Chronic subdural haematoma (CSDH) is a common neurosurgical condition in older adults, with a recurrence rate of approximately 7.1–13% after burr-hole drainage. Although surgical adjuncts such as subdural drains and middle meningeal artery embolisation may reduce recurrence, these are not suitable for all patients. Pharmacological strategies, including tranexamic acid, Goreisan and carbazochrome sodium sulfonate hydrate, have shown potential, but high-level evidence remains lacking. A prior retrospective study suggested that a triple oral regimen combining these agents may reduce recurrence. This randomised controlled trial aims to evaluate its efficacy and safety.

This is a prospective, multicentre, open-label, randomised controlled trial conducted across six hospitals in Ibaraki, Japan. A total of 180 patients undergoing first-time burr-hole surgery for CSDH will be randomised 1:1 to receive either triple therapy (Goreisan 7.5 g/day, carbazochrome sodium sulfonate hydrate 90 mg/day and tranexamic acid 750 mg/day for up to 90 days) or standard postoperative care. The primary outcome is recurrence requiring reoperation within 90 days. Secondary outcomes include time to recurrence and haematoma volume reduction on serial CT imaging. All analyses will follow the intention-to-treat principle, using logistic regression, Cox proportional hazards models and mixed-effects models.

Written, informed consent will be obtained from all participants at each participating hospital by trained staff from that hospital. The trial protocol has been approved by the ethics committee of the University of Tsukuba Hospital (approval no. TCRB23-025) and the Institutional Review Boards of all participating centres. Study findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. A summary of the results will also be provided to participating institutions and made publicly available in accordance with the BMJ Open data sharing policy.

jRCTs031240007.

Value-based healthcare (VBHC) strives to improve the healthcare system by focusing on value of care, that is, patient relevant outcomes relative to the costs for achieving these outcomes. Within VBHC, patient participation is crucial to identify patient relevant outcomes and value improvement potential. However, patient participation in VBHC initiatives remains limited. Therefore, we aimed to improve patient participation within VBHC teams with the ultimate aim to develop a practical guide for patient participation in VBHC.

An action research study.

This study was conducted in seven collaborating Dutch hospitals from March 2023 to November 2024.

Seven VBHC teams were selected to participate in the cyclical action research steps, that is, orientation, planning, implementation, and evaluation, in which patient participation was implemented or improved. These included the following patient groups: prostate cancer, vulnerable elderly, breast cancer, diabetes, maternity care, colorectal cancer and chronic kidney disease.

Both qualitative and quantitative data were collected. Qualitative data included observations and minutes of meetings with the intervention teams. Quantitative data included responses to the Public and Patient Engagement Evaluation Tool (PPEET) by multiple members of the intervention (n=7) and control teams (n=94) at three time points (T1=6 months, T2=12 months, T3=end of study). Qualitative data were thematically analysed and quantitative data were analysed descriptively. Finally, the data were triangulated to create an overview of lessons learnt in improving patient participation.

Patient participation goals varied across teams, leading to diverse actions, such as establishing a diabetes patient panel and distributing questionnaires to patients with colorectal cancer. PPEET results show that 71% of intervention team members reported that patient participation had an impact on the team’s outcomes compared with 44% in control teams (T3). Furthermore, 80% of the intervention team members initially wanted training in patient participation (T1), which dropped to 29% at T3. Overall, 22 lessons in improving patient participation in multidisciplinary project teams were identified and compiled into a practical guide.

The action research process improved the process and impact of patient participation in the intervention teams. Furthermore, the results indicate that the action research process enhanced the team members’ knowledge and skills on patient participation. The practical guide developed in this study can be used to support implementation of patient participation in VBHC.

To assess the prevalence and magnitude of undisclosed financial conflicts of interest (COIs) among physician-authors in high-impact US-based psychiatry journals.

Cross-sectional study comparing the author self-reported disclosures to the journal(s) with payments mandatorily reported in the Open Payments database.

