Stroke, Volume 56, Issue Suppl_1, Page AWP251-AWP251, February 1, 2025. Chronic subdural hematoma (cSDH) represents a relatively treatment-resistant pathologic process with a large impact on quality-adjusted life years. This risk is increased in the elderly, and the prevalence is expected to rise as the population ages. Expectant management and classical surgical treatment are associated with increased recurrence rate as well as complications. Middle meningeal artery (MMA) embolization is being utilized more frequently as adjunctive and primary treatment. It has demonstrated beneficial effects on recurrence and progression of cSDH. Here, we present the outcomes of this technique with different embolic agents in our patient population.IRB approval was obtained for this study. Retrospectively, all patients at a single institution who underwent endovascular MMA embolization with or without open surgical intervention for cSDH were included. Vulnerable populations were excluded. Demographic and medical data were collected at initial, 1-month, and 3-month time points if available and analyzed for differences with unpaired T-test, paired-T test, and chi-square test.Between 2020 and 2024, a total of 50 patients were treated with MMA embolization for cSDH. Mean age was 73 years. Majority were male. Most were on antithrombotic therapy. Of these, 34 had history of prior SDH, and 38 had history of head trauma. Of the 50 patients, 29 patients underwent combined open surgery and MMA embolization, while 21 underwent MMA embolization alone. The cSDH was bilateral in 23 patients and unilateral in 27 (13 right, 14 left) for a total of 73 cSDHs. Surgical evacuation was performed in 44 cSDHs. Liquid embolic agent (Onyx) was utilized for 32 patients, while particulate embolic agents (250-500 um) were utilized for 18 patients. Of the patients who had follow-up CTs at 1 month, there were 21 cSDHs treated with particles and 39 with Onyx. There was no significant difference in the proportions of patients undergoing surgery in addition to MMA embolization between the groups treated with Onyx and those treated with particle embolization. Additionally, there was no significant difference in the proportions of treated hemispheres with ≥ 50% reduction or ≥ 75% reduction between those treated with Onyx and those treated with particles.At our institution, there was no difference in reduction of cSDH with Onyx as compared to particle embolization. MMA embolization was associated with no recurrence or progression of cSDH at 3 months.
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Abstract TP15: Argatroban Among Patients with Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Stroke, Volume 56, Issue Suppl_1, Page ATP15-ATP15, February 1, 2025. Introduction:Argatroban, a direct thrombin inhibitor, is currently being investigated as a potential adjunct to the standard of care for the treatment of acute ischemic stroke (AIS). However, data regarding its impact on functional neurological outcomes have been inconclusive. Our objective was to compare neurological outcomes at 90 days among individuals with AIS randomized to argatroban with standard of care versus standard of care alone.Methods:We systematically searched MEDLINE, EMBASE, and Cochrane CENTRAL databases from their inception to July 2024 for randomized controlled trials of argatroban. The primary outcome was excellent functional outcome, as defined by a modified Rankin Scale (mRS) score of 0-1 at 90 days. The secondary endpoints were favorable functional outcome, defined by a mRS score of 0-2 at 90 days, and repeat stroke or other vascular events within 90 days. Safety endpoints included symptomatic intracranial hemorrhage and parenchymal hematoma at 90 days. Risk of bias was assessed using the Cochrane Risk of Bias Tool (RoB 2). Random-effects meta-analytic models were used to estimate pooled risk ratios (RRs) and 95% confidence intervals (CIs). Our protocol was preregistered on Open Science Framework (https://osf.io/tygwx/).Results:Four randomized controlled trials were included. A total of 1,595 participants were randomized to receive either argatroban with standard of care (n=807) or standard of care alone (n=788). Participants were mostly male (67.1%), and their median/mean age ranged from 57 to 69 years. When data were pooled across trials, the impact of argatroban on the likelihood to have a mRS score of 0-1 was inconclusive due to a wide CI (RR: 1.12; 95% CI: 0.88-1.41; I2: 63%) (Figure 1). Similar trends were observed for the other predefined outcomes. The RRs were 1.00 (95% CI: 0.87-1.14) for a mRS score of 0-2 (Figure 2) and 0.79 (95% CI: 0.44-1.44) for stroke or other vascular events. The pooled RRs for symptomatic intracranial hemorrhage and parenchymal hematoma were 1.09 (95% CI: 0.73-1.63) and 0.84 (95% CI: 0.48-1.47), respectively.Conclusions:Results were inconclusive due to small sample sizes. Currently, there is insufficient data to support the addition of argatroban to standard of care for the treatment of AIS. Evidence from available trials in this area supports the conduct of larger trials to determine the clinical value of argatroban.
