Tito R. Mendoza, Ph.D., MS, MEd from The University of Texas MD Anderson Cancer Center discusses Evaluating the psychometric properties of the Immunotherapy module of the MD Anderson Symptom Inventory.
Immunotherapies have revolutionized the treatment of multiple cancers, but their symptomatic toxicity is little understood. By questioning the patients themselves, the diagnosis of these symptoms is better done. Such studies, however, are subjective and, like bonafide science evidence, can face challenges. Demonstrating the validity of symptom evaluation methods, particularly through the elimination of measurement errors, if these tools are widely adopted, has the potential to improve patient care. To that end, we present the psychometric properties of the MD Anderson Symptom Inventory (MDASI-Immunotherapy EPT) Immunotherapy for Early-Phase Trials module in patients obtaining multiple immunotherapies in early-phase studies at a major cancer center.
The inventory was completed at baseline by one hundred and forty-five patients, with 85 of them still doing so after 9 weeks of treatment. The mean (±SD) age was 57.0±12.9 years for the patients. Also, 56% of the patients were women, 79% were white, and 49% had at least some college degree.
The MDASI-Immunotherapy EPT's internal accuracy reliability was excellent as the Cronbach alphas were at least 0.888 for all of its subscales (range 0.88-0.95). Established group validity based on success status groupings of the Eastern Cooperative Oncology Group was excellent for the MDASI-Immunotherapy EPT intensity (effect size, 0.96) and intervention (effect size, 0.82) subscales at 9 weeks after the start of an immunotherapy trial. Difficulty in recalling symptoms (effect size, -0.85), fever and/or chills (effect size, -0.63), disrupted sleep (effect size, -0.52), diarrhea (effect size, -0.42), and swelling of the hands, legs or feet were found to be significant changes (effect size, -0.39).
To conclude, MDASI-Immunotherapy EPT is an accurate, reliable, and sensitive instrument for symptomatic toxicity calculation.
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