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The assessment of fitness to drive in people with dementia.

OBJECTIVE: To determine whether cognitive tests predict fitness to drive in patients with dementia. DESIGN: Two group comparison of patients with dementia and healthy elderly volunteers, and comparison of patients with dementia who were found safe to drive and those found unsafe, followed by a validation study. PARTICIPANTS: Forty-two people with dementia and 33 healthy elderly volunteers with no known memory problems who were driving. Of the 42 people with dementia 37 were assessed on the road. A second sample of 17 people with dementia was also assessed on the road. MAIN MEASURES: Stroke Drivers Screening Assessment, Mini Mental State Examination, Salford Objective Recognition Test, Stroop Test, Test of Everyday Attention, Visual Object and Space Perception Battery, Behavioural Assessment of the Dysexecutive Syndrome, Adult Memory and Information Processing Battery. RESULTS: All healthy elderly volunteers were safe to drive but 10 of the 27 patients with dementia were unsafe. Discriminant function analysis identified a combination of tests, which correctly classified 92% of drivers with dementia as safe or unsafe. Validation of this prediction on an independent sample had 59% accuracy using a cut-off of 0 but 88% accuracy using a cut-off of 5. CONCLUSIONS: Safety to drive in people with dementia could be predicted from a combination of six cognitive tests. These correctly identified 67% of safe drivers in a validation sample. This assessment could be used to identify those who need evaluation of their safety on the road.

Aged↗

Detection of VX contamination in soil through solid-phase microextraction sampling and gas chromatography/mass spectrometry of the VX degradation product bis(diisopropylaminoethyl)disulfide.

A solid-phase microextraction (SPME) and gas chromatography-mass spectrometry (GC-MS) sampling and analysis method was developed for bis(diisopropylaminoethyl)disulfide (a degradation product of the nerve agent VX) in soil. A 30-min sampling time with a polydimethylsiloxane-coated fiber and high temperature alkaline hydrolysis allowed detection with 1.0 microg of VX spiked per g of agricultural soil. The method was successfully used in the field with portable GC-MS instrumentation. This method is relatively rapid (less than 1 h), avoids the use of complex preparation steps, and enhances analyst safety through limited use of solvents and decontamination of the soil before sampling.

Chemical Warfare Agents↗

Surveying vendors of street-vended food: a new methodology applied in two Guatemalan cities.

Lack of reliable data about street vendors, who are difficult to survey, has hampered efforts to improve the safety of street-vended food. A two-phase method for sampling vendors, surveying first in areas of concentrated vending activity identified by local authorities and second in randomly selected areas, was developed and implemented in two Guatemalan cities where street-vended food had been implicated in cholera transmission. In a 4-day survey in Escuintla, 59 vendors (42 from phase 1, 17 from phase 2) were interviewed. They demonstrated good knowledge of food safety and cholera but unsafe practices, implying that more effective, practical training was needed. In a 6-day survey in Guatemala City, 78 vendors (77 from phase 1, 1 from phase 2) were interviewed. Sixty-eight (87 %) vendors stored water, usually in wide-mouthed vessels prone to contamination; this led to a field test of a new system for safe water storage. Useful information for public health planning and intervention can be gathered rapidly with this new method for surveying street vendors.

Adolescent↗

[Clinical applications of synchrotron radiation X-ray].

Synchrotron Radiation X-ray (SR X-ray) is an extremely strong X-ray source with a photon number more than 10(4) compared with that of the current X-ray tube. X-rays obtained by monochromatizing SR X-ray have been applied to new techniques for medical diagnosis. Several studies are now being conducted at the beam site for medical use at the Accumulation Ring of the High Energy Physics Research Institute, Tsukuba. Applications being studied include (1) energy subtraction coronary angiography. (2) microdetection of metas in samples excised from subjects. (3) monochromatic X-ray computed tomography and so on. Energy subtraction coronary angiography might have a safety advantage over the current selective coronary angiography. Microdetection of mandatory metals and poisonous heavy metals in in vivo samples contributes to the development of pathologic knowledge and clinical treatment of cancer and heavy metal toxications. Monochromatic X-ray CT is expected to detect diseases in the early stage due to increased accuracy in CT values.

Energy-Generating Resources↗

Age differences in safety attitudes and safety performance in Hong Kong construction workers.

