Optimization of a quantitative signal detection algorithm for spontaneous reports of adverse events post immunization

Pharmacoepidemiology and Drug Safety

Volumn 22, Issue 5, 2013, Pages 477-487

  Van Holle, Lionel ^a   Bauchau, Vincent ^a  

^a GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

Author keywords

Cut off; Disproportionality; Optimization; Pharmacoepidemiology; Pharmacovigilance; Signal detection; Stratification; Threshold; Vaccine safety

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B VACCINE; DIPHTHERIA PERTUSSIS TETANUS VACCINE; HEPATITIS A HEPATITIS B VACCINE; HEPATITIS A VACCINE; INFLUENZA VACCINE; RECOMBINANT HEPATITIS B VACCINE; ROTAVIRUS VACCINE; WART VIRUS VACCINE;

ADOLESCENT; ADULT; ALGORITHM; ARTICLE; CHILD; DIAGNOSTIC TEST ACCURACY STUDY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FEMALE; HUMAN; IMMUNIZATION; INFANT; MAJOR CLINICAL STUDY; MALE; MULTI ITEM GAMMA POISSON SCHRINKER; PREDICTIVE VALUE; PRESCHOOL CHILD; PRIORITY JOURNAL; SCHOOL CHILD; SENSITIVITY AND SPECIFICITY; SIGNAL DETECTION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; AGE FACTORS; ALGORITHMS; DATA MINING; DATABASES, FACTUAL; FEMALE; HUMANS; MALE; PREDICTIVE VALUE OF TESTS; SEX FACTORS; VACCINES;

EID: 84877606638     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3392     Document Type: Article

References (23)

1. Bate A. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol 1998; 54: 315-321.
2. Dumouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat 1999; 53: 177-190.
3. Evans S. Use of Proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001; 10: 483-486.
4. van Puijenbroek EP. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf 2002; 11: 3-10.
5. Almenoff JS. Novel statistical tools for monitoring the safety of marketed drugs. Clin Pharmacol Ther 2007; 82(2): 157-166.
6. Bate A, Evans SJW. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf 2009; 18: 427-436.
7. Dumouchel W. Empirical Bayes Screening for Multi-Item Associations. Proceedings of the conference on knowledge discovery and data; 2001 Aug 26-29; ACM Press: San Diego (CA); 67-76.
8. Szarfman A. Use of Screening Algorithms and Computer Systems to Efficiently Signal Higher-Than-Expected Combinations of Drugs and Events in the US FDA's Spontaneous Report Database. Drug Saf 2002; 25(6): 381-392.
9. Gould AL. Practical pharmacovigilance analysis strategies. Pharmacoepidemiol Drug Saf 2003; 12: 559-574.
10. Matsushita Y. Criteria revision and performance comparison of three methods of signal detection applied to the spontaneous reporting database of a pharmaceutical manufacturer. Drug Saf 2007; 30(8): 715-726.
11. Woo J. Effects of stratification on data mining in the US Vaccine Adverse Event Reporting System (VAERS). Drug Saf 2008; 31(8); 667-674.
12. Hopstadius J. Impact of Stratification on Adverse Drug Reaction Surveillance. Drug Saf 2008; 31(11): 1035-1048.
13. FDA. Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. FDACDER/CBER, Rockville; March 2005. http://www.fda.gov/ohrms/DOCKETS/ac/05/briefing/2005-4136b1_02_Good%20Pharmacovigilance%20Practices.pdf (accessed 11 June 2012).
14. Van Holle L. Using time-to-onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof of concept study. Pharmacoepidemiol Drug Saf 2012; 21: 603-610.
15. Simpson EH. The interpretation of interaction in contingency tables. J. Royal Statistical Soc 1951; B13(2): 238-241.
16. Berlin C. Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker. Pharmacoepidemiol Drug Saf 2012; 21: 622-630.
17. Pizzoglio V. Implementation of an automated signal detection method in the French pharmacovigilance database: a feasibility study. Eur J Clin Pharmacol 2012; 68: 793-799.
18. Ahmed I. Pharmacovigilance data mining with methods based on false discovery rates: a comparative simulation study. Clin Pharmacol Ther 2010; 88(4): 492-8. Nature Publishing Group.
19. Ahmed I. Early detection of pharmacovigilance signals with automated methods based on false discovery rates - a comparative study. Drug Saf 2012; 35(6): 495-506.
20. Hauben M. Application of an Empiric Bayesian Data Mining Algorithm to Reports of Pancreatitis Associated with Atypical Antipsychotics. Pharmacotherapy 2004; 24(9): 1122-1129.
21. Hochberg AM. An evaluation of three signal-detection algorithms using a highly inclusive reference event database. Drug Saf 2009; 32(6): 509-525.
22. Hochberg AM. Systematic investigation of time windows for adverse event data mining for recently approved drugs. J Clin Pharmacol 2009; 49(6): 626-633.
23. Alvarez Y. Validation of statistical signal detection procedures in Eudravigilance post-authorization data - A retrospective evaluation of the potential for earlier signalling. Drug Saf 2010; 33(6): 475-487.