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PubMed2006

[Cardiac tolerance of moxifloxacin: Clinical experience from a large observational French study in usual medical practice (IMMEDIAT study)].

BACKGROUND: Moxifloxacin (Izilox) is prescribed for bacterial respiratory tract infections. ECG analysis done in clinical trials showed a mean QT prolongation at 6 ms that could lead to Torsades de Pointe. However, Izilox was well tolerated during clinical trials. To confirm the correct safety profile of Izilox in a large sample of patients, a French PMS study - MMEDIAT - was carried out in usual medical practice. METHODS: This prospective observational uncontrolled and monitored study was conducted in 13,578 patients with respiratory tract infection and treated with moxifloxacin 400 mg daily (duration: 5 to 10 days in accordance to the Market Authorization). Any clinical event being potentially a surrogate of a ventricular rhythm disorder ("critical event") were collected and analyzed by a Scientific Committee in charge to determine the potential cardiac origin of the reported event and to establish a causal relationship with the treatment. RESULTS: Among 13,578 patients, 1046 adverse events (678 patients [5%]) were reported, including 854 drug related events (564 patients [4.15%]). Of these 1046 adverse events, 95 (62 patients [0.46%]) were serious. A total of 189 critical adverse events (159 patients [1.2%]) were reviewed by the Scientific Committee. After analysis, 34 adverse events (28 patients [0.21%]) were assessed from potential cardiac origin. Of these 34 adverse events, 25 (19 patients [0.14%]) were assessed as drug-related: palpitations [13 patients], tachycardia [4 patients], malaise [4 patients], vertigo [3 patients] and pallor [1 patient]. All adverse events were transient and had favourable outcome. CONCLUSION: This PMS study confirmed that Izilox is well-tolerated in usual medical practice, in adequation with the safety data obtained in clinical trials.

Anti-Infective Agents↗
PubMed2001

Immunogenicity and safety of three commercial influenza vaccines in institutionalized elderly.

Influenza is a leading cause of morbidity and mortality in elderly people. This prospective, observed-blind, randomized, multicenter trial compares the immunogenicity and safety of three influenza vaccines in a sample of 635 elderly residents of four nursing homes in Milano (Italy). All vaccines were well tolerated: no serious adverse events were recorded, and a small number (9 subjects) of local and systemic reactions were observed. Twenty-nine oropharyngeal swabs were taken during the season from ILI (influenza-like illness) patients, none of whom was positive for influenza and other respiratory viruses. Immunogenicity was evaluated in a subgroup of 111 subjects with blood samples obtained just before vaccination and after 4 and 12 weeks. The adjuvanted vaccines, subunit vaccine with MF59 (a-SUV) and virosome subunit vaccine (v-SUV), induced a higher antibody response than whole virus vaccine (WVV). There was no significant difference between groups that received a-SUV and v-SUV, but the a-SUV group had higher values of geometric mean titres than the v-SUV group for H1N1 and B influenza strains. These findings suggest that influenza vaccination is effective, and they underscore the importance of vaccination programs for institutionalized elderly. Further studies are needed to compare other adjuvanted vaccines in order to define their different properties.

Adjuvants, Immunologic↗
PubMed1994

Understanding differences between high and low childhood accident rate areas: the importance of qualitative data.

