At the initial, pre-treatment study visit, participants reported the presence of symptoms that included items, such as fatigue, musculoskeletal pain, neurocognitive difficulties, fever, chills, or sleep disturbance observed concurrently with their acute illness. Since a validated symptom checklist does not exist for Lyme disease, this questionnaire was developed through a review of the literature and interviews with patients with a history of Lyme disease. Patients’ self-reported symptoms were elicited at all visits through a structured interview using a standardized written questionnaire of 37 symptoms. Retrospective studies of the long-term implications of PTLDS have shown that these symptoms may persist for years and negatively impact global life and Physical Functioning. These subjective symptoms must be continuous or relapsing for at least 6 months following completion of treatment and must be severe enough to reduce functional ability in the patient’s life. The Infectious Disease Society of America (IDSA) soon followed with a case definition of PTLDS that includes a documented episode of early or late Lyme disease with post-treatment resolution of objective symptoms of Lyme disease, but subsequent onset of symptoms of fatigue, widespread musculoskeletal pain, and/or complaints of cognitive difficulties. The term post-treatment Lyme disease syndrome (PTLDS) was coined to capture the pattern symptoms when they persist for longer than 6 months post-treatment. Over time, a pattern of findings emerged in the literature supporting the persistence of symptoms in a subgroup of individuals who had received treatment. Patient-reported symptoms, such as fatigue, cognitive dysfunction, and musculoskeletal pain, are common in both early and late phases of untreated illness. However, encephalitis with focal abnormalities on neuroimaging is rare in the United States. Less common features of late disease include neuropathy and chronic encephalopathy manifesting as memory deficits, concentration difficulties, and fatigue. When untreated, 60% of cases may develop “late” Lyme disease with joint pain and arthritis. Early disseminated infection may be associated with VII nerve palsy, cardiac disease, meningitis, and rarely, evidence of encephalitis. The infection may cause either localized or disseminated disease, with sensitive measures showing rates of blood borne infection as high as 70%. Clinical findings in early Lyme disease range from erythema migrans (EM) rash with or without “viral-like” systemic symptoms to patients presenting with symptoms in the absence of a diagnostic EM rash. More than 38,000 new cases were reported in the United States in 2009, but underreporting is estimated to be 6- to 12-fold, making the true number likely over 100,000 cases per year. Lyme disease, caused by the spirochete bacteria Borrelia burgdorferi, is the most common vector-borne infectious disease in North America.
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