bluuebunny/crossref_metadata_2025_split huggingface dataset:
Introduction of the Abbreviated Westmead Post-Traumatic Amnesia Scale and Impact on Length of Stay
Authors: Watson C. E. , Clous E. A. , Jaeger M. , D’Amours S. K. 
Published: April 2017

Background and Aims: Mild traumatic brain injury is a common presentation to Emergency Departments. Early identification of patients with cognitive deficits and provision of discharge advice are important. The Abbreviated Westmead Post-traumatic Amnesia Scale provides an early and efficient assessment of post-traumatic amnesia for patients with mild traumatic brain injuries, compared with the previously used assessment, the Modified Oxford Post-traumatic Scale. Material and Methods: This retrospective cohort study reviewed 270 patients with mild traumatic brain injury assessed for post-traumatic amnesia over a 2-year period between February 2011 and February 2013. It identified those assessed with Abbreviated Westmead Post-traumatic Amnesia Scale versus Modified Oxford Post-traumatic Scale, the outcomes of these post-traumatic amnesia assessments, the hospital length of stay for patients, and their readmission rates. Results: The Abbreviated Westmead Post-traumatic Amnesia Scale was used in 91% of patient cases (and the Modified Oxford Post-traumatic Scale in 7%), and of those assessed with the Abbreviated Westmead Post-traumatic Amnesia Scale, 94% cleared post-traumatic amnesia testing within 4 h. Of those assessed with the Abbreviated Westmead Post-traumatic Amnesia Scale, 56% had a shorter length of stay than had they been assessed with the Modified Oxford Post-traumatic Scale, resulting in 295 bed-days saved. Verbal and written discharge advice was provided to those assessed for post-traumatic amnesia to assist their recovery. In all, 1% of patients were readmitted for monitoring of mild post-concussion symptoms. Conclusion: The Abbreviated Westmead Post-traumatic Amnesia Scale provides an effective and timely assessment of post-traumatic amnesia for patients presenting to the Emergency Department with mild traumatic brain injury compared with the previously used assessment tool. It helps identify patients with cognitive impairment and the need for admission and further investigation, resulting in appropriate access to care. It also results in a decreased length of stay and decreased hospital admissions, with subsequent cost savings to the hospital.
Trauma in pregnancy: A review of the Pennsylvania Trauma Systems Foundation database
Authors: Schuster Meike , Becker Natasha , Young Amanda , Paglia Michael J , Mackeen A Dhanya 
Published: April 2017

Objective The goal of this study is to determine if injury severity score (ISS) of ≥9 and systolic blood pressure (SBP) predict poor maternal/pregnancy outcomes in blunt and penetrating trauma, respectively. Methods The Pennsylvania Trauma Systems Foundation database was used to identify pregnant trauma patients. Blunt trauma patients were analyzed with regard to ISS, while penetrating trauma patients were analyzed to determine whether SBP < 90 mmHg was predictive of poor maternal outcome. Results Patients with severe blunt injury (ISS ≥ 9) due to motor vehicle accident were less likely to wear seatbelts (51% vs. 63%, p = 0.005), and delivery was required in 17% of these patients as compared to 6% of the less severely injured, and only 6% of those were vaginal deliveries. Severely injured patients were discharged home 68% of the time and 6% died compared to less severely injured patients of which 83% were discharged home and <1% died; all other patients required discharge to a rehabilitation facility. Patients with penetrating trauma and SBP < 90 mmHg on arrival were more likely to require delivery (35% vs. 5%, p < 0.001) and were 14 times more likely to die (58% vs. 4%, p < 0.001) when compared to the normotensive group. Conclusion ISS ≥ 9 and SBP < 90 mmHg are predictors for poor outcomes after trauma during pregnancy. Severely injured blunt trauma patients often require surgery and delivery. Patients who present with SBP < 90 after penetrating trauma are more likely to deliver and are 14 times more likely to die.
Using phase II data for the analysis of phase III studies: An application in rare diseases
Authors: Wandel Simon , Neuenschwander Beat , Röver Christian , Friede Tim 
Published: April 2017

