Study protocol for a randomised open-label clinical trial examining the safety and efficacy of the Android Artificial Pancreas System (AAPS) with advanced bolus-free features in adults with type 1 diabetes: the 'CLOSE IT (Closed Loop Open SourcE In Type 1 diabetes) trial

Introduction
Multiple automated insulin delivery (AID) systems have become commercially available following randomised controlled trials demonstrating benefits in people with type 1 diabetes (T1D). However, their real-world utility may be undermined by user-associated burdens, including the need to carbohydrate count and deliver manual insulin boluses. There is an important need for a ‘fully automated closed loop’ (FCL) AID system, without manual mealtime boluses. The (Closed Loop Open SourcE In Type 1 diabetes) trial is a randomised trial comparing an FCL AID system to the same system used as a hybrid closed loop (HCL) in people with T1D, in an outpatient setting over an extended time frame.

Methods and analysis
Randomised, open-label, parallel, non-inferiority trial comparing the Android Artificial Pancreas System (AAPS) AID algorithm used as FCL to the same algorithm used as HCL. Seventy-five participants aged 18–70 will be randomised (1:1) to one of two treatment arms for 12 weeks: (a) FCL—participants will be advised not to bolus for meals and (b) HCL—participants will use the AAPS AID algorithm as HCL with announced meals. The primary outcome is the percentage of time in target sensor glucose range (3.9–10.0 mmol/L). Secondary outcomes include other glycaemic metrics, safety, psychosocial factors, platform performance and user dietary factors. Twenty FCL arm participants will participate in a 4-week extension phase comparing glycaemic and dietary outcomes using NovoRapid (insulin aspart) to Fiasp (insulin aspart and niacinamide).

Ethics and dissemination
Approvals are by the Alfred Health Ethics Committee (615/22) (Australia) and Health and Disability Ethics Committees (2022 FULL 13832) (New Zealand). Each participant will provide written informed consent. Data protection and confidentiality will be ensured. Study results will be disseminated by publications, conferences and patient advocacy groups.

Trial registration numbers
ACTRN12622001400752 and ACTRN12622001401741.

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Febbraio 2024

Priority strategies to reduce socio-gendered inequities in access to person-centred osteoarthritis care: Delphi survey

Objectives
Osteoarthritis (OA) prevalence, severity and related comorbid conditions are greater among women compared with men, but women, particularly racialised women, are less likely than men to access OA care. We aimed to prioritise strategies needed to reduce inequities in OA management.

Design
Delphi survey of 28 strategies derived from primary research retained if at least 80% of respondents rated 6 or 7 on a 7-point Likert scale.

Setting
Online.

Participants
35 women of diverse ethno-cultural groups and 29 healthcare professionals of various specialties from across Canada.

Results
Of the 28 initial and 3 newly suggested strategies, 27 achieved consensus to retain: 20 in round 1 and 7 in round 2. Respondents retained 7 patient-level, 7 clinician-level and 13 system-level strategies. Women and professionals agreed on all but one patient-level strategy (eg, consider patients’ cultural needs and economic circumstances) and all clinician-level strategies (eg, inquire about OA management needs and preferences). Some discrepancies emerged for system-level strategies that were more highly rated by women (eg, implement OA-specific clinics). Comments revealed general support among professionals for system-level strategies provided that additional funding or expanded scope of practice was targeted to only formally trained professionals and did not reduce funding for professionals who already managed OA.

Conclusions
We identified multilevel strategies that could be implemented by healthcare professionals, organisations or systems to mitigate inequities and improve OA care for diverse women.

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Febbraio 2024

Integrated palliative care in oncology: a protocol for a realist synthesis

Introduction
Emerging evidence suggests improved quality of life, reduced symptom burden and lower health services costs when integrated palliative care and cancer care are implemented. Integrated palliative care aims to achieve care continuity by integrating organisational, administrative and clinical services involved in patient care networks. However, integrated palliative care for cancer is not common practice. This project, therefore, aims to understand how integrated palliative care and cancer care works in different healthcare settings (inpatient/outpatient), and for which groups of people (at what stage of the cancer journey), so we can develop guidance for optimal delivery.

