Manual for Methods and Use of Routine Practice Data for Knowledge Generation

There are more and more good reasons for using existing care data, with the focus in particular on the use of register data. The associated, clearly structured methodological procedure has so far been insufficiently combined, prepared and presented transparently. The German Network for Health Services Research (DNVF) has therefore set up an ad hoc commission for the use of routine practice data (RWE/RWD). The rapid report prepared by IQWiG on the scientific development of concepts for generation of care-related data and their evalua-tion for the purpose of benefit assessment of medicinal products according to 35a SGB V is an essential step for the use of register data for the generation of evidence. The Memorandum Register - Update 2019 published by DNVF 2020 also describes the requirements and methodological foundations of registers. Best practice examples from oncology, which are based on the uniform oncological basic data set for clinical cancer registration ( 65c SGB V), show, for example, that guidelines can be checked and recommendations for guidelines and necessary interventions can be derived in the sense of knowledge-generating health services research using register data. At the same time, however, there are no clear quality requirements and structured formal and content-related procedures in the areas of data consolidation, data verification and the use of specific methods depending on the question at hand. The previously inconsistent requirements are to be revised and a method guide for the use of suited data is to be developed and published. The first chapter of the manual on methods of care-related data explains the objective and structure of the manual. It explains why the use of the term routine practice data is more effective than the use of the terms Real Word Data (RWD) and Real World Evidence (RWE). By avoiding the term real world it should be emphasized in particular that high-quality research can also be based on routine practice data (e. g. register-based comparative studies).