Biosafety level-2 laboratories are designated for work with human-derived samples or moderate-risk microorganisms that transmit primarily by direct contact exposures. Many laboratory procedures generate unseen droplets that contaminate workers' hands, equipment, and work surfaces. Workers' strict adherence to glove removal and handwashing is required prior to laboratory exit to prevent inadvertent transmission of pathogens to self or others. However, little is known about biosafety level-2 workers' compliance with these behaviors. In this article, glove removal and handwashing compliance upon laboratory exit were measured by direct observation of 93 biosafety level-2 research workers from 21 university laboratories. Participants completed a 41-item survey measuring social cognitive theory-based variables related to handwashing, self-reported compliance, and demographic factors. Survey items, observed exit frequency, and laboratory characteristics were evaluated for associations with handwashing compliance. Overall, observed glove removal and handwashing compliance upon laboratory exit were 43.0% (Standard Error [SE] = 2.3%), and 8.2% (SE = 1.2%), respectively, while workers' self-reported glove removal and handwashing compliance were 73.7% (SE = 3.6%) and 35.5% (SE = 4.1%), respectively. The average number of observed laboratory exits per hour was 2.8 for workers with any handwashing compliance vs. 5.4 for workers with no handwashing compliance (p = 0.0013). Among the cognitive variables, behavioral modeling by supervisors and coworkers had the strongest association with workers' compliance (slope = 3.5, SE = 1.3, p = 0.0113). Workers in laboratories with a written handwashing policy had higher compliance (Mean = 14.1%, SE = 5.9%) than workers in laboratories with no written policy (Mean = 1.1%, SE = 1.0%; p = 0.0488). Multi-faceted interventions that encourage modeling of the behavior by supervisors and coworkers, implementation of written handwashing policies, and efforts to reduce exit frequency by furnishing laboratories with necessary equipment and supplies may help improve compliance.
Pathogen transmission in the laboratory is thought to occur primarily through inhalation of infectious aerosols or by direct contact with mucous membranes on the face. While significant research has focused on controlling inhalation exposures, little has been written about hand contamination and subsequent hand-to-face contact (HFC) transmission. HFC may present a significant risk to workers in biosafety level-2 (BSL-2) laboratories where there is typically no barrier between the workers’ hands and face. The purpose of this study was to measure the frequency and location of HFC among BSL-2 workers, and to identify psychosocial factors that influence the behavior. Research workers (N = 93) from 21 BSL-2 laboratories consented to participate in the study. Two study personnel measured workers’ HFC behaviors by direct observation during activities related to cell culture maintenance, cell infection, virus harvesting, reagent and media preparation, and tissue processing. Following observations, a survey measuring 11 psychosocial predictors of HFC was administered to participants. Study personnel recorded 396 touches to the face over the course of the study (mean = 2.6 HFCs/hr). Of the 93 subjects, 67 (72%) touched their face at least once, ranging from 0.2–16.0 HFCs/hr. Among those who touched their face, contact with the nose was most common (44.9%), followed by contact with the forehead (36.9%), cheek/chin (12.5%), mouth (4.0%), and eye (1.7%). HFC rates were significantly different across laboratories F(20, 72) = 1.85, p = 0.03. Perceived severity of infection predicted lower rates of HFC (p = 0.03). For every one-point increase in the severity scale, workers had 0.41 fewer HFCs/hr (r = −.27, P < 0.05). This study suggests HFC is common among BSL-2 laboratory workers, but largely overlooked as a major route of exposure. Workers’ risk perceptions had a modest impact on their HFC behaviors, but other factors not considered in this study, including social modeling and work intensity, may play a stronger role in predicting the behavior. Mucous membrane protection should be considered as part of the BSL-2 PPE ensemble to prevent HFC.
