Chibuikem A Ikwuegbuenyi, François Waterkeyn, Arthur Okembo, Costansia Bureta, Kassim O Kassim, Hamisi K Shabani, Scott Zuckerman, Roger Härtl
{"title":"Presentation, Management, and Outcomes of Thoracic, Thoracolumbar, and Lumbar Spine Trauma in East Africa: A Cohort Study.","authors":"Chibuikem A Ikwuegbuenyi, François Waterkeyn, Arthur Okembo, Costansia Bureta, Kassim O Kassim, Hamisi K Shabani, Scott Zuckerman, Roger Härtl","doi":"10.14444/8575","DOIUrl":"10.14444/8575","url":null,"abstract":"<p><strong>Background: </strong>Trauma to the thoracic, thoracolumbar (TL), and lumbar spine is common and can cause disability and neurological deficits. Using a cohort of patients suffering from thoracic, TL, and lumbar spine trauma in a tertiary hospital in East Africa, the current study sought to: (1) describe demographics and operative treatment patterns, (2) assess neurologic outcomes, and (3) report predictors associated with undergoing surgery, neurologic improvement, and mortality.</p><p><strong>Methods: </strong>A retrospective cohort study of patient records from September 2016 to December 2020 was conducted at a prominent East Africa referral center. The study collected data on demographics, injury, and operative characteristics. Surgical indications were assessed using the AO (<i>Arbeitsgemeinschaft für Osteosynthesefragen</i>) TL fracture classification system and neurological function. Logistic regression analysis identified predictors for operative treatment, neurologic improvement, and mortality.</p><p><strong>Results: </strong>The study showed that 64.9% of the 257 TL spine trauma patients underwent surgery with a median postadmission day of 17.0. The mortality rate was 1.2%. Road traffic accidents caused 43.6% of the injuries. The most common fracture pattern was AO Type A fractures (78.6%). Laminectomy and posterolateral fusion were performed in 97.6% of the surgical cases. Patients without neurological deficits (OR: 0.27, 95% CI: 0.13-0.54, <i>P</i> < 0.001) and those with longer delays from injury to admission were less likely to have surgery (OR: 0.95, 95% CI: 0.92-0.99, <i>P</i> = 0.007). The neurologic improvement rate was 11.1%. Univariate analysis showed a significant association between surgery and neurologic improvement (OR: 3.83, 95% CI: 1.27-16.61, <i>P</i> < 0.001). However, this finding was lost in multivariate regression.</p><p><strong>Conclusions: </strong>This study highlights various themes surrounding the management of TL spine trauma in a low-resource environment, including lower surgery rates, delays from admission to surgery, safe surgery with low mortality, and the potential for surgery to lead to neurologic improvement.</p><p><strong>Clinical relevance: </strong>Despite challenges such as surgical delays and limited resources in East Africa, there is potential for surgical intervention to improve neurologic outcomes in thoracic, TL, and lumbar spine trauma patients.</p><p><strong>Level of evidence: 4: </strong></p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11287825/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140159249","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}
Kai-Uwe Lewandrowski, Heber Humberto Alfaro Pachicano, Rossano Kepler Alvim Fiorelli, John C Elfar, Stefan Landgraeber, Joachim Oertel, Stefan Hellinger, Álvaro Dowling, Paulo Sérgio Teixeira De Carvalho, Max R F Ramos, Helton Defino, João Paulo Bergamaschi, Paul Houle, Nicola Montemurro, Christopher Yeung, Marcelo Brito, Douglas P Beall, Gerd Ivanic, Zhang Xifeng, Zhen-Zhou Li, Hyeun-Sung Kim, Jin-Sung L Kim, Morgan P Lorio
{"title":"Comparative Analysis of Learning Curve, Complexity, Psychological Stress, and Work Relative Value Units for CPT 62380 Endoscopic Lumbar Spinal Decompression vs Traditional Lumbar Spine Surgeries: A Paired Rasch Survey Study.","authors":"Kai-Uwe Lewandrowski, Heber Humberto Alfaro Pachicano, Rossano Kepler Alvim Fiorelli, John C Elfar, Stefan Landgraeber, Joachim Oertel, Stefan Hellinger, Álvaro Dowling, Paulo Sérgio Teixeira De Carvalho, Max R F Ramos, Helton Defino, João Paulo Bergamaschi, Paul Houle, Nicola Montemurro, Christopher Yeung, Marcelo Brito, Douglas P Beall, Gerd Ivanic, Zhang Xifeng, Zhen-Zhou Li, Hyeun-Sung Kim, Jin-Sung L Kim, Morgan P Lorio","doi":"10.14444/8594","DOIUrl":"10.14444/8594","url":null,"abstract":"<p><strong>Background: </strong>Effective 1 January 2017, single-level endoscopic lumbar discectomy received a Category I Current Procedural Terminology (CPT) code 62380. However, no work relative value units (RVUs) are currently assigned to the procedure. An international team of endoscopic spine surgeons conducted a study, endorsed by several spine societies, analyzing the learning curve, difficulty, psychological intensity, and estimated work RVUs of endoscopic lumbar spinal decompression compared with other common lumbar spine surgeries.