Objective To test the reliability and validity of "the TCM Constitution Scale for Children Aged 1+ to 7 Years", and to optimize it. Methods Healthy children from 5 hospitals were selected for on-site inclusion. The reliability and validity of the scale were analyzed by means of decision value-critical ratio, item-total correlation method, Cronbach's α coefficient, split half reliability, retest reliability, and factor analysis,etc.,and the items with problems were summarized. Results Independent sample t-test was performed for the high and low subscales of 9 subscales, and the items of each subscale had t>3.000, P<0.05, without modification or deletion. Pearson correlation coefficient test was performed on 9 subscales, and the correlation coefficients of items Qi deficiency 9 and blood stasis 40 with the total score were all < 0.4, so it was considered to change or delete them. The Cronbach's α coefficient of the total scale and each subscale was >0.6, and the internal consistency was acceptable. After deleting items 5, 9, 13, 23, 29, 36, 40, 52, 58, 59, and 62, Cronbach's α coefficient increased, and it was considered to delete or change them. Principal component analysis was used to extract common factors based on eigenvalue greater than 1, and a total of 15 common factors were extracted, with a cumulative contribution rate of 62.226%. In order to further fit nine TCM constitution theories, the number of extraction factors was set at 9, and the cumulative contribution rate was shown to be 50.342%.In the structural validity analysis of each subscale, the one with 1 component had the dampness-heat quality and the peace quality; the one with 2 components had the Qi-deficiency quality, Yang-deficiency quality, phlegm-dampness quality, blood-stasis quality, Qi-stagnation quality and special quality subscale; the one with 3 components had the Yin-deficiency quality subscale. The factor loading for all subscale items was >0.4. Conclusion The reliability and validity of the "the TCM Constitution Scale for Children Aged 1+ to 7 Years" for the assessment of children's physical constitution are acceptable, but it still needs to be adjusted to improve its reliability and validity. Later, a discussion with relevant experts will be conducted, and the items with problems will be deleted or modified to form the second version of test of the "the TCM Constitution Scale for Children Aged 1+ to 7 Years", in order to make this scale more suitable for clinical identification of children's physical constitution.