Soap and water hand washing (HW) is recommended as the standard microbiological practice for removing transient microbes from laboratory workers' hands. The effectiveness of HW in preventing pathogen transmission depends largely on the technique used by the individual, but little is known about laboratory workers' compliance with recommended HW protocols. This study evaluated the quality of HW performed by research workers (N = 93) in 21 biosafety level 2 (BSL-2) laboratories at a large university. Study personnel measured the quality of workers' HW by direct observation while subjects performed their regularly assigned work tasks. Five HW quality indicators as well as hand and wrist jewelry use were measured using an existing tool designed for use in the healthcare setting and modified for this study. A total of 49 soap and water washes were measured during 118 hours of observation. Duration of scrubbing was 9 seconds or less in 41 (84%) cases. Soap was used in 45 (92%) washes, but in 25 (51%) cases where soap was used, lathering was not visible to the observer. Subjects covered dorsal, wrist, palm, and interdigital areas as recommended in only 16 (33%) cases. In 29 (59%) HW events subjects turned off the faucet with bare hands. Hand or wrist jewelry was worn by 60 (65%) participants while in the containment lab. In this study, four of five HW quality indicators were poorly performed. Poor quality HW may result in low reductions of transient pathogens on workers' hands, and may explain many laboratory-associated infections where the route of transmission is otherwise unknown.
Background: Carotenoids are an important group of phytonutrients that are abundant in fruits and vegetables. Epidemiological and clinical intervention studies have implied the presence of protective qualities of these nutrients against the development of a variety of chronic diseases. Previously, human carotenoid status has been assessed in serum and tissue using high-performance liquid chromatography (HPLC) methodology. Recently, a Raman spectroscopy (RS) based photonic method has been developed to accurately and noninvasively measure the carotenoid concentration in human skin.Objectives: (1) To validate skin RS methodology against standard serum carotenoid measurements by HPLC and (2) to establish and compare the reliability of the 2 methods.Design: This study included 372 healthy adults who provided 3 blood samples and 3 RS skin carotenoid measurements within an 8-day period; each day-matched blood sample and RS determination was spaced by >= 48 hours.Results: Consistent positive correlations were observed for each of 3 separate same-day correlation plots of total serum versus RS skin carotenoids. Overall estimate of the line of best fit from analysis of covariance. using all 3 samples (n = 1116), yielded a Pearson correlation of R = 0.81 (r(2) = 0.66; p < 0.001). Based on analysis of variance, RS skin carotenoid methodology exhibited 0.9% less variance over the 3 tests than serum carotenoids by the HPLC method (p < 0.03).Conclusions: RS accurately measures total carotenoids in human skin with less intra-individual variability than measurement of serum carotenoids by HPLC analysis. RS technology is a valid and reliable noninvasive method to rapidly assess carotenoid nutritional status in humans.
Background: A study was begun in 1965 to 1966 to determine whether children exposed to radioactive iodine from nuclear weapons testing at the Nevada Test Site from 1951 through 1962 were at higher risk of thyroid disease. In 1993, we reported that among those examined in 1985 to 1986 (Phase II) there was an association between radiation from the Nevada Test Site and thyroid neoplasms.Methods: We reevaluated the relationship between exposure to Nevada Test Site fallout and thyroid disease using newly corrected dose estimates and disease outcomes from the Phase II study. A prospective cohort of school children 12 to 18 years old living in Utah, Nevada, and Arizona was first examined for thyroid disease in 1965 to 1966 and reexamined in 1985 to 1986. In the Phase II report, 2497 subjects formed the basis for this analysis. Thyroid disease, including thyroid neoplasms and thyroiditis, was expressed as cumulative incidence and risk ratios (RRs) with a dose-response expressed as excess risk ratio (ERR/Gy).Results: The RR between thyroid radiation dose in the highest dose group and thyroid neoplasms increased from 3.4 (in the earlier analysis) to 7.5. The RR for thyroiditis increased from 1.1 to 2.7 with an ERR/Gy of 4.9 (95% confidence interval = 2.0 to 10.0). There were too few malignant thyroid neoplasms to estimate risk.Conclusions: Persons exposed to radioactive iodine as children have an increased risk of thyroid neoplasms and autoimmune thyroiditis up to 30 years after exposure.
