Development of a Uniform Apheresis Case Report Form for Standardized Collection of Apheresis Data

Area of Science:

• Medical Informatics
• Hematology
• Clinical Research

Background:

• Apheresis is increasingly utilized for various medical indications globally.
• Standardized data collection is crucial for advancing apheresis research, quality improvement, and patient care.
• Existing data collection methods lack uniformity, hindering comparative studies and benchmarking.

Purpose of the Study:

• To systematically develop a Uniform Apheresis Case Report Form (UACRF) for standardized data collection in apheresis.
• To establish common data elements (CDE) for therapeutic apheresis and white blood cell collections.
• To support research, quality initiatives, and enhance patient care in apheresis.

Main Methods:

• Convened a consensus panel of 17 experts in apheresis and data management.
• Conducted online meetings and a public comment period for draft development.
• Revised the draft form and converted it into an electronic case report form (eCRF).

Main Results:

• Developed the Uniform Apheresis Case Report Form (UACRF) with 16 modules and 137 data elements.
• The UACRF represents the first systematic effort to create CDE for therapeutic apheresis and white blood cell collections.
• The final UACRF version was finalized on August 24, 2023.

Conclusions:

• The UACRF provides a standardized framework for collecting critical data in apheresis procedures.
• Further validation is required to confirm the UACRF's effectiveness in data collection and usability.
• The UACRF has the potential to significantly advance apheresis research and clinical practice.