{"title":"Spine Wars: The Lessons of YODA.","authors":"Jens Chapman","doi":"10.1055/s-0033-1360453","DOIUrl":"https://doi.org/10.1055/s-0033-1360453","url":null,"abstract":"With this editorialmessage, Iwould like to encourage asmanyof our global interdisciplinary readers of 10,000—and moreover, PubMed readers—to pull the referenced articles below, and after privately reading them,discuss them inyour journal clubs, grand rounds, and scientificmeetings. The implications of the readings relate to howwe conduct our evidence evaluations as presented in published medical literature. Without wanting to sound overly dramatic, I do believe that we may have witnessed with these publications a cataclysmic change in the way prospective clinical science and trials in general—specifically, in spine—will be conducted and reported in the future. The topic of bone morphogenic protein has surely been a most contentious subject. Questions of patient safety (cancer risk, heterotopic bone formation, neuritis, dysphagia, and others) have been raised and the actual likelihood of these possible complications have been previously discussed here in EBSJ1 and in many other publications. It is not an exaggeration to speak of a “war” waged in the arena of academic publications and the court of public opinions through public media. To form your own opinion, I ask you to study the articles of Simmonds et al,2 and Fu et al,3 which are closely related to the much-anticipated results of the Yale University OpenData Access study (YODA)4 published in the June issue of the Annals of Medicine. The gist of my editorial message is, however, not focused on the merits of bone morphogenic protein, but rather on the bigger picture of how to conduct large-scale clinical research going forward. One of the main conclusions of the authors and commentators was that open data reporting for major clinical trials would have been preferable to avoid concerns about selective reportingof potentially important clinical findings.5,6 As shown by the open publication of this data in full cooperation with its industrial sponsor (Medtronic, Inc., Minneapolis, United States), the YODA publications2,3 resulted in a general call to conduct all future clinical trials with full data transparency and opportunity for data sharing among qualified investigators. This would signal a major departure from the traditional proprietaryand secrecy-cloaked nature, not only of industrysponsored research, but also any form of funded, clinical trialstype research, while also requiring a review of applicable patient privacy laws, as some patient identifierswill invariably become more apparent. However we look at it, the forces YODA has unleashedmay be truly transformational; it will be interesting to see how in the future, possibly contentious device-, technique-, or medication-based trials will be structured in light of this very noteworthy publication series. As always, I welcome your opinions in this interesting turn of events in the field of evidence-based medicine.","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"4 2","pages":"67"},"PeriodicalIF":0.0,"publicationDate":"2013-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0033-1360453","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32039848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Asking the right question: specifying your study question.","authors":"Annie L Raich, Andrea C Skelly","doi":"10.1055/s-0033-1360454","DOIUrl":"https://doi.org/10.1055/s-0033-1360454","url":null,"abstract":"The most important step in conducting a high-quality research study is to create a study question that will provide the guidance for the planning, analysis, and reporting of your study. The process of generating a novel, answerable study question seems like it should be simple at first blush. Perhaps your keen interest in a particular topic sparks an idea for a study that starts the creative process of hypothesizing and wondering “what if.” It is a wonderful experience to witness or be caught up in the joys of such a process. Finding inspiration for a study may, however, be a challenge, and the study idea emerges, instead, with time after thoughtful consideration of a topic. In either scenario, in order for you to design and execute your study, honing your idea and hypothesis into questions that can be realistically studied is required, adding a level of complexity to what at first seemed simple. \u0000 \u0000Creating the final study question is a formal and iterative process: You create an initial study question by answering questions, defining parameters, getting feedback from colleagues, and conducting a limited literature search. Then you refine your question and define major aspects of your study by using a Patients, Intervention, Comparison, and Outcomes (PICO) table for treatment and diagnostic studies, or a Patients, Prognostic factors, and Outcomes (PPO) table for prognostic studies. By taking the time to complete these steps, you will have a good structure for your research study and will be able to proceed to the next part, a literature review.","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"4 2","pages":"68-71"},"PeriodicalIF":0.0,"publicationDate":"2013-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0033-1360454","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32039849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Varun Puvanesarajah, Ioan A Lina, Jason A Liauw, Wesley Hsu, Peter C Burger, Timothy F Witham
