Abstract 4142506: Comparative Proteomic Analysis of Myocarditis: COVID-19 mRNA Vaccination vs. Pre-Pandemic Viral Etiologies

Circulation, Volume 150, Issue Suppl_1, Page A4142506-A4142506, November 12, 2024. Introduction:Myocarditis has been reported after mRNA-based COVID-19 vaccination, but the immune mechanisms remain unclear. This study aimed to identify the proteome-based immunopathogenesis of post-vaccination myocarditis compared to viral myocarditis in the pre-COVID-19 era.Methods:Proteomic analysis of right ventricle (RV) biopsy specimens was performed in myocarditis patients (pre-pandemic viral myocarditis: n=3, post-vaccination myocarditis: n=3) and controls (normal endomyocardial biopsy specimens of heart transplant recipients, n=4) using mass spectrometry. Differentially expressed proteins were analyzed with CIBERSORTx, Gene Ontology (GO) analysis, and Ingenuity Pathway Analysis (IPA). To examine the relationship between the SARS-CoV-2 spike protein and post-vaccination myocarditis, immunohistochemistry (IHC), mass spectrometry analysis of spike protein, and activation-induced marker (AIM) assay in T cells from RV samples were conducted.Results:In the proteomic analysis, 6,861 proteins were identified. Post-vaccination myocarditis showed increased extracellular matrix formation and cardiac fibrosis. Both pre-pandemic and post-vaccination myocarditis had elevated pro-inflammatory cytokine activities. However, post-vaccination myocarditis exhibited higher expression of interferon-alpha (IFNα) and pattern recognition receptor activation, including TLR3 and TLR7. Pre-pandemic myocarditis showed higher activation of the complement system, neutrophils, and NK cells, whereas post-vaccination myocarditis showed increased Th2 cell activation and classical macrophage activation. Spike protein and related T-cell activation were not detected.Conclusion:The immune activation in myocarditis after COVID-19 mRNA vaccination may be triggered by the mRNA in the vaccine via an IFNα-driven immune response, leading to autoimmune-like features. Further studies are necessary to validate whether these proteins correlate with clinical characteristics.

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Novembre 2024

Abstract 4146890: Analysis of In-Hospital Outcomes of Transcatheter Edge-to-Edge Repair of Mitral Valve in Patients with and without COVID-19: Insights from the National Inpatient Sample Data (2020-2021)

Circulation, Volume 150, Issue Suppl_1, Page A4146890-A4146890, November 12, 2024. Background:COVID-19 has introduced new complexities in the management of patients undergoing the transcatheter edge-to-edge repair (TEER) procedure of the mitral valve. This study compares outcomes of mitral valve TEER in patients with and without COVID-19, utilizing data from the National Inpatient Sample (2020-2021).Methods:We conducted a retrospective cohort study on 23,465 patients without COVID-19 and 85 patients with COVID-19 undergoing mitral valve TEER. Multivariate logistic regression was employed to compare outcomes, adjusting for potential confounders. Primary outcomes included mortality and major complications, while secondary outcomes encompassed specific procedural complications.Results:Patients with COVID-19 were younger (mean age: 73.176 vs. 76.178 years, p-value

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Novembre 2024

Protocol for an ambidirectional cohort study on long COVID and the healthcare needs, use and barriers to access health services in a large city in Southeast Brazil

Introduction
Post-COVID-19 condition, or syndrome, also known as long COVID, is an infection-associated chronic condition that can develop after a SARS-CoV-2 infection and last at least 3 months to years. Despite representing a high burden for the Unified Health System (SUS), which has affected millions of Brazilians, it has received limited attention in Brazil. Prevalence studies to date have failed to include a broad representation of the population, and there has been insufficient exploration of the impact on people’s lives and the burden of and barriers to accessing health services. This article presents the research protocol for the quantitative component of a mixed methods project to produce evidence to inform SUS’s provision of care for long COVID. The protocol was designed to study long COVID in SUS patients hospitalised for COVID-19 in a large city in Southeast Brazil to capture symptoms and factors associated with the syndrome, effects on quality of life and employment, health needs, use of health services and barriers to accessing necessary healthcare.

