Conectar
Measuring foetal heart rate (FHR) is critical for assessing foetal well-being, and traditional cardiotocography (CTG), though effective, has limitations such as cost, accessibility and observer bias. Newer non-invasive foetal ECG (NIFECG) devices offer more precise, reliable metrics for FHR variability and could enable remote monitoring, potentially improving early detection of foetal complications like hypoxia and stillbirth.
This is a single-centre prospective cohort study taking place in a tertiary maternity unit in the UK. Women with a singleton pregnancy over 26+0 weeks will be approached for participation in the control, foetal growth restriction (FGR) or diabetic groups. The NIFECG home monitoring schedule is 60 min daily for 7 days in the control group, daily from diagnosis until delivery for the FGR group, and daily from 36 weeks until delivery in the Insulin-dependent diabetic group. Longitudinal FHR raw ECG signals will be collected from participants across different gestational age ranges. Reference standards for FHR variability using metrics such as short-term variation, phase-rectified signal averaging acceleration and deceleration capacity will be established. The study will also aim to explore differences in FHR variability in FGR cases against controls and propose safety thresholds to guide decision-making for delivery.
Approvals have been obtained from the London Stanmore Research Ethics Committee and from the Medicines and Healthcare Regulatory Agency. The results will be published in peer-reviewed journals, presented at conferences and used by the commercial sponsor to pursue European Conformity regulatory compliance marking and future clinical studies.
A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.
The Validating Outcomes by Including Consumer Experience (VOICE) project is developing patient reported experience measure (PREM) tools to collect consumer feedback for Indigenous primary healthcare (IPHC) services’ accreditation and quality improvement processes. This study aimed to explore the views of health service staff about: (1) optimising the feasibility of collection, analysis and interpretation of findings; and (2) resourcing requirements for implementation of the PREM.
A participatory action research qualitative study design, guided by an Indigenous advisory group. Our team of Indigenous and non-Indigenous researchers conducted semistructured focus groups and individual interviews with IPHC staff. Focus groups and interviews were recorded, transcribed and thematically analysed. Multiple sense-making meetings were conducted with the Indigenous advisory group.
Eight partner IPHC services across four Australian states and territories.
All staff were eligible and invited to participate in the study via purposive and snowball sampling. Administrative staff (eg, receptionist, programme facilitator), clinicians/practitioners (eg, general practitioner, nurse, Aboriginal and Torres Strait Islander health workers and practitioners) and service managers (eg, CEO, practice manager) from partner health services participated.
63 staff participated; 44 attended across 13 focus groups, with the remainder participating in individual interviews. The majority of participants were between 35 years and 55 years old (52%), female (66%) and working in frontline IPHC service delivery roles (56%). Equal numbers identified as Indigenous (50%) and non-Indigenous (50%). Many had worked in the Indigenous health and well-being sector for over 10 years (40%). ‘Culturally safe care’ and ‘accountability’ were identified as primary themes and key reasons for gathering consumer feedback. Subthemes identified were ‘Relationships’, ‘trust and respect’, ‘communication about consumer feedback’, ‘timing and frequency of requesting consumer feedback’, ‘health service systems’, ‘health service and staff capacity’, ‘staff skills’ and ‘structure and administration of the PREM’. All themes and subthemes need to be considered for the successful design and implementation of PREMs in IPHC settings.
Many of the issues identified are not currently considered in the process of collecting PREM data for accreditation yet, if addressed, would likely improve the quality and relevance of data collected. The findings from this study will inform the co-design and validation of Indigenous-specific PREM tools to collect consumer feedback. Critically, service and community input will ensure the PREM tools meet service needs for continuous quality improvement and accreditation and reflect the priorities and values of Indigenous peoples.
To explore the lived experience following Roux-en-Y gastric bypass surgery of eight men and women in the South of England who had undergone surgery a minimum of 12 months prior.
This phenomenologically based qualitative study utilised Interpretative Phenomenological Analysis (IPA) as a framework for the analysis and exploration of participants' lived experiences.
Semi-structured individual interviews were conducted with eight men and women in the South of England in 2017.
Interpretative Phenomenological Analysis revealed four superordinate themes: Managing change and uncertainty; The affective experience of change; The post-operative body within its relational context; and The presence and absence of appropriate support.