{"title":"Desmoid Tumor Formation following Posterior Spinal Instrumentation Placement.","authors":"Varun Puvanesarajah, Ioan A Lina, Jason A Liauw, Wesley Hsu, Peter C Burger, Timothy F Witham","doi":"10.1055/s-0033-1357356","DOIUrl":"https://doi.org/10.1055/s-0033-1357356","url":null,"abstract":"<p><p>Study Design Case report. Objective The objective of the article is to illustrate a case of desmoid tumor (DT) formation after posterior instrumentation of the thoracic spine. Methods A 57-year-old woman presented with lower extremity clumsiness, balance, and ambulation difficulty resulting from spinal cord compression due to an upper thoracic atypical vertebral hemangioma. Ten months after undergoing embolization, resection, and placement of instrumentation for this lesion, the patient developed a growing mass at the rostral end of the incision. Biopsy revealed desmoid fibromatosis. The mass was removed via an en bloc resection. Histology revealed an infiltrative DT above the laminectomy site abutting the instrumentation. Results At 2-year follow-up, there was no evidence of recurrence of the tumor. Conclusion Paraspinal DTs have been reported in the literature to develop after surgical procedures of the spine. Often times, patients attribute swelling or fullness at the site of their surgery to scar tissue formation or instrumentation. One must consider the possibility of a DT in the setting of reported surgical site fullness or mass after spine surgery. It is thought that postoperative inflammation present in the surgical bed may promote formation of DTs. Instrumentation may also contribute to inflammation and increase the likelihood of developing a DT. Generous margins must be taken to prevent recurrence. </p>","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"4 2","pages":"137-42"},"PeriodicalIF":0.0,"publicationDate":"2013-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0033-1357356","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32040882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael Q Potter, Brandon D Lawrence, Daniel V Kinikini, Darrel S Brodke
{"title":"Periaortic pedicle screw removal with endovascular control of the aorta and intraoperative aortography: a case report and review of the literature.","authors":"Michael Q Potter, Brandon D Lawrence, Daniel V Kinikini, Darrel S Brodke","doi":"10.1055/s-0033-1357358","DOIUrl":"https://doi.org/10.1055/s-0033-1357358","url":null,"abstract":"<p><p>Study Design Case report and review of the literature. Objective The objective of the article is to report the case of a 20-year-old patient with a threatened aortic injury from pedicle screw instrumentation successfully managed without aortic grafting. Methods The patient's clinical course is retrospectively reviewed. The offending hardware was removed after gaining endovascular control of the aorta. Results Intraoperative aortography was normal and no graft was placed. The patient remains asymptomatic at 2 years after surgery. Conclusions Hardware impinging on the aorta can safely be removed by gaining endovascular control of the aorta. In the setting of normal intraoperative aortography in a young patient, we recommend against further intervention to avoid the known morbidity of aortic grafting. </p>","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"4 2","pages":"149-53"},"PeriodicalIF":0.0,"publicationDate":"2013-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0033-1357358","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32040884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Definition of Classes of Evidence (CoE) and Overall Strength of Evidence (SoE).","authors":"","doi":"10.1055/s-0033-1363168","DOIUrl":"https://doi.org/10.1055/s-0033-1363168","url":null,"abstract":"Cohort studies follow individuals with the exposure of interest over time and monitor for occurrence of the outcome of interest. Applies to cohort studies only. Authors must consider other factors that might influence patient outcomes and should control for them if appropriate. A good case-control study must have the all of the following: all incident cases from the defined population over a specified time period, controls that represent the population from which the cases come, exposure that precedes an outcome of interest, and accounting for other prognostic factors. A good cross-sectional studymust have all of the following: a representative sample of the population of interest, an exposure that precedes an outcome of interest (e.g., sex, genetic factor), an accounting for other prognostic factors, and for surveys, at