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Enrollment in the Zoster Eye Disease Study.
Elisabeth J Cohen1, Bennie H Jeng2, Andrea B Troxel3
1Department of Ophthalmology, NYU Grossman School of Medicine, New York, NY.
Cornea
|June 20, 2020
Summary
Investigator beliefs and patient preferences for antivirals, not randomization, hinder herpes zoster ophthalmicus (HZO) trial enrollment. New strategies are needed to establish an evidence-based standard of care for HZO.
Area of Science:
- Ophthalmology
- Infectious Diseases
- Clinical Trials
Background:
- Herpes zoster ophthalmicus (HZO) is a serious ocular condition.
- The Zoster Eye Disease Study (ZEDS) aims to evaluate the efficacy of prolonged suppressive valacyclovir for HZO complications.
- Current enrollment in ZEDS is significantly below projected targets.
Purpose of the Study:
- To identify barriers to participant enrollment in the Zoster Eye Disease Study (ZEDS).
- To explore potential strategies for overcoming these enrollment barriers.
Main Methods:
- An anonymous internet survey was administered to ZEDS investigators.
- The survey assessed investigator perceptions of patient and personal barriers to enrollment.
- Investigator opinions on the effectiveness of enrollment strategies were collected.
Main Results:
- A 54% response rate was achieved among ZEDS investigators.
- A majority of investigators agreed that HZO patients prefer antiviral treatment over randomization (69%) and that antivirals are effective (91%).
- Investigators reported that current enrollment strategies have been largely ineffective, with over half seeing potential in social media advertising.
Conclusions:
- Investigator confidence in antiviral efficacy and patient preference for treatment over randomization present significant barriers to ZEDS enrollment.
- Novel approaches are required to facilitate enrollment and establish an evidence-based standard of care for HZO treatment.
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