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PubMed1997

Powered wheelchairs: are we enabling or disabling?

Following the unsuccessful issue of three powered indoor National Health Service (NHS) wheelchairs, a survey was carried out of 40 users in a London wheelchair service to identify the problems with issue and possible areas for improvement to practice. The survey identified improvements that were necessary both from the service and the manufacturers' booklets. The improvements include the issue of written instructions and information to complement verbal instruction given at handover. Such information should be as interesting to read as possible, make use of appropriate language and diagrams (especially in area where English is often not the first language), colour, text and print size to maximise comprehension to these severely disabled users and often their elderly relatives or carers. The importance of the role of the rehabilitation engineer in training the user, giving instruction at handover and annual review are highlighted to ensure that the equipment remains working, suitable and up to date for the individual's needs. Training in interpersonal and communication skills and the importance of recall should also be emphasised. The implementation of the findings should lead to increasing contact with the service by the user, reduction in repair and replacement costs, regular review, correct supply and will therefore enable users to increase their independence with appropriate equipment.

Persons with Disabilities↗
PubMed1988

Prenatal diagnosis: general introduction, methodology, and review.

Prenatal diagnosis of hematologic disease has been performed in more than 10,000 fetuses since 1974, with the majority at risk for thalassemia. Fetal blood sampling was the initial method, but most centers are now changing to DNA technology, particularly using specimens obtained by chorionic villus sampling. Fetal blood globin chain composition and synthesis is examined using carboxymethyl cellulose columns, electrophoresis, and high performance liquid chromatography. Fetal globin DNA is tested for gene deletions, mutations that affect restriction enzyme cleavage sites, and restriction fragment length polymorphisms, and specific oligonucleotides are used to identify some point mutations. The current trend is for early sampling (by chorionic villus sampling), gene amplification, and specific DNA analyses. The safety of all methods (blood or DNA) is above 96%, and the accuracy more than 99%. The acceptability of these approaches has been high.

Female↗
PubMed2002

How safe is that burger?

We tested ground beef from across the U.S. for bacteria, spoilage, and fat content. Although most samples were OK, there are gaps in the safety net that could leave you vulnerable.

Animals↗
PubMed2004

Percutaneous renal biopsy as an outpatient procedure.

Percutaneous renal biopsy (PRB) is a safe and effective tool in the diagnosis and management of renal disease. It is the gold standard for evaluating renal parenchymal disease. It is both useful for diagnosis and monitoring progress of renal diseases. Where facilities and personnel are available to carry out the procedure in developing countries, it has become increasingly difficult for patients to pay for hospital admission fees, the procedure, and processing of the samples obtained. Information on the success rate and safety of the procedure is of interest to nephrologists for cost-benefit considerations and medicolegal purposes. This paper reports the outcome of outpatient PRB done among patients of the University College Hospital, Ibadan, Nigeria. With the use of ultrasound guidance, PRB remains a safe procedure and can be done on an outpatient basis.

Adult↗
PubMed2005

[Biochemical evaluation of the results of lipid regulating treatment in France].

The objective of the SPOT study (Study of Practice versus Objectives of Treatment) was the biochemical evaluation of the results of long term lipid regulating treatment in France, compared to the objectives defined by AFSSAPS (French regulatory agency for the safety of medical products) in 2000. A random sample of doctors was recruited in 21 French regions by the Regional Health Observation service. To be included in the SPOT study, the patients had to be on lipid regulating medication for at least six months and consent to biochemical evaluation following a consultation. A sample of 641 doctors examined 2,479 patients treated for 7 years on average. These middle aged patients (aged 63 +/- 11 years) were mostly taking statins (72%). They had an average total cholesterol level of 5.41 +/- 1.01 mmol/L (2.10 +/- 0.39 g/L). and LDL of 3.25 +/- 0.93 mmol/L (1.26 +/- 0.36 g/L), reflecting previous results and confirming the stability of their treatment. In primary prevention and in low risk subjects (with less than 2 associated risk factors), the AFSSAPS objectives were achieved in 95% of cases. In secondary prevention or in very high risk subjects (at least 3 associated risk factors 0), 35% of patients had LDL cholesterol greater than 3.4 mmol/L (1.30 g/L). The SPOT study, performed on subjects who had in theory been stabilised with lipid regulating medication, gave two conclusions: cardiovascular prevention with lipid regulating medication is improving in France, and the subjects at greatest risk attain the recommended objectives less often despite the expected benefit of treatment being higher.

