{"title":"Class or level of evidence: epidemiologic basis.","authors":"Joseph Dettori","doi":"10.1055/s-0032-1327804","DOIUrl":"https://doi.org/10.1055/s-0032-1327804","url":null,"abstract":"Class of evidence (CoE) is a hierarchical rating system used by EBSJ and most major scientific publications for classifying the overall quality of an individual study. It is a shortcut to identifying what is likely the best (or worst) evidence on a given topic. The “classes” range from I to IV with “CoE I” representing the highest level of evidence, and “CoE IV” representing the lowest level. Assigning a CoE to an individual article is an attempt to provide the reader with a relative assessment of the research study's risk of bias; that is, the likelihood that the results of the study are influenced by various biases rather than the intervention. This article intends to open the eyes of its readership to the many potential confounders and to look behind the claims of CoE 1. \u0000 \u0000Common sources of bias EBSJ considers when critically appraising a study include: \u0000 \u0000 \u0000Patient selection and allocation of treatment \u0000 \u0000 \u0000Intention-to-treat analysis \u0000 \u0000 \u0000Blind or independent assessment for important outcomes \u0000 \u0000 \u0000Co-interventions applied equally to study groups \u0000 \u0000 \u0000Patient follow-up rate of less than 85% \u0000 \u0000 \u0000Adequate sample size \u0000 \u0000 \u0000Controlling for possible confounding \u0000 \u0000 \u0000 \u0000Patient selection and allocation of treatment \u0000How patients are selected and allocated for treatment in a clinical study of efficacy and safety is paramount. Ideally, patients are selected based on chance to protect against selection bias and confounding.1 That is why a randomized controlled trial (RCT) is considered the best study design in reducing the risk of bias and achieving a high CoE. It is possible, however, when one conducts an RCT, to still introduce bias into the allocation process. How? Bias can be introduced by allowing those who enroll patients into a study to have access to upcoming assignments. Having access gives the enroller knowledge of the next assignment that could then influence whether a patient is included or excluded based on perceived prognosis. Therefore, care must be taken to ensure that the allocation of the patient to a particular treatment group is concealed; in other words, that the implementation of the random allocation sequence occurs without prior knowledge of treatment assignment.2 Some argue that RCTs that do not provide for proper allocation concealment overestimate the effect of a treatment as much as 30%–40%.3 In the critical appraisal process, one should evaluate whether the allocation was concealed. If it is not reported, be suspicious of potential bias.","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"3 3","pages":"9-12"},"PeriodicalIF":0.0,"publicationDate":"2012-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0032-1327804","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31334060","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 case of cervical metastases in a patient with preexisting cervical disc replacement and fusion after 2-year symptom-free interval: when do we need interdisciplinary diagnostics?","authors":"Markus Melloh, Thomas Barz","doi":"10.1055/s-0032-1327810","DOIUrl":"https://doi.org/10.1055/s-0032-1327810","url":null,"abstract":"<p><p>Recurrent cervical symptoms frequently occur after cervical disc replacement and fusion. To date, no algorithm for the diagnostic assessment of these symptoms has been established. We present a case report and review of the literature to illustrate the need for interdisciplinary diagnostics in recurrent cervicobrachialgia without pathological cervical imaging. The hospital chart, medical history, physical examination, and imaging of a single patient were reviewed. A 53-year-old man with preexisting cervical disc replacement and fusion presented with a new episode of cervicobrachialgia after a 2-year symptom-free interval. Cervical magnetic resonance imaging (MRI) showed no pathological findings. Six months later the patient reported increasing symptoms including numbness and weakness of the right arm. Repeated cervical MRI and thoracic computed tomography revealed cervical metastases with intraspinal tumor growth and an underlying extensive small cell bronchial carcinoma. In recurrent cervicobrachialgia, without pathological cervical imaging, interdisciplinary diagnostics are needed. Basic diagnostic tests may assist to exclude severe non-vertebrogenic pathologies.</p>","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"3 3","pages":"51-6"},"PeriodicalIF":0.0,"publicationDate":"2012-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0032-1327810","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31334063","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}
Anoushka Singh, Lindsay Tetreault, Michael G Fehlings, Dena J Fischer, Andrea C Skelly
