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BACKGROUND: COVID-19 vaccine mandates are considered a controversial public health policy both in public debate and among healthcare workers (HCWs). Thus, the objective of this systematic review is to give a deep insight into HCWs' views and attitudes towards COVID-19 vaccination mandates amid the ongoing COVID-19 pandemic. METHODS: A systematic literature search of five databases (PubMed, Scopus, Embase, CINAHL, and Web of Science) was conducted between July 2022 and November 2022. Original quantitative studies that addressed the attitudes of HCWs regarding COVID-19 vaccine mandates were considered eligible for this systematic review. All the included studies (n = 57) were critically appraised and assessed for risk of systematic bias. Meta-analyses were performed, providing a pooled estimate of HCWs' acceptance towards COVID-19 vaccine mandates for: 1. HCWs and 2. the general population. RESULTS: In total, 64% (95% CI: 55%, 72%) of HCWs favored COVID-19 vaccine mandates for HCWs, while 50% (95% CI: 38%, 61%) supported mandating COVID-19 vaccines for the general population. CONCLUSIONS: Our findings indicate that mandatory vaccination against COVID-19 is a highly controversial issue among HCWs. The present study provides stakeholders and policy makers with useful evidence related to the compulsory or non-compulsory nature of COVID-19 vaccinations for HCWs and the general population. Other: The protocol used in this review is registered on PROSPERO with the ID number: CRD42022350275.
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Introduction Due to improvements in breast cancer (BC) diagnostics and treatment, the population of BC survivors is growing. BC treatments may have adverse effects that lead to an increased risk of developing type 2 diabetes mellitus (T2D). It is therefore important to investigate the risk of T2D in patients with BC in general and according to type of adjuvant BC treatment. Objectives To conduct a systematic review and meta-analysis investigating the association between early BC and the risk of subsequent T2D diagnosis. A secondary aim was to examine this association according to type of adjuvant BC treatment-chemotherapy and endocrine therapy (ET). Methods We searched PubMed and Embase using variations of the search terms breast cancer (population), ET, tamoxifen, aromatase inhibitors (AIs) and chemotherapy (exposures), and diabetes mellitus (outcome). Two authors screened papers for eligibility by title and using Covidence and reviewed full texts of eligible papers. Guided by the Meta-analysis of Observational Studies in Epidemiology (MOOSE) checklist, study data were extracted. Using random-effects models, we calculated relative risks (RRs) and associated 95% confidence intervals (CIs) for the association between BC, adjuvant BC treatment (ET overall, tamoxifen, and AIs), and subsequent T2D. We used funnel plots to assess publication bias in the analyses. Results Among 16 eligible studies, 11 reported on T2D risk after BC, chemotherapy, or ET;five studies investigated more than one association. Compared with patients without BC, those with BC had elevated risk of T2D overall (RR=1.27, 95%CI=1.15-1.41), particularly those who received any ET (RR=1.23, 95% CI=1.16 1.32). Among BC patients only, risk of T2D was higher for those who received tamoxifen compared with those who did not receive tamoxifen (RR=1.19, 95% CI=1.13-1.25). Due to few studies, analyses investigating T2D risk after treatment with AIs and chemotherapy were inconclusive. Conclusion Our findings support an association between BC and subsequently elevated risk of T2D, particularly after tamoxifen use. Further research is needed to determine the impact of ET overall, AIs and chemotherapy on the incidence of T2D in patients with early BC.
