Interleukin-6 blocking agents for treating COVID-19: a living systematic review.
Background Different forms of vaccines have been developed to prevent the SARS‐CoV‐2 virus and subsequent COVID‐19 disease. Several are in widespread use globally. Objectives To assess the efficacy and safety of COVID‐19 vaccines (as a full primary vaccination series or a booster dose) against SARS‐CoV‐2. Search methods We searched the Cochrane COVID‐19 Study Register and the COVID‐19 L·OVE platform (last search date 5 November 2021). We also searched the WHO International Clinical Trials Registry Platform, regulatory agency websites, and Retraction Watch. Selection criteria We included randomized controlled trials (RCTs) comparing COVID‐19 vaccines to placebo, no vaccine, other active vaccines, or other vaccine schedules. Data collection and analysis We used standard Cochrane methods. We used GRADE to assess the certainty of evidence for all except immunogenicity outcomes. We synthesized data for each vaccine separately and presented summary effect estimates with 95% confidence intervals (CIs). Main results We included and analyzed 41 RCTs assessing 12 different vaccines, including homologous and heterologous vaccine schedules and the effect of booster doses. Thirty‐two RCTs were multicentre and five were multinational. The sample sizes of RCTs were 60 to 44,325 participants. Participants were aged: 18 years or older in 36 RCTs; 12 years or older in one RCT; 12 to 17 years in two RCTs; and three to 17 years in two RCTs. Twenty‐nine RCTs provided results for individuals aged over 60 years, and three RCTs included immunocompromized patients. No trials included pregnant women. Sixteen RCTs had two‐month follow‐up or less, 20 RCTs had two to six months, and five RCTs had greater than six to 12 months or less. Eighteen reports were based on preplanned interim analyses. Overall risk of bias was low for all outcomes in eight RCTs, while 33 had concerns for at least one outcome. We identified 343 registered RCTs with results not yet available. This abstract reports results for the critical outcomes of confirmed symptomatic COVID‐19, severe and critical COVID‐19, and serious adverse events only for the 10 WHO‐approved vaccines. For remaining outcomes and vaccines, see main text. The evidence for mortality was generally sparse and of low or very low certainty for all WHO‐approved vaccines, except AD26.COV2.S (Janssen), which probably reduces the risk of all‐cause mortality (risk ratio (RR) 0.25, 95% CI 0.09 to 0.67; 1 RCT, 43,783 participants; high‐certainty evidence). Confirmed symptomatic COVID‐19 High‐certainty evidence found that BNT162b2 (BioNtech/Fosun Pharma/Pfizer), mRNA‐1273 (ModernaTx), ChAdOx1 (Oxford/AstraZeneca), Ad26.COV2.S, BBIBP‐CorV (Sinopharm‐Beijing), and BBV152 (Bharat Biotect) reduce the incidence of symptomatic COVI...
Interleukin-1 blocking agents for treating COVID-19 (Review)
BackgroundNew metrics have been developed to assess the impact of research and provide an indication of online media attention and data dissemination. We aimed to describe online media attention of articles evaluating cancer treatments and identify the factors associated with high online media attention.MethodsWe systematically searched MEDLINE via PubMed on March 1, 2015 for articles published during the first 6 months of 2014 in oncology and medical journals with a diverse range of impact factors, from 3.9 to 54.4, and selected a sample of articles evaluating a cancer treatment regardless of study design. Altmetric Explorer was used to identify online media attention of selected articles. The primary outcome was media attention an article received online as measured by Altmetric score (i.e., number of mentions in online news outlets, science blogs and social media). Regression analysis was performed to investigate the factors associated with high media attention, and regression coefficients represent the logarithm of ratio of mean (RoM) values of Altmetric score per unit change in the covariate.ResultsAmong 792 articles, 218 (27.5%) received no online media attention (Altmetric score = 0). The median [Q1–Q3] Altmetric score was 2.0 [0.0–8.0], range 0.0–428.0. On multivariate analysis, factors associated with high Altmetric score were presence of a press release (RoM = 10.14, 95%CI [4.91–20.96]), open access to the article (RoM = 1.48, 95%CI [1.02–2.16]), and journal impact factor (RoM = 1.10, 95%CI [1.07–1.12]. As compared with observational studies, systematic reviews were not associated with high Altmetric score (RoM = 1.46, 95%CI [0.74–2.86]; P = 0.27), nor were RCTs (RoM = 0.65, 95%CI [0.41–1.02]; P = 0.059) and phase I/II non-RCTs (RoM = 0.58, 95%CI [0.33–1.05]; P = 0.07). The articles with abstract conclusions favouring study treatments were not associated with high Altmetric score (RoM = 0.97, 95%CI [0.60–1.58]; P = 0.91).ConclusionsMost important factors associated with high online media attention were the presence of a press release and the journal impact factor. There was no evidence that study design with high level of evidence and type of abstract conclusion were associated with high online media attention.Electronic supplementary materialThe online version of this article (doi:10.1186/s41073-017-0033-z) contains supplementary material, which is available to authorized users.
