Summary

Health-related quality-of-life (HRQOL) measures are increasingly important in clinical trials, particularly those included in new drug device applications to the FDA. Sharply increasing demand to license his leading cardiovascular measures for use in such studies forced John Spertus, MD MPH away from his all-paper management process to an online system. Here’s how we built it for him.

HRQOL License Management

Health-related quality-of-life (HRQOL) instruments are questionnaires that have been carefully created and validated against other standard clinical measures. The report, from the perspective of the patient’s experience, the outcomes of the interplay between a patient’s condition and the care she receives. Properly developed, they track patient status with high levels of sensitivity, specificity, and predictive power. Increasingly, the FDA and other regulatory agencies are requiring that these measures be evaluated in clinical trials leading to new drug applications and device submissions.

John Spertus, MD MPH is an academic cardiologist at the Mid-America Heart Institute in Kansas City, MO. He has developed three HRQOL instruments that have become the gold standards for tracking the health status of cardiac patients — the Seattle Angina Questionnaire (SAQ), the Kansas City Cardiomyopathy Questionnaire (KCCQ), and the Peripheral Artery Questionnaire (PAQ). Over the past decade, demand to use these instruments in clinical trials, patient registries, outcomes studies, and quality improvement initiatives has skyrocketed. John’s initial attempts to track usage of his instruments and issue licenses via paper systems simply became wholly unworkable.

At the time the Epimetrics Group was creating the CV Outcomes web site John uses to run the Cardiovascular Outcomes Research Consortium, he asked us to add a system that would handle licensing his questionnaires. This system needed to:

  • Handle his current instruments plus any new ones he develops.
  • Manage all related products for each instrument — the questionnaires themselves in all the available translations, the scoring instruction documents, and the various optional scoring tools (one set of which, the “Calculators,” we developed as well).
  • Implement the workflow process by which new licensees would submit a request, providing the necessary information for a license, John’s staff would review the requests, generate the needed documents (invoices and agreements), and log in payments and signed agreements, ultimately enabling licensees to download their stuff once all details were finalized.
  • Generate reminders to users based on the status of their license.
  • Deliver all licensed materials via downloads.
  • Provide real-time summaries of all licenses and revenues.
  • Provide search functions to track down specific licenses based on various criteria.
  • Integrate within the existing CORC web site to avoid a separate registration/login step for users.

We were able to add this functionality quite readily given the robust underlying infrastructure. The existing Users management system provided the secure access constraints needed for providing confidential access to licensees’ projects. The Ruby on Rails systems upon which Epimetrics Epicenter is built made it easy to create all the auxiliary entities involved in this system. Because it is a database-backed system, it provides real-time summaries about usage and revenues.

“We now have licensed our instruments to over 1500 projects involving nearly 11,000 sites and 200,000 patients,” reports John Spertus. “There is simply no way that we could handle this volume of activity without this online system.”

Created: September 15, 2009 12:51
Last updated: December 10, 2009 13:35


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