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PubMed2005

HER2/neu expression in bladder cancer: relationship to cell cycle kinetics.

BACKGROUND AND OBJECTIVES: The incidence of overexpression of HER2/neu in bladder cancer is one of the highest among all human malignancies tested; such overexpression is thought to play a role in the aberrant proliferation of cancer cells. This study was conducted to evaluate the quantitative assessment of HER2/neu expression by enzyme immunoassay (EIA) and its prognostic significance in differentiating between high and low proliferating tumors. PATIENTS AND METHODS: Tissue samples were collected from 35 patients with benign bladder lesions, 28 with bilharzial bladder cancer, and 25 with nonbilharzial bladder cancer. Twenty normal samples were obtained from normal safety margin areas in nonbilharzial bladder cancer patients. Out of the malignant samples, 22 were found to be squamous cell carcinoma and 31 were transitional cell carcinoma. All samples were examined for HER2/neu expression by EIA and Western blot (WB). Flow cytometric (FCM) analysis was also performed in all the samples provided. RESULTS: HER2/neu was found to be significantly overexpressed in the malignant group compared to the benign and normal groups (P < 0.001) and no significant difference was found between the bilharzial and nonbilharzial cancer groups or between the transitional and squamous cell carcinoma groups. HER2/neu was significantly correlated to ploidy (P = 0.001), synthetic phase fraction, SPF (P = 0.012), and DNA index (P = 0.002). No significant correlation was found between HER2/neu and stage or grade while it was significantly associated with lymph node status of the tumour (P = 0.02). CONCLUSION: HER2/neu can be measured reliably by the EIA method as confirmed by WB. The quantitative assessment of HER2/neu expression in malignant tumors aided by other proliferation markers such as SPF, DI, and ploidy could be useful in selecting patients for more aggressive treatment or for predicting outcome.

Cell Cycle↗
PubMed1993

Determination of pentamidine isethionate in air.

A concern currently exists regarding the potential for exposure of health care workers to pentamidine isethionate, a drug used for prevention and treatment of Pneumocystis carinii pneumonia in immunocompromised patients, including those with human immunodeficiency virus infection. In order to evaluate worker exposures, a sampling and analytical method for pentamidine isethionate in air has been developed. This method involves sampling with a 37-mm PVC membrane filter at 1 to 2 L/min, recovery with 3 mL of 50:50 ethanol:water with 0.085% phosphoric acid and 0.04% tetramethylammonium chloride in an ultrasonic bath for 10 min, and analysis by high performance liquid chromatography with fluorescence detection. The limit of detection is about 18 ng per sample, and the lower limit of quantitation is 50 ng per sample. Recoveries of pentamidine isethionate from PVC filters were 0.76 to 0.91 at 50 to 8820-ng levels of fortification. Samples were stable on PVC filters during 27 days of storage at room temperature. Because patients who are treated with pentamidine isethionate are at increased risk of contracting tuberculosis (TB), safety precautions for handling samples contaminated with TB were included in the sampling and analytical method.

Air↗
PubMed2001

Identification and classification of consumer food-handling behaviors for food safety education.

OBJECTIVE: To identify key behaviors associated with major food safety pathogen control factors. DESIGN: World Wide Web-based descriptive study with 4 tasks: compile a list of food-handling behaviors from the literature; use Delphi process to build consensus, rank order, and edit lists of behaviors; assess content and construct validity; and review results of Delphi process at a summit meeting of selected experts to make final recommendations for a food safety behavior list. SUBJECTS/SETTING: A convenience sample of 10 epidemiologists, 11 food microbiologists, 10 food safety educators, and 10 food safety policy makers was recruited from lists of nationally known experts. Twenty-four experts completed 4 rounds of surveys presented to them via a Web site. Six experts attended a face-to-face meeting to finalize behavior lists. Statistical analyses performed Descriptive statistics and sum of observation data were used to determine rank order and validity. RESULTS: Twenty-nine key food-handling behaviors for maintaining the safety of food and reducing the number of cases and outbreaks of foodborne illness were identified. These were rank-ordered within 5 pathogen control factors: practice personal hygiene, cook foods adequately, avoid cross-contamination, keep foods at safe temperatures, and avoid foods from unsafe sources. APPLICATIONS/CONCLUSIONS: This list of rank-ordered behaviors grouped by pathogen control factor should help dietitians and educators confidently teach food safety guidance that will be most effective in preventing illness.