We examined original research articles published between 1 January 2020 and 31 December 2022 in two prominent US-based psychiatry journals: the American Journal of Psychiatry (AJP) and Journal of the American Medical Association Psychiatry (JAMA-PSY). Of 2872 publications screened, 74 articles authored by 27 eligible US-based physician-authors met the inclusion criteria.

Total payments received by authors within the 3 years prior to publication and the proportion of undisclosed payments. Additional analyses assessed payment types (research vs general), author demographics and study characteristics associated with undisclosed COIs.

US$4.54 million was paid to authors in the two journals, of which US$645 135 (14.2%) were undisclosed. AJP authors received US$205 943 (7.5% of total payments) in undisclosed payments, while JAMA-PSY authors received US$439 192 (24.8%). Research payments constituted 82.3% of all undisclosed payments. Total undisclosed payments among the top 10 highest-earning authors accounted for 84.8% (AJP) and 99.6% (JAMA-PSY) of all undisclosed payments to journals. Nearly all undisclosed payments, 96.2%, were made to authors conducting randomised controlled trials.

Substantial undisclosed financial COIs were identified among the top 10 earners in high-impact psychiatry journals. These findings highlight potential risks to research transparency and integrity. Further research is needed to evaluate the effectiveness of disclosure policies and develop mechanisms to mitigate COIs in psychiatric research.

Adolescents in informal urban communities, defined as settlements that fall outside of formal governmental planning and regulatory frameworks, are at increasing risk of poor-quality diets and malnutrition in all its forms. The food environment is the interface of adolescent food choice and the broader food system, and food environment interventions have the potential to improve adolescent diets and nutritional outcomes.

We will conduct a mixed-methods study, integrating methods from participatory systems science and nutritional epidemiology to characterise linkages among adolescents’ neighbourhood and home food environments, and their food choices, diets and nutritional outcomes. We will recruit adolescents, caregivers, school staff and food system actors from five communities along a gradient of urban informality in Nairobi, Kenya, to participate in cognitive mapping, group-based modelling and a cohort study over one academic year to evaluate dietary choices and nutritional outcomes.

The study has been approved by the Research Ethics Committee of Rutgers University (Pro2024001981) and Amref Health Africa (P1831-2025). Adult participants will provide written informed consent, and adolescents will provide written informed assent to participate in the study. Findings will be disseminated through peer-reviewed journals, conference presentations and to participants through planned participatory interaction throughout the study.

Community paramedicine services (CPSs) may alleviate the increasing pressure on emergency medical services (EMSs) but lack the capacity for patient transport. The study aims to determine whether a municipality implementing the CPS between periods (CPS_REGION) compared with a control municipality (CTR_REGION) served by EMS only affected patient flow and safety in a rural Norwegian setting.

A quasi-experimental study evaluating patient flow and safety before and after the introduction of CPS in one of two rural municipalities.

Two rural Norwegian municipalities that were served by EMS from nearby municipalities before the study started.

Before and after the introduction of CPS, a total of 604 and 650 patients, respectively, were included in CPS_REGION, and 367 and 408 patients, respectively, in CTR_REGION.

CPS was introduced in CPS_REGION between the two data collection periods, whereas CTR_REGION continued to be served by EMS.

The outcome of patient flow was assessed by the number of admissions to nearby hospitals, the number of patient contacts and the location for delivery and treatment. The outcome for safety was assessed as the need for medical recontact within 7 days and 30-day mortality.

Hospital admission rates increased over the two study periods, being insignificant in CPS_REGION (+4.7%, p=0.373) and significant in CTR_REGION (+23.2%, p

Introducing CPS resulted in fewer hospital admissions, with more patients being treated locally. No safety concerns with respect to medical recontacts and 30-day mortality were observed. We conclude that CPS can alter patient flow towards more local treatment without compromising safety.

