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.
Gender-based violence is a worldwide health and social problem with negative short- and long-term health impacts. Sexual and gender minority people experience more gender-based violence and significant barriers to support. These populations are often not included in, or are actively excluded from, gender-based violence research, and sexual orientation and gender are generally poorly measured and reported. One recommendation put forth to improve the evidence base with regard to sexual and gender diversity is higher standards of research and reporting by academic journals. Given the leading role of nurse researchers in this area of women's health, this is a topic of particular importance for nursing research and education.
We examined the sexual and gender diversity-related guidance provided by academic violence journals to authors, editors and peer-reviewers.
We conducted a descriptive document analysis. Two researchers independently searched for, and coded, guidance related to sexual and gender diversity from 16 websites of academic journals focused on violence research.
While most journals included some mention of diversity or inclusion, only about half provided in-depth guidance for authors, editors and/or peer-reviewers. Guidance related to gender was more common than guidance for sexual diversity. The journals gave varied prominence to diversity-related guidance, and it was often difficult to locate.
To reflect the spectrum of lived experiences of gender and sexuality, publishers must actively direct authors, editors and reviewers to include, measure and report these experiences. This has not yet been fully achieved in the important area of gender-based violence research, and is of direct concern to nurse researchers who contribute significantly to this body of knowledge.
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.
To understand the social representations of bedside milk expression (BME) among mothers of preterm newborns in neonatal intensive care units (NICUs).
Qualitative descriptive study.
The study was conducted from July to August 2024 in two NICUs of a referral maternity hospital in Fortaleza, Brazil. Nineteen mothers of hospitalised premature newborns participated. Semi-structured interviews were conducted and subjected to thematic content analysis.
Mothers perceived BME as a meaningful act of protection and bonding, though some were unfamiliar with the practice. Emotional ambivalence was common, shaped by prior breastfeeding experiences and the context of prematurity. Discomfort related to privacy and shared spaces was noted. Support from healthcare professionals was essential to promote understanding and adherence.
Social representations of BME are shaped by emotional, social and institutional experiences. Anchored in prior breastfeeding experiences and cultural meanings of maternal care, the practice is objectified through both gestures of affection and tangible barriers.
Healthcare professionals, particularly nurses, should receive training to support mothers in BME. Structural improvements, privacy and emotional support are essential for fostering maternal autonomy and confidence.
This study highlights the barriers to BME, emphasising the role of healthcare support and the need for better infrastructure, privacy and training to enhance maternal confidence and breastfeeding.
The study followed the Consolidated Criteria for Reporting Qualitative Research checklist.
None.
This paper highlights the pivotal role of healthcare professional support in overcoming barriers to BME and promoting breastfeeding practices.
Fresh breast milk is considered the gold standard for reducing complications and improving survival in preterm infants. BME is recommended as an effective strategy to ensure the availability of fresh breast milk. Mothers' social representations of this practice remain underexplored within the neonatal intensive care context.
Explores mothers' social representations of BME in NICUs, addressing a significant gap in qualitative research. Reveals how emotional, social and institutional factors shape mothers' perceptions, motivations and challenges related to BME. Highlights the need for targeted professional support, improved infrastructure and privacy to enhance maternal autonomy and adherence to milk expression practices.
Healthcare professionals, particularly nurses, should receive specialised training to provide technical guidance and emotional support, enhancing mothers' confidence and autonomy in BME. Improving infrastructure and ensuring privacy in NICUs are crucial to creating supportive environments that facilitate milk expression and strengthen maternal–infant bonding. Institutional policies should integrate maternal-centred strategies to support breastfeeding continuity and promote humanised neonatal care.
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).
To examine the extent of adherence to high-level principles in remote prescribing and investigate how medical and non-medical prescribers comply with these principles.
Scoping Review.
A systematic search of CINAHL, PubMed, Medline, the Cochrane Database of Systematic Reviews, the Web of Science, and the Ovid Emcare databases was performed. A grey literature search was conducted on relevant professional websites and Google Scholar. Literature was searched from January 2007 to March 2025.
Research results were uploaded to Raayan for management and selection of evidence. Two reviewers independently scored and appraised papers using a structured data extraction form. The ‘United Kingdom High-level Principles for Good Practice in Remote Consultations and Prescribing’ served as a coding framework for deductive manifest content analysis.
Searches identified 6870 studies. After screening the title and abstract, 54 full texts were reviewed, and 14 studies were identified for analysis. Adherence to high-level principles was limited and inconsistent. Data categories were developed into 5 themes: (1) Patient privacy and vulnerability, (2) Adequate assessment, (3) Guidelines and evidence-based prescribing, (4) Investigations and safety netting, and (5) Organisational safety and creating safe systems.