PROBLEM: Safety in the construction industry is a major issue in Hong Kong, representing about 46% of all occupational injuries in 1998. This study explored linear and curvilinear relations between age and safety performance (accident rates and occupational injuries), as well as safety attitudes, in construction workers in Hong Kong. METHOD: A Chinese version of the Safety Attitude Questionnaire (SAQ by Donald & Canter) was developed and administered to a sample of Chinese construction workers (N=374, 366 males, 8 females) from 27 construction sites. RESULTS: Accident rates were not related to age. Occupational injuries were related to age in a curvilinear manner, with injuries at first increasing with age, then decreasing. Two safety attitude scales were related to age with older workers exhibiting more positive attitudes to safety. If age and tenure are controlled, some attitude scales are predictors of safety performance. IMPACT ON INDUSTRY: Management/supervisors, team leaders, and workers are all responsible for safety, and any negative bias toward older construction workers is unfounded.

Accident Prevention↗

Development and use of a sampling and analytical method for azodicarbonamide.

Azodicarbonamide is a medium temperature blowing agent used in the production of foamed polymers. Because of worker concern over health effects associated with its use, researchers from the National Institute for Occupational Safety and Health (NIOSH) conducted two health hazard evaluations. This paper describes the health concerns, the sampling and analytical method used, the environments sampled and the results of these surveys. Environmental samples were collected on Teflon filters for total dust and airborne concentration of azodicarbonamide. Analysis was accomplished by high performance liquid chromatography with identification and quantitation by UV detector response ratioing. Use of this method provided the sensitivity and specificity to analyze airborne azodicarbonamide concentrations and allowed evaluation of a workplace environment for a respiratory health hazard.

Air Pollutants, Occupational↗

Laparoscopic reoperation for failed antireflux procedures.

BACKGROUND: Laparoscopic fundoplication has become the criterion standard for the surgical treatment of gastroesophageal reflux disease. Recently, several patients were referred with recurrent symptoms of gastroesophageal reflux disease or severe dysphagia following previous antireflux surgery for possible laparoscopic reoperation. HYPOTHESIS: To determine the safety and efficacy of this procedure. DESIGN: Case series, consecutive sample. SETTING: University-affiliated and community tertiary care hospitals. PATIENTS: Prospective study of 27 consecutive patients undergoing attempted laparoscopic reoperation for symptoms of recurrent gastroesophageal reflux disease or intractable dysphagia following antireflux surgery. Patients were available for follow-up for 1 to 60 months postoperatively. INTERVENTIONS: All patients underwent preoperative workup and attempted laparoscopic reoperation for treatment of symptoms. MAIN OUTCOME MEASURES: Data were collected on preoperative symptoms and evaluation, operative time, blood loss, time to regular diet, length of hospitalization, morbidity, mortality, and long-term results. RESULTS: Twenty-six patients underwent successful laparoscopic operations, with no mortality and minimal morbidity. One patient underwent conversion to open laparotomy and then developed a proximal gastric leak, which was treated conservatively. Twenty-four patients began a liquid diet by postoperative day 1, and most were discharged from the hospital by postoperative day 3. One patient required dilation for postoperative dysphagia. The remaining patients are doing well and none have required treatment with acid-reducing medication. CONCLUSIONS: Although technically challenging, laparoscopic reoperation for recurrent gastroesophageal reflux disease can be performed safely and with excellent results. In the hands of experienced endoscopic surgeons, patients who have undergone unsuccessful antireflux surgery should be offered laparoscopic reoperation.

Adolescent↗

The need for more efficient trial designs.

The development lifecycle of most clinical products eventually includes the requirement of clinical trials. The objective of the clinical trials usually is the demonstration of the safety and efficacy of the product. The standard methods for sample size determination of these trials have the potential to be extremely inefficient. Adaptive techniques, in certain circumstances, have the potential to result in much more efficient designs. This would then result in the reduction of unnecessary additional exposure of study subjects to experimental products, and help minimize the costs and time to arrive at a statistically appropriate answer to the primary study questions.

Clinical Trials as Topic↗

Uptake of antineoplastic agents in pharmacy and hospital personnel. Part I: monitoring of urinary concentrations.

OBJECTIVES: There is a risk of adverse health effects for personnel with occupational exposure to antineoplastic agents. The aim of the present longitudinal study was to identify, quantify, and evaluate potential health hazards of occupationally exposed workers in pharmaceutical and oncological departments with central processing units for drug preparation. METHODS: One hundred operatives in 14 German hospital pharmacies and oncological departments underwent biological monitoring by providing urine samples up to four times over a period of 3 years. RESULTS: All antineoplastic agents that were considered (cyclophosphamide, ifosfamide, doxorubicin, epirubicin and platinum from cisplatin and carboplatin), were found in urine samples in up to 40% of participants. CONCLUSIONS: Despite standard safety precautions, such as the use of vertical laminar air flow safety cabinets, and personal protective clothing, incorporation of drugs was detected. Therefore, an environmental monitoring strategy should be developed in order to detect contamination and attempt to improve hygiene during work.