{"title":"Risk factors for development of cervical spondylotic myelopathy: results of a systematic review.","authors":"Anoushka Singh, Lindsay Tetreault, Michael G Fehlings, Dena J Fischer, Andrea C Skelly","doi":"10.1055/s-0032-1327808","DOIUrl":"https://doi.org/10.1055/s-0032-1327808","url":null,"abstract":"<p><strong>Study design: </strong> Systematic review.</p><p><strong>Study rationale: </strong> Cervical spondylotic myelopathy (CSM) is a common cause of spinal cord dysfunction that may be asymptomatic or may present with severe symptoms. Since CSM has an insidious manifestation, identification of risk factors associated with this condition may aid clinicians in monitoring high-risk patients and implementing appropriate management strategies.</p><p><strong>Objective: </strong> To assess sociodemographic, clinical, radiographic, and genetic risk factors associated with presence of CSM in patients 18 years or older.</p><p><strong>Methods: </strong> A systematic review of the literature was performed using PubMed, the National Guideline Clearinghouse Databases, and bibliographies of key articles to assess risk factors associated with CSM. Articles were reviewed by two independent reviewers based on predetermined inclusion and exclusion criteria. Each article was evaluated using a predefined quality-rating scheme.</p><p><strong>Results: </strong> From 486 citations, eight articles met all inclusion and exclusion criteria. Larger vertebral body and smaller spinal canal and Torg/Pavlov ratio were associated with CSM diagnosis, while gender was not associated with a CSM diagnosis across multiple studies. There were inconsistent reports with respect to increased age as a risk factor for CSM diagnosis.</p><p><strong>Conclusion: </strong> The limited data available suggests that inherent anatomical features that may contribute to congenital cervical stenosis may be associated with CSM. This systematic review is limited by the small number of high-quality studies evaluating prognostic factors for CSM. The overall strength of evidence for all risk factors evaluated is low.</p>","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"3 3","pages":"35-42"},"PeriodicalIF":0.0,"publicationDate":"2012-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0032-1327808","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31334061","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}
Giuseppe M V Barbagallo, Emily Yoder, Joseph R Dettori, Vincenzo Albanese
{"title":"Percutaneous minimally invasive versus open spine surgery in the treatment of fractures of the thoracolumbar junction: a comparative effectiveness review.","authors":"Giuseppe M V Barbagallo, Emily Yoder, Joseph R Dettori, Vincenzo Albanese","doi":"10.1055/s-0032-1327809","DOIUrl":"https://doi.org/10.1055/s-0032-1327809","url":null,"abstract":"<p><strong>Study design: </strong> Comparative effectiveness review.</p><p><strong>Objective: </strong> To determine the comparative effectiveness and safety of percutaneous minimally invasive versus open spine surgery for fractures of the thoracolumbar junction.</p><p><strong>Methods: </strong> A systematic review of the English-language literature was undertaken for articles published between 1970 and March 15, 2012. Reference lists of key articles were also systematically checked. We attempted to identify all articles that reported on the effectiveness and/or safety comparing minimally invasive surgery (MIS) with open surgery for thoracolumbar fractures in the adult population. Articles containing hematological or neoplastic fractures primarily were excluded. Other exclusions included reviews, editorials, case series, non-English-language written studies, and animal studies. We rated the overall body of evidence using a modified Grades of Recommendation Assessment, Development and Evaluation (GRADE) system for diagnostic and therapeutic studies.</p><p><strong>Results: </strong>• Two studies (Level of Evidence III) met our inclusion criteria. • Radiographic outcomes were similar between treatment groups. • Postoperative incisional pain was less in patients undergoing percutaneous MIS. • Patient function as assessed by the Hannover Spine Score, the SF-36 and the MacNab criteria were slightly higher in the percutaneous minimally invasive group, but not statistically significant. • Percutaneous MIS resulted in less blood loss and shorter length of hospital stay than open surgery. • No complications were reported using percutaneous MIS.</p><p><strong>Conclusion: </strong> Limited data suggest that percutaneous techniques are associated with less postoperative pain, less blood loss, a shorter hospital stay, and a slightly better functional outcome. However, concerns remain on the effectiveness of percutaneous techniques in correcting spinal deformity and achieving bony fusion. Further studies are needed to verify these preliminary findings.</p>","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"3 3","pages":"43-9"},"PeriodicalIF":0.0,"publicationDate":"2012-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0032-1327809","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31334062","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":"Obesity and early reoperation rate after elective lumbar spine surgery: a population-based study.","authors":"Cinzia Gaudelli, Ken Thomas","doi":"10.1055/s-0031-1298613","DOIUrl":"https://doi.org/10.1055/s-0031-1298613","url":null,"abstract":"<p><strong>Study design: </strong> Population-based retrospective cohort study.