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Spine surgery and its corresponding costs have increased in recent years and are variable across geographic regions. Discretionary care is the component of spending variation that is independent of illness severity, age, and regional pricing. It is unknown whether greater discretionary care is associated with improved safety for patients undergoing spine surgery, as we would expect from value-based health care.We conducted an analysis of 5 spine surgery cohorts based on Medicare claims from 2013 to 2017. Patients were grouped into quintiles based on the Dartmouth Atlas End-of-Life Inpatient Care Index (EOL), reflecting regional spending variation attributed to discretionary care. Multivariable regression examined the association between discretionary care and safety measures while controlling for age, sex, race, comorbidity, and hospital features.We observed a threefold to fourfold variation in 90-day episode-of-care cost across regions, depending on the cohort. Spine-specific spending was correlated with EOL quintile, confirming that spending variation is due more to discretionary care than it is to pricing, age, or illness severity. Greater spending across EOL quintiles was not associated with improved safety, and, in fact, was associated with poorer safety in some cohorts. For example, all-cause readmission was greater in the high-spending EOL quintile relative to the low-spending EOL quintile among the "fusion, except cervical" cohort (14.2% vs. 13.1%; OR = 1.10; 95% CI = 1.05 to 1.20), the "complex fusion" cohort (28.0% vs. 25.4%; OR = 1.15; 95% CI = 1.01 to 1.30), and the "cervical fusion" cohort (15.0% vs. 13.6%; OR = 1.12; 95% CI = 1.05 to 1.20).Wide variation in spending was not explained by differences in illness severity, age, or pricing, and increased discretionary care did not enhance safety. These findings point to inefficient use of health-care resources, a potential focus of reform.Economic and Decision Analysis Level IV. See Instructions for Authors for a complete description of levels of evidence.

Anal cancer has increasing incidence and is preceded by high‐grade anal intraepithelial neoplasia (HGAIN; AIN2–3). Previously, we identified and validated several methylation markers for accurate detection of anal cancer and HGAIN with cancer risk in HIV‐positive (HIV+) men who have sex with men (MSM). This study aimed to evaluate these markers in HIV‐negative risk groups. A cross‐sectional series of 176 tissue samples of anal cancer, AIN3, AIN2, AIN1 and control biopsies obtained in HIV‐negative women and men was tested for six methylation markers (ASCL1, LHX8, SST, WDR17, ZIC1 and ZNF582). Accuracy for detection of AIN3 and cancer (AIN3+) was determined by univariable and multivariable mixed‐effect ordinal logistic regression. Methylation levels of all markers increased with increasing severity of disease (P, Host cell DNA methylation plays a role in anal carcinogenesis in HIV‐negative (HIV‐neg) and HIV‐positive (HIV+) individuals, including men who have sex with men (MSM). Methylation levels are increased in high‐grade anal intraepithelial neoplasia at risk of progression towards anal cancer, making methylation markers promising prognostic biomarkers.

Background Minimal clinically important differences (MCIDs) for different patient outcome scores have been reported for various shoulder diseases, including shoulder arthroplasty and the nonoperative treatment of rotator cuff disease. The purpose of this study was to assess the MCID for the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score, the Simple Shoulder Test (SST), and a visual analog scale (VAS) measuring pain, after arthroscopic rotator cuff repair. Methods A total of 202 patients who underwent arthroscopic rotator cuff repair were retrospectively reviewed. ASES, SST, and VAS pain scores were collected preoperatively and at 1 year postoperatively. The MCID was then calculated via a 4-question anchor–based method. Results The MCID results for the ASES, SST, and VAS pain scores were 27.1, 4.3, and 2.4, respectively. Age at time of surgery, sex, anteroposterior tear size, and worker's compensation status were not associated with MCID values (P > .05). Conclusion The MCID values determined in the current study are higher than those previously identified for the nonoperative treatment of rotator cuff disease using the same anchor questions. Use of these higher values should be considered when evaluating improvements of individual patients after rotator cuff repair, to determine comparative effectiveness of various rotator cuff repair techniques and to determine sample sizes for prospective comparative trials of rotator cuff repair methods.

Objective: To examine effects of four different transcranial, red/near-infrared (NIR), light-emitting diode (tLED) protocols on naming ability in persons with aphasia (PWA) due to left hemisphere (...

Colorectal cancer (CRC) is the second leading cause for cancer-related death globally. Clinically, there is an urgent need for non-invasive CRC detection. This study assessed the feasibility of CRC detection by analysis of tumor-derived methylated DNA fragments in urine. Urine samples, including both unfractioned and supernatant urine fractions, of 92 CRC patients and 63 healthy volunteers were analyzed for DNA methylation levels of 6 CRC-associated markers (SEPT9, TMEFF2, SDC2, NDRG4, VIM and ALX4). Optimal marker panels were determined by two statistical approaches. Methylation levels of SEPT9 were significantly increased in urine supernatant of CRC patients compared to controls (p SEPT9 and SDC2 was able to detect up to 70% of CRC cases in urine supernatant at 86% specificity. First evidence is provided for CRC detection in urine by SEPT9 methylation analysis, which combined with SDC2 allows for an optimal differentiation between CRC patients and controls. Urine therefore provides a promising liquid biopsy for non-invasive CRC detection.

OBJECTIVE: To understand whether the Comprehensive Care for Joint Replacement (CJR) program induces participating hospitals to (1) preferentially select lower risk patients, (2) reduce 90‐day episode‐of‐care costs, (3) improve quality of care, and (4) achieve greater cost reduction during its second year, when downside financial risk was applied. DATA SOURCES: We identified beneficiaries of age 65 years or older undergoing hip or knee joint replacement in the 100% sample of Medicare fee‐for‐service inpatient (Part A) claims from January 1, 2013 to August 31, 2017. Cases were linked to subsequent outpatient, Part B, home health agency, and skilled nursing facility claims, as well as publicly available participation status for CJR. STUDY DESIGN: We estimated the effect of CJR for hospitals in the 67 metropolitan statistical areas (MSA) selected to participate in CJR (785 hospitals), compared to those in 104 non‐CJR MSAs (962 hospitals; maintaining fee‐for‐service). A difference‐in‐differences approach was used to detect patient selection, as well as to compare 90‐day episode‐of‐care costs and quality of care between CJR and non‐CJR hospitals over the first two performance years. DATA COLLECTION: We excluded 172 hospitals from our analysis due to their preexisting BPCI participation. We focused on elective admissions in the main analysis. PRINCIPAL FINDINGS: While reductions in 90‐day episode‐of‐care costs were greater among CJR hospitals (−$902, 95% CI: −$1305, −$499), largely driven by a 16.8% (p

STUDY DESIGN Surgeon survey. OBJECTIVE To examine factors influencing surgeons' definition of instability in grade 1 degenerative spondylolisthesis (DS) and assess treatment preferences for both stable and unstable DS. SUMMARY OF BACKGROUND DATA DS treatment options are broadly classified as decompression with or without fusion. In surgical decision-making, "instability" is frequently considered as a key factor. However, no consensus on the definition of instability exists. METHODS A survey was conducted to ascertain the minimum amounts of static translation, dynamic translation, and angulation change that surgeons considered significant for determining instability. The importance of other clinical and radiographic features were also assessed, and respondents' standard treatment for stable and unstable DS. RESULTS Out of 226 respondents, 99% deemed dynamic translation moderately to extremely influential for determining instability, whereas only 55% found static translation as important. The most prevalent cut-off values for dynamic (57%) and static translation (32%) were at least 2-4 mm and for angulation change at least 10-15 degrees (43%). Facet angulation was considered moderately to extremely important to determine instability by 69% of the surgeons, disk height by 67%, patient age by 64%, severity of stenosis by 55%, severity of back pain by 50%, patient-reported function by 49%, pelvic incidence by 47%, and severity of neurogenic claudication by 42%.Decompression with fusion was the preferred treatment method for unstable DS in 99% of the respondents. For stable DS, 40% would still perform fusion, whereas 60% preferred treatment with decompression-alone. Those who preferred fusion for stable DS reported significantly lower thresholds for static (P

Analysis of National Inpatient Sample (NIS), 2004 to 2015.Describe recent trends in US rates of lumbar fusion procedures and associated costs, by surgical indication.Spinal fusion is appropriate for spinal deformity and instability, but evidence of effectiveness is limited for primary disc herniation and spinal stenosis without instability. It remains controversial for treatment of axial pain secondary to degenerative disc disease. There are potential non-instability, non-deformity indications for fusion surgery, including but not limited to severe foraminal stenosis and third-time disc herniation.Elective lumber fusion trends were reported using Poisson regression, grouped by indication as degenerative scoliosis, degenerative spondylolisthesis, spinal stenosis, disc herniation, and disc degeneration. Generalize linear regression was used to estimate trends in hospital costs, adjusted for age, sex, indication, comorbidity, and inflation.Volume of elective lumbar fusion increased 62.3% (or 32.1% per 100,000 US adults), from 122,679 cases (60.4 per 100,000) in 2004 to 199,140 (79.8 per 100,000) in 2015. Increases were greatest among age 65 or older, increasing 138.7% by volume (73.2% by rate), from 98.3 per 100,000 (95% confidence interval [CI] 97.2, 99.3) in 2004 to 170.3 (95% CI 169.2, 171.5) in 2015. Although the largest increases were for spondylolisthesis (+47,390 operations, 111%) and scoliosis (+16,129 operations, 186.6%), disc degeneration, herniation, and stenosis combined to accounted for 42.3% of total elective lumbar fusions in 2015. Aggregate hospital costs increased 177% during these 12 years, exceeding $10 billion in 2015, and averaging more than $50,000 per admission.While the prevalence of spinal pathologies is not known, the rate of elective lumbar fusion surgery in the United States increased most for spondylolisthesis and scoliosis, indications with relatively good evidence of effectiveness. The proportion of fusions coded for indications with less evidence of effectiveness has slightly decreased in the most recent years.3.

