中文版「低血糖感知障礙量表」之發展與心理計量特性

Development and psychometric properties of the Chinese version of the Impaired Awareness Hypoglycemia Assessment Scale

10.6288/TJPH.202310_42(5).112068

翁修慧(Hsiu-Hui Weng)；吳嘉玲(Jia-Ling Wu)；鄭翔如(Hsiang-Ju Cheng)；葉淑婷(Shu-Tin Yeh)；陳華芬(Hua-Fen Chen)；李中一(Chung-Yi Li)

低血糖感知障礙 ； Clarke量表 ； Gold量表 ； 信度 ； 效度 ； Impaired Awareness of Hypoglycemia (IAH) ； Clarke questionnaire ； Gold questionnaire ； reliability ； validity

台灣公共衛生雜誌

42卷5期（2023 / 10 / 30）

530 - 541

繁體中文;英文

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.

1. Alkhatatbeh, MJ,Abdalqader, NA,Alqudah, MAY(2019).Impaired awareness of hypoglycaemia in insulin treated type 2 diabetes mellitus.Curr Diabetes Rev,15,407-413.
2. AlTowayan, A,Alharbi, S,Aldehami, M,Albahli, R,Alnafessah, S,Alharbi, AM(2023).Awareness level of hypoglycemia among diabetes mellitus type 2 patients in Al Qassim Region.Cureus,15,e35285.
3. American Diabetes Association. Hypoglycemia (low blood glucose). Available at: https://diabetes.org/healthy-living/medication-treatments/blood-glucose-testing-and-control/hypoglycemia. Accessed April 30, 2023.
4. Ausili, D,Bulgheroni, M,Ballatore, P(2017).Self-care, quality of life and clinical outcomes of type 2 diabetes patients: an observational cross-sectional study.Acta Diabetol,54,1001-1008.
5. Beshyah, SA,Beshyah, AS,Yaghi, S,Beshyah, WS,Frier, BM(2017).A global survey of licensing restrictions for drivers with diabetes.Br J Diabetes,17,3-10.
6. Cabré, C,Colungo, C,Vinagre, I,Jansà, M(2020).Conget Frequency and awareness of hypoglycemia in patients with type 2 diabetes treated with two or more insulin injections in primary care outpatient clinics.Prim Care Diabetes,14,168-172.
7. Clarke, WL,Cox, DJ,Gonder-Frederick, LA,Julian, D,Schlundt, D,Polonsky, W(1995).Reduced awareness of hypoglycemia in adults with IDDM. A prospective study of hypoglycemic frequency and associated symptoms.Diabetes Care,18,517-522.
8. Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 1934;26:404-13. doi:10.2307/2331986.
9. Cook, AJ,DuBose, SN,Foster, N(2019).Cognitions associated with hypoglycemia awareness status andsevere hypoglycemia experience in adults with type 1 diabetes.Diabetes Care,42,1854-1864.
10. de Mesa, U,Anonuevo-Cruz, MC,Nicodemus, N., Jr.,Reyes, NG(2017).Development and validation of a questionnaire evaluating impaired hypoglycemia awareness among adult Filipino patients with type 2 diabetes mellitus.J ASEAN Fed Endocr Soc,32,158-164.
11. Edridge, CL,Dunkley, AJ,Bodicoat, DH(2015).Prevalence and incidence of hypoglycaemia in 532,542 people with type 2 diabetes on oral therapies and insulin: a systematic review and meta-analysis of population based studies.PLoS One,10,e0126427.
12. Geddes, J,Wright, RJ,Zammitt, NN,Deary, IJ,Frier, BM(2007).An evaluation of methods of assessing impaired awareness of hypoglycemia in type 1 diabetes.Diabetes Care,30,1868-1870.
13. Ghandi, K,Pieri, B,Dornhorst, A,Hussain, S(2021).A comparison of validated methods used to assess impaired awareness of hypoglycaemia in type 1 diabetes: an observational study.Diabetes Ther,12,441-451.
14. Gold, AE,Macleod, KM,Frier, BM(1994).Frequency of severe hypoglycemia in patients with type I diabetes with impaired awareness of hypoglycemia.Diabetes Care,17,697-703.
15. Gomez-Peralta, F,Fornos, Pérez, JA,Molinero, A(2021).Adherence to antidiabetic treatment and impaired hypoglycemia awareness in type 2 diabetes mellitus assessed in Spanish community pharmacies: the ADHIFAC study.BMJ Open Diab Res Care,9,e002148.
16. Hatle, H,Bjørgaas, MR,Skrivarhaug, T(2020).Assessing awareness of hypoglycemia in children and adolescents with type 1 diabetes: evaluation of established questionnaires.Pediatri Diabetes,21,300-309.
17. Hendrieckx, C,Hagger, V,Jenkins, A,Skinner, TC,Pouwer, F,Speight, J(2017).Severe hypoglycemia, impaired awareness of hypoglycemia, and self-monitoring in adults with type 1 diabetes: results from diabetes MILES-Australia.J Diabetes Complications,31,577-582.
18. Islam, S(ed.)(2021).Diabetes: from Research to Clinical Practice: Volume 4.New York, NY:Springer.
