CoRDS Registry: An HIT Case Study Concerning Setup and Maintenance of a Disease Registry

CoRDS Registry: An HIT Case Study Concerning Setup and Maintenance of a Disease Registry

Seth Trudeau (Sanford Health, USA)
DOI: 10.4018/978-1-4666-2671-3.ch012

Abstract

The Coordination of Rare Diseases at Sanford (CoRDS) registry has been started to provide a central repository of data for participants suffering from a number of rare diseases and to provide those participants with a resource to learn more about their disease and, in a future enhancement, connect with others that are afflicted. The second purpose of the registry is to provide a resource for researchers to identify and recruit potential participants for their research studies. This case study will focus on the technical aspects of setting up a registry and providing access to participants and their medical team, who will enter data about their disease, and researchers, who will access de-identified data to include in their research. Security of the external website and access to Protected Health Information (PHI) are the main areas of concern with this registry.
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Project Background

In an article from Drolet and Johnson (2008), the authors reviewed a number of existing literature to formulate a more precise definition of a medical disease registry. They put forth the definition of “a medical data registry as a system functioning in patient management or research, in which a standardized and complete dataset including associated follow-up is prospectively and systematically collected for a group of patients with a common disease or therapeutic intervention” (pp. 1012-1013). They define 6 characteristics of a medical disease registry: merge-able data, standardized datasets, a set of rules for data collection, observations that are gathered over time, knowledge of outcomes through the use of follow-up, and characterizing the domain of the registry as chronic disease or acute/interventional therapy.

The CoRDS registry was initiated in June of 2010. As of October 2011, there were 98 registered patients covering 35 different rare diseases. The registry is being hosted at Sanford Research/USD in Sioux Falls, South Dakota and is supervised by Investigator David Pearce, PhD, Co-Investigator Chun-Hung Chan, PhD and coordinated by the CoRDS Administrator Liz Donohue. At this point in the registry’s existence contact between the registry and its participants is done primarily through telephone and postal mail. The administrator is also working with national and local organizations to promote awareness of the registry. The business needs for this project are to automate and expand the reach of this registry through a technology solution consisting of a Web-delivered portal for participants to enter information and for researchers to pull information back out. The registry does have a Web presence (www.sanfordresearch.org/cords) with some general information and contact details, but not much else.

As was mentioned before, Sanford Health uses software developed by Velos for the management of their clinical trials. This same software has a module for the creation and delivery of a participant portal via the Internet. The experiences of Sanford Health with the existing modules of the Velos application have been positive. The software and vendor support meets our needs for clinical trial management, the participant portal, and reporting on the data collected.

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