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Ejections of young children in motor vehicle crashes.

PURPOSE: The purpose of this study was to report the incidence of ejection from the vehicle among children involved in motor vehicle crashes, and to describe a novel mode of ejection from child safety seats. METHODS: The U.S. National Automotive Sampling System General Estimates System and the Fatality Analysis Reporting System databases from 1995 through 1999 were analyzed. A prospective two-center study of children involved in severe car crashes in Canada was performed. RESULTS: Only 0.2% of 5.5 million children involved in crashes experienced ejection, but 1924 (29%) of 6570 child fatalities involved ejections. Only 2.2% of children experienced rollover crashes, but these contributed 1832 (28%) of 6570 child passenger fatalities. Among 56 crashes, 5 restrained young children were ejected, 4 in rollover crashes. Ejection of a toddler through the shoulder straps of a forward-facing child safety seat was the mechanism of ejection in three of the five cases. CONCLUSION: Ejection from the vehicle is common (29%) among fatally injured children. Shoulder straps alone (as found in T-shield or overhead shield child seats) may not prevent the ejection of toddlers from child safety seats during rollovers.

Accidents, Traffic↗

Detection of contamination with antineoplastic agents in a hospital pharmacy department.

The contamination with fluorouracil, cyclophosphamide and methotrexate was studied in a hospital pharmacy department where these drugs were prepared. In the preparation room, air samples were taken before and during preparation of the drugs. Methotrexate was detected in one sample which was collected during preparation (0.3 micrograms/m3). Spot samples were taken in the vertical laminar airflow safety hood before and after preparation of the drugs and after cleaning of the hood. Contamination of the laminar airflow hood was: cyclophosphamide: 1-160 ng/cm2; fluorouracil: 10-62 ng/cm2 and methotrexate: 2-633 ng/cm2. Spot samples from the floor in front of and beneath the laminar airflow hood showed contamination with especially fluorouracil (48-236 micrograms/m2). The gloves used during preparation of the drugs were contaminated mainly with fluorouracil (5-980 ng/cm2). Urine samples from two workers involved in the preparation of the drugs were analysed for unmetabolized cyclophosphamide; it was not detected. Although no uptake of cyclophosphamide was established, it is shown that the methods for measurement of cyclophosphamide, fluorouracil and methotrexate in the preparation room are applicable for the control of occupational exposure to these drugs.

Air↗

Barriers to sun safety in a Canadian outpatient population.

BACKGROUND: It has long been recognized that compliance with recommended sun safety practices is suboptimal, yet few investigations have explored the barriers that people face in practicing good sun safety. In this context, barriers can exist at the following three levels: knowledge of sun safety, acquisition of sun safety information, and implementation of specific sun protective measures. OBJECTIVE: The investigation reported herein sought to elucidate barriers to sun safety that individuals face. Ultimately, this study aimed to qualify the possible barriers that lead to a misalignment of current recommendations and sun safety practices. METHODS: The study design was observational, and the instrument used for data collection was a self-administered questionnaire. Thirty-four outpatients of the RK Schachter Dermatology Centre of Sunnybrook and Women's College Health Sciences Centre (SWCHSC), Toronto, Ontario, as well as 27 outpatients of the Sport Care facility of SWCHSC were enrolled in the study. They represent the target population of those who are at greater risk of developing sun-related skin lesions. Data were analyzed using standard parametric and nonparametric techniques. Comparisons were made between the two outpatient groups and between other groups within the sample. RESULTS: In general, level of sun safety knowledge was fairly high, though compliance to sun safety measures was suboptimal in both populations. There were no significant differences regarding level of knowledge between the 2 outpatient groups. Deficiencies in knowledge centered around risk factors for skin cancer. Frequently cited barriers to sun safety include inconvenience (34% of respondents), forgetting to use sun safety measures (49%), a desire to be tanned (33%), and protective clothing being too hot to wear (56%). High compliers were notable for their great likelihood of being counseled by a physician about sun safety ( P < 0.025) and their slightly higher mean knowledge scores. CONCLUSIONS: These data support that knowledge alone does not predict compliance and that sun awareness campaigns should be evaluated based on their ability to affect behavior.

