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Chorionic villus sampling: evaluation of obstetric performance.

Chorionic villus sampling is frequently utilised in the Nottingham region as a means of early prenatal diagnosis of genetic problems. Its relative safety in the early antenatal period is well established but there has been some concern that perinatal mortality may be greater in the chorionic villus sampling group as compared to amniocentesis. We have in response studied our own data and report the obstetric outcome in 144 cases where the pregnancy has progressed beyond 28 weeks gestation. We have selected a procedure free control group matched for parity. We have found no significant difference in the perinatal outcome and obstetric performance and conclude that at this juncture we should continue to offer our services as chorionic villus sampling offers significant advantages in the first trimester over amniocentesis.

Adult↗

Percutaneous umbilical blood sampling: results from a multicenter collaborative registry. The Western Collaborative Perinatal Group.

Percutaneous umbilical blood sampling has become an important diagnostic tool in the evaluation of fetal health. Although recent reports have established the safety of this procedure, most have arisen from single centers with extensive experience. The Western Perinatal Collaborative Group has maintained a continuous registry of percutaneous umbilical blood sampling performed at the 13 member institutions for the years 1986 through 1990. During this period 302 procedures were performed. Primary indications for percutaneous umbilical blood sampling included Rh and non-Rh isoimmunization, intrauterine growth retardation, nonimmune hydrops, fetal anomalies, immune thrombocytopenia purpura, and rapid fetal chromosome analysis. Percutaneous umbilical blood sampling was successfully performed in 93.7% of cases with a sample withdrawn by a single puncture in 80.5% of attempts. In the majority of cases a 22-gauge needle was used. Postprocedural fetal death resulted in six cases (2.1%) and was most often associated with fetal anomalies or an abnormal karyotype. In conclusion, evaluation of the fetal state by percutaneous umbilical blood sampling is a safe and easily performed procedure, as demonstrated by a collaborative multicenter study.

Blood Specimen Collection↗

Evaluating the safety of interventions for prevention of perinatal transmission of HIV.

Efficient approaches are needed for obtaining reliable insights into the safety, in developing and developed country settings, of interventions for prevention of mother-to-child transmission (MCT) of HIV. A randomized trial designed with an appropriate sample size and adequate duration of follow-up provides a powerful tool for obtaining causal evidence regarding the safety and efficacy of MTC prevention interventions. Such trials are ideal for detecting adverse effects (AEs) that occur in the short or moderate term and with moderate to high frequency. Passive and active surveillance procedures, where practical, can provide valuable insights regarding long-term or rare AEs. Ideally, surveillance procedures should be carefully planned sufficiently early to allow prospective definition and uniform collection of important classes of AEs, enhancing the sensitivity and specificity of these surveillance data.

Anti-HIV Agents↗

Growth and toxin production by Clostridium botulinum in steamed rice aseptically packed under modified atmosphere.

Sales and consumption of ready-to-eat aseptic steamed rice products have increased manyfold in Japan over the past 10 years. To determine the safety of steamed rice (water content 60%, pH 6.5) aseptically packaged under modified atmosphere, challenge studies were performed using a mixture of Clostridium botulinum proteolytic strains (five strains of type A and five strains of type B). Atmospheric conditions of 0 and 15% oxygen (with 5% CO2 and 5% N2 as the balance) were used. No neurotoxins were detected, and organoleptically acceptable conditions persisted for 24 weeks at 15% oxygen conditions. However, botulinum neurotoxin was found in one of three samples at 12 weeks and in one of two samples at 24 weeks at 0% oxygen and 30 degrees C. When samples were inoculated with C. botulinum with amylase (0% oxygen), neurotoxin and sample spoilage was detected after only 1 week of storage. Challenge studies using proteolytic strains of C. botulinum mixed with Bacillus subtilis (amylase formers) also were performed with atmosphere conditions of oxygen at 0, 5, 10, and 15% (with 5% CO2 and 5% N2 as the balance). Under 10 and 15% oxygen conditions, neurotoxin was not detected after 1 week of storage, but sample spoilage was detected after the same period. Under 0% oxygen conditions, neurotoxin was detected at 1 week, but the sample remained organoleptically acceptable even after 2 weeks of storage. Both neurotoxin and sample spoilage were detected at 1 week of storage under 5% oxygen conditions. Based on these results, cocontamination of amylase-producing Bacillus with C. botulinum would increase the risk of foodborne botulism when aseptic rice samples are packed under low-oxygen conditions (<5%). Therefore, to ensure the safety of these products, packing under atmospheric containing more than 10% oxygen is recommended.

