Symptom Burden of Immune Checkpoint Inhibitor Therapy: Development of a Patient-Reported Outcome Measure.

PURPOSE: To develop and validate a patient-reported outcome questionnaire to measure the symptom burden of immune checkpoint inhibitors (ICIs).

PARTICIPANTS &

SETTING

22 patients were interviewed in stage 1, and 16 experts were queried in stage 2; 128 patients completed the preliminary MD Anderson Symptom Inventory for ICIs (MDASI-ICI) for psychometric validation, and 111 patients completed it for longitudinal analysis. All participants were patients, family caregivers, physicians, or other healthcare providers at a single clinic.

METHODOLOGIC APPROACH: Qualitative interviews and expert queries helped establish MDASI-ICI content domain. Patients on ICI therapy completed preliminary MDASI-ICI every two weeks for six months and comple-ted a single-item quality-of-life scale and Functional Assessment of Cancer Therapy-General monthly.

FINDINGS: MDASI-ICI symptom severity and interference scores were significantly higher in patients reporting lower quality of life and significantly correlated with Functional Assessment of Cancer Therapy-General total scores. Internal consistency and test-retest reliability were acceptable.

IMPLICATIONS FOR NURSING: Lack of accurate measures has affected the understanding of symptom burden of ICIs. The MDASI-ICI is a psychometrically sound, sensitive patient-reported outcome measure for ICI symptom burden in research or practice.