A J Armstrong1,2, J M Clark3, D T Ho1, C J Payne1, S Nolan2,4, L M Goodes2, L A Harvey5, R Marshall3, M P Galea6, S A Dunlop2. 1. Faculty of Medicine, Dentistry and Health Science, The University of Western Australia, Crawley, Western Australia, Australia. 2. School of Biological Sciences, The University of Western Australia, Crawley, Western Australia, Australia. 3. South Australian Spinal Cord Injury Research Centre, Centre for Orthopedics and Trauma Research, Faculty of Health Sciences, The University of Adelaide, Adelaide, South Australia, Australia. 4. Department of Physiotherapy, Royal Perth Hospital, Perth, Western Australia, Australia. 5. John Walsh Centre for Rehabilitation Research, Sydney School of Medicine, University of Sydney & Kolling Institute, Royal North Shore Hospital, St Leonards, New South Wales, Australia. 6. Department of Medicine (Royal Melbourne Hospital), The University of Melbourne, Parkville, Victoria, Australia.
Abstract
STUDY DESIGN: A 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. OBJECTIVES: To investigate assessor accuracy of neurological classification after spinal cord injury. SETTING: Australia and New Zealand. METHODS: ISNCSCI 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. RESULTS: Of 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. CONCLUSION: Given 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.
RCT Entities:
STUDY DESIGN: A 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. OBJECTIVES: To investigate assessor accuracy of neurological classification after spinal cord injury. SETTING: Australia and New Zealand. METHODS: ISNCSCI 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. RESULTS: Of 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. CONCLUSION: Given 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.
Authors: Christian Schuld; Julia Wiese; Andreas Hug; Cornelia Putz; Hubertus J A van Hedel; Martina R Spiess; Norbert Weidner; Rüdiger Rupp Journal: J Neurotrauma Date: 2011-11-07 Impact factor: 5.269
Authors: J D Steeves; D Lammertse; A Curt; J W Fawcett; M H Tuszynski; J F Ditunno; P H Ellaway; M G Fehlings; J D Guest; N Kleitman; P F Bartlett; A R Blight; V Dietz; B H Dobkin; R Grossman; D Short; M Nakamura; W P Coleman; M Gaviria; A Privat Journal: Spinal Cord Date: 2006-12-19 Impact factor: 2.772
Authors: William P Waring; Fin Biering-Sorensen; Stephen Burns; William Donovan; Daniel Graves; Amitabh Jha; Linda Jones; Steven Kirshblum; Ralph Marino; M J Mulcahey; Ronald Reeves; William M Scelza; Mary Schmidt-Read; Adam Stein Journal: J Spinal Cord Med Date: 2010 Impact factor: 1.985