Abstract: Background　Accurate assessment of immune-related adverse events（irAEs） in cancer patients through patient-reported outcomes facilitates early identification of irAEs and enables timely development and implementation of targeted intervention measures，which are essential for ensuring continued treatment and favorable prognosis. Currently，commonly used patient-reported outcome measures（PROMs） for tumor immunotherapy are mainly universal scales with poor content validity. Nearly 30% of common irAEs cannot be measured，and specific PROMs items vary，with no unified standards. There is also a lack of systematic evaluation of measurement performance，making it impossible to select the best assessment tool. Objective　To evaluate the psychometric properties of PROMs for cancer immunotherapy，providing evidence-based support for healthcare professionals to accurately assess immune-related adverse events and quality of life in cancer patients. Methods　According to the Consensus-Based Standards for the Selection of Health Measurement Tools（COSMIN） guidelines，we searched the following databases：CNKI，Wanfang Data，SinoMed，PubMed，Embase，CINAHL，and ProQuest. The search period was from the establishment of the databases to December 31，2024. Studies that included at least one evaluation of the measurement properties of PROMs related to tumor immunotherapy were included. Literature screening and data extraction were performed independently by two researchers. Quality assessment was conducted using the Chinese version of the COSMIN bias risk assessment checklist and the Chinese version of the COSMIN content validity scoring system. Finally，the modified quantitative system for evaluating evidence grading was used to form the recommended level and recommendation for the measurement tool. Results　A total of 9 studies were included，covering the Functional Assessment of Cancer Therapy-immune Checkpoint Inhibitor Treatment Patient-Specific Module（FACT-ICM），Chinese version of FACT-ICM（C-FACT-ICM），patient-reported outcome measures for anti-economic toxicity，patient-reported outcomes version of the common terminology criteria for adverse events（PRO-CTCAE） lung cancer subscale，MD Anderson Symptom Inventory module specific to immunotherapy for early-phase trials（MDASI-Immunotherapy EPT），Chinese version of MDASI-Immunotherapy EPT，lung cancer immunotherapy PRO-CTCAE subset， cancer immunotherapy patient symptom self-report scale，and lung cancer patient immune-related adverse event self-report symptom scale，totaling 9 immunotherapy PROMs. None of these PROMs reported cross-cultural validity，measurement error， or responsiveness. In terms of content validity，FACT-ICM and PROFFIT were rated as “adequate,” while the remaining scales were rated as “uncertain.” In terms of internal consistency，FACT-ICM was not validated，and PROFFIT was rated as “inadequate.” None of the scales met the criteria for “inadequate（-）” for any measurement attribute based on high-level evidence. All nine tools were assigned a B-level recommendation. Conclusion　The C-FACT-ICM can be temporarily recommended for use （Grade B recommendation）. In the future，this scale can be used to measure patient-reported outcomes in various types of tumor immunotherapy to improve its clinical applicability and practicality. However，overall，the methodological quality of tumor immunotherapy PROMs-related research and the measurement properties of the tools still need to be further verified and improved.

Key words: Cancer, Immunotherapy, Patient-reported outcome, Assessment tools, Systematic review, Psychometrics, COSMIN

摘要： 背景　通过患者报告结局精准评估肿瘤患者免疫相关不良反应（irAEs），有利于irAEs的早期识别，并及时进行针对性干预措施的制定和实施，是确保持续治疗和预后良好的保障。目前常用的肿瘤免疫治疗患者报告结局测量工具（PROMs）主要为普适性量表，内容效度差，近30%的常见irAEs无法被测量，特异性PROMs条目各异，尚无统一标准，且缺乏测量性能的系统评价，难以选择出最佳评估工具。目的　对肿瘤免疫治疗PROMs进行测量学属性评价，为医护人员准确评估肿瘤患者irAEs和生活质量提供循证依据。方法　根据健康测量工具选择的共识标准（COSMIN）指南要求，检索中国知网、万方数据知识服务平台、SinoMed、PubMed、Embase、CINAHL、ProQuest数据库，检索时限为建库至2024-12-31，纳入至少涉及1种肿瘤免疫治疗PROMs的测量学属性评价的研究。文献筛选和数据提取由2名研究者独立进行，使用COSMIN偏倚风险评价清单中文版和COSMIN内容效度评分系统中文版进行质量评价，最终使用改良版定量系统评价证据分级方法形成测量工具的推荐等级和推荐意见。结果　共纳入9篇文献，涉及癌症治疗功能评估—免疫检查点抑制剂治疗患者特异性模块（FACT-ICM）、中文版FACT-ICM（C-FACT-ICM）、抗经济毒性的患者报告结局测量工具、患者报告的不良事件通用术语标准（PRO-CTCAE）肺癌子量表、针对早期免疫治疗患者的MD安德森症状量表（MDASI-Immunotherapy EPT）、中文版MDASI-Immunotherapy EPT、肺癌免疫治疗PRO-CTCAE子集、癌症免疫治疗患者症状自我报告量表、肺癌患者免疫相关不良事件自我报告症状量表，共9个免疫治疗PROMs，均未报告跨文化效度、测量误差及反应度。内容效度方面，FACT-ICM和PROFFIT评价为“充分”，其余量表均为“不确定”；内部一致性方面，FACT-ICM未进行验证，PROFFIT评价为“不充分”，所有量表均不满足有高级别证据证明量表任一测量属性“不充分（-）”的条件，9个工具均为B级推荐等级。结论　C-FACT-ICM可暂时被推荐使用（B级推荐等级），未来可使用该量表在各类肿瘤免疫治疗患者报告结局的测量中使用，以提高其临床推广性和实用性。整体而言，肿瘤免疫治疗PROMs相关研究的方法学质量和工具的测量学属性还需进一步验证和完善。

关键词: 肿瘤, 免疫治疗, 患者报告结局, 评估工具, 系统评价, 测量学特征, COSMIN