Methods and analysis
We will conduct a realist synthesis to develop a programme theory of how integrated palliative care in cancer works, for whom and in what contexts to achieve improved symptom management and quality of life for patients and their families.
This realist synthesis will follow the five stages outlined by Pawson: (1) locating existing theories, (2) searching for evidence, (3) article selection, (4) extracting and organising data and (5) synthesising the evidence and drawing conclusions. We will work closely with our expert stakeholder group, which includes health and social care professionals providing palliative care and oncology; management and policy groups and members of the public and patients. We will adhere to RAMESES quality standards for undertaking a realist synthesis.

Ethics and dissemination
Ethics approval for this project is not required.
The realist synthesis will develop a programme theory that provides clarity on the optimal delivery of palliative care for adults with cancer. We will use the programme theory to coproduce guidance and user-friendly outputs, working with stakeholders to inform delivery of best practice. Findings will inform further research in integrated palliative care and cancer. Stakeholder engagement will assist in the dissemination of our findings.

PROSPERO registration number
CRD42023389791.

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Febbraio 2024

Multimodality magnetic resonance evaluating the effect of enhanced physical exercise on the growth rate, flow haemodynamics, aneurysm wall and ventricular-aortic coupling of patients with small abdominal aortic aneurysms (AAA MOVE trial): a study protocol for an open-label randomised controlled trial

Introduction
The best lifestyle for small abdominal aortic aneurysms (sAAA) is essential for its conservative management. Physical exercise can improve the cardiopulmonary function of the patients, but it remains unclear which specific type of exercise is most beneficial for individuals with sAAA. The current study was designed to investigate the effect of physician-guided enhanced physical exercise programme on the aorto-cardiac haemodynamic environment, aneurysm sac wall, cardiac function and growth rate of sAAA by multimodality MRI.

Methods and analysis
AAA MOVE study is a prospective, parallel, equivalence, randomised controlled trial. Eligible individuals will be recruited if they are diagnosed with sAAA (focal dilation of abdominal aorta with maximum diameter

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Febbraio 2024

Prevalence and drivers of nurse and physician distress in cardiovascular and oncology programmes at a Canadian quaternary hospital network during the COVID-19 pandemic: a quality improvement initiative

Objectives
To assess the prevalence and drivers of distress, a composite of burnout, decreased meaning in work, severe fatigue, poor work–life integration and quality of life, and suicidal ideation, among nurses and physicians during the COVID-19 pandemic.

Design
Cross-sectional design to evaluate distress levels of nurses and physicians during the COVID-19 pandemic between June and August 2021.

Setting
Cardiovascular and oncology care settings at a Canadian quaternary hospital network.

Participants
261 nurses and 167 physicians working in cardiovascular or oncology care. Response rate was 29% (428 of 1480).

Outcome measures
Survey tool to measure clinician distress using the Well-Being Index (WBI) and additional questions about workplace-related and COVID-19 pandemic-related factors.

Results
Among 428 respondents, nurses (82%, 214 of 261) and physicians (62%, 104 of 167) reported high distress on the WBI survey. Higher WBI scores (≥2) in nurses were associated with perceived inadequate staffing (174 (86%) vs 28 (64%), p=0.003), unfair treatment, (105 (52%) vs 11 (25%), p=0.005), and pandemic-related impact at work (162 (80%) vs 22 (50%), p

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Febbraio 2024

Fruquintinib plus oxaliplatin combined with S-1 (SOX) as neoadjuvant therapy for locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ): a multicentre, phase II, single-arm, open-label clinical trial (FRUTINEOGA) protocol

Introduction
Curing locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ) with surgery alone is challenging. Neoadjuvant chemotherapy (NCT) has become the standard treatment for patients with locally advanced GC/GEJ, and SOX is the most common neoadjuvant regimen in China. The generally good tolerability in patients and fruquintinib’s low potential for drug–drug interaction suggest that it may be highly suitable for combinations with other antineoplastic therapies. A combination of fruquintinib, S-1 and oxaliplatin can be a promising neoadjuvant treatment for locally advanced GC/GEJ. In this phase II study, we aim to investigate the efficacy and toxicity of fruquintinib plus SOX as neoadjuvant treatment for locally advanced GC/GEJ.