Abstract TP47: Brain iron metabolism impairment differs between aged mouse models of cerebral hypoperfusion and iron overload
Stroke, Volume 56, Issue Suppl_1, Page ATP47-ATP47, February 1, 2025. Introduction:Iron is the most abundant metal in the brain and plays an important role in cellular processes. Thus, an imbalance of iron metabolism in the brain negatively affects brain function. Iron accumulates in the brain with aging, which contributes to the progression of different neurological disorders. In two previous independent studies in our lab using an iron overload model and a chronic cerebral hypoperfusion (CCH) model (bilateral carotid artery stenosis, BCAS) in aged mice, we observed that mice of both models showed enhanced brain iron deposition and cognitive deficits, compared with control mice. Here, we investigate if these two models share the same molecular mechanisms in brain iron metabolism, and whether the combination of iron overload and CCH exacerbates the phenotype.Methodology:18-month-old C57BL/6 mice of both sexes were subjected to survival surgery to implant 0.18 mm diameter micro-coils in both common carotid arteries to induce CCH (BCAS mice). Sham mice underwent the same procedure without coil implantation. Two weeks after surgery, mice were administered 5% ferric citrate (FC, 3 alternate days/week for 6 weeks) by oral gavage as a model of iron overload or were given saline solution. Two months after surgery, mice were tested for open field, elevated plus maze, and fear conditioning. We analyzed their brains to determine the expression of genes involved in iron metabolism by qPCR.Results:Iron overload and/or BCAS did not affect body weight, nor velocity and distance moved of mice. However, FC mice showed reduced freezing time (p=0.002) in fear conditioning, and BCAS mice spent more time in the open arms (p=0.04) in the elevated plus maze, compared with control mice. We did not find differences between BCAS+FC mice and control mice. Interestingly, CCH reduced the levels of ferrous iron (p=0.049) in the serum of BCAS mice. We also found that BCAS, but not iron overload, increased the expression of bothGss(glutathione synthetase, an antioxidant enzyme; p=0.01) andNcoa4(nuclear coactivator 4, a mediator of ferritinophagy; p=0.005).Conclusions:BCAS and FC affect brain function via different mechanisms, and the combination of both does not worsen the phenotype. BCAS, but not FC, increased the expression ofGssandNcoa4. Next, we will determine whether ferritinophagy is activated in the brains of BCAS mice and whether the higher expression ofGssis a response to mitigate the oxidative stress induced by CCH.
Abstract TP50: Improvement in Alteplase Administration Time in Rural Emergency Department
Stroke, Volume 56, Issue Suppl_1, Page ATP50-ATP50, February 1, 2025. Background and Issue:The rural, critical access emergency department (ED) team was not consistently meeting the door-to-needle goal of 45 minutes for alteplase administration to acute stroke patients. The team’s process was ineffective in preparing for alteplase administration, resulting in delays in the administration of the thrombolytic.Purpose:The quality improvement project aimed to create a new, consistent process to administer alteplase to acute stroke patients promptly.Methods:There was a delay in acute stroke patients receiving alteplase after arrival to the rural, critical access ED. All stroke activations were reviewed as per the program’s guidelines. During the review, specific patterns were identified as barriers to meeting the program’s goals. It was noted that staff were accessing the automated medication cabinet multiple times for medications. The staff would retrieve the alteplase from the cabinet after the order was entered into the electronic medical record and then return to the cabinet to remove antihypertensives to treat the patient’s blood pressure before the alteplase administration. The action plan focused on creating a new process of establishing a virtual alteplase kit, which included two antihypertensive medications, in the automated medication cabinet. A stroke team member would retrieve the alteplase kit from the automated medication cabinet when the stroke activation was announced. While the patient was receiving the computed tomography exam, the team mixed the alteplase and prepared it for administration. Upon returning to the ED, the team obtained the patient’s weight and anticipated the alteplase order. Once the order was submitted by the physician and verified by the pharmacist, the team proceeded to administer the appropriate dose of alteplase.Results:Developing the virtual kit and the consistent process of retrieving the kit and early mixing of the alteplase in stroke activations, led to the team meeting the goal for alteplase administration. Before implementing the new process, the team met the alteplase door-to-needle goal 40% in one year. With the implementation of the consistent process and the virtual kit, the team met the door-to-needle goal 67% in less than a year.Conclusion:Implementing a standardized process in the rural, critical access emergency department decreased the door-to-needle time of the administration of alteplase, provided streamlined patient care, and improved patient outcomes.
