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PubMed1996

Safety and efficacy of hepatitis C virus antibody screening of blood donors with two sequential screening assays.

BACKGROUND: Reactive samples in hepatitis C virus (HCV) antibody screening of blood donors are currently referred for a confirmatory assay. This scheme is not optimally efficient and is expensive because of the lack of specificity and cost of confirmatory tests, as well as the need to discard false-positive donations. As in some human immunodeficiency virus antibody-confirmatory schemes, the safety and efficacy of confirming anti-HCV with two sequential screening assays were evaluated. STUDY DESIGN AND METHODS: Three combinations of two anti-HCV screening assays were used to test 75,874 blood donors. Results were compared with the routine testing scheme and HCV RNA detection in any enzyme immunoassay-repeatably reactive samples. RESULTS: The use of an alternative screening assay for repeat testing decreased the proportion of enzyme immunoassay-positive donors from 0.28 to 0.05 percent. All samples that were "confirmed" as positive by the standard combination of immunoassays and all HCV RNA-positive samples were detected by the sequential screening assays. No samples that had discordant results on primary and secondary screening assays were confirmed by recombinant immunoblot assay or were found to contain detectable HCV RNA. CONCLUSION: The combination of screening assays for anti-HCV confirmation was as safe as, cheaper than, and nearly as efficient as the standard testing scheme.

Blood Donors↗
PubMed2006

Measuring trust in medical researchers.

BACKGROUND: Concern is widespread that the public's and participants' trust in medical research is threatened, but few empirical measures of research trust exist. This project aims to enable more rigorous study of researcher trust by developing and testing appropriate survey measures. METHODS: Survey items were developed based on a conceptual model of the primary domains of researcher trust (safety, fidelity, honesty, global trust). Pilot testing was conducted on a regional convenience sample of adults (n = 124). Exploratory factor analyses of the data were performed, and an item selection procedure reduced the number of survey questions. A final set of 12 items was validated, and a 4-item short version of the researcher trust scale was selected and tested in a national web-based survey of asthma and diabetes patients (n = 3623). Further factor analysis and validation were performed on this larger sample. RESULTS: Both the full and short scales have a single-factor structure with acceptable internal reliability (alphas of 0.87 [12 items] and 0.72 [4 items]). Trust in physician researchers and trust in medical researchers generally were found not to be separate constructs. In the national sample, the short scale was positively associated with better health status, prior participation in medical research, and willingness to participate in a hypothetical medical research study, and negatively associated with African-American race and higher education. CONCLUSIONS: Trust in medical researchers is a measurable single-factor construct including trust in safety, researcher fidelity, and honesty. This new scale provides an empirical tool for informing the ethics and public policy of medical research.

Adult↗
PubMed2005

Advising patients about patient safety: current initiatives risk shifting responsibility.

BACKGROUND: Many health care providers now disseminate advisories telling patients what they can do to avoid errors and harms in their care. METHODS: The content of five leading safety advisories for patients was analyzed and a critique of their development, content, and impact was developed, drawing on published literature and 40 interviews with a diverse sample of 50 key informants. FINDINGS: Very little is known about the effects of the distribution of safety advisories to patients, but several grounds for concern were identified. There was a lack of attention to patients' perspectives during the development of advisory messages, and the advisories say little about what health care providers should do to ensure patient safety. Patients are given little practical support to carry out the recommended actions, and health professionals' responses may render their attempts to act to secure their own safety ineffective. Some messages suggest an inappropriate shifting of responsibility onto patients. Advice that involves checking on or challenging health professionals' actions appears to be particularly problematic for patients. Such behaviors conflict with the expectations many people have--and think health professionals have--of patients' roles. DISCUSSION: A serious commitment to optimizing patients' contributions to safe care requires a research-based understanding of patients' perspectives and more practical facilitation of patient involvement.

Counseling↗
PubMed2003

Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone.