19. Jansa, M,Quirós, C,Giménez, M,Vidal, M,Galindo, M,Conget, I(2015).Psychometric analysis of the Spanish and Catalan versions of a questionnaire for hypoglycemia awareness.Med Clin (Barc),144,440-444.
20. Jiang, YD,Chang, CH,Tai, TY,Chen, JF,Chuang, LM(2012).Incidence and prevalence rates of diabetes mellitus in Taiwan: analysis of the 2000-2009 Nationwide Health Insurance database.J Formos Med Assoc,11,599-604.
21. Korytkowski, MT(2004).Sulfonylurea treatment of type 2 diabetes mellitus: focus on glimepiride.Pharmacotherapy,24,606-620.
22. Lapostolle, F,Hamdi, N,Barghout, M(2017).Diabetes education of patients and their entourage: out-of-hospital national study (EDUCATED 2).Acta Diabetol,54,353-360.
23. Lever, J,Krzywinski, M,Altman, N(2017).Principal component analysis.Nat Methods,14,641-642.
24. Li, CY,Kuo, CL,Chang, YH,Lu, CL,Martini, S,Hou, WH(2022).Association between trajectory of severe hypoglycemia and dementia in patients with type 2 diabetes: a population-based study.J Epidemiol,32,423-430.
25. Lind, M,Bounias, I,Olsson, M,Gudbjörnsdottir, S,Svensson, AM,Rosengren, A(2011).Glycaemic control and incidence of heart failure in 20,985 patients with type 1 diabetes: an observational study.Lancet,378,140-146.
26. Man, REK,Fenwick, EK,Gan, ATL(2017).Association between perceived barriers to diabetes self-management and diabetic retinopathy in Asian patients with type 2 diabetes.JAMA Ophthalmol,135,1387-1393.
27. Michalos, AC(ed.)(2014).Encyclopedia of Quality of Life and Well-Being Research.Dordrecht, Netherlands:Springer.
28. Pleus, S,Freckmann, G,Schauer, S(2022).Self-monitoring of blood glucose as an integral part in the management of people with type 2 diabetes mellitus.Diabetes Ther,13,829-846.
29. Portela, RA,Silva, JRS,Nunes, FBBF,Lopes, MLH,Batista, RFL,Silva, ACO(2022).Diabetes mellitus type 2: factors related to adherence to self-care.Rev Bras Enferm,75,e20210260.
30. Stefenon, P,Silveira, ALMD,Giaretta, LS,Leitão, CB,Bauer, AC(2020).Hypoglycemia symptoms and awareness of hypoglycemia in type 1 diabetes mellitus: cross cultural adaptation and validation of the Portuguese version of three questionnaires and evaluation of its risk factors.Diabetol Metab Syndr,15,15.
31. Stoner, CR,Orrell, M,Spector, A(2018).The positive psychology outcome measure (PPOM) for people with dementia: psychometric properties and factor structure.Arch Gerontol Geriatr,76,182-187.
32. Tinsley, HEA(ed.),Brown, SD(ed.)(2000).Handbook of Applied Multivariate Statistics and Mathematical Modeling.Cambridge, Massachusetts:Academic Press.
33. Torimoto, K,Okada, Y,Hajime, M,Tanaka, K,Tanaka, Y(2018).Risk factors of hypoglycemia in patients with type 2 diabetes mellitus: a study based on continuous glucose monitoring.Diabetes Technol Ther,20,603-612.
34. van, Meijel, LA,de, Vegt, F,Abbink, EJ(2020).High prevalence of impaired awareness of hypoglycemia and severe hypoglycemia among people with insulin-treated type 2 diabetes: The Dutch Diabetes Pearl Cohort.BMJ Open Diabetes Res Care,8,e000935.
35. Wang, G,Fiedler, AK,Warth, RJ,Bailey, L,Shupe, PG,Gregory, JM(2022).Reliability and accuracy of telemedicinebased shoulder examinations.J Shoulder Elbow Surg,31,e369-e375.
36. Wang, JS,Lo, SH,Yeh, YP(2021).Distinct associations of self-monitoring of blood glucose with glycemic control and hypoglycemia between groups of recently diagnosed and long-term follow-up type 2 diabetes: The Taiwan Diabetes Registry.Int J Clin Pract,75,e14410.
37. WHO. WHO 2.0 translation package (version 1.0). Translation and linguistic evaluation protocol and supporting material. Available at: https://terrance.who.int/mediacentre/data/WHODAS/Guidelines/WHODAS%202.0%20Translation%20guidelines.pdf. Accessed April 1,2023.
38. Yu, X,Fan, M,Zhao, X(2023).Prevalence of impaired awareness of hypoglycaemia in people with diabetes mellitus: a systematic review and meta analysis from 21 countries and regions.Diabet Med,40,e15129.
39. 社團法人中華民國糖尿病學會=The Diabetes Association of the Republic of China (Taiwan)(2022).2022第2型糖尿病臨床照護指引.台北=Taipei:社團法人中華民國糖尿病學會=The Diabetes Association of the Republic of China (Taiwan).