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. Author manuscript; available in PMC: 2022 Feb 1.
Published in final edited form as: Contemp Clin Trials. 2021 Jan 12;101:106278. doi: 10.1016/j.cct.2021.106278

Table 2:

Case definitions for clinical adjudication

Disease Required features
Upper Respiratory Tract Disease38,39
  • Must have one or more of the following:
    • Nasal congestion
    • Rhinorrhea
    • Sore throat
Croup40,41
  • Must have seal-like barking cough based on adjudicator review of cough recording

Lower Respiratory Tract Disease4143
  • Must have one or more of the following:
    • Wheezing on auscultation or silent chest (no wheezing because of severe airway obstruction in status asthmaticus) at the time of recording
    • Any chest findings on auscultation, including crackles, bronchial breath sounds (tubular, hollow sounds associated with surrounding consolidation), or focally/asymmetrically decreased breath sounds
    • Increased work of breathing (e.g., using accessory muscles) unless this is purely associated with stridor or upper airway limitation
    • Chest pain or tightness not associated with musculoskeletal, chest wall, or cardiac disease
    • Productive cough > 5 days that is not explained by upper airway disease
    • Hypoxemia in the absence of cyanotic heart disease while awake (<90%)
Asth ma/Reactive Airways Disease44,45
  • Must be wheezing on auscultation or silent chest (no wheezing because of severe airway obstruction in status asthmaticus) at the time of recording

  • Must be responsive to bronchodilators either
    • During this illness, or
    • During prior illnesses
  • If subject has wheeze but no bronchodilator test is available (during this illness or during prior illness) then must diagnose as UNSURE

Viral Lower Respiratory Tract Infection43,46
  • Must have both of the following present:
    • Persistent cough
    • Diffuse crackles and/or wheeze that does not resolve with bronchodilator
  • If less than 2 years old, and if subject has wheeze but no bronchodilator test is available (during this illness or during prior illnesses) then may diagnose Viral LRTI as YES

  • If 2 years old or older, and if subject has wheeze but no bronchodilator test is available (during this illness or during prior illness) then must diagnose Viral LRTI as UNSURE

Bronchiolitis46
  • Must be less than 2 years old

  • Must have both of the following present:
    • Persistent cough
    • Diffuse crackles and/or wheeze that does not resolve with bronchodilator
  • If subject has wheeze but no bronchodilator test is available (during this illness or during prior illnesses) then may still diagnose Bronchiolitis as YES

Pneumonia23,24,41
  1. Clinical pneumonia: must have at least one finding in both of the following categories:
    • Reported history of fever in prior 48 hours, or fever present at the time of exam; cough, dyspnea, or chest pain
    • Focal chest findings, including crackles, bronchial breath sounds, or focally decreased breath sounds; OR chest radiograph with new consolidation

    Among subjects for whom a chest radiograph is being obtained by the clinical provider:

  2. WHO Primary Endpoint Pneumonia plus Clinical Pneumonia (Radiographic Pneumonia #1)

  3. WHO Primary Endpoint Pneumonia or Other Infiltrate plus Clinical Pneumonia (Radiographic Pneumonia #2)