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Development and validation of a symptom illustration scale from the patient-reported outcome common terminology criteria for adverse events for patients with breast cancer

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Abstract

Purpose

Emojis are commonly used for daily communication and may be useful in assessing patient-reported outcomes (PROs) in breast cancer. The purpose of this study is to develop and validate a Symptom Illustration Scale (SIS) as a new PRO measurement.

Methods

Eighteen original SIS items were developed from the PRO-CTCAE. In cohort one, the SIS validity and reliability were examined in patients with breast cancer, using a semi-structured five-question survey to investigate content validity. PROs with PRO-CTCAE and SIS were examined twice to determine criteria validity and test–retest reliability. In cohort two, the responsiveness of the scales were examined in patients treated with anthracycline, docetaxel, paclitaxel, and endocrine therapy. PROs with PRO-CTCAE and SIS were investigated two or three times, depending on the therapy.

Results

Patients were enrolled from August 2019 to October 2020. In cohort one (n = 70), most patients had no difficulties with the SIS, but 16 patients indicated that it was difficult to understand severities in the SIS. For criterion validity, Spearman rank correlation coefficients (rs) between PRO-CTCAE and SIS items were ≥ 0.41, except for “Decreased appetite.” For test–retest reliability, κ coefficients of the SIS were ≥ 0.41 for 16/18 items (88.9%). Response time was significantly shorter for the SIS than for PRO-CTCAE (p < 0.001). In cohort two (n = 106), score changes between PRO-CTCAE and SIS for relevant symptoms all had correlations with rs ≥ 0.41.

Conclusion

An original SIS from the PRO-CTCAE for patients with breast cancer were verified the validity, reliability, and responsiveness. Further studies to improve and validate the SIS are needed.

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Data availability

Upon request, the authors prepare to send relevant documentation or data without sensitive information in the form of confidential proprietary data in order to verify the validity of the results.

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Funding

This study was funded by Pfizer Inc.

Author information

Authors and Affiliations

  1. Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan

    Yoko Suzuki, Takayuki Iwamoto, Maya Uno, Minami Hatono, Yukiko Kajiwara, Yuko Takahashi, Mariko Kochi, Tadahiko Shien, Naruto Taira & Hiroyoshi Doihara

  2. Department of General Thoracic Surgery and Breast and Endocrinological Surgery, Okayama University, Okayama, Japan

    Yoko Suzuki, Maya Uno & Shinichi Toyooka

  3. Department of Breast and Thyroid Surgery, Kawasaki Medical School Hospital, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan

    Takayuki Iwamoto & Naruto Taira

  4. Breast Surgery, Kansai Medical University Hospital, Osaka, Japan

    Yuichiro Kikawa

  5. Biosciences, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan

    Yukari Uemura

  6. Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan

    Yasuhiro Hagiwara

  7. Shizuoka Graduate University of Public Health, Shizuoka, Japan

    Seiichiro Yamamoto

  8. Department of Surgery, Kawasaki Medical School General Medical Center, Okayama, Japan

    Hiroyoshi Doihara

Authors
  1. Yoko Suzuki
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  2. Takayuki Iwamoto
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  3. Maya Uno
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Contributions

All authors contributed to the study and design. Material preparation, data collection, and analysis were performed by YS, NT, TI, YK, YU, YH, and SY. The first draft of the manuscript was written by YS and all authors commented on versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Takayuki Iwamoto.

Ethics declarations

Conflict of interest

Tadahiko Shien, Yuichiro Kikawa, and Naruto Taira received an honorarium from Pfizer Inc.

Ethical approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Okayama University Hospital (Cohort one: Date 2019.5.28/No. 1907–038, Cohort two: Date 2019.11.29/No. 1907–042).

Research involving human participants and/or animals

This study involving human participants was in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Consent to participate

Written informed consent was obtained from all participants in the study.

Consent to publish

The authors affirm that all patients provided informed consent for publication of all figures and tables.

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Supplementary Information

Below is the link to the electronic supplementary material.

12282_2023_1480_MOESM1_ESM.tif

Supplementary file1 Figure S1 Correlation coefficients, κ coefficients, and concordance rates between the PRO-CTCAE and SIS at T2. The forest plots show correlation coefficients between the PRO-CTCAE and SIS at T1. κ coefficients and concordance rates are also shown. A, amount; CC: correlation coefficient; CI, confidence interval; SIS, Symptom Illustration Scale; F, frequency; I, interference; P, presence/absence; PRO, patient-reported outcome; ROC, rate of concordance; S, severity (TIF 128 KB)

12282_2023_1480_MOESM2_ESM.tif

Supplementary file2 Figure S2 Correlation coefficients, κ coefficients, and concordance rates between the PRO-CTCAE and SIS at T1 in the PRO-CTCAE group. The forest plots show correlation coefficients between the PRO-CTCAE and SIS at T1 in the PRO-CTCAE group. κ coefficients and concordance rates are also shown. A, amount; CC, correlation coefficient; CI, confidence interval; SIS, Symptom Illustration Scale; F, frequency; I, interference; P, presence/absence; PRO, patient- reported outcome; ROC, rate of concordance; S, Severity (TIF 132 KB)

12282_2023_1480_MOESM3_ESM.tif

Supplementary file3 Figure S3 Correlation coefficients, κ coefficients, and concordance rates between the PRO-CTCAE and SIS questionnaires at T1 in the SIS group. The forest plots show correlation coefficients between the PRO-CTCAE and SIS at T1 in the SIS group. κ coefficient and concordance are also shown. A, amount; CC, correlation coefficient; CI, confidence interval; SIS, Symptom Illustration Scale; F, frequency; I, interference; P, presence/absence; PRO, patient-reported outcome; ROC, rate of concordance; S, severity (TIF 132 KB)

