Abstract
OBJECTIVE: To identify and evaluate the methodological quality and psychometric properties of Patient-reported outcome measures (PROMs) for symptom assessment in patients with cancer undergoing immunotherapy. METHODS: A systematic search was performed in PubMed, Scopus, Cochrane Library, Web of Science, Embase, CINAHL, CNKI, WanFang, Vip, and SinoMed from their inception to February 10, 2025. Eligibility criteria required studies to focus on the development or validation of a PROM for symptom assessment in adult patients with cancer undergoing immunotherapy, and to report on at least one psychometric property. The methodological quality of the included studies and the psychometric properties of the corresponding instruments were evaluated using the COSMIN 2.0 guidelines.We synthesized the evidence pertaining to each measurement property from all included studies on the same PROM.The evidence quality was evaluated based on an adapted Grading of Recommendations Assessment, Development and Evaluation system. RESULTS: The final analysis included eight studies that reported on six PROMs. Because there was insufficient high-quality evidence, particularly for cross-cultural validity/measurement invariance and measurement error, no instrument could be recommended for use. However, the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) demonstrated the most potential, with high-quality evidence supporting its content validity, structural validity, and internal consistency. Notably, the primary goal of this instrument is to assess the overall symptom burden. CONCLUSIONS: There is a notable lack of fully validated, high-quality instruments for measuring the symptoms themselves in patients undergoing immunotherapy. Although the FACT-ICM is the most promising tool for assessing the overall symptom burden, it still requires further validation. Therefore, future research, depending on the specific objective, should focus on two key areas: more comprehensive validation of the FACT-ICM, and the validation or development of instruments specifically designed to quantify the symptoms themselves. SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD420250655464).