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Study Design: A single-center validation study. Objective: To translate and cross-culturally adapt the AO Spine PROST (Patient Reported Outcome Spine Trauma) into German, and to test its psychometric properties among German-speaking Swiss spine trauma patients. Methods: Patients were recruited from a level-1 Swiss trauma center. Next to the AO Spine PROST, the EQ-5D-3L questionnaire was used for concurrent validity. Questionnaires were filled out at two-time points for test-retest reliability. Patient characteristics were analyzed using descriptive statistics. For content validity, floor, and ceiling effects, as well as any irrelevant and missing questions were analyzed. Construct validity of the AO Spine PROST questionnaire to the EQ-5D-3L was tested using Spearman correlation tests. Results: The AOSpine PROST was translated and adapted into German using established guidelines. We included 179 patients. The floor effect for all items was well within the optimal range (below 15%), while the ceiling effect of seven items was within the optimal range. None of the items displayed a problematic floor or ceiling effect. The overall test-retest reliability of the total PROST score was excellent, with an ICC of.83 (95% CI.69-.91). The Spearman correlation coefficient between the total PROST summary score and EQ-5D-3 L was ρ =.63. Conclusions: The German version of the AO Spine PROST questionnaire demonstrated very good validity and reliability results. [ABSTRACT FROM AUTHOR]

Purpose: To report on the development of AOSpine CROST (Clinician Reported Outcome Spine Trauma) and results of an initial reliability study. Methods: The AOSpine CROST was developed using an iterative approach of multiple cycles of development, review, and revision including an expert clinician panel. Subsequently, a reliability study was performed among an expert panel who were provided with 20 spine trauma cases, administered twice with 4-week interval. The results of the developmental process were analyzed using descriptive statistics, the reliability per parameter using Kappa statistics, inter-rater rater agreement using intraclass correlation coefficient (ICC), and internal consistency using Cronbach's α. Results: The AOSpine CROST was developed and consisted of 10 parameters, 2 of which are only applicable for surgically treated patents ('Wound healing' and 'Implants'). A dichotomous scoring system ('yes' or 'no' response) was incorporated to express expected problems for the short term and long term. In the reliability study, 16 (84.2%) participated in the first round and 14 (73.7%) in the second. Intra-rater reliability was fair to good for both time points (κ = 0.40–0.80 and κ = 0.31–0.67). Results of inter-rater reliability were lower (κ = 0.18–0.60 and κ = 0.16–0.46). Inter-rater agreement for total scores showed moderate results (ICC = 0.52–0.60), and the internal consistency was acceptable (α = 0.76–0.82). Conclusions: The AOSpine CROST, an outcome tool for the surgeons, was developed using an iterative process. An initial reliability analysis showed fair to moderate results and acceptable internal consistency. Further clinical validation studies will be performed to further validate the tool. [ABSTRACT FROM AUTHOR]

Study Design: International validation study.Objective: To investigate the influence of the spine surgeons' level of experience on the intraobserver reliability of the novel AOSpine Thoracolumbar Spine Injury Classification system, and the appropriate classification according to this system.Summary Of Background Data: Wide variability has been demonstrated for intraobserver reliability of the AOSpine classification system. The spine surgeons' level of experience may play a crucial role in the appropriate classification of thoracolumbar fractures, and the degree of reproducibility of the same observer on separate occasions. However, this has not been previously investigated.Methods: After a training on the classification system, high quality CT images together with clinical data from 25 patients with thoracolumbar fractures were independently assessed by 100 spine surgeons from across the world on 2 different occasions, 1 month apart from each other. The spine surgeons were allocated to a subgroup, according to their years of experience. Intraobserver reliability was calculated for each individual surgeon and for each subgroup, using the Kappa statistics (κ). Descriptive statistics was used to describe any differences between the subgroups. Analysis of any misclassifications was performed by calculating sensitivity and specificity estimates.Results: Almost all surgeons demonstrated at least moderate intraobserver reliability. All surgeon subgroups demonstrated substantial reliability (κ = 0.67-0.69) for fracture subtype grading, and almost all subgroups demonstrated excellent reliability (κ = 0.79-0.83) for fracture morphology type regardless of subtype identified. In general, the fractures were most frequently misclassified by the most experienced surgeons. No major differences were observed among the subgroups when comparing the sensitivity and specificity rates.Conclusion: This international study demonstrated that the spine surgeons' level of experience does not substantially influence the classification and intraobserver reliability of the recently described AOSpine Thoracolumbar Spine Injury Classification System.Level Of Evidence: 4. [ABSTRACT FROM AUTHOR]

