Cross-sectional study design
anxiety/depression
DISEASE, RECRUITMENT
In the cross-sectional, observational study, SIC data were collected via a web-based survey from US adults with COVID-19 based on a positive test and current symptoms. Inclusion criteria were the following: adults (aged ≥ 18 years) with a self-reported positive COVID-19 test within 2 weeks of screening; ≥ 2 current, bothersome symptoms of COVID-19; and willingness to provide medical and demographic information and to complete the survey. Recruitment targets for the survey were set to ensure a diverse sample for age (up to 50% < 65 years old), hospitalization status (≥ 35 patients hospitalized because of COVID-19), preexisting comorbidities (causing higher risk for severe disease), race/ethnicity (up to 50% non-White), and disease severity (mild, moderate, and severe). Recruitment targets for the exit interviews also aimed for a diverse population with ≥ 50% minority status, with highest priority given to race/ethnicity other than White, education level less than high school/General Educational Development and variable access to health care. Participants received 100 USD in appreciation of their time for completing the web-based survey and an additional 100 USD for completion of the exit interview.Participants in the cross-sectional study completed the SIC, a study-specific Overall Symptom Checklist for the 30 SIC items (to identify symptoms that had been experienced but resolved; yes or no for each item), and an open-ended response option for any symptoms they experienced that were not captured in the checklist. Participants were asked 2 additional questions about what symptoms had to improve or resolve before they felt they could return to their usual activities and 4 questions about their access to and receipt of medical care related to COVID-19 (Table Psychometric performance of the SIC was evaluated using other PRO measures, including the Patient Global Impression of Severity (PGIS) [The EQ-5D-5L was used on an exploratory basis to rate current health status. The EQ-5D-5L evaluates 5 dimensions: mobility, daily activities, self-care, pain/discomfort, and anxiety/depression [After completing the web-based survey, participants were asked to participate in an in-depth exit interview using a semistructured guide to provide further details regarding their COVID-19 experience. Analysis of the exit interview data used a thematic qualitative approach with information from field notes and transcripts to identify dominant trends and generate themes or patterns in respondents’ symptom reports. Common themes were identified via constant comparative analysis, which also allowed confirmation of content validity and patient comprehension of the SIC.