Outcome reporting in studies on sacrococcygeal teratoma (SCT) is highly heterogeneous, which limits comparability across studies and thus hampers the development of international treatment guidelines.

Variation in treatment and access to facilities contributes to differences in outcome reporting between centres and countries. Establishing a Core Outcome Set (COS) can improve consistency in outcome reporting and facilitate global collaboration and data comparison. We therefore aim to develop a Core Outcome Set for SCT (COS-SCT) using the Delphi method to achieve consensus on key outcomes. This will enhance the standardisation of outcome reporting and improve the quality of research and clinical care for SCT patients globally.

The development of the COS-SCT will consist of three phases. First, a systematic review will be performed to identify outcomes reported in studies on the surgical treatment of SCT in children. Second, an international Delphi survey will be conducted among key stakeholders, including clinicians, researchers and patient representatives, to establish consensus on outcome prioritisation. Finally, a consensus meeting with representatives from all stakeholder groups will be held to ratify the final Core Outcome Set. The study will follow methodological guidance from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and will be developed and reported in accordance with the Core Outcome Set Standards for Development (COS-STAD) and Core Outcome Set Standards for Reporting (COS-STAR).

The medical research ethics committee of the Amsterdam University Medical Centre (Amsterdam UMC) confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study, and therefore a full review by the ethics committee is not required. This study is registered in the COMET initiative database. Results will be disseminated in peer-reviewed academic journals and conference presentations.

Trial registration number: COMET registration number 3485

Published clinical trials offer valuable insights into the clinical research landscape in Portuguese-speaking African countries (PSAC)—Angola, Cabo Verde, Guinea-Bissau, São Tomé and Príncipe and Mozambique. The objective of this comprehensive scoping review is to systematically map and analyse randomised clinical trials (RCTs) evaluating pharmacological interventions conducted in PSAC from 1995 to 2024, in order to identify research trends, targeted diseases, geographic distribution and evidence gaps to better understand the development and evolution of clinical trials in the region. This is the first comprehensive scoping review to examine the clinical trials landscape in PSAC.

This scoping review adheres to the Joanna Briggs Institute methodology for scoping reviews, which builds on the Arksey and O’Malley methodological framework (refined by Levac et al) and will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. A dual-search strategy will be used, consulting 4 electronic databases (MEDLINE, EMBASE, African Index Medicus, Cochrane Central Register of Clinical Trials) and 3 clinical trials registries platforms (Clinicaltrials.gov, International Clinical Trials Registry Platform, Pan African Clinical Trials Registry). Eligible studies will include RCTs conducted in at least one of the PSAC. Extracted data will include trial characteristics, targeted diseases, phases and designs, funding and ethical compliance. Risk of bias (RoB) will be assessed using the Cochrane RoB tool V.2.0 to evaluate the quality of the evidence included in the scoping review. Conclusions will be drawn upon the comparison between countries and their scope of clinical research, together with comparison with countries from other geographies, considering disease profiles.

Ethical approval is not required. Results will be disseminated through a peer-reviewed publication, conference presentation and in plain language in social media, both in Portuguese and in English.

This protocol is registered in the Open Science Framework https://osf.io/5nhc9.

To qualitatively explore patients’ lived experiences and coping mechanisms following mitral valve replacement (MVR) at the National Cardiac Institute in Tanzania.

A descriptive qualitative study using in-depth interviews and thematic analysis.

The study was conducted at the National Cardiac Institute, located in Dar es Salaam, the sole tertiary cardiac centre in Tanzania offering open-heart surgery.

17 participants were purposively sampled. Inclusion criteria were as follows: patients aged ≥18 years, had at least 28 days post-MVR, without chronic conditions (eg, diabetes and HIV) and attending postoperative cardiac clinics.

Semi-structured interviews conducted in May 2024 using an interviewer guide explored post-MVR challenges, daily life adjustments, patient-provider interactions and coping strategies. Thematic analysis was employed to identify key themes.

Three primary themes emerged: (1) Quality of life after MVR, encompassing physical, social, economic and psychological challenges; (2) Quality of care after MVR, highlighting patient-provider interactions and access to services; and (3) Adapting to post-MVR life, including psychological adaptation and lifestyle modification. Participants reported improved quality of life through shared experiences and support.

Patients experienced physical, socio-economic and psychological challenges post-MVR. However, quality of life improved through access to care, peer support and adaptive coping. Adaptation to life with an artificial valve is feasible with robust support systems, even in resource-limited settings.

