PURPOSE:The North West London Diabetes Cohort is established to provide systematic characterisation of a large diabetes population as a foundation for complications research and prognostic modelling. Many predictive modelling studies neglect the essential descriptive characterisation of underlying cohorts, focusing narrowly on model accuracy. This cohort profile addresses this gap by comprehensively describing the demographic composition, clinical characteristics and complication incidence patterns. The notably diverse, multiethnic population enables examination of ethnic disparities and supports future development of reliable prognostic models and evidence-based prevention strategies for diabetes complications. PARTICIPANTS:At baseline, 337 271 patients with diabetes were identified. It includes 279 067 patients with type 2 diabetes, 17 638 with type 1 diabetes, 33 590 with gestational diabetes and 6916 with unspecified diabetes. The earliest diabetes diagnosis dates to January 1932, with data updated to 27 May 2025. FINDINGS TO DATE:This cohort profile describes baseline characteristics of patients with comprehensive data collected on demographics (age, sex, Deprivation Index, ethnicity), clinical measures (glycated haemoglobin, body mass index, blood pressure, lipids and estimated glomerular filtration rate) and 14 major diabetes complications tracked longitudinally. Key findings for patients with type 2 diabetes reveal diabetic retinopathy as the most common complication (74.6 per 1000 person-years), followed by hypertension (51.0) and kidney disease (31.4). Cumulative incidence analyses using the Aalen-Johansen estimator, which accounts for mortality as a competing risk, demonstrated significant ethnic disparities, with black, Asian, mixed and other ethnic groups showing elevated risk compared with white patients. Time-varying Cox models identified strong clustering between cardiovascular and renal complications, confirming a cardiometabolic-renal syndrome. Mental health conditions (depression and anxiety) were prevalent throughout the disease timeline, occurring both before and after diabetes diagnosis. FUTURE PLANS:This cohort will be used as a platform for developing and validating prognostic models for diabetes complications, enabling risk stratification and targeted interventions. Future work will incorporate medication data to refine diabetes type classification, examine the effectiveness of antidiabetic medications in preventing different complications and address demographic differences in prognostic model performance and prediction accuracy. To better characterise lifestyle, further interrogation of electronic health record data will examine recording of advice given, including dietary advice, referral to weight management schemes and presence of alcohol consumption codes.
Introduction The aim of this systematic review protocol is to provide the current reported level of diagnostic performance of ultra-low field MRI (ULF-MRI) in brain imaging of both paediatrics (including neonates and infants) and adults from a range of neurological conditions. Methods and analysis We will use the population/problem, intervention, comparison and outcome framework to break down the keywords to search PubMed, Medline, CINHAL, Embase, Web of Science, Scopus, Cochrane Central Register of Controlled Trials and Google Scholar without restriction of geographical location, study design and publication status. Other sources such as the reference list of selected studies will also be searched, and the search will be documented with a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart. The Quality Assessment of Diagnostic Accuracy Studies 3 tool will be used to assess the quality of the retrieved studies. After screening the studies, a meta-analysis for the primary outcome of individual and pooled diagnostic accuracy will be conducted using Meta-DiSc V1.4. Results expressed as forest plots, pooled heterogeneity values, 95% CIs, probability values and summary receiver operating characteristic curve plots will be used for data synthesis. The review commenced in January 2026 and is anticipated to conclude in June 2026. At the time of protocol submission, study identification, screening, data extraction, quality assessment and evidence synthesis have not yet commenced. Ethics and dissemination The results of this systematic review will be disseminated in a peer-reviewed journal and presented at a relevant conference. Data do not include animal or human participant recruitment or personal individual data. All data are already published in the public domain; therefore, ethical approval is not required. PROSPERO registration number PROSPERO 1308164
Background Maternity Waiting Homes (MWHs) are a key strategy for improving maternal health by bringing expectant women closer to health facilities and skilled birth attendants. Despite their potential benefits, a woman’s stay is shaped by various factors, including emotional, social and logistical aspects. Objectives This study aimed to explore the lived experiences of pregnant women using maternity waiting homes in the Ari zone public health facilities, Ethiopia. Design A qualitative phenomenological study, grounded in a descriptive (Husserlian) phenomenological orientation and analysed using Colaizzi’s seven-step framework. Setting Public health facilities providing MWH services in the Ari zone, southern Ethiopia, ranging from a zonal hospital to primary health centres. Participants 15 pregnant women, who had stayed in an MWH for at least 1 week during their current pregnancy, selected using purposive sampling until data saturation was reached. Methods We conducted in-depth interviews from 15 June 2025 to 15 July 2025 to match the Study Area and Period section. The data were transcribed, translated and thematically analysed with Open Code software V.4.02 to identify key themes and subthemes. The rigour of the study was ensured by applying Guba’s trustworthiness criteria, with a focus on credibility, transferability, dependability and confirmability. Results Based on the findings, the experiences of women in maternity waiting homes centred on four main themes. Emotionally, women faced both isolation and anxiety from being away from home but also felt comfort and relief from being near medical care. Socially, they found support from other women and were influenced by the attitudes of health staff while also carrying the burden of family and cultural concerns. Practical challenges included significant financial burdens, lack of food and inadequate facilities. Despite these difficulties, women ultimately valued the homes for the increased confidence and improved access to skilled care they provided for a safer birth. Conclusions A woman’s experience in an MWH is shaped by a mix of emotional, social, infrastructural and cultural factors. To improve the use of MWHs and maternal health outcomes, it is crucial to enhance the quality of these facilities, offer psychosocial support and involve communities. Future intervention studies should test whether targeted psychosocial and food-security support measurably improve women’s experiences and MWH uptake.
