Search Results for: ESC 2022: Linea guida sulla cardio-oncologia

Objective
This study aimed to assess the impact of the COVID-19 pandemic on the characteristics and outcomes of patients with burns in a burn centre situated in Northwest China.

Design
A retrospective descriptive study.

Setting
This study was conducted in Tangdu Hospital, a major regional burn centre in Xi’an, Shaanxi Province of China.

Participants
A total of 1413 patients with burns were included in the study, with the admission period spanning from 2017 to 2019 (before the pandemic) and 2020 to 2022 (during the pandemic).

Results
Burn hospitalisations decreased during the pandemic for both children (9.80%) and adults (24.68%). The pandemic was associated with a decrease in work-related burns and a corresponding increase in the risk of domestic burns (both p

Objective
Community-engaged immersive rural experiences were limited during the COVID-19 pandemic when online learning was instigated across medical institutions globally. This study aimed to explore the impact of online learning on medical students’ satisfaction levels and intentions to practice in a rural area after graduation.

Design, setting and participants
We conducted a natural quasi-experimental longitudinal retrospective cross-sectional study during 2011–2022 for all Australian domestic medical students who undertook a Rural and Remote Medicine (RRM) placement at the University of Queensland. Anonymous administrative course evaluation data were collected for the same two questions in each cohort over 12 years, between 2011 and 2022.

Outcome measures
Change in students’ intention to pursue a rural medical career and teaching and placement satisfaction levels was determined. Longitudinal data illustrated trends in students’ intention and overall satisfaction across cohorts before and during COVID-19 disruptions.

Results
2695 students participated in the surveys with an average response rate of 81%. Intention levels remained steady between 2011 and 2019, during which students experienced a consistent face-to-face orientation and rural placement immersion. During the COVID-19 disruption phase, primarily in 2020 and 2021, students’ intention to pursue a rural medical career significantly decreased when online-only learning placements were implemented, with only 25% of students in the most impacted rotation indicating a strong positive intention, compared with a previous steady 75%. Comparatively, students’ satisfaction with the RRM programme remained steady across all the years at about 85–90%.

Conclusions
There appears to be a detrimental impact of a lack of immersive community-engaged education experiences on medical student’s intention to pursue a rural medical career. This natural experiment demonstrates that while online learning maintains student satisfaction levels, it lacks value and authenticity and does not inspire students to consider future rural careers. The value of face-to-face and immersive community-engaged experiences is fundamentally an important contributor to inspiring students to work in rural areas in the future.

This study quantifies losses and gains of obstetric care services at US rural and urban short-term acute care hospitals between 2010 and 2022.

Background
Caesarean section (CS) is an important indicator of access to and quality of maternal health services. The WHO recommends the Robson 10-group classification system as a global standard for assessing, monitoring and comparing CS rates at all levels. Identification of the Robson groups that contribute the most to the overall CS is important to determine possible modifiable factors in our attempts to reduce the CS rate. This study was designed to analyse CS deliveries performed in a tertiary referral centre in Somalia according to the Robson 10-group classification system.

Design
This retrospective study included data on consecutive mothers who had deliveries from 1 January 2022 to 1 July 2023.

Methods
Data were categorised according to the Robson classification. Each patient’s data was coded according to Robson’s specifications.

Results
A total of 3030 deliveries were analysed. Of these, 1156 (38.2 %) were CS. Among the five largest Robson groups, the highest absolute contribution to CSs was found in group 5, with 11.4% followed by group 10 with a corresponding contribution of 9.4%. In the next three largest Robson groups (groups 1, 3, 4), the absolute contributions were 3.9%, 3.4% and 3.3%, respectively. The total percentages of CSs among all deliveries (n=3030) and among all CSs (n=1156) in the five largest Robson groups were 31.3% and 82.2%, respectively.

Conclusion
Our analysis showed that the overall caesarean section rate was 38.2%, and those major contributors were Robson groups 5 and 10.

Objectives
This study aimed to explore the perceptions of donation coordinators in Canada and understand how the COVID-19 pandemic impacted their work activities.