Values and preferences are key determinants of optimal care, and variability in patient values and preferences often dictates differences in patient management. Clinicians’ views of patients’ values and preferences may differ across cultural aspects and stage of training, but the extent to which this is the case remains uncertain. One key value and preference issue is the trade-off between quantity and quality of life, and this issue is particularly prominent among patients with dementia. We therefore propose to investigate the extent to which physicians’ perceptions of optimal management for patients living with advanced dementia may differ due to cross-cultural factors and stage of medical training.

We will conduct a sequential explanatory mixed-methods study (QUAN -> qual). First, we will administer paper-based or electronic surveys during educational sessions, conferences and rounds to medical students, residents and physicians in ten countries, either in person or online. Following that, a qualitative inquiry, guided by the findings of the quantitative study and the principles of the interpretive description design, will inform an in-depth exploration of the predictive factors identified in the quantitative data analysis.

The Hamilton Integrated Research Ethics Board at McMaster University has approved this study (approval number 2024-17651). We will disseminate our findings in peer-reviewed publications and present results at conferences as oral and poster presentations.

Crohn’s disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract distinguished by progressive bowel damage with a risk of structuring and penetrating complications. It is characterised by focal or segmental transmural inflammation that disrupts intestinal mucosal integrity and favours the development of abscesses and fistulas. Perianal fistula develops in 13%–39% of patients with CD. Their care is difficult but improves with medical and surgical treatment to preserve anal continence and avoid a maximum proctectomy. Combined treatment with seton placement and concomitant anti-TNF (infliximab, adalimumab) allows wound healing in 40%–70% of cases. The currently available treatments are not curative and fail to provide a long-term resolution. The injection of adipose stromal cells is currently being evaluated in clinical studies for repair-damaged tissues in various diseases (limb ischaemia, osteoarthritis, systemic sclerosis, etc). Immunoregulatory and anti-inflammatory properties of AdMSC (adipose-derived stroma/stem cells) are responsible for accelerating healing and represent an innovative approach for treating perianal fistulas associated with CD.

This phase I/IIa study is designed to assess the treatment of complex perianal fistulas linked with CD after failure of conventional treatment by injection of AdMSC (CellReady) into the fistula. Two doses of associated AdMSC will be tested for a dose escalation (5x10⁷ and 10x10⁷ cells) and injected into the wall of the fistula. Those eligible for inclusion include patients with controlled luminal CD characterised by a Harvey-Bradshaw score below or equal to eight and diagnosed on clinical, endoscopic, histological and/or radiological criteria, a colonoscopy dating back less than 1 year without ulcer in the rectum and presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports. All patients must have social security insurance or equivalent social protection. The aim of this study is to determine the optimal dose corresponding to maximum efficacy 6 months after injection of cells with a treatment-related adverse event rate of 20%.

The EU CT number 2024-511821-75-00 was approved by the following Ethics Committee: CPP (committee for the protection of persons in French: comité de protection des personnes) Ouest 1 – Tours #2024UEMED-18 and ANSM (French Agency for the Safety of Health and Medicinal Products in French : Agence nationale de sécurité du médicament et des produits de santé) #2024-511821-75-00 (Sponsor number RC31/13/7030, protocol V2.1). The results will be disseminated through conventional scientific channels.

NCT06636032.

The results will be disseminated through conventional scientific channels.

To explore public perceptions of COVID-19 vaccine acceptance and hesitancy in India, and to identify underlying factors influencing attitudes toward vaccination during the second wave of the pandemic.

A cross-sectional qualitative study based on a grounded theory approach.

Community-based interviews conducted in Mumbai, a densely populated metropolitan city in India, during the second COVID-19 wave (April–June 2021).

Twenty purposively selected adults (men and women aged 22–87 years) from varied educational and occupational backgrounds. Inclusion criteria were willingness to participate and the ability to provide informed consent; individuals directly involved in COVID-19 vaccine policy or administration were excluded.

In-depth semi-structured interviews were conducted using an interview guide exploring perceptions of COVID-19 vaccination. Interviews were audio-recorded, transcribed verbatim and analysed inductively following grounded theory principles. Reflexivity was maintained throughout data collection and analysis.

Key emergent themes relating to vaccine acceptance, hesitancy and influencing factors such as safety concerns, efficacy perceptions, media influence and social determinants of vaccine choice.

