quantified neurological examination and assessment of Kurtzke s Functional Systems and Expanded Disability Status Scale in Multiple Sclerosis Exposé

Transcription

1 Electronic Scoring Tools data for capture a standardised management neurological system examination for a standardized and quantified neurological examination and assessment of Kurtzke s Functional Systems and Expanded Disability Status Scale in Multiple Sclerosis Neurostatus e-scoring (NESC) Exposé Version 1.0, September 2014

2 Imprint Producer / Contact Neurostatus Systems GmbH Murbacherstrasse Basel, Switzerland contact@neurostatus-systems.net Tel Scientific Lead Prof. Ludwig Kappos, MD Head Neurology & Marcus D Souza, MD University Hospital Neurology 4031 Basel, Switzerland Neurostatus Systems GmbH,

3 Welcome! NESC Admin The NESC ipad Welcome to Neurostatus e-scoring! Neurostatus e-scoring (NESC) introduces advanced electronic data capture technology on the NESC ipad. The system offers real time feedback to the EDSS Rater based on a sophisticated algorithm developed in collaboration with the MS Team of the University Hospital Basel, Switzerland under the guidance of Prof. Ludwig Kappos. Neurostatus e-scoring aims at improving data quality and consistency of EDSS (Expanded Disability Status Scale) assessments in clinical and study environments. The web-based Neurostatus data management application, NESC Admin, is designed to manage administration and monitoring tasks. NESC ipads are synchronized with the Neurostatus Database, providing immediate access to assessment data. The entire system was developed in compliance with GCP and 21 CFR part11 requirements. EDSS training and Neurostatus e-test certification is mandatory for EDSS Raters using the system. The electronic system does not reduce the need to ensure adequate competence for neurological examinations. The following pages provide more detailed information about Neurostatus e-scoring and our company s products and services. Yours Sincerely Franz Schnyder CEO Neurostatus Systems GmbH 3

4 Electronic Data CapturE Left: Data capture on the ipad, examination detail-view with Neurostatus Subscores. Center: Neurostatus Definitions available on the NESC ipad. Right: Requesting feedback based on the NESC Algorithm. Electronic data capture with real-time feedback Neurostatus e-scoring (NESC) offers electronic data capture on the NESC ipad with a sophisticated feedback system. In the first step of the Data Clarification Process (DCF), the Functional System (FS) Scores are checked against the Neurostatus Subscores. The EDSS Step is checked against the FS Scores and the Ambulation Score, according to the Neurostatus Definitions version 04/10.2. Before signing off an assessment on the NESC ipad, the EDSS Rater receives immediate feedback and is able to resolve inconsistencies. The final decision regarding the correct scores remains with the EDSS Rater, who can overrule the algorithm at any stage (providing a reason for the decision to overrule.) As a configurable option, prepopulated scores based on Normal Findings can be provided to speed up the assessment process. 4

5 Data Clarification Screenshot of an online query on NESC Admin, EDSS Rater view. The second step of the Data Clarification Process (DCF) is the EDSS Expert review performed on NESC Admin (the web-based data management system). In a dialog with the EDSS Expert, the EDSS Rater reviews and corrects inconsistent scores in a submitted examination. If a query is raised by the EDSS Expert, the EDSS Rater is automatically notified by . In addition to the algorithm feedback on the NESC ipad, this Data Clarification Process significantly contributes to the high level of data consistency and quality achieved with Neurostatus e-scoring. Traceability EDSS data records captured with the NESC ipad are transferred to NESC Admin. After the verification of the transfer, the EDSS data records are considered a certified copy of the source data and the records on the NESC ipad are deleted. PDFs with an audit trail can be exported for archival purposes. 5

6 Data Management Customized, user-specific notifications on the overview screen, EDSS Rater view. NESC Admin The online platform NESC Admin offers web-based data management, available for EDSS Raters, Study Nurses as well as Study Administrators. The information displayed on the overview page corresponds to individual user profiles and is sent in a weekly report if requested. Depending on the user role, information about the current study course, such as the number of active sites and patients, upcoming examinations, or pending queries is provided. User Management and Access Control Dedicated user roles are configurable as per sponsor s requests. Sophisticated access control determines read/write-permissions and limitations (e.g., blinded raters) for each user profile. All users are required to provide user verification (identity check) during the first login to NESC Admin. Personal login credentials can be used to access all Neurostatus electronic products and services. 6

7 Examination Detail View screen on NESC Admin, Global Study Administrator view. Monitoring and Reporting A real-time list and detailed view of all examinations is accessible at any time. Download of PDF printouts for each assessment is available. Reminders of system events are displayed under Alerts. An extensive logbook displays actions performed by site staff and administrators. Customized reports (e.g., disability progression and study overview) are available for download. 7

