Risultati per: Le linfoadenopatie vaccino COVID-19 correlate: ruolo della POCUS in Medicina Generale

“Vaccini aiutano a ridurre effetti a lungo termine”

Objectives
Ethical compliance of randomised controlled trials (RCTs) documented as ethics committee (EC) approval is vital for participant protection but is often overlooked by evidence synthesis producers despite regulatory mandates. We aimed to systematically assess reporting of ethics approval and informed consent (IC) in RCTs included in evidence syntheses and examined its potential impact on the study pool as part of a research integrity assessment (RIA).

Design
Meta-epidemiological study.

Setting
Assessment of ethics approval; domain 3 of the RIA tool developed for evidence syntheses.

Participants/subjects
COVID-19 RCTs included in evidence syntheses.

Primary outcomes
We extracted ethical items from study reports, that is, ethics approval statements, EC details, ethics approval numbers (ENs), IC and verified national recognition of ECs. RCTs were assessed regarding ethics approval and categorised as ‘no concern’, ‘awaiting classification’ or ‘exclude’ from the study pool. We also examined the impact of study settings on ethics approval reporting and discussed assessment reliability.

Results
We included 188 RCTs. 93% of primary study reports contained an ethics statement, 70% provided EC details, 44% reported EN and 91% mentioned IC. Trial registration records identified the EC in 8 RCTs and EN in 25 RCTs. Overall, 41% of RCTs reported all ethical items. Authors of 95 RCTs were contacted for missing information, yielding 22 satisfactory responses. Of the 151 RCTs with identified ECs, 88% were nationally recognised. Overall, 53% of RCTs were classified as ‘no concern’, 47% as ‘awaiting classification’ and none were excluded. Most were ‘awaiting classification’ due to reporting-related reasons. No significant differences in ethics approval reporting were observed across study settings, countries, or sample sizes.

Conclusions
Reporting of ethical items in RCTs remains inadequate. Including ethics approval details in reporting guidelines such as Consolidated Standards of Reporting Trials could improve this. Current under-reporting issues limit the reliability of the RIA tool’s ethics approval assessment.

Protocol registration
The protocol is available on OSF (https://osf.io/3bzeg).

Objectives
To examine the effectiveness of exercise interventions to improve long COVID symptoms and the tolerance of exercise interventions among people with long COVID.

Design
Systematic review.

Data sources
Medline via EBSCOhost, Embase via OVID and CENTRAL via the Cochrane Library up to 28 February 2023.

Eligibility criteria for selecting studies
Inclusion criteria were: (1) participants with long COVID, as defined by study authors; (2) random assignment to either an exercise intervention or a comparison group and (3) a quantitative measure of at least 1 of the 12 core long COVID outcomes. Exclusion criteria were: (1) signs or symptoms not reasonably attributable to prior SARS-CoV-2 infection; (2) pre-exposure or postexposure prophylaxis for COVID-19 or the prevention of long COVID symptoms and (3) interventions where the primary exercise component is breathing or respiratory muscle training.

Data extraction and synthesis
Two reviewers independently extracted data, and studies were narratively synthesised.

Results
Eight studies were included. Follow-up periods ranged from 2 to 28 weeks (mean=8.5 weeks). Sample sizes ranged from 39 to 119 (mean=56). All studies were in adults (mean age=49.9 years) and both sexes (mean female proportion=53.9%). Four studies were at low risk of bias, two were unclear and two were high. The evidence suggests that exercise interventions lead to short-term improvements in dyspnoea, fatigue, physical function and the physical domain of quality of life among people with long COVID. Of the five studies that reported adverse events, rates were low and, when reported, mild. Of the seven studies that reported sufficient relevant information, 1 of 252 participants who received exercise discontinued the intervention due to tolerance-related issues.

Conclusion
Available evidence suggests that exercise interventions may be beneficial and tolerable among some people with long COVID. However, the evidence base consists of a limited number of studies with small sample sizes and short follow-up periods.