This review provided insight into the challenges that medical prescribers face when adhering to governance principles during remote prescribing practice. However, no research about how non-medical prescribers integrate remote prescribing governance into their practice was found.
Remote prescribing has become firmly embedded within the current healthcare system and robust governance is required to safeguard patient outcomes. Further research exploring how non-medical prescribers integrate the high-level principles into practice will inform prescribing governance for this group.
No patient or public contribution was sought as the scoping review focused solely on the existing literature.
To canvas the contemporary contextual forces within the Australian residential aged care sector and argue for new research and innovation. There is a pressing need to provide systematised, high-quality and person-centred care to our ageing populations, especially for those who rely on residential care. This paper advances a warrant for establishing a new systematic framework for assessment and management that serves as a foundation for effective person-centred care delivery.
Position paper.
This paper promulgates the current dialogue among key stakeholders of quality residential aged care in Australia, including clinicians, regulatory agencies, researchers and consumers. A desktop review gathered relevant literature spanning research, standards and guidelines regarding current and future challenges in aged care in Australia.
This position paper explores the issues of improving the quality and safety of residential aged care in Australia, including the lingering impact of COVID-19 and incoming reforms. It calls for nurse-led research and innovation to deliver tools to address these challenges.
The paper proposes an appropriate holistic, evidence-based nursing framework to optimise the quality and safety of residential aged care in Australia.
This study did not include patient or public involvement in its design, conduct, or reporting.
Explore the care escalation process initiated by parents concerned about their hospitalised child's deterioration and healthcare providers' response to parental concerns.
A qualitative study using Charmaz's constructivist grounded theory.
Participants included healthcare providers, cultural mediators and parents of children hospitalized for ≥ 3 days, who had experienced previous urgent intensive care admission or parental concern during hospitalization, in a tertiary pediatric hospital. Data were collected through focus groups, and analyzed using a grounded theory methodology with NVivo Software.
A total of 13 parents, 7 cultural mediators and 68 healthcare providers participated in 16 focus groups. Two main categories were identified: (1) Parents navigating the uncertainty of the escalation system to get a response; (2) Healthcare providers balancing parents' concerns, their own situation awareness, escalation processes and team relations. We developed a Grounded theory called ‘Parents Supporting Timely Escalation Processes’ (P-STEP). By monitoring their children, parents identify early signs of deterioration and advocate for escalation. Reasons for concern are their child's behaviour, communication failure and admission on an off-service ward. Parents escalate by contacting ward providers, their child's specialist or the most trusted staff and, only selected parents, the Rapid Response Team. Staff escalate parents' concern according to their own situation awareness, parent evaluation and ward escalation practices. Parent's emotions and trust are influenced by the timeliness and type of staff response.
While some parents effectively advocate for their child, others face obstacles due to unclear and lack of formal care escalation systems. Understanding how parents escalate care and healthcare providers respond is essential to identify facilitators, barriers, key stakeholders, and implement a formal system for parent-initiated escalation of care.
Integrating parents into processes of escalation and rapid response systems could optimise early recognition and improve responsiveness in paediatric deterioration.
The study adheres to the COnsolidated criteria for REporting Qualitative research (COREQ) guidelines.
Parents and HCPs participated as interview respondents.
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.
Evaluate the effect of IV line labels on nurses' identification of high-alert medications in a simulated scenario of multiple infusions for critically ill patients.
Randomised crossover simulation experimental study.
A study was conducted on 29 nurses working in intensive care for over 6 months. They were given two critical scenarios in a simulated environment, one with labels and the other without labels, involving multiple intravenous infusions. The nurses had to identify the medications infused into the critical patients' intravenous lines and disconnect a specific line. The data were collected and analysed to evaluate the errors made by the nurses in identifying and disconnecting the medications and the time they spent carrying out the tasks. The Wilcoxon test was used to analyse the variation in outcome before and after the intervention.
Approximately one-third of the study participants incorrectly identified the intravenous lines in both scenarios. There was no significant difference in the average number of errors between the scenarios with and without labels. However, the time taken to perform the tasks in the scenario with labels was 1 min less than in the scenario without labels, suggesting a potential efficiency gain.
The labels on the intravenous lines allowed for quick drug identification and disconnection. The professionals performed similarly in correctly recognising the high-alert medication intravenous lines, in the scenarios with or without labels.
The label can be used as a technology to prevent misidentification of high-alert medications administered to critically ill patients through intravenous lines, thereby enhancing medication safety in healthcare institutions.
No Public Contribution.
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
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