Study Design: A systematic literature review.Objective: The aim of this study was (1) to identify patient-reported and clinician-based outcome measures most frequently used to evaluate the function and health of spine trauma patients, (2) to identify and quantify the concepts of these measures using the International Classification of Functioning, Disability, and Health (ICF) as reference, and (3) to describe their clinimetric properties.Summary Of Background Data: There is a real need for a disease-specific outcome instrument to measure the effect size of various treatment options in a variety of traumatic spinal column injuries.Methods: A systematic literature search was conducted in several databases. From the included studies, outcome measures were extracted. The items and underlying concepts of the identified outcome measures were specified and linked to the ICF categories. Finally, as far as available in literature, the clinimetric properties of the obtained measures were analyzed.Results: Out of 5117 screened references, 245 were included, and 17 different frequently used outcome measures were identified. Meaningful concepts of the items and response options of the retrieved outcome measures were linked to a total of 105 different ICF categories, aggregated to 57 first- or second-level categories. The categories were linked to the components activities and participation (n = 31), body functions (n = 17), environmental factors (n = 8), and body structures (n = 1). Overall, there is only limited evidence on the measurement properties, except for some disease-specific questionnaires, such as Oswestry Disability Index, Roland-Morris Disability Questionnaire, Neck Disability Index, and Cervical Spine Outcome Questionnaire.Conclusion: The current systematic literature review revealed great diversity in the use and content of outcome measures to evaluate the functioning and health of spine trauma patients, with 17 different outcome measures linked to 57 unique ICF categories. This study creates an evidence base for a consensus meeting during which a core set of ICF categories for outcome measurement in spine trauma will be decided.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

Study Design. Empirical cross-sectional multicenter study. Objective. To identify the most commonly experienced problems by patients with traumatic spinal column injuries, excluding patients with complete paralysis. Summary of Background Data. There is no disease or condition-specific outcome instrument available that is designed or validated for patients with spine trauma, contributing to the present lack of consensus and ongoing controversies in the optimal treatment and evaluation of many types of spine injuries. Therefore, AOSpine Knowledge Forum Trauma started a project to develop such an instrument using the International Classification of Functioning, Disability and Health (ICF) as its basis. Methods. Patients with traumatic spinal column injuries, within 13 months after discharge from hospital were recruited from 9 trauma centers in 7 countries, representing 4 AOSpine International world regions. Health professionals collected the data using the general ICF Checklist. The responses were analyzed using frequency analysis. Possible differences between the world regions and also between the subgroups of potential modifiers were analyzed using descriptive statistics and Fisher exact test. Results. In total, 187 patients were enrolled. A total of 38 (29.7%) ICF categories were identified as relevant for at least 20% of the patients. Categories experienced as a difficulty/impairment were most frequently related to activities and participation (n = 15), followed by body functions (n = 6), and body structures (n = 5). Furthermore, 12 environmental factors were considered to be a facilitator in at least 20% of the patients. Conclusion. Of 128 ICF categories of the general ICF Checklist, 38 ICF categories were identified as relevant. Loss of functioning and limitations in daily living seem to be more relevant for patients with traumatic spinal column injuries rather than pain during this time frame. This study creates an evidence base to define a core set of ICF categories for outcome measurement in adult spine trauma patients. [ABSTRACT FROM AUTHOR]

Study Design: Cross-sectional validation study.Objective: The aim was to validate the AO Spine Patient-Reported Outcome Spine Trauma (PROST) at a minimum of 12 months posttrauma and to evaluate patient characteristics, types of spine fractures, and treatment strategies as determinants of AO Spine PROST scores.Summary Of Background Data: The reliability and validity of the AO Spine PROST as a measure of health-related quality of life for more than 12 months after onset of spine trauma is unclear.Materials and Methods: Patients with a traumatic spine injury were recruited from a level-1 trauma center. They were asked to complete the AO Spine PROST, EuroQoL 5D-5L (EQ-5D-5L), and either Oswestry disability index (ODI) or neck disability index (NDI) for concurrent validity. Internal consistency was assessed by calculating the Cronbach α and item-total correlation coefficients. Test-retest reliability was evaluated using intraclass correlation coefficients. Spearman correlation tests were performed for the AO Spine PROST in correlation with the EQ-5D-5L, and either ODI or NDI. Determinants for AO Spine PROST score were analyzed using multivariate regression models.Results: A total of 175 patients participated in the cross-sectional arm and 49 in the test-retest arm of the study. Median duration of follow-up was 94.5 months. No floor or ceiling effects were seen. Internal consistency was excellent (α=0.98, item-total correlation coefficient: 0.73-0.91) as well as test-retest reliability (intraclass correlation coefficient=0.81). Satisfactory correlations were seen for the EQ-5D-5L (0.76; P <0.001), ODI (0.69; P <0.001), and NDI (0.68; P <0.001) with the AO Spine PROST. Multivariate linear regression models showed that having ≥1 comorbidities, duration of return to work within the range of 7 to 43 months and no return to work were significant independent determinants for a worse AO Spine PROST score.Conclusions: Very good long-term reliability and validity results were found for the AO Spine PROST. [ABSTRACT FROM AUTHOR]

