Boyer J G, Earp J A
Glaxo Wellcome Research and Development, Greenford, Middlesex, UK.
Med Care. 1997 May;35(5):440-53. doi: 10.1097/00005650-199705000-00003.
The aim of this 2-year research project was to develop an instrument specifically designed to assess the quality of life of people with diabetes.
The project was divided into two phases. In the first phase, information from a detailed literature review, from existing quality-of-life instruments, and from interviews with health professionals and people with diabetes was used to develop an initial instrument of 92 items considered to address important aspects of patients' lives. This questionnaire was mailed to 1,000 people with diabetes, and data from the 516 respondents were used to select the most important and useful items. Fifty items were excluded, leaving 42 items that constituted the pilot instrument. During phase 2, the pilot instrument was used to assess the quality of life of 427 diabetic patients who completed the revised questionnaire. After analyzing this data, three additional items were dropped. The final instrument consists of 39 items and covers five dimensions of patients' lives: Energy and Mobility, Diabetes Control, Anxiety and Worry, Social Burden, and Sexual Functioning.
The results of validity and reliability tests conducted to date testify to the relevance of the 39-item questionnaire (Diabetes-39) as a valid discriminative instrument, one which shows significant correlations with an overall quality-of-life assessment, the pattern of diabetes severity, and comorbidity. Further, the results from Diabetes-39 correlate well with the results from the established generic quality-of-life instrument, the Medical Outcomes Study 36-Item Short-Form Health Survey.
Validation of a quality-of-life instrument, however, is an ongoing process. Further research is required to corroborate these early findings and to ensure that this is an instrument that can capture data of greatest relevance to the diabetic patient and that is responsive to change in quality of life.
这个为期两年的研究项目旨在开发一种专门设计用于评估糖尿病患者生活质量的工具。
该项目分为两个阶段。在第一阶段，从详细的文献综述、现有的生活质量工具以及对医疗专业人员和糖尿病患者的访谈中获取信息，以开发一个包含92个项目的初始工具，这些项目被认为涵盖了患者生活的重要方面。这份问卷被邮寄给1000名糖尿病患者，来自516名受访者的数据被用于选择最重要和最有用的项目。50个项目被排除，剩下42个项目构成了试点工具。在第二阶段，试点工具被用于评估427名完成修订问卷的糖尿病患者的生活质量。在分析这些数据后，又去掉了另外三个项目。最终工具由39个项目组成，涵盖患者生活的五个维度：能量与活动能力、糖尿病控制、焦虑与担忧、社会负担以及性功能。
迄今为止进行的效度和信度测试结果证明了这份39项问卷（Diabetes-39）作为一种有效的鉴别工具的相关性，它与总体生活质量评估、糖尿病严重程度模式以及合并症显示出显著相关性。此外，Diabetes-39的结果与既定的通用生活质量工具医学结果研究36项简短健康调查的结果相关性良好。
然而，生活质量工具的验证是一个持续的过程。需要进一步的研究来证实这些早期发现，并确保这是一种能够获取与糖尿病患者最相关的数据并且能对生活质量变化做出反应的工具。