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Objectives: The aim of this study was to summarize the available evidence on the prevalence of stress, burnout, anxiety and depression among healthcare providers in the Gulf Cooperation Council (GCC) countries (KSA, Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates) during the COVID-19 pandemic. Methods: We searched PubMed, PsycINFO, Scopus, and Google scholar for related studies published between January 2020 and April 2021 and conducted a systematic review and meta-analysis. Results: Of the 1815 identified studies, 29 met the inclusion criteria, and 19 studies were included in the meta-analysis. The pooled estimate of prevalence for moderate to severe anxiety as reported using GAD-7 was 34.57% (95% CI = 19.73%, 51.12%), that for moderate to severe depression using PHQ-9 was 53.12% (95% CI = 32.76%, 72.96%), and that for moderate to severe stress using the 10-item Perceived Stress Scales was 81.12% (95% CI = 72.15%, 88.70%). Meta-analysis was not performed for burnout due to the small number of identified studies and the different tools used;however, the highest prevalence was reported at 76% (95% CI = 64%, 85%). Overall, a positive trend was observed over time for moderate to severe anxiety and depression, p = 0.0059 and 0.0762, respectively. Of note, the heterogeneity was significant among the studies, and many studies were of poor quality. Conclusion: The prevalence of mental health disorders during the current pandemic among healthcare workers in GCC countries is high. However, the results could be affected by the high heterogeneity and low quality studies. © 2022 [The Author/The Authors]
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Propose: Due to severe acute respiratory syndrome coronavirus 2(SARS-CoV- 2), novel coronavirus pneumonia (COVID-19) is a systemic viral disease that mostly affects the respiratory tract. Studies have shown that COVID-19 may increase the risk of autoantibody development in patients with connective tissue diseases (CTD) .However, data regarding the impact of COVID-19 pandemic on patients with CTD and drug use were relatively scarce. The prevalence of COVID-19 in CTD patients was estimated by means of meta-analysis, and the effect of the use of anti-rheumatic drugs on the clinical outcome of CTD patients with COVID-19 was investigated. Method(s): Cross-sectional investigations and case series on CTD and COVID-19 published by CBM, CNKI, China Science and Technology Journal Database, Wan Fang Data, PubMed, Embase, Web of Science, Cochrane Library and Medline from its establishment to April 5, 2022 were searched. A random effects model was used to pool data. Heterogeneity and risk of bias was examined with I-squared index (I2) statistic. Inconsistency was evaluated with the I2. Egger tests were used for the evaluation of potential publication bias (STATA v.12.0). Result(s): A total 11 studies involving 75908 participants were included in the meta-analysis (Table 1). The overall prevalence of COVID-19 among CTD patients was 3.3% (95%CI: 2.3%-4.3%) (Figure 1A), the hospitalization rate was 17.6% (95%CI: 7.5%-27.6%;Figure 1B), with the rate of 4.4% (95%CI: 2.8%-6.0%;Figure 1C)in ICU admission, and the mortality rate was 4.5% (95%CI: 2.5%-6.4%;igure 1D). Six of the studies included patients who used hydroxychloroquine as part of their treatment regimen, with 15.5% (95%CI: 5.6%-25.3%) adverse outcome rates (Figure 1E). Conclusion(s): Patients with CTD had a higher risk of COVID-19. Hydroxychloroquine might increase adverse outcome rate of COVID-19.
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Purpose: Novel Coronavirus pneumonia 2019 (COVID-19) caused by the novel coronavirus severe acute respiratory syndrome (SARS) coronavirus- 2 (CoV-2) is a highly contagious infection with high morbidity and mortality1. Patients with systemic lupus erythematosus (SLE) are considered to be susceptible to coronavirus due to impaired immune function2. This study aims to systematically evaluate the prevalence of COVID-19 in SLE patients, and futher explore the impact of antirheumatic drug on the clinical outcome of COVID-19 in SLE patients. Method(s): Systematic searches of PubMed, EMBASE, Web of Science, the Cochrane Library and Medline, CNKI, CBM, China Science and Technology Journal Database and Wan Fang Data were performed. Cross-sectional investigations and case series on SLE and COVID-19 were included. Random effects model was used to pool data. Heterogeneity and risk of bias was examined with I squared index (I2) statistic and Egger tests were used for the evaluation of potential publication bias (STATA v.12.0). Result(s): A total of 14 studies comprising 5115 SLE patients and 698 COVID-19 patients were identified. Overall prevalence of COVID-19 in SLE patients was 6.7% (95%CI: 4.4-9.1%). The hospitalization rate was 31.6% (95%CI: 15.8%-47.3%), with the rate of 22.2% (95%CI: 6.2-38.2%) of patients were admitted to ICU, and the death rate was 19.3% (95%CI: 2.7%-35.9%). Eight of the studies included patients who used hydroxychloroquine as part of their treatment regimen, with 5.7% (95%CI: 3.3%-8.0%) prevalence rate. The hospitalisation rates for SLE patients with COVID-19 infection who received glucocorticoid was 69.2% (95%CI: 46.8%-91.6%). The rates of hospitalisation in patients who received hydroxychloroquine was 59.2% (95%CI: 45.8%-72.6%), and in patients who received biologic disease-modifying anti-rheumatic drugs (b-DMARD) was 61.8% (95%CI: 32.7%-90.9%). The adverse outcome rate due to COVID-19 in patients with SLE was 34.1% (95% CI: 4.3%-64%). The rate of adverse outcome in SLE patients diagnosed with COVID-19 who received glucocorticoid was 22.9% (95%CI: 9%-31.5%), and in patients who received hydroxychloroquine was 22.9% (95%CI: 0.1%-45.7%, Figure 1). Conclusion(s): Patients with SLE had a higher risk of COVID-19. Anti-rheumatic drugs may help reduce the prevalence and overall rate of adverse outcomes of COVID-19. Figure 1.