Attitudes toward vaccination ranged from strong acceptance to hesitancy driven by concerns about safety, side effects and the speed of vaccine development. Media coverage, peer and healthcare professional opinions, and personal experiences shaped the decision of the participants. Cost considerations and lack of vaccine choice influenced uptake. Many participants favoured vaccination being voluntary rather than mandatory for the general population.

Trust in authorities, transparent risk communication and culturally sensitive engagement are critical to improving vaccine confidence. Public health strategies should address safety concerns, ensure equitable access and promote consistent messaging to enhance vaccine acceptance in current and future pandemic contexts.

Declined donor organs and explanted recipient organs may hold considerable value for biomedical research, particularly in advancing knowledge of disease mechanisms and supporting drug development. However, public perceptions of such use, and preferences for how consent should be obtained, remain underexplored.

Four workshops were held across the UK to examine the views of organ donor families and transplant recipients regarding the use of human organs in research, with a focus on myocardial regeneration. Each workshop included three brief presentations on transplantation and cardiac regeneration, followed by facilitated small-group discussions. Observational notes were taken to capture participants’ perspectives on the use of organs unsuitable for transplantation. A follow-up survey generated both quantitative and qualitative data, the latter analysed using thematic analysis.

Participants expressed strong support for the use of declined donor and explanted recipient organs in research. Transplant recipients frequently cited a desire to give back to the National Health Service (NHS), while donor families viewed research use as a meaningful way to honour their loved ones when transplantation was not possible.

This exploratory study highlights widespread support for using non-transplantable organs in research among individuals with personal experience of transplantation. The findings suggest a need for further research into how best to support and inform potential donors and families. Participants emphasised the importance of sensitive communication, clear consent processes and transparency regarding the use of donated organs.

We explored how key sociodemographic characteristics were associated with correct knowledge about antibiotics and antibiotic resistance (ABR) and appropriate usage of antibiotics from a One Health perspective among rural community members in Bangladesh.

Cross-sectional single-period survey.

Rural villages in Cumilla district, Bangladesh.

Eligibility criteria: aged ≥18. Across 50 clusters of villages, we approached 2160 community members and 2187 (98.8%) agreed to participate.

Primary outcomes: we collected two knowledge outcomes measuring the number of correctly answered binary/multiple-choice questions about (1) antibiotics and ABR and appropriate usage of antibiotics in relation to human illness and (2) antibiotics and ABR and appropriate usage of antibiotics in relation to animal health and the environment. Secondary outcomes: self-reported awareness of (1) antibiotics and (2) ABR.

Several sociodemographic characteristics were associated with variation in both knowledge outcomes. Education showed the strongest associations, with higher education levels associated with higher knowledge scores. For example, compared with having no formal/incomplete primary education, having higher education was associated with 10 percentage points (95% CI 8 to 12) and 6 percentage points (95% CI 3 to 8) higher mean knowledge scores for the knowledge outcomes 1 and 2, respectively. Having worked in the last month compared with not having worked was also weakly positively associated with both knowledge outcomes, and being female compared with being male was also weakly negatively associated with both knowledge outcomes.

Better public education is required to tackle ABR in Bangladesh but correct knowledge about antibiotics and ABR and appropriate usage of antibiotics in relation to humans, animals and the environment varies in relation to individuals’ education level, sex and working status. To maximise their effectiveness, interventions to tackle ABR must be flexible given recipients’ sociodemographic characteristics and pre-existing knowledge levels.

A healthy diet is a crucial component for adolescents’ health and wellbeing. Current literature surrounding dietary intake and its effect on cognition, mental health and wellbeing has mainly focused on children, not adolescents. This review aims to synthesise findings from studies that explore the relationship between dietary intake and cognition, mental health and wellbeing in the adolescent population.

Electronic searches will date from 1 January 2000 to 7 October 2024 and will be conducted in CENTRAL, MEDLINE/PubMed, CINAHL via EBSCOHOST, ERIC, British Education Index, Child and Adolescent Studies, Education research complete, Psychology and Behavioural Sciences Collection, Social Policy and Practice Embase, and APAPsychINFO via OvidSP. Articles will be screened using defined inclusion and exclusion criteria and assessed for eligibility by five independent reviewers. Discrepancies will be reviewed by a third reviewer. The selection process of included articles will be reported by using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. A narrative summary will be used to report and synopsise the extracted data.

