Synopsis
Definition
International GBS Outcome Study (IGOS) is a study of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barré syndrome (GBS).
Study aim
The IGOS aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with GBS, as early as possible after onset of disease.
Study design
A prospective observational international multi-centre study including at least 1000 patients with GBS and a follow-up period of at least one year.
Patients
All patients with GBS and variants of GBS, including Miller Fisher syndrome (MFS) and overlap syndromes, within two weeks of onset of weakness can be included.
Methods
Clinical information will be obtained via a web based data support according to a pre-defined protocol including eight visits: at entry, 1 week, 2 weeks, 4 weeks, 8 weeks, 13 weeks, 26 weeks and 52 weeks. Routine diagnostic electrophysiology data will be collected in the first week and if possible at 4 weeks. Serum samples will be obtained at all eight visits. DNA will be extracted from a single blood sample obtained in the first month. There is an option to participate in two additional research modules:
(1) collect cerebrospinal fluid (CSF) during routine diagnostic work-up for proteomic studies, and
(2) extend the follow-up to two and three years. Additional studies may be added in the future.
Organisation
Participation in IGOS is reserved for neurologists who are a member of the INC or participate in a region or country network lead by a member of the INC. Participants will own, share and use the data for research purposes only. IGOS will be supervised by a Steering Committee and Country and Region coordinators. Expertise Groups will focus on specific research areas, including:
• Prognostic modelling : development of models to predict clinical course and outcome
• Treatment interventions : defining treatment practice, effects and side-effects
• Pharmacokinetics of IVIg : defining serum IgG levels after IVIg in relation to outcome
• Electrophysiology : prognostic relevance of electrophysiological classification
• Preceding events : defining type of infections/vaccinations related to GBS and outcome
• Anti-neural antibodies : characterisation of serum antibodies related to GBS and outcome
• CSF biomarkers : proteomic studies of CSF in relation to GBS and outcome
• Genetic markers : genetic studies to define polymorphisms related to GBS and outcome
• Paediatric GBS : characterisation of clinical course and outcome in children with GBS
• Long-term outcome : residual disability and impact 2 and 3 years after disease onset
• Outcome measures : development of clinical outcome measures to monitor GBS
Expected results
IGOS will result in a large prospective, standardized clinical database and biobank from GBS patients. Expertise Groups will use these data to determine the processes of disease progression and recovery in GBS, to develop prognostic models, conduct selective therapeutic trials and personalize treatment.
Funding
The GBS-CIDP Foundation International has funded the IGOS. Additional funding will be sought.