Adult↗

Randomized trials stopped early for benefit: a systematic review.

CONTEXT: Randomized clinical trials (RCTs) that stop earlier than planned because of apparent benefit often receive great attention and affect clinical practice. Their prevalence, the magnitude and plausibility of their treatment effects, and the extent to which they report information about how investigators decided to stop early are, however, unknown. OBJECTIVE: To evaluate the epidemiology and reporting quality of RCTs involving interventions stopped early for benefit. DATA SOURCES: Systematic review up to November 2004 of MEDLINE, EMBASE, Current Contents, and full-text journal content databases to identify RCTs stopped early for benefit. STUDY SELECTION: Randomized clinical trials of any intervention reported as having stopped early because of results favoring the intervention. There were no exclusion criteria. DATA EXTRACTION: Twelve reviewers working independently and in duplicate abstracted data on content area and type of intervention tested, reporting of funding, type of end point driving study termination, treatment effect, length of follow-up, estimated sample size and total sample studied, role of a data and safety monitoring board in stopping the study, number of interim analyses planned and conducted, and existence and type of monitoring methods, statistical boundaries, and adjustment procedures for interim analyses and early stopping. DATA SYNTHESIS: Of 143 RCTs stopped early for benefit, the majority (92) were published in 5 high-impact medical journals. Typically, these were industry-funded drug trials in cardiology, cancer, and human immunodeficiency virus/AIDS. The proportion of all RCTs published in high-impact journals that were stopped early for benefit increased from 0.5% in 1990-1994 to 1.2% in 2000-2004 (P<.001 for trend). On average, RCTs recruited 63% (SD, 25%) of the planned sample and stopped after a median of 13 (interquartile range [IQR], 3-25) months of follow-up, 1 interim analysis, and when a median of 66 (IQR, 23-195) patients had experienced the end point driving study termination (event). The median risk ratio among truncated RCTs was 0.53 (IQR, 0.28-0.66). One hundred thirty-five (94%) of the 143 RCTs did not report at least 1 of the following: the planned sample size (n = 28), the interim analysis after which the trial was stopped (n = 45), whether a stopping rule informed the decision (n = 48), or an adjusted analysis accounting for interim monitoring and truncation (n = 129). Trials with fewer events yielded greater treatment effects (odds ratio, 28; 95% confidence interval, 11-73). CONCLUSIONS: RCTs stopped early for benefit are becoming more common, often fail to adequately report relevant information about the decision to stop early, and show implausibly large treatment effects, particularly when the number of events is small. These findings suggest clinicians should view the results of such trials with skepticism.

Clinical Trials Data Monitoring Committees↗

Backyard swimming pool safety inspections: a comparison of management approaches and compliance levels in three local government areas in NSW.

ISSUE ADDRESSED: Since 1992, swimming pool fencing has been a legislative requirement in New South Wales (NSW), yet compliance with the NSW Swimming Pool Act is mixed. Local councils are responsible for the enforcement of the act. However, their approach to enforcement and the management of backyard swimming pool safety inspections is varied. METHODS: A random sample of backyard swimming pools was inspected in Council A and existing compliance data for pools in two other councils (B and C) were obtained. Pool owners in Council A were surveyed regarding their attitudes to pool fencing and inspections. Semi-structured interviews were conducted with council employees. RESULTS: Pool compliance rates across the three council areas varied. In Councils A and C, 51% and 54% of pools, respectively, were found to be non-compliant at the first inspection. Following re-inspection in Council A of 227 pools, a further 125 pools reached compliance. In Council B, 97% of the inspected pools were compliant. CONCLUSIONS: This study provides evidence of poor backyard swimming pool safety compliance where local government inspection activity is minimal or non-existent.

Building Codes↗

Efficacy and safety of modified Mai-Men-Dong-Tang for treatment of allergic asthma.