Aged↗
PubMed1992

Glutaraldehyde: a potential health risk to nurses.

This article discusses the potential toxicity of glutaraldehyde, a chemical commonly used in endoscopy units. The literature review cites adverse health effects experienced by workers exposed to glutaraldehyde. The sampling methodology for glutaraldehyde relative to the Occupational Safety and Health standard for glutaraldehyde is presented. Air monitoring should be performed to assess employee exposure to airborne glutaraldehyde in endoscopy departments. Recommendations for reducing exposure to glutaraldehyde in endoscopy units are included.

Air Pollutants↗
PubMedDate not supplied

Effect of food on the pharmacokinetics of a new hydroxypropyl-beta-cyclodextrin formulation of itraconazole.

STUDY OBJECTIVE: To compare the pharmacokinetics of a single 100-mg oral dose of itraconazole administered as 10 ml of a 10-mg/ml itraconazole solution in hydroxypropyl-beta-cyclodextrin under fasting versus postprandial conditions. DESIGN: Open-label, two-way, randomized, crossover study. SETTING: Janssen Research Foundation, Belgium. PATIENTS: Twelve healthy volunteers. INTERVENTIONS: Blood samples were obtained for pharmacokinetic analyses immediately before dosing and at regular intervals up to 96 hours after each dose. Blood and urine samples were obtained for hematologic, biochemical, and urinary safety analyses at baseline and at the end of the study. MEASUREMENTS AND MAIN RESULTS: The mean peak plasma concentrations of both itraconazole and its active metabolite hydroxy-itraconazole were significantly higher under fasting conditions than under postprandial conditions. The mean times to peak concentration for both the parent compound and its metabolite were significantly shorter under fasting than under nonfasting conditions. The mean areas under the curve (AUC0-infinity and AUC0-24 hrs) were also significantly higher under fasting than under postprandial conditions. CONCLUSIONS: Our findings suggest that the higher bioavailability of this new formulation of itraconazole may be of benefit in seriously ill patients who are not able to ingest adequate quantities of food. The fact that the solution was also well tolerated and was not associated with clinically significant changes in any laboratory value further underscores the potential utility of this dosing form.

Adult↗
PubMedDate not supplied

Prevalence of assault and perception of risk of assault in urban public service employment settings.

This study describes the prevalence and correlates of physical assaults, threats of assault, and workers' perceptions of safety in selected urban employment settings. Questionnaires were mailed to a random sample of 1,763 persons working at various jobs and sites throughout Los Angeles County. Workers were asked to describe their work environments, their perceptions of personal safety at work, and physical assaults and threats they had experienced. Three percent of the respondents reported being assaulted within the previous year and 14% reported being threatened within the previous 30 days. Younger workers, more educated workers, and those who worked with clients or patients were more likely to report assaults. Approximately one third of those who reported threats or assaults described the perpetrator(s) as clients, patients, or persons in legal custody, and one third described the perpetrator(s) as co-workers or supervisors. Fifty-two percent of the workers reported being concerned about their safety at work.

Adult↗
PubMed2006

A European's perspective of COX-2 drug safety.

Regulators require less evidence to take action on drug safety concerns than would be required to grant drug efficacy claims. Such an asymmetrical view of risk points to the need for large studies to judge the safety of novel medicines compared with standard therapy as smaller sample sizes might produce unreliable and misleading toxicity signals. Large studies conducted in the classical manner are expensive and difficult to conduct. In addition, tight entry criteria and strictly protocolized care results in such trials having poor external validity. If the safety of medicines is to be judged efficiently, novel, easier to conduct, and less-expensive solutions are required. Such trials could have improved external validity were they incorporated into normal care. This paper discusses the safety of cyclooxygenase-2 inhibitors and describes the sort of studies that could be carried out to gather better safety information on their use versus standard nonsteroidal anti-inflammatory drugs.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1988

Anxiety reduction after chorionic villus sampling and genetic amniocentesis.

This study compares anxiety levels in women undergoing prenatal testing by means of chorionic villus sampling versus genetic amniocentesis. Chorionic villus sampling can be performed earlier in a pregnancy (8 to 12 weeks' gestation) but has a higher risk of miscarriage. Randomized to undergo chorionic villus sampling or genetic amniocentesis as part of a trial examining the safety and accuracy of these procedures, the women were studied at four time periods: time 1, before prenatal testing (9 to 12 weeks' gestation); time 2, after the chorionic villus sampling results were received (13 weeks); time 3, before the genetic amniocentesis results were known (18 weeks), and time 4, after all results were known (22 weeks). Although they were still at risk for miscarriage, members of the chorionic villus sampling group showed a sharp drop in anxiety levels immediately after receiving their results. The genetic amniocentesis group remained anxious until the last test time. In summary, prenatal testing by means of chorionic villus sampling resulted in earlier and sustained anxiety reduction.

