Three- and 4-Level Lumbar Arthrodesis Using Adjunctive Pulsed Electromagnetic Field Stimulation: A Multicenter Retrospective Evaluation of Fusion Rates and a Review of the Literature.

BACKGROUND: The incidence of 3- and 4-level lumbar arthrodesis is rising due to an aging population, and fusion rates affect clinical success in this population. Pulsed electromagnetic field (PEMF) stimulation is used as an adjunct to increase fusion rates following multilevel arthrodesis. The purpose of the study was to evaluate the fusion rates for subjects who underwent 3- and 4-level lumbar interbody arthrodesis following PEMF treatment. METHODS: In this retrospective, multicenter study, patient charts that listed 3- or 4-level lumbar arthrodesis with adjunctive use of a PEMF device were evaluated. Inclusion criteria included patients who were diagnosed with lumbar degenerative disease, spinal stenosis, and/or spondylolisthesis (grade 1 or 2). A radiographic evaluation of fusion status was performed at 12 months by the treating physicians. Fusion rates were stratified by graft material, surgical interbody approach, and certain clinical risk factors for pseudoarthrosis. RESULTS: A total of 55 patients were identified who had a 12-month follow-up. The radiographic fusion rate was 92.7% (51 patients) at 12 months. There were no significant differences in fusion rates for patients treated with allograft or autograft, for patients with different interbody approaches, or for those with or without certain clinical risk factors. CONCLUSIONS: With modern fusion techniques and PEMF, the overall fusion rate was high following 3- and 4-level lumbar arthrodesis. LEVEL OF EVIDENCE: 4. CLINICAL RELEVANCE: PEMF may be a useful adjunct for treatment of patients with surgical risk factors, such as multilevel arthrodesis, and clinical risk factors.

Comparison of 3 intranasal mists for anesthetizing maxillary teeth in adults: A randomized, double-masked, multicenter phase 3 clinical trial.

BACKGROUND: This double-masked, parallel-design, clinical trial assessed whether a combination nasal spray (K305; 3% tetracaine hydrochloride and 0.05% oxymetazoline hydrochloride) compared with a tetracaine-only spray and a placebo spray would be safer and superior in producing local anesthesia sufficient to complete a direct restorative procedure in maxillary nonmolar teeth. METHODS: The authors randomized eligible patients to receive K305 spray (n = 44), tetracaine hydrochloride spray (n = 44), or a placebo solution (n = 22). The authors compared the incidence of the primary efficacy end point-completion of the procedure without rescue local anesthetic-by means of a 1-tailed Fisher exact test. RESULTS: The end point incidence was 84.1% (95% confidence interval [CI], 69.9-93.4) with K305, 27.3% (95% CI, 15.0-42.8) with tetracaine only, and 27.3% (95% CI, 10.7-50.2) with placebo (P < .001 for K305 versus tetracaine only and versus placebo). Combination spray was associated with statistically significant but transient increases in blood pressure. The most frequent adverse events were rhinorrhea and nasal congestion, which resolved within 2 hours after treatment and occurred more often in the K305 group and tetracaine-only group. CONCLUSIONS: In this study population, the K305 combination nasal spray was safe and more effective in attaining pulpal anesthesia of maxillary teeth from premolar to premolar compared with tetracaine-only and placebo sprays. PRACTICAL IMPLICATIONS: The combination nasal spray might represent a valuable alternative to injected local anesthetic for patients undergoing invasive maxillary dental procedures. Clinicaltrials.gov: NCT01710787.

Double-masked, randomized, placebo-controlled study to evaluate the efficacy and tolerability of intranasal K305 (3% tetracaine plus 0.05% oxymetazoline) in anesthetizing maxillary teeth.

BACKGROUND: The authors compared the local anesthetic efficacy and safety of an intranasally administered formulation of tetracaine and oxymetazoline (K305) with placebo in adult participants undergoing single dental restorative procedures in teeth nos. 4 through 13. METHODS: The authors screened and allocated 150 participants in a double-masked, randomized fashion to either K305 or placebo nasal spray. The authors delivered the study drug as two 0.2-milliliter sprays separated by 4 minutes inside the nostril on the side ipsilateral to the tooth being treated. The authors administered a third 0.2-mL spray, if necessary, and administered 4% articaine with 1:200,000 epinephrine by means of injection if anesthesia was inadequate. Safety evaluations included participant reports of adverse events, vital signs, and alcohol sniff tests during the 2-hour study period and at a 1-day follow-up visit. The primary efficacy end point was anesthetic success defined as the completion of the dental procedure without the need for rescue injectable local anesthetic. The authors evaluated differences in success rates observed between K305 and placebo by using a 1-sided Fisher exact test. RESULTS: The overall success rates were 88.0% (95% confidence interval, 80.0-93.6) and 28% (95% confidence interval, 16.2-42.5) for K305 and placebo, respectively (P < .0001). The most frequent adverse effects in the K305 group were rhinorrhea (57.0%) and nasal congestion (26.0%). No serious adverse events occurred during this study. CONCLUSIONS: K305 was effective and well tolerated during restorative procedures in adult participants. PRACTICAL IMPLICATIONS: K305 provides a needleless alternative for obtaining maxillary pulpal anesthesia on premolars, canines, and incisors.

