Risultati per: Anticoagulazione nei pazienti con COVID-19

Efficace anche su ceppo dominante XEC

Introduction
In Germany, there has been no population-level pharmacoepidemiological study on the safety of the COVID-19 vaccines. One factor preventing such a study so far relates to challenges combining the different relevant data bodies on vaccination with suitable outcome data, specifically statutory health insurance claims data. Individual identifiers used across these data bodies are of unknown quality and reliability for data linkage.

Methods and analysis
As part of a larger pharmacovigilance study on the COVID-19 vaccines, called RiCO (German ‘Risikoevaluation der COVID-19-Impfstoffe’, Englisch ‘Risk assessment of COVID-19 vaccines’), a feasibility study is being conducted to determine the overall confidence level with which existing data can be analysed in relation to the safety of the COVID-19 vaccine. This RiCO feasibility study will establish a data flow combining claims data and vaccination data for a subsample of the total German population, describe data quality for each dataset from the various sources, estimate the proportion of the different linkage errors and will develop various approaches for linking the data in addition to the simple form of linkage using a common identifier in order to reduce possible linkage errors. These last three points are the core objective of the feasibility study. A secondary objective is to test the viability of the required data flow involving multiple stakeholders from different parts of the healthcare system.

Ethics and dissemination
Results will be published and used to plan the actual pharmacovigilance study on the COVID-19 vaccines for Germany, as well as future research on the role of COVID-19 vaccines as risk or protective factors for long-term COVID-19 effects. In accordance with national legal requirements, permission to use of the statutory health insurance claims data was requested and granted by the national regulatory authority for statutory health insurances. The vaccination data will be used in accordance with the requirements of the national regulation on COVID-19 vaccinations. Ethical approval was not required for this secondary data study and was therefore not sought. The results of the feasibility study will be published in a suitable, peer-reviewed scientific journal. Results will also be presented to stakeholders from German statutory health insurances and government organisations.

Objectives
This study aims to explore the relationship between the combined experiences of COVID-19 infection in individuals and their family members and the resulting fear of COVID-19, with a focus on the severity of symptoms and various sociodemographic factors.

Design
Longitudinal survey study.

Setting
The Japan COVID-19 and Society Internet Survey (JACSIS), a large-scale web panel survey administered in Japan.

Participants
Analysis was based on responses from 15 542 individuals who participated in all three waves of JACSIS conducted between 2020 and 2022.

Main outcome measures
The primary measure was the fear of COVID-19, assessed using the Fear of COVID-19 Scale. The study employed a two-way analysis of variance without repetition, Games-Howell post hoc tests and ordinary least-squares linear regression analysis, with time points treated as fixed effects.

Results
The study revealed significant differences in fear levels based on the combined COVID-19 infection experiences of respondents and their family members, with variations observed across different time points. Mild symptoms in either the respondents or their family members correlated with reduced fear (β=–0.584, SE=0.181, p=0.001), while severe symptoms were associated with increased fear (β=1.244, SE=0.217, p

Objectives
Post-COVID-19 condition (PCC), also referred to as Long COVID, has become an emerging public health issue requiring adequate prevention, treatment and management strategies. Evaluating these strategies from the patients’ perspective using patient-reported outcome measures (PROMs) is critical. In this systematic review, we aimed to critically appraise and summarise the quality of existing PROMs for PCC, and to identify PROMs that can be recommended for use in future research.

Design
Systematic review using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology.

Data sources
PubMed and Web of Science were searched on 16 January 2023 and again on 23 July 2024.

Eligibility criteria
We included studies reporting on the development and/or validation of any disease-specific PROMs for PCC.

Data extraction and synthesis
Two independent reviewers screened the results for eligibility. The methodological quality of each included study was assessed using the COSMIN Risk of Bias Checklist. We further evaluated the quality of measurement properties per PROM and study according to the criteria for good measurement properties as outlined in the COSMIN manual, and graded the evidence of the synthesised results. Based on the overall evidence, we derived recommendations for the use of the identified instruments.

