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Validation of a German Translation and Cultural Adaptation of the Addenbrooke's Cognitive Examination III

Validation of a German Translation and Cultural Adaptation of the Addenbrooke's Cognitive Examination III

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03460821
Enrollment
20
Registered
2018-03-09
Start date
2018-03-01
Completion date
2018-03-31
Last updated
2018-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurocognitive Dysfunction

Brief summary

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.

Detailed description

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: 1. Preparation 2. Forward Translation 3. Reconciliation 4. Back Translation 5. Back Translation Review 6. Harmonization 7. Cognitive Debriefing 8. Review of Cognitive Debriefing Results and Finalization 9. Proofreading 10. Final Report

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Insufficient knowledge of the German language

Design outcomes

Primary

MeasureTime frameDescription
Percentage of respondents who rate the questionnaire as applicable or not applicableUp to one monthThe 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.

Secondary

MeasureTime frameDescription
Percentage of the items which are rated as applicable or not applicableUp to one monthDescription: The applicability of each individual item 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
Mean/Median applicability of the entire surveyUp to one monthMean/Median applicability of the entire survey will be calculated using the applicability ratings of the entire survey (as described above)
Frequency of limiting factors of the entire Addenbrooke's Cognitive Examination - III questionnaireUp to one monthIf participants rate the entire survey as not applicable (rating \< 4) they are asked to choose a limiting factor from a predefined list. The frequency with which every limiting factor is mentioned is compiled to evaluate its impact on the entire survey
Frequency of limiting factors of the single itemsUp to one monthIf participants rate an item as not applicable (rating \< 4) they are asked to choose a limiting factor from a predefined list. The frequency with which every limiting factor is mentioned is compiled to evaluate its impact on the entire survey.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026