Relating spontaneous adverse experience reports to scores on a questionnaire querying tolerability

Area of Science:

• Ophthalmology
• Clinical Pharmacology
• Patient-Reported Outcomes

Background:

• Topical ophthalmic agents for ocular hypertension/glaucoma can cause side effects.
• Assessing patient-reported side effects is crucial for treatment adherence and quality of life.

Purpose of the Study:

• To examine the relationship between spontaneously reported adverse experiences (AEs) and checklist questionnaire responses.
• To investigate the impact of side effects on health-related quality of life in glaucoma patients.

Main Methods:

• A 4-week, randomized, open-label, two-period cross-over trial comparing dorzolamide and pilocarpine in 92 patients on timolol.
• Patients completed the Comparison of Ophthalmic Medications for Tolerability (COMTOL) questionnaire and provided spontaneous AE reports.
• Analysis focused on pilocarpine treatment periods due to limited spontaneous AEs with dorzolamide.

Main Results:

• 94% of patients not reporting spontaneous AEs indicated experiencing side effects on the COMTOL questionnaire.
• Patients spontaneously reporting AEs experienced more bother and greater negative impact on quality of life.
• Discontinuation due to AEs correlated with the highest reported bother and negative impact on quality of life.

Conclusions:

• Discrepancies exist between spontaneous AE reporting and checklist questionnaires.
• Spontaneous reporting appears more sensitive in identifying clinically meaningful side effects.
• The degree of bother from side effects influences reporting and treatment adherence in glaucoma management.