Tongxinluo capsule (TXL) is widely used in China as an adjunctive therapy for patients with acute coronary syndromes (ACS) who underwent percutaneous coronary intervention (PCI), collectively referred to as ACS-PCI. However, current evidence on its therapeutic effects and safety remains limited and insufficiently synthesised. This review aims to evaluate the therapeutic effects and safety of adding TXL to Western medical therapy (WM) in this population.

A systematic literature search was performed in PubMed, the Cochrane Library, CNKI, VIP and Wanfang from inception to August 2024; a rapid supplemental search was conducted up to November 2025, without language restrictions, to identify randomised controlled trials (RCTs) evaluating the therapeutic effects and safety of adding TXL to WM in patients with ACS-PCI. Dichotomous outcomes were summarised using risk ratios (RRs) with 95% CIs; absolute risk reductions (ARRs) were estimated as risk differences, and corresponding numbers needed to treat (NNTs) were calculated. Continuous outcomes were summarised using mean differences (MDs) with 95% CIs. All meta-analyses were performed using a random-effects model. The included studies generally had limitations in methodological quality, heterogeneity across analyses was low to moderate and the potential for publication bias could not be excluded. The evidence certainty for each outcome was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.

Eighteen RCTs involving 1800 participants were included. Low-certainty evidence indicated that adding TXL to WM may reduce the risks of restenosis (RR=0.30, 95% CI 0.10 to 0.91; ARR=0.056, NNT=18), revascularisation (RR=0.28, 95% CI 0.10 to 0.80; ARR=0.069, NNT=15), myocardial infarction (RR=0.44, 95% CI 0.20 to 0.98; ARR=0.033, NNT=31), angina (RR=0.32, 95% CI 0.17 to 0.61; ARR=0.076, NNT=14) and other cardiovascular events (RR=0.41, 95% CI 0.24 to 0.71; ARR=0.075, NNT=14). It also improved Seattle Angina Questionnaire scores (MD=8.82, 95% CI 6.58 to 11.05) and quality of life (qualitative synthesis). However, no statistically significant reductions were observed for sudden cardiac death (RR=0.39, 95% CI 0.12 to 1.27; ARR=0.022, NNT=45), or non-cardiovascular adverse events (RR=0.67, 95% CI 0.32 to 1.40; ARR=0.043, NNT=24) when TXL was added to WM.

Current evidence suggests that adjunctive TXL may reduce key cardiovascular events and improve symptoms and quality of life in patients with ACS-PCI, without increasing the risk of non-cardiovascular adverse events. However, all findings are based on low-certainty evidence. These results provide preliminary support for the use of TXL as an adjunctive therapy, but high-quality, multicentre RCTs are needed to confirm these effects and inform clinical guidelines.

CRD42024509453.

The COVID-19 pandemic accelerated telehealth adoption, offering remote consultations via phone and video. Allied health services are one part of the healthcare system where telehealth, in specific teleconsultations, has been applied and has shown promising results in improving healthcare access by breaking down financial, logistical and geographic barriers. However, more insight is needed into the consumer’s perspective. A consumer is anyone who has used, currently uses or will use telehealth for allied health services. Therefore, this study explores consumer experiences and preferences, identifying barriers and facilitators to telehealth for allied health services.

This qualitative study used focus group discussions to evaluate consumers’ experiences with telehealth for allied health services. Allied health was defined as healthcare professionals distinct from medical, dental and nursing fields. Eight focus groups with 57 participants were conducted. The participants were recruited from the general public as well as seldom represented communities such as a support service focused on improving and maintaining members’ mental health, the deaf and hard-of-hearing community, young disabled people and the Pacific Islander community. An inductive thematic analysis was used to analyse the data.