Design
A sequential mixed-method design incorporating a cross-sectional survey investigating demographic data, substance use and abuse and perceived stress related to the pandemic and semistructured qualitative interviews to further investigate those.

Setting
Organ donation organisations across Canada.

Participants
Canadian organ and tissue donation coordinators working within deceased donation programmes. Participants were recruited using a purposive sampling technique for the survey and qualitative interviews. Recruitment and data collection took place between January 2022 and March 2023.

Analysis
The data were analysed using descriptive statistics for the quantitative findings and content analysis for the qualitative data.

Results
Of the 175 available coordinators, 120 participated in the survey, and 39 participated in the qualitative interviews. The great majority were female (n=98; 81.7%), registered nurses (n=117; 97.5%) and on average 42 years old (SD=9.64). The survey result for perceived stress showed that, on average, coordinators did not experience high stress levels during the pandemic. We also identified an increase in the consumption of substances to manage workplace stress near the pandemic’s beginning. The qualitative interviews yielded two main themes (Personal Life Changes and Workplace Adjustments) in which coordinators reported their views on challenges with uncertainties, effects on their personal lives, redeployment, stressors and among others.

Conclusion
Our study’s results provide a comprehensive understanding of the perceptions and experiences of coordinators in Canada during the COVID-19 pandemic. Using a combination of methods, we identified various ways coordinators were affected by the pandemic in their personal and professional lives. These findings highlight the need to support the development of adaptive strategies and promote resilience during crises.

Objective
To identify patient and provider factors associated with lower rates of follow-up for positive depression screens in outpatient settings.

Design
Retrospective cohort study with electronic health record analysis investigating factors associated with follow-up care for patients with moderate-to-severe depressive symptoms. Patient and provider variables were associated with rates of follow-up for positive depression screens.

Setting
University of Utah and University of Utah Health-affiliated primary care and specialty clinics.

Participants
Adults who screened positive for depressive symptoms (score≥10) on the Patient Health Questionnaire (PHQ-9) at an ambulatory visit between 1 January 2021 and 31 January 2022. A total of 17 651 patients were included in the study.

Outcome measures
Follow-up for positive depression screens was defined as a new antidepressant prescription or completed mental health visit. Variables associated with follow-up included patient demographic data, anthropometric measures, geographical classification, primary language, comorbidities and socioeconomic factors as well as provider demographics, level of training and clinic type.

Results
5396 patients (30.6%) did not receive follow-up care for a positive PHQ-9 screen. Factors associated with lower rates of follow-up included male patients (gender; p=0.013), older patients (age group; p=0.016), non-White patients (ethnicity; p

Introduction
Digital trials are a promising strategy to increase the evidence base for common interventions and may convey considerable efficiency benefits in trial conduct. Although paediatric intensive care units (PICUs) are rich in routine electronic data, highly pragmatic digital trials in this field remain scarce. There are unmet evidence needs for optimal mechanical ventilation modes in paediatric intensive care. We aim to test the feasibility of a digital PICU trial comparing two modes of invasive mechanical ventilation using carbon dioxide (CO2) control as the outcome measure.

Methods and analysis
Single-centre, open-labelled, randomised controlled pilot trial with two parallel treatment arms comparing pressure control versus pressure-regulated volume control. Patients are eligible if aged 2 kg, have an arterial line and require >60 min of mechanical ventilation during PICU hospitalisation at the University Children’s Hospital Zurich. Exclusion criteria include cardiac shunt lesions, pulmonary hypertension under treatment and intracranial hypertension. CO2 is measured using three methods: end-tidal (continuous), transcutaneous (continuous) and blood gas analyses (intermittent). Baseline, intervention and outcome data are collected electronically from the patients’ routine electronic health records. The primary feasibility outcome is adherence to the assigned ventilation mode, while the primary physiological outcome is the proportion of time spent within the target range of CO2 (end-tidal, normocarbia defined as CO2 ≥ 4.5 and ≤ 6 kPa). Both primary outcomes are captured digitally every minute from randomisation until censoring (at 48 hours after randomisation, extubation, discharge or death, whichever comes first). Analysis will occur on an intention-to-treat basis. We aim to enrol 60 patients in total. Recruitment started in January 2024 and continued for 9 months.

