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PubMed2004

Food sampling practice in the United Kingdom.

As an integral part of the UK food surveillance scheme, routine food sampling is undertaken by officers at local councils. One of the main purposes of the food sampling programme is to detect food contaminants before they are sold to the public. This paper investigated the current UK food sampling activity undertaken by the local Environmental Health Departments and examined the effectiveness of the food programme. A national survey was undertaken by means of a questionnaire sent to 439 UK local authorities and a response rate of 39.2% (172 LAs) was achieved. Thirty-nine per cent of replies indicated that ensuring food safety and hygiene was the most important aim of sampling. Less than half of the returns suggested that their food programmes contributed to the prevention of foodborne illness. However, over three-quarters agreed that the current food sampling system could be improved upon. This study concluded that current UK food sampling is marginalized by financial constraints. In order to design an effective routine food programme, it should be based on an overall co-ordinated approach from local to European levels. Future work towards a statistically validated approach to the design will improve the effectiveness of food sampling programme.

Food Contamination↗
PubMed2004

An investigation of monitoring for sleep-related threat in primary insomnia.

In Study 1, individuals with primary insomnia (n=32) and good sleepers (n=38), recruited from a university population, completed a semi-structured interview. The interview assessed monitoring for sleep-related threat, negative thoughts and safety behaviours, at night and during the day. Compared to good sleepers, individuals with insomnia reported more frequent monitoring at night and during the day, more negative thoughts associated with monitoring at night and during the day, and the use of more safety behaviours associated with monitoring at night. A path analysis showed that the total monitoring frequency was significantly positively related to the score for total negative thoughts, which in turn, was significantly positively related to the total number of safety behaviours used. Study 2 aimed to test the generalisability of these findings in a clinical sample of individuals with primary insomnia (n=23). The results indicated that the clinical sample also engaged in monitoring for sleep-related threat, experienced negative thoughts and used safety behaviours. Further, more severe insomnia was associated with more negative thoughts and the use of more safety behaviours associated with monitoring at night. Together, these results are consistent with the proposal that monitoring for sleep-related threat functions to maintain insomnia by triggering negative thoughts and the use of safety behaviours. Future research is required to verify the proposed causal status of monitoring, using prospective designs and experimental manipulations.

Adaptation, Psychological↗
PubMed1992

Clinical pathology: preanalytical variation in preclinical safety assessment studies--effect on predictive value of analyte tests.

Significant differences in concentrations of analytes in samples may be introduced before samples enter analyzers. These differences are known as preanalytical variation and are part of the overall variation in analytical data. Preanalytical variation is caused by factors that operate during animal preparation prior to sampling, sample collection, sample processing, and sample storage prior to measurement. Preanalytical variation is important because it detracts from the predictive value of analyte measurements. Preanalytical variation may permanently damage data. Because its effects are difficult to quantitate it should be minimized in safety assessment studies. Sources of preanalytical variation are actions performed on animals prior to sample collection and actions performed on the specimen prior to analysis. Preanalytical variation produces a range of artefacts in experimental data. Consequences of preanalytical variation are loss of confidence in the data, obfuscation of real test article effects, false effects, and possibly the expense of repeating a study. To limit preanalytical variation, its sources must be identified, the effects documented, and measures devised to eliminate its sources. Predictive value (likelihood of actual disease) of appropriate clinical pathology tests in toxicology is inversely dependent on preanalytical variation: uncontrolled variation produces data with low predictive values, and controlled variation produces data with high predictive values.

Animals↗
PubMed1996

Asbestos exposure of building maintenance personnel.

The exposures of building maintenance personnel and occupants to airborne asbestos fibers, and the effects of operations and maintenance programs on those exposures, continue to be an important public health issue. The subject of this investigation was a large metropolitan county with numerous public buildings which routinely conducted air sampling for asbestos. A total of 302 personal air samples in nine task categories collected during maintenance worker activities in proximity to asbestos-containing materials were analyzed; 102 environmental air samples in four task categories were also analyzed. The arithmetic means of the 8-hr time weighted average exposures for personal sampling for each task category were all below the Occupational Safety and Health Administration permissible exposure level of 0.1 fibers (f)/cc > 5 microm. The highest mean 8-hr time weighted average exposure was 0.030 f/cc > 5 microm for ceiling tile replacement. The maximum asbestos concentration during sample collection for environmental samples was 0.027 f/cc > 5 microm. All asbestos-related maintenance work was done within the framework of an Operations and Maintenance Program (OMP) which utilized both personal protective equipment and controls against fiber release/dispersion. Results are presented in association with specific OMP procedures or controls. These results support the effectiveness of using Operations and Maintenance Programs to manage asbestos in buildings without incurring unacceptable risk to maintenance workers performing maintenance tasks.

