PMID- 35214773
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220301
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 10
IP  - 2
DP  - 2022 Feb 17
TI  - Adverse Events Reporting Quality of Randomized Controlled Trials of COVID-19 
      Vaccine Using the CONSORT Criteria for Reporting Harms: A Systematic Review.
LID - 10.3390/vaccines10020313 [doi]
LID - 313
AB  - BACKGROUND: Assessing the quality of evidence from vaccine clinical trials is 
      essential to ensure the safety and efficacy of the vaccine and further enhance 
      public acceptance. This study aims to summarize and critically evaluate the 
      quality of harm reporting on randomized controlled trials for the COVID-19 
      vaccine and determine the factors associated with reporting quality. METHODS: We 
      systematically searched the literature using PRISMA guidelines for randomized 
      controlled trials (RCT) on COVID-19 Vaccine until 30 December 2021. Published 
      articles were searched from electronic databases such as PubMed, Science Direct, 
      Google Scholar, and Bibliovid. Bias analysis was performed using RoB-2 tools. The 
      quality of reporting was assessed by the Consolidated Standards of Reporting 
      Trials (CONSORT) harm extension modified into 21 items. RESULTS: A total of 61 
      RCT studies (402,014 patients) were analyzed. Over half the studies demonstrated 
      adequate reporting (59.02%), and 21 studies (34.4%) reported a low risk of bias. 
      All studies reported death and serious adverse events (AEs), but only six studies 
      mentioned how to handle the recurrent AEs. Reporting of AEs in subgroup analysis 
      was also poor (25%). CONCLUSION: The RCTs on the COVID-19 vaccine were less 
      biased with good quality on reporting harm based on the modified CONSORT harm 
      extension. However, study quality must be considered, especially for a balance of 
      information between effectivity and safety.
FAU - Yuniar, Cindra Tri
AU  - Yuniar CT
AUID- ORCID: 0000-0001-5972-217X
AD  - Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut 
      Teknologi Bandung, Bandung 40132, Indonesia.
FAU - Pratiwi, Bhekti
AU  - Pratiwi B
AD  - Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut 
      Teknologi Bandung, Bandung 40132, Indonesia.
FAU - Ihsan, Ardika Fajrul
AU  - Ihsan AF
AD  - Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut 
      Teknologi Bandung, Bandung 40132, Indonesia.
FAU - Laksono, Bambang Tri
AU  - Laksono BT
AD  - Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut 
      Teknologi Bandung, Bandung 40132, Indonesia.
FAU - Risfayanti, Iffa
AU  - Risfayanti I
AD  - Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut 
      Teknologi Bandung, Bandung 40132, Indonesia.
FAU - Fathadina, Annisa
AU  - Fathadina A
AD  - Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut 
      Teknologi Bandung, Bandung 40132, Indonesia.
FAU - Jeong, Yeonseon
AU  - Jeong Y
AD  - Clinical Data Analysis, Evidence-Based Clinical Research Laboratory, Department 
      of Health Science & Clinical Pharmacy, College of Pharmacy, Chung-Ang University, 
      Seoul 06974, Korea.
FAU - Kim, Eunyoung
AU  - Kim E
AUID- ORCID: 0000-0003-3525-8805
AD  - Clinical Data Analysis, Evidence-Based Clinical Research Laboratory, Department 
      of Health Science & Clinical Pharmacy, College of Pharmacy, Chung-Ang University, 
      Seoul 06974, Korea.
LA  - eng
GR  - PN-10-46-2021/Institut Teknologi Bandung/
PT  - Journal Article
PT  - Review
DEP - 20220217
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC8875800
OTO - NOTNLM
OT  - COVID-19 vaccine
OT  - adverse event
OT  - harm
OT  - randomized controlled trial
OT  - systematic review
COIS- The authors declare no conflict of interest.
EDAT- 2022/02/27 06:00
MHDA- 2022/02/27 06:01
PMCR- 2022/02/17
CRDT- 2022/02/26 01:04
PHST- 2021/12/29 00:00 [received]
PHST- 2022/02/13 00:00 [revised]
PHST- 2022/02/15 00:00 [accepted]
PHST- 2022/02/26 01:04 [entrez]
PHST- 2022/02/27 06:00 [pubmed]
PHST- 2022/02/27 06:01 [medline]
PHST- 2022/02/17 00:00 [pmc-release]
AID - vaccines10020313 [pii]
AID - vaccines-10-00313 [pii]
AID - 10.3390/vaccines10020313 [doi]
PST - epublish
SO  - Vaccines (Basel). 2022 Feb 17;10(2):313. doi: 10.3390/vaccines10020313.