The Reliability and Validity of Perioperative Cognitive Test Network Platform for Monitoring Neurocognitive Changes

The Reliability and Validity of Perioperative Cognitive Test Network Platform for Monitoring Perioperative Neurocognitive Function Changes in Patients Undergoing Surgery

This study aimed to analyze the reliability and validity of the results of the new designed perioperative cognitive test network platform, and to judge the reliability and scientific nature of the perioperative cognitive test. And then to explore whether the perioperative cognitive test network platform can be used to evaluate the changes of perioperative cognitive function of patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Perioperative Neurocognitive Disorders

Detailed Description

Two cohorts of elderly healthy volunteers and elderly patients undergoing abdominal surgery will be included in this study. The cognitive function of the patients was tested one day before and seven days after operation. Healthy volunteers had two cognitive function tests at the same interval. The normality test is used to evaluate whether the test results accord with the normal distribution. The internal consistency of the test was evaluated by calculating the Cronbach coefficient, the content validity was evaluated by experts and the content validity index was calculated, and the construct validity of the test was evaluated by exploratory factor analysis and confirmatory factor analysis. The validity of the test was evaluated by calculating the effect scale.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Zhixin Wu, physician; Phone Number: 18392187971; Email: wuzhixin212@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study will include two groups: elderly healthy volunteers and elderly patients undergoing abdominal surgery.

Description

Inclusion Criteria:

• Age over 65
• Scheduled for abdominal surgery under general anesthesia (grade 3-4 surgery based on surgical grade)
• Informed consent has been obtained
• Healthy volunteer groups are listed as age-and sex-matched community groups

Exclusion Criteria:

• Unable to follow instruction and finish the firtst procedure
• Has severe visual or auditory problems
• History of drug or alcohol abuse (drinking more than 5U daily in the past 3 months, 1U equals 10ml or 8g pure alcohol, equivalent to >50 liquor over 100ml, two two
• Are diagnosed neuropsychological disease that needs treatment
• Clear history of severe cerebrovascular diseases (including cerebral hemorrhage and cerebral infarction), Parkinson's syndrome, schizophrenia, bipolar disorder, depression, dementia, Alzheimer's disease, etc
• Severe head trauma, carbon monoxide poisoning and other loss of consciousness more than 30 minutes
• MMSE score ≤23
• Participated this study or being participating other clinical research

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Elderly patients undergoing surgery; Older than or equal to 65 years of age; patients who intend to undergo major abdominal surgery under general anesthesia (grade 3-4 surgery based on surgical grade)
Elderly healthy volunteers; Age-and sex-matched community population

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability	Cronbach's alpha is used to assess the reliability and the internal consistency of this Cognitive test. Cronbach's alpha value >0.7 indicating the reliability of the test is acceptable.	Baseline Test：1 day before operation, Second Test: Day 7 after operation
Validity	Content validity, Construct validity and Responsiveness analysis are used to evaluate the validity of the cognitive test. The item-content validity index (I-cvi) is used evaluate the Content validity. I-cvi≥ 0.78 means the content validity is satisfactory. The Exploratory Factor Analysis (EFA) is used evaluate the Construct validity. The Kaiser-Mayer-Olkin (KMO) index (>0.6) is used to evaluate adaptability for factor analysis. Factor loading should >0.4. The Responsiveness analysis is used to evaluate the ability of this cognitive test that can reflect the change of cognitive function of the Interviewer during operation. Paired t-test can be used to compare whether the difference in score before and after is statistically significant. P value should < 0.05.	Baseline Test：1 day before operation, Second Test: Day 7 after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PND (Perioperative neurocognitive disorders)	PND is diagnosed by calculating the Z-score. The investigators get the score or accuracy and completion time of each test through the cognitive test network platform. Then Calculate Z-score: For each test, the mean practice effect is subtracted from the difference between preoperative and postoperative test scores; the result is then divided by the control group standard deviation to obtain a z-score. The z-scores of all tests in an individual patient are summarized and divided by the standard deviations for this sum of z-scores in the control subjects, creating a composite z-score. Cognitive decline is defined when two z-scores in individual tests or the composite z-score ≤-1.96. Perioperative neurocognitive disorders (PND) mainly refer to neurocognitive decline detected after surgery and anesthesia.	Baseline Test：1 day before operation, Second Test: Day 7 after operation

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders
• Other Study ID Numbers: KY20232188-C-1

Drug and device information, study documents

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