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

Meghan E McGrady; Vera Ignjatovic; Sophie Jones; Aisha Bruce; Neil A Goldenberg; Mattia Rizzi; Courtney D Thornburg; Kevin E Todd; Lori Luchtman-Jones

doi:10.1016/j.jtha.2024.04.003

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

J Thromb Haemost. 2024 Jul;22(7):2081-2092. doi: 10.1016/j.jtha.2024.04.003. Epub 2024 Apr 19.

Authors

Meghan E McGrady¹, Vera Ignjatovic², Sophie Jones³, Aisha Bruce⁴, Neil A Goldenberg⁵, Mattia Rizzi⁶, Courtney D Thornburg⁷, Kevin E Todd⁸, Lori Luchtman-Jones⁹

Affiliations

¹ Center for Adherence and Self-Management, Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA; Patient and Family Wellness Center, Cancer and Blood Diseases Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA. Electronic address: Meghan.McGrady@cchmc.org.
² Haematology, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
³ Haematology, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Clinical Haematology, The Royal Children's Hospital, Melbourne, Victoria, Australia; Department of Nursing, The University of Melbourne, Parkville, Victoria, Australia.
⁴ Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.
⁵ Johns Hopkins All Children's Institute for Clinical and Translational Research, St. Petersburg, Florida, USA; Departments of Pediatrics and Medicine, Division of Hematology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
⁶ Hematology/Oncology Unit, Division of Pediatrics, Lausanne University Hospital, Lausanne, Switzerland.
⁷ Division of Pediatric Hematology/Oncology, Rady Children's Hospital San Diego, San Diego, California, USA; Department of Pediatrics, UC San Diego School of Medicine, La Jolla, California, USA.
⁸ Department of Pediatric Hematology/Oncology, Children's Hospital of the King's Daughters, Norfolk, Virginia, USA.
⁹ Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA; Division of Hematology, Cancer and Blood Diseases Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.

PMID: 38642706
DOI: 10.1016/j.jtha.2024.04.003

Abstract

In response to growing recognition that nonadherence prevents children, adolescents, and young adults from achieving the therapeutic benefits of anticoagulant medication, the International Society on Thrombosis and Haemostasis Scientific and Standardization Committee Subcommittee on Pediatric and Neonatal Thrombosis and Hemostasis convened a working party on medication adherence. The primary aim of this article 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 article 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 International Society on Thrombosis and Haemostasis Scientific and Standardization Committee guidance has the potential to enhance the rigor and reproducibility of pediatric anticoagulant research.

Keywords: anticoagulants; medication adherence; pediatrics; self-management.

Publication types

Practice Guideline
Review

MeSH terms

Adolescent
Age Factors
Anticoagulants* / adverse effects
Anticoagulants* / therapeutic use
Child
Child, Preschool
Clinical Trials as Topic*
Guideline Adherence
Hemostasis* / drug effects
Humans
Infant
Infant, Newborn
Medication Adherence*
Research Design / standards
Thrombosis* / drug therapy
Thrombosis* / etiology
Thrombosis* / prevention & control

Substances

Anticoagulants