Ethics and dissemination
This study received ethical approval from the Cantonal Ethics Commission of Zurich (identification number: 2022–00829). Study results will be disseminated through publication in a peer-reviewed journal and other media like podcasts.

Trial registration number
NCT05843123.

“Il governo favorisce i privati, va sbloccato il contratto 2022/24”

Purpose
The childhood hand, foot and mouth disease (HFMD) sequelae cohort study (HNHFMDCS) is an ambispective cohort study of patients with HFMD based in Henan Province, China, consisting of patients treated in a key hospital for the diagnosis and treatment of HFMD in Henan Province. The study aims to investigate the long-term sequelae of HFMD survivors and to provide a comprehensive understanding of the potential harm caused by this infectious disease.

Participants
In the retrospective phase of the cohort study, children diagnosed with HFMD from January 2014 to January 2023 were included, and clinical and demographic information about the patients was collected through a self-developed questionnaire. Patients hospitalised with HFMD since January 2023 were enrolled in the prospective cohort phase of the study, and long-term follow-up will be performed after completion of the baseline investigation (interview and comprehensive physical examination), clinical laboratory examination and biospecimen collection.

Findings to date
For the retrospective analysis of the cohort, a total of 18 705 HFMD cases (11 834 males and 6871 females) were observed between 2014 and 2022, of which 17 202 were mild cases (10 839 males and 6363 females) and 1503 were severe cases (995 males and 508 females). Statistical analysis was performed on the collected clinical examination data, and descriptive statistical methods, including mean value, SD and t-test, were used to compare the intergroup data. All tests were bilateral, and p

Introduction
Several cardiovascular outcome trials have been conducted to assess the cardiovascular safety and efficacy of glucagon-like peptide-1 receptor agonists (GLP1-RAs) on cardiorenal outcomes in patients with type-2 diabetes (T2D). However, the strict requirements of randomised controlled trials to avoid most confounding factors are at the expense of external validity. Using national real-world data, we aimed to evaluate the effectiveness of GLP-1RAs in association with metformin especially on cardiovascular events, hospitalisation for heart failure and all-cause death in comparison with other diabetes treatment schemes using dipeptidyl peptidase IV inhibitors, sulfonylureas/glinides or insulin also associated with metformin. Sodium-glucose transport protein 2 inhibitors (SGLT-2i) will be excluded as comparators, as this class of oral hypoglycaemic agents just started in 2020 to be marketed in France.

Methods and analysis
The Système National des Données de Santé is a comprehensive nationwide administrative healthcare database in France that covers approximately 67 million people.
Several cohorts of adult patients with T2D initiating any GLP1-RA in dual or triple therapies, as recommended by the French Health authorities, will be identified in this database over the period 2016–2021. These cohorts will be defined by the combination of glucose-lowering drugs prescribed simultaneously with GLP1-RA and diabetes treatment received over a 6-month period before GLP1-RA initiation. They will be first matched with T2D controls (1:3 ratio) based on the year of drug initiation and treatment regimens before and simultaneously with GLP1-RA in the different selected cohorts. Comparative analyses will be conducted versus these control groups, adjusting for cardiovascular event history and a propensity score considering age, sex, area of residence, deprivation index, comorbidities, duration of diabetes, use of lipid-lowering drugs, anticoagulants, antiplatelet therapies and blood pressure-lowering therapies. Comparative analyses will be conducted versus these control groups, using a high-dimensional propensity scores method and fixed baseline characteristics. Treatment effects on the different outcomes measured will be estimated for each GLP1-RA group, through HR and their corresponding CIs (95% CI) using Cox regressions and/or competitive risk regressions when necessary.

