Pathway Of Low Anterior Resection syndrome (LARS) relief after Surgery (POLARiS): protocol for an international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort, with economic evaluation, process evaluation and qualitative sub-study, to explore the natural history of LARS and compare transanal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS following a high or low anterior resection for colorectal cancer

Introduction
As a result of improving survival rates, the adverse consequences of rectal cancer surgery are becoming increasingly recognised. Low anterior resection syndrome (LARS) is one such consequence and describes a constellation of bowel symptoms after rectal cancer surgery which includes urgency, faecal incontinence, stool clustering and incomplete evacuation. LARS has a significant adverse impact on quality of life (QoL) and symptoms are present in up to 75% of patients in the first year after surgery. Despite this, little is known about the natural history and there is poor evidence to support current treatment options.

Methods and analysis
The objectives of POLARiS are to explore the natural history of LARS and to evaluate the clinical and cost-effectiveness of transanal irrigation (TAI) or sacral neuromodulation (SNM) compared with optimised conservative management (OCM) for people with major LARS.
POLARiS is a prospective, international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort design, with internal pilot phase, qualitative sub-study, process evaluation and economic evaluation. Approximately 1500 adult participants from UK hospitals and 500 from Australian hospitals who have undergone a high or low anterior resection for colorectal cancer in the last 10 years will be recruited into the cohort. Six-hundred participants from the UK and 200 participants from Australia, with major LARS symptoms, defined as a LARS score of ≥30, will be recruited to the randomised controlled trial (RCT) element. Participants entering the RCT will be randomised between OCM, TAI or SNM, all with equal allocation ratios.
Cohort and RCT participants will be followed up for a 24-month period, completing a series of questionnaires measuring LARS symptoms and QoL, as well as clinical review for those in the RCT. A process evaluation, qualitative sub-study and economic evaluation will also be conducted.
The primary outcome measure of the POLARiS cohort and RCT is the LARS score up to 24 months post-registration/randomisation. Analyses of the RCT will be conducted on an intention-to-treat basis. Comparative effectiveness analyses for each endpoint will consist of two pairwise treatment comparisons: TAI versus OCM and SNM versus OCM. Secondary outcomes include health-related QoL, adverse events, treatment compliance and cost-effectiveness (up to 24 months post-registration/randomisation).

Ethics and dissemination
Ethical approval has been granted by Wales REC 4 (reference: 23/WA/0171) in the UK and Sydney Local Health District HREC (reference: 2023/ETH00749) in Australia. The results of this trial will be disseminated to participants on request and published on completion of the trial in a peer-reviewed journal and at international conferences.

Trial registration number
ISRCTN12834598; ACTRN12623001166662.

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Febbraio 2025

Trends in congenital anomalies and associated factors among newborns in Eastern Ethiopia: an 8-year open cohort analysis of the Kersa Health and Demographic Surveillance System

Objective
This study aimed to investigate the trends and factors associated with congenital anomalies (CAs) among newborns in Eastern Ethiopia from 2015 to 2022.

Design
Open cohort study.

Setting
The Kersa Health and Demographic Surveillance System (KHDSS), which is located in the Kersa district of the Oromia region in Eastern Ethiopia, covering 24 kebeles.

Population
Newborns registered at birth in the database of the KHDSS site in Eastern Ethiopia.

Methods
The KHDSS tracks demographic and health changes in the community. Newborn data were extracted using a checklist. Trends in CAs over time (in years) were analysed and the associated factors were identified through logistic regression analysis.

Outcome measure
Newborn CAs, which are structural or functional abnormalities present at birth, were assessed through thorough physical examinations and detailed interviews conducted by trained data collectors using a standardised questionnaire.

Results
Between 2015 and 2022, a total of 27 350 newborns were recorded in the KHDSS, 104 of whom had CAs. The overall rate of CAs was 3.83 per 1000 live births (95% CI 3.19, 4.61). There was a significant increase in the trend of CAs over the study period, with a Mantel-Haenszel 2 of 82.76 (p=0.001). Factors associated with CA included maternal age over 35 years (adjusted OR (AOR)=1.68, 95% CI 1.07, 2.62), place of birth (AOR=2.04, 95% CI 1.04, 4.02) and normal birth weight (AOR=0.14, 95% CI 0.04, 0.47).

Conclusion
The data from the KHDSS revealed a rising trend in CAs. CA was associated with factors such as the mother’s age, place of birth and the baby’s birth weight. It is crucial for healthcare providers and stakeholders to consider these factors in efforts to reduce the prevalence of CAs.