Adult↗
PubMed2004

Availability of safety net providers and access to care of uninsured persons.

OBJECTIVE: To understand how proximity to safety net clinics and hospitals affects a variety of measures of access to care and service use by uninsured persons. DATA SOURCES: The 1998-1999 Community Tracking Study household survey, administered primarily by telephone survey to households in 60 randomly selected communities, linked to data on community health centers, other free clinics, and safety net hospitals. STUDY DESIGN: Instrumental variable estimation of multivariate regression models of several measures of access to care (having a usual source of care, unmet or delayed medical care needs, ambulatory service use, and overnight hospital stays) against endogenous measures of distances to the nearest community health center and safety net hospital, controlling for characteristics of uninsured persons and other area characteristics that are related to access to care. The models are estimated with data from a nationally representative sample of uninsured people. PRINCIPAL FINDINGS: Shorter distances to the nearest safety net providers increase access to care for uninsured persons. Failure to account for the endogeneity of distance to safety net providers on access to care generally leads to finding little or no safety net effects on access. CONCLUSIONS: Closer proximity to the safety net increases access to care for uninsured persons. However, the improvements in access to care are relatively small compared with similar measures of access to care for insured persons. Modest expansion of the safety net is unlikely to provide a full substitute for insurance coverage expansions.

Adult↗
PubMed2005

Nationwide microbiological baseline data collected by sponge sampling during 1997 and 1998 for cattle, swine, turkeys, and geese.

During 1997 and 1998, the U.S. Food Safety and Inspection Service completed nationwide microbiological baseline studies on four separate categories of livestock and poultry. Data were collected by sponge-sampling techniques. These studies were designed to provide nationwide estimates of the prevalence of Salmonella and prevalence and concentrations of Escherichia coli in cattle (n = 1,881), swine (n = 2,127), turkeys (n = 1,396), and geese (n = 102) in establishments under federal inspection. Salmonella prevalence ranged from 1.2% in cattle to 6.9% in swine, 13.7% in geese, and 19.6% in turkeys. The prevalence of E. coli was 16.6% in cattle (geometric mean = 0.26 CFU/cm2), 44.1% in swine (mean = 0.78 CFU/cm2), 92.7% in turkey (mean = 2.46 CFU/cm2), and 96.5% in geese (mean = 1.97 CFU/cm2). These values are similar to or somewhat lower than previous baseline values obtained for steers and heifers, cows and bulls, market hogs, and young turkeys. This study is the first in which nationwide microbiological baseline data have been compiled for geese. These data will be useful to individuals working with hazard analysis critical control point plans and risk assessment and to the research and academic communities.

Abattoirs↗
PubMed1995

[Prenatal diagnosis].

A growing number of methods for the in-utero diagnosis of fetal disease became available during recent decades, mainly due to rapid advances in ultrasound technology and laboratory methods. Exclusion of fetal aneuploidy in pregnancies of women beyond 34 years is still by far the most common reason for an invasive procedure event at a time when the number of diagnosable inborn errors of metabolism and monogenetic disorders is increasing rapidly. Great efforts have been made to improve the poor predictive value of maternal age as an indicator for an increased risk for fetal aneuploidy. Maternal serum screening using various parameters [e.g. AFP, hCG, uE3] has been found effective in identifying the majority of pregnancies with Down syndrome in the second trimester. Current research goals are the optimal choice of markers and the introduction of maternal serum screening in the first trimester of pregnancy. Ultrasound is another suitable tool to identify pregnancies at high risk for aneuploidy at least in the hands of experienced operators. The diagnostic use of fetal cells in the maternal circulation is presently investigated in a large collaborative trial. Second trimester amniocentesis still is the most widely applied invasive technique in pregnancies with maternal age related risks for fetal aneuploidy. Safety and diagnostic accuracy are well established and amniotic fluid can easily be shipped. Without major changes in conventional sampling and laboratory techniques the procedure can be performed at 13 weeks of gestation and later. The safety and efficacy of first-trimester amniocentesis has still to be established in larger series. First-trimester chorionic villus sampling is a well-established alternative to amniocentesis with comparable procedure-related risks. It is the method of first choice in pregnancies at high risk for aneuploidy, inborn errors of metabolism and monogenic disorders, since uncultured villi can be used for a rapid diagnosis. Placental biopsy should also be considered in the second and third trimester of pregnancy for these indications whenever time is a critical issue. Fetal blood obtained by ultrasound-guided cordocentesis has successfully been used for the diagnosis of fetal infection and is at the same time another good source of cells for rapid karyotyping. Other invasive procedures such as fetal skin or liver biopsies for electron microscopy or specific metabolic tests are restricted to the relatively rare instances of diseases where DNA diagnosis is currently not available or uninformative. Providing information on the different alternatives in an individual situation is one of the critical issues in pregnancy care today.

