Zhang Defa, Wang Yali, Wang Qian, Mao Huiqing, Zhang Miaomiao, Xu Ping, Guo Shuo, Yan Rong
School of Nursing, Shandong First Medical University(Shandong Academy of Medical Sciences), Jinan, China.
Department of Respiratory Internal Medicine Ward 1, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Asia Pac J Oncol Nurs. 2025 Aug 19;12:100774. doi: 10.1016/j.apjon.2025.100774. eCollection 2025 Dec.
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.
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.
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.
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.
PROSPERO (CRD420250655464).
识别和评估用于接受免疫治疗的癌症患者症状评估的患者报告结局测量指标（PROMs）的方法学质量和心理测量特性。
从创刊至2025年2月10日，在PubMed、Scopus、Cochrane图书馆、科学网、Embase、CINAHL、中国知网、万方、维普和中国生物医学文献数据库中进行了系统检索。纳入标准要求研究聚焦于开发或验证用于接受免疫治疗的成年癌症患者症状评估的PROM，并报告至少一项心理测量特性。使用COSMIN 2.0指南评估纳入研究的方法学质量和相应工具的心理测量特性。我们综合了所有关于同一PROM的纳入研究中与每个测量特性相关的证据。基于改编后的推荐分级评估、制定和评价系统评估证据质量。
最终分析纳入了八项报告六种PROM的研究。由于高质量证据不足，特别是跨文化效度/测量不变性和测量误差方面，因此无法推荐使用任何工具。然而，癌症治疗免疫检查点调节剂功能评估量表（FACT-ICM）显示出最大潜力，有高质量证据支持其内容效度、结构效度和内部一致性。值得注意的是，该工具的主要目标是评估总体症状负担。
在接受免疫治疗的患者中，明显缺乏用于测量症状本身的经过充分验证的高质量工具。尽管FACT-ICM是评估总体症状负担最有前景的工具，但仍需要进一步验证。因此，未来的研究应根据具体目标，聚焦于两个关键领域：对FACT-ICM进行更全面的验证，以及对专门设计用于量化症状本身的工具进行验证或开发。
PROSPERO（CRD420250655464）