Methods and analysis
The FRUTINEOGA trial is a prospective, multicentre, phase II, single-arm, open-label clinical trial that will enrol 54 patients. Eligible patients will be registered, enrolled and receive 2–4 cycles of fruquintinib plus SOX, after which surgery will be performed and tumour regression will be evaluated. The primary endpoint is the pathological remission rate, and the secondary endpoints are disease-free survival, overall survival, objective response rate, major pathological response rate and R0 resection rate.

Ethics and dissemination
Written informed consent will be required from all patients enrolled, and it will be provided by them. The study protocol received approval from the independent ethical review committee of Guangxi Medical University Cancer Hospital, Wuming Hospital of Guangxi Medical University and Wuzhou Red Cross Hospital, Wuzhou Gongren Hospital (approval number: CS2021(96)). We will submit the finalised paper for publication on completing the analyses. This study will provide valuable insights to clinicians regarding the safety and efficacy of incorporating fruquintinib into SOX as neoadjuvant treatment for locally advanced GC/GEJ. The findings have the potential to inform future research proposals and may guide the use of fruquintinib in the neoadjuvant setting for locally advanced GC/GEJ.

Trial registration number
NCT05122091.

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Febbraio 2024

Barriers And Challenges Of Multidisciplinary Teams In Oncology Management: A Scoping Review Protocol

Introduction
Multidisciplinary teams (MDTs) are integral to oncology management, involving specialised healthcare professionals who collaborate to develop individualised treatment plans for patients. However, as cancer care grows more complex, MDTs must continually adapt to better address patient needs. This scoping review will explore barriers and challenges MDTs have encountered in the past decade; and propose strategies for optimising their utilisation to overcome these obstacles and improve patient care.

Methods and analysis
The scoping review will follow Arksey and O’Malley’s framework and begin with a literature search using keywords in electronic databases such as PubMed/MEDLINE, Scopus and PsychINFO, covering the period from January 2013 to December 2022 and limited to English language publications. Four independent reviewers will screen titles and abstracts based on predefined inclusion criteria, followed by full-text review of selected titles. Relevant references cited in the publications will also be examined. A Preferred Reporting Items for Systematic reviews and Meta-Analyses flow diagram will be utilised to illustrate the methodology. Data from selected publications will be extracted, analysed, and categorised for further analysis.

Ethics and dissemination
The results of the scoping review will provide a comprehensive overview of the barriers and challenges encountered by oncology MDTs over the past decade. These findings will contribute to the existing literature and provide insights into areas that require improvement in the functioning of MDTs in oncology management. The results will be disseminated through publication in a scientific journal, which will help to share the findings with the wider healthcare community and facilitate further research and discussion in this field.

Trial registration details
The protocol for this scoping review is registered with Open Science Framework, available at DOI 10.17605/OSF.IO/R3Y8U.

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Febbraio 2024

Adequacy of cancer-related pain management using the Pain Management Index among patients with cancer in the Northwest oncology centres of Ethiopia: an institutional-based cross-sectional study

Objective
The aim of this study was to assess the adequacy of cancer-related pain (CRP) management and associated factors among patients with cancer in the Northwest oncology centres of Ethiopia.

Design and setting
An institutional-based multicentre cross-sectional study was conducted among patients with cancer in the Northwest oncology centres of Ethiopia from May to July 2022.

