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

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Ophthalmology experts reached consensus on standardizing real-world data (RWD) collection and analysis. This aims to improve the consistency and reliability of RWD studies for better clinical decision-making.

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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.