关键词: 桥本甲状腺炎, 甲状腺功能减退症, 证候, 证候疗效评价, 量表, 条目筛选

Abstract: Abstract：Background 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 TCM syndrome efficacy. Objective To preliminarily develop a syndrome efficacy evaluation scale for HT-induced hypothyroidism. Methods 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. Results 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 syndrome elements 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, 3 for Qi deficiency, 4 for Qi stagnation, 1 for phlegm syndrome, 6 for blood stasis, 3 for dampness, and 2 for blood deficiency. The finalized scale comprises 8 syndrome elements and 49 four-diagnostic items. Conclusion This study preliminarily establishes a TCM syndrome efficacy evaluation scale for HT-induced hypothyroidism. Future work should focus on item weighting, multicenter validation, and reliability/validity assessments to provide a scientifically robust tool for syndrome efficacy evaluation and methodological references for similar scale development.

Key words: Hashimoto's thyroiditis, Hypothyroidism, Syndrome, Syndrome efficacy evaluation, Scale, Item screening