Clinical trial NCT03460821: Validation of a German Translation and Cultural Adaptation of the Addenbrooke's Cognitive Examination III
Official title: Validation of a German Translation and Cultural Adaptation of the Addenbrooke's Cognitive Examination III
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurocognitive Dysfunction
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female employees (≥ 18 years of age) of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité Universitätsmedizin Berlin experienced in the field of neurocognitive testing

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of respondents who rate the questionnaire as "applicable" or "not applicable"
timeFrame: Up to one month
Secondary outcomes:
measure: Percentage of the items which are rated as "applicable" or "not applicable"
timeFrame: Up to one month
measure: Mean/Median applicability of the entire survey
timeFrame: Up to one month
measure: Frequency of limiting factors of the entire Addenbrooke's Cognitive Examination - III questionnaire
timeFrame: Up to one month
measure: Frequency of limiting factors of the single items
timeFrame: Up to one month
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operaitve Intensive Care Medicine, Campus Charite Mitte (CCM) and Campus Virchow - Klinikum, Charite - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: