Greek Validation of ACE III Test in Perioperative Patients

Addenbrooke's Cognitive Examination III Scale as a Screening Tool for Cognitive Impairment in Surgical Population: Validity and Reliability of the Culturally Adapted Greek Version

Postoperative neurocognitive disorders, including postoperative delirium (POD) and postoperaive cognitive dysfunction (POCD), are common complications of perioperative neurocognition in elderly patients undergoing surgery. POD and POCD have short- and long-term consequences, such as increased hospital stays and costs, augmented morbidity and mortality, as well as higher risk for cognitive decline later in life. Therefore, early prevention and diagnosis of these conditions is of great importance.

A number of psychometric tests have been proposed as cognitive screening tools. Given the fact that many of them show weaknesses and difficulties in performance, scientists have sought for more useful alternatives. Montreal Cognitive Assessment (MoCA) is considered to be a good choice, as it has been successfully applied in the perioperative setting. What's more, it has been translated and validated for a Greek population with neurological disorders. Addenbrooke's Congnitive Examination III (ACE III) has been introduced recently into clinical practice. It is an easy to perform and detailed test that covers several neurocognitive domains and has shown high sensitivity and specificity in clinical conditions, including dementia and Alzheimer's disease. Although current literature lacks data concerning its perioperative use, ACE III could prove useful for screening patients undergoing surgery and anesthesia on the basis of its favorable characteristics as mentioned above.

The aim of this study is to translate the ACE III (English version 2012) into Greek and assess its validity in perioperative patients aged >55 years.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction

Detailed Description

In this prospective cohort study, the ACE III will be translated and adapted into the Greek language by the researchers according to the relative guidelines for cultural adaptation. Backward translation will be performed by a fluent bilingual specialist to ensure the optimum reliability of the questionnaire.

A total of 128 surgical patients are planned to be enrolled in the study protocol after informed consent. Primary screening of the whole population will be conducted at the pre-admission clinic using the MoCA test by two examiners in order to determine their cognitive status. Simultaneously, the ACE III will be applied to set the baseline measurements for each participant. Subjects with MoCA score <26 will form the patients' group while those with MoCA scores at least 26 will form the control group.

Screening with both MoCA and ACE-III tests will be repeated the day before surgery with at least a 7-day gap between the two assessments.

Total scores and subscores at both time-points will be calculated and comparative performance of all participants will be assessed after statistical analysis of collected data.

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

• Study Contact: Name: Maria Zouka, MD; Phone Number: +302313303631; Email: mariazouka@gmail.com
• Study Contact Backup: Name: Georgia Tsaousi, Ass. Prof.; Phone Number: +302310994855; Email: tsaousig@otenet.gr

Study Locations

• Greece
  • Thessaloniki, Greece, 54636
    • Ahepa University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

128 surgical patients (cognitively and non-cognitively impaired)

Description

Inclusion Criteria:

• Patients scheduled for surgical intervention
• At least of primary level of education

Exclusion Criteria:

• Neurodegenerative disease
• Cerebrovascular disease
• Psychiatric disorders
• History of head injury
• Use of medication affecting the CNS

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Controls; Participants scheduled for surgery with MoCA score ≥ 26 preoperatively
Patients; Participants scheduled for surgery with MoCA score < 26 preoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cultural adaption	Cultural adaption of ACE III (English version 2012) into the Greek language	2 months
Validation	Construct and convergent validity of the translated version of ACE III into the Greek language	2 months

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Principal Investigator: Maria Zouka, MD, Ahepa University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2020
• Primary Completion (Actual): April 28, 2020
• Study Completion (Actual): April 28, 2020

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Perioperative; MoCA; ACE III; Neurocognitive dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Cognitive Dysfunction; Postoperative Cognitive Complications; Emergence Delirium
• Other Study ID Numbers: ACEIIIPREOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No