Antimicrobial resistance (AMR) and plastic pollution are converging global crises that threaten both human health and environmental sustainability. Despite the growing recognition of these challenges, few legislative and policy frameworks acknowledge the complex interplay between antibiotic misuse and environmental plastic contamination. This protocol seeks to bridge that gap by critically examining policies in Europe and the Philippines, focusing on those that target antibiotic misuse and plastic pollution in human and animal health.

Document analysis will be employed to systematically review relevant legislative and policy frameworks. We will retrieve laws, regulations and policy documents from official databases, government websites and other sources using broad inclusion criteria. The extraction process and analysis will be guided by the READ (Ready, Extract, Analyse, Distill) approach which will ensure a thorough examination of how these documents address the dual challenges of AMR and plastic pollution. Particular attention will be paid to identifying policy gaps, overlaps and synergies that may affect the overall effectiveness and coherence of current governmental responses.

This policy review has been granted exemption from ethical review by the Research Institute for Tropical Medicine (RITM-IRB No. 2024-35), Philippines. The results are expected to provide a robust evidence base to inform the development of integrated policies at the nexus of global public health and environmental sustainability. Findings will be disseminated at academic conferences and peer-reviewed publications and to key stakeholders within European, Philippine, and international organisations.

The detailed protocol is pre-registered and openly available on the Open Science Framework (https://osf.io/3tkn2/overview).

Malnutrition is a highly prevalent chronic condition that contributes to higher morbidity and mortality in patients with multiple comorbidities. While positive effects of nutritional therapy in the in-hospital setting have recently been demonstrated, the benefits of long-term nutritional therapy after hospital discharge remain uncertain. Herein, we outline the design and rationale of the EFFORTII trial, the largest nutritional trial to date to assess the effects of continued nutritional support after hospital discharge in medical patients, with particular attention to key design decisions regarding nutritional strategy, patient selection criteria and study endpoints.

The Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery (EFFORTII) is an investigator-initiated, non-commercial randomised controlled trial designed to evaluate whether ongoing, individualised nutritional therapy after hospital discharge—targeted to meet specific energy and protein requirements—offers a cost-effective approach to lowering mortality, minimising complications and maintaining functional status compared with standard care. Eligible participants are adult, chronically ill medical inpatients at risk of malnutrition. Patients in the intervention group receive individualised nutritional therapy delivered by an experienced dietitian through a combination of telemedicine and in-person consultations. The intervention aims to meet personalised nutritional targets, supported by a trained dietitian. Control group patients receive nutritional counselling at discharge, but no structured nutritional management during follow-up. We designed the trial as an event-driven trial with a target of 247 mortality events (primary endpoint), which will be assessed over approximately 5 years until event-driven endpoint is met. The minimum total sample size is at least 802 participants, based on the assumed treatment HR of 0.70. The main trial is enrolling patients across multiple sites in Switzerland. During the trial, additional sites in Spain joined the study, and their data will be analysed using a patient-level pooled approach.

This study involves human participants and was first granted ethical approval by the Ethics Committee Northwest- and Central Switzerland and then by all participating local ethics committees. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed journals and academic conferences.

NCT04926597.

Adults with type 1 diabetes (T1D) are at markedly elevated risk of atherosclerotic cardiovascular disease (ASCVD). Guidelines recommend statin use for ASCVD prevention in diabetes between the ages of 40 and 75 years. This study aimed to evaluate statin prescribing rates for primary and secondary prevention of ASCVD in this age range with T1D and to identify disparities and barriers to optimal statin use.

A retrospective cross-sectional study of 266 adults with T1D aged 40–75 years was conducted at an integrated health system between 2020 and 2024. Demographic features, statin prescribing patterns, low-density lipoprotein (LDL) cholesterol levels and use of additional lipid-lowering agents were extracted from medical records. Barriers to prescribing were identified via endocrine physician documentation.

