甲状腺功能正常的桥本甲状腺炎证候疗效评价量表的初步研制：基于专家咨询和临床调查

Background  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 syndromeTCM syndrome evaluation serves as an evaluation index that superiorly reflects the advantages of TCM. Howevermost clinical studies lack quantitative and standardized evaluation methods for the efficacy of TCM syndromes. Objective  To preliminarily develop a TCM syndrome evaluation scale for Hashimoto's thyroiditis in patients with normal thyroid function. Methods  The study period was from August 2023 to December 2023. Guided by the TCM theory and international scale development methodsa 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 distributiondispersion trends Cronbach's alpha coefficientand correlation coefficient analyses. Results  Two rounds of expert consultations yielded 44 valid questionnaireswith the participation rate of 95.83% and 100%respectivelyand authority coefficient of 0.827 and 0.831respectively. 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 panel5 items for Qi stagnation syndrome4 for Qi deficiency syndrome3 for Phlegm syndrome8 for Yin deficiency syndrome3 for Blood stasis syndrome6 for Yang deficiency syndrome5 for FireHeatsyndromeand 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 yieldedcontaining 51 diagnostic items in eight syndromes9 items for Qi stagnation syndrome10 for Qi deficiency syndrome8 for Phlegm syndrome9 for Yin deficiency syndrome5 for Blood stasis syndrome13 for Yang deficiency syndrome8 for FireHeat syndromeand 8 for Blood deficiency syndrome.Conclusion  This study has preliminarily developed a TCM syndrome evaluation scale for Hashimoto's thyroiditis with normal thyroid functionlaying a foundation for the quantification of items and providing a methodological reference for the development of relevant scales.