Christie肺癌症状量表（CSI-Lung）电子患者报告结局测量工具的真实世界评估：效度、信度、反应性和患者体验
Real-world evaluation of the christie symptom inventory-lung cancer (CSI-lung) electronic patient-reported outcome measure: validity, reliability, responsiveness, and patient experiences.
作者
作者单位
- Division of Research and Innovation, The Christie NHS Foundation Trust, Manchester, United Kingdom. Electronic address: thitikorn.nuamek@nhs.net.
- School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong; Christie Patient-Centred Research, The Christie NHS Foundation Trust, Manchester, United Kingdom.
- Christie Patient-Centred Research, The Christie NHS Foundation Trust, Manchester, United Kingdom.
- Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom; Division of Cancer Sciences, The University of Manchester, Manchester, United Kingdom.
- Clinical Data and Outcome Unit, The Christie NHS Foundation Trust, Manchester, United Kingdom.
- School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong; Christie Patient-Centred Research, The Christie NHS Foundation Trust, Manchester, United Kingdom; Division of Nursing, Midwifery & Social Work, The University of Manchester, Manchester, United Kingdom. Electronic address: janelle.yorke@polyu.edu.hk.
摘要
中文
电子患者报告结局测量工具（ePROMs）在肿瘤学中的常规应用正在国际范围内扩展，但常规护理中最合适的工具仍不确定。Christie肺癌症状量表（CSI-Lung）是为常规护理开发的。本研究评估了其内容效度、基于真实世界数据的心理测量学性能和患者体验。采用COSMIN方法学指导进行的混合方法评估。通过9例患者的认知访谈评估内容效度，检查条目的相关性、可理解性和全面性。定量分析使用了来自2,483例肺癌患者常规收集的ePROM数据。使用二次加权Cohen's kappa评估重测信度，使用EQ-5D-5L和EQ-VAS定义健康状态稳定。使用Spearman相关与EQ-5D-5L评估结构效度（收敛效度），并比较不同ECOG体能状态（已知组效度）。使用症状变化与EQ-VAS变化之间的Kendall's tau评估反应性。通过274例患者完成的调查评估患者体验。访谈显示高相关性和可理解性。重测信度显示10/14条目的加权kappa>0.7，所有条目的一致性超过80%。所有条目均预期与EQ-5D-5L呈负相关，尤其是疲劳、疼痛和呼吸困难。已知组效度得到支持，体能状态较差的患者症状更重。反应性分析显示与EQ-VAS呈预期负相关。患者体验良好：93%认为CSI-Lung易于完成，92%认为具有临床实用性，89%认为对护理有支持作用。CSI-Lung显示出与临床预期一致的测量属性和高患者接受度，支持其用于常规护理以及在多样环境和人群中的进一步验证。
English
The routine use of electronic patient-reported outcome measures (ePROMs) in oncology is expanding internationally, yet uncertainty remains regarding the most suitable tool for routine care. The Christie Symptom Inventory-Lung Cancer (CSI-Lung) was developed for routine care. This study evaluated its content validity, psychometric performance using real-world data, and patient experience. A mixed-methods evaluation, guided by COSMIN methodology, was conducted. Content validity was assessed through cognitive interviews with nine patients, examining item relevance, comprehensibility, and comprehensiveness. Quantitative analyses used routinely collected ePROM data from 2,483 patients with lung cancer. Test-retest reliability was assessed using quadratic-weighted Cohen's kappa, with stable health defined using EQ-5D-5L and EQ-VAS. Construct validity was evaluated using Spearman correlations with EQ-5D-5L (convergent validity) and comparisons across ECOG performance status (known-groups validity). Responsiveness was assessed using Kendall's tau between symptom changes and EQ-VAS changes. Patients experience was evaluated through surveys completed by 274 patients. Interviews demonstrated high relevance and comprehensibility. Test-retest reliability showed weighted kappa > 0.7 for 10/14 items, with over 80% agreement across items. All items expectedly correlated negatively with EQ-5D-5L, particularly tiredness, pain, and breathlessness. Known-group validity was supported, with worse symptoms in patients with poorer performance status. Responsiveness analyses showed expected negative correlations with EQ-VAS. Patient experience was positive: 93% found CSI-Lung easy to complete, 92% clinically useful, and 89% supportive of care. CSI-Lung demonstrated measurement properties consistent with clinical expectations and high patient acceptability, supporting its use in routine care and further validation across diverse settings and populations.
分类与指标
- 研究类型
- 临床研究
- 病种
- 肺癌
- JCR 分区
- Q1
- 影响因子
- 5.3
- 新锐分区
- 2区