Nasal chondrocytes (NCs) have gained increased recognition for cartilage tissue regeneration. To assess NCs as a source for cell therapy treatment of intervertebral disc (IVD) degeneration, tissue-forming properties of NCs under physiological conditions mimicking the degenerated IVD were compared to those of mesenchymal stromal cells (MSCs) and articular chondrocytes (ACs), two cell sources presently used in clinical trials. Cells were cultured in a combination of low glucose, hypoxia, acidity and inflammation for 28 d. Depending on the conditions, cells were either cultured in the absence of instructive growth factors or underwent chondrogenic instructional priming by addition of transforming growth factor β1 (TGFβ1) for the first 7 d. Histology, immunohistochemistry, biochemistry, enzyme-linked immunosorbent assay (ELISA) and quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) analyses demonstrated limited cell maintenance and accumulation of cartilaginous extracellular matrix for MSCs in IVD conditions. ACs maintained a steady accumulation of glycosaminoglycans (GAGs) throughout all non-acidic conditions, with and without priming, but could not synthesise type II collagen (Col2). NCs accumulated both GAGs and Col2 in all non-acidic conditions, independent of priming, whereas MSCs strongly diminished their GAG and Col2 accumulation in an inflamed environment. Supplementation with inflammatory cytokines or an acidic environment affected NCs to a lower extent than ACs or MSCs. The data, overall indicating that in an inflamed IVD environment NCs were superior to ACs and MSCs, encourage further assessment of NCs for treatment of degenerative disc disease.

Background: Numerous studies have reported the incidence and outcomes of injuries in the men’s and women’s National Basketball Association (NBA and WNBA, respectively). Purpose: To synthesize published data regarding the incidence and outcomes of all injuries in the NBA and WNBA in a comprehensive review. Study Design: Systematic review; Level of evidence, 4. Methods: Following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched 3 electronic databases (PubMed, MEDLINE, Embase) for studies of all levels of evidence since 1990 pertaining to injuries sustained by active players in the NBA and WNBA. Studies were excluded if the cohort of interest included ≤3 active players. Results: The initial search of the 3 databases yielded 1253 unique studies, of which 49 met final inclusion criteria for this review. Only 4 studies included athletes in the WNBA. Based on the mean annual incidence, the 5 most common orthopaedic sports injuries sustained in the NBA were concussions (9.5-14.9 per year), fractures of the hand (3.5-5.5 per year), lower extremity stress fractures (4.8 per year), meniscal tears (2.3-3.3 per year), and anterior cruciate ligament tears (1.5-2.6 per year). Cartilage defects treated using microfracture, Achilles tendon ruptures, and anterior cruciate ligament injuries were 3 injuries that led to significant reductions in performance measurements after injury. Conclusion: With advances in sports technology and statistical analysis, there is rapidly growing interest in injuries among professional basketball athletes. High-quality prospective studies are needed to understand the prevalence and effect of injuries on player performance and career length. This information can inform preventative and treatment measures taken by health care providers to protect players and guide safe return to play at a high level.

Supplemental Digital Content is available in the text., Background: In anticipation of a demand surge for hospital beds attributed to the coronavirus pandemic (COVID-19) many US states have mandated that hospitals postpone elective admissions. Objectives: To estimate excess demand for hospital beds due to COVID-19, the net financial impact of eliminating elective admissions in order to meet demand, and to explore the scenario when demand remains below capacity. Research Design: An economic simulation to estimate the net financial impact of halting elective admissions, combining epidemiological reports, the US Census, American Hospital Association Annual Survey, and the National Inpatient Sample. Deterministic sensitivity analyses explored the results while varying assumptions for demand and capacity. Subjects: Inputs regarding disease prevalence and inpatient utilization were representative of the US population. Our base case relied on a hospital admission rate reported by the Center for Disease Control and Prevention of 137.6 per 100,000, with the highest rates in people aged 65 years and older (378.8 per 100,000) and 50–64 years (207.4 per 100,000). On average, elective admissions accounted for 20% of total hospital admissions, and the average rate of unoccupied beds across hospitals was 30%. Measures: Net financial impact of halting elective admissions. Results: On average, hospitals COVID-19 demand for hospital bed-days fell well short of hospital capacity, resulting in a substantial financial loss. The net financial impact of a 90-day COVID surge on a hospital was only favorable under a narrow circumstance when capacity was filled by a high proportion of COVID-19 cases among hospitals with low rates of elective admissions. Conclusions: Hospitals that restricted elective care took on a substantial financial risk, potentially threatening viability. A sustainable public policy should therefore consider support to hospitals that responsibly served their communities through the crisis.

Highlights • Children with COVID 19 disease are less symptomatic but they can be potential agents of transmission. • Most children with symptoms from COVID 19 disease (cough, fever, respiratory difficulties) show bnormalities in CXR. • Findings in CXR are non-specific and superimpose on other viral pneumonias. • Peripheral distribution of lung abnormalities is not a distinctive feature in paediatric population. • CXR have a role in the management of the disease in children., BACKGROUND The outbreak of COVID-19 has become pandemic. Pediatric population has been less studied than adult population and prompt diagnosis is challenging due to asymptomatic or mild episodes. Radiology is an important complement to clinical and epidemiological features. OBJECTIVE To establish the most common CXR patterns in children with COVID-19, evaluate interobserver correlation and to discuss the role of imaging techniques in the management of children. MATERIALS AND METHODS Forty-four patients between 0 and 16 years of age with confirmed SARS-Cov-2 infection and CXR were selected. Two paediatric radiologists independently evaluated the images and assessed the type of abnormality, distribution and evolution when available. RESULTS Median age was 79.8 months (ranging from 2 weeks to 16 years of age). Fever was the most common symptom (43.5 %). 90 % of CXR showed abnormalities. Peribronchial cuffing was the most common finding (86.3 %) followed by GGOs (50 %). In both cases central distribution was more common than peripheral. Consolidations accounted for 18.1 %. Normal CXR, pleural effusion, and altered cardiomediastinal contour were the least common. CONCLUSION The vast majority of CXR showed abnormalities in children with COVID-19. However, findings are nonspecific. Interobserver correlation was good in describing consolidations, normal x-rays and GGOs. Imaging techniques have a role in the management of children with known or suspected COVID-19, especially in those with moderate or severe symptoms or with underlying risk factors.

International audience; Background: Several observational studies have reported elevated baseline D-dimer levels in patients hospitalized for moderate to severe coronavirus disease 2019 (COVID-19). These elevated baseline D-dimer levels have been associated with disease severity and mortality in retrospective cohorts.Objectives: To review current available data on the association between D-Dimer levels and mortality in patients admitted to hospital for COVID-19.Methods: We performed a systematic review of published studies using MEDLINE and EMBASE through 13 April 2020. Two authors independently screened all records and extracted the outcomes. A random effects model was used to estimate the standardized mean difference (SMD) with 95% confidence intervals (CI).Results: Six original studies enrolling 1355 hospitalized patients with moderate to critical COVID-19 (391 in the non-survivor group and 964 in the survivor group) were considered for the final pooled analysis. When pooling together the results of these studies, D-Dimer levels were found to be higher in non-survivors than in-survivors. The SMD in D-Dimer levels between non-survivors and survivors was 3.59μg/L (95% CI 2.79-4.40μg/L), and the Z-score for overall effect was 8.74 (P

Background Guidelines remain unclear over whether patients with early stage oral cancer without overt neck disease benefit from upfront elective neck dissection (END), particularly those with the smallest tumours. Methods We conducted a randomised trial of patients with stage T1/T2 N0 disease, who had their mouth tumour resected either with or without END. Data were also collected from a concurrent cohort of patients who had their preferred surgery. Endpoints included overall survival (OS) and disease-free survival (DFS). We conducted a meta-analysis of all six randomised trials. Results Two hundred fifty randomised and 346 observational cohort patients were studied (27 hospitals). Occult neck disease was found in 19.1% (T1) and 34.7% (T2) patients respectively. Five-year intention-to-treat hazard ratios (HR) were: OS HR = 0.71 (p = 0.18), and DFS HR = 0.66 (p = 0.04). Corresponding per-protocol results were: OS HR = 0.59 (p = 0.054), and DFS HR = 0.56 (p = 0.007). END was effective for small tumours. END patients experienced more facial/neck nerve damage; QoL was largely unaffected. The observational cohort supported the randomised findings. The meta-analysis produced HR OS 0.64 and DFS 0.54 (p Conclusion SEND and the cumulative evidence show that within a generalisable setting oral cancer patients who have an upfront END have a lower risk of death/recurrence, even with small tumours. Clinical Trial Registration NIHR UK Clinical Research Network database ID number: UKCRN 2069 (registered on 17/02/2006), ISCRTN number: 65018995, ClinicalTrials.gov Identifier: NCT00571883.

