Successful International Collaborations (European EMSCI) - Clinician Perspective R. Rupp, M. Schubert
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1 52nd Annual Scientific Meeting of the International Spinal Cord Society, Istanbul, Turkey, Successful International Collaborations (European EMSCI) - Clinician Perspective R. Rupp, M. Schubert
2 Aims of the EMSCI-consortium Setup of a clinical database and infrastructure for interventional studies (Anti-Nogo, Novartis; stem cells, Stem Cell Inc.) Introduction of a standardized assessment scheme including examination and follow-up time schedule Establishment of a comprehensive database for quantification of recovery within first year after SCI Merging of individual data bases of several centers to a common, central database Possibility of statistical analysis of a large number of datasets in respect to prognosis, trends, benchmarking etc. Curt A, Schwab ME, Dietz V, Spinal Cord 42(1), 2004
3 Overview of EMSCI centers Nijmegen Heidelberg Garches Bayreuth Zürich State 6/ Supported by the Int. foundation for research in paraplegia (IFP) ( ) and Wings for Life ( )
4 Overview of EMSCI centers Glasgow Hamburg Amsterdam Nijmegen Halle Hess.-Licht. Bochum Bad Wildungen Heidelberg Frankfurt Garches Karlsbad Tübingen Ulm Nottwil Murnau Zürich Sion Bayreuth Prag Barcelona State 3/2013 Toledo Supported by the Int. foundation for research in paraplegia (IFP) ( ) and Wings for Life ( )
5 Standardized multicenter assessment ASIA Impairment ASIA light touch ASIA pin prick ASIA motor WISCI Timed up and go 10m Test 6min Test SCIM II SSEP MEP MNCV Standardized assessment of - neurological, - neurophysiological and - functional status of individuals after acute - traumatic or - ischemic + Time Schedule for 1 year follow-up Days after Injury SCI Five, in relation to date of injury fixed assessment periods (2, 4, 12, 24, 48 weeks)
6 Course of spontaneous recovery Data from (03/13) patients available Maximal neurological recovery in first 3 month Functional improvements delayed to neurological recovery (rehabilitation) Different patterns of recovery depending on lesion level Curt A, Van Hedel HJ, Klaus D, Dietz V, EM-SCI Study Group: Recovery from a spinal cord injury: significance of compensation, neural plasticity, and repair, J Neurotrauma 25(6), , 2008.
7
8 Overview EMSCI datasets Number of EMSCI datasets ( > in dark blue) Patients ASIA LT ASIA PP ASIA MS SCIM23 WISCI TUG 10m 6min per per SEP MEP NCV Schmerz Pain Overall 2,855 patients (10/13) documented
9 Introduction of core sets 100% ExamStages in CoreSets N(Total Sets) = % 80% 70% 60% 50% 40% missing done 30% 20% % 0% CoreSet: very acute acute I acute II acute III chronic complete datasets of at least one early and one late assessment of ISNCSCI, SCIM III, 10m-WalkingTest, WISCI II
10 Introduction of core sets
11 Number of core sets
12 Overview of EMSCI-centers 21 EMSCI-centers 15 active* centers (8 D, 2 CH, 2 ES, 1 UK, 1 NL 1 CZ) Bad Wildungen - Barcelona - Bayreuth - Glasgow - Halle - Heidelberg Hessisch-Lichtenau - Langensteinbach - Murnau - Nijmegen Nottwil - Prague - Toledo - Ulm - Zürich 6 passive centers Bochum - Garches Sion Tübingen Frankfurt Hamburg 1 future center Rome * Active centers provide core sets of more than 5 patients per year
13 Incentives for clinicians Financial compensation per complete core set (until 2009) Datasets needed for specific research question available on request in active centers Project management gives approval to specific research questions EMSCI-Study group as coauthor in publications mainly based on EMSCI-data (Co-)authorship of PIs / staff of the 4 centers providing the majority of datasets used for the specific publication
14 Incentives for clinicians
15 Maintaining a high level of data quality Processes within the project Processes within the centers Documentation Documentation Feedback of data manager Feedback of centers Internal center feedback
16 Motivation for certification of the EMSCI network Merging of single databases with an equivalent quality standard Establishment of a common quality management within the network Improvement of data quality with the aim of 100% error-free data or at least maintaining the level of quality with less resources Optimal management of the interface between participating centers Transparency of processes, responsibilities and decisions between the coordinating centers and the participating centers (Additional) Quality criterion in publications
