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

BACKGROUND: After antibiotic treatment of Lyme borreliosis, a subset of patients report persistent symptoms, also referred to as post-treatment Lyme disease syndrome. The reported prevalence of persistent symptoms varies considerably, and its pathophysiology is under debate. The LymeProspect study h...

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Autores principales: Vrijmoeth, Hedwig D., Ursinus, Jeanine, Harms, Margriet G., Zomer, Tizza P., Gauw, Stefanie A., Tulen, Anna D., Kremer, Kristin, Sprong, Hein, Knoop, Hans, Vermeeren, Yolande M., van Kooten, Barend, Joosten, Leo A. B., Kullberg, Bart-Jan, Hovius, Joppe W. R., van den Wijngaard, Cees C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6466793/
https://www.ncbi.nlm.nih.gov/pubmed/30987580
http://dx.doi.org/10.1186/s12879-019-3949-8
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author Vrijmoeth, Hedwig D.
Ursinus, Jeanine
Harms, Margriet G.
Zomer, Tizza P.
Gauw, Stefanie A.
Tulen, Anna D.
Kremer, Kristin
Sprong, Hein
Knoop, Hans
Vermeeren, Yolande M.
van Kooten, Barend
Joosten, Leo A. B.
Kullberg, Bart-Jan
Hovius, Joppe W. R.
van den Wijngaard, Cees C.
author_facet Vrijmoeth, Hedwig D.
Ursinus, Jeanine
Harms, Margriet G.
Zomer, Tizza P.
Gauw, Stefanie A.
Tulen, Anna D.
Kremer, Kristin
Sprong, Hein
Knoop, Hans
Vermeeren, Yolande M.
van Kooten, Barend
Joosten, Leo A. B.
Kullberg, Bart-Jan
Hovius, Joppe W. R.
van den Wijngaard, Cees C.
author_sort Vrijmoeth, Hedwig D.
collection PubMed
description BACKGROUND: After antibiotic treatment of Lyme borreliosis, a subset of patients report persistent symptoms, also referred to as post-treatment Lyme disease syndrome. The reported prevalence of persistent symptoms varies considerably, and its pathophysiology is under debate. The LymeProspect study has been designed to investigate the prevalence, severity, and a wide range of hypotheses on the etiology of persistent symptoms among patients treated for Lyme borreliosis in the Netherlands. METHODS: LymeProspect is a prospective, observational cohort study among adults with proven or probable Lyme borreliosis, either erythema migrans or disseminated manifestations, included at the start of antibiotic treatment. During one year of follow-up, participants are subjected to questionnaires every three months and blood is collected repeatedly during the first three months. The primary outcome is the prevalence of persistent symptoms after treatment, assessed by questionnaires online focusing on fatigue (CIS, subscale fatigue severity), pain (SF-36, subscale pain) and neurocognitive dysfunction (CFQ). Potential microbiological, immunological, genetic, epidemiological and cognitive-behavioral determinants for persistent symptoms are secondary outcome measures. Control cohorts include patients with long-lasting symptoms and unconfirmed Lyme disease, population controls, and subjects having reported a tick bite not followed by Lyme borreliosis. DISCUSSION: This article describes the background and design of the LymeProspect study protocol. This study is characterized by a prospective, explorative and multifaceted design. The results of this study will provide insights into the prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis, and may provide a rationale for preventive and treatment recommendations. TRIAL REGISTRATION: NTR4998 (Netherlands Trial Register). Date of registration: 13 February 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12879-019-3949-8) contains supplementary material, which is available to authorized users.
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spelling pubmed-64667932019-04-22 Prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis: study protocol for an observational, prospective cohort study (LymeProspect) Vrijmoeth, Hedwig D. Ursinus, Jeanine Harms, Margriet G. Zomer, Tizza P. Gauw, Stefanie A. Tulen, Anna D. Kremer, Kristin Sprong, Hein Knoop, Hans Vermeeren, Yolande M. van Kooten, Barend Joosten, Leo A. B. Kullberg, Bart-Jan Hovius, Joppe W. R. van den Wijngaard, Cees C. BMC Infect Dis Study Protocol BACKGROUND: After antibiotic treatment of Lyme borreliosis, a subset of patients report persistent symptoms, also referred to as post-treatment Lyme disease syndrome. The reported prevalence of persistent symptoms varies considerably, and its pathophysiology is under debate. The LymeProspect study has been designed to investigate the prevalence, severity, and a wide range of hypotheses on the etiology of persistent symptoms among patients treated for Lyme borreliosis in the Netherlands. METHODS: LymeProspect is a prospective, observational cohort study among adults with proven or probable Lyme borreliosis, either erythema migrans or disseminated manifestations, included at the start of antibiotic treatment. During one year of follow-up, participants are subjected to questionnaires every three months and blood is collected repeatedly during the first three months. The primary outcome is the prevalence of persistent symptoms after treatment, assessed by questionnaires online focusing on fatigue (CIS, subscale fatigue severity), pain (SF-36, subscale pain) and neurocognitive dysfunction (CFQ). Potential microbiological, immunological, genetic, epidemiological and cognitive-behavioral determinants for persistent symptoms are secondary outcome measures. Control cohorts include patients with long-lasting symptoms and unconfirmed Lyme disease, population controls, and subjects having reported a tick bite not followed by Lyme borreliosis. DISCUSSION: This article describes the background and design of the LymeProspect study protocol. This study is characterized by a prospective, explorative and multifaceted design. The results of this study will provide insights into the prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis, and may provide a rationale for preventive and treatment recommendations. TRIAL REGISTRATION: NTR4998 (Netherlands Trial Register). Date of registration: 13 February 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12879-019-3949-8) contains supplementary material, which is available to authorized users. BioMed Central 2019-04-15 /pmc/articles/PMC6466793/ /pubmed/30987580 http://dx.doi.org/10.1186/s12879-019-3949-8 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Vrijmoeth, Hedwig D.
Ursinus, Jeanine
Harms, Margriet G.
Zomer, Tizza P.
Gauw, Stefanie A.
Tulen, Anna D.
Kremer, Kristin
Sprong, Hein
Knoop, Hans
Vermeeren, Yolande M.
van Kooten, Barend
Joosten, Leo A. B.
Kullberg, Bart-Jan
Hovius, Joppe W. R.
van den Wijngaard, Cees C.
Prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis: study protocol for an observational, prospective cohort study (LymeProspect)
title Prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis: study protocol for an observational, prospective cohort study (LymeProspect)
title_full Prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis: study protocol for an observational, prospective cohort study (LymeProspect)
title_fullStr Prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis: study protocol for an observational, prospective cohort study (LymeProspect)
title_full_unstemmed Prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis: study protocol for an observational, prospective cohort study (LymeProspect)
title_short Prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis: study protocol for an observational, prospective cohort study (LymeProspect)
title_sort prevalence and determinants of persistent symptoms after treatment for lyme borreliosis: study protocol for an observational, prospective cohort study (lymeprospect)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6466793/
https://www.ncbi.nlm.nih.gov/pubmed/30987580
http://dx.doi.org/10.1186/s12879-019-3949-8
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