Air Pollutants↗
PubMed2004

Parental vaccine safety concerns. The experiences of pediatricians and family physicians.

OBJECTIVES: Recently several concerns regarding vaccine safety have received significant media attention. Primary care physicians are the most common interface for parents with the immunization delivery system and are likely to have the greatest opportunity for exposure and experience with parental vaccine safety concerns. METHODS: Mail survey study of a national random sample of 750 pediatricians (PDs) and 750 family physicians (FPs) was conducted in 2000. Outcome variables of primary interest included the number of parental vaccine refusals in the past year, frequency of specific parent vaccine safety concerns, and actions taken by physicians when parents refused a vaccine. Chi-square analysis was used to determine the significance of the association of each outcome variable of interest with physician specialty, frequency of vaccine refusal, and the demographic variables. Multivariate analysis explored the potential for independent predictors of physicians who experienced increases in vaccine refusal. RESULTS: The response rate was 70%. Overall, 93% of PDs and 60% of FPs reported at least one parental vaccine refusal in their practice in the past year. PDs also were more likely than FPs to report an increase in the number of vaccine refusals over the past year (18% v 8%, p =0.01), while FPs were more likely to report a decrease in vaccine refusals over the same time period (18% v 11%; p <0.5). PDs were more likely than FPs to provide additional information regarding vaccines to parents who refused vaccines and/or to discuss the issue at later visits. The most common concerns of parents were related to short-term reactions and pain from multiple injections. CONCLUSIONS: While almost all PDs and most FPs experienced at least one vaccine refusal from parents in the past year, far fewer physicians of both specialties observed an increase in their occurrence. Physicians must work to be consistently well informed of both the benefits of immunization as well as the issues of parental concern regarding vaccine safety.

Child, Preschool↗
PubMed1987

Correction of lithium levels for dose and blood sampling times.

Inconsistencies inherent in the clinical application of morning serum lithium levels can be eliminated by correcting the levels for variations in dosage schedule, rate of lithium elimination, and blood sampling time. In this report, graphs constructed from an accurate pharmacokinetic model of lithium elimination are used to convert the serum lithium level into the daily exposure of the body to lithium. This method facilitates safety and effectiveness in lithium treatment and enables outpatient blood samples for lithium levels to be conveniently drawn in the afternoon.

Ambulatory Care↗
PubMed2004

Late first-trimester invasive prenatal diagnosis: results of an international randomized trial.

OBJECTIVE: To assess, in a randomized trial, the safety and accuracy of amniocentesis and transabdominal chorionic villus sampling (CVS) performed at 11-14 weeks of gestation, given that this time frame is increasingly relevant to early trisomy screening. METHODS: We compared amniocentesis with CVS from 77 to 104 days of gestation in a randomized trial in a predominantly advanced maternal age population. Before randomization, the feasibility of both procedures was confirmed by ultrasonography, and experienced operators performed sampling under ultrasound guidance; conventional cytogenetic analysis was employed. The primary outcome measure was a composite of fetal loss plus preterm delivery before 28 weeks of gestation in cytogenetically normal pregnancies. RESULTS: We randomized 3,775 women into 2 groups (1,914 to CVS; 1,861 to amniocentesis), which were comparable at baseline. More than 99.6% had the assigned procedure, and 99.9% were followed through delivery. In contrast to previous thinking, in the cytogenetically normal cohort (n = 3,698), no difference in primary study outcome was observed: 2.1% (95% confidence interval 1.5, 2.8) for CVS and 2.3% (95% confidence interval, 1.7, 3.1) for amniocentesis. However, spontaneous losses before 20 weeks and procedure-related, indicated terminations combined were increased in the amniocentesis group (P =.07, relative risk 1.74). We found a 4-fold increase in the rate of talipes equinovarus after amniocentesis (P =.02) overall and in week 13 (P =.03, relative risk = 4.65), but data were insufficient to determine this risk in week 14. CONCLUSION: Amniocentesis at 13 weeks carries a significantly increased risk of talipes equinovarus compared with CVS and also suggests an increase in early, unintended pregnancy loss. LEVEL OF EVIDENCE: I

Abortion, Induced↗
PubMed1999

Quality of HMO vaccination databases used to monitor childhood vaccine safety. Vaccine Safety DataLink Team.

