Table 2 Data collection and measurements for all patients with confirmed Lyme borreliosis

Written information and informed consent

X

Baseline characteristics

X

Physical examination

X^a

X^ac

X^ac

X^ac

X^ac

Recording Lyme manifestation, treatment and concomitant medication

X

X^b

X

X

X

X

Recording adverse events

X

X^b

X

X

X^a

 Primary outcome: CIS (subscale fatigue), SF-36 (subscale pain), CFQ

X

X¹

X

X¹

X

 Clinical parameters: PHQ-15, SF-36 (subscale physical functioning and subscale social functioning), TiC-P (health-care use and absenteeism of work)

X

X

X

X

X

 Cognitive-behavioral parameters: brief IPQ, CBRSQ, HADS, SES-F, PCS, IPAQ

X

X

X

 Comorbidities: TiC-P (co-morbidity list)

X

X

 Comorbidities: PREDIS

X

 B. burgdorferi s.l. serology

X

X^ac

X

X^ac

 Serology other TBPs³

X²

X²

 PCR B. burgdorferi s.l. and other TBPs³ (blood)

X

X

 Genome wide association studies

X⁴

 Cytokine measurements in cell culture supernatants

X

X

 Gene expression micro-arrays on ex vivo stimulated PBMCs

X⁵

X⁵

 Skin biopsies: culture, MLST, PCR B. burgdorferi s.l. and other TBPs, gene-expression profiling

X⁶