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The LFA POINT Program

About

Program Overview

Development and Medical Oversight

Software

Upgrades, Hosting and Access

Technical and Test Assistance

Test Site Access, Test Preparation, and the “Smart Test” Process

Certificates of Completion

Demonstrations

Program Overview

The Lupus Foundation of America Professional Online Instrument Training Program (LFA POINT Program) is the gold-standard, web-based training and testing site for clinical instruments used in the assessment of people with lupus. It may be used by biotechnology and pharmaceutical companies seeking standardized training for clinical trials, and by investigators and their staff who participate in multi-center trials, and/or clinical research organization associates who monitor the correct use of lupus disease indices. The LFA POINT Program is the only continually monitored standard of the correct usage of each of the instruments.

The programs currently available on the site are the British Isles Disease Activity Group Index (BILAG Index), the Systemic Lupus Erythematosus Activity Index (SLEDAI-2K and SELENA-SLEDAI) and the SLE Responder Index (SRI), which incorporates both BILAG and SLEDAI components into a combined outcome, as well as the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI).

Development and Medical Oversight

The LFA POINT Program, which is currently being utilized in several, multi-center, international clinical trials and has over 3000 active users, is an educational program developed by Dr. Joan T. Merrill, Medical Director of the LFA, and Professor Caroline Gordon, Birmingham, England using proprietary software created by CRISALIS, LLC., a software development company located in Oklahoma City, Oklahoma. Drs. Merrill and Gordon, along with Dr. Jill Buyon, Dr. Murray Urowitz, Dr. Michelle Petri, Dr. David Isenberg, and Dr. Vicky Werth serve as program advisors, responsible for ongoing program development, content accuracy, updated testing, and oversight.

Software

The LFA POINT Program is a web-based application accessible by commonly used browsers such as Internet Explorer, Mozilla Firefox, and Safari. The front-end user interfaces are built using HTML, Javascript, and ASP.NET AJAX-based technologies. The back-end consists of an MS SQL Server 2008 Database Engine. The entire application is developed using Microsoft Visual Studio 2008/2010. Graphics and other aesthetics related to the site utilize primarily the most common commercial application software (i.e. Adobe, Microsoft).

Note: The speed of access will depend upon each user’s computer configuration and Internet connection speed. Users will not have to install any proprietary plug-ins. However, users will be required to download commercial application software plug-ins such as adobe Acrobat reader if they have not previously done so. Instructions will be provided to users in such situations.

Upgrades, Hosting and Access

The application is upgraded and deployed remotely by the developers using secure VPN and RDP processes. Only the developers will have access to these servers, and communication between the developers’ computers and the servers at the hosting facility will occur via a secure channel.

The LFA POINT Program is hosted using industry standard equipment that complies with security and reliability by the developers and its partners. More information can be provided upon request.

The entire application runs through 256 bit Hypertext Transfer Protocol Secure (HTTPS) which is a combination of the Hypertext Transfer Protocol and a cryptographic protocol. Digital certifications (SSL Plus) from Digicert, Inc. are installed on the servers for added protection and encryption of data.

Currently the application is not designed for use with portable application devices such as smart phones at this time, but does work seamlessly through the Internet with any PC and/or Mac.

Technical and Test Assistance

Technical and content inquiries are managed through a Helpdesk, accessible by email. Inquiry responses, whether technical or content/test – related occur within 24 hours after receiving notification, and error resolution will depend on the complexity of the problem.

Test Site Access, Test Preparation, and the “Smart Test” Process

Each company which subscribes to the LFA POINT Program has the choice to offer their study investigators by using the test site URL directly or through a company portal which includes a direct link from the company site to the test site. Each company will have its own, unique test site and each company’s test site will be password-protected.

Users have the opportunity to review the training materials available on the site before taking the exam, and to print the available resources for review and/or future reference in the clinic. Current complete resources are:

  • The BILAG 2004 Index glossary and instructions.
  • The BILAG 2004 Index scoring rules.
  • The BILAG 2004 Index teaching modules.
  • SLEDAI 2K, SELENA SLEDAI and Hybrid SLEDAI glossary and guidelines
  • SLE Responder Index (SRI)
  • CLASI video training and resources

After reviewing the resources, a user can begin the open book exam. Each exam is given on a split screen allowing easy reference back to the study materials, rules, or online calculator at any time. Rules do not have to be memorized, but they will need to be available for reference, as it is the application of the clinical information and the understanding of fundamental concepts of how observations are recorded and scored that is important.

Users can only advance through the test after each question is answered correctly. If the user answers a question incorrectly, he/she is immediately given feedback and a complete explanation detailing what was incorrect and why. Once explained, a new question covering the same concept will be provided by the program. If the user answers a question correctly, he/she also gets immediate feedback explaining why it was correct and why the alternative answers would have been incorrect. At the end of each of these feedback responses is a section entitled “clue to a future answer,” which may encourage an individual to take the time to read these discussions.

This “smart test” process will repeat until three questions on each of the fundamental concepts have been answered correctly, ensuring that every concept is understood by the time the test is completed.

A well-prepared user may complete the exam by answering as few as 21 questions, while a less-prepared user may need to respond to more questions. However, unlike conventional testing, a person cannot pass the test by answering only a percentage of the concepts correctly. This feature also limits the impact of the “lucky guess.”

The LFA POINT Program is equipped with a progressive save feature which allows flexibility in how and when a user studies for and takes the exam. Users can log-in, study/review materials and/or begin the test, stop and save their information, and return at a later time.

Certificates of Completion

Upon test completion, users receive a unique, non – transferrable certificate of completion generated specifically for the study protocol. Certificates of completion can be viewed, printed and/or saved at any time while it is valid.

Certificates of completion are valid for any assigned period of time or until the end of the study and remain stored within the system. All information will be sent to the sponsor through a secure and mutually agreed upon process once the study has closed (data lock). The company can obtain copies of the certificates and/or standard reports outlining who has completed the exam specifically for its study(ies). Each report is auto-generated and accessible through FTP. The option to automatically obtain reports uploaded to any FTP/SFTP is also available.

Demonstrations

To set up an online demonstration of the LFA POINT Program, please contact R. Paola Daly, MHS, Education and Research at the Lupus Foundation of America. Phone: 202-212-6777; email: daly@lupus.org.