Minimum Data Set for Treatment Effectiveness in Pyoderma Gangrenosum for an International Registry: An International...

Area of Science:

• Dermatology
• Clinical Research Methodology
• Health Informatics

Background:

• Pyoderma gangrenosum (PG) is a rare, painful neutrophilic dermatosis with significant impact on quality of life.
• Limited approved therapies, small clinical trials, and low-quality evidence hinder PG management.
• Patient data registries are crucial for improving evidence generation and clinical care for rare diseases like PG.

Purpose of the Study:

• To establish a consensus-based minimum data set for an international pyoderma gangrenosum (PG) treatment effectiveness registry.
• To utilize real-world clinical data to inform the development of this standardized registry.

Main Methods:

• A systematic literature review generated initial candidate data items.
• A modified Delphi survey process involving a multi-stakeholder international panel (45 participants) was employed.
• Consensus was achieved through three Delphi rounds and a virtual consensus meeting, followed by a verification survey.

Main Results:

• All 45 stakeholders completed the Delphi rounds, with high participation in subsequent consensus and verification steps.
• Out of 143 initial items across 24 domains, 118 items across 26 domains achieved consensus.
• The study successfully established a comprehensive minimum data set for a PG registry.

Conclusions:

• An international consensus has defined a standardized framework for collecting real-world data on pyoderma gangrenosum (PG).
• The developed registry will be vital for assessing treatment effectiveness, understanding disease progression, and enhancing patient outcomes.
• This resource will support future clinical trials, guideline development, and quality improvement initiatives for PG.