Consumer Product Safety↗
PubMed2005

Confirmatory and quantitative analysis of beta-lactam antibiotics in bovine kidney tissue by dispersive solid-phase extraction and liquid chromatography-tandem mass spectrometry.

A simple, rapid, rugged, sensitive, and specific method for the confirmation and quantitation of 10 beta-lactam antibiotics in fortified and incurred bovine kidney tissue has been developed. The method uses a simple solvent extraction, dispersive solid-phase extraction (dispersive-SPE) cleanup, and liquid chromatography-tandem mass spectrometry (LC/MS/MS) for confirmation and quantitation. Dispersive-SPE greatly simplifies and accelerates sample cleanup and improves overall recoveries compared with conventional SPE cleanup. The beta-lactam antibiotics tested were as follows: deacetylcephapirin (an antimicrobial metabolite of cephapirin), amoxicillin, desfuroylceftiofur cysteine disulfide (DCCD, an antimicrobial metabolite of ceftiofur), ampicillin, cefazolin, penicillin G, oxacillin, cloxacillin, naficillin, and dicloxacillin. Average recoveries of fortified samples were 70% or better for all beta-lactams except DCCD, which had an average recovery of 58%. The LC/MS/MS method was able to demonstrate quantitative recoveries at established tolerance levels and provide confirmatory data for unambiguous analyte identification. The method was also tested on 30 incurred bovine kidney samples obtained from the USDA Food Safety and Inspection Service, which had previously tested the samples using the approved semiquantitative microbial assay. The results from the quantitative LC/MS/MS analysis were in general agreement with the microbial assay for 23 samples although the LC/MS/MS method was superior in that it could specifically identify which beta-lactam was present and quantitate its concentration, whereas the microbial assay could only identify the type of beta-lactam present and report a concentration with respect to the microbial inhibition of a penicillin G standard. In addition, for 6 of the 23 samples, LC/MS/MS analysis detected a penicillin and a cephalosporin beta-lactam, whereas the microbial assay detected only a penicillin beta-lactam. For samples that do not fall into the "general agreement" category, the most serious discrepancy involves two samples where the LC/MS/MS method detected a violative level of a cephalosporin beta-lactam (deacetylcephapirin) in the first sample and a possibly violative level of desfuroylceftiofur in the second, whereas the microbial assay identified the two samples as having only violative levels of a penicillin beta-lactam.

Animals↗
PubMed1993

Development of a work behavior taxonomy for the safety function in industry.

A safety job activity questionnaire incorporating 24 job tasks was developed for describing the safety function within industry. This instrument was mailed to a stratified-proportionate sample of 1,190 working safety professionals representing 10 major industrial categories. Respondents rated the relative importance and amount of time spent on each of the 24 job activities. The overall response rate was 40%, producing 465 usable questionnaires. Factor analytic techniques were applied to each set of ratings to derive the principal dimensions of the safety position. Similar five-factor solutions emerged for both importance and time spent, accounting for 56% and 52% of the variance, respectively. The five job dimensions were: (i) serving as safety consultant and advisor, (ii) coordinating compliance and control activities, (iii) assessing the effectiveness of controls, (iv) analyzing hazards and losses, and (v) conducting specialized studies and reviews. Respondents, classified by industrial group and size of operation, were then compared using the job dimensions from the factor analyses. There were very few differences in the safety function across different industries or sizes of operations.

Factor Analysis, Statistical↗
PubMed1989

Studies of the bacteriological water quality for the intakes of different water treatment plants in greater Cairo.

Water samples from the intakes of 10 water treatment plants at Greater Cairo were bacteriologically tested for total bacterial counts, total coliforms, fecal coliform and fecal streptococci during 1984-1986. The total bacterial count ranged between 10(4)-10(6), 10(3)-10(6), and 10(3)-10(5)/ml during 1984, 85, and 86 respectively. Total coliform density ranged between 0-10(3), 10- greater than 10(4), and 10(2)- greater than 10(4)/100 ml during 1984, 85, and 86 respectively. Although fecal streptococci density does not exceed 10(3)/100 ml in most cases, large numbers of samples are negative for fecal streptococci. By using fecal streptococci as an indicator it is possible to avoid interference between the total bacterial count and coliforms detection. It is important to gain a real judgment about the public health safety by testing the sample for both coliforms and fecal streptococci.