Introduction Decisions regarding life-sustaining treatment and end-of-life care are among the most ethically complex and emotionally challenging decisions encountered in emergency departments and intensive care units. Such decisions frequently involve uncertainty regarding prognosis, limited time for deliberation and situations in which patients may lack decision-making capacity, requiring family members or surrogate decision-makers to participate in the decision-making process. Shared decision-making (SDM) has increasingly been recommended as an approach to align treatment decisions with patients’ values and preferences. Decision aids are evidence-based tools designed to support informed and value-congruent healthcare decisions by presenting available options, potential benefits and harms and opportunities for values clarification. Although decision aids have been extensively studied in chronic disease management and preference-sensitive healthcare decisions, their use in life-sustaining treatment and end-of-life care in emergency and intensive care settings remains fragmented and has not yet been comprehensively mapped. This scoping review aims to identify and map the existing literature on decision aids and related interventions that support SDM for life-sustaining treatment and end-of-life care in emergency and intensive care settings. Methods and analysis This scoping review will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR). Electronic searches will be performed in PubMed, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL and Ichushi-Web. Studies published in English or Japanese from January 2000 onwards will be eligible. Quantitative, qualitative, mixed-methods and descriptive studies addressing decision aids or related interventions designed to support SDM regarding life-sustaining treatment and end-of-life care among adult patients, family members, surrogate decision-makers or healthcare professionals in emergency and intensive care settings will be included. Two reviewers will independently screen studies, assess eligibility and chart data. Findings will be synthesised descriptively and presented in narrative and tabular formats. Ethics and dissemination Ethics approval is not required because this review will analyse data from publicly available literature and will not involve human participants. Findings will be disseminated through publication in a peer-reviewed journal and presentation at relevant scientific conferences.
Objectives To compare receipt of guideline-informed myocardial infarction (MI) care by mental disorder and assess how the COVID-19 pandemic affected associations. Design A population-based cohort study using linked electronic health records. Setting England, November 2019 to February 2023. Participants 131 075 adults with non-ST-elevation MI (NSTEMI) and 79 045 adults with ST-elevation MI (STEMI) were identified from the Myocardial Ischaemia National Audit Project, and their prior diagnoses of mental disorder were ascertained from linked hospitalisation and primary care records. Outcome measures We compared guideline-informed care standards for each of NSTEMI and STEMI between people with schizophrenia, bipolar disorder or depression versus those without any of these disorders. We used logistic regression to adjust for confounders and investigate differences over time. Results Mental disorder disparities were more evident for NSTEMI than STEMI. Following NSTEMI, people with a mental disorder had lower odds of angiography eligibility and receipt, cardiac ward admission and cardiac rehabilitation referral. ORs (95% CIs) ranged from 0.25 (0.20 to 0.31) for angiography receipt for schizophrenia to 0.92 (0.89 to 0.96) for cardiac ward admission for depression. Following STEMI, people with bipolar disorder were less likely to meet the 150 min call-to-balloon target (OR 0.72; 95% CI 0.55 to 0.93), and people with schizophrenia were less likely to receive rehabilitation referral (OR 0.38; 95% CI 0.23 to 0.61) or indicated secondary prevention medication (OR 0.46, 95% CI 0.27 to 0.77). There was no clear evidence that the COVID-19 pandemic affected disparities. Conclusions People with a mental disorder are less likely to receive guideline-informed MI care, with disparities greatest following NSTEMI and for people with schizophrenia.