Botulinum Toxins↗

College students' attitudes, practices, and knowledge of food safety.

A survey instrument was developed to assess attitudes, practices, and knowledge of food safety of college students in three U.S. geographic locations. Eight hundred twenty-four students in both food-related (one-third of sample) and nonfood-related disciplines completed the questionnaire during classroom periods. Data were analyzed to obtain total attitude, practice, and safety scores, with emphasis given to analyzing differences among disciplines and demographic characteristics. Mean scores were given for each of the survey items, and results from open-ended questions were discussed. Dietetic, food science, nutrition, and health majors had significantly (< or = 0.05) higher attitude scores than students majoring in other disciplines. No differences were found among disciplines for the practice scores, which ranged from 74 to 79% of the total possible practice score. Students enrolled in dietetics, arts and science (physical sciences), and veterinary medicine had significantly (< or = 0.05) higher knowledge scores, although the highest mean score (for dietetics) was only 74% of the total possible score. Women who had enrolled in a college course that included food safety information had significantly (< or = 0.05) higher attitude and practice scores. Such course enrollment led to both genders having significantly (< or = 0.05) higher knowledge scores than those without this opportunity. Implications were given for using these data to encourage college professors in food-related disciplines to become involved with the education of all future consumers, especially as the prevalence of food safety controversies is likely to increase as the food supply changes and technology becomes more sophisticated.

Adult↗

A reanalysis of the Cu-7 intrauterine contraceptive device clinical trial and the incidence of pelvic inflammatory disease: a paradigm for assessing intrauterine contraceptive device safety.

OBJECTIVE: We calculated and compared the incidence of pelvic inflammatory disease in a 10% random sample of the Cu-7 intrauterine contraceptive device (G.D. Searle & Co., Skokie, Ill.) clinical trial with the rates reported to the Food and Drug Administration and those in subsequent trials published in the world literature. STUDY DESIGN: A 10% random sample of the Cu-7 clinical trial was examined because calculations had demonstrated this random sample to be sufficient in size (n = 1614) to detect a difference in rates of pelvic inflammatory disease from those reported to the Food and Drug Administration. An audit of a subset of the patient files, compared with the original files in Skokie, Illinois, confirmed that the files available for analysis were complete. Standard definitions were used to identify cases of pelvic inflammatory disease and to calculate rates of pelvic inflammatory disease. The world literature on Cu-7 clinical trials was reviewed. RESULTS: The calculated crude and Pearl index rates of pelvic inflammatory disease were consistent with those rates previously reported to the Food and Drug Administration and published in the medical literature. Life-table pelvic inflammatory disease rates were not different between nulliparous and parous women and pelvic inflammatory disease did not differ from basal annual rates in fecund women. CONCLUSION: On the basis of the analysis of this 10% sample, the pelvic inflammatory disease patient rates reported to the Food and Drug Administration for the entire Cu-7 clinical trial are accurate and are similar to those published in the world literature.

Adult↗

Strategies of air sampling.

Considerations relevant to preparation for air sampling are reviewed, including purpose, recognition of need, and the logistics of obtaining the samples (where, when, how, and for how long). Three strategies of sampling focused on how many samples to obtain are discussed in detail, ie, the zoning strategy and strategies of the National Institute for Occupational Safety and Health (NIOSH) and the Mining Safety and Health Administration (MSHA). The purpose of the zoning method is to locate groups of employees with high exposures, while the NIOSH method aims at determining compliance of individual sample results with a regulatory standard. Similarities and differences between the methods are highlighted. The MSHA strategy is completely regulatory and represents a scientifically indefensible strategy. Finally, the advantages of incorporating the assumption of a distribution of workplace contaminant-in-air concentrations are noted.

Air Pollutants, Occupational↗

Symposium: animal food safety and dairy regulations, now and in the future. Animal food safety and dairy regulations, now and in the future: from farm to fork, a state perspective.

