Conectar
Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the National Health Service (NHS) diagnostic capacity.
The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken.
We will undertake three research workstreams (WS). In WS1, we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then later on the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. 973 participants will be recruited from three representative clinical contexts; suspected CRC, suspected inflammatory bowel disease and postpolypectomy surveillance. Up to 30 sites across the UK will be involved to maximise inclusivity. Measures of diagnostic accuracy will be reported along with CCE completion rates, number of colonoscopy procedures potentially prevented and adverse events, such as capsule retention. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice.
The study findings will provide the evidence base to inform future colorectal diagnostic services.
The study has approval from the North East—Tyne and Wear South research ethics committee (REC reference 24/NE/0178, IRAS 331349). The findings will be disseminated to the NHS, National Institute for Health and Care Excellence, other clinical stakeholders and participants, patients and the public.
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.
Multiple sclerosis (MS) is a chronic neurological condition that affects approximately 150 000 people in the UK and presents a significant healthcare burden, including the high costs of disease-modifying treatments (DMTs). DMTs have substantially reduced the risk of relapse and moderately reduced disability progression. Patients exhibit a wide range of responses to available DMTs. The Predicting Optimal INdividualised Treatment response in MS (POINT-MS) cohort was established to predict the individual treatment response by integrating comprehensive clinical phenotyping with imaging, serum and genetic biomarkers of disease activity and progression. Here, we present the baseline characteristics of the cohort and provide an overview of the study design, laying the groundwork for future analyses.
POINT-MS is a prospective, observational research cohort and biobank of 781 adult participants with a diagnosis of MS who consented to study enrolment on initiation of a DMT at the Queen Square MS Centre (National Hospital of Neurology and Neurosurgery, University College London Hospital NHS Trust, London) between 01/07/2019 and 31/07/2024. All patients were invited for clinical assessments, including the expanded disability status scale (EDSS) score, brief international cognitive assessment for MS and various patient-reported outcome measures (PROMs). They additionally underwent MRI at 3T, optical coherence tomography and blood tests (for genotyping and serum biomarkers quantification), at baseline (i.e., within 3 months from commencing a DMT), and between 6–12 (re-baseline), 18–24, 30–36, 42–48 and 54–60 months after DMT initiation.
748 participants provided baseline data. They were mostly female (68%) and White (75%) participants, with relapsing–remitting MS (94.3%), and with an average age of 40.8 (±10.9) years and a mean disease duration of 7.9 (±7.4) years since symptom onset. Despite low disability (median EDSS 2.0), cognitive impairment was observed in 40% of participants. Most patients (98.4%) had at least one comorbidity. At study entry, 59.2% were treatment naïve, and 83.2% initiated a high-efficacy DMT. Most patients (76.4%) were in either full- or part-time employment. PROMs indicated heterogeneous impairments in physical and mental health, with a greater psychological than physical impact and with low levels of fatigue. When baseline MRI scans were compared with previous scans (available in 668 (89%) patients; mean time since last scan 9±8 months), 26% and 8.5% of patients had at least one new brain or spinal cord lesion at study entry, respectively. Patients showed a median volume of brain lesions of 6.14 cm3, with significant variability among patients (CI 1.1 to 34.1). When brain tissue volumes z-scores were obtained using healthy subjects (N=113, (mean age 42.3 (± 11.8) years, 61.9% female)) from a local MRI database, patients showed a slight reduction in the volumes of the whole grey matter (–0.16 (–0.22 to –0.09)), driven by the deep grey matter (–0.47 (–0.55 to –0.40)), and of the whole white matter (–0.18 (–0.28 to –0.09)), but normal cortical grey matter volumes (0.10 (0.05 to 0.15)). The mean upper cervical spinal cord cross-sectional area (CSA), as measured from volumetric brain scans, was 62.3 (SD 7.5) mm2. When CSA z-scores were obtained from the same healthy subjects used for brain measures, patients showed a slight reduction in CSA (–0.15 (–0.24 to –0.10)).
