Development and validation of the patient-reported traditional Chinese medicine kidney deficiency pattern scale for patients with colorectal cancer

Objective: To develop a patient-reported traditional Chinese medicine kidney deficiency pattern (TCM-KDP) scale for colorectal cancer (CRC) patients and evaluate its reliability and validity. Methods: We administered the TCM-KDP questionnaire to postoperative patients with stage II and III CRC as pa...

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Main Authors: Yunzi Yan, Yufei Yang, Chunhui Ning, Shaohua Yan, Lingyun Sun
Format: Article
Language:English
Published: Elsevier 2025-07-01
Series:Journal of Traditional Chinese Medical Sciences
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Online Access:http://www.sciencedirect.com/science/article/pii/S209575482500050X
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author Yunzi Yan
Yufei Yang
Chunhui Ning
Shaohua Yan
Lingyun Sun
author_facet Yunzi Yan
Yufei Yang
Chunhui Ning
Shaohua Yan
Lingyun Sun
author_sort Yunzi Yan
collection DOAJ
description Objective: To develop a patient-reported traditional Chinese medicine kidney deficiency pattern (TCM-KDP) scale for colorectal cancer (CRC) patients and evaluate its reliability and validity. Methods: We administered the TCM-KDP questionnaire to postoperative patients with stage II and III CRC as part of a multicenter randomized controlled trial (RCT) conducted in China from December 2018 to September 2021. The TCM-KDP scale consists of eight items on patient-reported symptoms and is scored on a five-point Likert scale. The scale’s reliability was assessed using Cronbach’s α and test-retest reliability, while content validity was evaluated with the content validity index. We compared the differences in serum cytokine levels and other clinical factors between patients with higher and lower KDP scores. Results: Of the 378 patients analyzed in the original RCT, 352 (93.2%) completed the TCM-KDP questionnaire. The Cronbach’s α of the eight-item TCM-KDP scale was 0.734, and the test-retest reliability was 0.745. Our exploratory factor analysis yielded eight factors that explained the variance of 50.34%. The mean TCM-KDP score was 2.80 ± 0.92. Compared with patients with stage II CRC, those with stage III CRC had significantly higher TCM-KDP scores (2.25 vs. 2.50, P = .026). We categorized all patients into high- or low-KDP score groups (the cut-off score was 2.8). Patients with lower TCM-KDP scores had significantly higher serum interleukin-1β expression levels (P = .04). Conclusion: The patient-reported TCM-KDP scale demonstrated relatively good feasibility, internal consistency, and test-retest reliability among patients with CRC. Future studies could apply this scale to other cancer types and diseases.
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spelling doaj-art-3f0a20e9346b4511a1d6dfb05f9c03f72025-08-20T03:09:34ZengElsevierJournal of Traditional Chinese Medical Sciences2095-75482025-07-0112335836310.1016/j.jtcms.2025.04.003Development and validation of the patient-reported traditional Chinese medicine kidney deficiency pattern scale for patients with colorectal cancerYunzi Yan0Yufei Yang1Chunhui Ning2Shaohua Yan3Lingyun Sun4Xiyuan Hospital, China Academy of Chinese Medical Science, Beijing 100091, China; Graduate School, Beijing University of Chinese Medicine, Beijing 102488, ChinaXiyuan Hospital, China Academy of Chinese Medical Science, Beijing 100091, ChinaXiyuan Hospital, China Academy of Chinese Medical Science, Beijing 100091, ChinaDongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, ChinaXiyuan Hospital, China Academy of Chinese Medical Science, Beijing 100091, China; Corresponding author.Objective: To develop a patient-reported traditional Chinese medicine kidney deficiency pattern (TCM-KDP) scale for colorectal cancer (CRC) patients and evaluate its reliability and validity. Methods: We administered the TCM-KDP questionnaire to postoperative patients with stage II and III CRC as part of a multicenter randomized controlled trial (RCT) conducted in China from December 2018 to September 2021. The TCM-KDP scale consists of eight items on patient-reported symptoms and is scored on a five-point Likert scale. The scale’s reliability was assessed using Cronbach’s α and test-retest reliability, while content validity was evaluated with the content validity index. We compared the differences in serum cytokine levels and other clinical factors between patients with higher and lower KDP scores. Results: Of the 378 patients analyzed in the original RCT, 352 (93.2%) completed the TCM-KDP questionnaire. The Cronbach’s α of the eight-item TCM-KDP scale was 0.734, and the test-retest reliability was 0.745. Our exploratory factor analysis yielded eight factors that explained the variance of 50.34%. The mean TCM-KDP score was 2.80 ± 0.92. Compared with patients with stage II CRC, those with stage III CRC had significantly higher TCM-KDP scores (2.25 vs. 2.50, P = .026). We categorized all patients into high- or low-KDP score groups (the cut-off score was 2.8). Patients with lower TCM-KDP scores had significantly higher serum interleukin-1β expression levels (P = .04). Conclusion: The patient-reported TCM-KDP scale demonstrated relatively good feasibility, internal consistency, and test-retest reliability among patients with CRC. Future studies could apply this scale to other cancer types and diseases.http://www.sciencedirect.com/science/article/pii/S209575482500050XTraditional Chinese medicineKidney deficiency patternPatient-reported outcomeReliability and validityColorectal cancer
spellingShingle Yunzi Yan
Yufei Yang
Chunhui Ning
Shaohua Yan
Lingyun Sun
Development and validation of the patient-reported traditional Chinese medicine kidney deficiency pattern scale for patients with colorectal cancer
Journal of Traditional Chinese Medical Sciences
Traditional Chinese medicine
Kidney deficiency pattern
Patient-reported outcome
Reliability and validity
Colorectal cancer
title Development and validation of the patient-reported traditional Chinese medicine kidney deficiency pattern scale for patients with colorectal cancer
title_full Development and validation of the patient-reported traditional Chinese medicine kidney deficiency pattern scale for patients with colorectal cancer
title_fullStr Development and validation of the patient-reported traditional Chinese medicine kidney deficiency pattern scale for patients with colorectal cancer
title_full_unstemmed Development and validation of the patient-reported traditional Chinese medicine kidney deficiency pattern scale for patients with colorectal cancer
title_short Development and validation of the patient-reported traditional Chinese medicine kidney deficiency pattern scale for patients with colorectal cancer
title_sort development and validation of the patient reported traditional chinese medicine kidney deficiency pattern scale for patients with colorectal cancer
topic Traditional Chinese medicine
Kidney deficiency pattern
Patient-reported outcome
Reliability and validity
Colorectal cancer
url http://www.sciencedirect.com/science/article/pii/S209575482500050X
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