</p><p><strong>Methods: </strong>A survey comparing CPT 62380 to 10 other comparator CPT codes reflective of common spine surgeries was developed to assess the work RVUs in terms of learning curve, difficulty, psychological intensity, and work effort using a paired Rasch method.</p><p><strong>Results: </strong>The survey was sent to 542 spine specialists. Of 322 respondents, 150 completed the survey for a 43.1% completion rate. Rasch analysis of the submitted responses statistically corroborated common knowledge that the learning curve with lumbar endoscopic spinal surgery is steeper and more complex than with traditional translaminar lumbar decompression surgeries. It also showed that the psychological stress and mental and work effort with the lumbar endoscopic decompression surgery were perceived to be higher by responding spine surgeons compared with posterior comparator decompression and fusion surgeries and even posterior interbody and posterolateral fusion surgeries. The regression analysis of work effort vs procedural difficulty showed the real-world evaluation of the lumbar endoscopic decompression surgery described in CPT code 62380 with a calculated work RVU of 18.2464.</p><p><strong>Conclusion: </strong>The Rasch analysis suggested the valuation for the endoscopic lumbar decompression surgery should be higher than for standard lumbar surgeries: 111.1% of the laminectomy with exploration and/or decompression of spinal cord and/or cauda equina (CPT 63005), 118.71% of the laminectomy code (CPT 63047), which includes foraminotomy and facetectomy, 152.1% of the hemilaminectomy code (CPT 63030), and 259.55% of the interlaminar or interspinous process stabilization/distraction without decompression code (CPT 22869). This research methodology was endorsed by the Interamerican Society for Minimally Invasive Spine Surgery (SICCMI), the Mexican Society of Spinal Surgeons (AMCICO), the International Society For Minimally Invasive Spine Surgery (ISMISS), the Brazilian Spine Society (SBC), the Society for Minimally Invasive Spine Surgery (SMISS), the Korean Minimally Invasive Spine Surgery (KOMISS), and the International Society for the Advancement of Spine Surgery (ISASS).</p><p><strong>Clinical relevance: </strong>This study provides an updated reimbursement recommendation for endoscopic spine surgery.</p><p><strong>Level of evidence: </strong>Level 3.</p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11287802/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140871396","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":"Feasibility of C2 Lamina Screw Placement in a New Zealand Cohort: Computed Tomography Analysis According to Ethnicity and Gender.","authors":"Richard N Storey, Joseph F Baker","doi":"10.14444/8600","DOIUrl":"https://doi.org/10.14444/8600","url":null,"abstract":"<p><strong>Background: </strong>Previous analyses have suggested variations in cervical spine canal morphology according to ethnicity, possibly in part due to variations in the posterior elements. The potential for these variations to affect the placement of instrumentation is uncertain. The aim of this study was to report on the feasibility of C2 lamina screw insertion in a New Zealand cohort including analysis of Māori, the indigenous people of New Zealand.</p><p><strong>Methods: </strong>A trauma computed tomography database was accessed to identify suitable images. On axial images, where the isthmus was at its widest, the outer diameter (OD) and inner diameter (ID) of the lamina were measured. Screw length was measured from a proposed entry point to the contralateral junction of the lamina and lateral mass. The spinolaminar angle was measured as the angle subtended by the screw trajectory and midsagittal plane. A 5.5-mm OD was accepted as a threshold for the feasibility of lamina screw placement.