WebBioBank: A Web-based platform for data management in tdcs treatments. «tdcs Operative Unit» DEMO Version

Transcription

1 WebBioBank: A Web-based platform for data management in tdcs treatments «tdcs Operative Unit» DEMO Version Milan, July 2013

2 Administrator access Installation software Operative Unit access Database connection tdcs Distributors site New tdcs device registration Terms of use Documents

3 What is Webbiobank? : It is a web-based platform specifically developed to collect, share, and analyze clinical data, also for multicentric studies. What are the advantages of this system? : to use the platform you just need an internet browser; the system is fast and easy thanks to a simple user interface; data collection can be customized according to the study protocol; data collection is standardized among different clinical centers; data can be shared among different users and different clinical research centers all over the country; the system guarantees data sharing and analysis in anonymous form; data can be easily downloaded for subsequent analysis.

4 MULTICENTER DATA COLLECTION AND SHARING Different operative units (OUs) can be grouped in a super operative unit (sou) and can share data OUs belonging to the same sou use the same clinical forms for data collection to ensure standard protocols/data format

5 What is the «tdcs Operative Unit»? : It is a demo version of Operative Unit with the aim to support clinicians during the prescription of the transcranial Direct Current Stimulation (tdcs) treatment and the evaluation of the patients before and after the treatment. What are the advantages of tdcs Operative Unit? : operative instructions for the correct use of DC stimulator; terms and definitions for the correct prescription of tdcs treatment; calculation of safety parameters; list of tdcs montages from the literature and classified according to the pathology; 3D model of the electrode montages; patient s evaluation rating scales inside EHR; personal tdcs treatment parameters and montage inside EHR.

6 Access to the system Doctor access is via user= doctor.tdcs and password = tdcs.

7 Choice of the working environment

8 List of patients Patients are identified by a unique code (ID BAC) to ensure the anonymity; The registry is saved by each user to a file.xml. At click on the registry template and save the file.xml in a folder you want.

9 Create a new patient On the web-based platform only some information of patients are available: ID BAC, Date of registration, Operative Unit where the patient was inserted and the serial number of the DC stimulator used for patient s treatment. Personal data of patients are stored in local registry (.xml format) and are not available on the web-based platform: Name, Surname, Date of Birth, Gender, Tax Code, Group and Protocol.

10 Management template registry 1

11 Management template registry 2

12 Open data collection form EHR SECTION DESCRIPTION The DEMO EHR includes: pre-tdcs Evaluation Scale tdcs treatment post-tdcs Evaluation Scale From HDCprog to HDCstim Evaluation rating scales for the evaluation of the patient before tdcs treatment Presciption of stimulation parameters and electrode s montage for the patient. Evaluation rating scales for the evaluation of the patient after tdcs treatment DC stimulator programmation

13 Complete data collection form The DEMO EHR includes the following Clinical Data Forms: EHR SECTION pre-tdcs Evaluation Scale tdcs treatment post-tdcs Evaluation Scale From HDCprog to HDCstim CLINICAL DATA FORM Hamilton Depression Rating Scale, WHYMPI Pain Rating Scale (Part I, II, III) tdcs treatment parameter, Montages of electrodes Hamilton Depression Rating Scale, WHYMPI Pain Rating Scale (Part I, II, III) HDCprog menù

14 Data processing with Excel For each Clinical Data Form it is possible to export a table in Excel format.

15 Horizontal modules of «tdcs Operative unit»

16 Search tdcs montages 3D model of electrode montages; List of montages from the literature for the pathology selected; table of available published studies ordered by number and type of subject; Details and reference of the study selected;

17 Safety evaluation list of types of electrodes; insert the stimulation parameters and safety parameters will be calculated automatically;

18 Terms and Definitions General terms and definition useful for the correct administration of transcranial Direct Current Stimulation.

19 Use of MindCap Operative Instructions for the correct configuration of the electrodes dedicated to the patient and the replication of the montage at home.

20 Use of HDCkit Operative instructions and user manuals for the DC stimulator system HDCkit.