Assessment of knowledge and attitudes towards safety events reporting among residents in a community health system.

Background: Resident physicians are known to be infrequent reporters of patient safety events (PSE). Previous studies assessing barriers to resident PSE reporting have not considered possible cultural barriers faced by international medical graduates (IMG). This study aimed to assess the knowledge and attitudes of residents regarding PSE and possible barriers contributing to poor resident reporting. Methods: A cross sectional survey of all house staff undergoing post-graduate residency training at two independent community hospital based academic medical centers was conducted through an online questionnaire. Sample case vignettes were created to assess the residents' ability to identify safety events and classify them as near miss, adverse events or sentinel events and decide whether they were reportable. Results: The Reporting of PSE increased significantly by year of residency training (p < 0.005), with time taken to file a PSE being the strongest perceived barrier. There was no difference in PSE reporting between IMG's and non- IMG's. We identified major knowledge gaps with only 73.9%, 79.6% and 94.3% of respondents correctly identifying sentinel events, adverse events, and near misses, respectively. 58.1% of respondents did not think near misses were reportable. Conclusions: A lack of knowledge is the most important barrier towards PSE reporting. A different cultural background and lack of previous exposure to patient safety report by IMGs is not a significant barrier towards safety event reporting. In the short-term, it appears that focusing limited institutional resources on education rather than acculturation issues would have the greatest benefit.

Comparison of Blood Oxygenation Level-Dependent fMRI and Provocative DSC Perfusion MR Imaging for Monitoring Cerebrovascular Reserve in Intracranial Chronic Cerebrovascular Disease.

BACKGROUND AND PURPOSE: Loss of hemodynamic reserve in intracranial cerebrovascular disease reduces blood oxygenation level-dependent activation by fMRI and increases asymmetry in MTT measured by provocative DSC perfusion MR imaging before and after vasodilation with intravenous acetazolamide. The concordance for detecting hemodynamic reserve integrity has been compared. MATERIALS AND METHODS: Patients (n = 40) with intracranial cerebrovascular disease and technically adequate DSA, fMRI and provocative DSC perfusion studies were retrospectively grouped into single vessels proximal to and distal from the circle of Willis, multiple vessels, and Moyamoya disease. The vascular territories were classified as having compromised hemodynamic reserve if the expected fMRI blood oxygenation level-dependent activation was absent or if MTT showed increased asymmetry following vasodilation. Concordance was examined in compromised and uncompromised vascular territories of each group with the Fischer exact test and proportions of agreement. RESULTS: Extensive leptomeningeal collateral circulation was present in all cases. Decreased concordance between the methods was found in vascular territories with stenosis distal to but not proximal to the circle of Willis. Multivessel and Moyamoya diseases also showed low concordance. A model of multiple temporally displaced arterial inputs from leptomeningeal collateral flow demonstrated that the resultant lengthening MTT mimicked compromised hemodynamic reserve despite being sufficient to support blood oxygenation level-dependent contrast. CONCLUSIONS: Decreased concordance between the 2 methods for assessment of hemodynamic reserve for vascular disease distal to the circle of Willis is posited to be due to well-developed leptomeningeal collateral circulation providing multiple temporally displaced arterial input functions that bias the perfusion analysis toward hemodynamic reserve compromise while blood oxygenation level-dependent activation remains detectable.

Recombinant von Willebrand factor: a first-of-its-kind product for von Willebrand disease.

von Willebrand disease (VWD) is caused by quantitative or qualitative defects in von Willebrand factor (VWF). The mainstay of therapy is desmopressin, which is, however, not useful in certain forms of VWD notwithstanding adverse events. For these patients, plasma-derived factor VIII (pdFVIII)/VWF concentrates have been available for close to three decades but have a theoretical risk of disease transmission, hypersensitivity/allergic reactions, inhibitors and thrombosis. A recombinant VWF (vonicog alfa, Vonvendi™; manufactured by Baxalta, now part of Shire) was approved by the U.S. Food and Drug Administration (FDA) in December 2015. This review will survey the literature based on a MEDLINE review on the safety, efficacy and pharmacokinetics of Vonvendi. It will also summarize the ongoing studies on Vonvendi available in the public domain. Vonvendi may have an important role in the management of VWD. However, more studies are needed, especially in special populations such as surgical patients, patients with major gastrointestinal bleeding from arteriovenous malformations and pregnant women and children, who are most likely to benefit from it.

