In the clinical management of hypothyroidism secondary to Hashimoto's thyroiditis (HT-induced hypothyroidism), traditional Chinese medicine (TCM) demonstrates unique advantages through holistic regulatory effects. However, current clinical studies often lack quantitative and standardized tools for evaluating the efficacy of TCM syndrome.

To preliminarily develop a syndrome efficacy evaluation scale for HT-induced hypothyroidism.

The study period was from August 2023 to April 2024. Guided by international scale development principles and TCM theory, a theoretical framework was constructed. An initial item pool was established through literature review and preliminary clinical investigations. Subjective screening was conducted using the Delphi expert consultation method, while objective screening employed item distribution analysis, discrete trend analysis, Cronbach's α coefficient analysis, and correlation coefficient analysis.

In this study, we successfully established a core group of the scale (including 4 senior physicians, 3 attending physicians, 2 postgraduate students, and 1 statistical expert) and a working group (5 postgraduate students), which worked through the mechanism of collaborative meetings. Two rounds of expert consultations yielded 44 valid questionnaires, with expert response rates of 92.30% and 93.75%, and authority coefficients of 0.85 and 0.92. Eight syndromes and 70 four diagnostic information items were initially identified. Subsequent clinical investigations (419 valid questionnaires) and four statistical methods led to the exclusion of redundant items: 9 for Yang deficiency syndrome, 3 for Qi deficiency syndrome, 4 for Qi stagnation syndrome, 1 for Phlegm syndrome, 6 for Blood stasis syndrome, 4 for Yin deficiency syndrome, 3 for Pathogeny syndrome, and 2 for Blood deficiency syndrome. The finalized scale comprises 8 syndrome (Yang deficiency syndrome, Qi deficiency syndrome, Qi stagnation syndrome, Phlegm syndrome, Blood stasis syndrome, Yin deficiency syndrome, Pathogeny syndrome, Blood deficiency syndrome) and 48 four diagnostic information items.

This study has preliminarily established a TCM syndrome efficacy evaluation scale for HT-induced hypothyroidism, which can provide a basis for the quantification of items and a set of reference methods for the development of evidence efficacy evaluation scales.

在桥本甲状腺炎继发甲状腺功能减退症（以下简称桥本甲减）的临床管理中，中医药通过整体调节作用展现出独特优势，但目前多数临床研究缺乏定量化、标准化的桥本甲减中医证候疗效评价工具。

初步研制桥本甲减证候疗效评价量表。

研究时间为2023年8月—2024年4月。依据国际量表研制原则，结合中医理论，构建量表理论框架，并通过文献检索和课题组前期临床调查建立初始条目池；采用德尔菲专家咨询法进行主观筛选，结合条目分布考察法、离散趋势法、Cronbacn's α系数法和相关系数法进行客观筛选，最终确定量表条目。

本研究成功设立量表核心组（含高级职称医师4人、主治医师3人、研究生2人及统计专家1人）及工作小组（研究生5人），通过协作会议机制开展工作。两轮专家咨询共回收有效问卷44份，专家积极系数分别为92.30%和93.75%，专家权威系数分别为0.85和0.92，筛选得到8个证素及70个四诊信息条目；临床调查共回收419份有效问卷，结合4种数理化统计方法，剔除阳虚证9个条目，气虚证3个条目，气滞证4个条目，痰证1个条目，血瘀证6个条目，阴虚证4个条目，湿证3个条目，血虚证2个条目，最终确定8个证素（阳虚证、气虚证、气滞证、痰证、血瘀证、阴虚证、湿证、血虚证）及48个四诊信息条目，初步形成桥本甲减中医证候疗效评价量表。

本研究初步研制出桥本甲减中医证候疗效评价量表，可为下一步条目量化提供依据，并为证候疗效评价类量表研制提供一套可供参考的方法。