Objectives
This study aimed to evaluate the global, regional and national disparities in the quality of care for leukaemia and brain and central nervous system (CNS) tumours among children and adolescents aged 0–19 years. We also assessed temporal trends in the quality of care index (QCI) and explored associations with sociodemographic development levels, gender and age.

Setting
The study used data from the Global Burden of Disease (GBD) 2019 database, covering 204 countries and territories. The analysis included global, regional and national levels of care, stratified by sociodemographic index (SDI), gender and age groups.

Participants
The study included children and adolescents aged 0–19 years diagnosed with leukaemia or CNS tumours. Data on incidence, prevalence, mortality and disability-adjusted life years (DALYs) were extracted from the GBD 2019 database.

Primary and secondary outcome measures
The primary outcome was the QCI, constructed using principal component analysis from four secondary indicators: years of life lost to years lived with disability ratio, DALYs to prevalence ratio, mortality to incidence ratio and prevalence to incidence ratio. Secondary outcomes included temporal trends in QCI, gender disparity ratios (GDRs) and correlations between QCI and SDI levels.

Results
In 2019, leukaemia and CNS tumours accounted for 132 194 deaths globally. The QCI for leukaemia was 74.71, while for CNS tumours, it was 56.59. From 1990 to 2019, the QCI for CNS tumours increased significantly (estimated annual percentage change (EAPC)=1.45, 95% CI: 1.41 to 1.50), whereas the QCI for leukaemia showed a declining trend in middle and low-middle SDI regions (EAPC=–0.13, 95% CI: –0.16 to –0.09). Western Europe had the highest QCI for leukaemia (94.50), while South Asia had the lowest (57.64). Boys had lower QCI scores than girls, and the gender disparity in CNS tumours widened over time (GDR increased from 1.147 in 1990 to 1.160 in 2019). QCI was positively correlated with SDI levels (leukaemia: r=0.591, p

Objectives
To determine the occurrence and clinicodemographic associations of hospital-based specialist palliative care (SPC) referral before and during the COVID-19 pandemic, timing of completed SPC consultation and comparative prevalence of ‘no cardiopulmonary resuscitation (CPR)’ orders, and end-of-life medication use, according to SPC involvement.

Design
Cross-sectional secondary analysis of a retrospective cohort study with a pre-pandemic (November 2019 to February 2020) group (Pre-COVID, n=170) and two intra-pandemic (March to August 2020) groups, one without (COVID–ve, n=170) and one with COVID-19 infection (COVID+ve, n=85). In the cohort study, Pre-COVID and COVID–ve group decedents were matched 2:1 on age, sex and care service (internal medicine/intensive care unit (ICU)) at death with COVID+ve decedents. In our current secondary analysis, clinicodemographic variables associated with SPC referral were examined in multivariable logistic regression, reporting adjusted ORs (aORs) and 95% CIs.

Setting
One quaternary and two tertiary acute care hospitals.

Participants
Decedent cohort with a terminal hospital admission (N=425).

Main outcome measures
SPC referral (yes/no) and timing of completed SPC consultation before death. Additional outcomes included ‘no CPR’ status and end-of-life medication prescription and dosing.

Results
SPC referral occurred in 70 (41.2%), 71 (41.8%) and 26 (30.6%) of the Pre-COVID, COVID–ve and COVID+ve groups, respectively (p=0.18). The aORs for SPC referral were lower for deaths in ICU (0.07; 95% CI 0.03 to 0.16) and admissions from nursing homes/long-term care (0.45; 95% CI 0.23 to 0.9), and higher for active cancer (2.5; 95% CI 1.39 to 4.39). Recipients of SPC consultation, compared with non-recipients, more frequently had a ‘no CPR’ order, had it placed earlier and were more frequently prescribed palliative end-of-life medications.

Conclusions
Hospital SPC consultation rates early in the COVID-19 pandemic were largely maintained at pre-pandemic levels. Having active cancer was positively associated with SPC referral, whereas both ICU death and having a nursing home/long-term care pre-admission source were negatively associated with referral.