The availability of large, population-based, automated, medical care databases provides unique opportunities for monitoring the safety of childhood vaccines. The authors assessed the quality of automated vaccination databases by comparing them with vaccinations documented in paper-based medical records at three large US West Coast health maintenance organizations (HMOs) participating in the Vaccine Safety DataLink (VSD) study, a Centers for Disease Control and Prevention collaborative study of childhood vaccine safety. The authors randomly selected 1% or 2% samples of VSD study populations (n = 1,224-2,577) for data quality analyses. Agreement between automated and abstracted vaccinations required identical triads of child identification number, vaccination date, and vaccine type. Separate analyses were conducted for each HMO and for each vaccine type administered between 1991 and 1995. Agreement was measured by three matching proportions: 1) the proportion of automated vaccinations present in the abstracted source, 2) the proportion of abstracted vaccinations present in the automated source, and 3) the proportion of vaccinations from either source present in both sources. Overall, for common childhood vaccines, proportion 1 ranged from 83% to 99%, proportion 2 ranged from 82% to 98%, and proportion 3 ranged from 70% to 97%. Lack of automated data was the most frequent type of discrepancy, followed by date mismatches and vaccine type mismatches. Vaccination exposure classification errors in the range reported here were found by mathematical modeling to only modestly bias measured medical outcome rate ratios toward the null hypothesis. The results of the data quality analyses support the usefulness of vaccination exposure data derived from these automated HMO vaccination databases.

Abstracting and Indexing↗
PubMed2006

Modeling motor vehicle crashes using Poisson-gamma models: examining the effects of low sample mean values and small sample size on the estimation of the fixed dispersion parameter.

There has been considerable research conducted on the development of statistical models for predicting crashes on highway facilities. Despite numerous advancements made for improving the estimation tools of statistical models, the most common probabilistic structure used for modeling motor vehicle crashes remains the traditional Poisson and Poisson-gamma (or Negative Binomial) distribution; when crash data exhibit over-dispersion, the Poisson-gamma model is usually the model of choice most favored by transportation safety modelers. Crash data collected for safety studies often have the unusual attributes of being characterized by low sample mean values. Studies have shown that the goodness-of-fit of statistical models produced from such datasets can be significantly affected. This issue has been defined as the "low mean problem" (LMP). Despite recent developments on methods to circumvent the LMP and test the goodness-of-fit of models developed using such datasets, no work has so far examined how the LMP affects the fixed dispersion parameter of Poisson-gamma models used for modeling motor vehicle crashes. The dispersion parameter plays an important role in many types of safety studies and should, therefore, be reliably estimated. The primary objective of this research project was to verify whether the LMP affects the estimation of the dispersion parameter and, if it is, to determine the magnitude of the problem. The secondary objective consisted of determining the effects of an unreliably estimated dispersion parameter on common analyses performed in highway safety studies. To accomplish the objectives of the study, a series of Poisson-gamma distributions were simulated using different values describing the mean, the dispersion parameter, and the sample size. Three estimators commonly used by transportation safety modelers for estimating the dispersion parameter of Poisson-gamma models were evaluated: the method of moments, the weighted regression, and the maximum likelihood method. In an attempt to complement the outcome of the simulation study, Poisson-gamma models were fitted to crash data collected in Toronto, Ont. characterized by a low sample mean and small sample size. The study shows that a low sample mean combined with a small sample size can seriously affect the estimation of the dispersion parameter, no matter which estimator is used within the estimation process. The probability the dispersion parameter becomes unreliably estimated increases significantly as the sample mean and sample size decrease. Consequently, the results show that an unreliably estimated dispersion parameter can significantly undermine empirical Bayes (EB) estimates as well as the estimation of confidence intervals for the gamma mean and predicted response. The paper ends with recommendations about minimizing the likelihood of producing Poisson-gamma models with an unreliable dispersion parameter for modeling motor vehicle crashes.

