The lipedema common case report form as a research tool: standardizing lipedema data collection

Area of Science:

• Medical Research
• Clinical Data Management
• Adipose Tissue Disorders

Background:

• Lipedema is a poorly understood chronic adipose tissue condition affecting women.
• Lack of standardized diagnostic criteria and measurement variability hinder research comparability.
• Inconsistent data collection impedes advances in clinical practice and patient care.

Purpose of the Study:

• To develop a Lipedema Common Case Report Form (CCRF) as a research data harmonization tool.
• To address challenges posed by inconsistent definitions and data collection in lipedema research.
• To facilitate the development of standardized diagnostic and research methodologies for lipedema.

Main Methods:

• Collaborative development involving clinicians, researchers, and biostatisticians.
• Review of existing lipedema clinical guidelines and development of lipedema-specific Common Data Elements (CDEs).
• Iterative refinement through piloting, participant/clinician feedback, and biostatistical review.

Main Results:

• The final Version 1 CCRF instrument comprises 682 CDEs across four classifications: Core, Supplemental Highly Recommended, Supplemental, and Exploratory.
• The CCRF is designed as a structured framework for harmonized data collection.
• The instrument is prepared for dissemination and intended for adoption in lipedema research starting in 2026.

Conclusions:

• The Lipedema Common Case Report Form (CCRF) provides a standardized framework to improve data consistency and comparability in lipedema research.
• Widespread adoption of the CCRF is expected to facilitate future research and the development of standardized methodologies.
• This initiative aims to enhance the evidence base for lipedema, ultimately benefiting clinical practice and patient care.