The enforcement of dairy and food safety regulations has fallen most heavily on the states in the past, and this responsibility will no doubt continue, and even expand, in the future. States must be concerned not only about their own state laws but also about the impact of increasing federal regulations. The protection of sample integrity and chain of custody is an important function of a state regulatory program for food safety. Because of increasing demands imposed by new technology and food safety requirements, and because of very limited resources, states have difficulty maintaining adequate regulatory programs. The future challenge will be the ability of states to coordinate regulation, sample analysis, and enforcement between federal and state agencies. States must continue their roles of ensuring consumers that food is safe and wholesome while maintaining viable state food industries.

Dairying↗

Guidelines for the performance of CD4+ T-cell determinations in persons with human immunodeficiency virus infection.

This document has been developed by CDC to give guidance to laboratories performing lymphocyte immunophenotyping assays in human immunodeficiency virus-infected persons. The recommendations in this document reflect current technology in a field that is rapidly changing. The recommendations apply to laboratory safety, specimen collection, specimen transport, maintenance of specimen integrity, specimen processing, flow cytometer quality control, sample analyses, data analysis, data storage, data reporting, and quality assurance.

CD4-Positive T-Lymphocytes↗

Perceived knowledge, attitudes, and practices of California registered dietitians regarding dietary supplements.

A convenience sample of California registered dietitians (RDs) (n=253) completed a survey investigating the perceived knowledge, attitudes, and practices of RDs who had or had not received formal training in use of dietary supplements. We also examined whether differences existed between RDs registered before or after 1997, when the American Dietetic Association began requiring that dietetics curricula include basic knowledge of dietary supplements. Statistical analysis included analysis of variance and chi2 analysis. Among this sample of RDs from California, those registered before 1997 (n=194) were more likely (P<0.05) to agree that they are knowledgeable regarding supplement use, safety, interactions, and contraindications than those registered after 1997 (n=46), and were more likely (P<0.05) to assess client use. Among this sample of RDs from California, those reporting that they had received formal training in dietary supplements (n=145) were more likely (P<0.05) than those who had no formal training in supplement use (n=105) to agree that they are comfortable discussing supplements with the public; are knowledgeable regarding uses, safety, interactions, and contraindications of supplements; and assess client use. Providing RDs professional education opportunities on supplements continues to be warranted.

Allied Health Personnel↗

Factors affecting pelvic and thoracic forces in near-side impact crashes: a study of US-NCAP, NASS, and CIREN data.

The goal of this study was to identify variables related to vehicle design which are associated with pelvic and thoracic accelerations as measured by the driver's (near side) crash dummy during new car assessment program (NCAP) testing of motor vehicles. Vehicle specific parameters were analyzed using NCAP side impact test results. Data from national automotive sampling system, crashworthiness data system (NASS-CDS) and crash injury research and engineering network (CIREN) (both National Highway Traffic Safety Administration (NHTSA) injury databases) were assessed to confirm NCAP test observations. In addition, door armrest stiffness measurements were performed using a mechanical tester on a sample of 40 vehicles. NCAP data showed that of 10 variables tested using multiple linear regression, vehicle weight and door crush correlated with pelvic acceleration of the driver's crash dummy (overall, r2=0.58, p=0.002, n=165). For thoracic trauma index (TTI) vehicle weight and peak door velocity correlated, significantly (overall, r2=0.41, p=0.03, n=165). Mean TTI was 63.7 g with no side airbag (n=108) and 55.6 g with a thoracic side airbag (n=54), p=0.01. The mean vehicle weight and door crush between airbag and no airbag groups were not significantly different. NASS-CDS data demonstrated a direct relationship between increased door crush and increased abbreviated injury score (AIS). CIREN data showed that occupants who sustained pelvic injuries had a median AIS of 3 with 24.9 cm of door crush, with abdominal injuries, a median AIS of 3 and 30 cm of crush, and with thoracic injuries, a median AIS of 4 and 34 cm of door crush. In addition, the frequency of bilateral pelvic injuries was significantly higher for subjects in CIREN crashes who were in a vehicle with a center console, but only if door intrusion was greater than 15 cm. This information may be useful in design of vehicles with greater protection in side impact crashes.

Acceleration↗

Endocrine and metabolic effects of long-term administration of [Nle27]growth hormone-releasing hormone-(1-29)-NH2 in age-advanced men and women.

