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PubMed1987

Low fetal loss rates after ultrasound-proved viability in early pregnancy.

Once pregnancy is recognized clinically, it is accepted that 12% to 15% undergo spontaneous abortion. However, the actual time of fetal demise has not yet been determined. To address this question, the outcomes of pregnancies identified before 21 days of conception by serum beta-human chorionic gonadotropin assays were studied. All subjects underwent ultrasound examinations at eight and 12 weeks' gestation. Among 220 women who had a viable pregnancy at eight weeks, only seven (3.2%) experienced a fetal loss thereafter. The results of this study suggest that most clinically recognized spontaneous abortions manifested after eight weeks actually represent pregnancies in which fetal demise occurred before eight weeks. These findings have important implications with respect to the safety of chorionic villi sampling and to the identification of exogenous agents that cause fetal wastage.

Abortion, Spontaneous↗
PubMed1985

Why proof of safety is much more difficult than proof of hazard.

On the basis of simple, generally accepted biostatistical and public health principles, it is shown that for environmental health hazards a proof of safety is much more difficult than a proof of hazard. The effective sample sizes required for proof of safety are orders of magnitude greater than what is feasible in biostatistical-epidemiological studies. Although many assurances of safety "in the name of science" have been issued by government agencies and others, few if any of these assurances are statistically valid.

Accident Prevention↗
PubMed1994

Effect of heating sera under conditions necessary for deactivation of human immunodeficiency virus on commonly monitored therapeutic drugs.

Minimizing the risk of infection of laboratory staff from contaminated blood samples is a major safety goal in a clinical laboratory. One dangerous pathogen, the human immunodeficiency virus (HIV) can be deactivated by heating sera at 56 degrees C for 30 min. We studied the effect of such heat treatment on serum concentrations of 11 commonly monitored therapeutic drugs. We used blood specimens collected in serum separator tubes (SSTs), which were routinely submitted for therapeutic drug monitoring in our laboratory for this study. Concentrations of digoxin in sera were measured using a fluorescence polarization immunoassay (FPIA), while concentrations of tobramycin, gentamicin, vancomycin, theophylline, valproic acid, procainamide, N-acetylprocainamide (NAPA), phenytoin, phenobarbital, and carbamazepine were measured by enzyme-multiplied immunoassay technique assays using a Monarch 2000 analyzer. We observed no significant change in the concentration of any drug except phenytoin and carbamazepine following heating at 60 degrees C. The decrease in concentration of phenytoin and carbamazepine after heating was related to absorption of the drug to the gel rather than the instability of the drug under heating conditions. We conclude that blood contaminated with HIV may be deactivated by heating prior to analysis for most of the routinely monitored therapeutic drugs.

Blood Proteins↗
PubMed1997

Curdlan sulfate (CRDS) in a 21-day intravenous tolerance study in human immunodeficiency virus (HIV) and cytomegalovirus (CMV) infected patients: indication of anti-CMV activity with low toxicity.

