ISTH

ISTH standardizes clinical data elements to harmonize data collection and definitions for venous thromboembolism (VTE) research.

Key Features:

• Standardization: Provides predefined clinical data elements to standardize data collection across VTE studies.
• Structured Data Elements: Supplies structured elements intended for development of research datasets and case report forms (CRFs) with consistent definitions and coding.
• Facilitation of Meta-Analyses: Enables between-study comparisons and pooled analyses by promoting common data standards.
• Project Taxonomy and Definitions: Establishes a project-specific taxonomy and defined data element specifications to ensure consistent interpretation.
• Scope: Comprises 512 unique data elements covering VTE-relevant domains.

Scientific Applications:

• Study design acceleration: Uses pre-defined elements to reduce time required to design VTE research studies.
• Improved data quality: Promotes consistent data collection to enhance dataset reliability for clinical and epidemiological analyses.
• Cross-study collaboration: Facilitates comparison and collaboration across international VTE studies and meta-analytic efforts.

Methodology:

An International Society on Thrombosis and Haemostasis–led task force of over 50 researchers organized into seven working groups (General Core Data Elements; Anticoagulation and Other Therapies; Chronic VTE and Functional Outcomes; Diagnosis of VTE; Malignancy; Perioperative; Predictors of VTE) used teleconferences, Steering Committee oversight, and a public comment period to identify key data elements, develop definitions, and establish the project-specific taxonomy.