Among 266 adults with T1D aged 40–75 years, only 43.2% (95% CI 0.37 to 0.49) were prescribed guideline-recommended statin and 39.3% of those with a history of ASCVD received a high-intensity statin. Overall, 47.7% (95% CI 0.42 to 0.54) of patients achieved the latest LDL cholesterol targets, and 53.0% (95% CI 0.47 to 0.59) if using pre-2023 targets. Deferral to another healthcare professional (23.3%), statin intolerance (15.8%), and clinical inertia (9.0%) were the most common barriers to therapy. In multivariable analyses, female sex was independently associated with lower odds of receiving guideline-recommended statin therapy (aOR 0.45, 95% CI 0.24 to 0.85, p=0.015) and lower odds of achieving LDL targets (OR 0.43, 95% CI 0.28 to 0.64, p=0.046), while ASCVD history was associated with higher odds of statin use (aOR 2.75, 95% CI 1.34 to 5.57, p=0.005). Very few patients received adjunctive lipid-lowering agents (ezetimibe 4.1%, PCSK9 inhibitor 0.4%, none on bempedoic acid).

Notable gaps exist in statin prescribing and LDL goal attainment among adults with T1D, particularly women. Efforts to enhance care coordination, promote healthcare professional education and expand the use of adjunctive lipid-lowering therapies may help improve cardiovascular prevention in this high-risk population.

Psychedelic-assisted therapy shows promise for treating various mental health conditions; however, its reliance on intensive psychological preparation limits its broader application. Digital health interventions have the potential to address this limitation by providing structured, accessible and scalable preparation solutions. This randomised controlled feasibility trial aims to evaluate the feasibility and preliminary efficacy of the Digital Intervention for Psychedelic Preparation (DIPP), a 21-day mobile-accessible programme designed to prepare individuals for psychedelic experiences.

The study will recruit 40 non-treatment-seeking adults without a clinical diagnosis, randomly assigning them to one of two conditions: (1) DIPP-MEDITATE, which combines daily guided meditation with background music or (2) DIPP-MUSIC, which provides the same background music without guided meditation. Both groups will complete the 21-day digital intervention remotely. Following the intervention, participants will attend an in-person supervised psilocybin session, receiving a standardised 25 mg dose. Primary outcomes focus on feasibility metrics including recruitment efficiency, participant retention and adherence to the intervention protocol. Secondary outcomes assess subjective feasibility, acceptability and preliminary efficacy, specifically evaluating psychedelic preparedness, the quality of the psychedelic experience and changes in wellbeing, with follow-up assessments at 2 weeks, and at 3, 6 and 9 months post-session. Exploratory measures include neuroimaging, physiological, cognitive and psychological assessments, as well as voice note experience sampling through a chatbot (referred to as ‘DIPP-bot’) to monitor inner speech, thought and emotional states during the intervention and follow-up periods.

Approved by UCL Research Ethics Committee (ID: 19113/003), this study follows the Declaration of Helsinki. Results will be published in peer-reviewed journals and presented at conferences. Confidentiality will be maintained throughout.

NCT06815653.

Common mental health outcomes among children in conflict with the law in correctional facilities in Africa are an under-researched area with significant public health implications. This review will synthesise available and accessible evidence on the prevalence and associated factors of common mental health outcomes among children in conflict with the law in Africa.

Comprehensive electronic searches will date from 01 January 2015 to 31 December 2025 and will be conducted in PubMed, Sabinet, Scopus, EBSCOhost, Web of Science and PsycINFO. Articles will be screened using defined inclusion and exclusion criteria and assessed for eligibility by three independent reviewers. Discrepancies will be reviewed by a ninth reviewer. The selection process of included articles will be reported by using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses will be used. The Mixed Methods Appraisal Tool will assess study quality, and data will be synthesised using meta-analysis or a narrative synthesis approach, depending on heterogeneity levels.

This study will not require ethical approval from an institutional review board, as it does not entail the direct collection of data from children in conflict with the law, nor does it pose any risk to their privacy. Once finalised, the full review report will be submitted for publication in a peer-reviewed journal. The key findings will also be shared at both local and international conferences, highlighting common mental health outcomes among children in conflict with the law.

CRD420251011484.

To date, few studies have investigated the factors associated with musculoskeletal patients’ willingness to donate biological samples and their knowledge regarding the use of such samples. We investigated the associations between these distinct knowledge factors, patients’ willingness to donate and socio-demographic factors.

Cross-sectional survey.

Musculoskeletal outpatient clinics across four sites in England, representing varied demographic populations.

A total of 469 adult patients attending musculoskeletal appointments were recruited through convenience sampling.

Ordinal regression models were employed to identify socio-demographic and clinical predictors of patients’ willingness to donate biological samples. Other outcome measures specifically in two areas of patient knowledge include: (1) knowledge of sample use and (2) knowledge of surgical waste tissue value and management.