Modelling with both standard statistics and machine learning approaches is currently planned to predict individualised treatment response by integrating all the demographic, socioeconomic, clinical data with imaging, genetic and serum biomarkers. The long-term output of this research is a stratification tool that will guide the selection of DMTs in clinical practice on the basis of the individual prognostic profile. We will complete long-term follow-up data in 4 years (January 2029). The biobank and MRI repository will be used for collaborative research on the mechanisms of disability in MS.
A thoracic aortic aneurysm (TAA) is often considered a precursor to an acute type A aortic dissection (ATAAD), a life-threatening condition requiring immediate surgical intervention. While both conditions share histopathological similarities, less is known about their overlap in clinical cardiovascular risk factors. This study aimed to map the cardiovascular disease burden in patients with ATAAD and compare it with patients with TAA.
A multicentre retrospective study.
The data were collected from electronic health records of two academic hospitals located in the Netherlands.
Patients who were treated surgically for ATAAD or TAA between 2000 and 2022 were eligible. This study included 731 patients with ATAAD and 480 patients with TAA.
Hypertension was equally prevalent in both groups (50.9% vs 50.6%, p=0.921). Diabetes was uncommon (3.3% vs 6.7%, p=0.638). Hyperlipidaemia (9.6% vs 20.0%, p=0.001) and peripheral arterial disease (8.8% vs 22.7%, p
This study suggests distinct cardiovascular risk profiles in patients with ATAAD and patients with TAA, highlighting the importance of tailored treatment strategies for aortic disease. Further research is needed to investigate the pathophysiological mechanisms underlying these differences and their impact on thoracic aortopathy.
This study examined the patterns and persistence of SARS-CoV-2 seropositivity among college students from March to November 2020. Using data from a sample of students at Indiana University, we assessed (1) the duration and seropositivity following reverse transcription-PCR (RT-PCR)-confirmed SARS-CoV-2 infection and (2) persistence of seropositivity over 10 weeks between two laboratory antibody test visits.
The longitudinal study was conducted at Indiana University from September to November 2020, with two laboratory antibody tests, and included self-reported RT-PCR results before the observational period from as early as 20 March 2020. This 6–9 month period contributes to our understanding of seropositivity dynamics. The study included 172 college students who had previously tested positive for SARS-CoV-2 and measured their seropositivity.
Our results showed a notable decline (66.7%) in antibody positivity over the observed period. Additionally, 12 weeks postinfection, most students with a SARS-CoV-2 infection history (75%) were no longer seropositive.
These findings reveal a nuanced picture of antibody dynamics, highlighting the complex interplay of factors among college students. The study underscores the need for continued research on antibody levels among young adults to better understand the drivers of variations in antibody persistence.
Persistent epithelial defect (PED) management can be challenging. First line of treatment includes lubrication, bandage contact lenses and punctal plugs. The second line of treatment includes autologous serum (AS). Topical insulin has been shown to be safe for topical use and improve corneal epithelial healing. Therefore, a controlled clinical trial (control group with current standard treatment, ie, AS) multicentre, randomised and with a blind third observer will be conducted to evaluate the efficacy and safety of the use of insulin eye-drops in the treatment of PED.
A preselection of patients with epithelial defect after 1 week of treatment will be made and blood tests will be obtained in order to dispense AS if necessary. After 2 weeks of standard treatment, if the PED persists and the patient meets criteria, patients will be enrolled after signing an informed consent form. Patients will be randomly allocated to receive either insulin (1 UI/mL, 4 times a day) or AS (20%, 5–6 times a day) eye-drops for 3 months. 234 patients will be included, 117 in each treatment group. The main variable (PED size) will be obtained from slit-lamp photographs, an objective and easily quantifiable variable which will be evaluated by a blinded investigator (third observer). Patients will be examined every 3–5 days until week 4 of study treatment and once a week until 6 weeks, to continue with a visit every 2 weeks until reaching 3 months of follow-up. Primary endpoints are: complete epithelialisation, epithelialisation rate (initial defect area/days until epithelialisation) and time until complete closure.
Ethical approval has been obtained from Hospital Clinico San Carlos in Madrid and Agencia Española del Medicamento y Productos Sanitarios (AEMPS). The findings will be disseminated in peer-reviewed publications and presentations at meetings.
EudraCT 2022-003589-19.