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Febbraio 2025

Barriers and enablers of access to diabetes eye care in Auckland, New Zealand: a qualitative study

Objective
To explore the barriers and enablers to accessing diabetes eye care services among adults in Auckland.

Design
This was a qualitative study that used semistructured interviews. We performed a thematic analysis and described the main barriers and enablers to accessing services using the Theoretical Domains Framework.

Setting
The study took place in two of the three public funding and planning agencies that provide primary and secondary health services in Auckland, the largest city in Aotearoa New Zealand.

Participants
Thirty people with diabetes in Auckland who had experienced interrupted diabetes eye care, having missed at least one appointment or being discharged back to their general practitioner after missing several appointments.

Results
We identified barriers and enablers experienced by our predominantly Pacific and Māori participants that aligned with 7 (of the 14) domains in the Theoretical Domains Framework. The most reported barriers were transport issues, lack of awareness regarding the importance of retinal screening, time constraints, limited and/or inflexible appointment times and competing family commitments. Enablers included positive interactions with healthcare providers and timely appointment notifications and reminders.

Conclusions
Diabetes eye services could be made more responsive by addressing systemic barriers such as service location and transport links, appointment availability and meaningful information to aid understanding.

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Gennaio 2025

Abstract WP187: Graph neural networks for impossible transfemoral access pre-procedural prediction in stroke mechanical thrombectomy

Stroke, Volume 56, Issue Suppl_1, Page AWP187-AWP187, February 1, 2025. Introduction:3 to 5% of patients undergoing endovascular thrombectomy present impossible catheter access to the occlusion site from transfemoral access (TFA), largely attributed to complex arterial anatomy. Radial access can be an effective bailout strategy, but intraprocedural delays may negatively impact outcomes. Novel image processing algorithms allow for advanced characterization of vascular pathways from baseline neuroimaging, enabling the exploration of predictive models of impossible TFA before arterial puncture.Methods:A retrospective cohort of patients with an anterior large vessel occlusion who received thrombectomy from TFA between 2017 and 2023 were included in this study. A previously described automatic vascular analysis software was used to generate centerline graphs from the aorta to the intracranial occlusion site from baseline CTA. ArterialGNet, a graph neural network based on graph attention designed to integrate descriptors of centerline pathways extracted at three different distance scales, was trained for impossible TFA prediction. Five-fold cross validation was used for model derivation. The method was compared to a previously introduced random forest ensemble model with extreme gradient boosting (XGBRF) based on six vascular tortuosity descriptors of the aortic and supra-aortic regions.Results:A total of 745 patients (aged 78 years IQR 68-85, 56% women) were included in this study. Patients treated between 2017 to 2022 (n=568, 3.2% with impossible TFA) were used for model training and validation. Patients treated in 2023 (n=177, 3.4% with impossible TFA) were held out for testing. In validation, the best-performing configuration of ArterialGNet achieved a C-statistic of 0.82 (95%CI 0.74-0.90), similar to the baseline model (0.82, 95%CI 0.77-0.88). Comparable outcomes were observed in the final testing for ArterialGNet (0.84, 95%CI: 0.82–0.86). In contrast, the XGBRF model exhibited signs of overfitting (0.65, 95% CI: 0.53–0.78). In final testing, ArterialGNet predicted impossible TFA with a sensitivity of 0.80 (95%CI 0.66-0.94) and a specificity of 0.84 (95%CI 0.76-0.91). Median processing time for ArterialGNet was below 4 min.Conclusions:A novel model for impossible TFA prediction was validated with a large dataset. Impossible TFA prediction before arterial puncture may assist in decision support for initial access selection in thrombectomy, reducing intraprocedural delays and potentially improving clinical outcomes.

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Gennaio 2025

Abstract TMP48: Racial, Ethnic and Rural Disparities in Access to Acute Stroke Capabilities Persist even with Telestroke