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Purpose: The pandemic of novel coronavirus disease 2019 (COVID-19) caused by the emerging severe acute respiratory syndrome coronavirus 2 (sars-cov- 2) has become a global health crisis (WHO, 2020b), leading to large number of infections and deaths. Autoimmune rheumatic diseases (ARD) are characterized by immune dysfunction and more susceptible to infection. The prevalence of COVID-19 in ARD patients was estimated by means of meta-analysis, and the effect of the use of anti-rheumatic drugs on the clinical outcome of ARD patients with COVID-19 was investigated. Method(s): Cross-sectional investigations and case series on ARD and COVID-19 published by CBM, CNKI, China Science and Technology Journal Database, Wan Fang Data, PubMed, Embase, Web of Science, Cochrane Library and Medline from its establishment to June 26, 2022 were searched. Random effects model was used to pool data. Heterogeneity and risk of bias was examined with I-squared index (I2) statistic. Egger tests were used for the evaluation of potential publication bias (STATA v.12.0). Result(s): A total of 65 studies comprising 135 515 patients were identified. Overall prevalence of COVID-19 in ARD patients was 5.4% (95%CI: 4.3%-6.5%). The hospitalisation rate due to COVID-19 was 35.9% (95% CI: 28.3%-43.4%). The hospitalisation rates for ARD patients diagnosed with COVID-19 who received glucocorticoid was 35.9% (95%CI: 31.4%-40.4%). The rates of hospitalisation in patients who received hydroxychloroquine was 39.9% (95%CI: 34.5%-45.3%), and in patients who received biologic disease-modifying anti-rheumatic drugs (b-DMARD) was 38.1% (95%CI: 33.6%-42.5%), which were both higher than total hospitalisation. The mortality due to COVID-19 in patients with ARD was 6.0% (95% CI: 5.1%-6.8%). The mortality in ARD patients diagnosed with COVID-19 who received glucocorticoid was 5.3% (95%CI: 4.3%-6.2%), and in patients who received b-DMARD was 5.8% (95%CI: 4.9%-6.7%). Mortality rates for patients who received hydroxychloroquine was 5.2% (95%CI: 4.2%-6.2%) (Figure 1). Conclusion(s): Patients with ARD had a higher risk of COVID-19. Use of glucocorticoids decrease mortality in these patients suffered from COVID-19 infection. Though patients had a higher hospitalisation rates but lower mortality among patients prescribed b-DMARD or hydroxychloroquine. (Figure Presented).
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Purpose: No comprehensive statistical assessment of publication bias has been conducted in remdesivir-based intervention research for COVID-19 patients. This study aims to examine all meta-analyses of the efficacy of remdesivir interventions in COVID-19 patients and perform a statistical assessment of publication bias. Design/methodology/approach: This is an analytic study conducted to assess the impact of publication bias on the results of meta-analyses of remdesivir-based interventions in patients infected with COVID-19. All English full-text meta-analyses published in peer-reviewed journals in 2019–2021 were included. A computerized search of PubMed and Web of Science electronic databases was performed on December 24, 2021. The trim-and-fill method calculated the number of missing studies and the adjusted cumulative effect sizes. Findings: The final analysis comprised 21 studies with 88 outcomes. The investigation revealed missing studies in 46 outcomes (52%). Seventy-six missing studies were replaced in the outcomes using the trim-and-fill procedure. The adjusted recalculated effect sizes of the 27 outcomes increased by an average of 0.04. In comparison, the adjusted effect size of 18 outcomes fell by an average of 0.036. Only 14 out of 46 outcomes with publication bias were subjected to a gray literature search (30%). To discover related research, no gray literature search was conducted in most outcomes with publication bias (n = 32;70%). In conclusion, the reported effect estimates regarding the effect of remdesivir in COVID-19 patients are only slightly affected by publication bias and can be considered authentic. Health-care decision-makers in COVID-19 should consider current research results when making clinical decisions. Research limitations/implications: Most health decisions are based on the effect sizes revealed in meta-analyses. When deciding on remdesivir-based treatment for COVID-19 patients, therefore, the outcomes of this investigation may be of paramount importance to health policymakers, leading to better treatment strategies. Practical implications: According to the results, no major publication bias and missing studies were detected on average. Therefore, the calculated effect sizes of remdesivir-based interventions on meta-analyses can be used as authentic and unbiased benchmarks by health-care decision-makers in treating patients with COVID-19. Originality/value: This is the first study to examine the effect of publication bias and gray literature searches on the results of meta-analyses of treatment with COVID-19 (remdesivir). © 2023, Emerald Publishing Limited.