</p><p><strong>Results: </strong>One hundred eighty-seven images were assessed: 115 New Zealand European and 72 Māori. The mean age of the cohort was 41.9 years (SD 19.6), and most patients (64%) were men. For the entire cohort, mean OD was 6.6 and 6.8 mm on the right and left, respectively; the mean inner diameter was 3.5 and 3.8 mm; mean screw length was 31.5 and 31.5 mm; and mean spinolaminar angle was 46.0° and 46.1°. C2 lamina screw placement was feasible in a majority of patients. Considering only Māori patients, placement was feasible in 96% of right and 94% of left laminae in men but 72% of right and 72% of left laminae in women.</p><p><strong>Conclusions: </strong>In a majority of patients, C2 lamina screw placement is feasible. However, advanced imaging must be carefully assessed preoperatively because data suggest that Māori women may not necessarily have optimal anatomy.<b>Clinical Relevance</b>Care needs to be taken when assessing and planning surgery inpatients of different ethnicities because variations may exist in the morphology of the posterior elements of C2, leading to variation in optimal fixation strategy.<b>Level of Evidence</b>3.</p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140871500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
K. Lewandrowski, Abduljabbar Alhammoud, S. Schlesinger, Benjamin R Gelber, Mark B Gerber, Morgan Lorio
{"title":"Surgeon Perceptions of Performing Transforaminal Lumbar Interbody Fusion in an Ambulatory Surgical Center vs Hospital Setting in the Elderly Population: Results of a Surgeon Survey.","authors":"K. Lewandrowski, Abduljabbar Alhammoud, S. Schlesinger, Benjamin R Gelber, Mark B Gerber, Morgan Lorio","doi":"10.14444/8596","DOIUrl":"https://doi.org/10.14444/8596","url":null,"abstract":"BACKGROUND\u0000There is an increasing acceptance of conducting minimally invasive transforaminal lumbar interbody fusion (TLIF) in ambulatory surgical centers (ASCs). The Centers for Medicare and Medicaid Services (CMS) introduced the Hospitals Without Walls (HWW) program in March 2020. This program granted hospitals regulatory flexibility to offer services and procedures in nontraditional locations, including ASCs. However, implementation hurdles persist.\u0000\u0000\u0000METHODS\u0000A survey was sent to 235 surgeons regarding the use of ASCs for performing TLIF surgeries on elderly patients. Multiple-choice questions covering various aspects of TLIF practice preferences, including surgical indications, decision factors for choosing ASCs over hospitals, implementation hurdles, reimbursement concerns, staffing issues, and the impact of CMS rules and regulations on TLIF in ASCs, particularly concerning physician ownership and self-referral conflicts governed by the Stark law, were asked.\u0000\u0000\u0000RESULTS\u0000The survey completion rate was 25.8% (Figure 1). The most common surgical indications for TLIF in ASCs were spondylolisthesis (80%), spinal stenosis (62.5%), and low back pain (47.5%). Most surgeons (78%) believed TLIF could be safely performed in ASCs. Streamlined workflow, lower infection rates, and cost-effectiveness were advantages listed by 58.5% of surgeons. Patient's medical history (75.8%), followed by ASC resources and capabilities (61%) and surgeon preference (61%), were relevant factors. Higher efficiencies at ASCs (14.6%), contractual issues (9.8%), and ownership issues (7.3%) were less relevant to surgeons. About 65.9% of surgeons reported lower reimbursement in ASCs, and 43.9% said it was an implementation hurdle. Lower direct costs were reported by 53.7% of surgeons. Other hurdles included a lack of trained staff (24.4%), inadequate staffing (22.0%), cost overruns (26.8%), high Joint Commission or the Accreditation Association for Ambulatory Health Care credentialing costs, and surgeons feeling uncomfortable performing TLIF in ASCs (22.0%). Only 17.1% listed medical problems as a reason their patient was considered unsuitable for the ASC environment. A majority (53.7%) stated that their ASCs complied with strict Stark requirements by disclosing physician ownership interests. However, 22% of surgeons reported self-referrals under the \"In-Office Ancillary Services Exception\" allowed by the Stark law.\u0000\u0000\u0000CONCLUSION\u0000Our survey data show that surgeons' perceptions of current CMS rules and regulations may hinder the transition into the ASC setting because they think the reimbursement is too low and the regulatory burden is too high. ASCs have disproportionally higher initial acquisition and ongoing costs related to staff training and maintenance of the TLIF technology that CMS should consider when determining the appropriate financial remuneration for these complex procedures.