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

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

doi:10.20517/2394-4722.2019.38

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

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

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

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.

Original language	English
Pages (from-to)	1-14
Number of pages	14
Journal	Journal of Cancer Metastasis and Treatment
Volume	6
DOIs	https://doi.org/10.20517/2394-4722.2019.38
State	Published - 2020

Bibliographical note

Publisher Copyright:
© The Author(s) 2020.

Funding

Laurie E. Steffen McLouth was supported by NCI R25 CA122061 (PI: Avis); Adam P. Dicker received additional support from the National Cancer Institute, the Prostate Cancer Research Program (Dept. of Defense), the American Society of Radiation Oncology, the American Society of Clinical Oncology, NRG Oncology, and the Prostate Cancer Foundation; Josephine Feliciano received additional support from Bristol Myers Squibb and Astra Zeneca. Heather S.L. Jim is a consultant for RedHill BioPharma Ltd and Janssen Scientific Affairs; Aaron R. Hansen is a consultant for Merck (compensated) and GSK (compensated), and has received grant/research support from (Clinical Trials for institution) from Genentech/Roche, Merck, GSK, Bristol-Myers Squibb, Novartis, Boston Biomedical, Boehringer-Ingelheim, AstraZeneca, Medimmune, Janssen, Karyopharm, and Macrogenics; David Cella is the President and owner of FACIT.org; Kimberly A. Webster is an owner of FACIT.org; Clifton O. Bingham III is a consultant to Bristol Myers Squibb, Regeneron/Sanofi, and Genentech/Roche, and has received grant support from Bristol Myers Squibb; Adam P. Dicker is an advisor for Roche, EMD Serono, Celldex, Janssen, Cybrexa, Self Care Catalysts, Oncohost, ThirdBridge, and Noxopharm (compensated), and to Google LaunchPad Accelerator, Dreamit Ventures, and Evolution Road (uncompensated). He has also provided expert testimony for Intellectual property (Wilson Soncini); Josephine Feliciano is a consultant to Astra Zeneca, Genentech, Eli Lilly, Pfizer, and Merck. Sheetal Kircher, Monica Janda, Laurie E. Steffen McLouth, N. Lynn Henry, Mary O’Connor and Kari Ala-leppilampi declare no relevant interests, financial or otherwise.

Funders	Funder number
Oncolys BioPharma Co., Ltd.
Dreamit Ventures
Google LaunchPad Accelerator
Prostate Cancer Research Program (Dept. of Defense
National Childhood Cancer Registry – National Cancer Institute	R25 CA122061
National Childhood Cancer Registry – National Cancer Institute
Prostate Cancer Foundation
American Society for Radiation Oncology
Bristol-Myers Squibb
AstraZeneca
GlaxoSmithKline
American Society of Clinical Oncology
NRG Oncology

Keywords

Immunotherapy
cancer
immune checkpoint modulators
immune-related adverse events
oncology
patient reported outcomes
quality of life

ASJC Scopus subject areas

Oncology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.20517/2394-4722.2019.38

Cite this

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., Feliciano, J., Henry, N. L., McLouth, L. E. S., & 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, 1-14. https://doi.org/10.20517/2394-4722.2019.38

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title = "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",

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.",

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

note = "Publisher Copyright: {\textcopyright} The Author(s) 2020.",

year = "2020",

doi = "10.20517/2394-4722.2019.38",

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Webster, KA, O'Connor, ML, Hansen, AR, Kircher, S, Jim, HSL, Dicker, AP, Janda, M, Ala-Leppilampi, K, Bingham, CO, Feliciano, J, Henry, NL, McLouth, LES & 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, vol. 6, pp. 1-14. https://doi.org/10.20517/2394-4722.2019.38

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. / Webster, Kimberly A.; O'Connor, Mary L.; Hansen, Aaron R. et al.
In: Journal of Cancer Metastasis and Treatment, Vol. 6, 2020, p. 1-14.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Webster, Kimberly A.

AU - O'Connor, Mary L.

AU - Hansen, Aaron R.

AU - Kircher, Sheetal

AU - Jim, Heather S.L.

AU - Dicker, Adam P.

AU - Janda, Monika

AU - Ala-Leppilampi, Kari

AU - Bingham, Clifton O.

AU - Feliciano, Josephine

AU - Henry, Norah Lynn

AU - McLouth, Laurie E.Steffen

AU - Cella, David

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

KW - Immunotherapy

KW - cancer

KW - immune checkpoint modulators

KW - immune-related adverse events

KW - oncology

KW - patient reported outcomes

KW - quality of life

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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

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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Cite this