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Background: Glucocorticoid (GC) use is well established in the treatment of rheumatics diseases, particularly rheumatoid arthritis (RA). The use of low dose GC has been endorsed by EULAR recommendations for the management of rheumatic and musculoskeletal diseases even if in the context of SARS-CoV-2, but long-term use is generally discouraged. Objectives: To estimate the prevalence of glucocorticosteroids induced osteoporosis (GIOP) on bone mineral density (BMD) in African adult patients with infammatory rheumatic diseases. Methods: For this systematic review and meta-analysis, PubMed, Google Scholar, Scopus and African index medicus were systematically searched up to December 2020 without language restrictions. We included studies as follows: population-based or hospital-based study, study with sufficient information to estimate the prevalence of GIOP and osteoporotic fractures in African patients with rheumatic disease. Searches were limited to peer-reviewed full text articles. A standardized data extraction form was used to collect information from eligible studies. A random-effects meta-analysis was conducted to obtain the pooled prevalence of GIOP in these studies. The meta-analysis was strati-fed by geographical region. The study is registered with PROSPERO, number CRD42021256252. Results: Our search identifed 8571 studies, of which 8 studies were included in the systematic review from only four African countries and 7 studies in the meta-analysis. The pooled prevalence of osteoporotic fractures in our study was 47.7% (95% CI 32.9-62.8) with 52.2% (95% CI 36.5-67.6) in North Africa and 15.4% (95% 1.9-45.4%) in South Africa (SA). There was no evidence of publication bias, although heterogeneity was high (p=0.018). There was no data from sub-Saharan Africa apart from the two studies from SA. Conclusion: The overall prevalence of GIOP in African adult patients with infam-matory rheumatic diseases was high at 47.7% (95% CI 32.9-62.8). Meta-analysis calculation revealed patient geographic origin as possible confounding factors of the proportion outcomes and further studies are required.
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Background: Novel Coronavirus pneumonia 2019 (COVID-19) is a systemic infectious disease with prominent involvement of the respiratory tract, due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)[1]. Systemic lupus erythematosus is charcterized by an aberrant immune response with the presence of circulating autoantibodies, lymphopenia, and proinfammatory[2]. They are immune-compromised and vulnerable to infections with immune-suppressants treatment. However, data regarding the impact of COVID-19 pandemic in patients with SLE and drug use were relatively scarce. Objectives: The prevalence of COVID-19 in SLE patients was estimated by means of meta-analysis, and the effect of the use of anti-rheumatic drugs on the clinical outcome of SLE patients with COVID-19 was investigated. Methods: Cross-sectional investigations and case series on SLE and COVID-19 published by CBM, CNKI, China Science and Technology Journal Database, Wan Fang Data, PubMed, Embase, Web of Science, Cochrane Library and Medline from its establishment to November 10, 2021 were searched. Random effects model was used to pool data. Heterogeneity and risk of bias was examined with I-squared index (I2) statistic. Inconsistency was evaluated by using the I2. Egger tests were used for the evaluation of potential publication bias (STATA v.12.0). Results: A total of 14 studies comprising 5365 patients were identifed (Table 1). Overall prevalence of COVID-19 in SLE patients was 1.5% (95%CI: 1.2%-1.8%). Eight of the studies included patients who used hydroxychloroquine as part of their treatment regimen, with 29.8% (95%CI: 25.8%-33.8%) hospitalization rates and 14.6% (95%CI: 11.5%-17.8%) adverse outcome rates. Among patients treated with hydroxychloroquine throughout the course of disease, the prevalence was 0.7% (95%CI: 0.4%-1.0%, Figure 1). Conclusion: Patients with SLE had a higher risk of COVID-19. Hydroxychloro-quine might beneft to reduce the overall hospitalization rate and prevalence rate of COVID-19, and alleviate infammatory damage in the chronic stage of viral infection by inhibiting over activation of the immune system.
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Background The recent Covid-19 pandemic has accelerated the use of LSRs and PMAs, viewed as the 'next generation systematic reviews and meta-analyses'. LSRs and PMAs are prospective designs that can reduce the problems of traditional retrospective meta-analyses (MA) such as selective outcome reporting and publication bias, missing data, etc., and thus offer a better option for incorporating and generating new evidence. Objectives We propose the Bayesian approach as a method for analysing LSRs and PMAs. Bayesian Meta Analysis (BMA) is particularly appealing - actually, natural - for these designs as it clearly reflects the process of learning, defined as new evidence coming to update the previous knowledge, that is intrinsic to LSRs and PMAs. Methods Results pooled in the previous update of the LSR, or derived from the studies already known in the PMA, can be used to provide an objective/historical prior distribution. The combination of this information with the accumulated results (conditioning on these) provides the posterior probability distribution that can be used as the prior in the next iteration of the LSR/PMA (yesterday's posterior becomes tomorrow's prior). Results We will show an example of BMA on a LSR of the association between Covid-19 and asthmatic patients and give practical suggestions for its use. Discussion Without relying on asymptomatic normality assumptions, BMA is suitable as it is a coherent and flexible framework that, in comparison with frequentist MAs, allows a better assessment of the between-study variance and overcomes some common issues as dealing with missing data and publication bias.
