An alarmingly low number of children meet public health guidelines for physical activity and dietary behaviours and, therefore, are at increased risk of developing lifestyle-related diseases. This paper describes the protocol of the B-Challenged project, which aims to co-create systemic actions to promote active outdoor play and healthy dietary behaviours before, during or after their outdoor play together with children themselves.

In five European countries, child-centred Participatory Action Research (PAR)—combined with systems dynamics methods—was conducted with 15–20 child co-researchers (aged 9–12 years) and 15–20 adult actors (eg, youth workers, local policy makers). In the first phase, the main drivers of children’s active outdoor play and related dietary behaviours were mapped by (1) analysing existing cohort data, and (2) conducting child-centred PAR. In the second phase, systemic actions targeting the local physical and social environments will be co-created and implemented by child co-researchers and adult actors to promote children’s active outdoor play and related healthy dietary behaviours. A mixed-methods design will be used to evaluate (1) if actions positively contributed to systems change and 6- to 12-year-olds’ outdoor play and related dietary behaviours (140 children per country); (2) the process of conducting multi-actor, child-centred PAR and implementing the co-created actions and (3) if the child-centred PAR positively contributed to child co-researchers’ feelings of empowerment.

Ethics approval for the mapping phase was obtained and approval for implementation and evaluation will be obtained from the five local research institutions. Participating children, one of their parents/caregivers and adult actors had given informed consent before participating in the project. Throughout the project, child-friendly methods, materials and language will be applied, and ethical challenges and potential solutions will be discussed. Project results will be disseminated locally and internationally through various channels and activities among the scientific community, professionals—for example, in health and policy making, children and other citizens.

NCT07136376.

To estimate the population-level incidence of emergency department (ED) visits for violent behaviour, identify associated factors and quantify the contribution of people presenting to ED for violent behaviour on the total number of ED visits for mental health problems.

Retrospective cohort study.

Regional healthcare authority serving a population of 1.2 million in Romagna, Italy, January 2022 to December 2023.

871 119 residents (70% of the regional population; 55.6% female) alive on 1 January 2022 with data on comorbidities. Participants were followed until 31 December 2023 with censoring at death.

Primary outcome: incidence of ED visits for violent/homicidal. Factors associated with violent ED visits were examined. Secondary outcome: quantification of the contribution of people presenting to ED for violent behaviour on the total number of ED visits for any mental health problem.

286 individuals (76.9% male) had 573 ED visits for violent behaviour, representing 4.2% of all psychiatric ED visits with an annual incidence rate of 3.48 per 10 000 person-years (95% CI 3.21 to 3.78). Male sex was associated with violent behaviour (OR 3.85, 95% CI 2.60 to 5.70; OR 4.64, 95% CI 3.12 to 6.92 among mental health service users). High comorbidity and prior mental health service use increased the risk. Having an ED visit for violent behaviour was associated with higher odds (OR 10.9, 95% CI 8.02 to 14.96) and higher incidence rate (incidence rate ratio 1.51, 95% CI 1.35 to 1.69) of psychiatric ED visits for other mental health problems.

ED visits for violent behaviour occur at relatively low population rates but predominantly affect high-risk groups: males with prior mental health service contact and either minimal or very high comorbidity. These findings supported the need for tailored interventions that address both the immediate risk of violence and underlying mental health issues, especially for high-risk groups.

To explore the barriers and facilitators in adherence to the guidelines in the management of benign paroxysmal positional vertigo from the perspective of primary care physicians.

Qualitative study using focus groups.

L’Hospitalet del Llobregat (Barcelona), Spain.

Qualitative study using focus groups. Structured 90 min focus groups were conducted until data saturation was reached. Each session included a moderator and an observer from the research team. Sessions were transcribed and thematically analysed by three independent researchers.

Purposeful sampling was used to form four groups of 4–10 participants, selected by sex, age, years of experience and primary care team (PCT). Participants were recruited between January and February 2023.

A total of 34 family physicians belonging to four PCTs participated in the study. The main barriers identified were a lack of time, negative initial experiences, a fear of harming patients (especially older adults), difficulty in nystagmus visualisation and challenges in managing patient expectations, as many preferred medication over physical manoeuvres. Facilitators included potential time savings from effective early management, the value of initial practical training with periodic refreshers, access to expert consultants for case discussions and the availability of digital tools, such as tutorials, videos and aids for nystagmus interpretation.