Only 37% of participants were aware of the term ‘biobank’. Despite this, participants showed a high level of knowledge regarding both biological sample use and surgical waste tissue management, although their understanding varied considerably by ethnicity and education. Participants with no formal education exhibited a lower level of knowledge in both areas related to sample use and surgical waste tissue management for biomedical research ((OR 0.30, 95% CI 0.14 to 0.61; p=0.001); (OR=0.29, 95% CI 0.16 to 0.52, p

Despite low awareness, musculoskeletal patients showed a high willingness to participate in biobanking. However, significant disparities by ethnicity and education persist. Targeted, inclusive engagement strategies are needed to address under-representation and foster informed, equitable participation of musculoskeletal patients in biomedical research.

Alcohol consumption is an increasingly recognised modifiable risk factor for dementia, yet whether it has differential impacts on dementia subtypes and its role in disease progression remains unclear. This study aims to: (1) quantify the association between alcohol intake and incidence of dementia subtypes and (2) examine whether individuals who drink heavily and develop dementia referred to hereafter as ‘alcohol-related’—have poorer post-diagnosis outcomes compared with other dementia cases. Clarifying these relationships will determine whether alcohol selectively increases risk for specific dementia phenotypes or broadly heightens neurodegenerative vulnerability, with implications for prevention, clinical counselling and therapeutic targeting.

This population-based cohort study of alcohol and dementia will use linked UK electronic health records from Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics (ONS). Participants will be eligible if they have available linked data from January 1998, when ONS death registrations became available, until the end of follow-up. Alcohol exposure will be defined through self-reported recorded weekly alcohol units and diagnostic codes for harmful or dependent alcohol use. Primary outcomes including incident all-cause and subtype-specific dementia (eg, Alzheimer’s, vascular, Lewy body, Parkinson’s, frontotemporal) as well as secondary outcomes (ie, mortality, care-home entry and neuropsychiatric symptoms). Key covariates encompassing socio-demographic factors, smoking and relevant comorbidities will be adjusted for. Multivariable Cox proportional hazards and Fine-Gray competing risk models will estimate associations with dementia incidence. Post-diagnosis prognosis will be compared for dementia in individuals with a history of heavy alcohol use (‘alcohol-related’) and dementia in individuals with minimal alcohol exposure (‘non-alcohol-related’) cases using survival and logistic regression models. Multiple testing correction will be applied across dementia subtype comparisons. Alcohol exposure will be modelled continuously and non-linearly using restricted cubic splines and categorically using binary indicators of harmful/dependent use. Missing covariate data will be assessed and addressed using appropriate methods, including multiple imputation and complete-case analysis. Data extraction and analysis are scheduled from October 2025 to October 2026.

Use of de-identified routine data will proceed under existing Research Ethics Committee and data governance approvals. Findings will be disseminated via open-access peer-reviewed journals, academic conferences and summaries targeted at patient, public and policy audiences. The results of this study will be reported according to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) guidelines.

This project, in adult surgical patients, will evaluate whether the creation of a customised checklist, driven by a clinical decision support tool, is able to improve anaesthesia providers’ adherence to consensus guidelines and standardised practice recommendations for the prevention of postoperative nausea and vomiting (PONV).

The intervention will be evaluated using a sequential, repeated crossover design at the institutional level, with designated washout, control and intervention periods. The surgical case will serve as the unit of analysis. The primary outcome is adherence to appropriate PONV prophylaxis administration guidelines. Secondary outcomes include the incidence of PONV and length of stay in the postanaesthesia care unit (PACU).

This protocol and statistical analysis plan provide an outline of the study design, primary and secondary end points and analytic approach. The Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting trial has received approval from the Vanderbilt University Institutional Review Board (IRB: 250773). The results will be disseminated through peer-reviewed publications and presentations at national conferences. Findings from this trial will inform best practices for timely antiemetic prophylaxis, with the goal of reducing PONV incidence and shortening PACU stay.

NCT07152249.

PRELUCA is a randomised, intervention, non-inferiority study designed to use real-time, longitudinal circulating tumour DNA (ctDNA) measurements to evaluate the efficacy of immunotherapy in patients with advanced non-small cell lung cancer (NSCLC). The primary outcome is overall survival between the two groups: the standard of care group (computer tomography scan evaluation) and intervention group (ctDNA evaluation).

