• Said Sadiqi, A Mechteld Lehr, Marcel W Post, Wilco C H Jacobs, Bizhan Aarabi, Jens R Chapman, Robert N Dunn, Marcel F Dvorak, Michael G Fehlings, S Rajasekaran, Luiz R Vialle, Alexander R Vaccaro, and F Cumhur Oner.
• Department of Orthopaedics, University Medical Center Utrecht, HP G05.228, P.O. Box 85500, 3508GA Utrecht, The Netherlands. Electronic address: s.sadiqi-3@umcutrecht.nl.
• Spine J. 2016 Aug 1; 16 (8): 962-70.

Background ContextThere is no outcome instrument specifically designed and validated for spine trauma patients without complete paralysis, which makes it difficult to compare outcomes of different treatments of the spinal column injury within and between studies.PurposeThe paper aimed to report on the evidence-based consensus process that resulted in the selection of core International Classification of Functioning, Disability, and Health (ICF) categories, as well as the response scale for use in a universal patient-reported outcome measure for patients with traumatic spinal column injury.Study Design/SettingThe study used a formal decision-making and consensus process.Patient SampleThe sample includes patients with a primary diagnosis of traumatic spinal column injury, excluding completely paralyzed and polytrauma patients.Outcome MeasuresThe wide array of function and health status of patients with traumatic spinal column injury was explored through the identification of all potentially meaningful ICF categories.MethodsA formal decision-making and consensus process integrated evidence from four preparatory studies. Three studies aimed to identify relevant ICF categories from three different perspectives. The research perspective was covered by a systematic literature review identifying outcome measures focusing on the functioning and health of spine trauma patients. The expert perspective was explored through an international web-based survey among spine surgeons from the five AOSpine International world regions. The patient perspective was investigated in an international empirical study. A fourth study investigated various response scales for their potential use in the future universal outcome instrument. This work was supported by AOSpine. AOSpine is a clinical division of the AO Foundation, an independent medically guided non-profit organization. The AOSpine Knowledge Forums are pathology-focused working groups acting on behalf of AOSpine in their domain of scientific expertise.ResultsCombining the results of the preparatory studies, the list of ICF categories presented at the consensus conference included 159 different ICF categories. Based on voting and discussion, 11 experts from 6 countries selected a total of 25 ICF categories as core categories for patient-reported outcome measurement in adult traumatic spinal column injury patients (9 body functions, 14 activities and participation, and 2 environmental factors). The experts also agreed to use the Numeric Rating Scale 0-100 as response scale in the future universal outcome instrument.ConclusionsA formal consensus process integrating evidence and expert opinion led to a set of 25 core ICF categories for patient-reported outcome measurement in adult traumatic spinal column injury patients, as well as the response scale for use in the future universal disease-specific outcome instrument. The adopted core ICF categories could also serve as a benchmark for assessing the content validity of existing and future outcome instruments used in this specific patient population.Copyright © 2016 Elsevier Inc. All rights reserved.

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