Despite low sensitivity and implementation challenges, the tuberculin skin test (TST) remains the standard-of-care tuberculosis (TB) infection test in Mexico. Interferon gamma release assays (IGRA) may overcome TST-related challenges. Within the confines of the local programmatic setting, this cross-sectional study evaluated the prevalence of TB infection (TBI) and concordance of TST and IGRA in three high-risk populations in Mexicali, Baja California, Mexico.
Household contacts (HHC) of individuals with TB, people who use drugs (PWUD), people deprived of liberty (PDL) and prison employees underwent evaluation for TBI using TST and QIAreach, a novel IGRA. Prevalence of infection, concordance of test results and reactivity trends of time-to-results (TTR) by TST-induration size were assessed.
In total, 214 of 411 (52.07%) people who had TST and 269 of 460 (58.48%) people who had IGRA tested positive for TBI. Frequency of infection varied across risk groups (HHC 29 (29.6%); PWUD 67 (70.53%); PDL 111 (56.06%) and prison employees 7 (35.0%), p20 mm, p=0.05).
All risk groups had a high frequency of TBI, necessitating locally tailored guidelines for screening, treatment and management of TBI to optimise care for vulnerable populations.
Combined vascular endothelial growth factor/programmed death-ligand 1 blockade through atezolizumab/bevacizumab (A/B) is the current standard of care in advanced hepatocellular carcinoma (HCC). A/B substantially improved objective response rates compared with tyrosine kinase inhibitor sorafenib; however, a majority of patients will still not respond to A/B. Strong scientific rationale and emerging clinical data suggest that faecal microbiota transfer (FMT) may improve antitumour immune response on PD-(L)1 blockade. Early trials in melanoma with FMT and reinduction of immune checkpoint blockade (ICI) therapy in patients with anti-PD-1-refractory metastatic melanoma were reported in 2021 and demonstrated reinstatement of response to ICI therapy in many patients. Due to anatomical vicinity and the physiological relevance of the gut-liver axis, we hypothesise HCC to be a particularly attractive cancer entity to further assess a potential benefit of FMT in combination with ICI towards increased antitumour immunity. Additionally, HCC often occurs in patients with liver cirrhosis, where liver function is prognostically relevant. There is evidence that FMT may increase hepatic function and therefore could positively affect outcome in this patient population.
This prospective, multicentre, randomised, placebo-controlled, double-blind phase II clinical trial has been designed to assess immunogenicity and safety of FMT via INTESTIFIX 001 combined with A/B in advanced HCC in comparison to A/B with placebo. Primary endpoints are measured as tumour CD8+ T cell infiltration after 2 cycles of treatment with vancomycin, A/B+INTESTIFIX 001 in comparison to vancomycin-placebo, A/B+INTESTIFIX 001-placebo and safety of the therapeutic combination in advanced HCC. INTESTIFIX 001 is an encapsulated FMT preparation by healthy donors with a high alpha-diversity in their gut microbiome for oral administration, manufactured by the Cologne Microbiota Bank (CMB). Sample size was calculated to achieve a specific expected accuracy for the primary immunological endpoint. 48 subjects will be randomised to reach a goal of 42 usable measurements in the modified intention-to-treat set. Subjects will be randomised in a 2:1 ratio to A/B or placebo (28 A/B, 14 placebo).
The study was approved by ethics committee review and the German Federal Ministry of Drugs and Medical Devices. The trial is registered under EU CT no. 2023-506887-15-00. The outcome of the study will be disseminated via peer-reviewed publications and at international conferences.
The COVID-19 pandemic has made long-standing nursing workforce challenges apparent on an international scale. Decision-makers must develop multi-pronged approaches to foster the development and maintenance of a strong nursing workforce to support health systems. These approaches require attendance to recruitment and retention initiatives that show promise for stabilising the nursing workforce now and into the future.
Searches were conducted across MEDLINE, Embase, CINAHL and Scopus from January 2014 up to 11 March 2024. This rapid umbrella review protocol is guided by the Joanna Briggs Institute scoping review methodology and adheres to Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. The research question guiding this review is: what structures have healthcare systems put in place to stabilise, support and sustain the nursing workforce? This review will include existing reviews of nursing workforce initiatives with outcomes that impact nursing recruitment and retention. Results will support local health transformation including the development of a jurisdictional nursing workforce stabilisation strategy. Findings from this review will be relevant for the design, refinement and implementation of nursing workforce sustainability strategies in countries around the globe and may apply to strategies for other healthcare workers.