Stroke, Volume 56, Issue Suppl_1, Page ATMP48-ATMP48, February 1, 2025. Background:Telestroke may mitigate racial/ethnic and rural disparities in access to acute stroke expertise. Objective: to examine the relationship between patient race/ethnicity and presentation to an emergency department (ED) with acute stroke capabilities, including telestroke, and whether this varied by rurality.Methods:Data maintained by the California Department of Health Care Access and Information identified all statewide acute stroke encounters in 2021. ED capabilities were from the 2021 National ED Inventory-USA database (e.g., telestroke capability). ED acute stroke capabilities were defined as any stroke center status (including acute stroke ready hospital or equivalent) or telestroke capability. Logistic regression models examined the association between patient race/ethnicity, rurality and presentation to an ED with acute stroke capabilities, accounting for age, sex, and expected payer, overall and stratified by rurality. Our first outcome of interest was presentation to an ED with any stroke center status. Then, to examine whether access improved with inclusion of telestroke, the outcome included presentation to an ED with any stroke center status or telestroke capability.Results:In 2021, 264 of 325 California EDs (81%) had acute stroke capabilities, 52% with telestroke (with or without stroke center status). Of 63,252 encounters, 2,050 (3%) presented to an ED without capabilities. Overall, Hispanic, non-Hispanic patients of non-White race and rural patients had lower odds of access to acute stroke capabilities (Table 1). Odds of access did not improve with inclusion of EDs with telestroke (Table 1). When stratified by rurality, there were no differences in access by race/ethnicity for rural patients, but urban Hispanic, urban non-Hispanic Black and urban non-Hispanic patients of other race had lower odds of access relative to urban non-Hispanic White patients (Table 2).Conclusions:Most California EDs have acute stroke capabilities, with few patients presenting to non-capable centers. Overall, rural patients had lower odds of presenting to an ED with capabilities. Racial/ethnic disparities in access were distinct between urban and rural settings, with no racial/ethnic disparity among rural patients but lower odds of access for Hispanic and non-white urban patients. The inclusion of ED telestroke capability in the definition of acute stroke capabilities did not mitigate disparities in access.

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Gennaio 2025

Abstract TP327: Prevalence of healthcare access measures among stroke survivors aged 18-64, Behavioral Risk Factor Surveillance System, United States, 2011–2022

Stroke, Volume 56, Issue Suppl_1, Page ATP327-ATP327, February 1, 2025. Self-reported stroke prevalence has increased among US adults aged 18-64 over the past decade and is projected to rise. As younger stroke survivors live longer, access to healthcare is essential for the detection, treatment, and monitoring of cardiovascular disease (CVD) risk factors to prevent recurrent stroke or other acute CVD events. Adults aged 1 personal healthcare provider, the ability to afford to see a doctor in the past year, and a routine checkup within the past year).Most stroke survivors reported healthcare access: 86.3% (95% CI 85.7 – 86.8 had insurance coverage and >1 personal healthcare provider); 26.6% (95% CI 25.9 – 27.3) couldn’t afford a doctor in the past year; and 81.2% (95% CI 80.6 – 81.1) had a routine checkup in the past year. Statistically significant differences (p < 0.05) were found across all sociodemographic groups. Younger adults (aged 18-29 and 30-44), men, and those with lower education reported less healthcare access. Varying measures of access were reported across racial/ethnic groups.Overall, most stroke survivors reported access to healthcare, although opportunities exist to improve access for younger adults, men, different racial/ethnic minorities, and those with lower education. Prior access to healthcare might have contributed to stroke survival for some individuals. Continued and improved healthcare access could help prevent recurrent stroke or other acute CVD event among stroke survivors.

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Gennaio 2025

Abstract TP129: Both English and non-English speaking patients with large-vessel occlusion receive timely access to thrombectomy

Stroke, Volume 56, Issue Suppl_1, Page ATP129-ATP129, February 1, 2025. Introduction:An equitable health system requires access to clinical advances across society. In stroke, mechanical thrombectomy (MT) has revolutionized the field by providing an acute therapy with unprecedented reduction in morbidity and mortality. Its benefit depends heavily on the duration between stroke onset and cerebral reperfusion. As such, patient factors associated with delays in care can influence outcomes after MT and lead to health inequities. Communication is paramount to a neurological evaluation. In a predominantly English-speaking medical system, we hypothesized that patients with a primary language other than English who presented to the hospital with large-vessel occlusion ischemic stroke (LVO) might experience delays in care resulting in longer times to MT.Methods:We conducted a single-center retrospective cohort study to investigate the impact of primary language on door-to-puncture time (DTP) among patients with LVO who presented to a single comprehensive stroke center between 01/2020 and 05/2024 and underwent MT. We employed non-parametric statistics to compare patient demographics and clinical outcomes and a LASSO approach to identify independent predictors of DTP.Results:Of the 413 patients who underwent MT, 52 (13%) were non-English-speaking (Table 1). In the overall cohort, patients were on average 71 years of age and majority male (57%). They presented to the hospital 8.1 hours after last known well with a mean NIHSS of 19. Compared with the English-speaking cohort, non-English-speaking patients presented earlier to the hospital after last known well (6.1 hours versus 8.1 hours, p = 0.110), were more likely to receive thrombolysis (33% versus 14%, p < 0.001), and had higher rates of hypertension (63% versus 44%, p < 0.008) and lower rates of congestive heart failure (12% versus 30%, p = 0.005). Neither DTP (60 minutes versus 60 minutes, p = 0.900) nor door to needle time (time to administration of thrombolytic, 43 minutes versus 47 minutes, p = 0.600) differed between non-English and English-speaking patients. Regression analysis identified a history of dyslipidemia (decreased DTP 8 min, 95% CI 2-14 min) and having received IV thrombolysis (increased DTP 13 min, 95% CI 5-21 min), but not primary language, as independent predictors of DTP.Conclusions:Our comprehensive stroke center promotes an equitable health system by providing a timely opportunity for MT after LVO irrespective of patient language.

