Psychometric evaluation of the Symptoms of Infection with Coronavirus-19 (SIC): results from a cross-sectional study and a phase 3 clinical trial.

BACKGROUND: The Symptoms of Infection with Coronavirus-19 (SIC) is a 30-item patient-reported outcome (PRO) measure scored by body system composites to assess signs/symptoms of coronavirus disease 2019 (COVID-19). In addition to cross-sectional and longitudinal psychometric evaluations, qualitative exit interviews were conducted to support the content validity of the SIC. METHODS: In a cross-sectional study, adults diagnosed with COVID-19 in the United States completed the web-based SIC and additional PRO measures. A subset was invited to participate in phone-based exit interviews. Longitudinal psychometric properties were assessed in ENSEMBLE2, a multinational, randomized, double-blind, placebo-controlled, phase 3 trial of the Ad26.COV2.S COVID-19 vaccine. Psychometric properties evaluated included structure, scoring, reliability, construct validity, discriminating ability, responsiveness, and meaningful change thresholds of SIC items and composite scores. RESULTS: In the cross-sectional study, 152 participants completed the SIC (mean age, 51.0 ± 18.6 years) and 20 completed follow-up interviews. Fatigue (77.6%), feeling unwell (65.8%), and cough (60.5%) were symptoms most frequently reported. SIC inter-item correlations were all positive and mostly moderate (r ≥ 0.3) and statistically significant. SIC items and Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) scores correlated as hypothesized (all r ≥ 0.32). Internal consistency reliabilities of all SIC composite scores were satisfactory (Cronbach's alpha, 0.69-0.91). SIC composite scores correlated moderately (r = 0.30-0.49) to strongly (r ≥ 0.50) with PROMIS-29 scores and Patient Global Impression of Severity (PGIS) ratings (all P < 0.01). A variety of signs/symptoms were cited in exit interviews, and participants considered the SIC straightforward, comprehensive, and easy to use. From ENSEMBLE2, 183 participants with laboratory-confirmed moderate to severe/critical COVID-19 were included (51.5 ± 14.8 years). Strong test-retest reliabilities were observed for most SIC composite scores (intraclass correlations ≥ 0.60). Statistically significant differences across PGIS severity levels were found for all but 1 composite score, supporting known-groups validity. All SIC composite scores demonstrated responsiveness based on changes in PGIS. CONCLUSIONS: The psychometric evaluations provided strong evidence for the reliability and validity of the SIC for measuring COVID-19 symptoms, supporting its use in vaccine and treatment trials. In exit interviews, participants described a broad range of signs/symptoms consistent with previous research, further supporting the content validity and format of the SIC.

Coronavirus disease 2019 (COVID-19) is a serious disease that continues to evolve globally. Researchers developed the Symptoms of Infection with Coronavirus-19 (SIC), a 30-item questionnaire designed for patients to report signs and symptoms of COVID-19. In this study, the researchers formally analyzed how well the SIC measures the patient experience with COVID-19, using survey and clinical trial data as well as telephone interviews. Adults with COVID-19 and at least 2 bothersome symptoms completed the web-based survey, and some of these individuals also participated in in-depth interviews. Participants in a clinical trial for a COVID-19 vaccine also completed the SIC measure. The SIC was compared with other commonly used questionnaires that evaluate patient experience. The most commonly reported symptoms of COVID-19 were fatigue, feeling unwell, cough, weakness, and headache. The items for individual symptoms (e.g., "cough") and combined scores for body systems (e.g., "respiratory system") performed well in statistical analyses. Participants found the SIC to be straightforward, comprehensive, and easy to use. The SIC may prove useful in the future for vaccine and treatment trials for COVID-19.

Long-term orientation and demographics predict the willingness to quarantine: A cross-national survey in the first round of COVID-19 lockdown.

To be or not to be quarantined? That is the question posed by COVID-19 pandemic to almost every resident in the world. Approximately three months after the first application of the COVID-19 lockdown to residents in 17 Asian, African, European, American, and Oceanian countries, we carried out a cross-national survey of 26,266 residents via online platforms such as Sojump and Prolific to investigate their willingness to quarantine and its influencing factors. Findings show that 1) The willingness to quarantine is low in countries with high long-term orientation; 2) Females are more willing to be quarantined than males; 3) Gender difference on willingness to quarantine is large among people with older age and low education. Theoretical and managerial implications are discussed. Understanding how culture and demographics affect people's willingness to quarantine not only provides insight into how to respond to the current pandemic, but also helps the world prepare for future crises.

Inequality in Social Support Associated With Mild Cognitive Impairment: A Cross-Sectional Study of Older (≥60 Years) Residents in Shanghai, China.