Testing rates for hepatitis C virus (HCV) of new prison entrants vary considerably between prisons, with particularly low rates in category B male remand prisons. Improvement in testing rates will require an understanding of the underlying reasons.

To investigate the rates and uptake of testing for HCV in new entrants to three category B prisons in England and to use an implementation science framework to analyse the facilitators and barriers to meeting national standards for HCV testing in a prison healthcare environment.

This mixed-methods non-interventional study collated three data sets: anti-HCV testing uptake in prisons, plus data on the prior location of each individual (transfer from another prison or community) and their length of stay; a questionnaire designed to identify reasons for decline of a test administered to people in prison (PIP) who refused testing; qualitative interviews with key stakeholders in the process of prison HCV testing, with analysis based on the Consolidated Framework for Implementation Research (CFIR) to enable identification of barriers and facilitators to testing.

This study was conducted in the East Midlands region of England.

Data were obtained from three category B male remand prisons.

Primary outcome measures: This descriptive study sought to understand factors that influence anti-HCV test uptake in three English remand prisons. The selected prisons serve a combined population of 2.3 million and have the capacity to accommodate a total of 2030 prisoners. The testing rates within 4 weeks of arrival in the three prisons over a 12-month study period (March 2022–March 2023) were 17.2%, 28.3% and 42.5%. PIP were more likely to be tested if they arrived from the community compared with interprison transfer (39.13% vs 29.5%). Testing uptake rates increased with length of prison stay (12.4%, 33.6% and 40.7% for stays of 0–7, 15–21 and >28 days, respectively). The most common reasons for not accepting a test were a lack of interest and not wanting to be retested. 13 semistructured interviews revealed 21 barriers and 9 facilitators to testing, summarised in 5 overarching themes: misunderstanding of the concept of opt-out testing; nurses not meeting performance targets due to competing priorities; prison regime hampering healthcare delivery; absence of a specifically appointed co-ordinator who is held to account; incentivising nurses to test and PIP to accept testing.

The rates of testing for HCV in three category B male remand prisons were far below national standards. Key recommendations to improve testing rates, based on the CFIR analysis are (1) to appoint a dedicated senior healthcare staff member who combines responsibility, accountability and authority to proactively oversee testing and ongoing referral processes; (2) to reintroduce an education programme for prison healthcare teams to teach about HCV, cirrhosis and how to deliver ‘opt-out’ conversations and respond to typical responses and (3) to adopt more widely the strategy already shown to be successful in increasing test uptake by the Hepatitis C Trust HITT programme and offer simple incentives.

This qualitative study explores the experiences of medical students involved in clinical work and learning under distant supervision, aiming to understand their adaptation, challenges and learning processes in the context of clinical uncertainty and reduced oversight.

This study employed a constructivist grounded theory (CGT). CGT was chosen for its strength in examining complex social interactions and uncovering emergent themes that are not fully explained by existing theoretical frameworks. Data were collected through 13 semi-structured, in-depth interviews with medical students who actively participated in clinical care under conditions of limited supervision and high responsibility.

Faculty of Medicine, Switzerland.

We conducted interviews with 13 medical students who worked in Mobile SWAB Teams during the COVID-19 pandemic.

Students described a shift from observation to actively taking on a professional role. This experience provided a unique opportunity for medical students to apply their knowledge and skills in real-world settings, develop a sense of autonomy and foster personal growth. Acknowledging the importance of effective communication, teamwork and decision-making in providing patient care, they embraced the concept of self-regulated learning (SRL).

Creating a supportive learning environment that promotes SRL encourages collaboration and enables medical students to take on clinical tasks with increasing autonomy. In our study, working under distant supervision promoted reflection, strengthened communication and supported both clinical development and identity formation. This approach highlights the value of integrating supported responsibility and guided reflection into future models of clinical education.