We used multicenter international data from the International Society of Heart and Lung Transplantation Mechanically Assisted Circulation Support (IMACS) registry to determine bloodstream infection (BSI) event rate, independent risk factors, and association with mortality.Included were patients registered in IMACS from January 2013 through December 2015, assessed BSI event rate of mechanical circulatory support (MCS) and non-MCS-related BSIs, and conducted univariate and multivariate analyses between BSI with baseline characteristics and mortality.We documented 1,606 BSIs in 1,231 of 10,171 MCS recipients (12%), with an event rate of 2.43 BSIs/100 patient-months within 3 months after implant (early onset) and 1.03 BSIs/100 patient-months after 3 months (late onset). Of these episodes, 1,378 (85.8%) were non- MCS-related BSI. Increasing body mass index and bilirubin were independent correlates of MCS-related BSI. Independent correlates of non-MCS-related BSI included older age, higher body mass index, previous cardiac surgery, baseline chronic renal disease and dialysis, pre-implant frailty, presence of biventricular assist device, total artificial heart or right ventricular assist device, and Interagency Registry for Mechanically Assisted Circulatory Support category 1. Survival after 3 months after implant of patients who developed early-onset BSI was 56.9% at 24 months vs 77.4% in patients without early-onset BSI (p0.001). Early-onset BSI was an independent correlate of mortality at 3 months after implantation (hazard ratio, 2.56; 95% confidence interval, 2.09-3.15; p0.001).Early-onset BSI was associated with significantly increased 24-month mortality. More than 85% of these BSIs were not device related. There is an opportunity for infection prevention practices to decrease the BSI event rate, which may affect 24-month survival. These data can also serve as benchmarking for individual institutions.

Background Utilization of total knee and hip arthroplasty has greatly increased in the past decade in the United States; these are among the most expensive procedures in patients with Medicare. Advances in surgical techniques, anesthesia, and care pathways decrease hospital length of stay. We examined how trends in hospital cost were altered by decreases in length of stay. Methods Procedure, demographic, and economic data were collected on 6.4 million admissions for total knee arthroplasty and 2.8 million admissions for total hip arthroplasty from 2002 to 2013 using the National (Nationwide) Inpatient Sample, a component of the Healthcare Cost and Utilization Project. Trends in mean hospital costs and their association with length of stay were estimated using inflation-adjusted, survey-weighted generalized linear regression models, controlling for patient demographic characteristics and comorbidity. Results From 2002 to 2013, the length of stay decreased from a mean time of 4.06 to 2.97 days for total knee arthroplasty and from 4.06 to 2.75 days for total hip arthroplasty. During the same time period, the mean hospital cost for total knee arthroplasty increased from $14,988 (95% confidence interval [CI], $14,927 to $15,049) in 2002 to $22,837 (95% CI, $22,765 to $22,910) in 2013 (an overall increase of $7,849 or 52.4%). The mean hospital cost for total hip arthroplasty increased from $15,792 (95% CI, $15,706 to $15,878) in 2002 to $23,650 (95% CI, $23,544 to $23,755) in 2013 (an increase of $7,858 or 49.8%). If length of stay were set at the 2002 mean, the growth in cost for total knee arthroplasty would have been 70.8% instead of 52.4% as observed, and the growth in cost for total hip arthroplasty would have been 67.4% instead of 49.8% as observed. Conclusions Hospital costs for joint replacement increased from 2002 to 2013, but were attenuated by reducing inpatient length of stay. With demographic characteristics showing an upward trend in the utilization of joint arthroplasty, including a shift toward younger population groups, reduction in length of stay remains an important target for procedure-level cost containment under emerging payment models.

Background: Class II histone deacetylase (HDAC) inhibitors induce hypoxia-inducible factor-1 and -2α degradation and have antitumour effects in combination with vascular endothelial growth factor (VEGF) inhibitors. In this study, we tested the safety and efficacy of the HDAC inhibitor vorinostat and the VEGF blocker bevacizumab in metastatic clear-cell renal cell carcinoma (ccRCC) patients previously treated with different drugs including sunitinib, sorafenib, axitinib, interleukin-2, interferon, and temsirolimus. Methods: Patients with up to two prior regimens were eligible for treatment, consisting of vorinostat 200 mg orally two times daily × 2 weeks, and bevacizumab 15 mg kg−1 intravenously every 3 weeks. The primary end points were safety and tolerability, and the proportion of patients with 6 months of progression-free survival (PFS). Correlative studies included immunohistochemistry, FDG PET/CT scans, and serum analyses for chemokines and microRNAs. Results: Thirty-six patients were enrolled, with 33 evaluable for toxicity and efficacy. Eighteen patients had 1 prior treatment, 13 patients had 2 prior treatments, and 2 patients were treatment naïve. Two patients experienced grade 4 thrombocytopenia and three patients had grade 3 thromboembolic events during the course of exposure. We observed six objective responses (18%), including one complete response and five partial responses. The proportion of patients with PFS at 6 months was 48%. The median PFS and overall survival were 5.7 months (confidence interval (CI): 4.1–11.0) and 13.9 months (CI: 9.8–20.7), respectively. Correlative studies showed that modulation of specific chemokines and microRNAs were associated with clinical benefit. Conclusions: The combination of vorinostat with bevacizumab as described is relatively well tolerated. Response rate and median PFS suggest clinical activity for this combination strategy in previously treated ccRCC.

PROBLEM ADDRESSED: Adults with intellectual and developmental disabilities (IDD) are a complex population that could benefit from improved care coordination across health and social sectors, as they experience poorer health and have higher rates of emergency department use and hospitalization due to ambulatory care–sensitive conditions. OBJECTIVE OF PROGRAM: To pilot a novel, enhanced model of care coordination for complex patients with IDD. PROGRAM DESCRIPTION: Health Links is a provincial care-coordination program for patients with complex health care needs. This pilot program adapted Health Links to include a guide and training specific to adults with IDD to ensure that these patients’ needs were met and high-quality, efficient care was provided. CONCLUSION: A tailored care-coordination approach for adults with IDD was able to identify complex patients in need and successfully bridge cross-sectoral care.

Study design An analysis of the State Inpatient Database of North Carolina, 2005 to 2012, and the Nationwide Inpatient Sample, including all inpatient lumbar fusion admissions from nonfederal hospitals. Objective The aim of the study was to examine the influence of a major commercial policy change that restricted lumbar fusion for certain indications and to forecast the potential impact if the policy were adopted nationally. Summary of background data Few studies have examined the effects of recent changes in commercial coverage policies that restrict the use of lumbar fusion. Methods We included adults undergoing elective lumbar fusion or re-fusion operations in North Carolina. We aggregated data into a monthly time series to report changes in the rates and volume of lumbar fusion operations for disc herniation or degeneration, spinal stenosis, spondylolisthesis, or revision fusions. Time series regression models were used to test for significant changes in the use of fusion operation following a major commercial coverage policy change initiated on January 1, 2011. Results There was a substantial decline in the use of lumbar fusion for disc herniation or degeneration following the policy change on January 1, 2011. Overall rates of elective lumbar fusion operations in North Carolina (per 100,000 residents) increased from 103.2 in 2005 to 120.4 in 2009, before declining to 101.9 by 2012. The population rate (per 100,000 residents) of fusion among those under age 65 increased from 89.5 in 2005 to 101.2 in 2009, followed by a sharp decline to 76.8 by 2012. There was no acceleration in the already increasing rate of fusion for spinal stenosis, spondylolisthesis, or revision procedures, but there was a coincident increase in decompression without fusion. Conclusion This commercial insurance policy change had its intended effect of reducing fusion operations for indications with less evidence of effectiveness without changing rates for other indications or resulting in an overall reduction in spine surgery. Nevertheless, broader adoption of the policy could significantly reduce the national rates of fusion operations and associated costs. Level of evidence 3.

