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A toolkit for the collection of thrombosis-related data elements in COVID-19 clinical studies

Deborah M Siegal1,2, Geoffrey D Barnes3, Nicole J Langlois2

  • 1Department of Medicine, University of Ottawa, Ottawa, ON, Canada.

Blood Advances
|December 22, 2020
PubMed

Insights

Standardized data elements were developed to improve the study of thrombosis in coronavirus disease 2019 (COVID-19). This aims to enhance data collection and comparison for better understanding of COVID-19-related thrombotic events.

Area of Science:

  • Hematology
  • Infectious Diseases
  • Cardiovascular Medicine

Background:

  • Thrombosis is a significant complication of coronavirus disease 2019 (COVID-19), especially in severe cases.
  • The exact incidence of thrombotic events in COVID-19 is unclear due to varied study methodologies and reporting.
  • Standardization is needed for reliable data collection and analysis of COVID-19-related thrombosis.

Purpose of the Study:

  • To develop standardized data elements for studying thrombosis in COVID-19.
  • To facilitate consistent data collection across diverse clinical studies.
  • To improve the comparability and pooling of research findings on COVID-19 and thrombosis.

Main Methods:

  • Collaboration between the American Society of Hematology Research Collaborative and the International Society on Thrombosis and Haemostasis COVID-19 Task Force.
  • Development of data elements across key domains: venous thromboembolism, myocardial infarction, stroke, peripheral arterial thrombosis, bleeding, laboratory tests, and antithrombotic therapy.
  • Creation of three levels of detail for data elements to suit various study designs and interventions.

Main Results:

  • Established comprehensive sets of standardized data elements for COVID-19 thrombosis research.
  • Included previously published elements where applicable to ensure consistency.
  • Designed elements with tiered detail for flexibility in research application.

Conclusions:

  • Standardized variables enhance the quality and efficiency of data collection in clinical studies.
  • Standardization enables better comparison of results across different research projects.
  • Facilitates future data pooling for more robust analyses of COVID-19-associated thrombotic events.

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