Defining a standards framework for ophthalmology real-world data methodologies through an expert-led Delphi consensus

Area of Science:

• Ophthalmology
• Real-World Data (RWD) Research
• Methodology Standardization

Background:

• Real-world data (RWD) is crucial in ophthalmology for understanding outcomes and practices.
• Methodological inconsistencies in RWD studies limit comparability and generalizability.
• Standardization is needed to enhance the value of ophthalmology RWD.

Purpose of the Study:

• Achieve expert agreement on the necessity of standardized methodologies for ophthalmology RWD studies.
• Identify essential clinical and patient-reported data elements for RWD collection.
• Explore strategies for consistent implementation of RWD standards.

Main Methods:

• A modified Delphi methodology was employed.
• A steering committee developed 38 consensus statements.
• An online survey was distributed to 244 healthcare professionals, primarily retina specialists.

Main Results:

• Consensus was achieved on all 38 statements (100%), with 95% reaching over 90% agreement.
• Key areas of consensus included RWD collection standards, analysis methodology, and patient-reported outcomes.
• Eight key recommendations for consistent RWD implementation were developed.

Conclusions:

• The consensus provides a framework for more consistent and reliable ophthalmology RWD studies.
• Standardized methodologies will improve the generalizability of RWD findings.
• Enhanced RWD evidence will support better clinical decision-making and patient outcomes.