Influenza and other respiratory viruses: standardizing disease severity in surveillance and clinical trials

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.

KEYWORDS:

• Disease severity
• influenza-like illness
• influenza
• respiratory syncytial virus
• human metapneumovirus
• human rhinovirus
• adenovirus
• seasonality
• antivirals
• clinical trials

Acknowledgments

BR wrote the initial draft of the manuscript. MA, FT, XC and PO were in charge of data aggregation, acquisition and QC/QA, and provided important input into the manuscript. XM conducted and interpreted the systematic literature review. BK and CH were in charge of data standardization, CH provided database maintenance and management. BS designed and supervised the laboratory analyses. TC, PM conducted the data analysis. BR designed the QM Program and the ViVI Disease Severity Score and supervised the project. All Authors take responsibility for the integrity of the data and the accuracy of the data analysis. All authors have seen and approved the final version of the manuscript.

The authors would like to express their gratitude to the team at the Robert Koch Institute for providing virology testing in-kind and to the Vienna Vaccine Safety Initiative for providing the ViVI Disease Severity Score and mobile application. TC was funded by the German Ministry of Research and Education (BMBF) project grant 3FO18501 (Forschungscampus MODAL). The authors would also like to express their thanks to members of the ViVI Think Tank for their expert feedback and encouragement throughout the course of the project.

Supplemental meterial

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