Scholarlink

Background <p>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> Methods <p>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> Results <p><b>P</b>atients (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 &gt; 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> Conclusion <p>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>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Validation of the Symptom Illustration Scale within an electronic Patient-Reported Outcomes Monitoring environment for metastatic breast cancer patients undergoing chemotherapy

  • 期刊论文

  • 发表日期：

    2025年4月10日

查看全文
  • 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

摘要

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.