{"title":"转移性乳腺癌患者接受化疗的电子患者报告结果监测环境中症状说明量表的验证。","authors":"Azusa Jo, Takayuki Iwamoto, Youko Suzuki, Ryohei Ogata, Yoshikazu Koike, Tsunehisa Nomura, Katsuhiro Tanaka, Yuichiro Miyoshi, Kyoko Hara, Seiji Yoshitomi, Hajime Hikino, Hirotoshi Takahashi, Daisuke Takabatake, Shinichiro Kubo, Masahiko Ikeda, Tadahiko Shien, Hiroyoshi Doihara, Yuichiro Kikawa, Naruto Taira","doi":"10.1007/s12282-025-01702-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>To enhance patient outcomes, we previously developed \"Hibilog\", an app that allows patients to report symptoms electronically. The paper-based Symptom Illustration Scale (SIS) was adapted using stickers and emojis to evaluate patient-reported outcomes (PROs). This study aimed to validate SIS within an electronic PRO monitoring environment for metastatic breast cancer patients undergoing chemotherapy.</p><p><strong>Methods: </strong>The patients used the Electronic Patient-Reported Outcomes Monitoring (ePROM) \"Hibilog\" application to answer a questionnaire consisting of 18 items selected from the Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE), focusing on symptoms related to breast cancer treatment, along with the corresponding SIS questionnaire. Symptom monitoring began upon registration and continued every two weeks until the completion of the study. The primary outcome was the criterion-related validity of the SIS against PRO-CTCA using the ePROM. The secondary endpoints included the response rate, response time, and missing rates for each item.</p><p><strong>Results: </strong>Patients (n = 75) were registered between September 2019 and March 2020. For criterion validity, the Spearman rank correlation coefficients between the PRO-CTCAE and SIS items showed high correlations (rs ≥ 0.41) for all 18 items. The κ correlation coefficient indicated a high correlation (κ > 0.41) in 11 of the 18 items (61.1%), unlike the correlation with continuous variables. In terms of response and missing rates, the SIS in ePROM demonstrated similarly high performance as our results. Additionally, the average response time was 3.0 min (SD 4.2) for SIS, with a substantially shorter response time.</p><p><strong>Conclusion: </strong>We conclude that SIS is a useful tool in an ePROM environment for patients with MBC undergoing chemotherapy. The clinical utility of SIS in an ePRO environment needs to be validated to develop a more accurate scale for capturing patient symptoms.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":"783-791"},"PeriodicalIF":2.9000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Validation of the Symptom Illustration Scale within an electronic Patient-Reported Outcomes Monitoring environment for metastatic breast cancer patients undergoing chemotherapy.\",\"authors\":\"Azusa Jo, Takayuki Iwamoto, Youko Suzuki, Ryohei Ogata, Yoshikazu Koike, Tsunehisa Nomura, Katsuhiro Tanaka, Yuichiro Miyoshi, Kyoko Hara, Seiji Yoshitomi, Hajime Hikino, Hirotoshi Takahashi, Daisuke Takabatake, Shinichiro Kubo, Masahiko Ikeda, Tadahiko Shien, Hiroyoshi Doihara, Yuichiro Kikawa, Naruto Taira\",\"doi\":\"10.1007/s12282-025-01702-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>To enhance patient outcomes, we previously developed \\\"Hibilog\\\", an app that allows patients to report symptoms electronically. 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The secondary endpoints included the response rate, response time, and missing rates for each item.</p><p><strong>Results: </strong>Patients (n = 75) were registered between September 2019 and March 2020. For criterion validity, the Spearman rank correlation coefficients between the PRO-CTCAE and SIS items showed high correlations (rs ≥ 0.41) for all 18 items. The κ correlation coefficient indicated a high correlation (κ > 0.41) in 11 of the 18 items (61.1%), unlike the correlation with continuous variables. In terms of response and missing rates, the SIS in ePROM demonstrated similarly high performance as our results. Additionally, the average response time was 3.0 min (SD 4.2) for SIS, with a substantially shorter response time.</p><p><strong>Conclusion: </strong>We conclude that SIS is a useful tool in an ePROM environment for patients with MBC undergoing chemotherapy. 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引用次数: 0