A surgical procedure is a complex behavior that can be constructed from foundation or component behaviors. Both the component and the composite behaviors built from them are much more likely to recur if it they are reinforced (operant learning). Behaviors in humans have been successfully reinforced using the acoustic stimulus from a mechanical clicker, where the clicker serves as a conditioned reinforcer that communicates in a way that is language- and judgment-free; however, to our knowledge, the use of operant-learning principles has not been formally evaluated for acquisition of surgical skills.Two surgical tasks were taught and compared using two teaching strategies: (1) an operant learning methodology using a conditioned, acoustic reinforcer (a clicker) for positive reinforcement; and (2) a more classical approach using demonstration alone. Our goal was to determine whether a group that is taught a surgical skill using an operant learning procedure would more precisely perform that skill than a group that is taught by demonstration alone.Two specific behaviors, "tying the locking, sliding knot" and "making a low-angle drill hole," were taught to the 2014 Postgraduate Year (PGY)-1 class and first- and second-year medical students, using an operant learning procedure incorporating precise scripts along with acoustic feedback. The control groups, composed of PGY-1 and -2 nonorthopaedic surgical residents and first- and second-year medical students, were taught using demonstration alone. The precision and speed of each behavior was recorded for each individual by a single experienced surgeon, skilled in operant learning. The groups were then compared.The operant learning group achieved better precision tying the locking, sliding knot than did the control group. Twelve of the 12 test group learners tied the knot and precisely performed all six component steps, whereas only four of the 12 control group learners tied the knot and correctly performed all six component steps (the test group median was 10 [range, 10-10], the control group median was 0 [range, 0-10], p = 0.004). However, the median "time to tie the first knot" for the test group was longer than for the control group (test group median 271 seconds [range, 184-626 seconds], control group median 163 seconds [range 93-900 seconds], p = 0.017), whereas the "time to tie 10 of the locking, sliding knots" was the same for both groups (test group mean 95 seconds ± SD = 15 [range, 67-120 seconds], control group mean 95 seconds ± SD = 28 [range, 62-139 seconds], p = 0.996). For the low-angle drill hole test, the test group more consistently achieved the ideal six-step behavior for precisely drilling the low-angle hole compared with the control group (p = 0.006 for the median number of technique success comparison with an odds ratio [at the 95% confidence interval] of 82.3 [29.1-232.8]). The mean time to drill 10 low-angle holes was not different between the test group (mean 193 seconds ± SD = 26 [range, 153-222 seconds]) and the control group (mean 146 seconds ± SD = 63 [range, 114-294 seconds]) (p = 0.084).Operant learning occurs as the behavior is constructed and is highly reinforced with the result measured, not in the time saved, but in the ultimate outcome of an accurately built complex behavior.Level II, therapeutic study.

Despite widespread use of behavioral observations to evaluate child feeding behaviors in research and clinical practice, few studies have comprehensively characterized mealtimes or identified features that differentiate children with and without disordered feeding; these were the aims of the current study. Mealtime observations were conducted for 18 children with avoidant restrictive food intake disorder (ARFID) and 21 typically developing children. Observations were coded inductively, and associations between disorder and observed mealtime actions were examined. Most behaviors were observed across both clinical and nonclinical mealtimes, and many did not differ in frequency between children with and without ARFID. However, significant group differences were observed in the frequencies of behaviors relating to food intake, visual and physical engagement with feeding, and movement during mealtimes. The comparability of behaviors across clinical and nonclinical groups suggests that eating behaviors exist on a continuum from "normal" to "abnormal," with group differences relating to frequency rather than type of behavior. The behavioral differences observed in this study suggest that identification of children with ARFID should focus on child engagement with food and restlessness during mealtimes. Reliance on emotional and escape-maintained behaviors will lead to underrecognition of families in need of clinical support.

Background: As the population of older adults continues to increase, the dissemination of strategies to maintain independence of older persons is of critical public health importance. Recent large-scale clinical trial evidence has definitively shown intervention of moderate-intensity physical activity (PA) reduces major mobility disability in at-risk older adults. However, it remains unknown whether structured PA interventions, with demonstrated efficacy in controlled, clinical environments, can be successfully disseminated into community settings to benefit wider populations of older adults. Objective: To assess the dissemination of an evidence-based PA program for older adults by evaluating program participation and its impact on mobility, strength and quality of life. Setting: An urban senior center. Participants: Fifty older adults (71.2 ± 8 years aged; BMI: 30.1 ± 7 kg/m2). Intervention: Average of 8.0 ± 1.8 months of participation in the Fit-4-Life Program, a community-based PA and nutrition counseling intervention. Measurements: Mobility (Short Physical Performance Battery (SPPB)), self-reported physical activity (CHAMPS questionnaire), leg strength, grip strength, and quality of life (Quality of Well-Being Self-Administered (QWB-SA) scale) were assessed at baseline and follow-up. Results: Mean attendance was 55.8%. Fourteen participants were lost to follow-up. Those who dropped-out engaged in less PA at baseline (78 ± 108 mins/wk) compared to those who completed follow-up (203 ± 177 mins/wk, P=0.01). Participants exhibited sustained increases of PA (65 ± 153 mins/wk, P= 0.08), and there were meaningful improvements in SPPB (0.5 ± 0.2, P< 0.01), knee extensor strength (2.6 ± 4.4 kg, P< 0.01) and QWB-SA (0.04 ± 0.09, P= 0.05). Conclusion: The dissemination of a clinically efficacious PA intervention into a community-based setting can improve mobility, strength and quality of life for older adults. This knowledge may be helpful for the design and implementation of larger-scale PA intervention studies designed to preserve mobility in older adults within community-based settings.

Nucleic acid testing (NAT) for hepatitis C virus (HCV) is recommended for screening of organ donors, yet not all donor infections may be detected. We describe three US clusters of HCV transmission from donors at increased risk for HCV infection. Donor's and recipients' medical records were reviewed. Newly infected recipients were interviewed. Donor-derived HCV infection was considered when infection was newly detected after transplantation in recipients of organs from increased risk donors. Stored donor sera and tissue samples were tested for HCV RNA with high-sensitivity quantitative PCR. Posttransplant and pretransplant recipient sera were tested for HCV RNA. Quasispecies analysis of hypervariable region-1 was used to establish genetic relatedness of recipient HCV variants. Each donor had evidence of injection drug use preceding death. Of 12 recipients, 8 were HCV-infected-6 were newly diagnosed posttransplant. HCV RNA was retrospectively detected in stored samples from donor immunologic tissue collected at organ procurement. Phylogenetic analysis showed two clusters of closely related HCV variants from recipients. These investigations identified the first known HCV transmissions from increased risk organ donors with negative NAT screening, indicating very recent donor infection. Recipient informed consent and posttransplant screening for blood-borne pathogens are essential when considering increased risk donors.

Posttransplant lymphoproliferative disorder (PTLD) is an infrequent but serious complication of solid organ transplantation. Early detection and initiation of therapy may improve outcomes. The purpose of this study was to identify human leukocyte antigen (HLA) type as risk and prognostic factors for PTLD.A review was undertaken to identify PTLD cases treated at our institution over the past 25 years. Logistic regression and Cox Proportional Hazards were used to model risk factors for PTLD and clinical outcomes in patients with PTLD.One hundred six cases of PTLD were identified with 1392 solid-organ transplant recipient controls. Epstein-Barr virus (EBV) seronegative status pretransplant (odds ratio [OR] = 7.61, 95% confidence interval [95% CI] = 3.83-15.1) and receipt of a nonkidney transplant were associated with an increased risk of PTLD. Being African American and receipt of a living-related kidney transplant were associated with a decreased risk of PTLD. The HLA-B40 group was a risk factor for PTLD in EBV-seronegative individuals (OR = 8.38, 95% CI = 2.18-32.3), whereas HLA-B8 was a risk factor for PTLD in EBV-seropositive individuals (OR = 3.29, 95% CI = 1.52-7.09). Specific HLA types were not associated with graft failure or mortality after PTLD diagnosis. In PTLD patients, central nervous system (CNS) involvement, bone marrow involvement, T-cell PTLD, and age were associated with increased mortality.Human leukocyte antigen-B40 group and HLA-B8 were identified as novel susceptibility factors for PTLD in EBV-seropositive and EBV-seronegative individuals, respectively. Multicentered, large prospective studies of PTLD with correlative immunologic work are needed to test the significance of these observed associations.

Evaluate whether mortality after discharge is elevated in geriatric fracture patients whose lower extremity weight-bearing is restricted.Retrospective cohort study SETTING: Urban Level 1 trauma center PATIENTS/PARTICIPANTS: 1746 patients65 years of age INTERVENTION: Post-operative lower extremity weight-bearing status MAIN OUTCOME MEASURE: Mortality, as determined by the Social Security Death Index RESULTS: Univariate analysis demonstrated that patients who were weight-bearing as tolerated on bilateral lower extremities (BLE) had significantly higher 5-year mortality compared to patients with restricted weight-bearing on one lower extremity and restricted weight-bearing on BLE (30%, 21% and 22% respectively, p 0.001). Cox regression analysis controlling for variables including age, Charlson Comorbidity Index, Injury Severity Scale, combined UE/LE injury, injury mechanism (high vs low), sex, BMI and GCS demonstrated that, in comparison to patients who were weight bearing as tolerated on BLE, restricted weight-bearing on one lower extremity had a hazard ratio (HR) of 0.97 (95% confidence interval 0.78 to 1.20, p = 0.76) and restricted weight-bearing in BLE had a HR of 0.91 (95% confidence interval 0.60 to 1.36, p = 0.73).In geriatric patients, prescribed weight-bearing status did not have a statistically significant association with mortality after discharge, when controlling for age, sex, body mass index, medical comorbidities, Injury Severity Scale (ISS), mechanism of injury, nonoperative treatment and admission GCS. This remained true in when the analysis was restricted to operative injuries only.