Background: Clinical research and drug development in orphan diseases are challenging, since large-scale randomized studies are difficult to conduct. Formally synthesizing the evidence is therefore of great value, yet this is rarely done in the drug-approval process. Phase III designs that make better use of phase II data can facilitate drug development in orphan diseases. Methods: A Bayesian meta-analytic approach is used to inform the phase III study with phase II data. It is particularly attractive, since uncertainty of between-trial heterogeneity can be dealt with probabilistically, which is critical if the number of studies is small. Furthermore, it allows quantifying and discounting the phase II data through the predictive distribution relevant for phase III. A phase III design is proposed which uses the phase II data and considers approval based on a phase III interim analysis. The design is illustrated with a non-inferiority case study from a Food and Drug Administration approval in herpetic keratitis (an orphan disease). Design operating characteristics are compared to those of a traditional design, which ignores the phase II data. Results: An analysis of the phase II data reveals good but insufficient evidence for non-inferiority, highlighting the need for a phase III study. For the phase III study supported by phase II data, the interim analysis is based on half of the patients. For this design, the meta-analytic interim results are conclusive and would justify approval. In contrast, based on the phase III data only, interim results are inconclusive and require further evidence. Conclusion: To accelerate drug development for orphan diseases, innovative study designs and appropriate methodology are needed. Taking advantage of randomized phase II data when analyzing phase III studies looks promising because the evidence from phase II supports informed decision-making. The implementation of the Bayesian design is straightforward with public software such as R.
Treatment of missing data in follow-up studies of randomised controlled trials: A systematic review of the literature
Authors: Sullivan Thomas R , Yelland Lisa N , Lee Katherine J , Ryan Philip , Salter Amy B 
Published: April 2017

Background/aims: After completion of a randomised controlled trial, an extended follow-up period may be initiated to learn about longer term impacts of the intervention. Since extended follow-up studies often involve additional eligibility restrictions and consent processes for participation, and a longer duration of follow-up entails a greater risk of participant attrition, missing data can be a considerable threat in this setting. As a potential source of bias, it is critical that missing data are appropriately handled in the statistical analysis, yet little is known about the treatment of missing data in extended follow-up studies. The aims of this review were to summarise the extent of missing data in extended follow-up studies and the use of statistical approaches to address this potentially serious problem. Methods: We performed a systematic literature search in PubMed to identify extended follow-up studies published from January to June 2015. Studies were eligible for inclusion if the original randomised controlled trial results were also published and if the main objective of extended follow-up was to compare the original randomised groups. We recorded information on the extent of missing data and the approach used to treat missing data in the statistical analysis of the primary outcome of the extended follow-up study. Results: Of the 81 studies included in the review, 36 (44%) reported additional eligibility restrictions and 24 (30%) consent processes for entry into extended follow-up. Data were collected at a median of 7 years after randomisation. Excluding 28 studies with a time to event primary outcome, 51/53 studies (96%) reported missing data on the primary outcome. The median percentage of randomised participants with complete data on the primary outcome was just 66% in these studies. The most common statistical approach to address missing data was complete case analysis (51% of studies), while likelihood-based analyses were also well represented (25%). Sensitivity analyses around the missing data mechanism were rarely performed (25% of studies), and when they were, they often involved unrealistic assumptions about the mechanism. Conclusion: Despite missing data being a serious problem in extended follow-up studies, statistical approaches to addressing missing data were often inadequate. We recommend researchers clearly specify all sources of missing data in follow-up studies and use statistical methods that are valid under a plausible assumption about the missing data mechanism. Sensitivity analyses should also be undertaken to assess the robustness of findings to assumptions about the missing data mechanism.
Predictors and characteristics of angioectasias in patients with obscure gastrointestinal bleeding identified by video capsule endoscopy
Authors: Nennstiel Simon , Machanek Annkathrin , von Delius Stefan , Neu Bruno , Haller Bernhard , Abdelhafez Mohamed , Schmid Roland M , Schlag Christoph 
Published: April 2017

