Evaluation, analysis, and reporting of medication adherence for clinical trials of anticoagulants in children: Guidance from the ISTH SSC Subcommittee on Pediatric and Neonatal Thrombosis and Hemostasis

In response to growing recognition that non-adherence prevents children, adolescents, and young adults from achieving the therapeutic benefits of anticoagulant medication, the ISTH SSC Subcommittee on Pediatric and Neonatal Thrombosis and Hemostasis convened a working party on medication adherence. The primary aim of this manuscript was to synthesize recommendations from the larger adherence science literature to provide guidance regarding the classification, collection, and interpretation of anticoagulation adherence data. The secondary aim of this manuscript was to evaluate the degree to which trials published from 2013 to 2023 adhered to these guidance recommendations. As less than half of all trials reported on adherence and none included all recommended elements, the proposed ISTH SSC guidance has the potential to enhance the rigor and reproducibility of pediatric anticoagulant research.