Background Wearable biometric monitoring devices (BMDs) have the potential to transform the conduct of randomized controlled trials (RCTs) by shifting the collection of outcome data from single measurements at predefined time points to dense continuous measurements. Methods Methodological systematic review to understand how recent RCTs used BMDs to measure outcomes and to describe the reporting of these RCTs. Electronic search was performed in the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE and completed a page-by-page hand search in five leading medical journals between January 1, 2018, and December 31, 2018. Three reviewers independently extracted all primary and secondary outcomes collected using BMDs, and assessed (1) the definitions used to summarize BMD outcome data; (2) whether the validity, reliability, and responsiveness of sensors was reported; (3) the discrepancy with outcomes prespecified in public clinical trial registries; and (4) the methods used to manage missing and incomplete BMD outcome data. Results Of the 4562 records screened, 75 RCTs were eligible. Among them, 24% tested a pharmacological intervention and 57% used an inertial measurement sensor to measure physical activity. Included trials involved 464 outcomes (average of 6 [SD = 8] outcomes per trial). In total, 35 trials used a BMD to measure a primary outcome. Several issues affected the value and transparency of trials using BMDs to measure outcomes. First, the definition of outcomes used in the trials was highly heterogeneous (e.g., 21 diabetes trials had 266 outcomes and 153 had different unique definitions to measure diabetes control), which limited the combination and comparison of results. Second, information on the validity, reliability, and responsiveness of sensors used was lacking in 74% of trials. Third, half (53%) of the outcomes measured with BMDs had not been prespecified, with a high risk of outcome reporting bias. Finally, reporting on the management of incomplete outcome data (e.g., due to suboptimal compliance with the BMD) was absent in 68% of RCTs. Conclusions Use of BMDs to measure outcomes is becoming the norm rather than the exception in many fields. Yet, trialists need to account for several methodological issues when specifying and conducting RCTs using these novel tools.
Objectives: New forms of research involving collective intelligence (CI) of diverse individuals mobilized through crowdsourcing is successfully emerging in various fields. This scoping review aimed to describe these methods across different fields and propose a framework for implementation. Study Design and Setting: We searched seven electronic databases for reports describing projects that had mobilized CI with crowdsourcing. We used content analysis to develop themes and categories of the methods. Results: We identified 145 reports. CI was mobilized to generate ideas, conduct evaluations, solve problems, and create intellectual outputs. Most projects (n 5 110, 76%) were open to the public without restrictions on participants' expertise. Participants contributed to projects by independent contribution (i.e., no interaction with other participants) (n 5 50, 34%), collaboration (n 5 41, 28%), competitions (n 5 33, 23%), and playing games (n 5 16, 11%). In total, 61% of articles (n 5 89) reported methods to evaluate participants' contribution and decision-making process: 43% used an independent panel of experts and 18% involved end users. We identified challenges in implementation and sustainability of CI and proposed solutions. Conclusion: New research methods based on CI through crowdsourcing could transform clinical research. This framework facilitates the implementation of these methods.
Randomized controlled trials (RCTs) are essential to support clinical decision making. We assessed the transparency, completeness and consistency of reporting of 244 reports (120 peer-reviewed journal publications; 124 preprints) of RCTs assessing pharmacological interventions for the treatment of COVID-19 published the first 17 months of the pandemic (up to May 31, 2021). Transparency was poor. Only 55% of trials were prospectively registered; 39% made their full protocols available and 29% provided access to their statistical analysis plan. Only 6% completely reported the most important information. Primary outcome(s) reported in trial registries and published reports were inconsistent in 47% of trials. Of the 124 RCTs published as preprint, 76 were secondarily published in a peer-reviewed journal. There was no major improvement after the peer-review process. Lack of transparency, completeness and consistency of reporting is an important barrier to trust, interpretation and synthesis in COVID-19 clinical trials.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.