Methods and analysis
An ambidirectional cohort study to capture data retrospectively and prospectively from adults previously discharged from SUS hospitals for COVID-19. The study involves up to two telephone surveys with the patients or proxies selected from a sampling plan for population estimates. Survey questions include baseline and follow-up data on demographic, socioeconomic, comorbidities, work status, health-related quality of life, vaccination status, long COVID symptoms, healthcare needs, use and barriers to access. Descriptive and appropriate multivariable analyses will be employed.

Ethics and dissemination
The project was approved by the Research Ethics Committees of participant institutions and by the Brazilian National Research Ethics Commission. All participants provided verbal consent. We plan to publish articles in scientific journals and multimedia resources for SUS professionals and the general population.

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Novembre 2024

Traditional, complementary and integrative medicine therapies for the treatment of mild/moderate acute COVID-19: protocol for a systematic review and network meta-analysis

Background
Increasing evidence has emerged for traditional, complementary and integrative medicine (TCIM) to treat COVID-19 which requires systematic summaries of the net benefits of interventions against standard care and one another. The study aims to conduct a systematic review and network meta-analysis (NMA) regarding TCIM therapies for treating mild/moderate acute COVID-19, potentially informing the WHO guideline development and clinical decision-making.

Methods and analysis
We will search Embase, MEDLINE, Virtual Health Library on Traditional Complementary and Integrative Medicine, Cochrane Central Register of Controlled Trials, WHO’s International Clinical Trials Registry Platform with additional searches of Chinese and Korean literature sources for randomised controlled trials comparing TCIM with placebo, standard care, no treatment or with an alternate type of TCIM to treat COVID-19. We will limit the search dates from 2020 to 28 March 2024. Reviewers will, in duplicate, screen eligible articles, extract data and evaluate the risk of bias. We will conduct frequentist network meta-analyses for network comparisons and each outcome. We will assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach and classify interventions from most to least effective or harmful.

Ethics and dissemination
This NMA is based on the existing trials and data which is not subject to ethical approval. We will publish the NMA in a peer-reviewed journal. This may provide methodological reference and clinical evidence for TCIM on future epidemic-prone diseases.

PROSPERO registration number
CRD42024517321.

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Novembre 2024

Experiences of physiotherapists working with adults living with Long COVID in Canada: a qualitative study

Objectives
To explore experiences of physiotherapists working with adults living with Long COVID in Canada.

Design
Cross-sectional descriptive qualitative study involving online semi-structured interviews.

Participants
We recruited physiotherapists in Canada who self-identified as having clinically treated one or more adults living with Long COVID in the past year.

Data collection
Using an interview guide, we inquired about physiotherapists’ knowledge of Long COVID, assessment and treatment experiences, perspectives on physiotherapists’ roles, contextual and implementation factors influencing rehabilitative outcomes, and their recommendations for Long COVID rehabilitation. Interviews were audio-recorded, transcribed verbatim and analysed using a group-based thematic analytical approach. We administered a demographic questionnaire to describe sample characteristics.

Results
13 physiotherapists from five provinces participated; most were women (n=8; 62%) and practised in urban settings (n=11; 85%). Participants reported variable amounts of knowledge of existing guidelines and experiences working with adults living with Long COVID in the past year. Physiotherapists characterised their experiences working with adults living with Long COVID as a dynamic process involving: (1) a disruption to the profession (encountering a new patient population and pivoting to new models of care delivery), followed by (2) a cyclical process of learning curves and evolving roles of physiotherapists working with persons living with Long COVID (navigating uncertainty, keeping up with rapidly emerging evidence, trial and error, adapting mindset and rehabilitative approaches and growing prominence of roles as advocate and collaborator). Participants recommended the need for education and training, active and open-minded listening with patients, interdisciplinary models of care, and organisational- and system-level improvements to foster access to care.

Conclusions
Physiotherapists’ experiences involved a disruption to the profession followed by a dynamic process of learning curves and evolving roles in Long COVID rehabilitation. Not all participants demonstrated an in-depth understanding of existing Long COVID rehabilitation guidelines. Results may help inform physiotherapy education in Long COVID rehabilitation.

