Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis, health outcomes have improved. This paper evaluates the health system costs and the health-related quality of life implications of these guidelines.

A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015.

Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months.

Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS) and the EuroQoL; healthcare costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life Years (QALYs) were calculated from the EQ-5D utility scores. Cost–utility analysis was performed using the NHS and Social Care perspective.

A total of 49 patients were included; 35 were treated within 48 hours, ‘early’ (median (IQR) 8.25 [3.7–20.5]) and 14 were treated after 48 hours ‘delayed’ (median (IQR) 93.9 [66.7–100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared with 4 (29%) in the delayed group. According to GOS, 10 (29%) had a good recovery in the early treatment group, but only 1 (7%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p

This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment.

Salvage prostatic bed radiotherapy (PBRT) is a standard in case of biochemical recurrence following radical prostatectomy (RP) for prostate cancer (PC). The management of isolated prostatic bed recurrence following RP and PBRT is debated. Reirradiation within stereotactic body radiotherapy (SBRT) guided by metabolic imaging could be a relevant option in this case. In parallel, metformin, an economically viable and well-tolerated oral antidiabetic agent, has demonstrated its radiosensitising properties. This phase I/II clinical trial aims to (i) determine the optimal dose for SBRT reirradiation, (ii) conduct safety assessments and (iii) evaluate the efficacy of the metformin and SBRT combination.

We conducted a prospective, non-randomised, open-label, multicentre, dose escalation, phase I/II study involving a minimum of 44 patients. Eligible patients must have biochemical recurrence (Prostate Specific Antigen (PSA)>0.2 ng/mL and confirmed ascending trend in at least two successive assays), occurring at least 2 years after PBRT and prior RP for PC (including low, intermediate and high risk with a single risk factor) and no Common Terminology Criteria for Adverse Events (CTCAE) grade>=2 toxicity following PBRT. The recurrence should be visible on MRI and/or Positron Emission Tomography (PET) Choline and/or PET PSMA, without evidence of pelvic lymph node recurrence or metastatic disease. The primary objective of phase I is to determine the optimal SBRT dose (5x6, 6x6, or 5x5 Gy) based on dose-limiting toxicity (DLT). The dose will be chosen using a time-to-event continual reassessment method based on DLT, defined as CTCAE grade ≥3 gastrointestinal or genitourinary toxicity, or any other grade 4 adverse event. The primary outcome of the phase II is to estimate the efficacy of SBRT in combination with metformin in terms of biological relapse-free survival (bRFS) rate at 3 years. Secondary outcomes include 5-year bRFS rate, early/late genitourinary and gastrointestinal toxicities, quality of life, biochemical response rate, clinical progression-free survival and overall survival (OS).

Ethical approval has been obtained from the Ethics committee "SUD EST III Bron" Ref.CPP 2020-042B (20.05.07.72735) and the National Agency for the Safety of Medicines (ANSM) Ref. ANSM MEDAECNAT-2020-05-00009. The ethics approval obtained covers all the sites that will take part in this study. The study’s findings will be disseminated through publications and conference presentations.

NCT04536805, Registration Date: 2020-08-17

Ventral hernia repair is among the most commonly performed general surgical procedures, during which meshes are often used to provide further support to weakened or damaged tissue surrounding the hernia repair site. Slowly resorbable synthetic meshes have recently emerged as a valid choice, as confirmed by published clinical evidence on launched meshes in the repair of ventral hernias showing satisfactory results. This study was designed to assess the performance and safety of a newly developed slowly fully resorbable self-gripping synthetic mesh in patients undergoing ventral hernia repair through open surgery in clean and clean-contaminated fields.

