The efficacy of traditional Chinese medicine (TCM) on the treatment of Hashimoto thyroiditis with normal thyroid function is increasingly pronounced. Under the current diagnosis and treatment mode combining both the disease itself and the relevant syndrome, TCM syndrome evaluation serves as an evaluation index that superiorly reflects the advantages of TCM. However, most clinical studies lack quantitative and standardized evaluation methods for the efficacy of TCM syndromes.

To preliminarily develop a TCM syndrome evaluation scale for Hashimoto's thyroiditis in patients with normal thyroid function.

The study period was from August to December 2023. Guided by the TCM theory and international scale development methods, a theoretical framework for developing a TCM syndrome evaluation scale for Hashimoto's thyroiditis in patients with normal thyroid function was established. An initial scale item pool was generated through literature review and preliminary clinical surveys by the research team. Items were refined using a combination analysis of subjective selection via the Delphi method and objective selection methods of item distribution, dispersion trends, Cronbach's alpha coefficient, and correlation coefficient analyses.

A total of 22 valid questionnaires were collected in both rounds of expert consultation, making a total of 44 valid questionnaires, with the participation rate of 95.83% and 100.00%, respectively, and authority coefficient of 0.827 and 0.831, respectively. Eight key syndromes and 71 diagnostic information items associated with TCM syndrome evaluation were screened. A total of 369 valid questionnaires were collected from clinical surveys. Through the integration of four mathematical statistical methods and discussions with the expert panel, 5 items for Qi stagnation syndrome, 4 for Qi deficiency syndrome, 3 for Phlegm syndrome, 8 for Yin deficiency syndrome, 3 for Blood stasis syndrome, 6 for Yang deficiency syndrome, 5 for Fire (Heat) syndrome, and 2 for Blood deficiency syndrome were removed. A preliminary formation of the TCM syndrome evaluation scale for Hashimoto's thyroiditis in patients with normal thyroid function was yielded, containing 51 diagnostic items in eight syndromes: 9 items for Qi stagnation syndrome, 10 for Qi deficiency syndrome, 8 for Phlegm syndrome, 9 for Yin deficiency syndrome, 5 for Blood stasis syndrome, 13 for Yang deficiency syndrome, 8 for Fire (Heat) syndrome, and 8 for Blood deficiency syndrome.

This study has preliminarily developed a TCM syndrome evaluation scale for Hashimoto's thyroiditis with normal thyroid function, laying a foundation for the quantification of items and providing a methodological reference for the development of relevant scales.