The Danish Multiple Sclerosis Registry Published in Brain and Behavior on October 30, 2020
All three researchers obtained Neurostatus certification before data collection . To calculate time to EDSS 6, we included all patients who had reached EDSS 6 and where we knew the year of EDSS 6. We also included those with an updated EDSS in the past 2 years ( n = 1702) and patients with a known EDSS below four in the last 6 years ( n = 180).
Statistical Analysis Page 10 of 44 The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. Treatments and assessments are determined by the treating neurologist and dictated by clinical practice and available guidelines. A steering committee decides on the data analysis. Participating neurologists are all members of the BSGMS and have expertise in treating MS patients and have EDSS-neurostatus certification. neurologist who had appropriate Neurostatus certification training. EDSS is performed only in MS patients and ranges from 0 to 10, higher val-ues indicate greater disability. The Multiple Sclerosis Severity Score (MSSS) was calculated from the EDSS and duration of disease for each patient using the algorithms provided by Background Clinical trials established the efficacy and safety of natalizumab.
It provides transferrable certification for all major clinical MS and NMO trials. NeuroStatus • A modification of the original Kurtzke scale by Kappos • Eliminates some ambiguities • In general use in clinical trials • On-line training & certification • Basis for this session NeuroStatus Quality of EDSS assessment is monitored by Neurostatus certification of investigators. Informed consent (as required by local laws and regulations) is provided by each participant in MSBase. At each contributing center the project has Human Research Ethics Committee approval or exemption. Neurostatus-EDSS The Neurostatus-EDSS (EDSS-NS) is a mainstay for clinical trials in Multiple Sclerosis , as an essential endpoint to assess and monitor level of disability over time. This intricate neurological exam includes assessment of seven Functional Systems and Ambulation, with determination of a final EDSS step score. Neurostatus e-Test is the industry-leading online certification platform for physicians using the Neurostatus/EDSS Scale within clinical trials.
Note: After January 2006 only the Neurostatus Training DVD-ROM will be delivered. Neurostatus.net. Independent Platform for training and certification of physicians participating in projects that use a standardised, quantified neurological examination and assessment of Kurtzke’s Functional Systems and the Expanded Disability Status Scale in Multiple Sclerosis.
expertise in treating MS patients and have EDSS-neurostatus certification. •. Participation is on a voluntary basis. •. Steering committee from the BSGMS decides
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Disability was measured using the EDSS, with neurostatus certification required at each participating center to improve the reliability of clinical disability assessment. 24 Relapse was defined as the occurrence of new symptoms or exacerbation of existing symptoms persisting for at least 24 hours, in the absence of concurrent illness or fever
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Neurostatus e-Test is a web-based interactive test and certification tool for physicians who are interested in using a standardised scoring system for the Expanded Disability Status Scale (EDSS) and its Functional Systems (FS) in the context of multi-centre or single centre clinical studies. Neurostatus scoring documents In order to assure high reliability of assessment, it is essential to have a standardised examinations and consistent definitions for the Functional System scores. It is highly recommended that physicians seeking certification first become familiarised with the Neurostatus Scoring Documents or equivalent case report forms for the respective study. Since 2004, Neurostatus e-Test has been used worldwide to certify EDSS Raters participating in MS and NMO studies conducted around the world. The certification process ensures that the EDSS Raters are familiar with the Definitions of Neurostatus/EDSS before examining patients in clinical practice and capturing data with the Neurostatus Scoring Documents or the NESC iPad .
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Neurostatus e-Test is a web-based interactive test and certification tool for physicians who are interested in using a standardised scoring system for the Expanded Disability Status Scale (EDSS) and its Functional Systems (FS) in the context of multi-centre or single centre clinical studies. The Steering Committee of each study will decide which level is needed for a successful Neurostatus Qualification. Level A = passing 30 of a possible 50 points: Allows re-certification for studies requiring Level A Qualification. Level B = passing 34 of a possible 50 points: Allows re-certification for studies requiring Level A or B Qualification. Investigators who have a valid e-Test Qualification on Neurostatus.net can be automatically re-certified for additional studies.
Misidentification occurred equally across participants with and without an MS diagnosis. Download : Download high-res image (474KB) Download : Download full-size image; Figure 1. All three researchers obtained Neurostatus certification before data collection . To calculate time to EDSS 6, we included all patients who had reached EDSS 6 and where we knew the year of EDSS 6.
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For certification as a blinded coordinator for the TREAT-MS trial, the MSFC manual and training videos for the MSFC components, low contrast vision testing and the SDMT should be reviewed followed by the completion of an attestation form. I. Read the MSFC manual. II. Watch the following five videos
Participating neurologists are all members of the BSGMS and have expertise in treating MS patients and have EDSS-neurostatus certification. Neurostatus-EDSS. The Neurostatus-EDSS (EDSS-NS) is a mainstay for clinical trials in Multiple Sclerosis, as an essential endpoint to assess and monitor level of disability over time.This intricate neurological exam includes assessment of seven Functional Systems and Ambulation, with determination of a final EDSS step score.