Children from refugee families resettled in the USA face higher risks of serious mental health challenges compared with their native-born peers. Research shows that refugee youth in high-income countries frequently suffer from trauma-associated disorders such as post-traumatic stress disorder (PTSD), depression and anxiety. The high prevalence of trauma-associated mental health problems among these youth may be attributed to their own trauma exposure, especially if born in conflict zones, and post-resettlement challenges like poverty, acculturation difficulties, racism and discrimination. However, they may also suffer from the effects of intergenerational trauma, where parental war trauma impacts them. This study aims to adapt and test an intervention addressing intergenerational trauma-related emotional and behavioural health outcomes among US-born children of refugee parents in Omaha and Lincoln, Nebraska.

This is a two-arm cluster randomised type I hybrid effectiveness-implementation trial. Guided by the Social Action and Family Systems theories and applying them to the intergenerational transmission of trauma framework, the combination intervention consists of family strengthening model delivered through multiple family groups+peer mentoring programme called TeenAge Health Consultants (TAHC) adapted for delivery in virtual environment (Virtual TAHC). A total of 154 US-born adolescents of parent resettled as refugees (77 per study arm), ages 14–17 and at least one biological parent per youth (dyads) will be recruited from four comparable communities utilising community-based participatory research approach and randomised to usual care or intervention group. The intervention will be implemented for up to 16 weeks, with assessments at baseline, after intervention completion and 6 months follow-up. To determine study feasibility, we will use binary metrics of participant enrolment of 70% or more and retention of 80% or more at 12 months. To assess study acceptability, we will determine participant satisfaction with the study based on the Client Satisfaction Questionnaire (CSQ-8). To maximise rigour, our analyses will follow an intention-to-treat (ITT) approach. For primary inferential analyses, we will fit two-level generalised linear mixed models to continuous primary outcomes. The models will include fixed effects for study arm, time and their interaction terms. We will perform time-averaged comparisons of post-baseline repeatedly measured observations across study arms to examine intervention effects over the duration of the postintervention study period. To delineate barriers and facilitators to implementation and implementation strategies, we will apply a more integrative approach, using both inductive and deductive approaches guided by the grounded theory and integrative theory that combines both deductive and inductive approaches. Finally, we will integrate findings from the quantitative and qualitative analysis to provide additional explanation and context for our quantitative findings.

Voluntary written informed assent and consent will be obtained from all participants, adolescents and their parents, respectively. All study procedures received approval from Washington University in St. Louis Institutional Review Board (IRB #202307081).

Study findings will be disseminated through publications in scientific journals and presentations at national and international conferences. We also plan to provide community education about the study through a dissemination conference at the end of the study.

NCT06176638.

Advancements in technology for treating diabetes mellitus (DM) are progressing rapidly. With the growing availability and use of continuous glucose monitoring (CGM) systems and continuous subcutaneous insulin infusion (CSII), glucose regulation is improved in individuals with DM, which will lead to less long-term complications and reduce the overall disease burden on patients with DM. Collecting vast amount of biomedical data, these devices combined with clinical outcome data provide more insight into the development and treatment of the disease. The objective of the DIABASE initiative is to collect and examine real-world data from medical devices and clinical practice in a registry.

The ongoing study is structured as an observational study registry. Clinical data and real-world data from diabetes wearable devices, such as CGM and CSII, are aggregated in the database. Clinical data is automatically extracted from the hospital’s electronic health record. Data from wearables is periodically collected manually from the various online data platforms for sharing and automatically added to the database.

This study is exempted from ethics approval by the Medical Research Ethics Committees United (MEC-U) since participants are not subject to procedures and are not required to follow rules of behaviour (approval ID: AW23.009/W20.197). The execution of this study has been approved by the board of the study site Hospital Group Twente (ZGT) (ZGT20-40). Results will be shared through scientific meetings and publications and through articles for the general public.

NCT05584293; Pre-results.