Institutional research ethics board exemption was received. The research team is supported by an advisory group that includes provider and patient partners. The results from this study will inform the Nursing Workforce Strategy for the province of Nova Scotia as part of a larger Canadian Institutes of Health Research-funded project. They will also inform broader planning and strategy in Canada through integration with other evidence-generation activities such as comparative policy analyses and workforce planning exercises. Finally, the results will be published in a peer-reviewed journal.
Registered through Open Science Framework: https://doi.org/10.17605/OSF.IO/CUJYK
Osteoarthritis (OA) is a degenerative and progressive joint condition causing pain and disability. Physical exercise is recognised as the most effective intervention since individuals with this condition often experience muscle weakness, balance deficits and chronic pain. Additionally, knee osteoarthritis (KOA) is associated with central sensitisation, contributing to chronic pain conditions. Transcranial Direct Current Stimulation (tDCS), a non-invasive neuromodulation technique, has been employed to induce changes in pain perception by altering cortical excitability, potentially reducing chronic pain.
This is a protocol for a randomised controlled trial. Participants will be allocated to two groups: G1 (active tDCS combined with exercise) and G2 (sham tDCS combined with exercise). The intervention protocol will last for 5 weeks, with two sessions per week on non-consecutive days. Pain intensity will be assessed as the primary outcome using the Numeric Rating Scale (NRS). The sample size was calculated based on a minimum clinically important difference of 3 points on the NRS between groups, with a statistical power of 80% and a significance level of 5%. Secondary outcomes will include physical function and global perceived change.
This protocol was approved by the Research Ethics Committee of the Trairi School of Health Sciences, Federal University of Rio Grande do Norte (Approval Number: 6.801.827), and it is in accordance with the Declaration of Helsinki for human research. Results will be published in peer-reviewed journals and presented at scientific events. This trial is registered in the Brazilian Clinical Trials Registry.
Brazilian Clinical Trials Registry (RBR-5pb2g33).
Oral diseases are a major contributor to global disability but remain largely neglected in health policy, especially in low- and middle-income countries. India carries a disproportionately high burden of dental caries and periodontal disease, with limited access to oral healthcare and high reliance on out-of-pocket expenditure (OOPE). Despite this, there is a lack of synthesised economic evidence specific to India, which limits informed policymaking and resource allocation. This systematic review aims to assess the economic burden and financial impact of oral diseases in India—at individual, household, health system and societal levels—focusing on direct and indirect costs, including OOPE and catastrophic health expenditure (CHE).
This review will follow the JBI methodology for economic evaluation evidence and adhere to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. A three-step search strategy will be used to identify relevant studies from databases, including MEDLINE (Ovid), Embase, Scopus, CINAHL (Ovid), Dentistry and Oral Sciences Source (EBSCO) and Cochrane CENTRAL, as well as grey literature sources.
We will include studies conducted in India that report on the economic burden or financial impact of oral diseases at the individual, household or population level. Eligible designs include cost-of-illness studies, cost analysis, cost-outcome analysis and health expenditure analysis using cross-sectional (including repeated cross-sectional) or cohort designs, as well as analyses based on secondary datasets. Studies using econometric, statistical or modelling methods, with or without comparators, will be included. Mixed-methods studies will be eligible if they provide extractable quantitative data.
Two reviewers will independently screen and appraise studies using JBI critical appraisal tools suited to each study design. Data extraction will focus on direct and indirect costs, including OOPE and financial impacts, such as CHE, hardship financing and poverty effects. Findings will be presented narratively and, where feasible, pooled in a meta-analysis using MetaXL V.5 software.
This review does not involve the collection or analysis of individual patient data. Instead, it will use data from publicly available economic research studies. All data sources will be appropriately cited. Extracted data will be systematically curated and managed using version-controlled spreadsheets and reference software. As this is a secondary analysis of published literature, ethical approval is not required. Findings will be disseminated through peer-reviewed publications and scientific presentations, as well as shared with policymakers and community health organisations via policy briefs and stakeholder outreach.
