Ripamonti Carla, Leporati Rita, De Feo Giulia, Di Pede Patricia, Toffolatti Luisa, Guglielmo Mauro, La Carpia Domenico, Miccinesi Guido, Chiesi Francesca
Department of Medical Oncology and Haematology, Oncology-Supportive Care Unit, Fondazione IRCCS, Istituto Nazionale Tumori Di Milano, 20133, Milan, Italy.
Medical Oncology Unit, Fondazione IRCCS, Istituto Nazionale Tumori Di Milano, 20133, Milan, Italy.
Support Care Cancer. 2022 Mar;30(3):1923-1933. doi: 10.1007/s00520-021-06594-y. Epub 2021 Oct 8.
The routine use of patient-reported outcomes (PROs) in clinical practice improves quality of care, it helps in reducing the access to emergency services and unscheduled visits, and it can improve cancer patients' time survival. The Edmonton Symptom Assessment System (ESAS) is a PRO largely used in different care settings to monitor physical and psychological symptoms. Nonetheless, along with these symptoms, literature also highlighted the presence and effect of spiritual pain, financial distress, and social isolation on quality of care, treatment effectiveness, and survival.
The aims of the current study were (a) to complete the Italian version of the ESAS validation process by adding the missing symptom "insomnia" and (b) to develop and validate the ESAS-Total Care (ESAS-TC) that is intended to evaluate and screen not only physical and psychological symptoms but also spiritual pain, discomfort deriving from financial problems associated with illness, and suffering related to social isolation.
A sample of Italian native outpatients, who referred to the dedicated Supportive Care Unit of the Fondazione IRCCS, Istituto Nazionale deiTumori (INT), Milano, were asked to fill the ESAS-TC to assess item properties, factorial structure, internal consistency, test-retest reliability (patients were asked to retake the scale after 2-6 weeks), and external validity. Concerning the latter, other self-administered scales were employed to assess perceived stress (Perceived Stress Scale), unmet needs (using theNeed Evaluation Questionnaire that describes informative, assistance/care, relational, needs for psycho-emotional support, material needs), and perceived social support (administering the Multidimensional Scale of Perceived Social Support that evaluates perceived support of family, friends, and significant others in the wider social field).
The scales were administered to 243 patients with solid (90%) and hematologic (10%) cancers, mean age 62.6, female 76.5%. Analysis suggested that a single factor better represents the structure of the ESAS scales, their internal consistency and test-retest reliability were good, and evidence of construct and criterion validity were provided. Additionally, incremental validity of the ESAS-TC was proved showing that the added items offer a unique contribution in predicting the patient's stress. Finally, known groups validity was confirmed testing the differences in the ESAS scores due to the Karnofsky Performance Status.
The current study allowed to complete the validation of the Italian version of the ESAS and to develop a psychometrically sound scale, the ESAS-Total Care, that potentially helps in moving cancer research toward personalized total cancer care.
在临床实践中常规使用患者报告结局（PROs）可提高护理质量，有助于减少急诊服务的使用和非预约就诊次数，还能提高癌症患者的生存时间。埃德蒙顿症状评估系统（ESAS）是一种在不同护理环境中广泛用于监测身体和心理症状的PRO。尽管如此，除了这些症状外，文献还强调了精神痛苦、经济困扰和社会隔离对护理质量、治疗效果和生存的影响。
本研究的目的是：（a）通过添加缺失的症状“失眠”来完成ESAS意大利语版本的验证过程；（b）开发并验证ESAS全护理版（ESAS-TC），旨在评估和筛查不仅包括身体和心理症状，还包括精神痛苦、因疾病相关财务问题引起的不适以及与社会隔离相关的痛苦。
选取意大利本土门诊患者样本，这些患者转诊至米兰国立肿瘤研究所（INT）IRCCS基金会的专门支持护理单元，被要求填写ESAS-TC以评估项目属性、因子结构、内部一致性、重测信度（要求患者在2至6周后重新进行量表测试）和外部效度。关于外部效度，使用其他自填式量表来评估感知压力（感知压力量表）、未满足的需求（使用需求评估问卷，该问卷描述信息、协助/护理、关系、心理情感支持需求、物质需求）以及感知社会支持（使用多维感知社会支持量表，评估在更广泛社会领域中家庭、朋友和重要他人的感知支持）。
对243例实体癌（90%）和血液癌（10%）患者进行了量表测试，平均年龄62.6岁，女性占76.5%。分析表明，单一因素能更好地代表ESAS量表结构，其内部一致性和重测信度良好，并提供了结构效度和效标效度的证据。此外，证明了ESAS-TC的增量效度，表明添加的项目在预测患者压力方面具有独特贡献。最后，通过测试卡氏功能状态导致的ESAS评分差异，确认了已知群体效度。
本研究完成了ESAS意大利语版本的验证，并开发了一个心理测量学上合理的量表ESAS全护理版，这可能有助于推动癌症研究朝着个性化的全面癌症护理发展。
