Detection of Adverse Drug Reaction Signals in the Thai FDA Database: Comparison Between Reporting Odds Ratio and Bayesian Confidence Propagation Neural Network Methods

被引:4
|
作者
Bunchuailua, Waranee [1 ,2 ]
Zuckerman, Ilene H. [3 ]
Kulsomboon, Vithaya [4 ]
Suwankesawong, Wimon [5 ]
Singhasivanon, Pratap [2 ]
Kaewkungwal, Jaranit [2 ]
机构
[1] Silpakorn Univ, Dept Community Pharm, Fac Pharm, Muang 73000, Nakhon Pathom, Thailand
[2] Mahidol Univ, Fac Trop Med, Dept Trop Hyg, Bangkok, Thailand
[3] Univ Maryland, Sch Med, Dept Pharmaceut Hlth Serv Res, Baltimore, MD 21201 USA
[4] Chulalongkorn Univ, Dept Social & Adm Pharm, Fac Pharmaceut Sci, Bangkok, Thailand
[5] Thai Food & Drug Adm, Hlth Prod Vigilance Ctr, Nonthaburi, Thailand
来源
DRUG INFORMATION JOURNAL | 2010年 / 44卷 / 04期
关键词
Adverse drug reaction; Spontaneous reporting; Signal detection; ROR; BCPNN; ACTIVE ANTIRETROVIRAL THERAPY; VIRUS-INFECTED PATIENTS; DATA MINING APPROACH; LACTIC-ACIDOSIS; COMBINATION THERAPY; HYPERLACTATEMIA; DISPROPORTIONALITY; PHARMACOVIGILANCE; DISCONTINUATION; STRATIFICATION;
D O I
10.1177/009286151004400404
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
The study aimed to compare performance between the reporting odds ratio (ROR) and the Bayesian confidence propagation neural network (BCPNN) methods in identifying serious adverse drug reactions (ADRs) using the Thai FDA spontaneous database. The two methods were retrospectively applied to identify new, serious ADRs reported with antiretroviral therapy (ART) drugs using the data set between 1990 and 2006. We plotted the ROR and the information component against time to compare the differential timing of signal detection and the pattern of signaling over time between these methods. The ROR and the BCPNN methods identified the associations between ART drugs and serious ADRs at the same time. Both methods were similar in detecting the first signal of a potential ADR. However, the pattern of signaling seems relatively different with each method. Additional analyses of different drugs, ADRs, and databases will contribute to increase understanding of methods for post-marketing surveillance using spontaneous reporting system.
引用
收藏
页码:393 / 403
页数:11
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  • [1] Detection of Adverse Drug Reaction Signals in the Thai FDA Database: Comparison between Reporting Odds Ratio and Bayesian Confidence Propagation Neural Network Methods
    Waranee Bunchuailua
    Ilene H. Zuckerman
    Vithaya Kulsomboon
    Wimon Suwankesawong
    Pratap Singhasivanon
    Jaranit Kaewkungwal
    [J]. Drug information journal : DIJ / Drug Information Association, 2010, 44 (4): : 393 - 403
  • [2] Detection of Adverse Drug Reaction Signals in the Thai FDA Database: Comparison between Reporting Odds Ratio and Bayesian Confidence Propagation Neural Network Methods
    Bunchuailua, Waranee
    Zuckerman, Ilene H.
    Kulsomboon, Vithaya
    Suwankesawong, Wimon
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2009, 18 : S166 - S166
  • [3] A COMPARISON OF SIGNAL DETECTION PERFORMANCE BETWEEN REPORTING ODDS RATIO AND BAYESIAN CONFIDENCE PROPAGATION NEURAL NETWORK METHODS ON ADVERSE DRUG REACTION SPONTANEOUS REPORTING DATABASE OF THE THAI FDA
    Bunchuailua, W.
    Zuckerman, I
    Kulsomboon, V
    Suwankesawong, W.
    Singhasivanon, P.
    Kaewkungwal, J.
    [J]. VALUE IN HEALTH, 2010, 13 (07) : A508 - A508
  • [4] A Comparison of Methods for Signal Detection on Adverse Drug Reaction Spontaneous Reporting Database of the Thai FDA
    Bunchuailua, W.
    Zuckerman, I. H.
    Kulsomboon, V.
    Suwankesawong, W.
    Singhasivanon, P.
    Kaewkungwal, J.
    [J]. DRUG SAFETY, 2009, 32 (10) : 950 - 951
  • [5] An Assessment of Bayesian Confidence Propagation Neural Network Method for Adverse Drug Reaction Signal Generation in Presence of Reporting Bias
    Ghosh, P.
    Dewanji, A.
    [J]. DRUG SAFETY, 2011, 34 (10) : 913 - 914
  • [6] Extended likelihood ratio test-based methods for signal detection in a drug class with application to FDA's adverse event reporting system database
    Zhao, Yueqin
    Yi, Min
    Tiwari, Ram C.
    [J]. STATISTICAL METHODS IN MEDICAL RESEARCH, 2018, 27 (03) : 876 - 890
  • [7] Detection of Adverse Drug Reaction Signals Using an Electronic Health Records Database: Comparison of the Laboratory Extreme Abnormality Ratio (CLEAR) Algorithm
    Yoon, D.
    Park, M. Y.
    Choi, N. K.
    Park, B. J.
    Kim, J. H.
    Park, R. W.
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2012, 91 (03) : 467 - 474
  • [8] A comparison of measures of disproportionality for signal detection on adverse drug reaction spontaneous reporting database of Guangdong province in China
    Li, Chanjuan
    Xia, Jielai
    Deng, Jianxiong
    Jiang, Jing
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2008, 17 (06) : 593 - 600
  • [9] Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database
    Rolfes, Lean
    van Hunsel, Florence
    Caster, Ola
    Taavola, Henric
    Taxis, Katja
    van Puijenbroek, Eugene
    [J]. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2018, 84 (07) : 1514 - 1524
  • [10] COMPARISON OF DRUG SAFETY SIGNAL DETECTION BETWEEN SPONTANEOUS REPORTING DATABASES AND EU-ADR LONGITUDINAL DATABASE NETWORK
    Trifiro, G.
    Patadia, V.
    Schuemiel, M. J.
    Coloma, P.
    Gini, R.
    Herings, R.
    Mazzaglia, G.
    Picelli, G.
    Scotti, L.
    Peder, L.
    [J]. BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY, 2011, 109 : 84 - 84