中文版「低血糖感知障礙量表」之發展與心理計量特性

目標：本研究旨在針對英文版Clarke與Gold之低血糖感知障礙（Impaired Awareness of Hypoglycemia, IAH）量表進行中文化（分別稱Clarke-TW與Gold-TW），並評估其信、效度特性。方法：組成雙語專家小組利用翻譯-回譯程序進行量表中文化。於2022年9月至11月完成898位由台南市19家藥局、診所及衛生所針對20歲以上三個月內曾接受胰島素注射或磺醯脲類口服藥物治療之第二型糖尿個案進行方便抽樣與面對面訪談，評估社區糖尿病個案IAH盛行狀況。根據調查數據本研究評估量表之內部一致性信度、再測信度以及建構效度等。結果：本研究由雙語專家小組首先確認中文版量表之內容效度；Clarke-TW內部一致性信度係數Kuder-Richarson-20為0.481，4周再測信度係數Intra-class Correlation Coefficient（ICC）為0.660。Gold-TW也有類似的ICC（0.653）；檢定Clarke與Gold中文版量表IAH狀況與性別（p=0.32、0.70）或受雇狀態（p=0.08、0.29）均無顯著相關；但與規律自我血糖監測與一年內是否有接受視網膜檢查均呈顯著負相關性（p<0.001），前述結果支持兩個中文化量表具有已知族群效度。因素分析也識別Clarke-TW具有2個構面，且主軸因素法顯示模式配適度良好。結論：Clarke-TW與Gold-TW量表具有中等程度的再測信度與良好建構效度；兩個量表呈現的整體IAH盛行率分別為36.1%（95%CI: 32.9%−39.3%）與49.4%（95%CI: 46.1%−52.3%）。因兩個量表題目簡單且方便應用，建議可以考慮於社區調查中使用，用以評估糖尿病個案低血糖認知障礙盛行率。

Objectives: This study was conducted to translate Clark’s and Gold’s questionnaires on impaired awareness of hypoglycemia (IAH) from English to Chinese (Clarke-TW and Gold-TW, respectively) and evaluate their reliability and validity. Methods: A bilingual expert group translated and back-translated the original questionnaires to develop the Clarke-TW and Gold-TW questionnaires. Convenient sampling was performed across 19 pharmacies, clinics, and public health centers in Tainan between September to November 2022. Thus, we recruited 898 patients (age≥20 years) with type 2 diabetes who had received insulin injection or oral sulfonylureas over the previous 3 months. Face-to-face interviews were conducted with these individuals. IAH prevalence, internal consistency, test–retest reliability, and construct validity were evaluated for both questionnaires. Results: The bilingual expert group confirmed the content validity of the two questionnaires. For Clark-TW, the Kuder–Richarson-20 coefficient was 0.481 and the 4-week test–retest intraclass correlation coefficient was 0.660. The intraclass correlation coefficient for Gold-TW was 0.653. IAH prevalence measured using Clarke-TW and Gold-TW exhibited no association with sex (p = .32 and .70, respectively) or employment status (p = .08 and .29, respectively). However, routine self-monitoring of blood glucose and a retinal examination in the previous year were significantly associated with reduced IAH prevalence regardless of the measurement tool used (p < .001); this finding supports the questionnaires’known-group validity. Factor analyses identified two factors from Clarke-TW; principal axis factoring indicated that the two-factor model fit was adequate. Conclusions: Both Clarke-TW and Gold-TW have moderate test–retest reliability and satisfactory construct validity. The overall IAH prevalence measured using Clarke-TW and Gold-TW was 36.1% (95% confidence interval: 32.9%-39.3%) and 49.4% (95% confidence interval: 46.1%-52.3%), respectively. Both questionnaires are straightforward and convenient and can be used in community surveys to estimate IAH prevalence among patients with diabetes.