Abstract
BackgroundIn Belgium, different routine surveillance systems are in place to follow-up Lyme borreliosis trends. However, accurate data on the disease and monetary burden for the different clinical manifestations are lacking. Despite recommended antibiotic treatment, a proportion of Lyme patients report persisting aspecific symptoms for six months or more (e.g. fatigue, widespread musculoskeletal pain, cognitive difficulties), a syndrome now named “post-treatment Lyme disease syndrome” (PTLDS). Controversy exists on the cause, incidence and severity of PTLDS. This study aims to estimate the incidence of PTLDS in patients with Lyme borreliosis and to quantify the disease burden and economic costs associated with the different clinical manifestations of Lyme borreliosis in Belgium.MethodsThe project is a prospective cohort study in which about 600 patients with an erythema migrans and 100 patients with disseminated Lyme borreliosis will be followed up. Questionnaires, including the SF-36 vitality and pain subscale, the Cognitive Failure Questionnaire and the EQ-5D-5L, will be used to collect information on acute and persisting symptoms and the impact on quality of life. Symptom frequency and severity will be compared with self-reported pre-Lyme health status, a control group and existing Belgian population norms. Additionally, information on the associated costs and possible risk factors for the development of PTLDS will be collected.DiscussionA study of the health burden will allow evaluation of the relative importance of Lyme borreliosis in Belgium and information on the economic cost will help to formulate cost-effective measures. There are only few prospective studies conducted estimating the incidence of PTLDS and even though discussion exists about the prevalence of subjective symptoms in the general population, a control group of non-Lyme borreliosis participants has often not been included.
Highlights
In Belgium, different routine surveillance systems are in place to follow-up Lyme borreliosis trends
If an infection is not treated with appropriate antibiotics, it can possibly evolve to disseminated Lyme borreliosis affecting the skin, the nervous system (Lyme neuroborreliosis), the joints or more rarely, the heart or the eyes [1, 12]
Study objectives The aim of the study is to evaluate the incidence of and possible risk factors for the development of post - treatment Lyme disease syndrome (PTLDS) and to estimate the disease burden and economic cost associated with the different clinical manifestations of Lyme borreliosis in Belgium
Summary
In Belgium, different routine surveillance systems are in place to follow-up Lyme borreliosis trends. The most common clinical manifestation is an erythema migrans (EM), a red expanding rash which occurs in 60 to 95% of symptomatic infections, within days to weeks after the tick bite [6,7,8,9,10,11] In this early disease stage, flu-like symptoms (e.g. fever, headache, fatigue, arthralgia’s, myalgia’s) may accompany EM or appear separately. It has been reported that some people still suffer from a range of nonspecific symptoms after an infection: fatigue, widespread musculoskeletal pain or cognitive difficulties (e.g. memory problems, difficulties concentrating, problems finding words) If these symptoms persist for more than six months after treatment in correctly diagnosed Lyme patients and are of such severity that they influence the patient’s daily life, this is referred to as post-Lyme disease syndrome [2], later named post-treatment Lyme disease syndrome (PTLDS) [13,14,15]
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