Comprehensibility and Usability of an Electronic COVID-19 Daily Symptom Diary
ISPOR US 2022 -- Symptoms of COVID-19 infection are heterogeneous and range from mild to severe. Common symptoms include fever, cough, tiredness and loss of taste or smell. To facilitate the development of drugs and biological products for the treatment of COVID-19 infection in the outpatient setting, fit-for purpose assessments of COVID-19 symptoms are needed. FDA issued guidance for the assessment of COVID-19 symptoms in outpatient clinical trials including key COVID-19 symptoms that should be evaluated systematically to provide an accurate evaluation of treatment benefit. The guidance recommends the: 1) use of patient-reported outcome (PRO) instruments administered electronically on a daily basis; 2) evaluation of the PRO instrument's comprehensibility and usability for COVID-19 symptom assessment; and 3) inclusion of a minimum number of key symptoms for daily assessment to minimize patient burden.