Mapping Outcomes and Registries Used in Current Danish Pharmacoepidemiological Research

Charlotte Thor Petersen; Kristoffer Jarlov Jensen; Mary Rosenzweig; Benedikte Irene von Osmanski; Mikkel Zöllner Ankarfeldt; Janne Petersen

doi:10.2147/CLEP.S341480

Mapping Outcomes and Registries Used in Current Danish Pharmacoepidemiological Research

Clin Epidemiol. 2022 Apr 26:14:521-542. doi: 10.2147/CLEP.S341480. eCollection 2022.

Authors

Charlotte Thor Petersen^{1

2}, Kristoffer Jarlov Jensen¹, Mary Rosenzweig², Benedikte Irene von Osmanski^{1

2}, Mikkel Zöllner Ankarfeldt¹, Janne Petersen^{1

3}

Affiliations

¹ Copenhagen Phase IV Unit (Phase4CPH), Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark.
² Life Science Insights Centre, DLI Market Intelligence, Copenhagen, Denmark.
³ Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.

Abstract

Purpose: 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: Denmark; drugs; pharmacoepidemiology; registries; review.

Publication types

Review