From trial to practice: incidence and severity of COVID-19 vaccine side effects in a medically at-risk and vaccine-hesitant community.

BACKGROUND: The rapid authorization and widespread rollout of COVID-19 vaccines in the United States demonstrated a need for additional data on vaccine side effects, both to provide insight into the range and severity of side effects that might be expected in medically-diverse populations as well as to inform decision-making and combat vaccine hesitancy going forward. Here we report the results of a survey of 4825 individuals from southcentral Kentucky who received two doses of either the Pfizer-BioNTech (BNT162b2) or Moderna (mRNA-1273) vaccine between December 14, 2020 and May 1, 2021. As new versions of the vaccine are rolled-out, local initiatives such as this may offer a means to combat vaccine hesitancy in reference to COVID-19, but are also important as we face new viral threats that will necessitate a rapid vaccine rollout, and to combat a growing public distrust of vaccines in general. METHODS: Individuals that received two doses of either BNT162b2 or mRNA-1273 between December 14, 2020 and May 1, 2021 were sent a survey, created by the research team. Respondents were asked to rate the incidence and severity of 15 potential side effects and two related outcomes following each of their two doses of the vaccine. All statistical analyses were carried out using SYSTAT, version 13. The data were analyzed utilizing a range of statistical tests, including chi-square tests of association, Cohen's h, Kruskal-Wallis test one-way nonparametric ANOVA, least-squares regression, and Wilcoxon signed-ranks test. Significance was assessed using Bonferroni-adjusted criteria within families of tests. RESULTS: In general, the pattern and severity in side effects was similar to both clinical trial data as well as other published studies. Responses to the mRNA-1273 vaccine were more severe than to BNT162b2, though all were generally in the mild to moderate category. Individuals who reported having previously tested positive for COVID-19 reported stronger responses following the first dose of either vaccine relative to COVID-naïve individuals. The reported severity to the COVID-19 vaccine was positively correlated with self-reported responses to other vaccines. CONCLUSIONS: Our findings allow broad-scale estimates of the nature and severity of reactions one might expect following vaccination within a clinically-diverse community, and provide a context for addressing vaccine hesitancy in communities such as ours, where locally-generated data and communication may be more influential than national trends and statistics in convincing individuals to become vaccinated. Further, we argue this community-based approach could be important in the future in three key ways: 1) as new boosters and modified vaccines re-volatilize vaccine hesitancy, 2) as new vaccines receive similar testing and rapid authorization, and 3) to combat vaccine hesitancy in other arenas (e.g., annual vaccines, childhood vaccines).

Patient Perspectives With Telehealth Visits in Cardiology During COVID-19: Online Patient Survey Study.

BACKGROUND: The rise of COVID-19 and the issue of a mandatory stay-at-home order in March 2020 led to the use of a direct-to-consumer model for cardiology telehealth in Kentucky. Kentucky has poor health outcomes and limited broadband connectivity. Given these and other practice-specific constraints, the region serves as a unique context to explore the efficacy of telehealth in cardiology. OBJECTIVE: This study aims to determine the limitations of telehealth accessibility, patient satisfaction with telehealth relative to in-person visits, and the perceived advantages and disadvantages to telehealth. Our intent was two-fold. First, we wanted to conduct a rapid postassessment of the mandated overhaul of the health care delivery system, focusing on a representative specialty field, and how it was affecting patients. Second, we intend to use our findings to make suggestions about the future application of a telehealth model in specialty fields such as cardiology. METHODS: We constructed an online survey in Qualtrics following the Patient Assessment of Communication During Telemedicine, a patient self-report questionnaire that has been previously developed and validated. We invited all patients who had a visit scheduled during the COVID-19 telehealth-only time frame to participate. Questions included factors for declining telehealth, patient satisfaction ratings of telehealth and in-person visits, and perceived advantages and disadvantages associated with telehealth. We also used electronic medical records to collect no-show data for in-person versus telehealth visits to check for nonresponse bias. RESULTS: A total of 224 respondents began our survey (11% of our sample of 2019 patients). Our recruitment rate was 86% (n=193) and our completion rate was 62% (n=120). The no-show rate for telehealth visits (345/2019, 17%) was nearly identical to the typical no-show rate for in-person appointments. Among the 32 respondents who declined a telehealth visit, 20 (63%) cited not being aware of their appointment as a primary factor, and 15 (47%) respondents cited their opinion that a telehealth appointment was not medically necessary as at least somewhat of a factor in their decision. Both in-person and telehealth were viewed favorably, but in-person was rated higher across all domains of patient satisfaction. The only significantly lower mean score for telehealth (3.7 vs 4.2, P=.007) was in the clinical competence domain. Reduced travel time, lower visit wait time, and cost savings were seen as big advantages. Poor internet connectivity was rated as at least somewhat of a factor by 33.0% (35/106) of respondents. CONCLUSIONS: This study takes advantage of the natural experiment provided by the COVID-19 pandemic to assess the efficacy of telehealth in cardiology. Patterns of satisfaction are consistent across modalities and show that telehealth appears to be a viable alternative to in-person appointments. However, we found evidence that scheduling of telehealth visits may be problematic and needs additional attention. Additionally, we include a note of caution that patient satisfaction with telehealth may be artificially inflated during COVID-19 due to external health concerns connected with in-person visits.