Adult↗

Thermotolerance of meat spoilage lactic acid bacteria and their inactivation in vacuum-packaged vienna sausages.

Heat resistance of three meat spoilage lactic acid bacteria was determined in vitro. D-values at 57, 60 and 63 degrees C were 52.9, 39.3 and 32.5 s for Lactobacillus sake, 34.9, 31.3 and 20.2 s for Leuconostoc mesenteroides and 22.5, 15.6 and 14.4 s for Lactobacillus curvatus, respectively. The three lactic acid bacteria were heat sensitive, as one log reductions in numbers were achieved at 57 degrees C in less than 60 s. Z-values could not be accurately determined as D-values did not change by a factor of 10 over the temperature range studied. In-package pasteurization processes were calculated using the highest in vitro D-value and applied to vacuum-packaged vienna sausages. Microbiological shelf life (time for lactic acid bacteria count to reach 5 x 10(6) CFU/g) increased from 7 days for non-pasteurized samples to 67, 99 and 119 days for samples of the three pasteurization treatments at 8 degrees C storage. Enterobacteriaceae were detected at levels of log 4.0 CFU/g in non-pasteurized samples, but were reduced to < log 1.0 CFU/g in pasteurized samples. The incidence of listeriae in non-pasteurized samples was low as only one Listeria innocua strain was isolated. No Listeria spp. were isolated from pasteurized samples. Numbers of Clostridium isolates increased from one in non-pasteurized samples to 25 in pasteurized samples. Increasing incidences of clostridia, and the presence of C. perfringens in pasteurized samples indicated that in-package pasteurization could compromise product safety.

Clostridium↗

Iris-supported phakic lenses (rigid vs foldable version) for treating moderately high myopia: randomized paired eye comparison.

PURPOSE: To compare refractive performance of Artisan (Ophtec, Groningen, The Netherlands) or Verisyse phakic intraocular lens and its foldable version, Artiflex (Ophtec), for the correction of moderately high myopia. DESIGN: Randomized pilot study. METHODS: setting: Institutional practice. patient population: Thirty-one patients with myopia that ranged from -6 to -14 diopters (D). interventional procedure: One eye was implanted with an Artisan phakic intraocular lens (PIOL) and the other with an Artiflex PIOLs. main outcome measures: Primary outcome measure was the percentage of eyes with uncorrected visual acuity (UCVA) of >20/40 at one year after the operation. Main secondary outcome measures were the safety index, the change of two lines or more of best spectacle-corrected visual acuity (BSCVA) and the endothelial cell count. RESULTS: No intraoperative complications were noticed. One year after surgery, the percentage of eyes with UCVA of >20/40 was 51.6% (16/31 patients) for Artisan-treated eyes and 77.4% (24/31 patients) for Artiflex-treated eyes (P = .033). One month after surgery, this same percentage was 42.9% (13/31 patients) and 77.4% (24/31 patients), respectively (P = .004). The safety index at one year was 1.13 +/- 0.24 for Artisan-treated eyes and 1.12 +/- 0.21 for Artiflex-treated eyes, which is a difference that was not statistically significant (P = 0.742). At one year after surgery, the changes of two lines or more of BSCVA and the endothelial cell loss were similar for both groups. CONCLUSION: To correct moderately high myopia, the Artiflex lens provides a faster visual recovery and a better UCVA than does the Artisan lens. The safety of the lens should be supported by an enlarged sample size and a longer follow-up period.

Adult↗

Uridine uptake inhibition as a cytotoxicity test for a human hepatoma cell line (HepG2 cells): comparison with the neutral red assay.

This study describes a sensitive microassay for measuring cytotoxicity based on the degree of inhibition of RNA synthesis in HepG2 cells. RNA synthesis is measured by the kinetic uptake of radiolabeled uridine. A large number of compounds were tested in a wide range of concentrations. The concentration required to induce 50% inhibition of HepG2 uridine uptake rates (IC(50)) was determined for each compound and used to rank its potency. These IC(50)s were compared with IC(50)s measured with the neutral red assay. 2-acetylaminofluorene, benzo[a]pyrene and methylnitrosourea were not cytotoxic in the neutral red assay. Uridine uptake was always inhibited at lower concentrations than those required in the neutral red assay, suggesting that the uridine uptake assay is a more sensitive indicator of toxic action than the neutral red inclusion. Uridine uptake assay provides a rapid and quantitative method for assessing toxicity in a human cell line. Application of this method to bottled spring waters are described. Due to its high sensitivity and reproducibility, this method provides a suitable tool for screening a great number of samples and will be a helpful test for evaluating food safety and controlling the recycling process of wrapping materials.