This study evaluated tolerance (and possible efficacy) for 21 days of i.v. administration at three dose levels of curdlan sulfate (CRDS) (a semisynthetic sulfated polysaccharide), administered over 30 minutes, in HIV and CMV (in some cases) infected individuals with CD4 levels < 500 cells/mm3. Half of the subjects were previously treated with reverse transcriptase inhibitors (RTI) (which were continued during the CRDS administration) and half the patients had no prior RTI treatment. Evaluation of other sulfated polysaccharides in HIV had been discontinued due to side effects and lack of activity. Three groups of HIV patients (also including subsets with CMV infection) were treated separately with 50 mg/70 Kg, 100 mg/70 Kg and 200 mg/70 Kg of CRDS infused i.v. over thirty minutes daily for 21 days. In each dose group, half of the patients selected were being treated with a RTI and half were on no RTI. Patients were monitored for CD4 cell levels, viral load in some cases, and safety parameters in blood. Samples of urine and semen were additionally taken for CMV by culture and for PCR assay in subsets of participants. CRDS in this 21 day study was well-tolerated and produced few reportable side effects. Systematic decreases in platelets and increases in p24 antigen previously seen with dextran sulfate were not observed in this study with CRDS. In the 21 patients testing positive for CMV at the start of the study, 12 were CMV negative at the end of 21 days. In an untreated historical control group, 0/36 went from CMV positive to negative over a period of 13-15 years. The anti-CMV activity of CRDS in this study, therefore, had a p value < 0.001, based on these historical controls. The marked temporary increases in CD4 levels seen in the single dose and the seven-day CRDS studies on HIV patients were also seen for 21 days in the current study (p = 0.0001). Treatment with CRDS seems promising against CMV in HIV infected patients, even with once daily dosing of this two-hour half-life drug. CRDS was well tolerated and its lack of toxicity makes it an attractive candidate for CMV-infected HIV patients. Multiple daily dosing, or the continuous infusion of CRDS, could lead to increased effectiveness against both HIV and CMV, especially in combination with other agents. Given the toxicity of existing anti-CMV agents, and considering the emerging importance of CMV in atherosclerotic disease, further studies on CRDS are warranted.

AIDS-Related Opportunistic Infections↗
PubMed1996

Chorionic villus sampling: clinical experience of the initial 750 cases.

OBJECTIVE: To assess the factors that might influence the success rate, safety and reliability of chorionic villus sampling (CVS) and to evaluate the relationship between CVS and other congenital anomalies. DESIGN: Analysis of the outcome of 750 cases of CVS (730 cases with transcervical and 20 cases with transabdominal). SETTING: The outpatient prenatal genetic clinic of a university tertiary care center. SUBJECT: Seven hundred and fifty pregnant women that underwent CVS for prenatal genetic diagnosis from 7 to 12 weeks of gestation. RESULTS: Advanced maternal age was the most common indication for CVS (32.8%). The overall sampling success rate was 98.0% (735/750), representing 93.9% at 7 to 8 weeks, 98.1% at 9 to 10 weeks, and 98.3% at 11 to 12 weeks of gestation. The majority of cases (93.1%) required one or two aspirations. Cytogenetic analysis routinely included direct overnight and long-term culture methods which revealed 16 abnormalities (2.2%). Of 735 cases in which CVS was successful, 700 advanced to normal offspring, 17 had therapeutic termination, and 18 resulted in spontaneous abortions; there was an overall fetal loss rate of 2.4% (18/750). CONCLUSION: CVS in early pregnancy is a relatively safe and reliable method of prenatal genetic diagnosis capable of replacing genetic amniocentesis. However, it must be done by experienced personnel. No congenital anomalies were found to be related to CVS in this series.

Adult↗
PubMed2003

Biosafety concerns for shared flow cytometry core facilities.

Many researchers who need flow cytometry for their projects have neither sufficient funds nor the work volume to justify the purchase of an analytic cytometer or cell sorter. In shared flow cytometry facilities, costs for instrument purchases, cytometer maintenance, and personnel are pooled to provide economic services for a multitude of users when they are required. Owing to the diverse nature of the samples that are submitted to core facilities, the biohazard potential of the samples can vary dramatically. For the safety of facility personnel and users, it is critical that information about hazards contained in the samples be transmitted to instrument operators before flow cytometry experiments are started. During 1999 the former Biosafety Committee of the International Society for Analytical Cytology formulated a framework biosafety questionnaire for shared facilities designed to request information about the hazard potential of experimental samples from investigators who wish to use the facility. In this report we review safety issues that are pertinent to flow cytometry core facilities by discussing the individual components of this biosafety questionnaire.

Animals↗
PubMed1999

Workers' right-to-know legislation: does it work?

