Enabling Precision Medicine With Digital Case Classification at the Point-of-Care

Abstract

Infectious and inflammatory diseases of the central nervous system are difficult to identify early. Case definitions for aseptic meningitis, encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM) are available, but rarely put to use. The VACC-Tool (Vienna Vaccine Safety Initiative Automated Case Classification-Tool) is a mobile application enabling immediate case ascertainment based on consensus criteria at the point-of-care. The VACC-Tool was validated in a quality management program in collaboration with the Robert-Koch-Institute. Results were compared to ICD-10 coding and retrospective analysis of electronic health records using the same case criteria. Of 68,921 patients attending the emergency room in 10/2010–06/2013, 11,575 were hospitalized, with 521 eligible patients (mean age: 7.6 years) entering the quality management program. Using the VACC-Tool at the point-of-care, 180/521 cases were classified successfully and 194/521 ruled out with certainty. Of the 180 confirmed cases, 116 had been missed by ICD-10 coding, 38 misclassified. By retrospective application of the same case criteria, 33 cases were missed. Encephalitis and ADEM cases were most likely missed or misclassified. The VACC-Tool enables physicians to ask the right questions at the right time, thereby classifying cases consistently and accurately, facilitating translational research. Future applications will alert physicians when additional diagnostic procedures are required.

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study

“…Neuroinflammatory adverse events (NIAE) such as acute disseminated encephalomyelitis (ADEM) or Guillain-Barré syndrome constitute rare events to be encountered during post-marketing surveillance [18,24,29,30]. NIAE should be ascertained and reported swiftly, to facilitate thorough investigation.…”

“…The ascertainment of adverse events should rely on predefined case criteria, thereby diminishing ascertainment bias [21][22][23][24]. In an effort to harmonize ascertainment procedures internationally, consensus case definitions have been published for various adverse events, designed to be independent of a presumed trigger [26][27][28].…”

“…Using the VACCTool on hand-held devices, physicians are enabled to 'ask the right questions at the right time', i.e., when the patient is present and all relevant data can be solicited [24]. Using the VACC-Tool, adverse events can be detected and reported securely and in CDISC and health insurance portability and accountability act (HIPAA)-compliant digital data format [24]. The VACC-Tool 1.0 (beta-version) was validated as described previously [24].…”

“…Using the VACC-Tool, adverse events can be detected and reported securely and in CDISC and health insurance portability and accountability act (HIPAA)-compliant digital data format [24]. The VACC-Tool 1.0 (beta-version) was validated as described previously [24]. Version 1.0 was restricted to capturing four distinct NIAE, namely aseptic meningitis, encephalitis, myelitis, and ADEM.…”

“…Healthcare professionals should avoid jumping to conclusions about potential causes of adverse events, unless the event has been confirmed and the causal relationship established [25]. Safety reports should therefore be verified and ascertained before any causal relationships between a potential trigger (such as a drug or vaccine) and a suspected adverse event are evaluated [23][24][25].…”