Participants described the complex nature of the post-operative experience and highlighted the deeply personal nature of the adjustment required following surgery. The process of change and adjustment does not represent a smooth transition from pre- to post-operative life, and the experience of weight loss is intertwined with relationships that require patients to renegotiate the ways in which they understand themselves within social encounters.
The clinical significance of this study lies in its support for the contribution that an existential phenomenological approach can offer in supporting individuals who choose to have bariatric surgery through its acknowledgment of the body as a site of experience which is situated within a person's wider social, cultural and historical world. These findings contribute an in-depth appreciation of the biopsychosocial experiences of individuals following Roux-en-Y gastric bypass surgery that can be applied in nursing practice to better inform the development of appropriate ways in which to support the overall wellbeing of individuals who made the decision to undergo bariatric surgery.
Limited patient involvement was incorporated, focusing on feedback on the interview process.
The aim of this research was to describe factors that influence Intensive Care Unit liaison nurses' decision to stand down a medical emergency team call response. The decision to end a medical emergency team response for a deteriorating patient is referred to as the medical emergency team call stand-down decision. Intensive Care Unit liaison nurses, also known internationally as critical care outreach nurses, make medical emergency team call stand-down decisions in complex and challenging clinical environments. However, the factors influencing these decisions are not well described in the literature.
Exploratory descriptive qualitative study.
Seven Intensive Care Unit liaison nurses who attended medical emergency team calls in a large acute metropolitan tertiary referral public hospital, with a mature three-tiered rapid response system, were observed and interviewed. Observations of 50 medical emergency team call responses and 50 post medical emergency team call interviews were conducted between March 2022 and August 2022. Findings were analysed using inductive content analysis.
Intensive Care Unit liaison nurse decisions to stand down MET call responses were influenced by three intrinsic factors: (1) propositional knowledge, (2) experiential knowledge, (3) situational knowledge and information processing styles. Intensive Care Unit liaison nurses utilised these intrinsic factors to support their decision to terminate medical emergency team call response.
This study explored the intrinsic influences on individual Intensive Care Unit liaison nurses in deciding to end a medical emergency team call. By highlighting these individual influences on decision-making, the findings may be used to support medical emergency team responders educational needs and identification of potential heuristics and biases inherent in clinical decision-making which contribute to adverse events.
No patient or public contribution.
By understanding the influences on an individual's clinical decision-making, strategies can be put in place for educational development and support for experiential learning. The study highlights areas of potential bias and heuristic use that may lead to sub-optimal clinical decisions and increased risk for deteriorating patients. Research findings can be applied internationally to a range of rapid response systems and critical care outreach teams that respond to deteriorating patients.
The consolidated criteria for reporting qualitative research (COREQ) guidelines were used for reporting this study.
by Charlotte J. Whiffin, Kathleen Joy O. Khu, Brandon G. Smith, Isla Kuhn, Santhani M. Selveindran, Laura Hobbs, Samin Davoody, Yusuf Docrat, Orla Mantle, Upamanyu Nath, Lara Onbaşı, Stasa Tumpa, Ignatius N. Esene, Harry Mee, Fergus Gracey, Shobhana Nagraj, Tom Bashford, Angelos G. Kolias, Peter J. Hutchinson
Following calls for more qualitative research in neurosurgery, this scoping review aimed to describe the range and reach of qualitative studies relevant to the field of neurosurgery and the patients and families affected by neurosurgical conditions. A systematic search was conducted in September 2024 across six databases: Medline via Ebsco; Embase via OVID; PsycINFO via Ebsco; Scopus; Web of Science Core Collection; and Global Health via Ebsco. Eligibility criteria were based on Population, Concept, and Context. The search identified 18,809 hits for screening with 812 included in the final analysis. Seven themes were identified from a content analysis of study aims: 1 Perspectives of living with a neurosurgical condition; 2 Family perspectives; 3 Perceptions of neurosurgery; 4 Perceptions of general healthcare care; 5 Decision making; 6 Advancing neurosurgery; and, 7 Understanding neurosurgical conditions. Traumatology was identified as the most researched sub-specialty (43.2%) yet few studies were led explicitly by a neurosurgeon (1.6%) or those with a neurosurgical affiliation (10.5%). Lead authors were predominantly from high income countries (93.7%), as were most multi-author teams (86.6%). There was a trend towards increasing publication over time; however, only 8.4% of papers were published in neurosurgical specific journals. The data set had an average Field Weighted Citation Impact of 0.96 and Field Weighted Views Impact of 1.11, 18.9% were cited in policy documents in 15 countries. This scoping review provides a comprehensive picture of the current qualitative research base in neurosurgery and suggests ways to improve the conduct and reporting of such studies in the future. Addressing these challenges is crucial if qualitative research is to advance the neurosurgical evidence base in a rigorous way.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.
