Journal of Traditional Chinese Medicine ›› 2026, Vol. 46 ›› Issue (5): 1295-1306.DOI: 10.19852/j.cnki.jtcm.2026.05.022
• Idea and Methodology • Previous Articles Next Articles
Quality criteria for measuring properties of diagnostic scale for Traditional Chinese Medicine syndromes
FANG Ge1,2, LI Lin2, LI Xiantao3, CHEN Jiaxu4, ZHOU Xuan4, HU Zhixi2(
)
- 1
School of Traditional Chinese Medicine ,Hunan Traditional Chinese Medical College Zhuzhou 412000, China
2School of Traditional Chinese Medicine ,Hunan University of Chinese Medicine Changsha 410208, China
3School of Basic Medical Science ,Guangzhou University of Chinese Medicine Guangzhou 510006, China
4Formula-Pattern Research Center ,School of Traditional Chinese Medicine, Jinan University Guangzhou 510632, China
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Received:2025-02-12Accepted:2025-12-24Online:2026-10-15Published:2026-10-09 -
Contact:Prof. HU Zhixi, School of Traditional Chinese Medicine, Hunan University of Chinese Medicine, Changsha 410208, China. 003405@hnucm.edu.cn,Telephone: +86-18719139564 -
Supported by:Key Areas of Research and Development Plan of Guangdong Province: a Systematic Study of the Diagnostic Criteria for Qi Stagnation Syndrome(2020B1111100001);National Natural Science Foundation of China: Exploring the Pathological Mechanism of Myocardial Fibrosis in Ischemic Heart Failure Based on miR-155 Regulation of Macrophage Polarization and its Interventional Approach Based on Evidence(82274412);Hunan Provincial Natural Science Foundation of China: Based on the Concept of “Heart-kidney Disharmony,” this Study Explores the Pathological Mechanisms of Hypertension, Heart Failure, and Renal Fibrosis(2020JJ4062);Effects and Mechanism of Endurance Exercise on Myocardial Fibrosis in Hypertensive Heart Failure Based on miR-378(2020JJ5408)
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FANG Ge, LI Lin, LI Xiantao, CHEN Jiaxu, ZHOU Xuan, HU Zhixi. Quality criteria for measuring properties of diagnostic scale for Traditional Chinese Medicine syndromes[J]. Journal of Traditional Chinese Medicine, 2026, 46(5): 1295-1306.
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Table 1 Quality criteria for the property measurements of the diagnostic criteria for TCM syndromes
| Property | Definition | Quality criteria |
|---|---|---|
| Literature review | Systematically collects disease descriptions in the TCM literature, organizes physicians’ experience, and provides basic data to establish scale items | + A good search strategy; Clear inclusion/exclusion criteria; Quantified and graded |
| − No searched strategy; Vague inclusion and exclusion criteria; Not quantified and graded | ||
| Clinical data | Primarily cross-sectional and retrospective studies | + The pool of the top 20 items and the remaining low-frequency words are selected as alternative items |
| − All items are considered alternate items | ||
| Subjective screening | Delphi method, soliciting experts’ anonymous opinions of the item pool | + (a) Expert concentration: average >2 (rate 0-4), grade sum >30% of full score ratio, and full score ratio >30% and (b) expert coordination coefficient: coordination coefficient >0.1 |
| − (a) Expert concentration: average ≤2 (rate 0-4), grade sum ≤30% of full score ratio, and full score ratio ≤30%; and (b) expert coordination coefficient: coordination coefficient ≤0.1 | ||
| Objective screening | The extent to which the results of participant interviews are examined using various statistical methods | + (a) Item distribution inspection method: a response rate ≤80% for any option; (b) t-test: P-value < 0.05; (c) discrete trend method: S ≥0.9; (d) correlation coefficient method: correlation coefficient of ≥0.4; and (e) Cronbach’s α coefficient method: If Cronbach’s α changes little, it is retained |
| − (a) Item distribution inspection method: a response rate >80% in any option; (b) t-test: P-value ≥0.05; (c) discrete trend method: S < 0.9; (d) correlation coefficient method: correlation coefficient of < 0.4; and (e) Cronbach’s α coefficient method: If Cronbach’s α increases significantly, consider deleting the item | ||
| Item weighting methods | Items were quantified | + Formulas used to determine item scores |
