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Public knowledge and perceptions about unplanned pregnancy and contraception in three countries.

A 1994-1995 survey of men and women aged 18-44 in the United States, Canada and the Netherlands revealed considerable differences in public knowledge and perceptions about unplanned pregnancy and contraception. The proportion who believe that unplanned pregnancy is a "very big problem" is 60% in the United States, 36% in Canada and 6% in the Netherlands. Americans are more likely than their Canadian or Dutch counterparts to cite societal problems as significant factors in the rate of unplanned pregnancy; higher proportions of Americans also cite the cost of contraceptives (52% vs. 46% of Canadians and 34% of Dutch men and women) and an inability to obtain methods (66%, 51% and 33%, respectively). In all three countries, adults are generally well informed about the relative effectiveness of commonly used contraceptives, but Americans are more skeptical about method safety and effectiveness. For example, 17% think the pill is "very safe," compared with 21% of Canadians and 40% of the Dutch; and whereas 64% of Americans consider the pill "very effective," 73% of Canadians and 90% of Dutch men and women give it this rating. Health care professionals are the most frequently cited source of contraceptive information, but only 51-63% of adults have ever discussed contraception with such a practitioner.

Adolescent↗

The Adolescent Lifestyle Questionnaire: development and psychometric testing.

This paper describes the development and psychometric testing of an instrument designed to measure healthy lifestyle in adolescents. The Adolescent Lifestyle Questionnaire (ALQ) was tested on 292 adolescents residing in eastern Canada using item analysis, factor analysis, and reliability measures. Factor analysis isolated seven dimensions to a healthy lifestyle in adolescents, which accounted for 56.0% of the variance in the 43-item measure. The seven factors were: identity awareness, nutrition, physical participation, safety, health awareness, social support, and stress management. The alpha reliability coefficient for the total scale is .91; alpha coefficients for the subscales range from .60 to .88. The instrument warrants further testing and development with different adolescent populations. The instrument will enable researchers to investigate lifestyle patterns in adolescents and to assess the impact of interventions of lifestyle change in this population.

Adolescent↗

Working and living conditions of construction workers: comparison between large and small construction sites in northeastern Thailand.

This study examined differences in working and living conditions of construction workers in large and small construction sites in Northeastern Thailand. Data were collected by questionnaires, through observation and interviewing. A total of 812 construction workers from 20 large sites and 24 small sites were studied. Working and living conditions among the construction workers were generally poor. However, they were better at the large sites than the small ones. The data suggest an urgent need to improve sanitation and safety conditions on the construction sites and camp sites, including personal protective devices and improved welfare for the workers and their families.

Adolescent↗

Lack of detectable allergenicity of transgenic maize and soya samples.

BACKGROUND: The safety issues regarding foods derived from genetically modified (GM) plants are central to their acceptance into the food supply. The potential allergenicity of proteins newly introduced in GM foods is a major safety concern. OBJECTIVE: We sought to monitor, in potentially sensitive human populations, the allergenicity effects of 5 GM materials obtained from sources with no allergenic potential and already under commercialization in the European Union. METHODS: We have performed skin prick tests with protein extracts prepared from transgenic maize (MON810, Bt11, T25, Bt176) and soya (Roundup Ready) samples and from nontransgenic control samples in 2 sensitive groups: children with food and inhalant allergy and individuals with asthma-rhinitis. We have also tested IgE immunoblot reactivity of sera from patients with food allergy to soya (Roundup Ready) and maize (MON810, Bt11, Bt176) samples, as well as to the pure transgenic proteins (CryIA[b] and CP4 5-enolpyruvylshikimate-3-phosphate synthase). RESULTS: None of the individuals undergoing tests reacted differentially to the transgenic and nontransgenic samples under study. None of the volunteers tested presented detectable IgE antibodies against pure transgenic proteins. CONCLUSION: The transgenic products under testing seem to be safe in terms of allergenic potential. We propose postmarket testing as an important screening strategy for putative allergic sensitization to proteins introduced in transgenic plants.

Adolescent↗

Techniques of chorion villus sampling.

