The Clinical Course of COVID-19 in the Outpatient Setting: A Prospective Cohort Study
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Abstract
Background
Outpatient coronavirus disease 2019 (COVID-19) has been insufficiently characterized. To determine the progression of disease and determinants of hospitalization, we conducted a prospective cohort study.
Methods
Outpatient adults with positive reverse transcription polymerase chain reaction results for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were recruited by phone between April 21 and July 23, 2020, after receiving outpatient or emergency department testing within a large health network in Maryland, United States. Symptoms were collected by participants on days 0, 3, 7, 14, 21, and 28, and portable pulse oximeter oxygen saturation (SaO2), heart rate, and temperature were collected for 15 consecutive days. Baseline demographics, comorbid conditions, and vital signs were evaluated for risk of subsequent hospitalization using negative binomial and logistic regression.
Results
Among 118 SARS-CoV-2-infected outpatients, the median age (interquartile range [IQR]) was 56.0 (50.0–63.0) years, and 50 (42.4%) were male. Among individuals in the first week of illness (n = 61), the most common symptoms included weakness/fatigue (65.7%), cough (58.8%), headache (45.6%), chills (38.2%), and anosmia (27.9%). Participants returned to their usual health a median (IQR) of 20 (13–38) days from symptom onset, and 66.0% of respondents were at their usual health during the fourth week of illness. Over 28 days, 10.9% presented to the emergency department and 7.6% required hospitalization. The area under the receiver operating characteristics curve for the initial home SaO2 for predicting subsequent hospitalization was 0.86 (95% CI, 0.73–0.99).
Conclusions
Symptoms often persisted but uncommonly progressed to hospitalization among outpatients with COVID-19. Home SaO2 may be a helpful tool to stratify risk of hospitalization.
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SciScore for 10.1101/2020.09.01.20184937: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Study design: In an Institutional Review Board-approved study, persons ≥ age 18 who attended one of the Johns Hopkins Health System COVID-19 testing sites and tested positive for SARS-CoV-2 were offered enrollment in the study, excluding patients hospitalized at the time of screening.
Consent: Verbal consent was obtained via telephone.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Analyses were performed using Stata version 16.0 (StataCorp LLC, College Station, TX, USA) and figures were created using Stata or R statistical platform … SciScore for 10.1101/2020.09.01.20184937: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Study design: In an Institutional Review Board-approved study, persons ≥ age 18 who attended one of the Johns Hopkins Health System COVID-19 testing sites and tested positive for SARS-CoV-2 were offered enrollment in the study, excluding patients hospitalized at the time of screening.
Consent: Verbal consent was obtained via telephone.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Analyses were performed using Stata version 16.0 (StataCorp LLC, College Station, TX, USA) and figures were created using Stata or R statistical platform version 4.0.1 (R Foundation). StataCorpsuggested: (Stata, RRID:SCR_012763)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:While this is the largest prospective outpatient cohort to characterize the clinical course of COVID-19, the study has several limitations. First, this study predominantly included older individuals to increase the statistical power for severe outcomes given the known association between age and hospitalization(12). Symptoms including severity and duration of illness may differ considerably in younger individuals and our results are more generalizable for persons of similar ages (24). Outpatients have been previously found to be younger and have less comorbidities compared to hospitalized patients(25). Second, the recruitment strategy may have skewed the study population. For instance, participants with milder symptoms and those with altruistic professions (e.g. healthcare workers) could have been more likely to participate in the study processes than others. A quarter of participants had symptoms of onset 10 days prior to enrollment, and therefore a proportion of participants may have been selected who had successfully passed a time window of disease severity. Additionally, due to operational requirements, Spanish-speakers were not enrolled proportionate to cases early after study initiation and individuals without active mobile phone access were not enrolled. Third, missing data from loss to follow-up or withdrawals during the study period could have skewed the longitudinal severity of results. For example, participants with milder illness could have been more likely to wit...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04496466 Enrolling by invitation Clinical Characterization Protocol for Severe Infectious Dis… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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