PMID- 26060294
OWN - NLM
STAT- MEDLINE
DCOM- 20160606
LR  - 20200225
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Print)
IS  - 1058-4838 (Linking)
VI  - 61
IP  - 6
DP  - 2015 Sep 15
TI  - Advanced Clinical Decision Support for Vaccine Adverse Event Detection and 
      Reporting.
PG  - 864-70
LID - 10.1093/cid/civ430 [doi]
AB  - BACKGROUND: Reporting of adverse events (AEs) following vaccination can help 
      identify rare or unexpected complications of immunizations and aid in 
      characterizing potential vaccine safety signals. We developed an open-source, 
      generalizable clinical decision support system called Electronic Support for 
      Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist 
      clinicians with AE detection and reporting. METHODS: ESP-VAERS monitors patients' 
      electronic health records for new diagnoses, changes in laboratory values, and 
      new allergies following vaccinations. When suggestive events are found, ESP-VAERS 
      sends the patient's clinician a secure electronic message with an invitation to 
      affirm or refute the message, add comments, and submit an automated, prepopulated 
      electronic report to VAERS. High-probability AEs are reported automatically if 
      the clinician does not respond. We implemented ESP-VAERS in December 2012 
      throughout the MetroHealth System, an integrated healthcare system in Ohio. We 
      queried the VAERS database to determine MetroHealth's baseline reporting rates 
      from January 2009 to March 2012 and then assessed changes in reporting rates with 
      ESP-VAERS. RESULTS: In the 8 months following implementation, 91 622 vaccinations 
      were given. ESP-VAERS sent 1385 messages to responsible clinicians describing 
      potential AEs. Clinicians opened 1304 (94.2%) messages, responded to 209 (15.1%), 
      and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs 
      were sent automatically. Reported events included seizure, pleural effusion, and 
      lymphocytopenia. The odds of a VAERS report submission during the implementation 
      period were 30.2 (95% confidence interval, 9.52-95.5) times greater than the odds 
      during the comparable preimplementation period. CONCLUSIONS: An open-source, 
      electronic health record-based clinical decision support system can increase AE 
      detection and reporting rates in VAERS.
CI  - (c) The Author 2015. Published by Oxford University Press on behalf of the 
      Infectious Diseases Society of America. All rights reserved. For Permissions, 
      please e-mail: journals.permissions@oup.com.
FAU - Baker, Meghan A
AU  - Baker MA
AD  - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim 
      Health Care Institute Division of Infectious Diseases, Department of Medicine, 
      Brigham and Women's Hospital, Boston, Massachusetts.
FAU - Kaelber, David C
AU  - Kaelber DC
AD  - Center for Clinical Informatics Research and Education, MetroHealth System School 
      of Medicine, Case Western Reserve University, Cleveland, Ohio.
FAU - Bar-Shain, David S
AU  - Bar-Shain DS
AD  - Center for Clinical Informatics Research and Education, MetroHealth System School 
      of Medicine, Case Western Reserve University, Cleveland, Ohio.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for 
      Disease Control and Prevention, Atlanta, Georgia.
FAU - Zambarano, Bob
AU  - Zambarano B
AD  - Commonwealth Informatics Inc, Waltham, Massachusetts.
FAU - Mazza, Megan
AU  - Mazza M
AD  - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim 
      Health Care Institute.
FAU - Garcia, Crystal
AU  - Garcia C
AD  - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim 
      Health Care Institute.
FAU - Henry, Adam
AU  - Henry A
AD  - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim 
      Health Care Institute.
FAU - Platt, Richard
AU  - Platt R
AD  - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim 
      Health Care Institute.
FAU - Klompas, Michael
AU  - Klompas M
AD  - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim 
      Health Care Institute Division of Infectious Diseases, Department of Medicine, 
      Brigham and Women's Hospital, Boston, Massachusetts.
LA  - eng
GR  - CC999999/Intramural CDC HHS/United States
GR  - 200-2011-42037/PHS HHS/United States
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20150609
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Aged, 80 and over
MH  - Child
MH  - Child, Preschool
MH  - *Decision Support Systems, Clinical
MH  - Drug-Related Side Effects and Adverse Reactions/*diagnosis
MH  - Female
MH  - Health Services Research
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - Middle Aged
MH  - Ohio
MH  - *Risk Management
MH  - Vaccines/administration & dosage/*adverse effects
MH  - Young Adult
PMC - PMC6642796
MID - NIHMS1025268
OTO - NOTNLM
OT  - adverse event
OT  - adverse reaction
OT  - immunization
OT  - reporting
OT  - vaccine
EDAT- 2015/06/11 06:00
MHDA- 2016/06/09 06:00
PMCR- 2019/07/21
CRDT- 2015/06/11 06:00
PHST- 2015/01/24 00:00 [received]
PHST- 2015/05/31 00:00 [accepted]
PHST- 2015/06/11 06:00 [entrez]
PHST- 2015/06/11 06:00 [pubmed]
PHST- 2016/06/09 06:00 [medline]
PHST- 2019/07/21 00:00 [pmc-release]
AID - civ430 [pii]
AID - 10.1093/cid/civ430 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2015 Sep 15;61(6):864-70. doi: 10.1093/cid/civ430. Epub 2015 Jun 
      9.