This is a prospective, multicentre, single-arm study that will be conducted in up to 20 European and US sites with a total of 163 patients undergoing midline primary or incisional ventral hernia repair in clean or clean-contaminated surgical fields using an open surgical approach and implanted with Transorb self-gripping resorbable mesh in retrorectus placement with or without transversus abdominis release. The study will include patients ≥18 years old, presenting at least one risk factor impairing wound healing. The primary endpoint will be hernia recurrence rate within 12 months, postoperatively evaluated by physical exam; secondary endpoints will include hernia recurrence rate within 1 month, 6 months, 24 months, 36 months, 48 months and 60 months postoperatively, hernia recurrence rate resulting in reoperation, hernia recurrence rate reported by patients, time to hernia recurrence, rate of surgical site occurrence (SSO), rate of SSO requiring procedural interventions, surgeon satisfaction and change in patient-reported pain and quality of life. The study will be considered successful if the upper limit of the 95% Bayesian credible interval for the primary endpoint is less than 14.2%. Descriptive statistics will be used to summarise secondary study endpoints unless otherwise noted.

The multicentre, single-arm, prospective study of Transorb self-gripping resorbable mesh in subjects undergoing open repair of ventral hernia study will be conducted in compliance with the Good Clinical Practice standards, ISO 14155:2020 and the Declaration of Helsinki. The publication plan includes dissemination of the 12-month, 24-month, 36-month, 48-month and 60 month study results.

The RECOVER study has been registered at clinicaltrials.gov (NCT06449378).

Social accountability is a key value and aspirational goal of many medical institutions. While much has been studied on social accountability in the context of medical education and institutions, less research has examined how social accountability influences research. In light of this absence, the objective of our scoping review is to research the following questions: (1) What characterises socially accountable research (SAR), and how is it expressed and experienced? (2) How do language, positionality, and worldview influence SAR?, and (3) What structures and considerations are necessary to support successful SAR in local and global contexts?

To answer the above research questions, the Arksey and O’Malley, Levac et al, Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Joanna Briggs Institute (JBI) guidelines will be followed. The search strategy was adapted and applied to MEDLINE, Embase, ERIC, and CINAHL databases. A total of n=5289 eligible articles were identified. Articles were excluded if they were published before 1995, were in a language other than English, or were duplicates, leaving n=2840 articles for title/abstract screening.

Ethical approval is not required to complete this study. We will take an integrated knowledge translation approach. Throughout the project, results will be disseminated to knowledge users (ie, consultations, following Arksey and O’Malley). Our findings will be presented to the larger academic community, policymakers, and healthcare practitioners through presentations, reports, newsletters, and an online repository.

Open Science Framework 16 July 2024. osf.io/mvhnu.

There are no clearly defined family profiles with an overall view of the predictors of early childhood caries (ECCs). The aim of our study was to identify the profiles of families that are particularly affected by ECCs. We also examined the factors that can be acted on to promote oral health.

In this single-centre cross-sectional study, the researchers examined the mouths of 300 children with caries and recorded the Decayed, Missing and Filled Teeth Index (dmft). These observations were supplemented by a questionnaire completed by the families, focusing in particular on their sociodemographic characteristics (e.g. age, parents’ professions and jobs, social assistance and family composition).

This work was conducted at Lille University Hospital between 2019 and 2024.

The participants included 300 caregiver-child dyads with children under the age of 6 years.

Childhood Caries Index (dmft) and family characteristics associated with ECCs.

A multiple correspondence analysis was used, followed by a hierarchical clustering on principal components analysis, to identify the family profiles associated with ECC risk.

Of the patients included in the study, 42% were girls, 58% were boys and their mean age was 4 years (±1.1 years). The mean dfmt index was 8.7 (±4.6); 77% of the participants had lesions on the smooth surfaces of the teeth, and 80% of the participants had a severe stage of caries disease. The analysis revealed three high-risk profiles based on the characteristics of the child’s mother and the family sibling composition. The first profile was larger families where the focal child was not the eldest. The second profile was families with foreign-born mothers and a low socioeconomic level. The third profile was families with mothers facing geographical and financial difficulties in accessing healthcare.

This study enabled us to identify the profiles of families at risk of caries. These at-risk profiles highlight the need to implement specific interventions acting at different levels and focused on oral health education in interprofessional practice during the key period of the first 1000 days of life. These factors could help to bridge the gap between oral health and general health, improve children’s oral health and reduce social health inequalities.