Study Design. Retrospective analysis of Medicare claims linked to hospital participation in the Center for Medicare and Medicaid Innovation's episode-based Bundled Payment for Care Improvement (BPCI) program for lumbar fusion. Objective. To describe the early effects of BPCI participation for lumbar fusion on 90-day reimbursement, procedure volume, reoperation, and readmission. Summary of Background Data. Initiated on January 1, 2013, BPCI's voluntary bundle payment program provides a predetermined payment for services related to a Diagnosis-Related Group-defined “triggering event” over a defined time period. As an alternative to fee-for-service, these reforms shift the financial risk of care on to hospitals. Methods. We identified fee-for-service beneficiaries over age 65 undergoing a lumbar fusion in 2012 or 2013, corresponding to the years before and after BPCI initiation. Hospitals were grouped based on program participation status as nonparticipants, preparatory, or risk-bearing. Generalized estimating equation models adjusting for patient age, sex, race, comorbidity, and hospital size were used to compare changes in episode costs, procedure volume, and safety indicators based on hospital BPCI participation. Results. We included 89,605 beneficiaries undergoing lumbar fusion, including 36% seen by a preparatory hospital and 7% from a risk-bearing hospital. The mean age of the cohort was 73.4 years, with 59% women, 92% White, and 22% with a Charlson Comorbidity Index of 2 or more. Participant hospitals had greater procedure volume, bed size, and total discharges. Relative to nonparticipants, risk-bearing hospitals had a slightly increased fusion procedure volume from 2012 to 2013 (3.4% increase vs. 1.6% decrease, P = 0.119), did not reduce 90-day episode of care costs (0.4% decrease vs. 2.9% decrease, P = 0.044), increased 90-day readmission rate (+2.7% vs. −10.7%, P = 0.043), and increased repeat surgery rates (+30.6% vs. +7.1% points, P = 0.043). Conclusion. These early, unintended trends suggest an imperative for continued monitoring of BPCI in lumbar fusion. Conclusion. Level of Evidence: 3

This pilot, open-protocol study examined whether scalp application of red and near-infrared (NIR) light-emitting diodes (LED) could improve cognition in patients with chronic, mild traumatic brain injury (mTBI). Application of red/NIR light improves mitochondrial function (especially in hypoxic/compromised cells) promoting increased adenosine triphosphate (ATP) important for cellular metabolism. Nitric oxide is released locally, increasing regional cerebral blood flow. LED therapy is noninvasive, painless, and non-thermal (cleared by the United States Food and Drug Administration [FDA], an insignificant risk device). Eleven chronic, mTBI participants (26-62 years of age, 6 males) with nonpenetrating brain injury and persistent cognitive dysfunction were treated for 18 outpatient sessions (Monday, Wednesday, Friday, for 6 weeks), starting at 10 months to 8 years post- mTBI (motor vehicle accident [MVA] or sports-related; and one participant, improvised explosive device [IED] blast injury). Four had a history of multiple concussions. Each LED cluster head (5.35 cm diameter, 500 mW, 22.2 mW/cm(2)) was applied for 10 min to each of 11 scalp placements (13 J/cm(2)). LEDs were placed on the midline from front-to-back hairline; and bilaterally on frontal, parietal, and temporal areas. Neuropsychological testing was performed pre-LED, and at 1 week, and 1 and 2 months after the 18th treatment. A significant linear trend was observed for the effect of LED treatment over time for the Stroop test for Executive Function, Trial 3 inhibition (p=0.004); Stroop, Trial 4 inhibition switching (p=0.003); California Verbal Learning Test (CVLT)-II, Total Trials 1-5 (p=0.003); and CVLT-II, Long Delay Free Recall (p=0.006). Participants reported improved sleep, and fewer post-traumatic stress disorder (PTSD) symptoms, if present. Participants and family reported better ability to perform social, interpersonal, and occupational functions. These open-protocol data suggest that placebo-controlled studies are warranted.

The objectives of this study were (1) to identify distinct subtypes of older Korean immigrants based on their levels of religiosity/spirituality (R/S) and (2) to determine if the identified subtypes differed by demographic characteristics, perceived health, depression, and life satisfaction.Factor mixture models were evaluated with a nonprobability sample of older Korean immigrants (N=200) residing in the New York City area in 2009 to classify typologies of R/S. Multiple regression was used to test the associations between the R/S subtypes and outcomes (perceived health, depression, and life satisfaction) while controlling for demographics.Two substantively distinct latent profiles were identified: normally religious/spiritual ('average R/S') and minimally religious/spiritual ('low R/S'). The average R/S subgroup (74.4%) showed higher means than those in the low R/S subgroup (25.6%) on all six R/S class indicators. Subtypes did not differ on age, education, income, marital status, living arrangements, or years in the USA. However, males were more likely than females to be 'average R/S.' The 'average R/S' subtype had significantly greater life satisfaction than their 'low R/S' counterpart. No differences between the two subtypes were found on perceived health or depression.Findings highlight the importance of the classifications of R/S for mental health outcomes, and they indicate that relationships among R/S, various demographic characteristics, and physical/mental health are complex. Future research should validate and refine this classification of R/S in order to help identify particular sources of health risks/behaviors, relevant treatments, and health-promoting interventions within homogenous subtypes of older Korean immigrants.

Adjuvant-induced arthritis in rats decreases body weight and muscle mass. Melanocyte stimulating hormone administration to arthritic rats decreases inflammation and skeletal muscle wasting. In this study, we investigate whether activation of melanocortin-4 receptor by RO27-3225 administration is able to prevent the effect of arthritis on the expression of muscle-specific E3 ubiquitin ligases and MyoD in two different muscles, gastrocnemius (a mainly fast type muscle) and soleus (slow type). Arthritis was induced in male Wistar rats by intradermal injection of Freund's adjuvant. Control and arthritic rats were injected with RO27-3225 (180 μg/kg i.p. twice a day) or saline, for 8 days. Body weight change, food intake and arthritis index were assessed daily. After sacrifice, serum insulin-like growth factor -1 (IGF-1) and corticosterone, as well as nuclear factor-κB(p65), cyclooxygenase-2 (COX-2), atrogene and MyoD in gastrocnemius and soleus were analysed. Administration of RO27-3225 to arthritic rats decreased arthritis scores, hind paw volume as well as nuclear factor-κB(p65) phosphorylation in gastrocnemius and soleus. However, RO27-3225 was not able to modify the effects of arthritis on serum IGF-1 and corticosterone. RO27-3225 ameliorates arthritis-induced decrease in food intake, body weight gain, epidydimal white adipose tissue and soleus weight, but not in gastrocnemius weight. Arthritis increased COX-2, atrogin-1 and MuRF1 expression in gastrocnemius and soleus, whereas RO27-3225 prevented this increase in soleus but not in gastrocnemius. Arthritis also increased MyoD expression in gastrocnemius and soleus (P0.01). RO27-3225 decreased MyoD expression in gastrocnemius but not in soleus of arthritic rats. In control rats RO27-3225 did not modify MyoD expression in gastrocnemius or soleus. In conclusion, our data suggest that in arthritic rats, RO27-3225 treatment decreases inflammation and muscle atrophy, preventing atrogene upregulation in slow type muscle but not in gastrocnemius. The lack of effect in the gastrocnemius can be related to the inability of RO27-3225 to prevent arthritis-induced corticosterone upregulation as well as IGF-1 downregulation.

The file attached to this record is the author's final peer reviewed version. The Publisher's final version can be found by following the DOI link. This study assessed the specificity and sensitivity of two commonly used psychometric methods to assess ARFID in children. To achieve this, a sample of 329 mothers and one father completed the Behavioral Pediatrics Feeding Assessment Scale (BPFAS) and the Child Food Neophobia Scale (CFNS). A Receiver Operating Characteristic (ROC) analysis indicated that both measures were able to successfully differentiate a known clinical sample from those of typically developing population. Although the BPFAS was more accurate at differentiating ARFID from the general population, the CFNS was acceptable and on some metrics better than its longer counterpart. The ability of a food neophobia scale to differentiate clinical and population samples, and detect gradation of food avoidance within the population sample, suggests that the multitude of psychometric measures available may be measuring similar constructs. Therefore, confidence can be expected in cross-site comparisons despite each using different psychometric measures of food avoidance in children.

Regionalization of perinatal care has been developed to improve the survival of preterm babies. The mortality rate is higher among very premature infants born outside level-3 maternity units. The objective of this study was to evaluate the preventability of these very premature births occurring outside recommendations within level-2B maternity units. The secondary objective was to describe the care of premature infants between 23 and 24 weeks.This is a single-center retrospective qualitative study of the care delivery pathways. Thirty-one deliveries in which the fetus was alive between 23 and 30 weeks+6 days occurred in a level-2B maternity unit in Thionville, France, between 1 January 2013 and 31 December 2015. After oral presentation of the cases, a level 2-3 multidisciplinary committee of experts in Lorraine evaluated the preventability criteria and reasons, and divided the deliveries into three groups: (i) birth in level-2B institutions avoidable, (ii) inevitable with factors related to the mother or the organization of care, (iii) with no inevitable factors.Out of the 31 deliveries included, the committee classified six deliveries as preventable, 14 as inevitable with factors, and 11 as inevitable with no factors. The criteria for preventability of birth in a level-2B unit were underestimation of maternal and fetal risk, an erroneous initial estimate of term or preterm labor, and two births in the upper limits of the French recommendations for in utero transfer. Nineteen of the 35 premature infants before 31 weeks' gestation died, 16 children were transferred to a level-3 maternity ward, and 16 children were allowed to go home.Analysis of the obstetrical-pediatric care course by an expert committee determined the preventability of the average birth and prematurity in level-2B maternity units in Lorraine for a small but significant number of cases. The local regionalization of neonatal care could be improved by the application of this method of analysis to other maternity wards in the Lorraine network.