BACKGROUND: Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone has been proposed, but its efficacy and safety have not been well studied. METHODS: We conducted a multicenter, randomized, placebo-controlled trial involving 326 opiate-addicted persons who were assigned to office-based treatment with sublingual tablets consisting of buprenorphine (16 mg) in combination with naloxone (4 mg), buprenorphine alone (16 mg), or placebo given daily for four weeks. The primary outcome measures were the percentage of urine samples negative for opiates and the subjects' self-reported craving for opiates. Safety data were obtained on 461 opiate-addicted persons who participated in an open-label study of buprenorphine and naloxone (at daily doses of up to 24 mg and 6 mg, respectively) and another 11 persons who received this combination only during the trial. RESULTS: The double-blind trial was terminated early because buprenorphine and naloxone in combination and buprenorphine alone were found to have greater efficacy than placebo. The proportion of urine samples that were negative for opiates was greater in the combined-treatment and buprenorphine groups (17.8 percent and 20.7 percent, respectively) than in the placebo group (5.8 percent, P<0.001 for both comparisons); the active-treatment groups also reported less opiate craving (P<0.001 for both comparisons with placebo). Rates of adverse events were similar in the active-treatment and placebo groups. During the open-label phase, the percentage of urine samples negative for opiates ranged from 35.2 percent to 67.4 percent. Results from the open-label follow-up study indicated that the combined treatment was safe and well tolerated. CONCLUSIONS: Buprenorphine and naloxone in combination and buprenorphine alone are safe and reduce the use of opiates and the craving for opiates among opiate-addicted persons who receive these medications in an office-based setting.

Administration, Sublingual↗
PubMed1999

Microbiological survey of tofu sold in a rural Illinois county.

The purpose of this study was to determine the microbial status of tofu sold in a rural Illinois county and assess the factors contributing to the safety of tofu. Six brands of tofu from eight different stores (60 total samples) were purchased and analyzed for temperature, pH, total aerobic bacteria, and the presence of coliforms. Relationships between age, temperature, pH of tofu, and total aerobic bacteria were tested. An analysis of variance was also performed to test for differences in total bacterial counts among the brands. Mean aerobic bacterial counts ranged from 0 to 7.76 x 10(7) CFU/g. Fifty-five percent of the tofu tested fell within the excellent range for freshness as delineated by the standards developed by the Soyfoods Association of North America, 6.7% fell within the acceptable range, 6.7% within the marginal range, and 28% within the unacceptable range. Sixteen percent of the samples contained coliform bacteria. No significant correlation was found between variables, except pH with total aerobic bacterial counts (r = -0.51) and pH with eosin-methylene blue agar counts (r = -0.67). Most of the tofu was displayed at unsafe temperatures (>5 degrees C) for potentially hazardous foods. This study confirmed the concerns regarding safety of tofu sold in the grocery stores. Based on these results, special training on tofu storage and handling is recommended for grocery stores selling this food product.

Enterobacteriaceae↗
PubMed2004

The sumatriptan/naratriptan aggregated patient (SNAP) database: aggregation, validation and application.

Pooled data from multiple clinical trials can provide information for medical decision-making that typically cannot be derived from a single clinical trial. By increasing the sample size beyond that achievable in a single clinical trial, pooling individual-patient data from multiple trials provides additional statistical power to detect possible effects of study medication, confers the ability to detect rare outcomes, and facilitates evaluation of effects among subsets of patients. Data from pharmaceutical company-sponsored clinical trials lend themselves to data-pooling, meta-analysis, and data mining initiatives. Pharmaceutical company-sponsored clinical trials are arguably among the most rigorously designed and conducted of studies involving human subjects as a result of multidisciplinary collaboration involving clinical, academic and/or governmental investigators as well as the input and review of medical institutional bodies and regulatory authorities. This paper describes the aggregation, validation and initial analysis of data from the sumatriptan/naratriptan aggregate patient (SNAP) database, which to date comprises pooled individual-patient data from 128 clinical trials conducted from 1987 to 1998 with the migraine medications sumatriptan and naratriptan. With an extremely large sample size (>28000 migraineurs, >140000 treated migraine attacks), the SNAP database allows exploration of questions about migraine and the efficacy and safety of migraine medications that cannot be answered in single clinical trials enrolling smaller numbers of patients. Besides providing the adequate sample size to address specific questions, the SNAP database allows for subgroup analyses that are not possible in individual trial analyses due to small sample size. The SNAP database exemplifies how the wealth of data from pharmaceutical company-sponsored clinical trials can be re-used to continue to provide benefit.