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Novembre 2024

Variations in COVID-19 vaccine hesitancy over time: a serial cross-sectional study in five West African countries

Objectives
This study aims to identify the factors influencing vaccine hesitancy, willingness and its variation over time in order to inform more responsive strategies for increasing vaccination uptake. The specific objectives are: (1) to describe and compare levels of COVID-19 vaccine hesitancy among the general population in rural and urban settings in West Africa over time and (2) to identify factors associated with COVID-19 vaccination willingness and hesitancy among the general population across five West African countries over time.

Design
Following a baseline survey (Wave I), three serial cross-sectional surveys (Waves II-IV) were implemented.

Setting
The study was conducted in Burkina Faso, Guinea, Mali, Senegal and Sierra Leone from November 2021 to July 2022.

Participants
A total of 13 571 study participants were included in the study (n=4373, n=4593 and n=4605 for survey Waves II, III and IV, respectively). Inclusion criteria were being 18 years or older, living in the study area and willing to provide informed consent. A two-stage sampling strategy was used to select the sample from among the general population.

Primary and secondary outcomes
Primary outcomes were the variability of vaccine hesitancy over time and across the five West African countries. Secondary outcomes were factors associated with vaccine willingness.

Results
A small but steady increase in hesitancy to COVID-19-vaccination can be observed across countries, with an upward trend of vaccine hesitancy reported by 952 participants (33.9 %) in Wave II, 1055 (37.3%) in Wave III and 1089 (38.1%) in Wave IV. Among the countries included, Senegal shows the highest level of vaccine hesitancy (‘Definitely no’ and ‘Probably no’ ranging from 50.2% to 56.0% and 26.2 to 28.3%, respectively). At the same time, Senegal has the lowest vaccination coverage overall. Across all five countries and survey waves, the primary factor associated with vaccination willingness is fear of experiencing severe COVID-19 disease (Wave II: OR 0.42, 95% CI 0.34 to 0.51, Wave III: OR 0.48, 95% CI 0.40 to 0.59 and Wave IV: OR 0.54, 95% CI 0.44 to 0.66). Perceived improved financial status seems to influence willingness to get vaccinated negatively (OR 0.57, 95% CI 0.40 to 0.81) and unlike in Western, Educated, Industrialised, Rich and Democratic countries, men seem more reluctant to get vaccinated than women (OR 0.77, 95%, CI 0.65 to 0.93).

Conclusions
Our findings suggest that vaccine hesitancy should be monitored over time to inform communication strategies, which are responsive to changes in vaccination-related public sentiments. Additionally, a focus on social solidarity and the importance of women in vaccination advocacy can help improve COVID-19 vaccination coverage in West Africa.

Trial registration number
The general protocol is registered on clinicaltrial.gov (protocol number: NCT04912284).

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Novembre 2024

Evaluation of occupational therapy in persons with COVID-19: a pre-post observational cohort study

Background
Persons with COVID-19 may experience limitations in daily functioning and can be referred to occupational therapy.

Objectives
To evaluate changes in daily functioning, cognitive complaints, fatigue and self-management of persons with COVID-19 who received occupational therapy in primary care.

To get insights in the volume and duration of occupational therapy.

Design
A pre-post observational cohort study from October 2020 until April 2021.

Setting
Fifty-eight occupational therapy practices in primary care throughout the Netherlands participated with 68 occupational therapists.

Participants
228 adults (≥18 years) with COVID-19, referred to occupational therapy, gave informed consent and participated in the pre-post evaluation. The mean age was 49 years (SD 13) and 79% of the patients was female. The most frequently reported complaints included fatigue and cognitive complaints.

Interventions
Occupational therapy using Dutch guidelines for occupational therapy in clients with COVID-19.

Outcome measures
Performance and satisfaction with performance using the Canadian Occupational Performance Measure (COPM); the impact of Cognitive Complaints on Participation (CoCo-P); and daily activities, self-management and perceived contribution of occupational therapy using the Patient Reported Outcome Measure for Occupational Therapy (PROM-OT).

