Future observational studies should be more consistent in the choice of study population, age at exposure, follow-up, indication for and type of surgery, and outcomes. Assessment of sensory-motor development seems feasible in young children (age <4 yr), and intelligence/cognition in older children.

Real-world data (RWD) collected in routine health care processes and transformed to real-world evidence have become increasingly interesting within the research and medical communities to enhance medical research and support regulatory decision-making. Despite numerous European initiatives, there is still no cross-border consensus or guideline determining which qualities RWD must meet in order to be acceptable for decision-making within regulatory or routine clinical decision support. In the absence of guidelines defining the quality standards for RWD, an overview and first recommendations for quality criteria for RWD in pharmaceutical research and health care decision-making is needed in Austria. An Austrian multistakeholder expert group led by Gesellschaft für Pharmazeutische Medizin (Austrian Society for Pharmaceutical Medicine) met regularly; reviewed and discussed guidelines, frameworks, use cases, or viewpoints; and agreed unanimously on a set of quality criteria for RWD. This consensus statement was derived from the quality criteria for RWD to be used more effectively for medical research purposes beyond the registry-based studies discussed in the European Medicines Agency guideline for registry-based studies. This paper summarizes the recommendations for the quality criteria of RWD, which represents a minimum set of requirements. In order to future-proof registry-based studies, RWD should follow high-quality standards and be subjected to the quality assurance measures needed to underpin data quality. Furthermore, specific RWD quality aspects for individual use cases (eg, medical or pharmacoeconomic research), market authorization processes, or postmarket authorization phases have yet to be elaborated.

UNSTRUCTURED Real-world data (RWD) collected in routine healthcare processes and transformed to real-world evidence (RWE) has become increasingly interesting within research and medical communities to enhance medical research and support regulatory decision making. Despite numerous European initiatives, there is still no cross-border consensus or guideline determining which quality RWD must meet in order to be acceptable for decision making within regulatory or routine clinical decision support. An Austrian expert group led by GPMed (Gesellschaft für Pharmazeutische Medizin, Austrian Society for Pharmaceutical Medicine) reviewed drafted guidelines, published recommendations or viewpoints to derive a consensus statement on quality criteria for RWD to be used more effectively for medical research purposes beyond registry-based studies discussed in the European Medicines Agency (EMA) guideline for registry-based studies