Results
We identified 23 studies reporting on 11 PROMs measuring functional status (COVID-19 Yorkshire Rehabilitation Scale, C19-YRS; Modified COVID-19 Yorkshire Rehabilitation Scale, C19-YRSm; Functional Impairment Checklist, FIC; Post-COVID-19 Functional Status Scale, PCFS), symptom burden and impact (Long COVID Symptom and Severity Score, LC-SSS; Long COVID Symptom Tool, LCST; Long COVID Impact Tool, LCIT; Symptom Burden Questionnaire Long COVID, SBQ-LC), quality of life (Post-acute COVID-19 Quality of Life instrument, PAC-19QoL) and stigma (Long COVID Stigma Scale, LCSS; Post-COVID-19 Condition Stigma Questionnaire, PCCSQ). Sample sizes of the included studies ranged from 29 to 1969 participants. Overall, 95 single studies on measurement properties were evaluated. Among the identified instruments, the Long Covid Stigma Scale (LCSS) showed sufficient content validity and internal consistency and can be recommended for use according to COSMIN criteria. Our assessment of measurement properties revealed significant evidence gaps for all PROMs, indicating the need for further validation studies to make an adequate decision on the recommendation for their use. Content validity is a major shortcoming of all included instruments.

Conclusion
The LCSS measuring stigma can be recommended for use in future research. For the assessment of PCC symptoms and impact, no instrument with sufficient measurement properties is currently available. Further validation of all identified PROMs is indicated, in particular comprehensive assessments of content validity involving experts and patients.

PROSPERO registration number
CRD42023391238.

Objective
The COVID-19 pandemic required the rapid and often widespread implementation of medical practices without robust data. Many of these practices have since been tested in large, randomised trials and were found to be in error. We sought to identify incorrect recommendations, or reversals, among National Institute of Health COVID-19 guidelines and Food and Drug Administration (FDA) approvals and authorisations.

Design
Retrospective cross-sectional study.

Participants
Recommended medical practices and FDA authorisations or approvals for COVID-19 prevention, treatment and/or management.

Main outcome measures
The frequency and characteristics of COVID-19 medical reversals, defined as practices that were implemented and/or recommended during the pandemic, but were later tested in randomised trials that failed to find benefit.

Results
We found 332 COVID-19 recommendations. 85 (25.6%) opposed a medical practice, 23 (6.9%) were to continue a pre-COVID standard of care without deviation and 224 (67.5%) reccommended a new medical practice. We found randomised trials assessing 72 of these practices (32.1%), among which 25 (35%) were found to be in error and deemed medical reversals. Among medical reversals, 21 (84%) were prescription medications and 1 (4%) was convalescent plasma. 17 (68%) were repurposed medications. Two (8%) were procedures or mechanical interventions and one (4%) was a device. 16 (64%) reversals pertained to the hospital setting (4 to intensive care units), 4 (16%) were non-specific (ie, applicable to any setting), 4 (16%) pertained to a non-hospital setting and 1 pertained to healthcare workers.

Conclusion
When faced with a novel pandemic, policymakers rapidly made hundreds of specific medical recommendations. More than two out of three were never robustly tested. Among practices tested in a randomised fashion, one in three was made in error. Pandemic recommendation errors were substantial. Early and coordinated efforts to initiate randomised trials, even during dire situations, may mitigate the perpetuation of ineffective practices.

Objectives
To describe the impact of the COVID-19 pandemic on hypertension diagnosis and management in UK primary care.

Design
Population-based cohort study.

Setting
Over 2000 general practices across the UK contributing to the Clinical Practice Research Datalink.

Participants
A cohort of 23 076 390 patients over 18 years of age and registered with their general practice for at least 1 year between 2011 and 2022, who did not have a previous diagnosis of hypertension. From these patients, a subcohort of 712 461 patients diagnosed with hypertension between 2011 and 2022 was selected.

Primary and secondary outcome measures
Coprimary outcomes included rates of hypertension diagnosis and rates of antihypertensive treatment initiation, treatment change and blood pressure measurement in patients newly diagnosed with hypertension.

Results
In April 2020, the first month of lockdown, incident hypertension diagnosis rates fell by 65% (95% CI 64% to 67%) compared with historical trends and remained depressed until November 2021, leading to 51 000 fewer diagnoses than expected by March 2022. However, by March 2022, there were 2.6% fewer diagnoses than expected in Scotland, compared with 20%–30% fewer in other UK Nations. Rates of treatment initiation and change fell by 47% (95% CI 43% to 51%) and 36% (95% CI 33% to 38%), respectively, in April 2020. However, initiation rates rebounded above expectations and remained elevated until March 2022. Blood pressure measurements fell by 69% (95% CI 65% to 72%) in April 2020, recovering in February 2021.

