Protocol for a longitudinal cohort study of Lyme disease with physical, mental and immunological assessment

Publication type: 
Journal Article
Publication date: 
2023-11
Journal/Series title: 
BMJ Open
Volume: 
13
Issue: 
11
Abstract: 

This study is a longitudinal cohort study that will recruit 120 participants with Lyme disease in Ontario and Nova Scotia, Canada, with follow-up for up to 24 months. Data will be collected using the Short-Form 36 physical and mental component summaries, Depression and Anxiety Severity Scale Questionnaire, Fatigue Severity Scale and a battery of neuropsychological tests. Mononuclear cells, gene expression and cytokine profiling from blood samples will be used to assess immunological response. Analyses will include the use of non-linear mixed-effects modelling and proportional hazards models.