Background Context Minimally invasive lumbar spinal stenosis procedures have uncertain long-term value. Purpose This study sought to characterize factors affecting the long-term cost-effectiveness of such procedures using interspinous spacer devices (“spacers”) relative to decompression surgery as a case study. Study Design Model-based cost-effectiveness analysis. Patient Sample The Medicare Provider Analysis and Review database for the years 2005–2009 was used to model a group of 65-year-old patients with spinal stenosis who had no previous spine surgery and no contraindications to decompression surgery. Outcome Measures Costs, quality-adjusted life years (QALYs), and cost per QALY gained were the outcome measures. Methods A Markov model tracked health utility and costs over 10 years for a 65-year-old cohort under three care strategies: conservative care, spacer surgery, and decompression surgery. Incremental cost-effectiveness ratios (ICER) reported as cost per QALY gained included direct medical costsfor surgery. Medicare claims data were used to estimate complication rates, reoperation, and related costs within 3 years. Utilities and long-term reoperation rates for decompression were derived frompublished studies. Spacer failure requiring reoperation beyond 3 years and post-spacer health utilities are uncertain and were evaluated through sensitivity analyses. In the base-case, the spacer failure rate was held constant for years 4–10 (cumulative failure: 47%). In a “worst-case” analysis, the 10-year cumulative reoperation rate was increased steeply (to 90%). Threshold analyses were performed to determine the impact of failure and post-spacer health utility on the cost-effectiveness of spacer surgery. Results The spacer strategy had an ICER of $89,500/QALY gained under base-case assumptions, and remained under $100,000 as long as the 10-year cumulative probability of reoperation did not exceed 54%. Under worst-case assumptions, the spacer ICER was $482,000/QALY and fell below $100,000 only if post-spacer utility was 0.01 greater than post-decompression utility or the cost of spacer surgery was $1,600 less than the cost of decompression surgery. Conclusions Spacers may provide a reasonably cost-effective initial treatment option for patients with lumbar spinal stenosis. Their value is expected to improve if procedure costs are lower in outpatient settings where these procedures are increasingly being performed. Decision analysis is useful for characterizing the long-term cost-effectiveness potential for minimally invasive spinal stenosis treatments and highlights the importance of complication rates and prospective health utility assessment.

Retrospective analysis of patients undergoing elective lumbar fusion operations, comparing rates of repeat spine surgery based on method of ascertainment. We report the accuracy of a claims-based approach for reporting repeat surgery compared to medical records abstraction as the “gold standard.” Previous studies have reported the validity of a claims-based algorithm for grouping patients by surgical indication and classifying operative features, but their accuracy in measuring surgical quality indicators has not been widely examined. We identified a subset of patients undergoing elective lumbar fusion operations at a single institution from 1996–2011, excluding those with spinal fracture, spinal cord injury, or cancer. From the medical record we abstracted the incidence of repeat spine operation or re-hospitalization at one-year. We cross-classified each event record with its corresponding value derived from claims. The sensitivity and specificity of the claims-based approach were calculated for reoperation within 30, 90, and 365 days, and all-cause hospital readmission within 30 days. Medical records linked to claims data were obtained for 520 patients undergoing elective lumbar fusion. Reoperation rates based on chart review were 1.0%, 1.3%, 3.6%, compared to 0.8%, 1.7%, and 3.8% based on the final claims methods at 30, 90, and 365 days, respectively. The claims-based algorithm had sensitivities of 80.0%, 100%, and 94.1% and specificities of 100%, 99.6%, 99.2% for repeat surgery within 30, 90, and 365 days, respectively. The sensitivity for all-cause readmission was 50%. Health care quality improvement efforts often rely on administrative data to report surgical safety. We found that claims-based ascertainment of safety at a single institution was very accurate. However, accuracy depended on careful attention to the timing of outcomes, as well as the definitions and coding of repeat surgery, including how orthopaedic device removal codes are classified. Level of Evidence: 3

Background: Recombinant bone morphogenetic proteins (BMPs) are growth factors utilized in lumbar arthrodeses. Limited data from randomized trials suggest that BMP may increase cancer risk. We sought to evaluate cancer risk and mortality following the use of BMP in lumbar arthrodesis. Methods: Within the linked Surveillance, Epidemiology, and End Results (SEER) Program-Medicare cohort, we conducted a case-cohort study of 7,278 individuals who were ≥65 years of age and had undergone a lumbar arthrodesis from 2004 to 2011. Of these patients, 3,627 were individuals in a 5% random subcohort of Medicare enrollees in SEER areas including 191 who developed cancer, and there were 3,651 individuals outside the subcohort who developed cancer. Weighted Cox proportional-hazards regression was used to estimate hazard ratios (HRs) and 95% confidence intervals (95% CIs) for cancer on the basis of exposure to BMP. Results: In the SEER-Medicare subcohort, 30.7% of individuals who underwent a lumbar arthrodesis received BMP. BMP was not associated with overall cancer risk in univariate analyses (HR, 0.92 [95% CI, 0.82 to 1.02]) or after adjustment for demographic characteristics, comorbidities, hospital size, history of cancer, and calendar year (adjusted HR, 0.94 [95% CI, 0.84 to 1.05]). Individual cancer types were also not significantly elevated (p > 0.05 for all) in BMP users compared with nonusers. In addition, BMP use was not associated with a new cancer in people who had cancer prior to undergoing lumbar arthrodesis (adjusted HR, 1.04 [95% CI, 0.71 to 1.52]) or with mortality after a cancer diagnosis (adjusted HR, 1.05 [95% CI, 0.93 to 1.19]). Conclusions: In a large population of elderly U.S. adults undergoing lumbar arthrodesis, BMP use was not associated with cancer risk or mortality. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Background/Objective Papular epidermal nevus with skyline basal cell layer (PENS) is a recently described type of epidermal nevus with characteristic histopathologic findings, mainly regular, rectangular acanthosis and a well-demarcated basal cell layer with clear palisading and separation between basal cell nuclei and the first row of Malpighian cell nuclei. Although the first reports described randomly distributed lesions appearing sporadically in otherwise healthy patients, cases of Blaschkoid distribution, lesions associated with extracutaneous manifestations, and familial cases have been reported. Methods We performed a review of the clinical charts of all patients with histologic diagnosis of PENS in our hospital. We evaluated epidemiologic, clinical, and histologic features. We then reviewed the literature with a particular emphasis on the presence or absence of extra-cutaneous associations. Results Three patients with PENS are described. One had a single lesion, one had three lesions, and one, a patient with mild developmental delay, a curved penis, and hypospadias, had multiple lesions. Conclusion The probability of having extracutaneous manifestations is 6.3 times as great in individuals with more than four lesions. Therefore these patients may need closer follow-up.

Background: Surgical site infection after spine surgery is a well-known complication that can result in poor outcomes, arthrodesis-site nonunion, and neurological injury. We hypothesized that a higher surgical invasiveness score will increase the risk for surgical site infection following spine surgery. Methods: Data were examined from patients undergoing any type of spinal surgery from January 1, 2003, to December 31, 2004, at two academic hospitals. The surgical invasiveness index is a previously validated instrument that accounts for the number of vertebral levels decompressed, arthrodesed, or instrumented as well as the surgical approach. Relative risks and 95% confidence intervals were calculated for each of the categorical variables. Multivariate binomial stepwise logistic regression was used to examine the association between surgical invasiveness and surgical site infection requiring a return to the operating room for treatment, adjusting for confounding risk factors. Results: The regression analysis of 1532 patients who were evaluated for surgical site infection identified the following significant risk factors for surgical site infection: a body mass index of >35 (relative risk, 2.24 [95% confidence interval, 1.21 to 3.86]; p = 0.01), hypertension (relative risk, 1.73 [95% confidence interval, 1.05 to 2.85]; p = 0.03), thoracic surgery versus cervical surgery (relative risk, 2.57 [95% confidence interval, 1.20 to 5.60]; p = 0.01), lumbosacral surgery versus cervical surgery (relative risk, 2.03 [95% confidence interval, 1.10 to 4.05]; p = 0.02), and a surgical invasiveness index of >21 (relative risk, 3.15 [95% confidence interval, 1.37 to 6.99]; p = 0.01). Conclusions: Patients undergoing more invasive spine surgery as measured with the surgical invasiveness index had greater risk for having a surgical site infection that required a return to the operating room for treatment. Surgical invasiveness was the strongest risk factor for surgical site infection, even after adjusting for medical comorbidities, age, and other known risk factors. The magnitude of this association should be considered during surgical decision-making and intraoperative and postoperative care of the patient. These findings further validate the importance of the invasiveness index when performing safety and clinical outcome comparisons for spine surgery. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

This study sought to discover if an optimum 1 cm(2) area in the non-damaged right hemisphere (RH) was present, which could temporarily improve naming in chronic, nonfluent aphasia patients when suppressed with repetitive transcranial magnetic stimulation (rTMS). Ten minutes of slow, 1Hz rTMS was applied to suppress different RH ROIs in eight aphasia cases. Picture naming and response time (RT) were examined before, and immediately after rTMS. In aphasia patients, suppression of right pars triangularis (PTr) led to significant increase in pictures named, and significant decrease in RT. Suppression of right pars opercularis (POp), however, led to significant increase in RT, but no change in number of pictures named. Eight normals named all pictures correctly; similar to aphasia patients, RT significantly decreased following rTMS to suppress right PTr, versus right POp. Differential effects following suppression of right PTr versus right POp suggest different functional roles for these regions.