Amniocentesis↗
PubMed1997

Randomised study of risk of fetal loss related to early amniocentesis versus chorionic villus sampling.

BACKGROUND: Several cohort studies have shown the feasibility of early amniocentesis (between 11 and 13 weeks of gestation) as an alternative to chorionic villus sampling (CVS) for karyotyping, but the only completed randomised study of fetal safety showed a significant fetal-loss risk related to first-trimester amniocentesis. We assessed fetal safety in early amniocentesis and CVS. METHODS: We assessed early amniocentesis at 11-13 weeks gestational age compared with the fetal risk associated with CVS at 10-12 weeks. 1160 pregnant women were randomly assigned one procedure (581 early amniocentesis, 579 CVS) after a baseline ultrasound examination at 10 weeks' gestation and were followed up until birth. Total fetal loss and neonatal morbidity were the primary outcome measures. Sampling success and pregnancy complications were secondary outcomes. We used a filter to increase the cell yield in the early amniotic-fluid samples. CVS was transabdominal. FINDINGS: We found a significantly increased occurrence of talipes equinovarus in the early amniocentesis group (p < 0.01), the risk of which was associated with sampling at the earliest gestational ages and with temporary leakage of amniotic fluid after sampling. Therefore, the trial was stopped early, which reduced the power of the safety study. 4.8% (27) of fetuses in the CVS group and 5.4% (30) in the early amniocentesis group were lost after randomisation (p = 0.66). More detailed survival analysis did not show any significant differences in fetal loss rates. Leakage of amniotic fluid after sampling occurred significantly more frequently after early amniocentesis than after CVS (p < 0.001), but we found no other major differences in pregnancy complications. Significantly more CVS than early amniocentesis procedures were repeated or failed to produce a karyotype (p < 0.01). INTERPRETATION: Even though the numbers were small, we found an association between early amniocentesis and talipes equinovarus. We believe this association to be true, since it supports a trend in a similar randomised study. Our results show that early amniocentesis, when done with the filter technique, is associated with an abortion risk similar to CVS, although the limited size of our study population reduced the strength of this conclusion.

Abortion, Spontaneous↗
PubMedDate not supplied

Food safety knowledge, perceptions, and behaviors among middle school students.

OBJECTIVE: To assess the level of food safety knowledge, perceptions, and self-reported food-handling behaviors among middle school students. DESIGN: Baseline questionnaire administered in class that assessed background characteristics, knowledge, behaviors, and perceptions related to food safety. PARTICIPANTS: 178 seventh and eighth grade students from 4 schools in central Pennsylvania. MAIN OUTCOME MEASURES: Food safety knowledge, perceptions, and self-reported food-handling behaviors. ANALYSIS: Independent samples t test tested differences between genders and bivariate correlation analysis explored associations among knowledge, perceptions, and behavior (P <.05). RESULTS: Food safety knowledge score was 7.2 +/- 1.6 of a maximum of 10 points. Perceived self-efficacy and severity of a foodborne illness were high, but perceived susceptibility was low. Girls scored higher on the self-efficacy and severity scale (P <.01). Self-efficacy correlated positively with knowledge and behavior (P <.0001) and severity with knowledge (P <.01). One fifth reported taking risks in food handling and one fifth reported having been sick because of something they ate. CONCLUSIONS AND IMPLICATIONS: There is a disconnection between middle school students' food safety knowledge, perceptions, and behaviors. A need for relevant and motivating food safety education exists in this group.

Adolescent↗
PubMedDate not supplied

Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial.

