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Table 4 Data collection and measurements for the observational cohort

From: Validation of cellular tests for Lyme borreliosis (VICTORY) study

 

Baseline

6 weeks

3 months

6 months

9 months

12 months

Written information and informed consent

X

     

Baseline characteristics

X

     

Physical examination

X

     

Recording LB manifestation, treatment and concomitant medication

X

 

X

X

X

X

Recording adverse events

X

 

X

X

 

X

Laboratory measurements

 B. burgdorferi s.l. serology

X

 

X

   

 Spirofind Revised

X

 

X

   

 QuantiFERON-LB

X

 

X

   

 iSpot Lyme

X

 

X

   

 LTT-MELISA

X

 

X

   

Questionnaires

 CIS1 (subscale fatigue), SF-36 (subscale pain), CFQ

X

 

Xa

X

Xa

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

     
  1. For explanation of abbreviations, see the main text
  2. aCIS questionnaire only short version, to limit the burden for patients