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Clinical Trial Summary

Validation of the Malay version of 3D-CAM, involving two-staged process.

1. Translation and cultural adaptation of 3D-CAM into the Malay language.

2. Testing for Validity and Reliability of the translated 3D-CAM tool to detect postoperative delirium.


Clinical Trial Description

1. Translation and Cultural Adaptation

The research panel, who consisted of experts in the clinical field of anesthesia, did the meticulous process of translation and cultural adaptation of 3D-CAM.

This process included independent translation by the research panel, reconciliation of two independent translated 3D-CAM, ethics approval prior to pilot study on 20 relevant subjects, back translation into English and finalizing the Malay version of 3D-CAM for the next phase of testing.

2. Testing for Validity and Reliability of the translated 3D-CAM tool

Patients were recruited pre-operatively after reading the patient's information sheet and signing the informed consent.

Post-operatively, two trained assessors separately administered the Malay 3D-CAM on the recruited patients. One of the trained assessors administered the original 3D-CAM on the same patients at a different time. Standard reference of diagnosing delirium was made by a psychiatrist using the DSM V criteria, after interviewing the patients.

1. For validity, the diagnosis of delirium made using the Malay 3D-CAM tool was tested against the standard reference for diagnosing delirium according to the DSM V criteria made by a psychiatrist

2. For inter-rater reliability, the diagnosis of delirium made by two trained assessors using the Malay 3D-CAM tool were statistically compared.

3. For parallel reliability, the diagnosis of delirium made using the Malay 3D-CAM was compared to the original English version of 3D-CAM. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03366896
Study type Interventional
Source University of Malaya
Contact
Status Completed
Phase N/A
Start date June 26, 2016
Completion date September 30, 2016

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