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Introducción. Uno de los desafíos de la educación contemporánea es desarrollar alumnado competente para desenvolverse efectivamente en el mundo cada vez más competitivo en el que vivimos. Esta investigación tiene, como tema de estudio, la inteligencia desde la perspectiva de Howard Gardner. Exalta la riqueza de su enfoque multidisciplinario. Objetivo. El objetivo del estudio es determinar y comparar el nivel de desarrollo de las inteligencias múltiples en el estudiantado ingenieril de la Universidad Tecnológica de Panamá (UTP) por facultad y carrera, a modo de brindar recomendaciones para mejorar los métodos de enseñanza. Metodología. La investigación cuenta con un diseño de campo descriptivo-comparativo con un enfoque cuantitativo. La muestra de la investigación es de 85 estudiantes que cursan el último año de carreras ingenieriles, a quienes se les aplicó un cuestionario adaptado del instrumento psicológico IAMI-R; al que, posteriormente a la recolección de datos, se le realizaron análisis estadísticos descriptivos y comparativos a través de Minitab. Resultados. Los resultados señalan que la inteligencia lingüística y lógico-matemática son las más prevalentes en el estudiantado de las diferentes facultades de la UTP. Por otro lado, las inteligencias cinestésica-corporal y naturalista se encuentran entre las dos menos desarrolladas para el 83% de las facultades, con excepción de la Facultad de Ciencias y Tecnología, ya que la inteligencia naturalista es la tercera menos desarrollada. Conclusiones. Se concluye que hay diferencias significativas en el nivel de desarrollo de las inteligencias múltiples entre facultades y carreras a las que pertenece el estudiantado de la UTP. El estudio determina que la inteligencia cinestésica-corporal y naturalista se encuentran entre las menos desarrolladas, por esta razón se recomienda, a la universidad, implementar actividades para desarrollar estas inteligencias, como la dramatización o estudiar el lenguaje corporal.

We conducted laboratory experiments to investigate a suspected effect of tetrahydrofuran (THF) on quantifying crystalline silica in samples collected from working with engineered stone when THF is used to process samples prior to the X-ray diffraction (XRD) analysis. Two groups of samples from grinding either engineered stone or granite were simultaneously taken from a laboratory testing system, with one group of samples using THF for processing and another group using muffle furnace for ashing. For each stone type, we also tested four levels of respirable dust loading on the samples by varying the grinding time from 1 to 8 min. Statistical analysis of the experimental results on crystalline silica contents of the two groups of samples showed that the difference between the two methods was not significant (P ≥ 0.05) for the granite at all four levels of respirable dust loading and for the engineered stone at the two levels of respirable dust loading greater than 0.5 mg. However, the crystalline silica content from using THF processing was significantly lower (P = 0.001) than that from using muffle furnace ashing for engineered stone when the respirable dust loading levels were less than 0.5 mg. For the engineered stone dust samples with grinding times of 1 and 2 min, the average respirable dust loading was about 0.19 and 0.34 mg, respectively; while the crystalline silica content from using THF processing was 30.9 and 21.5% lower than that from using muffle furnace ashing, respectively. Since most full-shift samples from field assessments in this industry are expected to have respirable dust loading less than 0.5 mg, muffle furnace or radio frequency plasma ashing should be specified as the preferred sample processing method instead of the THF processing method for quantification of crystalline silica when engineered stone is expected to present to avoid artificially reduced silica content values, which are likely caused by the reactions between THF and the resins in engineered stone.

Emergency medical service (EMS) providers have a higher potential exposure to infectious agents than the general public (Nguyen et al., 2020, “Risk of COVID-19 Among Frontline Healthcare Workers and the General Community: A Prospective Cohort Study,” Lancet Pub. Health, 5(9), pp. e475–e483; Brown et al., 2021, “Risk for Acquiring Coronavirus Disease Illness Among Emergency Medical Service Personnel Exposed to Aerosol-Generating Procedures,” Emer. Infect. Disease J., 27(9), p. 2340). The use of protective equipment may reduce, but does not eliminate their risk of becoming infected as a result of these exposures. Prehospital environments have a high risk of disease transmission exposing EMS providers to bioaerosols and droplets from infectious patients. Field intubation procedures may be performed causing the generation of bioaerosols, thereby increasing the exposure of EMS workers to pathogens. Additionally, ambulances have a reduced volume compared to a hospital treatment space, often without an air filtration system, and no control mechanism to reduce exposure. This study evaluated a containment plus filtration intervention for reducing aerosol concentrations in the patient module of an ambulance. Aerosol concentration measurements were taken in an unoccupied research ambulance at National Institute for Occupational Safety and Health (NIOSH) Cincinnati using a tracer aerosol and optical particle counters (OPCs). The evaluated filtration intervention was a containment pod with a high efficiency particulate air (HEPA)-filtered extraction system that was developed and tested based on its ability to contain, capture, and remove aerosols during the intubation procedure. Three conditions were tested (1) baseline (without intervention), (2) containment pod with HEPA-1, and (3) containment pod with HEPA-2. The containment pod with HEPA-filtered extraction intervention provided containment of 95% of the total generated particle concentration during aerosol generation relative to the baseline condition, followed by rapid air cleaning within the containment pod. This intervention can help reduce aerosol concentrations within ambulance patient modules while performing aerosol-generating procedures.

Ultraviolet germicidal irradiation uses ultraviolet C (UV-C) energy to disinfect surfaces in clinical settings. Verifying that the doses of UV-C energy received by surfaces are adequate for proper disinfection levels can be difficult and expensive. Our study aimed to test commercially available colorimetric labels, sensitive to UV-C energy, and compare their precision with an accepted radiometric technique. The color-changing labels were found to predictably change color in a dose-dependent manner that would allow them to act as a qualitative alternative to radiometry when determining the minimum UV-C energy dosage received at surfaces. If deployed using careful protective techniques to avoid unintentional exposure to sunlight or other light sources, the use of colorimetric labels could provide inexpensive, easy, and accurate verification of effective UV-C dosing in clinical spaces.