\u0000\u0000\u0000CLINICAL RELEVANCE\u0000ASC offers a viable and attractive option for their TLIF procedure with ","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140653271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Navigating the Future of Spine Surgery: A Surgeon's Reflection on Coding, Reimbursement, and Emerging Technologies.","authors":"Morgan Lorio","doi":"10.14444/8597","DOIUrl":"https://doi.org/10.14444/8597","url":null,"abstract":"","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140738704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ari R. Berg, A. Fano, Jacob Ball, Matthew Weintraub, Michael W Fields, Ashok Para, Folorunsho Edobor-Osula, Alice Chu, Michael J. Vives, Neil Kaushal
{"title":"Evaluating the Readability of Patient Education Materials for Anterior Vertebral Body Tethering, Distraction-Based Methods, and Posterior Spinal Fusion for the Treatment of Pediatric Spinal Deformity.","authors":"Ari R. Berg, A. Fano, Jacob Ball, Matthew Weintraub, Michael W Fields, Ashok Para, Folorunsho Edobor-Osula, Alice Chu, Michael J. Vives, Neil Kaushal","doi":"10.14444/8591","DOIUrl":"https://doi.org/10.14444/8591","url":null,"abstract":"BACKGROUND\u0000The Internet is an important source of information for patients, but its effectiveness relies on the readability of its content. Patient education materials (PEMs) should be written at or below a sixth-grade reading level as outlined by agencies such as the American Medical Association. This study assessed PEMs' readability for the novel anterior vertebral body tethering (AVBT), distraction-based methods, and posterior spinal fusion (PSF) in treating pediatric spinal deformity.\u0000\u0000\u0000METHODS\u0000An online search identified PEMs using the terms \"anterior vertebral body tethering,\" \"growing rods scoliosis,\" and \"posterior spinal fusion pediatric scoliosis.\" We selected the first 20 general medical websites (GMWs) and 10 academic health institution websites (AHIWs) discussing each treatment (90 websites total). Readability tests for each webpage were conducted using Readability Studio software. Reading grade levels (RGLs), which correspond to the US grade at which one is expected to comprehend the text, were calculated for sources and independent t tests compared with RGLs between treatment types.\u0000\u0000\u0000RESULTS\u0000The mean RGL was 12.1 ± 2.0. No articles were below a sixth-grade reading level, with only 2.2% at the sixth-grade reading level. AVBT articles had a higher RGL than distraction-based methods (12.7 ± 1.6 vs 11.9 ± 1.9, P = 0.082) and PSF (12.7 ± 1.6 vs 11.6 ± 2.3, P = 0.032). Materials for distraction-based methods and PSF were comparable (11.9 ± 1.9 vs 11.6 ± 2.3, P = 0.566). Among GMWs, AVBT materials had a higher RGL than distraction-based methods (12.9 ± 1.4 vs 12.1 ± 1.8, P = 0.133) and PSF (12.9 ± 1.4 vs 11.4 ± 2.4, P = 0.016).\u0000\u0000\u0000CLINICAL RELEVANCE\u0000Patients' health literacy is important for shared decision-making. Assessing the readability of scoliosis treatment PEMs guides physicians when sharing resources and discussing treatment with patients.\u0000\u0000\u0000CONCLUSION\u0000Both GMWs and AHIWs exceed recommended RGLs, which may limit patient and parent understanding. Within GMWs, AVBT materials are written at a higher RGL than other treatments, which may hinder informed decision-making and patient outcomes. Efforts should be made to create online resources at the appropriate RGL. At the very least, patients and parents may be directed toward AHIWs; RGLs are more consistent.\u0000\u0000\u0000LEVEL OF EVIDENCE: 3","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140743162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jack Zhong, Jarid Tareen, Kimberly Ashayeri, C. Leon, E. Balouch, Nicholas A. O'Malley, C. Stickley, C. Maglaras, Brooke K. O'Connell, Ethan W. Ayres, C. Fischer, Yong Kim, T. Protopsaltis, A. Buckland
