Cardiogenic shock (CS) is a complex syndrome characterised by primary cardiac dysfunction. Despite advances in therapeutic options such as mechanical cardiac support, it remains associated with high mortality. Although previous registries have described heterogeneous populations and outcomes across different centres, contemporary real-world data on management practices remain limited. This gap is particularly evident in low- and middle-income countries, where there is no robust registry that clearly defines the current state of CS management. Therefore, a multicentre registry is needed to better characterise current practices and outcomes. Our study aims to gain insight into current therapeutic trends in Mexico, a low- to middle-income country with a significant cardiovascular disease burden.

The Mexican Registry of Cardiogenic Shock is a quality initiative that aims to identify therapeutic trends, demographic characteristics and clinical presentations. It also aims to evaluate outcomes, including mortality and cognitive function at in-hospital and 1-year follow-ups, and to identify areas for improvement in the care process across the broad spectrum of CS.

Ethical approval for this multicentre study was obtained from the local research ethics committees of all participating institutions. The study results will be disseminated to all participating institutions in the form of summary reports and presentations on completion of the analysis.

The overuse of antibiotics for respiratory tract infections in primary healthcare in rural China is a particular challenge and is highly related to antibiotic resistance. Our research team designed a multi-component intervention focusing predominantly on health practitioners to reduce antibiotic prescriptions in rural communities of China. The effects of the intervention were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of the implementation of the intervention and related influencing factors.

Qualitative process study nested in a randomised controlled trial, including observation and semi-structured interviews.

Primary healthcare in rural China.

27 health practitioners from township health centres assigned to the intervention arm.

A complex intervention to reduce antibiotic prescriptions in rural communities of China, which includes the following components: training for health practitioners, a public letter of commitment, patient leaflets, a decision support system and a peer support group.

Not applicable.

Data were analysed using thematic analysis.

The overall multi-component intervention was described as useful in reducing antibiotic prescribing, with a particularly high acceptance and use of patient leaflets and the public letter of commitment among health practitioners. There were mixed views on the decision support system and peer support group. Practitioners reported usability-related barriers to using the decision support system during consultations. Practitioners did not understand the role or benefits of the peer support group and found it difficult to initiate group discussions, due to the lack of any existing clinical team at the primary care level.

The multi-component intervention appears to be acceptable and useful in primary healthcare in rural China. Successful implementation requires a comprehensive understanding of the contextual characteristics of the setting. Interventions to reduce antibiotic prescribing in China in the future could consider wider stakeholders including patients, retail pharmacies and health authorities.

ISRCTN30652037 (01/12/2020).

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.

To describe the prevalence and characteristics of traditional, complementary and integrative medicine (TCIM) practice and product use by the population of the UK providing up-to-date data on the landscape of TCIM use in the UK.

A cross-sectional online survey, administered using the Qualtrics platform, among adults (aged 18 years and over) residing in the UK (England, Wales, Scotland or Northern Ireland). Data were collected between May and October 2024. The 40-item instrument covered four domains: demographics, health status, use of health products and practices, and use of health services. Descriptive statistics were used to summarise survey responses, and ² tests were applied to assess associations between participant characteristics and TCIM use. Backwards stepwise logistic regression was conducted to identify predictors of TCIM use across four outcome categories (p≤0.05).

The sample (n=1559) was broadly representative of the UK population. Prevalence of any TCIM use over a 12-month period was 65.9% with 19.1% consulting a TCIM practitioner and 63.3% using any TCIM product or practice. Bodywork therapists (massage therapists 9.4%, chiropractors 7.9%, yoga teachers 5.0%) and homeopaths (4.1%) were the most commonly consulted TCIM practitioners and Anthroposophic doctors were the least commonly consulted (2.1%). Among TCIM products, vitamin and mineral supplements were the most commonly used (37.3%) and relaxation or meditation practices were reported by 19.4% of respondents. TCIM users were more likely to be female, identify as Asian or Black, have a chronic disease diagnosis, report good health, possess private health insurance, have a higher education level, be employed (or seeking employment) and sometimes experience financial management difficulties.

There is substantial use of TCIM across the UK adult population and there is a need for more research on integrating TCIM into mainstream healthcare and the National Health Service. Clear strategies are necessary to enhance communication between TCIM and conventional healthcare providers, ensure patient safety and promote person-centred, coordinated models of care.

Patient-reported experience measures (PREMs) are measures of patients’ perceptions of care they receive. PREMs are critical in developing and evaluating programmes that aim to improve patient healthcare experiences and quality of care (QoC) according to patient-defined needs. This review aims to map key domains of PREMs across distinct healthcare technical areas and life stages from globally available literature.

