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Development of a Patient-Reported Outcome Measure for Hypereosinophilic Syndrome
Paneez Khoury1, Sana Mahmood2, Alexis Berry2
1Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Md; Laboratory of Allergic Diseases, NIAID, NIH, Bethesda, Md.
The Journal of Allergy and Clinical Immunology. in Practice
|September 22, 2025
Summary
New patient-reported outcome measures, the Hypereosinophilic Syndromes Symptom Inventory (HES-SI) and HES-MBS, show promise for assessing symptom severity in HES clinical trials.
Area of Science:
- Clinical Research
- Patient-Reported Outcomes
- Psychometrics
Background:
- No validated patient-reported outcome (PRO) measures exist for hypereosinophilic syndromes (HES).
- Previous attempts to develop PROs for HES have been unsuccessful.
- Mepolizumab trials utilized patient-reported severity but lacked formal PRO development.
Purpose of the Study:
- To develop and validate novel PRO measures for HES.
- To assess symptom severity and patient experience of disease activity.
- To adhere to FDA guidance for developing symptom outcome metrics.
Main Methods:
- Utilized FDA guidance for symptom scale development.
- Employed psychometric analysis and patient-administered questionnaires.
- Recruited 63 heterogeneous HES patients for a natural history study.
- Collected HES Symptom Inventory (HES-SI) and HES-MBS data over 3 months.
Main Results:
- HES-SI and HES-MBS scores strongly correlated with Patient Global Assessment (r = 0.69-0.81, P < .0001).
- Both measures demonstrated sensitivity to change over time.
- Test-retest reliability was established for the HES-SI and HES-MBS.
Conclusions:
- The HES-SI and HES-MBS provide reliable and valid preliminary evidence for HES clinical trials.
- These PRO measures can detect changes in HES symptoms.
- Further research is needed to confirm their ability to measure treatment efficacy.
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