least a 80% return rate. A case-series design for prognosis is one where all the patients in the study have the exposure of interest. Since all the patients have the exposure, risks of an outcome can be calculated only for those with the exposure, but cannot be compared with those who do not have the exposure. For example, a case-series evaluating the effect of smoking on spine fusion that only recruits patients who smoke can simply provide the risk of patients who smoke that result in pseudarthrosis but cannot compare this risk to those that do not smoke.","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"4 2","pages":"167"},"PeriodicalIF":0.0,"publicationDate":"2013-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0033-1363168","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32038560","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comments on: Efficacy of Bracing versus Observation in the Treatment of Idiopathic Scoliosis (Evid Based Spine Care J 2011;2(2):25-34).","authors":"Dietrich Schlenzka, Timo Yrjoenen","doi":"10.1055/s-0033-1357352","DOIUrl":"https://doi.org/10.1055/s-0033-1357352","url":null,"abstract":"As enthusiastic readers of EBSJ, we thank the authors for the immense work they have done in tackling a difficult and important topic.1 In general, we agree with their conclusions. We also support their call for more reliable evidence. And we share the hope of the editors that large studies currently on the way in North America will provide it. \u0000 \u0000There are, however, two points in their article we are wondering about. \u0000 \u0000The first one is the inclusion of the work by Mannherz et al. According to the inclusion criteria, only publications dealing with adolescent idiopathic scoliosis should be considered. The article by Mannherz et al, however, is reporting on patients with juvenile idiopathic scoliosis. This is declared in the title of the article with the patients' mean age being 7 years. \u0000 \u0000The second point is related to the “Illustrative Case.” This leaves several questions. What is the purpose of the authors having selected this case? Fig. 3 shows a lumbar curve of approximately 44 degrees with marked apical rotation and a thoracic curve of approximately 43 degrees with minimal rotation. No further data are provided (Skeletal age? Menarchal status? Risser grade?). In our opinion, the majority of surgeons using braces would have said at this point that a successful outcome of bracing is very unlikely because the curve magnitude is beyond the generally accepted indication criteria. Provided that the patient would have a significant amount of growth left, some would possibly have started bracing immediately. To wait for further progression and to start bracing 6 months later (lumbar curve 48 degrees, apical rotation increased, Fig. 4) seems very strange. Continuation of bracing at the age of 15 years (lumbar curve 64 degrees, Fig. 7) is also difficult to understand. \u0000 \u0000Necessary core conditions for successful brace treatment are satisfactory in-brace correction and patient compliance. No reliable data are given on that. In the text, it is said that the patient was “extremely compliant.” How was this measured? \u0000 \u0000Unfortunately, both points raised by us skew the picture into the direction of a more nihilistic attitude toward bracing. This could give the reader the wrong impression of possible bias. For the sake of the reputation of the journal, this should be avoided by all means.","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"4 2","pages":"165"},"PeriodicalIF":0.0,"publicationDate":"2013-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0033-1357352","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32038558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Brad A Culotta, Donald A Deinlein, Steven M Theiss, Jack E Lemons
{"title":"An extension-distraction injury of the thoracic spine with traumatic partial correction of thoracic kyphosis.","authors":"Brad A Culotta, Donald A Deinlein, Steven M Theiss, Jack E Lemons","doi":"10.1055/s-0033-1347132","DOIUrl":"https://doi.org/10.1055/s-0033-1347132","url":null,"abstract":"<p><p>Study Design The study is a case report. Objective The authors aim to report an unusual injury pattern in a patient previously treated for thoracic kyphoscoliosis. Methods A postoperative (computed tomography) CT of a healthy 24-year-old man who underwent posterior instrumentation and fusion for a kyphoscoliosis deformity was compared with a CT performed after a motor vehicle accident (MVA) 1 year later, which resulted in an extension-distraction injury of T8 with no neurologic deficit. Cobb angles of the thoracic sagittal images of both CTs were measured using a digital measuring device and the values were recorded. Results Initial postoperative sagittal CT images demonstrate a 67-degree residual thoracic kyphosis compared with the post-MVA sagittal CT images, which reveal a 54-degree thoracic kyphosis, a 13-degree improvement in sagittal alignment. Conclusion It