A scoping review adapting Arksey and O’Malley’s framework and Joanna Briggs Institute’s guidelines for the conduct of scoping reviews.

Google Scholar, PubMed, WHO, US Academy of Medicine and USAID Momentum.

PREMs literature from electronic repositories of grey and peer-reviewed publications, published in English historically up to September 2023.

Two lead reviewers with support from the technical working group co-created a review framework of healthcare technical areas, life stages and PREMs domains. We screened eligible articles, prioritising reviews except for technical areas with no reviews, where we then selected individual studies. We charted, analysed and synthesised data from 52 eligible articles.

PREMs literature has recently increased, especially in low-income and middle-income countries (LMICs), although studies in high-income countries (HICs) dominate in proportion (n=38; 73.1%). Out of 52 eligible articles, technical areas with most publications were sexual and reproductive health (n=21; 40.4%) and general outpatient care (n=11; 21.2%). Studies in adulthood (n=24; 46.2%) and from pregnancy and birth to postnatal (n=16; 30.8%) were most represented. PREMs studies reported mostly on communication and rapport (n=33; 63.5%) and respect and dignity (n=42; 80.8%) domains. Nearly a quarter (n=12; 23.1%) of the articles included only validated tools; the rest included a combination of validated and unvalidated measures. Of the tools relating to life stages of babies, younger children and older adults, the majority (n=17; 94.4%) included patient proxies.

PREMs, as an important component of QoC measurement, are increasing across several healthcare technical areas and life stages with commonalities and notable distinctions in measurement domains and tools. Evidence on PREMs largely comes from HICs. Evidence on critical, yet sometimes overlooked domains, highlights key QoC implementation gaps. The adaptation and utilisation of PREMs in programmes, especially in LMICs and under-represented technical areas, present opportunities to close the QoC disparities in those settings. Strategic, concerted efforts towards the harmonisation of PREMs tools across multiple life course stages and technical areas are critically needed in high-level quality improvement efforts.

Gestational weight gain (GWG) is an important indicator of maternal nutrition to be monitored during pregnancy. However, there is no evidence-based tool that can be used to monitor it across all geographic locations and pre-pregnancy body mass index (BMI) categories. The WHO is undertaking a project to develop GWG charts by pre-pregnancy BMI category, and to identify GWG ranges associated with the lowest risks of adverse maternal and infant outcomes. This protocol describes all the steps that will be used to accomplish the development of these GWG charts.

This project will involve the analysis of individual participant data (researcher-collected or administrative). To identify eligible datasets with GWG data, a literature review will be conducted and a global call for data will be launched by the WHO. Eligible individual datasets obtained from multiple sources will be harmonised into a pooled database. The database will undergo steps of cleaning, data quality assessment and application of individual-level inclusion criteria. Heterogeneity of maternal weight and GWG will be assessed to verify the possibility of combining datasets from multiple sources and regions into a single database. Generalized Additive Models for Location, Scale and Shape will be applied for the construction of the centile curves. Diagnostic measures, internal and external validation procedures will also be performed.

This project will include an analysis of existing study de-identified data. To be included in the pooled database, each included study should have received ethics approvals from relevant committees. Manuscripts will be submitted to open-access journals and a WHO document will be published, including the GWG charts and cut-offs for application in antenatal care.

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

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

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

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

The substantial case detection gap in the field of child tuberculosis (TB) disease is largely driven by inadequate diagnostic tools and approaches. Chest radiographs (CXRs) remain a key component in the evaluation of children and young adolescents (0–15 years) with presumptive TB, aiding clinicians in making the diagnosis and discriminating children with TB from those with other diseases. Widespread use and optimal interpretation of CXR is hampered by a lack of access to well-trained specialists to interpret images. Artificial intelligence CXR interpretation software, termed computer-aided detection (CAD), is now well developed for adults, yet few products have been evaluated in children. The CXR features of child TB are different from those of adults, and as a result, the performance of these CAD algorithms, largely developed for use in adults, will be suboptimal when used in children. Adapting, or fine-tuning adult CAD algorithms, using CXR images from children with presumptive TB, could allow optimisation of these products for use in children. We, therefore, set out to develop a large image and data repository collected from children evaluated for TB (called Catalysing Artificial Intelligence for Paediatric Tuberculosis Research, CAPTURE) with the purpose of evaluating current CAD products and then working with developers and other partners to optimise CAD algorithms for use in children.