Accidents, Traffic↗
PubMed2004

Australian and New Zealand birth cohort studies: breadth, quality and contributions.

OBJECTIVE: To understand factors associated with successfully conducting longitudinal studies across early childhood by (i) describing the designs of Australian and New Zealand birth cohort studies; (ii) describing the breadth of variables studied; and (iii) identifying factors influencing study quality, productivity and contributions. METHODS: A systematic review was undertaken of 13 birth cohort studies. Data were collected from published papers and questionnaires administered to study investigators. RESULTS: These single cohort studies recruited children prior to their first birthday. Using an ecological model as an organizing framework, the studies were found to have contributed to knowledge about health and development in multiple domains and well beyond early childhood. Areas for increased focus included policy-relevant environmental factors such as child-care and rural/urban differences, and the influence of fathers, family factors, peers, social competence, and genetic factors. Investigators' responses indicated desires for an increased depth of data collection and stronger sampling designs. Data quality was enhanced by maintaining skilled staff and reduced by inadequate data for tracking study participants. Productivity ranged from 1 to 760 publications per study (median = 14.0). The most productive studies were those that had started before 1990, had representative samples, ongoing funding, and larger research teams. Policy impacts have included changed infant sleeping practices, reduced environmental lead emissions and regulated swimming pool safety standards. CONCLUSIONS: A suite of coordinated and nested studies could meet sampling needs and facilitate depth of inquiry. Stable, long-term funding is required to staff and maintain well-designed longitudinal studies that can address priority research areas and contribute to the development of health and social policy.

Australia↗
PubMedDate not supplied

Multicenter evaluation of a new ultrasound-guided biopsy device: Improved ergonomics, sampling and rebiopsy rates.

The purpose of this study was to evaluate performance, ergonomics, and immediate rebiopsy rate of a new vacuum-assisted biopsy (VAB) device for ultrasound-guided breast biopsies. Between December 2002 and April 2003, 113 patients meeting study criteria were biopsied at four centers using the new 9 gauge VAB device. The device has a radiofrequency-tipped probe, 360 degrees vacuum, a circumferential cutter, and a coaxial cannula for multiple sampling. Patient and procedural data included breast composition, lesion characteristics, number of samples, procedure time, and complications. Quality of samples, lesion access, and ergonomic features were assessed qualitatively and compared with prior experience with other biopsy devices. Immediate rebiopsy rate included high-risk lesions requiring surgical excision (obligate rebiopsy) and lesions requiring rebiopsy due to discordance or insufficient samples yielding nondiagnostic material. Data were analyzed using the Wilcoxon signed-rank test. One hundred thirteen patients aged 20-83 years (mean 52) were successfully biopsied with dense/fibrous breast tissue in 60% and dense/fibrous lesions in 49%. Lesions measured 6-63 mm (mean 17); 97% were masses. Five circumferential specimens (range 2-19) were obtained in 6 minutes (range 2-20). Operators rated safety and comfort comparable with existing devices and rated sample quality, breast/lesion penetration, and positioning ease/accuracy superior (p < 0.01). Diagnoses included 37 cancers, 70 benign, and six high-risk lesions with one upgrade from atypical ductal hyperplasia to ductal carcinoma in situ at surgery. Excluding obligate excision in high-risk diagnoses, the immediate rebiopsy rate was 2%. No complications required intervention. The new VAB device provides diagnostic samples and reduces sampling error defined by immediate rebiopsy rate. Compared with other devices, it is more ergonomic to target and position for sampling, particularly in dense breast tissue or lesions.

Adult↗
PubMed1998

Increased interleukin-6 levels in nasal lavage samples following experimental influenza A virus infection.

Interleukin-6 (IL-6) is a pleotropic cytokine implicated in the pathogenesis of local inflammation during viral upper respiratory infections. This study determined if experimental influenza A virus infection causes local IL-6 production. Seventeen healthy, adult subjects were intranasally inoculated, by course drops, with a safety-tested strain of influenza A/Kawasaki/86 (H1N1) virus. Nasal lavage samples were collected, symptoms were recorded, and expelled nasal secretions were weighed once before and then daily for 8 days after the virus inoculation. Lavage samples were submitted for virus culture and were examined for IL-6 and IL-4 by enzyme-linked immunosorbent assay. The IL-6, but not IL-4, levels were significantly increased in the nasal lavage samples of the 12 subjects who shed virus but not in those of the 5 subjects who did not shed virus. Moreover, the elevations in IL-6 levels were related temporally to the development of nasal symptoms and secretions but not to systemic symptoms. These results suggest a role for locally produced IL-6 in the pathogenesis and expressed symptomatology of influenza A virus infection.

