@article{HoppeObermeierMehlhansetal., author = {Hoppe, Christian and Obermeier, Patrick and Mehlhans, S. and Alchikh, Maren and Seeber, L. and Tief, Franziska and Karsch, K. and Chen, X. and Boettcher, Sindy and Diedrich, S. and Conrad, Tim}, title = {Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study}, series = {Drug Safety}, volume = {39}, journal = {Drug Safety}, number = {10}, doi = {10.1007/s40264-016-0437-6}, pages = {977 -- 988}, 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. METHODS: 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). RESULTS: 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. CONCLUSION: 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.}, language = {en} } @article{RathConradMylesetal., author = {Rath, Barbara and Conrad, Tim and Myles, Puja and Alchikh, Maren and Ma, Xiaolin and Hoppe, Christian and Tief, Franziska and Chen, Xi and Obermeier, Patrick and Kisler, Bron and Schweiger, Brunhilde}, title = {Influenza and other respiratory viruses: standardizing disease severity in surveillance and clinical trials}, series = {Expert Review of Anti-infective Therapy}, volume = {15}, journal = {Expert Review of Anti-infective Therapy}, number = {6}, doi = {10.1080/14787210.2017.1295847}, pages = {545 -- 568}, abstract = {Introduction: Influenza-Like Illness is a leading cause of hospitalization in children. Disease burden due to influenza and other respiratory viral infections is reported on a population level, but clinical scores measuring individual changes in disease severity are urgently needed. Areas covered: We present a composite clinical score allowing individual patient data analyses of disease severity based on systematic literature review and WHO-criteria for uncomplicated and complicated disease. The 22-item ViVI Disease Severity Score showed a normal distribution in a pediatric cohort of 6073 children aged 0-18 years (mean age 3.13; S.D. 3.89; range: 0 to 18.79). Expert commentary: The ViVI Score was correlated with risk of antibiotic use as well as need for hospitalization and intensive care. The ViVI Score was used to track children with influenza, respiratory syncytial virus, human metapneumovirus, human rhinovirus, and adenovirus infections and is fully compliant with regulatory data standards. The ViVI Disease Severity Score mobile application allows physicians to measure disease severity at the point-of care thereby taking clinical trials to the next level.}, language = {en} } @article{ObermeierHeimBiereetal., author = {Obermeier, Patrick and Heim, A. and Biere, Barbara and Hage, E. and Alchikh, Maren and Conrad, Tim and Schweiger, Brunhilde and Rath, Barbara}, title = {Clinical characteristics and disease severity associated with adenovirus infections in infants and children - discovery of a novel adenovirus, HAdV-D80}, series = {Clinical Infectious Diseases}, journal = {Clinical Infectious Diseases}, language = {en} }