Objective: Measure changes in the prevalence of behavioral factors including police-reported fatigue and alcohol intoxication, as well as self-reported seatbelt use, and assess their effect on hospitalization or death after a motor vehicle crash. Methods: Probabilistic linkage was used to match drivers in motor vehicle crashes with hospital discharge records for the years 1992-1997. Frequencies of specific behavioral factors were evaluated using the Cochran-Armitage test for trend. Odds ratios and corresponding 95% confidence intervals were calculated using generalized estimating equations (GEEs) with crash and driver characteristics as independent variables and hospitalization or death as the dependent variable. Results: The analysis database consisted of 450,286 crash driver records, which linked to 4219 (0.9%) hospitalizations or deaths. There was an increasing trend for self-reported seatbelt use among crash-involved drivers from 80.5% in 1992 to 89.3% in 1997 (P < 0.001). Police-reported alcohol intoxication among crash-involved drivers showed a decreasing trend from 2.4% in 1992 to 1.5% in 1997 (P < 0.001). There was no trend for police-reported fatigue-related crashes. Odds ratios of hospitalization or death for seatbelt use, alcohol involvement, and fatigue were significant and did not fluctuate considerably between 1992 and 1997. Seatbelt use offered a protective effect from hospitalization or death, while alcohol intoxication and fatigue contributed to increased likelihood of hospitalization or death. Conclusions: These results suggest that while some improvement has been made in decreasing seatbelt non-use and driver alcohol intoxication among crash-involved drivers, no improvement has been made in reducing fatigue-related crashes. (C) 2003 Elsevier Science Ltd. All rights reserved.
The purpose of this study was to determine if it is necessary to use generalized estimating equations (GEEs) in the analysis of seat belt effectiveness in preventing injuries in motor vehicle crashes. The 1992 Utah crash dataset was used, excluding crash participants where seat belt use was not appropriate (n=93,633). The model used in the 1996 Report to Congress [Report to congress on benefits of safety belts and motorcycle helmets, based on data from the Crash Outcome Data Evaluation System (CODES). National Center for Statistics and Analysis, NHTSA, Washington, DC, February 1996] was analyzed for all occupants with logistic regression, one level of nesting (occupants within crashes), and two levels of nesting (occupants within vehicles within crashes) to compare the use of GEEs with logistic regression. When using one level of nesting compared to logistic regression, 13 of 16 variance estimates changed more than 10%, and eight of 16 parameter estimates changed more than 10%. In addition, three of the independent variables changed from significant to insignificant (α=0.05). With the use of two levels of nesting, two of 16 variance estimates and three of 16 parameter estimates changed more than 10% from the variance and parameter estimates in one level of nesting. One of the independent variables changed from insignificant to significant (α=0.05) in the two levels of nesting model; therefore, only two of the independent variables changed from significant to insignificant when the logistic regression model was compared to the two levels of nesting model. The odds ratio of seat belt effectiveness in preventing injuries was 12% lower when a one-level nested model was used. Based on these results, we stress the need to use a nested model and GEEs when analyzing motor vehicle crash data.
Background: Medical problems may affect the ability to drive motor vehicles, and programs that control the issuing of driver licenses to individuals with medical conditions exist in most states. The main activity of these programs is the imposition of restrictions upon the driving privileges of individuals with medical conditions that are deemed to pose some risk to Public safety. However, little is known about the effectiveness of these licensing programs. Objective: The objective of this study was to compare the rates of adverse driving events (crash, at-fault crash and citations) experienced by drivers licensed with medical conditions to those of age-, sex- and location-matched controls. Separate comparisons were made for drivers reporting medical conditions licensed with full driving privileges, and those with restricted driving privileges (e.g. speed, area and time of day). Design: Retrospective case-control. Methods: The study population was all drivers licensed in the state of Utah who reported a medical condition on their driver license application, over the 5-year period 1992-1996. Drivers enter the program by self-reporting their medical problems. Control drivers were chosen from the entire population of drivers licensed in Utah for the same period. Information on driver license status, participation in the medical conditions program, citations, involvement in crashes, and death certificate data was obtained from the relevant state agencies. Probabilistic linkage methodology was used to link the records in these disparate databases for eventual analysis. Rates of citation, crashes and at-fault crashes, expressed as events per 10000 license days, were calculated separately for program drivers and their corresponding control groups for each medical condition category and restriction status. These data were used to determine an estimate of relative risk (RR) and 95% confidence intervals. Results: As a group, medical conditions drivers had modestly elevated rates of adverse driving events compared with control drivers (RR 1.09-1.74). Rates in the largest medical category, 'cardiovascular conditions', were not higher than controls. Rates were higher than control for some conditions, such as 'alcohol' and 'learning and memory', for some adverse events (RR 2.2-5.75). Drivers with more than one medical condition appeared comparable to the general group of medical conditions program drivers. Conclusions: Drivers in Utah medical conditions program had modestly elevated rates of adverse driving events compared to matched controls. Possible underreporting of medical conditions and accurate assessment of exposure rates are potential weaknesses in the program. (C) 2002 Elsevier Science Ltd. All rights reserved.