Adult↗
PubMed1998

Dietitians employed by health care facilities preferred a HACCP system over irradiation or chemical rinses for reducing risk of foodborne disease.

OBJECTIVE: To survey dietitians in health care facilities about the acceptability of alternative meat and poultry processing methods designed to reduce the risk of foodborne disease and their willingness to pay for these processes. SUBJECTS: A geographically representative sample of 600 members of The American Dietetic Association who work in health care facilities. The response rate was 250 completed questionnaires from 592 eligible subjects (42%). DESIGN: A mail survey was used to gather information on the acceptability of a Hazard Analysis and Critical Control Point (HACCP) system, chemical rinses, and irradiation for increasing the safety of food. Discrete choice contingent valuation was used to determine the acceptability at current prices and at 5, 10, and 25 cents per pound above current prices. STATISTICAL ANALYSES: Logistic regression was used to estimate mean willingness to pay (the maximum amount respondents are willing to pay) for each process. A simultaneous equations regression model was used to estimate the effects of other variables on acceptability. RESULTS: Respondents expressed a high level of concern for food safety in health care facilities. The estimated mean willingness to pay was highest for a HACCP system and lowest for chemical rinses. CONCLUSIONS/APPLICATIONS: The successful adoption of alternative methods to increase food safety depends on their acceptance by foodservice professionals. The professionals sampled were most accepting of a HACCP system, somewhat less accepting of irradiation, and least accepting of new chemical rinses. Poultry and beef processors and government agencies concerned with food safety may want to take into account the attitudes of foodservice professionals.

Animals↗
PubMed2026

Temporal Patterns in the Occurrence of Principal Salmonella Serotypes for Raw Meat and Poultry Products in the United States: 1998-2024.

Microbial foodborne pathogens, such as Salmonella, have the characteristic that only some subgroups of these bacteria are highly pathogenic to humans. For the Salmonella species enterica, there are more than 2,600 serotypes. These serotypes can be host-adapted so that for any animal reservoir, such as a particular food animal species, fewer than 10 serotypes make up more than fifty percent of isolates found in the reservoir. The highly concentrated nature of serotypes within a reservoir is a key to the findings of many studies and the cornerstone of some food safety programs. Nevertheless, a key limitation is that the dominant serotypes for a reservoir are likely to change over time. This is problematic because the risk of illness associated with a reservoir can increase dramatically if a more pathogenic serotype replaces one or more less pathogenic serotypes, and vice versa. In the United States, meat and poultry have been sampled continuously by the United States Department of Agriculture Food Safety and Inspection Service (USDA FSIS) for nearly 30&#xa0;years. For this study, these data are used to describe how the occurrence of the most common serotypes for each sampled commodity has changed over time. Insight into how often and how rapidly the most common serotypes change is important for designing effective mitigation strategies. To aid the development of such a mitigation strategy, we developed a classification system to categorize serotypes based on the direction and magnitude of change in each serotype over time. This information is combined with a ranking system that describes the relative virulence of each serotype using genomic and epidemiological virulence patterns. We then developed a heuristic system to support risk management decisions regarding the potential risks and benefits of applying serotype-specific interventions.

Compositional data↗
PubMed1982

Are datascreen terminals a source of increased PCB-concentrations in the working atmosphere?

