Table 1.

Enrollment criteria considered in prior studies of previously treated Lyme disease.

Typical signs of Lyme disease by history (i.e., not symptoms alone)

Typical persistent symptoms of previously treated Lyme disease

Severity level of symptoms and/or of functional impairment

Symptom onset coincident or within a window of time after diagnosis and treatment

Persistent symptoms are either continuous or relapsing/remitting

Specific maximum or minimum duration of illness prior to enrollment

Laboratory test confirmation (e.g., standard reference criteria &/or “in-house” criteria)

History of exposure to a Lyme endemic area

Prior antibiotic therapy for Lyme disease (e.g., a minimum or maximum amount)

Exclusion of pre-existing confounding disorders/diseases/infections

Ascertainment methods: self-report; clinician records; pharmacy records; and/or lab test records