{"title":"Does Bone Morphogenetic Protein Use Reduce Pseudarthrosis Rates in Single-Level Transforaminal Lumbar Interbody Fusion Surgeries?","authors":"Jack Zhong, Jarid Tareen, Kimberly Ashayeri, C. Leon, E. Balouch, Nicholas A. O'Malley, C. Stickley, C. Maglaras, Brooke K. O'Connell, Ethan W. Ayres, C. Fischer, Yong Kim, T. Protopsaltis, A. Buckland","doi":"10.14444/8590","DOIUrl":"https://doi.org/10.14444/8590","url":null,"abstract":"BACKGROUND\u0000Recombinant human bone morphogenetic protein 2 (rhBMP-2, or BMP for short) is a popular biological product used in spine surgeries to promote fusion and avoid the morbidity associated with iliac crest autograft. BMP's effect on pseudarthrosis in transforaminal lumbar interbody fusion (TLIF) remains unknown.\u0000\u0000\u0000OBJECTIVE\u0000To assess the rates of pseudarthrosis in single-level TLIF with and without concurrent use of BMP.\u0000\u0000\u0000METHODS\u0000This was a retrospective cohort study conducted at a single academic institution. Adults undergoing primary single-level TLIF with a minimum of 1 year of clinical and radiographic follow-up were included. BMP use was determined by operative notes at index surgery. Non-BMP cases with iliac crest bone graft were excluded. Pseudarthrosis was determined using radiographic and clinical evaluation. Bivariate differences between groups were assessed by independent t test and χ 2 analyses, and perioperative characteristics were analyzed by multiple logistic regression.\u0000\u0000\u0000RESULTS\u0000One hundred forty-eight single-level TLIF patients were included. The mean age was 59.3 years, and 52.0% were women. There were no demographic differences between patients who received BMP and those who did not. Pseudarthrosis rates in patients treated with BMP were 6.2% vs 7.5% in the no BMP group (P = 0.756). There was no difference in reoperation for pseudarthrosis between patients who received BMP (3.7%) vs those who did not receive BMP (7.5%, P = 0.314). Patients who underwent revision surgery for pseudarthrosis more commonly had diabetes with end-organ damage (revised 37.5% vs not revised 1.4%, P < 0.001). Multiple logistic regression analysis demonstrated no reduction in reoperation for pseudarthrosis related to BMP use (OR 0.2, 95% CI 0.1-3.7, P = 0.269). Diabetes with end-organ damage (OR 112.6,95% CI 5.7-2225.8, P = 0.002) increased the risk of reoperation for pseudarthrosis.\u0000\u0000\u0000CONCLUSIONS\u0000BMP use did not reduce the rate of pseudarthrosis or the number of reoperations for pseudarthrosis in single-level TLIFs. Diabetes with end-organ damage was a significant risk factor for pseudarthrosis.\u0000\u0000\u0000CLINICAL RELEVANCE\u0000BMP is frequently used \"off-label\" in transforaminal lumbar interbody fusion; however, little data exists to demonstrate its safety and efficacy in this procedure.\u0000\u0000\u0000LEVEL OF EVIDENCE: 3","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140747791","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Lorio, William C Watters, Betsy H. Grunch, Andrew K Metzger, K. Lewandrowski, Jon E Block, Gunnar B J Andersson
{"title":"Utilization of Bone-Anchored Annular Defect Closure to Prevent Reherniation Following Lumbar Discectomy: Overcoming Barriers to Clinical Adoption and Market Access.","authors":"M. Lorio, William C Watters, Betsy H. Grunch, Andrew K Metzger, K. Lewandrowski, Jon E Block, Gunnar B J Andersson","doi":"10.14444/8592","DOIUrl":"https://doi.org/10.14444/8592","url":null,"abstract":"While achieving premarket approval from the US Food and Drug Administration represents a significant milestone in the development and commercialization of a Class III medical device, the aftermath endeavor of gaining market access can be daunting. This article provides a case study of the Barricaid annular closure device (Barricaid), a reherniation reduction device, which has been demonstrated to decrease the risk of suffering a recurrent lumbar intervertebral disc herniation. Following Food and Drug Administration approval, clinical adoption has been slow due to barriers to market access, including the perception of low-quality clinical evidence, questionable significance of the medical necessity of the procedure, and imaging evidence of increased likelihood of vertebral endplate changes. The aim of this article is to provide appropriate examination, rationale, and rebuttal of these concerns. Weighing the compendium of evidence, we offer a definition of a separate and unique current procedural terminology code to delineate this procedure. Adoption of this code will help to streamline the processing of claims and support the conduct of research, the evaluation of health care utilization, and the development of appropriate medical guidelines.","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140746215","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ahmad Assi, Mohammad Daher, Ziad Zalaquett, Marven Aoun, Bryan Youssef, G. Kreichati, K. Kharrat, A. Sebaaly