Develop and simulate test a digital alert dashboard drawing from existing data to support nurses, care workers and managers in residential aged care.
Participatory action research, co-designing for an Australian 64-bed residential site.
Qualitative data were collected through focus groups and analysed using reflective thematic analysis.
Nursing-theory and evidence-based Nursing Data Domain Standards (NDDS) were developed to support internal triaging of fundamental and clinical care in a non-clinical environment. A co-designed retrospective digital alert dashboard (Aged Care Electronic Dashboard Information Tool—ACED-IT) representing the Standards was created and tested. Twenty aged care nurses, care workers and managers found it had promise in enhancing quality of care, improving resident health and reducing adverse events.
Maximising efficient use of resident-level data with a system that empowers nurse decision-makers is crucial to support effective care design and harm prevention.
ACED-IT has the potential to improve visibility of resident needs, support staff to adjust their workflow based on in-house triage, enhance supervision of staff and quality of care and reduce preventable complications.
Digital systems that enable nursing care escalation and triaging for early intervention are needed in residential aged care settings. The co-designed system was perceived by registered nurses, care workers and managers to have the potential to improve care quality and efficiency. Using an evidence-informed nursing framework to identify day-to-day care indicators can be widely implemented by government regulators, software providers and residential care providers on an international scale to improve resident experience.
This study adhered to the relevant EQUATOR guidelines, specifically the COREQ (Consolidated Criteria for Reporting Qualitative Research) Checklist.
A member of the public participated in the Advisory Group, observed and contributed to the co-design process and reviewed the manuscript.
To clarify the definition and evolution of Patient and Public Involvement and Engagement (PPIE) and identify its attributes, antecedents, and consequences in health-related research.
This study follows Rodgers' evolutionary concept analysis with a seven-step framework.
Datasets were searched using terms related to PPIE and key categories (i.e., attributes, antecedents, and consequences). Data were sourced from CINAHL, PsycInfo, Scopus, PubMed, and Web of Science covering publications from inception to October 31, 2024. Document titles, abstracts, and keywords were manually screened to identify relevant studies for full-text review.
A total of 1751 documents were screened, resulting in 38 eligible studies included in the final analysis. PPIE has evolved from a narrow focus on patient inclusion and participation, where patients had minimal influence on research and researchers resisted sharing control of research, to a collaborative model emphasising sustained partnerships, shared contributions, equitable power distribution, and active involvement across research stages. This shift has been driven by research innovation, a growing emphasis on healthcare equity and patient-centred care, technological advances, and stakeholder advocacy (e.g., patients, funders, ethics committees). While PPIE enhances research relevance and impact, barriers, such as resource constraints, power imbalances, patient limited research capabilities and increased researcher workload persist. Facilitators, such as training programmes, standardised guidelines, flexible arrangements and transparent communication can enable meaningful partnerships.
The concept of PPIE is evolving toward greater clarity and consistency in research, positioning patients and the public as active, essential contributors rather than passive participants. Barriers and facilitators were identified to inform its utilisation in research.
This study clarifies the conceptual ambiguities of PPIE, informs theory development, and provides actionable insights. Healthcare and nursing researchers can draw on its findings to utilise PPIE to enhance collaborative and inclusive research practices that align with the needs of patients and the public.
This study adheres to the PRISMA (2020) reporting guidelines for systematic reviews.
One of our co-authors is a patient with lived experience of cancer, who contributed valuable comments and suggestions to enhance this paper.
To discuss the multi-centre qualitative methodology as a unique design, articulate its guiding paradigm/theoretical perspectives, and highlight its methodological and methodical issues. A secondary objective is to generate further scholarly discourse regarding the multi-centre approach within the broader qualitative research tradition.
Methodological discussion.