Five main themes were identified. First, the consumer with their individual characteristics and context played a major role in the suitability of telehealth. Second, the allied health practitioner and their skills influenced the quality and therefore the success of remote consultations. Further, the relationship between consumer and practitioner contributed to the success of telehealth. The appointment itself was equally often discussed. While telehealth improved access to care, remote appointments were seen as more suitable for questions and verbal exchanges. Lastly, the technology was an important factor with the availability of necessary technology and the accessibility of it playing a central role.

The findings reinforce existing research while highlighting new insights from often under-represented groups, emphasising the importance of telehealth choice, accessible technology and quality standards.

Patient safety is a central pillar of healthcare quality. However, with repeated examples of failure emerging across healthcare, there is an ongoing need to better understand how the safety of care can be improved for patients. Evidence suggests that some population groups are more likely to inequitably experience healthcare harm. This review will look at what evidence exists on understanding patient safety harm and its causes and impact on different population groups and particularly those from marginalised backgrounds. It will also focus on what actions can be taken to address patient safety disparities and service improvements, including with patient and public involvement.

A scoping review of empirical and grey literature will be conducted following the Joanna Briggs Institute guidance. Medical databases such as Medline, EMBASE, PsycINFO will be searched for peer-reviewed articles and grey literature sources such as BASE, institutional and government repositories will be searched for reports, independent reviews, confidential enquiries, etc. These will be searched from 2001 to present for publications in English. Title and abstract and full text screening will be undertaken by one or more people acting as first reviewers and validated by a second reviewer. A data extraction form will be used to extract data including equity considerations following the PRO EDI framework. Data will be grouped thematically and analysed using a narrative approach.

Ethics approval is not required for this work as the information used is publicly available. The findings of the review will be disseminated through stakeholder meetings, a peer-reviewed publication and conference presentations.

osf.io/4mfus.

To explore the experiences of clinicians providing pastoral and mental health services to racially and ethnically minoritised students (REMS) at UK universities, aiming to understand the challenges REMS face in accessing support and to identify ways to improve service inclusivity.

Qualitative study using semi-structured interviews.

Student health and well-being services at five universities in the North East of England, a region with comparatively low racial diversity.

Ten clinicians (nine female, one male; nine White British, one other ethnic background; mean age 42.8 years) working in therapeutic roles with experience supporting REMS. Participants were recruited via opportunity sampling.

Semi-structured interviews, averaging 44 min, were video-recorded, transcribed verbatim and analysed using thematic analysis to identify key themes.

Six overarching themes were identified: (1) the chokehold of layered systemic challenges, (2) dynamics of power, (3) lack of safety for REMS, (4) "Am I really getting it?", (5) psychological therapies for white people by white people and (6) the thirst for expertise. Clinicians were enthusiastic about providing culturally responsive care but reported limited access to reflective spaces and training. Contextual factors—including racism, Brexit and the marketisation of higher education—were perceived to affect service delivery and REMS’ engagement with mental health support. Business-model approaches to service provision were sources of frustration.

Clinicians face structural and systemic challenges in providing culturally sensitive mental health support to REMS. Enhancing staff training, reflective practice and service adaptation may improve access and efficacy. Findings offer practical insights for universities aiming to strengthen equity in student mental health services, and future work could evaluate interventions to increase clinician preparedness and REMS engagement.

The treatment of tobacco dependence in patients admitted to hospital is a priority for the National Health Service in England. We aimed to conduct an economic analysis of a pilot ‘opt-out’ tobacco dependence treatment intervention adapted from the Ottawa Model of Smoking Cessation.

Observational cost analysis of an inpatient tobacco dependence treatment intervention, and matched cohort study comparing readmission costs between patients who received the intervention and benchmarked equivalents who did not.

11 acute inpatient wards in a major teaching hospital in London, England.

673 patients who smoked, admitted between 1 July 2020 and 30 June 2021.

The intervention consisted of the systematic identification of smoking status, automatic referral to tobacco dependence advisors, provision of pharmacotherapy and behavioural support throughout the hospital stay and telephone support for 6 months after discharge.