Clinical Trials as Topic↗
PubMed2002

Assessment of safety of frozen foods.

This study aimed to assess the microbiological quality of 90 frozen food samples (50 samples of raw frozen vegetables including molokeya, okra, green peas, peas + carrot, and artichoke, 20 of frozen poultry products and 20 of frozen meat products), and to assess the level of women practice during handling. A cross-sectional study was conducted. Results showed that the mean aerobic mesophilic plate count of frozen vegetables was 3.4 x 10(5) +/- 7.3 x 10(5) cfu/g. The mean mold and yeast count was 3.9 x 10(3) +/- 1.1 x 10(4) cfu/g. The mean coliform count was 3.9 x 10 +/- 6.6 x 10 m.o./g. In case of meat product, the mean aerobic count was 2.3 x 10(5) +/- 3.2 x 10(5), that of mold and yeast was 2.5 x 10(5) +/- 8.8 x 10(5) cfu/g and that of coliform was 3.2 x 10(2) +/- 3.8 x 10(2) m.o./g. Poultry products on the other hand had a mean aerobic count of 6.8 x 10(5) +/- 1.6 x 10(6), a mean mold and yeast count of 3.5 x 10(5) +/- 7.4 x 10(5) cfu/g and a mean coliform count of 6.4 x 10(2) +/- 5.2 x 10(2) m.o./g. Fecal coliforms were detected only in 60.0% of meat product samples and in 45.0% of poultry product samples. On the other hand Staph aureus was detected only in 10.0% of poultry product samples. Difference between the 5 types of vegetables was statistically significant (P = 0.00, and 0.02, respectively) for total plate and mold and yeasts counts. Among the 113 interviewed women, 80 used frozen food products. Twenty six of them (32.5%) had scores < 50%, those were classified as being bad as they were handling frozen food improperly which would contribute to outbreaks of food borne diseases. Less than 4% of the users used satisfactory practice during handling frozen foods. Illiteracy affected significantly the level of practice.

Animals↗
PubMed2006

The utility of a workplace injury instrument in prediction of workplace injury.

Workplace injuries are common and destructive to persons, organisations, and society. Various instruments presently exist that are designed to assess the factors underlying workplace injury. The study reports on the construct and predictive validity of a 46-item instrument, the safety perception survey (SPS), currently used to assess safety climate in industrial organisations throughout Australia. Initially, factor analysis was conducted on the data from a sample of 1238 employees from nine organisations, which indicated a one-factor solution, was the best fit. A structural equation model (SEM) linking injury rates to the safety climate measure for 16 sub-groups of six industrial organisations indicated that the measure contributed just 23% of the variance in injury rates. Interestingly, the results indicated that the number of employees was a better and more significant predictor of injury (R(2)=0.48). It is proposed that the SPS as is would need to be modified significantly from its current form to produce improvements in validity, as in its current form the survey is no more predictive of injury than organisational size. Future research into safety climate measures should incorporate predictive validity analysis on injury rates, as for many organisations; this is a performance outcome measure.

Accidents, Occupational↗
PubMed2003

Unintentional and undetermined firearm related deaths: a preventable death analysis for three safety devices.

OBJECTIVE: To determine the proportion of unintentional and undetermined firearm related deaths preventable by three safety devices: personalization devices, loaded chamber indicators (LCIs), and magazine safeties. A personalized gun will operate only for an authorized user, a LCI indicates when the gun contains ammunition, and a magazine safety prevents the gun from firing when the ammunition magazine is removed. DESIGN: Information about all unintentional and undetermined firearm deaths from 1991-98 was obtained from the Office of the Chief Medical Examiner for Maryland, and from the Wisconsin Firearm Injury Reporting System for Milwaukee. Data regarding the victim, shooter, weapon, and circumstances were abstracted. Coding rules to classify each death as preventable, possibly preventable, or not preventable by each of the three safety devices were also applied. RESULTS: There were a total of 117 firearm related deaths in our sample, 95 (81%) involving handguns. Forty three deaths (37%) were classified as preventable by a personalized gun, 23 (20%) by a LCI, and five (4%) by a magazine safety. Overall, 52 deaths (44%) were preventable by at least one safety device. Deaths involving children 0-17 (relative risk (RR) 3.3, 95% confidence interval (CI) 2.1 to 5.1) and handguns (RR 8.1, 95% CI 1.2 to 53.5) were more likely to be preventable. Projecting the findings to the entire United States, an estimated 442 deaths might have been prevented in 2000 had all guns been equipped with these safety devices. CONCLUSION: Incorporating safety devices into firearms is an important injury intervention, with the potential to save hundreds of lives each year.