Objectives To assess the implementation of infection prevention and control (IPC) measures and associated factors in healthcare in low-resource settings during the COVID-19 pandemic. Design Multinational cross-sectional study. Setting The study was conducted from February to November 2022 in Côte d’Ivoire, Democratic Republic of Congo, Madagascar and Nigeria. Participants A total of 6749 healthcare workers (HCWs) at 324 healthcare facilities (HCFs) were enrolled from different levels of care and types. Primary and secondary outcomes Standardised HCW and HCF questionnaires assessed COVID-19-related exposures and IPC measures and descriptive analyses were conducted overall and by country and HCF. Partial proportional odds models were used to assess factors associated with HCW compliance to hand hygiene and mask wearing. Results Among 324 HCFs, the reported presence of IPC programmes ranged from 51.4% (n=111) at primary non-hospitals to 83.3% (n=18) at tertiary HCFs. More than half reported no patient or HCW screening (57.4%, n=186). Only 19.8% (n=64) reported handrub at point of care in every room. Among 6749 enrolled HCWs, 54.0% were working in high-risk patient care. More HCWs reported sufficient availability of masks (62.7%, n=4231) compared with respirators (28.5%, n=1926). HCW compliance with hand hygiene and mask wearing, respectively, was improved by presence of an IPC programme (OR: 1.3, 95% CI 1.2 to 1.5; OR: 1.4, 95% CI 1.2 to 1.6), IPC training received by the HCW (OR: 1.5, 95% CI 1.3 to 1.7; OR: 1.3, 95% CI 1.2 to 1.5) and availability of handrub and masks, respectively (OR: 5.9, 95% CI 4.1 to 8.4; OR: 2.3, 95% CI 2.0 to 2.7). Conclusions We conducted a large survey including HCFs across levels of care and type in urban and rural regions in sub-Saharan Africa. Critical gaps in IPC programmes and access to IPC equipment during the COVID-19 pandemic hindered HCW compliance with recommended IPC practices. To improve general infection control and pandemic preparedness in low-resource settings, continued focus on strengthening IPC programmes and ensuring access to materials/equipment is essential.
Introduction Sleep is an important natural process carried out by the human body. It allows the body to rest and the brain to process information attained over the course of the day. Sleep is intrinsically linked to mental health, with those with mental illness more likely to require support in attaining adequate sleep. Recently, the College of Psychiatrists in Ireland’s REFOCUS committee has sought to co-design an information leaflet for those with mental illness detailing the latest recommendations from the literature regarding sleep for this population, regardless of whether or not they take psychotropic medications. Given the rapidly expanding research focus on this topic, there are many published systematic reviews on the subject. As such, this proposed umbrella review seeks to collate the existing qualitative-based systematic reviews into sleep and mental illness and synthesise them in order to draw out the key recommendations that can be used by the committee to co-design an information leaflet to be used in practice to support service users with sleep disturbance. Method and analysis This proposed review aims to explore how service users of mental health services experience sleep with and without the medication used to treat mental illness. An umbrella review that is compliant with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) is proposed. Search terms are stated, and a variety of databases (Medline, Embase, CINAHL, Web of Science, Scopus) will be searched. The search range is from 1 January 2016 to present (2026). Ethics and dissemination Given that this paper presents a protocol for an umbrella review into sleep and mental illness, no ethical approval was required. The proposed umbrella review has been registered with the repository: PROSPERO on 18 March 2026 where it is freely available. The results of the umbrella review will be disseminated through both a peer reviewed publication and through an information leaflet co-designed by the College of Psychiatrists in Ireland’s REFOCUS committee. This protocol and subsequent umbrella review is and will be co-designed by psychiatrists, service users and family members of those with mental illness. Such individuals are named authors on this protocol and will be named authors on the proposed umbrella review as well. PROSPERO registration CRD420261343674.