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Gennaio 2025

Abstract 61: (PFO-ACCESS): Augmenting Communications for medical care or Closure in the Evaluation of Stroke patients with cardiac Shunts

Stroke, Volume 56, Issue Suppl_1, Page A61-A61, February 1, 2025. Introduction:Patent Foramen Ovale (PFO) contributes to a quarter of Embolic strokes of Undetermined Source (ESUS). Although benefit of PFO closure in selected patients has been demonstrated, our workflow resulted in a low rate of PFO evaluation for closure. The aim of the PFO-ACCESS program (which included implementation of the Viz.ai PFO-specific communications module) was to determine any change in PFO management due to improved communication between stroke and interventional cardiology (IC) teams.Methods:In this Quality Improvement (QI) project, we compared pre-PFO ACCESS (12/22-11/23) to post- periods (11/23-6/24) for PFO referrals. The Viz.ai PFO module was deployed to the stroke team and IC team members. No other workflow changes were introduced. Key performance indicators (KPIs) included referral frequency, PFO closure rates, and referral- related time intervals. Statistical comparisons utilized Mann-Whitney U tests.Results:The post-implementation period noted a 492% PFO referral increase (11,65(annualized);p

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Gennaio 2025

Abstract WMP2: A Trial of Patients Receiving Remote Ischemic Conditioning in Early Stroke (PRICES) in a Tertiary Hospital in the Philippines: An Open Label Study

Stroke, Volume 56, Issue Suppl_1, Page AWMP2-AWMP2, February 1, 2025. The treatment strategy for acute ischemic stroke (AIS) is reperfusion. In addition, neuroprotective measures have influenced outcomes in mortality, morbidity, and disability. Remote ischemic conditioning (RIC) is a neuroprotective measure that minimizes ischemic reperfusion injury to the target organ. Previous trials have showed its safety and efficacy, but its impact to vascular cognitive impairment and quality of life is undermined. This study aimed to demonstrate its efficacy and impact in terms of disability, cognitive impairment, and quality of life.This is a single center, open-label trial conducted in a tertiary center in the Philippines which included 104 patients randomized to RIC (n=52) and control (n=52) groups. One dose of RIC comprised of 4 cycles of BP cuff inflation 20mmHg above baseline systolic blood pressure (ceiling of 180mmHg) for 5 minutes followed by 5 minutes of cuff deflation; a total of 8 doses of RIC were given over four days with 12 hour intervals. The control arm did not receive cuff inflations; both groups received guideline-based standard stroke care.Out of 104 patients, 10 (9.6%) were excluded from full analysis; 6 patients were excluded due to mortality, while 4 patients failed to undergo MOCA-P and HRQoL testing due to severe aphasia. RIC procedure was completed according to the study protocol in all enrolled 52 patients.Both groups had similar baseline clinical and radiologic findings. NIHSS scores across admission, 24 hours, and discharge timepoints show significant change in the RIC group, while the control group only showed significant NIHSS change between the admission and 24 hour timepoints. The mean MOCA-P scores are 26.5 for RIC group vs control group (25.9). Subgroup analysis for MOCA-P classification showed that RIC group had more normal scores (70.8%) vs control group (65.2%). The control group also had more patients under moderate/severe scores (6.4%). The mean HRQoL score at 90 days for RIC group was 90.6 vs 84.7 for control group. Subgroup analysis showed that the RIC group had a mean pain score of 92.5 vs control group 78.7, which was statistically significant (p

