Table 2.
Burden of Lyme disease study-specific procedures
| LD case participants | Controls | ||||||
| Procedure/assessment | Visit 1 Day 1* |
Visit 2 Day 28 |
Visit 3 Month 10† |
Visit 4 Month 16–18‡ |
Visit 5 Month 22–24‡ |
Contact 1 Day 1 |
Contact 2 Month 16–18 |
| Screening, demographics and informed consent/assent | X | X | X | X | X | X | |
| Confirm eligibility (inclusion criteria) | X | X | |||||
| Patient (or parent/legal guardian) interview, including symptoms and LD risk factors | X | X | X | X | X | X | |
| Study blood sample for Lyme serology, and scavenge residual SOC cerebral spinal fluid and synovial fluid specimens if available | X | X | X | ||||
| Photograph of LD manifestations, and two 2 mm skin punch biopsies of any LD-related rash | X | ||||||
| Chart review to collect details of current illness and SOC physical exam findings | X | X | X | X | X | ||
| Collect prespecified medical history of clinical significance including past LD diagnoses | X | X | X | X | X | X | X |
| Collect SOC LD diagnostic laboratory testing results | X | X | X | X | X | ||
| Collect LD treatment and healthcare resource utilisation, and LD event outcome | X | X | X | X | X | ||
| Record clinical diagnosis and LD manifestation categories experienced based on clinical assessment | X | X | X | ||||
| Record clinical assessment of persistent symptoms/PTLD | X | X | X | ||||
| Collect Charlson Comorbidity Index information | X | X | |||||
| Collect health survey outcome information | X | ||||||
| Assess adverse events (2 hours after blood draw and 24 hours after skin punch biopsy) and research related injuries | X | X | X | X | X | ||
| Assess interest in participation in follow-up studies, and the potential for the participant to meet phase III exclusion criteria | X | X | |||||
*If the participant is ≥21 days after LD diagnosis at visit 1, then visit 2 data collection will be performed at visit 1 and no separate visit 2 will be performed.
†Visit 3 will take place approximately 9–10 months after visit 2. The latter part of the visit window could be extended up to 12 months after visit 2 if the participant’s persistent symptoms have not reached a 6-month duration after the completion of antibiotic therapy. Participants who did not have a separate visit 2 will have visit 3 approximately 9–10 months after visit 1.
‡Participants who had any persistent symptoms (including PTLD) documented at visit 3 will be invited for long-term follow-up at approximately 6–8 months (visit 4) and 12–14 months (visit 5) after visit 3. Participants are interviewed, have medical record review performed and LD event outcome will be reassessed.
LD, Lyme disease; PTLD, post-treatment Lyme disease; SOC, standard of care.