General Information

Real World Clinical Data

Real-world clinical data is needed to understand the course of disease, assess clinical effectiveness of medicines and to remain alert to unexpected serious adverse events or frequencies of adverse events https://spiral.imperial.ac.uk:8443/handle/10044/1/44898. The OPTIMISE Project Team, which has involved neurologists from several UK centres, was created to address this need for multiple sclerosis (MS) care.

Addressing the Need for Prospective Pharmacovigilance Monitoring with DMT Use

The primary objective of the OPTIMISE Team has been to encourage MS neurologists to record comprehensive, standardised data on their patient. This will enable sharing of anonymised data with other clinicians and researchers to answer the questions importing for improving patient care and health outcomes. The OPTIMISE Team has focused particularly on collecting data to assist in monitoring of benefits and risks of disease modifying therapies for prospective pharmacoviligance monitoring.

OPTIMISE MS Clinical Research Data Management Software

While software tools for MS patient data entry and curation have been generated before, none are in wide-enough use. One major challenge is to balance comprehensiveness of data collection with the sustainability of data entry in a busy clinic environment. Another is to ensure compliance with basic requirements for data security, audit and the ability to remove data fully if consent is withdrawn.

The OPTIMISE Team has worked with a core group of MS neurologists and solicited views of patients, industry and regulators regarding the kinds of data that are needed to make clinical decisions, to meet needs for prospective pharmacovigilance and that are practical to acquire. The Team explored ways of making them easier to record. OPTIMISE software developers then implemented these user requirements as the software downloadable here. This tool now is freely available for use by clinicians for MS care research.

The tool is provided “as is” as open access code under the terms of an MIT License (Open Source Initiative). The open access software provides users with a secure path to “future proofing” the software by giving control to them.

The OPTIMISE software will generate .json output files. Users are encouraged to share anonymized data with larger registry efforts, such as MSBase https://www.msbase.org/ or the UK MS Register (for UK based clinicians, https://www.ukmsregister.org/Portal/Home).

Additional updates to the tool will be provided periodically. In registering as part of approval for the software download, the OPTIMISE team will receive your approval to hold your contact details to allow us to update you as the software is enhanced. Feedback regarding to software is welcome: please send comments by email to ******.

Other Tools for Real World Data Collection

The OPTIMISE Team also is working to develop other tools for real world data collection for MS care. A recent report describes personalised, continuous, quantitative gait speed analysis in the home environment using a simple, low cost accelerometer (https://www.frontiersin.org/articles/10.3389/fneur.2018.00561/full). Software and sample data for researchers who wish to explore this area is available (https://github.com/akaraspt/ms-gait-calibrate).

Getting Started

OPTIMISE is accessible through this website in two forms: direct access to our demo servers and packaged containers.

To access our demo server, simply head here.

If you are an IT professional and would rather deploy the application on premise you can get this done in four simple steps.

  1. Install Docker version 18.x.y-ce.
    Instructions available here.

  2. Then, install Docker Compose version 1.8.x.
    Instructions available here.

  3. Create a directory where you would want the Optimise data to be stored and cd> into it.

  4. Finally, run this simple command in a privileged shell
    curl -s https://optimise-ms.org/install | bash :

How to access it ?

After successfully executing the installation command the application will be available on port 8080. This can be changed by directly editing the docker-compose.yml file present in the installation directory.

What about upgrades ?

At any point it is possible to upgrade to the latest version of Optimise by simply going to the same folder you created in step 1 and run the installation command of step 4 again.

What about the database storage?

The option to store the database externally is planned to be made available in future releases.

User Guide

OPTIMISE MS is a system for recording data including demographics, clinical events, treatments and tests according to CDISC standards for Multiple Sclerosis. OPTIMISE MS allows researchers to better monitor MS patients’ progress, record outcomes and evaluate treatments.

The user can enter demographic, medical history and family medical history, clinical event, visit, test and treatment data.

OPTIMISE MS can be used in two modes; the off-site mode when networking is enabled and the on-premise mode when networking is disabled.

Logging in

To start using the OPTIMISE portal first open your favorite modern browser.

Then, enter the hosting address in the address bar.

You should see the following screen. Enter the user name and password that were given to you and click the Sign in button. The default username is admin and the password is admin.

login

If the log-in is successful, you should see the following screen.

initial

If the log-in is unsuccessful, you will get a message. Re-enter user credentials.

loginFail

In order to search for a patient, click in the search box and enter the patient ID. Choose from the list of patient IDs below the search box.

search

A timeline and any Medical History information about the patient already in the database will be available in the left panel. The patient profile is available in the right panel. Primary Diagnosis (if entered), Immunisation and Pregnancy information is also available in the right panel. The data entry for these sections is described in the section Entering patient data.

