PMID- 37264496
OWN - NLM
STAT- MEDLINE
DCOM- 20230915
LR  - 20230929
IS  - 1365-2125 (Electronic)
IS  - 0306-5251 (Linking)
VI  - 89
IP  - 10
DP  - 2023 Oct
TI  - Drug safety signal detection in a regional healthcare database using the 
      tree-based scan statistic and comparison to 3 other mining methods.
PG  - 3037-3045
LID - 10.1111/bcp.15810 [doi]
AB  - AIMS: To evaluate and compare the relative performance of the tree-based scan 
      statistic (TreeScan) with the crude cohort study, Bayesian confidence propagation 
      neural network (BCPNN) and Gamma Poisson Shrinker (GPS) in detecting 
      statin-related adverse events (AEs) in an electronic healthcare database. 
      METHODS: Data from a Chinese healthcare database from 2010 to 2016 were 
      evaluated. We identified statin users based on prescription information in their 
      out-/in-patient records, and AEs were defined according to the ICD-10 codes in 
      patients' diagnosis records. TreeScan was applied to detect AE signals related to 
      statin use and was compared with 3 other methods based on sensitivity, 
      specificity, positive predictive value, negative predictive value, accuracy, the 
      Youden index, area under the precision-recall curve and the area under the 
      receiver operating characteristic curve. RESULTS: A total of 224 187 patients 
      were enrolled and divided into 85 758 statin users and 138 429 nonusers. TreeScan 
      generated 29 positive signals, of which 9 were known AEs. The sensitivities of 
      TreeScan, BCPNN and GPS were all 69.2%, which was higher than that of the crude 
      cohort study (46%). The specificity (82.3%), positive predictive value (31.0%), 
      negative predictive value (95.9%), accuracy (81.0%), Youden index (51.5%) and 
      area under the receiver operating characteristic curve (75.8%) of TreeScan were 
      the highest among the 4 methods. CONCLUSION: TreeScan outperformed the crude 
      cohort, BCPNN and GPS in detecting statin-related AEs in an electronic healthcare 
      database. Therefore, it can be used as a complementary tool for other signal 
      detection methods in drug safety surveillance.
CI  - (c) 2023 British Pharmacological Society.
FAU - Hailong, Li
AU  - Hailong L
AUID- ORCID: 0000-0001-6481-401X
AD  - Department of Pharmacy, West China Second University Hospital, Sichuan 
      University, Chengdu, China.
AD  - Evidence-Based Pharmacy Center, West, Second University Hospital, Sichuan 
      University, Chengdu, China.
AD  - Key Laboratory of Birth Defects and Related Diseases of Women and Children, 
      Ministry of Education, Sichuan University, Chengdu, China.
FAU - Houyu, Zhao
AU  - Houyu Z
AD  - Key Laboratory of Epidemiology of Major Diseases, Ministry of Education, Peking 
      University, Beijing, China.
AD  - Department of Epidemiology and Biostatistics, School of Public Health, Peking 
      University, Beijing, China.
FAU - Hongbo, Lin
AU  - Hongbo L
AD  - Yinzhou District Center for Disease Control and Prevention, Ningbo, China.
FAU - Peng, Shen
AU  - Peng S
AD  - Yinzhou District Center for Disease Control and Prevention, Ningbo, China.
FAU - Siyan, Zhan
AU  - Siyan Z
AD  - Key Laboratory of Epidemiology of Major Diseases, Ministry of Education, Peking 
      University, Beijing, China.
AD  - Department of Epidemiology and Biostatistics, School of Public Health, Peking 
      University, Beijing, China.
AD  - Research Center of Clinical Epidemiology, Peking University Third Hospital, 
      Beijing, China.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230615
PL  - England
TA  - Br J Clin Pharmacol
JT  - British journal of clinical pharmacology
JID - 7503323
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
SB  - IM
MH  - Humans
MH  - *Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects
MH  - Bayes Theorem
MH  - Cohort Studies
MH  - Databases, Factual
MH  - Delivery of Health Care
MH  - Adverse Drug Reaction Reporting Systems
OTO - NOTNLM
OT  - active surveillance
OT  - adverse events
OT  - drug safety
OT  - signal detection
OT  - statin
OT  - tree-based scan statistic
EDAT- 2023/06/02 01:07
MHDA- 2023/09/15 06:42
CRDT- 2023/06/01 23:52
PHST- 2023/05/03 00:00 [revised]
PHST- 2022/11/23 00:00 [received]
PHST- 2023/05/28 00:00 [accepted]
PHST- 2023/09/15 06:42 [medline]
PHST- 2023/06/02 01:07 [pubmed]
PHST- 2023/06/01 23:52 [entrez]
AID - 10.1111/bcp.15810 [doi]
PST - ppublish
SO  - Br J Clin Pharmacol. 2023 Oct;89(10):3037-3045. doi: 10.1111/bcp.15810. Epub 2023 
      Jun 15.