17 Quality in EMSCI is, when the sponsors come back and not the data!
18 Maintaining data quality - electronic EMSCI-database Personal data Scheduling Reports Assessment data Structured entry of patient and tests data Online-plausability check of data Scheduling functions Identification of missing tests data Freezing of datasets Standard reports Designed for multicenter use De-centralized data storage and automated export of anonymized datasets Data archiving and administration in coordination center Rupp R., Schweidler J., Curt A., Dietz V., Gerner H.J.: An electronic tool for multi-center administration, assessment and analysis of clinical trials in spinal cord injury, Biomed Tech 50, Suppl 1, Part 2, , 2005
19 Computational algorithm for ISNCSCI classification Computational algorithm for determination of - Neurological Level (NL) - Motor levels (ML) - Sensory levels (SL) - Zones of Partial Preservation (ZPPs) - Complete/ Incomplete - Impairment Scale (AIS)
20 Maintaining data quality internal quality control Regular (at least annually, better quaterly) reports from central EMSCI-database coordinator Regular internal audits Continuous plausibility checks
21 Maintaining data quality - exchange of information Annual regular EMSCI-newsletter Annual EMSCI-meeting with presentations about current state and progress in data acquisition and research results and ideas Regular (2x-3x per year) ISNCSCI instructional courses in Heidelberg Analysis of ISNCSCI Pre-Post-Tests N= Schuld et al.: Effect of formal training in scaling, scoring and classification of the International Standards for Neurological Classification of Spinal Cord Injury, Spinal Cord 51,
22 Exchange of network experience Results of the EMSCI ISNCSCI/ASIA Instructional Courses Nov ISNCSCI instructional courses in HD Percentage of correct answers 100,00% 90,00% 80,00% Results of the EMSCI ISNCSCI/ASIA Instructional Courses Jan ,00% 100,00% 60,00% 90,00% 50,00% 80,00% 40,00% 70,00% 100,00% (n=10) 30,00% 60,00% 90,00% 20,00% 50,00% 80,00% 10,00% 40,00% 70,00% 0,00% 30,00% 60,00% AIS Completeness Motor Levels Motor ZPPs Sensory Levels Sensory ZPPs 20,00% 50,00% Pre Test 44,17% 65,00% 28,33% 77,92% 38,33% 75,42% Post Test 84,17% 10,00% 40,00% 98,33% 75,00% 91,67% 97,50% 90,00% 0,00% 30,00% AIS Completeness 20,00% Motor Levels Motor ZPPs Sensory Levels Sensory ZPPs Percentage of correct answers Percentage of correct answers Results of the EMSCI ISNCSCI/ASIA Instructional Courses May 2012 Pre Test 41,25% 10,00% 71,25% 45,00% 72,50% 68,75% 71,25% Post Test 86,25% 98,75% 0,00% 79,38% 88,75% 98,75% 91,88% AIS Completeness Motor Levels Motor ZPPs Sensory Levels Sensory ZPPs Pre Test 48,75% 93,75% 40,63% 48,13% 86,25% 46,25% Post Test 90,00% 100,00% 81,25% 97,50% 98,75% 96,88% Schuld C, Wiese J, Franz S, Putz C, Stierle I, Smoor I, Weidner N; EMSCI Study Group, Rupp R.: Effect of formal training in scaling, scoring and classification of the International Standards for Neurological Classification of Spinal Cord Injury, Spinal Cord 51(4):282-8, 2013
23 Exchange of network experience ISNCSCI instructional courses in HD Precentage of correct answers [%] ASIA Impairment Scale Motor Levels Nov 11 Jan 12 May 12 Nov 12 Feb 13 Apr 13 Determination of Motor Levels and distinction between ASIA B vs. ASIA C or D seem to be most difficult Constant improvement through revised content of the course and handouts
24 Center satisfaction survery 2 2 Center satisfaction survey quality management 3 2,8 2,6 2,4 2,2 2 1,8 1,6 1,4 grade (1-4) mean and SD 1,2 1 1,8 1,8 1,6 1,6 3 2,8 2,6 2,4 2,2 2 1,8 1,6 Center satisfaction survey quality management Info/Newsletter Info newsletter Info/ Homepage Info/ Annual Meeting Info homepage customer service ASIA course Info homepage customer service Neurophys. course Info annual meeting 1,4 grade (1-4) mean and SD 1,4 1,4 1, ,8 2,6 3 2,4 2,8 2,2 2 2, , , ,6 Newsletter 1,4 2,2 Homepage 1,2 2 Center satisfaction survey quality management grade (1-4) mean and SD Info annual meeting ASIA course Neurophys. course 1 Info newsletter customer service ASIA course Neurophys. course Reply from 14 centers Best ranked: ISNCSCI-courses (1.23) Worst ranked: annual meeting (1.92) 1,8 1,6 1,4 1,2 1 Center satisfaction survey quality management Newsletter Homepage annual meeting customer service ISNCSCI- Courses Overall Note (1-4) Mittelwert und Standardabweichung Grade Grade 1,2 1, Newsletter Homepage
25 Thanks to all contributing to EMSCI!
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