PMID- 22084201
OWN - NLM
STAT- MEDLINE
DCOM- 20120301
LR  - 20211021
IS  - 1527-974X (Electronic)
IS  - 1067-5027 (Print)
IS  - 1067-5027 (Linking)
VI  - 19
IP  - 1
DP  - 2012 Jan-Feb
TI  - Improving patient safety via automated laboratory-based adverse event grading.
PG  - 111-5
LID - 10.1136/amiajnl-2011-000513 [doi]
AB  - The identification and grading of adverse events (AEs) during the conduct of 
      clinical trials is a labor-intensive and error-prone process. This paper 
      describes and evaluates a software tool developed by City of Hope to automate 
      complex algorithms to assess laboratory results and identify and grade AEs. We 
      compared AEs identified by the automated system with those previously assessed 
      manually, to evaluate missed/misgraded AEs. We also conducted a prospective 
      paired time assessment of automated versus manual AE assessment. We found a 
      substantial improvement in accuracy/completeness with the automated grading tool, 
      which identified an additional 17% of severe grade 3-4 AEs that had been 
      missed/misgraded manually. The automated system also provided an average time 
      saving of 5.5 min per treatment course. With 400 ongoing treatment trials at City 
      of Hope and an average of 1800 laboratory results requiring assessment per study, 
      the implications of these findings for patient safety are enormous.
FAU - Niland, Joyce C
AU  - Niland JC
AD  - Department of Information Sciences, City of Hope National Medical Center, Duarte, 
      California, USA. jniland@coh.org
FAU - Stiller, Tracey
AU  - Stiller T
FAU - Neat, Jennifer
AU  - Neat J
FAU - Londrc, Adina
AU  - Londrc A
FAU - Johnson, Dina
AU  - Johnson D
FAU - Pannoni, Susan
AU  - Pannoni S
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
DEP - 20111114
PL  - England
TA  - J Am Med Inform Assoc
JT  - Journal of the American Medical Informatics Association : JAMIA
JID - 9430800
SB  - IM
MH  - *Clinical Laboratory Information Systems
MH  - Clinical Trials as Topic
MH  - Drug-Related Side Effects and Adverse Reactions/*diagnosis
MH  - Electronic Data Processing
MH  - Humans
MH  - Laboratories
MH  - *Patient Safety
MH  - *Software
MH  - User-Computer Interface
PMC - PMC3240768
COIS- Competing interests: None.
EDAT- 2011/11/16 06:00
MHDA- 2012/03/02 06:00
PMCR- 2011/11/14
CRDT- 2011/11/16 06:00
PHST- 2011/11/16 06:00 [entrez]
PHST- 2011/11/16 06:00 [pubmed]
PHST- 2012/03/02 06:00 [medline]
PHST- 2011/11/14 00:00 [pmc-release]
AID - amiajnl-2011-000513 [pii]
AID - 10.1136/amiajnl-2011-000513 [doi]
PST - ppublish
SO  - J Am Med Inform Assoc. 2012 Jan-Feb;19(1):111-5. doi: 
      10.1136/amiajnl-2011-000513. Epub 2011 Nov 14.