We identified approximately 20 studies, from which potentially up to 11 000 CXRs could be used for the proposed project. CXRs and data were eligible for inclusion in the CAPTURE repository if collected from high-quality child TB diagnostic studies that enrolled children with presumptive TB and if CXRs were obtained as part of the baseline assessment. All lead investigators of these studies are members of the CAPTURE consortium. The images and metadata contributed are centrally collated and the key variable of TB case classification as confirmed, unconfirmed or unlikely TB, using an established consensus case definition, is available. All CXRs included in the CAPTURE repository have a consensus radiological interpretation allocated by a panel of independent expert child TB CXR readers who have classified them as ‘unreadable’, ‘normal’, ‘abnormal typical of TB’ or ‘abnormal not typical of TB’. To determine diagnostic performance of existing CAD products, we will evaluate these against a primary composite clinical reference standard (confirmed TB and unconfirmed TB vs unlikely TB), as well as other secondary microbiological and radiological reference standards. A subset of images will be subsequently allocated to a ‘training set’ and made available to developers, academic groups or other parties to either develop novel paediatric CAD products or fine-tune existing adult ones, which will then be re-evaluated by the CAPTURE team using an image subset (‘validation set’) that is independent of the training set.

The CAPTURE study has been approved by Stellenbosch University Health Research Ethics Committee (N22/09/113), with additional ethics approval or waivers by relevant local authorities obtained by consortium members contributing data if required. The final pooled, harmonised and cleaned dataset, as well as the deidentified, renamed CXR images, is stored on a secure cloud-based server. All analyses of existing CAD products, as well as the paediatric-optimised products, will be published in peer-reviewed publications and shared with other stakeholders like the WHO and donor and procurement organisations to guide policy updates and procurement pathways to ensure widespread uptake.

Few studies have examined how psychosocial risk and protective factors in adolescence shape mental health outcomes and other multimorbid conditions in adulthood, particularly among Canadian youth. The Research on Eating and Adolescent Lifestyle (REAL) 2.0 study was a 15-year follow-up cohort study designed to investigate how early etiological factors, including body image and disordered eating symptoms in adolescence, contribute to the development of eating, weight-related concerns, mental health and substance use health problems in early adulthood. In this paper, we describe the REAL 2.0 cohort’s demographic and clinical characteristics alongside an overview of the study procedures, laying the groundwork for collaboration on future learnings with this unique data.

The cross-sectional REAL study initially surveyed middle and high school students from 2004 to 2010 (n=3043) across 43 schools in the Ottawa, Canada region. Of those, respondents in grade 7 or 9 (n=1197 from 25 of the 43 original schools) were asked to participate in a longitudinal arm of the study that consisted of yearly follow-ups. From the longitudinal cohort, there were 278 participants (29.1% male; M_age=28.6) from those who consented to be re-contacted (n=912), who completed the REAL 2.0 survey electronically (30.4%), providing comprehensive data on demographic, clinical, eating and weight-related behaviour, psychological, social, environmental and substance use health factors in adulthood.

9.4% of REAL 2.0 participants met DSM-5 criteria for an eating disorder, while 17.6% met criteria for disordered eating. Moderate to severe anxiety was reported by 28% of participants, while 21.6% experienced moderate to severe depressive symptoms. Regarding substance use, 16.9% engaged in hazardous drinking, 16.9% used cannabis daily or almost daily, and 4.3% reported daily tobacco use.

REAL 2.0 has the potential to answer multiple research questions about several mental health outcomes, but its priority focus is to answer questions related to risk and protective factors of multimorbidity in adulthood. Additionally, profiling work, linked to health service utilisation data for systems planning work and predictive modelling studies are secondary goals. By leveraging the Health Data Nexus (HDN) platform, we welcome collaboration with interested researchers who would like to utilise the breadth of data both in adolescence and adulthood to answer other pertinent aetiological questions in mental health and substance use health outcomes. Future plans to conduct additional follow-ups remain feasible.

Qualitative research addresses ‘how’ and ‘why’ questions in healthcare. It captures the complexity of clinical practice by providing insights into experiences, behaviours and context often missed by quantitative methods. The objective of this review was to explore the volume, trends and adherence to reporting standards in qualitative research across hospital-based medical subspecialties.

Longitudinal bibliometric review.

Ovid Medline, Embase and Emcare were searched for qualitative research published between 2000 and 2024 in 12 medical subspecialties. For each subspecialty, the number and percentage of qualitative publications was identified. Adherence to reporting standards was assessed in a random sample of publications covering all subspecialties.

Between 2000 and 2024, 715 471 qualitative research studies were published across 12 medical subspecialties, representing 1.36% of all studies (52 620 042). Neurology and oncology had the highest number of qualitative studies (116 835 and 106 360). Although infectious diseases contributed a lower absolute number of qualitative studies (59 947), they had the highest proportion relative to all studies (4.07%). Conversely, nephrology and haematology exhibited the lowest number of qualitative studies (14 510 and 29 198) and smallest proportions (0.90% and 0.81%). Overall, the annual proportion of qualitative research increased from 0.64% (6052/945 008) in 2000 to 1.95% (56 909/2 919 825) in 2024. However, the relative positions remained largely stable over time.