The use of polychlorinated biphenyls (PCBs) restricted to closed systems. They are thus still used as dielectric fluids in capacitors and transformers. The hypothesis that skin rashes and excema reported among datascreen operators might be caused by leakage of PCB from components in the screen terminals was investigated. No information about the chemical content of the electric components in the actual datascreen terminals were available. The PCB-concentration in the atmosphere in a workplace where such skin reactions had previously occurred was therefore determined. Air was sampled through 2 or 3 days, during work hours only. A glass fiber backed by an amberlite XAD-2 column was used to trap the sample. The total level of PCBs in this sample was analysed by glass-capillary gas chromatography with electron capture detection. Commercial PCB mixtures were used as standards. PCB-concentrations in the working atmosphere (56-81 ng/M3) were about 50-80 times the level of PCB in samples collected outside the building. Indoor and outdoor samples differed also qualitatively. The indoor samples contained only Aroclor 1242, while the outdoor samples contained a mixture of Aroclor 1242 and 1254. The amounts of PCBs measured were below the safety level for working atmosphere, as recommended by NIOSH in 1977. However, knowing that the samples were collected in an office where there was no known use of PCBs, the levels found were unexpectedly high. Further investigations should therefore be undertaken to clarify whether datascreen terminals might be sources of PCB-contamination.

Air Pollutants↗
PubMed1995

Early amniocentesis: a clinical review.

Early amniocentesis at less than 14 weeks gestation is becoming more common in prenatal diagnosis populations. Randomized studies are minimal and have not had the power to determine the accuracy and safety of the procedure compared to chorionic villus sampling or mid-trimester amniocentesis. Procedures at 11+0-12+6 weeks should be considered experimental. This clinical review considers the ethics, embryology, and clinical experience (cytogenetics, AFP, AChE, procedure and cytogenetic failures, spontaneous and therapeutic pregnancy losses, congenital anomalies) of early amniocentesis.

Amniocentesis↗
PubMed2005

Concealment of drugs by police detainees: lessons learned from adverse incidents and from 'routine' clinical practice.

This is a collaborative piece of work undertaken between the PCA and a Principal FME. The study is based on 16 cases of internal drug concealment drawn from 43 drug-related deaths in custody in England and Wales between 1997 and 2002. These data are supplemented by three case studies from a county force involving non-fatal drug concealment to illustrate practical custody issues. The majority of the 16 deaths were white (n = 12) and male (n = 13) with a mean age of 34 years. In half of the cases, the deceased was known or believed to have concealed drugs orally at the point of initial contact with police. In 4/16 cases, the individual first showed signs of medical distress in a public place, a further 4 collapsed on arrival at the police station and two more detainees were subsequently found collapsed in their cell. Drug toxicity was the most common cause of death (10/16). In 5 cases death was caused by airway obstruction by swallowed packages. Both cocaine (14/16) and cannabis (8/16) traces were found in post-mortem samples. The report emphasises the need for a safety first approach.

Adolescent↗
PubMed2005

Development, validation, and implementation of a multiplex immunoassay for the simultaneous determination of five cytokines in human serum.

Quantification of biomarkers can provide important information about the safety and efficacy of candidate drugs. Unfortunately, limited sample volume and excess costs often limit analysis of multiple biomarkers. We developed, optimized, validated, and implemented a multiplex immunoassay for simultaneous measurement of multiple circulating cytokines: IL-1beta, TNFalpha, IL-6, IL-8, and IL-10. Multiplex immuoassays were performed using the Luminex LabMAP instrument. Capture antibodies for each cytokine were covalently bound to distinct microsphere subsets distinguished by differing dye ratios. The concentration of each individual cytokine determined by measuring orange fluorescence produced by a complex of a biotinylated cytokine-specific antibody and streptavidin-phycoerythrin. The lower limit of quantification for all assays was 20 pg/mL with the exception of IL-8 which was 100 pg/mL. The inter-assay precision was less than 25%CV for all analytes at all control levels both pre-study and in-study. The percent recovery ranged from 83 to 108% pre-study and 90 to 125% in-study. In a linearity assessment, a 15,000 pg/mL multi-analyte control could be diluted 1:50 and maintain expected accuracy. We measured the cytokine concentrations in more than 2000 serum samples from patients with sepsis. Multiplex results for IL-6 were compared to a conventional commercially available ELISA kit. The degree of agreement between the two methods as measured by the concordance correlation coefficient was 84.5%. Multiplex results were 2.36-fold higher than ELISA values on the average. After adjusting for this mean difference, the 95% empirical limits of agreement for the ratio of individual sample values were 0.33, 2.65. This multiplex immunoassay provided simultaneous measurement of circulating cytokines using 80% less patient specimen compared to traditional approaches and at a significantly decreased cost. Efficient use of this platform requires process improvements to fully maximize the positive impact of multiplex assays in clinical drug development.

Cytokines↗