PMID- 19148879
OWN - NLM
STAT- MEDLINE
DCOM- 20090427
LR  - 20220309
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 18
IP  - 3
DP  - 2009 Mar
TI  - Early adverse drug event signal detection within population-based health networks 
      using sequential methods: key methodologic considerations.
PG  - 226-34
LID - 10.1002/pds.1706 [doi]
AB  - PURPOSE: Active surveillance of population-based health networks may improve the 
      timeliness of detection of adverse events (AEs). Our objective was to expand our 
      previous signal detection work by investigating the effect on signal detection of 
      alternative study specifications. METHODS: We compared the signal detection 
      performance under various study specifications using historical data from nine 
      health plans involved in the HMO Research Network's Center for Education and 
      Research on Therapeutics (CERT). Five drug-event pairs representing generally 
      accepted associations with an AE and two pairs representing "negative controls" 
      were analyzed. Alternative study specifications related to the definition of 
      incident users and incident AEs were assessed and compared to our previous 
      findings. RESULTS: Relaxing the incident AE exclusion criteria by (1) including 
      members with prior outpatient diagnoses of interest and (2) halving (to 90 days) 
      the time window specified to define incident exposure and diagnoses increased the 
      number of members under surveillance and as a consequence increased the number of 
      exposed days and diagnoses by about 10-20%. The alternative specifications tend 
      to result in earlier signal detection by 10-16 months, a likely consequence of 
      more exposures and events entering the analysis. CONCLUSIONS: This paper provides 
      additional preliminary information related to conducting prospective safety 
      monitoring using health plan data and sequential analytic methods. Our findings 
      support continued investigation of using health plan data and sequential analytic 
      methods as a potentially important contribution to active drug safety 
      surveillance.
CI  - (c) 2009 John Wiley & Sons, Ltd.
FAU - Brown, Jeffrey S
AU  - Brown JS
AD  - Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard 
      Pilgrim Health Care, Boston, MA 02215, USA. jeff_brown@harvardpilgrim.org
FAU - Kulldorff, Martin
AU  - Kulldorff M
FAU - Petronis, Kenneth R
AU  - Petronis KR
FAU - Reynolds, Robert
AU  - Reynolds R
FAU - Chan, K Arnold
AU  - Chan KA
FAU - Davis, Robert L
AU  - Davis RL
FAU - Graham, David
AU  - Graham D
FAU - Andrade, Susan E
AU  - Andrade SE
FAU - Raebel, Marsha A
AU  - Raebel MA
FAU - Herrinton, Lisa
AU  - Herrinton L
FAU - Roblin, Douglas
AU  - Roblin D
FAU - Boudreau, Denise
AU  - Boudreau D
FAU - Smith, David
AU  - Smith D
FAU - Gurwitz, Jerry H
AU  - Gurwitz JH
FAU - Gunter, Margaret J
AU  - Gunter MJ
FAU - Platt, Richard
AU  - Platt R
LA  - eng
GR  - 2U18HS010391/HS/AHRQ HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
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  - Competitive Medical Plans/organization & administration/statistics & numerical 
      data
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Health Maintenance Organizations/organization & administration/statistics & 
      numerical data
MH  - Humans
MH  - Insurance Claim Review/statistics & numerical data
MH  - Medical Records Systems, Computerized/statistics & numerical data
MH  - Population Surveillance/*methods
MH  - Product Surveillance, Postmarketing/*methods/statistics & numerical data
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
EDAT- 2009/01/17 09:00
MHDA- 2009/04/28 09:00
CRDT- 2009/01/17 09:00
PHST- 2009/01/17 09:00 [entrez]
PHST- 2009/01/17 09:00 [pubmed]
PHST- 2009/04/28 09:00 [medline]
AID - 10.1002/pds.1706 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2009 Mar;18(3):226-34. doi: 10.1002/pds.1706.