CRD420251030651.
Neonatal death and later disability remain common sequelae of hypoxic-ischaemic encephalopathy (HIE) despite the now standard use of therapeutic hypothermia (HT). New therapeutic approaches to brain protection are required. Melatonin is an indolamine hormone with free-radical scavenging, antiapoptotic, anti-inflammatory and gene regulatory neuroprotective properties, which has extensive preclinical evidence of safety and efficacy. Pharmacokinetic (PK) data suggest it is necessary to reach melatonin levels of 15–30 mg/L within 6–8 hours of hypoxia-ischaemia for brain protection. We developed a novel Good Manufacturing Practice (GMP) grade melatonin in ethanol 50 mg/mL solution for intravenous use. In preclinical studies, ethanol is an adjuvant excipient with additional neuroprotective benefit; optimised dosing protocols can achieve therapeutic melatonin levels while limiting blood alcohol concentrations (BACs).
The Acute High Dose Melatonin for Encephalopathy of the Newborn (ACUMEN) Study is a first-in-human, international, multicentre, phase 1 safety study of intravenous melatonin in babies with moderate/severe HIE receiving HT. Sixty babies will be studied over two phases: a dose escalation study including four dose levels to establish the recommended phase 2 dose (RP2D), followed by a 6-month cohort expansion study of RP2D to further characterise PKs and affirm safety. Participants will receive a 2-hour intravenous infusion of melatonin within 6 hours of birth, followed by five maintenance doses every 12 hours to cover the period of HT. Plasma melatonin and BACs will be monitored. The RP2D will be based on the attainment of therapeutic melatonin levels while limiting BACs and the frequency of dose-limiting events (DLEs). A Bayesian Escalation with Overdose Control approach will be used to estimate the risk of DLE per dose level, with a target level of
Approval has been given by the London Central National Health Service Health Research Authority Ethics Committee (25/LO/0170) and UK Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency. Separate approvals have been sought in Ireland and Australia. Dissemination will be via peer-reviewed journals, conference presentations, public registries and plain language summaries for parent/legal guardian(s), in accordance with national requirements.
ISRCTN61218504. EU CT: 2025-520538-49-00.
Publication based on the UK protocol V.3.0, 08 May 2025
Hospitalisation is one of the most stressful life events for older adults, particularly for those who are pre-frail or frail. Multi-component community-based interventions have the potential to address the complex needs of older adults post-acute care admission. While some available interventions have been developed with end-user engagement, fully involving older people who are pre-frail or frail in the design of interventions has been less common. Multi-component community-based interventions that address the needs of older adults and their care partners with potential implementation barriers informed by healthcare providers, community partners and health system decision makers are needed. This protocol paper describes the planned process of co-designing for older patients discharged into the community, a Post-Acute Care Intervention for Frailty using Information and Communication technology.
The development of a complex multi-component frailty intervention which meets older people’s needs involves several concurrent tasks and methodologies, each informed by co-design and conducted with consideration to eventual implementation. These tasks include: (1) establishing a Research Advisory Board, (2) assessing the feasibility and validity of using hospital administrative data to identify frail or pre-frail older adults and their needs, (3) conducting a needs assessment of patients returning to the community, (4) mapping community assets to identify existing programmes and services to help tailor the intervention, (5) co-designing a multicomponent frailty intervention, (6) selecting study outcome measures and (7) selecting and tailoring a digital health patient portal to support intervention delivery, data capture and communication.
Each task requiring ethics approval will be submitted to the Hamilton Integrated Research Ethics Board at McMaster University. Results will be disseminated through peer-reviewed journal articles, conferences and networks of relevant knowledge users who have the capacity to promote dissemination of the results. A toolkit will be developed to help researchers and healthcare providers replicate the methodology for other populations.