Possibile lun egame con l’aumento del tempo che si trascorre al chiuso

Objectives
Patient information sheets (PISs) and informed consent forms (ICFs) are essential tools to communicate and document informed consent for clinical trial participation. These documents need to be easily understandable, especially when used to take informed consent from acutely unwell patients. Health literacy guidance recommends written information should be at a level between reading ages 9–11. We aimed to assess the readability and complexity of PISs/ICFs used for clinical trials of acute therapies during the COVID-19 pandemic.

Design
Retrospective document analysis.

Setting
PISs/ICFs used in trials involving pharmaceutical interventions recruiting hospitalised patients with COVID-19 during the first year of the pandemic were sourced from hospitals across the UK.

Primary and secondary outcome measures
PISs/ICFs were assessed for length, approximate reading time and subsection content. Readability and language complexity were assessed using Flesch-Kincaid Grade Level (FKGL) (range 1–18; higher is more complex), Gunning-Fog (GFOG) (range 1–20; higher is more complex) and Flesch Reading Ease Score (FRES) (range 0–100; below 60 is ‘difficult’ for comprehension).

Results
13 documents were analysed with a median length of 5139 words (range 1559–7026), equating to a median reading time of 21.4 min (range 6.5–29.3 min) at 240 words per minute. Median FKGL was 9.8 (9.1–10.8), GFOG 11.8 (10.4–13) and FRES was 54.6 (47.0–58.3). All documents were classified as ‘difficult’ for comprehension and had a reading age of 14 years old or higher.

Conclusions
All PISs/ICFs analysed contained literary complexity beyond both recommendations and the reading level of many in the UK population. Researchers should seek to improve communications to improve trial volunteer comprehension and recruitment.

Objectives
This study aimed to estimate the prevalence of individuals experiencing financial hardship and to examine the relationship between their experiences of financial hardship and psychological distress during and after the COVID-19 lockdowns.

Design
This is a secondary analysis of data from four repeated state-wide surveys conducted in 2020 and 2022.

Setting
Victoria, Australia.

Participants and outcome measures
All Victorian residents aged 18 years and above were eligible. Psychological distress was assessed using the Kessler Psychological Distress Scale-6 Item version (K6), while financial hardship was assessed using a nine-item scale. Relationships between experiencing any form of financial hardship and experiencing high psychological distress (K6≥19) were evaluated using an autoregressive and cross-lagged model that used data from all four surveys.

Results
A total of 2000, 2000, 2349 and 2444 individuals responded to surveys 1, 2, 3 and 4, respectively. The proportion of people experiencing at least one form of financial hardship increased from 23.5% in 2020 (the first year of the pandemic) to 38.5% in 2022 (the third year of the pandemic). The most vulnerable groups facing financial hardship included young people, Aboriginal & Torres Strait Islanders, individuals with disabilities and those with low income. The proportions of individuals experiencing high psychological distress followed a quadratic trajectory, with the peak occurring between the first and third years of the pandemic. Experiencing financial hardship was consistently associated with high psychological distress at each time point in this study. However, there was no evidence of a longitudinal relationship between financial hardship and high psychological distress.

Conclusions
The data from this study confirmed a significant increase in the proportion of individuals facing financial hardship among the adult population in Victoria from the first to the third year of the COVID-19 pandemic. This study does not ascertain a longitudinal effect of financial hardship on psychological distress during the pandemic. Further research is warranted to confirm this finding.

Preliminary data show that both vaccines protected against infection and hospitalization.

Introduction
The elderly are particularly vulnerable to morbidity and mortality from COVID-19, the disease caused by the SARS-CoV-2. Approximately 20% of the elderly showed no antibodies 3–5 months post-second dose of the COVID-19 vaccine. As probiotics have been shown to increase influenza-specific antibody levels post-influenza vaccination, we aim to reduce the percentage of participants without antibodies against the SARS-CoV-2 spike protein receptor-binding domain (anti-S1-RBD) at 6 months post-vaccination.