Whilst randomized studies into the safety of chorionic villus sampling (CVS) are already under way the technique is now offered as an acceptable alternative to amniocentesis in many diagnostic centres. In counselling, the obstetrician can now quote a risk to the pregnancy of 2-4% which, even if the inevitable losses before 16 weeks are excluded, represents probably at least twice the risk of amniocentesis. The evolution of the obstetric procedures has meant that the transcervical approach to CVS has been the most popular to date but there is now increasing interest in transabdominal aspiration as it minimizes the possibility of infection. The two best known transcervical methods are aspiration with a plastic or metal cannula and biopsy with rigid forceps. The majority of aspirations have been performed using the Portex cannula technique. Using this, three centres (Milan, Chicago and Philadelphia) have had experience of over 5000 cases with a failure rate of less than 1% and a minimal fetal loss of 2.2%. However, the proportion of fetal losses may be between 4 and 7% by the time complete obstetric follow-up is available (Brambati et al, 1985). A similar technique has been used with a variety of cannulae. The experience of the first 1000 cases from San Francisco (Hogge et al, 1986) led them to conclude that CVS by this technique was acceptably safe but that continuing investigation was needed before CVS was offered routinely as an alternative to amniocentesis. The only other transcervical technique that is practical for routine use is biopsy with rigid forceps. The failure and fetal loss rates associated with this method are comparable to the aspiration technique. The pioneering work of Hahnemann and his colleague Smidt-Jensen has established transabdominal aspiration as a reliable alternative approach. Its main advantage should be to minimize the risk of infection which is inherent in all transcervical techniques. In addition, it does not need to be confined to 9-11 weeks gestation and thus offers couples the possibility of diagnosis between 12 and 14 weeks rather than waiting for amniocentesis at 16 weeks. The quality and quantity of the sample depends on the size of the needle used and the technique is said to have high patient acceptability. Nevertheless, fetal losses occur following the procedure (1.8-3.2%) and it may not always be successful (failure rate 1.9-4.2%).

Biopsy, Needle↗

The safety and efficacy of chorionic villus sampling for early prenatal diagnosis of cytogenetic abnormalities.

Chorionic villus sampling is a method of prenatal diagnosis in the first trimester of pregnancy in which tissue for genetic study is aspirated from the developing placenta by means of a catheter inserted transcervically under the guidance of ultrasonography. In this seven-center study, we compared the safety and efficacy of chorionic villus sampling in 2278 women with those of amniocentesis at 16 weeks' gestation in 671 women. Both groups were made up primarily of well-educated private patients; they were recruited in the first trimester of pregnancy and had viable pregnancies verified by ultrasound examination. Cytogenetic diagnoses resulted from 97.8 percent of the chorionic villus sampling procedures and 99.4 percent of the amniocenteses (P less than 0.05); aneuploidy was found in 1.8 and 1.4 percent, respectively, of the cases in which diagnoses were made. Of the women who underwent chorionic villus sampling, 17 (0.8 percent) subsequently had an amniocentesis because the diagnosis was ambiguous. Two of the diagnoses of aneuploidy (one tetraploidy, one trisomy 22) were later proved to be incorrect. On the basis of pediatric examination of the infants subsequently born to the women in the sample, there were no errors in the determination of sex or the identification of the major trisomies (21, 18, and 13). The rate of combined losses due to spontaneous and missed abortions, termination of abnormal pregnancies, stillbirths, and neonatal deaths was 7.2 percent in the group that underwent chorionic villus sampling and 5.7 percent in the group that had amniocentesis. After adjustment for slight differences in gestational and maternal age, the total loss rate for the women in the chorionic villus sampling group exceeded that for the amniocentesis group by only 0.8 percentage points (80 percent confidence interval, -0.6 to 2.2). The rate of loss of chromosomally normal fetuses after chorionic villus sampling was 10.8 percent among women in whom three or four attempts were made to place the transcervical catheter, as compared with 2.9 percent in those in whom only one attempt was necessary (P less than 0.01). There were no serious maternal infections among the women in this study or among an additional 1990 women who underwent chorionic villus sampling (upper 95 percent confidence limit, 0.08 percent). We conclude that chorionic villus sampling is a safe and effective technique for the early prenatal diagnosis of cytogenetic abnormalities, but that it probably entails a slightly higher risk of procedure failure and of fetal loss than does amniocentesis.