Abstract TP43: Diabetes Increases Endothelin-A Receptor (ETAR) Expression and Senescence in a Novel Multi-Etiology Model of Vascular Contributions to Cognitive Impairment and Dementia (VCID)
Stroke, Volume 56, Issue Suppl_1, Page ATP43-ATP43, February 1, 2025. Introduction:Cerebrovascular pathologies leading to VCID are diverse, but preclinical models mainly rely on chronic hypoperfusion-mediated neuroinflammation in otherwise healthy animals. Since diabetes increases VCID risk, our first goal was to develop a multi-etiology model of VCID in diabetes. Given that endothelin-1 (ET-1) contributes to decreased cerebral blood flow in multiple dementia models and that ETAR-mediated senescence in brain microvascular endothelial cells, our second goal was to assess ETARs in this VCID model.Methods:Control and diabetic male Wistar rats were subjected to sham or a novel VCID model of microemboli (ME) injection followed by unilateral common carotid artery occlusion (UCCAO). Animals were followed for 22 weeks by several behavioral tests. Hematoxylin/Eosin (HE) and Luxol-fast blue staining (LFB) were used to assess brain pathologies. ETAR, hypoxia, and senescence markers were assessed by immunoblotting and immunohistochemistry.Results (Table):Tissue damage in the striatum was greater, and the corpus callosum myelination score was lower in the diabetic UCCAO+ME group. ETARs, hypoxia marker HIF1α, and senescence marker p21 levels were increased in the UCCAO+ME diabetic group; while ETBRs rather decreased. Open Field revealed anxiety-like behavior (a significant decrease in time spent and entry frequency at the center square) and an increase in overall inactivity of D UCCAO+ME at week 22. Novel object recognition test showed a distinctive decline in the recognition and discrimination indices in the D UCCAO+ME group compared to the BL D UCCAO+ME and WK22 D sham groups. Of note, these animals exhibited a depressive-like behavior with a much lower entry frequency to the novel arm of the Y-maze despite their normal motor function compared to other groups.Conclusion:This multi-etiology model of VCID, especially in comorbid disease models, may serve as a more clinically relevant model of VCID. Given that post-mortem brain ET-1 levels correlate with tissue hypoxia and disease severity in patients with dementia, further understanding of the regulation and effects of cerebral microvascular ETAR in neurovascular dysfunction is likely to identify novel therapeutic targets.
