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There is no specific measure available for patients with spinal trauma to apply in comparative effectiveness analyses, which contributes to the present lack of consensus and ongoing controversies regarding the optimal treatment and evaluation of many types of spinal injuries. Therefore, the AOSpine Knowledge Forum on Spinal Cord Injury and Trauma initiated a project to develop and validate such an instrument, which includes both the patients' and health professionals' perspective. The International Classification of Functioning, Disability and Health (ICF) is used as the basis. The preparatory phase of this project focused on identifying all potentially meaningful ICF categories for patients with spinal trauma, excluding patients with complete paralysis and patients with polytrauma, from three different perspectives: research, expert, and patient perspective. The results of these studies created the necessary background for a consensus meeting during which a selection of core categories was decided.Material and Methods   The research perspective was covered by a systematic literature review, from 2000 to June 2013, identifying outcome measures focusing on the functioning and health of patients with spinal trauma. The content of these outcome measures was linked to the ICF using established linking rules. The expert perspective was explored through an international cross-sectional web-based survey among spine surgeons from the five AOSpine International world regions. The surgeons were asked to give their opinion on the relevance of a compilation of 143 ICF categories for patients with spinal trauma. The patient perspective was investigated in an international empirical cross-sectional multicenter study, using the general ICF Checklist of 128 categories as a reference.Results   Of 6,415 screened references, 217 were included in the systematic review, and 15 frequently used outcome measures were identified. The content of these measures was linked to 57 different ICF categories. A total of 150 AOSpine International members participated in the expert survey. Of 143 ICF categories included in the survey, 13 were identified as “definitely relevant” by ≥ 80% of the participants. The empirical study, including 187 patients from nine trauma centers in seven countries, yielded 38 ICF categories as the most important for ≥ 20% of the patients. Combining these results, the list of ICF categories presented at the consensus meeting included 157 different ICF categories at the first or second level (44 on the component body functions, 16 on body structures, 64 on activities and participation, and 33 on environmental factors). Overall, 11 experts from six countries attended the consensus meeting. Ultimately, a total of 25 ICF categories were selected for outcome measurement in adult spinal trauma patients. This core set included 9 categories from the component body functions, 14 from activities and participation, and 2 from environmental factors.Conclusion   A formal consensus process integrating evidence and expert opinion led to a core set of ICF categories for outcome measurement in patients with spinal trauma. In future studies, the Patient Reported Outcome under development will be subjected to further validation and cross-cultural adaptation.

Toward the Development of an International Disease-Specific Outcome Instrument for Spinal Trauma