Adolescent↗
PubMedDate not supplied

Metalworking fluid exposures in small machine shops: an overview.

Sampling was conducted in 79 small machine shops to assess airborne exposures to metalworking fluids (MWFs). Measured exposures were compared with data from the literature and exposure criteria currently recommended by the National Institute for Occupational Safety and Health and the Occupational Safety and Health Administration MWF Standards Advisory Committee. Sixty-two percent of 942 personal samples collected were less than the recommended exposure limit (REL) of 0.50 mg/m3 for total particulate. However, at least 1 sample exceeded the REL in 61 of the 79 facilities studied; 100% of the samples collected in 10 shops were greater than the REL. Similar trends were found for thoracic particulate exposures where 75% of 238 samples were below the thoracic particulate REL of 0.40 mg/m3. The ratio between thoracic and total particulate for 238 paired samples was 0.55 (r2=0.73). Workers exposed to straight fluids had the highest exposures (GM=0.67 mg/m3) when compared with workers exposed to other classes of MWFs. The highest exposures were measured for grinding and hobbing (GM=0.67 and 0.60 mg/m3, respectively). Measurements using personal impactors indicated that particle size distributions of MWF aerosols had an average mass median aerodynamic diameter of 5.3 microm. Straight oils and soluble fluids tended to be associated with larger particles than were other fluid types; grinding and turning produced the largest particles, whereas hobbing resulted in the smallest. In general, exposures were similar in magnitude and particle size to those previously reported in large automotive plants. Therefore, workers in these small shops may have risks of adverse health effects similar to those demonstrated in the automotive industry.

Aerosols↗
PubMed1993

Acute traumatic injuries in underground bituminous coal miners.

Using injury information from the 1986 Mine Safety and Health Administration database, and demographic information from a 1986 sample survey of the miner population, acute traumatic injury rates for male workers in underground bituminous coal mines were computed by age, current job experience, and total mine work experience. Three groups of workers assessed in this study showed the highest injury rates: workers aged 15-30 years; workers with between 2 and 3 years of experience; and workers with 10 or more years of experience in the current job. Injury rates decline with age in each time-interval of current job category and each total mine working experience category. Experience per se does not appear to be related to lower injury rates independent of age, which is paradoxical. The interaction of worker age with length of current or total mining experience is complex. The potential for catastrophic multiple fatalities and severe injuries suggests that additional work is needed to study, simultaneously, factors such as training and job task, and those that describe specific work exposures and mining hazards.

Accidents, Occupational↗
PubMed2004

A field method for near real-time analysis of perchloroethylene in end-exhaled breath.

The field method for near real-time analysis of perchloroethylene (Perc) in breath is simple, fast, and reproducible for Perc breath analysis in field settings and should prove useful in industrial hygiene practice. The method allows Perc monitoring with good specificity to the sub-part per million (ppm) level within minutes of exposure. A commercially available, portable gas chromatograph with a photoionization detector was used in these analyses. Gas chromatograph settings were optimized in the laboratory for measurement of Perc in Tedlar bags. Laboratory development of the method included evaluation of the sensitivity, specificity, precision, and speed of analysis for Perc. Replicate aliquots of Perc at concentrations ranging from 0.01 to 100 ppm were used to construct a calibration curve. The mean retention time for Perc was 238 sec. The impact of potential interference by acetone, toluene, isoprene, methanol, ethanol, acetaldehyde, carbon tetrachloride, benzene, or chloroform was evaluated by mixing Perc with each compound and performing analyses. Measurements of Perc in human breath samples collected in Tedlar bags in a workplace setting were made and compared to measurements of the same samples made by an established analytical method using charcoal tubes (National Institute of Occupational Safety and Health [NIOSH] Method 1003). The accuracy, precision, and speed of the gas chromatograph method were determined. Measurements made with the new method were within a margin of +/- 8.8% (95% CI, n = 6) of measurements made according to NIOSH Method 1003 for field samples in the range of 0.9 to 6 ppm. Method precision was determined by calculating the pooled coefficient of variation for all measurements (replicates = 3) made in the field and was found to be 5.8%.