This systematic review does not require ethical approval. The dissemination strategy for this review comprises peer-reviewed publications, public health conference presentations and providing a valuable reference for healthy-food interventions in school and community-based settings as well as identifying gaps in the current literature and informing policy and practice.

CRD42025633083.

Cisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect.

The SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m². Each subject will receive transtympanic STS injections in one ear, chosen by randomisation, before each cisplatin infusion. The contralateral ear serves as an internal control. The primary objective is efficacy (ie, clinically relevant benefit) of transtympanic STS injections against CIHL, defined as a difference in threshold shift of ≥10 decibels between baseline and 3 months after treatment in favour of the STS-treated ear. Secondary objectives include the difference in mean threshold shifts on frequencies essential for speech and extended high frequencies, as well as the difference between both ears in the gradation of hearing loss as defined by ototoxicity grading scales.

The medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals.

CTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.

Heart failure (HF), chronic kidney disease (CKD) and atherosclerotic cardiovascular disease (ASCVD) are highly prevalent conditions that often coexist. Using electronic health records (EHRs), we evaluated the 1-year risk of all-cause death, major cardiovascular and kidney events in patients with HF, CKD, ASCVD and with combinations of these conditions, compared with an unselected control population aged ≥75 years.

Retrospective cohort study based on EHR data.

Integrated primary and secondary health unit located in the North of Portugal. Eligible adult patients were identified using EHRs from 2008 to June 2022.

Eight cohorts were defined: (1) control: patients with ≥75 years; (2) ASCVD alone; (3) HF alone; (4) CKD alone; (5) cardiorenal syndrome (CRS): combined HF+CKD; (6) atherosclerotic HF: combined ASCVD+HF without CKD; (7) atherosclerotic CKD: combined ASCVD+CKD without HF and (8) combined ASCVD+CRS. The risk of these conditions was compared with controls using propensity score age-sex matching. We identified 19 129 patients with ASCVD alone, 13 640 patients with HF alone, 40 545 with CKD alone and 10 499 with CRS. The control group comprised 36 532 patients aged 75 years or older.

The primary outcome was all-cause mortality. The main secondary outcomes were cardiovascular death, HF hospitalisations and end-stage renal disease.

The 1-year mortality rate was 0.65% in the control cohort, 5.6% for patients with ASCVD alone, 6.05% for patients with HF alone and 3.53% for patients with CKD alone. Adjusted risk of all-cause death was significantly increased in the ASCVD-alone (HR: 8.42, 95% CI 7.12 to 9.95), HF-alone (HR: 9.19, 95% CI 7.75 to 10.9) and CKD-alone (HR: 5.35, 95% CI 4.62 to 6.19) cohorts, compared with control population; however, patients with the combination of all three conditions (ie, ASCVD+CRS) had the highest mortality risk (HR: 14.18, 95% CI 11.62 to 17.3). A similar association pattern was observed for cardiovascular death, HF events and end-stage renal disease.

Our results support the concept of an atherosclerotic cardiorenal phenotype, with a very high risk of mortality, cardiovascular and renal adverse events. Implementation strategies are required to target these conditions simultaneously.

Glioblastoma multiforme (GBM) is an aggressive primary brain tumour associated with a poor prognosis despite standard-of-care treatment, including surgical resection, radiotherapy and temozolomide (TMZ) chemotherapy. Certepetide (also known as LSTA1, CEND-1) is an investigational tumour-penetrating peptide that facilitates the extravascular delivery and intratumoural penetration of co-administered immune/chemotherapeutics; however, it has not yet been evaluated in clinical trials for the treatment of intracranial malignancies.

LSTA1-GBM-2A is an exploratory phase 2a, double-blind, placebo-controlled, randomised, proof-of-concept investigator-initiated trial assessing the safety, tolerability and preliminary efficacy of certepetide in combination with standard-of-care TMZ, compared with TMZ with a matching placebo, in subjects with newly diagnosed GBM.

The trial is funded by Lisata Therapeutics, sponsored by Tartu University Hospital and conducted at hospitals in Estonia and Latvia. Subjects are randomised in a 2:1 ratio. Following initial surgery and radiotherapy with concurrent TMZ, the subjects receive intravenous certepetide or placebo alongside six cycles of adjuvant TMZ treatment. The primary endpoint is overall survival. The target number of subjects is 30. The first subject was recruited in January 2024, and accrual is ongoing.