The primary outcomes were cost-per-patient, cost-per-quit and incremental cost effectiveness ratio among patients who received the intervention. The secondary outcomes were patient-level readmission costs and bed-days from 6 months after discharge, compared between the intervention group and a group of matched benchmark patients who smoked but did not receive the intervention.

The total cost of the intervention was £178 105. On the basis of 104 patients who reported not smoking at 6 months, the cost-per-quit was £1712.55, equating to an estimated age-adjusted incremental cost per life year gained of £3325. Among 611 patients who were successfully matched to a benchmark cohort, readmissions for patients in the intervention group cost £492 k less than their benchmark equivalents over 21 months from 1 January 2021 to 30 September 2022 (£266 k vs £758 k), incurred 414 fewer bed days (303 vs 717) and readmitted at a lower rate (5% vs 11%). There were reduced readmission rates and costs among all patients who received the intervention compared with their benchmarked equivalents, regardless of smoking status at 6 months, except among those who opted out.

A pilot ‘opt-out’ tobacco dependence treatment intervention implemented in an acute hospital setting in London demonstrated value for money through reduced readmission rates and costs among all patients who received it.

To determine age-specific and age-standardised incidence trends of acute rheumatic fever (ARF) or rheumatic heart disease (RHD) among Indigenous Western Australians aged less than 35 years of age.

A population-based retrospective cohort study with linked data analysis.

Western Australian hospital admissions (1996–2022) and RHD notifications to the state-based register (2011–2015).

Patients, both Indigenous and non-Indigenous aged

Of 1746 incident ARF/RHD cases, 1526 (87%) were Indigenous peoples, with the highest rates observed in patients aged 5–14 years, with an annual estimated increase of 4.3% (95% CI 3.2% to 5.2%). The 0–4 years age group experienced an annual increase in incidence rates of 4.8% (95% CI 1.4% to 8.2%). Overall, Indigenous patients experienced an annual increase of 1.9% (95% CI 1.3% to 2.6%) from 1996 to 2022. However, most cases (n=894) were identified after multiple significant policy developments (2011–2022) with an annual increase of 5.7% (95% CI 3.7% to 7.5%) for this period.

Increasing trends of incident ARF/RHD were observed in Indigenous patients aged under 15 years, with the greatest annual increments observed after policy implementation for disease reporting and awareness in the period from 2011 to 2022. Improvement in case ascertainment of ARF/RHD may be contributing towards increasing trends with improved reporting and monitoring of incident cases in very young Indigenous Australians more recently.

Streptococcus pneumoniae serotype 3 (SPN3) remains a significant contributor to invasive pneumococcal disease globally, despite its inclusion in widely administered vaccines. The next generation of pneumococcal vaccines may confer better protection against this serotype, reducing disease burden. We describe an ethically approved protocol for a double-blind randomised controlled trial assessing the impact of VAXNEUVANCE (15-valent pneumococcal conjugated vaccine (PCV15)) and 0.9% saline (placebo) on the acquisition, density and duration of SPN3 carriage using a controlled human infection model.

Healthy adults aged 18–50 years will be randomised 1:1 to receive PCV15 or placebo. Participants will be considered enrolled on the trial at vaccination. One month following vaccination, all participants will be intranasally inoculated with SPN3. Following inoculation, participants will be followed up on days 2, 7, 14 and 28 to monitor safety, SPN3 colonisation status, density and duration, as well as immune responses. The primary endpoint of the study is to assess the rate of SPN3 acquisition between vaccinated and unvaccinated participants defined by classical microbiological methods. Secondary endpoints will determine the density and duration of SPN3 colonisation and compare the immune responses between study groups. An exploratory cohort of 5 participants will be asked to consent to a nasal biopsy procedure during a screening visit and a second nasal biopsy 28 days after PCV15 vaccination. This cohort will only receive PCV15 and will not be challenged. Through this exploratory cohort, we will explore gene expression changes induced by PCV15 vaccination and their visualisation (spatial location) within the nasal tissue.

