File Download

There are no files associated with this item.

  Links for fulltext
     (May Require Subscription)
Supplementary

Article: Comparison of sensitivity and timing of early signal detection of four frequently used signal detection methods: An empirical study based on the US FDA adverse event reporting system database

TitleComparison of sensitivity and timing of early signal detection of four frequently used signal detection methods: An empirical study based on the US FDA adverse event reporting system database
Authors
KeywordsAdverse Reaction Monitoring
Pharmaceutical Industry
Pharmacovigilance
Postmarketing Surveillance
Issue Date2008
Citation
Pharmaceutical Medicine, 2008, v. 22 n. 6, p. 359-365 How to Cite?
AbstractBackground: There are limited published comparative data regarding the sensitivity and timing of early signal detection with commonly used signal detection methods (SDMs), including the reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC) and gamma Poisson shrinker (GPS). Objective: To examine the sensitivity and timing of early signal detection across four SDMs using the Adverse Events Reporting System (AERS) database of the US Food and Drug Administration. Methods: The four SDMs were applied to retrospectively detect ten confirmed drug-event combinations (DECs). The sensitivity to detect adverse events was defined as the percentage of DECs detected by the respective SDMs as positive signals. The timing of early signal detection was measured by comparing the index date of withdrawal (IDW), defined as the date on which the drug was removed from the market, with the index date of detection (IDD), defined as a date on which the signal was significantly detected by the SDM. Results: The estimated sensitivity was 100% for ROR, 90% for PRR and IC and 70% for GPS. The sensitivity increased with increasing numbers of reports per DEC. Compared with the IDW, the signals were detected on average 10 quarters earlier by ROR, 9 quarters earlier by PRR, 9.9 quarters earlier by the IC and 4.7 quarters earlier by GPS. Conclusions: The sensitivity and timing of early signal detection varies across the four SDMs. Numerically, the ROR showed better performance in sensitivity and early signal detection based on ten selected DECs. Given the limited number and range of DECs selected in this study and the unavailability of specificity assessment, further large-scale prospective studies are warranted in order to provide better guidance on the selection of SDMs. © 2008 Adis Data Information BV. All rights reserved.
Persistent Identifierhttp://hdl.handle.net/10722/92100
ISSN
2015 SCImago Journal Rankings: 0.224
References

 

DC FieldValueLanguage
dc.contributor.authorChen, Yen_HK
dc.contributor.authorGuo, JJen_HK
dc.contributor.authorSteinbuch, Men_HK
dc.contributor.authorLin, Xen_HK
dc.contributor.authorBuncher, CRen_HK
dc.contributor.authorPatel, NCen_HK
dc.date.accessioned2010-09-17T10:36:05Z-
dc.date.available2010-09-17T10:36:05Z-
dc.date.issued2008en_HK
dc.identifier.citationPharmaceutical Medicine, 2008, v. 22 n. 6, p. 359-365en_HK
dc.identifier.issn1178-2595en_HK
dc.identifier.urihttp://hdl.handle.net/10722/92100-
dc.description.abstractBackground: There are limited published comparative data regarding the sensitivity and timing of early signal detection with commonly used signal detection methods (SDMs), including the reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC) and gamma Poisson shrinker (GPS). Objective: To examine the sensitivity and timing of early signal detection across four SDMs using the Adverse Events Reporting System (AERS) database of the US Food and Drug Administration. Methods: The four SDMs were applied to retrospectively detect ten confirmed drug-event combinations (DECs). The sensitivity to detect adverse events was defined as the percentage of DECs detected by the respective SDMs as positive signals. The timing of early signal detection was measured by comparing the index date of withdrawal (IDW), defined as the date on which the drug was removed from the market, with the index date of detection (IDD), defined as a date on which the signal was significantly detected by the SDM. Results: The estimated sensitivity was 100% for ROR, 90% for PRR and IC and 70% for GPS. The sensitivity increased with increasing numbers of reports per DEC. Compared with the IDW, the signals were detected on average 10 quarters earlier by ROR, 9 quarters earlier by PRR, 9.9 quarters earlier by the IC and 4.7 quarters earlier by GPS. Conclusions: The sensitivity and timing of early signal detection varies across the four SDMs. Numerically, the ROR showed better performance in sensitivity and early signal detection based on ten selected DECs. Given the limited number and range of DECs selected in this study and the unavailability of specificity assessment, further large-scale prospective studies are warranted in order to provide better guidance on the selection of SDMs. © 2008 Adis Data Information BV. All rights reserved.en_HK
dc.languageengen_HK
dc.relation.ispartofPharmaceutical Medicineen_HK
dc.subjectAdverse Reaction Monitoringen_HK
dc.subjectPharmaceutical Industryen_HK
dc.subjectPharmacovigilanceen_HK
dc.subjectPostmarketing Surveillanceen_HK
dc.titleComparison of sensitivity and timing of early signal detection of four frequently used signal detection methods: An empirical study based on the US FDA adverse event reporting system databaseen_HK
dc.typeArticleen_HK
dc.identifier.emailChen, Y:ychenc@hkucc.hku.hken_HK
dc.identifier.authorityChen, Y=rp1318en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.2165/1317117-200822060-00006en_HK
dc.identifier.scopuseid_2-s2.0-69549096044en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-69549096044&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume22en_HK
dc.identifier.issue6en_HK
dc.identifier.spage359en_HK
dc.identifier.epage365en_HK
dc.identifier.eissn1179-1993-

Export via OAI-PMH Interface in XML Formats


OR


Export to Other Non-XML Formats