ImportanceOnce-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis.ObjectiveTo evaluate the efficacy of roflumilast cream, 0.3%, applied once daily for 8 weeks in 2 trials of patients with plaque psoriasis.Design, Setting, and ParticipantsTwo phase 3, randomized, double-blind, controlled, multicenter trials (DERMIS-1 [trial 1; n = 439] and DERMIS-2 [trial 2; n = 442]) were conducted at 40 centers (trial 1) and 39 centers (trial 2) in the US and Canada between December 9, 2019, and November 16, 2020, and between December 9, 2019, and November 23, 2020, respectively. Patients aged 2 years or older with plaque psoriasis involving 2% to 20% of body surface area were enrolled. The dates of final follow-up were November 20, 2020, and November 23, 2020, for trial 1 and trial 2, respectively.InterventionsPatients were randomized 2:1 to receive roflumilast cream, 0.3% (trial 1: n = 286; trial 2: n = 290), or vehicle cream (trial 1: n = 153; trial 2: n = 152) once daily for 8 weeks.Main Outcomes and MeasuresThe primary efficacy end point was Investigator Global Assessment (IGA) success (clear or almost clear status plus ≥2-grade improvement from baseline [score range, 0-4]) at week 8, analyzed using a Cochran-Mantel-Haenszel test stratified by site, baseline IGA score, and intertriginous involvement. There were 9 secondary outcomes, including intertriginous IGA success, 75% reduction in Psoriasis Area and Severity Index (PASI) score, and Worst Itch Numeric Rating Scale score of 4 or higher at baseline achieving 4-point reduction (WI-NRS success) at week 8 (scale: 0 [no itch] to 10 [worst imaginable itch]; minimum clinically important difference, 4 points).ResultsAmong 881 participants (mean age, 47.5 years; 320 [36.3%] female), mean IGA scores in trial 1 were 2.9 [SD, 0.52] for roflumilast and 2.9 [SD, 0.45] for vehicle and in trial 2 were 2.9 [SD, 0.48] for roflumilast and 2.9 [SD, 0.47]) for vehicle. Statistically significantly greater percentages of roflumilast-treated patients than vehicle-treated patients had IGA success at week 8 (trial 1: 42.4% vs 6.1%; difference, 39.6% [95% CI, 32.3%-46.9%]; trial 2: 37.5% vs 6.9%; difference, 28.9% [95% CI, 20.8%-36.9%]; P P P P Conclusions and RelevanceAmong patients with chronic plaque psoriasis, treatment with roflumilast cream, 0.3%, compared with vehicle cream resulted in better clinical status at 8 weeks. Further research is needed to assess efficacy compared with other active treatments and to assess longer-term efficacy and safety.Trial RegistrationClinicalTrials.gov Identifiers: NCT04211363, NCT04211389

A survey was administered to 385 noise-exposed workers from an auto parts factory and 1268 non-noise-exposed health department employees in China. Individual 8 h A-weighted equivalent sound levels (LAeq,8h), earplug personal attenuation ratings (PARs), and pure-tone audiometric tests were performed. The average LAeq,8h of noise-exposed workers was 87 dB (A) with a mean PAR of 7 dB. The prevalence of high-frequency hearing loss was 65% for noise-exposed workers and 33% for the non-noise-exposed employees. The use of earplugs had no observable effect on the prevalence of high-frequency hearing loss of the study participants (OR 0.964, 95% CI 0.925–1.005, p = 0.085). No significant relationship between the effectiveness offered by earplug use and high-frequency hearing thresholds at 3, 4, and 6 kHz was found (t = −1.54, p = 0.125). The mandatory requirement of earplug use without individualized training on how to wear HPDs correctly had no detectable effect on the prevention of hearing loss at the auto parts factory. The hearing conservation program at the surveyed factory was not effective. Periodic hearing tests, earplug fit testing, expanding the offer of different types of hearing protection, and employee education about the importance of protecting their hearing were recommended to the occupational health and safety program.

Objective: This article describes the development of a prototype dry decontamination system (DryCon) for use in the event of a contamination incident involving a particulate contaminant. Disrobing and showering is currently recommended almost exclusively in mass decontamination, although it may not be feasible when water is scarce, in cold weather environments, or when there may be compliance issues with the requirement to disrobe, ie, unwillingness to disrobe. During disrobing, dust particles could also re-aerosolize, leading to inhalation of contaminants. Design: The DryCon prototype uses air jets for dry decontamination. The system is portable and can run on building-supplied 220-V power or generator power. Multiple contaminated persons can be treated rapidly, one after the other, using this system. Setting: We tested DryCon in a controlled environment, using a manikin and three different types of fabric squares to investigate its effectiveness, with a decontamination time of 60 seconds. Main outcome: At the higher airflow tested, ie, 90 percent of full blower speed or approximately 540 cfm (15 m3 / minute), mean decontamination efficiencies of 56.8 percent, 70.3 percent, and 80.7 percent were measured for firefighter (FF) turnout fabric, cotton denim, and polyester double knit fabric, respectively. Results: Removal of this easily re-aerosolized fraction of the contaminants helps protect contaminated people, as well as healthcare providers they come in contact with, from the potential risk of further inhalation exposures from the re-aerosolization caused by doffing clothing. Conclusion: The results demonstrate the promise of the DryCon system for use where water is not available, as a first step prior to wet decontamination, or in an industrial setting for post-work-shift decontamination. Further lab and field research will be necessary to prove the effectiveness of this technique in real-world applications and to determine if respiratory protection or other personal protective equipment (PPE) is needed during use of the DryCon system.

The state of Colorado currently lacks research that looks at the impact of various life stressors on individuals’ emotional well-being, specifically mental disorders, physical health conditions, social media usage, and employment status. This influences the ability of policies to combat the current rising mental health crisis and maximize people’s emotional well-being, making it crucial to gain a better understanding of these factors. The need for this research has been further exacerbated with the rise of the pandemic, as social media usage, changes in employment, and mental and physical health are more volatile than normal. This research study had 55 participants through the use of an anonymous survey sent to residents of Colorado ages 18 and older to analyze and visualize how emotional well-being is affected by these four life stressors. Conducting linear regressions, correlation tests, and plotting our results showed that employment status was the most statistically significant factor in an individual’s emotional well-being, followed by the prevalence of mental disorders. In turn, we recommend that policymakers and other stakeholders in Colorado actively work to combat the negative effects of volatile employment and mental disorders, which will ultimately better the emotional well-being of their citizens.

Introduction: Bempedoic acid (BA), an ATP-citrate lyase inhibitor, lowers low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia. Objective: To report efficacy and safety of BA by sex in patients with elevated LDL-C. Methods: Data were pooled from 4 phase 3 randomized (2:1), double-blind studies investigating oral BA (180 mg once daily) vs placebo for 12 weeks to 52 weeks in adults receiving maximally tolerated statins who required additional LDL-C lowering, analyzed by sex. The primary efficacy endpoint was % change in LDL-C from baseline to week 12. Results were analyzed in cohorts with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (“ASCVD/HeFH on statins pool”, n=3009) or history of statin intolerance (“statin intolerant pool”, n=614). Safety assessments included treatment-emergent adverse events (TEAEs). Results: Of all participants, 34.3% were women. Significant LDL-C lowering from baseline with BA vs placebo was demonstrated in both pools and sexes ( P < 0.001; Table 1 ), with greater lowering in women vs men in the ASCVD/HeFH on statins pool ( P = 0.04). Rates of TEAEs were similar across groups ( Table 2 ). Rates of common TEAEs were similar in both pools and sexes, except urinary tract infection (men: BA, 2.8%; placebo, 3.0%; women: BA, 8.0%; placebo, 10.3%) and pain in extremity (men: BA, 2.5%; placebo, 1.2%; women: BA, 4.2%; placebo, 2.9%), which occurred more frequently in women. Conclusion: BA lowered LDL-C significantly in both women and men, with greater effect in women vs men in both pools, and a safety profile generally comparable to placebo in both sexes.