This protocol has been reviewed by the sponsor, funder and external peer reviewers. The study is approved by the NHS Research and Ethics Committee (Reference: 24/SC/0388) and by the Medicines and Healthcare Products Regulatory Agency (Reference: CTA 21584/0485/001-0001).

NCT06731374 – ISRCTN91656864.

To estimate the sociodemographic and geographical variation in prescribing selective serotonin reuptake inhibitors (SSRIs) and medications for attention-deficit/hyperactivity disorder (ADHD) to children and young people (CYP) in North West London, UK.

Cross-sectional population-based study.

General practices in North West London, UK, with data for the period 2020–2022 obtained from the Discover Now platform, which covers approximately 95% of the local population.

762 390 CYP aged 5–24 years in the year 2022.

Primary outcome: Prescription rates of SSRIs and ADHD medications. Secondary outcomes: Associations between prescription rates and sociodemographic factors, including age, gender, geographical area (local authority), ethnicity and socioeconomic deprivation (measured using the Index of Multiple Deprivation).

The total sample comprised 762 390 CYP. 2.20% of the sample were prescribed an SSRI (95% CI 2.17% to 2.24%) and 0.50% an ADHD medication (95% CI 0.49% to 0.52%) in years 2020–2022. High deprivation was associated with the highest rates of an SSRI prescription (2.5%). In contrast, low deprivation was associated with the highest rates of an ADHD medication prescription (0.70%). This divergent pattern was evident in some London boroughs and not in others. The relationship between level of area deprivation and prescription rates also differed by borough. Overall, the sociodemographic factors could not explain most of the variation in prescription rates (Pseudo R² 0.18 for SSRI and 0.06 for an ADHD medication).

Prescriptions for common mental disorders and ADHD for CYP from North West London varied by sociodemographic characteristics and London borough of residence, potentially exacerbating mental health inequalities. To monitor and address these inequalities, more extensive use of linked electronic health records should be undertaken; for example, data on mental health diagnosis and service utilisation are needed to investigate the relationship between diagnosis and treatment over time.

Addressing physical inactivity is a promising dementia risk reduction strategy due to its direct benefits for brain health, and indirect benefits for other modifiable dementia risk factors. A potential limitation of previous interventions is that they often overlook how increasing physical activity affects other behaviours throughout the 24-hour day, such as sleep and sedentary behaviour, which are also important for brain health. Further, interventions are rarely tailored to the individual, considering their needs, preferences and constraints that may serve as barriers or facilitators to behaviour change. The current phase I randomised controlled trial, Small Steps, aims to investigate feasibility, acceptability and preliminary effectiveness of a personalised 24-hour time-use intervention to improve lifestyle and cognitive health in older adults.

Participants aged ≥65 years from Adelaide, South Australia will be recruited and randomised to either the Extended or Condensed programme. During the first 12 weeks, participants in the Extended programme will use a tailored website to set personalised weekly goals to move towards their ‘optimal’ 24-hour day for brain health, facilitated by weekly website ‘check-ins’ and weekly phone calls with a research staff member. Participants randomised to the Condensed programme will have access to the website educational resources only but will not undergo personalised goal setting or telephone calls. Following the introductory phase (first 12 weeks), phone calls will be gradually withdrawn for the Extended programme. Primary (feasibility and acceptability) and secondary outcomes (changes in time use, cognitive function and behaviour change metrics) will be assessed 12, 24 and 36 weeks after the beginning of the intervention.

Ethics approval has been obtained from the University of South Australia’s Human Research Ethics Committee (205989). Study findings will be disseminated through peer-reviewed journal articles, conference presentations, media releases and community engagement.

NCT06291909).

International pilot projects focusing on next-generation sequencing in newborn screening (NBS), that is, genomic NBS (gNBS), have been established thanks to continuous therapeutic progress and the massive development of new genetic technologies with rapidly decreasing costs. Given the highly encouraging results of the French SeDeN project regarding anticipated acceptability among professionals and parents, it is now appropriate to launch a similar pilot project in France, in collaboration with other international initiatives under the International Consortium on Newborn Sequencing framework.

