Objective

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To evaluate the reliability and validity of the traditional Chinese medicine （TCM） diagnostic scale for liver constraint and

qi

stagnation syndrome of breast fibroadenoma.

Methods

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A total of 125 patients with breast fibroadenoma were investigated by using the TCM diagnostic scale for liver constraint and

qi

stagnation syndrome with 12 syndrome items. The validity of the scale was tested by structural validity， convergence validity and discriminant validity analysis. The internal consistency reliability， split-half reliability and retest reliability of the scale were calculated to evaluate the reliability.

Results

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Of all 125 questionnaires， four with completion rate less than 90% were excluded， and 121 questionnaires were valid， with an effective recovery rate of 96.8%. The completion time of the scale questionnaire was 7.96 ± 0.34 minutes， and there was no missing item values of the included questionnaires. Structural validity analysis showed that the maximum cumulative variance contribution rate was 59.479% when three common factors were extracted in the exploratory factor analysis； the absolute value of the exclusion factor load coefficient was set as ≥0.5， and then the scale could be divided into three dimensions， namely primary symptoms， secondary symptoms， and tongue and pulse. In terms of confirmatory factor analysis， the chi-square value/ degree of freedom （χ

2

/ df） was 1.075 （＜3）， and the root mean square error of approximation （RMSEA） was 0.025 （＜0.05）； the goodness-of-fit index （GFI） was 0.925， and the comparative goodness-of-fit index （CFI） was 0.990， while the incremental goodness-of-fit index （IFI） was 0.990， the Tucker-Lewis （TLI） was 0.987， and all values were greater than 0.9. Convergence validity analysis showed that all items factor loadings were greater than 0.5， with the average variance extraction values greater than 0.4， and the combined reliability greater than 0.7. The discriminant validity analysis showed that three-factor model fitting index was better than that of two-factor and single-facotr models （

P

＜0.01）. The overall internal consistency coefficient of the diagnostic scale was 0.830， and the total split-half reliability coefficient was 0.784， with the total test-retest reliability of 0.929 through reliability test.

Conclusion

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The TCM diagnostic scale for liver constraint and

qi

stagnation syndrome of breast fibroadenoma has good reliability and validity， which can meet the actual needs of clinical diagnosis.