</p><p><strong>Clinical question: </strong> Are patients with a body mass index (BMI) of 35 or more who undergo elective lumbar spine surgery at increased risk of post-surgical complications, as evidenced by reoperation within a 3-month period?</p><p><strong>Methods: </strong> The Alberta Health and Wellness Administrative database was queried to identify patients who underwent elective lumbar spine surgery over a 24-month period. This same database was used to classify subjects as obese (BMI ≥35) and non-obese (BMI <35) and to determine who underwent repeated surgical intervention. The rate of reoperation was determined for both the obese and non-obese groups; further analyses were performed to determine whether certain subjects were at increased risk of reoperation.</p><p><strong>Results: </strong> The point estimate for relative risk for requiring reoperation was 1.73 (95% confidence interval, 1.03-2.90) for obese subjects compared with non-obese subjects. The adjusted point estimate shows that deformity correction surgery is predictive for early reoperation while obesity is not.</p><p><strong>Conclusions: </strong> In obese subjects we observed an increased complication rate after elective lumbar spine surgery, as evidenced by reoperation rates within 3 months. When we considered other possible associations with reoperation, in adjusted analysis, deformity surgery was found to be predictive of early reoperation.Final class of evidence-prognosisSTUDY DESIGNProspective CohortRetrospective Cohort•Case controlCase seriesMETHODSPatients at similar point in course of treatment•F/U ≥ 85%•Similarity of treatment protocols for patient groups•Patients followed up long enough for outcomes to occur•Control for extraneous risk factorsOverall class of evidenceIIIThe definiton of the different classes of evidence is available on page 55.</p>","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"3 2","pages":"11-6"},"PeriodicalIF":0.0,"publicationDate":"2012-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0031-1298613","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31114478","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}
Erik P Severson, Dmitri A Sofianos, Amy Powell, Michael Daubs, Rakesh Patel, Alpesh A Patel
{"title":"Spinal fractures in recreational bobsledders: an unexpected mechanism of injury.","authors":"Erik P Severson, Dmitri A Sofianos, Amy Powell, Michael Daubs, Rakesh Patel, Alpesh A Patel","doi":"10.1055/s-0031-1298617","DOIUrl":"https://doi.org/10.1055/s-0031-1298617","url":null,"abstract":"<p><strong>Study design: </strong> Retrospective case series and literature review.</p><p><strong>Objective: </strong> To report and discuss spinal fractures occurring in recreational bobsledders.</p><p><strong>Summary of background data: </strong> Spinal fractures have been commonly described following traumatic injury during a number of recreational sports. Reports have focused on younger patients and typically involved high-impact sports or significant injuries. With an aging population and a wider array of recreational sports, spinal injuries may be seen after seemingly benign activities and without a high-impact injury.</p><p><strong>Methods: </strong> A retrospective review of two patients and review of the literature was performed.</p><p><strong>Results: </strong> Two patients with spinal fractures after recreational bobsledding were identified. Both patients, aged 57 and 54 years, noticed a simultaneous onset of severe back pain during a routine turn on a bobsled track. Neither was involved in a high-impact injury during the event. Both patients were treated conservatively with resolution of symptoms. An analysis of the bobsled track revealed that potential forces imparted to the rider may be greater than the yield strength of vertebral bone.</p><p><strong>Conclusions: </strong> Older athletes may be at greater risk for spinal fracture associated with routine recreational activities. Bobsledding imparts large amounts of force during routine events and may result in spinal trauma. Older patients, notably those with osteoporosis or metabolic bone disease, should be educated about the risks associated with seemingly benign recreational sports.</p>","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"3 2","pages":"43-8"},"PeriodicalIF":0.0,"publicationDate":"2012-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0031-1298617","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31114482","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":"Commentary.","authors":"Bellabarba Carlo","doi":"10.1055/s-0032-1330921","DOIUrl":"https://doi.org/10.1055/s-0032-1330921","url":null,"abstract":"Case Sara, a 23-year-old woman, was admitted to the transplant service with early-onset idiopathic pulmonary fibrosis, neutropenia and anemia. Both her mother and brother were affected with the same disorder. Her mother died several years ago, ventilated in the intensive care unit (ICU); a death Sara describes as horrible. After witnessing the death of her mother, Sara said repeatedly \" I will never die that way \". As a result she appointed her aunt power of attorney for personal care. Her brother had a successful transplant 3 years ago and is known to the