Colony Count, Microbial↗
PubMed1993

Early transabdominal chorionic villus sampling in couples at high genetic risk.

OBJECTIVE: The purpose of the study was to evaluate the feasibility and safety of transabdominal chorionic villus sampling before 9 weeks' gestation. STUDY DESIGN: Two hundred pregnancies at risk for beta-thalassemia (n = 198) or Duchenne muscular dystrophy (n = 2) underwent transabdominal CVS at 6 through 8 weeks. Sampling success and fetal loss are expressed in percentages. RESULTS: Sampling was successful in all cases (100%). Forty-eight fetuses were affected by beta-thalassemia and one by Duchenne muscular dystrophy. The percentage of fetal loss, expressed as a proportion of continuing pregnancies, was 4.0%. All women (n = 144) have been delivered, and no misdiagnoses have occurred. We observed one anencephalus and one mild limb defect consisting of absence of distal phalanges of index and little fingers of both hands and distal phalanges of both little toes. CONCLUSION: Transabdominal CVS before 9 weeks is a reliable and relatively safe method for prenatal diagnosis in patients at high risk for genetic diseases. However, further studies are necessary to assess the risk to the fetus.

Adult↗
PubMed2006

Patient safety perceptions: a survey of Iowa physicians, pharmacists, and nurses.

BACKGROUND: Patient safety is of concern to consumers, health professionals, policymakers, insurers, and researchers. OBJECTIVE: Assess the perceptions of health care providers regarding the impact of parts of the health care system on patient safety, barriers to patient safety, and strategies to improve patient safety. METHODS: Statewide survey mailed in May 2001. Participants rated the impact of 10 parts of the health care system on patient safety, selected barriers to patient safety that they thought should be priorities, and selected the best strategies for improving patient safety. RESULTS: Of random samples of 1310 physicians, 1310 pharmacists, and 2620 nurses licensed by the state of Iowa, 5075 providers were eligible and 2388 responded (47%). Provider education, norms and values, patient and family characteristics, and continuity of care were rated as having a major impact on patient safety by at least 70% of each provider group. A general lack of consensus exists among providers about which barriers to patient safety should be priorities and which strategies would best improve the system. However, a majority of providers agreed that educating patients about their role in health care and sharing information between providers and across settings of care are important strategies for improving patient safety. CONCLUSION: In areas in which providers agree on the best strategies, broader, system-wide interventions that include physicians, pharmacists, and nurses in multiple settings may be implemented to improve patient safety. Health care organizations and providers must get patients more involved in their care by asking them to help define roles, design educational materials, and develop useful methods of sharing information across settings.

Health Care Surveys↗
PubMed2004

Minimization of sample size when comparing two small probabilities in a non-inferiority safety trial.

In clinical trials success rates of two treatments to be compared often range from 10 to 90 per cent. When the comparison probabilities are (much) smaller than 10 per cent, standard methods for sample size and power calculations may provide invalid results. This situation may occur when there is interest in safety rather than in efficacy. In such trials, no more patients should be included than strictly necessary. We compared the results of maximum likelihood methods for the computation of sample sizes in a non-inferiority trial, including exact procedures and considered unequal sample sizes for experimental and reference treatment. An exact, unequal sample size maximum likelihood procedure is advocated when the specified non-zero risk difference under the null hypothesis is not too large. Such a procedure is also indicated when the parameter of interest is the relative risk, rather than the risk difference.

Clinical Trials, Phase II as Topic↗
PubMed2004

Food safety practices and readiness to implement HACCP programs in assisted-living facilities in Iowa.

