Outcomes measures in current Danish pharmacoepidemiological research: a protocol for a systematic mapping review

Abstract

There is a growing interest in complementing the evidence on efficacy and safety of medicinal products gained by randomised clinical trials with real-world data and real-world evidence. Registries provide important sources of real-world data but are typically initiated for administrative purposes. The Danish national registries capture a wide range of information such as health care contacts, social, and economic data; and thereby offer unique possibilities for pharmacoepidemiological research. To gain insight into how registry-based outcome measures from mostly administrative databases are used in real-world evidence studies, the present literature review will investigate the current practice in registry-based studies using Danish health data. A systematic mapping review will be conducted using the literature databases PubMed®/MEDLINE and Scopus®. The search will include Danish registry-based studies aiming at evaluating the effectiveness or safety of medicinal products published from January 1st, 2018 to December 31st, 2019. Data extraction will include the Anatomical Therapeutic Chemical code level 2 of the medicinal product of interest, the outcome measures used, the registry of which the outcome measure has been obtained as well as how the quality of the outcome measure has been considered. The outcome measures extracted will be presented as a categorical overview. These categories will be associated with therapeutic exposure, registry of origin and refereed validation of the outcomes. This systematic mapping review will, as far as we know, be the first of its kind to map outcome measures from Danish national registries used for safety and efficacy studies.