Principle considerations for the risk assessment of sprayed consumer products.

In recent years, the official regulation of chemicals and chemical products has been intensified. Explicitly for spray products enhanced requirements to assess the consumers'/professionals' exposure to such product type have been introduced. In this regard the Aerosol-Dispensers-Directive (75/324/EEC) with obligation for marketing aerosol dispensers, and the Cosmetic-Products-Regulation (1223/2009/EC) which obliges the insurance of a safety assessment, have to be mentioned. Both enactments, similar to the REACH regulation (1907/2006/EC), require a robust chemical safety assessment. From such assessment, appropriate risk management measures may be identified to adequately control the risk of these chemicals/products to human health and the environment when used. Currently, the above-mentioned regulations lack the guidance on which data are needed for preparing a proper hazard analysis and safety assessment of spray products. Mandatory in the process of inhalation risk and safety assessment is the determination and quantification of the actual exposure to the spray product and more specifically, its ingredients. In this respect the current article, prepared by the European Aerosol Federation (FEA, Brussels) task force "Inhalation Toxicology", intends to introduce toxicological principles and the state of the art in currently available exposure models adapted for typical application scenarios. This review on current methodologies is intended to guide safety assessors to better estimate inhalation exposure by using the most relevant data.

A lung dosimetry model of vapor uptake and tissue disposition.

Inhaled vapors may be absorbed at the alveolar-capillary membrane and enter arterial blood flow to be carried to other organs of the body. Thus, the biological effects of inhaled vapors depend on vapor uptake in the lung and distribution to the rest of the body. A mechanistic model of vapor uptake in the human lung and surrounding tissues was developed for soluble and reactive vapors during a single breath. Lung uptake and tissue disposition of inhaled formaldehyde, acrolein, and acetaldehyde were simulated for different solubilities and reactivities. Formaldehyde, a highly reactive and soluble vapor, was estimated to be taken up by the tissues in the upper tracheobronchial airways with shallow penetration into the lung. Vapors with moderate solubility such as acrolein and acetaldehyde were estimated to penetrate deeper into the lung, reaching the alveolar region where absorbed vapors had a much higher probability of passing through the thin alveolar-capillary membrane to reach the blood. For all vapors, tissue concentration reached its maximum at the end of inhalation at the air-tissue interface. The depth of peak concentration moved within the tissue layer due to vapor desorption during exhalation. The proposed vapor uptake model offers a mechanistic approach for calculations of lung vapor uptake, air:tissue flux, and tissue concentration profiles within the respiratory tract that can be correlated to local biological response in the lung. In addition, the uptake model provides the necessary input for pharmacokinetic models of inhaled chemicals in the body, thus reducing the need for estimating requisite parameters.

Derivation of mass transfer coefficients for transient uptake and tissue disposition of soluble and reactive vapors in lung airways.