Automation↗
PubMed2005

Reassessment of defibrase in treatment of acute cerebral infarction: a multicenter, randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of defibrase in patients with acute cerebral infarction by a large sample, multicenter, randomized, double-blind, placebo-controlled clinical trial. METHODS: Patients with acute cerebral infarction within 12 hours of stroke onset were randomly assigned to receive either an initial intravenous infusion of defibrase 15 U plus normal saline 250 mL or 250 mL of normal saline only. Subsequent infusions of defibrase 5 U or placebo (normal saline) were given on the 3rd, 5th, 7th, and 9th day, respectively. Both groups received standard care of acute cerebral infarction. The primary efficacy outcome was functional status (Barthel Index) at 3 months after treatment. Safety outcome were bleeding events and mortality rate. Secondary outcome included Chinese Stroke Scale (CSS) score at 14 days and recurrence rate of stroke at 1 year. RESULTS: A total of 1053 patients were enrolled at 46 centers from September 2001 to July 2003, and 527 patients were randomly assigned to receive defibrase and 526 to receive placebo. A similar proportion of patients in both groups completed a full course of treatment. There was a significantly greater proportion of favorable functional status (Barthel Index > or = 95) in defibrase group than in placebo group at 3 months (52.2% vs. 42.8%, P < 0.01), and the proportion of dependent functional status (Barthel Index < or = 60) was a little lower in defibrase group compared with placebo group (27.7% vs. 32.4%). These differences were more obvious among patients who were treated within 6 hours of stroke onset. Patients in defibrase group had better improvement with respect to CSS score than those in placebo group at 14 days (P < 0.05). Recurrence rate of stroke at 1 year was lower in the defibrase group compared with placebo group (6.2% vs. 10.1%, P = 0.053). Patients in defibrase group had higher risk of extracranial bleeding events (4.7% vs. 1.5%, P < 0.01) and a tendency of higher risk of symptomatic intracranial hemorrhage. The hemorrhage incidence was higher in patients with fibrinogen level < 130 mg/dL than > or = 130 mg/dL (10.6% vs. 3.8%, P < 0.05). Mortality rate at 3 months were slightly higher in defibrase group than placebo group (5.9% vs. 4.2%). CONCLUSIONS: The defibrase is effective to improve neurological function and function of daily living for patients with acute cerebral infarction within 12 hours of symptom onset. The efficacy was even better for acute cerebral infarction within 6 hours of onset. The increased risks of intra- and extracranial hemorrhage during defibrase administration were related to the plasma fibrinogen level.

Adult↗
PubMed1986

Safety indices associated with the use of contingent restraint procedures.

The safety of four general classes of contingent restraint was evaluated in a sample of 231 institutionalized mentally retarded persons. The use of mechanical restraints resulted in a significantly lower injury rate than did personal restraint. The use of restraint in emergency situations was found to be more dangerous than the planned use of such procedures.

Accident Prevention↗
PubMed2000

[Home accidents among small children and preventive potential].

BACKGROUND: The incidence of childhood home injuries is currently high. A portion of these injuries could be prevented by simple safety precautions. MATERIAL AND METHOD: This study is based on data from the Norwegian National Injury Sample Register. We used this register to estimate the frequency of selected product-related injuries among Norwegian children aged two to three. We also used data from another study of home safety precautions taken by mothers of two-year olds. RESULTS: The most frequently reported injuries were falls from staircases and falls in bathrooms. The most severe were injuries related to stairs, medical drugs, and hazardous substances. The survey showed that a significant portion of parents do not take precautions to reduce the risk of injuries related to staircases, bathroom floor, electric cooker and poisoning with medical drugs. INTERPRETATION: There seems to be a potential for improved use of safety measures against product-related childhood injuries. Previous studies have shown that the interventions that are most effective in changing risk behaviour are a combination of legislation, educational campaigns, information to parents on home hazard reduction, and free supply of security equipment.