Adherence to reporting standards was generally good, particularly in relation to methodological coherence. However, there was under-reporting of positionality (where researchers consider how their identity and standpoint may influence the research process) and reflexivity (where researchers critically reflect on how their assumptions and decisions shape the study).

Qualitative research is under-represented in medical subspecialties but has increased steadily over time, with notable variation in adoption between subspecialties. While overall adherence to reporting standards is good, greater attention to positionality and reflexivity is needed to enhance transparency and rigour.

In early stage non-small cell lung cancer (NSCLC), recurrence is frequent despite surgery and systemic treatments. Observational studies suggest that physical exercise and nutrition could improve outcomes, such as survival and treatment tolerance; however, solid evidence is lacking. The STARLighT trial aims to assess the effects of a telehealth-delivered combined exercise and nutrition intervention on clinical, biological and patient-reported outcomes in early stage NSCLC.

STARLighT is a multicentre master protocol study conducted in Italy, comprising two cohorts of patients affected by early stage NSCLC (stages IB–IIIA) epidermal growth factor receptor and anaplastic lymphoma kinase wild type. Cohort A will include 46 patients with resectable NSCLC receiving neoadjuvant treatment and will exploit a single-arm phase II design. Cohort B will enrol 268 patients undergoing adjuvant treatment (including as a part of a perioperative strategy) and proposes a randomised controlled phase III design. Patients in Cohort A and those allocated to the interventional arm in Cohort B will receive a tailored telehealth-delivered exercise and nutritional intervention. The control group will receive the usual care plus educational material. For cohort A, two coprimary endpoints are set: pathological complete response and quality of life, whereas the primary endpoint for cohort B is 2-year disease-free survival. Secondary and exploratory endpoints include a series of clinical (eg, overall survival and safety), biological (immune–inflammatory markers, gut microbiota and transcriptomics) and patient-reported outcomes (eg, sleep habits, physical activity, anxiety and depression and distress) evaluations.

The study is approved by the Ethics Committee of the University of Verona (Prot. No. 33979) and registered on ClinicalTrials.gov (NCT07042724). Findings will be disseminated through peer-reviewed journals, scientific meetings, public forums and guideline updates.

Clinicaltrial.gov: NCT07042724.

Visual Hallucinations (VHs) (seeing things that others do not, or visions) are a common feature of psychosis, causing significant distress and disability. Services rarely ask about these important experiences, and crucially there are no proven beneficial psychological treatments. There are at least two key challenges faced when treating VHs. First, people report not knowing why they see things others don’t, which leads them to feel alone and different from others. Second, they feel they cannot trust their own eyes to tell what is real or not, which can lead to fears they will be hurt or harmed by the VH, or even if they know the experience is not real, they may fear that they are losing their mind, or that they are not able to control or manage their experiences. For these reasons, they may struggle to put skills and strategies into practice when in the presence of the VH. Consequently, we have developed a novel treatment that addresses these core issues. First, we have a psycho-education and coping strategies package called Visual Unusual Sensory Experiences (VUSE) that uses the best aspects of digital technology (animations, videos) to explain why people have VHs and provides normalising information to help the person to feel less alone. It introduces coping strategies that are then tested in Virtual Reality sessions (VR for Visions VRV) where a representation of the visual experience is provided, enabling the person to safely develop skills and gain a sense of mastery and empowerment. We now plan to test this approach in a proof-of-concept study to help determine if this will help people use these skills in the real world and so help reduce distress, improve functioning and quality of life. We will address uncertainties in the feasibility of developing and delivering this treatment and inform its future use in a larger trial.

The study is a single arm feasibility trial (n=16) evaluating VUSE+VRV and treatment as usual. The study is recruiting people with psychosis and distressing VHs in one NHS Trust and uses independent but non-blind research assistants to undertake assessments before, during and after treatment (at baseline, 6, 12 week) and at follow-up (16 weeks). Quantitative information on recruitment rates, adherence and completion of outcome assessments (VHs, other psychiatric symptoms, quality of life and perceived recovery) will be collected. Qualitative interviews will capture service-users’ experience of therapy. Analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention.

The trial has received NHS Ethical and Health Research Authority approval (25/EM/0077). Informed consent will be obtained from all participants. Findings will be disseminated directly to participants, and services as well as through open access peer-reviewed publication(s).

ISRCTN11350954.