[Routine Practice Data for Evaluating Intervention Effects: Part 2 of the Manual].

The evaluation of intervention effects is an important domain of health services research. The ad hoc commission for the use of routine practice data of the German Network for Health Services Research (DNVF) therefore provides this second part of its manual focusing on the use of routine practice data for the evaluation of intervention effects. First, we discuss definition issues and the importance of contextual factors. Subsequently, general requirements for planning, data collection and analysis as well as concrete examples for the evaluation of intervention effects for the 3 fields of application regarding pharmacotherapy, nonpharmaceutical interventions as well as complex interventions are elaborated. We consider scenarios in which no information from randomized controlled trials (RCTs) comparing the two groups directly is yet available or in which RCTs are already available but an extension of the research question is required. In all examples either with or without randomization, the first and foremost question is always whether the data source is suitable for the specific research question. Most of the examples chosen are from oncology trials, because the necessary data are already available for Germany, at least in some form. Finally, the manual discusses possible challenges for future use of these data.
Competing Interests: JS nutzt regelmäßig GKV-Routinedaten für wissenschaftliche Forschungsprojekte und ist Leiter des Deutschen Neurodermitisregisters TREATgermany. Er erhielt institutionelle Unterstützung für wissenschaftliche Forschungsprojekte von Sanofi, Novartis, Pfizer und ALK und war als Berater gegen ein Honorar für Sanofi, Novartis, ALK und Lilly tätig. Die anderen Autoren geben keine Interessenkonflikte an.
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