2-Acetylaminofluorene↗

Is there a need for a national or a global apheresis registry?

Indications for apheresis may vary and more than 45 different diagnoses have been reported from various countries. New devices are being developed and, in the beginning their clinical implications and use are limited to detect rare but important side effects. However, to achieve more reliable information on the effects and side effects we need more extensive sampling of data. Collection of such data is considered a safety and quality issue in several countries. However, data is still limited and little is known about therapeutic apheresis practised around the world including the incidence and pattern of adverse events. The establishment of national registries and analyses of data on a global level therefore seems important. Thus the World Apheresis Association (WAA) has initiated a global apheresis registry for therapeutic procedures and collection of e.g., stem cells. The WAA registry is Internet based and the site is at www.iml.umu.se/medicin. A login code to test the registry is needed (AL61TMS). This report deals with the aim of a global registry as well as some comparative data regarding findings of the Canadian, French and Swedish registries.

Blood Component Removal↗

FIx controller: an instrument to automatically adjust inspired oxygen fraction using feedback control from a pulse oximeter.

OBJECTIVE: To develop an instrument to help prevent pulmonary O2 toxicity, a syndrome that manifests itself in adult intensive care patients. METHODS: We designed, built, and tested a device that controls FIO2 exposure using oxygen saturation measured with a pulse oximeter (SpO2) in a negative feedback control system. A target SpO2 is designated by the clinician and the system adjusts the FIO2 from a mechanical ventilator so as to minimize the difference between the measured SpO2 and the target. Important elements of the system include a conservative artifact rejection algorithm, a gainscheduled sampled-data proportional-integral-derivative (PID) controller, and a safety system to prevent inspired mixtures with undesirably low FIO2 due to device failure. RESULTS: The control system was tuned in a series of animal experiments. Acceptable clinical response of the system was obtained using a gain-scheduled controller algorithm whereby the gain of the proportional term of a PID controller was adjusted based on the error signal and measured minute ventilation. Also, the artifact rejection algorithm and safety systems were successfully tested using simulation. CONCLUSIONS: Testing the effectiveness of this instrument will require comparison with manual control of FIO2 in an appropriately designed trial.

Algorithms↗

New perspectives on the role of aldosterone excess in cardiovascular disease.

1. Evidence from recent experimental and clinical studies suggests that excessive circulating levels of aldosterone can bring about adverse cardiovascular sequelae independent of the effects on blood pressure. Examples of these sequelae are the development of myocardial and vascular fibrosis in uninephrectomized, salt-loaded rats infused with mineralocorticoids and, in humans, an association of aldosterone with left ventricular hypertrophy, impaired diastolic and systolic function, salt and water retention causing aggravation of congestion in patients with established congestive cardiac failure (CCF), reduced vascular compliance and an increased risk of arrhythmias (resulting from intracardiac fibrosis, hypokalaemia, hypomagnesaemia, reduced baroreceptor sensitivity and potentiation of catecholamine effects). 2. These sequelae of aldosterone excess may contribute to the pathogenesis and worsen the prognosis of CCF and hypertension. 3. The heart and blood vessels may be capable of extra-adrenal aldosterone biosynthesis, raising the possibility that aldosterone may have paracrine or autocrine (and not just endocrine) effects on cardiovascular tissues. 4. The high prevalence of CCF, which is associated with secondary aldosteronism, and primary aldosteronism (PAL; recently recognized to be a much more common cause of hypertension than was previously thought) argue for an important role for aldosterone excess as a cause of cardiovascular injury. 5. The recognition of non-blood pressure-dependent adverse sequelae of aldosterone excess raises the question as to whether normotensive individuals with PAL, who have been detected as a result of genetic or biochemical screening among families with inherited forms of PAL, are at excess risk of cardiovascular events. 6. Provided that patients are carefully investigated in order to permit the appropriate selection of specific surgical (laparoscopic adrenalectomy for PAL that lateralizes on adrenal venous sampling) or medical (treatment with aldosterone antagonist medications) management and safety considerations for the use of aldosterone antagonists are kept in mind, the appreciation of a widening role for aldosterone in cardiovascular disease should provide a substantially better outlook for many patients with CCF and hypertension.