Rather than an emphasis on only experiences, the multi-centre approach is presented as a unique design which also focuses on uncovering why a phenomenon or problem exists and perceptions regarding the phenomenon/problem. With its focus on capturing multiple subjective realities, the multi-centre qualitative design is arguably underpinned by pragmatist constructivism which offers a robust framework for researching phenomenon in a way that is both theoretically informed and practically relevant. Methodologically, the multi-centre qualitative research design emphasises a problem-centred enquiry, collaborative approach and rigorous study protocols, systematic site selection, contextual immersion and sensitivity and methodical flexibility.
With the rapidly evolving nursing and global health landscape, the multi-centre design lends itself to exploring and capturing perceptions on a larger scale compared to single site studies. Careful planning, availability of adequate resources, rigorous protocols and quality assurance plans are critical to ensuring its success.
The multi-centre approach offers the possibility of undertaking the same study across multiple settings/locations which has the potential to improve representation and strengthen transferability.
This methodological discussion offers clarity regarding the use of the multi-centre approach and offering strategies for its subsequent uptake in nursing and healthcare research.
Not applicable.
No patient or public contribution.
by John Bosco Asiimwe, Hellen Namawejje, Faith Rachel Mirembe, Annet Adong, Jolly Achola, Herbert Nabaasa, Jebena Mulusew, Jonathan Izudi, Damazo T. Kadengye
A substantial proportion (7%) of people in Uganda practice open defecation. A Community-Led Total Sanitation (CLTS) project was started in 2011 to reduce indiscriminate disposal of excreta but the effect has not been rigorously evaluated. We, therefore, evaluated the effect of CLTS on reducing open defecation in the program intervention districts in Uganda. We used the 2016 Uganda Demographic and Health Survey (UDHS) data to conduct a quasi-experimental study using a propensity score matching (PSM) approach. The intervention group consisted of districts that implemented the CLTS and the comparison group were districts that did not implement the CLTS. We matched the intervention and comparison groups on several covariates in a 1:1 ratio within a caliper of 20% of the standard deviation of the propensity score. We confirmed balance in covariates using standardized mean difference (SMD) beingWith growing access to the internet, online mindfulness programmes have become more commonly used to manage physical and mental health conditions. This scoping review aims to determine the nature and extent of the literature, and key characteristics, of online mindfulness-based interventions (MBIs) for adults with physical or mental health conditions.
A scoping review guided by the Joanna Briggs Institute framework.
MEDLINE, CINAHL, Embase, PsycINFO, Allied and Complementary Medicine and the Cochrane Central Register of Controlled Trials.
Studies focusing on online MBIs, online mindfulness-based stress reduction and online mindfulness-based cognitive therapy (MBCT) in adults with a physical or mental health condition were included.
Study and participant characteristics, key intervention characteristics, outcome measures and results were abstracted.
84 studies were included. Online MBIs have been studied in many different physical and mental health conditions; however, 63 of the included studies were for physical health conditions. MBCT was the most common intervention type assessed, with 33 of the included studies assessing it. Regarding intervention characteristics, intervention duration was similar across intervention type at 8 weeks, with sessions led by therapists, clinicians or mindfulness instructors. Web-based and videoconferencing were the most common delivery formats. Intervention content generally remained similar to standardised MBIs, with the addition of psychoeducation and disease management. Many studies did not report on tailoring the intervention to the participant population. There was a lack of consistency in reporting intervention characteristics.
This review highlights some evidence for online mindfulness programmes for both physical and mental health conditions. However, intervention componentry remains somewhat obscure, and reporting on tailoring appears relatively sparse. Greater consistency in reporting intervention componentry will improve knowledge and study in this area and enhance the translation of these interventions to clinical settings.
Our objectives were (1) to characterise the age-sex-standardised prevalence of comorbidities among people living with HIV (PLWH) and people not living with HIV (PnLWH) between 2001 and 2019 and (2) to examine the effect of comorbidities on direct healthcare costs among PLWH and PnLWH.
This was a retrospective, matched cohort study conducted with the Comparative Outcomes and Service Utilisation Trends (COAST) cohort, which contained all known PLWH in British Columbia (BC), Canada and a general population sample.
BC, Canada.
A total of 9554 PLWH and 47 770 PnLWH from the COAST cohort were followed between 2001 and 2019. Participants were at least 19 years old and 82% male in both groups.