Abortion, Spontaneous↗

Amniocentesis and chorionic villus sampling.

Amniocentesis performed at 16 to 18 weeks' gestation has been the gold standard approach for prenatal cytogenetic diagnosis. Over the past few years, large collaborative studies on chorionic villus sampling have confirmed the safety and efficacy of chorionic villus sampling as a viable alternative for women seeking prenatal diagnosis. While the expanding experience with chorionic villus sampling has answered questions regarding the safety of the transabdominal approach, it has also raised questions concerning possible associations with limb abnormalities, its usefulness in multiple gestations, and the clinical significance of confined placental mosaicism. These issues, as well as the technical and gestational age limitations of chorionic villus sampling, have led many investigators to study the technical feasibility, safety, and accuracy of amniocentesis performed in the first trimester or early second trimester. While this approach appears both safe and efficacious, there are concerns regarding orthopedic abnormalities and the reliability of first-trimester amniotic fluid acetylcholinesterase and alpha-fetoprotein levels in the diagnosis of neural tube defects.

Abortion, Spontaneous↗

Microbial and mycotoxic contamination of peppers and food safety.

Twelve random samples of pepper powders were analyzed for contamination by microorganisms of public health significance (bacteria, moulds) and for aflatoxin B1 concentration. Black peppers were more heavily contaminated than white peppers but the most important bacteria causing foodborne diseases were not isolated; The mould flora was dominated by xerophilic species, particularly Aspergillus fumigatus, A. flavus, A. niger and A. ochraceus. These potentially pathogenic species can be dangerous for predisposed patients. The most striking result concerns aflatoxin B1 which was detected in every sample analyzed and could not always be correlated with the occurrence of a mycotoxinogenic strain of Aspergillus, suggesting the use of a sterilizing treatment previously. So, the detection of aflatoxin B1 must be a necessary criterion to be added to microbial criteria to appreciate the quality of peppers.

Aflatoxin B1↗

Improving transfusion safety by electronic identification of patients, blood samples, and blood units.

To evaluate the feasibility of using an electronic identification system to improve safety and documentation of blood transfusions, a hand-held bar code scanner and data terminal, portable label printer, and related software were integrated into all phases of the blood transfusion process, including sample collection, laboratory testing, and administration of blood components. The study was conducted in two hospitals, one in Italy and the other in the United States. Each hospital used different laboratory analysers and information systems. A total of 621 blood components were transfused to 177 patients using 331 blood samples with 100 percent accuracy and electronic documentation of all pertinent patient, staff, sample, testing, and component information. Bar code reading and related electronic technology can be adapted to improve transfusion safety and reduce the risk of human errors at all steps of the blood transfusion process.

Journal Article↗

Safety, efficacy and cost of three cervical cytology sampling devices in a prenatal clinic.

OBJECTIVE: To evaluate and compare the safety, efficacy and cost of three cervical cytology sampling devices in pregnant women presenting for prenatal care to the obstetrics clinic, at Medical College of Pennsylvania Hospital. STUDY DESIGN: From September 7, 1993, to November 5, 1993, 61 cervical cytologic smears were obtained using the Cell-Sweep. From November 8, 1993, to January 7, 1994, 66 smears were obtained using the Ayre spatula/Cytobrush, and from January 10, 1994, to February 18, 1994, 55 smears were obtained using the Ayre spatula/cotton swab. The rate of smears with no endocervical component or with epithelial cell abnormality was determined for each group. The patients' medical records were reviewed retrospectively to determine complications occurring within two weeks of smear collection. RESULTS: Fifteen (25%) smears in the Cell-Sweep group, one (1.5%) in the Cytobrush group and nine (16%) in the cotton swab group were satisfactory but limited by absence of an endocervical component (P < .0006). None of the smears were unsatisfactory. Eleven (18%) smears in the Cell-Sweep group, eight (12%) in the Cytobrush group and nine (16%) in the cotton swab group revealed an epithelial cell abnormality (P = .643). For all three groups there was a low rate of spontaneous abortion, preterm spontaneous rupture of membranes or preterm labor occurring within two weeks of collection. There was no statistically significant difference in these complications between the three groups (P = .7). The Ayre spatula/cotton swab is the least expensive device. CONCLUSION: The Ayre spatula/cotton swab was the most satisfactory of the three methods tested for obtaining cervical cytology during pregnancy. It is safe and cost-effective and identifies the same proportion of epithelial cell abnormalities as the Ayre spatula/Cytobrush and the Cell-Sweep.