Haematuria contributes significantly to emergency urology admissions with over 4 per 1000 annual UK emergency admissions and 10% readmitted within 30 days. However, there is limited focus on optimising inpatient pathways internationally. Existing studies highlight a substantial underlying malignancy rate (32%) in patients presenting with visible haematuria, yet many receive inconsistent care, leading to prolonged hospital stays and increased resource use. A systematic review performed by our research group found no large-scale prospective studies have been performed in this area, and little is known about current practice. This study aims to address these gaps by investigating current management practices and their impact on outcomes, with the goal of informing evidence-based guidelines and improving patient care.
The Ward AdmiSsion of Haematuria: an Observational mUlticentre sTudy is an international, multicentre prospective observational study designed to describe the management of patients with unplanned admission to hospital with haematuria under the care of the urology team. The study will use a collaborative methodology using the British Urology Researchers in Surgical Training model. This model delivers international multicentre studies by empowering trainees to lead all aspects of multi-centre clinical studies, building research skills cost-effectively while shaping the future urological consultant workforce. Data on demographics, comorbidities, management practices and outcomes will be collected using a standardised case report form and analysed using multilevel linear regression modelling. Primary outcomes include length of stay, while secondary outcomes cover hospitalisation free survival, mortality, readmission rates at 90 days and resource use. The study was launched in January 2024 and will continue follow-up data collection through December 2025. Patient and public involvement (PPI) has been integral to the study design, ensuring that outcomes reflect patient priorities and that the research addresses key areas of concern.
Ethical and regulatory approvals will be obtained as required in each participating region. In the UK, the study is classified as a service evaluation and does not require individual patient consent. Participating sites must obtain local audit department approval. Data will be collected and stored securely, ensuring patient confidentiality. Results will be disseminated through scientific conferences, peer-reviewed publications and patient advocacy groups.
To assess the implementation feasibility and acceptability of a structured digital psychosocial communication tool (DIALOG+) to strengthen the quality of person-centric care in psychiatric settings within Pakistan and India.
A hybrid inductive and thematic qualitative analysis using individual interviews (IDIs) and focus group discussions (FGDs).
Two psychiatric hospitals (Karwan-e-Hayat and Jinnah Postgraduate Medical Centre) in Karachi, Pakistan and one psychiatric care organisation (Schizophrenia Research Foundation) in Chennai, India
Interviews were conducted with 8 mental health clinicians and 40 patients who completed the DIALOG+ pilot as well as wider stakeholders, that is, 12 mental health clinical providers, 15 caregivers of people with psychosis and 13 mental health experts.
A technology-assisted communication tool (DIALOG+) to structure routine meetings and inform care planning, consisting of monthly sessions over a period of 3 months. The intervention comprises a self-reported assessment of patient satisfaction and quality of life on eight holistic life domains and three treatment domains, followed by a four-step solution-focused approach to address the concerns raised in chosen domains for help.
Key insights for the implementation feasibility and acceptability of DIALOG+ were assessed qualitatively using inductive thematic analysis of 22 IDIs and 8 FGDs with 54 individuals.
Clinicians and patients ascribed value to the efficiency and structure that DIALOG+ introduced to consultations but agreed it was challenging to adopt in busy outpatient settings. Appointment systems and selective criteria for who is offered DIALOG+ were recommended to better manage workload. Caregiver involvement in DIALOG+ delivery was strongly emphasised by family members, along with pictorial representation and relevant life domains by patients to enhance the acceptability of the DIALOG+ approach.
Findings highlight that the feasibility of implementing DIALOG+ in psychiatric care is closely tied to strategies that address clinician workload. Promoting institutional ownership in strengthening resource allocation is essential to reduce the burden on mental health professionals in order to enable them to provide more patient-centric and holistic care for people with psychosis. Further research is required to explore the appropriateness of including caregivers in DIALOG+ delivery to adapt to communal cultural attitudes in South Asia.
To seek consensus among global experts on concepts, measures and approaches to guide national and global action to address HIV-related stigma and formulate a call to action. This outlines priorities to unite actors in more effectively responding to and resourcing efforts to address HIV-related stigma.
An adapted Delphi consensus-building process using two rounds of online questionnaires.
Online questionnaires sent to a global expert panel.
50 global experts on HIV-related stigma and discrimination representing sectors including civil society, people living with HIV and key populations, research and academia, clinical practice, law, non-profit organisations, the United Nations, and policy and donor organisations.