Evaluation of vapor uptake by lung airways and subsequent dose to lung tissues provides the bridge connecting exposure episode to biological response. Respiratory vapor absorption depends on chemical properties of the inhaled material, including solubility, diffusivity, and metabolism/reactivity in lung tissues. Inter-dependent losses in the air and tissue phases require simultaneous calculation of vapor concentration in both phases. Previous models of lung vapor uptake assumed steady state, one-way transport into tissues with first-order clearance. A new approach to calculating lung dosimetry is proposed in which an overall mass transfer coefficient for vapor transport across the air-tissue interface is derived using air-phase mass transfer coefficients and analytical expressions for tissue-phase mass transfer coefficients describing unsteady transport by diffusion, first-order, and saturable pathways. Feasibility of the use of mass transfer coefficients was shown by calculating transient concentration levels of inhaled formaldehyde in the human tracheal airway and surrounding tissue. Formaldehyde tracheal air concentration and wall-flux declined throughout the breathing cycle. After the inhalation period, peak tissue concentration moved from the air-tissue interface into the tissue due to desorption into the air and continued diffusional transport across the tissue layer. While model predictions were performed for formaldehyde, which serves as a model of physiologically relevant, highly reactive vapors, the model is equally applicable to other soluble and reactive compounds.

Blood pressure, left ventricular mass, and lead exposure in battery manufacturing workers.

BACKGROUND: Although debate about the relationship between lead and blood pressure has focused on low environmental lead levels, industrial exposure remains a concern. METHODS: We measured blood pressure and left ventricular mass (LVM) in 108 battery manufacturing workers, and calculated cumulative and historic average measures of blood lead. RESULTS: Diastolic pressure increased with increasing lead levels, with a significant (P = 0.04) 5 mmHg difference in mean pressure between the highest and lowest cumulative exposure levels. Diastolic pressure increased with the log of cumulative lead (P = 0.06). Both hypertension (defined as currently medicated or systolic > 160 mmHg or diastolic > 95 mmHg) and LVM increased nonsignificantly with increasing lead exposure (P-values > or = 0.17 for hypertension and > or = 0.20 for LVM). CONCLUSIONS: We found a small effect of blood lead on diastolic blood pressure, particularly for a cumulative measure of exposure, but no convincing evidence of associations between lead and other blood-pressure-related outcomes. Published 2001 Wiley-Liss, Inc.

Lactating adenoma--cytomorphologic study with review of literature.

Lactating adenoma is an uncommon well-differentiated benign tumor of secretory mammary epithelium that occurs in pregnant and lactating women. Three percent of all breast cancers are diagnosed during pregnancy and need to be differentiated from other breast masses occurring in pregnancy and lactational states. Its origin, though controversial, is believed to be de novo or a variant of pre-existing tubular adenoma or fibroadenoma, that reflects the morphologic changes resulting from the physiologic state of pregnancy. Four pregnant/lactating women presenting with solitary breast masses were aspirated. Spontaneous regression of the mass was observed in two of the four cases, one underwent excision biopsy and one case was lost to follow up. All four cases were diagnosed as lactating adenoma on fine needle aspiration cytology. Cytomorphologic features included cellular aspirates comprising of epithelial cells, scattered and in small groups. The acinar cells had foamy to vacuolated cytoplasm. The nucleus had prominent nucleoli. Background showed abundant foamy material. Biopsy confirmed lactating adenoma in one of the cases. Lactating adenoma needs to be differentiated from other breast masses, including carcinoma, in pregnant or lactating women. Sonographic studies are not diagnostic and surgical biopsies are not recommended as a majority of the lesions are known to regress spontaneously.

Coat's disease: an uncommon lesion of eye--a case report.

Coat's Disease, first reported in 1908, is a rare disease which is usually seen in young males presenting with complaints of unilateral vision loss. Microscopically, retinal telangiectasis and exudative retinal detachment is seen. Attempts should be made for differentiating and early detection of this disease to avoid enucleation of eye ball. Here we discuss a case report of a child manifesting as coat's disease in which a clinical diagnosis of Retinoblastoma was given and eye was enucleated.

Characterisation of respiratory health and exposures at a sintered permanent magnet manufacturer.

