Development of a Functional Assessment of Chronic Illness Therapy item library and primary symptom list for the assessment of patient-reported adverse events associated with immune checkpoint modulators.

Authors

• Kimberly A Webster
• Mary L O'Connor
• Aaron R Hansen
• Sheetal Kircher
• Heather S L Jim
• Adam P Dicker
• Monika Janda
• Kari Ala-Leppilampi
• Clifton O Bingham
• Josephine Feliciano
• Norah Lynn Henry
• Laurie E Steffen McLouth
• David Cella

Publication/Presentation Date

1-1-2020

Abstract

AIM: To develop a comprehensive item library of patient-reported, immunotherapy-related adverse events (irAEs) that draws from and expands on the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System.

METHODS: Literature review and iterative expert input. Based on a literature review of irAEs, we developed a framework of immunotherapy classes and their associated symptoms. Clinical experts then reviewed iterations of symptom summaries and item maps linked to the immunotherapy framework. Experts provided content review and feedback was shared across experts until consensus was reached. The iterative process facilitated creation of a Primary Symptom List associated with immune checkpoint modulators (ICMs), drawn from the larger set of symptoms. Existing FACIT items were mapped to the symptom list, and new items were written as needed to create the item library.

RESULTS: The full item library of irAEs is comprised of 239 items, covering 142 unique symptoms across 75 inflammatory reactions/immune conditions. A subset of 66 items comprises a Primary Symptom List considered most common/relevant to ICM treatment. This includes gastrointestinal, skin, pulmonary, neurologic, musculoskeletal, and multiple miscellaneous and constitutional symptoms.

CONCLUSION: The FACIT Immunotherapy Item Library is a compilation of 239 self-report items that capture the wide range of AEs experienced by people receiving immune treatments. A subset of 66 items comprises a Primary Symptom List meant for ICM therapy. Use of items selected from this library is encouraged in clinical research and clinical practice evaluation.

Volume

6

ISSN

2394-4722

Published In/Presented At

Webster, K. A., O'Connor, M. L., Hansen, A. R., Kircher, S., Jim, H. S. L., Dicker, A. P., Janda, M., Ala-Leppilampi, K., Bingham, C. O., 3rd, Feliciano, J., Lynn Henry, N., Steffen McLouth, L. E., & Cella, D. (2020). Development of a Functional Assessment of Chronic Illness Therapy item library and primary symptom list for the assessment of patient-reported adverse events associated with immune checkpoint modulators. Journal of cancer metastasis and treatment, 6, 8. https://doi.org/10.20517/2394-4722.2019.38

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

34790879

Department(s)

Administration and Leadership

Document Type

Article