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1.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-314433

ABSTRACT

Background: COVID-19 is a rapidly spreading disease that is causing extensive burdens across the world. Effective vaccines to prevent COVID-19 are urgently needed. Several vaccines have been accepted by regulatory authorities, but their individual and relative efficacy and adverse effects remain unclear.Methods: We conducted a systematic review of randomised clinical trials with network meta-analysis and Trial Sequential Analysis (TSA). Searches were made in CENTRAL, MEDLINE, Embase, and other sources from inception to May 12, 2021 for randomised clinical trials, assessing vaccines for COVID-19 . At least two independent reviewers screened studies, extracted data, and assessed the risk of bias. Our primary outcomes included all-cause mortality, vaccine efficacy, and serious adverse events.Findings We identified 22 trials;19 trials randomising 144 434 participants were included in our analyses. mRNA vaccines (efficacy 95%, 95% confidence interval (CI) 92% to 97%;69 285 participants;2 trials;GRADE: moderate certainty) and viral vector vaccines (efficacy 68%, 95% CI 61% to 74%;71 401 participants;5 trials;GRADE: low certainty) prevented COVID-19. Viral vector vaccines decreased mortality (risk ratio (RR) 0·25, 95% CI 0·09 to 0·67;67 563 participants;3 trials, GRADE: low certainty), but data on mRNA vaccines are still imprecise. None of the vaccines showed evidence of a difference on serious adverse events, but observational evidence indicated rare serious adverse events. mRNA and viral vector vaccines increased the risk of non-serious adverse events. Interpretation The evidence suggests that mRNA vaccines and viral vector vaccines are effective in preventing COVID-19. mRNA vaccines seem most effective in preventing COVID-19, but viral vector vaccines seem most effective in reducing mortality. mRNA vaccines and viral vector vaccines increase the risks of rare serious adverse events according to observational evidence. Further trials and longer follow-up are necessary to provide better insight into the safety profile of these vaccines. Registration Information: PROSPERO CRD42020196492. Funding Information: The Copenhagen Trial Unit funded the wages for the authors affiliated with the Copenhagen Trial Unit. None of the authors received any specific funding related to the review. Declaration of Interests: The authors declare that they have no known competing interests.

2.
PLoS One ; 17(1): e0260733, 2022.
Article in English | MEDLINE | ID: covidwho-1643240

ABSTRACT

BACKGROUND: COVID-19 is rapidly spreading causing extensive burdens across the world. Effective vaccines to prevent COVID-19 are urgently needed. METHODS AND FINDINGS: Our objective was to assess the effectiveness and safety of COVID-19 vaccines through analyses of all currently available randomized clinical trials. We searched the databases CENTRAL, MEDLINE, Embase, and other sources from inception to June 17, 2021 for randomized clinical trials assessing vaccines for COVID-19. At least two independent reviewers screened studies, extracted data, and assessed risks of bias. We conducted meta-analyses, network meta-analyses, and Trial Sequential Analyses (TSA). Our primary outcomes included all-cause mortality, vaccine efficacy, and serious adverse events. We assessed the certainty of evidence with GRADE. We identified 46 trials; 35 trials randomizing 219 864 participants could be included in our analyses. Our meta-analyses showed that mRNA vaccines (efficacy, 95% [95% confidence interval (CI), 92% to 97%]; 71 514 participants; 3 trials; moderate certainty); inactivated vaccines (efficacy, 61% [95% CI, 52% to 68%]; 48 029 participants; 3 trials; moderate certainty); protein subunit vaccines (efficacy, 77% [95% CI, -5% to 95%]; 17 737 participants; 2 trials; low certainty); and viral vector vaccines (efficacy 68% [95% CI, 61% to 74%]; 71 401 participants; 5 trials; low certainty) prevented COVID-19. Viral vector vaccines decreased mortality (risk ratio, 0.25 [95% CI 0.09 to 0.67]; 67 563 participants; 3 trials, low certainty), but comparable data on inactivated, mRNA, and protein subunit vaccines were imprecise. None of the vaccines showed evidence of a difference on serious adverse events, but observational evidence suggested rare serious adverse events. All the vaccines increased the risk of non-serious adverse events. CONCLUSIONS: The evidence suggests that all the included vaccines are effective in preventing COVID-19. The mRNA vaccines seem most effective in preventing COVID-19, but viral vector vaccines seem most effective in reducing mortality. Further trials and longer follow-up are necessary to provide better insight into the safety profile of these vaccines.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/epidemiology , COVID-19/prevention & control , SARS-CoV-2/pathogenicity , /administration & dosage , COVID-19/mortality , COVID-19/pathology , COVID-19 Vaccines/adverse effects , Humans , Network Meta-Analysis , Randomized Controlled Trials as Topic , SARS-CoV-2/immunology , Survival Analysis , Treatment Outcome , Vaccines, Inactivated , Vaccines, Subunit , /adverse effects
3.
Acta Anaesthesiol Scand ; 65(10): 1505-1513, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1455490