OBJECTIVE: To evaluate current food-handling practices and employee food safety knowledge and attitudes and to provide baseline data for implementing the Hazard Analysis and Critical Control Point (HACCP) program in assisted-living foodservices for elderly persons. DESIGN: Food-handling practices were observed at each assisted-living facility using a structured observation form. A validated questionnaire was used to determine demographic information and employees' attitudes and knowledge about food safety. SUBJECTS/SETTING: A convenience sample of 40 assisted-living facilities in Iowa was recruited from a list obtained from the Iowa Department of Elder Affairs. STATISTICAL ANALYSES PERFORMED: Descriptive statistics were used to summarize data. One-way analysis of variance was used to assess differences in attitudes and food safety knowledge among the managers, cooks, and other foodservice employees. Multiple linear regression determined the relationship between manager and facility demographics and the food safety practice score. RESULTS: Proper food-handling practices were followed in many assisted-living facilities, but areas in need of improvement were identified. Some HACCP prerequisite programs were found to be inadequate, including a lack of written standard operating procedures, documentation of food safety practices, and training. Temperatures and chemical concentrations need to be checked routinely. Foodservice employees had a significant amount of food safety knowledge (14.6+/-3.0 out of 20 possible points), and employees with food safety certification scored higher than those with no certification (15.6+/-2.6 and 13.9+/-3.1, respectively; P </=.001). CONCLUSIONS: Training programs, both basic food safety and the HACCP program, will support improvement of safe food-handling practices and implementation of prerequisite programs and the HACCP program. Developing prerequisite programs, including sanitation standard operating procedures, will aid assisted-living facilities in moving toward HACCP program implementation.

Adult↗
PubMed2003

The culture of safety: results of an organization-wide survey in 15 California hospitals.

OBJECTIVE: To understand fundamental attitudes towards patient safety culture and ways in which attitudes vary by hospital, job class, and clinical status. DESIGN: Using a closed ended survey, respondents were questioned on 16 topics important to a culture of safety in health care or other industries plus demographic information. The survey was conducted by US mail (with an option to respond by Internet) over a 6 month period from April 2001 in three mailings. SETTING: 15 hospitals participating in the California Patient Safety Consortium. SUBJECTS: A sample of 6312 employees generally comprising all the hospital's attending physicians, all the senior executives (defined as department head or above), and a 10% random sample of all other hospital personnel. The response rate was 47.4% overall, 62% excluding physicians. Where appropriate, responses were weighted to allow an accurate comparison between participating hospitals and job types and to correct for non-response. MAIN OUTCOME MEASURES: Frequency of responses suggesting an absence of safety culture ("problematic responses" to survey questions) and the frequency of "neutral" responses which might also imply a lack of safety culture. Responses to each question overall were recorded according to hospital, job class, and clinician status. RESULTS: The mean overall problematic response was 18% and a further 18% of respondents gave neutral responses. Problematic responses varied widely between participating institutions. Clinicians, especially nurses, gave more problematic responses than non-clinicians, and front line workers gave more than senior managers. CONCLUSION: Safety culture may not be as strong as is desirable of a high reliability organization. The culture differed significantly, not only between hospitals, but also by clinical status and job class within individual institutions. The results provide the most complete available information on the attitudes and experiences of workers about safety culture in hospitals and ways in which perceptions of safety culture differ among hospitals and between types of personnel. Further research is needed to confirm these results and to determine how senior managers can successfully transmit their commitment to safety to the clinical workplace.

Adult↗
PubMed2006

Transabdominal chorionic villus sampling (CVS) for prenatal diagnosis of genetic disorders.

OBJECTIVE: To determine the safety and outcome of transabdominal Chorionic Villus Sampling (CVS) for prenatal diagnosis of genetic disorders. DESIGN: Descriptive study. PLACE AND DURATION OF STUDY: Department of Pathology, PNS Shifa, Karachi, from January 2003 to December 2004. PATIENTS AND METHODS: A total of 143 couples with request for prenatal diagnosis of various genetic disorders were studied. Transabdominal CVS was done under local anesthesia and ultrasound guidance. A Co-axial Chorion Biopsy needle set with an outer guide and an inner aspiration needle was used. The needle was introduced into the placenta in its longitudinal direction. Once the needle was adequately placed, the chorionic villi were aspirated with a to and fro jiggling movement of the aspiration needle and a suction force was applied through a syringe. Results were recorded and analyzed for descriptive statistics. RESULTS: A total of 144 CVSs were done in the outdoor on 143 couples including one with a twin pregnancy. The most common indication was b-thalassaemia (97%). Most procedures (76%) were done between 12 and 14 weeks (range 10-21 weeks). All placental positions including 52% anterior and 48% posterior were approachable through the trans-abdominal route. Most aspirations were easy, however, in 28% the aspiration was difficult due to a variety of factors. The overall success rate was 100%. In 85% of the cases sample yield was >25mg while in the remaining cases 10-25mg of sample was obtained that allowed a comfortable diagnosis. The procedure related abortion occurred in 1/144 (0.7%). CONCLUSION: Transabdominal CVS is a useful outdoor procedure for prenatal diagnosis. Placentae in almost any position can be approached without significant risk to the mother and the fetus.