Abortion, Spontaneous↗

[I131 in blood samples: management in the laboratory].

OBJECTIVES: Patients treated by (131)I may require blood sampling in the days following its administration. We investigated the safety of such samples in terms of radioactivity and the possible disturbance of the analyses by these "131I-spiked" samples. METHOD: 1) The radioactivity of blood samples from 131I-treated patients was measured (dose rate, surface activity, total activity) ; 2) The risk for the personnel was subsequently evaluated and ; 3) The interference of this 131I-generated radioactivity on the results of routine automated and IRMA assays was investigated. RESULTS: 1) All RA measures but two were found below the European limits ; 2) Irradiation of personnel was negligible ; 3) The faint radioactivity did not disturb any analyses. CONCLUSION: These data demonstrate the safety that results from the negligible radioactivity in these blood samples.

Drug Contamination↗

Clinical safety evaluation of combination vaccines.

The development plan for new combination vaccines should include clinical studies designed to provide an adequate safety database (as well as efficacy data) to support licensure. Ideally, randomized studies to compare the safety of the combination vaccine with the separately administered components (or already licensed combinations of components) should be performed. For new combination vaccines having components with proven efficacy, comparative immunogenicity data may provide a sufficient basis to support efficacy, precluding the need for a large efficacy study. In the absence of the safety database that would have been derived from such an efficacy study, it is important to conduct a comparative safety study with a sample size suitable for the evaluation of less common adverse events. For large safety trials, a simplified design where only a subset of subjects is assessed in detail for the more common adverse events may be appropriate.

Biometry↗

A note on the safety testing of vaccines.

The use of the hypergeometric distribution in calculations of sample volumes for safety testing is criticized. Alternative interpretations of the concept of ;infective ml. doses' lead to slightly different solutions, the simplest of which, involving the exponential function, is recommended for general use.

Humans↗

How readable are child safety seat installation instructions?

OBJECTIVES: To measure the required reading level of a sample of child safety seat (CSS) installation instructions and to compare readability levels among different prices of CSSs to determine whether the lower cost seats to which low-income parents have greater access are written to a lower level of education. METHODS: A CD-ROM containing CSS installation instructions was obtained from the National Highway Traffic Safety Administration. Pricing information was obtained for available models from an Internet-based company that provides comparative shopping information. Paper copies of the instruction sets were generated, and their readability levels were determined using the SMOG test. A second rater was used in addition to the primary investigator to assess interrater reliability of the SMOG as applied to the instruction sets. RESULTS: The readability of instruction sets ranged from the 7th- to 12th-grade levels, with an overall mean SMOG score of 10.34. No significant associations were found to exist between readability and seat prices; this was observed whether the data were treated as continuous or categorical. CONCLUSIONS: CSS instruction manuals are written at a reading level that exceeds the reading skills of most American consumers. These instruction sets should be rewritten at a lower reading level to encourage the proper installation of CSSs.

Adult↗

Negotiated safety relationships and sexual behavior among a diverse sample of HIV-negative men who have sex with men.

OBJECTIVE: To examine the prevalence of negotiated safety (NS) in a diverse sample of HIV-negative men who have sex with men (MSM), characteristics of MSM practicing NS, and adherence to NS. METHODS: This was a cross-sectional survey of San Francisco MSM recruited from venues and community organizations. NS relationships were defined as those in which HIV-negative men were in seroconcordant primary relationships for >/=6 months, had unprotected anal intercourse (UA) together, and had rules prohibiting UA with others. Adherence to NS was determined from self-reported sexual behavior in the prior 3 months. Presence of an agreement with NS partners to disclose rule breaking was also determined. RESULTS: Of 340 HIV-negative participants, 76 (22%) reported a current seroconcordant primary relationship for >/=6 months. Of these 76 men, 38 (50%) had NS relationships, 30 (39%) had no UA with primary partners, and 8 (11%) had UA with primary partners without rules prohibiting UA with others. In multivariate analysis, NS was more common than no UA with primary partners in younger men. Among 38 NS men, 29% violated their NS-defining rule in the prior 3 months, including 18% who reported UA with others, and 18% reported a sexually transmitted infection (STI) in the prior year. Only 61% of NS men adhered fully to rules and agreed to disclose rule breaking. CONCLUSIONS: Although NS was commonly practiced among HIV-negative men in seroconcordant relationships, some men violated NS-defining rules, placing themselves and potentially their primary partners at risk for HIV infection. Prevention efforts regarding NS should emphasize the importance of agreement adherence, disclosure of rule breaking, and routine STI testing.

