Armstrong A J, Clark J M, Ho D T, Payne C J, Nolan S, Goodes L M, Harvey L A, Marshall R, Galea M P, Dunlop S A
Faculty of Medicine, Dentistry and Health Science, The University of Western Australia, Crawley, Western Australia, Australia.
School of Biological Sciences, The University of Western Australia, Crawley, Western Australia, Australia.
Spinal Cord. 2017 Nov;55(11):994-1001. doi: 10.1038/sc.2017.67. Epub 2017 Jun 20.
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.
To investigate assessor accuracy of neurological classification after spinal cord injury.
Australia and New Zealand.
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.
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.
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.
在2010年至2014年开展的三项多中心随机对照试验(脊髓损伤与身体活动研究,SCIPA)中,对评估者使用国际脊髓损伤神经分类标准(ISNCSCI)的准确性进行回顾性审计,该标准于2011年修订。
调查脊髓损伤后神经分类的评估者准确性。
澳大利亚和新西兰。
在随机分组前,由经过培训的临床医生进行ISNCSCI检查。数据手动记录,ISNCSCI工作表分发给各小组,达成共识并对工作表进行校正。一个审计团队使用2014年的计算机化ISNCSCI算法检查手动工作表。另一个审计团队评估2014年的计算机化算法是否准确反映了2011年前后的ISNCSCI标准。
在208份ISNCSCI工作表中,24份被排除。在其余184份工作表中,47份(25.5%)与2014年的计算机化算法一致,137份(74.5%)包含一个或多个错误。错误存在于运动(30.1%)或感觉(12.4%)平面、部分保留区(24.0%)、运动/感觉评分(21.5%)、美国脊髓损伤协会损伤分级(AIS,8.3%)以及完全/不完全分类(0.8%)。其他困难包括在遗漏肛门收缩/感觉时的分类、神经平面错误以及违反“在不可测试的肌节中运动跟随感觉规则”(7.4%)。小组错误包括校正错误或遗漏,或对正确工作表进行错误更改。
在这种长期临床试验环境中,鉴于手动ISNCSCI工作表存在不准确之处,持续培训和计算机化算法对于确保ISNCSCI的准确评分、分级和分类以及临床试验的可信度至关重要。