Participants
All oncology patients at selected hospitals who fulfilled the inclusion criteria during the data collection period were the study population.

Main outcome measures
The main outcome of this study was the adequacy of CRP management, which was measured by the Pain Management Index (PMI). A systematic random sampling technique was used to select representatives from each study area. Data entry and analysis were done using EpiData V.4.6.1 and SPSS V.26, respectively. Binary logistic regression was conducted to determine independent predictors of the adequacy of CRP management. A p value of

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Febbraio 2024

Use of herbal medicine during pregnancy and associated factors among pregnant women with access to public healthcare in west Shewa zone, Central Ethiopia: sequential mixed-method study

Objective
This study was aimed at assessing the prevalence of herbal drug use among pregnant women with access to modern medicine and associated factors in public health facilities in the west Shewa zone, Oromia regional state, Ethiopia.

Design
A sequential mixed-method study approach was carried out among pregnant women and other stakeholders.

Setting
This study was conducted at public health facilities, including 3 public hospitals and 20 health centres, in the west Shewa zone of Ethiopia.

Participants
A systematically selected sample of 411 pregnant women was participated in the quantitative study. For the qualitative method, focus group discussions and in-depth interviews were conducted among pregnant women attending antenatal care and key informants using an interview guide until data saturation was achieved.

Primary outcome
For outcome variables, the respondents were asked if they used any herbal medicine during their current pregnancy. It was then recorded as 0=no and 1=yes.

Results
The prevalence of herbal medicines was found to be 19.7%. The most commonly used herbal medicines were Zingiber officinale, Ocimum gratissimum, Eucalyptus globules, Allium sativum and Rutacha lepensis. Herbal medicine use during pregnancy was significantly associated with older maternal age (adjusted OR (AOR) 2.4, 95% CI 1.2 to 5.1), urban residence (AOR 2.3, 95% CI 1.3 to 3.7) and second trimester of pregnancy (AOR 2.3, 95% CI 1.3 to 4.5).

Conclusions
In this study, one in five pregnant women uses herbal medicine, which is relatively low. Sociodemographic factors and the duration of pregnancy affected the utilisation of herbal drugs during pregnancy. The most common herbals used by pregnant women were intended to treat minor disorders of pregnancy and medical disorders such as hypertension.

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Febbraio 2024

Multicentre, parallel, open-label, two-arm, randomised controlled trial on the prognosis of electrical impedance tomography-guided versus low PEEP/FiO2 table-guided PEEP setting: a trial protocol

Introduction
Previous studies suggested that electrical impedance tomography (EIT) has the potential to guide positive end-expiratory pressure (PEEP) titration via quantifying the alveolar collapse and overdistension. The aim of this trial is to compare the effect of EIT-guided PEEP and acute respiratory distress syndrome (ARDS) network low PEEP/fraction of inspired oxygen (FiO2) table strategy on mortality and other clinical outcomes in patients with ARDS.

Methods
This is a parallel, two-arm, multicentre, randomised, controlled trial, conducted in China. All patients with ARDS under mechanical ventilation admitted to the intensive care unit will be screened for eligibility. The enrolled patients are stratified by the aetiology (pulmonary/extrapulmonary) and partial pressure of arterial oxygen/FiO2 (≥150 mm Hg or

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Febbraio 2024

Experiences and opinions of general practitioners with patient online record access: an online survey in England

Objective
To describe the experiences and opinions of general practitioners (GPs) in England regarding patients having access to their full online GP health records.

Design
Convenience sample, online survey.

Participants
400 registered GPs in England.

Main outcome measures
Investigators measured GPs’ experiences and opinions about online record access (ORA), including patient care and their practice.