The panel reached consensus on 55 points relating to the 12 broad themes extracted from the evidence base. These comprised the importance of addressing HIV-related stigma at scale; HIV-related stigma terms and definitions; Frameworks; Programming and approaches; Community leadership in HIV-related stigma-reduction implementation; Intersectional stigma and discrimination; Stigma and discrimination measures and assessment scales; Monitoring and evaluation; Stakeholder and community participation in monitoring and evaluation; Knowledge gaps and research needs; Funding and Commitment calls. From these, a consensus statement and call to action were formulated on priorities for strong political and financial commitments by all countries to reduce and mitigate HIV-related stigma and achieve global HIV targets adopted in 2021.
This study illustrated that global experts across sectors consider that action is needed to support the three critical enablers of the HIV response—society, systems and services—to ensure that HIV services are non-discriminatory and person-centred. The importance of attention and action to reduce stigma is critical in the current geopolitical and funding crisis affecting HIV and global health.
Adolescents and young adults (AYAs) in low- and middle-income countries (LMICs) are at high risk of harmful sexual and reproductive health (SRH) practices due to limited knowledge, low availability or acceptability of modern contraceptives, gender inequality and cultural practices like child marriage. Preventive and educational interventions by lay health workers or through technological means are a cost-effective and scalable solution. Unfortunately, too little is currently known about the scope, content and conditions of the effectiveness and sustainability of these approaches and synthetic evidence on this topic is scarce. To help fill this knowledge gap and to identify where further research is needed, we will conduct a scoping review of technology-based or lay health-worker delivered preventive and educational SRH interventions targeting AYAs in LMICs. This information is valuable to both policymakers and researchers as it provides a synthesis of existing interventions, highlights best practices for their implementation and identifies potential avenues for future research.
This review will include studies on SRH preventive and educational interventions targeting AYAs aged 10–24 years in LMICs. It encompasses interventions delivered by lay health workers or via technological means, assessing various outcomes including but not limited to SRH literacy, sexual risk behaviours, pregnancies, sexually transmitted infections and gender-based violence. Key databases, including PubMed via MEDLINE and Embase, will be searched from 1 January 2000 up to 23 January 2024, using a comprehensive search strategy. Screening will be conducted using Covidence software. Data extraction will cover study details, methods, intervention strategies, outcomes and findings. A narrative synthesis will be conducted following synthesis without meta-analysis guidelines.
The scope of this scoping review is limited to publicly accessible databases that do not require prior ethical approval for access. The findings will be disseminated through peer-reviewed journal publications, as well as presentations at national and international conferences and stakeholder meetings in LMICs.
The final protocol is prospectively registered with the Open Science Framework on 7 May 2024 (osf.io/vna2z).
We aimed to determine the prevalence of hospital discharge communication problems in adults of 10 high-income nations and the associated factors.
Secondary analysis of cross-sectional survey data.
2023 Commonwealth Fund International Health Policy Survey for Adults, including data from residents of Australia, Canada, France, Germany, the Netherlands, New Zealand, Sweden, Switzerland, the UK and the USA.
3763 survey respondents aged 18 and older who reported hospitalisation at least one time in the past 2 years.
Our primary outcome measure is poor discharge communication (PDC), which is a composite variable comprising three questions regarding the provision of written information, follow-up arrangement and discussion of medications at time of discharge.
The overall PDC rate was 17.1%, with the highest in Germany (19.7%) and the lowest in the Netherlands (9.2%). No follow-up arrangement was the most commonly reported problem (22.8%). Respondents who concerned about social service needs and mental health issues were more likely to report PDC.
Providers should consider factors which impact PDC at hospital discharge and tailor communication appropriately. Hospitals, communities and countries should work towards policies that address underlying issues related to social determinants of health, including support for lower-income patients, improved treatment access for patients with physical and mental health conditions, and food and housing stability.
To identify distinct sleep quality patterns among patients with heart failure (HF) using a person-centred approach and explore demographic and clinical predictors of these patterns.
Secondary analysis of baseline cross-sectional data from the MOTIVATE-HF (MOTIVATional intErviewing to improve self-care in Heart Failure patients) randomised controlled trial. Latent class analysis (LCA) was applied to Pittsburgh Sleep Quality Index (PSQI) component scores to identify distinct subgroups of patients. Demographic, clinical and psychological variables were examined as potential predictors of cluster membership.