Study Design: Multicenter validation study.Objective: The aim of this study was to translate and adapt the AOSpine PROST (Patient Reported Outcome Spine Trauma) into English, and test its psychometric properties among North-American spine trauma patients.Summary Of Background Data: In the absence of an outcome instrument specifically designed and validated for traumatic spinal column injury patients, it is difficult to measure the effect size of various treatment options. The AOSpine Knowledge Forum Trauma initiated a project and developed the AOSpine PROST consisting of 19 items.Methods: Patients were recruited from two level-1 North-American trauma centers. For concurrent validity, next to AOSpine PROST also 36-item Short-Form Health Survey (SF-36) was filled out by patients. Patient characteristics were analyzed using descriptive statistics. Floor and ceiling effects as well as the number of inapplicable and missing questions were analyzed for content validity. Cronbach α and item-total correlation coefficients (ITCCs) were calculated for internal consistency. Spearman correlation tests were performed within AOSpine PROST items and in correlation to SF-36. Test-retest reliability was assessed using intraclass correlation coefficients (ICCs). Factor analysis was performed to explore any dimensions within AOSpine PROST.Results: The AOSpine PROST was translated adapted into English using established guidelines. Of 196 enrolled patients, 162 (82.7%) met the inclusion criteria and provided sufficient data. Content validity showed good results, and no floor and ceiling effects were seen. The internal consistency was excellent (Cronbach α = 0.97; ITCC 0.50-0.90) as well as test-retest reliability (ICC = 0.97). Spearman correlations were good (0.29-0.85). The strongest correlations of AOSpine PROST with SF-36 were seen with the physical components (0.69-0.82; P < 0.001). Factor analysis revealed two possible dimensions (Eigen values >1), explaining 75.7% of variance.Conclusion: The English version of AOSpine PROST showed very good validity and reliability. It is considered as a valuable tool, and has the potential to contribute to the reduction of ongoing controversies in spine trauma care.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

Study Design: International web-based survey.Objective: To identify clinical and radiological parameters that spine surgeons consider most relevant when evaluating clinical and functional outcomes of subaxial cervical spine trauma patients.Summary Of Background Data: Although an outcome instrument that reflects the patients' perspective is imperative, there is also a need for a surgeon reported outcome measure to reflect the clinicians' perspective adequately.Methods: A cross-sectional online survey was conducted among a selected number of spine surgeons from all five AOSpine International world regions. They were asked to indicate the relevance of a compilation of 21 parameters, both for the short term (3 mo-2 yr) and long term (≥2 yr), on a five-point scale. The responses were analyzed using descriptive statistics, frequency analysis, and Kruskal-Wallis test.Results: Of the 279 AOSpine International and International Spinal Cord Society members who received the survey, 108 (38.7%) participated in the study. Ten parameters were identified as relevant both for short term and long term by at least 70% of the participants. Neurological status, implant failure within 3 months, and patient satisfaction were most relevant. Bony fusion was the only parameter for the long term, whereas five parameters were identified for the short term. The remaining six parameters were not deemed relevant. Minor differences were observed when analyzing the responses according to each world region, or spine surgeons' degree of experience.Conclusion: The perspective of an international sample of highly experienced spine surgeons was explored on the most relevant parameters to evaluate and predict outcomes of subaxial cervical spine trauma patients. These results form the basis for the development of a disease-specific surgeon reported outcome measure, which will be a helpful tool in research and clinical practice.Level Of Evidence: 4. [ABSTRACT FROM AUTHOR]

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: The 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/setting: The study used a formal decision-making and consensus process.Patient Sample: The sample includes patients with a primary diagnosis of traumatic spinal column injury, excluding completely paralyzed and polytrauma patients.Outcome Measures: The 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.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 non-profit 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, 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.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. [ABSTRACT FROM AUTHOR]