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. 2012 Jan-Feb;19(1):111-5.
doi: 10.1136/amiajnl-2011-000513. Epub 2011 Nov 14.

Improving patient safety via automated laboratory-based adverse event grading

Joyce C Niland  1 , Tracey Stiller, Jennifer Neat, Adina Londrc, Dina Johnson, Susan Pannoni
Affiliations

Improving patient safety via automated laboratory-based adverse event grading

Joyce C Niland et al. J Am Med Inform Assoc. 2012 Jan-Feb.

Abstract

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.

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Conflict of interest statement

Competing interests: None.

Figures

Figure 1
Figure 1
Example of laboratory-based adverse event (AE) grading algorithms for two CTCAE V.3.0 organ systems: blood/bone marrow and metabolic/laboratory. LLN, lower limit of normal; ULN, upper limit of normal; WBC, white blood cell.
Figure 2
Figure 2
CALAEGS screenshots showing the entry screen for assessing a single laboratory result, for example, from an outside laboratory with no electronic file available (left), and the flowsheet generated to grade multiple laboratory-based adverse events (AEs) imported from an electronic file (right). CALAEGS, Cancer Automated Lab-based Adverse Event Grading Service.
Figure 3
Figure 3
Missed/misgraded adverse events (AEs) by the manual assessment method, against the true grade as detected by CALAEGS; dashed boxes highlight the severe (grade 3, 4) missed/misgraded AEs. *Misgraded because of wrong direction: term incorrectly identified as ‘hyper’ instead of ‘hypo’. CALAEGS, Cancer Automated Lab-based Adverse Event Grading Service.
See this image and copyright information in PMC

References

    1. Jenkins J, Hubbard S. History of clinical trials. Semin Oncol Nurs 1991;7:228–34 - PubMed
    1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet 2001;357:1191–4 - PubMed
    1. Martin PJ, Antin JH, Weisdorf DJ, et al. Reporting of adverse event data in hematopoietic stem cell transplantation clinical trials involving investigational new drugs or devises: a report from the William Guy Forbeck Foundation 2001 focus meeting on clinical trials in hematopoietic stem cell transplantation. Biol Blood Marrow Transplant 2002;8:295–302 - PubMed
    1. Goldberg RM, Sargent DJ, Morton RF, et al. Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group s real-time toxicity monitoring program. J Clin Oncol 2002;20:4591–6 - PubMed
    1. Bates DW, Evans RS, Murff H, et al. Detecting adverse events using information technology. JAMIA 2003;10:115–28 - PMC - PubMed

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