Methods and analysis
Our study design is a double-blind randomised controlled trial, using intention-to-treat analysis. Eligible participants are a purposive sample of 688 adults aged 65–89 years, in Quebec, Canada, not diagnosed with COVID-19 in the 3 months prior to recruitment and who wish to receive a government-recommended mRNA booster (Pfizer-BioNTech, Moderna) vaccine. The intervention consists of one capsule/day of a probiotic dietary supplement of Lacticaseibacillus rhamnosus and Lacticaseibacillus casei 6×109 CFU/capsule or a placebo, for 15 days pre-booster and post-booster vaccine. All participants provide dried blood spot samples at three timepoints (inclusion, 3 and 6 months post-vaccination) and a stool sample for microbiome analysis. A subgroup of 100 participants living near Sherbrooke, Quebec, is expected to volunteer for two onsite blood-test visits (at inclusion and 6 months post-vaccination). The primary outcome is the percentage of participants without anti-S1-RBD antibodies at 6 months post-vaccination. Secondary outcomes include longitudinal analysis of anti-S1-RBD and anti-N antibodies at three timepoints. In the subgroup, serum levels of neutralising antibodies will be determined at inclusion and 6 months post-vaccination. Probiotic and vaccine side effects are monitored. At the end of the study, we expect to identify the adjuvant effect of probiotic on vaccine-induced immune response.

Ethics and dissemination
The study was approved by Research Ethics Board of the Centre Intégré Universitaire de Santé et des Services Sociaux de l’Estrie- Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l’Estrie-CHUS) and the CHU de Québec-Université Laval # MP-31-2022-4598 as well as Health Canada. All participants will provide informed consent. Results will be disseminated to the scientific community and to all networks related in this research.

Trial registration number
NCT05195151.

Introduction
Under-vaccination among underserved groups remains low due to existing disparities. This is particularly the case with postpandemic COVID-19 vaccinations and other vaccine-preventable diseases, including measles, mumps, rubella or influenza. Therefore, we aim to (1) determine the feasibility and practicality of implementing a patient engagement tool (PET) and gain vital insights to plan a subsequent definitive randomised controlled trial (RCT) to evaluate the effectiveness of this tool for increasing uptake of COVID-19 and influenza vaccinations and (2) define the appropriate level of support needed for healthcare providers at site-level to ensure successful implementation of the PET and to identify supporting activities needed to implement interventions for COVID-19 and influenza vaccinations.

Methods and analysis
This is a randomised controlled feasibility study evaluating a co-designed PET, involving randomisation at individual and cluster levels. For individual randomisation, patients will be individually randomised 1:1 to receive the intervention (PET) or routine care; whereas for cluster randomisation, six GP (General Practitioner) practices will be randomised 1:1 and divided into two tranches at two separate time points. Both groups will receive training and software activation. Data will be analysed using statistical software R (V.4.0 or greater) or STATA (V.17 or greater). Baseline characteristics will be summarised and presented in groups based on an intention-to-treat basis with categorical data, including demographics, socioeconomic variables, comorbidities and vaccination status.

Ethics and dissemination
Ethical approval was granted by the Westminster Ethics Committee (ref: 316860). Our dissemination strategy targets three audiences: (1) policy makers, public and health service managers, and clinicians responsible for delivering vaccines and infection prevention services; (2) patients and public from underserved population groups and (3) academics.

Trial registration number
ClinicalTrials.gov (NCT05866237).

Objectives
After taking a heavy toll on the world population, the COVID-19 pandemic is now an endemic disease of global public health significance that requires long-term application of control measures, which will likely be influenced by people’s sources of information, knowledge and attitude about COVID-19 and their previous use of control measures. This study aimed to further the understanding of COVID-19 information sources, knowledge, attitude and control practices and their predictors among community members in Ebonyi state, Nigeria during the COVID-19 pandemic.

Design
Analytical cross-sectional survey.

