PMID- 28155198
OWN - NLM
STAT- MEDLINE
DCOM- 20171215
LR  - 20191210
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 40
IP  - 5
DP  - 2017 May
TI  - Validation of New Signal Detection Methods for Web Query Log Data Compared to 
      Signal Detection Algorithms Used With FAERS.
PG  - 399-408
LID - 10.1007/s40264-017-0507-4 [doi]
AB  - INTRODUCTION: Post-marketing drug surveillance is largely based on signals found 
      in spontaneous reports from patients and healthcare providers. Rare adverse drug 
      reactions and adverse events (AEs) that may develop after long-term exposure to a 
      drug or from drug interactions may be missed. The US FDA and others have proposed 
      that web-based data could be mined as a resource to detect latent signals 
      associated with adverse drug reactions. METHODS: Recently, a web-based search 
      query method called a query log reaction score (QLRS) was developed to detect 
      whether AEs associated with certain drugs could be found from search engine query 
      data. In this study, we compare the performance of two other algorithms, the 
      proportional query ratio (PQR) and the proportional query rate ratio (Q-PRR) 
      against that of two reference signal-detection algorithms (SDAs) commonly used 
      with the FDA AE Reporting System (FAERS) database. RESULTS: In summary, the web 
      query methods have moderate sensitivity (80%) in detecting signals in web query 
      data compared with reference SDAs in FAERS when the web query data are filtered, 
      but the query metrics generate many false-positives and have low specificity 
      compared with reference SDAs in FAERS. CONCLUSION: Future research is needed to 
      find better refinements of query data and/or the metrics to improve the 
      specificity of these web query log algorithms.
FAU - Colilla, Susan
AU  - Colilla S
AD  - Pharmacoepidemiology, Global Safety Sciences, Sanofi, 55 Corporate Dr., 
      Bridgewater, NJ, 08807, USA. susan.colilla@sanofi.com.
FAU - Tov, Elad Yom
AU  - Tov EY
AD  - Microsoft Research, 13 Shenkar St., 4672513, Herzeliya, Israel.
FAU - Zhang, Ling
AU  - Zhang L
AD  - Pharmacoepidemiology, Global Safety Sciences, Sanofi, 55 Corporate Dr., 
      Bridgewater, NJ, 08807, USA.
FAU - Kurzinger, Marie-Laure
AU  - Kurzinger ML
AD  - Pharmacoepidemiology & Signal Detection, Global Safety Sciences, Sanofi, 1 Avenue 
      Pierre Brossolette, 91385, Chilly-Mazarin, France.
FAU - Tcherny-Lessenot, Stephanie
AU  - Tcherny-Lessenot S
AD  - Pharmacoepidemiology & Signal Detection, Global Safety Sciences, Sanofi, 1 Avenue 
      Pierre Brossolette, 91385, Chilly-Mazarin, France.
FAU - Penfornis, Catherine
AU  - Penfornis C
AD  - Pharmacoepidemiology & Signal Detection, Global Safety Sciences, Sanofi, 1 Avenue 
      Pierre Brossolette, 91385, Chilly-Mazarin, France.
FAU - Jen, Shang
AU  - Jen S
AD  - Baxalta US, Inc., Global Drug Safety, 650 E. Kendall St., Cambridge, MA, 02142, 
      USA.
FAU - Gonzalez, Danny S
AU  - Gonzalez DS
AD  - US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 
      20993, USA.
FAU - Caubel, Patrick
AU  - Caubel P
AD  - Pfizer, Worldwide Safety, 235 E. 42nd St., New York, NY, 10017, USA.
FAU - Welsh, Susan
AU  - Welsh S
AD  - Pharmacoepidemiology, Global Safety Sciences, Sanofi, 55 Corporate Dr., 
      Bridgewater, NJ, 08807, USA.
FAU - Juhaeri, Juhaeri
AU  - Juhaeri J
AD  - Pharmacoepidemiology, Global Safety Sciences, Sanofi, 55 Corporate Dr., 
      Bridgewater, NJ, 08807, USA.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Validation Study
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - *Algorithms
MH  - Data Mining/methods
MH  - Databases, Factual
MH  - Drug Interactions
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Humans
MH  - Internet
MH  - Product Surveillance, Postmarketing/*methods
MH  - Time Factors
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2017/02/06 06:00
MHDA- 2017/12/16 06:00
CRDT- 2017/02/04 06:00
PHST- 2017/02/06 06:00 [pubmed]
PHST- 2017/12/16 06:00 [medline]
PHST- 2017/02/04 06:00 [entrez]
AID - 10.1007/s40264-017-0507-4 [pii]
AID - 10.1007/s40264-017-0507-4 [doi]
PST - ppublish
SO  - Drug Saf. 2017 May;40(5):399-408. doi: 10.1007/s40264-017-0507-4.