Abstract WP261: Tortuosity and Navigation in Mechanical Thrombectomy: A Computational Study of Anatomical Challenges
Stroke, Volume 56, Issue Suppl_1, Page AWP261-AWP261, February 1, 2025. Mechanical thrombectomy (MT) is an established treatment for anterior circulation stroke due to large vessel occlusion. Multiple endovascular approaches exist to reach the same target, yet determining the best route remains unclear. Operators often rely on subjective and qualitative factors in their decision-making due to a lack of quantitative data. The primary navigation challenge stems from the interaction between devices (catheters, guidewires) and arterial anatomy. This study uses computational modeling to simulate these interactions, aiming to identify anatomical features that contribute most to procedural difficulty. We evaluated navigation tortuosity in anterior MT cases by comparing vessel centerlines derived from imaging (TI-tortuosity index) with computationally simulated device navigation in 107 patient anatomies. Twelve pathways were analyzed by considering femoral and radial approaches targeting the right or left carotid terminus (RCA, LCA) and the right or left vertebral arteries (RVert, LVert). Finite element modeling was employed to simulate device navigation with two primary metrics: local bending energy (LBE—representing the acuteness of a 2 cm segment of the path highlighting local curvature) and device tortuosity index (dTI) to measure overall tortuosity of the simulated device. Cases included surgical notes detailing procedure duration like time to first pass (FP) and Likert scores of operator-reported navigation difficulty. The relationship between case difficulty and computed metrics was assessed using Kendall’s tau. Vessel centerline metrics varied based on approach and target vessel. Time to FP showed the strongest associations with case difficulty, followed by LBE. These associations improved when utilizing the simulated device TI. Device simulation metrics outperformed vessel centerline metrics in predicting case difficulty. However, no metric—whether from imaging or simulation—outperformed time to FP in predicting case difficulty. Our findings underscore the variability in centerline metrics based on anatomy and choice of arterial access. While time to FP remains strongly correlated with procedural difficulty, centerline metrics can be obtained preoperatively to predict navigation challenges. Notably, simulated device metrics demonstrate superior predictive performance compared to traditional vessel centerlines, suggesting that endovascular simulations could be crucial for preoperative planning to assess navigation difficulty.
Abstract TMP2: Flow diversion treatments for unruptured intracranial aneurysms: real-world perioperative outcomes, hospital readmissions, and impact of comorbid anxiety and mood disorders
Stroke, Volume 56, Issue Suppl_1, Page ATMP2-ATMP2, February 1, 2025. Introduction:Flow diversion (FD) is a minimally invasive treatment for unruptured intracranial aneurysms (UIA) and is often preferred over open cerebrovascular surgery; however, FD patients are at risk of post-procedural stroke and hemorrhage. Furthermore, UIA patients often have comorbid anxiety and mood disorders (AMD); whether these patients are at increased risk of adverse outcomes following FD is unclear.Methods:This was a retrospective analysis of the 2020-21 National Readmissions Database (NRD) in the United States. Patients who underwent elective FD placement were identified. Initial hospitalization outcomes were assessed. Patients who had an uncomplicated FD placement were followed for the calendar year for non-elective hospital readmissions. Risks of readmission for patients with and without baseline AMD were compared using Cox regression models adjusting for major confounders.Results:9,523 elective FD patients were identified, of whom 243 (2.6%) and 314 (3.3%) suffered perioperative stroke and intracranial hemorrhage (ICH), respectively, and 2,800 (29.4%) had baseline AMD. Six-month readmission rate for any reason, stroke or hemorrhage, and major stroke or hemorrhage (that led to patient morbidity or mortality) were 6.9%, 3.9%, and 1.8%, respectively (Figure 1). Patients with baseline AMD had a significantly higher risk of overall hospital readmissions than those without (adjusted hazards ratio 1.48 [95%CI 1.14 to 1.93], p=0.003; Figure 2). Further analyses revealed that patients with baseline AMD did not have a higher risk of any stroke or hemorrhage confirmed during readmissions (HR 1.25 [95%CI 0.78-2.00], p=0.36; Figure 3), but they did have a significantly higher risk of readmissions without confirmed stroke or hemorrhage (HR 1.72 [95%CI 1.18 to 2.51], p=0.005; Figure 3). Among readmitted AMD patients without confirmed stroke or hemorrhage, 15.4% suffered short-term morbidity, which incurred a median cost of $11,725 USD per patient.Conclusions:In routine United States clinical practice, the perioperative risks of stroke and ICH for FD patients were 2.6% and 3.3% respectively, and the risk major stroke or hemorrhage within 6 months after hospital discharge was 1.8%. Baseline AMD was associated with a significantly increased risk of hospital readmissions without confirmed stroke or hemorrhage, highlighting the need for a better understanding of how comorbid AMD may impact patient outcomes following FD.
