epicare a network for rare and complex epilepsies · 8 13-to get patients in the database, refer to...
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D8.2 SOP for use of E-pilepsy E-database
Grant agreement no. 769051
EpiCARE – a network for rare and
complex epilepsies HP-ERN-2016 European Reference Networks / Framework Partnership Agreement
D8.2 SOP for use of E-pilepsy E-database
Work Package: WP8: Surgery (E-pilepsy)
Due date of deliverable: 31 Aug 2017
Actual submission date: 26Th February 2018
Start date of project: March 1, 2017 Duration: 12 months
Lead beneficiary for this deliverable: 28 EpiCARE centres
Contributors: Francesca Pittau, Anne-Laure.Charlois, Philippe Ryvlin
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“This project has received funding from the European Union’s HP-ERN-2016 European
Reference Networks / Framework Partnership Agreement Grant under the Grant Agreement
No 769051“
Project co-funded by the European Commission within the HP-ERN-2016 European Reference Networks grant
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Disclaimer
The content of this deliverable does not reflect the official opinion of the European Union.
Responsibility for the information and views expressed herein lies entirely with the author(s).
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Table of contents
Contents
1. Version log .......................................................................................................................... 3 2. Introduction ........................................................................................................................ 4 3. Installing a RedCap server ................................................................................................... 5 4. Centralized RedCap in Lausanne ......................................................................................... 8 5. Importing E-Database eCRF onto your local RedCap server............................................... 8 Data Collection ......................................................................................................................... 11
1. Version log
Version Date Released by Nature of Change
1.0 February 20 2018
F. Pittau,
CHUV
First draft
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2. Introduction
E-Database has been developed during the E-PILEPSY pilot network of cooperation in epilepsy
surgery, in collaboration with the international league against epilepsy. It was deployed in the
E-PILEPSY then EpiCare networks, to prospectively collect all relevant information on pre-
surgical evaluation and epilepsy surgery:
https://lren.chuv.ch/redcap/redcap_v7.0.0/DataEntry/record_home.php?pid=157
The E-Database eCRF has been developed through RedCap, an open-access and academic led
eCRF solution currently used by 535.000 users in 2380 institutions over 110 countries
(including most EU countries) https://www.project-redcap.org/. To accommodate with the
regulatory and technical requirements of the various participating centers, RedCap E-
Database can be used in two ways: 1) using a local server installed in the hospital intranet, 2)
using a central server installed at the University Hospital of Lausanne (CHUV). Both methods
are presented in this SOP. Currently, 42 European epilepsy surgery centers are registered in E-
PILEPSY E-Database, with a majority using a local server. At any time, participants using such
a local server can decide to share their data with other centers to extract information of
interest.
The next stages of E-Database development consist in deploying it further within the EpiCare
network and get pre-surgical data being captured more systematically. The following SOP aims
at facilitating these developments.
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3. Installing a RedCap server
1- Contact the administrators REDCAP neighboring centers (name (s) and address (s) email (s) in
the mail sent). If you do not have contact (no email or unavailable, please refer to B))
2- Install REDCAP in your center
3- Creating your Redcap account (username and login name)
4- After entering the password, Go to "Create New Project"
5- Project title: epilepsy, Purpose: Practice/just for fun
6- Select "Create an empty project (blank slate)" and "Create project". Opening the Project Set
up page.
7- In the "Design your data collection tools" tab, select "Upload data dictionary"
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8- Check that the "Auto-numbering for records" to be disabled (no entry sign) in the "Enable
optional modules and customizations" tab.
9- Select the file (file sent by email, always in csv format)
10- Upload file 10
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11- Information message to accept the changes: click on "commit changes"
12- The various items of basic downloaded are on the left column.
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13- To get patients in the database, refer to the document 3: Data collection.
4. Centralized RedCap in Lausanne If you cannot install Redcap with other centers, we will create an account on our base in
Lausanne.
1) For this you simply report it by sending an email to:
- Anne Laure Charlois: [email protected]
- Francesca Pittau : [email protected]
With your first name, last name and email address.
2) Create your account
3) To refer to the document logger 2.
4) To enter your patients refer to the document 3.
5. Importing E-Database eCRF onto your local RedCap server 1- Creating Your Redcap account (username and login name)
2- After entering the password, Go to "Create New Project»
3- Project title: epilepsy, Purpose: Practice / just for fun
4- Select "Create an empty project (blank slate)" and "Create project". Opening the Project Set
up page.
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5- Check the "Auto-numbering for records" to be disabled (no entry sign) in the "Enable optional
modules and customizations" tab.
6- In the "Design your data collection tools" tab, select "Upload data dictionary"
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7- Select the file (file sent by email, always in csv format)
8- 9- Upload file
10- Information message to accept the changes: click on "commit changes"
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11- The various items of basic downloaded are on the left column.
12- To return patients in the database, refer to the document 3: Data collection.
Data Collection A) Patient Identification :
1- Go to « Add/Edit record »
2- Enter a new patient (Study ID) using the following coding:
Creation Study ID: - - - - - - - -
Example: center #01, patient #022, name=Dupont, first name=André ID=01022DAN
WARNING ! Your center number is : 54
Center number
c
1st letter of the Last name
2 first letters of the First name
Patient number
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3- Once the Study ID is created, type enter and the "Demographic" page opens automatically
4- Fill variables
5- Enter 'complete' if all the data is completed
6- Click on either “Save Record”, “Save and Continue” or “Save and go to Next Form”
B) Long-term video scalp-EEG monitoring (VEEG)
1- In the left menu, you can go directly to "Long term video scalp-EEG monitoring"
2- If done, click 'Yes' and fill variables
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3- On the same page, Fill adverse events
4- If there are adverse events, fill the variables, then 'Complete' and 'Save and Continue'
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C) Invasive EEG
1- In the menu on the left you can go straight to "Invasive EEG"
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2- If done, click 'Yes' and fill the variables
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3- On the same page, Fill adverse events
If there are adverse events fill the variables, then'Complete 'and' Save and Continue’
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5. At the end "Save Record"
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D) Surgery
1- In the left menu, you can go directly to "Epilepsy surgery"
2- If done, click 'Yes' and fill variables
3- On the same page, complete adverse events as well as patient’s status
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4- If there are adverse events, fill the variables, then 'Complete' and 'Save and
Continue’
5- If Surgery not done, click 'No', and fill variables (reason for not operating and patient’s
status) then’Complete’ and ‘Save Record’
E) Follow up
1- In the left menu, you can go directly to "Follow up"
2- Complete the patient's status in terms of crisis in “Seizure free for ≥ 1 year”
3- Complete medications, neurostimulations
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4- Complete if the patient was operated ILAE classification and complete seizures if there were
new.
5- Then 'Complete' and 'Save and Record'
6- Return to "Add / Edit record" to enter a new patient.
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