The aim of this study was to evaluate the efficacy and safety of a Chinese herbal formula modified Mai-Men-Dong-Tang (mMMDT) for treatment of persistent, mild-to-moderate asthma. A total of 100 asthmatic patients were enrolled and assigned to three treatment groups in this double-blind, randomized, placebo-controlled clinical trial. Over a period of 4 months, patients in groups A and B received 80 and 40 mg/kg/day of mMMDT, while those in group C received a placebo. Efficacy variables included changes in forced expiratory volume in 1 s (FEV1), symptom score, serum total immunoglobulin E (IgE), and dust mite-specific IgE. Safety assessments included complete blood count, and liver and kidney function. Relative to baseline, significantly greater increases in FEV1 were demonstrated for both A and B groups in comparison with the placebo-treated analog (both p <0.05). Further, similar improvements in symptom score were observed for both mMMDT treatment groups. The serum total IgE for group A showed a decreasing tendency after treatment but no statistical difference was noted. Furthermore, no drug-related adverse effects were reported. Blood test, and liver and kidney function were within normal range during the study, with no marked changes demonstrated over time. In conclusion, the Chinese herbal formula mMMDT provided improvements in lung function and relieved asthma symptoms in our sample of patients. Given its efficacy and safety, we consider mMMDT a credible treatment regimen for persistent, mild-to-moderate asthma.

Adolescent↗

How willing are parents to improve pedestrian safety in their community?

STUDY OBJECTIVE: To determine how likely parents would be to contribute to strategies to reduce pedestrian injury risks and how much they valued such interventions. DESIGN: A single referendum willingness to pay survey. Each parent was randomised to respond to one of five requested contributions towards each of the following activities: constructing speed bumps, volunteering as a crossing guard, attending a neighbourhood meeting, or attending a safety workshop. SETTING: Community survey. PARTICIPANTS: A sample of 723 Baltimore parents from four neighbourhoods stratified by income and child pedestrian injury risk. Eligible parents had a child enrolled in one of four elementary schools in Baltimore City in May 2001. MAIN RESULTS: The more parents were asked to contribute, the less likely they were to do so. Parents were more likely to contribute in neighbourhoods with higher ratings of solidarity. The median willingness to pay money for speed bumps was conservatively estimated at $6.43. The median willingness to contribute time was 2.5 hours for attending workshops, 2.8 hours in community discussion groups, and 30 hours as a volunteer crossing guard. CONCLUSIONS: Parents place a high value on physical and social interventions to improve child pedestrian safety.

Accidents, Traffic↗

Evaluation of concurrent personal measurements of acrylonitrile using different sampling techniques.

In a retrospective assessment of employee exposure to acrylonitrile (AN) for an epidemiological study, investigators from the National Cancer Institute (NCI) and the National Institute for Occupational Safety and Health (NIOSH) evaluated the feasibility of using historic acrylonitrile air samples without modification. The evaluation discussed here was to determine whether the air sampling results across plants were comparable. During site visits to each plant conducted between 1984 and 1986, study investigators collected personal air samples for four days on approximately ten jobs per day. During these visits, IHs at seven of the eight plants also collected personal samples to compare their sample values to the study-collected sample values. Each plant's IH collected these concurrent measurements for their own use and independent of the IHs at the other plants. The plant IHs had no common sampling protocol but, rather, used professional judgment in deciding sampling logistics for their concurrent measurement. In addition, each plant IH used a different laboratory to analyze samples (the study industrial hygienists used one laboratory). Three sampling methods were used by plant industrial hygienists to collect concurrent measurements: charcoal tubes, passive monitors, and porous polymer tubes. The study investigators only used charcoal tubes. Two hundred and sixty four (264) pairs of concurrent measurements were collected. To assess the +/- comparability of the data sets, paired-observation tests were used. The two sets of charcoal tubes were found to compare favorably with each other. The study's charcoal tubes were 1.2 times higher than results from plant passive monitors. No correlation was found between the study's charcoal tube results and plant porous polymer tube results, although the means for 34 pairs of samples were equivalent. As a result of this evaluation, the investigators decided that no adjustments would be made to the plant measurements. This type of evaluation should be considered when using measurement data in multisite epidemiological studies.

Acrylonitrile↗

Methods for the transcervical collection of fetal cells during the first trimester of pregnancy.