Background Bempedoic acid (BA) is an oral first-in-class, ATP-citrate lyase inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) levels in adults with hypercholesterolemia. In the phase 3 CLEAR Harmony study (NCT02666664, n=2230), BA 180 mg for 52 weeks significantly lowered LDL-C at week 12 compared with placebo and was maintained for 52 weeks in hypercholesterolemic patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) on stable, maximally tolerated statins. Purpose To report long-term safety, tolerability, and efficacy of BA from the CLEAR Harmony open-label extension (OLE) study (NCT03067441). Methods After completing the 52-week placebo-controlled CLEAR Harmony study, patients immediately entered the OLE and received BA for 78 weeks, followed by a 4-week washout period; the potential cumulative exposure to BA was 2.5 years. The primary endpoint was long-term safety of BA in the OLE. Results A total of 1462 patients enrolled in the OLE (BA n=970; placebo n=492 from CLEAR Harmony). At OLE baseline, mean (SD) age was 66.9 (8.7) years, 73.9% were male, 96.3% had ASCVD, 3.7% had HeFH with or without ASCVD, and all were receiving statins (93.5% moderate or high intensity). At baseline of CLEAR Harmony, patients had mean (SD) LDL-C of 102.9 (29.9) mg/dL (BA) and 99.0 (24.2) mg/dL (placebo). The majority of OLE patients (86.2%, n=1260) completed 78 weeks of BA treatment. At week 12 and 78 of OLE treatment, respectively, mean LDL-C lowering from CLEAR Harmony baseline was –14.9% and –14.4%. A total of 1143 patients (78.2%) reported a treatment-emergent adverse event (TEAE), and 299 (20.5%) reported a serious TEAE. TEAEs of special interest, determined by the therapeutic area or prior observations in preclinical or early clinical studies, occurred at similar rates as CLEAR Harmony (creatine kinase elevations, 1.8%; gout, 2.6%; hepatic enzyme elevations, 2.0%; hypoglycemia, 1.2%; muscular disorders, 8.5%; neurocognitive disorders, 0.9%; new onset/worsening diabetes mellitus, 5.5%; renal disorders, 2.8%) with biochemical changes that were stable over the course of the study and approached baseline levels after treatment discontinuation. Overall, 114 patients (7.8%) reported a TEAE leading to discontinuation of BA (most common: myalgia [0.6%], muscle spasm [0.5%]). Conclusion Durable lipid lowering was observed through 78 weeks of BA treatment and patient adherence to BA therapy was high (86.2%). Overall safety during the OLE was similar to results reported in the 52-week-long CLEAR Harmony study and the overall BA phase 3 clinical program, with no new safety findings. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Esperion Therapeutics, Inc., funded the research for this study and provided writing support for this abstract. Medical writing assistance was provided by Agnella Izzo Matic, PhD, CMPP, and Kelly M Cameron, PhD, CMPP, of JB Ashtin.

Background: Current guidelines support aggressive LDL-C lowering in patients with diabetes. We assessed the efficacy and safety of BA, a first-in-class ATP-citrate lyase inhibitor, by baseline glycemic status (diabetes, prediabetes, or normoglycemia) in patients with hypercholesterolemia. Methods: Four phase 3 trials randomized 3623 patients on stable lipid-lowering therapy to receive BA 180 mg or placebo (PBO) once daily for 12 to 52 weeks. Studies were grouped into 2 pools by enrollment criteria (52-weeks in patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia vs. 12- or 24- weeks in patients with statin intolerance). Primary efficacy endpoint was percent change from baseline to week 12 in LDL-C. Results: In both pools, BA significantly lowered LDL-C compared with PBO, regardless of baseline glycemic status (all P Conclusion: BA significantly lowered LDL-C and had a safety profile comparable to PBO, regardless of baseline glycemic status. Disclosure L.A. Leiter: Advisory Panel; Self; Abbott, Amgen, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Servier. Research Support; Self; Amgen, AstraZeneca, Kowa Pharmaceuticals America, Inc., Medicines Company. Speaker’s Bureau; Self; Amgen, AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Medscape, Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Servier. M. Banach: Advisory Panel; Self; Esperion Therapeutics, Inc., Novo Nordisk Inc. Research Support; Self; Resverlogix Corp. Speaker’s Bureau; Self; Amgen, Sanofi. A.L. Catapano: Other Relationship; Self; Akcea Therapeutics, Amgen, Daiichi Sankyo, Esperion Therapeutics, Inc., Kowa Company, Ltd., Menarini Group, Mylan, Novartis, Ionis Pharmaceuticals, Medco, MSD, Recordati, Astrazeneca, Aegerion, Amryt, Eli Lilly, Genzyme, Regeneron Pharmaceuticals, Sanofi. P. Duell: Consultant; Self; Akcea Therapeutics, AstraZeneca, Esperion Therapeutics, Inc. Other Relationship; Self; Regeneron Pharmaceuticals, REGENXBIO Inc., Retrophin, Inc. A. Gotto: Board Member; Self; Esperion Therapeutics, Inc. Consultant; Self; Amarin Corporation, Kowa Company, Ltd. Other Relationship; Self; Ionis Pharmaceuticals, Inc. U. Laufs: Advisory Panel; Self; Esperion Therapeutics, Inc. G. Mancini: Advisory Panel; Self; Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Boehringer Ingelheim (Canada) Ltd., Esperion Therapeutics, Inc., HLS Therapeutics, Inc., Sanofi. K.K. Ray: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Esperion Therapeutics, Inc., Novo Nordisk Inc., Sanofi. J.C. Hanselman: Employee; Self; Esperion Therapeutics, Inc. Stock/Shareholder; Self; Esperion Therapeutics, Inc. A. Feng: Employee; Self; Esperion Therapeutics, Inc. H. Bays: Advisory Panel; Self; Esperion Therapeutics, Inc. Consultant; Self; Kowa Company, Ltd. Research Support; Self; Abbott, Acasti, Akcea, Amarin Corporation, Amgen, AstraZeneca, Dr. Reddy’s Laboratories, Esperion Therapeutics, Inc., Gan & Lee Pharmaceuticals, Ionis Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Johnson & Johnson, LIB, Lilly Diabetes, Matinas BioPharma, Medicines Company, MedImmune, Merck & Co., Inc., Novo Nordisk A/S, Pfizer Inc., Regeneron Pharmaceuticals, Sanofi.

