Analysis of Medication Data With the ApoMining-Database

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to analyse medication data from the BioCog Study with the ApoMining-Database and to determine the positive and negative predictive value from the ApoMining-Database for prediction of postoperative delirium (POD).

Detailed Description
-----------------
From 2014-2017 the BioCog Study (ClinicalTrials.gov Identifier: NCT02265263) collected data from 439 perioperative elderly patients in Campus Virchow - Klinikum, Universitätsmedizin Berlin. According to the study protocol, a delirium assessment was performed each day after operation until the 7th postoperative day. At this time, it is known which patients developed postoperative delirium (POD) and which did not. Additionally, from each patient data on long-term medication before operation and applied medication during operation and in the recovery room were collected. In this study, the investiagtors analyse the long-term medication and the perioperative medication from BioCog-Study patients with the ApoMining-Database (http://www.apothesen.de/index.php?id=878; ApoThesenGmbH; Bad Münstereifel; Germany). The ApoMining-Database is a medication database, which analyse tolerability and risks of medications for the elderly. The database generates a hit once a medication reveal a risk for delirium. Additionally, the database can calculate the anticholinergic burden of the medication according to the prescribing information. Whereas the investigators already know, which patient developed a POD, they will determine positive and negative predictive value from the ApoMining-Database for prediction of postoperative delirium.

Official Title
-----------------
Analysis of Medication Data With the ApoMining-Database - - A Retrospective Analysis of Data From BioCog Study

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: From BioCog study (NCT02265263) Exclusion Criteria: From BioCog study (NCT02265263) Additionally for this analysis: Inclusion criteria: • Enrollment at Campus Virchow - Klinikum, Charité - Universitätsmedizin Berlin Exclusion criteria: No delirium assessment No long-term medication before operation

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 91 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value of postoperative delirium | Positive predictive value of the application of the ApoMining-Database for prediction of postoperative Delirium (the prediction of delirium by Apomining data base compared to occurence of Delirium in BioCog study) | Up to 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value of postoperative delirium | Negative predictive value of the application of the ApoMining-Database for prediction of postoperative delirium. | Up to 7 days after surgery | 
| Cholinesterase activity | Cholinesterase activity is assessed by Acetylcholinesterase and Butyrylcholinesterase within the BioCog study | Before surgery, one day after surgery, 3 months after surgery | 
| Delirium | Delirium is defined within the BioCog study: according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) and/or as ≥ 2 cumulative points in the nursing Delirium Screening Scale (Nu-DESC) and/or a positive Confusion Assessment Method (CAM) and/or Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score and/or patient chart review that shows descriptions of delirium. | Up to 7 days after surgery |