The primary outcomes were the age-sex-standardised prevalence of 16 comorbidities, calculated annually, among PLWH and PnLWH. Secondary outcomes included direct healthcare costs associated with each comorbidity among PLWH and PnLWH. Outcomes were ascertained from administrative health databases.
PLWH exhibited a higher age-sex-standardised prevalence of most comorbidities compared with PnLWH over the study period. Relative disparities in liver and kidney diseases markedly decreased since 2008. Disparities in the prevalence of mental health disorders and substance use disorder (SUD) were consistently large throughout the study period. Comorbidities were associated with high healthcare costs, especially among PLWH.
This study underscores the persistent and evolving burden of non-AIDS-defining comorbidities among PLWH, even in the context of improved HIV management. The high prevalence of mental health disorders and SUD, coupled with the substantial healthcare costs associated with these conditions, emphasises the need for holistic and integrated care models that address the full spectrum of health challenges faced by PLWH.
To discuss the dyadic and triadic interviewing techniques as distinct approaches to data collection in qualitative research.
Methodological/methodical discussion.
Underpinned by a layered theoretical basis involving interpretivism, social constructivism and symbolic interactionism, dyadic and triadic interviewing approaches represent a tapestry that seeks to illuminate not only what participants think at the individual level, but also how they think together to generate shared, nuanced meanings. Key methodical considerations include participant recruitment and selection to form the dyads or triads, ethical issues, navigating power dynamics, determining saturation at the dyad or triad level and shifting the unit of analysis from the individual level to the dyad or triad level. Notable challenges to using these approaches include logistical complexity, ethical risks and the great need for skilled moderation.
Dyadic and triadic interviewing techniques occupy a vital methodological niche in qualitative studies, particularly within the contexts of health and social care research where relational dynamics and collaborative decision-making are central. By foregrounding co-constructed narratives and real-time interactions, dyadic and triadic interviewing techniques illuminate the interplay of individual agency, power asymmetries and cultural norms, offering insights that transcend the limitations of individual interviews or focus groups.
The increasing complexity of care, treatment pathways, recovery and family-centered decision making warrants engagement beyond individual interviews. Dyadic and triadic interview techniques facilitate this by combining the in-depth benefit of individual interviews and shared interpretations of focus group discussions to capture meanings and experiences.
This methodological/methodical discussion offers clarity to employing dyadic or triadic interviewing approaches to improve their uptake in health and social care research.
Not applicable.
No patient or public contribution.
To investigate the effects of the Family-Centred Empowerment Model on informal caregivers on individuals with chronic diseases.
The Family-Centred Empowerment Model may help address informal caregivers' challenges in chronic disease management, including caregiver burden. However, its effectiveness for informal caregivers of chronic disease patients remains unclear.
Systematic review and meta-analysis of randomised controlled trials and quasi-experimental studies.
The review followed the PRISMA 2020 guidelines. A comprehensive search was conducted in EMBASE, PubMed, Cochrane Library, Web of Science, CINAHL, CNKI, SinoMed and Wanfang Data from their inception to January 2024. Two investigators independently evaluated study quality using the Cochrane Risk of Bias Tool and the Joanna Briggs Institute checklist.
This review included 22 studies. The meta-analysis demonstrated that the Family-Centred Empowerment Model significantly reduced caregiver burden, stress and anxiety. Subgroup analyses further revealed a positive effect on reducing caregiver burden across both paediatric and adult patient populations. Additionally, the intervention's effect on caregiver burden remained significant for 1–3 months following the intervention. While the model did not significantly affect the pooled outcome for care ability, subgroup analyses indicated that the model was more effective at improving care ability 3 weeks post-intervention compared to immediately after the intervention.
The Family-Centred Empowerment Model for informal caregivers of chronic disease patients may help reduce caregiver burden, stress and anxiety, while gradually improving care ability. However, it has no significant effect on depression or family function.
The review provides valuable evidence to guide clinicians in implementing the Family-Centred Empowerment Model for informal caregivers of chronic disease patients. By applying this model, caregivers can reduce burdens, stress and anxiety while enhancing their care abilities.
As a systematic review and meta-analysis, these details did not apply to our work.