Ethics and dissemination
The study has been approved by an independent ethics committee (Comité éthique et scientifique pour les recherches, les études et les évaluations dans le domaine de la santé, Paris, France; reference: 8699786, dated 2 June 2022) and has been registered with the French National Data Protection Commission (Commission Nationale de l’Informatique et des Libertés, Paris, France; reference: 922161, dated 26 June 2022). The findings of this study will be published in peer-reviewed scientific journals and presented at international conferences.

Trial registration number
F20220803152803.

Introduction
Type 2 diabetes mellitus (T2DM) is a major burden on public health worldwide. To reduce adverse events and complications, effective T2DM self-management is required. Self-management and glycaemic control are generally poorer in lower educated people compared with higher educated people. This study aims to assess the (cost-)effectiveness and to conduct a process evaluation of a diabetes self-management programme, ‘Powerful Together With Diabetes’ (PTWD), which is specifically developed for patients from lower educational groups.

Methods and analysis
The PTWD programme is focused on attaining basic knowledge and skills for effective diabetes self-management. In a previous study (the Diabetes in Social Context (DISC) study), lower-educated participants enjoyed the PTWD programme as well as improved their T2DM-related behaviours. The design of the study is an effectiveness-implementation hybrid type 2 trial. We will conduct mixed methods effectiveness, process and economic evaluations. To investigate the (cost-)effectiveness, a two-arm quasi-experimental trial will be conducted with a parallel mixed method process evaluation. The primary outcome of the study is change in haemoglobin A1c levels from baseline to 12 months. Secondary outcomes include use of primary and secondary care, medication use, blood biomarkers, T2DM self-management health behaviours, anthropometrics, and quality of life. Data will be collected with questionnaires, physical activity trackers and registration data from general practitioner registries. To see if the results are maintained, we will also measure the outcomes 24 months after baseline. Study participants are patients from lower educational groups living with T2DM between 35 and 70 years old. Participants will be recruited through general practices, and the intervention will be held in community centres. Our aim is to include 114 participants in the intervention group and 570 participants in the control group.

Ethics and dissemination
This study has been approved by the Medical Ethics Committee of the Academic Medical Center in Amsterdam (#2021_222). Participants will sign an informed consent form prior to enrolment. Manuscripts with the results of the effectiveness, economic and process evaluations will be published in peer-reviewed journals.

Trial registration number
ISRCTN12982302 ISRCTN registry (registered on 29 March 2022).

Background
At the European level, several regulatory measures (ie, priority medicines (PRIME) scheme, accelerated assessment, conditional marketing authorisation and authorisation under exceptional circumstances) are in place with the aim to expedite the marketing authorisation process for medicines targeting unmet medical needs (UMNs). However, the potential impact of these measures on subsequent decisions regarding market access at the national level, and ultimately if medicines making use of these supporting measures reach the patient earlier, remains unclear.

Objectives
This study seeks to (1) assess the impact of such European regulatory measures on the number of successful applications and time to reimbursement of this group of medicines in the national context of Belgium and (2) evaluate the association between the application of European regulatory measures and Belgian measures (ie, early access pathways and managed entry agreements).

Design
A total of 322 medicines granted a European centralised marketing authorisation between 2015 and 2020, excluding generic products/biosimilars, were included in the study. For this set of medicines, data on European and Belgian regulatory and market access measures were extracted from the websites of the responsible European and Belgian authorities and completed with requested information up to December 2022. Regression analysis was used to assess the association between the application of European regulations and Belgian measures. Survival and regression analysis was used to test the impact of such regulatory measures on the time to and rate of reimbursement in Belgium.

Results
From the total sample (n=322), 34% (n=108) received a European regulatory measure, and also 34% (n=108) had a Belgian measure applied. Overall, 63% (n=202) of the total sample was submitted for reimbursement in Belgium, and of these, 83% (n=167) were reimbursed at the time of assessment. The median regulatory assessment time at the European level was approximately 14 months, while the median Belgian reimbursement assessment time was approximately 11 months. The study found that regulatory measures did not significantly impact the European or national assessment times or status. A significant reduction in European regulatory assessment time was observed only in the cases of the PRIME scheme (p=0.0087) and accelerated assessment (p

Introduction
Cardiovascular diseases (CVDs) present differently in women and men, influenced by host-microbiome interactions. The roles of sex hormones in CVD outcomes and gut microbiome in modifying these effects are poorly understood. The XCVD study examines gut microbiome mediation of sex hormone effects on CVD risk markers by observing transgender participants undergoing gender-affirming hormone therapy (GAHT), with findings expected to extrapolate to cisgender populations.