BackgroundIn obscure gastrointestinal bleeding, angioectasias are common findings in video capsule endoscopy (VCE).ObjectiveThe objective of this study was to identify predictors and characteristics of small bowel angioectasias.MethodsVideo capsule examinations between 1 July 2001 and 31 July 2011 were retrospectively reviewed. Patients with obscure gastrointestinal bleeding were identified, and those with small bowel angioectasia were compared with patients without a definite bleeding source. Univariate and multivariable statistical analyses for possible predictors of small bowel angioectasia were performed.ResultsFrom a total of 717 video capsule examinations, 512 patients with obscure gastrointestinal bleeding were identified. Positive findings were reported in 350 patients (68.4%) and angioectasias were documented in 153 of these patients (43.7%). These angioectasias were mostly located in the proximal small intestine (n  = 86, 56.6%). Patients’ age >65 years (odds ratio (OR) 2.15, 95% confidence interval (CI) 1.36–3.38, p  = .001) and overt bleeding type (OR 1.89, 95% CI 1.22–2.94, p  = .004) were identified as significant independent predictors of small bowel angioectasia.ConclusionAngioectasias are the most common finding in VCE in patients with obscure gastrointestinal bleeding. They are mostly located in the proximal small bowel and are associated with higher age and an overt bleeding type.
Traumatic Cervical Unilateral and Bilateral Facet Dislocations Treated With Anterior Cervical Discectomy and Fusion Has a Low Failure Rate
Authors: Anissipour Alireza K. , Agel Julie , Baron Matthew , Magnusson Erik , Bellabarba Carlo , Bransford Richard J. 
Published: April 2017

Study Design: Retrospective radiographic and chart review. Objective: To define the rate and associated risk factors of treatment failure of anterior cervical fusion for treatment of cervical facet dislocations. Methods: Between 2004 and 2014, a retrospective review at a single level 1 trauma center identified 38 patients with unilateral or bilateral dislocated facet(s) treated with anterior cervical discectomy and fusion (ACDF). Two patients were eliminated due to less than 30-day follow-up. Demographic data, initial neurological exams, surgical data, radiographic findings, and follow-up records were reviewed. Results: Of the 36 patients with facet dislocations treated with ACDF using a fixed locking plate, 16 were unilateral and 20 were bilateral. The mean age was 35 years (range 13-58). Mean follow-up was 323 days (range 30-1998). There were 3 treatment failures (8%). Three of 7 (43%) endplate fractures failed ( P < .01), and 1/28 (4%) facet fractures failed ( P = .13). The mean time to failure was 4 weeks (1-7 weeks). One treatment failure had a facet fracture, and all 3 failures had an associated endplate fracture. Conclusion: Treatment failure occurred in 3 out of 36 (8%) patients with facet fracture dislocations treated with anterior cervical discectomy, fusion, and plating. Rates of failure are lower than has been previously reported. Endplate fractures of the inferior level in jumped facets appears to be a major risk factor of biomechanical failure. However, a facet fracture may not be a risk factor for failure. In the absence of an endplate fracture, ACDF is a reasonable treatment option in patients with single-level cervical facet dislocation.
Spine Stereotactic Body Radiotherapy: Indications, Outcomes, and Points of Caution
Authors: Tseng Chia-Lin , Eppinga Wietse , Charest-Morin Raphaele , Soliman Hany , Myrehaug Sten , Maralani Pejman Jabehdar , Campbell Mikki , Lee Young K. , Fisher Charles , Fehlings Michael G. , Chang Eric L. , Lo Simon S. , Sahgal Arjun 
Published: April 2017