Attenuation of the GH and insulin-like growth factor I (IGF-I) axis in aging may be responsible for changes in body composition and metabolism. This relationship has been confirmed by studies of recombinant human GH replacement in aging men and women, but the adverse effects encountered limit its clinical utility. The use of GHRH or its analogs may be an alternative mode for restoring the GH-IGF-I axis in aging individuals. Here we report the endocrine-metabolic changes in response to a GHRH analog in age-advanced men and women. A single blind, randomized, placebo-controlled trial of 5 months duration was conducted. Ten women and 9 men between the ages of 55-71 yr self-injected placebo (saline) s.c. nightly for 4 weeks followed by 16 weeks of [Nle27]GHRH-(1-29)-NH2 at a dose of 10 microg/kg. Subjects underwent 12-h nocturnal (2000-0800 h) frequent blood sampling (10-min intervals) and 24-h urine collection at baseline, after 4 weeks of placebo injections, and after 16 weeks of GHRH analog administration. GH responses to GHRH analog and spontaneous GH pulsatility were assessed. Subjects were also monitored 2, 4, 8, and 12 weeks after commencement of GHRH analog treatment. Blood pressure, body weight, and fasting insulin and glucose levels were recorded at each visit. Serum concentrations of IGF-I, IGF binding protein-1 (IGFBP-1), IGFBP-3, GH-binding protein (GHBP), lipids, and safety laboratory tests (complete blood count and chemistry profile) were measured in fasting samples (0800-0900 h). Body composition was determined by dual energy x-ray absorptiometry scan, and skin thickness was measured at four sites, including the right and left hand and volar forearm, by Harpenden skin calipers. Insulin sensitivity was assessed by a frequently sampled i.v. glucose tolerance test. Quality of life parameters, including sleep, were evaluated through self-administered questionnaires. Nightly GHRH analog administration at 2100 h induced, within 10 min, an acute release of GH, which lasted for 2 h. The GH-releasing effect of GHRH analog was sustained during the course of the study. Compared with placebo, GHRH analog induced a significant increase in 12-h integrated nocturnal GH levels in women (P < 0.01) and men (P < 0.05). This was accompanied, within 2 weeks, by increased serum levels of IGF-I (P < 0.05) and IGFBP-3 (P < 0.001), but not IGFBP-1, which remained elevated for 12 weeks, returning toward baseline by 16 weeks in both genders. Within 4 weeks, GHBP concentrations were significantly increased (P < 0.01) in women, but not in men. Although blood pressure and body weight were unaffected, GHRH analog treatment resulted in a significant increase in skin thickness (P < 0.05) in both genders and increased lean body mass in men only (P < 0.05), with no other changes in body composition or bone mineral density in either gender. There was a trend for a positive nitrogen balance in both genders, which became significant (P = 0.03) when the data were combined. Fasting insulin and glucose levels were unaltered, but a significant increase in insulin sensitivity occurred in men (P < 0.05), but not in women. Assessment of quality of life parameters revealed a significant improvement in general well-being (P < 0.05) and libido (P < 0.01) in men, but not in women, and sleep quality was unaffected in both genders. The only adverse side-effect was transient hyperlipidemia, which resolved by the end of the study. We conclude that nightly administration of GHRH analog for 4 months in age-advanced men and women activated the somatotropic axis. Although an increase in skin thickness was found in both genders, increases in lean body mass, insulin sensitivity, general well-being, and libido occurred in men but not in women. These observations suggest that GHRH analog administration induced anabolic effects favoring men more than women. Further studies are needed to define the gender differences observed in response to GHRH analog administration.

Aged↗

NTP Toxicity Study Report on the atmospheric characterization, particle size, chemical composition, and workplace exposure assessment of cellulose insulation (CELLULOSEINS).

