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

Area of Science:

• Oncology
• Patient-Reported Outcomes
• Clinical Therapeutics

Background:

• Immune checkpoint inhibitors (ICIs) are crucial cancer therapies.
• Understanding the symptom burden associated with ICIs is vital for patient care.
• Existing measures may not fully capture the unique symptom experience of ICI therapy.

Purpose of the Study:

• To develop and validate a patient-reported outcome questionnaire for assessing the symptom burden of immune checkpoint inhibitors (ICIs).
• To establish a reliable and sensitive tool for measuring ICI-related symptoms.

Main Methods:

• Qualitative interviews and expert consultations defined the content domain.
• A preliminary version of the MD Anderson Symptom Inventory for ICIs (MDASI-ICI) was developed.
• Psychometric validation involved 128 patients, with 111 participating in longitudinal analysis.

Main Results:

• The MDASI-ICI demonstrated acceptable internal consistency and test-retest reliability.
• Higher symptom severity and interference scores correlated with lower quality of life.
• Scores on the MDASI-ICI significantly correlated with the Functional Assessment of Cancer Therapy-General.

Conclusions:

• The MDASI-ICI is a psychometrically sound patient-reported outcome measure.
• This tool is sensitive to changes in symptom burden for patients on ICIs.
• The MDASI-ICI can be utilized in research and clinical practice to better understand ICI symptom burden.