Results
A total of 400 GPs from all regions of England responded. A minority (130, 33%) believed ORA was a good idea. Most GPs believed a majority of patients would worry more (364, 91%) or find their GP records more confusing than helpful (338, 85%). Most GPs believed a majority of patients would find significant errors in their records (240, 60%), would better remember their care plan (280, 70%) and feel more in control of their care (243, 60%). The majority believed they will/already spend more time addressing patients’ questions outside of consultations (357, 89%), that consultations will/already take significantly longer (322, 81%) and that they will be/already are less candid in their documentation (289, 72%) after ORA. Nearly two-thirds of GPs believed ORA would increase their litigation (246, 62%).

Conclusions
Similar to clinicians in other countries, GPs in our sample were sceptical of ORA, believing patients would worry more and find their records more confusing than helpful. Most GPs also believed the practice would exacerbate work burdens. However, the majority of GPs in this survey also agreed there were multiple benefits to patients having online access to their primary care health records. The findings of this survey also contribute to a growing body of contrastive research from countries where ORA is advanced, demonstrating clinicians are sceptical while studies indicate patients appear to derive multiple benefits.

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Febbraio 2024

Abstract WP44: Assessing Timely Care of WI's Critical Access Hospitals Acute Stroke Patients With a Speed and Efficiency Task Force

Stroke, Volume 55, Issue Suppl_1, Page AWP44-AWP44, February 1, 2024. Introduction:Data indicates that rural residents are at 30% higher risk of stroke.2Thirty percent of Wisconsin’s (WI) residents live in a rural area and are more often served by smaller, critical access hospitals (CAH). WI Coverdell Stroke Program (Coverdell) data entry into Get With The Guidelines-Stroke® (GWTG) for 2022 shows 22.3% of stroke patient’s transfer from a spoke, often CAH, to a larger tertiary or hub hospital. To assist Coverdell participating (CAH) in timely care of acute stroke patients, Coverdell, American Heart Association® (AHA), and 32 CAH’s partnered to form a Speed and Efficiency Taskforce (TF).Methods:An agreed upon charter, framework and data goals were established in May 2022. Metrics of EMS pre-notification, arrival to CT, and door to needle (DTN) times were regularly reviewed. Evaluation of patients arriving within 4.5 hours of last known well (LKW), median DTN, and percent DTN < 60 minutes were analyzed in two arrival windows. Hypothesized differences when comparing arrival windows of 0700-1900 and 1901-0659 were that the 1901-0659 window would have extended treatment times due to lack of 24/7 CT coverage and LKW not validated from others.Results:Data analysis for 2022. N=179• Arrival to CT: 10 minutes faster in 1901-0659 window• Median DTN: 3 minutes faster in 0700-1900 window (71 vs 74 minutes respectively)• % DTN within 60 minutes: 12% higher compliance in 0700-1900 windowConclusions:Coverdell CAH’s are initiating the CT in a timely manner. Times are lower for arrivals between 1901-0659, ruling out delays due to CT tech non-availability. Delays in DTN treatment times within 60 minutes of arrival are more significant in the 1901-0659 arrival timeframe. The potential causes are a delay in telestroke consult with decision to treat, internal hospital delays in mixing and delivering thrombolytics, CT availability, and family/significant others present. Further research regarding arrival time affecting treatment need to be considered.

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Febbraio 2024

Abstract TP80: Differences in Access to Post Acute Care Services Between Traditional Medicare and Medicare Advantage Beneficiaries in Michigan

Stroke, Volume 55, Issue Suppl_1, Page ATP80-ATP80, February 1, 2024. Introduction:In recent years, Medicare Advantage (MA) enrollment in the US has increased dramatically relative to traditional Medicare (TM). There is evidence to suggest that MA stroke patients are less likely to receive inpatient rehabilitation facility (IRF) based care in favor of home health. To evaluate potential gaps in quality of care, we compared post-acute care use patterns following hospitalization for acute stroke between TM and MA populations.Methods:We probabilistically linked data from Michigan’s Get With The Guidelines-Stroke registry and Michigan Value Collaborative multipayer claims data registry for 16,231 TM and MA beneficiaries discharged alive following acute stroke (ICD-10 I61-I63) between 2016-2020. We used discharge claims to identify the initial discharge destination classified as home, home health, IRF, skilled nursing facility (SNF) or other. Unadjusted differences in proportions and time trends between TM and MA populations were assessed using chi square statistical tests.Results:TM and MA-insured patients constituted 75.1% and 24.9% of the 16,231 stroke discharges, respectively. Compared with TM, MA beneficiaries were older (77.4 vs 75.8,P