Cellulose insulation (CI) is a type of thermal insulation produced primarily from recycled newspapers. The newspapers are shredded, milled, and treated with fire-retardant chemicals. The blowing process for installing CI generates a significant quantity of airborne material that presents a potential inhalation hazard to workers. CI was selected for study based upon the high production volume, the potential for widespread human exposure, and a lack of toxicity data; insufficient information was available to determine whether inhalation studies in laboratory animals were technically feasible or necessary. Studies were conducted to characterize the chemical and physical properties of CI aerosols, to evaluate the potential acute pulmonary toxicity of CI, and to assess occupational exposure of CI installers. Workplace exposure assessments were conducted in collaboration with the National Institute for Occupational Safety and Health (NIOSH, 2001). EVALUATION OF THE CHEMICAL COMPOSITION, PARTICLE SIZE, AND PULMONARY TOXICITY OF CELLULOSE INSULATION: Chemical analyses were performed on samples of bulk CI from four major United States manufacturers. All samples of the bulk CI were found to contain primarily amorphous cellulose (60% to 65%) with a smaller crystalline component (35% to 40%). The crystalline phase was primarily native cellulose (75% to 85%) with a minor amount of cellulose nitrate (15% to 25%). Elemental analyses of acid digests of CI materials indicated that the major components (>0.1% by weight) included aluminum, boron, calcium, sodium, and sulfur. An acid-insoluble residue present in all four materials (3% to 5% of original sample weight) was found to consist primarily of aluminum silicate hydroxide (kaolinite; approximately 85%) with minor amounts (<5% each) of magnesium silicate hydroxide (talc), potassium aluminum silicate hydroxide (muscovite), and titanium oxide (rutile). Solvent extracts of the bulk materials were analyzed for organic components by gas chromatography with flame ionization detection. Analyses revealed a mass of poorly resolved peaks. Because of the very low concentrations, further quantitative and qualitative analyses were not performed. An aerosol generation system was designed to separate CI particles based upon aerodynamic size and to simulate the process used during CI installation at work sites. Less than 0.1% of each of the CI samples was collected as the small respirable particle fraction. The mean equivalent diameter of respirable particles ranged from 0.6 to 0.7 mum. The numbers of fibers in the respirable fractions ranged from 9.7 x 103 to 1.4 x 106 fibers/g of CI. The respirable particle fractions did not contain cellulose material and consisted mainly of fire retardants and small quantities of clays. The respirable fraction from one CI sample was administered by intratracheal instillation to male Fischer 344 rats at doses of 0, 0.625, 1.25, 2.5, 5, or 10 mg/kg body weight; the bronchoalveolar lavage (BAL) fluid cellularity was evaluated 3 days later. Based upon the relatively mild severity of the inflammatory response, a dose of 5 mg/kg body weight was selected for use in a subsequent 28-day study. Rats received CI, titanium dioxide (particle controls), or sterile saline (controls). BAL fluid was evaluated 1, 3, 7, 14, and 28 days after instillation, and lung histopathology was evaluated 14 and 28 days after treatment. CI caused a greater influx of inflammatory cells than titanium dioxide and caused significant increases in BAL fluid protein and lactate dehydrogenase. These CI-induced changes in BAL fluid parameters were transient and by day 14 were not significantly different than those observed in rats treated with titanium dioxide or phosphate-buffered saline. Unlike titanium dioxide, CI treatment caused a minimal to mild nonprogressive, minimally fibrosing granulomatous pneumonitis characterized by nodular foci of macrophages and giant cells. These results indicated that few respirable particles or fibers are likely generated during the CI application and that the acute pulmonary toxicity is minimal. EXPOSURE ASSESSMENT OF CELLULOSE INSULATION APPLICATORS: The CI exposure assessment was conducted with 10 contractors located across the United States. Air samples of total dust and respirable dust were collected for scanning electron microscopy (SEM) to characterize any fibers in the dust. Two SEM air samples for each day of CI activities were collected from the installer and hopper operator. Bulk CI samples were collected and analyzed for metal, boron, and sulfate content. Real-time and video exposure monitoring was conducted to further characterize the CI dust and workers' exposures. The exposure assessment also included a medical component. Investigators collected 175 personal breathing zone (PBZ) total dust, 106 area total dust, and 90 