Validation Study of the Malay Version of 3D-CAM

Not Applicable

Completed

• Conditions: Postoperative Delirium; Diagnosis, Psychiatric
• Interventions: Diagnostic Test: Malay 3D-CAM diagnostic tool 1; Diagnostic Test: Malay 3D-CAM Diagnostic tool 2

• Registration Number: NCT03366896
• Lead Sponsor: University of Malaya

Brief 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.

Detailed 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 Timeline

• Study Start: 2016-06-26
• Primary Completion: 2016-09-26
• Study Completion: 2016-09-30
• Status Verified: 2017-12
• Study First Submitted: 2017-12-03
• Study First Submitted QC: 2017-12-06
• Last Update Submitted: 2017-12-06
• Study First Posted: 2017-12-08
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Age 65 years old and above
• Patients undergoing non-cardiac surgery

Exclusion Criteria

• Patients undergoing cardiac Surgery
• Unable to communicate in the Malay Language
• Patients who were in the intensive care unit peri-operatively
• Patients whose surgery was cancelled
• Patients who were deaf and dumb
• Patients who had been diagnosed as delirious or has psychosis history before assessment
• Glasgow Coma Scale of < 12 / 15
• Patients who remained comatose throughout the investigation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Delirium	Malay 3D-CAM diagnostic tool 1	Diagnosis of delirium according to 5th Edition of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by Psychiatrist.
Delirium	Malay 3D-CAM Diagnostic tool 2	Diagnosis of delirium according to 5th Edition of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by Psychiatrist.

Primary Outcome Measures

Name	Time	Method
Construct Validity	3 months	Assess validity of the translated Malay 3D-CAM to Standard Reference for Diagnosis of Delirium

Secondary Outcome Measures

Name	Time	Method
Factors associated with post-operative delirium	3 months	Assess factors associated with post-operative delirium
Inter-rater Reliability	3 months	Assess the inter-rater reliability of 2 trained assessor using the Malay 3D-CAM
Parallel Reliability	3 months	Assess the parallel reliability of using Malay 3D-CAM to the original version of 3D-CAM