8 Products and Services Interactive training for a standardized and quantified neurological examination and assessment of Kurtzke s Functional Systems and the Expanded Disability Status Scale in Multiple Sclerosis The Neurostatus EDSS Training-modules are designed to ensure consistency in EDSS assessments and data capture. In combination with Neurostatus e-scoring on the ipad, Neurostatus EDSS training improves the inter- and intra-rater reliability of EDSS examinations. EDSS Training by an expert of the University Hospital Basel and familiarization with the Neurostatus Training DVD-ROM and Scoring Documents are highly recommended for physicians seeking certification. Interactive test and certification tool for a standardized and quantified neurological examination and assessment of Kurtzke s Functional Systems and the Expanded Disability Status Scale in Multiple Sclerosis Neurostatus e-test is a web-based interactive test and certification tool for physicians interested in using a standardized scoring system for EDSS and its Functional Systems (FS) in multi- or single-center clinical studies. Forum for the discussion of questions on the standardized and quantified neurological examination and assessment of Kurtzke s Functional Systems and the Expanded Disability Status Scale in Multiple Sclerosis The Neurostatus Public Forum provides answers to frequently asked questions regarding EDSS scoring. New questions are periodically answered by the expert team at the University Hospital Basel, Switzerland. 8

9 1 1 1 Scoring tools for a standardized and quantified neurological examination and assessment of Kurtzke's Functional Systems and the Expanded Disability Status Scale in Multiple Sclerosis Scoring Sheet for a standardised, quantified neurological examination and assessment of Kurtzke s Functional Systems and Expanded Disability Status Scale in Multiple Sclerosis STUDY NAME DEMO STUDY SYNOPSIS 1. Visual Ambulation Score PERSONAL INFORMATION 2. Brainstem Patient 3. Pyramidal EDSS Step Date of Birth (04-Jun-1980) Cerebellar Centre Nr/Country Name of EDSS rater 5. Sensory 6. Bowel/Bladder Signature Date of Examination Cerebral 1. VISUAL ( OPTIC ) FUNCTIONS OPTIC FUNCTIONS OD OS Scotoma Visual acuity CC SC * Disc pallor Visual fields 2. BRAINSTEM FUNCTIONS CRANIAL NERVE EXAMINATION Extraocular movements (EOM) impairment Nystagmus Trigeminal damage Facial weakness 3. PYRAMIDAL FUNCTIONS REFLEXES R > < L Biceps Triceps Brachioradialis Knee Ankle Plantar response FUNCTIONAL SYSTEM SCORE Hearing loss Dysarthria Dysphagia Other cranial nerve functions FUNCTIONAL SYSTEM SCORE Knee extensors Plantar flexion (feet/toes) Dorsiflexion (feet/toes) * Position test UE, pronation * Position test UE, downward drift * Position test LE, sinking Cutaneous reflexes * Palmomental reflex LIMB STRENGTH R L Deltoid Biceps Triceps Wrist/finger flexors Wrist/finger extensors Hip flexors Knee flexors * Able to lift only one leg at a time (grade in ) * Walking on heels * Walking on toes * Hopping on one foot SPASTICITY Arms Legs Gait OVERALL MOTOR PERFORMANCE FUNCTIONAL SYSTEM SCORE CC = corrected SC = without correction * = optional part of the examination 1 = converted FS Score The Neurostatus Scoring tools facilitate standardized EDSS assessments on paper and on the ipad, in single- and multi-center trials, medical practices, and MS Centers all over the world. 9

10 System Benefits Highly improved data quality: inconsistencies reduced significantly compared to Paper & Pencil assessments Complete validated and digital Neurostatus/EDSS data records, including footprint approximately three weeks after examination Highly effective Data Clarification Process offers a scientific dialog between EDSS Expert and EDSS Rater Speedy data capture advanced and user friendly interface Real-time feedback on the NESC ipad minimizes the number of queries (DCFs) and allows fast clarification to avoid backlogs Check box on the NESC ipad to indicate a potential relapse Continuous education for EDSS Raters through real-time feedback on the NESC ipad and EDSS Expert interaction during DCF Real-time data monitoring provides permanent overview and access to all data alerts to configurable recipients indicating a potential relapse, before and after DCF To-do section for study personnel offers current view on open tasks Weekly reports on number of patients, examinations, expert reviews, and queries. Customizable and configurable reporting for Study Administrators Configurable data transfer to sponsor s database Last but not least: The Neurostatus products and services constitute a robust all-in-one system and service package, from EDSS Rater training up to validated electronic EDSS data records, developed and maintained by one highly competent team. 10

11 Neurostatus Systems Countries with certified EDSS Raters Countries with certified EDSS Raters using Neurostatus e-scoring Worldwide distribution of Neurostatus services. Neurostatus Systems Neurostatus Systems is based in Switzerland and has been in operation in more than 130 studies for the training and certification of EDSS Raters since Scientific Support Our service is sustained by the ongoing scientific collaboration with the MS Center of the Basel University Hospital, under the guidance of its head Prof. L. Kappos. The implementation of the NESC Algorithm was jointly developed under this institutional support. The center employs EDSS Experts for EDSS training and scientific monitoring. Distribution Neurostatus Systems has issued more than e-test certifications to more than neurologists in over 70 countries and receives around 80 new registrations monthly on Neurostatus.net. Since 2011, clinical trials are increasingly using electronic feedback with the NESC Algorithm to improve data consistency. In August 2013, the first multi national trial started using Neurostatus e-scoring on more than 300 sites in over 30 countries. 11

12 Next Steps For thorough planning of the system setup, we recommend a time-window of six months from first contact to going live. Please contact us for detailed information and further steps: kick-off telephone conference additional documentation live demonstration of Neurostatus e-scoring quotes and agreements. Contact Neurostatus Systems GmbH Murbacherstrasse Basel, Switzerland contact@neurostatus-systems.net Tel