BACKGROUND: The research discussed in the paper was undertaken for a District Health Authority to aid the development of appropriate policies to achieve the Health of the nation strategic target for reducing the death rate from accidents amongst children under 15. There has been a great deal of quantitative and epidemiological research into childhood accidents which has demonstrated a clear social class gradient in childhood accidents, fatalities and injuries. Less research has been undertaken into the possible reasons for the 'social patterning' of accidents and other aspects of health. Recent sociological research on childhood accidents has adopted a more qualitative approach and studied childhood safety within a family and community context. This approach has been used in the Huddersfield study on parental perspectives on childhood safety. METHODS: In-depth interviews were held with a sample of parents from a high and a low childhood accident rate area. RESULTS: The two focus areas reveal contrasting social profiles. There were significant differences on a number of aspects of parental perceptions on safety and beliefs about accidents, in the two areas. Analysis of accident events revealed that all the families in the high childhood accident rate area sample had children who had had an accident in the past which required hospital treatment. A high proportion of their children had experienced 'near misses'. In contrast, half the families in the low childhood accident rate area had children who had experienced an accident in the past and a much smaller proportion had experienced 'near misses'. All the parents in the sample from both areas developed rules, routines and practices to keep their children safe. The study suggests that there are social class differences in the effective use of these safety rules. CONCLUSION: Qualitatively orientated sociological research into parental perspectives on childhood safety contributes to an understanding of the reasons for the social patterning of childhood accidents. Such information should be of help to professionals in their prevention and safety promotion work.

Accident Prevention↗
PubMedDate not supplied

[Fundamental safety requirements in the use of live vaccine in food animals].

Live vaccines have a number of advantages over inactivated ones--above all in respect of the stimulation of cell-mediated immune reactions. Various live vaccines, based on viruses, bacteria, fungi or parasites, have been approved for use in Germany in animals used as a source of food. Safety requirements obviously play a more important role for live vaccines, both in vaccine development and in batch testing, than with inactivated vaccines. Vaccine strains isolated from tissue samples must be clearly distinguishable from field strains. The safety of overdoses and the spread of the vaccine strain in the immunized animals have to be investigated, as well as shedding of the vaccine strain and its safety in non-target species. Any impact of a live vaccine strain on humans and the environment must be assessed. Live vaccines will remain an important research field in the long term, with efforts focused on developing deletion mutants and vector vaccines.

Animal Diseases↗
PubMed1997

Preventing nursing student exposure incidents: the role of personal protective equipment and safety engineered devices.

This descriptive study used a self-selected sample of 580 newly licensed Virginia registered nurses to examine risk factors for percutaneous (needlestick) and mucocutaneous (splash) exposure incidents to blood or body fluids that occurred while they were nursing students. Fifty-one exposure incidents were reported by 42 respondents (7% of total). Twenty of 31 percutaneous exposure incidents were potentially preventable through the use of safety-engineered devices. Similarly, 4 of 10 mucocutaneous incidents occurring during routine procedures were potentially preventable through the use of personal protective equipment. Limited use of safety-engineered devices and personal protective equipment in the occurrence of nursing student exposure incidents suggests that active steps by schools of nursing to ensure student access to and use of personal protective equipment and safety-engineered devices may minimize exposure incident risk for students.

Chi-Square Distribution↗
PubMed1997

Bacterial typing: storing and processing of stabilized reference bacteria for polymerase chain reaction without preparing DNA--an example of an automatable procedure.

This paper examines the use of bacteria killed on blood-storage paper as templates (ghosts) and takes, as an example, the PCR ribotyping (amplification of the intergenic spacer regions between the 16S and 23S ribosomal RNA genes) of bacteria as described by Kostman et al. (J. Infect. Dis. 171, 204-208, 1995). All procedures have been particularly designed to be compatible with automation. DNA preparation is inappropriate for routine, high-volume sequence amplification from a diversity of microorganism cultures. Blood-storage/processing media provide another way of processing samples for PCR with distinctive aspects of increased safety and ease of automatibility. Blood-storage paper can be used for killing and processing bacteria to DNA-containing ghosts for reliable PCR. From as little as a few microliters of an overnight culture or a reasonably sized, single colony, rapid processing of large sample numbers is possible. FTA blood-storage medium has additional utility in that long-term cataloguing, storage, and processing of paper, loaded with culture, for PCR, is possible via a variety of sample wash sequences. It can be performed at convenience, after collection, and can be delayed indefinitely. using this approach, the repeatability of some PCR-ribotyping methodology of the type used by Kostman et al. (J. Clin. Microbiol. 30, 2084-2087, 1992) was examined as an exercise to demonstrate the practicality of FTA blood-paper usage and to check some basic features of PCR ribotyping. Five strains of Staphylococcus and one strain Escherichia coli were stored and processed on FTA blood paper, the PCR-ribotype patterns were analyzed and found to be the equal of patterns previously seen via additional DNA preparations.

