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Results for “Technical working group”

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At least 109 records · Page 6Linked to original sources

PubMed2002

An international collaborative study on a method for determination of formaldehyde in veterinary vaccines.

An international collaborative study of a quantitative colorimetric method for determination of formaldehyde in veterinary vaccines was conducted on a series of replicate, blinded veterinary vaccine products by 15 laboratories in three regions: North America, Europe and Japan. Participants conducted determinations using a modification of a method from the European Pharmacopoeia, a colorimetric method based on the reaction of formaldehyde with methylbenzothiazolone hydrazone hydrochloride. For this study, three licensed vaccine products containing formaldehyde were revialed, randomly numbered, tested for uniformity and distributed by one of the participating laboratories through regional coordinators to collaborators. One of the revialed products was spiked with a known amount of formaldehyde and included in the test series. Results along with all raw data were returned to the distributing laboratory for consolidation and statistical treatment. For the modified method spike recovery was 101% and reproducibility (inter-laboratory variation expressed as relative standard deviation) ranged from 18.0 to 8.0% for respective formaldehyde concentrations of 0.28 to 1.07 g/l. Based on the study, the method was proposed by the Biologicals Working Group of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) as a candidate for the VICH Guideline standard method for residual formaldehyde.

Chlorine↗

PubMed1998

Genetic toxicology.

Systems for testing genetic toxicology are components of carcinogenic and genetic risk assessment. Present routine genotoxicity-testing is based on at least 20 years of development during which many different test systems have been introduced and used. Today, it is clear that no single test is capable of detecting all genotoxic agents. Therefore, the usual approach is to perform a standard battery of in-vitro and in-vivo tests for genotoxicity. Work-groups of the European Union (EU), the Organization for Economic Co-operation and Development (OECD), and, very recently, the work-group of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) have defined such standard battery tests. These and some currently used supplementary or confirmatory tests are briefly discussed here. Additional test systems for the assessment of genotoxic and carcinogenic hazard and risk are seriously needed. These tests must be more relevant to man than are current assays and less demanding in respect of cost, time and number of animals. Another aspect for reassessment derives from the actual situation in the pharmaceutical industry. Companies have to prepare for the world economy of the 21st century. Therefore, pharmaceutical research is speeding up tremendously by use of tools such as genomics, combinatorial chemistry, high throughput screening and proteomics. Toxicology and genotoxicology need to re-evaluate their changing environment and must find ways to respond to these needs. In conclusion, genetic toxicology needs to answer questions coming from two major directions: hazard and risk identification and high throughput testing.

Humans↗

PubMed1999

[Standardization. Sterilization standards and their impact on hospital services].

The European commission produced series of Directives which were aimed at harmonizing the European market whilst maintaining high standards to protect the citizens. Within each directive drafted Essential Requirements which had to be satisfied in order to market throughout Europe. The Medical Device Directive (93/42/EEC) covers the vast majority of medical devices including active non-implantable and non-active implantable medical devices. Demonstration of compliance to harmonized European Standards (EN) was proof of compliance with Essential Requirements of the Directives. The European Standards Body (CEN) created a series of European Standards which would enable to demonstrate compliance with Essential Requirements. The CEN organisation has a pyramidal structure. Standards are produced in the CEN Technical Committees (TC's) composed of representatives from each country's own standards organization. The Technical Committee in turned created a series of Working Groups (WG), who's job it was to actually generate the text of the standards. Two of standards committees are working to generate standards which relate to sterilizers and sterilization: TC102--the standards emanating from this committee are product related, TC 204--the standards relate to sterilization practice. In Poland, the standarisation activity is provide by Polish Committee of Standardisation. From 5th June 1997 operate Problem Commission number 272 for sterilization affairs. The job of the commission consist on translation of European'offs Standards and transform them to Polish Standards. After accede Poland to European Union, Polish hospitals will have to adjust to European Standards.

Centralized Hospital Services↗

PubMed2003

GELLO: an object-oriented query and expression language for clinical decision support.

GELLO is a purpose-specific, object-oriented (OO) query and expression language. GELLO is the result of a concerted effort of the Decision Systems Group (DSG) working with the HL7 Clinical Decision Support Technical Committee (CDSTC) to provide the HL7 community with a common format for data encoding and manipulation. GELLO will soon be submitted for ballot to the HL7 CDSTC for consideration as a standard.

Decision Making, Computer-Assisted↗

PubMed1994

Clinical utility of cellular DNA measurements in prostate carcinoma. Consensus Conference on Diagnosis and Prognostic Parameters in Localized Prostate Cancer. Stockholm, Sweden, May 12-13, 1993.