Workers' right-to-know (WRTK) laws and regulations were established to empower workers to protect their health by providing them with information about the hazards to which they are exposed while at work. The present study was conducted to examine the implementation of WRTK regulations in Israel. We interviewed 552 workers and 33 safety officers from a random sample employed at 50 industrial plants. The workers' questionnaire included items on awareness and self-management of workplace hazards, and the safety officers answered questions about job experience and hazards communications to workers. In 36% of cases workers and their safety officers disagreed about the existence of hazards in the workplace (p < 0.001). Most (78%) of the workers' knowledge about work hazards was based on informal sources, i.e., not those stipulated by the regulations. There were also discrepancies between worker and safety officer reports regarding the provision of safety training upon employment (p < 0.001), recent instructions about special risks and distribution of relevant printed material. We found that more than 5% of workers were unable to read the language in which the hazards material was written and 22% had levels of education below that required to comprehend the technical terms used. There are serious problems in the implementation of WRTK regulations in Israel. We recommend that employers be made aware of the importance of these laws and of their proactive duty to comply with them and that the material distributed to workers be written in simpler terms and/or explained orally in a language they understand. These findings have important implications for all countries with similar legislation and should form the basis for further and more comprehensive studies world-wide.

Adolescent↗
PubMed2000

Learning in medicine: chorionic villus sampling.

Operator experience is considered to influence the safety and success of medical procedures. We performed a retrospective survey to assess learning curves in chorionic villus sampling (CVS). Data of 2081 consecutive women, in whom CVS was carried out in a tertiary care university hospital for prenatal diagnosis, were available for analysis. Endpoints of the analysis were fetal loss, failure of the procedure and need for several needle insertions. Frequencies of each endpoint were calculated and plotted for consecutive series of 50 samplings per operator. Logistic regression analysis was used to quantify the effect of operator experience. We observed a statistically significant learning effect for the unit as a whole as assessed by fetal loss figures and the same tendency for need to do several insertions. We did not observe a (collective) learning effect for failure of the procedure. Individual operators showed a significant learning profile for some endpoints. The individual learning profile predominantly depended on previous experience in amniocentesis. Our study substantiates the presence of a learning curve for CVS. This supports the view that centralization and restriction of CVS to a limited number of experienced operators within centres, is likely to have a positive influence on safety and success of the procedure.

Abortion, Spontaneous↗
PubMed1996

The short insulin tolerance test: feasibility study using venous sampling.

The short insulin tolerance test (ITT) is both a simple and valid method of quantifying insulin sensitivity although arterialization of samples and the risk of hypoglycaemia remain as potential difficulties. We examined the safety and reproducibility of using venous sampling with insulin doses of 0.1 U kg-1 and 0.05 U kg-1 in healthy subjects. Whole blood glucose concentrations were measured contemporaneously and the rate of plasma glucose decline (mmol l-1 min-1) for each test was estimated from unlogged venous plasma glucose concentrations measured at 1 min intervals. The mean rates of plasma glucose decline for the 0.1 U kg-1 and 0.05 U kg-1 insulin doses were 0.26 mmol l-1 min-1 (n = 11, range = 0.17-0.41, intrasubject coefficient of variation (CV) = 9.4%) and 0.25 mmol l-1 min-1 (n = 6, range 0.19-0.46, intrasubject CV = 15.9%), respectively. Reversal of significant hypoglycaemia was necessary in one subject before 15 min post-insulin. We found that: (1) venous sampling provides a reproducible measure of glucose uptake after insulin, (2) contemporaneous bedside glucose sampling identifies those at risk of significant hypoglycaemia during the ITT, and (3) the 0.1 U kg-1 dose response is more reproducible and no less safe than the half dose response. We conclude that the current ITT protocol would be made safer and simpler with the above modifications although further studies comparing venous with arterialized sampling are needed.

Adult↗
PubMed1988

Post-processing microflora and the shelf stability of gari marketed in Port Harcourt.