The purpose of our study was to evaluate the impact of shoulder belt use on motor vehicle crash ejection, morbidity and mortality. We analyzed motor vehicle crash records linked to hospital inpatient data for front seat occupants of passenger cars in Utah between 1994 and 1996 (n = 103,035). Stochastic simulations were used to adjust for possible seatbelt misclassification. There were 276 (0.3%) occupants coded as using only a shoulder belt. The adjusted odds of ejection for shoulder only belted occupants was higher compared to lap-shoulder belted (odds ratio (OR) = 18.9; 95% confidence interval (CI) = 15.1, 25.1) and lap only belted occupants (OR = 4.3; 95% Cl = 2.9, 7.7). There was no difference in the odds of ejection for an occupant using a shoulder belt only and an occupant using no seatbelt (OR = 1.1; 95% CI = 1.0, 1.3). Occupants using a shoulder belt only were more likely to sustain a fatal or hospitalizing injury than lap-shoulder belted (OR = 2.3; 95% Cl = 1.9, 3.0), and lap only belted occupants (OR = 1.8; 95% CI = 1.3, 2.7), while controlling for other covariates. Occupants using only a shoulder belt had the same odds of a fatal or hospitalizing injury as unbelted occupants (OR = 1.1; 95% Cl = 0.9, 1.4). Average hospital inpatient length of stay, charges and injury severity scores were similar for all restraint types. These results stress the need for the use of a lap belt in conjunction with the shoulder belt.
Radiographic changes of rickets are well characterized, but no method of grading the severity of these changes has been in general use. Consequently, it is difficult to compare objectively or follow radiographic improvement. We prospectively evaluated the utility and reproducibility of a scoring method for measuring the severity of rickets. A 10-point score for radiographs of wrists and knees was devised to assess the degree of metaphyseal fraying and cupping and the proportion of the growth plate affected. The score progresses in half point increments from zero (normal) to 10 points (severe). Four trained physicians independently scored radiographs on two separate occasions from 67 children with active rickets. A broad representation of mean radiographic scores was moderately correlated with alkaline phosphatase (r=0.58). Interobserver correlation of radiographic scores was 0.84 or greater for all observer pairs and intraobserver correlation was 0.89 or greater for each observer. Researchers and clinicians should find the score useful to assess objectively the severity of rickets.
BACKGROUNDNutritional rickets remains prevalent in many tropical countries despite the fact that such countries have ample sunlight. Some postulate that a deficiency of dietary calcium, rather than vitamin D, is often responsible for rickets after infancy.METHODSWe enrolled 123 Nigerian children (median age, 46 months) with rickets in a randomized, double-blind, controlled trial of 24 weeks of treatment with vitamin D (600,000 U intramuscularly at enrollment and at 12 weeks), calcium (1000 mg daily), or a combination of vitamin D and calcium. We compared the calcium intake of the children at enrollment with that of control children without rickets who were matched for sex, age, and weight. We measured serum calcium and alkaline phosphatase and used a 10-point radiographic score to assess the response to treatment at 24 weeks.RESULTSThe daily dietary calcium intake was low in the children with rickets and the control children (median, 203 mg and 196 mg, respectively; P=0.64). Treatment produced a smaller increase in the mean (+/-SD) serum calcium concentration in the vitamin D group (from 7.8+/-0.8 mg per deciliter [2.0+/-0.2 mmol per liter] at base line to 8.3+/-0.7 mg per deciliter [2.1+/-0.2 mmol per liter] at 24 weeks) than in the calcium group (from 7.5+/-0.8 [1.9+/-0.2 mmol per liter] to 9.0+/-0.6 mg per deciliter [2.2+/-0.2 mmol per liter], P<0.001) or the combination-therapy group (from 7.7+/-1.0 [1.9+/-0.25 mmol per liter] to 9.1+/-0.6 mg per deciliter [2.3+/-0.2 mmol per liter], P<0.001). A greater proportion of children in the calcium and combination-therapy groups than in the vitamin D group reached the combined end point of a serum alkaline phosphatase concentration of 350 U per liter or less and radiographic evidence of nearly complete healing of rickets (61 percent, 58 percent, and 19 percent, respectively; P<0.001).CONCLUSIONSNigerian children with rickets have a low intake of calcium and have a better response to treatment with calcium alone or in combination with vitamin D than to treatment with vitamin D alone.