Aldosterone↗

Arthroscopic meniscus repair with bioabsorbable arrows.

PURPOSE: The clinical results of a single surgeon's experience with Meniscus Arrows (Bionx, Blue Bell, PA) for meniscal repair are reviewed and reported to determine the safety and efficacy of this device. TYPE OF STUDY: Consecutive sample. METHODS: Over a 3-year period, the senior author has used only Meniscus Arrows for all meniscal repairs. All patients who underwent meniscal repair with at least 12 months of follow-up were evaluated for this study. Thirty patients had a meniscal repair, and 29 were available for follow-up. The average age at surgery was 29 years (range, 15 to 45 years) and there were 24 male and 5 female patients; 25 patients had an anterior cruciate ligament (ACL) reconstruction with the meniscal repair, 2 repairs were performed in ACL-deficient knees, and 2 repairs were performed in ACL stable knees. The average follow-up was 24 months (range, 12 to 42 months). RESULTS: The average Lysholm knee scores for ACL reconstruction, ACL-intact, and ACL-deficient knees improved from 47, 6, and 35, respectively, to 91, 96, and 81 postoperatively. Tegner activity scores improved from 2.7, 0, and 1.5, respectively, to 7.4, 6.5, and 4.5 after surgery. There were no surgical complications, no infections, and no neurovascular injuries. Five patients had mild subcutaneous irritation caused by the Arrow tips, but in each case this resolved within 3 to 7 months. There were 2 failures (7%) that required later arthroscopy and partial meniscectomy. One failure was in an ACL-deficient knee, and the other was in an ACL-reconstructed knee. CONCLUSIONS: Although the data presented in this report are based on short-term clinical follow-up, the preliminary results of the Meniscal Arrow repair are encouraging.

Absorbable Implants↗

Collaborative testing of a gas chromatographic charcoal tube method for seven organic solvents.

The National Institute for Occupational Safety and Health has undertaken a program to provide reliable sampling and analytical methods for a number of industrial hygiene uses. Recommendation of methods to the Department of Labor for compliance testing and inclusion of methods in critera for Recommended Standards for Occupational Exposures are two prime areas of utilization. This paper presents the results of our initial efforts in collaborative testing. The method is a charcal tube sampling procedure and a gas chromatographic analytical technique. Samples of seven single component solvents which included benzene, carbon tetrachloride, chloroform, dioxane, ethylene dichloride, trichloroethylene, and xylene along with two solvent mixtures which consisted of a benzene-xylene combination and an ethylene dichloride-trichloroethylene conbination were tested in two phases by 15 participating laboratories. The data analysis indicates the overalll error associated with the method and identifies sources of error within each segment of the method.

Benzene↗

Comparison of a direct-reading device to gravimetric methods for evaluating organic dust aerosols in an enclosed swine production environment.

The production of livestock in enclosed facilities has become an accepted practice, driven by the need for increased efficiency. Exposure to organic dusts, containing various bioactive components, has been identified an important risk factor for the high rate of lung disease found among workers in these environments. Assessment of organic dust exposure requires technical skills and instrumentation not readily available to most agricultural enterprises. Development of a simple, cost-effective method for measuring organic dust levels would be useful in evaluating and controlling exposures in these environments. The objective of this study was to evaluate the usefulness of the direct reading MIE PDM-3 Miniram for estimating organic dust concentrations in enclosed swine production facilities. Responses from the MIE PDM-3 Miniram were compared to gravimetric methods for total and inhalable dust. Total dust determinations were conducted in accordance with the National Institute for Occupational Safety and Health (NIOSH) method 0500. Inhalable particulate mass (IPM) sampling was conducted using SKC brand IOM (Institute of Occupational Medicine) sampling cassettes, which meet the American Conference of Governmental Industrial Hygienists ACGIH criteria for inhalable dust sampling. This study design also allowed for the comparison of traditional total dust method to the IPM method, in collecting organic dusts in an agricultural setting. Fifteen sets of side-by-side samples (Miniram, total dust, and IPM) were collected over a period of six months in a swine confinement building. There were statistically significant differences in the results provided by the three sampling methods. Measurements for inhalable dust exceeded those for total dust in eleven of fifteen samples. The Miniram time-weighted average (TWA) response to the organic dust was always the lower of the three methods. A high degree of correlation was found among all three methods. The Miniram performed well under field conditions of varying temperature and humidity. The Miniram has the potential to predict the inhalable and total dust concentrations, assuming a correction factor for the organic dust being measured is applied.

Aerosols↗