{"title":"Intensive Care Unit Admission After Spine Surgery: A Narrative Review.","authors":"Ahmad Assi, Mohammad Daher, Ziad Zalaquett, Marven Aoun, Bryan Youssef, G. Kreichati, K. Kharrat, A. Sebaaly","doi":"10.14444/8593","DOIUrl":"https://doi.org/10.14444/8593","url":null,"abstract":"INTRODUCTION\u0000Intensive care unit (ICU) admissions constitute a substantial financial challenge for health care systems and patients and are linked to various potentially life-altering complications. A wide range of patient-related, surgical, and medical factors are associated with an increased risk of ICU admission following spine surgery.\u0000\u0000\u0000DISCUSSION\u0000The most notable examples include lung, heart, and kidney disease, as well as estimated blood loss and length of surgery. Various scores that include the most significant patient- and procedure-related factors have been described to assess the risk associated with surgery for individual patients. To date, the fusion risk score and the American Society of Anesthesiologists score have been the most useful in predicting postoperative complications and admission to the ICU. However, other risk factors have also been implicated in ICU admission and length of stay. The current scores must further adapt by using the available evidence to fulfill their intended purpose. Moreover, a handful of measures have shown efficacy in decreasing ICU admission and length of stay, with their benefits still to be demonstrated by future research.\u0000\u0000\u0000CONCLUSION\u0000This review underscores the risk factors predictive of ICU admission following spine surgery and will help surgeons and clinicians in patient stratification. However, future studies are needed to validate the role of protective measures in preventing ICU admissions and the significance of certain risk factors.","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140746796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Leo Swee Liang Chong, Mark Zhu, Joseph Frederick Baker
{"title":"Quality Assessment of Degenerative Cervical Myelopathy Information on the Internet.","authors":"Leo Swee Liang Chong, Mark Zhu, Joseph Frederick Baker","doi":"10.14444/8566","DOIUrl":"10.14444/8566","url":null,"abstract":"<p><strong>Background: </strong>Patient education is a key element of spinal surgery informed consent. Patients frequently access health information online, yet this information is unregulated and of variable quality. We aimed to assess the quality of information available on degenerative cervical myelopathy (DCM) websites with a focus on identifying high-quality information websites.</p><p><strong>Methods: </strong>We performed a Google search using keywords pertaining to DCM. The top 50 websites returned were classified based on their publication source, intended audience, and country of origin. The quality of these websites was assessed using both the DISCERN instrument and Journal of the American Medical Association (JAMA) benchmark criteria. We also utilized a novel Myelopathy Information Scoring Tool (MIST) to assess the comprehensiveness, accuracy, and detail of online DCM information.</p><p><strong>Results: </strong>The mean DISCERN score was 39.9 out of 80. Only one-quarter of these websites were rated \"good\" or \"excellent\" using DISCERN, and the remaining were rated \"very poor,\" \"poor,\" and \"fair.\" The mean JAMA benchmark score was 1.6 out of 4, with 23 out of 50 websites scoring 0. Evaluation using MIST found a mean score of 25.6 out of 50. Using 30 points as a satisfactory MIST cutoff, 72% of DCM websites were deemed critically deficient and unsatisfactory for comprehensive patient education. Both DISCERN and MIST indicated poorest information pertaining to surgical risks and complications as well as treatment outcomes. Websites such as Orthoinfo.aaos.org and Myelopathy.org provided reliable, trustworthy, and comprehensive patient education.</p><p><strong>Conclusions: </strong>Information available on almost three-quarters of DCM websites was of poor quality, with information regarding complications and treatment outcomes most deficient. Clinicians should be aware of quality sites where patients may be directed to augment patient education and surgical counseling.</p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265354/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138831990","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}