Conclusions
Hypertension diagnosis and management in UK primary care were significantly disrupted during the COVID-19 pandemic. Future studies should investigate the potential clinical implications for the cardiovascular health of the UK population.

Objectives
The long-term impact of the COVID-19 pandemic on the mental health issues of the general population in Japan is unclear. Thus, we examined the long-term effects of the COVID-19 pandemic on fear of COVID-19 and psychological distress and determined their causal relationships among the general population in Japan.

Design and setting
A longitudinal online survey was conducted by a Japanese online survey company to investigate the items regarding personal demographics, fear of COVID-19 (Japanese version of the fear of COVID-19 scale) and psychological distress (Japanese version of the Kessler 6 scale).

Participants
The participants were 274 individuals (women=44.2%) with a mean age of 51.6 years (SD=13.6) who responded to the online surveys in September 2020 (Time 1: T1) and January 2023 (Time 2: T2).

Results
The paired t-test showed that fear of COVID-19 decreased significantly from T1 to T2 (t=2.79, df=273, p

Purpose
In the setting of an established childhood pneumococcal vaccination programme with immediate initiation and treatment of antiretroviral therapy (ART) for people living with HIV (PLWH), the risk of adult pneumococcal community-acquired pneumonia (CAP) is not recently described. We aimed to investigate CAP incidence, recurrence, mortality, risk factors and microbiology before and during the COVID-19 pandemic.

Participants
Adults aged ≥18 years were enrolled in three South African provinces from March 2019 to October 2021, with a brief halt during the initial COVID-19 lockdown. The first group, PdCAP, a surveillance cohort, had their data abstracted to estimate the population incidence of physician-diagnosed CAP by counting incident CAP patients presenting to emergency rooms (ER) and mapping them to catchment areas linked to census data. From those admitted to wards from ERs, a prospective cohort (HospCAP) was enrolled and followed up to 1 year after discharge. Microbiology testing was performed and data were abstracted and collected for economic assessments. A third group (StART) of PLWH without respiratory illness at enrolment, attending primary healthcare clinics to initiate or reinitiate ART, was prospectively enrolled and followed. HospCAP and StART participants (totalling 2950 participants) were followed for at least 1 year and assessed for CAP episodes, hospitalisations and mortality.

Findings to date
Surveillance identified 6546 patients attending ERs with physician-diagnosed CAP; 61/6546 (0.9%) died in the ER. We prospectively enrolled 2000 hospitalised patients with CAP of whom 1079/2000 (54.0%) were PLWH. Overall, 271/2000 (13.6%) hospitalised CAP patients died during their first admission and 298/2000 (14.9%) died during follow-up. Among StART cohort, 18/950 (1.9%) died during follow-up.

Future plans
Planned analyses include incidence estimates of pneumococcal serotype-specific adult CAP and its recurrence, using Urinary Antigen Detection assay results to model the burden of pneumococcal CAP better and health economics analyses.

Comunicato del 19/12/2024 n°33

Objectives
This study aimed to investigate the experiences of healthcare workers in long-term care facilities (LTCFs) during cohort quarantine for the COVID-19 pandemic in South Korea.

Design
A qualitative study using thematic analysis.

Setting and participants
Ten workers from two LTCFs that underwent cohort quarantine due to COVID-19 in South Korea, including direct-care staff and administrators.

Methods
In-depth, semi-structured interviews were conducted from 23 April to 7 May 2021. Data were analysed using Braun and Clarke’s thematic analysis approach.

Results
Five main themes emerged: (1) adapting to unprecedented infection control measures; (2) enduring prolonged cohort quarantine situation; (3) confronting social stigma and discrimination; (4) developing organisational resilience; and (5) recognising the need for systemic support.

Conclusions
This study provides insights into the multifaceted experiences of LTCF workers during the COVID-19 quarantine. The findings suggest the need for enhanced infection control training, mental health support, and systemic changes to better prepare LTCFs for any future pandemic.