The OSHA final rule on respirable crystalline silica (RCS) will require hydraulic fracturing companies to implement engineering controls to limit workers' exposure to RCS. RCS is generated by pneumatic transfer of quartz-containing sand during hydraulic fracturing operations. Chronic inhalation of RCS can lead to serious disease, including silicosis and lung cancer. NIOSH research identified at least seven sources where RCS aerosols were generated at hydraulic fracturing sites. NIOSH researchers developed an engineering control to address one of the largest sources of RCS aerosol generation, RCS escaping from thief hatches on the top of sand movers. The control, the NIOSH Mini-Baghouse Retrofit Assembly (NMBRA), mounts on the thief hatches. Unlike most commercially available engineering controls, the NMBRA has no moving parts and requires no power source. This article details the results of an evaluation of generation 3 of the NMBRA at a sand mine in Arkansas from May 19-21, 2015. During the evaluation, 168 area air samples were collected at 12 locations on and around a sand mover with and without the NMBRA installed. Analytical results for respirable dust and RCS indicated the use of the NMBRA effectively reduced concentrations of both respirable dust and RCS downwind of the thief hatches. Reductions of airborne respirable dust were estimated at 99+%; reductions in airborne RCS ranged from 98-99%. Analysis of bulk samples of the dust showed the likely presence of freshly fractured quartz, a particularly hazardous form of RCS. Use of an improved filter fabric and a larger area of filter cloth led to substantial improvements in filtration and pressures during these trials, as compared to the generation 2 NMBRA. Planned future design enhancements, including a weather cover, will increase the performance and durability of the NMBRA. Future trials are planned to evaluate the long-term operability of the technology.

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This study was conducted at 5 Veterans Administration Medical Centers (VAMCs). A cross sectional survey was administered to 134 workers who routinely lift and mobilize patients within their workplaces' safe patient handling and mobility (SPHM) programs, which are mandated in all VAMCs. The survey was used to examine a comprehensive list of SPHM and non-SPHM variables, and their associations with self-reported musculoskeletal injury and pain. Previously unstudied variables distinguished between "bariatric" (≥300 lb or 136 kg) and "non-bariatric" (300 lb or 136 kg) patient handling. Significant findings from stepwise and logistic regression provide targets for workplace improvements, predicting: lower injury odds with more frequently having sufficient time to use equipment, higher back pain odds with more frequent bariatric handling, lower back pain odds with greater ease in following SPHM policies, and lower odds of upper extremity pain with more bariatric equipment, and with higher safety climate ratings.

An interlaboratory study was carried out to evaluate the use of acid-soluble cellulosic air sampling capsules for their suitability in the measurement of trace elements in workplace atmospheric samples. These capsules are used as inserts to perform closed-face cassette sample collection for occupational exposure monitoring. The interlaboratory study was performed in accordance with NIOSH guidelines that describe statistical procedures for evaluating measurement accuracy of air monitoring methods. The performance evaluation materials used consisted of cellulose acetate capsules melded to mixed-cellulose ester filters that were dosed with multiple elements from commercial standard aqueous solutions. The cellulosic capsules were spiked with the following 33 elements of interest in workplace air monitoring: Ag, Al, As, Ba, Be, Ca, Cd, Co, Cr, Cu, Fe, In, K, La, Li, Mg, Mn, Mo, Ni, P, Pb, Sb, Se, Sn, Sr, Te, Ti, Tl, V, W, Y, Zn, Zr. The elemental loading levels were certified by an accredited provider of certified reference materials. Triplicates of media blanks and multielement-spiked capsules at three different elemental loadings were sent to each participating laboratory; the elemental loading levels were not revealed to the laboratories. The volunteer participating laboratories were asked to prepare the samples by acid dissolution and to analyze aliquots of extracted samples by inductively coupled plasma atomic emission spectrometry in accordance with NIOSH methods. It was requested that the study participants report their analytical results in units of μg of each target element per internal capsule sample. For the majority of the elements investigated (30 out of 33), the study accuracy estimates obtained satisfied the NIOSH accuracy criterion (A < 25%). This investigation demonstrates the utility of acid-soluble internal sampling capsules for multielement analysis by atomic spectrometry.

Denosumab has been shown to reduce tumor size and progression, reform mineralized bone, and increase intralesional bone density in patients with giant cell tumor of bone (GCTB); however, radiologic assessment of tumors in bone is challenging. The study objective was to assess tumor response to denosumab using three different imaging parameters in a prespecified analysis in patients with GCTB from two phase 2 studies. The studies enrolled adults and adolescents (skeletally mature and at least 12 years of age) with radiographically measurable GCTB that were given denosumab 120 mg every 4 weeks, with additional doses on days 8 and 15 of cycle 1. The proportion of patients with an objective tumor response was assessed using either Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST), European Organisation for Research and Treatment of Cancer response criteria (positron emission tomography [PET] scan criteria), or inverse Choi density/size (ICDS) criteria. Target lesions were measured by computed tomography or magnetic resonance imaging (both studies), PET (study 2 only), or plain film radiograph (study 2 only). Most patients (71.6%) had an objective tumor response by at least one response criteria. Per RECIST, 25.1% of patients had a response; per PET scan criteria, 96.2% had a response; per ICDS, 76.1% had a response. 68.5% had an objective tumor response ≥ 24 weeks. Using any criteria, crude incidence of response ranged from 56% (vertebrae/skull) to 91% (lung/soft tissue), and 98.2% had tumor control ≥ 24 weeks. Reduced PET avidity appeared to be an early sign of response to denosumab treatment. Modified PET scan criteria and ICDS criteria indicate that most patients show responses and higher benefit rates than modified RECIST, and therefore may be useful for early assessment of response to denosumab. ClinicalTrials.gov Clinical Trials Registry NCT00396279 (retrospectively registered November 6, 2006) and NCT00680992 (retrospectively registered May 20, 2008).