Objective: Social support plays a critical role in the detection and management of mild cognitive impairment (MCI). However, socioeconomic inequalities exist in both social support and health care services. Our study aimed to compare the level of social support received by MCI patients in comparison with those without MCI and to determine its link with income. Methods: Secondary data analyses were performed. Social support was measured using the Duke Social Support Index (DSSI) and satisfaction ratings. Multivariate logistic regression models were constructed to determine the associations of personal income and MCI with social support after adjustment for variations in the sociodemographic and health characteristics of the respondents. The multiplicative and additive interaction effects of income and MCI were further examined through introducing the MCI*Income variable to the regression models and using the relative excess risk due to interaction (RERI) analysis, respectively. Results: The logistic regression models showed that the respondents with MCI had significantly lower social support as measured by the DSSI scores (AOR = 33.03, p < 0.001) and satisfaction ratings (AOR = 7.48, p < 0.001) compared with those without MCI. Similarly, social support decreased with lower personal income (p < 0.001). There existed a significant multiplicative interaction effect between personal income and MCI on social support (AOR = 0.30-0.32, p < 0.01). The gap in social support between those with and without MCI was higher in the higher income group compared with the lower income group (p < 0.001). No significant additive interaction effects on social support were found between MCI and income. Conclusions: There are significant disparities in social support between people living with and without MCI. Such a gap is more profound in people with higher income. The inequality in social support associated with MCI may present a significant challenge to the successful implementation of community MCI detection and management.

A systematic review and meta-analysis of children with coronavirus disease 2019 (COVID-19).

To provide a comprehensive and systematic analysis of demographic characteristics, clinical symptoms, laboratory findings, and imaging features of coronavirus disease 2019 (COVID-19) in pediatric patients. A meta-analysis was carried out to identify studies on COVID-19 from 25 December 2019 to 30 April 2020. A total of 48 studies with 5829 pediatric patients were included. Children of all ages were at risk for COVID-19. The main illness classification ranged as: 20% (95% confidence interval [CI]: 14%-26%; I2 = 91.4%) asymptomatic, 33% (95% CI: 23%-43%; I2 = 95.6%) mild and 51% (95% CI: 42%-61%; I2 = 93.4%) moderate. The typical clinical manifestations were fever 51% (95% CI: 45%-57%; I2 = 78.9%) and cough 41% (95% CI: 35%-47%, I2 = 81.0%). The common laboratory findings were normal white blood cell 69% (95% CI: 64%-75%; I2 = 58.5%), lymphopenia 16% (95% CI: 11%-21%; I2 = 76.9%) and elevated creatine-kinase MB 37% (95% CI: 25%-48%; I2 = 59.0%). The frequent imaging features were normal images 41% (95% CI: 30%-52%; I2 = 93.4%) and ground-glass opacity 36% (95% CI: 25%-47%; I2 = 92.9%). Among children under 1 year old, critical cases account for 14% (95% CI: 13%-34%; I2 = 37.3%) that should be of concern. In addition, vomiting occurred in 33% (95% CI: 18%-67%; I2 = 0.0%) cases that may also need attention. Pediatric patients with COVID-19 may experience milder illness with atypical clinical manifestations and rare lymphopenia. High incidence of critical illness and vomiting symptoms reward attention in children under 1 year old.

Quantifying the Time-Lag Effects of Human Mobility on the COVID-19 Transmission: A Multi-City Study in China.

The first wave of the 2019 novel coronavirus (COVID-19) epidemic in China showed there was a lag between the reduction in human mobility and the decline in COVID-19 transmission and this lag was different in cities. A prolonged lag would cause public panic and reflect the inefficiency of control measures. This study aims to quantify this time-lag effect and reveal its influencing socio-demographic and environmental factors, which is helpful to policymaking in controlling COVID-19 and other potential infectious diseases in the future. We combined city-level mobility index and new case time series for 80 most affected cities in China from Jan 17 to Feb 29, 2020. Cross correlation analysis and spatial autoregressive model were used to estimate the lag length and determine influencing factors behind it, respectively. The results show that mobility is strongly correlated with COVID-19 transmission in most cities with lags of 10 days (interquartile range 8 - 11 days) and correlation coefficients of 0.68 ± 0.12. This time-lag is consistent with the incubation period plus time for reporting. Cities with a shorter lag appear to have a shorter epidemic duration. This lag is shorter in cities with larger volume of population flow from Wuhan, higher designated hospitals density and urban road density while economically advantaged cities tend to have longer time lags. These findings suggest that cities with compact urban structure should strictly adhere to human mobility restrictions, while economically prosperous cities should also strengthen other non-pharmaceutical interventions to control the spread of the virus.

Children with coronavirus disease 2019: A review of demographic, clinical, laboratory, and imaging features in pediatric patients

There is a current outbreak of coronavirus disease 2019 (COVID-19), with a global spread. With the rapid increase in the number of infections, an increase is observed in the number of children with COVID-19. Most research findings are regarding adult cases, which are not always transferrable to children. Evidence-based studies are still expected to formulate clinical decisions for pediatric patients. In this review, we included 2597 pediatric patients that reported recently and evaluated the demographic, clinical, laboratory, and imaging features of children with COVID-19. We found that even lymphopenia was the most common lab finding in adults;it infrequently occurred in children (9.8%). Moreover, elevated creatine kinase MB isoenzyme was much more commonly observed in children (27.0%) than that in adults, suggesting that heart injury would be more likely to occur in pediatric patients. Our analysis may contribute to determine the spectrum of disease in children and to develop strategies to control the disease transmission.