BACKGROUND: Vaccination against the most common oncogenic human papillomavirus (HPV) types, HPV-16 and HPV-18, could prevent development of up to 70% of cervical cancers worldwide. We did a randomised, double-blind, controlled trial to assess the efficacy, safety, and immunogenicity of a bivalent HPV-16/18 L1 virus-like particle vaccine for the prevention of incident and persistent infection with these two virus types, associated cervical cytological abnormalities, and precancerous lesions. METHODS: We randomised 1113 women between 15-25 years of age to receive three doses of either the vaccine formulated with AS04 adjuvant or placebo on a 0 month, 1 month, and 6 month schedule in North America and Brazil. Women were assessed for HPV infection by cervical cytology and self-obtained cervicovaginal samples for up to 27 months, and for vaccine safety and immunogenicity. FINDINGS: In the according-to-protocol analyses, vaccine efficacy was 91.6% (95% CI 64.5-98.0) against incident infection and 100% against persistent infection (47.0-100) with HPV-16/18. In the intention-to-treat analyses, vaccine efficacy was 95.1% (63.5-99.3) against persistent cervical infection with HPV-16/18 and 92.9% (70.0-98.3) against cytological abnormalities associated with HPV-16/18 infection. The vaccine was generally safe, well tolerated, and highly immunogenic. INTERPRETATION: The bivalent HPV vaccine was efficacious in prevention of incident and persistent cervical infections with HPV-16 and HPV-18, and associated cytological abnormalities and lesions. Vaccination against such infections could substantially reduce incidence of cervical cancer.

Adolescent↗
PubMed1986

Residue levels of hexachlorobenzene in meat and poultry in the food supply of the USA.

Since the early 1970s, the Food Safety and Inspection Service of the US Department of Agriculture has monitored fat samples from meat and poultry for residues of hexachlorobenzene (HCB). The violative level for enforcement activities is 0.5 ppm. Data on HCB residues found in meat and poultry have been organized on the basis of nationwide occurrence over time, according to geographic groupings and according to species. A further distinction has been made between grazing animals, e.g., cattle, sheep, horses, and non-grazers such as swine and poultry. From 1972 to 1977, HCB residues were detected in all species tested. Of the samples analysed, the percentage containing HCB ranged from 7 (in 1973) to 41 (in 1977). In 1978, the percentage declined to 26 and continued to drop in 1979 to 8. From 1980 to the present time, detectable levels (greater than 0.01 ppm) of HCB have been found in 3-6% of the samples analysed with 95% of those samples containing less than 0.1 ppm. Only seven out of more than 25,000 samples analysed since 1980 contained HCB levels greater than 0.05 ppm. Comparisons of HCB in animal tissues collected from the five geographic regions of the Food Safety and Inspection Service indicated frequently that in the western and south-western regions of the USA a greater number of animals showed detectable levels of HCB in their fat. In 1984, the incidence for all samples was 4.4%. Figures for the regions varied from 1.4% in the southeast to 6.6% in the southwest. Comparison of the frequency of HCB in the fat of different species indicated that horses, sheep and cattle show detectable amounts of HCB more frequently than poultry and swine. These data seem to reflect production practices in that animals which graze at some period of their lives may be exposed to HCB more frequently than non-grazing animals.

Animals↗
PubMed2005

The occurrence of Vibrio species in tropical shrimp culture environments; implications for food safety.

The occurrence of various Vibrio species in water, sediment and shrimp samples from multiple shrimp farm environments from the east and west coast of India was studied. The relative abundance was higher in west coast farms (ca. 10(4) cfu/ml water) when compared to the east coast (ca. 10(2) cfu/ml water). Vibrio alginolyticus (3-19%), V. parahaemolyticus (2-13%), V. harveyi (1-7%) and V. vulnificus (1-4%) were the predominant Vibrio species identified by standard biochemical testing. In some cases, V. cholerae could be found, but all isolates were negative for the cholera toxin (ctx) gene that is associated with choleragenic strains. The biochemical identification of V. parahaemolyticus, the other human pathogen among the species mentioned above, was confirmed by PCR targeting the toxR gene and a 387 bp chromosomal locus specific for this species. Furthermore, the presence of the virulence-associated tdh (thermostable direct haemolysin) and trh (TDH-related haemolysin) genes in the V. parahaemolyticus isolates was also detected by PCR. Only 2 out of 47 isolates were tdh positive and one contained the trh gene. However, since V. cholerae, V. parahaemolyticus and V. vulnificus species are recognized as a major cause of seafood-borne illness, it is important to pay attention to post-harvest handling and adequate cooking.

Animals↗