Faculty Bibliography

Purpose/UNASSIGNED:Herpes zoster (HZ) has been identified as a potential association with the BNT162b2 COVID-19 vaccination. This study evaluated this possible association in a cohort of patients receiving the vaccination. Methods/UNASSIGNED:Epic electronic health records of adult patients who received at least one COVID-19 vaccination between January 12, 2020 and 9/30/2021 within the NYU Langone Health were reviewed to analyze a new diagnosis of herpes zoster within 3 months before compared to 3 months after vaccination. Results/UNASSIGNED:Of the 596,111 patients who received at least one COVID-19 vaccination, 716 patients were diagnosed with HZ within three months prior to vaccination, compared to 781 patients diagnosed within 3 months afterwards. Using the chi-square test for independence of proportions, there was not a statistically significant difference in frequency of HZ before (proportion: 0.0012, 95% CI: [0.0011, 0.0013]) vs. after vaccination (proportion: 0.0013, 95% CI: [0.0012, 0.0014]); (p = 0.093). Conclusions and importance/UNASSIGNED:This study did not find evidence of an association between COVID-19 vaccination and a new diagnosis of HZ. We encourage health care professionals to strongly recommend COVID-19 vaccinations per Centers for Disease Control (CDC) recommendations and vaccination against HZ according to Food and Drug Administration (FDA) approval for the recombinant zoster vaccine.

PURPOSE/OBJECTIVE:The purpose of this study was to describe the rationale and design of the Zoster Eye Disease Study (ZEDS). METHODS:ZEDS is a National Eye Institute-supported randomized clinical trial designed to determine whether 1 year of suppressive valacyclovir in patients with herpes zoster ophthalmicus (HZO) reduces complications because there is currently no high-quality evidence to support its use. Eligible patients are 18 years and older, immunocompetent, have a history of a typical rash at disease onset, and have had a record of active epithelial or stromal keratitis or iritis within 1 year before enrollment. Exclusion criteria include estimated glomerular filtration rate less than 45 or pregnancy. The primary endpoint is the time to first occurrence of new or worsening dendriform epithelial keratitis, stromal keratitis without or with ulceration, endothelial keratitis, or iritis due to HZO during 12 months of study treatment requiring prespecified treatment changes. The study has 80% power to detect a 30% difference between treatment groups, with a 30% rate of endpoints by 1 year assumed among controls. Secondary and exploratory questions include whether there is a persistent treatment benefit during the 6 months after treatment, whether development of postherpetic neuralgia varies by treatment group, and whether vaccinations against herpes zoster affect study outcomes and coronavirus disease 19 status. RESULTS:Over approximately 4 years, over 400 study participants have been enrolled. CONCLUSIONS:ZEDS aims to provide scientific evidence on whether suppressive valacyclovir treatment improves outcomes in HZO and should become the standard of care.

Purpose/UNASSIGNED:To report 3 otherwise healthy patients with Herpes zoster reactivation shortly after administration of a mRNA vaccine against the novel COVID-19 virus. Observations/UNASSIGNED:Patient 1 is a 54 year old who presented with Herpes zoster meningitis complicated by enhancing nodular leptomeningeal lesions of the spinal cord. The subsequent two patients had Herpes zoster ophthalmicus of the cornea (Case 2) and eyelid (Case 3). All three presented within 2 weeks of receiving the Pfizer/BioNTech COVID-19 vaccine. Conclusions/UNASSIGNED:Herpes zoster may be a side effect of m RNA vaccination against the Sars-CoV2 vaccine and requires further investigation.

Background/UNASSIGNED:Little outcome data exist on 3-year MD (3YMD) programs to guide residency program directors (PDs) in deciding whether to select these graduates for their programs. Objective/UNASSIGNED:To compare performance outcomes of 3YMD and 4-year MD (4YMD) students at New York University Grossman School of Medicine. Methods/UNASSIGNED:In 2020, using the Kirkpatrick 4-level evaluation model, outcomes from 3 graduating cohorts of 3YMD students (2016-2018) were compared with the 4YMD counterparts. Results/UNASSIGNED:=.03), other metrics and overall intern ratings did not differ by pathway. Conclusions/UNASSIGNED:Exploratory findings from a single institution suggest that 3YMD students performed similarly to 4YMD students in medical school and the first year of residency.