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Gennaio 2025

Abstract 44: Minimally Invasive Surgery is Associated with Improved Outcomes Compared to Open Craniotomy with Clot Evacuation after Spontaneous Intracerebral Hemorrhage in the AHA Get With The Guidelines Registry

Stroke, Volume 56, Issue Suppl_1, Page A44-A44, February 1, 2025. Introduction:Data are lacking on outcomes of minimally invasive surgery (MIS), an emerging surgical treatment for spontaneous intracerebral hemorrhage (ICH), compared to conventional open craniotomy with clot evacuation. We therefore sought to evaluate ICH outcomes after MIS vs conventional clot evacuation in a real-world, nationally representative US cohort.Methods:We performed a retrospective cohort study of patients with ICH from 2011-2021 in the Get With The Guidelines-Stroke registry. The exposure was the type of surgery, classified as open craniotomy with clot evacuation versus MIS (either endoscopic surgical evacuation or stereotactic evacuation with fibrinolytic therapy). The primary outcome was in-hospital mortality, and secondary outcomes included discharge disposition, ambulatory status at discharge, and modified Rankin score at discharge. Using overlap propensity matching, we matched patients with MIS versus open craniotomy on age, sex, race, NIH Stroke Scale, prior antithrombotic therapy, external ventricular drain use, and withdrawal of care. The overlap weighting creates exact balance on the mean of every measured covariate when the propensity score is estimated by logistic regression, and therefore, mimics the attributes of a clinical trial. Each MIS patient was matched with multiple patients who received open craniotomy, based on the propensity score. Logistic regression was used to study the relationship of the type of surgery with outcomes. Pre-specified subgroup analyses were stratified by age, sex, race, NIHSS, EVD use, and annual ICH volume.Results:Among 555,964 patients with ICH, MIS was performed in 703 patients (330 had stereotactic surgery and 373 had endoscopic surgery) and open craniotomy was performed in 7067 patients. In the matched cohort, in-hospital deaths occurred in 60/446 (13.5%) with MIS and 648/3675 (17.6%) with open craniotomy. In regression analyses, MIS was associated with lower odds of in-hospital mortality (aOR, 0.7; CI, 0.5-0.9), unfavorable discharge (aOR, 0.7; CI, 0.6-0.9), and higher odds of discharge to rehabilitation (aOR, 1.3; CI, 1.1-1.5), but not with functional outcomes (Table). In pre-specified subgroup analyses, lower mortality was noted with MIS in older patients and men (Figure).Conclusions:In a large, diverse US cohort of ICH patients, MIS was associated with lower odds of in-hospital mortality and better discharge disposition compared to open craniotomy with clot evacuation.

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Gennaio 2025

Abstract WP78: Improving Quality of Care through the Implementation of a Dietitian-Led Enteral Access Team in the Post-Acute Stroke Population

Stroke, Volume 56, Issue Suppl_1, Page AWP78-AWP78, February 1, 2025. Introduction:Dysphagia affects approximately 30-80% of ischemic stroke patients. While most patients recover swallowing functions within a week, 10-50% may experience persistent issues for up to six months post-stroke. Early enteral access is critical for providing hydration, nutrition, and medication to these patients. Stroke patients often require specialized nutritional support through feeding tubes. At a large urban academic comprehensive stroke center, we identified an opportunity to develop a model that supports and streamlines feeding tube placement for this population to enhance care quality and improve patient outcomes.Methods:This retrospective study evaluated enteral feeding support in 43 post-acute stroke patients from October 2023 through July 31st. We compared tube placements and outcomes between nursing staff and a dietitian-led enteral access team. Nursing staff used standard NG tube procedures, while the dietitian-led team employed advanced techniques, including an electromagnetic device and bridle retention system to enhance tube stability and reduce need for replacements. We also assessed discharges to acute rehabilitation with bridled small-bore tubes who would have otherwise required PEG placement.Results:Out of 43 patients, 7 patients had NG tubes placed by nursing staff and 36 by the dietitian-led team. All 7 patients required replacement and were ultimately escalated to the dietitian-led team. The dietitian-led team achieved greater tube stability using advanced techniques and required only 1 replacement. A total of 13 patients were discharged to rehabilitation with bridled tubes.Conclusion:In conclusion, we found that a dietitian-led enteral access team can maintain high-quality care and satisfaction through advanced enteral tube placement techniques. Additionally, a subset of patients were able to defer PEG placement allowing for additional time for recovery from dysphagia. Future considerations include evaluating nurse workload reduction, decreased hospital stays, and accelerated rehabilitation placement with early, secure enteral access.

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Gennaio 2025