PERIGENOMED is a large-scale project designed to provide the first concrete evidence on the relevance of gNBS in France. It includes two clinical trials. We present here the design chosen for the first clinical trial (PERIGENOMED-CLINICS 1). PERIGENOMED-CLINICS 1 aims to assess the feasibility, real-world acceptability, psychosocial impact and organisational pathways of panel-based genomic newborn screening in France, involving 2500 participants. Solo-GS targeting two lists of gene–disease dyads responsible for treatable (list 1; 400 genes, 171 diseases/group of diseases) or actionable (list 2 optional; 407 genes, 218 diseases/group of diseases) rare and severe early-onset diseases will be proposed in five health institutions. Ancillary social and impact studies will also be included.

All study procedures have been reviewed and approved by relevant French ethics committees and regulatory authorities (CPP Est II-2024-A02224-43, 1 January 2025). Results of the project will be disseminated through peer-reviewed publications, national and international conferences, and public engagement initiatives, in coordination with stakeholders.

NCT06875089.

To quantify and describe the use of real-world data (RWD) in National Institute for Health and Care Excellence (NICE) oncology technology appraisal (TA) final appraisal determination documents.

A systematic literature review was conducted on pharmaceutical NICE oncology TAs published between April 2000 and March 2024 (covering financial years 2000/2001 to 2023/2024 inclusive) extracted on 22 August 2023 (2000/2001 - 2022/2023) and 8 August 2024 (2023/2024).

NICE TA final appraisal determination documents.

All pharmaceutical oncology TAs published between April 2000 and March 2024 (financial years 2000/2001 to 2023/2024) that did not go on to be terminated.

The data required for eligibility screening was extracted from an Excel file directly from the NICE website, where data related to each TA was extracted using an automated script derived from published sources. TAs were assessed based on prespecified review criteria covering whether an RWD submission was reported by the committee, and if so, which RWD sources were used, alongside the methods reported and any feedback from the committee regarding the use of RWD. Bias was not assessed as part of the study.

Of 310 TAs identified, 135 (48.0%) used RWD. A variety of RWD types were used, mostly from UK or US data sources. 47 TAs (34.8%) leveraged RWD from multiple sources. RWD was mostly used in comparisons of survival (41.5%), to inform utility values (26.7%) and to compare baseline characteristics (19.3%), with matched adjusted indirect comparisons (MAICs) and external control arms (ECAs), seen from 2015 and 2018, respectively. The committee expressed concerns around the RWD presented by the company in 53 TAs (39.2%), the most common being a lack of generalisability to the UK population and/or National Health Service practice and comprehensiveness of the RWD.

This study quantifies the increasing use of diverse RWD sources in NICE oncology TAs, as well as the shift towards more complex methods like MAICs and ECAs. The feedback of the NICE committee highlights key areas of improvement as the generalisability and maturity of the RWD presented.

Radiological imaging is a central facet of the multidisciplinary evaluation of suspected child physical abuse. Current guidelines for the imaging of suspected child physical abuse are often unclear, incomplete and highly variable regarding recommendations on critical questions, thereby risking clinical heterogeneity, unstructured decision-making and missed diagnoses. We, therefore, aim to develop and report an evidence-based and consensus-derived international guideline for the radiological investigation of index and contact children in the context of suspected physical abuse and to ascertain areas of scientific uncertainty to inform future research priorities.

The international guidelines for the imaging investigation of suspected child physical abuse (IGISPA) consensus group includes formal representation from 127 recognised experts across 14 subspecialties, six continents and 32 national and/or international organisations. Participants will be divided into five longitudinal subgroups (indications for imaging, skeletal imaging, visceral imaging, neuroimaging and postmortem imaging) with three cross-cutting themes (radiography, genetics and adaptations for low- and lower-middle-income countries). Each subgroup will develop preliminary consensus statements via integration of current evidence-based guidelines, systematic literature review and the clinical expertise of a multinational group of experts. Statements will then undergo anonymised voting in a modified e-Delphi process and iterative revision until consensus (≥80% agreement) is achieved. Final statements will undergo both internal and external peer review prior to endorsement.