Purpose/UNASSIGNED:To describe steps taken that enabled a high rate of retention and early resumption of enrollment in the Zoster Eye Disease Study (ZEDS), a randomized controlled trial funded by the National Eye Institute, during the first 13 months (3/1/2020-3/31/2021) of the COVID-19 pandemic. Methods/UNASSIGNED:A number of responses were implemented in ZEDS when the focus shifted to retention of study participants at the beginning of the pandemic including frequent communication with the participating clinical centers (PCCs) about remote visits, local lab work, shipping study medication, and completion of revised case report forms. Additional payments were provided to the PCCs. Remote activation of PCCs continued. Screening and enrollment visits gradually resumed when allowed. Results/UNASSIGNED:Communication with PCCs increased, and average attendance at monthly coordinator teleconferences went up from 17 to 47. Remote visits peaked in April 2020, accounting for 75% (33/44) of study visits, then declined to less than 10% of study visits beginning August 2020. Overall, 97% (590/609) of study visits were completed. Only 5.5% (9/165) of study participants withdrew consent, and 2.4% (4/165) were lost to follow-up. Enrollment returned to pre-pandemic levels by September 2020. Discussion/UNASSIGNED:Strong communication and unwavering commitment, combined with the technological capability for remote work, visits, and shipment of study medication, were key to the successful retention of study participants and resumption of enrollment. Conclusions/UNASSIGNED:Rapid responses to challenges to trials caused by the COVID-19 pandemic can enable them to continue successfully and provide insights into the planning of future trials.

ABSTRACT:This brief definitive review of herpes zoster (HZ) will cover the current state of knowledge and questions that remain to be answered regarding HZ in general and HZ ophthalmicus in particular. A question-and-answer format will be used to address various important topics related to this common and serious disease. Questions to be addressed relate to common misconceptions, contagiousness of infection, unknowns regarding pathogenesis, rising incidence, risk factors and complications, relationship with temporal arteritis, vaccination, and current and future antiviral treatment. In addition, the importance of the Zoster Eye Disease Study to determine the efficacy of suppressive valacyclovir treatment in preventing complications of HZ ophthalmicus and the need to support enrollment will be discussed.

PURPOSE/OBJECTIVE:To present the results of a survey of the Zoster Eye Disease Study (ZEDS) investigators regarding barriers to the enrollment of study participants and approaches to overcome them. METHODS:ZEDS is a multicenter randomized clinical trial supported by the National Eye Institute to determine whether prolonged suppressive valacyclovir reduces the complications of herpes zoster ophthalmicus (HZO), relative to placebo. Enrollment of study participants is currently far below expectations. An institutional review board-approved anonymous internet survey was conducted of ZEDS investigators to study their experiences and opinions regarding barriers to enrollment and various approaches to overcome them. RESULTS:The overall survey response rate was 54% (79/145). Only 29% (23/79) agreed that it is easy to enroll study participants. Regarding patient barriers, 69% (55/79) agreed that HZO patients want to be treated with antiviral medication and 69% (54/78) agreed that HZO patients on antivirals do not want to be randomized. Regarding personal barriers facing investigators, 91% (72/79) agreed that antivirals are effective and 100% that the research questions ZEDS is designed to answer are very important. Fewer than 30% of respondents believed that steps taken to increase enrollment have been very helpful. Over half (54%, 42/78) believed that advertising on social media would be moderately or very effective. CONCLUSIONS:Belief among ZEDS investigators that antivirals are effective, and the preference of patients to be treated with antivirals rather than be randomized in ZEDS, are major barriers to enrollment. New approaches to overcoming barriers are necessary to develop an evidence-based standard of care for treatment of HZO.

The revision of the curriculum at New York University School of Medicine in 2010, with a reduction of the preclerkship curriculum to 18 months, made it possible to offer an accelerated 3-year pathway in 2013 for students who know their career path. The goals of the program include individualizing education, reducing student debt, and integrating undergraduate and graduate medical education. This accelerated 3-year doctor of medicine (3YMD) pathway is the first program of its kind in the United States to offer conditional acceptance to residency programs in all specialties through the National Resident Matching Program. Since inception of the pathway 6 years ago, 81 students have graduated. Critical components to successfully launch and implement the program are described.Unwavering commitment to the program as a high institutional priority by the dean and vice dean for education facilitated the support required by department chairs and residency program directors and the flexibility needed for success. Alignment between the 3- and 4-year pathways has made it possible to add points of entry into the 3-year pathway during the second and third years and to shift back into the 4-year pathway, as warranted. Modifications to how 3YMD students are mentored included changing the role of the departmental advisor and adding a dedicated 3YMD pathway advisor who serves as an advocate for both the students and the program. Having a relatively large number of 3YMD students has contributed to the success of the program and facilitated acceptance by the residencies.