| − No formulas used to determine item scores | ||
| Diagnostic threshold | ROC analysis | + ROC curve of >0.6 |
| − ROC curve of ≤0.6 | ||
| Internal consistency | Items in a (sub)scale are intercorrelated, thus measuring the same construct | + Cronbach’s α: 0.70-0.90 |
| − Cronbach’s α: < 0.70 or >0.90 | ||
| Split-half | Test of how consistently a quantity is represented across items | + Cronbach’s α: 0.70-0.90 |
| − Cronbach’s α: < 0.70 or >0.90 | ||
| Test-retest | After the scale measures the same measurement object, it is re-measured using the same scale within a certain period (less than two weeks) | + ICC or weighted kappa is ≥0.40 |
| − ICC or weighted kappa is < 0.40 | ||
| Interrater consistency | Clinicians from multiple centers with different backgrounds and professional knowledge of Chinese medicine | + ICC or weighted kappa is ≥0.40; and ≥10 clinicians |
| − ICC or weighted kappa is < 0.40; and < 10 clinicians | ||
| Content validity | Degree of coincidence between the content actually measured by a scale and the content to be measured | + I-CVI >0.78 and S-CVI >0.80 |
| − I-CVI ≤0.78 and S-CVI ≤0.80 | ||
| Criterion validity | Correlation between the scale and gold standard | + correlation coefficient is >0.70 |
| − correlation coefficient is ≤0.70 | ||
| Structural validity | Degree of correlation between specific construct items, which is consistent with the theoretical hypothesis | + CFA: RMSEA < 0.08, and GFI, AGFI, NFI, IFI, TLI, and CFI >0.80 |
| − CFA: RMSEA ≥0.08, and GFI, AGFI, NFI, IFI, TLI, and CFI ≤0.80 | ||
| Convergent validity | Computed from the hypothesis item-subscale correlation | + correlation coefficient ≥0.40 |
| − correlation coefficient < 0.40 | ||
| Discriminant validity | Comparing and analyzing score differences in different characteristic populations | + t-test: t >1 and P < 0.05. |
| − t-test: t ≤1 and P ≥0.05. |
Table 1 Quality criteria for the property measurements of the diagnostic criteria for TCM syndromes
| Property | Definition | Quality criteria |
|---|---|---|
| Literature review | Systematically collects disease descriptions in the TCM literature, organizes physicians’ experience, and provides basic data to establish scale items | + A good search strategy; Clear inclusion/exclusion criteria; Quantified and graded |
| − No searched strategy; Vague inclusion and exclusion criteria; Not quantified and graded | ||
| Clinical data | Primarily cross-sectional and retrospective studies | + The pool of the top 20 items and the remaining low-frequency words are selected as alternative items |
| − All items are considered alternate items | ||
| Subjective screening | Delphi method, soliciting experts’ anonymous opinions of the item pool | + (a) Expert concentration: average >2 (rate 0-4), grade sum >30% of full score ratio, and full score ratio >30% and (b) expert coordination coefficient: coordination coefficient >0.1 |
| − (a) Expert concentration: average ≤2 (rate 0-4), grade sum ≤30% of full score ratio, and full score ratio ≤30%; and (b) expert coordination coefficient: coordination coefficient ≤0.1 | ||
| Objective screening | The extent to which the results of participant interviews are examined using various statistical methods | + (a) Item distribution inspection method: a response rate ≤80% for any option; (b) t-test: P-value < 0.05; (c) discrete trend method: S ≥0.9; (d) correlation coefficient method: correlation coefficient of ≥0.4; and (e) Cronbach’s α coefficient method: If Cronbach’s α changes little, it is retained |
| − (a) Item distribution inspection method: a response rate >80% in any option; (b) t-test: P-value ≥0.05; (c) discrete trend method: S < 0.9; (d) correlation coefficient method: correlation coefficient of < 0.4; and (e) Cronbach’s α coefficient method: If Cronbach’s α increases significantly, consider deleting the item | ||
| Item weighting methods | Items were quantified | + Formulas used to determine item scores |
| − No formulas used to determine item scores | ||
| Diagnostic threshold | ROC analysis | + ROC curve of >0.6 |
| − ROC curve of ≤0.6 | ||
| Internal consistency | Items in a (sub)scale are intercorrelated, thus measuring the same construct | + Cronbach’s α: 0.70-0.90 |
| − Cronbach’s α: < 0.70 or >0.90 | ||
