F or weeks we watched as Wuhan, China, was ravaged by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), wondering what the future had in store for us. On January 21, 2020, the first known case of coronavirus disease 2019 (COVID-19) on US soil was identified 20 miles north of Seattle in the town of Everett, WA. On Friday, February 28, the nation's first reported death due to COVID-19 infection was disclosed, followed by the second mortality case a mere 48 hours later. Both were patients with kidney failure dialyzing with Northwest Kidney Centers in our ambulatory clinics and subsequently under the care of our Hospital Services team. During the course of that weekend, our organization was brought to the forefront of the COVID-19 pandemic, mandating an immediate and coordinated response. Our approach to managing the threat in our outpatient facilities has been summarized elsewhere. 1 This editorial focuses on the acute care setting by considering 3 key questions.
Background The FLU-PRO Plus is a patient-reported outcome data collection instrument assessing symptoms of viral respiratory tract infections across eight body systems. This study evaluated the measurement properties of FLU-PRO Plus in a study enrolling individuals with COVID-19. Methods Data from a prospective cohort study (EPICC) in US Military Health System (MHS) beneficiaries evaluated for COVID-19 was utilized. Adults with symptomatic SARS-CoV-2 infection with FLU-PRO Plus survey information within one week of symptom onset were included. Reliability of FLU-PRO Plus was estimated using intraclass correlation coefficients (ICC; 2 days reproducibility). Known-groups validity was assessed using patient global assessments (PGA) of disease severity. Patient report of return to usual health was used to assess responsiveness (day 1-6/7). Results 226 SARS-CoV-2 positive participants were included in the analysis. Reliability among those who reported no change in their symptoms from one day to the next was high for most domains (ICC range 0.68-0.94 for day 1 to day 2). Construct validity was demonstrated by moderate to high correlation between the PGA rating of disease severity and domain and total scores (e.g., total scores correlation: 0.69 (influenza-like illness severity), 0.69 (interference in daily activities), and -0.58 (physical health)). In addition, FLU-PRO Plus demonstrated good known-groups validity, with increasing domain and total scores observed with increasing severity ratings. Conclusions FLU-PRO Plus performs well in measuring signs and symptoms in SARS-CoV-2 infection with excellent construct validity, known-groups validity, and responsiveness to change. Standardized data collection instruments facilitate meta-analyses, vaccine effectiveness studies, and other COVID-19 research activities.
Background Early recognition of high-risk patients with COVID-19 may improve outcomes. Although many predictive scoring systems exist, their complexity may limit utility in COVID-19. We assessed the prognostic performance of the National Early Warning Score (NEWS) and an age-based modification (NEWS+age) among hospitalized COVID-19 patients enrolled in a prospective, multicenter U.S. Military Health System (MHS) observational cohort study. Methods Hospitalized adults with confirmed COVID-19 not requiring invasive mechanical ventilation at admission and a baseline NEWS were included. We analyzed each scoring system’s ability to predict key clinical outcomes, including progression to invasive ventilation or death, stratified by baseline severity (low (0-3), medium (4-6) and high (≥7)). Results Among 184 included participants, those with low baseline NEWS had significantly shorter hospitalizations (p<0.01) and lower maximum illness severity (p<0.001). Most (80.2%) of low NEWS versus 15.8% of high NEWS participants required no or at most low flow oxygen supplementation. Low NEWS (≤3) had a negative predictive value of 97.2% for progression to invasive ventilation or death; a high NEWS (≥7) had high specificity (93.1%) but low positive predictive value (42.1%) for such progression. NEWS+age performed similarly to NEWS at predicting invasive ventilation or death (NEWS+age: AUROC 0.69; 95% CI 0.65-0.73; NEWS: AUROC 0.70; 0.66-0.75). Conclusions NEWS and NEWS+age showed similar test characteristics in an MHS COVID-19 cohort. Notably, low baseline scores had excellent negative predictive value. Given their easy applicability, these scoring systems may be useful in resource-limited settings to identify COVID-19 patients who are unlikely to progress to critical illness.
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