Prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis: study protocol for an observational, prospective cohort study (LymeProspect)
Abstract 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...
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-04-01
|
| Series: | BMC Infectious Diseases |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12879-019-3949-8 |
| _version_ | 1818245471933562880 |
|---|---|
| author | Hedwig D. Vrijmoeth Jeanine Ursinus Margriet G. Harms Tizza P. Zomer Stefanie A. Gauw Anna D. Tulen Kristin Kremer Hein Sprong Hans Knoop Yolande M. Vermeeren Barend van Kooten Leo A. B. Joosten Bart-Jan Kullberg Joppe W. R. Hovius Cees C. van den Wijngaard |
| author_facet | Hedwig D. Vrijmoeth Jeanine Ursinus Margriet G. Harms Tizza P. Zomer Stefanie A. Gauw Anna D. Tulen Kristin Kremer Hein Sprong Hans Knoop Yolande M. Vermeeren Barend van Kooten Leo A. B. Joosten Bart-Jan Kullberg Joppe W. R. Hovius Cees C. van den Wijngaard |
| author_sort | Hedwig D. Vrijmoeth |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-12T14:33:27Z |
| format | Article |
| id | doaj.art-e3e96edd91884fe4877425766b36d429 |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-12-12T14:33:27Z |
| publishDate | 2019-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-e3e96edd91884fe4877425766b36d4292022-12-22T00:21:26ZengBMCBMC Infectious Diseases1471-23342019-04-011911910.1186/s12879-019-3949-8Prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis: study protocol for an observational, prospective cohort study (LymeProspect)Hedwig D. Vrijmoeth0Jeanine Ursinus1Margriet G. Harms2Tizza P. Zomer3Stefanie A. Gauw4Anna D. Tulen5Kristin Kremer6Hein Sprong7Hans Knoop8Yolande M. Vermeeren9Barend van Kooten10Leo A. B. Joosten11Bart-Jan Kullberg12Joppe W. R. Hovius13Cees C. van den Wijngaard14Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical CenterDepartment of Internal Medicine, Division of Infectious Diseases & Center for Experimental and Molecular Medicine, Amsterdam UMC, University of AmsterdamNational Institute for Public Health and Environment (RIVM), Center for Infectious Disease ControlLyme Center Apeldoorn, Gelre HospitalDepartment of Internal Medicine, Division of Infectious Diseases & Center for Experimental and Molecular Medicine, Amsterdam UMC, University of AmsterdamNational Institute for Public Health and Environment (RIVM), Center for Infectious Disease ControlNational Institute for Public Health and Environment (RIVM), Center for Infectious Disease ControlNational Institute for Public Health and Environment (RIVM), Center for Infectious Disease ControlDepartment of Medical Psychology, Amsterdam UMC, University of AmsterdamLyme Center Apeldoorn, Gelre HospitalLyme Center Apeldoorn, Gelre HospitalDepartment of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical CenterDepartment of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical CenterDepartment of Internal Medicine, Division of Infectious Diseases & Center for Experimental and Molecular Medicine, Amsterdam UMC, University of AmsterdamNational Institute for Public Health and Environment (RIVM), Center for Infectious Disease ControlAbstract 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.http://link.springer.com/article/10.1186/s12879-019-3949-8Lyme diseaseBorreliosisErythema MigransBorreliaPersistent symptomsPost-treatment Lyme disease syndrome |
| spellingShingle | Hedwig D. Vrijmoeth Jeanine Ursinus Margriet G. Harms Tizza P. Zomer Stefanie A. Gauw Anna D. Tulen Kristin Kremer Hein Sprong Hans Knoop Yolande M. Vermeeren Barend van Kooten Leo A. B. Joosten Bart-Jan Kullberg Joppe W. R. Hovius Cees C. van den Wijngaard Prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis: study protocol for an observational, prospective cohort study (LymeProspect) BMC Infectious Diseases Lyme disease Borreliosis Erythema Migrans Borrelia Persistent symptoms Post-treatment Lyme disease syndrome |
| 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 | Lyme disease Borreliosis Erythema Migrans Borrelia Persistent symptoms Post-treatment Lyme disease syndrome |
| url | http://link.springer.com/article/10.1186/s12879-019-3949-8 |
| work_keys_str_mv | AT hedwigdvrijmoeth prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT jeanineursinus prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT margrietgharms prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT tizzapzomer prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT stefanieagauw prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT annadtulen prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT kristinkremer prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT heinsprong prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT hansknoop prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT yolandemvermeeren prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT barendvankooten prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT leoabjoosten prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT bartjankullberg prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT joppewrhovius prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect AT ceescvandenwijngaard prevalenceanddeterminantsofpersistentsymptomsaftertreatmentforlymeborreliosisstudyprotocolforanobservationalprospectivecohortstudylymeprospect |