Study Design: A broad narrative review. Objectives: The objective of this article is to provide a technical review of spine stereotactic body radiotherapy (SBRT) planning and delivery, indications for treatment, outcomes, complications, and the challenges of response assessment. The surgical approach to spinal metastases is discussed with an overview of emerging minimally invasive techniques. Methods: A comprehensive review of the literature was conducted on the techniques, outcomes, and developments in SBRT and surgery for spinal metastases. Results: The optimal management of patients with spinal metastases is complex and requires multidisciplinary assessment from an oncologic team that is familiar with the shifting paradigm as a consequence of evolving techniques in surgery and stereotactic radiation, as well as new developments in systemic agents. The Spinal Instability Neoplastic Score and the epidural spinal cord compression (Bilsky) grading system are useful tools that facilitate communication among oncologic team members and can direct management by providing a baseline assessment of risks prior to therapy. The combined multimodality approach with “separation surgery” followed by postoperative spine SBRT achieves thecal sac decompression, improves tumor control, and avoids complications that may be associated with more extensive surgery. Conclusion: Spine SBRT is a highly effective treatment that is capable of delivering ablative doses to the target while sparing the critical organs-at-risk, chiefly the critical neural tissues, within a short and manageable schedule. At the same time, surgery occupies an important role in select patients, particularly with the expanding availability and expertise in minimally invasive techniques. With rapid adoption of spine SBRT in centers outside of the academic setting, it is imperative for the practicing oncologist to understand the relevance and application of these evolving concepts.
Management of Thoracic Disc Herniations via Posterior Unilateral Modified Transfacet Pedicle–Sparing Decompression With Segmental Instrumentation and Interbody Fusion
Authors: Carr Daniel A. , Volkov Andrey A. , Rhoiney David L. , Setty Pradeep , Barrett Ryan J. , Claybrooks Roderick , Bono Peter L. , Tong Doris , Soo Teck M. 
Published: April 2017

Study Design: Retrospective consecutive case series. Objective: The objective of this case series was to demonstrate the safety of a modified transfacet pedicle–sparing decompression and instrumented fusion in patients with thoracic disc herniations (TDHs). Methods: Consecutive patients undergoing operative management of TDH from July 2007 to December 2011 using a posterior unilateral modified transfacet pedicle–sparing approach were identified. All patients underwent open or minimally invasive modified transfacet pedicle–sparing discectomy and segmental instrumentation with interbody fusion, performed by four different surgeons. Pre- and postoperative visual analog scale (VAS) pain scores, Nurick grade, and American Spinal Injury Association Impairment Scale (AIS) were analyzed from a retrospective chart review. Estimated blood loss and complications were also obtained. Results: Fifty-one patients were included that had operations for TDH. Thirty-nine patients had single level decompression and 12 had multilevel decompression. The total number of levels operated on was 64. Five patients were treated with minimally invasive surgery. A herniated disc level of T11-12 (n = 17) was treated most often. One major complication of epidural hematoma occurred. Minor complications such as malpositioned hardware, postoperative hematoma, wound infection, pseudoarthrosis, and pulmonary complications occurred in a few patients. Follow-up ranged from 1 to 46 months with 1 patient lost to follow-up. From preoperative to final postoperative: mean VAS scores improved from 8.31 to 4.05, AIS in all patients remained stable or improved, and Nurick scores improved from 3 to 2.6 on average. No intraoperative or permanent neurological deficit occurred. Conclusion: In our surgical series, 51 consecutive patients underwent modified transfacet pedicle–sparing approach to TDHs and experienced improvement of functional status as well as improvement of objective pain scales with no neurological complications. The posterior unilateral modified transfacet pedicle–sparing decompression and instrumented fusion approach to the thoracic spine is a safe and reproducible procedure for the treatment of TDHs.
Use of Bivector Traction for Stabilization of the Head and Maintenance of Optimal Cervical Alignment in Posterior Cervical Fusions
Authors: Karikari Isaac O. , Bumpass David B. , Gum Jeffrey , Sugrue Patrick , Chapman Todd M. , Elsamadicy Aladine A. , Riew K. Daniel 
Published: April 2017