| Split-half | Test of how consistently a quantity is represented across items | + Cronbach’s α: 0.70-0.90 |
| − Cronbach’s α: < 0.70 or >0.90 | ||
| Test-retest | After the scale measures the same measurement object, it is re-measured using the same scale within a certain period (less than two weeks) | + ICC or weighted kappa is ≥0.40 |
| − ICC or weighted kappa is < 0.40 | ||
| Interrater consistency | Clinicians from multiple centers with different backgrounds and professional knowledge of Chinese medicine | + ICC or weighted kappa is ≥0.40; and ≥10 clinicians |
| − ICC or weighted kappa is < 0.40; and < 10 clinicians | ||
| Content validity | Degree of coincidence between the content actually measured by a scale and the content to be measured | + I-CVI >0.78 and S-CVI >0.80 |
| − I-CVI ≤0.78 and S-CVI ≤0.80 | ||
| Criterion validity | Correlation between the scale and gold standard | + correlation coefficient is >0.70 |
| − correlation coefficient is ≤0.70 | ||
| Structural validity | Degree of correlation between specific construct items, which is consistent with the theoretical hypothesis | + CFA: RMSEA < 0.08, and GFI, AGFI, NFI, IFI, TLI, and CFI >0.80 |
| − CFA: RMSEA ≥0.08, and GFI, AGFI, NFI, IFI, TLI, and CFI ≤0.80 | ||
| Convergent validity | Computed from the hypothesis item-subscale correlation | + correlation coefficient ≥0.40 |
| − correlation coefficient < 0.40 | ||
| Discriminant validity | Comparing and analyzing score differences in different characteristic populations | + t-test: t >1 and P < 0.05. |
| − t-test: t ≤1 and P ≥0.05. |
Figure 1 Diagnostic criteria for TCM syndromes
Figure 1 Diagnostic criteria for TCM syndromes
Table 2 Summary of the assessment of measurement properties among TCM diagnostic scales for functional dyspepsia
| Scale | TCM functional gastrointestinal disorders scale | TCM syndrome differentiation instrument for functional gastrointestinal disorders | TCM syndrome differentiation instrument for functional gastrointestinal disorders (amended) | TCM functional dyspepsia scale | Stomach Qi defificiency pattern assessment scale | ||
|---|---|---|---|---|---|---|---|
| Establishment of an item pool | Literature review | + | + | + | + | + | |
| Clinical data | + | − | − | − | − | ||
| Item screening methods | Subjective screening | − | − | − | − | + | |
| Objective screening | + | + | + | + | − | ||
| Item weighting methods | − | − | − | + | − | ||
| Diagnostic threshold | − | − | − | + | + | ||
| Clinical evaluation | Reliability | Internal consistency | + | − | − | − | + |
| Split-half | + | − | − | − | − | ||
| Test-retest | − | − | − | + | − | ||
| Inter-rater consistency | − | − | − | − | − | ||
| Validity | Content validity | + | − | − | − | − | |
| Criterion validity | − | − | − | + | + | ||
| Structural validity | + | + | + | − | − | ||
| Convergent validity | − | − | − | − | − | ||
| Discriminant validity | + | + | − | − | − | ||
Table 2 Summary of the assessment of measurement properties among TCM diagnostic scales for functional dyspepsia
| Scale | TCM functional gastrointestinal disorders scale | TCM syndrome differentiation instrument for functional gastrointestinal disorders | TCM syndrome differentiation instrument for functional gastrointestinal disorders (amended) | TCM functional dyspepsia scale | Stomach Qi defificiency pattern assessment scale | ||
|---|---|---|---|---|---|---|---|
| Establishment of an item pool | Literature review | + | + | + | + | + | |
| Clinical data | + | − | − | − | − | ||
| Item screening methods | Subjective screening | − | − | − | − | + | |
| Objective screening | + | + | + | + | − | ||
| Item weighting methods | − | − | − | + | − | ||
| Diagnostic threshold | − | − | − | + | + | ||
| Clinical evaluation | Reliability | Internal consistency | + | − | − | − | + |
| Split-half | + | − | − | − | − | ||
| Test-retest | − | − | − | + | − | ||
| Inter-rater consistency | − | − | − | − | − | ||
| Validity | Content validity | + | − | − | − | − | |
| Criterion validity | − | − | − | + | + | ||
| Structural validity | + | + | + | − | − | ||
| Convergent validity | − | − | − | − | − | ||
| Discriminant validity | + | + | − | − | − | ||
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