Neurostatus Systems AG

Neurostatus
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PLEASE NOTE: Since the beginning of August 2016 all Neurostatus products and services are operated and maintained by the Department of Neurology at the University Hospital Basel UHBS. Contact the UHBS also for a Licence to capture and validate electronic Neurostatus/EDSS examination data.

Neurostatus services cover the whole lifecycle of the Neurostatus/EDSS scale for use in clinical trials including EDSS rater training and online certification as well as EDSS Expert data review and a scientific forum for Q&A.

NEUROSTATUS/EDSS TRAINING

In order to improve the consistency both between different examining physicians (inter-rater reliability) and between different examinations by the same physician (intra-rater reliability), the Neurostatus/EDSS-training method was developed.

This training program consists of EDSS Expert face to face and telephone trainings provided by Neurologists of the University Hospital Basel and is accompanied by the Neurostatus Training DVD Rom. Standardised neurological examinations of several MS patients were recorded and incorporated into this educational and instructional tool. The videos have been used worldwide to train more than 10’000 Neurostatus/EDSS raters participating in many multi-centre studies conducted around the world in the last 20 years.

Both inter- and intra-rater reliability are improved by this training method (Lechner-Scott et al., 1998). The improvement in rater reliability is very important to help in reaching maximal statistical power of clinical trials.

ONLINE CERTIFICATION

Neurostatus e-Test is the industry-leading online certification platform for physicians using the Neurostatus/EDSS Scale within clinical trials. It provides transferrable certification for all major clinical MS and NMO trials.

The platform hosts more than 70 active trials and served more than 130 clinical trials since 2003. Up to date about 10’000 Neurostatus/EDSS raters are certified on our platform.

SCORING DOCUMENTS AND ELECTRONIC DATA CAPTURE

The Neurostatus Scoring Documents have been developed and improved since the 1980’s and are now available in version 04/10.2. The printed version of the Scoring Sheets can be used for assessments in paper based trials and as a backup solution for trials using Neurostatus e-Scoring.

The most powerful way to capture Neurostatus/EDSS patient records within clinical trials is the usage of Neurostatus e-Scoring. The mobile electronic data capture system improves data quality significantly by using implemented feedback and data clarification functionality supported by the Neurostatus e-Scoring Algorithm. A validation study proved the efficiency and efficacy of the iPad based data capture application, which is accompanied by a web based data management application.

Neurostatus Systems provides the e-Scoring system as a validated Software as a Service (SaaS) solution. Study setup, system training and technical support processes are available to make the implementation of the system for the clinical trial management as easy as possible.

EXPERT REVIEW AND FORUM

The University Hospital Basel (UHBS), Department of Neurology, chaired by Prof. L. Kappos provides the services around the scientific expertise to successfully conduct clinical trials. This includes the data clarification processes in Neurostatus e-Scoring and the public forum. The Neurostatus public forum provides answers regarding Neurostatus/EDSS scoring. 

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Poster presentation at Ectrims in Boston

Our scientific partner Marcus D'Souza, MD, of the University Hopital Basel presented a poster about the validation study of the Neurostatus e-Scoring Algorithm. The following article has been published by "Neurology Reviews", September 15, 2014:

Automating and Improving the EDSS—Validation of the eEDSS

BOSTON—An electronic version of the Expanded Disability Status Scale (EDSS), the eEDSS, an algorithm-based, tablet-driven tool, is superior to the standard paper version in providing consistent assessments, according to the results of a validation study presented at the 2014 Joint ACTRIMS/ECTRIMS Meeting.

“By reducing noise, the eEDSS should have a positive impact on the accuracy of individual assessments and statistical power in clinical trials,” said Marcus D’Souza, MD, from the Department of Neurology, University Hospital, Basel, Switzerland, and colleagues.

The EDSS is the most widely used disability rating scale in multiple sclerosis (MS), but has been criticized for its low reliability. To improve reliability, a standardized version of the EDSS (Neurostatus) was established during the last two decades and is used in most major clinical studies, including many of the pivotal trials for regulatory approval of MS drugs.

To further improve EDSS reliability, Dr. D’Souza and colleagues developed the electronic capturing and real-time feedback EDSS (eEDSS), an algorithm-based evaluation performed with a tablet computer (iPad). The eEDSS provides immediate feedback, based on the Neurostatus definitions, indicating inconsistencies in the scoring of parts of the neurologic examination, functional systems, ambulation score, and EDSS. The final decision on the correct scores remains with the physician, who can overrule the algorithm. To validate their tool, the researchers compared results obtained with the standardized EDSS paper version (pEDSS) and the eEDSS.

Three certified EDSS raters who received training in the use of the eEDSS examined 100 patients with MS with varying degrees of neurologic deficits. Each patient was assessed twice. The first rater began by using the pEDSS and then switched to the eEDSS after seeing a third of the study population. In parallel, the second EDSS rater assessed the same patients on the same day using the eEDSS and switched accordingly. pEDSS and eEDSS were compared for the frequency of inconsistencies in the assignment of the functional systems, ambulation score, and EDSS using generalized mixed-effects models and the exact McNemar test. Calculation of functional system scores based on Neurostatus Subscores were then checked by a third EDSS rater who was blinded for type of assessment, EDSS examiner, and patient.

For all examined end points, errors were more likely when using the pEDSS compared with using the eEDSS. Examiners were three times as likely to make an error of any type when using the pEDSS compared with using eEDSS (odds ratio, 2.93). Functional systems errors were more likely when pEDSS was used compared with eEDSS (odds ration 2.54). Errors were much more likely to occur for patients with low EDSS scores (3.5 or lower) than for those with high EDSS scores (3.5 or higher), with an odds ratio of 5.32. Errors in calculation of functional systems after exclusion of the cerebral functional system were much more likely when pEDSS was used compared with eEDSS (odds ratio 3.107). Ambulation score errors and EDSS errors were rare (five and eight, respectively) and not statistically significant between the pEDSS and eEDSS.

Glenn S. Williams

Copyright © 2014 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.