Bacteria↗
PubMed2006

Validation of a questionnaire used to assess safety and professionalism among arborists.

This article summarizes a validation study of an instrument designed to measure safety and professionalism practices of arborists. A sample of 386 arborists from the State of Louisiana responded to the 58-item questionnaire. Analyses focused on several aspects of Messick's validation framework. Structural validity evidence was provided by analyses that indicate that the measures are unidimensional. Content validity evidence was supported by generally high positive values of the biserial correlations and optimal values of standardized mean-square item fit indices. Substantive validity evidence was provided by analyses that support the use of the two-point rating scale and a rank ordering of item means that is consistent with substantive theory. Person fit indices indicated little misfit among measures. Support for the generalizability aspect of validity was provided by an acceptable level of internal consistency and fairly tight error bands around estimated arborist measures. Additionally, few items exhibited DIF. Finally, with respect to the external aspect of validity, group differences between arborist measures were consistent with substantive theory.

Adult↗
PubMed2004

Analytical techniques and method validation for the measurement of selected semivolatile and nonvolatile organofluorochemicals in air.

The widespread use of semi- and nonvolatile organofluorochemicals in industrial facilities, concern about their persistence, and relatively recent advancements in liquid chromatography/mass spectrometry (LC/MS) technology have led to the development of new analytical methods to assess potential worker exposure to airborne organofluorochemicals. Techniques were evaluated for the determination of 19 organofluorochemicals and for total fluorine in ambient air samples. Due to the potential biphasic nature of most of these fluorochemicals when airborne, Occupational Safety and Health Administration (OSHA) versatile sampler (OVS) tubes were used to simultaneously trap fluorochemical particulates and vapors from workplace air. Analytical methods were developed for OVS air samples to quantitatively analyze for total fluorine using oxygen bomb combustion/ion selective electrode and for 17 organofluorochemicals using LC/MS and gas chromatography/mass spectrometry (GC/MS). The experimental design for this validation was based on the National Institute of Occupational Safety and Health (NIOSH) Guidelines for Air Sampling and Analytical Method Development and Evaluation, with some revisions of the experimental design. The study design incorporated experiments to determine analytical recovery and stability, sampler capacity, the effect of some environmental parameters on recoveries, storage stability, limits of detection, precision, and accuracy. Fluorochemical mixtures were spiked onto each OVS tube over a range of 0.06-6 microg for each of 12 compounds analyzed by LC/MS and 0.3-30 microg for 5 compounds analyzed by GC/MS. These ranges allowed reliable quantitation at 0.001-0.1 mg/m3 in general for LC/MS analytes and 0.005-0.5 mg/m3 for GC/MS analytes when 60 L of air are sampled. The organofluorochemical exposure guideline (EG) is currently 0.1 mg/m3 for many analytes, with one exception being ammonium perfluorooctanoate (EG is 0.01 mg/m3). Total fluorine results may be used to determine if the individual compounds quantified provide a suitable mass balance of total airborne organofluorochemicals based on known fluorine content. Improvements in precision and/or recovery as well as some additional testing would be needed to meet all NIOSH validation criteria. This study provided valuable information about the accuracy of this method for organofluorochemical exposure assessment.

Air Pollution, Indoor↗
PubMed1993

Evaluation of sampling and analytical methods for the determination of chlorodifluoromethane in air.

