PMID- 24596340
OWN - NLM
STAT- MEDLINE
DCOM- 20150511
LR  - 20220330
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 23
IP  - 9
DP  - 2014 Sep
TI  - A detection algorithm for drug-induced liver injury in medical information 
      databases using the Japanese diagnostic scale and its comparison with the Council 
      for International Organizations of Medical Sciences/the Roussel Uclaf Causality 
      Assessment Method scale.
PG  - 984-8
LID - 10.1002/pds.3603 [doi]
AB  - PURPOSE: Drug-induced liver injury (DILI) is one of the primary targets for 
      pharmacovigilance using medical information databases (MIDs). Because of 
      diagnostic complexity, a standardized method for identifying DILI using MIDs has 
      not yet been established. We applied the Digestive Disease Week Japan 2004 
      (DDW-J) scale, a Japanese clinical diagnostic criteria for DILI, to a DILI 
      detection algorithm, and compared it with the Council for International 
      Organizations of Medical Sciences/the Roussel Uclaf Causality Assessment Method 
      (CIOMS/RUCAM) scale to confirm its consistency. Characteristics of DILI cases 
      identified by the DDW-J algorithm were examined in two Japanese MIDs. METHODS: 
      Using an MID from the Hamamatsu University Hospital, we constructed a DILI 
      detection algorithm on the basis of the DDW-J scale. We then compared the 
      findings between the DDW-J and CIOMS/RUCAM scales. We examined the 
      characteristics of DILI after antibiotic treatment in the Hamamatsu population 
      and a second population that included data from 124 hospitals, which was derived 
      from an MID from the Medical Data Vision Co., Ltd. We performed a multivariate 
      logistic regression analysis to assess the possible DILI risk factors. RESULTS: 
      The concordance rate was 79.4% between DILI patients identified by the DDW-J and 
      CIOMS/RUCAM; the Spearman rank correlation coefficient was 0.952 (P < 0.0001). 
      Men showed a significantly higher risk for DILI after antibiotic treatments in 
      both MID populations. CONCLUSIONS: The DDW-J and CIOMS/RUCAM algorithms were 
      equivalent for identifying the DILI cases, confirming the utility of our DILI 
      detection method using MIDs. This study provides evidence supporting the use of 
      MID analyses to improve pharmacovigilance.
CI  - Copyright (c) 2014 John Wiley & Sons, Ltd.
FAU - Hanatani, Tadaaki
AU  - Hanatani T
AD  - Division of Medicinal Safety Science, National Institute of Health Sciences, 
      Tokyo, Japan; Department of Regulatory Science, Graduate School of Pharmaceutical 
      Sciences, Nagoya City University, Aichi, Japan.
FAU - Sai, Kimie
AU  - Sai K
FAU - Tohkin, Masahiro
AU  - Tohkin M
FAU - Segawa, Katsunori
AU  - Segawa K
FAU - Kimura, Michio
AU  - Kimura M
FAU - Hori, Katsuhito
AU  - Hori K
FAU - Kawakami, Junichi
AU  - Kawakami J
FAU - Saito, Yoshiro
AU  - Saito Y
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20140305
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/statistics & numerical data
MH  - *Algorithms
MH  - Chemical and Drug Induced Liver Injury/*diagnosis/epidemiology/etiology
MH  - Databases, Factual/*statistics & numerical data
MH  - Female
MH  - Humans
MH  - Japan
MH  - Logistic Models
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Pharmacovigilance
MH  - Risk Factors
MH  - Statistics, Nonparametric
OTO - NOTNLM
OT  - DDW-J
OT  - antibiotics
OT  - drug-induced liver injury
OT  - medical information database
OT  - pharmacoepidemiology
OT  - pharmacovigilance
EDAT- 2014/03/07 06:00
MHDA- 2015/05/12 06:00
CRDT- 2014/03/06 06:00
PHST- 2013/07/31 00:00 [received]
PHST- 2014/01/20 00:00 [revised]
PHST- 2014/01/29 00:00 [accepted]
PHST- 2014/03/06 06:00 [entrez]
PHST- 2014/03/07 06:00 [pubmed]
PHST- 2015/05/12 06:00 [medline]
AID - 10.1002/pds.3603 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2014 Sep;23(9):984-8. doi: 10.1002/pds.3603. Epub 
      2014 Mar 5.