Deliverable D3.3. Multicenter databases MASTERMIND

Transcription

1 Deliverable D3.3 Multicenter databases MASTERMIND MAnagement of mental health disorders Through advanced technologyand services telehealth for the MIND GA no

2 PROJECT ACRONYM: MasterMind CONTRACT NUMBER: DISSEMINATION LEVEL: NATURE OF DOCUMENT: Confidential Other TITLE OF DOCUMENT: Multicenter databases REFERENCE NUMBER: D3.3 WORKPACKAGE CONTRIBUTING TO THE DOCUMENT: WP3 VERSION: V1.0 EXPECTED DELIVERY DATE: 28 th February 2015 DATE: 27 th February 2015 AUTHORS (name and organisation): Elisa Visentin, Silvia Mancin (Arsenàl.IT) This document provides a guide on the use of data collection tools for both online questionnaires tool and csv files tool. How to monitor status of enrolment and compilations collected is also explained. Finally responsibilities and permission of actors involved in data collection are explained. REVISION HISTORY REVISION DATE COMMENTS AUTHOR /02/2015 First Version Silvia Mancin and Elisa Visentin /02/2015 Version for issue John Oates Outstanding Issues: None Filename: MasterMind D3.3 v1.0 Multicenter databases Statement of originality: This deliverable contains original unpublished work except where clearly indicated otherwise. Acknowledgement of previously published material and of the work of others has been made through appropriate citation, quotation or both. The information in this document is provided as is and no guarantee or warranty is given that the information is fit for any particular purpose. The user thereof uses the information at its sole risk and liability.

3 Executive Summary This deliverable D3.2 Multicentre Database specification explains how the database will be populated, what are the tools provided for data collection, the use of the codebooks, and how build the patient and professional ID. It explains how to collect data using the two methods of data collection: Online tool: how to access the tool, how to fill in the CRF forms and save the data, how to export the data collected. CSV tool: how to use the codebook as a guide to compiling CSV files, how to fill them in, how to upload them to the Arsenàl.IT portal, and how to download the reports containing the wrong and processed rows. The dashboard and its functionalities are also explained. Overall, it explains the different responsibilities and permissions for each actor that takes part on the process of data collection: data enterer, data manager and coordinators. Confidential Page 3 of 17 V1.0 / 27 th February 2015

4 Table of Contents EXECUTIVE SUMMARY 3 TABLE OF CONTENTS 4 1. INTRODUCTION Purpose of this document Glossary 5 2. ACCESS TO THE TOOLS FOR THE DATA COLLECTION Access to Arsenàl.IT portal 6 3. ONLINE QUESTIONNAIRES Filling in online questionnaires Warnings Review of saved surveys Export of uploaded questionnaire CSV FILES TOOL Creating CSV files Upload CSV files in the portal Error and processed rows reports DASHBOARD DATA COLLECTION ACTORS: RESPONSIBILITIES AND PERMISSIONS 17 Confidential Page 4 of 17 V1.0 / 27 th February 2015

5 1. Introduction 1.1 Purpose of this document This document explains in detail how to use the tools for data collection (online questionnaire tool and CSV files tool), the dashboard and all the information contained, and the responsibilities of the actors involved in data collection. 1.2 Glossary CSV CRF Comma separated Value Case Report Form Confidential Page 5 of 17 V1.0 / 27 th February 2015

6 2. Access to the tools for the data collection Data are collected using two different tools: online tool and CSV tool. The online tool gives the possibility to collect all data by filling in the online questionnaires in the web portal. The CSV gives the possibility to collect data by uploading the CSV file on the web portal. Both tools are available in the Arsenàl.IT portal. 2.1 Access to Arsenàl.IT portal To access to the web site, every data manager and data enterer has to own credentials (username and password). Arsenàl.IT is in charge of providing these credentials to all identified data managers and data enterers. The steps are explained below and showed in Figure Link to 2. Access with the assigned credentials (username and password). 3. After clicking on sign in button, you will view the home page of the Mastermind project (shown in Figure 2). Figure 1: Access with assigned credentials In the home page, at the top you can find five labels (see Figure 2) that correspond to five links: - Home : redirect to the home page. - Documentation : sends to a session where some useful documentation for the use of web portal will be stored: codebooks, CSV templates, deliverables D3.2 and D Questionnaire : sends to the section dedicated to online questionnaires. - CSV : sends to the section dedicated to the upload and export of CSV files. - Dashboard : opens the page containing dashboards. Confidential Page 6 of 17 V1.0 / 27 th February 2015

