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Patient Registry
After a lot of planning and anticipation, the FMD Registry is now ready to begin enrolling patients. In the first phase, there are nine sites that are going to participate in the registry, including seven that are in the United States. These sites are: Cleveland Clinic in Cleveland, Ohio, Ochsner Clinic in New Orleans, LA, Mount Sinai School of Medicine, New York, NY, Mayo Clinic, Rochester, MN, Institute of Vascular Health in South Carolina, North Central Heart Institute, Sioux Falls, SD, and the University of Michigan, Ann Arbor, MI. There are also centers in Germany and The Netherlands that will also be participating. Since funding to support the registry is very limited, these sites were chosen by a multidisciplinary committee because they treat a large enough number of patients with FMD and thus will be able to rapidly accumulate as much information as possible. As soon as additional monies become available, more centers will be added.
Each person agreeing to participate in the registry must first sign a consent form. The consent forms are often lengthy and detailed because they are formatted similarly to those used in clinical research. It's important to remember that the FMD registry is a data registry only - no experimental research is being conducted. Clinical data is collected in a de-identified manner and placed into a database. Clinical data includes elements such as date of diagnosis, types of tests conducted and results of these tests, past medical history, family history, subsequent clinical events and any clinical outcomes. All of these data elements are important to determine the natural course of the disease and to determine which procedures are more effective to relieve symptoms and reduce adverse outcomes.
Since patient privacy laws were enacted in 2003, physicians must have individual patients' consents to place data in a central registry. No names, addresses, social security numbers, or any personal information are included in the registry. Each patient is assigned a unique ID number which identifies individual patients to the treating physician. All staff involved with the registry can identify sites and patients by numbers only. Many measures are taken to secure the information including multiple firewalls, encryption codes, and de-identifiers.
Since FMD is not commonly recognized and often misdiagnosed, the only way to gather enough information to learn how to better diagnose and treat patients is to form a data registry which allows collection of many cases from multiple institutions. With large numbers of cases, physicians can create statistical models that can accurately predict which tests/procedures/medications result in the best outcomes. It often takes time to gather enough information in order to adequately analyze the results. Based upon the current number of sites involved (which is limited by the funding available to coordinate the registry), it will most likely take up to a year before enough data is gathered to adequately analyze. |
Pam Mace with the doctors from the FMD Clinic at the Cleveland Clinic.
How fitting that Pam was there to be the first to sign up for the new Patient Registry!
Please call 216-445-3689 or 800-223-2273(Toll Free) to schedule an appointment with Dr. Gornik.
Firas AlSolaiman, MD, Heather Gornik, MD, Pam Mace RN, Jerry Bartholomew, MD, May Nacion, Research Assistant
(Esther Kim, MD, missing from photo)
We will update this page as more information becomes available |
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