12282_2023_1480_MOESM4_ESM.tif

Supplementary file4 Figure S4 Test-retest reliability between T1 and T2 in the PRO-CTCAE group. The forest plots show the κ coefficient and 95% confidence interval between T1 and T2 in the PRO-CTCAE group. Concordance rates are also shown. A, amount; CI, confidence interval; SIS, Symptom Illustration Scale; F, frequency; I, interference; P, presence/absence; PRO, patient-reported outcome; ROC, rate of concordance; S, severity (TIF 136 KB)

12282_2023_1480_MOESM5_ESM.tif

Supplementary file5 Figure S5 Test-retest reliability between T1 and T2 in the SIS group. The forest plots show κ coefficients and 95% confidence intervals between T1 and T2 in the SIS group. Concordance rates are also shown. A, amount;. CI, confidence interval; SIS, Symptom Illustration Scale; F, frequency; I, interference; P, presence/absence; PRO, patient-reported outcome; ROC, rate of concordance; S, severity (TIF 136 KB)

12282_2023_1480_MOESM6_ESM.tif

Supplementary file6 Figure S6 Correlation coefficients for score changes from T1 to T3 between the PRO-CTCAE and SIS questionnaires in the anthracyline group. The forest plots show correlation coefficients of score changes from T1 to T3 between the PRO-CTCAE and SIS. A, amount; CC, correlation coefficient; CI, confidence interval; SIS, Symptom Illustration Scale; F, frequency; I, interference; P, presence/absence; PRO, patient-reported outcome; S, severity (TIF 111 KB)

12282_2023_1480_MOESM7_ESM.tif

Supplementary file7 Figure S7 Correlation coefficients for score changes from T1 to T2 between the PRO-CTCAE and SIS questionnaires in the docetaxel group. The forest plots show correlation coefficients of score changes from T1 to T2 between the PRO-CTCAE and SIS. A, amount; CC, correlation coefficient; CI, confidence interval; SIS, Symptom Illustration Scale; F, frequency; I, Interference; P, presence/absence; PRO, patient-reported outcome; S, severity (TIF 111 KB)

12282_2023_1480_MOESM8_ESM.tif

Supplementary file8 Figure S8 Correlation coefficients for score changes from T1 to T3 between the PRO-CTCAE and SIS in the docetaxel group. The forest plots show correlation coefficient of score changes from T1 to T3 between the PRO-CTCAE and SIS. A, amount; CC, correlation coefficient; CI, confidence interval; SIS, Symptom Illustration Scale; F, frequency; I, interference; P, presence/absence; PRO: patient-reported outcome; S, severity (TIF 111 KB)

12282_2023_1480_MOESM9_ESM.tif

Supplementary file9 Figure S9 Correlation coefficients for score changes from T1 to T2 between the PRO-CTCAE and SIS in the paclitaxel group. The forest plots show correlation coefficients of score changes from T1 to T2 between the PRO-CTCAE and SIS. A, amount; CC, correlation coefficient; CI, confidence interval; SIS, Symptom Illustration Scale; F, Frequency; I, Interference; P, presence/absence; PRO, patient-reported outcome; S, severity (TIF 111 KB)

12282_2023_1480_MOESM10_ESM.tif

Supplementary file10 Figure S10 Correlation coefficients for score changes from T1 to T3 between the PRO-CTCAE and SIS in the paclitaxel group. The forest plots show the correlation coefficient of score changes from T1 to T3 between the PRO-CTCAE and SIS. A, amount; CC, corelation coefficient; CI, confidence interval; SIS, Symptom Illustration Scale; F, frequency; I, interference; P, presence/absence; PRO, patient-reported outcome; S, severity (TIF 110 KB)

12282_2023_1480_MOESM11_ESM.tif

Supplementary file11 Figure S11 Correlation coefficients for score changes from T1 to T2 between the PRO-CTCAE and SIS in the endocrine cohort. The forest plots show correlation coefficients of score changes from T1 to T2 between the PRO-CTCAE and SIS. A, amount; CC, correlation coefficient; CI, confidence interval; SIS, Symptom Illustration Scale; F, frequency; I, interference; P, presence/absence; PRO, patient-reported outcome; S, severity (TIF 111 KB)

12282_2023_1480_MOESM12_ESM.tif

Supplementary file12 Figure S12 Questionnaire for the Symptom Illustration Scale v.1.0. English translations were added to the original Japanese version for publication: 5) Diarrhea, 6) Shortness of breath, 7) Swelling, 8) Rash, 9) Hair loss, 10) Numbness & tingling, 11) General pain, 12) Joint pain, 13) Insomnia, 14) Fatigue, 15) Anxious, 16) Vaginal discharge, 17) Vaginal dryness, and 18) Hot flashes, continued from Figure 4 (TIF 292 KB)

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Supplementary file18 (TIF 264 KB)

Supplementary file19 (DOCX 16 KB)

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Suzuki, Y., Iwamoto, T., Uno, M. et al. Development and validation of a symptom illustration scale from the patient-reported outcome common terminology criteria for adverse events for patients with breast cancer. Breast Cancer 30, 856–868 (2023). https://doi.org/10.1007/s12282-023-01480-3

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  • DOI: https://doi.org/10.1007/s12282-023-01480-3

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