Adult↗
PubMed2004

Sampling and analysis of butyltin compounds in air using gas chromatography and flame photometric detection.

Organotin compounds are used in a variety of applications including stabilizers, catalysts, antifouling agents, and biocides. Because of the widespread use of organotin compounds in industry and their wide range of toxic effects, it is important to measure worker exposure to specific organotin compounds. Three butyltin compounds were selected for this study--butyltin trichloride, dibutyltin dichloride, and tributyltin chloride. These three compounds are typically present in the same work environment; therefore, developing a sampling and analytical method that would allow all three butyltin compounds to be sampled and analyzed simultaneously was desired. A derivatization procedure using sodium tetraethylborate (STEB) was selected for study and validation. The validation study demonstrated that sampling using the Occupational Safety and Health Administration (OSHA) Versatile Sampler (OVS) with XAD-2 resin sorbent and analysis using gas chromatography/flame photometric detection (GC/FPD) can be used to evaluate worker exposures to specific butyltin chlorides over the range of 5 to 270 micrograms/m3 collected at a flowrate of 0.25 L/min over a 3-hour period for a 45-L air sample. Breakthrough studies at 1.5 times the occupational exposure guideline (OEG) of 0.05 mg/m3 showed that samples could be collected at flowrates up to 0.5 L/min for 12 hours without breakthrough. The 14-day storage stability study showed apparent degradation of tributyltin and monobutyltin within a 3-day storage period at both ambient and refrigerated temperatures. There was no further degradation from 3 to 14 days. The stability of dibutyltin was unaffected by storage condition over the 14-day storage study. Subsequent stability studies incorporating a spiking solution control sample were conducted extending the stability study out to 27 days. These data show that all three butyltins were stable at either ambient or refrigerated conditions.

Air Pollution, Indoor↗
PubMed2004

Prevalence and characteristics of Shiga toxin-producing Escherichia coli, Salmonella spp. and Campylobacter spp. isolated from slaughtered sheep in Switzerland.

Caecum samples collected from 653 slaughtered sheep from two Swiss abattoirs were examined. The aim of this study was: (i) to determine the prevalence of Shiga toxin-producing Escherichia coli (STEC), Salmonella spp. and Campylobacter spp.; (ii) to further characterize isolated strains; and (iii) to discuss the results obtained with their relevance to food safety. The percentage of samples testing positive for STEC by a polymerase chain reaction was 29.9%. The prevalence of positive Salmonella spp. samples was 11.0% and of Campylobacter spp. 17.5%. In 55.3% of the 76 isolated non-O157 STEC strains, stx2 variants (mostly stx2d) were detected. Additional virulence factors were harbored by 55.3% of the STEC strains, 10.5% of them being eae positive, 55.3% ehxA positive and 2.6% astA positive. All isolated salmonella were identified as Salmonella enterica subsp. diarizonae serovar 61:k:1,5,(7). Pulsed-field gel electrophoresis (PFGE) was performed for genotyping and 22 different restriction endonuclease digestion profiles were found among these strains for the different farms of origin. Of the 114 isolated Campylobacter spp. strains, 64.9% were shown to be Campylobacter jejuni and 35.1% Campylobacter coli, nine strains showed resistance against tetracycline, ciprofloxacin/nalidixic acid or streptomycin. In conclusion, sheep are a reservoir for the pathogens of latent zoonoses as non-O157 STEC, S. enterica subsp. diarizonae and Campylobacter spp. The maintenance of slaughter hygiene is consequently of crucial importance. It can be measured in daily practice by "slaughter-process-controls" and regular microbiological monitoring of carcasses. These are valuable tools for verifying slaughter hygiene according to hazard analysis critical control point principles.

Abattoirs↗
PubMed2004

Posttraumatic stress disorder, depression, and perceived safety 13 months after September 11.