Results
COPM-performance score improved with a mean difference of 2.9 points (95% CI 2.7 to 3.2), and COPM-satisfaction score improved with 3.2 points (95% CI 2.9 to 3.5). CoCo-P score improved with a mean difference of 20.9 points (95% CI from 14.4 to 27.4), and PROM-OT improved with 42.8 points (95% CI from 40.2 to 45.4). Participants received a median of seven sessions of occupational therapy (IQR 5–10) with a median duration of 18 weeks (IQR 12–25). They valued the contribution of occupational therapy to their improved functioning with a mean score of 8 (SD 1.4) and recommended this to others with a mean score of 9 (SD 1.2).

Conclusions
Persons with COVID-19 who received occupational therapy in primary care improved significantly in daily functioning and highly valued occupational therapy.

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Novembre 2024

Impact of the COVID-19 pandemic on maternal, neonatal and child health service utilisation, delivery and health outcomes in Gauteng province, South Africa: an interrupted time series (ITS) analysis

Background
Gauteng was one of the provinces in South Africa most hit by COVID-19. However, there has been no assessment of the pandemic’s impact on essential maternal, neonatal and child health (MNCH) services in Gauteng, for planning against future emergencies. This study sought to assess the impact of the COVID-19 pandemic on essential MNCH service utilisation, delivery and health outcomes in Gauteng province.

Methods
We employed a quasi-experimental interrupted time series (ITS) study design, using the District Health Information System (DHIS) data set to evaluate the impact of COVID-19 on eight key MNCH indicators between March 2019 to February 2021. Using Stata V.17.0 and 5% alpha, a segmented linear regression (ITS) model quantified the trends of the indicators before COVID-19 (March 2019 to February 2020) (β1), the immediate change in level due to the March 2020 lockdown (β2), the post-lockdown (March 2020 to February 2021) trend (β4) and the change in gradient from before to after the lockdown (β3).

Results
COVID-19 lockdown exerted a significant decline in primary healthcare headcount

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Novembre 2024

Do summaries of evidence enable informed decision-making about COVID-19 and influenza vaccination equitably across more and less disadvantaged groups? Study protocol for a multi-centre cluster randomised controlled trial of 'fact boxes in health and social care in Germany

Introduction
Evidence summaries on the benefits and harms of treatment options support informed decisions under controlled conditions. However, few studies have investigated how such formats support decision-making across different social groups. There is a risk that only disadvantaged people will be able to make informed health decisions—possibly increasing the health equity gap. It is also unclear whether they support decision-making in the field at all. The aim of our study is to assess whether evidence summaries based on the fact box format can help people from different social groups make informed decisions about COVID-19 and influenza vaccinations, and thus reduce inequity in health communication.

Methods and analysis
In a multi-centre, cluster-randomised, controlled trial, health educators from usual care and outreach work in Germany will be randomised in a 1:1 ratio to provide either usual health communication plus an evidence summary (‘fact box’) or usual health communication. Health educators provide a flyer about COVID-19 or influenza vaccination which contains a link to an online study either with (intervention) or without (control) fact box on the reverse side. Flyer and online study will be available in Arabic, German, Turkish and Russian language. The primary outcome is informed vaccination intention, based on vaccination knowledge, attitudes, intentions and behaviour. Secondary outcomes include risk perception, decisional conflict and shared decision-making. We will use linear mixed models to analyse the influence of both individual (eg, education status) and cluster level factors and account for the expected cluster variability in realising usual health communication or the intervention. The statistical analysis plan includes the selection of appropriate measures of effect size and power calculation, assuming a sample size of 800 patients.

Ethics and dissemination
The trial has been approved by the Ethics Committee of the University of Potsdam, Germany (application numbers: 34/2021 and 57/2022).
Results will be disseminated through peer-reviewed journals, conferences and to relevant stakeholders.

Protocol version
Version 6 (4 October 2024); Preprint available on Research Square: https://doi.org/10.21203/rs.3.rs-3401234/v3

Trial registration number
NCT06076421.

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Novembre 2024