In early 2020, there was a limited understanding of the symptoms experienced by outpatients with COVID-19. The SE-C19 questions were developed based on the CDC symptom list [14 ] and published literature available at the time [15 ]. Item generation and evaluation of content validity of the SE-C19 were informed by the good measurement principles outlined in the FDA PRO guidance [12 (link)] and the Patient-Focused Drug Development guidance [16 ].
Symptoms identified in the literature and on the CDC website were used to develop 23 questions concerning the following: feeling feverish, chills, sore throat, cough, shortness of breath or difficulty breathing, nausea, vomiting, diarrhea, headache, red or watery eyes, body and muscle aches, loss of taste or smell, fatigue, loss of appetite, confusion, dizziness, pressure or tight chest, chest pain, stomachache, rash, sneezing, sputum/phlegm, and runny nose. Patients were asked to select which of the symptoms they had experienced in the past 24 h in an electronic diary, then rate the severity of each selected symptom at its worst in that 24-h period on a severity scale (mild, moderate, or severe). To aid interpretation of the SE-C19, additional questions were developed to assess patients’ global impressions of overall symptom severity and return to usual health/daily activities, in line with FDA recommendations [6 ]. The electronic app could be accessed using a smartphone, tablet, or computer.
Symptoms identified in the literature and on the CDC website were used to develop 23 questions concerning the following: feeling feverish, chills, sore throat, cough, shortness of breath or difficulty breathing, nausea, vomiting, diarrhea, headache, red or watery eyes, body and muscle aches, loss of taste or smell, fatigue, loss of appetite, confusion, dizziness, pressure or tight chest, chest pain, stomachache, rash, sneezing, sputum/phlegm, and runny nose. Patients were asked to select which of the symptoms they had experienced in the past 24 h in an electronic diary, then rate the severity of each selected symptom at its worst in that 24-h period on a severity scale (mild, moderate, or severe). To aid interpretation of the SE-C19, additional questions were developed to assess patients’ global impressions of overall symptom severity and return to usual health/daily activities, in line with FDA recommendations [6 ]. The electronic app could be accessed using a smartphone, tablet, or computer.
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