Accidental Falls↗
PubMed2004

Assessing and intervening on OSH programmes: effectiveness evaluation of the Wellworks-2 intervention in 15 manufacturing worksites.

AIMS: (1) To develop a transparent and broadly applicable method for assessing occupational safety and health (OSH) programmes or management systems; (2) to assess OSH programmes in a sample of manufacturing worksites; and (3) to determine whether a management focused occupational health intervention results in greater improvement in OSH programmes compared to minimal intervention controls. METHODS: OSH programmes were assessed using an adaptation of the US Occupational Safety & Health Administration's 1995 Program Evaluation Profile. Scores were generated from 91 binary indicator variables grouped under four "Essential Elements". Essential Element scores were weighted to contribute to an overall programme score on a 100 point scale. Seventeen large manufacturing worksites were assessed at baseline; 15 sites completed the 16 month intervention and follow up assessments. RESULTS: There was considerable variation in Essential Element scores across sites at baseline as judged by our instrument, particularly in "management commitment and employee participation" and "workplace analysis". Most sites scored highly on "hazard prevention and control" and "training and education". For overall OSH programme scores, most sites scored in the 60-80% range at baseline, with four sites scoring below 60%, suggesting weak programmes. Intervention sites showed greater improvements than controls in the four programme elements and in overall programme scores, with significantly greater improvements in "management commitment and employee participation". CONCLUSIONS: The OSH programme assessment method used is broadly applicable to manufacturing work settings, and baseline profiles suggest needs for improvement in OSH programmes in most such worksites. Despite a small sample size, results showed that sustained management focused intervention can result in improvement in these OSH programme measures.

Community Participation↗
PubMed2005

Persistence of Escherichia coli and Salmonella in surface soil following application of liquid hog manure for production of pickling cucumbers.

Liquid hog manure is routinely applied to farm land as a crop fertilizer. However, this practice raises food safety concerns, especially when manure is used on fruit and vegetable crops. The objectives of this project were to evaluate the persistence of Escherichia coli and Salmonella in surface soil after application of liquid hog manure to fields where pickling cucumbers were grown and to verify the microbiological quality of harvested cucumbers. Mineral fertilizers were replaced by liquid hog manure at various ratios in the production of pickling cucumbers in a 3-year field study. The experimental design was a randomized complete block comprising four replicates in sandy loam (years 1, 2, and 3) and loamy sand (year 3). Soil samples were taken at a depth of 20 cm every 2 weeks after June application of organic and inorganic fertilizers. Vegetable samples were also taken at harvest time. Liquid hog manure, soil, and vegetable (washed and unwashed) samples were analyzed for the presence of Salmonella and E. coli. An exponential decrease of E. coli populations was observed in surface soil after the application of manure. The estimated average time required to reach undetectable concentrations of E. coli in sandy loam varied from 56 to 70 days, whereas the absence of E. coli was estimated at 77 days in loamy sand. The maximal Salmonella persistence in soil was 54 days. E. coli and Salmonella were not detected in any vegetable samples.

Animals↗
PubMed2003

Stopping clinical trials because of treatment ineffectiveness: a comparison of a futility design with a method of stochastic curtailment.

This paper introduces a simple futility design that allows a comparative clinical trial to be stopped due to lack of effect at any of a series of planned interim analyses. Stopping due to apparent benefit is not permitted. The design is for use when any positive claim should be based on the maximum sample size, for example to allow subgroup analyses or the evaluation of safety or secondary efficacy responses. A final frequentist analysis can be performed that is valid for the type of design employed. Here the design is described and its properties are presented. Its advantages and disadvantages relative to the use of stochastic curtailment are discussed.

Data Interpretation, Statistical↗