is unusual for a patient with long posterior instrumentation of the spine to sustain a spinal fracture without breakage of the rods, which were 6-mm nickel-titanium alloy with two crosslinks. Although sustaining plastic deformation, the rods maintained their integrity to the degree that the patient required no subsequent treatment to his spine at 12 months follow-up. It is rare to sustain a vertebral fracture without implant failure, which occurred in this case. </p>","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"4 2","pages":"126-31"},"PeriodicalIF":0.0,"publicationDate":"2013-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0033-1347132","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32040880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Micah W Smith, Prokopis Annis, Brandon D Lawrence, Michael D Daubs, Darrel S Brodke
{"title":"Early proximal junctional failure in patients with preoperative sagittal imbalance.","authors":"Micah W Smith, Prokopis Annis, Brandon D Lawrence, Michael D Daubs, Darrel S Brodke","doi":"10.1055/s-0033-1357366","DOIUrl":"https://doi.org/10.1055/s-0033-1357366","url":null,"abstract":"<p><p>Study Type Retrospective review. Introduction Sagittal imbalance has been associated with lower health-related quality of life outcomes, and restoration of imbalance is associated with improved outcomes.123 The long constructs used in adult spinal deformity have potential consequences such as proximal junctional kyphosis (PJK). Clinically, the development of PJK may not be as important as failure of the construct or vertebrae at the proximal end. As PJK does not lead to worse clinical outcomes,45 we define the term early proximal junctional failure (EPJF) as fracture, implant failure, or myelopathy due to stenosis at the upper instrumental vertebra (UIV) or UIV + 1 within 6 months of surgery. Objective The purpose of this study is to report the incidence of EPJF in patients who are sagittally imbalanced preoperatively and to identify risk factors postoperatively that correlate with EPJF using commonly reported sagittal balance parameters. Methods We reviewed 197 patients with preoperative sagittal imbalance by at least one of the following: sagittal vertical axis more than 5 cm, global sagittal alignment more than 45 degrees, pelvic incidence-lumbar lordosis more than 10 degrees, or spine-sacral angle less than 120 degrees. Radiographic measurements also included proximal junctional angle, thoracic kyphosis, lumbar lordosis, pelvic parameters, and sagittal balance parameters/formulas, as well as UIV angle, UIV spinosacral angle, and UIV plumb line to assess as potential risk factors. EPJF incidence was calculated postoperatively for each of the accepted sagittal balance parameters/formulas. Results EPJF was observed in 49 of 197 patients (25%) with preoperative sagittal imbalance and was more common in fusions with UIV in the lower thoracic spine (TS) (35%) than in those with UIV in the upper TS (10%) or lumbar (25%) (p = 0.007). Of the 49 EPJF patients, 16 patients (33%) required revision surgery within the first year, for an overall early revision rate of 8%. The incidence of EPJF was no different in patients with or without postoperative sagittal balance. No parameter/formula was more sensitive than another in predicting EPJF. Conclusions The incidence of EPJF (25%) is greater in this sagittally imbalanced group than previously reported for adult deformity patients, occurring most often when the UIV is in the lower TS. Sagittal balance correction was not correlated with change in incidence of EPJF. Despite the high incidence, the early revision rate within the first year is low. </p>","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"4 2","pages":"163-4"},"PeriodicalIF":0.0,"publicationDate":"2013-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0033-1357366","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32038557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Robert P Norton, Kristina Bianco, Virginie Lafage, Frank J Schwab
{"title":"Complications and intercenter variability of three-column resection osteotomies for spinal deformity surgery: a retrospective review of 423 patients.","authors":"Robert P Norton, Kristina Bianco, Virginie Lafage, Frank J Schwab","doi":"10.1055/s-0033-1357364","DOIUrl":"https://doi.org/10.1055/s-0033-1357364","url":null,"abstract":"<p><p>Study Type Retrospective review of a prospectively collected multicenter database. Introduction Three-column resection osteotomies (3CO), including pedicle subtraction osteotomies and vertebral column resections are performed for correction of sagittal deformity; however, they have high rates of reported complications. This study examined the incidence and intercenter variability of major intraoperative complications (IOC), postoperative complications (POC), and overall complications (IOC + POC) up to 6 weeks postoperation. Objective The aim of the study is to examine the incidence and intercenter variability of major complications associated with 