OBJECTIVE:To determine whether a clinical, nonradiographic criterion can be used to predict when the tip of a blindly placed feeding tube is in the small intestine. DESIGN:Prospective sample. SETTING:Pediatric intensive care unit at a tertiary care children's hospital. PATIENTS:Critically ill children requiring transpyloric feeding. INTERVENTIONS:The small bowel was intubated, using a blind, bedside transpyloric feeding tube placement protocol. The feeding tube was considered to be in the small bowel when <2 mL of a 10- mL aliquot of insufflated air could be aspirated from the feeding tube. This clinical criterion was confirmed with an abdominal radiograph. MEASUREMENTS AND MAIN RESULTS:Patient age ranged from 1 month to 19 yrs (median 6 months). Weight ranged from 2.2 to 60 kg (median 4.9). Median time to feeding tube placement was 10 mins (range 5 to 60). Eighty-nine percent of the patients were mechanically ventilated, while 28% of these patients were pharmacologically paralyzed. Seventy-five feeding tubes were inserted. There were no known complications. Ninety-nine (74/75) percent of the feeding tubes were positioned in the small bowel. The inability to aspirate insufflated air correctly predicted small bowel intubation with 99% certainty (Sequential Probability Ratio Test, p = .05 and power = .80). This test incorrectly predicted the position of only one feeding tube, the 26th, which was in the stomach. Of the 74 feeding tubes positioned in the small bowel, 13 feeding tubes were in the duodenum and 61 were in the jejunum. CONCLUSIONS:The inability to aspirate insufflated air confirms the transpyloric position of a feeding tube. Other clinical criteria did not successfully predict small bowel intubation. Use of this single test may obviate confirmatory abdominal radiographs in carefully selected patients and may lead to more cost-effective and timely initiation of enteral feedings.
OBJECTIVE:(1) To confirm a previous observation that serum phospholipase A2 (PLA2) activity correlates with disease activity in rheumatoid arthritis (RA); and (2) to determine whether serum PLA2 activity changes after treatment with methotrexate (MTX), auranofin (AF), or a combination of the 2 (COMBO).METHODS:Sera obtained at baseline and after treatment from 100 patients with RA (40 MTX, 32 AF, and 28 COMBO) who participated in a multicenter, double blind trial were tested for PLA2 activity using an assay that measures the release of radiolabeled 14C oleic acid from the cell membrane of Escherichia coli. Detailed statistical analysis was performed using previously collected clinical data to determine whether correlations exist between RA disease activity and serum PLA2 activity; whether baseline serum PLA2 activity predicted a therapeutic response in any treatment group; and whether there was a significant change in serum PLA2 activity after treatment in patients who responded to the various drugs.RESULTS:Baseline serum PLA2 activity was significantly increased in patients with RA compared to healthy controls. No correlation between serum PLA2 activity and RA disease activity was noted at baseline. Mean serum PLA2 activity did not change significantly after treatment with MTX, AF, or COMBO in either treatment responders or nonresponders.CONCLUSION:Serum PLA2 activity is increased in patients with RA compared to healthy controls, but does not correlate with disease activity in patients, nor does it predict a response to treatment with MTX, AF, or COMBO. Serum PLA2 activity also did not change significantly after treatment with any of the above agents.
Two groups of visually impaired older adults, minimally (n = 40) and severely impaired (n = 40), were compared on depression, anxiety, life satisfaction, and various dimensions of control. The relationship of control to depression, anxiety, and life satisfaction among the severely impaired then was examined. The severely impaired were found to be significantly more depressed and scored lower in perceptions of control than the minimally impaired, but significant differences were not found in anxiety and life satisfaction. Among the severely impaired, perceived control and the internal domain of locus of control were strongly related to levels of depression, anxiety, and life satisfaction.
