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Randomized Controlled Trial Multicenter Study
Achieving assessor accuracy on the International Standards for Neurological Classification of Spinal Cord Injury.
- A J Armstrong, J M Clark, D T Ho, C J Payne, S Nolan, L M Goodes, L A Harvey, R Marshall, M P Galea, and S A Dunlop.
- Faculty of Medicine, Dentistry and Health Science, The University of Western Australia, Crawley, Western Australia, Australia.
- Spinal Cord. 2017 Nov 1; 55 (11): 994-1001.
Study DesignA retrospective audit of assessor accuracy using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) in three multicentre randomised controlled trials (SCIPA: Spinal Cord Injury and Physical Activity) spanning 2010-2014 with standards revised in 2011.ObjectivesTo investigate assessor accuracy of neurological classification after spinal cord injury.SettingAustralia and New Zealand.MethodsISNCSCI examinations were undertaken by trained clinicians prior to randomisation. Data were recorded manually and ISNCSCI worksheets circulated to panels, consensus reached and worksheets corrected. An audit team used a 2014 computerised ISNCSCI algorithm to check manual worksheets. A second audit team assessed whether the 2014 computerised algorithm accurately reflected pre- and post-2011 ISNCSCI standards.ResultsOf the 208 ISNCSCI worksheets, 24 were excluded. Of the remaining 184 worksheets, 47 (25.5%) were consistent with the 2014 computerised algorithm and 137 (74.5%) contained one or more errors. Errors were in motor (30.1%) or sensory (12.4%) levels, zone of partial preservation (24.0%), motor/sensory scoring (21.5%), ASIA Impairment Scale (AIS, 8.3%) and complete/incomplete classification (0.8%). Other difficulties included classification when anal contraction/sensation was omitted, incorrect neurological levels and violation of the 'motor follows sensory rule in non-testable myotomes' (7.4%). Panel errors comprised corrections that were incorrect or missed or incorrect changes to correct worksheets.ConclusionGiven inaccuracies in the manual ISNCSCI worksheets in this long-term clinical trial setting, continued training and a computerised algorithm are essential to ensure accurate scoring, scaling and classification of the ISNCSCI and confidence in clinical trials.
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