Clinically important difference in dry eye: change in IDEEL-symptom bother

Area of Science:

• Ophthalmology
• Clinical Research
• Patient-Reported Outcomes

Background:

• Dry eye disease significantly impacts daily life and quality of life.
• Validated questionnaires are essential for measuring symptom severity and treatment efficacy.
• The Impact of Dry Eye on Everyday Living (IDEEL) questionnaire assesses dry eye symptom bother, quality of life, and treatment satisfaction.

Purpose of the Study:

• To evaluate the utility of the 20-item IDEEL Symptom Bother (IDEEL-SB) module in discriminating self-assessed dry eye severity.
• To determine the clinically important difference (CID) in IDEEL-SB scores corresponding to a global assessment of change in dry eye condition after treatment.

Main Methods:

• Dry eye subjects were randomized to one of three tear replacements.
• The IDEEL-SB was administered at baseline, 1 week, and 4 weeks.
• A global change questionnaire (5-point Likert scale) assessed overall health and dry eye status.
• Receiver-operator curve (ROC) analysis and various IDEEL-SB change criteria were used to determine CID.

Main Results:

• The study included 74 subjects (52% female, mean age 54.0 years).
• Baseline IDEEL-SB scores differed significantly across severity groups: mild (40.0), moderate (50.6), and severe (64.3) (p=0.001).
• A 12-point change in IDEEL-SB score was identified as a clinically significant change in symptoms via ROC analysis.

Conclusions:

• A 12-point shift in the IDEEL-SB module represents a clinically important difference (CID).
• This CID is based on ROC analysis and correlates with global assessments of treatment-induced changes in dry eye condition.
• The IDEEL-SB is a valuable tool for assessing dry eye severity and treatment response.