Objective: COVID-19, caused by a coronavirus, SARS-CoV-2, has been the cause of the global pandemic from 2020-2022. Due to COVID-19’s novelty, there exist no validated patient reported outcome (PRO) tools that allow for proper evaluation of patient infection severity based on symptom reporting. The aim of this study was to elicit the symptoms profile experienced with COVID-19 using a qualitative approach and develop an initial Patient Reported COVID-19 Sign and Symptom Diary (PRO COVID-19) (electronic diary; eDiary).
Methods: Leveraging research regarding signs and symptoms of COVID-19 around the world, an electronic patient reported outcome (ePRO) tool was developed and utilized among adult COVID-19 patients enrolled in a COVID-19 interventional trial in the US. Upon study exit, a subset of patients opted into an exit interview regarding use of the ePRO where three key processes were executed to support validation of the tool, 1) concept elicitation (CE) to encourage spontaneous responses regarding how participants characterize their symptoms of COVID-19, 2) cognitive debriefing (CD) using a think-aloud method to explore the relevance, clarity, and understandability of the ePRO, and 3) usability testing (UT) to determine ease or difficulty of use of the tool interface in its electronic format.
Results: Twenty-one patients (n=21) completed the exit interview. In the CE, the most common symptom reported was fatigue/tiredness (76%), followed by loss of sense of smell (71%), and body aches (67%). Overall, 23 symptoms were identified in CE, 12 symptoms occurred in approximately 29% to 76% of the participants, nine symptoms reported in 10% to 24% and two symptoms occurring in 5%. The CD portion of the interview found that ePRO elements were well understood. Findings supported maintaining the items as written and adding “head congestion” as a symptom which was frequently reported by patients, as well as “loss of appetite” (52% each). Twenty (20) symptoms were included in the final eDiary. For UT, 100% of patients responded favorably to the ease of use of the ePRO, with 95% patients seeing no issues during use.
Conclusions: The initial Patient Reported COVID-19 Sign and Symptom Diary (PRO COVID-19) in electronic format was demonstrated to be a valid PRO tool for clinical diagnostic and investigation use among COVID-19 patients to help clinicians assess severity of infection.
Audience Take Away:
- Introduction to a validated patient reported outcome tool for COVID-19 infection
- Report on COVID-19 symptomology and quality of life impact