Validation of cellular tests for Lyme borreliosis (VICTORY) study

BMC Infectious Diseases

Table 2 Data collection and measurements for Lyme borreliosis cases

	Baseline	10 days	2 weeks	6 weeks	3 months	6 months	9 months	12 months
Written information and informed consent	X
Baseline characteristics	X
Physical examination	X^a				X^ac	X^ac	X^ac	X^ac
Recording LB manifestation, treatment and concomitant medication	X		X^b		X	X	X	X
Recording adverse events	X		X^b		X	X		X^a
Laboratory measurements
B. burgdorferi s.l. serology	X	X^ac		X	X^ac
Spirofind Revised	X			X	X^c
QuantiFERON-LB	X			X	X^c
iSpot Lyme	X			X	X^c
LTT-MELISA	X			X	X^c
Biopsies from skin manifestations (optional)	X^cd			X^cd	X^cd
Questionnaires
CIS1 (subscale fatigue), SF-36 (subscale pain), CFQ	X				X^e	X	X^e	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

For explanation of abbreviations, see the main text
^aPatients included through the clinical expert centers for Lyme borreliosis only
^bPatients included through the website www.tekenradar.nl only. ^cThese visits and laboratory measurements can be left out if patients are not able or not willing to. This is regarded as an allowed deviation from the protocol
^dThree skin biopsy samples of the skin lesion at baseline and if still present at 6 weeks or at 3 months time point. ^eCIS questionnaire only short version, to limit the burden for patients

ISSN: 1471-2334