Objective
Long COVID encompasses a range of symptoms in which fatigue is one of the most prevalents. It is clear from other conditions that the definition and measurement of fatigue can be complex, but it is not clear how fatigue is defined and measured in long COVID. To advance our understanding, this review summarises the definitions and measures of long COVID fatigue being used by researchers.

Design
Scoping review following JBI methodology and reports using the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews.

Data sources
Medline, Scopus, CINAHL, PsycINFO, EMCARE, Web of Science, Epistemonikos, Cochrane Central Register of Controlled Trials, Dimensions, Overton and ProQuest Dissertation & Theses Database were searched from January 2020 to May 2023.

Eligibility criteria
This review included quantitative and qualitative studies that included any definition of long COVID and/or measurement tool that purported to quantify either the impact, severity or symptoms of long COVID fatigue.

Data extraction and synthesis
Two independent reviewers screened the title, abstracts and full texts of the selected studies based on the inclusion criteria. Data extraction was performed by two independent reviewers. The data were summarised in tabular format and a narrative summary.

Results
The search retrieved 9839 studies, of which 57 met the inclusion criteria. Only 21 (37%) provided a definition of fatigue. Definitions ranged across physical, mental, cognitive, emotional, psychosocial, central, peripheral, postexertional symptom exacerbation and general dimensions of fatigue. Fifty-five (96%) used a measurement or assessment of fatigue. Twenty-six measures of fatigue were identified: 21 self-report measures (eg, Fatigue Assessment Scale) and five fatigability measures that purport to reflect changes in physiological processes that contribute to or reflect fatigue (eg, change in force generating capacity of a muscle).

Conclusions
The definitions identified demonstrate considerable diversity, each highlighting different dimensions of long COVID fatigue. Long COVID fatigue was predominantly measured through self-report methods, which were problematic. There is an urgent need to better understand long COVID fatigue and to identify the different mechanisms involved. In order to do this, we need consistency with the language around fatigue and its measurement within research and across disciplines.

Review registration
The protocol has been registered on open science framework (https://doi.org/10.17605/OSF.IO/HNF8Z).

Objectives
Access to healthcare and accurate health information is a persistent issue for people experiencing homelessness (PEH), one heightened by the COVID-19 pandemic and exacerbated by issues of health literacy and mistrust. Strategies involving community health workers (CHWs) have the potential to improve education and service delivery for PEH. The objective of this study is to assess PEH knowledge, attitudes and barriers to COVID-19 testing and vaccination, and the impact of CHW-led education within a homeless shelter in Indiana.

Design/setting
Between November 2021 and April 2022, 15 sessions were held at a homeless shelter that combined focus group discussions with COVID-19-related education. Pre-/post-tests measured knowledge gains and attitude shifts among PEH. Guided by the socioecological model, thematic analysis of focus group transcripts identified key motivators and barriers to COVID-19 vaccination and testing.

Participants
78 PEH (73% male, 74% white, mean age=48).

Outcome measures
COVID-19-related knowledge gains and willingness to receive testing and vaccination among PEH.

Results
Completion of an educational session was associated with a significant increase in knowledge scores (mean pre-test score=10.76/15, SD=2.16; mean post-test score=13.58/15, SD=1.72; p

Objective
To analyse the effects of tracheostomy timing on COVID-19 outcomes by comparing mortality rates at different time points (7, 10 and 14 days).

Design
Systematic review and meta-analysis.

Data sources
PubMed, Embase, Cochrane Library, Web of Science and Scopus were searched from 31 August 2023 to 6 September 2023.

Primary and secondary outcomes measures
The primary outcome was short-term mortality, defined as intensive care unit (ICU) mortality, hospital mortality and 28-day or 30-day mortality. The secondary outcomes included mechanical ventilation duration, ICU and hospital days.

Results
Among 3465 patients from 12 studies, the 10-day subgroup analysis revealed higher mortality for earlier tracheostomy than for later tracheostomy (49.7% vs 32.6%, OR 1.91, 95% CI 1.37–2.65). No significant differences were observed at 7- and 14-day marks. Earlier tracheostomy was associated with shorter mechanical ventilation (mean difference=–7.35 days, 95% CI –11.63 to –0.38) and ICU stays (mean difference=–11.24 days, 95% CI –18.50 to –3.97) compared with later tracheostomy. Regarding hospital stay, the later tracheostomy group exhibited a trend towards longer-term inpatients, with no significant difference.