Abstract TP45: Advancements in Digital Cognitive Assessments for Post-Stroke Patients: A Scoping Review
Stroke, Volume 56, Issue Suppl_1, Page ATP45-ATP45, February 1, 2025. Introduction:Standardized cognitive assessments such as the Montreal Cognitive Assessment (MOCA) and Mini-Mental State Examination (MMSE) are generally administered using paper-and-pencil methods. Technological advancements have digitized these exams and expanded cognitive testing capabilities in the post-stroke population.Methods:Studies from 2010-2022 were identified from PubMed, Embase, Web of Science, Cumulated Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, and Google Scholar to include digital cognitive assessments utilized for acute and chronic ischemic and hemorrhagic stroke patients. The research questions aim to evaluate technical aspects of digital tests, digital tool effectiveness, cognitive domains assessed, study population characteristics, patient usability, and exam feasibility. The methodological framework for this review included research question identification, relevant study collection, final study selection, data extraction, analysis, and summary. Covidence was used to compile relevant studies.Results:72 articles were included for final analysis. 8 different digital methods (e.g., tablet, computer, virtual reality) were used to assess cognition, with 26 studies creating a new cognitive test and 24 creating a cognitive test based on a standardized exam. Participants were tested in both acute and chronic phases (5 strictly in acute, 55 strictly in subacute/chronic, and 11 in both). 58% of articles assessed ischemic and hemorrhagic stroke participants, and 9 studies only tested aphasia patients. Exams consisted of a variety of cognitive domains, with the majority of studies testing multiple domains (e.g., executive functioning, attention, and visuospatial processing), and some studies testing only one cognitive domain. The average rate of digital test completion was 95%. Validation of the digital tool was compared with a standardized, paper-and-pencil test (e.g., MOCA, MMSE) in 48 articles (67%). An overall positive satisfaction with the digital test was seen in 8 articles that incorporated patient questionnaires.Conclusion:This review suggests that post-stroke digital cognitive assessments are feasible in the acute and post-acute settings across multiple domains similar to the MOCA and MMSE. Enhancements in these tools will expand access to testing and allow for increased identification of post-stroke cognitive impairment.
Barriers and facilitators to global access to life-saving skills training: an international cross-sectional survey
Introduction
Emergency care begins in the community, who are often the first on the scene. Where emergency care systems are nascent or absent, bystanders represent the only prehospital emergency care that victims might receive. It is important to equip bystanders through life-saving skills training (LST). The aim of this study was to describe access to LST for laypersons globally and to determine barriers or facilitators for access to LST globally.
Methods
A global cross-sectional, online survey was undertaken with stakeholders involved in LST programmes and policies through purposive, snowball sampling. The invitation for participation was distributed to local, regional and international emergency care and resuscitation organisations and their membership. Data were collected using a custom-designed survey, based on the literature and following pilot testing. Data were analysed descriptively and visualised according to countries and regions. Logistic regression was used to identify variables predictive of LST.
Results
A total of 302 responses from 67 countries were analysed. Majority of responses were from high- or upper-middle income countries (61.2%) compared with low- or lower-middle income countries (38.8%). All respondents from Europe reported reliable access to LST. Of respondents who reported no LST is delivered, the highest proportion of these represented the Eastern Mediterranean (18.2%), Africa (17.1%) and South America (16.9%). The most common barrier to accessing LST were cultural views surrounding LST (69.2%), while the most common facilitator was interpersonal relationships to encourage the uptake of LST (71.9%). Country level of income (adjusted OR (AOR) 4.31 (95% CI 1.62 to 11.45), p
Successful open defecation-free intervention in low- and middle-income countries: a qualitative synthesis systematic review protocol
Introduction
The results of open defecation-free (ODF) programmes vary greatly, especially in low- and middle-income countries (LMICs). This study will systematically investigate available qualitative research to identify the elements contributing to open defecation programmes’ effectiveness in various situations across LMICs. Furthermore, this review seeks to identify gaps in the available literature and areas that require additional investigation and action.