The inclusion and exclusion criteria align with European Society for Medical Oncology treatment guidelines and permit broad inclusion of NSCLC patients, ensuring ‘real-world’ representativeness. The study uses a tumour-informed method, using baseline next generation sequencing analyses to design patient-specific droplet digital PCR assays, which are run with collected blood samples 1 week prior to the intended treatment, enabling real-time evaluation via ctDNA Response Evaluation Criteria in Solid Tumours.

Inclusion began in July 2023 and patients are now being actively included in five locations across Denmark. Approval by The Committee on Health Research Ethics of Region Zealand was gained on 4 May 2023.

NCT05889247.

This scoping review protocol aims to examine the role of the Internal Regulation Core (IRC) as an intra-hospital governance structure that coordinates capacity and patient flow and may function as a strategic hub for disruptive innovation in hospital management. By integrating organisational routines, rules and, when available, enabling technologies, IRCs may strengthen operational efficiency and contribute to higher-quality care delivery. As hospitals face increasing operational complexity and constrained resources, clarifying what IRCs are, how they are implemented across settings, and what innovations and impacts are reported has become a priority.

This scoping review will follow the Joanna Briggs Institute guidance and Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. A comprehensive search will be conducted across five databases (MEDLINE/PubMed, Embase, Scopus, Web of Science and LILACS) and grey literature sources, without language or date restrictions. The searches were conducted up to 6 July 2025. Two reviewers will independently screen studies and extract data using a standardised form; disagreements will be resolved by consensus or a third reviewer. Findings will be synthesised descriptively and thematically, with results presented in tables and narrative summaries, including innovation streams.

Open Science Framework (10.17605/OSF.IO/HWZJS).

Hypotension is a frequent complication after induction of general anaesthesia leading to end-organ injury, for which elderly and multimorbid patients are particularly susceptible. The extent of hypotension depends, among other factors, on the dose and rate of propofol administration. Target-controlled infusion systems are widely used to administer short-acting anaesthetics such as propofol and remifentanil. Commonly, induction is started with a fixed effect-site concentration. Titration, an alternative method of induction using an incremental augmentation of propofol, leads to a reduced induction dose and rate of propofol. We hypothesise that the titration method improves haemodynamic stability compared with conventional induction.

This multicentre, expertise-based randomised controlled trial takes place at four Swiss hospitals. Patients ≥55 years of age undergoing non-cardiac surgery under general anaesthesia using propofol target-controlled infusion are randomised to either a conventional or a titrated anaesthesia induction method. Patients, statisticians and, if resources allow, outcome assessors will be blinded. The primary endpoint is the mean arterial pressure under the individual baseline mean arterial pressure (area under threshold) during the first 30 min after start of induction. Secondary endpoints include the maximum deviation from baseline mean arterial pressure, haemodynamic rescue methods, propofol consumption and neurocognitive recovery after regaining consciousness.

A total of 320 patients are required to have an 80% chance of observing superiority of titration for the area under the threshold as significant at the 5% level, assuming a true difference of 100 mm Hg*min. The area under threshold and the maximum deviation will be compared between arms using mixed linear regression models.

Ethical approval has been obtained from all responsible ethics committees (BASEC2025-01007). The results will be presented at international meetings and published in peer-reviewed journals and may contribute to a change in clinical practice for anaesthesia induction using target-controlled infusion systems with propofol.

clinicaltrials.gov (NCT06980688) and www.humanforschung-schweiz.ch (HumRes67022).

Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.

To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.

The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.

MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.

MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.

MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.

This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.

NCT07050823/NCT07093021/NCT07134855.

Each year, millions of people experience recurrent diverticulitis episodes. Elective sigmoid colon resection reduces the risk of recurrence, but The American Society of Colon and Rectal Surgeons recommends individualising surgical decisions based on the impact of the condition on a patient’s quality of life (QoL). However, no threshold for QoL impairment has been established to guide decision-making, and evidence comparing elective colectomy with medical management in terms of QoL limitation is limited. To address these gaps and to guide treatment decision-making, we designed the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) trial.

The COSMID trial is a large, pragmatic randomised trial including patients with QoL-limiting diverticulitis that aims to determine if partial colectomy is superior to medical management and explore subgroups that are more likely to respond to each treatment.