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Providing sensible estimates of the mean incubation time for COVID-19 is important yet complex. This study aims to provide synthetic estimates of the mean incubation time of COVID-19 by capitalizing on available estimates reported in the literature and exploring different ways to accommodate heterogeneity involved in the reported studies. Online databases between January 1, 2020 and May 20, 2021 are first searched to obtain estimates of the mean incubation time of COVID-19, and meta-analyses are then conducted to generate synthetic estimates. Heterogeneity of the studies is examined via the use of Cochran's Q $Q$ statistic and Higgin's & Thompson's I 2 ${I}^{2}$ statistic, and subgroup analyses are conducted using mixed effects models. The publication bias issue is assessed using the funnel plot and Egger's test. Using all those reported mean incubation estimates for COVID-19, the synthetic mean incubation time is estimated to be 6.43 days with a 95% confidence interval (CI) [5.90, 6.96], and using all those reported mean incubation estimates together with those transformed median incubation estimates, the estimated mean incubation time is 6.07 days with a 95% CI [5.70, 6.45]. The reported estimates of the mean incubation time of COVID-19 vary considerably due to multiple reasons, including heterogeneity and publication bias. To alleviate these issues, we take different angles to provide a sensible estimate of the mean incubation time of COVID-19. Our analyses show that the mean incubation time of COVID-19 between January 1, 2020 and May 20, 2021 ranges from 5.68 to 8.30 days.
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COVID-19 , HumansABSTRACT
BACKGROUND: Reporting bias poses a fundamental threat to the transparency and validity of interpretations of clinical trials, which may, in part, be mitigated through access Clinical Study Reports (CSRs). The European Medicines Agency (EMA), under their Policy 0070, prospectively publishes clinical data, including CSRs, submitted as part of marketing authorization applications or post-authorization procedures, although this practice is currently suspended for non-COVID-19 medicines, and have set out planned timelines for publication. METHODS: We conducted a cross-sectional study assessing the content and characteristics of all clinical data packages released by the EMA under Policy 0070 and the time to their publication. We extracted the number and characteristics of trials included in the clinical packages, assessed the delay to publication relative to the EMAs planned timeline and whether it differed between the EMAs various transparency measures and types of application procedures. RESULTS: We identified 148 clinical data packages that contained data on a total of 1,005 clinical trials, of which 261 (26%) were labelled as phase 3 trials. Full CSRs were available for 913 (90â¢8%) of the trials. The median time to publication was 511 (IQR 411 to 574) days. Only 2 (1â¢4%) of the clinical data packages were published within the EMA's planned timeline. The delay was shorter for clinical data packages released under the EMAs transparency measures for COVID.19 medicines compared with their standard transparency measure. CONCLUSION: The clinical data packages released by the EMA under Policy 0070 contained CSRs on many trials but were published with considerable delays relative to the timeline set forth by the EMA, reducing their potential impact on reporting bias.
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COVID-19 , COVID-19/epidemiology , Cross-Sectional Studies , Humans , Research ReportABSTRACT
Purpose of Study Coronavirus disease (COVID-19) can range from asymptomatic infection to severe illness with multiorgan failure. Recent studies demonstrated an association between lower serum lipid levels namely high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total cholesterol (TC) and COVID-19 disease severity. But the results lack consistency, and the magnitude of the association is currently unknown. Methods Used We conducted a systematic review and metaanalysis on the difference in HDL, LDL, TC, and triglycerides (TG) levels between 1) COVID-19 patients and healthy controls 2) COVID-19 patients with and without severe disease 3) COVID-19 patients who died and who survived. We included articles from PubMed and Embase up to September 1, 2021. We analyzed the pooled mean differences (pMD) in lipid levels (mg/dL) for the above-mentioned groups using random effects meta-analysis and assessed publication bias using funnel plots. Summary of Results Among the 441 articles retrieved, 29 articles (26 retrospective and 3 prospective cohorts) met the inclusion criteria with an aggregate of 256,721 participants. Patients with COVID-19 had lower HDL (pMD = -6.95), and TC (pMD = -14.9) levels (table 1 and figure 1). There was no difference in LDL and TG levels among patients with and without COVID-19. Patients with severe COVID-19 had lower HDL (pMD = -4.4), LDL (pMD = -4.4), and TC (pMD = -10.4) levels compared to non-severe COVID-19 patients. Patients who died had lower HDL (pMD = -2.5), LDL (pMD = -10.6) and TC (pMD = -14.9) levels. TG levels did not differ with COVID-19 severity or mortality. None of the above analyses showed statistically significant publication bias. Conclusions Our analysis demonstrated lower lipid levels in COVID-19 patients compared to healthy controls. Among COVID-19 patients, lower HDL, LDL, and TC levels were associated with severity and mortality. We believe that reduced lipoprotein levels are secondary to systemic inflammation and hepatic dysfunction. Lipid levels could be explored as potential prognostic factors in patients with COVID-19. (Table Presented).
