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Area of Science:

  • Ophthalmology
  • Clinical Research
  • Psychometrics

Background:

  • Diabetic retinopathy (DR) significantly impacts vision and quality of life.
  • Assessing health-related quality of life (HRQoL) in clinical trials is crucial for treatment evaluation.
  • Visual acuity (VA) and patient-reported outcomes (PROs) are key endpoints in DR research.

Purpose of the Study:

  • To compare Rasch-calibrated and non-Rasch-calibrated health-related quality-of-life domain scores with visual acuity (VA).
  • To evaluate treatment group differences in these scores across randomized clinical trials for proliferative diabetic retinopathy (PDR).
  • To determine the utility of different scoring methods in capturing treatment effects.

Main Methods:

  • Simulated 10,000 randomized controlled trials (RCTs) using bootstrapping from the Diabetic Retinopathy Clinical Research (DRCR) Network Protocol S data.
  • Analyzed individual patient VA and National Eye Institute Visual Function Questionnaire-25 (VFQ-25) responses.
  • Calculated Pearson correlation coefficients between treatment group differences in mean VA and mean domain scores, and effect sizes.

Main Results:

  • Rasch-calibrated VFQ-25 domains (visual function, socioemotional, combined) showed the highest correlation with VA differences.
  • Original composite and near activities domains also demonstrated similar correlations.
  • Largest effect sizes were observed for the original composite, mental health, dependency, and peripheral vision domains.

Conclusions:

  • Rasch-calibrated VFQ-25 domains, particularly visual function, socioemotional, and combined scores, correlate strongly with VA changes in PDR.
  • While Rasch calibration offers superior psychometrics, the original composite VFQ-25 scoring may be acceptable.
  • These findings inform the selection of appropriate outcome measures in DR clinical trials.