At a WHO consensus conference on Early Diagnosis and Prognostic Parameters in Localized Prostate Cancer, a working group discussed the clinical utility of DNA measurements in stages T2 and T3 prostate carcinoma. Incidentally discovered prostate cancer of stage T1 was excluded. The members of the working group, representing various clinical and laboratory disciplines, discussed technical considerations of DNA measurements by flow and image analysis, pretreatment prediction of prognosis, and posttreatment clinical relevance. The group agreed to subdivide tumors into diploid, tetraploid and non-tetraploid aneuploid, expressing various degrees of aggressiveness and gave guidance for the definition of limits of these groups. The panel agreed that knowledge on DNA ploidy prior to treatment is of value in treatment decisions, particularly when surveillance is a treatment option. Aneuploid tumors can be expected to respond very poorly to either irradiation or endocrine therapy, and the presence of aneuploid tumor, either on pretreatment biopsies or in radical prostatectomy specimens, is an ominous sign. The identification of a group of patients with a uniformly poor prognosis should encourage medical oncologists and basic scientists to develop adequate treatment options for this particular group. The panel expressed a strong opinion that DNA ploidy should be uniformly studied in clinical trials, particularly in patients with localized prostate cancer.

Biopsy↗

PubMed2004

Laparoscopic antireflux surgery.

Laparoscopic antireflux surgical procedures were introduced into clinical practice a little more than a decade ago. Today, they constitute a well-established treatment modality for gastro-esophageal reflux disease. With the introduction of laparoscopy, there has been a significant increase in the number of antireflux procedures performed annually in the United States. This most likely indicates more willingness by patients and referring physicians to consider the less invasive approach, rather than a change in the indications of surgical therapy. The main indications for surgical treatment continue to be relapse on medical therapy, intolerance of medications or the patient's choice of not taking medications chronically. A key to successful outcome following antireflux surgical procedures is careful patient selection and work-up. The use of endoscopy, contrast studies, esophageal manometry and 24-h pH studies is of paramount importance. Typical of many laparoscopic operations, antireflux procedures evolved with time and underwent several technical refinements. There continues to be considerable debate on some of the technical aspects of these procedures and on the long-term difference in outcome between partial and complete fundoplication. The superiority of the laparoscopic approach over the open approach has been established, with short-term advantages observed. Long-term outcome between the open and laparoscopic approaches appears to be equivalent. Failures of surgical therapy can be broadly divided into 2 groups: 1) improper patient selection and work-up and 2) technical failures. Redo laparoscopic antireflux operations are technically challenging but feasible in experienced hands.

Body Mass Index↗

PubMed1979

[Film work of an autonomous group of patients].

For the past 16 years an autonomous group of patients has been making films at the university psychiatric clinic in Lausanne. A professional technician is available for consultation on technical problems, but strictly refrains from intervening in the creative work proper. In this way authentic documents emerge dealing with the group's collective experience, whilst each participant is conscious of his personal involvement in the enterprise. There is a discussion of the various therapeutic aspects of this kind of group work.

Acting Out↗

PubMed1981

Correlates of class rank of high school handicapped students in mainstream vocational education programs.

This study examined the relationship between performance in a training program (class rank) and intelligence-skills (Purdue Pegboard, Weschler, a work-behavior rating scale) for a group of handicapped students "mainstreamed" into two regular vocational-technical high school programs IQ type of disability, work-personal behaviors ratings and prior academic achievement were found to be predictors of class rank.

Achievement↗

PubMedDate not supplied

Immune alterations in humans exposed to the termiticide technical chlordane.

Lymphocyte phenotype frequencies and in vitro functional assays were studied in 27 individuals who had been exposed to technical chlordane in their homes or at their places of work. A control group consisted of 118 individuals who were similar to the exposed group with respect to age and sex distribution, and who had not knowingly experienced exposure to technical chlordane, was chosen for study. A significantly increased frequency of cortical thymocytes in the circulation (CD1) (p less than .001) and a decreased frequency of the suppressor-inducer phenotype CD45RA/T4 (p less than .01) were noted in the exposed group. Both kappa and lambda light-chain frequencies were elevated (p less than .01). Proliferative responses to the three mitogens tested, PHA, CONA, PWM, and to allogeneic lymphocytes in the mixed-lymphocyte culture assay were significantly lower than in controls (p less than .01). Responses in assays of the natural killer function were not significantly different from those of controls, but Fc receptor-associated K cell function was significantly greater than responses in controls. Of 12 individuals tested for evidence of autoimmunity, 11 demonstrated some increased titer of a form of autoantibody. This cluster of significant findings demonstrates the emergence of aberrant peripheral T and B cell regulation and a potential for autoimmune activation, detectable up to 10 y after exposure to technical chlordane.

Adipose Tissue↗

PubMed2004

Overview of an interlaboratory collaboration on evaluating the effects of model hepatotoxicants on hepatic gene expression.