COSMID will recruit 250 English-speaking and Spanish-speaking adults with imaging-confirmed and QoL-limiting diverticulitis (defined using a modified diverticulitis-related QoL survey). Participants are randomly assigned to undergo elective partial colectomy or receive comprehensive medical management (eg, selected from options including fibre, probiotics, mesalamine and rifaximin). A total of 100 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary outcome is the time-averaged score of the Gastrointestinal Quality of Life Index at 6, 9 and 12 months after randomisation. Secondary outcomes include clinical adverse events, healthcare utilisation, recurrent episodes of diverticulitis and additional patient-reported outcomes like the Diverticulitis Quality of Life instrument, decisional regret and work productivity. Exploratory analyses aim to identify differential treatment effects based on patients’ characteristics.

This trial was approved by the Vanderbilt Institutional Review Board (IRB) on 26 August 2019 (IRB #191217). Vanderbilt serves as the institutional review board of record for the following study sites: Albany Medical College, Allegheny Health, Atrium Health Carolinas Medical Center, Virginia Mason Medical Center, Boston University Medical Center, Cedars-Sinai Medical Center, UT Health Lyndon B. Johnson Hospital, Medical University of South Carolina, New York-Presbyterian Queens, Stanford University, University of Pennsylvania, University of California San Diego, University of California San Francisco, University of Colorado Denver, University of Florida, University of Iowa, University of Utah, University of Washington Medical Center, University of South Florida, University of Rochester Medical Center, University of Texas Southwestern Medical Center, Virginia Commonwealth University, Lahey Hospital & Medical Center, Weill Cornell Medical Center and Northwell Health. Rush University Medical Center (approved 8 January 2020), Columbia University Medical Center (approved 28 January 2020), Northwestern University (approved 19 March 2020), Mount Carmel Health System (approved 5 May 2020) and Memorial Health University Medical Center (approved 4 April 2022) are regulated and were approved by their respective IRBs. Results from this trial will be presented at international conferences and published in peer-reviewed journals.

NCT04095663.

To examine the association between birth intervals and perinatal mortality in Indonesia.

Cross-sectional study using reproductive calendar data from the 2017 Indonesia Demographic and Health Survey.

Nationally representative households in Indonesia.

A total of 17 171 women aged 15–49 with pregnancies in the 5 years preceding the survey. Women with missing data or multiple births were excluded.

Perinatal mortality, defined as stillbirths and early neonatal deaths.

The perinatal mortality rate was 22 per 1000 births. Short birth intervals (

Short and long birth intervals were associated with higher perinatal mortality in Indonesia, with additional associations observed for antenatal care visits, maternal age and newborn sex. These findings underscore the importance of promoting healthy birth spacing within maternal and child health programmes and integrating postpartum family planning into routine care. Further longitudinal research is needed to confirm causal pathways and inform targeted interventions.

The term ‘culture of care’ began to be used following the Francis Report in the UK in 2013. This concept involves three dimensions: personal care, leadership care and co-worker care. Personal care focuses on employees’ attitudes and behaviours. Co-worker care relates to a sense of community, and leadership care relates to how employees perceive leaders and managers as caring individuals dedicated to ensuring the well-being of others. Previous studies investigating culture assessment tools used in the healthcare system reported that although organisations are increasingly using culture assessment instruments, there is a focus on assessing safety and quality cultures rather than on caring perspectives. This scoping review aims to map existing studies related to the assessment of culture of care.

This scoping review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews. The search strategy will include four indexed databases (PubMed, EMBASE, Cochrane Library and Latin American and Caribbean Literature in Health Sciences) and additional sources not retrieved with the adopted search strategy. The search strategy will be constructed using the controlled vocabulary in Health Sciences Descriptors, Medical Subject Headings and Emtree. Relevant articles in all languages, without restrictions related to date of publication, will be considered eligible for inclusion. Two independent researchers will select articles based on the inclusion criteria, and a third author will be consulted to establish consensus, if necessary. Data extraction will involve a form with information on the study characteristics, methodological issues and main results from the evidence sources. The extracted data will be analysed using descriptive and content analysis.

Ethics approval is not required, as this review will use data from publicly available bibliographic sources. The results will be disseminated through publications in scientific journals and presentation of the evidence to interested parties.