Excessive sedentary behaviour (SB) is highly prevalent among children and adolescents and young adults (AYAs) treated for cancer. Although SB is associated with adverse health outcomes in adults with cancer, little is known about SB in younger cancer patients and survivors. In this scoping review, we aim to summarise current literature on (1) the association between SB and clinical outcomes and (2) results of intervention trials to reduce SB, specifically in paediatric and AYA cancer patients and survivors.

The scoping review will follow the five stages described in the Arksey and O’Malley methodology framework. We will conduct a comprehensive search in five varied electronic databases (PubMed, Embase, Web of Science, CINAHL and SportDiscus) for original articles published in peer-reviewed journals since 1 January 2000, and search reference lists of identified articles and previous review articles. All original research article types will be considered (ie, cross-sectional, cohort, interventional trials). Two reviewers will independently screen all articles based on predetermined inclusion and exclusion criteria, including (1) more than half the sample at the time of study must have been children (0–14 years old) and/or adolescent and young adults (AYAs, 15–39-year old) who were being or had been previously treated for cancer and (2) reporting of SB. Data will be extracted as a descriptive and quantitative summary of each study’s key characteristics and results. Study-specific quality assessment will be performed using established tools. Results will be presented in evidence tables with an accompanying narrative summary.

Ethics approval is not required as only publicly available data will be analysed. Results will be published in a peer-reviewed journal and may be presented at a scientific conference.

The protocol is registered in Open Science Framework (https://osf.io/ua8z9).

Exacerbations of chronic obstructive pulmonary disease (COPD) can lead to reduced lung function and worse clinical outcomes. Previous studies have reported associations between severe exacerbations and increased risk of hospitalisation and/or mortality. This meta-analysis examined the impact of moderate exacerbations on the risk of future exacerbations and all-cause mortality.

This meta-analysis included seven observational studies from the EXACOS (EXAcerbations of COPD and their OutcomeS)/AVOIDEX (Impact of AVOIDing EXacerbations of COPD) programme studies.

This meta-analysis used data from regional claims databases or electronic healthcare records from seven countries.

The individual studies included patients with a diagnosis of COPD and ≥12 months of data availability before (regarded as baseline) and after the index (ie, the date of the first COPD diagnosis), with postindex data considered the follow-up period.

The number of COPD exacerbations experienced during the baseline period (ie, the exposure variable) was used to categorise patients into the following groups: no exacerbations, one moderate exacerbation only or two or more moderate/severe exacerbations. Outcomes assessed included risk of COPD exacerbations and all-cause mortality during follow-up as a function of baseline exacerbations. For meta-analyses, all rate ratios (RRs) were log-transformed, and associations were pooled across studies using random-effects meta-analysis models.

Among 2 733 162 patients with COPD, one moderate exacerbation was significantly associated with a twofold increased risk of future exacerbations compared with having no exacerbations during baseline, with pooled RRs (95% CIs) of 2.47 (1.47 to 4.14) at 1 year, 2.49 (1.38 to 4.49) at 2 years and 2.38 (1.30 to 4.34) at 3 years postindex. The pooled RR (95% CI) for all-cause mortality was 1.30 (1.05 to 1.62), indicating a 30% increase in risk following one moderate exacerbation versus no exacerbations.

Preventing moderate exacerbations in patients with COPD should be a priority that may improve patient trajectories and outcomes.

Opioid use disorder (OUD) is a debilitating condition characterised by the overuse of opioid medications and the development of physical and/or psychological dependence. Consequences of this condition include chronic impairment, distress and later life-altering health conditions such as overdose, all of which have been highlighted by the prominence of OUD in the USA in recent years. Buprenorphine is a standard OUD treatment and commonly used for pain management. Understanding changes in distribution patterns across the USA is vital for continuing to improve outcomes for OUD patients.