Objectives This study investigated whether continuous AI and/or elevated mean arterial pressure (MAP) were associated with false positive results for flow obstruction in echocardiographic ramp speed tests in patients with a continuous-flow left ventricular assist device. Background Failure to reduce the left ventricular end-diastolic diameter (LVEDD) with increasing device speeds in a ramp test is predictive of pump obstruction. Aortic insufficiency (AI) or increased MAP can diminish the ability to unload the left ventricle. Methods LVEDD was plotted against device speed, and a linear function slope was calculated. A flat LVEDD slope (≥–0.16) was considered abnormal (suggestive of obstruction). Ramp test results were compared in patients with or without either AI or increased MAP at baseline speed, and receiver-operator characteristic (ROC) curves were constructed for predictors of device obstruction. Device thrombosis was confirmed by direct visualization of clot at explantation or on inspection by the manufacturer. Results Of 78 ramp tests (55 patients), 36 were abnormal (18 true positive, 18 false positive), and 42 were normal (37 true negative, 5 false negative). In patients with AI, LVEDD slope was –0.14 ± 0.17, which was consistent with device obstruction (vs. –0.25 ± 0.11 in patients without AI; p Conclusions Abnormal loading conditions due to AI or elevated MAP may result in false positive ramp tests.

Exposure control system performance was evaluated during aircraft paint spraying at a military facility. Computational fluid dynamics (CFD) modeling, tracer gas testing, and exposure monitoring examined contaminant exposure versus crossflow ventilation velocity. CFD modeling using the RNG k-ε turbulence model showed exposures to simulated methyl isobutyl ketone of 294 and 83.6 ppm, as a spatial average of five worker locations, for velocities of 0.508 and 0.381 m/s (100 and 75 fpm) respectively. In tracer gas experiments, observed supply/exhaust velocities of 0.706/0.503 m/s (136/99 fpm) were termed full-flow, and reduced velocities were termed 3/4-flow and half-flow. Half-flow showed higher tracer gas concentrations than 3/4-flow, which had the lowest time-averaged concentration, with difference in log means significant at the 95% confidence level. Half-flow compared to full-flow and 3/4-flow compared to full-flow showed no statistically significant difference. CFD modeling using these ventilation conditions agreed closely with the tracer results for the full-flow and 3/4-flow comparison, yet not for the 3/4-flow and half-flow comparison. Full-flow conditions at the painting facility produced a velocity of 0.528 m/s (104 fpm) midway between supply and exhaust locations, with the supply rate of 94.4 m3/s (200,000 cfm) exceeding the exhaust rate of 68.7 m3/s (146,000 cfm). Ventilation modifications to correct this imbalance created a mid-hangar velocity of 0.406 m/s (80.0 fpm). Personal exposure monitoring for two worker groups—sprayers and sprayer helpers (“hosemen”)—compared process duration means for the two velocities. Hexavalent chromium (Cr[VI]) exposures were 500 vs. 360 μg/m3 for sprayers and 120 vs. 170 μg/m3 for hosemen, for 0.528 m/s (104 fpm) and 0.406 m/s (80.0 fpm) respectively. Hexamethylene diisocyanate (HDI) monomer means were 32.2 vs. 13.3 μg/m3 for sprayers and 3.99 vs. 8.42 μg/m3 for hosemen. Crossflow velocities affected exposures inconsistently, and local work zone velocities were much lower. Aircraft painting contaminant control is accomplished better with the unidirectional crossflow ventilation presented here than with other observed configurations. Exposure limit exceedances for this ideal condition reinforce continued use of personal protective equipment.

Bone complications of metastatic disease, including skeletal-related events (SREs), impair patients' functioning and quality of life. In a randomized, phase 3 trial of 1,776 patients with metastases from solid tumors (except breast or prostate) or multiple myeloma, denosumab was non-inferior to zoledronic acid (ZA) in delaying or preventing SREs. This ad hoc analysis reports outcomes in the subgroup of 1,597 patients with solid tumors, excluding patients with multiple myeloma. Patients received monthly subcutaneous denosumab 120 mg or intravenous ZA 4 mg, adjusted for creatinine clearance, with calcium and vitamin D supplementation recommended. Endpoints included times to first on-study SRE, first-and-subsequent SREs, and pain worsening. Denosumab significantly delayed time to first on-study SRE compared with ZA (HR, 0.81; 95 % CI, 0.68–0.96) and time to first-and-subsequent SREs (RR, 0.85; 95 % CI, 0.72–1.00). Denosumab also significantly delayed time to development of moderate or severe pain (HR, 0.81; 95 % CI, 0.66–1.00), pain worsening (HR, 0.83; 95 % CI, 0.71–0.97), and worsening pain interference in patients with no/mild baseline pain (HR, 0.77; 95 % CI, 0.61–0.96). Adverse event rates were 96 % in both groups. Grade 3 or 4 hypocalcemia, mostly without clinical sequelae, was more frequent in denosumab-treated patients (denosumab 4 %, ZA 2 %). Osteonecrosis of the jaw occurred infrequently (denosumab 0.8 %, ZA 1.1 %). Denosumab was more effective in delaying or preventing SREs in patients with bone metastases from solid tumors and also prevented pain progression compared to ZA in this ad hoc analysis.

Reactive oxygen species (ROS) have been shown to be a contributor to aging and disease. ROS also serve as a trigger switch for signaling cascades leading to corresponding cellular and molecular events. In the central nervous system (CNS), microglial cells are likely the main source of ROS production. However, activated astrocytes also appear to be capable of generating ROS. In this study we investigated ROS production in human astrocytes stimulated with interleukin (IL)-1β and interferon (IFN)-γ and its potential harmful effects. Although IFN-γ alone had no effect, it potentiated IL-1β-induced ROS production in a time-dependent manner. One of the sources of ROS in IL-1β-activated astrocytes was from increased superoxide production in mitochondria accompanied by enhanced manganese superoxide dismutase and inhibited catalase expression. NADPH oxidase (NOX) may also contribute to ROS production as astrocytes express NOX isoforms. Glutamate uptake, which represents one of the most important methods of astrocytes to prevent excitotoxicity, was down-regulated in IL-1β-activated astrocytes, and was further suppressed in the presence of IFN-γ; IFN-γ itself exerted minimal effect. Elevated levels of 8-isoprostane in IL-1β ± IFN-γ-activated human astrocytes indicate downstream lipid peroxidation. Pretreatment with diphenyleneiodonium abolished the IL-1β ± IFN-γ-induced ROS production, restored glutamate uptake function and reduced 8-isoprostane to near control levels suggesting that ROS contributes to the dysfunction of activated astrocytes. These results support the notion that dampening activated human astrocytes to maintain the redox homeostasis is vital to preserve their neuroprotective potential in the CNS.

