NARCOMS Report-Registry Status
Tuula Tyry, PhD, MAED, Narcoms Program and Editorial Manager – Barrow Neurological Institute, Phoenix, Arizona
Introduction
The CMSC/NARCOMS MS Patient Registry has now been operating for about 10 years. It has collected self-reported data from over 31,000 people with multiple sclerosis (MS). The accumulated data are used to match participants with clinical trials and other MS-related research studies nationwide and also to facilitate epidemiological research in MS. The purpose of this review is to summarize the current status of the Registry––not only to inform clinicians and researchers about the features of the database, but also to encourage the participants to continue responding to the update surveys.
Enrollment
Enrollment in the Registry is voluntary and open to all adults diagnosed with MS. Figure 1 illustrates the number of unique enrollments over the past 10 years. After a slow initial recruitment the annual enrollment has fluctuated between 1,000 and 4,000. There was a significant spike in enrollments in the year 2000 resulting from a large recruitment mailing to the members of the National MS Society.
Figure 2 demonstrates participants’ adherence to the Registry by year of enrollment. It is quite remarkable that about half or more of each year’s enrollees are still actively participating in the Registry––some having completed update surveys for as long as 10 years! On the other hand, participants who have chosen not to update their information for the past 2+ years or longer are considered inactive. Among the US registrants, there are currently 8,920 of these 2+ year nonresponders. Inactive status is also assigned to participants who were initially misdiagnosed (89), were lost to follow-up (2,737), have withdrawn (457), are deceased (768), or have incomplete data (61). Figure 3 illustrates the percentage of each of these categories among the US participants. Overall, about 60% (almost 18,000) of the US participants have maintained an active status.
Geographic Distribution
Figure 4 illustrates the current geographic distribution of all unique enrollments (both active and inactive participants). Although all 50 states in the US, as well as Puerto Rico and the District of Columbia, are represented in the Registry, the data still can not be considered populationbased. Currently the states with the largest number of Registry participants are California, New York, and Florida. The goal of the Registry is to enroll at least 10% of the estimated 400,000 MS population in the US and to increase recruitment to 50% in selected areas.
Demographics
Table 1 provides basic demographic information on all U.S. participants. Almost three out of four participants are female. Almost 90% of the participants are White non-Hispanic, but the registry also has a substantial number of African Americans (1,332) as well as Native American Indians (309) and people reporting Latino heritage (591). Over 80% of the participants are currently between 35 and 65 years of age with 35% in the group of 45 to 54 year olds. At the time of their enrollment 97% of the participants had some form of health insurance (e.g. Private, Medicare, Medicaid, CHAMPUS, VA or other). 4,954 participants (16%) have identified themselves as being honorably discharged from active duty in the U.S. Armed Services. 4,113 of the participating veterans are male and 841 female. Disease and Treatment Characteristics Table 2 shows the patient determined disease step (PDDS) scores and treatment status among the 9,471 U.S. participants who returned the semiannual update survey in Spring 2005. About half of the responders report regular use of ambulatory aids (e.g. cane, crutches, scooter, or wheelchair) while 25% have none or only mild symptoms affecting their lifestyle. About 60% of the responders had been on FDA approved disease modifying (DM) therapies within the previous six months, including over 200 participants who were treated with Tysabri® before it was withdrawn from the market in February 2005. 3,528 participants (37%) had not been treated with any of these DM agents or Novantrone® (mitoxantrone).
Conclusion and Future Directions
The CMSC/Narcoms project is designed to continue until a cure is found. The Registry will continue to recruit new participants while continuing the follow-up of those already enrolled. As illustrated in Figure 5, among those who enrolled in 2005 the most often cited source for hearing about NARCOMS was the Internet. Incidentally, the percentage of participants taking the enrollment and/or the semiannual surveys online has steadily climbed to about 70%. The chart also shows, however, that the combination of “word of mouth†and “other†(sources such as a family member) accounted for even a higher percentage of the new enrollments. We gratefully acknowledge this as another indication of the continued collaborative effort from the part of the Registry participants as well as their friends and families. Thank you.