Evaluating the psychometric properties of the Immunotherapy module of the MD Anderson Symptom Inventory

Abstract

IntroductionImmunotherapies 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.MethodsOne 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.ResultsThe 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).ConclusionsIn conclusion, the MDASI-Immunotherapy EPT is a valid, reliable, and sensitive tool for measuring symptomatic toxicity.

Associations between the gut microbiome and fatigue in cancer patients

“…Fatigue was assessed using the MD Anderson Symptom Inventory (MDASI)-immunotherapy module (MDASI-Immunotherapy), which has been validated for the assessment of 20 symptoms, including seven immunotherapy-specific items and six interference items 15 . Patients completed the module before they started immunotherapy and rated their symptoms and interference on a scale of 0–10 (0 = no symptom or no interference, 10 = worst symptom imaginable or complete interference).…”

“…Using responses to the fatigue item, we categorized patients as having low fatigue (scores of 0–4) or high fatigue (scores of 5–10). The MDASI-Immunotherapy for early phase trials (EPT) has been shown to be valid and reliable 15 . In addition, it has been shown that the fatigue experience and its impact are reported along a single dimension and can be expressed as a single number 16 .…”

Validación del cuestionario básico de síntomas M. D. Anderson (MDASI) para pacientes con cáncer en población mexicana

“…Las características psicométricas del área intensidad de síntomas es similar con la versión original de Cleeland et al (14) quienes encontraron para el Factor I una consistencia interna de 0,85 y para el Factor II de 0,82. Así como con estudios previos en población asiática y caucásica con alfas de 0,80 a 0,92 (11,(18)(19)(20) . Otros estudios en población europea han identificado un solo factor en el área de intensidad de síntomas (α=0,78) (21) , o tres factores (síntomas generales, síntomas gastrointestinales y componentes afectivos y cognitivos) con alfas entre 0,69 y 0,79 (20,21) .…”

“…En relación al área de Interferencia en la vida cotidiana en pacientes mexicanos, el MDASI mostró una adecuada consistencia interna (α=0,90) y una varianza explicada de 67,49% lo cual concuerda con la versión original de Cleeland et al (14) quienes reportan una consistencia interna de 0,94. Otros estudios han identificado valores de 0,79 a 0,93 (11,19,20,(22)(23)(24)(25)(26) lo cual indica adecuadas consistencias internas en poblaciones caucásicas y asiáticas.…”

Strategies for improving the management of immune-related adverse events

“… 77 78 For example, early and effective supportive care intervention may improve a patient’s tolerance of the drug, increase adherence to treatments, enhance health-related quality of life, and ultimately improve survival outcomes. 76 79 As assessing symptoms between visits allows better understanding of the symptomatic adverse effects of treatment as well as better tracking of disease-related symptoms, 80 81 a validated symptom assessment tool such as the MD Anderson Symptom Inventory, 82 which can be completed at home, may be used to assess longitudinal changes in symptoms.…”