3CO. Patients and Methods A retrospective review of patients with 3CO from eight different sites was performed. The incidence and types of complications were determined for the study population (N = 423). The analysis compared patients with one (n = 391) and two (n = 32) osteotomies, as well as patients with a thoracic osteotomy (ThO) (n = 72) versus a lumbosacral osteotomy (LSO) (n = 319) of the spine. Subsequent analysis was performed to compare sites with low-osteotomy volumes (< 50 patients) to sites with large osteotomy volumes (more than 50 patients). Major blood loss (MBL) was defined as more than 4L. Results Of the 423 patients, the incidence of major IOC, POC, and overall complications was 28, 45, and 58%, respectively (Table 1). The most common major IOC was MBL (24%) and the most common POC was unplanned return to the operating room (OR) (19%). Other IOC included cord deficit (2.6%), pneumothorax (1.5%), large vessel injury (1.7%), nerve root injury (1.4%), and cardiac arrest (0.2%). Other POC included motor deficit (12.1%), deep infection (7.6%), acute respiratory distress/failure (4.7%), deep venous thrombosis (3.1%), pulmonary embolism (2.8%), arrhythmia (1.2%), reintubation and sepsis (0.7%), cauda equine syndrome, myocardial infarction, visual deficit, stroke (0.5%), and death (0.2%). Patients with one 3CO had significantly less POC (43 vs. 69%, p < 0.01) and overall complications (57 vs. 75%, p < 0.01) than patients with two 3CO (Fig. 1). IOC, MBL, and return to the OR were not significantly different between groups. Patients with ThO had significantly more POC (66 vs. 39%, p < 0.01) and overall complications (76 vs. 53%, p < 0.001) than patients with LSO. Patients with LSO had more MBL (25 vs. 14%, p = 0.04). Patients with ThO had more unplanned return to OR (41 vs. 14%, p < 0.001) (Fig. 2). The incidence of IOC was greater for the low-volume sites than high-volume sites (46 vs. 23%, p < 0.001). Low-volume sites had a higher frequency of patients with MBL than high-volume sites (45 vs. 18%, p < 0.001) (Fig. 3). Patients who experienced MBL had a significantly longer operating time (p < 0.001) and a higher risk of developing other IOC, POC, and overall complications (OR = 2.18, 1.51, 1.63, respectively) than patients who did not experience substantial blood loss. Conclusions The o","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"4 2","pages":"157-9"},"PeriodicalIF":0.0,"publicationDate":"2013-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0033-1357364","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32040886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A validated classification for external immobilization of the cervical spine.","authors":"Micha Holla, Joske M R Huisman, Allard J F Hosman","doi":"10.1055/s-0033-1357353","DOIUrl":"https://doi.org/10.1055/s-0033-1357353","url":null,"abstract":"<p><p>Study Design Interobserver and intraobserver reliability study. Objective The aim of this study is to validate a new classification system of external cervical spine immobilization devices by measuring the interobserver and intraobserver agreement. Methods A classification system, with five main categories, based on the anatomical regions on which the device supports, was created. A total of 28 independent observers classified 50 photographs of different devices, designed to immobilize the cervical spine according to the new proposed classification system. At least 2 weeks later, the same devices were classified again in a new random order. Before and after the classification, all the participants answered questions about the usefulness of the proposed classification. Results The mean interobserver and intraobserver agreement Fleiss' kappa was 0.88 and 0.91, respectively. Both are, according to the interpretation described by Landis and Koch, \"almost perfect.\" A majority of the participators answered that they needed a classification (89%) and considered the classification to be clear (96%). All the participants considered the classification to be useful in clinical practice. Conclusion This study showed that the new classification of external cervical spine immobilizers, based on anatomical support areas, has an excellent interobserver and intraobserver agreement. Furthermore, the study participants considered the proposed classification to be clear and useful in clinical practice. As the majority of patients with cervical spine injuries are treated with external immobilization devices, this new classification system can improve the closed treatment of cervical spine injuries in daily clinical practice. Furthermore, it makes reproducible comparisons between groups possible, which are essential for further evolution of evidence-based spine care. </p>","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"4 2","pages":"72-7"},"PeriodicalIF":0.0,"publicationDate":"2013-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0033-1357353","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32039850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}