Practice-Based Research Network Partnership with CDC to Acquire Clinical Specimens to Study the Etiology of Southern Tick-Associated Rash Illness (STARI)

The Journal of the American Board of Family Medicine

Meagan F. Vaughn³  Philip D. Sloane⁴  Kyle Knierim²  Dax Varkey²  Barbara J. B. Johnson¹  Mark A. Pilgard¹ 

[1] Centers for Disease Control and Prevention, Ft. Collins, CO (MAP, BJBJ);Cecil G. Sheps Center for Health Services Research (PDS, KK, DV), University of North Carolina–Chapel Hill, Chapel Hill;Department of Epidemiology, School of Public Health (MFV), University of North Carolina–Chapel Hill, Chapel Hill;Department of Family Medicine, School of Medicine (PDS), University of North Carolina–Chapel Hill, Chapel Hill

关键词: Practice-Based Research Networks;    PBRNs;    Centers for Disease Control and Prevention;    CDC;    Southern Tick-Associated Rash;   

DOI  :  10.3122/jabfm.2010.06.100098

学科分类：过敏症与临床免疫学

来源: The American Board of Family Medicine

【 摘 要 】

Introduction: Erythema migrans (EM) is an annular, erythematous, expanding rash that is characteristic of early Lyme disease. In the southern United States, however, many cases of EM seem to have an etiology different from that of Lyme disease. This little-understood condition is called Southern tick-associated rash illness.

Methods: With the goal of obtaining biological specimens and clinical histories from 12 to 20 STARI patients for use in etiologic research, microbiologists from the Centers for Disease Control and Prevention contacted the North Carolina Network Consortium, a statewide consortium of practice-based research networks. This article describes the methods by which the North Carolina Network Consortium successfully identified and enrolled Southern tick-associated rash illness patients into a primary care-based research protocol.

Results: A total of 23 patients were enrolled, with 100% attainment of the desired specimens. After an initial lack of success, the revised protocol identified and trained physicians practicing in endemic areas for the illness, used a coordinator with 24-hour availability, recruited participants using newspaper notices and medical providers, and provided regular reminders and progress updates.

Conclusions: A practice-based research network can help basic scientists identify patients and collect specimens for clinically relevant research.

• Practice-Based Research Networks
• PBRNs
• Centers for Disease Control and Prevention
• CDC
• Southern Tick-Associated Rash

Erythema migrans (EM) is an annular, erythematous, expanding rash that is characteristic of early Lyme disease, an infectious disease that is endemic in the northeast, north central, and Pacific northwest of the United States. In the southeastern and southcentral states, cases of EM have also been reported since the mid 1980s^1–3; however, antibodies to Borrelia burgdorferi, the cause of Lyme disease, are infrequently identified in these patients and no cultures of B. burgdorferi have been grown from them.^1,2,4 Thus, EM in this region is believed to often represent an illness that is not Lyme disease, the etiology of which is unknown. This illness has been provisionally named Southern tick-associated rash illness (STARI).

Compared with Lyme disease, which is transmitted by the tick vector Ixodes scapularis, STARI is associated with the bite from the lone star tick (Amblyomma americanum).^5–7 In recent years, A. americanum has been increasingly reported in areas endemic for Lyme disease.^6,8 Because a clinical diagnosis of early Lyme disease is often based on the presence of an EM rash, the increasing area of overlap where both tick vectors are present creates difficulties for diagnosis and treatment of patients with EM in these regions.

Other than the known tick association, the etiology, natural history, and appropriate treatment of STARI remain largely unknown. Wormser et al^9,10 compared microbiologic and clinical characteristics of patients who had EM rashes in New York (an area endemic for Lyme disease) and Missouri (a nonendemic area). Although 75% of patients from New York were seropositive for antibodies to B. burgdorferi, all patents with EM from Missouri were seronegative. The EM rashes, although generally similar in appearance, were slightly smaller, more circular, and more likely to have central clearing in Missouri patients than New York patients. In addition, Missouri patients had a milder illness with a shorter duration and fewer symptoms.¹⁰

Several studies have investigated the role of Borrelia lonestari and Rickettsia amblyommii as possible etiologic agents of STARI, but the results have indicated that they are unlikely to be the causal agents.^9,11,12 Without an understanding of the etiology of STARI, development of clinical and surveillance case definitions and laboratory methods to differentiate STARI from early Lyme disease is not possible. Because the etiology of STARI remains unknown it is difficult to develop evidence-based treatment guidelines for STARI patients. For these reasons it is imperative that the etiology of STARI be determined.

Difficulties with recruiting patients who have STARI and obtaining suitable biological specimens and clinical data have been limiting factors in the research efforts toward identifying the etiology of STARI. Convalescent serum samples, which require the patient to return for a second visit several weeks after the initial visit, can be particularly difficult to obtain. Because it is likely that the majority of STARI patients present to primary care physicians, the primary care office is a logical setting in which to seek to obtain biological specimens for research. However, practice-based research studies tend to suffer from problems with recruitment and retention of primary care physicians because of such issues as a lack of interest in the research topic, the requirement of a large time commitment, poor compensation, not having a voice in the research process, and not seeing the results of experimental tests as they are performed.^13,14

Practice-based research networks (PBRNs) have become an important mechanism to involve primary care physicians in clinical and epidemiological research. In this article we describe a partnership between microbiologists at the US Centers for Disease Control and Prevention (CDC) and a statewide PBRN for the purpose of obtaining patient specimens to help identify the etiologic agent of STARI. We describe the methods used to engage primary care physicians in this basic science research and to complete a complex data collection protocol.

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