In January 1989, the Occupational Safety and Health Administration (OSHA) published revised permissible exposure limits (PELs) for 212 compounds and established PELs for 164 additional compounds. In cases where regulated compounds did not have specific sampling and analytical methods, methods were suggested by OSHA. The National Institute for Occupational Safety and Health (NIOSH) Manual of Analytical Methods (NMAM) Method 1020, which was developed for 1,1,2-trichloro-1,2,2-trifluoroethane, was suggested by OSHA for the determination of chlorodifluoromethane in workplace air. Because this method was developed for a liquid and chlorodifluoromethane is a gas, the ability of NMAM Method 1020 to adequately sample and quantitate chlorodifluoromethane was questioned and tested by researchers at NIOSH. The evaluation of NMAM Method 1020 for chlorodifluoromethane showed that the capacity of the 100/50-mg charcoal sorbent bed was limited, the standard preparation procedure was incorrect for a gas analyte, and the analyte had low solubility in carbon disulfide. NMAM Method 1018 for dichlorodifluoromethane uses two coconut-shell charcoal tubes in series, a 400/200-mg tube followed by a 100/50-mg tube, which are desorbed with methylene chloride. This method was evaluated for chlorodifluoromethane. Test atmospheres, with chlorodifluoromethane concentrations from 0.5-2 times the PEL were generated. Modifications of NMAM Method 1018 included changes in the standard preparation procedure, and the gas chromatograph was equipped with a capillary column. These revisions to NMAM 1018 resulted in a 96.5% recovery and a total precision for the method of 7.1% for chlorodifluoromethane. No significant bias in the method was found. Results indicate that the revised NMAM Method 1018 is suitable for the determination of chlorodifluoromethane in workplace air.

Air Pollutants, Occupational↗
PubMed1990

Effect of storage temperature on the stability of the liquid polyvalent antivenom produced in Costa Rica.

The effect of storage temperature on the stability of the liquid polyvalent (crotaline) antivenom produced at the Instituto Clodomiro Picado, Costa Rica, was studied during a twelve-month period. The following parameters were evaluated: neutralizing potency against lethal activity of Bothrops asper venom; protein and phenol concentrations; pH; turbidity; safety; and sterility. Analyses were performed each month on different samples of a batch, stored at 4, 23, 30 and 37 degrees C. No significant (P greater than 0.1) variations occurred in potency, protein and phenol concentrations, pH, sterility or safety, at any of the storage temperatures during the study period. However, visual inspection revealed a moderate increase in turbidity of the samples stored at 23, 30 and 37 degrees C, at nine, four and three months, respectively. Culture of samples excluded the possibility of microbial contamination of the product leading to turbidity. Chromatographic and electrophoretic analyses demonstrated that turbidity was caused by the formation of heterogeneous protein aggregates of high molecular weight. Present results support the conclusion that, although storage temperature (up to 37 degrees C for twelve months) does not alter antivenom potency, it significantly influences the formation of protein aggregates. This phenomenon can be prevented by recommending the storage of antivenom at refrigeration temperature.

Animals↗
PubMedDate not supplied

Assessment of coke oven emissions exposure among coking workers.

Coking workers are regularly exposed to coke oven emissions, which consist primarily of polycyclic aromatic hydrocarbons and volatile organic compounds. This study measured the workers' exposure to the benzene soluble fraction of total particulates (BSF). The study population consisted of 88 coking workers as an exposure group and 59 referents. Personal breathing-zone samples of BSF and total particulates were taken from all study subjects for 3 consecutive days. The highest BSF concentrations were found among the topside oven workers (geometric mean; range) (microgram/m3): lidman (515; 72-18, 181), tar chaser (432; 51-4334), and larry car operator (185; 55-649). The lowest was 7 micrograms/m3 in the referents. Among the samples at the topside oven 84% exceeded the Occupational Safety and Health Administration standard (150 micrograms/m3 BSF). The percentage of BSF in total particulates varied across job classifications, ranging from 0.3% in wharfmen to 24% in tar chasers. Area sampling indicated that the BSF concentration at the topside area was sixtyfold higher than that at the administrative area, which was approximately 2 km from the coke oven plant.

Air Pollutants, Occupational↗
PubMed1997

Suitability of preadmission blood samples for pretransfusion testing in elective surgery.