Health systems should invest in protected time for history-taking and physical examination, and in regular, updated training for primary care professionals. This could improve vertigo management and reduce unnecessary investigations and medications, ultimately benefiting both patients and the healthcare system.

The MD Anderson Oropharynx Cancer (MDA-OPC) cohort is a unique single-institution, prospective longitudinal cancer cohort. The cohort aims to enhance the therapeutic index of OPC management by supporting data needs for independent investigators to conduct rigorous observational studies examining exposures and factors associated with acute and late toxicities, cancer progression, recurrence, new malignancies and quality of life in OPC survivors.

A total of 1811 patients with OPC with a minimum follow-up of 6 months have been consented to our prospective registry between 18 March 2015 and 29 December 2023. Clinical and treatment (Tx) data are available on all patients, including previously untreated patients (1443, 80%). Most previously untreated patients (97%) consented to longitudinal patient-reported outcomes and functional assessments for critical time points including pre-Tx, during-Tx and post-Tx at 3–6 months, 12 months, 18–24 months and annually up to 5 years.

The median age for the MDA-OPC cohort is 66 years (range, 25–96) with the majority being male (89%), white (92%) and with human papillomavirus (HPV)/p16-associated OPC (88%) primarily located in the tongue base or tonsil (90%). For previously untreated patients, 79% were diagnosed with stage I/II disease, and nearly half underwent curative intent chemoradiation. Overall survival was significantly higher for HPV/p16-associated OPC at 1 year (98% vs 93%) and 5 years (83% vs 54%; p

Future work includes expansion of the MDA-OPC cohort and survivorship surveillance to 10 years under the recently funded OPC-SURVIVOR research programme (P01CA285249), which aims to identify non-invasive, clinic-ready biomarkers and examine novel phenotypes and mechanistically matched mitigation strategies for latent OPC sequelae. Additionally, we aim to expand our advanced data infrastructure by integrating large data streams from parallel clinical trials and imaging registries.

NCT01893307, NCT03145077.

A successful extubation process is critical for the future health outcomes of paediatric patients, as it tests the functioning of the respiratory system without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety or discomfort in patients, which may sometimes lead to an increased likelihood of reintubation. Music-based interventions and therapies have been shown to be effective in reducing anxiety and stress levels in ventilated patients in the paediatric intensive care unit (PICU), but studies evaluating the effect of music therapy during the extubation process in the PICU are scarce.

This is a pragmatic multicentre randomised clinical trial with two parallel arms. The intervention group will receive standard care + music therapy during the extubation process, and the control group will receive standard care alone. The main outcome measure is heart rate, which will be measured every minute for 5 min pre-extubation, during the extubation process and up to 10 min postextubation. Secondary outcome measures are: oxygen saturation, respiratory rate, blood pressure and heart rate variability. A total of 82 patients will be randomised.

This study was approved by the Research Ethics Committee of the Fundación Universitaria Sanitas (CEIFUS 1356-24, date of approval: 3 May 2024). All parents or legal guardians of patients will sign a written informed consent, and if applicable, assent from participants will be sought. The results will be disseminated through publications in peer-reviewed journals, conferences and presentations at the hospitals’ clinical committees.

Version 1.0, 18 December 2024.

NCT06591533, trial registration date: 10 September 2024.

Violence against women (VAW) is a public health, gender equality and human rights issue, with women with disabilities facing heightened risks due to intersecting discrimination. However, research on violence against people with disabilities often lacks sex-disaggregated data and primarily focuses on intimate partner violence, neglecting other perpetrators like family members or caregivers and leading to potential underestimation of its prevalence.

This protocol outlines the methods for a systematic review and meta-analysis to estimate the global prevalence of VAW with disabilities, focusing on intimate partner violence by intimate partners, domestic violence and sexual violence by any perpetrator. The review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and will include population-based quantitative studies focusing on women with disabilities aged 15 and older. 12 databases will be searched, and records will be screened by two independent reviewers. The risk of bias will be assessed. The global prevalence and pooled ORs comparing women with and without disabilities will be calculated.

