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A toolkit for the collection of thrombosis-related data elements in COVID-19 clinical studies.
Siegal, Deborah M; Barnes, Geoffrey D; Langlois, Nicole J; Lee, Adrienne; Middeldorp, Saskia; Skeith, Leslie; Wood, William A; Le Gal, Grégoire.
  • Siegal DM; Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
  • Barnes GD; Ottawa Hospital Research Institute, Ottawa, ON, Canada.
  • Langlois NJ; Division of Cardiovascular Medicine, Department of Internal Medicine, Frankel Cardiovascular Center, University of Michigan, Ann Arbor, MI.
  • Lee A; Ottawa Hospital Research Institute, Ottawa, ON, Canada.
  • Middeldorp S; Division of Hematology & Hematological Malignancies, Department of Medicine, University of Calgary, Calgary, AB, Canada.
  • Skeith L; Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands; and.
  • Wood WA; Division of Hematology & Hematological Malignancies, Department of Medicine, University of Calgary, Calgary, AB, Canada.
  • Le Gal G; Division of Hematology, Department of Medicine, University of North Carolina, Chapel Hill, NC.
Blood Adv ; 4(24): 6259-6273, 2020 12 22.
Article in English | MEDLINE | ID: covidwho-992409
ABSTRACT
Thrombosis has emerged as an important complication of coronavirus disease 2019 (COVID-19), particularly among individuals with severe illness. However, the precise incidence of thrombotic events remains uncertain due to differences in study design, patient populations, outcome ascertainment, event definitions, and reporting. In an effort to overcome some of these challenges and promote standardized data collection and reporting in clinical studies, the American Society of Hematology Research Collaborative COVID-19 Non-Malignant Hematology Task Force, in collaboration with the International Society on Thrombosis and Haemostasis COVID-19 Task Force, developed sets of data elements in the following domains venous thromboembolism, myocardial infarction, stroke/transient ischemic attack, peripheral arterial thrombosis, bleeding, laboratory investigations, and antithrombotic therapy. Data elements in each of these domains were developed with 3 levels of detail to facilitate their incorporation into studies evaluating a range of interventions and outcomes. Previously published data elements were included where possible. The use of standardized variables in a range of clinical studies can enhance the quality of data collection, create efficiency, enhance comparison of results across studies, and facilitate future pooling of data sets.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thrombosis / User-Computer Interface / Databases, Factual / Web Browser / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Long Covid Limits: Humans Language: English Journal: Blood Adv Year: 2020 Document Type: Article Affiliation country: Bloodadvances.2020003269

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thrombosis / User-Computer Interface / Databases, Factual / Web Browser / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Long Covid Limits: Humans Language: English Journal: Blood Adv Year: 2020 Document Type: Article Affiliation country: Bloodadvances.2020003269