Three healthcare settings in Italy: hospital, outpatient and community-based care.
510 adult patients diagnosed with HF (New York Heart Association (NYHA) class II–IV) with poor self-care were included. Patients with severe cognitive impairment or recent myocardial infarction were excluded.
Primary outcome: Sleep quality, measured using the PSQI, analysed through LCA to identify sleep disturbance clusters. Secondary outcomes included demographic and clinical characteristics predicting cluster membership.
The mean age was 72.4 years (SD=12.3), with most participants married or partnered (62%) and retired or unemployed (83.9%). Mild comorbidities were present in 53.3% of the sample (mean Charlson Comorbidity Index (CCI)=2.91, SD=1.98), and 61.4% were classified in NYHA class II. Three sleep quality clusters emerged: (1) adequate sleep duration but disturbed sleep and daytime dysfunction (46.1%); (2) severe sleep problems with low use of sleeping medications (25.3%); and (3) minor sleep problems with mild disturbances (28.6%). Patients in Cluster 1 were older (mean age=73.3 years), had lower physical and mental quality of life (Short-Form 12 Physical Component Summary=33.66; Mental Component Summary=42.65), and higher anxiety (Hospital Anxiety and Depression Scale-A=8.82). Patients in Cluster 2 had more severe comorbidities (CCI=3.55), poorer cognitive function (Montreal Cognitive Assessment (MoCA)=21.5) and lower ejection fraction (mean=40%). Patients in Cluster 3 were younger (mean age=68.2 years), had better cardiac function (ejection fraction=46.6%), better cognitive status (MoCA=24.5) and the highest quality of life (Kansas City Cardiomyopathy Questionnaire=63.1).
Patients with HF exhibit heterogeneous sleep quality patterns with specific clinical and psychological profiles. These findings highlight the need for personalised interventions, systematic sleep assessments and the integration of cardiac rehabilitation strategies into standard HF care.
Acute intracerebral haemorrhage (ICH) is devastating with a 1 month mortality rate of ~40%. Cerebral oedema can complicate acute ICH and is associated with poor outcome. In patients with large ICH, the accompanying swelling increases mass effect and causes brain herniation. Mannitol, an osmotic diuretic, is used to treat cerebral oedema after traumatic brain injury, but its safety and efficacy in ICH is unclear. We aim to assess the feasibility of a phase II randomised, controlled trial of mannitol in patients with ICH with, or at risk of, cerebral oedema to inform a definitive trial.
The mannitol for cerebral oedema after acute intracerebral haemorrhage trial (MACE-ICH) aims to include 45 ICH participants from 10 UK sites with estimated largest diameter of haematoma volume >2 cm, presenting within 72 hours of onset with, or at risk of, cerebral oedema (limited Glasgow Coma Scale (GCS)8) with or without mass effect. Participants will be randomised (1:1:1) to 1 g/kg 10% single-dose intravenous mannitol, 1 g/kg 10% mannitol followed by a second dose at 24 hours, or standard care alone. Outcome assessors will be masked to treatment allocation. Feasibility outcomes include proportion of patients approached being randomised, participants receiving allocated treatment, recruitment rate, treatment adherence and follow-up. Secondary outcomes include serum electrolytes and osmolality at days 1–2; change in ICH and oedema volume at day 5; number of participants who developed urinary tract infection, GCS and National Institutes of Health Stroke Scale at day 5±2; length of hospital stay, discharge destination and death up to day 28; death and death or dependency by day 180 and disability (Barthel Index), quality of life (EuroQol, 5-D) and cognition (telephone mini-mental state examination) at day 180.
MACE-ICH received ethics approval from the East Midlands-Leicester Central research ethics committee (22/EM/0242). The trial is funded by a National Institute for Health and Care Research RfPB grant (203080). The results will be published in an academic journal and disseminated through academic conferences and patient support groups. Reporting will be in line with Consolidated Standards of Reporting Trials recommendations.
ISRCTN15383301; EUDRACT 2022-000283-22.
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