This human study has been ethically approved by the French Committee for the Protection of Individuals (N° 2019-A00827-50).

The protocol is recorded on clinicaltrials.gov, with ID: NCT04195607.

Breast cancer is the most commonly diagnosed cancer among women worldwide. Survivors often experience physical and psychological effects arising from breast cancer and its treatment, which can last months and years, adversely impacting quality of life. As the number of early breast cancer survivors increases, models of specialist-led follow-up care in hospital settings are not sustainable and evidence suggests that they may not meet survivors’ needs. Nurse-enabled, shared-care, follow-up models between cancer specialist and primary care teams have potential to address this need.

The proposed research is a multicentre, prospective, pragmatic, stepped-wedge cluster-randomised trial designed to test the effectiveness and implementation of IBIS-Survivorship, a follow-up care model for patients with early breast cancer who have completed primary treatment. The IBIS-Survivorship intervention involves a nurse-led consultation, development of a Survivorship Care Plan and case-conferencing between a breast care nurse and the patient’s primary care provider. This study seeks to recruit 1079 breast cancer survivors across six cancer centres (clusters) in Australia. Health-related quality of life at 12 months assessed by the Functional Assessment of Cancer Therapy - Breast Cancer questionnaire will be the primary endpoint, along with a range of patient-reported outcomes, safety indicators and cost-effectiveness measures as secondary endpoints. General and generalised linear mixed models will be used to assess the effectiveness of the intervention versus usual care. Implementation and process outcomes will be assessed using the Reach Effectiveness Adoption Implementation Maintenance framework.

Ethical approval was provided by the Metro South Hospital and Health Service Human Research Ethics Committee (HREC/2020/QMS/59892) and reciprocally across the other five trial sites under National Mutual Acceptance arrangements. Results will be disseminated through peer-reviewed academic journal publications and presentations at national and international conferences.

Australia and New Zealand Clinical Trials Registry (ANZCTR) Trial ID: ACTRN12621000188831.

Maternal preconception obesity and adverse gestational metabolic health increase the risk of childhood obesity in offspring, but the preconception period may be an opportune time to intervene, given the motivation of the mother and the epigenetic changes that may be beneficial for the gametes during this period. However, there is a lack of studies evaluating children born to women who have had a preconception intervention. Our group has therefore designed an ancillary study to assess children born to women enrolled in the obesity-fertility randomised controlled trial (RCT), who were 6–12 years of age, with the objective of evaluating the effect of a lifestyle intervention delivered during preconception and pregnancy on adiposity and cardiometabolic parameters in the offspring. This manuscript details the study protocol.

This is an ancillary nested cohort study of the obesity-fertility RCT. Women with obesity and infertility were recruited at an academic fertility clinic and randomised to the control group, which followed usual care, or to the intervention group, which received a lifestyle intervention alone for the first 6 months and then in combination with fertility treatments for up to 18 months or until the end of pregnancy. Those who have given birth to a single child are invited to participate in this follow-up study with their child aged 6–12 years. This study started in November 2023 and is expected to end in May 2025. The primary outcome is age-adjusted and sex-adjusted body mass index z-scores in children. Secondary outcomes are anthropometry, body composition, lifestyle, physical fitness level and blood or saliva markers of cardiometabolic health in both mothers and children. Of the 130 women who participated in the obesity-fertility RCT, 52 mother-child dyads (24 in the control group; 28 in the intervention group) were potentially eligible for this follow-up study. Comparisons between groups will be performed using unpaired tests and adjusted for potential confounders using multivariable regression models. This study will provide important new data on the impact of a preconception lifestyle intervention, maintained throughout pregnancy, on the health trajectory of children and mothers 6–12 years after delivery.

The study has been approved by the institutional research ethics review boards of the Centre intégré universitaire de santé et de services sociaux de l’Estrie – Centre hospitalier universitaire de Sherbrooke. The results will be widely disseminated to the scientific community, relevant health professionals and general public.

ClinicalTrials.gov (NCT06402825).