Gari was examined for its post-processing microbial content. Aerobic mesophilic bacteria and fungi were isolated from all samples. The total viable bacterial counts ranged from 2.0 X 10(2) to 8.0 X 10(4) cfu/g. Fungal counts ranged from 1.0 X 10(2) to 1.5 X 10(4) cfu/g. The total viable counts of fresh samples were much lower than those of market and packaged samples. Bacillus, Micrococcus and Proteus spp. were the bacteria isolated, Aspergillus niger, Aspergillus flavus and Penicillium spp. the fungi. Food borne parasites and pathogens such as Staph. aureus and Clostridium perfringens were not found. The gari samples were quite stable, having a shelf life of 3-6 months. The water activities of the samples ranged from 0.52 to 0.68. Based on the microbial counts of the samples, the critical upper limit for the safety of gari was set at 10(4) cfu/g dry sample.

Bacteria, Aerobic↗
PubMed1994

Ultrasound-guided fetal skin sampling for prenatal diagnosis of genodermatoses.

OBJECTIVE: To evaluate the safety and diagnostic efficacy of ultrasound-guided fetal skin sampling for the prenatal diagnosis of genodermatoses. METHODS: Seventeen pregnancies seen over 6.5 years were analyzed retrospectively. Fifteen were at risk for junctional epidermolysis bullosa and two for recessive dystrophic epidermolysis bullosa. Under ultrasound guidance, a biopsy forceps was inserted through a 14-gauge catheter and directed toward the fetus (thorax, back, or buttocks) to obtain skin samples. The procedures were performed at a mean of 18.3 weeks' gestation (range 16.5-19.5). RESULTS: Fetal skin sampling was successful in all cases; the mean number of biopsies taken was 3.6 (range two to five). Five of the 17 fetuses were determined to be affected, each with junctional epidermolysis bullosa; these pregnancies were terminated electively and the prenatal diagnoses confirmed. The remaining 12 pregnancies resulted in the delivery of healthy infants at or after 37 weeks' gestation. There were no pregnancy-related complications, specifically preterm rupture of the membranes or preterm labor. Three of the 12 infants had minor skin blemishes believed to be due to the skin sampling. CONCLUSION: Ultrasound-guided fetal skin sampling is the procedure of choice when fetal skin is required for prenatal diagnosis of genodermatoses.

Biopsy↗
PubMed2002

Procedural risks versus theology: chorionic villus sampling for Orthodox Jews at less than 8 weeks' gestation.

OBJECTIVE: According to Orthodox Jewish law, abortion is only permitted before 40 days post conception. This evaluation was performed to determine the feasibility and safety of performing chorionic villus sampling (CVS) at 7 to 8 weeks' gestation so that genetic results would be useful for these patients. STUDY DESIGN: We evaluated a sequential series of 82 Orthodox Jewish patients who chose CVS at <63 days' gestation. Outcome measures included procedure success rates, laboratory success rates, pregnancy outcomes, and complications. RESULTS: CVS was successful in all cases. Ninety-one percent were performed transcervically, with 30% requiring 2 or more insertions. Abnormal results were found in 16 (20%). Of 61 cases with normal genetic and ultrasound results, spontaneous losses at less than 28 weeks occurred in 3 (5%). These rates are higher than the 2.3% loss rate and the 1.2% multiple insertion rate seen at our center when sampling is performed at the usual gestational ages of 10 to 12 weeks. One baby had a severe limb reduction defect (1.6%). CONCLUSION: In very experienced hands, CVS can be safely and reliably performed at very early gestational ages. The ability to obtain an early diagnosis may be associated with increased but acceptable complication rates, including a 1% to 2% risk of limb reduction defects. There are patients for whom the usual paradigms do not suffice, and obtaining an early disgnosis provides them the opportunity to trade increased risks for reproductive choice. The ethical issues are complex, but such decisions can be supported by extensive and detailed informed consent.