Inhalation of respirable crystalline silica (RCS) is a significant risk to worker health during well completions operations (which include hydraulic fracturing) at conventional and unconventional oil and gas extraction sites. RCS is generated by pneumatic transfer of quartz-containing sand during hydraulic fracturing operations. National Institute for Occupational Safety and Health (NIOSH) researchers identified concentrations of RCS at hydraulic fracturing sites that exceed 10 times the Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (PEL) and up to 50 times the NIOSH Recommended Exposure Limit (REL). NIOSH research identified at least seven point sources of dust release at contemporary oil and gas extraction sites where RCS aerosols were generated. NIOSH researchers recommend the use of engineering controls wherever they can be implemented to limit the RCS released. A control developed to address one of the largest sources of RCS aerosol generation is the NIOSH mini-baghouse assembly, mounted on the thief hatches on top of the sand mover. This article details the results of a trial of the NIOSH mini-baghouse at a sand mine in Arkansas from November 18-21, 2013. During the trial, area air samples were collected at 12 locations on and around a sand mover with and without the mini-baghouse control installed. Analytical results for respirable dust and RCS indicate the use of the mini-baghouse effectively reduced both respirable dust and RCS downwind of the thief hatches. Reduction of airborne respirable dust ranged from 85-98%; reductions in airborne RCS ranged from 79-99%. A bulk sample of dust collected by the baghouse assembly showed the likely presence of freshly fractured quartz, a particularly hazardous form of RCS. Planned future design enhancements will increase the performance and durability of the mini-baghouse, including an improved bag clamp mechanism and upgraded filter fabric with a modified air-to-cloth ratio. Future trials are planned to determine additional respirable dust and RCS concentration reductions achieved through these design changes.

Introduction : Female sex workers (FSW) have high rates of unintended pregnancy, sexually transmitted infections including HIV, and other adverse sexual and reproductive health outcomes. Few services for FSWs include contraception. This mixed-methods study aimed to determine the rate, predictors and consequences of unintended pregnancy among FSWs in Mombasa, Kenya. Methods : A prospective cohort study of non-pregnant FSWs was conducted. Quantitative data were collected quarterly, including a structured questionnaire and testing for pregnancy and HIV. Predictors of unintended pregnancy were investigated using multivariate logistic regression. Qualitative data were gathered through focus group discussions and in-depth interviews with FSWs who became pregnant during the study, and interviews with five key informants. These data were transcribed, translated and analysed thematically. Results : Four hundred women were enrolled, with 92% remaining in the cohort after one year. Fifty-seven percent reported using a modern contraceptive method (including condoms when used consistently). Over one-third (36%) of women were using condoms inconsistently without another method. Twenty-four percent had an unintended pregnancy during the study. Younger age, having an emotional partner and using traditional or no contraception, or condoms only, were independent predictors of unintended pregnancy. Women attributed pregnancy to forgetting to use contraception and being pressured not to by clients and emotional partners, as well as "bad luck". They described numerous negative consequences of unintended pregnancy. Conclusion : Modern contraceptive uptake is surprisingly low in this at-risk population, which in turn has a high rate of unintended pregnancy. The latter may result in financial hardship, social stigma, risk of abandonment, or dangerous abortion practices. FSWs face considerable barriers to the adoption of dual method contraceptive use, including low levels of control in their emotional and commercial relationships. Reproductive health services need to be incorporated into programs for sexually transmitted infections and HIV, which address the socially-determined barriers to contraceptive use.

Respirable crystalline silica dust exposure in residential roofers is a recognized hazard resulting from cutting concrete roofing tiles. Roofers cutting tiles using masonry saws can be exposed to high concentrations of respirable dust. Silica exposures remain a serious threat for nearly two million U.S. construction workers. Although it is well established that respiratory diseases associated with exposure to silica dust are preventable, they continue to occur and cause disability or death. The effectiveness of both a commercially available local exhaust ventilation (LEV) system and a water suppression system in reducing silica dust was evaluated separately. The LEV system exhausted 0.24, 0.13, or 0.12 m(3)/sec of dust laden air, while the water suppression system supplied 0.13, 0.06, 0.03, or 0.02 L/sec of water to the saw blade. Using a randomized block design, implemented under laboratory conditions, the aforementioned conditions were evaluated independently on two types of concrete roofing tiles (s-shape and flat) using the same saw and blade. Each engineering control (LEV or water suppression) was replicated eight times, or four times for each type of tile. Analysis of variance was performed by comparing the mean airborne respirable dust concentrations generated during each run and engineering control treatment. The use of water controls and ventilation controls compared with the "no control" treatment resulted in a statistically significant (p0.05) reduction of mean respirable dust concentrations generated per tile cut. The percent reduction for respirable dust concentrations was 99% for the water control and 91% for the LEV. Results suggest that water is an effective method for reducing crystalline silica exposures. However, water damage potential, surface discolorations, cleanup, slip hazards, and other requirements may make the use of water problematic in many situations. Concerns with implementing an LEV system to control silica dust exposures include sufficient capture velocity, additional weight of the saw with the LEV system, electricity connections, and cost of air handling unit.

Recent advances in field-portable X-ray fluorescence (FP XRF) spectrometer technology have made it a potentially valuable screening tool for the industrial hygienist to estimate worker exposures to airborne metals. Although recent studies have shown that FP XRF technology may be better suited for qualitative or semiquantitative analysis of airborne lead in the workplace, these studies have not extensively addressed its ability to measure other elements. This study involved a laboratory-based evaluation of a representative model FP XRF spectrometer to measure elements commonly encountered in workplace settings that may be collected on air sample filter media, including chromium, copper, iron, manganese, nickel, lead, and zinc. The evaluation included assessments of (1) response intensity with respect to location on the probe window, (2) limits of detection for five different filter media, (3) limits of detection as a function of analysis time, and (4) bias, precision, and accuracy estimates. Teflon, polyvinyl chloride, polypropylene, and mixed cellulose ester filter media all had similarly low limits of detection for the set of elements examined. Limits of detection, bias, and precision generally improved with increasing analysis time. Bias, precision, and accuracy estimates generally improved with increasing element concentration. Accuracy estimates met the National Institute for Occupational Safety and Health criterion for nearly all the element and concentration combinations. Based on these results, FP XRF spectrometry shows potential to be useful in the assessment of worker inhalation exposures to other metals in addition to lead.

An evaluation was carried out to investigate the suitability of polyvinyl chloride (PVC) internal capsules, housed within air sampling devices, for gravimetric analysis of airborne particles collected in workplaces. Experiments were carried out using blank PVC capsules and PVC capsules spiked with 0,1 – 4 mg of National Institute of Standards and Technology Standard Reference Material® (NIST SRM) 1648 (Urban Particulate Matter) and Arizona Road Dust (Air Cleaner Test Dust). The capsules were housed within plastic closed-face cassette samplers (CFCs). A method detection limit (MDL) of 0,075 mg per sample was estimated. Precision Sr at 0,5 - 4 mg per sample was 0,031 and the estimated bias was 0,058. Weight stability over 28 days was verified for both blanks and spiked capsules. Independent laboratory testing on blanks and field samples verified long-term weight stability as well as sampling and analysis precision and bias estimates. An overall precision estimate Ŝrt of 0,059 was obtained. An accuracy measure of ±15,5% was found for the gravimetric method using PVC internal capsules.