This study used the Drug Enforcement Administration’s Automated Reports and Consolidated Ordering System (ARCOS) and the US Census Bureau Population Estimates databases to analyse changes in buprenorphine distribution among pharmacies and hospitals from 2019 to 2023, to determine temporal patterns and to identify state-level disparities using the data. The data were corrected for population to identify patterns of buprenorphine distribution in the USA from 2021 to 2022 and 2022 to 2023 through examining percent changes in milligrams per 100 population at the national and state levels.

The year-to-year percent change of national buprenorphine distribution from pharmacies has remained positive but changed from a 12.2% increase from 2019 to 2020 (figure 4) to a four per cent increase every year from 2020 to 2023. From 2021 to 2022, there was a +4.9% increase in total grams of buprenorphine distributed to pharmacies and a 95% CI [–5.1, 14.9], with the District of Columbia, South Dakota and Nebraska outside of the 95% CI. Distribution to hospitals increased by 10.2% [-32.3, 52.7] during 2021–2022, with Hawaii, New Hampshire and Delaware being outside of 95% CI. From 2022 to 2023, there was an increase of +5.7% and 95% CI [–3.5, 14.9] in pharmacy distribution, with states including Washington, Rhode Island and Kansas remain outside of the 95% CI. Hospital distribution has decreased from twenty per cent between 2019 and 2020 (figure 4) to eighteen per cent between 2022 and 2023.

Following increases in buprenorphine distribution during the COVID pandemic, a consistent increase has continued year-over-year in most states and the country overall by both pharmacies and hospitals. Some states (eg, Rhode Island, Georgia, District of Columbia) have not followed this pattern. Notably, Hawaii went from the most negative percent change in hospital distribution to the most positive change in the timeframe analysed. This may offer opportunities to analyse more specific impacts of the increased buprenorphine distribution on populations and their outcomes associated with OUD.

Venous thromboembolism (VTE) occurs when a blood clot forms in a vein. It is comprised of deep vein thrombosis (DVT) and pulmonary embolism and can be potentially life-threatening. Patients undergoing surgery are at increased risk of developing VTE within hospital admission and 90 days after hospital discharge are collectively known as hospital-acquired thrombosis (HAT). Without the use of thromboprophylaxis, the untreated risk of VTE is reported to be as high as 40–60% in those undergoing major orthopaedic procedures and around 15–40% in the general surgical population.

HAT accounts for around 12 000 deaths per year in the UK. For patients undergoing surgery, there is good evidence for the use of thromboprophylaxis to prevent VTE.

Thromboprophylaxis is available in both pharmacological and mechanical forms. While there is a huge body of evidence demonstrating that pharmacological thromboprophylaxis significantly reduces VTE by 30–65%, the benefit of graduated compression stockings (GCS) has been called into question. The GRACE study (Graduated Compression stocking as an adjunct to Extended duration pharmacological thromboprophylaxis for venous thromboembolism prevention) aims to evaluate the adjuvant benefit of GCS in addition to extended duration pharmacological thromboprophylaxis (EDPTP) for elective surgical patients at highest risk of VTE.

GRACE is a pragmatic, multicentre randomised trial of adults undergoing surgery who are at high risk of VTE. Participants are randomised into a 1:1 ratio to either EDPTP and compression stockings (control arm) or EDPTP (intervention arm). Following randomisation, participants will undergo surgery and be followed up centrally at 7, 21–35 and 90 days after their procedure. All participants will be offered a bilateral full lower limb duplex scan at 21–35 days post procedure to capture any asymptomatic DVT.

The trial aims to randomise 8608 participants from around 50 National Health Service (NHS) and non-NHS sites in the UK over a 24-month period. The primary endpoint is any imaging-confirmed incidence of VTE within 90 days of surgery.

On 20 December 2023, GRACE received favourable ethical approval from the Wales Research Ethics Committee 3 Cardiff (23/WA/0350) and the Health Research Authority (IRAS 333539). The results of the study will be disseminated via peer-reviewed publications, presentation at national and international conferences and to study participants via electronic newsletter and social media channels.

ISRCTN11667770.