Abortion, Spontaneous↗
PubMed1991

Assessment of biological reagents for presence of human immunodeficiency virus-1 (HIV-1) antigens.

We tested 122 biological reagents including laboratory quality assurance sera and therapeutic human immune serum globulin products using an immunoenzymometric assay (IEMA) for HIV-1 antigens. Biological reagents tested were 64 HIV-1 antibody non-reactive and 44 HIV-1 antibody reactive quality assurance samples, and 14 HIV-1 antibody reactive human immune serum globulins from 21 manufacturers. Twenty-one of these biological reagents were previously reported by us as Western blot reactive. All 122 samples tested were non-reactive for HIV-1 antigens. Low incidence of HIV-1 antigen in these biological reagents should not alter laboratory safety practices in which all samples are considered infectious. Use of HIV-1 antigen measurements, either alone or with HIV-1 antibody determinations does not increase the likelihood of detecting HIV-1 reactive samples.

AIDS Serodiagnosis↗
PubMedDate not supplied

Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.

CONTEXT: Randomized trials with adequate sample size offer an opportunity to assess the safety of new medications in a controlled setting; however, generalizable data on drug safety reporting are sparse. OBJECTIVE: To scrutinize the completeness of safety reporting in randomized trials. DESIGN, SETTING, AND PATIENTS: Survey of safety reporting in 192 randomized drug trials 7 diverse topics with sample sizes of at least 100 patients and at least 50 patients in a study arm (N = 130074 patients). Trial reports were identified from comprehensive meta-analyses in 7 medical areas. MAIN OUTCOME MEASURES: Adequate reporting of specific adverse effects and frequency and reasons for withdrawals due to toxic effects; article space allocated to safety reporting and predictors of such reporting. RESULTS: Severity of clinical adverse effects and laboratory-determined toxicity was adequately defined in only 39% and 29% of trial reports, respectively. Only 46% of trials stated the frequency of specific reasons for discontinuation of study treatment due to toxicity. For these 3 parameters, there was significant heterogeneity in rates of adequate reporting across topics (P =.003, P<.001, and P =.02, respectively). Overall, the median space allocated to safety results was 0.3 page. A similar amount of space was devoted to contributor names and affiliations (P =.16). On average, the percentage of space devoted to safety in the results section was 9.3% larger in trials involving dose comparisons than in those that did not (P<.001) and 3.8% smaller in trials reporting statistically significant results for efficacy outcomes (P =.047). CONCLUSIONS: The quality and quantity of safety reporting vary across medical areas, study designs, and settings but they are largely inadequate. Current standards for safety reporting in randomized trials should be revised to address this inadequacy.

Adverse Drug Reaction Reporting Systems↗
PubMed1992

Compliance of Michigan dentists with radiographic safety recommendations.

We surveyed a random sample of 398 Michigan dentists in private practice to determine their compliance with the American Dental Association Council's recommendations for radiographic equipment and techniques. The response rate was 67% of the questionnaires delivered successfully. The majority of dentists use only D-speed film (73%) and round collimation of the x-ray beam (90%). Only 5% have an x-ray machine equipped with a rectangular collimator and 18% have at least one machine with a pointed cone. Leaded apron use is almost universal, but only 49% of the dentists use cervical collars in addition to the apron. The majority of dentists surveyed do not comply with the American Dental Association Council's recommendations on film speed, collimation, and use of leaded cervical collar. Using effective dose equivalents determined by Gibbs et al. for a variety of radiographic techniques, we estimate that an eight-fold reduction in radiation dose could be achieved without eliminating a single radiograph if all dentists used E-speed film and collimation of the beam to the size of the film.

Attitude of Health Personnel↗
PubMed2004

Effects of changes in patient cost sharing and drug sample policies on prescription drug costs and utilization in a safety-net-provider setting.