Impact of tobacco-related health warning labels across socioeconomic, race and ethnic groups: results from a randomized web-based experiment.

BACKGROUND: The U.S. Family Smoking Prevention and Tobacco Control Act of 2009 requires updating of the existing text-only health warning labels on tobacco packaging with nine new warning statements accompanied by pictorial images. Survey and experimental research in the U.S. and other countries supports the effectiveness of pictorial health warning labels compared with text-only warnings for informing smokers about the risks of smoking and encouraging cessation. Yet very little research has examined differences in reactions to warning labels by race/ethnicity, education or income despite evidence that population subgroups may differ in their ability to process health information. The purpose of the present study was to evaluate the potential impact of pictorial warning labels compared with text-only labels among U.S. adult smokers from diverse racial/ethnic and socioeconomic subgroups. METHODS/FINDINGS: Participants were adult smokers recruited from two online research panels (n = 3,371) into a web-based experimental study to view either the new pictorial warnings or text-only warnings. Participants viewed the labels and reported their reactions. Adjusted regression models demonstrated significantly stronger reactions for the pictorial condition for each outcome salience (b = 0.62, p<.001); perceived impact (b = 0.44, p<.001); credibility (OR = 1.41, 95% CI = 1.22-1.62), and intention to quit (OR = 1.30, 95% CI = 1.10-1.53). No significant results were found for interactions between condition and race/ethnicity, education, or income. The only exception concerned the intention to quit outcome, where the condition-by-education interaction was nearly significant (p = 0.057). CONCLUSIONS: Findings suggest that the greater impact of the pictorial warning label compared to the text-only warning is consistent across diverse racial/ethnic and socioeconomic populations. Given their great reach, pictorial health warning labels may be one of the few tobacco control policies that have the potential to reduce communication inequalities across groups. Policies that establish strong pictorial warning labels on tobacco packaging may be instrumental in reducing the toll of the tobacco epidemic, particularly within vulnerable communities.

Efficacy of etanercept in the tumor necrosis factor receptor-associated periodic syndrome: a prospective, open-label, dose-escalation study.

OBJECTIVE: To investigate the efficacy of etanercept in improving the symptoms and underlying inflammation in patients with tumor necrosis factor receptor-associated periodic syndrome (TRAPS). METHODS: Fifteen patients with TRAPS were enrolled in a prospective, open-label, dose-escalation study. Patients recorded attacks, symptom severity, and use of ancillary medications in a daily diary. Blood samples were collected during each period and measured for levels of acute-phase reactants. Between 7 years and 9 years after the conclusion of the initial study, patients completed a followup survey and were evaluated to determine the long-term outcome of etanercept treatment. RESULTS: Etanercept treatment significantly attenuated the total symptom score and reduced the frequency of symptoms. Etanercept also reduced levels of acute-phase reactants, particularly during asymptomatic periods. During a 10-year followup period, patients continued to receive etanercept for a median of 3.3 years, with a number of patients switching to anti-interleukin-1ß receptor therapy or not receiving biologic agents, most frequently citing injection site reactions and lack of efficacy as reasons for discontinuation. However, patients continuing to receive etanercept had reduced symptoms at followup. CONCLUSION: Etanercept reduces symptoms and serum levels of inflammatory markers of TRAPS in a dose-dependent manner, but does not completely normalize symptoms or acute-phase reactant levels. Although long-term adherence to etanercept is poor, continuing to receive etanercept may provide continued symptomatic benefit.

A 1-year randomized trial of calcium acetate versus sevelamer on progression of coronary artery calcification in hemodialysis patients with comparable lipid control: the Calcium Acetate Renagel Evaluation-2 (CARE-2) study.

