VAED was first observed following randomised trials of an inactivated respiratory syncytial virus (RSV) vaccine more than 5 decades ago 10–13. ...the safety profile in populations not involved in the ...clinical trials, such as frail elderly with multiple comorbidities, pregnant and lactating women, and immunosuppressed patients, is likely to be first elicited from post-implementation studies. First described in April 2020 in the UK, MISC-C has since been described globally wherever SARS-CoV-2 has been circulating.
Severe diarrhea from rotavirus remains an important cause of illness in infants. In this trial, investigators in Indonesia assessed the potential benefit of a neonatal rotavirus vaccine.
Immunization implementation in the community relies upon post-licensure vaccine safety surveillance to maintain safe vaccination programs and to detect rare AEFI not observed in clinical trials. The ...increasing availability of electronic health-care related data and correspondence from both health-related providers and internet-based media has revolutionized health-care information. Many and varied forms of health information related to adverse event following immunization (AEFI) are potentially suitable for vaccine safety surveillance. The utilization of these media ranges from more efficient use of electronic spontaneous reporting, automated solicited surveillance methods, screening various electronic health record types, and the utilization of natural language processing techniques to scan enormous amounts of internet-based data for AEFI mentions. Each of these surveillance types have advantages and disadvantages and are often complementary to each other. Most are "hypothesis generating," detecting potential safety signals, where some, such as vaccine safety datalinking, may also serve as "hypothesis testing" to help verify and investigate those potential signals.
Cardiovascular disease contributes substantially to global mortality and morbidity. Respiratory tract infections, particularly influenza, may trigger an increase in the short-term risk of acute ...myocardial infarction (AMI) and stroke. Recent studies have also linked this risk to other respiratory viruses, including respiratory syncytial virus (RSV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, the pathogen-specific relative contributions, the strength of their associations, and overall public health significance are poorly understood. Assuming causal links, understanding, quantifying, and comparing the effects of different pathogens as triggering factors for acute cardiovascular events is critical to guide future research and prevention. Our aim is to conduct a systematic review to examine the relative effects of laboratory-confirmed respiratory virus infections as triggers for acute myocardial infarction and stroke. We will conduct a comprehensive search of Ovid MEDLINE, PubMed, Ovid Embase, Cochrane Library Central Register of Controlled Trials, and Web of Science, from inception to the end of March 2024. Studies capturing respiratory viral infection(s) using laboratory-confirmatory methods, incidence of AMI or stroke (ischaemic or haemorrhagic), and those involving human participants in any country, will be assessed for eligibility. We will include the following analytical epidemiological study types: randomised controlled trials, cohort and case-control studies, self-controlled case series, and case-crossover designs. We will not impose restrictions on the date, language, study population, geographical region, or sample size, to minimise the risk of introducing biases. Search results will be screened for eligibility by two independent reviewers, and discrepancies resolved by consensus and/or arbitration by a third reviewer. We will assess the risk of bias among the included studies by adopting the Cochrane Collaboration tools for randomised and non-randomised studies. The overall quality of studies will be assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. We will examine sources of heterogeneity, and if studies are sufficiently homogeneous, a meta-analysis will be conducted to calculate the pooled effect sizes. Reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Timely adverse event following immunisation (AEFI) signal event detection is essential to minimise further vaccinees receiving unsafe vaccines. We explored the proportional reporting ratio (PRR) ...ability to detect two known signal events with influenza vaccines with the aim of providing a model for prospective routine signal detection and improving vaccine safety surveillance in Australia.
Passive AEFI surveillance reports from 2008-2017 relating to influenza vaccines were accessed from the Australian SAEFVIC (Victoria) database. Proportional reporting ratios were calculated for two vaccine-event categories; fever and allergic AEFI. Signal detection sensitivity for two known signal events were determined using weekly data; cumulative data by individual year and; cumulative for all previous years. Signal event thresholds of PRR ≥2 and Chi-square ≥4 were applied.
PRR provided sensitive signal detection when calculated cumulatively by individual year or by all previous years. Known signal events were detected 15 and 11 days earlier than traditional methods used at the time of the actual events.
Utilising a single jurisdiction's data, PRR improved vaccine pharmacovigilance and showed the potential to detect important safety signals much earlier than previously. It has potential to maximise immunisation safety in Australia. This study progresses the necessary work to establish national cohesion for passive surveillance signal detection and strengthen routine Australian vaccine pharmacovigilance.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
There are limited data comparing the performance of the two commercially available interferon gamma (IFN-gamma) release assays (IGRAs) for the diagnosis of tuberculosis (TB) in children. We compared ...QuantiFERON-TB gold In Tube (QFT-IT), T-SPOT.TB and the tuberculin skin test (TST) in children at risk for latent TB infection or TB disease.
The results of both IGRAs were compared with diagnosis assigned by TST-based criteria and assessed in relation to TB contact history. Results from the TST and at least one assay were available for 96 of 100 children. Agreement between QFT-IT and T-SPOT.TB was high (93% agreement, kappa = 0.83). QFT-IT and T-SPOT.TB tests were positive in 8 (89%) and 9 (100%) children with suspected active TB disease. There was moderate agreement between TST and either QFT-IT (75%, kappa = 0.50) or T-SPOT.TB (75%, kappa = 0.51). Among 38 children with TST-defined latent TB infection, QFT-IT gold and T-SPOT.TB assays were positive in 47% and 39% respectively. Three TST-negative children were positive by at least one IGRA. Children with a TB contact were more likely than children without a TB contact to have a positive IGRA (QFT-IT LR 3.9; T-SPOT.TB LR 3.9) and a positive TST (LR 1.4). Multivariate linear regression analysis showed that the magnitude of both TST induration and IGRA IFN-gamma responses was significantly influenced by TB contact history, but only the TST was influenced by age.
Although a high level of agreement between the IGRAs was observed, they are commonly discordant with the TST. The correct interpretation of a negative assay in a child with a positive skin test in clinical practice remains challenging and highlights the need for longitudinal studies to determine the negative predictive value of IGRAs.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The primary aims of this study were to determine the volume of blood submitted for culture in routine clinical practice and to establish the proportion of blood cultures with a blood volume ...inadequate for reliable detection of bacteremia.
The volumes of blood samples submitted for culture from infants and children up to 18 years of age were measured over a 6-month period. Blood cultures were deemed adequate submissions if they contained an appropriate (age-related) volume of blood and were submitted in the correct blood culture bottle type. During the study, an educational intervention designed to increase the proportion of adequate blood culture submissions was undertaken.
The volume of blood submitted in 1358 blood culture bottles from 783 patients was analyzed. Of the 1067 preintervention blood cultures, 491 (46.0%) contained an adequate blood volume and only 378 (35.4%) were adequate submissions on the basis of collection into the correct blood culture bottle type. After the intervention, there were significant increases in both the proportion of blood cultures containing an adequate blood volume (186 63.9% of 291 cultures) and the proportion of adequate submissions (149 51.2% of 291 cultures). Overall, blood cultures with an adequate blood volume were more likely than those with an inadequate blood volume to yield positive blood culture results (34 5.2% of 655 cultures vs 14 2.1% of 648 cultures). Similarly, adequate blood culture submissions were more likely than inadequate submissions to yield positive blood culture results (26 5.1% of 506 cultures vs 22 2.8% of 797 cultures).
In routine clinical practice, a negative blood culture result is almost inevitable for a large proportion of blood cultures because of the submission of an inadequate volume of blood. Even after an educational intervention, nearly one half of blood cultures were inadequate submissions.
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