Validation of a German Translation and Cultural Adaptation of the Addenbrooke's Cognitive Examination III
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of respondents who rate the questionnaire as "applicable" or "not applicable"
研究概览
简要总结
The aim of the entire project was to perform a translation and cultural adaptation of the Addenbrooke's Cognitive Examination - III (ACE-III), adhering to the Translation and Cultural Adaptation of Patient Reported Outcomes Measures-Principles of Good Practice, in order to make it available to German clinicians.
Part of the translation process is the cognitive debriefing which will be performed as a survey which rates the applicability of every single item as well as of the entire Addenbrooke's Cognitive Examination - III tool.
详细描述
The recent demographic developments have drastically increased the importance of developing applicable approaches to the diagnostics of dementia and the general evaluation of cognitive function. Many different tests were developed to thoroughly evaluate neurocognitive function.
The Addenbrooke's Cognitive Examination, developed in 2000, was one such tests and has served as an open source neurocognitive examination tool ever since. The current version is the Addenbrooke's Cognitive Examination III (ACE-III). The aim was to develop a tool that would be able to identify dementia in its early stages and also to differentiate between the different types of dementia.
In order to achieve reliable results, cognitive tests should be conducted in a familiar language and draw from the cultural background a participant is familiar with. The ACE-III and all its predecessors were developed in English and for an English-speaking cultural background, not directly applicable to the typical German patient. This made it necessary to perform not only a verbatim translation of test contents, but also to appropriately adapt the test content to reflect the cultural background of the typical German patient. The International Society For Pharmacoeconomics and Outcomes Research (ISPOR) - Task Force for Translation and Cultural Adaptation has developed the "Translation and Cultural Adaptation of Patient Reported Outcomes Measures-Principles of Good Practice", to ensure a consistent and rigorous methodology in the process of translating and adapting patient-reported outcomes measures.
The Principles of Good Practice consist of ten steps:
- Preparation
- Forward Translation
- Reconciliation
- Back Translation
- Back Translation Review
- Harmonization
- Cognitive Debriefing
- Review of Cognitive Debriefing Results and Finalization
- Proofreading
- Final Report
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female employees of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité Universitätsmedizin Berlin (residents, specialist physician for anesthesiology, senior physicians, medical students engaged in research projects)
- •.- ≥ 18 years of age
- •Experience in the field of neurocognitive testing
排除标准
- •Insufficient knowledge of the German language
结局指标
主要结局
Percentage of respondents who rate the questionnaire as "applicable" or "not applicable"
时间窗: Up to one month
The overall applicability of the German translation will be evaluated on a scale from 0 (not applicable) to 5 (applicable without any restrictions). A priori, a score of ≥ 4 was defined as indicating applicability. The overall applicability will be judged by the amount of survey respondents rating the entire battery as applicable, in relation to the total number of respondents.
次要结局
- Percentage of the items which are rated as "applicable" or "not applicable"(Up to one month)
- Mean/Median applicability of the entire survey(Up to one month)
- Frequency of limiting factors of the entire Addenbrooke's Cognitive Examination - III questionnaire(Up to one month)
- Frequency of limiting factors of the single items(Up to one month)
研究者
Claudia Spies
Head of the Department of Anesthesiology and operative Intensive Care Medicine (CCM, CVK)
Charite University, Berlin, Germany