PURPOSE: The impact of cost-containment strategies on prescription drug utilization and costs in an ambulatory care safety-net-provider setting was studied, along with the impact of these strategies on patient out-of-pocket expenditures. METHODS: Aggregate monthly prescription drug cost and utilization data were obtained from a health system's outpatient pharmacy computer system for the targeted clinic. The data represented approximately 42,000 patient visits over 38 months. Univariate and multivariate statistics were used to evaluate the influence of copayment increases and changes in prescription drug sample policies on prescription drug costs, prescription drug utilization, and patient expenditures. RESULTS: Prescription drug copayment increases were associated with significant decreases in prescription drug utilization and costs. An average per visit prescription drug copayment increase of $5 was associated with a significant reduction in prescription drug utilization per visit and a $26.07 reduction in prescription drug expenditures per visit per month. Removal of samples from the clinic did not result in a significant decrease in either prescription drug costs or utilization. The presence of samples, however, was associated with a significant reduction in per visit patient expenditures by an amount similar to the copayment for one brand-name prescription drug per visit. CONCLUSION: An increase in patient copayments was associated with reductions in a clinic's drug expenditures and prescription drug utilization per visit. Removal of prescription drug samples had no effect except increasing patients' out-of-pocket drug costs.

Cost Sharing↗
PubMedDate not supplied

Validation of a microwell DNA probe assay for detection of Listeria spp. in foods Performance-tested method 010403.

A new DNA hybridization assay in microwell format for detection of Listeria spp. in foods and environmental samples was developed. This assay uses Listeria-specific oligonucleotide probes labeled with horseradish peroxidase and a photometrically determined end point. Validation studies with 15 different food commodities and a variety of environmental sample types were conducted to compare the performance of this alternative test versus reference methods. Meats, seafood, dairy products, and vegetables comprised the categories of food tested. Food samples were inoculated at 2 levels and refrigerated or frozen for at least 72 h. Uninoculated (negative) control samples were included in each trial. Samples were enriched according to the procedure recommended by either the U.S. Food and Drug Administration (FDA) or the U.S. Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS). Samples enriched for 24 h were transferred to Oxford agar plates and incubated for 24 h. The surface of the plates was then swabbed and any growth present was transferred to phosphate buffer solution for the performance of the DNA assay. A standard confirmation procedure was used to compare the number of positive samples obtained with the DNA method versus reference methods. Statistical analyses of the results indicate that the proposed alternative method performs equally to cultural reference methods. The DNA assay is able to detect as low as 1 colony-forming unit of Listeria in a 25 g food sample, with results available as early as 48 h after the start of sample enrichment.

Bacteriological Techniques↗
PubMed1993

HPLC analysis of salinomycin in human plasma using pre-column oxidation and automated heart cut column switching.

Salinomycin is a polyether antibiotic used to promote growth in cattle and poultry. Workers may be exposed to salinomycin through handling of animal feeds that contain the drug and it is necessary to monitor plasma samples from these workers for salinomycin to ensure safety. A method for analysis of salinomycin in plasma samples was therefore developed. Salinomycin and the internal standard narasin are extracted into iso-octane then subjected to silica gel solid-phase extraction in which the sample is washed with methylene chloride-methanol (98.5:15) then eluted with a 90:10 proportion of the same mixture. Both salinomycin and narasin are oxidized with pyridinium dichromate to form a chromophore absorbing at 225 nm. The concentrated product was injected onto a C18 pre-column and heart cut from 1.85 to 3.65 min onto a C18 analytical column. The method was shown to be selective for salinomycin and narasin in six blank plasma samples. The method was linear over a range of 15-300 ng ml-1 with a detection limit of approximately 5 ng ml-1. The mean absolute recovery was found to be 93.4 and 97.9% for salinomycin and narasin, respectively. The method was accurate to within 5% at all concentrations studied. Within-run and between-run precision were both less than 8% RSD at all concentrations studied and the method was suitable for the purpose of monitoring plasma from exposed agricultural workers.

Anti-Bacterial Agents↗