Secondary analysis of statutorily collected routine data: Strengths, limitations and examples of use

Abstract

Real-world data are gaining increasing attention as an inevitable adjunct to the evidence gathered by randomized controlled trials (RCT). Registry data are often limited through voluntary participation of selected physicians, hospitals and patients (selection bias) as well as insufficient data validation (information bias); however, secondary analysis of statutorily collected data can overcome some of these limitations and enable nationwide (full) surveys to be conducted. This is especially important for the analysis of structural aspects of health care. This article provides an introduction to the methodology of secondary data analysis of routine data in Germany that are collected on the basis of statutory regulations. The article emphasizes the strengths and limitations and gives an overview of possible applications, including recent examples focusing on vascular medicine.