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Objective: To systematically evaluate the incidence of adverse reactions to coronavirus disease 2019 (COVID-19) vaccination. Methods: We systematically searched PubMed, Embase, The Cochrane Library, Web of Science, CNKI, WanFang Data, and VIP Database from the inception of each database to August 31, 2021. Randomized controlled clinical trials (RCTs) on the safety of different types of COVID-19 vaccines were retrieved and analyzed. A random or fixed-effects model was used with an odds ratio as the effect size. The quality of each reference was evaluated. The incidence of the adverse reactions of the placebo group and the vaccination group was compared. Heterogeneity and publication bias were taken care of by meta-regression and sub-group analyses. Results: A total of 13 articles were included, with 81 287 subjects. Compared with the placebo group, the vaccination group showed a higher combined risk ratio (RR) of total adverse reactions (RR=1.67, 95% CI: 1.46-1.91, P<0.01), local adverse reactions (RR=2.86, 95% CI: 2.11-3.87, P<0.01), systemic adverse reactions (RR=1.25, 95% CI: 0.92-1.72, P=0.16), pain (RR=2.55, 95% CI: 1.75-3.70, P<0.01), swelling (RR=4.16, 95% CI: 1.71-10.17, P=0.002, fever (RR=2.34, 95% CI: 1.84-2.97, P<0.01), fatigue (RR=1.36, 95% CI: 1.32-1.41, P<0.01) and headache (RR=1.22, 95% CI: 1.18-1.26, P<0.01). The subgroup analysis showed the incidence of adverse reactions of the vaccination group after injection of the three COVID-19 vaccines (inactivated viral vaccines, mRNA vaccines and adenovirus vector vaccines) was higher than that of the placebo group, and the difference between the placebo group and the vaccination group in the mRNA vaccine subgroup and the adenovirus vector vaccine subgroup was statistically significant (P<0.01). The incidence of adverse reactions after injection of COVID-19 vaccine in subgroups of different ages was significantly higher than that in the placebo group (P<0.01). Conclusions: COVID-19 vaccines have a good safety, among which adenovirus vector vaccine has the highest incidence of adverse reactions. Both adolescents and adults vaccinated with novel coronavirus vaccine have a certain proportion of adverse reactions, but the symptoms are mild and can be relieved by themselves. Our meta-analysis can help boost global awareness of vaccine safety, promote mass vaccination, help build regional and global immune barriers and effectively curb the recurrency of COVID-19.
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Introduction: The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was declared a global pandemic by the World Health Organization (WHO) in March 2020. Although left ventricular global longitudinal strain (LV-GLS) has been validated as a prognostic marker in other disease processes, the utility of LV-GLS in risk stratification of coronavirus disease 2019 (COVID19) remains controversial. This study aimed to investigate the prognostic value of echocardiographic findings, including LV-GLS in patients with COVID-19. Hypothesis: LV-GLS is associated with poor clinical outcomes in patients with COVID-19. Methods: We comprehensively searched the databases of MEDLINE and EMBASE from inception to June 2021. Included studies were published observational studies that reported an association between echocardiographic findings and prognostic valve in COVID-19. Data from each study were combined with random-effects, generic inverse variance method of DerSimonian and Laird to calculate pooled odds ratios and their 95% confidence intervals at 0.05 significance level. Sensitivity analysis and funnel plot were assessed for the validity of the results. Results: Six observational studies from August 2020 to May 2021 were included in this metaanalysis. The pooled odds ratio for COVID-19 mortality for each 1% change in LV-GLS was 1.452 (95% confidence interval 1.186 to 1.778, P < 0.001). There was moderate heterogeneity with an Isquare value of 49.9%. Sensitivity analysis showed no significant deviation from pooled odds ratios. There was no evidence of publication bias from the funnel plot and Egger's test. Conclusions: LV-GLS measurement has prognostic value in risk stratification among COVID-19 patients. Low LV-GLS is independently associated with poor clinical outcomes.
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Introduction: The coronavirus disease 2019 (COVID-19) pandemic has influenced epidemiology through direct and indirect effects, yet the impact on out-of-hospital cardiac arrest (OHCA) is unclear. We aimed to evaluate the impact of the pandemic on the incidence, characteristics, and clinical outcomes of OHCA. Hypothesis: We hypothesized that compared to the pre-pandemic period, the COVID-19 pandemic period was associated with increased incidence and case fatality rate (CFR) of OHCA, as well as decreased rates of intermediate clinical outcomes (termination of resuscitation [TOR], return of spontaneous circulation [ROSC], survival to hospital admission, and survival to hospital discharge). We further postulated that there was a change in the etiologies of OHCA during the pandemic as well as a decline in the rate of shockable rhythm as the initial presenting rhythm. Methods: In this systematic review and meta-analysis, five scientific databases were searched from inception to May 3, 2021. Meta-analyses were performed for the primary outcomes, secondary outcomes, and clinical characteristics. This study was registered in the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42021253879). Results: The search yielded 966 articles. 20 articles were included for analysis. The COVID-19 pandemic was associated with a 39.5% increase in pooled annual OHCA incidence (p<0.001). Pooled CFR was increased by 2.65% (p<0.001), with an odds ratio (OR) of 1.95 for mortality (95% confidence interval [95%CI] 1.51-2.51). There was increased field TOR (OR=2.46, 95%CI 1.62- 3.74). There were decreased ROSC (OR=0.65, 95%CI 0.55-0.77), survival to hospital admission (OR=0.65, 95%CI 0.48-0.89), and survival to discharge (OR=0.52, 95%CI 0.40-0.69). There was decreased shockable rhythm (OR=0.73, 95%CI 0.60-0.88) and increased asphyxial etiology of OHCA (OR=1.17, 95%CI 1.02-1.33). There was moderate-to-high statistical heterogeneity. Findings were robust to sensitivity analyses, with no publication bias detected. Conclusions: The COVID-19 pandemic was associated with significant changes in OHCA epidemiology. Compared to the pre-pandemic period, the pandemic period was associated with increased OHCA incidence and worse outcomes.