The objective of this laboratory study was to identify and measure manganese (Mn) fractions in chamber-generated welding fumes (WF) and to evaluate and compare the results from a sequential extraction procedure for Mn fractions with that of an acid digestion procedure for measurement of total, elemental Mn. To prepare Mn-containing particulate matter from representative welding processes, a welding system was operated in short circuit gas metal arc welding (GMAW) mode using both stainless steel (SS) and mild carbon steel (MCS) and also with flux cored arc welding (FCAW) and shielded metal arc welding (SMAW) using MCS. Generated WF samples were collected onto polycarbonate filters before homogenization, weighing and storage in scintillation vials. The extraction procedure consisted of four sequential steps to measure various Mn fractions based upon selective solubility: (1) soluble Mn dissolved in 0.01 M ammonium acetate; (2) Mn (0,II) dissolved in 25 % (v/v) acetic acid; (3) Mn (III,IV) dissolved in 0.5% (w/v) hydroxylamine hydrochloride in 25% (v/v) acetic acid; and (4) insoluble Mn extracted with concentrated hydrochloric and nitric acids. After sample treatment, the four fractions were analyzed for Mn by inductively coupled plasma-atomic emission spectroscopy (ICP-AES). WF from GMAW and FCAW showed similar distributions of Mn species, with the largest concentrations of Mn detected in the Mn (0,II) and insoluble Mn fractions. On the other hand, the majority of the Mn content of SMAW fume was detected as Mn (III,IV). Although the concentration of Mn measured from summation of the four sequential steps was statistically significantly different from that measured from the hot block dissolution method for total Mn, the difference is small enough to be of no practical importance for industrial hygiene air samples, and either method may be used for Mn measurement. The sequential extraction method provides valuable information about the oxidation state of Mn in samples and allows for comparison to results from previous work and from total Mn dissolution methods.

National Institute for Occupational Safety and Health (NIOSH) researchers evaluated two exhaust stack designs for reducing carbon monoxide (CO) exposures from gasoline-powered generator exhaust on houseboats. Tests were conducted (a) after dark, (b) in high-temperature and high-humidity environments, (c) during temperature inversions, (d) under various generator loads, and (e) at different houseboat trim angles. Two different designs of houseboat exhaust stacks were evaluated and compared with the side-exhaust configuration, which is standard on many houseboats. The two designs were flagpole and vertical stack. Both exhaust stacks performed dramatically better than the standard water level, side-exhaust configuration. The highest mean CO concentrations on the upper and lower decks of the houseboat with the vertical exhaust stack were 27 ppm and 17 ppm. The highest mean CO concentrations on the upper and lower decks of the houseboat with the modified flagpole stack were 5 ppm and 2 ppm. These findings are much lower than the 67 ppm and 341 ppm for the highest mean CO concentrations found on the upper and lower decks of houseboats having the usual side-exhausted configuration. The NIOSH evaluation also indicated that high-temperature and high-humidity levels, temperature inversions, generator loading, and houseboat trim angles had little effect on the exhaust stack performance. It also demonstrated the importance of proper design and installation of exhaust stacks to ensure that all exhaust gases are released through the stack. Based on the results of this work, NIOSH investigators continue to recommend that houseboat manufacturers, rental companies, and owners retrofit their gasoline-powered generators with exhaust stacks to reduce the hazard of CO poisoning and death to individuals on or near the houseboat.

Background Although asphalt fume is a recognized irritant, previous studies of acute symptoms during asphalt paving have produced inconsistent results. Between 1994 and 1997, the National Institute for Occupational Safety and Health (NIOSH) evaluated workers at seven sites in six states. Methods NIOSH (a) measured exposures of asphalt paving workers to total (TP) and benzene-soluble particulate (BSP), polycyclic aromatic compounds, and other substances; (b) administered symptom questionnaires pre-shift, every 2 hr during the shift, and post-shift to asphalt exposed and nonexposed workers; and (c) measured peak expiratory flow rate (PEFR) of asphalt paving workers when they completed a symptom questionnaire. Results Full-shift time-weighted average exposures to TP and BSP ranged from 0.01 to 1.30 mg/m3 and 0.01 to 0.82 mg/m3, respectively. Most BSP concentrations were

This study investigated the relationship between anti-factor Xa (anti-FXa) and activated partial thromboplastin time (aPTT) for monitoring intravenous unfractionated heparin (IV-UFH) in patients with continuous-flow left ventricular assist devices (CF-LVADs).CF-LVADs have become mainstream therapy for patients with advanced heart failure. Thromboembolic events, device thrombosis, and bleeding continue to be a challenge with this technology. Adequate anticoagulation is required to prevent these adverse events.A prospective study of consecutive patients implanted with a CF-LVAD was conducted. Paired samples were considered concordant if aPTT values fell into expected ranges for subtherapeutic, therapeutic, and supratherapeutic anti-FXa levels. Heparin dosing was on the basis of anti-Xa levels.A total of 340 paired values from 38 patients were evaluated. Anti-FXa and aPTT were discordant in 253 samples (74.4%), with a high degree of variability in aPTT for any given anti-FXa level (r(2) = 0.57). Results were discordant in 104 samples (63.8%) from patients undergoing bridging therapy with warfarin and in 149 samples (84.2%) from patients with device obstruction and/or hemolysis (p0.001). The most common pattern of discordance was a supratherapeutic aPTT value despite a therapeutic anti-FXa level (49.1% for bridging vs. 75.8% for device obstruction and/or hemolysis; p0.001).Levels of aPTT were disproportionately prolonged relative to the corresponding anti-FXa levels in CF-LVAD patients, particularly those with device obstruction. Hemolysis and warfarin administration may falsely elevate aPTT, resulting in overestimation of heparin concentration and under-anticoagulation. Use of aPTT and anti-FXa to guide heparin therapy may lead to different estimates of heparin concentration in the same patient.

