TITLE: Thyroid eye disease and COVID-19 vaccination
DATE: Wednesday, 25 January 2023
TIME: 1:30–3:00 PM
INVESTIGATORS:
Patcharaporn Chandraparnik (1,2)
Andrea Kossler (1)
- Ophthalmology Department, Byers Eye Institute
- Ophthalmology Department, Phramongkutklao Hospital/College of Medicine, Bangkok, Thailand
LOCATION: Conference Room X399, Medical School Office Building, 1265 Welch Road, Stanford, CA
WEBPAGE: https://dbds.stanford.edu/data-studio/
ABSTRACT
The Data Studio Workshop brings together a biomedical investigator with a group of experts for an in-depth session to solicit advice about statistical and study design issues that arise while planning or conducting a research project. This week, the investigator(s) will discuss the following project with the group.
INTRODUCTION
COVID-19 vaccine has been proved for efficacy and safety. Recently, there is emerging evidence of thyroid dysfunction after COVID-19 vaccination. This retrospective cohort study will be the first to examine the association between reactivation of TED and COVID-19 vaccination. Apart from thyroid dysfunction, there are case series reported on reactivation or worsening of thyroid eye disease (TED). There are five case series with a total of 14 patients that report on reactivation or new onset of TED after COVID-19 vaccination. Due to limited study, no conclusion about the association between vaccine and reactivation of disease was established.
The incidence for development of TED in Graves’ disease (GD) patients is approximately 15–30%. The pooled prevalence of TED among GD patients was 46% (CI: 37%–55%) in women and 49% (CI: 39%–60%) in men. The prevalence of active TED among TED patients was 32% (CI: 18%–48%) in women and 42% (CI: 27%–59%) in men. In a single center study of first-visit patients (N=415) with one physician during the period 2006 to 2012, 15.7% (m=65) of inactive TED patients had recurrent active TED with a mean interval of 10.3 years (range 2–56 years) between first and second event. Most patients experienced reactivation within 5 years after their first event (50.8%) and all but 7 patients experienced recurrence within 20 years after their first active phase.
HYPOTHESIS & AIM
Our hypothesis is that COVID-19 vaccination will increase incidence of active TED in inactive TED and Graves’ disease patients. Our aim is to assess the incidence of reactivation of thyroid eye disease (TED) in inactive TED or new onset of TED in Graves’ disease patients who receive COVID-19 vaccine compare to patients who do not receive COVID-19 vaccine.
DATASET
We plan to collect data of pre-existing TED patient from Oculoplastic clinic, Byers Eye Institute.
a. Inactive TED patients without history of vaccination (before January 2018) follow for 1 years whether they develop active TED
b. Inactive TED patients who received vaccine (after January 2021) and follow for 1 year whether they develop active TED
We also plan to collect data of Graves’ disease patients from Endocrine Clinic, Stanford Hospital.
a. Graves’ disease patients without history of vaccination (before January 2018) follow for 1 year whether they develop active TED
b. Graves’ disease patients who received vaccine (after January 2021) follow for 1 year whether they develop active TED
(The first American case of COVID infection -January 2020
COVID-19 vaccines became available in December 2020
Hx vaccine will check from Epic or call the patient)
The primary outcome will be Relative risk between [the incidence of Graves’ disease patient who received vaccine develop active TED] compare to [the incidence of Graves’ disease patient develop active TED before vaccine era]
STATISTICAL MODEL
Relative risk between [the incidence of Graves’ disease and inactive TED patients who received vaccine develop active TED] compare to [the incidence of Graves’ disease patient and inactive TED develop active TED]. Accepted clinical significance at 20% increase incidence of active TED in vaccinated patient compare to non-vaccinate patient.
STATISTICAL ISSUES
- Due to low incidence of active thyroid eye disease each year, how should I design my project? Cohort? Case control? or something else?
- Is 1-year follow-up enough to show the significance of this study?
- Sample size calculation
- Should I set the data collection as below?
- Inactive TED patients without history of vaccination (before January 2018) follow for 1 years whether they develop active TED
- I plan to collect the non-vaccinate patient before outbreak of COVID infection which is January 2020 to decrease the confounder of COVID infection-induced reactivation of TED.
- How could we manage the confounder, effect modifier? The previous studies of risk factors of active TED still do not have the results in the same way and there are a lot of confounders.
ZOOM MEETING INFORMATION
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