Validation Study of the Malay Version of 3D-CAM (VS-MEDCAM)

University of Malaya

Status: Completed

Conditions: Diagnosis, Psychiatric; Postoperative Delirium

Treatments: Diagnostic Test: Malay 3D-CAM Diagnostic tool 2; Diagnostic Test: Malay 3D-CAM diagnostic tool 1

Study type: Interventional

Funder types: Other

Identifiers

NCT03366896

MEDCAM1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Delirium

Experimental group

Description:

Diagnosis of delirium according to 5th Edition of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by Psychiatrist.

Treatment:

Diagnostic Test: Malay 3D-CAM diagnostic tool 1

Diagnostic Test: Malay 3D-CAM Diagnostic tool 2