Background: For carefully selected patients with lumbar stenosis, decompression surgery is more efficacious than nonoperative treatment. However, some patients undergo repeat surgery, often because of complications, the failure to achieve solid fusion following arthrodesis procedures, or persistent symptoms. We assessed the probability of repeat surgery following operations for the treatment of lumbar stenosis and examined its association with patient age, comorbidity, previous surgery, and the type of surgical procedure. Methods: We performed a retrospective cohort analysis of Medicare claims. The index operation was performed in 2004 (n = 31,543), with follow-up obtained through 2008. Operations were grouped by complexity as decompression alone, simple arthrodesis (one or two disc levels and a single surgical approach), or complex arthrodesis (more than two disc levels or combined anterior and posterior approach). Reoperation rates were calculated for each follow-up year, and the time to reoperation was analyzed with proportional hazards models. Results: The probability of repeat surgery fell with increasing patient age or comorbidity. Aside from age, the strongest predictor was previous lumbar surgery: at four years the reoperation rate was 17.2% among patients who had had lumbar surgery prior to the index operation, compared with 10.6% among those with no prior surgery (p < 0.001). At one year, the reoperation rate for patients who had been managed with decompression alone was slightly higher than that for patients who had been managed with simple arthrodesis, but by four years the rates for these two groups were identical (10.7%) and were lower than the rate for patients who had been managed with complex arthrodesis (13.5%) (p < 0.001). This difference persisted after adjusting for demographic and clinical features (hazard ratio for complex arthrodesis versus decompression 1.56, 95% confidence interval, 1.26 to 1.92). A device-related complication was reported at the time of 29.2% of reoperations following an initial arthrodesis procedure. Conclusions: The likelihood of repeat surgery for spinal stenosis declined with increasing age and comorbidity, perhaps because of concern for greater risks. The strongest clinical predictor of repeat surgery was a lumbar spine operation prior to the index operation. Arthrodeses were not significantly associated with lower rates of repeat surgery after the first postoperative year, and patients who had had complex arthrodeses had the highest rate of reoperations. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Patients who undergo Epstein-Barr virus (EBV) seromismatch (D+/R-) transplants have a higher risk for the development of post-transplant lymphoproliferative disorder (PTLD). Adult renal transplant recipients at a single institution were prospectively monitored for EBV during the first year post-transplant. Over a 2-year period, 34 patients (7.78%) were identified as being EBV D+/R-recipients. Patients who developed symptoms or had persistent viremia were pre-emptively administered rituximab. Six recipients were discharged without monitoring on the protocol. Of those six, three (50%) developed PTLD and all three lost their grafts. Twenty (60.6%) of the 34 recipients developed viremia during the first year post-transplant. Of the recipients who became viremic, six (30%) received rituximab. None of the six who received rituximab-developed PTLD. We found that recipients who were not monitored on the protocol were more likely to have PTLD and graft loss compared to those who were (p = 0.008). Post-transplant monitoring of adults who undergo EBV D+/R-kidney transplants for viremia and symptoms associated with EBV infection may prompt intervention which reduces the incidence of PTLD within the first year. Use of rituximab in preventing PTLD among patients with primary EBV infection requires further prospective study to determine its overall safety and efficacy.

article i nfo Article history: The arcuate fasciculus (AF) is a white matter pathway traditionally considered to connect left Broca's area with posterior language zones. We utilized diffusion tensor imaging (DTI) in eight healthy subjects (5 M) to track pathways in the horizontal mid-portion of the AF (hAF) to subregions of Broca's area — pars triangularis (PTr) and pars opercularis (POp); and to ventral premotor cortex (vPMC) in the right and left hemispheres (RH, LH). These pathways have previously been studied in the LH, but not in the RH. Only 1/8 subjects showed fiber tracts between PTr and hAF in the RH (also, only 1/8 in the LH). In contrast to PTr, 5/8 subjects showed fiber tracts between POp and hAF in the RH (8/8 in the LH). Fiber tracts for vPMC were similar to those of POp, where 7/8 subjects showed fiber tracts between vPMC and hAF in the RH (8/8 in the LH). Our designated hAF could have included some of the superior longitudinal fasciculus (SLF) III, because it is difficult to separate the two fiber bundles. The SLF III has been previously reported to connect supramarginal gyrus with POp and vPMC in the LH. Thus, although the present DTI study showed almost no pathways between PTr and hAF in the RH (and in the LH), robust pathways were observed between POp and/or vPMC with hAF in the RH (and in LH). These results replicate previous studies for the LH, but are new, for the RH. They could contribute to better understanding of recovery in aphasia.

Infection as a complication of long-term left ventricular assist device (LVAD) support leads to significant morbidity and mortality. Obesity, a possible risk factor for other postoperative cardiovascular surgical site infections, is an increasingly prevalent condition among recipients of LVAD devices. We retrospectively analyzed 145 LVADs that remained in place beyond 30 days over a nine-year period at a single medical institution. Statistical analysis was carried out using univariate and multivariable logistic regression and chi(2)-testing where indicated. Body mass index (BMI) had no effect on the incidence of infectious outcomes regardless of age, gender, underlying pathogen or device type. This included the morbidly obese population as well (BMI >or=40). Independent of BMI, device type did have an effect, with the HeartMate XVE increasing the risk for infections [odds ratio (OR) 4.3 with 95% confidence interval (CI) 2.1-8.8, P=0.0001] and the HeartMate II reducing the risk (OR 0.21 with 95% CI 0.09-0.50, P=0.0001). The risk for infection after LVAD placement for long-term support is likely to be a multi-factorial phenomenon. BMI, including morbid obesity, does not appear to be a statistically significant relevant factor in determining that risk. Device type may have an effect, however, on risk of infection in long-term support.

Although evidence suggests that patients with left hemisphere strokes and non-fluent aphasia who receive 1Hz repetitive transcranial magnetic stimulation (rTMS) over the intact right inferior frontal gyrus experience persistent benefits in naming, it remains unclear whether the effects of rTMS in these patients generalize to other language abilities. We report a subject with chronic non-fluent aphasia who showed stable deficits of elicited propositional speech over the course of 5 years, and received 1200 pulses of 1Hz rTMS daily for 10 days at a site identified as being optimally responsive to rTMS in this patient. Consistent with prior studies there was improvement in object naming, with a statistically significant improvement in action naming. Improvement was also demonstrated in picture description at 2, 6, and 10 months after rTMS with respect to the number of narrative words and nouns, sentence length, and use of closed class words. Compared to his baseline performance, the patient showed significant improvement on the Western Aphasia Battery (WAB) subscale for spontaneous speech. These findings suggest that manipulation of the intact contralesional cortex in patients with non-fluent aphasia may result in language benefits that generalize beyond naming to include other aspects of language production.

Objective: To present pretreatment and post-treatment language data for a nonfluent aphasia patient who received 2 treatment modalities: (1) continuous positive airway pressure (CPAP) for his sleep apnea, starting 1-year poststroke; and (2) repetitive transcranial magnetic brain stimulation (TMS), starting 2 years poststroke. Background: Language data were acquired beyond the spontaneous recovery period of 3 to 6 months poststroke onset. CPAP restores adequate oxygen flow throughout all stages of sleep, and may improve cognition. A series of slow, 1 Hz repetitive TMS treatments to suppress a posterior portion of right pars triangularis has been shown to improve phrase length and naming in chronic nonfluent aphasia. Method: The Boston Diagnostic Aphasia Examination and Boston Naming Test were administered pre-CPAP, and after 2 to 5 months of CPAP. These same tests were administered pre-TMS, and at 3 and 6 months post-TMS, and again 2.4 years later. Results: Post-CPAP testing showed increased Phrase Length, Auditory Comprehension, and naming Animals and Tools/Implements (Boston Diagnostic Aphasia Examination). Testing at 3 and 6 months post-TMS showed significant increase in Phrase Length, Auditory Comprehension, and Boston Naming Test compared with pre-TMS. These gains were retained at 2.4 years post-TMS. CPAP use continued throughout.Conclusions: Physiologic treatment interventions may promote language recovery in chronic aphasia.

The GDR-MONICA project comprises 25 administratively defined areas with a population of nearly two million people aged 25–64. Data from the first random sample survey are reported here. The survey gathered information regarding risk factors, dietary behaviour, physical activity and psychosocial factors from 11,281 persons aged 25–64. The average risk factor levels were high in the population: The mean casual blood pressure was 140/88 mmHg and 138/86 mmHg for men and women respectively. In both sexes the mean total cholesterol level exceeded 6.1 mmol/L, and the mean body mass index (BMI) was just over 26.0. The study population consumed, on average, excessive amounts of energy, fat, alcohol, and sodium, and too few carbohydrates. Preliminary conclusions regarding unfavourable trends in risk factor levels have been drawn by comparing the present data with other recent reliable epidemiological studies.