BACKGROUND: Previous clinical trials showed that progression of coronary artery calcification (CAC) may be slower in hemodialysis patients treated with sevelamer than those treated with calcium-based phosphate binders. Because sevelamer decreases low-density lipoprotein cholesterol (LDL-C) levels, we hypothesized that intensive lowering of LDL-C levels with atorvastatin in hemodialysis patients treated with calcium acetate would result in CAC progression rates similar to those in sevelamer-treated patients. STUDY DESIGN: Randomized, controlled, open-label, noninferiority trial with an upper bound for the noninferiority margin of 1.8. SETTING & PARTICIPANTS: 203 prevalent hemodialysis patients at 26 dialysis centers with serum phosphorus levels greater than 5.5 mg/dL, LDL-C levels greater than 80 mg/dL, and baseline CAC scores of 30 to 7,000 units assessed by means of electron-beam computed tomography. INTERVENTIONS: 103 patients were randomly assigned to calcium acetate, and 100 patients to sevelamer for 12 months to achieve phosphorus levels of 3.5 to 5.5 mg/dL. Atorvastatin was added to achieve serum LDL-C levels less than 70 mg/dL in both groups. OUTCOMES & MEASUREMENTS: The primary end point was change in CAC score assessed by means of electron-beam computed tomography. RESULTS: After 12 months, mean serum LDL-C levels decreased to 68.8 +/- 22.0 mg/dL in the calcium-acetate group and 62.4 +/- 23.0 mg/dL in the sevelamer group (P = 0.3). Geometric mean increases in CAC scores were 35% in the calcium-acetate group and 39% in the sevelamer group, with a covariate-adjusted calcium acetate-sevelamer ratio of 0.994 (95% confidence interval, 0.851 to 1.161). LIMITATIONS: Treatment assignment was not blinded. The 1.8 a priori margin is large, CAC is a surrogate outcome, duration of treatment was short, and dropout rate was high. CONCLUSIONS: With intensive lowering of LDL-C levels for 1 year, hemodialysis patients treated with either calcium acetate or sevelamer experienced similar progression of CAC.

Pegasys: software for executing and integrating analyses of biological sequences.

BACKGROUND: We present Pegasys--a flexible, modular and customizable software system that facilitates the execution and data integration from heterogeneous biological sequence analysis tools. RESULTS: The Pegasys system includes numerous tools for pair-wise and multiple sequence alignment, ab initio gene prediction, RNA gene detection, masking repetitive sequences in genomic DNA as well as filters for database formatting and processing raw output from various analysis tools. We introduce a novel data structure for creating workflows of sequence analyses and a unified data model to store its results. The software allows users to dynamically create analysis workflows at run-time by manipulating a graphical user interface. All non-serial dependent analyses are executed in parallel on a compute cluster for efficiency of data generation. The uniform data model and backend relational database management system of Pegasys allow for results of heterogeneous programs included in the workflow to be integrated and exported into General Feature Format for further analyses in GFF-dependent tools, or GAME XML for import into the Apollo genome editor. The modularity of the design allows for new tools to be added to the system with little programmer overhead. The database application programming interface allows programmatic access to the data stored in the backend through SQL queries. CONCLUSIONS: The Pegasys system enables biologists and bioinformaticians to create and manage sequence analysis workflows. The software is released under the Open Source GNU General Public License. All source code and documentation is available for download at http://bioinformatics.ubc.ca/pegasys/.

Treatment of hyperphosphatemia in hemodialysis patients: The Calcium Acetate Renagel Evaluation (CARE Study).

BACKGROUND: Hyperphosphatemia underlies development of hyperparathyroidism, osteodystrophy, extraosseous calcification, and is associated with increased mortality in hemodialysis patients. METHODS: To determine whether calcium acetate or sevelamer hydrochloride best achieves recently recommended treatment goals of phosphorus

The relationship between educational attainment and relapse among alcohol-dependent men and women: a prospective study.

BACKGROUND: We investigated the relationship between educational attainment and drinking outcomes after discharge from inpatient treatment for alcohol dependence. METHODS: Between 1993 and 1996, we consecutively recruited 41 women and 60 men hospitalized for alcohol dependence and followed them up monthly for 1 year. We conducted structured interviews during hospitalization and at monthly intervals after discharge for 1 year. We examined the relationship between educational attainment before treatment and postdischarge drinking outcomes, including time to relapse. RESULTS: After covariate adjustment, educational level was a significant predictor of drinking outcomes. CONCLUSIONS: Lower levels of educational attainment before entry into treatment predicted shorter times to first drink and relapse in both women and men. The association of educational attainment and treatment outcome for alcohol dependence warrants further investigation.

History of abuse and drinking outcomes following inpatient alcohol treatment: a prospective study.

Little is known about the impact of sexual or physical abuse history on response to alcohol treatment. This prospective study investigated the relationships between sexual and physical abuse histories, participants' characteristics, and response to inpatient alcohol treatment. Forty-one women and 59 men were assessed monthly for 1 year following hospitalization for alcohol dependence. Survival analyses showed that sexual abuse history was associated with shorter times to first drink and relapse. Physical abuse history was not associated with poorer drinking outcomes. Although women were more likely than men to have a history of sexual abuse, no gender differences were found in drinking outcomes. Poorer drinking outcomes were found among participants who at baseline were not married, had less than a college education, were not employed full time, or carried a diagnosis of depression or other psychiatric disorder. When adjusted for these characteristics, the associations between sexual abuse history and times to first drink and relapse were no longer statistically significant. While sexual abuse history is a clinically meaningful predictor of return to drinking we note the importance of considering patients' background and clinical characteristics in examining the impact of sexual abuse history on drinking outcomes following treatment.