This study was approved by the Republic of Estonia State Agency of Medicines (17 October 2023) and the State Agency of Medicines of the Republic of Latvia (1 February 2024). The results of this study will be published in peer-reviewed journals and reported at academic conferences.

2023-506813-23-00.

Early childhood—specifically, the period from 0 to 6 years of age—is a critical time in children’s lives with rapid growth in their cognitive, social and emotional development. This period has also been shown to be the most effective time for early interventions. The use of artificial Intelligence (AI) for supporting early child development is increasing alongside the rapid advancement of technology. AI can be used directly by children (eg, for implementing adaptive technologies), by individuals who interact with children (eg, educators, parents, nurses), and by individuals indirectly supporting early child development (eg, early childhood researchers or policy analysts). This scoping review will provide a roadmap for relevant stakeholders on how AI has been applied within and across different contexts to support infants and young children’s development, as well as the most predominant AI technologies used across various contexts.

The current study follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Review The search syntax will be applied in PsycINFO, ERIC, Education Source, CINHAL, MEDLINE, Embase and IEEE Xplore. The purpose of this study is to curate and synthesise academic papers to examine the application of AI for supporting the development of children between birth and age 6 years of age. Studies with children or individuals who work directly or indirectly with children will be included. Part of the abstract and full-text screening will be conducted by two researchers, with discrepancies being resolved by the lead authors. In addition, AI will be used to help with study screening and data extraction once confirmed to be reliable (Cohen’s kappa >0.80). Thematic and content analyses will be conducted to identify the types of AI products used and their applications in different contexts, the most predominant AI products used within and across each context, as well as how children’s developmental outcomes are impacted by the use of these AI products. Where applicable, visualisations such as tables, graphs and figures will be used to synthesise the data across contexts and AI products used to support early development of young children.

This study aims to identify the key factors driving excessive alcohol and salt consumption in Ghana, both of which are modifiable risk factors for diseases such as cardiovascular conditions and cancers. Using the socio-ecological model (SEM), we qualitatively examine stakeholder perspectives to gain a comprehensive understanding of the influences contributing to these unhealthy consumption patterns.

A qualitative study was conducted using semi-structured interviews. Transcripts were analysed thematically, with identified drivers mapped onto the corresponding levels of influence within the SEM.

The study included 21 purposively sampled stakeholders from government and academic institutions in Ghana, including policymakers, practitioners and researchers.

Drivers of excessive salt and alcohol consumption were identified across all five levels of the SEM. At the intrapersonal level, disregard for health risks was a key factor. Community-level drivers included easy access to unhealthy foods and cultural norms promoting alcohol use at social events and salt in traditional dishes. At the societal and policy levels, inadequate regulation of the alcohol and food industries was found to reinforce lower-level drivers, further encouraging unhealthy consumption.

This study highlights the multilevel influences on alcohol and salt consumption, emphasising the interactions across SEM levels. It highlights that addressing unhealthy consumption is not solely a matter of personal responsibility, demonstrating that societal and policy factors play a significant role in shaping health and dietary behaviours. The findings underscore the need for comprehensive public health strategies that address influences at multiple levels to effectively reduce excessive alcohol and salt intake.

Providing care in a patient’s preferred language improves health outcomes and patient satisfaction. In Ontario, access to French-speaking physicians (FSPs) is estimated using FSP-to-Francophone population ratios and compared with total physician-to-total population ratios. This approach fails to consider the fact that FSPs also serve non-Francophone patients and that Francophones must compete with the entire population to access FSPs. As a result, this approach inaccurately suggests that Francophones have better access to language-concordant care than Anglophones/Allophones. We propose a novel approach to address this issue, enabling unbiased comparisons of access to language-concordant care across linguistic groups.

This secondary analysis of publicly available data containing linguistic variables for the Ontario population (Statistics Canada, 2021 Census) and for family physicians (FPs) (College of Physicians and Surgeons of Ontario, January 2024) calculated competition-adjusted ratios and probabilities of accessing language-concordant care.

Ontario, Canada.

Census and publicly available data on FPs (ie, those providing comprehensive family medicine care to the community) and the Ontario population were obtained.