Before termination of pregnancy, four techniques for retrieving fetal cells transcervically were investigated: uterine lavage, endocervical lavage, cytobrush and mucus aspiration. The yield of fetal cells in these samples was studied and found to be somewhat better after uterine lavage. A preliminary assessment of the safety of mucus aspiration was carried out before transcervical chorionic villus sampling (CVS) in continuing pregnancies. No difference in outcome to a control group having only CVS was found.

Biopsy↗

Patient safety features of clinical computer systems: questionnaire survey of GP views.

AIM: To investigate general practitioners' (GPs') stated knowledge, use and training needs related to the patient safety features of computerised clinical systems in England. DESIGN: Questionnaire survey. SUBJECTS AND SETTING: GPs from six English primary care trusts. OUTCOME MEASURES: GPs' views on the importance of specified patient safety features on their computer system; their knowledge of the presence of specified safety features; previous training and perceived future training needs. RESULTS: Three hundred and eighty one GPs (64.0%) completed and returned the questionnaire. Although patient safety features were considered to be an important part of their computer system by the vast majority of GPs, many were unsure as to whether the system they were currently using possessed some of the specified features. Some respondents erroneously believed that their computers would warn them about potential contraindications or if an abnormal dose frequency had been prescribed. Only a minority had received formal training on the use of their system's patient safety features. CONCLUSIONS: Patient safety was an issue high on the agenda of this GP sample. The importance of raising GPs' awareness of both the potential use and deficiencies of the patient safety features on their systems and ensuring that appropriate training is available should not be underestimated.

Adult↗

Effect of processed and non-processed coffee samples on gastric potential difference. Study with healthy male Helicobacter pylori-positive and Helicobacter pylori-negative volunteers.

In an open trial with 18 healthy male volunteers (21-45 years old) the effect of processed (test) and non-processed (reference) coffee samples of same origin on the gastric potential difference (GPD) was studied. Test coffee samples were processed with the patented "Darboven improvement procedure" before roasting. All treatment groups were subdivided according to the Helicobacter pylori status of the volunteers. The evaluation of the target parameters Reizindex (RI), area under the baseline (AUB), maximum potential difference (Pdmax) and total time (ttot) revealed a significant lower RI (p = 0.0282) and AUB (p = 0.0136), and a significant shorter ttot (p = 0.0286) for the processed coffee. Total cholesterol, high-density lipoprotein (HDL) cholesterol, and pancreatic peptides showed a comparable marked increase of the arithmetic mean with both coffee samples, however, being more intense in the Helicobacter pylori-positive subgroup than in the Helicobacter pylori-negative subgroup. No negative findings concerning tolerability and safety could be seen. In conclusion, the test coffee samples processed with a new method to improve the stomach mucosal irritation-potential of coffee charges revealed a remarkably lower stomach mucosal irritation.

Adult↗

Initial experience with EUS-guided trucut needle biopsies of perigastric organs.

BACKGROUND: The aims of this study were to determine the feasibility, safety, and yield of a 19-gauge EUS-guided-trucut needle for obtaining biopsy specimens of perigastric organs. METHODS: The study was performed in swine under general anesthesia. EUS-guided trucut needle biopsy specimens were obtained from the spleen, liver, pancreas body, and left kidney. Biopsy specimens were assessed for size, fragmentation, and representation of the target organ. OBSERVATIONS: Twenty-eight biopsy specimens were obtained from the 4 target organs with two needles. Median biopsy length was 6 mm (spleen), 4 mm (liver), 6 mm (left kidney), and 2 mm (pancreas body). Of all the specimens, 75% to 100% had tissue representative of the target organ. EUS visualization of the needle was excellent and no complications were identified. CONCLUSIONS: Use of the trucut needle under EUS guidance to obtain biopsy specimens of perigastric organs appears safe and yields specimens that are representative of the target organ sampled. Further study of the utility and safety of this needle in humans is warranted.

Animals↗

Perception of risk by home health care administrators and field workers.