Findings will contribute to global efforts in addressing VAW with disabilities, informing the development of targeted, evidence-based policies and programmes and ensuring that interventions are responsive to their specific needs and circumstances.

Ethics approval is not required, as this review analyses previously published data. Findings will inform ongoing World Health Organization (WHO)/Human Reproductive Programme (HRP) work on strengthening the measurement of VAW with disabilities and will be disseminated through a peer-reviewed publication, conference presentations and sharing with relevant organisations.

CRD42023427512.

Patient safety culture plays a crucial role in reducing clinical errors. By improving healthcare professionals’ and patients’ understanding of human fallibility and error attribution, patient care can be enhanced, fostering greater engagement from both groups. A Just Culture approach, which balances accountability and learning from errors, is a key factor in fostering this safety culture. The DECIDE Project aims to: (1) examine the conceptualisation of human fallibility within and beyond healthcare, (2) identify barriers and facilitators to Just Culture adoption, (3) assess the impact of psychoeducational interventions on professionals’ and social leaders’ attitudes toward clinical errors and (4) develop a roadmap for Just Culture implementation in healthcare.

A 36-month mixed-methods study including qualitative research, a survey of 1255 healthcare professionals, an experimental study with 180 participants (60 per arm) testing interventions based on cognitive dissonance and reasoned action theories and a consensus conference to develop a Just Culture roadmap. Participants include professionals from hospitals, primary care, long-term care, nursing homes and social leaders in Spain. The qualitative data collected during stages 1 and 4 will be analysed using MAXQDA software. In identifying factors related to the implementation of Just Culture during stage 2, ANOVA, t-tests and multiple linear regression will be conducted. To examine the effects of the interventions in phase 3, a linear mixed-effects model for repeated measures will be employed.

This study has received ethical approval from three institutional review boards. Findings will be disseminated through peer-reviewed publications, conference presentations and policy recommendations aimed at integrating Just Culture into national and international patient safety strategies. By promoting a constructive approach to errors, the project could enhance incident reporting, strengthen professional engagement in safety policies and foster a culture of learning and accountability. Its findings will guide policy recommendations for integrating Just Culture into national and international patient safety strategies, with potential applications beyond Spain.

NCT06835517.

Cytomegalovirus (CMV) infection is a common complication in patients undergoing haematopoietic stem cell transplantation (SCT). Letermovir (LTV) prophylaxis during the first 100 days post-SCT is effective and safe in preventing this infection, although it may be associated with a delay in CMV-specific immune reconstitution. Hence, a study is needed to evaluate whether the absence of CMV-specific immune reconstitution at the end of LTV prophylaxis is associated with the development of late infection. This could facilitate the individualisation of CMV prophylaxis duration in these patients.

INMUNOEND is a multicentre, prospective, observational, non-interventional study including CMV seropositive patients undergoing allo-SCT who receive LTV prophylaxis during the first 100 days post SCT. Immunological and virological monitoring will be conducted until day+200 post-SCT. The primary outcome is the percentage of patients who develop clinically significant CMV infection up to day+200 post-SCT after completing LTV prophylaxis. Data collected will include baseline characteristics of the haematological diseases and comorbidities, variables related to SCT (ie, engrafment, graft-versus-host disease, use of LTV and CMV replication) and variables related to CMV-specific immune reconstitution.

Ethical approval has been obtained from the institutional review board (Comité de Ética de la Investigación de Córdoba; SICEIA-2024–0 01 762). The results of this study will be published in peer-reviewed journals and disseminated at national and international conferences.

NCT06814301.

To evaluate the cost-effectiveness of anti-vascular endothelial growth factor (VEGF) treatments for neovascular age-related macular degeneration (nAMD) using a value-based model that considers drug durability, dosing regimens and real-world administration strategies, including safe vial fractionation.

Model-based pharmacoeconomic analysis using data from randomised clinical trials and network meta-analyses. Analysis conducted from the payer perspective using cost data from the Spanish National Health System.