OBJECTIVE:To demonstrate the reliability and validity characteristics of a fast, intensively focused functional assessment questionnaire that has been used in rheumatoid arthritis clinical trials by the Cooperative Systematic Studies of Rheumatic Diseases group (CSSRD).METHODS:Data from three double-blind, controlled clinical trials by CSSRD were used to examine the properties of the Functional Assessment Survey as a measure of physiologic function.RESULTS:The Functional Assessment Survey has reasonable test-retest reliability and convergent validity with the Steinbrocker et al. functional class. It demonstrated appropriate divergent validity with other clinical measures of response, as well as discriminant validity.CONCLUSIONS:The CSSRD Functional Assessment Survey is brief, intensive, and focused. Reliability and validity characteristics have been documented.
Motor vehicle crashes are a leading cause of injury and mortality in the United States. The effectiveness of seat belt use has been difficult to study because of the unavailability of population-based crash data bases that include all noninjured occupants. The 1991 Utah Crash Outcome Data Evaluation System data base was developed to determine seat belt effectiveness. It includes occupants of all police-reported motor vehicle crashes. Seat belt effectiveness may be overestimated, however, because of self-reporting of seat belt use when crash occupants are questioned by police. The effect of misclassification of seat belt use on the calculated odds ratio associated with seat belt use was studied by using logistic regression models of four levels of injury. The odds ratio associated with seat belt use for any degree of injury was 0.448 [95% confidence interval (CI) 0.425-0.473]; the odds ratios associated with seat belt use for injuries requiring outpatient emergency care, hospitalization, or fatalities were 0.476 (95% CI 0.449-0.504), 0.203 (95% CI 0.170-0.241), and 0.148 (95% CI 0.097-0.226), respectively. Adjustment of the fraction of correct classification of seat belt use among reported belt users decreased the protective effect associated with seat belt use for all four levels of injury. This is consistent with overestimation of seat belt effectiveness associated with nondifferential misclassification. Based on the assumption that the 1991 observational use rate applies to the 1991 crash population, odds ratios were corrected for seat belt self reporting bias. The corrected odds ratio associated with protection from any degree of injury was 0.723 (95% CI 0.685-0.763); the corrected odds ratios associated with seat belt use and injuries requiring outpatient emergency care, hospitalization, or fatalities were 0.747 (95% CI 0.705-0.791), 0.505 (95% CI 0.421-0.606), and 0.455 (95% CI 0.296-0.697), respectively. The study results confirm the protective effect of seat belts in motor vehicle crashes and provide a methodology for correcting seat belt effectiveness estimates.
OBJECTIVETo determine the safety and efficacy of aminobenzoate potassium (KPAB) in treating the skin manifestations of scleroderma.METHODSVia a 48-week prospective, randomized, double blind, placebo controlled trial we compared the efficacy of KPAB 12 g/day with matching placebo. Outcome measures included skin mobility and thickening scores, patient and physician global assessments and, measurements of maximal oral aperture and hand range of motion.RESULTSOf 146 patients who entered the study, 76 (52%) completed. Demographics of the study population included age 49 +/- 13 years, 83% women, mean (range) disease duration was 104 (7-600) months. There were no differences in the demographics of the KPAB vs placebo nor the group that completed the study compared with the withdrawal group. There were no clinical or statistically significant differences between the KPAB and the placebo treated groups in any of the outcome measures. Subgroup analyses of skin mobility and skin thickening based on age, extent of disease, severity of disease, duration of disease and involved vs uninvolved skin were performed, but no differences were noted. The overall compliance to the medical regimen was > or = 75% in 93% of patients completing the study. Eighteen patients in the KPAB group and 6 placebo patients withdrew due to adverse drug reactions (ADR). The most common withdrawals for ADR were gastrointestinal intolerance and headaches. All ADR resolved following withdrawal of medication.CONCLUSIONKPAB did not alter the skin changes of scleroderma in a group of patients with relatively longstanding stable disease. KPAB was reasonably well tolerated in this group of patients.