Adolescent↗

Safety of cordocentesis under ultrasound guidance for fetal blood sampling.

In the present study, we attempted to assess the safety and the risk of cordocentesis under ultrasound guidance for fetal blood sampling. Forty-five cordocenteses in 43 cases were carried out. These forty-three cases included 23 nonimmunologic hydrops fetalis, 12 congenital fetal malformations, 3 chromosome aberrations, 3 Rh isoimmunization, and 2 idiopathic thrombocytopenic purpura. Gestational age when cordocentesis was performed ranged from 17 to 39 weeks of gestation. In 42 (93.3%) out of 45 procedures, pure fetal blood was obtained. Postpuncture bleeding was observed in 17 cases (37.8%). In 12 (70.6%) out of 17 cases, bleeding stopped within 2 minutes. In only one case, bleeding continued for 11 minutes and cesarean section was performed due to fetal distress. Cardiotocogram obtained after cordocentesis revealed no ominous signs in the other 44 procedures. The other complications, including premature rupture of the membranes, premature labor, and intrauterine infection, did not occur during or after this procedure. There were no cases in which any kind of injury to the placenta or umbilical cord was observed.

Blood Specimen Collection↗

A National Australian Food Safety Telephone Survey.

A sample of 1,203 randomly selected Australian households participated in a national telephone food safety survey. All respondents were aged 18 years or over, were the main grocery buyers of the household, purchased red meat products at least once a month, and regularly prepared food in the household. There were significant gaps observed in the food safety knowledge of many respondents surveyed. Forty percent of respondents thawed raw meat at room temperature, 85% allowed cooked foods to cool at room temperature before refrigerating, and almost 70% of respondents were not aware of the correct refrigeration temperature for storage of perishable food. Almost 25% of respondents failed to identify that washing hands before handling food and during food preparation was important in reducing the risk of cross-contamination and possible foodborne illness. Seventy-five percent of the respondents recognized that there was a likelihood of foodborne illness occurring in the home, and 25% of respondents had changed their eating habits because of publicity surrounding food poisoning outbreaks. The findings raise important concerns about domestic food handling practices in Australian homes and the level of food safety knowledge in the community generally.

Adolescent↗

Reliability of bedside ABO testing before transfusion.

BACKGROUND: Previous studies of bedside transfusion compatibility tests have shown high rates of erroneous transfusion decision, due to defective techniques and poor user performance. An experimental study was conducted to evaluate the error rate obtained with a new ready-to-use device (Vu-Test, Medigis), in comparison with the most popular bedside card used in France (Safety-Test ABO, Diagast Laboratories). STUDY DESIGN AND METHODS: A stratified random sample of nurses performed, in the clinical departments where they worked, cross-matches on 12 randomly and blindly selected paired donor-recipient blood samples with Safety-Test ABO and Vu-Test. The nurses detected agglutination, interpreted compatibility, decided whether to transfuse, and gave their opinion of the two devices. Three independent experts reviewed photographs of each test result. RESULTS: Thirty-five trained nurses and 10 student nurses carried out 268 tests with each device. One-hundred ninety tests (70.9%) performed with Safety-Test ABO and 177 tests (66.0%) performed with Vu-Test were entirely error-free (p=0.23). The risk of erroneous detection of agglutination was not different between the devices (p=0.69), but was significantly lower when the nurse had experience in transfusion (p < 0.001). According to the experts, Vu-Test was significantly better than Safety-Test ABO. CONCLUSION: Although the experts considered Vu-Test to be better than Safety-Test ABO, error rates were high with both devices.

ABO Blood-Group System↗