The home health care industry has grown significantly over the past 15 years, primarily as the result of an increasing percentage of elderly needing services. Although personal risk has always been a contextual factor of home visiting, an additional challenge facing home health care administrators today is ensuring field worker safety, because visits are now made 24 hr a day, 7 days a week. The purpose of this study was to compare home health care administrators' with field workers' perceptions of risk involved in making home visits. The Home Health Care Perception of Risk Questionnaire (HHCPRQ), a self-report measure, was administered to a national random sample of 93 home health care administrators and 705 field workers to determine perception of risk within the context of making home visits. Findings indicate significant differences between home health care administrators' and field workers' perceptions of risk in making home visits. Suggestions for enhancing communication among all agency personnel and developing in-service education programs that are specifically for field workers are identified.

Administrative Personnel↗

The Swiss cheese model of safety incidents: are there holes in the metaphor?

BACKGROUND: Reason's Swiss cheese model has become the dominant paradigm for analysing medical errors and patient safety incidents. The aim of this study was to determine if the components of the model are understood in the same way by quality and safety professionals. METHODS: Survey of a volunteer sample of persons who claimed familiarity with the model, recruited at a conference on quality in health care, and on the internet through quality-related websites. The questionnaire proposed several interpretations of components of the Swiss cheese model: a) slice of cheese, b) hole, c) arrow, d) active error, e) how to make the system safer. Eleven interpretations were compatible with this author's interpretation of the model, 12 were not. RESULTS: Eighty five respondents stated that they were very or quite familiar with the model. They gave on average 15.3 (SD 2.3, range 10 to 21) "correct" answers out of 23 (66.5%)--significantly more than 11.5 "correct" answers that would expected by chance (p < 0.001). Respondents gave on average 2.4 "correct" answers regarding the slice of cheese (out of 4), 2.7 "correct" answers about holes (out of 5), 2.8 "correct" answers about the arrow (out of 4), 3.3 "correct" answers about the active error (out of 5), and 4.1 "correct" answers about improving safety (out of 5). CONCLUSION: The interpretations of specific features of the Swiss cheese model varied considerably among quality and safety professionals. Reaching consensus about concepts of patient safety requires further work.

Adult↗

Anti-HBc & HBV-DNA detection in blood donors negative for hepatitis B virus surface antigen in reducing risk of transfusion associated HBV infection.

BACKGROUND & OBJECTIVE: Though sensitive screening assays for detection of hepatitis B virus surface antigen (HBsAg) are available, occasional cases of post-transfusion hepatitis B virus infection (PTH) still occur. The present study was undertaken to assess the prevalence of anti-hepatitis B core (anti-HBc) positivity and presence of HBV-DNA in serum sample of healthy blood donors negative for both HBsAg and anti-HCV antibody in Shiraz, Iran. Since anti-HBc detection is not mandatory in Iran, we evaluated whether anti-HBc detection could be adopted as a screening assay for safety of donated blood. METHODS: Two thousands serum samples negative for both HBsAg and anti-HCV collected from healthy blood donors were tested for the presence of anti HBc antibody. All samples positive for anti-HBc antibody were then investigated for determination of anti-HBc titre, anti-HBs titre, HbeAg and anti-HBe antibody by enzyme immunoassay (EIA). Every sample that tested negative for HBsAg but positive for anti-HBc alone or in combination with other serological markers was also examined for the presence of HBV-DNA by polymerase chain reaction (PCR). RESULTS: Of the 2000 samples tested, 131 (6.55%) blood samples were found to be positive for anti- HBc. HBV DNA was detected among 16 of 131(12.2%) anti-HBc positive specimens. Further, there was an association between the titration of anti-HBc antibody and the intensity of expected PCR product band. The liver function test results were all in normal range except in 4 of 16 HBV-DNA positive subjects. The mean levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in HBV-PCR positive subjects were 14 IU/l and 23.7 IU/l respectively. INTERPRETATION & CONCLUSION: Anti-HBc antibody should be tested routinely on blood donors volunteers and if the sample found positive regardless of anti-HBs titre, the blood should be discarded. Further testing for HBV-DNA would be appropriate to follow up the donor for HBV infection.

Adolescent↗

An assessment of heavy metals and boron contamination in workplace atmospheres from ceramic factories.