area respirable dust air samples during CI-related activities at the 10 contractor sites. Twenty-six employees' total dust 8-hour time-weighted averages (TWAs) exceeded the Occupational Safety and Health Administration (OSHA) permissible exposure limit (PEL) of 15 mg/m3, and 42 exceeded the American Conference of Governmental Industrial Hygienists (ACGIH) threshold-limit value (TLV) of 10 mg/m3. Respirable dust air sampling and real-time monitoring with particle size discrimination indicated low levels of respirable dust generation. The SEM analyses revealed that fibers were an average 28 mum in length and ranged from 5 mum to 150 mum. CI installers' PBZ total dust, area total dust, and area respirable dust air samples were all significantly higher during dry attic applications than wet attic applications (P<0.01). Conversely, the hopper operators' total dust exposures were significantly higher during wet wall and ceiling applications than dry wall and ceiling applications (P=0.02). Analyses of variance tests revealed that exposure concentrations in total dust air samples collected in the PBZ of all CI workers, including installers working in attics, installers during wall applications, hopper operators during attic applications, and hopper operators during wall and ceiling applications, varied significantly during dry applications (P<0.01). The respirable dust air samples collected in attic areas, hopper areas during attic applications, and hopper areas during wall and ceiling applications also differed significantly during dry applications (P=0.03). Twenty-three workers participated in the medical phase of the investigation. The workers completed medical and work history questionnaires, performed serial peak flow tests, and completed multiple acute symptom surveys. The medical questionnaires indicated respiratory, nasal, and skin symptoms that employees attributed to CI exposure. The most common symptoms reported while working with CI included nasal symptoms (35%), eye symptoms (35%), and morning phlegm production (25%). There was a temporal association between CI exposure and eye symptoms, but there was little evidence of lower respiratory system health conditions associated with CI exposure. CONCLUSIONS: Chemical analyses of the four bulk CI samples revealed only minor differences in additives. The major elemental components detected were aluminum, boron, calcium, sodium, and sulfur, but they were attributed to the fire retardants aluminum sulfate, boric acid, and sodium sulfate. For all four CI samples, less than 0.1% by weight was collected as the small respirable particle fraction. The fractions consisted mainly of fire retardants and smaller quantities of clays and did not contain cellulose material. Intratracheal instillation of the respirable fraction in rats produced minimal to mild inflammatory responses in the lungs with no increase in severity by 28 days after dosage. Although a significant increase in lung collagen was detected at day 28 in treated rats, microscopic evaluation revealed only a minimal to mild increase in collagen fibrils associated with granulomatous nodules. The results of these studies indicated that few respirable particles or fibers are generated during the aerosolization of CI, and that even at very high doses of respirable CI particles, acute pulmonary toxicity is minimal. These results are supported by the NIOSH workplace exposure assessment conducted on CI workers. Based on the air sample data collected from the 10 contractor site visits, there is a potential for overexposure to CI; however, respirable dust concentrations were typically low. There was increased potential for 8-hour TWAs exceeding the OSHA PEL for total and respirable dust when employees were involved in CI application activities for longer periods of time. There was evidence of work-related eye and mucous membrane irritation among some workers, which were possibly caused by the additives present in CI, such as boric acid. There was little evidence of lower respiratory system health conditions associated with CI exposure. Based upon the results of the CI chemical characterization studies, the pulmonary toxicity study, and the worksite exposure assessment, the NTP concluded that additional studies of CI in laboratory animals are not warranted at this time. However, the animal pulmonary toxicity studies and worker health surveys focused on acute CI exposures and do not preclude the possibility of toxicity resulting from chronic exposure. Although exposure concentrations of respirable CI particulate matter were low, additional information is needed on the biodurability and reactivity of CI particles and fibers in the respiratory tract. CI should continue to be regarded as a nuisance dust, and workers should continue to wear protective masks to prevent inhalation exposure to CI dusts.