BACKGROUND: North American transfusion guidelines do not stipulate a time limit between drawing the specimen for pretransfusion testing and giving the transfusion to patients who have not received a transfusion or been pregnant in the preceding 3 months. British guidelines suggest that separated plasma and serum can be stored at -30 degrees C for up to 6 months, but they draw attention to the paucity of evidence concerning the use of stored samples. In Australia, transfusion guidelines recommend a maximum of 10 days' validity for pretransfusion specimens, which requires the patient to present for pretransfusion testing within 10 days of admission or to undergo retesting after admission, which in turn necessitates additional time in the hospital before operation. The study was performed to document the safety of using for pretransfusion testing a blood sample collected more than 10 days before surgery. STUDY DESIGN AND METHODS: Samples from 500 patients scheduled for elective surgery who had not been pregnant or received a transfusion in the previous 3 months were separately tested in blood group and antibody screens at an interval from 11 to 335 days before admission and again on admission. RESULTS: No clinically significant change was detected in the red cell antibody status of the paired samples of any patient. CONCLUSION: For patients who have not been transfused or pregnant in the previous 3 months, it is safe to crossmatch blood for transfusion by using a sample collected well in advance of elective surgery and stored at -30 degrees C.

Blood Grouping and Crossmatching↗
PubMed1995

Bacteriologic culture and histologic examination of samples collected from recumbent cattle at slaughter.

OBJECTIVE: To evaluate the potential food safety risks constituted by recumbent cattle that are slaughtered for edible beef. DESIGN: Prospective case series. ANIMALS: Thirty cattle in recumbency that passed a routine antemortem inspection at a US federally inspected abattoir. PROCEDURE: Aerobic, bacteriologic culture of blood samples taken immediately prior to slaughter and of spleens taken during viscera inspection. Gross lesions were recorded, and samples of liver, lung, kidney, and heart were collected from each animal for routine light microscopic examination. RESULTS: Bacteremia caused by Salmonella dublin was documented in 1 cow that had arthritis. Two other cows were condemned after postmortem inspection: 1 because of pneumonia and pleuritis and the other because of vegetative endocarditis. Three carcasses were retained and later condemned because of antibiotic residues in tissues; 1 of these cows had mastitis, 1 had liver abscesses, and 1 was the cow with vegetative endocarditis. Sarcocystosis was found in 27 of 30 hearts, but other clinically important histologic lesions were observed only in liver samples. In 11 of the 30 cows, multifocal, microscopic foci of hepatitis were observed, suggesting that terminal embolic bacterial showering of the liver had occurred in these animals. Liver samples were not submitted for bacteriologic culture. CLINICAL IMPLICATIONS: Most recumbent cows slaughtered for edible beef are not contaminated by bacteria; however, the viscera from these animals may present a food safety danger. Efforts should be made to develop rapid tests to identify bacteremic animals at slaughter and to more fully evaluate terminal showering of viscera by bacteria in cattle at slaughter.

Abattoirs↗
PubMed2002

The efficiency of alkaline extraction for the recovery of hexavalent chromium (CrVI) from paint samples and the effect of sample storage on CrVI recovery.

Workplace exposures to CrVI, a human carcinogen, are significant in spraying operations of chromate-containing paints. Accurate determination of CrVI in paint aerosol air samples is important in assessing a worker's exposure to CrVI. National Institute for Occupational Safety and Health method 7604 is widely used for determining CrVI in air samples. It utilizes an alkaline extraction procedure. It was historically validated for paint aerosol samples containing 24.5 to 61.5 microg of CrVI. The literature documented potential airborne CrVI exposures greater than 61.5 microg in recent paint spraying operations. The efficiency of the alkaline method at extracting CrVI from paint samples containing 250 to 3000 microg of CrVI was determined. Paint was prepared, sampled, extracted twice and then digested. Extracts were analyzed for CrVI and digestates of the residual Cr were analyzed for total Cr. Alkaline extraction of paint samples using NIOSH method 7604 resulted in quantitative recoveries for paint samples with CrVI filter loadings from 250 to 3000 microg. A decrease in CrVI extraction efficiency was observed in samples containing > 1000 microg of CrVI. A second extraction improved the recovery of CrVI in these samples. Refrigerating paint aerosol samples for up to 2 weeks did not affect their CrVI content.

