TY - JOUR
T1 - Evaluating the psychometric properties of the Immunotherapy module of the MD Anderson Symptom Inventory
AU - Sheshadri, Ajay
AU - Altan, Mehmet
AU - Hess, Kenneth
AU - George, Goldy
AU - Stephen, Bettzy
AU - Castillo, Lilibeth
AU - Rodriguez, Enedelia
AU - Gong, Jing
AU - Peterson, Christine
AU - Rodon Ahnert, Jordi
AU - Fu, Siqing
AU - Piha-Paul, Sarina A.
AU - Pant, Shubham
AU - Dumbrava, Ecaterina
AU - Yap, Timonthy A.
AU - Janku, Filip
AU - Tsimberidou, Apostolia M.
AU - Subbiah, Vivek
AU - Karp, Daniel D.
AU - Zarifa, Abdulrazzak
AU - McQuinn, Lacey M.
AU - Cleeland, Charles
AU - Hong, David S.
AU - Naing, Aung
N1 - Funding Information:
Funding Preparation of this report was funded in part by an NIH grant (R01CA242565; to TRM, DH, and GG) and supported by the NIH/NCI under award number P30CA016672 and used the Clinical Translational Science Award 1UL1 TR003167, Assessment, Intervention and Measurement (AIM) Facility and the Biostatistics Shared Resource.
Publisher Copyright:
© 2020 Author(s) (or their employer(s)). Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2020/10/23
Y1 - 2020/10/23
N2 - Introduction Immunotherapies have revolutionized the treatment of various cancers, but little is known about their symptomatic toxicity. Assessing these symptoms is best accomplished by asking the patients themselves. However, such reports are subjective and may face challenges as bonafide scientific data. Demonstrating the validity of symptom assessment tools, mainly through the reduction of measurement errors, has the potential to improve patient care if these tools are widely adopted. To that end, we present herein the psychometric properties of the Immunotherapy for Early-Phase Trials module of the MD Anderson Symptom Inventory (MDASI-Immunotherapy EPT) in patients receiving various immunotherapies in early phase trials at a major cancer center. Methods One hundred forty-five patients completed the inventory at baseline, with 85 of them also doing so after 9 weeks of treatment. The mean (±SD) age of the patients was 57.0±12.9 years. Also, 56% of the patients were women, 79% identified as white, and 49% had at least some college education. Results The internal consistency reliability of the MDASI-Immunotherapy EPT was excellent, as the Cronbach's alphas for all of its subscales were at least 0.88 (range 0.88-0.95). Known-group validity based on Eastern Cooperative Oncology Group performance status groupings was excellent at 9 weeks after the start of an immunotherapy trial for the MDASI-Immunotherapy EPT severity (effect size, 0.96) and interference (effect size, 0.82) subscales. We found substantial changes in the symptom items difficulty remembering (effect size,-0.85), fever and/or chills (effect size,-0.63), disturbed sleep (effect size,-0.52), diarrhea (effect size,-0.42), and swelling of hands, legs, or feet (effect size,-0.39). Conclusions In conclusion, the MDASI-Immunotherapy EPT is a valid, reliable, and sensitive tool for measuring symptomatic toxicity.
AB - Introduction Immunotherapies have revolutionized the treatment of various cancers, but little is known about their symptomatic toxicity. Assessing these symptoms is best accomplished by asking the patients themselves. However, such reports are subjective and may face challenges as bonafide scientific data. Demonstrating the validity of symptom assessment tools, mainly through the reduction of measurement errors, has the potential to improve patient care if these tools are widely adopted. To that end, we present herein the psychometric properties of the Immunotherapy for Early-Phase Trials module of the MD Anderson Symptom Inventory (MDASI-Immunotherapy EPT) in patients receiving various immunotherapies in early phase trials at a major cancer center. Methods One hundred forty-five patients completed the inventory at baseline, with 85 of them also doing so after 9 weeks of treatment. The mean (±SD) age of the patients was 57.0±12.9 years. Also, 56% of the patients were women, 79% identified as white, and 49% had at least some college education. Results The internal consistency reliability of the MDASI-Immunotherapy EPT was excellent, as the Cronbach's alphas for all of its subscales were at least 0.88 (range 0.88-0.95). Known-group validity based on Eastern Cooperative Oncology Group performance status groupings was excellent at 9 weeks after the start of an immunotherapy trial for the MDASI-Immunotherapy EPT severity (effect size, 0.96) and interference (effect size, 0.82) subscales. We found substantial changes in the symptom items difficulty remembering (effect size,-0.85), fever and/or chills (effect size,-0.63), disturbed sleep (effect size,-0.52), diarrhea (effect size,-0.42), and swelling of hands, legs, or feet (effect size,-0.39). Conclusions In conclusion, the MDASI-Immunotherapy EPT is a valid, reliable, and sensitive tool for measuring symptomatic toxicity.
KW - biostatistics
KW - immunotherapy
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U2 - 10.1136/jitc-2020-000931
DO - 10.1136/jitc-2020-000931
M3 - Article
C2 - 33097611
AN - SCOPUS:85094685112
SN - 2051-1426
VL - 8
JO - Journal for immunotherapy of cancer
JF - Journal for immunotherapy of cancer
IS - 2
M1 - e000931
ER -