Conclusions
No significant difference in short-term mortality was observed between patients undergoing tracheostomy at 7 and 14 days; however, at 10 days, later tracheostomy resulted in a lower mortality rate. Accordingly, subtle timing differences may impact short-term results in COVID-19 patients. Considering that the later tracheostomy group had longer mechanical ventilation and ICU stays, additional research is required to determine an optimal timing that reduces mortality cost-effectively.

Objectives
This study examined parental experiences with COVID-19 vaccination and factors contributing to COVID-19 vaccine hesitancy (CVH) among them to help guide future policy initiatives.

Design
Cross-sectional study.

Setting
Lahore, the second largest metropolis in Pakistan.

Participants
This study was conducted among parents residing in Lahore from March to April 2023. Participants were recruited via convenience sampling.

Outcome measures
Data were collected using a prevalidated questionnaire that consisted of four sections: (1) informed consent, (2) demographic details, (3) COVID-19 vaccine uptake in children aged 5–17 years, parents’ experience with childhood COVID-19 vaccination and their intention to vaccinate their unvaccinated children and (4) a modified 5C scale tailored to determine parents’ confidence, complacency, constraints, calculation and collective responsibility with regard to COVID-19 vaccination.

Results
This study included 414 parents (median age=37 years; mothers=62%). COVID-19 vaccination rates for children in the age groups 12–17 years and 5–11 years were 72.5% and 30.1%, respectively. Transient adverse events following immunisation were reported by 32.7% of parents. Of parents with unvaccinated children aged 12–17 years, only 35% intended to vaccinate them. The majority of parents were not willing to vaccinate their children below 11 years of age. Parents with a self-reported positive history of COVID-19 disease (OR=2.531, p=0.016), and confident in the vaccine’s safety and efficacy (OR=1.968, p=0.010), were more inclined to vaccinate their 5–11 years. In terms of vaccination of children below 5 years, confidence in the vaccine (OR=2.942, p=0.003) and a sense of collective responsibility were positive predictors (OR=2.260, p=0.035), while calculation was identified as a negative predictor of parents’ intention to vaccinate their under 5 years (OR=0.421, p=0.018).

Conclusion
CVH was significantly higher among parents of children aged 5–11 years and children younger than 5 years old. Priority should be given by health authorities to address parental concerns about vaccines and ensure that parents understand the significance of vaccination in protecting their children, to increase vaccination rates. This is because hesitancy towards one specific vaccine can negatively impact hesitancy rates in general.

Introduction
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a disabling condition that can affect adolescents during a vulnerable period of development. The underlying biological mechanisms for ME/CFS remain unclear and have rarely been investigated in the adolescent population, despite this period representing an age peak in the overall incidence. The primary objective of this is to provide a foundational set of biological data on adolescent ME/CFS patients. Data generated will be compared with controls and over several time points within each patient to potentially develop a biomarker signature of the disease, identify subsets or clusters of patients, and to unveil the pathomechanisms of the disease.

Methods and analysis
This protocol paper outlines a comprehensive, multilevel, longitudinal, observational study in paediatric ME/CFS. ME/CFS patients aged 12–19 years and controls will donate biosamples of urine, blood, and peripheral blood mononuclear cells for an in-depth omics profiling analysis (whole-genome sequencing, metabolomics and quantitative proteomics) while being assessed by gold-standard clinical and neuropsychological measures. ME/CFS patients will then be provided with a take-home kit that enables them to collect urine and blood microsamples during an average day and during days when they are experiencing postexertional malaise. The longitudinal repeated-measures study design is optimal for studying heterogeneous chronic diseases like ME/CFS as it can detect subtle changes, control for individual differences, enhance precision and boost statistical power. The outcomes of this research have the potential to identify biomarker signatures, aid in understanding the underlying mechanisms, and ultimately, improve the lives of children with ME/CFS.

Ethics and dissemination
This project was approved by the Royal Children’s Hospital’s Human Research Ethics Committee (HREC 74175). Findings from this study will be disseminated through peer-reviewed journal publications and presentations at relevant conferences. All participants will be provided with a summary of the study’s findings once the project is completed.

Da allora quasi 800 milioni di contagi e 7 milioni di morti