Implementing online interventions in ICare: A biostatistical perspective

Abstract

The implementation of research studies is a highly complex process. All decisions with respect to the study design impact the statistical analyses and interpretation of the results. Within the ICare research project (EU H2020 Grant agreement 634757) seven research trials are conducted to generate evidence on efficacy, effectiveness and the dissemination potential of online interventions targeting eating disorders, common mental health problems and resilience. Within the project a central biometrical unit was established to manage and coordinate data collection, processing and statistical data analysis. This allows for harmonized trial planning, conduct, data management processes and analysis strategies. The purpose of this article is to describe the common concepts underlying all seven ICare trials. This includes development of (adaptive sequential) study designs, handling of missing values, general data management and processing as well as data protection aspects.