Fixed-combination tablets of candesartan (orally administered as the pro-drug candesartan cilexetil and hereafter referred to as candesartan) and hydrochlorothiazide (HCTZ) 8/12.5 mg and 16/12.5 mg are effective and well tolerated. However, some patients require higher doses to attain target blood pressure, and combination tablets containing candesartan and HCTZ at the upper end of their respective dose ranges are now being developed. This study aimed to assess the antihypertensive effect and tolerability of the combination of candesartan 32 mg and HCTZ 25 mg versus candesartan 32 mg monotherapy, HCTZ 25 mg monotherapy, and placebo.This was a randomized, double-blind, parallel-group study, with 8 weeks of follow-up, carried out in primary-care outpatients. 1524 men or women (age 20-80 years) with mild to moderate primary hypertension and sitting diastolic blood pressure (DBP) 90-114 mmHg after 4 weeks' single-blind placebo treatment were included in the study. Candesartan/HCTZ 32/25 mg combination therapy, candesartan 32 mg monotherapy, HCTZ 25 mg monotherapy, and placebo, allocated in a 5 : 5 : 5 : 1 ratio, were administered once daily. The main outcome measure was adjusted (analysis of covariance) mean reductions in systolic blood pressure (SBP) and DBP.Mean reductions in SBP and DBP were significantly greater with candesartan/HCTZ 32/25 mg (21/14 mmHg) than with candesartan 32 mg (13/9 mmHg), HCTZ 25 mg (12/8 mmHg) or placebo (4/3 mmHg) [p0.001 for all comparisons]. The proportion of patients with controlled blood pressure (SBP140 mmHg and DBP90 mmHg) at the end of the study was also significantly greater in the candesartan/HCTZ 32/25 mg group (63%) than in the other treatment groups (p0.001 for all comparisons). All study treatments were generally well tolerated.The antihypertensive effect of candesartan/HCTZ 32/25 mg represents fully additive contributions from each of its components, and is generally well tolerated in patients with mild to moderate primary hypertension. This combination adds to the treatment options for improving blood pressure control in patients with hypertension.

STUDY DESIGN Retrospective cohort study using a hospital discharge registry of all nonfederal acute care hospitals in Washington state. OBJECTIVES To determine the cumulative incidence of reoperation following lumbar surgery for degenerative disease and, for specific diagnoses, to compare the frequency of reoperation following fusion with that following decompression alone. SUMMARY OF BACKGROUND DATA Repeat lumbar spine operations are generally undesirable, implying persistent symptoms, progression of degenerative changes, or treatment complications. Compared to decompression alone, spine fusion is commonly viewed as a stabilizing treatment that may reduce the need for additional surgery. However, indications for fusion surgery in degenerative spine disorders remain controversial, and the effects of fusion on reoperation rates are unclear. METHODS Adults who underwent inpatient lumbar surgery for degenerative spine disorders in 1990-1993 (n = 24,882) were identified from International Classification of Diseases ninth Revision, Clinical Modification codes and then categorized as having either a lumbar decompression surgery or lumbar fusion surgery. We then compared the subsequent incidence of lumbar spine surgery between these groups. RESULTS Patients who had surgery in 1990-93 had a 19% cumulative incidence of reoperation during the subsequent 11 years. Patients with spondylolisthesis had a lower cumulative incidence of reoperation after fusion surgery than after decompression alone (17.1% vs. 28.0%, P = 0.002). For other diagnoses combined, the cumulative incidence of reoperation was higher following fusion than following decompression alone (21.5% vs. 18.8%, P = 0.008). After fusion surgery, 62.5% of reoperations were associated with a diagnosis suggesting device complication or pseudarthrosis. CONCLUSION Patients should be informed that the likelihood of reoperation following a lumbar spine operation is substantial. For spondylolisthesis, reoperation is less likely following fusion than following decompression alone. For other degenerative spine conditions, the cumulative incidence of reoperation is higher or unimproved after a fusion procedure compared to decompression alone.

Few studies have examined the relative impact of co-occurring child characteristics on problematic feeding behavior. The aim of the current study was to assess the relative contributions of parent-perceived child characteristics in multivariable models of child feeding behavior. One hundred sixty-one mothers reported on their child's feeding behavior and a number of key child characteristics. These characteristics were entered into controlled multivariable models of child feeding behavior, using child and parent frequency domains of the Behavioral Pediatrics Feeding Assessment Scale (BPFAS; W. Crist et al., 1994) as outcome measures. Child feeding problems were positively associated with food neophobia and external behavioral and social issues, but not with most domains of temperamental difficulty or sensory sensitivity. Feeding problem frequency was associated with externalizing symptoms whereas parental perceptions of problems and coping were associated with social-interaction problems in the child. Population feeding problems appear to be external and interactive problems rather than driven by innate or internalizing factors. The association with externalizing symptoms suggests that feeding problems at this level may fall within a wider profile of challenging behavior; however, the existence of problematic feeding behaviors may constitute a challenge for parents only when the child's social interactions also are seen to be deficient.

Infection is a major complication of hematopoietic cell transplantation. Prolonged neutropenia and graft-versus-host disease are the 2 major complications with an associated risk for infection, and these complications differ according to the graft source. A phase 3, multicenter, randomized trial (Blood and Marrow Transplant Clinical Trials Network [BMT CTN] 0201) of transplantation of bone marrow (BM) versus peripheral blood stem cells (PBSC) from unrelated donors showed no significant differences in 2-year survival between these graft sources. In an effort to provide data regarding whether BM or PBSC could be used as a preferential graft source for transplantation, we report a detailed analysis of the infectious complications for 2 years after transplantation from the BMT CTN 0201 trial. A total of 499 patients in this study had full audits of infection data. A total of 1347 infection episodes of moderate or greater severity were documented in 384 (77%) patients; 201 of 249 (81%) of the evaluable patients had received a BM graft and 183 of 250 (73%) had received a PBSC graft. Of 1347 infection episodes, 373 were severe and 123 were life-threatening and/or fatal; 710 (53%) of these episodes occurred on the BM arm and 637 (47%) on the PBSC arm, resulting in a 2-year cumulative incidence 84.7% (95% confidence interval [CI], 79.6 to 89.8) for BM versus 79.7% (95% CI, 73.9 to 85.5) for PBSC, P = .013. The majority of these episodes, 810 (60%), were due to bacteria, with a 2-year cumulative incidence of 72.1% and 62.9% in BM versus PBSC recipients, respectively (P = .003). The cumulative incidence of bloodstream bacterial infections during the first 100 days was 44.8% (95% CI, 38.5 to 51.1) for BM versus 35.0% (95% CI, 28.9 to 41.1) for PBSC (P = .027). The total infection density (number of infection events/100 patient days at risk) was .67 for BM and .60 for PBSC. The overall infection density for bacterial infections was .4 in both arms; for viral infections, it was .2 in both arms; and for fungal/parasitic infections, it was .04 and .05 for BM and PBSC, respectively. The cumulative incidence of infection before engraftment was 47.9% (95% CI, 41.5 to 53.9) for BM versus 32.8% (95% CI, 27.1 to 38.7) for PBSC (P = .002), possibly related to quicker neutrophil engraftment using PBSC. Infections remain frequent after unrelated donor hematopoietic cell transplantation, particularly after BM grafts.

The purpose of this study was to examine the associations of physical health stressors and coping resources with depressive symptoms among American Indian older adults age 50 years or older. The study used a convenience sample of 227 rural American Indian older adults. A hierarchical multiple regression tested three sets of predictors on depressive symptoms: (a) sociodemographics, (b) physical health stressors (functional disability and chronic medical conditions), and (c) coping resources (social support and spirituality). Most participants reported little difficulty in performing daily activities (e.g., eating, dressing, traveling, and managing money), while presenting over two types of chronic medical conditions. Depressive symptoms were predicted by higher scores on perceived social support and lower scores on functional disability; women and those having no health insurance also had higher levels of depressive symptoms. Findings suggest that social work practitioners should engage family and community support, advocate for access to adequate health care, and attend to women's unique circumstances and needs when working with American Indian older adults.

BackgroundWe compared the effects of two uniquely different lower extremity power training interventions on changes in muscle power, physical performance, neuromuscular activation, and muscle cross sectional area in mobility-limited older adults.MethodsFifty-two subjects (78±5 years, short physical performance battery score: 8.1±1) were randomized to either 16 weeks of progressive high velocity resistance training performed at low external resistance (40% of the 1-repetition maximum [1-RM] [LO]) or high external resistance (70% of 1RM [HI]). Both groups completed three sets of leg and knee extension exercises at maximum voluntary velocity, two times per week. Neuromuscular activation was assessed using surface electromyography and muscle cross sectional area (CSA) was measured using computed tomography.ResultsAt 16 weeks, LO and HI exhibited significant and similar within-group increases of leg extensor peak power (~34% vs ~42%), strength (~13% vs ~19%), and SPPB score (1.4±0.3 vs 1.8±0.3 units), respectively (all P < .03). Improvements in neuromuscular activation occurred in LO (P = .03) while small gains in mid-thigh muscle CSA were detected in LO (1.6%, P = .35) and HI (2.1%, P = .17). No significant between-group differences were evident for any measured parameters (all P > .25).ConclusionsHigh velocity resistance training with low external resistance yields similar improvements in muscle power and physical performance compared to training with high external resistance in mobility-limited elders. These findings may have important implications for optimizing exercise interventions for older adults with mobility limitations.