OBJECTIVES:Malnutrition is a significant problem in critically ill patients and is associated with higher mortality, morbidity and healthcare costs. Enteral nutrition (EN), being more physiological than parenteral nutrition, helps reduce complications. This study evaluated how well EN practices in Turkish intensive care units (ICUs) align with current clinical nutrition guidelines. DESIGN AND SETTING:This multicentre, prospective, point-prevalence study was carried out in six ICUs in Türkiye. PARTICIPANTS:Adult patients (≥18 years) who had stayed in the ICU for at least 48 hours and had received EN for a minimum of 24 hours on either of the two prespecified point-prevalence dates (30 July and 30 August 2025) were eligible. All patients meeting these criteria were included. INTERVENTIONS:No intervention was performed. Existing EN practices were evaluated against guideline-based recommendations. PRIMARY OUTCOME MEASURES:EN practices were assessed according to initiation time, type of EN tube, method of EN administration, rate of achieving calorie and protein target, management of conditions requiring EN interruption and use of prokinetic agents. Guideline adherence was evaluated using a protocol based on European Society for Clinical Nutrition and Metabolism (ESPEN), American Society for Parenteral and Enteral Nutrition (ASPEN) and Turkish Society of Clinical Enteral and Parenteral Nutrition (KEPAN) recommendations. RESULTS:98 patients were included; 60 patients (61.2%) were male, and the median age was 72 (IQR 59-79) years. EN was initiated within 48 hours in 72 patients (73.5%), while 13 (13.3%) delays lacked clinical justification. The median percentage of administered energy and protein compared with the targets was 87% (IQR 69.6%-100%) and 82% (IQR 64.9%-100%), respectively. However, only 27 patients (27.6%) achieved 100% of both energy and protein requirements. Failure to achieve nutritional targets was significantly associated with a higher number of comorbidities (p=0.007), higher body mass index (p=0.017) and renal dysfunction (p=0.041). EN continued despite contraindications in 14 patients (14.3%), who had significantly higher Acute Physiology and Chronic Health Evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA) and Nutrition Risk in Critically Ill (NUTRIC scores (all p<0.05). CONCLUSIONS:Among patients receiving EN, overall adherence to guideline recommendations was high. However, improvements are needed in achieving nutritional targets and optimising prokinetic use.
Introduction Clinical reasoning is an essential competency for all physicians, and fostering this skill in medical students is a primary objective of medical education. Currently, clinical reasoning is predominantly cultivated through experiences in clinical settings; however, this approach presents certain limitations. The emergence of innovative medical simulation teaching methods has led to the increasing utilisation of standardised patient (SP) simulations in medical education. However, the specific contribution of the SP teaching method to the development of clinical reasoning skills in medical students remains unclear. Therefore, we propose a systematic review to summarise the impact of the SP teaching method on the clinical reasoning competence of medical students.Methods and analysis This systematic review protocol adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines for reporting results. A comprehensive literature search will be conducted across five major online databases: PubMed, Embase, Web of Science, Education Research Complete and the Cochrane Library. The screening process comprises an initial review of titles and abstracts to identify relevant studies efficiently, followed by a full-text assessment of the selected articles. Two reviewers will independently conduct study selection, data extraction and risk of bias assessment. Data extraction will be performed using a standardised form. The primary outcome is clinical reasoning competence, and secondary outcomes are communication skills and student satisfaction. The risk of bias in included studies will be evaluated using the Cochrane Risk of Bias tool 2. Depending on the literature search results and the characteristics of the selected studies, a meta-analysis will be conducted where feasible. Otherwise, a narrative synthesis will be performed.Ethics and dissemination This study presents a protocol for a systematic review and does not involve human subjects. The findings will be disseminated through publication as a manuscript submitted to a peer-reviewed journal.PROSPERO registration number CRD420251163882.
Introduction Upper aerodigestive tract (UADT) malignancies, involving oral cavity, pharynx, larynx and related anatomical regions, are associated with substantial morbidity and mortality worldwide. Early diagnosis remains challenging because conventional diagnostic approaches are often invasive, costly and frequently detect disease at advanced stages. MicroRNAs (miRNAs) involved in post-transcriptional gene regulation have recently emerged as promising minimally invasive biomarkers due to their remarkable stability in biological fluids and their dysregulated expression in cancer. Although literature showcases the diagnostic value of miRNA signatures for UADT malignancies, the reported diagnostic performance remains inconsistent. Therefore, a comprehensive synthesis of current evidence is essential to determine the overall diagnostic precision and clinical applicability of miRNA-based assays.Methods and analysis We will report the results of the systematic review as per Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) reporting guidelines and adhere to the recommendations of the Cochrane Collaboration Handbook for Diagnostic Test Accuracy Reviews for conducting this review. The electronic databases of PubMed, Scopus, Web of Science and Embase will be systematically searched from inception onwards. Studies assessing the diagnostic performance of miRNA biomarkers in histopathologically confirmed UADT malignancies will be included. Two authors will independently perform study selection, data extraction and quality assessment (Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2)). Diagnostic accuracy meta-analysis will be conducted using a hierarchical bivariate random-effects model (Reitsma model) to jointly pool sensitivity and specificity estimates while accounting for heterogeneity and threshold effects. Hierarchical summary receiver operating characteristic curves will be constructed, and we will analyse pooled estimates of sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic OR at 95% CIs. Meta-regression followed by subgroup analysis will be undertaken to explore potential sources of heterogeneity, including specimen type, miRNA profiling method, study design and patient characteristics.Ethics and dissemination This study will synthesise data from previously published literature without involving individual patient data or direct participant involvement. Findings from this review will be dispersed via publication in a peer-reviewed journal and through presentations at National/International scientific platforms.PROSPERO registration details CRD420261384413.