Annals of Oncology 25 (Supplement 4): iv494–iv510, 2014 doi:10.1093/annonc/mdu354.8 sarcoma 1419PD ASSESSMENT OF SURGICAL DOWNSTAGING IN AN OPEN-LABEL PHASE 2 TRIAL OF DENOSUMAB IN PATIENTS WITH GIANT CELL TUMOR OF BONE Aim: Surgical resection, the standard treatment for giant cell tumor of bone (GCTB), may be associated with severe morbidity and may not be curative for all lesions. In an open-label phase 2 study, treatment with denosumab was associated with delayed surgery and/or a less morbid procedure in most patients with resectable GCTB. We report an unplanned, interim analysis of surgical downstaging in patients with Table: 1419PD abstracts Actual On-Study Procedure Planned Procedure Curettage (n=80) Marginal Excision (n=3) En Bloc Excision (n=1) Hemipelvectomy (n=10) Amputation (n=40) Joint/prosthesis replacement (n=25) Joint resection/fusion (n=35) En bloc resection (n=85) En bloc excision (n=8) Marginal excision (n=1) Curettage (n=18) En Bloc Resection (n=20) Joint Resection/ Fusion (n=5) Joint/Prosthesis Replacement (n=6) Amputation (n=1) © European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. Downloaded from http://annonc.oxfordjournals.org/ at University of California, Los Angeles on August 31, 2015 S. Ferrari 1 , P. Rutkowski 2 , R.J. Grimer 3 , P.D. Stalley 4 , S.P.D. Dijkstra 5 , A. Pienkowski 2 , G. Vaz 6 , L.L. Seeger 7 , A. Feng 8 , B.A. Bach 9 Chemotherapy Unit, Istituto Ortopedico Rizzoli, Bologna, ITALY Soft Tissue/bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, POLAND Orthopaedic Oncology Unit, Royal Orthopaedic Hospital, Birmingham, UK Department of Orthopaedic Surgery, Royal Prince Alfred Hospital, Sydney, NSW, AUSTRALIA Department of Orthopedic Surgery, Leiden University Medical Center, Leiden, NETHERLANDS Department of Orthopedic Surgery, Edouard Herriot Hospital, Lyon, FRANCE Department of Radiology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA Global Development Oncology Therapeutics, Amgen Inc., Thousand Oaks, CA, USA resectable GCTB whose initially planned surgery was expected to result in severe morbidity. Methods: Adults or skeletally mature adolescents with resectable GCTB received denosumab 120 mg SC every 4 weeks and on study days 8 and 15. Planned and actual GCTB surgical procedures after treatment are reported. Procedure selection and timing were based on review of radiographic imaging and clinical response. Results: Overall, 222 patients enrolled and were evaluable for surgical downstaging (men, 46%; median age, 34 y); most had lesions in the lower (n=117) and upper (n=62) extremities or pelvis/sacrum (n=33). In total, 190 (86%) patients had either no surgery (n=106; 48%) or a less morbid procedure (n=84; 38%). All 222 patients received denosumab; median (range) time on denosumab was 14.1 (1.0−57.1) months for all patients and 18.4 (1.0−57.1) months for the 106 patients with no surgery. The proportions of patients with a planned surgical procedure who did not undergo surgery were: hemipelvectomy (n=8/10; 80%), amputation (n=32/40; 80%), joint/prosthesis replacement (n=6/25; 24%), joint resection/fusion (n=14/35; 40%), en bloc resection (n=31/85; 36%), en bloc excision (n=7/8; 88%), curettage (n=8/18; 44%). The native joint preservation rate was 96% in the 25 patients with a planned joint/prosthesis replacement and 86% in 35 patients with a planned joint resection/ fusion. Conclusions: Consistent with initial results, treatment with denosumab was associated with avoidance of invasive surgery or a less morbid procedure than was planned in most patients with resectable GCTB. Disclosure: S. Ferrari: Advisory board (Amgen Inc., GlaxoSmithKline); research funding (MolMed, Pharmar, Morphotek, Amgen Inc.); honoraria (Takeda); P. Rutkowski: honoraria for lectures (Amgen Inc.); R.J. Grimer: Advisory board (Amgen Inc.); S.P.D. Dijkstra: advisory board (Implantcast GmbH); L.L. Seeger: honoraria for advisory boards and travel expenses (Amgen Inc.); A. Feng: employment by and stock ownership in Amgen Inc.; B.A. Bach: employment by and stock ownership in Amgen Inc. All other authors have declared no conflicts of interest.

Giant cell tumor of bone (GCTB) is an aggressive primary osteolytic tumor. GCTB often involves the epiphysis, usually causing substantial pain and functional disability. Denosumab, a fully human monoclonal antibody against receptor activator of nuclear factor κΒ ligand (RANKL), is an effective treatment option for patients with advanced GCTB. This analysis of data from an ongoing, open-label study describes denosumab's effects on pain and analgesic use in patients with GCTB.Patients with unresectable disease (e.g. sacral or spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into Cohort 1 (N = 170), and patients with resectable disease whose planned surgery was associated with severe morbidity (e.g. joint resection, limb amputation, or hemipelvectomy) were enrolled into Cohort 2 (N = 101). Patients received denosumab (120 mg) subcutaneously every four weeks, with additional doses on study days 8 and 15. Patients assessed worst pain severity with the Brief Pain Inventory - Short Form (BPI-SF) at baseline, at each visit for the first six months, and every three months thereafter.Clinically relevant pain improvement was reported by 29% of patients in Cohort 1 and 35% in Cohort 2 during week 1 and by ≥ 50% of patients in each cohort at each study visit from months 2-30. Median time to clinically relevant improvement was 30 (95% CI 16, 57) days in Cohort 1 and 15 (95% CI 15, 29) days in Cohort 2. Results in patients with moderate/severe pain at baseline were similar. Fewer than 30% of patients in Cohort 1 and 10% in Cohort 2 experienced clinically relevant pain worsening at any visit through 27 months. Most patients had no/low analgesic use during the study.Most patients treated with denosumab experienced clinically relevant decreases in pain within two months.

Three extraction methods were compared for their effectiveness in the quantitative removal of endotoxin from unused and used bulk water-soluble metalworking fluid (MWF) samples. Soluble, synthetic, and semisynthetic fluids were studied. The three modes of extraction consisted of (1) pyrogen-free water (PFW); (2) PFW and Tween 20 (polyoxyethylene sorbitan monolaurate); and (3) PFW, Tween 20, and sonication. Results suggest that vigorous recovery methods yield higher amounts of endotoxin from MWF samples than mild recovery methods in PFW alone. Additional studies are required to aid in the understanding of the factors that significantly affect endotoxin extraction yields from these fluids.

Industrial hygiene laboratories use one of three analytical techniques (X-ray diffraction spectrometry, infrared absorption spectrometry, and colorimetric spectrophotometry) for the quantitative determination of crystalline silica. Interlaboratory variability historically has been high for these analyses (∼25–35% relative standard deviation). Agreement between laboratories, as measured by the American Industrial Hygiene Association Proficiency Analytical Testing program over the period April 1990 through April 1998, was studied. Analysis of over 11,000 data points (laboratory/sample/round combinations) showed some significant differences between analytical methods in their relative recovery and precision, although overall mean recoveries were similar for the three techniques. Relative recovery of colorimetric results (but not those of the X-ray or infrared results) was significantly affected by sample loading in the range 40–170 µg silica per sample. Differences on the order of 5–10% were produced in some...