As an anonymous survey of consenting healthcare professionals, this study did not require ethical approval. Experts provided written informed consent to participate prior to commencement of the modified Delphi process. The IGISPA consensus statement and any subsequent guidance will be published open access in peer-reviewed medical journals.

Poststroke depression affects approximately 30% of stroke survivors and is linked to worse functional outcomes, cognitive decline, reduced quality of life and increased mortality. While early treatment of poststroke mental health conditions is critical, current pharmacological options offer limited efficacy. Music listening interventions are a promising, low-risk, accessible and affordable alternative that may enhance recovery through engagement of reward-related brain circuits. However, most music listening studies have focused on the acute stage of stroke, lack objective measures of music engagement and rarely assess underlying neural mechanisms. To address these gaps, we propose a feasibility study of a remotely delivered music-listening intervention for individuals with chronic stroke, incorporating objective tracking of music exposure and multimodal assessments of mental health, cognitive, neural and physiological changes.

We will conduct a parallel group randomised controlled feasibility trial enrolling 60 patients with chronic stroke from a well-characterised stroke registry in New York City. Participants will be randomised to either an intentional music listening (IML) group or an active control group that listens to audiobooks. The study includes a 4-week preintervention period during which no treatment is administered; this phase is designed to assess the stability of outcome measures. Following this, participants will engage in 1-hour daily listening sessions over a 4-week intervention period. All listening activity (ie, track identity, duration and engagement) will be continuously tracked using custom open-source software, providing a measure of treatment dose. Behavioural outcomes related to mental health will be assessed at baseline, preintervention, postintervention and 3-month follow-up. Multimodal biomarkers (functional and structural MRI, electrodermal activity and heart rate) will be collected preintervention and postintervention. The primary objective is to establish feasibility, defined by rates of retention and adherence, treatment fidelity, feasibility, acceptability and participant burden. Secondary outcomes include recruitment and randomisation rates. This trial will provide essential data to inform the design of future large-scale clinical studies of IML for poststroke mental health recovery.

The study was approved by New York University’s Institutional Review Board (FY2024-8826). All human participants will provide written informed consent prior to participation and will be adequately compensated for their time. Results will be reported in peer-reviewed journals.

NCT07127159.

This study validates the previously tested Screening for Poverty And Related social determinants to improve Knowledge of and access to resources (‘SPARK Tool’) against comparison questions from well-established national surveys (Post Survey Questionnaire (PSQ)) to inform the development of a standardised tool to collect patients’ demographic and social needs data in healthcare.

Cross-sectional study.

Pan-Canadian study of participants from four Canadian provinces (SK, MB, ON and NL).

192 participants were interviewed concurrently, completing both the SPARK tool and PSQ survey.

Survey topics included demographics: language, immigration, race, disability, sex, gender identity, sexual orientation; and social needs: education, income, medication access, transportation, housing, social support and employment status. Concurrent validity was performed to assess agreement and correlation between SPARK and comparison questions at an individual level as well as within domain clusters. We report on Cohen’s kappa measure of inter-rater reliability, Pearson correlation coefficient and Cramer’s V to assess overall capture of needs in the SPARK and PSQ as well as within each domain. Agreement between the surveys was described using correct (true positive and true negative) and incorrect (false positive and false negative) classification.

There was a moderate correlation between SPARK and PSQ (0.44, p60), SPARK correctly classified 90.5% (n=176/191).

SPARK provides a brief 15 min screening tool for primary care clinics to capture social and access needs. SPARK was able to correctly classify most participants within each domain. Related ongoing research is needed to further validate SPARK in a large representative sample and explore primary care implementation strategies to support integration.