MEMORI-net platform for data collection [Specification document]
A summary of the specification document
Authors: Sara Marceglia, Roberto Prandin
Date: April 23rd, 2018
The platform aims at collecting the clinical data during the application of the rehabilitation protocol established by the clinical panel of MEMORI-net. The Platform will be used in the different clinical centers involved in the MEMORI-net project during the protocol validation phase. The clinicians involved in MEMORI-net will use the Platform both as reference for protocol compliance and for allowing the collection of data. The platform will guarantee patient’s deidentification, and will implement workflow control for supporting the correct protocol application, also when the patient is treated in different centers at different stages. The platform will guarantee access to patient’s data only to operative units that are in charge of treating him/her.
The collection process follows the clinical protocol for post-stroke rehabilitation that was defined by the panel of experts part of the MEMORI-net consortium. The proposed protocol comprises 5 main phases, namely T0, T1, T2, T3, and T4. The assessments will cover up to 3 months from the end of the rehabilitation phase.
The following UML use-case diagram depicts the users (sticky men) that are expected to take part of the process, according to specific use cases (ovals).
Only users connected to use cases within the ICT-Platform framework will have a direct access to the system. However, for the purpose of fully describing the process and the platform specifications, they are all reported in the diagram:
- CLINICIAN/EXPERIMENTER: they will have access to the system in order to fill in the evaluations, and to review data from single patients. The clinicians in charge of each patient will be able to view data only from their patients;
- RESEARCHER: this user will be allowed to see data from all the participating units, for the purpose of extracting data for statistical analyses. The researcher will be able to visualize aggregated data in an anonymous form;
- PATIENT/CAREGIVER: they are part of the process, since they will complete some tests and assessments, but won’t be able to access the system;
- ADMINISTRATOR: this role is required to manage access policies, and to perform maintenance operations on the system;
- TECHNICAL ASSISTANT: this role will have access to the system with the purpose of performing assistance to the main users.
The ICT platform, according to Figure 3, will guarantee the functionalities described in the following sections:
- login: the system will grant access to all the clinicians of the operative units involved in the project;
- new eCRF opening and Patient code generation: each Operative Uniti (OU) has the possibility to open a new eCRF, anytime a new patient is enrolled in the study. Opening a new eCRF implies the creation of a new patient ID, which will serve as identifier for the patient throughout the study;
- eCRF fill-in and rehabilitation protocol execution: since enrolled patients will change institution (OU) during the rehabilitation process, it is necessary that the center treating and evaluating the patient is authorized to access the eCRF. To do so, the patient (or caregiver) will provide the USB bracelet to the OU experimenter who will use the QR code in it to recall the eCRF for the first time. Once the eCRF is recalled through the QR code, the OU will be considered authorized to view and modify the data in it;
- data export: the system will allow exporting all the completed Timepoints. It can be saved on the USB bracelet for patient’s use. Also, the Researcher will be allowed to enter the data sources, and to perform queries in order to extract data for statistical analysis;
- data visualization: the system will allow to visualize longitudinal patient’s data (the time course of specific variables of a single patient throughout the proptocol) and aggregated data (average of the patient’s scores at different time points);
- system administration: among the other maintenance functionalities, the System Administrator will be in charge of access control and credentials, as well as of periodic backup of the data collected.
The system will be implemented according to two main phases:
- Phase 1 – First release to allow data collection start (June 2018)
- Phase 2 – Second release to allow new functionalities (data export, data visualization, December 2018)
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