The occupational exposure in workplace atmospheres of ceramic factories to some metals (Ba, Cd, Co, Cr, Cu, Ni, Zn) and boron has been studied. During 1994 samples were collected at several ceramic factories from the Comunitat Valenciana (Spain) in a random fashion to avoid correlation problems regarding data analysis; factories were sampled to provide a representative cross-section. Powdered samples were treated with concentrated nitric acid according to the National Institute for Occupational Safety and Health (NIOSH) digestion procedure for the analysis of metals in air samples. Heavy metals were analyzed by AAS and boron by UV/Visible spectrophotometry using the Azomethine-H method. Concentrations found for Cd, Cr, Cu, Ni and Zn were considered very low in the environment of this industrial sector. However, Co, Ba and B were detected in several samples with concentrations above the threshold limit value (TLV), referred to airborne concentrations of substances in workplace atmospheres. Principal component analysis (PCA) has also been carried out in order to classify the workplaces studied and their potential hazard to the workers.

Air Pollutants, Occupational↗

Attitudes and concerns amongst laboratory staff regarding handling of HIV positive biological specimens.

AIMS: to ascertain attitudes and concerns of laboratory staff towards handling of HIV positive biological samples. METHOD: an anonymous questionnaire regarding various aspects of biological sample handling was distributed to laboratory staff from the Wellington Area Health Board laboratories. RESULTS: of a total of 133 laboratory staff (response rate: 56.4%), five were seriously considering leaving, and another ten would have chosen another career if given prior information in regard to handling HIV positive biological samples. Of the responders, 22.8% and 38.3% considered that their employer does not provide adequate safety measures and education respectively in regard to HIV. CONCLUSIONS: handling of HIV positive biological samples does not greatly contribute to attrition amongst laboratory staff. Given the concern of laboratory staff for safety and education in regard to HIV, a continuous in-service educational programme would be desirable.

Attitude of Health Personnel↗

Product equivalence study comparing the tolerability, pharmacokinetics, and pharmacodynamics of various human immunoglobulin-G formulations.

In this randomized, double-blind, parallel-group study, a commercially available human immunoglobulin-G product, IVIG, was compared with two test formulations: (1) IVIG-N, which is a nanofiltered formulation of IVIG, and (2) IVIG-L, which is a nanofiltered, liquid, ready-for-use IgG formulation containing nicotinamide, L-proline, and L-isoleucine as stabilizers. Three groups of 10 healthy subjects each received a single 0.6 g/kg dose of one of the formulations infused over 3.5 to 6.8 hours, depending on the total volume to be infused. Blood samples were obtained over a 6-week period to assess pharmacokinetics, immunogenicity, and the pharmacodynamic effects on leukocytes and TNF-alpha. A blood sample was taken at 6 months for a viral safety check. Administrations were generally well tolerated with only one reference IVIG infusion stopped prematurely due to headache. The IgG Cmax and AUC over the 6-week blood sampling period from both test formulations satisfied equivalence criteria compared with the reference formulation. In subjects receiving IVIG-L, peak concentrations of the stabilizer nicotinamide ranged from 0.34 to 0.47 mmol/L and of nicotinamide-N-oxide from 0.03 to 0.04 mmol/L, which are below those reported to cause adverse events. During the infusion of IVIG, leukocyte counts initially declined from a baseline of 5.7 +/- 1.1 x 10(9)/L to 3.7 +/- 0.8 x 10(9)/L at 2 to 4 hours and returned to baseline by 24 hours. TNF-alpha levels, reflecting activation of the monocyte-macrophage system by the infused IVIG, rose from a baseline of 13 +/- 4 pg/mL to a peak of 272 +/- 324 pg/mL at 2 to 4 hours and returned to baseline by 24 hours. These patterns were generally similar for the test formulations, with the exception that the increase in TNF-alpha levels was dampened for IVIG-N, although this was not statistically significant. There was no evidence of immunogenicity or viral transmission from any of the formulations. Hence, these three formulations were generally well tolerated, yielded similar systemic exposure to IgG over a 6-week period after administration, and did not give rise to immunogenicity or viral safety concerns.

Adolescent↗