摘要
背景：为了提高患者的治疗效果，我们之前开发了“Hibilog”，一个允许患者以电子方式报告症状的应用程序。基于纸张的症状说明量表（SIS）使用贴纸和表情符号来评估患者报告的结果（PROs）。本研究旨在验证SIS在电子PRO监测环境下对接受化疗的转移性乳腺癌患者的疗效。方法：患者使用电子预后监测（ePROM）“Hibilog”应用程序回答一份调查问卷，包括从患者报告的结果-不良事件通用术语标准（PRO-CTCAE）中选择的18个项目，重点关注与乳腺癌治疗相关的症状，以及相应的SIS问卷。症状监测从注册开始，每两周持续一次，直到研究完成。主要结果是使用ePROM的SIS对抗PRO-CTCA的标准相关效度。次要终点包括每个项目的响应率、响应时间和缺失率。结果：患者（n = 75）在2019年9月至2020年3月期间登记。在效度方面，PRO-CTCAE和SIS的18个条目的Spearman等级相关系数均呈高相关（rs≥0.41）。与连续变量的相关性不同，18项中有11项（61.1%）的κ相关系数为高相关（κ > 0.41）。在响应和缺失率方面，ePROM中的SIS表现出与我们的结果相似的高性能。此外，SIS的平均反应时间为3.0 min (SD 4.2)，反应时间大大缩短。结论：我们得出结论，SIS是一个有用的工具，在ePROM环境下的患者接受化疗的MBC。需要验证SIS在ePRO环境中的临床应用，以开发更准确的量表来捕获患者症状。
Validation of the Symptom Illustration Scale within an electronic Patient-Reported Outcomes Monitoring environment for metastatic breast cancer patients undergoing chemotherapy.
Background: To enhance patient outcomes, we previously developed "Hibilog", an app that allows patients to report symptoms electronically. The paper-based Symptom Illustration Scale (SIS) was adapted using stickers and emojis to evaluate patient-reported outcomes (PROs). This study aimed to validate SIS within an electronic PRO monitoring environment for metastatic breast cancer patients undergoing chemotherapy.
Methods: The patients used the Electronic Patient-Reported Outcomes Monitoring (ePROM) "Hibilog" application to answer a questionnaire consisting of 18 items selected from the Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE), focusing on symptoms related to breast cancer treatment, along with the corresponding SIS questionnaire. Symptom monitoring began upon registration and continued every two weeks until the completion of the study. The primary outcome was the criterion-related validity of the SIS against PRO-CTCA using the ePROM. The secondary endpoints included the response rate, response time, and missing rates for each item.
Results: Patients (n = 75) were registered between September 2019 and March 2020. For criterion validity, the Spearman rank correlation coefficients between the PRO-CTCAE and SIS items showed high correlations (rs ≥ 0.41) for all 18 items. The κ correlation coefficient indicated a high correlation (κ > 0.41) in 11 of the 18 items (61.1%), unlike the correlation with continuous variables. In terms of response and missing rates, the SIS in ePROM demonstrated similarly high performance as our results. Additionally, the average response time was 3.0 min (SD 4.2) for SIS, with a substantially shorter response time.
Conclusion: We conclude that SIS is a useful tool in an ePROM environment for patients with MBC undergoing chemotherapy. The clinical utility of SIS in an ePRO environment needs to be validated to develop a more accurate scale for capturing patient symptoms.
期刊介绍：
Breast Cancer, the official journal of the Japanese Breast Cancer Society, publishes articles that contribute to progress in the field, in basic or translational research and also in clinical research, seeking to develop a new focus and new perspectives for all who are concerned with breast cancer. The journal welcomes all original articles describing clinical and epidemiological studies and laboratory investigations regarding breast cancer and related diseases. The journal will consider five types of articles: editorials, review articles, original articles, case reports, and rapid communications. Although editorials and review articles will principally be solicited by the editors, they can also be submitted for peer review, as in the case of original articles. The journal provides the best of up-to-date information on breast cancer, presenting readers with high-impact, original work focusing on pivotal issues.
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