Objective Mental health disorders among children and young people are a substantial global public health concern. Barriers to accessing specialist mental health services, particularly long waiting times, can exacerbate poor mental health. Recently, there has been an increase in the adoption of social prescribing to support children and young people to address this concern; however, the evidence of its impact on mental health remains limited. The key objective of this study was to explore how children, young people and their families experience the impact of a new social prescribing service in the Northwest of England.Design The qualitative study adopted an Interpretive Description (ID) approach defined by Sally Thorne. Reporting of the study adhered to the Consolidated Criteria for Reporting Qualitative Research (COREQ).Participants and setting Semistructured interviews were conducted with 15 children and young people aged 8–17 years who had accessed the social prescribing service. In addition, 27 parents and caregivers of children and young people who had accessed the service were also interviewed. This study formed part of an independent evaluation of the service in which interviews took place both face to face and online.Data analysis Inductive reflexive thematic analysis outlined by Braun and Clarke was employed to analyse the data.Results Five themes emerged which described the perceived impact of the service and the key mechanisms of how the impact may have been achieved. Children and young people described feeling less emotional distress, lower levels of anxiety and increased social confidence. The impact extended beyond those in direct receipt of the service, reducing parental stress, improving family interaction and strengthening relationships. Key mechanisms underpinning the impact included a trusting relationship with a link worker and the learning of cognitive coping strategies that were employed to help overcome emotional distress.Conclusions The findings suggest that social prescribing may function as a relational early intervention that supports emotional stabilisation and re-engagement with education and social contexts. However, further research is needed to confirm and quantify the effectiveness across different service models and settings.
Objectives The transition into fatherhood is considered a profound life stage, involving personal development, lifestyle and emotional adjustments. Fathers’ mental health can be adversely impacted by this transition. Fathers express isolation, exclusion and limited support within perinatal services. Restricted emotional support for fathers presents negative consequences for the whole family dynamic. Limited research has explored father and professional input associated with paternal perinatal support and how healthcare services and child and family services can respond to engaging fathers and their mental and emotional support needs. This qualitative study aims to explore fathers’ mental health and well-being experiences (referring to emotional or/and social well-being) and support needs within the perinatal period, as well as current viewpoints of perinatal services (maternity, healthcare and social care services) from both fathers’ and professionals’ perspectives.Design In-depth semistructured interviews and focus groups were carried out as part of a qualitative study.Setting Fathers’ resident within the North East and North Cumbria (NENC) and services and organisations from the voluntary, community and social enterprise (VCSE) sector and social care services across the NENC, who associate with supporting families and children, and perinatal mental health.Participants Fathers (n=21) and professionals (VCSE and social care services) (n=9).Results Reflexive thematic analysis of 30 participants’ accounts identified two main themes and five subthemes: (1) ‘The Pregnant and Postnatal Man’ and (2) Removing the cloak of fatherhood invisibility. These themes centred around the isolation of fathers and limited emotional and mental support within the parenting transition.Conclusions The findings suggest that greater father inclusion within perinatal services, policies and antenatal education may help fathers feel more recognised and supported throughout the perinatal journey. Recognition of fathers’ emotional well-being and mental health, by adopting a ‘whole family’ emotional support approach within perinatal services was considered important to support fathers and the family dynamic in facilitating a positive transition for the whole family.