This study assessed relationships between exposure to the September 11, 2001, terrorist attack, current posttraumatic stress disorder (PTSD), current major depression, and current safety perceptions in a sample of 212 Pentagon staff members 13 months after the attack. Forty-eight respondents (23 percent) had possible PTSD; eight (4 percent) had probable major depression. Respondents who were directly exposed to the attack were more likely to have PTSD and major depression and were less likely to have a perception of safety at work and in usual activities and travel only. In contrast, respondents with PTSD reported a lower perception of safety at home, at work, and in usual activities and travel.

Adult↗
PubMed2000

High-throughput quantitative bioanalysis by LC/MS/MS.

This review article discusses the most recent significant advances in the sample preparation and mass spectrometry aspects of high-throughput bioanalysis by LC/MS/MS for the quantitation of drugs, metabolites and endogenous biomolecules in biological matrices. The introduction and implementation of automated 96-well extraction has brought about high-throughput approaches to the biological sample preparation techniques of solid-phase extraction, liquid-liquid extraction and protein precipitation. The fast-flow on-line extraction technique is a different high-throughput approach that has also significantly speeded up analysis by LC/MS/MS. The use of pierceable caps for biological tubes further enhances the analysis speed and improves the safety in handling biological samples. The need for adequate chromatographic separation in order to eliminate interferences due to metabolites and/or matrix effects in LC/MS/MS is discussed. To highlight our limited understanding of atmospheric pressure ionization mass spectrometry, results from recent investigations that appear to be counter-intuitive are presented. Looking ahead to the future, multiplexed LC/MS/MS systems and capillary LC are presented as areas that can bring about further improvements in analysis speed and sensitivity to quantitative bioanalysis by LC/MS/MS.

Acetonitriles↗
PubMed1979

Prenatal diagnosis of beta-thalassemia.

Prenatal diagnosis was attempted in 14 fetuses at risk for homozygous beta-thalassemia, gestational age 18-22 weeks. In 4 cases the placenta was entirely anterior, placental aspiration under ultrasonic control only had to be used for fetal blood sampling. In 10 fetuses fetoscopy was used for puncture of a chorionic blood vessel. Diagnoses were based on the rate of in vitro synthesis of beta-globin related to total non-alphaglobin synthesis. With the aid of fetoscopy, nearly pure fetal blood was obtained in general. Placental aspiration resulted in samples which contained a low percentage of fetal and a high percentage of maternal cells. The attempt of fetal blood sampling resulted in fetal loss in two cases. In 2 aspiration cases no diagnosis could be made because the samples were inadequate. In 2 cases the diagnosis was established in spite of low fetal cell content through determination of the specific radioactivity in the placental and pure maternal blood. Until now 6 children have been born in whom prenatal diagnosis had been attempted, none of them has homozygous thalassemia. Present efforts are directed toward improving the safety of fetal blood sampling and the biochemical methods for the diagnosis in placental samples with low fetal cell content. Although the prenatal diagnosis of beta-thalassemia is possible, the procedure has still to be considered experimental.

Female↗
PubMed1987

Spontaneous fetal loss after demonstration of a live fetus in the first trimester.

Chorionic villus sampling is being considered as an alternative to amniocentesis for genetic evaluation. The risk of subsequent spontaneous abortion from this invasive procedure, however, remains unclear. A prospective analysis of pregnancy outcome after ultrasound documentation of fetal viability at eight to 12 weeks' gestation was carried out in an uninstrumented population of patients to establish a background loss rate against which to evaluate the safety of chorionic villus sampling. All patients presenting to the authors' private practice from December 1983 to January 1986 were enrolled in the study. An ultrasound examination was performed at the first visit to confirm intrauterine pregnancy and assess gestational age; in gestations less than eight weeks, the sonogram was repeated four weeks later. Four hundred eighty-nine delivered patients are the subject of this study. We evaluated the differences between this group and those patients presenting either with a blighted ovum or beyond the first trimester, as well as the outcome of those patients with spotting early in gestation. This study suggests that if a live fetus is documented by ultrasonography at eight to 12 weeks' gestation, the risk of spontaneous abortion before 20 weeks' gestation in an uninstrumented population is 2.0%.

Adult↗