Methods and analysis
Inclusion criteria were developed considering issues related to open defecation in LMICs, sanitation interventions and behavioural change. Research examining sanitation interventions in schools, shelters, disability communities and virtual communities was excluded, as the review focused exclusively on community-based interventions. Studies published in English and Indonesian were included without limitation of the initial year until 31 January 2025. Systematic research will be carried out using ScienceDirect, PubMed, ProQuest and Scopus databases. Information from grey literature, including conference proceedings and reports from relevant organisations, will be systematically searched using Google Scholar and the websites of leading institutions, such as the WHO, UNICEF and WaterAid. This systematic review did not impose any restrictions on the place and date of publication. Two reviewers followed Joanna Briggs Institute guidelines in selecting studies, conducting critical appraisal using confidential tools and extracting data using a structured approach. Data synthesis will be performed using meta-aggregate methods to identify the themes. A ConQual Summary will be used to assess confidence in the findings.
Ethics and dissemination
The findings of the systematic review will be disseminated through a publication in a peer-reviewed journal and presented at a relevant conference. Since the data used will not contain individual patient information, ethical approval is unnecessary.
PROSPERO registration number
CRD42023408851.
Acceptability and feasibility of shared medical appointments to support self-management of anxiety and depression in primary care in England: a qualitative study of service user/patient perspectives
Objective
Shared medical appointments (SMAs) are an innovative care delivery method that provides delivery of clinical care while also supporting self-management. Their usefulness for mental health conditions has only briefly been explored, though early evidence demonstrates their utility for supporting mental health management. Therefore, this study set out to better understand the views that adults with anxiety and depression have towards SMAs as a way of receiving care to support self-management in primary care.
Design and methods
A qualitative study using 1:1 semi-structured interviews which were analysed thematically following Braun and Clarke’s six-phase reiterative process. We employed a deductive, theory-informed approach to thematically analyse the data.
Participants
The final sample consisted of 17 predominantly White ethnic adults with a clinical diagnosis of anxiety and/or depression from five different regions in England. Participants represented a broad age group (22–74 years) and a range of socioeconomic backgrounds.
Results
Three main themes were established: (1) motivation to attend an SMA, (2) barriers and challenges to SMA engagement and (3) implementation preferences. The concept of SMAs was largely acceptable to participants, although participants reported several factors that would influence their decision to attend an SMA. Participants held some reservations but were on the whole receptive to the idea. The main benefits reported were peer support, support for self-management and quicker access to care. Drawbacks reported included risks to patient confidentiality, negative impact on emotional well-being and the unsuitability of the group setting for some patients. Some salient preferences identified included face-to-face/hybrid delivery formatting and mental health specialist involvement.
Conclusions
SMAs in primary care to support anxiety and depression self-management would be acceptable to patients, contingent on the mode of delivery of the SMAs. Future acceptability research should explore SMA appropriateness for diverse patient populations of different ethnic backgrounds, to inform their potential wider roll-out in English primary care.
Barriers and enablers encountered by bereaved informal motor neuron disease (MND) caregivers when trying to access bereavement support: a qualitative cross-sectional thematic analysis of semistructured interviews with 6-36 months postbereavement informal MND caregivers in the UK
Background
Caregivers of people with motor neuron disease (MND) face more negative consequences of caregiving than other terminal illnesses. The impact of this caregiver burden can negatively influence bereavement outcomes.
Objectives
This study aims to explore the support needs of caregivers of people with MND, the types of bereavement services they use, or the reasons for not using bereavement services, and understanding the opportunities and barriers to accessing bereavement services.
Design
The design of the study was a qualitative interview study using thematic analysis following the method of Braun and Clarke (2006).
Setting and participants
Twenty bereaved caregivers of people with MND were purposively sampled. Participants were recruited through the Lancashire and South Cumbria MND Care and Research Centre.
Results
Thematic analysis revealed four overarching themes: (1) type of support accessed, (2) the importance of people who understand, (3) barriers to accessing support, and (4) being (un)prepared for death and afterwards.
Conclusions
Caregivers of people with MND require people who understand their unique needs to support them, alongside professional support, to prepare them for the death of their loved one and beyond. Barriers to accessing support included the need for in-person support, insufficient financial support or signposting to relevant services and being unprepared for death and bereavement.
