测量烦人的更年期症状：MenoScores 问卷的制定和验证。
Measuring bothersome menopausal symptoms: development and validation of the MenoScores questionnaire.
机构信息
Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Q, P.O. Box 2099, 1014, Copenhagen K, Denmark.
The Research Unit of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Q, 1014, Copenhagen K, Denmark.
出版信息
Health Qual Life Outcomes. 2018 May 16;16(1):97. doi: 10.1186/s12955-018-0927-6.
BACKGROUND
The experience of menopausal symptoms is common and an adequate patient-reported outcome measure is crucial in studies where women are treated for these symptoms. The aims of this study were to identify a patient-reported outcome measure for bothersome menopausal symptoms and, in the absence of an adequate tool, to develop a new measure with high content validity, and to validate it using modern psychometric methods.
METHODS
The literature was reviewed for existing questionnaires and checklists for bothersome menopausal symptoms. Relevant items were extracted and subsequently tested in group interviews, single interviews, and pilot tests. A patient-reported outcome measure was drafted and completed by 1504 women. Data was collected and psychometrically validated using item-response theory Rasch Models.
RESULTS
All questionnaires identified in the literature lacked content validity regarding bothersome menopausal symptoms and none were validated using item-response theory. Our content validation resulted in a draft measurement encompassing 122 items across eight domains. Following psychometrical validation, the final version of our patient-reported outcome measure, named the MenoScores Questionnaire, encompassed 51 items, including one single item, covering 11 scales.
CONCLUSION
Menopausal symptoms are multidimensional with some symptoms unquestionably related to the menopausal transition. We identified four constructs of importance: hot flushes, day-and-night sweats, general sweating, and menopausal-specific sleeping problems. The MenoScores Questionnaire is condition-specific with high content validity and adequate psychometrical properties. It is designed to measure bothersome menopausal symptoms and all scales are developed and psychometrically validated using item-response theory Rasch Models.
TRIAL REGISTRATION
Approved by the Danish Data Agency (J.nr. 2015-41-4057). Ethics Committee approval was not required.
背景
绝经症状较为常见，在针对这些症状对女性进行治疗的研究中，充分的患者报告结局测量至关重要。本研究的目的是确定一种用于绝经症状困扰的患者报告结局测量工具，若没有充分的工具，我们将开发一种具有较高内容效度的新工具，并使用现代心理计量学方法对其进行验证。
方法
对现有用于绝经症状困扰的问卷和清单进行文献回顾。提取相关项目，随后在小组访谈、单独访谈和试点测试中进行测试。起草一份患者报告结局测量工具，并由 1504 名女性完成。使用项目反应理论（IRT）Rasch 模型收集数据并进行心理计量验证。
结果
文献中确定的所有问卷在绝经症状困扰方面均缺乏内容效度，且均未使用项目反应理论进行验证。我们的内容验证产生了一份草稿测量，涵盖了 8 个领域的 122 个项目。经过心理计量验证，我们的患者报告结局测量工具的最终版本，命名为 MenoScores 问卷，包含 51 个项目，包括一个单项，涵盖 11 个量表。
结论
绝经症状具有多维性，其中一些症状无疑与绝经过渡有关。我们确定了四个重要的结构：热潮红、日夜盗汗、一般性出汗和绝经特异性睡眠问题。MenoScores 问卷具有特异性，内容效度高，心理计量学特性良好。它旨在测量绝经症状困扰，所有量表均使用项目反应理论（IRT）Rasch 模型开发和心理计量验证。
试验注册
获得丹麦数据署批准（J.nr. 2015-41-4057）。无需伦理委员会批准。
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