A model-based analysis compared five anti-VEGF agents—innovator and biosimilar ranibizumab, aflibercept 2 mg, brolucizumab and faricimab—across three dosing regimens: fixed, Pro Re Nata and Treat-and-Extend (TAE). Administration formats included single-use vials, prefilled syringes and vial fractionation (VF), with or without dead-space-free (DSF) syringes to minimise waste. The primary outcome was cost per optimal responder, defined as a patient gaining ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, with and without adverse events. Cost-effectiveness was evaluated using Number Needed to Treat (NNT), Net Efficacy Adjusted for Risk-NNT (adjusted for safety) and incremental cost-effectiveness ratios. Secondary outcomes included the number of treated patients and optimal responders achievable within a fixed 1 000 000 budget.

The most cost-effective strategy was aflibercept 2 mg under a TAE regimen using DSF VF, with a total cost of 6214 per patient and a cost per optimal responder of 27 155. Under a fixed budget of 1 000 000, this approach allowed treatment of 160 patients, yielding 36 optimal responders. Faricimab with DSF VF ranked second, with a total cost of 5847 and a cost per optimal responder of 28 652, treating 171 patients and achieving 34 responders. In contrast, single-use vials without VF led to substantially higher total costs (eg, 11 305 for aflibercept TAE) and lower treatment capacity (eg, 88 patients treated).

This model demonstrates that combining durable agents, extended dosing intervals and optimised delivery strategies (eg, prefilled syringes and DSF VF) can substantially improve the cost-effectiveness and sustainability of anti-VEGF therapy in public health systems.

The combination with corticosteroids as immunomodulators has been the subject of debate in different infectious syndromes. The main objective of this study is to evaluate the efficacy (the percentage of patients hospitalised with influenza with a status of 3 or higher according to the Hospital Recovery Scale (HRS) on day 7 after the start of treatment) and safety of dexamethasone.

Investigator-initiated multicentre, blinded, randomised placebo-controlled trial with two parallel treatment arms. The study population will consist of adult patients (over 18 years of age) hospitalised with severe influenza. One arm will receive one capsule of 6 mg of dexamethasone for 7 days, and the other arm will receive one capsule of placebo for 7 days of antibiotic treatment for 7 days or longer. Both groups will receive oseltamivir (75 mg/12 hours orally) for 5 days, extendable to 10 days depending on the investigator decision. Randomisation will occur in equal proportion (1:1). Patients with bronchial hyper-responsiveness that requires systemic corticosteroids for more than 24 hours, preinclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methylprednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone), inability to administer oral oseltamivir, patients with severe comorbidity with a life expectancy of

The study is approved by the Institutional Review Board of Alicante Health Department—Dr. Balmis General University Hospital (LOC-100061146). The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal

NCT06528444.

To estimate the frequency of antidiabetic prescriptions in type 2 diabetes mellitus (T2DM) in Spain and describe changes in prescription patterns between 2018–2022 and 2023-2024.

Observational study.

Patients from primary care centres newly diagnosed with T2DM in 2018–2022 and 2023–2024.

In each period, the prescription frequency of an antidiabetic medication at the diagnosis of T2DM was calculated and subsequently subdivided into monotherapy and combination therapy. The prescription frequency of the most common antidiabetic drugs was also calculated. Calculations were made for the entire group of subjects and stratified by sex and age (under 60 years and 60 years or older). Comparison of the frequencies between the two periods was performed using the chi-square test.

In 2018–2022 and 2023–2024, 78.4% and 88.9% of patients, respectively, were prescribed an antidiabetic medication. The prescription frequencies for monotherapy and combination therapy were 66.1% and 33.9% in the first period and 57.4% and 42.6% in the second. The prescription frequencies for metformin as monotherapy and combination therapy were 57.4% and 27.8% in the first period and 46.6% and 39.8% in the second. Prescribing metformin with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide receptor 1 agonists (GLP1a) was the most frequent combination therapy: 12.8% in 2018–2022 and 29.5% in 2023–2024. With a few exceptions, the prescribing pattern was similar by sex and age. The difference between the prescribing distributions in the two periods is significant.

Antidiabetic medication prescribing at the diagnosis of T2DM was high. Most prescriptions contained metformin. Monotherapy decreased in 2023–2024 compared with 2018–2022, while combination therapy increased due to increased prescriptions of metformin with SGLT2i and/or GLP1a.