Development and reliability of the AOSpine CROST (Clinician Reported Outcome Spine Trauma): a tool to evaluate and predict outcomes from clinician’s perspective

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

Reliability, validity and responsiveness of the Dutch version of the AOSpine PROST (Patient Reported Outcome Spine Trauma).

PURPOSE To validate the Dutch version of AOSpine PROST (Patient Reported Outcome Spine Trauma). METHODS Patients were recruited from two level-1 trauma centers from the Netherlands. Next to the AOSpine PROST, patients also filled out SF-36 for concurrent validity. Descriptive statistics were used to analyze the characteristics. Content validity was assessed by evaluating the number of inapplicable or missing questions. Also floor and ceiling effects were analyzed. Internal consistency was assessed by calculating Cronbach's α and item-total correlation coefficients (itcc). Spearman correlation tests were performed within AOSpine PROST items and in correlation with SF-36. Test-retest reliability was analyzed using Intraclass Correlation Coefficients (ICC). Responsiveness was assessed by calculating effect sizes (ES) and standardized response mean (SRM). Factor analysis was performed to explore any dimensions within AOSpine PROST. RESULTS Out of 179 enrolled patients, 163 (91.1%) were included. Good results were obtained for content validity. No floor or ceiling effects were seen. Internal consistency was excellent (Cronbach's α = 0.96, itcc 0.50-0.86), with also good Spearman correlations (0.25-0.79). Compared to SF-36, the strongest correlation was seen for physical functioning (0.79; p  1), explaining 65.4% of variance. CONCLUSIONS Very satisfactory results were obtained for reliability, validity and responsiveness of the Dutch version of AOSpine PROST. Treating surgeons are encouraged to use this novel and validated tool in clinical setting and research to contribute to evidence-based and patient-centered care

Reliability and Validity of the English Version of the AOSpine PROST (Patient Reported Outcome Spine Trauma).

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 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

Surgeon Reported Outcome Measure for Spine Trauma an International Expert Survey Identifying Parameters Relevant for The Outcome of Subaxial Cervical Spine Injuries

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.: While an outcome instrument that reflects the patients’ perspective is imperative, there is also a need for a surgeon reported outcome measure (SROM) 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 months - 2 years) and long term (≥2 years), 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, while 5 parameters were identified for the short term. The remaining 6 parameters were not deemed relevant. Minor differences were observed when analyzing the responses according to each world region, or spine surgeons’ degree of experience. CONCLUSIONS.: 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 SROM, which will be a helpful tool in research and clinical practice.Level of Evidence:

Surgeon Reported Outcome Measure for Spine Trauma an International Expert Survey Identifying Parameters Relevant for The Outcome of Subaxial Cervical Spine Injuries

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.: While an outcome instrument that reflects the patients’ perspective is imperative, there is also a need for a surgeon reported outcome measure (SROM) 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 months - 2 years) and long term (≥2 years), 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, while 5 parameters were identified for the short term. The remaining 6 parameters were not deemed relevant. Minor differences were observed when analyzing the responses according to each world region, or spine surgeons’ degree of experience. CONCLUSIONS.: 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 SROM, which will be a helpful tool in research and clinical practice.Level of Evidence:

Development of the AOSpine Patient Reported Outcome Spine Trauma (AOSpine PROST): A universal disease-specific outcome instrument for individuals with traumatic spinal column injury

To report on the multi-phase process used in developing the AOSpine Patient Reported Outcome Spine Trauma (AOSpine PROST), as well as the results of its application in a pilot study. The International Classification of Functioning, Disability and Health (ICF) methodology was used as the basis for the development of this tool. Four preparatory studies and a consensus conference were performed, and resulted in the selection of 25 core ICF categories as well as the scale for use. The first draft of the Dutch version of AOSpine PROST was pilot tested among a consecutively selected representative sample of 25 spine trauma patients, using the 'think aloud' and 'probing' methods. Of the 25 core ICF categories, 9 related to body functions, 14 activities and participation, and 2 environmental factors. Those 25 core categories were implemented into the selected response scale, and resulted in a draft version of AOSpine PROST consisting of 19 items. From the pilot study, very satisfactory results were obtained for comprehensibility, relevance, acceptability, feasibility and completeness, as well as high internal consistency (Cronbach's alpha = 0.926). Following the ICF methodology and including the results of 4 different preparatory studies and a consensus conference, the AOSpine PROST is developed. Taking the results from the subsequent pilot study into account, a definite version to be further validated will be developed. The AOSpine PROST has the potential to be a helpful tool in clinical practice and research to compare various treatments and improve the quality of health care