Department of Endocrinology, Tenri Hospital, Tenri, Japan.
J Med Econ. 2012;15(3):556-63. doi: 10.3111/13696998.2012.665111. Epub 2012 Feb 23.
We developed and evaluated the psychometric properties of the Diabetes Therapy-Related QOL (DTR-QOL) as a disease-specific, self-administered questionnaire to assess the influence of diabetes treatment on patient QOL, regardless of treatment method.
This new questionnaire was developed and validated in a standardized manner: Item development, pilot-testing and psychometric validation. A survey was conducted using the provisional version of the questionnaire, and reliability and validity were evaluated with psychometric testing.
The provisional version of the questionnaire was generated with 29 items through literature review and pilot testing. For psychometric assessment, analyses were performed on the responses of 284 adult Japanese patients with diabetes. Factor analysis by the principal factor method with promax rotation revealed 4 factors; "burden on social activities and daily activities" (13 items), "anxiety and dissatisfaction with treatment" (8 items), "hypoglycemia" (4 items), and "satisfaction with treatment" (4 items). For reliability, the intraclass correlation was 0.92, and Cronbach's alpha coefficient was 0.94, indicating adequate test-retest reliability and internal consistency. For known-group validity, there were significant differences in scores for following variables: age, diabetes type, HbA1c, treatment method, glycemic control, hypoglycemia, nocturnal hypoglycemia, concern about weight gain, health status (patient assessment), and degree of communication with physician.
The DTR-QOL, with good reliability and validity, can assess the influence of diabetes treatment on patient QOL. The DTR-QOL can be used regardless of treatment method that patients receive, and this characteristic enables to detect a difference on patients QOL between treatment methods before and after a switch of treatment. Limitations of this study include representativeness of the patient sample. The relatively small number of patients with type 1 diabetes should be noted. Also, responsiveness of the DTR-QOL has not yet been examined.
我们开发并评估了糖尿病治疗相关生活质量问卷（DTR-QOL）的心理测量特性，该问卷是一种疾病特异性的、自我管理的问卷，用于评估糖尿病治疗对患者生活质量的影响，而不论治疗方法如何。
通过文献回顾和预试验，以标准化的方式开发和验证了这个新的问卷。使用问卷的临时版本进行了一项调查，通过心理测量测试评估了可靠性和有效性。
通过文献回顾和预试验，生成了问卷的临时版本，共 29 个条目。为了进行心理测量评估，对 284 名成年日本糖尿病患者的回答进行了分析。通过主成分法与 promax 旋转的因子分析，揭示了 4 个因子；“社会活动和日常活动负担”（13 个条目）、“对治疗的焦虑和不满”（8 个条目）、“低血糖”（4 个条目）和“对治疗的满意度”（4 个条目）。对于可靠性，组内相关系数为 0.92，Cronbach's alpha 系数为 0.94，表明有足够的重测信度和内部一致性。对于已知组有效性，以下变量的得分存在显著差异：年龄、糖尿病类型、HbA1c、治疗方法、血糖控制、低血糖、夜间低血糖、对体重增加的关注、健康状况（患者评估）和与医生沟通的程度。
DTR-QOL 具有良好的可靠性和有效性，可以评估糖尿病治疗对患者生活质量的影响。无论患者接受何种治疗方法，都可以使用 DTR-QOL，这种特性可以在治疗方法改变前后检测到患者生活质量在治疗方法之间的差异。本研究的局限性包括患者样本的代表性。应注意 1 型糖尿病患者的数量相对较少。此外，DTR-QOL 的反应性尚未得到检验。
