocardial damage occurs via a wide range of inflammatory mediators, including bacterial toxins, the extent of bacterial-driven myocardial injury in human sepsis remains unclear. This scoping review aims to map existing evidence, identify knowledge gaps and guide future research priorities.

This scoping review will follow the Joanna Briggs Institute methodology for scoping reviews. The review is anticipated to start on 12 December 2024 and be completed by 31 October 2025. A comprehensive search will be conducted in MEDLINE (PubMed), Web of Science and EMBASE. Two independent reviewers will screen titles and abstracts, followed by a full-text review of potentially eligible studies. Studies focusing on the role of bacteria and/or their toxins in myocardial injury in adult patients with sepsis will be included. Data will be independently extracted using predefined forms, and findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis extension for Scoping Reviews guidelines.

Ethical approval is not required for this scoping review. On completion, findings will be submitted for publication in a peer-reviewed medical journal and presented at scientific conferences. The results will help identify and analyse knowledge gaps, providing valuable insights to inform future research in patients with sepsis.

Registered on Open Science Framework 3 March 2025.

The use of digitally enabled technology is considered a promising platform to prevent morbidity and enhance youth mental health as youth are growing up in the digital world and accessing the Internet at increasingly younger age. This scoping review will identify, describe and categorise the models, frameworks and strategies that have been used to study the implementation of digital mental health interventions targeted at youth aged 15–34 years.

We will conduct a scoping review following the Arksey-O’Malley five-stage scoping review method and the Scoping Review Methods Manual by the Joanna Briggs Institute. Implementation methods will be operationalised according to pre-established aims: (1) process models that describe or guide the implementation process; (2) evaluation frameworks evaluating or measuring the success of implementation; and (3) implementation strategies used in isolation or combination in implementation research and practice. Primary research studies in all languages will be identified in CINAHL, Cochrane Central Register of Controlled Trials, Embase, ERIC, Education Research Complete, MEDLINE and APA PsycINFO on 6 January 2025. Two reviewers will calibrate screening criteria and the data charting form and will independently screen records and abstract data. We will use the Evidence Standards Framework for Digital Health Technologies by the National Institute for Health and Care Excellence to classify digital interventions based on functions, and a pre-established working taxonomy to synthesise conceptually distinct implementation outcomes. Convergent integrated data synthesis will be performed.

Ethical approval is not applicable as this scoping review will be conducted only on data presented in the published literature. Findings will be published and directly infused into our multidisciplinary team of academic researchers, youth partners, health professionals and knowledge users (healthcare and non-governmental organisation decision makers) to co-design and pilot test a digital psychoeducational health intervention to engage, educate and empower youth to be informed stewards of their mental health.

Undergoing pancreatic surgery represents an exceptional situation for the individual patient who therefore requires appropriate preoperative information. In daily clinical practice, however, there is often a lack of time for adequate patient information and education, which may be associated with stress, fears and worries with potentially negative impact on patient-reported and postoperative outcomes. The aim of the INFORM trial is to evaluate the impact of video-assisted preoperative patient information on patient-reported and surgical outcomes in patients scheduled for elective pancreatic resection.

The INFORM trial is an open-label, randomised controlled pilot trial with two parallel study groups and a planned sample size of 80 patients with any indication for pancreatic resection. The intervention group will receive access to videos providing detailed information on the planned surgery and the perioperative procedures within 2 weeks before surgery in addition to the standard preoperative preparations. The control group will only receive the standard preoperative preparations without video. Quality of life (QLQ), satisfaction with information on disease and treatment as well as disease symptoms will be assessed using the European Organisation For Research and Treatment of Cancer QLQ INFO25, C30 and PAN26 questionnaires. Surgical complications will be assessed according to appropriate classifications by Clavien and Dindo and the International Study Group of Pancreatic Surgery (ISGPS). To account for the potential impact of cancer treatment on the outcome parameters, a subgroup analysis including only patients without malignancy will be performed. In addition, potential influencing factors on QLQ scores will be investigated by comparing QLQ scores among appropriate subsets of patients.

This trial was approved by the institution’s Ethics Committee (reference number 1479/2024). All trial procedures are performed in accordance with the ICH E6 harmonised tripartite guideline on Good Clinical Practice and the ethical principles of the Declaration of Helsinki. Once the study has been completed, the results will be published in due course.

German Clinical Trial Register number: DRKS00035173. Registered 14 October 2024 (https://drks.de/search/de/trial/DRKS00035173/details).

Children with medical complexity (CMC) are a subset of children with special healthcare needs, defined by high healthcare utilisation, severe single or multisystem organ dysfunction, and in many cases, reliance on medical technology. In the emergency care setting, known challenges for this population include poor quality of care, avoidable admissions and high caregiver and provider burden. While experts and professional societies recommend emergency care planning tools to address these concerns, evidence to support effectiveness and implementation of such tools is lacking. Through a human-centred design approach, we recently engaged key partners to create and optimise an emergency care action plan (ECAP) for infants with medical complexity. Here, we describe the protocol for a pilot type 1 hybrid effectiveness-implementation randomised controlled trial (RCT) for infants with medical complexity aimed to evaluate ECAP effectiveness and implementation.

Infants with medical complexity and their caregivers will be randomly assigned to the intervention group (ECAP) or control group (standard care) in a pilot type 1 hybrid effectiveness-implementation RCT. The primary outcome is number of inpatient hospital days for infant participants. Additional effectiveness outcomes include perceived avoidance of emergency department (ED) visits, healthcare costs, caregiver stress and self-efficacy. Preliminary implementation outcomes include acceptability, feasibility, appropriateness and usability, as well as contextual barriers and facilitators to reach, adoption and implementation. Key partners, including caregivers of CMC and healthcare providers, will be engaged throughout the implementation of the ECAP and execution of the trial.

This study was approved by the University of Vermont Institutional Review Board (STUDY00002937). Findings will be disseminated through peer-reviewed publications, conference presentations, and focus groups and interviews with key stakeholders.

NCT06444282.

The perspectives of stakeholders directly affected by mental health services for autism spectrum disorder (ASD) are essential for the quality of these services. However, it is crucial that these perspectives are informed by the best available evidence and adapted to the local context. This study aims to analyse barriers related to mental health services for children and adolescents with ASD from the perspective of families and caregivers, considering social, racial and gender aspects.

Three steps will be taken: stakeholder engagement through an online meeting to refine the research question and understand the magnitude of the problem; (b) qualitative evidence synthesis using five databases and grey literature to identify studies that have collected and analysed qualitative data on barriers to mental health services for children and adolescents with ASD in Brazil. Only studies conducted in Brazil that consider the perspectives of family members and caregivers will be included. (c) A citizen panel with families of children and adolescents with ASD will be used to discuss and validate the synthesis findings.

We will provide a set of evidence-informed and stakeholder-experienced barriers to mental health services for children with ASD in Brazil. This represents an effort to engage stakeholders in evidence descriptions to inform policy. We plan to disseminate the findings through various means, including peer-reviewed journal publications, presentations at national conferences, invited workshops and webinars, patient associations and academic social media platforms. The project was approved by the Ethics Committee for Research at the University of Sorocaba (approval number 78747224.7.0000.5500).

Open Science Framework—10.17605/OSF.IO/DVAKG.