7 Figure 2: Buttons to access different sections of the portal Confidential Page 7 of 17 V1.0 / 27 th February 2015

8 3. Online questionnaires This section explains how to fill in and save online questionnaires, and to export the collected data. 3.1 Filling in online questionnaires You can find the web site s section dedicated to online questionnaire by clicking on Questionnaire button (see Figure 2) in the home page. After that, a page containing the list of questionnaires will be opened (Figure 3). Choose the questionnaire you want to fill in, and click on it. The form will open and you can start to insert data (Figure 4). Figure 3: List of questionnaires In the forms, the mandatory fields (as indicated in the codebook) are highlighted by a "*". This means that these fields must be filled in, otherwise the questionnaires cannot be submitted. Answers can be of different types: in some cases, they require to flag one of a number of possible answers (arrow n. 1 in Figure 4); sometimes they require to insert an alphanumeric code (arrow n. 2), text, a number, or a date. Once you have answered all questions, you can save the questionnaire. There are two ways to save a survey: clicking on the Submit button, or on the Save as draft button, at the bottom of the form (see the red rectangle in Figure 4). Submit runs only if the survey contains all mandatory answers and the data format is correct (what happens if one of the previous conditions is violated is explained in section 3.2), so it can only be used if all the whole mandatory part of the form are completed correctly. In any case, once the questionnaire has been submitted, it is still possible to change data contained (see section 3.3). Save as draft can be used where the data enterer does not have all data available at the time: he/she can fill in some fields, save the questionnaire as a draft and at a later time complete the questionnaire. When all data is inserted in a form, the Submit button has to be clicked. After clicking Submit, if there are no errors in the data, a new web page with confirmation of the correct operation and a new empty survey form, ready to be completed, will open. Confidential Page 8 of 17 V1.0 / 27 th February 2015

9 Only submitted surveys are uploaded into the central database, because certainly they contain all mandatory data, as opposed to the draft questionnaires. Figure 4: Example of a questionnaire form Confidential Page 9 of 17 V1.0 / 27 th February 2015

10 3.2 Warnings If a data enterer tries to submit a questionnaire that contains errors, i.e. the wrong format in one answer, or mandatory fields skipped, it is not possible to accept the form. Error warnings are displayed, with information about the type of error, as show in Figure 5. This shows two types of alerts: one advises that the format of data is not correct (first arrow in Figure 5), the other that a mandatory field is empty. Data enterer can correct the errors, and then resubmit the form. Figure 5: Error warnings 3.3 Review of saved surveys Once submitted or saved as a draft, a data enterer can open it and review or complete the data entered. To open a saved form, the data manager and data enter have to follow this procedure: Access the questionnaires list by clicking on Questionnaire in the grey box on the top of the page. Choose the survey to be opened. Click on View instances button on the left (Figure 6). Figure 6: View instances button A list of completed surveys will open (Figure 7). Search the list for the form you want to open. Click on View button (highlighted in red in Figure 7). The form will open. Confidential Page 10 of 17 V1.0 / 27 th February 2015

11 Modify data. Figure 7: List of instances and View button. Re-submit the form or save as draft. The new form will appear in the list of instances. 3.4 Export of uploaded questionnaire After the 5 th day and by the 10 th day of every month, submitted questionnaires are uploaded into the central database. By the 10 th day of every month, the data contained in them are made available to partners in the form of CSV files. These CSV files follow the template of CSV files shared with partners and described in D3.2. Every online questionnaire corresponds to a different file, named similarly to the CRFs. For example, data inserted in the form called Post_study_CSQ3_professional are contained in a file named post_study_csq3_processed_country_date, where country is the region of a pilot site and date is the date on which data are exported from central database. For example post_study_csq3_professional_processed_treviso_ csv contains data inserted into Post_study_CSQ3_professional by the pilot site Treviso and extracted from database on 6 th April The procedure to download CSV files is explained below: Click on the CSV box on the grey line at the top of the page (see Figure 2, rectangle n. 4). Click on the country name. Click on Processed folder (Figure 8). Figure 8: Processed folder Confidential Page 11 of 17 V1.0 / 27 th February 2015

12 Choose the CSV and click on Download button (Figure 9, red rectangle) and based on the settings of your browser, the file will be downloaded into a folder on your PC. Figure 9: Download button in Processed folder Confidential Page 12 of 17 V1.0 / 27 th February 2015

13 4. CSV files tool This section explains the procedures to send CSV files to Arsenàl.IT, and download the reports containing errors and rows uploaded into the database. 4.1 Creating CSV files Data is collected in different CRFs that correspond to different sheets in the codebook. Every sheet corresponds to an online questionnaire and to a CSV file. CSV files have to be completed following the rules explained in codebook and using the shared template. Further explanations can be found in deliverable D3.2. The list of CSV files that can be completed is: pre_patient_country pre_professional_country rom_country safety_professional_country post_patient_country post_csq8_patient_country post_sus_patient_country post_csq3_prof_country post_sus_professional_country Before uploading files, country has to be changed to the name of the region they refer to. For example, the correct name for rom_country for Piemonte s pilot site is rom_piemonte.csv. Each partner must respect the rule for the name of the files as reported above. 4.2 Upload CSV files in the portal By the 5 th day of each month, the data manager has to upload CSV files containing data of his/her pilot site onto Arsenàl.IT portal. The delimiter has to be semicolon, otherwise files cannot be processed. The upload process is: Click on CSV button in the home page. Click on folder Country (Figure 10, rectangle n. 1). Upload folder will appear (Figure 10, rectangle n. 2). Click on Add document button (Figure 10, rectangle n. 3). Confidential Page 13 of 17 V1.0 / 27 th February 2015