Setting and participants
We conducted a survey among all consenting/assenting community members aged 15 years and above in 28 randomly selected geographical clusters between 12 March and 9 May 2022. Data were collected through a structured, interviewer-administered questionnaire using KoBoCollect installed in Android devices.

Analysis
Descriptive and inferential statistical analyses were done, including multivariate generalised estimating equations.

Results
10 825 participants were surveyed. The radio was the most common individual source of information about COVID-19 (used by 71.9% of the participants), and also the main and most trusted source of information for majority of the participants (46.1% and 44.7%, respectively). This was followed by family members/relatives/friends (61.8%) as the next most common source of information about COVID-19. Next to radio, family members/relatives/friends (13.2%) were the second main source of information, followed by health workers (13.0%). Meanwhile, health workers (15.2%) were the second most trusted source of COVID-19 information, next to radio. Traditional media was the main and also the most trusted source of information (55.6% and 54.3%, respectively), followed by interpersonal sources (36.9% and 39.7%, respectively) and internet/social media/text messages (7.5% and 6.0%, respectively). 10.1%, 51.4% and 23.7% of the participants had good knowledge, good attitude and good control practice, respectively. The strongest and most important predictor of the main and most trusted sources of information was gender. Other predictors included marital status, educational level, age and occupation. Good attitude, being married and educational level were strong predictors of good control practices.

Conclusion
The evidence from this study should be used to guide subsequent policy actions on COVID-19 or other similar health emergencies in order to enhance effective emergency health information dissemination and optimal use of control measures by community members in Ebonyi state, Nigeria and in other similar settings.

Vademecum contro false notizie, “vitamina A non è alternativa”

Annals of Internal Medicine, Ahead of Print.

Objectives
To evaluate hospital outcomes and their predictors during the pandemic for patients with and without COVID-19, stratified by the presence of acute kidney injury (AKI).

Design
Retrospective observation study using the Hospital Episodes Statistics database for England.

Participants
2 385 337 unique hospital admissions of adult patients from March 2020 to March 2021 in England.

Main outcome measures
COVID-19 cases were identified by the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code of U07.1. Patients with suspected COVID-19 (U07.2 code) and patients with end-stage kidney disease on chronic dialysis (N18.6 and Z99.2) were excluded. AKI cases were identified by the ICD10 code. Patients were categorised into four groups based on COVID-19 and AKI diagnoses: Group 1—neither; Group 2—COVID-19 only; Group 3—AKI only; Group 4—both. A multivariable logistic regression model was created with in-hospital mortality as the outcome, including diagnostic groups, demographics, admission methods, comorbidity severity, deprivation index and intensive therapy unit (ITU) admission.

Results
Among 2 385 337 admissions involving 663 628 patients, 856 544 had AKI (N17 codes) and 1 528 793 did not. Among patients without AKI, there were 1,008,774 admissions among 133,988 individuals without COVID-19 (Group 1) and 520,019 admissions among 256,037 individuals with COVID-19 (Group 2). Among patients with AKI, there were 630,342 admissions among 218,270 individuals without COVID-19 (Group 3) and 226,202 admissions among 55,333 individuals with COVID-19 (Group 4). Patients in group 4 were older (75.4 ± 13.8 years) and had greater length of stay (17.1 ± 17 days) than all other groups. They also had and had a greater proportion of males, ethnic minorities and comorbidities than other groups. Mortality was highest in Group 4 (28.7%) and lowest in Group 1 (1.1%). The increased risk of death persisted after controlling for multiple baseline factors (OR for death vs Group 1: Group 4—22.28, Group 2—9.67, Group 3—6.44). ITU admission was least required in Group 1 (1.2%) and most in Group 4 (10.9%), with mortality at 4.8% versus 47.8%, respectively.

Conclusions
Patients with COVID-19 and AKI have a high risk of mortality and should be recognised early and provided with optimal support. Planning for future pandemics should ensure adequate critical care and acute dialysis capacity.

Trial registration number
NCT04579562.

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