Carcinogens↗
PubMed1975

Laboratory contamination of blood cultures.

A prospective study of the use of a laminar flow cabinet, an exhaust-ventilated safety hood, and the open bench for the microbiological examination of blood is described. Blood samples from 1600 patients were subcultured on the open bench, 2700 in a safety hood, and 2607 in a laminar flow cabinet. Use of the laminar flow cabinet produced a significantly greater level of contamination than the other methods, and it is concluded that the exhaust-ventilated safety hood should be used for this procedure.

Bacteriological Techniques↗
PubMed2005

Shirt designs for sun protection.

The objectives of the study reported here were to document consumer attitudes, risk understanding, and behaviors with respect to sun safety and to define consumer preferences for protective shirt design and labeling. A sample of 1,508 adults was surveyed at the 2002 Farm Progress Show sun-safety exhibit. Results showed that people generally understood the longterm risk from exposure to ultraviolet radiation, but did not routinely use sun-protective clothing to avoid it. Design features preferred by consumers for sun-safe shirts were significantly related to demographic characteristics, including age, education, sex, occupation, and employment status. Overall, the sun-safe shirt design most preferred can be summarized as a casual-style, solid-color, knit shirt with a crew neck or collar. Over 80 percent of participants favored Ultraviolet Protective Factor labeling as well as other consumer labeling such as information on care, fiber content, colorfastness, and finishes applied to shirts. Industrial and educational implications are provided.

Adult↗
PubMedDate not supplied

Sampling-dependent up-regulation of gene expression in sequential samples of human airway epithelial cells.

As part of a study of in vivo gene expression levels in the human airway epithelium in response to chronic cigarette smoking, we have identified a number of genes whose expression levels are altered in a time-dependent fashion resulting from the procedure used to sample epithelial cells. Fiberoptic bronchoscopy and airway epithelium brushing were used to obtain independent samples from a single individual, 1st from the right lung, followed by sampling of the left lung. We observed that a specific subset of early response genes encoding proteins involved in transcription, signal transduction, cell cycle/growth, and apoptosis were significantly up-regulated in the left lung samples (the 2nd region to be sampled) compared with the right lung samples (the 1st region to be sampled). This response was due to the temporal nature of the sampling procedure and not to inherent gene expression differences between airway epithelium of the right and left lungs. When the order of sampling was reversed, with the left airway epithelium sampled 1st, the same subset of genes were up-regulated in the samples obtained from the right airway epithelium. The time-dependent up-regulation of these genes was likely in response to the stress of the procedure and/or the anesthesia used. Sampling-dependent uncertainty of gene expression is likely a general phenomenon relevant to the procedures used for obtaining biological samples, particularly in humans where the sampling procedures are dependent on ensuring comfort and safety.

Apoptosis↗
PubMed2000

Living on the edge: a phenomenological study of medically uninsured working Americans.

An estimated 35 to 50 million Americans have no medical insurance; the vast majority are employed persons and their dependents. This phenomenological study was developed to make visible the experience of working Americans living on the edge-forced to walk a fine line between health and illness without the safety net of medical insurance. A purposive sample of 12 individuals was asked, "What is it like to be working and without medical insurance? Based on textual analysis, using an adaptation of Colazzi's method, themes were grouped into four theme clusters: A Marginalized Life, Up Against Rocks and Hard Places, Making Choices-Chancing It, and Getting By-More or Less. These are illustrated through commentary and direct quotation to depict an overall sense of the experience. Implications for nurses charged with addressing the needs of the medically uninsured and for nursing as a whole are discussed.

Adult↗