BACKGROUND CONTEXT: There 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.
PURPOSE: 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 traumatic spinal column injury patients. STUDY DESIGN/SETTING: A formal decision-making and consensus process. PATIENT SAMPLE: Patients with traumatic spinal column injury as primary diagnosis, excluding completely paralyzed and poly-trauma patients. OUTCOME MEASURES: The wide array of function and health status of traumatic spinal column injury patients was explored through the identification of all potentially meaningful ICF categories.
METHODS: A 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 nonprofit organization. The AOSpine Knowledge Forums are pathology focused working groups acting on behalf of AOSpine in their domain of scientific expertise.
RESULTS: Combining 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, eleven experts from six 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.
CONCLUSIONS: A 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.