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

Neurocognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03460821
• Other study ID #: ACE-III
• Status: Completed
• First received: February 27, 2018
• Last updated: April 10, 2018
• Start date: March 1, 2018
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Neurocognitive Dysfunction

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Operaitve Intensive Care Medicine, Campus Charite Mitte (CCM) and Campus Virchow - Klinikum, Charite - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of respondents who rate the questionnaire as "applicable" or "not applicable"	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.	Up to one month
Secondary	Percentage of the items which are rated as "applicable" or "not applicable"	Description: 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	Up to one month
Secondary	Mean/Median applicability of the entire survey	Mean/Median applicability of the entire survey will be calculated using the applicability ratings of the entire survey (as described above)	Up to one month
Secondary	Frequency of limiting factors of the entire Addenbrooke's Cognitive Examination - III questionnaire	If 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	Up to one month
Secondary	Frequency of limiting factors of the single items	If 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.	Up to one month