Introduction Oligoprogressive disease (OPD) is a clinically significant pattern of progression observed in patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer treated with endocrine therapy (ET) and cyclin-dependent kinase (CDK) 4/6 inhibitors. Stereotactic ablative body radiotherapy (SABR) is an emerging strategy that may ablate resistant subclones and prolong the benefit of systemic therapy. The AVATAR-II trial investigates whether the addition of SABR to continued systemic therapy can delay the need to change treatment strategy.Methods and analysis AVATAR-II is a multicentre, randomised, open-label, phase II randomised controlled trial enrolling 74 patients with histologically confirmed ER-positive, HER2-negative advanced breast cancer and 1–5 sites of extracranial OPD. Eligible patients must have demonstrated clinical benefit (stable disease or partial response) from ET and CDK4/6 inhibitors for at least 6 months prior to randomisation. Participants will be randomised 1:1 to either SABR to all OPD sites with continuation of current systemic therapy (Arm A) or physician’s choice of systemic therapy (Arm B). The primary endpoint is time to treatment failure, defined as progression not amenable to SABR, cessation of systemic therapy or death. The secondary endpoints include progression-free survival (PFS), PFS2, overall survival, treatment-related adverse events and patient-reported quality of life using the Functional Assessment of Cancer Therapy–Breast score.Ethics and dissemination This study received ethical approval from the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC), under approval number 25/45 and HREC reference HREC/105165/PMCC. Results of the study will be disseminated via peer-reviewed presentation at scientific conferences and open-access publication.Trial registration number NCT06882499.
Introduction Hypertrophic cardiomyopathy (HCM) is a genetic cardiovascular disorder affecting approximately 1 in 200 to 1 in 500 adults, with nearly 70% exhibiting the obstructive phenotype Hypertrophic Obstructive Cardiomyopathy (HOCM). Randomised trials have demonstrated the efficacy of mavacamten, a first-in-class cardiac myosin inhibitor which significantly reduced outflow tract gradients and improved symptoms, exercise capacity and quality of life in the HOCM cases. Despite these findings, prospective real-world data on its safety and effectiveness remain limited, particularly in non-Western populations and further evidence from routine clinical practice is needed.Methods and analysis PERSIA-HOCM is a prospective, multicentre, observational study to be conducted at 19 cardiovascular referral centres in Iran. Adults aged 18 years or older with symptomatic obstructive HCM, defined as New York Heart Association (NYHA) class II to IV and a left ventricular outflow tract (LVOT) gradient of at least 50 mm Hg at rest or with provocation, who are prescribed mavacamten, will be enrolled. Key exclusions include left ventricular ejection fraction below 55%, non-obstructive phenotype and lack of consent. Participants will be followed for 1 year at 4-week intervals. Data collection will include symptoms, NYHA class, vital signs, echocardiographic parameters (including outflow gradients and ejection fraction), mavacamten dosing and adjustments and concomitant therapies. Echocardiography will be performed at weeks 4, 8, 12 and 24. Safety will be assessed using a predefined adverse event framework that includes mortality, hospitalisations and major clinical events. At weeks 12 and 48, cardiac troponin, N-terminal pro B-type natriuretic peptide and quality of life will be assessed. Primary endpoints will be safety, change in the NYHA class, resting and provoked LVOT gradient, quality of life, cardiac biomarkers and left ventricular ejection fraction. Secondary endpoints will include cardiac magnetic resonance imaging parameters for cardiac fibrosis, peak oxygen intake and genotype-based outcome. Analyses will be performed using R V.4.5.1, employing descriptive statistics, paired sample t tests and McNemar’s test.Ethics and dissemination Ethical approval was obtained from the Research Ethics Committee of Rajaie Cardiovascular, Medical and Research Institute/Iran National Committee for Ethics in Biomedical Research (Code: IR.RHC.REC.1404.210). Written informed consent will be required and filled by the patients. Considering full data confidentiality, analysis reports will be public every 6 months. Findings will be disseminated through peer-reviewed publications and scientific conferences.
OBJECTIVES:This study explored perspectives of practitioners providing weight management support for urban-dwelling young adults (18-35 years) with obesity in Sri Lanka, addressing an important evidence gap in understanding obesity management from a provider perspective. STUDY DESIGN:This descriptive qualitative study employed face-to-face semi-structured interviews, and the data were analysed using a framework approach within thematic analysis. STUDY SETTING AND PARTICIPANTS:Eight purposively selected practitioners involved in weight management in the Colombo District, Sri Lanka, were interviewed. Participants represented key domains of comprehensive obesity management, including dietary, physical activity, behaviour and medical management. Recruitment continued until thematic saturation was achieved. RESULTS:Two key themes emerged from the data: (1) Barriers to effective weight management and (2) Strategies to improve weight management. Within the first theme, five subthemes emerged, including limited knowledge and confidence among practitioners, provider attitudes towards clients, resource and service limitations, client motivation and adherence challenges and cultural and religious influences and myths. The second theme comprised four subthemes: early detection with a proper referral system, comprehensive and individualised care approach, continuous follow-up and self-monitoring and supportive social environment. CONCLUSIONS:The findings indicate that obesity management is hindered by fragmented care, with provider, client and system-level factors constraining practitioners' weight management efforts and limiting opportunities for improved care. These findings suggest the potential value of strengthening interdisciplinary referral pathways and targeted training to support more coordinated care.
Objectives To develop a consensus-based preliminary quality assessment framework using a modified nominal group technique (NGT) to describe the key indicators of an optimal medication error report (MER).Design A modified NGT consensus study comprising one face-to-face nominal group session and one round of follow-up emails using Microsoft Excel.Setting A face-to-face consensus session took place in Birmingham, West Midlands, UK.Participants A group of UK national medication safety experts and frontline healthcare professionals, including pharmacists, doctors and nurses (n=11), participated in the nominal group session. Of these, eight were female, and the rest were male. Panel members were selected based on their expertise or practice in medication safety. Non-UK medication safety experts and healthcare professionals were excluded from the study.Primary and secondary outcome measures The primary outcome was the development of the proposed Quality of Medication Error Reports (QoMER) framework. Secondary outcomes included the identification of key quality indicators (QIs) for high-quality MERs, inclusion votes, ranking scores and votes used to determine consensus and to inform the exploratory weighted scoring system.Results The proposed QoMER scoring framework comprises nine QIs organised under three main themes. The most prioritised QI was that the report should provide sufficient details of the patient and context. Participants ranked the weighted scoring approach as the most appropriate method for combining the completeness and perceived importance of each QI. Qualitative data, including audio-recorded discussions and written ideas, were transcribed and analysed inductively using Braun and Clarke’s thematic analysis. Quantitative data, comprising inclusion votes, ranking scores and weighting values, were summarised descriptively. This integrated analytical approach ensured that both participant discussion and numerical agreement informed the final QoMER scoring framework.Conclusions Medication errors lack qualitative depth in reporting, which affects learning, reflection and prevention. QoMER is proposed as a consensus-derived preliminary framework for the structured assessment and categorisation of MER quality by addressing nine QIs. These QIs may help promote more complete and actionable reporting, although further empirical validation is required before conclusions can be drawn about reliability, usability or impact on patient and medication safety.
Introduction Treatment responses to systemic therapies for atopic dermatitis (AD) may vary significantly based on medication types, treatment duration, concomitant topical corticosteroid use and specific patient subgroups. Evidence regarding the optimal medication selection and predictors of treatment response is warranted. A systematic approach to studying the effectiveness of systemic treatments from multiple perspectives may generate previously unreported evidence. We aim to quantitatively evaluate the time-course and effectiveness of various systemic treatments for AD, and to identify associated factors that significantly affect their effectiveness, using a pharmacodynamic model-based meta-analysis (MBMA). This protocol describes the methods for this analysis.Methods and analysis Data for the analysis will mainly originate from the database of a living network meta-analysis. We will include randomised controlled trials examining systemic treatments against placebo or any active comparator in patients with moderate-to-severe AD. The Investigator Global Assessment Scale, the Eczema Area and Severity Index Scale, the Patient Oriented Eczema Measure Scale and scales measuring quality of life or itch will be used as outcome measures. Study screening, data extraction and quality assessment will be conducted by two investigators independently. Where available, we will extract efficacy outcome data at each follow-up time point. We will use MBMA, the core principle of which involves developing a pharmacodynamic model to synthesise these longitudinal trial-level data. Whenever possible, modelling and simulation will be conducted for both binary and continuous outcomes. This MBMA will be performed using hierarchical models with non-linear mixed-effects methods including structural, random-effects and covariate models with the maximum likelihood estimation method. Response to systemic treatments will be analysed by conducting 1000 Monte Carlo simulations. Potential influencing factors will be tested using covariate modelling and subgroup analysis.Ethics and dissemination Ethical approval is not required for this study. Results from our analyses will be published in a peer-reviewed journal.PROSPERO registration number CRD420251068535
Background Older Chinese adults in the UK face unique needs when engaging in physical activity (PA), yet culturally appropriate strategies to promote PA remain limited.Objective To develop culturally appropriate PA promotion strategies for older Chinese adults living in the UK.Methods The intervention development comprised two stages: design and optimisation. It was informed by previous research findings and input from public and community involvement and engagement. Stage 1 combined the person-based approach (PBA), which involved developing guiding principles, an intervention planning table and a logic model, with seven steps of the Behaviour Change Wheel (BCW) to identify intervention functions, behaviour change techniques (BCTs) and delivery modes to enhance older Chinese adults’ capability, opportunity and motivation for PA. Stage 2 used think-aloud interviews with 10 older Chinese adults to optimise the intervention.Results Six intervention functions (education, persuasion, incentivisation, training, modelling and enablement), 27 BCTs and multiple delivery modes were identified in stage 1. In stage 2, based on think-aloud interviews with 10 participants, three prototypes were retained in their original form, one new element was added and three were removed. The remaining components were retained with either minor or major modifications. The final strategies included culturally tailored PA booklets, monthly workshops and social media support groups.Conclusions By integrating evidence, theory and stakeholder perspectives, and by combining the PBA with the BCW, this study developed the first culturally appropriate PA promotion strategies for older Chinese adults in the UK. Further research is needed to evaluate their feasibility, acceptability and effectiveness.
