title: Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study.
abstract: Regulatory authorities often receive poorly structured safety reports requiring considerable effort to investigate potential adverse events post hoc. Automated question-and-answer systems may help to improve the overall quality of safety information transmitted to pharmacovigilance agencies. This paper explores the use of the VACC-Tool (ViVI Automated Case Classification Tool) 2.0, a mobile application enabling physicians to classify clinical cases according to 14 pre-defined case definitions for neuroinflammatory adverse events (NIAE) and in full compliance with data standards issued by the Clinical Data Interchange Standards Consortium.
  
  
  
  The validation of the VACC-Tool 2.0 (beta-version) was conducted in the context of a unique quality management program for children with suspected NIAE in collaboration with the Robert Koch Institute in Berlin, Germany. The VACC-Tool was used for instant case classification and for longitudinal follow-up throughout the course of hospitalization. Results were compared to International Classification of Diseases , Tenth Revision (ICD-10) codes assigned in the emergency department (ED).
  
  
  
  From 07/2013 to 10/2014, a total of 34,368 patients were seen in the ED, and 5243 patients were hospitalized; 243 of these were admitted for suspected NIAE (mean age: 8.5 years), thus participating in the quality management program. Using the VACC-Tool in the ED, 209 cases were classified successfully, 69 % of which had been missed or miscoded in the ED reports. Longitudinal follow-up with the VACC-Tool identified additional NIAE.
  
  
  
  Mobile applications are taking data standards to the point of care, enabling clinicians to ascertain potential adverse events in the ED setting and during inpatient follow-up. Compliance with Clinical Data Interchange Standards Consortium (CDISC) data standards facilitates data interoperability according to regulatory requirements.
authors.affiliation: Department of Pediatrics, Charité University Medical Center Berlin, Berlin, Germany.|Vienna Vaccine Safety Initiative, Berlin, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Hoppe
authors.affiliation: Department of Pediatrics, Charité University Medical Center Berlin, Berlin, Germany.|Vienna Vaccine Safety Initiative, Berlin, Germany.
authors.forename: Patrick
authors.initials: P
authors.lastname: Obermeier
authors.affiliation: Department of Pediatrics, Charité University Medical Center Berlin, Berlin, Germany.|Vienna Vaccine Safety Initiative, Berlin, Germany.
authors.forename: Susann
authors.initials: S
authors.lastname: Muehlhans
authors.affiliation: Department of Pediatrics, Charité University Medical Center Berlin, Berlin, Germany.|Vienna Vaccine Safety Initiative, Berlin, Germany.
authors.forename: Maren
authors.initials: M
authors.lastname: Alchikh
authors.affiliation: Department of Pediatrics, Charité University Medical Center Berlin, Berlin, Germany.|Vienna Vaccine Safety Initiative, Berlin, Germany.
authors.forename: Lea
authors.initials: L
authors.lastname: Seeber
authors.affiliation: Department of Pediatrics, Charité University Medical Center Berlin, Berlin, Germany.|Vienna Vaccine Safety Initiative, Berlin, Germany.
authors.forename: Franziska
authors.initials: F
authors.lastname: Tief
authors.affiliation: Department of Pediatrics, Charité University Medical Center Berlin, Berlin, Germany.|Vienna Vaccine Safety Initiative, Berlin, Germany.
authors.forename: Katharina
authors.initials: K
authors.lastname: Karsch
authors.affiliation: Department of Pediatrics, Charité University Medical Center Berlin, Berlin, Germany.|Vienna Vaccine Safety Initiative, Berlin, Germany.
authors.forename: Xi
authors.initials: X
authors.lastname: Chen
authors.affiliation: National Reference Centre for Poliomyelitis and Enteroviruses, Robert Koch Institute, Berlin, Germany.
authors.forename: Sindy
authors.initials: S
authors.lastname: Boettcher
authors.affiliation: National Reference Centre for Poliomyelitis and Enteroviruses, Robert Koch Institute, Berlin, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Diedrich
authors.affiliation: Department of Mathematics and Computer Sciences, Freie Universität Berlin, Berlin, Germany.
authors.forename: Tim
authors.initials: T
authors.lastname: Conrad
authors.affiliation: Vienna Vaccine Safety Initiative, Berlin, Germany.|Clinical Data Interchange Standards Consortium, Austin, TX, USA.
authors.forename: Bron
authors.initials: B
authors.lastname: Kisler
authors.affiliation: Department of Pediatrics, Charité University Medical Center Berlin, Berlin, Germany. barbara.rath@gmail.com.|Vienna Vaccine Safety Initiative, Berlin, Germany. barbara.rath@gmail.com.
authors.forename: Barbara
authors.initials: B
authors.lastname: Rath
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D000465:Algorithms; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000453:epidemiology; D004636:Emergency Service, Hospital / Q000458:organization & administration / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D063731:Mobile Applications; D009422:Nervous System Diseases / Q000139:chemically induced; D019095:Point-of-Care Systems / Q000458:organization & administration*