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Febbraio 2024

Abstract WMP46: Rurality Affects Access to Mechanical Thrombectomy for Large Vessel Occlusion Stroke on a Global Scale

Stroke, Volume 55, Issue Suppl_1, Page AWMP46-AWMP46, February 1, 2024. Introduction:Global mechanical thrombectomy access (MTA) for large vessel occlusion (LVO) stroke is extremely low. Rural patients are less likely to receive initial care at a thrombectomy-capable hospital. While regional studies have suggested rurality as a barrier to MTA, the magnitude and variability of this effect across countries is unknown. The aim of this study is to evaluate the association of country-level % of the rural population with access to mechanical thrombectomy.Methods:We conducted an online survey of 75 countries through the Mission Thrombectomy 2020+ (MT2020+) global professional peer network between November 22, 2020, and February 28, 2021. Questions included country-level availability of MT centers, operators, procedures, reimbursement, emergency medical services, cultural barriers, and other factors affecting systems of stroke care. MTA was defined as the estimated proportion of patients with thrombectomy-eligible LVOs receiving MT in each region annually. We used the World Bank data to obtain the income class based on per capita GNI of a country and the proportion of rural population expressed as % of total population of each country. In the final analysis, 60 countries were included. We used multivariable-adjusted generalized linear models with logit link to evaluate the association of rural population % with MT access.Results:The median country-level % of rural population among 60 countries was 30.5% (IQR 16.1-45.7%). In univariable generalized linear models, each 5% increase in country-level % of rural population was associated with 22% lower odds of MT access (OR 0.78, 95%CI 0.70-0.86, p

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Febbraio 2024

Abstract 26: Regional Inequities in Access to Stroke Facilities in India – Estimating Travel Distance and Times for Thrombolysis and Thrombectomy

Stroke, Volume 55, Issue Suppl_1, Page A26-A26, February 1, 2024. Introduction:Stroke is a global health concern, with its impact more pronounced in low- and middle-income countries like India. The access to acute stroke treatments, especially intravenour thrombolysis and mechanical thrombectomy, is limited. This research dives into the regional variations in the distribution and accessibility of stroke centers in India.Methods:Data on stroke centers, including those capable of intravenous thrombolysis (IVT) and endovascular treatment (EVT), was gathered from pertinent medication and device providers and geocoded. We estimated driving distances and travel durations between population centers and their proximate IVT and EVT stroke facilities using Google Distance Matrix API, which provided gross estimations. We then compared the estimates across different zones to look at regional disparities in access to stroke facilities.Results:Of the 566 IVT-capable centers spread across 26 states/UTs, 361 (63%) were equipped for EVT. The average stroke centres per million (SCPM) population was 0.41 and 0.26 for IVT-C and EVT-C, respectively. Majority of stroke centres were located in the south zone ( >35%), followed by the western and central zones, while the north, east and northeast zones collectively accounted for just 15% of stroke facilities. Median travel distances to IVT and EVT centers were 114 km and 140 km, respectively. Median travel durations to access IVT and EVT facilities stood at 3.04 and 3.46 hours, respectively. The median duration in the south zone for IVT-C and EVT-C centers was 2 and 2.5Conclusions:The findings of this gross estimations a comprehensive view of stroke care infrastructure in India, highlighting significant regional disparities. The substantial travel times and distinct inconsistencies in stroke care facility availability underscore the need for strategic policy interventions and focused interventions, particularly in underserved regions.

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Febbraio 2024