PROSPERO (CRD42024505357)
Coronary artery disease (CAD) is a main cause of incapacitating adverse cardiac events in aviation. Military aircrew ≥40 years in the Netherlands undergo a 5-year exercise ECG (X-ECG), which lacks precision to identify relevant CAD. The study aim was to identify the screening value of cardiac CT (CCT) in asymptomatic military aircrew.
Prospective, single-centre, cross-sectional study.
Conducted at the Centre for Man in Aviation, Royal Netherlands Air Force. CT scans were performed at the University Medical Centre, Utrecht.
Asymptomatic military aircrew ≥40 years were asked to undergo CCT, with coronary artery calcium score (CACS) and coronary CT angiography (CCTA), following their aeromedical exam. CCT was performed in 211 participants (median age 49.3 years (43.6–52.8), 98% men, 65% pilots).
The main objective was to determine the prevalence of relevant CAD. Clinically relevant CAD (CR-CAD) is defined as CACS ≥100 and/or a stenosis ≥50%. Aeromedically relevant CAD (AR-CAD) includes CR-CAD and/or a left main stenosis >30% or an aggregate stenosis ≥120%. Secondary objectives included assessing the prevalence of mild coronary stenosis (defined as 25%–49% stenosis), the presence of high-risk plaque (HRP) features and CCT safety.
CR-CAD was found in 25 male aircrew (12%), with a CACS of ≥100 in 21 (10%) and a stenosis ≥50% in 10 (5%), including two with CACS 0. Two additional men had ≥120% aggregate stenosis, bringing total AR-CAD to 27 (13%). Twenty-nine men (14%) had mild stenosis. HRP features were present in 44 (21%). There were no CT-related complications. Of 196 participants who underwent X-ECG, seven showed abnormal results; one had relevant CAD.
Contrast-enhanced CCTA provides additional information both on high-risk features and obstructive CAD compared with CACS only. CCT is safe and is of additional value to X-ECG in a low-risk population with a high-hazard occupation.
Background
Chronic pain is a major cause of distress and disability, and biomarkers may aid in the assessment and treatment of it. Urine metabolites may be valuable bioindicators that can provide biological insight regarding chronic pain.
Objectives
To investigate the relationship between a multimarker composite measure of metabolites and patient-reported outcomes scores in adults with chronic pain, using data from a pragmatic clinical trial with a sequential, multiple-assignment randomized trial design.
Methods
Self-reported measures and urine samples from 169 active-duty service members with chronic pain were collected. Urine was analyzed using a preestablished panel of metabolites, including four previously identified biomarkers of pain: kynurenic acid, pyroglutamic acid, ethylmalonic acid, and methylmalonate. Multivariable linear regression models—adjusted for participant characteristics such as age and sex—were used to cross-sectionally examine the relationship between 11 patient-reported outcomes (fatigue, sleep-related impairment, anxiety, depression, anger, pain catastrophizing, physical function, pain interference, satisfaction with participation with social roles, pain intensity, and pain impact score) and the four urine metabolites both individually and as a composite (urine metabolite pain indicator, or UMPI). Given the study’s small sample size and exploratory nature, a significance threshold of p ≤ .10 was used for all analyses.
Results
The UMPI showed statistically significant associations with five self-reported measures (fatigue, anxiety, depression, physical functioning, and pain impact score); adjusted Pearson correlations ranged from .18 to .25. Individual metabolite analyses supported these findings, with all relationships between individual metabolites and self-reported measures showing positive associations. Kynurenic acid and ethylmalonic acid showed the strongest associations, each having statistically significant relationships with four individual self-reported measures, while pyroglutamic acid had statistically significant relationships with three self-reported measures and methylmalonate with none. The UMPI demonstrated feasible reliability.
Discussion
Our finding of associations between the UMPI and components of the self-reported measures supports the development of the UMPI and these four urine metabolites as biomarkers for chronic pain outcomes. Further research is planned and will be essential for establishing mechanistic insight and guiding biomarker development within the context of pain management. Hypertensive disorders of pregnancy (HDP), including gestational hypertension and pre-eclampsia, affect approximately 10% of pregnancies worldwide and contribute significantly to fetal and maternal morbidity and mortality. Early identification of HDP would facilitate targeted surveillance and personalised care in order to mitigate the severity of complications and improve pregnancy outcomes. Uric acid is a marker of oxidative stress, inflammation and endothelial dysfunction, and has been proposed as a predictor of hypertensive disease. Salurate is a salivary uric acid test that has the potential to identify pregnant women at risk of developing HDP several weeks before clinical manifestation.