Aerosols↗

Carbon and nitrogen stable isotopes as indicative of geographical origin of marijuana samples seized in the city of São Paulo (Brazil).

The drug trafficking is one of the most serious problems related to the Public Safety in Brazil, especially in the most populous areas of the country, as is the case of the city of São Paulo. In this work, it was developed a methodology that can help tracking the traffic routes of marijuana samples seized in the city of São Paulo, based on stable carbon and nitrogen isotopes, which are related to the climate and plant growth conditions. A model to classify the origin of unknown samples was built using linear discriminant analysis based on about 150 samples apprehended in the main producing regions of the country. Results for 76 samples seized in the city of São Paulo showed that most of them were cultivated in a humid region with the same origin as those from Mato Grosso do Sul. The provenance of 13 outliers samples from Northeast region (an important producing region) also were evaluated and some of them presented same profile of those from Mato Grosso do Sul, pointing to the existence of the traffic routes between the Northeast and Midwest region, probably as a consequence of the intensive field raids by Brazilian Federal Government since 1999.

Journal Article↗

[Fetal chromosome abnormalities diagnosed by chorionic villi sampling].

Chorionic villus sampling was performed for chromosome analysis in 387 cases during a 4-year-period. In 115 cases transcervical while in 272 cases transabdominal sampling was carried out. Chromosomal abnormalities were found in 25 cases (6.4%). Autosomal trisomies occurred in 17 cases, structural anomalies in 2 cases and sex chromosomal aberrations in 6 cases. The pregnancy was terminated in 19 cases because of chromosome abnormality, in 5 further cases because of X-linked disease and male fetus. After transcervical sampling spontaneous abortion occurred in 7 cases (5.8%), while after transabdominal sampling in 8 cases (2.8%). The authors prefer in their practice the early transabdominal CVS, which can be performed safety already at the end of the first trimester.

Chorionic Villi Sampling↗

Characteristics and toxicological processing of postmortem pilot specimens* from fatal civil aviation accidents.

INTRODUCTION: Autopsied biosamples from civil aviation accident pilot fatalities are submitted to the Civil Aerospace Medical Institute (CAMI) for toxicological evaluation. However, such evaluation is dependent on types and amounts of submitted samples, and obtaining suitable samples is governed by the nature of the accident. Characteristics of those samples and associated toxicological processing have not been well documented in the literature. METHOD: Therefore, the CAMI Toxicology Database was searched for these aspects. RESULTS: CAMI received samples from the pilot fatalities (CAMI cases) of approximately 80% of the 1990-2000 aviation accidents reported by the National Transportation Safety Board. Accidents and cases during June-September were higher than the other months, and more than half of the received cases had multiple samples in sufficient amounts. For example, out of 1891 cases processed for the 1996-2000 accidents, 1211 had at least adequate amounts of blood, urine, and/or vitreous humor; 324 had inadequate amounts of blood and urine; and 356 had no blood or urine. Muscle, liver, lung, and/or kidney samples were submitted in 90% of the cases, while cerebrospinal fluids were submitted in only 8% of the cases. The toxicologically preferred samples, blood and urine, were available in 78% and 56% of the 1891 cases, respectively. Out of 51 cases containing only one sample type, 46 had muscle and the remaining 5 had other sample types. Samples were primarily analyzed for combustion gases, alcohol/volatiles, and drugs. Generally, the presence of analytes is demonstrated in at least two different sample types by using two different analytical techniques for reporting a particular case as "positive." An effective quality-assurance/quality-control is maintained throughout the process. CONCLUSION: In the majority of the aviation accidents, sufficient amounts and types of biological samples were submitted for toxicological evaluation.

Accidents, Aviation↗

The randomized concentration-controlled trial: an evaluation of its sample size efficiency.

A randomized concentration-controlled trial (RCCT) is one in which subjects are randomly assigned to predetermined levels of average plasma drug concentration. These target concentrations can be achieved (within reasonable ranges) by an individualized pharmacokinetically controlled dosing scheme. The RCCT is designed to minimize the interindividual pharmacokinetic (PK) variability within comparison groups and consequently decrease the variability in clinical response within these groups. In this paper, we investigate the extent of improvement in sample size efficiency that can be gained from the RCCT design in comparison to the traditional randomized dose-controlled trial (RDCT) design. Our investigations involve both theoretical arguments and simulation studies, illustrated with data on PK and pharmacodynamic (PD) characteristics of the antiasthma drug theophylline. Aside from safety concerns that strongly suggest the use of RCCT for drugs with narrow therapeutic windows, sample size considerations favor the choice of RCCT in many situations, as shown in this paper.

Administration, Oral↗

Food safety education: health professionals' knowledge and assessment of WIC client needs.

A written questionnaire was used to assess the opportunities and challenges for food safety education in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). The sample included directors and health professionals with nutrition counseling responsibilities in 79 WIC clinics in a midwestern state. Seventy-two percent of the clinics participated in the study. Data analysis included descriptive statistics, chi(2) analysis, and Cronbach's alpha. Seventy-two percent reported offering food safety advice to 20% or more of their clients daily. Ninety percent identified the food-safety knowledge of their WIC clients to be fair to very poor. The need for food safety handouts, targeted for WIC clients, was identified by 27% of the respondents. WIC professionals are promoting safe food handling among a high-risk population group. Expansion of current food-safety education efforts with WIC clients is encouraged with emphasis on methods to effectively overcome barriers to safe food handling.

Adult↗