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ABSTRACT: Objective
To assess whether direct to healthcare professional communications (DHPCs) are of sufficient quality to be applicable in clinical practice and study how the quality differs according to safety concerns and type of monitoring.Design
Retrospective cohort study.Setting
DHPCs containing monitoring instructions were identified among all DHPC issued in Denmark between 2007 and 2018.Intervention
Quality of information of monitoring instructions was assessed according to the Systematic Information for Monitoring (SIM) score. Associations between different characteristics of instructions and the SIM score were compared with analysis of variance and the post hoc test Tukey's honestly significant difference if significant.Results
In total, 297 DHPCs w
SUBMITTER: Hojer MG
PROVIDER: S-EPMC7223281 | biostudies-literature | 2020 May
REPOSITORIES: biostudies-literature