Sintered permanent magnets are made from the powdered metals of cobalt, nickel, aluminium, and various rare earths. During production, exposure to respirable crystalline silica and asbestos may also occur. Reported here is a cross sectional study of 310 current and 52 retired hourly employees who worked 10 or more years making sintered magnets. Each participant had a chest radiograph, spirometry, and completed a respiratory questionnaire. Illness logs were also reviewed to calculate the incidence of recorded respiratory disorders. The prevalences of abnormalities in pulmonary function and respiratory symptoms were not higher than found in an external referent population. Although the prevalence of diffuse parenchymal opacities consistent with pneumoconiosis (four workers) was similar to the referent population, one worker had radiographic findings consistent with silicosis and two workers had profusion scores of 1/2 or above, not seen in the referent group. The incidence of reported respiratory conditions in the log, including asthma, was 10 times that of other manufacturers in the same industrial classification category. Excessive exposures to cobalt, nickel, and respirable silica were shown by environmental measurements.

Interpretation and communication of the results of medical field investigations.

Since the controversy over cytogenetic test results at the Love Canal in New York State, there has been increasing concern about the communication of medical test results to participants in field studies. To identify the range of issues that arise and to present examples of practices that might be useful for consideration, we have drawn from 15 years of experience in interpreting and communicating the results of medical field investigations by the National Institute for Occupational Safety and Health. The investigations were qualitatively characterized according to study type and design, substances involved, language used in the notification of results, and the nature of the efforts to put results in perspective. Based on this evaluation, the following recommendations are made: (1) provide a comprehensible consent form, (2) interpret results for study participants, (3) use clear language, (4) be explicit about uncertainty of findings, (5) where appropriate, indicate the need for medical follow-up, (6) provide results promptly, (7) provide overall study results, (8) evaluate the impact of the notification, (9) train investigators in the practice of communicating results.

Investigation of occupational cancer clusters: theory and practice.

Local and federal government agencies are often asked to investigate apparent clusters of cancer in communities or workplaces. Often these investigations cannot utilize the methods that have been developed for evaluation of disease clusters because the clusters are too small, and the populations to be studied and the periods of time to be covered are determined in an a posteriori manner. Still, government investigators are called upon to render an official opinion of the apparent clusters. Application of a theoretical approach to cluster analysis must give way to a more pragmatic approach. A review of 61 investigations of apparent clusters conducted by the National Institute for Occupational Safety and Health (NIOSH) during the period 1978-84 showed that most of the clusters contained five or fewer cases and had no plausible occupational etiology. Despite the few clusters that were identified, these investigations generally provided a service to workers and employers who were concerned about occupational cancer.

Neurologic dysfunction from exposure to 2-t-butylazo-2-hydroxy-5-methylhexane (BHMH): a new occupational neuropathy.

Seven cases of subacute central and peripheral neurologic dysfunction developed in 18 workers employed in the manufacture of reinforced plastic bathtubs. Cases were characterized by weight loss, dizziness, paresthesias, muscle weakness, incontinence, memory loss, and loss of peripheral, color, and night vision. Neuropathies began distally, involved both sensory and motor function, and were associated with prolonged sensory latency, muscle fibrillation, and reduced numbers of functioning motor units. One patient developed posterior lenticular cataracts. Slow improvement occurred on removal from exposure, but residual neuropathies persisted for as long as two years. Epidemiologic investigation disclosed that the first case developed approximately two weeks after introduction of a new plastic foaming agent, 2-t-butylazo-2-hydroxy-5-methylhexane (BHMH). All cases occurred in workers exposed directly to BHMH. No new cases developed after use of BHMH was discontinued. A survey of the firm which produced BHMH and of 68 user firms found two additional clusters of mild neuropathy which may have been caused by BHMH. BHMH was withdrawn from distribution following discovery of these cases. Subsequently, BHMH has been shown in rats to be a potent neurotoxin. Adequate premarket testing could have averted this outbreak.

Creating an indoor environmental problem from a nonproblem: a need for cautious evaluation of antibodies against hapten-protein complexes.