transplant team. Sara has now deteriorated with possible community-acquired pneumonia (cultures negative to date) and is hypotensive. In discussion with the transplant team Sara says she wants a transplant, but refuses ventilation. Her last words to the ICU team before intubation are: \" No don't put the tube down … I don't want it … I don't want to die like my mother … please, no \". On the night that Sara's condition deteriorated, the decision to intubate was made by the ICU resident with support from the transplant team. After 10 days, the patient remains unstable on increasing ventilatory support. The family is insistent on continuing treatment despite the earlier wishes of Sara. The transplant team assures the family that Sara can be maintained indefinitely on ventilation and they can perform the transplant unless she gets an infection. The ICU team is experiencing growing tension, as their efforts to maintain life support are increasingly difficult with little hope of survival. Sara is now on high-frequency oscillating ventilation. The ICU nurses are unclear of the plan as previously policy stipulated that ventilated patients were not transplant candidates. They find the family's expectations of complete recovery unrealistic. They want to know what is realistic to expect.","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"3 2","pages":"48"},"PeriodicalIF":0.0,"publicationDate":"2012-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3516461/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31114483","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 P Silverstein, Selvon F St Clair, Isador H Lieberman
{"title":"Thoracic pedicle subtraction osteotomy in a pediatric patient: a case report.","authors":"Michael P Silverstein, Selvon F St Clair, Isador H Lieberman","doi":"10.1055/s-0031-1298618","DOIUrl":"https://doi.org/10.1055/s-0031-1298618","url":null,"abstract":"<p><strong>Study design: </strong> Case report.</p><p><strong>Objective: </strong> To describe a case of thoracic pedicle subtraction osteotomy (PSO) for congenital kyphosis in a child.</p><p><strong>Background information: </strong> Although congenital kyphosis is rare, it is a challenging cause of pediatric myelopathy and frank paralysis. Even less common is the use of PSO for the surgical management of focal congenital kyphosis. We present the case of a child with congenital kyphosis that was managed with a pedicle subtraction osteotomy.</p><p><strong>Methods: </strong> A detailed history and physical examination were performed with careful review of the patient's medical records and x-ray studies. A PSO at T11 was performed along with T9 through L1 instrumented posterolateral fusion.</p><p><strong>Case description: </strong> A 10-year-old girl was evaluated for walking difficulty and a lump on her back. Physical examination revealed a sharp gibbus kyphosis in the lower thoracic spine with tenderness and bilateral back muscle spasms. The patient displayed difficulty with balance lacking a smooth, regular gait rhythm. Clonus and radiculopathy were not present. Plain x-ray of the thoracolumbar spine revealed hyperkyphosis and failure of anterior wall segmentation between T10 and T11 vertebral bodies. Cobb's angle measured 65 degrees. Due to her symptoms and degree of correction required, we elected to perform a PSO at T11 along with T9 to L1 posterolateral instrumentation fusion. No intraoperative complications occurred. There was a significant improvement in her posture and gait.</p><p><strong>Discussion: </strong> A thoracic PSO for congenital kyphosis was safely performed with an excellent outcome. To our knowledge, this is the first PSO procedure performed in Uganda.</p>","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"3 2","pages":"49-54"},"PeriodicalIF":0.0,"publicationDate":"2012-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0031-1298618","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31111680","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":"Globalization of spine care: how are we doing and what are we doing?","authors":"Jens Chapman","doi":"10.1055/s-0031-1298611","DOIUrl":"https://doi.org/10.1055/s-0031-1298611","url":null,"abstract":"Let me address your pressing first question right away: both, US government officials in charge of PubMed, and our publisher Thieme Verlag, have assured me repeatedly that all of our EBSJ files are being actively (albeit slowly) downloaded as we are speaking and will be available online before years-end inclusive of all previously published articles to date. Delays apparently were caused by a combination of ‘technical difficulties’ and shortage in US government staffing. On behalf of the editorial staff and AOSpine International, I wish to apologize to all of those who are looking for our very noteworthy publications online and had a hard time finding them so far—your patience hopefully will be rewarded soon.","PeriodicalId":89675,"journal":{"name":"Evidence-based spine-care journal","volume":"3 2","pages":"5-6"},"PeriodicalIF":0.0,"publicationDate":"2012-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1055/s-0031-1298611","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31114476","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}