PROMS IN LONG-COVID AND ME/CFS/POST-VIRAL FATIGUE: ANALYSIS OF STUDY RECORDS FROM THE PAST 2 YEARS (2024-2026)
Author(s)
Agata Los, PhD1, Kathleen Bowes, PhD1, Huong Le, PhD2, Areeha Alam, BSc1, Zarmina Khankhel, MPH2.
1Genesis Research Group, London, United Kingdom, 2Genesis Research Group, Hoboken, NJ, USA.
1Genesis Research Group, London, United Kingdom, 2Genesis Research Group, Hoboken, NJ, USA.
OBJECTIVES: Long-COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) share substantial symptom overlap, including fatigue and post-exertional symptom exacerbation, often assessed using patient-reported outcome measures (PROMs). We examined patterns in PROM selection across these conditions through a structured review of trial and observational study records.
METHODS: Clinicaltrials.gov was searched for interventional and observational studies reporting PROMs in adults with long-COVID or ME/CFS. Records of eligible studies completed between 01/01-2024-01/01/2026 were screened by a single reviewer, with 30% dual-reviewed for quality assurance. PROMs were extracted, classified as standardized or custom/non-standardized measures, and grouped by concept.
RESULTS: Eighty-six interventional (long-COVID: 80, ME/CFS: 5, both: 1) and 19 observational (long-COVID: 18, ME/CFS: 1) studies were identified. Overall, 193 unique standardized PROMs were used in 85/86 interventional studies. The following PROM categories were evaluated in long COVID studies: symptoms/symptom burden (132 unique PROMs), health-related quality of life (HRQoL; 25), functional status (24), health behaviours (6), and patient experience (1). PROMs in ME/CFS studies covered only HRQoL (7) or symptoms/ symptom burden (5). Compared with interventional studies, observational studies evaluated a limited range of PROM categories: PROMs in long COVID studies covered symptoms/symptom burden (29), HRQoL (7), and functional status (4); one standardized PROM was used in the ME/CFS study.
Non-standardized PROMs were used less frequently than standardized measures in both study types. In interventional studies, custom PROMs assessed daily functioning, health behaviours, HRQoL, patient experience, and symptoms. Those in observational studies measured daily functioning, patient experience, recovery, and symptoms.
CONCLUSIONS: In terms of categories covered, PROMs for long-COVID were more diverse than PROMs for ME/CFS, although comparison was constrained by limited data. Overall, there may be scope for ME/CFS studies to utilize more varied PROMs to capture the nuances of the impact on patients’ lived experiences.
METHODS: Clinicaltrials.gov was searched for interventional and observational studies reporting PROMs in adults with long-COVID or ME/CFS. Records of eligible studies completed between 01/01-2024-01/01/2026 were screened by a single reviewer, with 30% dual-reviewed for quality assurance. PROMs were extracted, classified as standardized or custom/non-standardized measures, and grouped by concept.
RESULTS: Eighty-six interventional (long-COVID: 80, ME/CFS: 5, both: 1) and 19 observational (long-COVID: 18, ME/CFS: 1) studies were identified. Overall, 193 unique standardized PROMs were used in 85/86 interventional studies. The following PROM categories were evaluated in long COVID studies: symptoms/symptom burden (132 unique PROMs), health-related quality of life (HRQoL; 25), functional status (24), health behaviours (6), and patient experience (1). PROMs in ME/CFS studies covered only HRQoL (7) or symptoms/ symptom burden (5). Compared with interventional studies, observational studies evaluated a limited range of PROM categories: PROMs in long COVID studies covered symptoms/symptom burden (29), HRQoL (7), and functional status (4); one standardized PROM was used in the ME/CFS study.
Non-standardized PROMs were used less frequently than standardized measures in both study types. In interventional studies, custom PROMs assessed daily functioning, health behaviours, HRQoL, patient experience, and symptoms. Those in observational studies measured daily functioning, patient experience, recovery, and symptoms.
CONCLUSIONS: In terms of categories covered, PROMs for long-COVID were more diverse than PROMs for ME/CFS, although comparison was constrained by limited data. Overall, there may be scope for ME/CFS studies to utilize more varied PROMs to capture the nuances of the impact on patients’ lived experiences.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PCR145
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Infectious Disease (non-vaccine), Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)