Validation of the Greek Version of the Confusion Assessment Method Diagnostic Algorithm (CAM) and the Nursing Delirium Screening Scale (Nu-DESC) and Their Inter-rater Reliablity

Study Overview
=================
Brief Summary
-----------------
This study attempts to validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC in patients undergoing surgery under general anesthesia.

Detailed Description
-----------------
Accurate diagnosis for Greek speaking patients suffering from postoperative delirium is limited by the need for a translation of standardized tools that were investigated for their inter-rater reliability/agreement. Our primary aim is to validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC in patients undergoing surgery under general anesthesia. Our secondary aim is to estimate the diagnostic accuracy of NuDESK in our population. This study will provide the first official Greek translation of CAM and Nu-DESC, according to the ISPOR guidelines, and the first evaluation of their inter-rater agreement.

Official Title
-----------------
Validation of the Greek Version of the Confusion Assessment Method Diagnostic Algorithm (CAM) and the Nursing Delirium Screening Scale (Nu-DESC) and Their Inter-rater Reliablity: A Prospective Cohort Study

Conditions
-----------------
Postoperative Delirium

Intervention / Treatment
-----------------
* Other: CAM, Nu-DESC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients over 60 years of age an American Society of Anesthesiologists (ASA) physical status I to III undergoing elective non-cardiac surgery under general anaesthesia native speakers of the Greek language eligible to leave the post-anaesthesia care unit an expected in-hospital stay of at least 24 hours following surgery Exclusion Criteria: refused to participate or sign the informed consent form surgery or anaesthesia within the last 30 day any prior or current history involving an affliction of the central nervous system severe hearing or visual impairment psychiatric disorders sa core less than 5 according the Geriatric Depression Scale (GDS-15) a score less than 4 for females and less than 2 for males according to the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L.) alcohol consumption less than 35 units/week drug dependence previous neuropsychological testing haemodynamical instability peri-procedural desaturation (one or more events of SpO2<80% for more than 2 minutes)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POD CAM Nu-DESC<br>Patients undergoing surgery under general anesthesia assessed for POD with CAM and Nu-DESC | Other: CAM, Nu-DESC<br>* Two trained raters, who are blinded and have no access to each other's evaluation, administer the CAM and Nu-DESC questionnaires in each shift, during the first postoperative day after the discharge from the post-anaesthesia care unit, independently. The two assessments are completed within 60 minutes of each other. If the research team set the diagnosis of POD, the appropriate treatment will be initiated, according to the Hospital's protocol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the Greek version of the CAM Diagnostic Algorithm and Nu-DESC | validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC | 1st postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of the inter-rater agreement of the Greek versions of the CAM and Nu-DESC | estimate the inter-rater agreement of the Greek versions of the CAM and Nu-DESC | 1st postoperative day | 
| Incidence of POD in our study sample. | Estimate the incidence of POD in our study sample. | 1st postoperative day |