14 Click on Browse Figure 10: Add document in Upload folder Choose the file to be uploaded and click open After the previous operation, a page will open to confirm the upload. If the chosen file is correct, click on Upload Files (Figure 11, rectangle n. 1); if it is not correct click on Cancel Upload (Figure 11, rectangle n. 2). In this case, click UPLOAD on the white block on the top and you will restart the process (Figure 12, red arrow) Figure 11: Confirming or deleting the file chosen for the upload. Figure 12: Restarting the upload procedure. After the click on Upload Files, a page will open with confirmation (Figure 13); it is then possible to upload another file. Confidential Page 14 of 17 V1.0 / 27 th February 2015

15 Figure 13: Confirmation of uploaded file The procedure of uploading files can be interrupted if the file format is not recognised, or the file name contains not allowed characters (e.g. / ). Files have to be named following the rule explained in the previous paragraph. Files named incorrectly will not be uploaded into database. By the 15th day of each month, Arsenàl.IT deletes files from Upload folder. 4.3 Error and processed rows reports Before uploading data into central database, Arsenàl.IT will check if all mandatory fields are filled in. To know which variables are mandatory refer to codebook. Rows in which any errors are found are not uploaded into central database. They are collected in a CSV file, called for example questionnaire_rejected_country_date.csv". This file contains all the variables of the original file and two additional columns: error_desc, which describe the errors detected, and error_field, which identifies which are the wrong variables. A CSV file is made available containing the rows uploaded into the database. Its name is questionnaire_processed_country_date.csv. For example, suppose that Scotland upload the CSV file rom_scotland.csv by 5 th May and that an error is detected in some rows. On 7 th May two files will be generated called rom_rejected_scotland_ csv and rom_processed_scotland_ csv. Both files, the one identifying errors and the one containing the uploaded rows, are made available by the 10 th day of each month in a folder called Processed (Figure 8). The procedure to download both files is: Click on CSV button in the top of the page (Figure 2). Click on Country. Click on Processed folder (Figure 8). Click on Download button (Figure 9); based on the settings of your browser, the file will be downloaded into a folder on your PC (Figure 10). The files in Processed folder will not be deleted for the duration of the study, so every Partner has the history of its uploads. Confidential Page 15 of 17 V1.0 / 27 th February 2015

16 5. Dashboard As explained in D3.2, the dashboard is a tool for monitoring the status of enrolment and data collection. Data manager and data enterer can see it by clicking Dashboard button on the top of the page, and then on Country. The dashboard is composed of two different reports: Status of enrolment and Status of compilations. In addition, the overall project status of enrolment is available. Status of enrolment report (Figure 14) shows how many patients have been enrolled in green, how many patients are missing to reach target in red, and the percentages of the two groups against country s target (refer to y axis). Pilot site and project s status of enrolment are viewed in the same way. Figure 14: Status of enrolment The Status of compilations report works in the same way, and shows for every questionnaire or CSV file how many records (rows) are uploaded into databases. The dashboard is updated when the central database is updated, so by the 10 th day of each month. Coordinators can see the status of enrolment of each pilot site. Confidential Page 16 of 17 V1.0 / 27 th February 2015

17 6. Data collection actors: responsibilities and permissions There are three types of actor involved in data collection: data enterer, data manager and project coordinator. The first two actors take an active part in data collection, whereas coordinators have a controller role. The permissions and responsibilities are different, as explained below. Data enterer Role: filling in online questionnaires. Permissions: - In online questionnaires section, can see only his/her own entered data, cannot see data of the other data enterers of his/her pilot size. - Data enterer cannot see the CSV file section. - In dashboard, can see data referred to his/her pilot size and to whole project. Data manager Role: - doing the quality assurance of the data, inserted both by data enterers in online questionnaires and in CSV file; - linking local variables names to the central database variables names; - uploading / exporting the CSV file from Processed folder; - doing the internal training for the team in the use of CSV / online tools; - any other technical issue concerning the database. Permissions: - In online questionnaire section, can see the data entered by all the data enterers of his pilot site. - In CSV file section, can access Upload and Processed folders and upload, download and delete files. - In dashboard, can see the status of his/her pilot site and of whole project. Coordinators Role: monitor the status of enrolment and data collection. Permissions: On dashboard, coordinators can see the detailed status of enrolment for all pilot sites and the whole project. Unless specified otherwise by an agreement between all partners, each partner can see and download only their own data. Confidential Page 17 of 17 V1.0 / 27 th February 2015