This is a prospective, multicentre, observational, cohort study with health economics evaluation. Women aged 16 and above, with a viable singleton pregnancy at 1:300 will be eligible for recruitment. Participants will perform weekly remote salivary uric acid testing from enrolment until the conclusion of pregnancy and upload results of colourimetric paper tests via a smartphone application. We will validate a predictive algorithm that analyses colour data from several consecutive samples to detect patterns that predict whether HDP is likely to occur. The primary outcome is test performance for the prediction of HDP. Secondary outcomes include adherence to sampling and test performance for predicting gestational diabetes, stillbirth and fetal growth restriction. Data on pregnancy outcomes will be collected from the medical notes, compared with the predictions made by the algorithm and subjected to statistical analysis.
Approval has been obtained from Cambridge East Research Ethics Committee (REC reference 24/EE/0123), Medicines and Healthcare products Regulatory Agency (CI/2024/0038/GB) and Health Research Authority (IRAS ID 337290). Results of the study will be published in peer-reviewed journals and presented at national and international conferences.
4, 4 July 2024.
Despite expert recommendations to prioritise non-invasive and patient-centred approaches for behavioural crisis management, physical restraints are commonly used in the emergency department (ED). Patients describe the restraint process as coercive and dehumanising. The use of peer support workers, who are individuals with lived experience of mental illness and behavioural conditions, has shown positive patient outcomes when assisting individuals experiencing behavioural crises. However, there is limited evidence of the implementation of such an approach in the ED setting. The goal of this study is to evaluate if the implementation of a Peer support enhanced Agitation Crisis response Team (PACT) for behavioural crisis management in the ED is more effective than usual care to reduce restraint use and improve outcomes among patients presenting to the ED with behavioural crises.
We will first conduct a stakeholder-informed needs assessment to codesign the protocol and then train staff and peers in PACT intervention readiness. Next, a stepped-wedge, cluster-randomised controlled trial will be conducted over 3 years at five ED sites across a healthcare system in the Northeast USA. The PACT intervention will integrate peer delivery of trauma-informed care within a structured, interprofessional, team-based response protocol for behavioural crisis management. The primary outcome is the rate of physical restraint and/or sedation use. The secondary outcome is the level of patient agitation during the ED visit. Analyses of primary and secondary outcomes will be conducted using generalised linear mixed models.
This protocol has been approved by the Yale University Human Investigation Committee (protocol number 2000037554). The study is deemed minimal risk and has been granted a waiver of consent for trial participants. However, verbal consent will be obtained for a subset of patients receiving follow-up data collection. Results will be disseminated through publications in open-access, peer-reviewed journals, via scientific presentations, or through direct mail notifications.
Clinicaltrials.gov: NCT06556069.
Postbariatric hypoglycaemia (PBH) is a complex medical condition with a significant impact on patients’ quality of life. The underlying mechanisms remain to be elucidated. We have shown that food ingestion increases IL-1β and subsequently stimulates insulin secretion. We therefore hypothesised that overactivation of the IL-1β pathway could lead to PBH by promoting excessive insulin secretion after a meal. In a proof-of-concept study, we have shown that acute treatment with the IL-1 receptor antagonist anakinra can attenuate PBH after a single liquid mixed meal. This study aims to validate this therapeutic approach over a longer period of time using the long-acting anti-IL-1β antibody canakinumab.
In this prospective, randomised, double-blind, placebo-controlled, multicentre trial, we plan to enrol 62 adult patients after bariatric surgery with frequent, postprandial hypoglycaemia (ie,
The trial was approved by the Cantonal Ethics Committee ‘Ethikkommission Nordwest- und Zentralschweiz’ in January 2022 (#2021–02325), as well as by Swissmedic in April 2022 (#701280). Current, approved protocol version 1.3 of 28.03.2023. The study is actively recruiting. Results will be published in a relevant scientific journal and communicated to participants and relevant institutions through dissemination activities. Individual data are accessible on request.
The study is registered with the www.clinicaltrials.gov registry (
FreshRSS 