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

From: Prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis: study protocol for an observational, prospective cohort study (LymeProspect)

  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 Xa     Xac Xac Xac Xac
Recording Lyme manifestation, treatment and concomitant medication X   Xb   X X X X
Recording adverse events X   Xb   X X   Xa
 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        
Laboratory measurements
B. burgdorferi s.l. serology X Xac   X Xac    
 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        
  1. aPatients included through the clinical expert centers for Lyme borreliosis only
  2. bPatients included through the website only
  3. 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
  4. 1CIS questionnaire only short version, to limit the burden for patients
  5. 2In cases (patients with persistent symptoms) and twice as much controls (patients without persistent symptoms), starting with the 6 weeks sample. If borderline or positive, the baseline sample will be tested as well
  6. 3Serology on Babesia spp., Rickettsia conorii, Anaplasma phagocytophilum (commercially available) and Borrelia miyamotoi (experimental). Quantitative PCR including Babesia spp., Rickettsia spp., Anaplasma phagocytophilum, Neoehrlichia mikurensis, as well as a pan relapsing fever Borrelia qPCR (if positive, a specific Borrelia miyamotoi qPCR will be performed)
  7. 4In the first consecutive included 600 patients with erythema migrans
  8. 5In a selection of patients, included through the clinical expert centers for Lyme borreliosis
  9. 6In patients with a skin manifestation included through the clinical expert centers for Lyme borreliosis (only after additional consent). Both the affected and contra-lateral side will be investigated
  10. Abbreviations: (q)PCR (quantitative) polymerase chain reaction, TBPs tick-borne pathogens, PBMCs peripheral blood mononuclear cells, MLST Multilocus sequence typing. For the abbreviations of the various questionnaires, see the main text