Dataset Information

Safety of COVID-19 vaccines in patients with non-communicable diseases: a protocol for systematic review and meta-analysis of randomised controlled trials.

ABSTRACT:

Introduction

The COVID-19 global pandemic has posed enormous threats to public health around the world. Vaccines are considered the best therapeutic strategy against the COVID-19 pandemic. However, the adverse reactions of vaccines significantly affect the rates of vaccination and may be more serious in patients with non-communicable diseases (NCDs). This protocol aims to conduct a systematic review and meta-analysis of randomised controlled trials (RCTs) which analysed the safety of vaccines in patients with NCDs.

Methods and analysis

This study will be according to the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. A comprehensive search will be carried out to identify registered RCTs in PubMed, Embase, Web of Science, ClinicalTrials.gov and Cochrane Library between 1 January 2020 and 31 May 2022. Selection of trials, data extraction, risk of bias assessment and quality of evidence assessment will be done by two researchers, and disagreements will be resolved by the corresponding author. The primary outcomes are local and systemic adverse events of vaccines in patients with NCDs. Additional outcomes are related events caused by vaccine adverse events, including but not limited to cases of adverse events leading to discontinuation from a dose or withdrawal from participation in the trial. Heterogeneity will be assessed with I² statistics and data analysis will be conducted with RevMan V.5.4.1.

Ethics and dissemination

This is a protocol and ethical approval is not necessary. The results of this protocol will be disseminated to peer-reviewed publications or conference presentations.

Prospero registration number

CRD42021254914.

SUBMITTER: Shi C

PROVIDER: S-EPMC9174532 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Safety of COVID-19 vaccines in patients with non-communicable diseases: a protocol for systematic review and meta-analysis of randomised controlled trials.

Shi Chengqian C Wu Mizhi M Wang Xinchang X Yang Kepeng K

BMJ open 20220524 5

<h4>Introduction</h4>The COVID-19 global pandemic has posed enormous threats to public health around the world. Vaccines are considered the best therapeutic strategy against the COVID-19 pandemic. However, the adverse reactions of vaccines significantly affect the rates of vaccination and may be more serious in patients with non-communicable diseases (NCDs). This protocol aims to conduct a systematic review and meta-analysis of randomised controlled trials (RCTs) which analysed the safety of vac ...[more]

PMID: 35613806

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Project description:IntroductionAlthough interest in including non-randomised studies of interventions (NRSIs) in meta-analysis of randomised controlled trials (RCTs) is growing, estimates of effectiveness obtained from NRSIs are vulnerable to greater bias than RCTs. The objectives of this study are to: (1) explore how NRSIs can be integrated into a meta-analysis of RCTs; (2) assess concordance of the evidence from non-randomised and randomised trials and explore factors associated with agreement; and (3) investigate the impact on estimates of pooled bodies of evidence when NRSIs are included.Methods and analysisWe will conduct a systematic survey of 210 systematic reviews that include both RCTs and NRSIs, published from 2017 to 2022. We will randomly select reviews, stratified in a 1:1 ratio by Core vs non-Core clinical journals, as defined by the National Library of Medicine. Teams of paired reviewers will independently determine eligibility and abstract data using standardised, pilot-tested forms. The concordance of the evidence will be assessed by exploring agreement in the relative effect reported by NRSIs and RCT addressing the same clinical question, defined as similarity of the population, intervention/exposure, control and outcomes. We will conduct univariable and multivariable logistic regression analyses to examine the association of prespecified study characteristics with agreement in the estimates between NRSIs and RCTs. We will calculate the ratio of the relative effect estimate from NRSIs over that from RCTs, along with the corresponding 95% CI. We will use a bias-corrected meta-analysis model to investigate the influence on pooled estimates when NRSIs are included in the evidence synthesis.Ethics and disseminationEthics approval is not required. The findings of this study will be disseminated through peer-reviewed publications, conference presentations and condensed summaries for clinicians, health policymakers and guideline developers regarding the design, conduct, analysis, and interpretation of meta-analysis that integrate RCTs and NRSIs.

Dataset Information

Safety of COVID-19 vaccines in patients with non-communicable diseases: a protocol for systematic review and meta-analysis of randomised controlled trials.

Introduction

Methods and analysis

Ethics and dissemination

Prospero registration number

Publications

Safety of COVID-19 vaccines in patients with non-communicable diseases: a protocol for systematic review and meta-analysis of randomised controlled trials.

Similar Datasets

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