The protocol was registered in the Open Science Framework (DOI: 10.17605/OSF.IO/U9Q53).

Venous thromboembolism (VTE) is a common complication of traumatic brain injury (TBI) and is associated with increased morbidity and mortality. Low molecular weight heparin (LMWH) is recommended for prophylaxis against VTE after trauma but may increase the risk of progression of intracranial bleeding. Limited evidence exists to guide clinicians regarding the optimal timing of VTE prophylaxis in patients with acute TBI. This randomised controlled trial (RCT) will directly compare the safety and effectiveness of early versus delayed initiation of LMWH in patients with moderate to severe TBI.

The study design is a Bayesian adaptive RCT comparing early (within three calendar days of injury) versus delayed (after study Day 7) VTE prophylaxis with the LMWH, dalteparin. All patients receive sequential compression devices until study Day 8. The co-primary effectiveness outcome is the development of clinically important VTE at study Day 8. The co-primary safety outcome is the development of clinically important intracranial bleeding at study Day 8. Secondary outcomes are mortality and functional outcomes (Glasgow Outcome Scale Extended and EQ-5D) measured at study Days 30 and 180; clinically diagnosed VTE to Day 30 and progression of intracranial bleeding to Day 8.

This study has been approved through Clinical Trials Ontario’s streamlined ethics review process (board of record, Sunnybrook Health Sciences Centre) and all participating centres. It is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and Health Canada regulatory requirements. We anticipate that the trial will achieve wide dissemination through publication in a peer-reviewed medical journal and presentation at international conferences targeting the fields of critical care, trauma and neurosurgery. The results of this trial will help guide clinicians aiming to balance the risks and benefits of early anticoagulant prophylaxis after TBI and will inform guideline development.

NCT03559114.

To partner with healthcare professionals and other stakeholders to identify top 10 research priorities within universal child and adolescent health promotion and disease preventive services.

The study used an adapted James Lind Alliance (JLA) approach. This included a priority setting partnership within the field of municipal health promotion and preventive services for children and adolescents, the gathering of research needs as reported by a national sample of healthcare professionals and other stakeholders and the sorting, evidence checking and final prioritisation of two top 10 lists corresponding with the two municipal service areas: (1) pregnancy care and child health centres 0–5 years and (2) school health service and youth health centres. The research needs were collected using an online survey asking: ‘In your opinion, what should scientific communities in Norway conduct research on to enhance child and adolescent health promotion and preventive services?’. Suggested needs framed as topics were sorted and categorised in Microsoft Excel. The digital survey Nettskjema was applied for final prioritisation by voting.

Municipal child and adolescent health promotion and disease prevention services in Norway.

Altogether, 1141 healthcare professionals and other stakeholders (government administrators and university staff).

The participants submitted a total of 1780 research needs. Following the steps of the JLA priority setting process, the two final top 10 lists were generated. The lists include research priorities relating to, for example, health literacy, mental health promotion, counselling and teaching, follow-up of children and families in vulnerable positions and interdisciplinary collaboration.

Research priorities for child and adolescent health promotion and preventive services were identified through structured user involvement of healthcare professionals and other stakeholders using the JLA framework. The two lists address key knowledge gaps and reflect current societal and professional challenges. The findings can enhance research relevance, foster collaboration and guide research and research funding.

Haemophilia is a rare inherited bleeding disorder with complex support and costly treatment. Comprehensive care for people with haemophilia (PwH) must take place in structured and continuously evaluated treatment centres. The aim of the Public Assistance for People with Haemophilia in Brazil Project (PATCH Project) is to assess the infrastructure, human resources and healthcare delivery processes of Brazilian Blood Centres (BC) involved in the provision of haemophilia care.

This is a nationwide cross-sectional study involving 98 BC across Brazil’s 26 states and the Federal District, focusing on the care provided to PwH. A self-administered structured questionnaire was prepared, based on national and international recommendations for management, treatment and outcomes assessment in PwH. The criteria of the World Federation of Haemophilia and the European Association for Haemophilia and Allied Disorders will be used to define standards of quality.

Ethical approval for this study was granted by the Human Research Ethics Committee of the Federal University of Goiás, the coordinating centre (protocol CAAE 53863221.8.0000.5078), and subsequently by all participating institutions. Written informed consent is obtained from all participants prior to enrolment. Study findings will be disseminated through publication in peer-reviewed journals and presentation at international scientific conferences. Research data will be managed in accordance with ethical and legal standards and will be made available on reasonable request to support future investigations.

