Tuula Tyry, PhD––NARCOMS Program Manager, Barrow Neurological Institute, Phoenix, Arizona

Introduction
As many of you already know, the North American Research Committee on Multiple Sclerosis (NARCOMS) project is now part of a more extensive program entitled Global Demyelinating Disease Registry. This entity currently consists only of Global MS Patient Registry, but is designed to later expand to include similar voluntary registries for other demyelinating diseases. In the meanwhile, its original core component, long known simply as the NARCOMS Registry, continues in its important dual role of expediting and facilitating multi-site clinical trial recruitment and providing a data source for a wide-range of MS research projects.

Peer-Reviewed Publications
Over a period of more than 10 years, de-identified NARCOMS data have been featured at an annually increasing rate in 32 peer-reviewed articles in addition to almost 100 scientific posters and presentations (Figure 1). Sharing the results with the scientific community via a wide-range of journals and conferences is an important way to spread the knowledge and insight gained from analyzing the Registry data and to inspire further studies in MS. It also helps in getting the latest information to the practitioners as quickly as possible, thus bridging together research and clinical work while also providing a reliable source of information for health care policy and advocacy initiatives. Abstracts or full-length articles of most of the NARCOMS publications are readily available with search word “NARCOMS” at www.pubmed.gov. Should you need assistance in locating any of the publications, please feel free to contact us at 1-800-253-7884 or MSregistry@narcoms.org.

The Database
As of Spring 2009, the NARCOMS database has self-report data on over 34,000 patients with MS, who have volunteered information on a variety of topics, such as demographics, disease and treatment status and history, disability level and progression, quality of life, health care service utilization, and lifestyle choices. After completing a baseline enrollment survey by mail or online, participants are asked to update their information twice per year and answer additional questions in areas of current research interest. In recent years each of these semi-annual surveys has been completed by over 10,000 participants, representing as many as 2 out 3 registrants classified as active at the time. This report will briefly summarize the basic demographic and disease characteristics of the entire NARCOMS population and present recent statistics obtained from the Fall 2008 update survey.

NARCOMS Population Characteristics
Despite its increasingly large size, the NARCOMS database is not population-based and may thus not be fully representative of the total MS population in the United States. However, as seen in Table 1, the general characteristics of the Registry population are quite comparable to those typically reported for MS. To more thoroughly investigate the nature and magnitude of a potential selection bias, we are collaborating with other groups and institutions, such as the Rocky Mountain MS Center in Colorado, to increase Registry recruitment in specific regions. A high rate of coverage in a particular area will ultimately enhance our ability to assess data from other regions more accurately as well. We truly appreciate all the assistance we have been getting from the Registry participants in spreading the word online, in support groups, and through various MS events.

Fall 2008 Update Survey
The Fall 2008 update survey was sent to 15,529 active participants. A total of 10,232 people (66%) completed and returned the entire survey, two out of three opting to do it online. Over 75% of the responders were women and about 30% were under 50 years of age. As seen in Figure 2, the distribution of Patient Determined Disease Step (PDDS) levels was rather even across the range, with well over 1,000 responders at each level, except for the Moderate (768) and Bedbound (121) categories.

Relapse History and Disease Progression
A total of 2,542 responders reported one or more relapse episodes in the preceding 6-month period. Less than one in four or 910, of the total of 3,896 relapses reported required steroid treatment. A total of 4,374 (43%) responders reported symptom worsening not due to relapses. As compared to overall symptoms experienced 6 months earlier, current symptoms were at least a little better for 1,011 (10% ), unchanged for 4109 (40%), a little worse for 3,829 (37%), and worse or much worse for 1,273 (12%) of the responders. Nevertheless, responses to the first question of the SF12 quality of life questionnaire indicated that 69% of the responders viewed their general health as good or better and only 5% rated it poor.

Current Therapy
As seen in previous reports, more than two out of three responders (71%) reported receiving some form of immunologic therapy. The break down of current DMA treatment status by agent is presented in Figure 3. Please note that the 1,632 responders who have participated in clinical trials in the past or are currently enrolled (292) were not excluded from this analysis. Immunosuppressive treatment with mitoxantrone was reported by 111 responders (<1%) and oral prednisone use by 768 (7%). A total of 491 responders (5%) were on long-term IV steroid therapy. The use of supplements has increased slightly from previous reports, with 4,72 (49%) responders taking calcium, 4,638 (45%) vitamin D, and 5,562 (54%) multivitamins.

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Healthcare Service Utilization
As seen in Table 2, the majority of responders had visited their primary care provider (60%) or a neurologist specializing in MS (58%) in the past 6 months. Other frequently visited providers include internist (26%), ophthalmologist (23%), general neurologist (21%), physical therapist (21%), and optometrist (20%). Please note that we did not inquire about the actual number of visits with each of the providers, only whether their services where used or not. In addition to provider visits, 977 (10%) responders had to visit the ER in the past 6 months, while 888 (9%) reported an overnight hospital stay, typically for reasons that were not directly related to MS.

Future Plans
The immediate focus of the registry is to finalize the administrative changes related to the transfer of the database and customer service operations from Phoenix and Denver to the new NARCOMS Operations Center at University of Alabama at Birmingham, AL. At the same time NARCOMS research and administrative teams are already working on the Fall 2009 update survey as well as being involved in planning and conducting several additional data analysis and data collection projects scheduled for 2009 and beyond. With guidance from the NARCOMS Steering Committee, we are also getting ready to launch the next phase of the Latino cohort expansion project, increase recruitment efforts in Canada and initiate a more closely tracked inception cohort of newly diagnosed patients with MS. We will welcome collaboration, guidance, assistance, and support for any of these upcoming projects––thank you.

Summary and Conclusions
From a research point of view, the current state of the Registry already provides large sample sizes for cross-sectional analyses, an expanding true longitudinal cohort in the thousands, an extensive range of variables, and a reasonable level of racial, ethnic, and geographic diversity in its population. Once fully implemented, the administrative and workflow changes introduced in the recent months will enhance the interaction with both the Registry participants and the MS research community by allowing for more effective electronic and print-based data sharing for educational and informative purposes.

As always, we are eager to acknowledge that the success of the NARCOMS program relies on the continued collaboration and support of patients with MS and their families. This unique partnership developed over the years allows all of those involved to contribute to the global MS knowledgebase in many more ways than otherwise feasible. Thank you all for making it possible.

This entry was posted on Thursday, August 13th, 2009 at 8:11 am and is filed under All Articles, NARCOMS. You can follow any responses to this entry through the RSS 2.0 feed.