Methods and analyses
This observational, longitudinal cohort study includes baseline, 1- and 2-year follow-ups with transgender participants beginning GAHT. It involves comprehensive phenotyping and microbiome genotyping, integrating computational analyses of high-dimensional data. Microbial diversity will be assessed using gut, skin, and oral samples via 16S rRNA and shotgun metagenomic sequencing of gut samples. Blood measurements will include sex hormones, CVD risk markers, cardiometabolic parameters, cytokines, and immune cell counts. Hair samples will be analysed for cortisol. Participants will complete online questionnaires on physical activity, mental health, stress, quality of life, fatigue, sleep, pain, and gender dysphoria, tracking medication use and diet to control for confounders. Statistical analyses will integrate phenomic, lifestyle, and multi-omic data to model health effects, testing gut microbiome mediation of CVD risk as the endocrine environment shifts between that typical for cisgender men to women and vice versa.

Ethics and dissemination
The study adheres to Good Clinical Practice and the Declaration of Helsinki. The protocol was approved by the Charité Ethical Committee (EA1/339/21). Signed informed consent will be obtained. Results will be published in peer-reviewed journals and conferences and shared as accessible summaries for participants, community groups, and the public, with participants able to view their data securely after public and patient involvement review for accessibility.

Trial registration number
The XCVD study was registered on ClinicalTrials.gov (NCT05334888) as ‘Sex-differential host-microbiome CVD risk — a longitudinal cohort approach (XCVD)” on 4 April 2022. Data set link can be found at https://classic.clinicaltrials.gov/ct2/show/NCT05334888.

Objectives
This study aims (1) to assess the prevalence of severe fatigue among the general population of Geneva, 2 years into the COVID-19 pandemic and (2) to identify pandemic and non-pandemic factors associated with severe fatigue.

Design
Cross-sectional population-based survey conducted in Spring 2022.

Setting
General adult population of Geneva, Switzerland.

Participants
6870 adult participants, randomly selected from the general population, included in the Specchio-COVID-19 cohort study, were invited to answer an online health survey.

Outcome and cofactor measure
Prevalence of severe fatigue was measured by the Chalder Fatigue Questionnaire with a cut-off score≥4 out of 11. We assessed prevalence ratios of severe fatigue considering sociodemographic factors, health and behavioural characteristics (body mass index, depression, recent diagnosis of chronic disease or allergy, acute health event, smoking status, physical activity and sleep quality) and recent self-reported COVID-19 infections.

Results
A total of 4040 individuals participated (participation rate 59%, 58% were women, mean age 53.2 (SD=14.1 years)). Overall prevalence of severe fatigue was 30.7% (95% CI=29.2%–32.1%). After adjusting for age, sex, educational level and pre-existing comorbidities, the following characteristics were associated with severe fatigue: individuals aged 18–24 years (adjusted prevalence ratio (aPR)=1.39 (1.10–1.76)) and 25–34 years (aPR=1.23 (1.05–1.45)), female sex (aPR=1.28 (1.16–1.41)), depression (aPR=2.78 (2.56–3.01)), occurrence of health events unrelated to COVID-19 (aPR=1.51 (1.38–1.65)) and self-reported COVID-19 infection in the past 12 months (aPR=1.41 (1.28–1.56)). After further adjustment for depression, previous associations were maintained except for young age.

Conclusions
About one-third of the adult general population of Geneva experienced severe fatigue, 2 years into the COVID-19 pandemic. Heightened fatigue among young adults is partly explained by depressive symptoms. Recent COVID-19 infection is substantially associated with severe fatigue, regardless of infection severity or co-occurrence of depressive disorder.

