Introduction And Objective: The European Medicines Agency (EMA) maintains a list of designated medical events (DMEs), events that are inherently serious and are prioritized for signal detection, irrespective of statistical criteria. We have analysed the results of our previously published scoping review to determine whether DME signals differ from those of other adverse events in terms of time to communication and characteristics of supporting reports of suspected adverse drug reactions.
Methods: For all signals, we obtained the launch year of medicinal products from textbooks or regulatory agencies, extracted the year of the first report in VigiBase and calculated the interval between the first report and communication (time to communication, TTC).
Introduction And Objective: Signals of adverse drug reactions (ADRs) can be supported by reports of ADRs and by interventional and non-interventional studies. The evidence base and features of ADR reports that are used to support signals remain to be comprehensively described. To this end, we have undertaken a scoping review.
View Article and Find Full Text PDFBackground: Maritime and river travel may be associated with respiratory viral spread via infected passengers and/or crew and potentially through other transmission routes. The transmission models of SARS-CoV-2 associated with cruise ship travel are based on transmission dynamics of other respiratory viruses. We aimed to provide a summary and evaluation of relevant data on SARS-CoV-2 transmission aboard cruise ships, report policy implications, and highlight research gaps.
View Article and Find Full Text PDFAims: This study aims to compare biomarkers of potential harm between people switching from smoking combustible cigarettes (CC) completely to electronic cigarettes (EC), continuing to smoke CC, using both EC and CC (dual users) and using neither (abstainers), based on behaviour during EC intervention studies.
Design: Secondary analysis following systematic review, incorporating inverse variance random-effects meta-analysis and effect direction plots.
Setting: This study was conducted in Greece, Italy, Poland, the United Kingdom and the United States.
Background: The optimal time for initiation of dialysis and which modality to choose as the starting therapy is currently unclear. This systematic review aimed to assess the recommendations across high-quality clinical practice guidelines (CPGs) related to the start of dialysis.
Methods: We systematically searched MEDLINE, EMBASE, Web of Science, LILACS, and databases of organisations that develop CPGs between September 2008 to August 2021 for CPGs that addressed recommendations on the timing of initiation of dialysis, selection of dialysis modality, and interventions to support the decision-making process to select a dialysis modality.
Objective: To evaluate the effectiveness of CH as an intracanal medicament compared to no dressing and / or other intracanal medicaments to control postoperative pain in patients with apical periodontitis requiring primary root canal therapy.
Materials And Methods: We conducted electronic searches in PubMed, EMBASE, Scopus and Cochrane Library, Open Gray, and Google Scholar. A structured Population-Intervention-Comparison-Outcome of the review was as follows: Population: adults who presented with apical periodontitis requiring primary root canal therapy; Intervention: CH intracanal medicament; Comparison: no dressing/other intracanal medicaments; Main Outcome: Postoperative pain.
Background: Modes of transmission of SARS-CoV-2 are of key public health importance. SARS-CoV-2 has been detected in the feces of some COVID-19 patients, suggesting the possibility that the virus could, in addition to droplet and fomite transmission, be transmitted via the orofecal route.
Methods: This review is part of an Open Evidence Review on Transmission Dynamics of COVID-19.
Background: The role of SARS-Cov-2-infected persons who develop symptoms after testing (presymptomatics) or not at all (asymptomatics) in the pandemic spread is unknown.
Objectives: To determine infectiousness and probable contribution of asymptomatic persons (at the time of testing) to pandemic SARS-CoV-2 spread.
Data Sources: LitCovid, medRxiv, Google Scholar, and WHO Covid-19 databases (to 31 March 2021) and references in included studies.
SARS-CoV-2 RNA has been detected in fomites which suggests the virus could be transmitted via inanimate objects. However, there is uncertainty about the mechanistic pathway for such transmissions. Our objective was to identify, appraise and summarise the evidence from primary studies and systematic reviews assessing the role of fomites in transmission.
View Article and Find Full Text PDFIntroduction: Patients with end-stage renal disease may require arteriovenous (AV) access in the form of arteriovenous fistulae (AVFs) or arteriovenous grafts (AVGs) for haemodialysis. AV access dysfunction requires intervention such as plain balloon angioplasty or covered stents to regain patency.
Aim: To systematically review and meta-analyse the patency outcomes of covered stents in failing haemodialysis AV access, compared with balloon angioplasty.
SARS-CoV-2 transmission has been reported to be associated with close contact with infected individuals. However, the mechanistic pathway for transmission in close contact settings is unclear. Our objective was to identify, appraise and summarise the evidence from studies assessing the role of close contact in SARS-CoV-2 transmission.
View Article and Find Full Text PDFIntroduction: The effectiveness of intracanal cryotherapy for reducing postoperative pain is unclear. The objective of this systematic review was to evaluate the effect of intracanal cryotherapy on postoperative pain after root canal therapy in patients with pulpal or periradicular pathosis.
Methods: We searched PubMed, Embase, Scopus, and the Cochrane Library as well as the top 3 endodontic journals for relevant articles.
Background: Signals of adverse drug reactions (ADRs) form the basis of some regulatory risk-minimization actions in pharmacovigilance. Reviews of limited scope have highlighted that such signals are mostly supported by reports of ADRs or multiple types of evidence. The time that elapses between a report of a suspected ADR and the communication of a signal has not been systematically characterized.
View Article and Find Full Text PDFObjectives: Compared with guideline recommendations, antibiotic overuse is common in treating cellulitis. We conducted a systematic review and meta-analyses on antibiotic route and duration of treatment for cellulitis in adults and children.
Methods: We searched MEDLINE, EMBASE and trial registries from inception to Dec 11, 2019 for interventional and observational studies of antibiotic treatment for cellulitis.
Background: There is uncertainty about the usefulness of ambulatory blood pressure (ABP) in predicting cardiovascular disease (CVD) risk. Our objective was to compare the prognostic value of ABP versus clinic blood pressure (BP) in CVD.
Methods: We conducted electronic searches on Medline, Embase, and the Cochrane library up to July 2018.
Aims: To compare the benefits and harms of naltrexone-bupropion using evidence from clinical study reports.
Methods: We searched Food and Drug Administration and European Medicines Agency websites, PubMed, and Clinicaltrials.gov (May 2016) to identify pivotal trials; we then sent a freedom of information request to the European Medicines Agency (July 2016).
BMJ Evid Based Med
December 2020
Background: Ketamine is a phencyclidine intravenous anaesthetic that blocks N-methyl-d-aspartate receptors and HCN channels in the CNS. Lately it has gained acceptance in a low-dose form, with studies showing an analgesic benefit in orthopaedic surgery. Our goal was to critically appraise and synthesise current evidence regarding use of low-dose ketamine in major, painful orthopaedic surgeries.
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