Study Design: Retrospective analysis of consecutive case series. Objective: To introduce a novel method of stabilizing the cranium using bivector traction in posterior cervical fusions. Methods: A retrospective review of 50 consecutive patients undergoing instrumented posterior cervical arthrodesis was performed. All patients had at least 3 levels of subaxial fusion using the bivector traction apparatus. Patients’ demographic data was recorded for the following: pre- and postoperative cervical lordosis, pre- and postoperative cervical sagittal vertical alignment (cSVA), and intraoperative complications from pin placements. Results: A total of 50 patients were studied. There were 31 females and 19 males. The mean age at the time of surgery was 49 years (range 35-79). A mean 5.8 levels were fused. The most common levels fused were C2-T3 in 14 patients followed by C2-T2 in 7 patients. In no case did the surgeon or assistant have to scrub out to adjust the alignment. The mean pre- and postoperative cervical lordosis was −6.0° and −10°, respectively ( P = .04). The mean pre-and postoperative cSVA was 30.5 mm and 32 mm, respectively ( P = .6). There were no complications related to placement of the Gardner-Well tongs. Conclusion: The bivector traction is an easy, safe, and effective method of stabilizing the head and obtaining adequate cervical sagittal alignment.
Impact of the Economic Downturn on Elective Lumbar Spine Surgery in the United States: A National Trend Analysis, 2003 to 2013
Authors: Bernstein David N. , Brodell David , Li Yue , Rubery Paul T. , Mesfin Addisu 
Published: April 2017

Study Design: Retrospective database analysis. Objective: The impact of the 2008-2009 economic downtown on elective lumbar spine surgery is unknown. Our objective was to investigate the effect of the economic downturn on the overall trends of elective lumbar spine surgery in the United States. Methods: The Nationwide Inpatient Sample (NIS) was used in conjunction with US Census and macroeconomic data to determine historical trends. The economic downturn was defined as 2008 to 2009. Codes from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), were used in order to identify appropriate procedures. Confidence intervals were determined using subgroup analysis techniques. Results: From 2003 to 2012, there was a 19.8% and 26.1% decrease in the number of lumbar discectomies and laminectomies, respectively. Over the same time period, there was a 56.4% increase in the number of lumbar spinal fusions. The trend of elective lumbar spine surgeries per 100 000 persons in the US population remained consistent from 2008 to 2009. The number of procedures decreased by 4.5% from 2010 to 2011, 7.6% from 2011 to 2012, and 3.1% from 2012 to 2013. The R2 value between the number of surgeries and the S&P 500 Index was statistically significant ( P ≤ .05). Conclusions: The economic downturn did not affect elective lumbar fusions, which increased in total from 2003 to 2013. The relationship between the S&P 500 Index and surgical trends suggests that during recessions, individuals may utilize other means, such as insurance, to cover procedural costs and reduce out-of-pocket expenditures, accounting for no impact of the economic downturn on surgical trends. These findings can assist multiple stakeholders in better understanding the interconnectedness of macroeconomics, policy, and elective lumbar spine surgery trends.
Spine Degenerative Conditions and Their Treatments: National Trends in the United States of America
Authors: Buser Zorica , Ortega Brandon , D’Oro Anthony , Pannell William , Cohen Jeremiah R. , Wang Justin , Golish Ray , Reed Michael , Wang Jeffrey C. 
Published: April 2017

Study Design: Retrospective database study. Objective: Low back and neck pain are among the top leading causes of disability worldwide. The aim of our study was to report the current trends on spine degenerative disorders and their treatments. Methods: Patients diagnosed with lumbar or cervical spine conditions within the orthopedic subset of Medicare and Humana databases (PearlDiver). From the initial cohorts we identified subgroups based on the treatment: fusion or nonoperative within 1 year from diagnosis. Poisson regression was used to determine demographic differences in diagnosis and treatment approaches. Results: Within the Medicare database there were 6 206 578 patients diagnosed with lumbar and 3 156 215 patients diagnosed with cervical degenerative conditions between 2006 and 2012, representing a 16.5% (lumbar) decrease and 11% (cervical) increase in the number of diagnosed patients. There was an increase of 18.5% in the incidence of fusion among lumbar patients. For the Humana data sets there were 1 160 495 patients diagnosed with lumbar and 660 721 patients diagnosed with cervical degenerative disorders from 2008 to 2014. There was a 33% (lumbar) and 42% (cervical) increases in the number of diagnosed patients. However, in both lumbar and cervical groups there was a decrease in the number of surgical and nonoperative treatments. Conclusions: There was an overall increase in both lumbar and cervical conditions, followed by an increase in lumbar fusion procedures within the Medicare database. There is still a burning need to optimize the spine care for the elderly and people in their prime work age to lessen the current national economic burden.