Trial registration number
CCER project ID 2020-00881.

Background
Secondary mitral regurgitation (SMR) is a condition affecting the left ventricle (LV) rather than the mitral valve (MV). If the MV remains structurally unchanged, enlargement of the LV or impairment of the papillary muscles can occur. Several mechanical interventions are available to dictate the resolution of MR. However, there is a lack of robust data to compare MV replacement, MV repair (including subvalvular repair) and transcatheter mitral valve procedures (TMVp). This study aims to compare the effectiveness and clinical outcomes of TMVp using the edge-to-edge mitral valve repair technique and standard surgical mitral valve procedures in patients with SMR.

Methods and analysis
Five cardiac surgery centres from four European countries and Japan have collaborated to create a multicentre observational registry (TEERMISO). The registry will enrol consecutive patients who underwent mechanical intervention for SMR between January 2007 and December 2023. The investigators assessed the difference between replacement and repair for both the standard surgical approach and the transcatheter procedure. The main clinical outcome will be the degree of LV remodelling as assessed by the Left Ventricular End-Diastolic Volume Index at 10 years. The study will measure several secondary endpoints, including all-cause mortality as the primary endpoint, followed by functional status, hospitalisation, neurocognition, physiological measures (echocardiographic assessment), adverse events and reoperation.

Ethics and dissemination
Ethics approval was obtained in Montpellier University Hospital on 24 May 2022 (Institutional Review Board Approval Number: IRB-MTP_2022_05_202201143). The results of the main study and each sub-analysis will be submitted for publication in a peer-reviewed journal.

Trial registration number
NCT05090540.

Background
Approximately 69%–89% of people with severe mental illnesses, particularly psychosis, experience a treatment gap in low- and middle-income countries (LMICs) due to factors such as low public spending on health and weak healthcare systems. The PIECEs project aims to assess the effectiveness and cost-effectiveness of a solution-focused resource-oriented approach (DIALOG+) for improving the quality of life and mental well-being of people with psychosis in India and Pakistan.

Methods
The research design of this analysis is an economic evaluation piggybacked on the PIECEs randomised control trial to test the feasibility of DIALOG+ in India and Pakistan. It implies a cost-utility analysis with a health system perspective. The costs include the cost of the intervention, the cost of healthcare providers and the cost to the household. The primary outcome will be quality-adjusted life years. Incremental cost, incremental effectiveness and incremental cost-effectiveness ratios will be calculated using linear regression models with a hierarchical data structure. A probabilistic sensitivity analysis will be carried out to test for the uncertainty surrounding the estimates of cost-effectiveness.

Discussion
This study will provide evidence of a patient-centred approach to improve the quality of community-based care for people with psychosis in India and Pakistan. The economic evaluation will support efforts to scale up low-cost healthcare interventions such as DIALOG+ to rural and unserved areas, which is otherwise challenging in the resource-constrained health systems in many LMICs.

Conclusion
The evidence on the cost-effectiveness of DIALOG+ will contribute to efforts to improve community-based care and the quality of life for millions of people suffering from mental health problems in India and Pakistan who experience psychosis.

Ethics and dissemination
This study is approved by the Queen Mary Ethics of Research Committee (UK), Institutional Ethics Committee of SCARF (India), IRD’s Independent Institutional Review Board (IRD_IRB_2021_01_005) (Pakistan), Karawan-e-Hayat Management Committee (Institutional Approval) (Pakistan), Jinnah Postgraduate Medical Centre Research Committee (NO.F.2-81/2021-GENL/60224/JPMC) (Pakistan), Aga Khan’s Ethics Research Committee (2021-5933-17533) (Pakistan) and National Bio-Ethics Committee, Pakistan (Ref: No.4–87/NBC-774/22/2037 Date: 17 May 2022).
The findings of this research will be widely disseminated through research publications and engagement with the communities and the healthcare providers in the public and not-for-profit sectors.

Trial registration number
ISRCTN13022816.