PMID- 32456068
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240329
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 8
IP  - 2
DP  - 2020 May 22
TI  - Safety Surveillance of Pneumococcal Vaccine Using Three Algorithms: 
      Disproportionality Methods, Empirical Bayes Geometric Mean, and Tree-Based Scan 
      Statistic.
LID - 10.3390/vaccines8020242 [doi]
LID - 242
AB  - Introduction: Diverse algorithms for signal detection exist. However, 
      inconsistent results are often encountered among the algorithms due to different 
      levels of specificity used in defining the adverse events (AEs) and signal 
      threshold. We aimed to explore potential safety signals for two pneumococcal 
      vaccines in a spontaneous reporting database and compare the results and 
      performances among the algorithms. Methods: Safety surveillance was conducted 
      using the Korea national spontaneous reporting database from 1988 to 2017. Safety 
      signals for pneumococcal vaccine and its subtypes were detected using the 
      following the algorithms: disproportionality methods comprising of proportional 
      reporting ratio (PRR), reporting odds ratio (ROR), and information component 
      (IC); empirical Bayes geometric mean (EBGM); and tree-based scan statistics 
      (TSS). Moreover, the performances of these algorithms were measured by comparing 
      detected signals with the known AEs or pneumococcal vaccines (reference 
      standard). Results: Among 10,380 vaccine-related AEs, 1135 reports and 101 AE 
      terms were reported following pneumococcal vaccine. IC generated the most safety 
      signals for pneumococcal vaccine (40/101), followed by PRR and ROR (19/101 each), 
      TSS (15/101), and EBGM (1/101). Similar results were observed for its subtypes. 
      Cellulitis was the only AE detected by all algorithms for pneumococcal vaccine. 
      TSS showed the best balance in the performance: the highest in accuracy, negative 
      predictive value, and area under the curve (70.3%, 67.4%, and 64.2%). Conclusion: 
      Discrepancy in the number of detected signals was observed between algorithms. 
      EBGM and TSS calibrated noise better than disproportionality methods, and TSS 
      showed balanced performance. Nonetheless, these results should be interpreted 
      with caution due to a lack of a gold standard for signal detection.
FAU - Lee, Hyesung
AU  - Lee H
AD  - School of Pharmacy, Sungkyunkwan University, Suwon 16419, Korea.
FAU - Kim, Ju Hwan
AU  - Kim JH
AD  - School of Pharmacy, Sungkyunkwan University, Suwon 16419, Korea.
FAU - Choe, Young June
AU  - Choe YJ
AD  - College of Medicine, Hallym University, Chuncheon 24252, Korea.
FAU - Shin, Ju-Young
AU  - Shin JY
AD  - School of Pharmacy, Sungkyunkwan University, Suwon 16419, Korea.
AD  - Samsung Advanced Institute for Health Sciences and Technology (SAIHST), 
      Sungkyunkwan University, Seoul 06355, Korea.
LA  - eng
GR  - HG18C0068/the Goverment-wide R&D Fund for Infectious Disease Research (GFID)/
PT  - Journal Article
DEP - 20200522
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC7349998
OTO - NOTNLM
OT  - empirical Bayes geometric mean
OT  - pneumococcal vaccine
OT  - quantitative signal detection
OT  - tree-based scan statistics
COIS- Shin reported receiving grants from the Ministry of Food and Drug Safety, the 
      Ministry of Health and welfare, the National Research Foundation of Korea, and 
      Government-wide R&D Fund for infectious disease research. No other disclosures 
      were reported.
EDAT- 2020/05/28 06:00
MHDA- 2020/05/28 06:01
PMCR- 2020/05/22
CRDT- 2020/05/28 06:00
PHST- 2020/04/21 00:00 [received]
PHST- 2020/05/14 00:00 [revised]
PHST- 2020/05/19 00:00 [accepted]
PHST- 2020/05/28 06:00 [entrez]
PHST- 2020/05/28 06:00 [pubmed]
PHST- 2020/05/28 06:01 [medline]
PHST- 2020/05/22 00:00 [pmc-release]
AID - vaccines8020242 [pii]
AID - vaccines-08-00242 [pii]
AID - 10.3390/vaccines8020242 [doi]
PST - epublish
SO  - Vaccines (Basel). 2020 May 22;8(2):242. doi: 10.3390/vaccines8020242.