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This article describes publication bias, its most frequent causes, its characteristics, the regulatory tools to avoid it, and some statistical techniques to analyze it. These techniques are explained and applied to three therapeutic interventions related to the 2019 coronavirus disease (COVID-19): corticosteroids, ivermectin, and tocilizumab. Risk of publication bias was detected for ivermectin and tocilizumab. Systematic reviews and meta-analyses are secondary research designs that provide a reference to guide decision-making. They are prone to different types of bias, i.e., a systematic deviation in the results. Even if carried out with methodological rigor, their validity can be threatened by publication bias. This is defined as the act of concealing or delaying publication, withholding data arising from research studies, or both. Up to half of controlled trials remain unpublished. During the H1N1 virus pandemic, publication bias from industry-funded studies led to the recommendation and large-scale procurement of oseltamivir, a drug that later proved to have no relevant beneficial effects. Two-thirds of clinical trial funding for COVID-19 comes from the pharmaceutical industry. In the context of the COVID-19 pandemic, studies are published at an accelerated pace, making it very important to understand and identify publication bias. To reduce publication bias it is necessary to regulate the registration and publication of clinical trials, but this requires coordination among countries and international bodies. It is important to suspect and attempt to identify publication bias for decision making.
Este artigo descreve o viés de publicação, suas causas mais frequentes, suas características, as ferramentas regulatórias para evitá-lo e algumas técnicas estatísticas para analisá-lo. Essas técnicas são explicadas e aplicadas a três intervenções terapêuticas relacionadas à doença pelo coronavírus 2019 (COVID-19, na sigla em inglês): corticoides, ivermectina e tocilizumabe. Detectou-se risco de viés de publicação para ivermectina e tocilizumabe. As revisões sistemáticas e as meta-análises são delineamentos de pesquisa secundária que constituem uma referência para orientar a tomada de decisão. Estão propensas a diferentes tipos de viés, que é um desvio sistemático nos resultados. Mesmo tendo sido desenvolvidas com rigor metodológico, sua validade pode ser ameaçada pelo viés de publicação, que é definido como o ato de ocultar ou atrasar a publicação, reter dados de pesquisa ou ambos. Até metade dos estudos controlados realizados jamais são publicados. Durante a pandemia pelo vírus H1N1, o viés de publicação de estudos financiados pela indústria levou à recomendação e à compra, em grande escala, do medicamento oseltamivir que, mais tarde, ficou conhecido por não ter efeitos benéficos relevantes. Dois terços do financiamento para os ensaios clínicos referentes à COVID-19 vêm da indústria farmacêutica. No contexto da atual pandemia de COVID-19, os estudos vêm sendo publicados em ritmo acelerado; portanto, é fundamental conhecer e identificar o viés de publicação. Para reduzi-lo, é necessário regulamentar o registro de a publicação de ensaios clínicos, o que requer coordenação entre países e organismos internacionais. É importante suspeitar e tentar identificar o viés de publicação para a tomada de decisão.