The Protocol for the Multi-Ethnic, multi-centre raNdomised controlled trial of a low-energy Diet for improving functional status in heart failure with Preserved ejection fraction (AMEND Preserved)
Introduction
Heart failure with preserved ejection fraction (HFpEF) is characterised by severe exercise intolerance, particularly in those living with obesity. Low-energy meal-replacement plans (MRPs) have shown significant weight loss and potential cardiac remodelling benefits. This pragmatic randomised trial aims to evaluate the efficacy of MRP-directed weight loss on exercise intolerance, symptoms, quality of life and cardiovascular remodelling in a multiethnic cohort with obesity and HFpEF.
Methods and analysis
Prospective multicentre, open-label, blinded endpoint randomised controlled trial comparing low-energy MRP with guideline-driven care plus health coaching. Participants (n=110, age ≥18 years) with HFpEF and clinical stability for at least 3 months will be randomised to receive either MRP (810 kcal/day) or guideline-driven care for 12 weeks. Randomisation is stratified by sex, ethnicity, and baseline Sodium Glucose Cotransporter-2 inhibitor (SGLT2-i) use, using the electronic database RedCap with allocation concealment. Key exclusion criteria include severe valvular, lung or renal disease, infiltrative cardiomyopathies, symptomatic biliary disease or history of an eating disorder. Participants will undergo glycometabolic profiling, echocardiography, MRI for cardiovascular structure and function, body composition analysis (including visceral and subcutaneous adiposity quantification), Kansas City Cardiomyopathy Questionnaire (KCCQ) and Six-Minute Walk Test (6MWT), at baseline and 12 weeks. An optional 24-week assessment will include non-contrast CMR, 6MWT, KCCQ score. Optional substudies include a qualitative study assessing participants’ experiences and barriers to adopting MRP, and skeletal muscle imaging and cardiac energetics using 31Phosphorus MR spectroscopy.
Statistical analysis
Complete case analysis will be conducted with adjustment for baseline randomisation factors including sex, ethnicity and baseline SGLT2-i use. The primary outcome is the change in distance walked during the 6MWT. The primary imaging endpoint is the change in left atrial volume indexed to height on cardiac MRI. Key secondary endpoints include symptoms and quality of life measured by the KCCQ score.
Ethics and dissemination
The Health Research Authority Ethics Committee (REC reference 22/EM/0215) has approved the study. The findings of this study will be published in peer-reviewed journals.
Trial registration number
NCT05887271.
Analytical approaches to evaluate risk factors of multimorbidity: a systematic scoping review protocol
Introduction
Understanding causal risk factors that contribute to the development of multimorbidity is essential for designing and targeting effective preventive strategies. Despite a large body of research in this field, there has been little critical discussion about the appropriateness of the various analytical approaches used. This proposed scoping review aims to summarise and appraise the analytical approaches used in the published literature that evaluated risk factors of multimorbidity and to provide guidance for researchers conducting analyses in this field.
Methods and analysis
We will systematically search three electronic databases—Embase, Global Health and MEDLINE, as well as the reference lists of identified relevant review articles, from inception to September 2024. We will screen titles and abstracts using the artificial intelligence-aided software ASReview, followed by screening for eligible articles in full text and extracting data. We will then categorise the analytical approaches used across studies, provide a comprehensive overview of the methodology and discuss the potential strengths and limitations of each analytical approach.
Ethics and dissemination
We will undertake a secondary analysis of published literature; therefore, ethical approval is not required. The results will be disseminated through an open-access, peer-reviewed publication. This systematic scoping review will serve as a guide for researchers in selecting analytical approaches for aetiological multimorbidity research, thereby improving the quality and comparability of research in this field.
Mama Empoderada: study protocol for a pilot trial of a novel parenting and mental health prevention intervention for migrant mothers with young children at the Mexico-US border
Introduction
Migrant women in transit face high risk of developing mental health problems such as depression and anxiety, driven by gendered social-structural factors including violence, social isolation, migration uncertainty, limited access to services and gender inequities. Although migrant women who endure such conditions have high need for mental health prevention, few evidence-based interventions are tailored to this population. Moreover, while women and children’s mental health are interconnected, few mental health interventions address parenting needs. The aim of this study is to pilot-test a novel parenting and mental health prevention intervention for migrant mothers with young children (MMC) in Tijuana, Mexico, including (a) assessing acceptability; (b) estimating effect sizes on symptoms of depression, anxiety, and parenting stress; (c) identifying which theory-based mechanisms of action predict changes in outcomes; and (d) identifying factors associated with differential intervention response.