Province-wide, the crude ratio of FSPs per 1000 Francophones was 3.46. After adjusting for competition, the ratio of FSP per 1000 population was 0.12, compared with a general physicians-per-1000 population ratio of 1.05. Anglophones/Allophones attached to a FP have a 100% probability of receiving care in English compared with an 11.4% probability for Francophones to receive care from a FSP. Expressed otherwise, Anglophones/Allophones are 8.8 times more likely to receive language-concordant care (ie, care in English) than Francophones.

Although crude physician-to-population ratios overestimate Francophones’ access to FSPs, competition-adjusted ratios and probabilities demonstrate that they are much less likely to access language-concordant care than Anglophones/Allophones. This novel approach has equity implications for health human resources planning and can be applied to other linguistic minority groups and healthcare providers.

The teaching profession plays a crucial role in society. From educating and forming future generations to fulfilling various administrative tasks and managing expectations and experiences that reach beyond the classroom—teachers face immense demands on their time, energy, and emotional resources. Consequently, they are subject to high work burden. This is reflected in the high prevalence of burnout, anxiety, and depression among teachers. A scoping review of factors associated with these outcomes in teachers is required to inform the further development of preventive occupational medicine strategies. In this scoping review, we aim to (i) identify and (ii) appraise the factors (eg, workplace, environmental, lifestyle, psychological) associated with burnout, anxiety, and depression specific to secondary school teachers and to (iii) synthesise the findings from the perspective of preventive occupational medicine.

The scoping review will be performed following the PRISMA extension for Scoping Reviews guidance. A systematic literature search will be conducted in the Medline, Web of Science Core Collection, PsychInfo, and Cochrane Library databases using search terms pertinent to secondary school teachers as the population of interest and depression, anxiety, and burnout as the outcomes of interest. Returned articles from the database search published pre-2017 will be excluded for the following reasons; namely, (a) that current literature will more closely reflect the current demands of the teachers, (b) the timing fits with recent systematic reviews highlighting burnout, anxiety, and depression as major problems among teachers, and (c) it facilitates feasibility of review in terms of the volume of studies. Remaining records will then be deduplicated and screened against predefined eligibility criteria that also add focus on teachers and these outcomes. Relevant data concerning factors associated with burnout, anxiety, and depression in teachers will be extracted and mapped. A narrative appraisal of included studies will be employed that will be specific to the validity of the results regarding factors (exposures, mediators, effect modifiers) that may affect the outcomes of interest (as opposed to more generic appraisal of the entirety of individual articles). Findings will be narratively synthesised from the perspective of preventive occupational medicine.

Formal ethical approval is not required as primary data will not be collected in this study. The findings of this study will be disseminated through peer-reviewed publication, conference presentation, and condensed summaries for key stakeholders and partners in the field (including teachers, schools, and governing bodies).

The protocol was registered on the Open Science Framework on 26.06.2025 and can be identified using the following link: https://doi.org/10.17605/OSF.IO/BKX56.

Hospital falls persist as a major threat to patient safety. This study aimed to develop an interprofessional reference standard to prevent, manage and report hospital falls.

A Delphi consensus methodology, informed by the Conducting and Reporting Delphi Studies guideline, was used to design the reference standard. An interprofessional expert panel (n=47) of health professionals, researchers, policymakers and consumers participated in three Delphi rounds. Following the review of clinical guidelines, an e-Delphi survey was developed and piloted to derive 60 initial items for the standard. Two iterative rounds of e-Delphi surveys were distributed via Research Electronic Data Capture and included free-text questions and 9-point Likert scales. An online consensus meeting followed, to ratify the final standard.

In the first Delphi round, there was over 80% agreement for 44/60 items to be included in the reference standard. This increased to 48/60 items in Round 2. At the final consensus meeting, 12 items still did not reach consensus for inclusion and one was added, yielding 49 items. Items that replicated text according to falls with injury/without injury were combined, resulting in 42 items in the final reference standard. Agreed items included: (1) brief screening of falls risk on hospital admission; (2) comprehensive falls assessment for inpatients who are older, frailer or have complex conditions; (3) single interventions (such as environmental adaptations and exercise); (4) multifactorial interventions; (5) education of patients, families and staff; (6) optimising local falls hospital policies, procedures and leadership capability; (7) optimising documentation and reporting; (8) improving accreditation processes; (9) workforce redesign to augment falls education. Items that did not reach agreement (n=12) pertained to alarms, bed rails, grip socks, artificial intelligence, volunteers and care bundles.