ABSTRACT
Background: The prevalence and prognostic implications of heart failure (HF), as a complication of COVID-19 infection remains unclear. Aims: We performed a systematic review and metanalysis aimed to evaluate the pooled incidence of acute HF as a cardiac complication of COVID- 19 disease and to estimate the related mortality risk in these patients. Methods: Data were obtained searching MEDLINE, Scopus and Web of Science for all investigations published any time to December 26, 2020. If statistical heterogeneity was 50%, the results were derived from the fixedeffects model otherwise the random-effects model. Results: Overall, 1064 patients [mean age 66 years, 618 males] were included in the final analysis reviewing six investigations. The cumulative in-hospital rate of COVID-19 patients complicated by acute HF ranged between 6.9 to 63.4% among the studies reviewed. A random effect model revealed a pooled incidence of COVID-19 patients complicated by acute HF in 20.2% of cases (95% CI: 11.1-33.9%, p<0.0001 I2=94.4%) (Figure 1, Panel A). A second pooled analysis, based on a random-effect model, confirmed a significant increased risk of death in COVID-19 patients complicated by acute HF during the infection (OR 9.36, 95% CI 4.76-18.4, p<0.0001, I2=56.6%) (Figure 1, Panel B). The Egger's tests revealed no evidence of publication bias in estimating both the primary and secondary outcome (t=0.058, p=0.956 and t=1.402, p=0.233, respectively). Meta-regression analysis, using age as moderator variable, failed in founding a statistically significant relationship with the incidence of acute HF onset as a complication of COVID-19 disease (p=0.062) or the mortality risk among the same subjects (p=0.053). Conclusions: Acute HF represents a frequent complication of COVID-19 infection associated with a higher risk of mortality in the short-term period.
ABSTRACT
Background: The prevalence and prognostic implications of coronary artery disease (CAD) in patients infected by the novel coronavirus 2019 disease (COVID-19) remain unclear. Purposes: We conducted a systematic review and meta-analysis to investigate the prevalence and mortality risk in COVID-19 patients with preexisting CAD. PRISMA. guidelines were followed in ing data and assessing validity. We searched Medline, Scopus and Web of Science to locate all articles published up to December 8, 2020 reporting data of COVID-19 survivors and non-survivors with pre-existing CAD. Data were pooled using the Mantel-Haenszel random effects models with odds ratio (OR) as the effect measure with the related 95% confidence interval (CI). Statistical heterogeneity between groups was measured using the Higgins I2 statistic. Results: Twenty-four studies, enrolling 22744 patients [mean age 58.2 and 70.9 years for survivors and non-survivors (p<0.0001), respectively], met the inclusion criteria and were included into the final analysis. The pooled prevalence of pre-existing CAD in COVID-19 patients was 11.5% (95% CI 0.097-0.136) and resulted significantly higher in non-survivors compared to survivors (16.7% vs 7.1%, respectively, p<0.0001). A randomeffect model confirmed a significant higher risk of death in COVID- 19 patients with pre-existing CAD in the short-term period (OR 2.96, 95% CI 2.18-4.03, p<0.0001, I2=79%) (Figure 1). A meta-regression, using age as moderator, did not identify any statistical significance (Coeff: -0.046, 95% CI -0.101-0.009, p=0.104). The Egger's regression test (t=0.596;p=0.06) confirmed that there were not statistically evidences of publication bias Conclusions: Pre-existing CAD in COVID-19 patients significantly increased the risk of death during the infection.
ABSTRACT
Introduction: COVID-19 is a recent infection that affects the whole world. Symptoms such as dyspnea and/or chest pain may persist in some people after the acute infection phase. However, the extent of this phenomenon is not yet well known. Purpose: To determine the prevalence of dyspnea and/or chest pain at least at one month after COVID-19 infection diagnosis. Methods: EMBASE, Ovid MEDLINE in-process and other nonindexed citations, and Ovid MEDLINE (between 1948 and January 15, 2021), and EBM Reviews-Cochrane Central Register of Controlled Trials and EBM Reviews-Cochrane Database of Systematic Reviews (between 2005 and January 15, 2021) were searched for a combination of keywords related to the type of exposure (COVID-19 infection) and to the type of outcomes (dyspnea persistence and/or chest pain persistence at least one month after COVID-19 infection diagnosis). Two independent reviewers selected studies of any design and in any language, using original data. Descriptive and quantitative information was extracted from each selected study and study quality was also assessed. We estimated prevalence in percentage and 95% Cis for each outcome, using a random-effects model. Statistical heterogeneity across the studies was calculated by the I2 statistic to quantify inconsistencies between studies. To assess the potential for publication bias, we visually inspected funnel plots and added the Egger's regression test p-value for funnel symmetry. Results: After an exhaustive screening of 1287 citations in title and , 31 studies were reviewed from entire article and 10 studies with 2004 patients were finally selected for meta-analysis. Interrater agreements were very high (0.91 and 1 respectively for the two selection steps). The pooled dyspnea persistence prevalence from 10 studies was of 39%;95% Ci [29%-49%], p<0.01, I2=91%, Egger's regression test p=0.19. The pooled chest pain persistence prevalence from 6 studies was of 18%;95% Ci [11%-24%], p<0.01, I2=89%, Egger's regression test p=0.12). Conclusion: Dyspnea and/or chest pain persistence prevalences after COVID-19 infection diagnosis are unexpectedly high, at least at one month. We have to take into account high heterogeneity due to subjects characteristics, various COVID-19 infection severities and study methodologies but there were no statistical argument for a publication bias. Nevertheless, this phenomenon requires more research to determine the long-term prevalence of these symptoms persistence and the mechanisms involved.