Creating a new patient

In order to create a new patient, click on the search box button and enter the patient ID. If there are no patients with the entered ID, you may create a new patient by clicking the button as shown below.

createNewPatient

Once you click the Create button, you should fill the following form and click Submit in order to create the patient. A warning message will be shown if any of the field(s) are not filled.

newPatient

If the patient creation is successful, you should see the following page.

newPatient

In order to return to the Initial page, click the button near the top centre of the screen highlighted below.

newPatient

In order to update the consent, click on the consent button as shown below.

consent

The current consent status of the patient is always shown on screen.

updatedConsent

You can delete the patient using the delete button.

delete

delete

Entering patient data

In order to enter Immunisation data, click on Add immunisation.

imm

Enter any data as shown below.

imm

Enter any data as shown below and click Submit to create a new immunisation entry.

imm

The new entry will be added to the list of immunisations.

imm

In order to enter Pregnancy data, click on Record pregnancy.

pregnancy

Fill in the relevant form and click Submit.

pregnancy

The new pregnancy information will be added to the list.

pregnancy

The visit menu is highlighted in red below.

visitmenu

In order to create a visit, click on the Create visit button at the top centre of the page. To enter Test, Treatment and Clinical Event data, you need to create a visit first.

visitmenu

Fill in the required fields and click submit to create the visit.

visit

The new entry will be added to the Medical History section.

visit

Click on Edit / Add and fill the fields in the right panel as required. Click Save at the bottom right of the page to save the entry.

visit

In order to create a new Test, hover over the appropriate button and select a visit.

newtrt

newtrt

Fill in the treatment form in the right panel and click submit to create a new treatment.

newtrt

The new entry will be added to the relevant Visit entry in the Medical History section. Click on 'Interruption' to enter data for any interruptions.

trtdata

trtdata

trtdata

trtdata

In order to enter clinical event data, hover over Record Event and select a visit.

newce

Fill in the new CE form in the right panel and click submit to create the entry.

newCE

The new entry will be added to the relevant Visit entry in the Medical History section. Click on 'Results' to enter further test data.

CEdata

Using the Timeline

You may click on the Timeline to access (view/edit) the corresponding entry in Medical History Summary.

timeline

Exporting patient data

In order to export the database as separate csv files, click on the export button (highlighted in red) and choose where to save the files.

export

Admin settings

The administrator can read messages about the software, manage the users (create and delete user accounts) and view the action log by accessing the Admin settings.

adminSettings

adminOptions

The administrator can manage the users (create and delete user accounts) by accessing the relevant option (Manage users) in Admin menu. The Admin menu can be accessed by clicking the icon highlighted in red.

adminManage

The administrator can view the access log by clicking on View access log in the Admin menu.

adminView

Logging out

To log out click on the icon located at the bottom left of the page as shown below.

logout

Where is the source code ?

As we are currently in preview; the source code is not yet available. Keep watching for some update soon

Release note

OPTIMISE is finally starting its journey to help you collect data for MS patients.

Creation of the OPTIMISE Database tool was sponsored by Imperial College London and generously funded by Biogen. This project also has been supported by the Imperial College NIHR Biomedical Research Centre Brain Sciences Theme. The core OPTIMISE Team exercising oversight over the software development project included Ruth Dobson (St George’s Hospital), Matt Craner (University of Oxford & Frimley Health Foundation Trust), James Overell (University of Glasgow), Gavin Giovannoni (Barts and The London Hospitals), Cheryl Hemingway (Great Ormond Street Hospital), Yi-ke Guo (Imperial College Data Science Institute) and Paul Matthews (Imperial College London NIHR Biomedical Research Centre and Division of Brain Sciences, Department of Medicine). Developers on the project included May Young, Fangde Liu, Chon Sou, Pierre-Marie Danieu, Eleni Pissaridou and Florian Guitton (Imperial College Data Science Institute). All of the team have benefited from the input of many clinicians and patients with MS.

Note on usage

The software for download is provided “as is” for research use. It is strongly recommended that users familiarise themselves with local and applicable national data protection requirements (for UK and European users, see, e.g., https://www.eugdpr.org/).

Preview software

Please note that OPTIMISE v1.9.0 is currently released as a preview software. There is no guarantee the software will behave in the intended ways. Come back here anytime for updates.

Browser and device support

OPTIMISE is built to work best in the latest desktop and mobile browsers, meaning older browsers might display differently certain components or not render a functional application at all.

Supported browsers

Specifically, we support the latest versions of the below metioned browsers and platforms.

Alternative browsers which use the latest version of WebKit, Blink, or Gecko, whether directly or via the platform's web view API, are not explicitly supported. However, OPTIMISE should (in most cases) display and function correctly in these browsers as well. More specific support information is provided below.

Desktop browsers

Similarly, the latest versions of most desktop browsers are supported.

Chrome Edge Firefox
Mac Supported N/A Supported
Windows Supported Supported Supported

For Firefox, in addition to the latest normal stable release, we also support the latest Extended Support Release (ESR) version of Firefox.

Unofficially, OPTIMISE should look and behave well enough in Chromium and Chrome for Linux, Firefox for Linux, and Internet Explorer 11, as well as Microsoft Edge, though they are not officially supported.

Mobile devices

There is currently limited to no support for mobile devices.

License FAQs

OPTIMISE is released under the MIT license and is copyright 2018 Imperial College London. Boiled down to smaller chunks, it can be described with the following conditions.

It requires you to:

  • Keep the license and copyright notice included in OPTIMISE's CSS and JavaScript files when you use them in your works

It permits you to:

  • Freely download and use OPTIMISE, in whole or in part, for personal, private, company internal, or commercial purposes
  • Use OPTIMISE in packages or distributions that you create
  • Modify the source code
  • Grant a sublicense to modify and distribute OPTIMISE to third parties not included in the license

It forbids you to:

  • Hold the authors and license owners liable for damages as OPTIMISE is provided without warranty
  • Hold the creators or copyright holders of OPTIMISE liable
  • Redistribute any piece of OPTIMISE without proper attribution

It does not require you to:

  • Include the source of OPTIMISE itself, or of any modifications you may have made to it, in any redistribution you may assemble
  • Submit changes that you make to OPTIMISE back to the OPTIMISE project (though such feedback is encouraged)

The full OPTIMISE license is located in the project repository for more information.