一种用于测量瑞典国家糖尿病登记处患者报告结局和体验的疾病特异性问卷：内容有效性、表面有效性和重测信度的开发和评估。
A disease-specific questionnaire for measuring patient-reported outcomes and experiences in the Swedish National Diabetes Register: Development and evaluation of content validity, face validity, and test-retest reliability.
机构信息
University of Gothenburg, Sahlgrenska Academy, Institute of Medicine, SE-413 46 Gothenburg, Sweden; Dalarna University, School of Education, Health and Social Studies, SE-791 88 Falun, Sweden.
Dalarna University, School of Education, Health and Social Studies, SE-791 88 Falun, Sweden; Uppsala University, Department of Medical Sciences, SE-751 85 Uppsala, Sweden.
出版信息
Patient Educ Couns. 2018 Jan;101(1):139-146. doi: 10.1016/j.pec.2017.07.016. Epub 2017 Jul 14.
OBJECTIVE
To describe the development and evaluation of the content and face validity and test-retest reliability of a disease-specific questionnaire that measures patient-reported outcomes and experiences for the Swedish National Diabetes Register for adult patients who have type 1 or type 2 diabetes.
METHODS
In this methodological study, a questionnaire was developed over four phases using an iterative process. Expert reviews and cognitive interviews were conducted to evaluate content and face validity, and a postal survey was administered to evaluate test-retest reliability.
RESULTS
The expert reviews and cognitive interviews found the disease-specific questionnaire to be understandable, with relevant content and value for diabetes care. An item-level content validity index ranged from 0.6-1.0 and a scale content validity/average ranged from 0.7-1.0. The fourth version, with 33 items, two main parts and seven dimensions, was answered by 972 adults with type 1 and type 2 diabetes (response rate 61%). Weighted Kappa values ranged from 0.31-0.78 for type 1 diabetes and 0.27-0.74 for type 2 diabetes.
CONCLUSIONS
This study describes the initial development of a disease-specific questionnaire in conjunction with the NDR. Content and face validity were confirmed and test-retest reliability was satisfactory.
PRACTICE IMPLICATIONS
With the development of this questionnaire, the NDR becomes a clinical tool that contributes to further understanding the perspectives of adult individuals with diabetes.
目的
描述一种专门用于测量瑞典国家糖尿病登记处（NDR）成人 1 型和 2 型糖尿病患者报告结局和体验的疾病特异性问卷的内容和表面有效性以及重测信度的开发和评估。
方法
在这项方法学研究中，使用迭代过程分四个阶段开发问卷。专家审查和认知访谈用于评估内容和表面有效性，邮寄调查用于评估重测信度。
结果
专家审查和认知访谈发现，该疾病特异性问卷易于理解，具有相关性且对糖尿病护理有价值。各项目的内容有效性指数范围为 0.6-1.0，量表内容有效性/平均范围为 0.7-1.0。第四版有 33 个项目，分为两个主要部分和七个维度，由 972 名 1 型和 2 型糖尿病患者（应答率为 61%）回答。1 型糖尿病的加权 Kappa 值范围为 0.31-0.78，2 型糖尿病的加权 Kappa 值范围为 0.27-0.74。
结论
本研究描述了与 NDR 联合开发的一种疾病特异性问卷的初步开发。内容和表面有效性得到了确认，重测信度令人满意。
实践意义
随着该问卷的开发，NDR 成为一种临床工具，有助于进一步了解糖尿病患者的观点。
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