Clinical Epidemiology (Apr 2022)
Mapping Outcomes and Registries Used in Current Danish Pharmacoepidemiological Research
Abstract
Charlotte Thor Petersen,1,2 Kristoffer Jarlov Jensen,1 Mary Rosenzweig,2 Benedikte Irene von Osmanski,1,2 Mikkel Zöllner Ankarfeldt,1 Janne Petersen1,3 1Copenhagen Phase IV Unit (Phase4CPH), Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark; 2Life Science Insights Centre, DLI Market Intelligence, Copenhagen, Denmark; 3Section of Biostatistics, University of Copenhagen, Copenhagen, DenmarkCorrespondence: Charlotte Thor Petersen, Life Science Insights Centre, DLI Market Intelligence, Copenhagen, Denmark, Tel +45 30 35 20 43, Email [email protected]: There is an increasing need for national and international pharmacoepidemiological studies based on high-quality real-world data of which the Danish registries are a valuable source. In lack of a complete overview of which data are used to assess real-world drug safety and effectiveness outcomes, we aimed to map the outcomes, data sources, and the reporting of outcome quality in recent pharmacoepidemiological studies.Methods: We conducted a systematic mapping review of pharmacoepidemiological studies based on Danish registries investigating drug safety and/or effectiveness, published in the period 2018– 2019, identified in PubMed and Scopus. Extraction included: Anatomical Therapeutic Chemical level 2 code for drug exposures, outcomes, outcome data sources, and quality of outcomes.Results: Of the 210 included studies, 96% used outcomes categorized as Clinical, 4% utilized outcomes categorized as Society-related, 5% used outcomes categorized as Healthcare cost and utilization, and 3% of the studies applied outcomes categorized as Patient-reported in which the percentages are not mutually exclusive. Diagnosis (66%) and Mortality (38%) were the two most utilized subcategories among those categorized as Clinical outcomes. Danish Health Data Authority and Statistics Denmark registries were the most reported outcome data sources (90%). Ninety-six studies (46%) reported one or more quality parameters related to their outcomes of interest with accuracy/validity being the most reported parameter (22%).Conclusion: The Danish registries support a wide range of outcomes. Across therapeutic areas, most studies investigate traditional clinical outcomes of disease and mortality based on data from a small number of available registries. In contrast, clinical and biochemical databases, despite potentially offering outcomes with high responsiveness, and the high-quality social and healthcare cost registries were rarely used as outcome data sources.Keywords: pharmacoepidemiology, registries, review, Denmark, drugs