ABSTRACT

BACKGROUND: Multimodal analgesia is the leading principle for managing postoperative pain. Recent guidelines recommend combinations of paracetamol and a non-steroidal anti-inflammatory drug (NSAID) for most surgeries. Glucocorticoids have been used for decades due to their potent anti-inflammatory and antipyretic properties. Subsequently, glucocorticoids may improve postoperative analgesia. We will perform a systematic review to assess benefits and harms of adding glucocorticoids to paracetamol and NSAIDs. We expect to uncover pros and cons of the addition of glucocorticoid to the basic standard regimen of paracetamol and NSAIDs for postoperative analgesia. METHOD: This protocol for a systematic review was written according to the The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search for trials in the following electronic databases: Medline, CENTRAL, CDSR and Embase. Two authors will independently screen trials for inclusion using Covidence, extract data and assess risk of bias using Cochrane's ROB 2 tool. We will analyse data using Review Manager and Trial Sequential Analysis. Meta-analysis will be performed according to the Cochrane guidelines and results will be validated according to the eight-step procedure suggested by Jakobsen et al We will present our primary findings in a 'summary of findings' table. We will evaluate the overall certainty of evidence using the GRADE approach. DISCUSSION: This review will aim to explore the combination of glucocorticoids together with paracetamol and NSAIDs for postoperative pain. We will attempt to provide reliable evidence regarding the role of glucocorticoids as part of a multimodal analgesic regimen in combination with paracetamol and NSAID.


Subject(s)
Acetaminophen , Pharmaceutical Preparations , Acetaminophen/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Glucocorticoids , Humans , Meta-Analysis as Topic , Pain, Postoperative/drug therapy , Systematic Reviews as Topic
4.
Acta Anaesthesiol Scand ; 65(1): 128-134, 2021 01.
Article in English | MEDLINE | ID: covidwho-1455487

ABSTRACT

BACKGROUND: Post-operative pain treatment with ketamine has been demonstrated to have post-operative opioid-sparing and anti-hyperalgesic effects. However, evidence regarding the beneficial and harmful effects and the optimal dose and timing of perioperative treatment with ketamine for patients undergoing spinal surgery is unclear. The objective of this systematic review is to assess the analgesic, serious and non-serious adverse effects of perioperative pain treatment with ketamine for patients undergoing spinal surgery. METHODS: This protocol for a systematic review is written according to The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search Embase, CENTRAL, PubMed, WHO's ICTRP, EU Clinical Trial Register and ClinicalTrials.gov to identify relevant randomised clinical trials. We will include all randomised clinical trials assessing perioperative ketamine treatment versus placebo or no intervention for patients undergoing spinal surgery. Two authors will independently screen trials for inclusion using Covidence, extract data and assess risk of bias using Cochrane's RoB tool. We will analyse data using Review Manager and Trial Sequential Analysis. Meta-analysis will be performed according to the Cochrane guidelines and results will be validated according to the eight-step procedure suggested by Jakobsen et al. We will present our primary findings in a 'summary of findings' table. We will evaluate the overall certainty of evidence using the GRADE approach. DISCUSSION: This systematic review will assess the beneficial and harmful effects of perioperative pain treatment with ketamine for patients undergoing spinal surgery and have the potential to inform best practice and advance research.


Subject(s)
Ketamine , Humans , Ketamine/therapeutic use , Meta-Analysis as Topic , Pain, Postoperative/drug therapy , Systematic Reviews as Topic
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