INTRODUCTION:Chronic pain is a public health priority that affects 18% of Dutch and 16% of German adults, representing a major societal burden. The Ems Dollart Region (EDR), which forms the northern part of the Dutch-German border area, is particularly characterised by lower incomes, more physically demanding jobs and lower health literacy, which are associated with higher pain prevalence. Individuals with lower socioeconomic status face greater pain-related disability and reduced quality of life. Public health campaigns underpinned by pain science education provide a strategy to improve understanding of pain among the wider public by addressing common misconceptions about its causes and management. However, large-scale population-level interventions and evaluations of such campaigns remain limited. METHODS AND ANALYSIS:This protocol describes the design and implementation of a cross-border public health campaign in the EDR, aimed at improving public understanding of pain, changing attitudes and beliefs and promoting healthy behaviours. We will conduct a quasi-experimental before-after study in the EDR with a control group in Flanders (Belgium). The intervention is guided by behaviour change and biopsychosocial models. The campaign will deliver tailored content via social media, broadcast, print and online advertisements over a 24-month period. Two independent cross-sectional samples will be surveyed at baseline and at 2-year follow-up, comprising 3200 participants per measurement wave from three regions: the Netherlands and Germany as intervention regions, and Flanders, Belgium, as the control region. The primary outcome is the prespecified Pain Concepts Questionnaire ratio score, assessing pain-related knowledge, attitudes and beliefs. The primary analysis will use an adjusted difference-in-differences framework to estimate whether change in the primary outcome differs between the combined intervention regions and the control region. Secondary analyses will examine the Netherlands and Germany separately and will evaluate healthcare utilisation, medication use, health-related quality of life and work absenteeism. ETHICS AND DISSEMINATION:This study protocol was reviewed by the Medical Ethics Review Board of the University Medical Center Groningen and the University of Oldenburg. The study was considered not subject to the Medical Research Involving Human Subjects Act (non-WMO declaration; reference number M24.345555, issued on 31 December 2024) and was approved by the University of Oldenburg Ethics Committee (reference number 2025-056, issued on 07 March 2025). Informed consent was obtained electronically by the research agency at the time of participants' registration with the research panel. Study findings, regardless of outcome, will be disseminated through peer-reviewed publications and presentations at national and international conferences.
Objectives To explore feasibility and estimate cost of a home-based intervention for COVID-19 patients requiring oxygen therapy.Design and setting Participatory action study embedded in a regional collaborative healthcare network.Participants 13 patients were included (77% female; mean age 68 years, SD 18.2).Intervention A previously designed intervention was piloted and iteratively evaluated in a multidisciplinary expert panel using a participatory action research approach.Primary and secondary outcome measures We scrutinised clinical course data and monitored adverse events. Feasibility was assessed using 12 key elements related to (1) communication, (2) logistics, (3) treatment and remote monitoring and (4) adverse events. In an explorative cost analysis, intervention costs were compared with hospital admission costs as the reference.Results Home-based management lasted for 7 days (SD 3.4) on average, with 4 days (SD 2.6) oxygen therapy. No intervention-related adverse events occurred. Main challenges were related to interprofessional communication, nursing care organisation and timely delivery of oxygen concentrators. Excluding costs for setting up the intervention, costs were estimated at €1124 per patient and this was mainly driven by costs on the first day. Compared with hospital admission, the cost-saving potential is estimated at €1087 to €2850 per patient.Conclusions An acute home-based care intervention embedded in a regional collaborative care network for patients with acute respiratory tract infections requiring oxygen therapy seems feasible and is potentially cost-saving.Trial registration number The Dutch Trial Register CCMO: NL77421.041.21; OMON Register: NL-OMON22655.
