PMID- 31189217
OWN - NLM
STAT- MEDLINE
DCOM- 20200629
LR  - 20210109
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 28
IP  - 10
DP  - 2019 Oct
TI  - Time to onset in statistical signal detection revisited: A follow-up study in 
      long-term onset adverse drug reactions.
PG  - 1283-1289
LID - 10.1002/pds.4790 [doi]
AB  - PURPOSE: In a previous study, we developed a signal detection method using the 
      time to onset (TTO) of adverse drug reactions (ADRs). The aim of the current 
      study was to investigate this method in a subset of ADRs with a longer TTO and to 
      compare its performance with disproportionality analysis. METHODS: Using The 
      Netherlands's spontaneous reporting database, TTO distributions for drug-ADR 
      associations with a median TTO of 7 days or more were compared with other drugs 
      with the same ADR using the two-sample Anderson-Darling (AD) test. Presence in 
      the Summary of Product Characteristics (SPC) was used as the gold standard for 
      identification of a true ADR. Twelve combinations with different values for the 
      number of reports and median TTO were tested. Performance in terms of sensitivity 
      and positive predictive value (PPV) was compared with disproportionality 
      analysis. A sensitivity analysis was performed to compare the results with those 
      from the previous study. RESULTS: A total of 38 017 case reports, containing 
      32 478 unique drug-ADR associations. Sensitivity was lower for the TTO method 
      (range 0.08-0.34) compared with disproportionality analysis (range 0.60-0.87), 
      whereas PPV was similar for both methods (range 0.93-1.0). The results from the 
      sensitivity analysis were similar to the original analysis. CONCLUSIONS: Because 
      of its low sensitivity, the developed TTO method cannot replace 
      disproportionality analysis as a signal detection tool. It may be useful in 
      combination with other methods.
CI  - (c) 2019 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & 
      Sons Ltd.
FAU - Scholl, Joep H G
AU  - Scholl JHG
AUID- ORCID: 0000-0002-9222-5965
AD  - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
AD  - Department of PharmacoTherapy - Epidemiology & -Economics, University of 
      Groningen, Groningen, The Netherlands.
FAU - van Hunsel, Florence P A M
AU  - van Hunsel FPAM
AUID- ORCID: 0000-0001-8965-3224
AD  - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
FAU - Hak, Eelko
AU  - Hak E
AUID- ORCID: 0000-0003-0849-7210
AD  - Department of PharmacoTherapy - Epidemiology & -Economics, University of 
      Groningen, Groningen, The Netherlands.
FAU - van Puijenbroek, Eugene P
AU  - van Puijenbroek EP
AUID- ORCID: 0000-0002-2236-1398
AD  - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
AD  - Department of PharmacoTherapy - Epidemiology & -Economics, University of 
      Groningen, Groningen, The Netherlands.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20190612
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  - Databases, Factual/statistics & numerical data
MH  - Drug-Related Side Effects and Adverse Reactions/diagnosis/*epidemiology/etiology
MH  - Feasibility Studies
MH  - Follow-Up Studies
MH  - Humans
MH  - *Models, Statistical
MH  - Netherlands/epidemiology
MH  - *Pharmacovigilance
MH  - Predictive Value of Tests
MH  - Sensitivity and Specificity
MH  - Time Factors
PMC - PMC6852418
OTO - NOTNLM
OT  - ADR
OT  - latency
OT  - pharmacoepidemiology
OT  - pharmacovigilance
OT  - signal detection
OT  - time to onset
COIS- The authors declare no conflict of interest.
EDAT- 2019/06/13 06:00
MHDA- 2020/07/01 06:00
PMCR- 2019/11/13
CRDT- 2019/06/13 06:00
PHST- 2018/08/20 00:00 [received]
PHST- 2019/03/19 00:00 [revised]
PHST- 2019/03/26 00:00 [accepted]
PHST- 2019/06/13 06:00 [pubmed]
PHST- 2020/07/01 06:00 [medline]
PHST- 2019/06/13 06:00 [entrez]
PHST- 2019/11/13 00:00 [pmc-release]
AID - PDS4790 [pii]
AID - 10.1002/pds.4790 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2019 Oct;28(10):1283-1289. doi: 10.1002/pds.4790. 
      Epub 2019 Jun 12.