Methods and analysis
‘Mamá Empoderada’ (Mom Power) is a theory-based, trauma-informed group intervention to promote mental health and responsive parenting among mothers with young children (0–5 years). This is an evidence-based intervention that has been previously evaluated in the USA and has been recently adapted for Spanish-speaking mothers. We have recently adapted this intervention for MMC in Mexico and will conduct a pilot randomised controlled trial (RCT) of the intervention with MMC (n=100; Ntreatment=50; Ncontrol=50). The intervention group (IG) will receive 10 group and three individual sessions addressing attachment-based parenting skills, linkage to resources (eg, food, shelter), social support, and self-care and resilience over a 5-week period. The control group will receive standard of care programming and will be offered participation in the intervention following completion. Both groups will complete baseline and exit surveys, as well as follow-up surveys at 2, 4 and 6 months postintervention. Statistical analyses will compare primary (ie, symptoms of depression and anxiety; parenting stress) and intermediate outcomes (eg, resilience, service utilisation) by exposure to intervention condition.
Ethics and dissemination
This study is approved by the San Diego State University and El Colegio de la Frontera Norte Institutional Research Boards. Findings will inform a larger trial to evaluate intervention efficacy. In collaboration with our community partners, results will be disseminated via peer-reviewed publications; presentations; and plain-language reports, infographics, and presentations to community, clinical, and policy audiences. If efficacious, this intervention is highly promising as a novel, low-cost, and feasible model that could be implemented in border settings in Mexico, the USA and elsewhere. Amid rising population displacement and prolonged and traumatic migration journeys, this study addresses an urgent need for scalable and tailored mental health prevention for MMC in border contexts.
Trial registration number
NCT06468046.
Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol for a factorial randomised controlled trial
Introduction
Traditional Chinese medicine (TCM) is commonly used alongside Western medicine for stroke management in China. However, there is significant variation in TCM practice, and the utilisation of evidence-based clinical practice guidelines is inadequate. This study aims to evaluate the effectiveness of three popular frameworks—Consolidated Framework for Implementation Research (CFIR), Theoretical Domains Framework (TDF) and Normalization Process Theory (NPT)—in improving implementation outcomes for the integrated TCM and Western medicine clinical practice guideline for stroke management.
Methods and analysis
This study employs a hybrid type III design with a factorial randomised controlled trial, where 45 TCM hospitals will be randomly assigned to one of eight experimental conditions based on the use or non-use of each framework (CFIR, TDF, NPT). The factorial design allows for the evaluation of the main effects of each framework and their two-way and three-way interactions, offering insights into which combination of frameworks is most effective in enhancing implementation outcomes. The factorial design provides greater efficiency compared with traditional designs by enabling the simultaneous testing of multiple interventions and their combinations with the same sample size, which increases statistical power. Implementation facilitators will be trained to support the guideline adoption process, with interventions aligned to specific framework components (eg, CFIR for identifying barriers and facilitators, TDF for understanding behavioural influences and NPT for normalising practices within organisational routines). Outcomes will be evaluated using the RE-AIM framework (reach, effectiveness, adoption, implementation and maintenance). Hierarchical logistic regression models will test the study hypotheses, and qualitative methods, such as interviews and focus groups, will provide contextual understanding. Additionally, a cost-effectiveness analysis will be conducted to assess the economic feasibility of the implementation strategies.
Ethics and dissemination
This trial has been approved by the Institutional Review Board of Southern Medical University (approval number: #202261) and follows all relevant ethical guidelines for research involving human participants. On completion, the findings will be shared with patients, healthcare providers and stakeholders through various dissemination activities, including workshops and presentations within relevant TCM and stroke management networks. The results will be published in peer-reviewed academic journals and presented at national and international conferences to inform future practice and policy on the integration of TCM and Western medicine for stroke management.
Trial registration details
This study has been registered on the Open Science Framework with the DOI: 10.17605/OSF.IO/NJEVB.