Unraveling neurosarcoidosis in The Netherlands: prevalence, diagnostic work-up and treatment

OBJECTIVE: In the Netherlands about 8,000 patients are suffering from sarcoidosis. Between 400-1200 may have any form of neurological involvement. Concrete knowledge on optimal care is lacking. We aim to unravel the prevalence of neurosarcoidosis, it’s various manifestations, and identify best clinical practice in The Netherlands as well international and in the future also worldwide, starting in the USA.. HYPOTHESIS: Nationwide collection of data on neurosarcoidosis, its various manifestations, diagnosis and treatment responses will provide necessary information on presence, prognosis and therapy efficacy in neurosarcoidosis. STUDY DESIGN: A systematic literature review (Phase I). Online data collection at baseline, after 6 months and 1 year (gathered from questionnaires) (Phase II; observational study). Clinical data are collected from the treating physician. Information from Phase I and II will be supplemented and used to evaluate the evidence for the management of neurosarcoidosis according to Delphi consensus methodology that engages sarcoidosis experts worldwide (Phase III). The extracted data will be used to prepare a feasibility study to establish treatment interventions that positively affect patient perceived QOL including perceived function. STUDY POPULATION/DATASET: Patients with probable and confirmed neurosarcoidosis. INTERVENTION: The observational study will provide substantive evidence for the development of recommendations, with emphasis on stratification by manifestation type and on best practice to optimize patient-centered care for neurosarcoidosis patients. The preliminary recommendations would be an immediate tool to support and guide the general clinician through a panel of experts. The recommendations will also provide the basis for a feasibility study. OUTCOME MEASURES: Optimization of the diagnostic work-up and treatment. These will be evaluated by both sarcoidosis-specific and generic QOL measures, reduction of neurosarcoidosis related symptoms, treatment continuation and cessation, and healthcare system utilisation. SAMPLE SIZE: 200 patients with neurosarcoidosis (this number is feasible). DATA ANALYSIS: Linear mixed modelling. Multivariate logistic regression models are used to adjust for differences in baseline characteristics between compared various manifestations. Paired T-test for QOL outcomes. COLLABORATION/CONNECTION: Dr. Elske Hoitsma, Leiden, NL Prof. Dr. Jolanda De Vries, Tilburg University, psychologist, Tilburg, NL Dr. Lesley Ann Saketkoo, New Orleans, USA WASOG : World Association of Sarcoidosis and Other Granulomatous Disorders (www.wasog.org) FSR: Foundation for Sarcoidosis Research, USA (www.stopsarcoidosis.org) TIME SCHEDULE: December 2015-April 2016: optimizing website April 2016-January 2018: study will run. January 2018-October 2018: data analysis and Delphi procedure November 2018-July 2019: implementation new guidelines and initiation of a feasibility study