Not applicable

Post-traumatic neck pain is common, representing a substantial human and societal burden. About 15%–25% of individuals involved in an accident causing whiplash continue to experience moderate-to-severe symptoms and functional impairment 1 year post-trauma. Factors such as age, high pain intensity, hypersensitivity to pain and early post-traumatic hyperarousal are associated with persistent neck pain. However, multiple questions remain unanswered regarding how best to improve early care. As such, research on recovery patterns (including indicators for health economic burden) and their predictors is still needed, including biomarkers for pre-traumatic and peri-traumatic stress, and the value of early prediction tools.

This prospective cohort study will include 100 participants (≥18 years) suffering from post-traumatic neck pain sustained within 72 hours of an accident. At baseline (a combination of inclusion and 1 week assessment), eligible participants will undergo a thorough evaluation, including assessment of descriptive characteristics, self-reported variables (eg, pain, disability, sleep quality and post-traumatic stress), biomarkers (eg, heart rate variability (HRV) and hair cortisol) and clinical tests (eg, cervical range of motion). Follow-up will be conducted at 3, 6 and 12 months post-trauma. Further, register data (eg, data on labour market attachment) will be added for the period. Among other methods, a receiver operating characteristic (ROC) curve and multivariable regression analyses will be used to evaluate performance and associations of the prediction tools and their associations with measures of HRV.

The sample size calculation is based on previous studies, estimating that 15% of participants will develop moderate-to-severe ongoing symptoms. Using a conservative estimate, 64 participants are needed to achieve a statistical power of 90% with an expected area under the curve of 0.80. Accounting for a 25% loss to follow-up, 80 participants are required. For regression analysis, 100 participants will be included. The prediction tool will be validated using ROC analysis, sensitivity and specificity. Logistic regression models will be performed with and without biomarkers and pain sensitivity. Health economic costs will be compared across groups. Multivariable regression will examine the link between HRV and post-traumatic stress disorder, adjusting for confounders and a moderation analysis will assess hair cortisol as a potential moderator.

The study is approved by the Regional Committee on Health Research Ethics of Southern Denmark (S-20230037). Due to the acute nature of recruitment, the study design does not allow for a 24-hour reflection period; however, this approach has been approved by the Committee.

Study results will be published in peer-reviewed journals and disseminated through non-scientific outlets, including patient and professional publications, press releases and social media. If effective, workshops for clinicians will be organised. Results will be published regardless of outcome, with coauthorships following ICMJE guidelines.

NCT06176209.

Health systems must guarantee access to quality, safe and effective medicines. Essential medicine lists (EMLs) are crucial prioritisation tools to inform coverage decisions and steward limited health resources under the context of universal healthcare. This study aims to develop a consolidated framework for prioritising the assessment of health technologies to review and update EML for treating diseases or health problems managed in primary healthcare (PHC).

A mixed-methods approach was designed to validate the framework. An initial scoping systematic review will be conducted to search for studies that describe criteria used to prioritise the assessment of health technologies for PHC. The relevant studies will be examined using the Joanna Briggs Institute methodological framework for scoping review studies. A comprehensive search was conducted in the following sources: PubMed, Embase, Cochrane Library, Virtual Health Library (LILACS, WHO IRIS, IBECS, PAHO-IRIS, PAHO, LIS, BRISA), Health System Evidence, Global Healths, Health Evidence and Epistemonikos from the inception until February 2025. Two review authors will screen and extract data independently. The extracted data will be qualitatively analysed and presented in a diagrammatic or tabular form, alongside a narrative summary, in line with Preferred Reporting Items for Systematic Reviews and Meta-Analysis: Extension for Scoping Reviews reporting guidelines. An iterative process online using the Delphi hybrid with stakeholders through predetermined consensus thresholds, a combination of a four-point Likert scale and open-ended questions will be conducted to select and validate the criteria identified in the scoping review.

We will provide a consolidated framework to inform decision-makers for prioritising the assessment of health technologies for the national EML for PHC. This is an important step in using evidence to inform public health policies. We plan to share findings through a variety of means, including publications in peer-reviewed journals, presentations at national conferences, invited workshops and webinars, email discussion lists affiliated with our institutions and professional associations, and academic social media.