This new reference standard provides a checklist for staff, patients, managers and policymakers to reduce unwanted variations in prevention, management and reporting of hospital falls.

ANZCTR 386960

Suicide is a leading cause of preventable death worldwide. Evidence supports the impact of providing active contact for individuals who have attempted suicide. The current systematic review and meta-analyses aim to investigate the effects of suicide prevention strategies implemented through remote and synchronous technology-based interventions.

Systematic review, narrative synthesis and meta-analysis.

Electronic databases (PubMed, PsycINFO, Scopus and Web of Science) and grey literature sources (ClinicalTrials.gov and Google Scholar) were searched until December 2024.

Eligible articles assessed suicide prevention interventions for participants over 12 years with prior suicidal behaviour. Eligible study designs included randomised controlled trials and non-randomised clinical trials published in English or Spanish.

Screening, selection process, data extraction and risk of bias assessment were performed independently by two reviewers. Data on suicide-related factors and adherence to treatment were extracted. Meta-analyses were conducted to determine effect sizes (Hedges’ g) for suicidal ideation, risk ratios (RR) for suicide attempts and Peto odds ratios (OR) for suicide. Heterogeneity was assessed using the Cochrane’s Q test, tau² statistic and I² value. Publication bias was investigated employing funnel plots and Egger’s test.

A total of 28 studies, comprising 10 015 participants in the intervention group and 10 726 in the comparison group, were included in the systematic review and meta-analyses. Synchronous remote-based interventions were effective in preventing repeated suicide attempts at 1 month (RR 0.73, 95% CI 0.62 to 0.85, I²=0.0%, Q=0.70, tau²=0.00), 6 months (RR 0.56, 95% CI 0.34 to 0.95, I²=85.4%, Q=54.92, tau²=0.36) and 12 months (RR 0.68, 95% CI 0.49 to 0.96, I²=87.6%, Q=72.63, tau²=0.27). Additionally, these interventions were associated with a reduction in suicide-related deaths at 18 months (Peto OR 0.18, 95% CI 0.08 to 0.44, I²=0.0%, Q=0.03, tau²=0.00). Effects on suicidal ideation were not statistically significant at any time point (Hedges’ g –0.07 to –0.28, I²=0.0 to 69.3%, Q=1.16 to 7.38, tau²=0.00 to 0.14).

Synchronous remote-based interventions demonstrate a potential benefit in preventing suicide attempts and deaths by suicide and may serve as an adjunct to usual treatment; however, the effect on suicidal ideation appears limited. The observed heterogeneity warrants caution when interpreting these findings. Future research should prioritise methodological enhancements to improve the quality and consistency of evidence, as well as investigate the mediating processes underlying their effectiveness in reducing suicidal behaviour.

CRD42021275044.

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

A cross-sectional mixed methods online survey.

Primary care in England.

120 clinical pharmacists with experience in conducting SMRs in primary care.

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

The TRAjectory of knee heaLth in runners (TRAIL) study is a prospective cohort study investigating the long-term knee health trajectories of runners with and without a heightened osteoarthritis risk. This study aims to describe the recruitment results and baseline characteristics of the TRAIL cohort.

Runners aged 18–50 years and running ≥3 times and ≥10 km per week on average in the past 6 months were eligible. Participants were recruited via running podcasts, running clubs and social media between July 2020 and August 2023. Data were collected at study enrolment and at a face-to-face baseline testing session, which occurred a median of 33 weeks (IQR 18 to 86 weeks) after enrolment. Follow-up data collection is ongoing.

Out of 462 runners who completed an online registration form, 268 runners enrolled, of which 135 had a history of knee surgery (46% females) and 133 were non-surgical controls (50% females). 60% of the surgery group had undergone anterior cruciate ligament reconstruction, 33% meniscus and/or cartilage surgery, and 7% other knee surgery. 54 participants previously enrolled were unable to continue in the study before attending baseline data collection. Of the 214 runners who remained in the study and attended baseline data collection, 108 had a history of knee surgery (49% females) and 106 did not have a history of knee surgery (51% females).

Participants will be followed for 10 years through ongoing patient-reported outcomes and continuous monitoring of training loads using wearable devices. At baseline, 4- and 10-year follow-up, knee MRI and knee-health patient-reported outcomes will be collected to evaluate structural and symptomatic knee osteoarthritis progression. Data will inform guidelines for safe running practices and rehabilitation post-knee surgery.