An epidemic of illness in three schools in New York State occurred in early 1983. An epidemiological review of the problem led to the conclusion that some of the symptoms could have been explained by irritant reactions to boiler exhaust gases but that a major factor was likely public concern about environmental contamination and heightened awareness of common minor symptoms and of exacerbations of chronic illnesses. Diphenylmethane diisocyanate (MDI) from polyurethane insulation had previously been suspected as a potential cause. An earlier investigation had found low levels of anti MDI-human serum albumin in a small number of subjects who did not have typical symptoms of identified MDI or other hypersensitivity syndromes. Similar antibodies were found in two of nine unaffected children in Chicago, who served as a comparison group. The identification of these antibodies, however, was inappropriately used to support the idea of a school contaminated with MDI in spite of the absence of detectable MDI in the environment. The availability of highly sensitive immunoassays should not be inappropriately used to accelerate the fear of environmental toxins when there is no clinical correlation.

An epidemic of psychogenic illness in an electronics plant.

We investigated an outbreak of illness in electronics plant workers. Questionnaire data revealed that 98 employees experienced symptoms, including light- headedness , headache, sleepiness, and numbness/tingling of the face or extremities. Attack rates by work station followed no apparent pattern. Extensive medical and environmental evaluation, including air sampling for numerous solvents and gases, provided no physical or chemical explanation for the epidemic. Compared with well employees, ill employees were more commonly female, complained more frequently of bothersome odors, and believed that greater danger existed of the illness recurring. Blood gas analyses of seven of 11 ill workers showed respiratory alkalosis, consistent with hyperventilation. The poorly defined nature of this illness, the absence of exposures to environmental contaminants in concentrations exceeding recommended limits, and the evidence of hyperventilation suggest that this outbreak was an incident of industrial psychogenic illness.

The efficacy of a population-based comparison group in cross-sectional occupational health studies.

The availability and the choice of appropriate comparison groups are essential for valid occupational epidemiologic studies. Too often, however, adequate comparison groups cannot easily be found within a workplace environment or extracted from the general population. An evaluation of the efficacy of using a pool of comparison subjects from the health and Nutrition Examination Survey (HANES) was performed on data gathered by the National Institute for Occupational Safety and Health in 1979. Comparison groups from the HANES pool were derived for 246 workers at four different commercial/industrial facilities in the Niagara Falls, New York, area and the comparability between the groups was assessed for several demographic, behavioural, and biomedical variables. The HANES groups exhibited a high degree of comparability with regard to most variables, excluding ancestry. The HANES pool may serve as a useful source of subjects to allow for the comparison of disease rates where occupational exposure is the key distinguishing feature between groups.

An outbreak of introduced malaria in California possibly involving secondary transmission.

During 1974, 12 cases of Plasmodium vivax malaria were reported from an agricultural area in California's Sacramento Valley. At least three of these cases resulted from local mosquito transmission. The imported cases were in Punjabi immigrants except for one in an American-born visitor to the Punjab. This is the 11th reported outbreak of introduced malaria in the United States since 1952, and the first in California since 1957. A unique aspect of this outbreak is the likelihood that secondary transmission occurred. Extensive surveillance activities, including a house-to-house case-finding survey in a 15-square-kilometer area of suspected transmission, yielded no new malaria cases, but the activities may have increased awareness of malaria among both the medical community and the public, and thus facilitated the detection of later cases. The occurrence of local malaria transmission coincided with unusually high numbers of Anopheles freeborni. The increase in imported malaria cases probably reflects a resurgence of malaria in Punjab State, India.

Trichinosis acquired at sea--report of an outbreak.

In 1974, at least 13 persons acquired trichinosis aboard a luxury liner en route to Alaska. Epidemiologic investigation implicated ground beef served on the ship as the vehicle of transmission. The beef is thought to have been contaminated by pork which had previously been frozen, though presumably not under trichinacidal conditions. To our knowledge, this is the first report of trichinosis acquired at sea.