ABSTRACT
Introduction: PrecISE is an ongoing Phase II clinical trial sponsored by the National Heart, Lung, and Blood Institute to investigate the efficacy of several treatments for severe asthma. The threat of COVID-19 has raised interest in obtaining reliable spirometry data for asthma research and clinical care in a remote, “no-touch” fashion. Prior studies of the accuracy of remote spirometry have not included real-time coaching. The PrecISE investigators hypothesized that remote spirometry with real-time video coaching could provide an accurate FEV1 for use as a study endpoint in a clinical trial setting. Methods: PrecISE network participants had remote spirometry post-bronchodilator (4 puffs of albuterol) measured with video coaching from trained research coordinators using the ZEPHYRx platform connected to MIR Spirobank Smart handheld spirometers. Remote spirometry measurements occurred within a +/- 3-day window from scheduled in-person PrecISE visits during which in-person spirometry with bronchodilator challenge was measured with standard equipment (Vyaire Medical). All measurements occurred during the screening/run-in period of the PrecISE protocol. Both remote and in-person spirometry was overread by the PrecISE Spirometry Core and only included in analysis if sessions met ATS acceptability and reproducibility criteria. Correlations between remote and in-person FEV1 and FVC were analyzed, and Bland-Altman plots generated. As a comparison, within subject biological variability was measured using data from separate in-person visits during the screening/run-in period. Results: A total of 128 pairs of remote/in-person spirometry data were obtained. The mean FEV1 for remote spirometry was 2.50 L (SD 0.81) and for inperson spirometry was 2.42 L (SD 0.80), with an estimated correlation of 0.95 (95% CI: 0.93, 0.97). The mean difference in FEV1 (in-person - remote) was -0.07 L (95% CI: -0.11, -0.03, SD 0.25). The mean FVC for remote spirometry was 3.72 L (SD 1.01) and for in-person spirometry was 3.53 L (SD 0.93), with an estimated correlation of 0.91 (95% CI: 0.87, 0.93). The mean difference in FVC (in-person - remote) was -0.19 L (95% CI: -0.27, -0.12, SD 0.42). A total of 142 pairs of repeated in-person spirometry measurements were performed (median time between measurements: 43 days), with mean difference in FEV1 of -0.01 L (95% CI: -0.06, 0.03) and FVC of -0.02 L (95% CI: -0.07, 0.03). Bland-Altman plots for FEV1 differences are shown in Figure 1. Conclusions: Remote spirometry with real-time video coaching provides a reliable FEV1 measurement which correlates closely with in-person spirometry and is suitable for use in clinical trials. (Figure Presented).
ABSTRACT
Rationale: School-centered asthma programs demonstrate a significant impact on asthma. The Colorado Comprehensive School-Centered Asthma Program (AsthmaCOMP) has demonstrated reduced asthma hospitalizations, ED visits and asthma attacks. The COVID-19 pandemic has disproportionally impacted minority communities including school disruptions since March 2020. We, therefore, evaluated the impact of COVID-19 restrictions on asthma control in children with families who identified social determinants of health (SDOH). We hypothesized that COVID-19 restrictions, specifically the abrupt school closures, would result in loss of asthma control, especially for children with previously identified SDOH, due to limited access to health care. Methods: AsthmaCOMP is implemented in 40 elementary schools, enrolling students ages 5 to 11, in a patient education and care coordination program. Most students come from low-income families with limited resources. There are 2 cohorts (Cohort 1/2018-2019: 45 students-Cohort 2/2019-2020: 83 students) meeting with asthma counselors every 3 months. We compared asthma clinical outcomes (ACT scores and ED visits) before and during the pandemic assessing the impact of COVID-19 restrictions on asthma in children with and without SDOH. We evaluated similar data from students who were lost to follow-up for impact on program engagement. Results: Outcomes were evaluated at 3 intervals: beginning of the school year, mid-year, and end of year (See Figure 1 below). Results showed no change in asthma control for both cohorts, as indicated by ACT scores, for students with or without identified SDOH. In cohort 1, an increase in ED visits for students without identified SDOH was noted during the pandemic. Students lost to follow-up had worse asthma clinical outcomes at baseline, particularly those students with identified SDOH. Conclusions: Students participating in AsthmaCOMP maintained asthma control despite COVID-19 restrictions. Students with poorly controlled asthma at baseline, particularly those with identified SDOH were more likely to be lost to follow-up. This study reinforces the importance and effectiveness of school-based asthma programs in improving asthma control, even for high-risk populations with SDOH. Students without identified SDOH were more likely to be seen in the ED during the pandemic;perhaps this is related to disruption of social structure which may evoke SDOH not previously identified. Future studies are needed to explore the mechanisms by which the pandemic and restrictions affect children with asthma and SDOH.