Item comprehension and content coverage of patient-reported outcome measures for long COVID: a qualitative study.

PURPOSE: Fit-for-purpose clinical outcome assessments are essential to inform medical product development, but outcome measures for Long COVID, a new and devastating phenomenon, have not yet been established. The objective of this study was to evaluate item comprehension and content coverage of four selected patient-reported outcome measures (PROMs) for use in a Long COVID clinical trial platform. METHODS: A noninterventional, cross-sectional qualitative cognitive debriefing study of English-speaking adults with Long COVID was conducted, with interviews taking place virtually between August and November 2024. Recruitment was managed by a research firm. The main outcomes of the study were participant comprehension and relevance of the selected PROMs, including symptoms and functioning as measured by modified versions of the DePaul Symptom Questionnaire-Post-Exertional Malaise, Everyday Cognition Scale 2 questionnaire, Composite Autonomic Symptom Score-31, and Orthostatic Hypotension Questionnaire. RESULTS: Participants were able to comprehend most items and indicated they were relevant to their experiences with Long COVID. Participants identified potential enhancements to the measures such as simplifying instructions, modifying item wording, and reducing PROM length. Interviewers observed cognitive burden during some of the interviews. CONCLUSIONS: Based on the overall support for comprehension and relevance of items within each measure, use of these measures within the Long COVID clinical trial platform was generally supported. Future work, including qualitative and quantitative studies, could improve the experience of PROM data collection in this context. Clinical trial protocols for Long COVID should carefully consider burden on participants when collecting PROMs.

Duke Scholars

Author Christina Kelsey Zigler Population Health Sciences

Author Kevin Phillip Weinfurt Population Health Sciences

Author Kanecia Obie Zimmerman Pediatrics, Critical Care Medicine