DNA microarrays and related tools offer promise for identification of pathways involved in toxic responses to xenobiotics. To be useful for risk assessment, experimental data must be challenged for reliability and interlaboratory reproducibility. Toward this goal, the Hepatotoxicity Working Group of the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) Technical Committee on Application of Genomics to Mechanism-Based Risk Assessment evaluated and compared biological and gene expression responses in rats exposed to two model hepatotoxins--clofibrate and methapyrilene. This collaborative effort provided an unprecedented opportunity for the working group to evaluate and compare multiple biological, genomic, and toxicological parameters across different laboratories and microarray platforms. Many of the results from this collaboration are presented in accompanying articles in this mini-monograph, whereas others have been published previously. (Italic)In vivo(/Italic) studies for both compounds were conducted in two laboratories using a standard experimental protocol, and RNA samples were distributed to 16 laboratories for analysis on six microarray platforms. Histopathology, clinical chemistry, and organ weight changes were consistent with reported effects. Gene expression results demonstrated reasonable agreement between laboratories and across platforms. Discrepancies in expression profiles of some individual genes were largely due to platform differences and approaches to data analysis rather than to biological or interlaboratory variability. Despite these discrepancies there was overall agreement in the biological pathways affected by these compounds, demonstrating that transcriptional profiling is reproducible between laboratories and can reliably identify affected pathways necessary to provide mechanistic insight. This effort represents an important first step toward the use of transcriptional profiling in risk assessment.

Animals↗

PubMed2005

Standardized assessment of cell proliferation: the approach of the RITA-CEPA working group.

Since 1985, quantitative data on cell proliferation increasingly form an integral part in the risk assessment of many pharmaceutical, chemical, and agrochemical compounds. Technical guides for the conduct of cell proliferation studies are not readily available. The detection of cell proliferation relies almost exclusively on immunohistochemistry, which is rarely standardized between laboratories. Against this background pathologists formed the RITA-CEPA working group with the aim of elaborating standard guides for the conduct of cell proliferation studies. We present here, as examples, the general BrdU guide as well as the organ-specific guides for hepatocytes, thyroid gland follicular cells, and renal tubular epithelial cells in the rat. Today, RITA-CEPA has available guides for BrdU cell proliferation studies in 20 organs as well as for studies with PCNA as proliferation marker and for apoptosis studies with the TUNEL technique. The relevant information from more than 500 selected publications is organized in a database structure to make it easily traceable. New hardware and software used for image analysis are being assessed and are included in the information exchange practiced in the CEPA working group. Further fields of major relevance for cell proliferation studies, such as statistics and the validation of image analysis equipment in a GLP environment are investigated. A guide on the use of statistics in cell proliferation studies is in preparation. CEPA-group members meet regularly to exchange information. They use the electronic database for planning and interpretation of cell proliferation studies. CEPA will continue with the preparation of organ guides and expand the series for other proliferation markers, e.g. Ki-67. It promotes standardization of techniques applied in proliferation studies, especially immunohistochemistry and image analysis. Members of the CEPA-group have access to a comprehensive and steadily increasing knowledge base on all aspects of cell proliferation. Membership of the CEPA group is open for all industrial organizations who develop chemical, agrochemical, or pharmaceutical products.

Animals↗

PubMed1997

Overview of DOD activities in ecological risk assessment.

Under the Comprehensive Environmental Response, Compensation and Liability Act, Congress has mandated that all designated hazardous waste sites will be remediated to protect human health and the environment. This law is the driving force behind the Department of Defense (DOD) ecological risk assessment (ERA) program. Ecological risk assessments are currently underway at many DOD sites with budgets ranging from five thousand to ten million dollars. However, with the advent of downsizing government and shrinking funds, efforts are being made within DOD to better refine these assessments. Two DOD work groups function to develop guidance for and assist project managers with the ERA process. These groups are the Army Biological Technical Assistance Group chaired by the Army Environmental Center and the Tri-Service Ecological Risk Assessment Work Group (ERWG) chartered by the Tri-Service Environmental Support Centers Coordinating Committee. Membership in the Tri-Service ERWG includes all facets of DOD. In the research arena, the Fate & Effects Research and Development Program is one of four primary thrust areas under the Army's Environmental Quality Technology Program "Clean Up" pillar. This program is currently being executed by three laboratories, the Waterways Experiment Station, Vicksburg, MS, the Army Center for Health Promotion and Preventive Medicine, Aberdeen Proving Ground, MD, and the Army Center for Environmental Health Research (Provisional), Ft. Detrick, MD. The goal of this program is to provide tools to improve environmental risk assessments, both human and ecological. The research is geared toward addressing user requirements and is defined by the Fate and Effects Research Program.

Ecology↗

PubMed1987

Discrepancies in the study of byssinosis in China.

The existence of byssinosis in China was first reported in 1964. Detailed studies only started in the late 1970s and early 1980s. The work of the WHO study group as edited by the Technical Report Series no. 684, "Recommended health-based occupational exposure limits for selected vegetable dusts," promotes the further study of occupational disease in China; a few points need further discussion. The word byssinosis translated in Chinese is misleading as to the real pathogenesis of the disease. Some still believe cotton dust causes interstitial fibrosis, while the majority of researchers agree with the WHO study group. A poorly designed animal model may have led to the (incorrect) conclusion that dust from carding room is toxic if it is injected intratracheally. The reasons for the controversy in the prevalence of byssinosis in different reports in earlier years are the different diagnosis criteria and the fact that dust sampling methods were not standardized; pulmonary function tests were not used as a routine index; chronic bronchitis and smoking are now recognized as confounders and should have been considered. This Institute initiated the hygiene standards study on cotton dust and recommended 1 mg/m3 for respirable dust and 3 mg/m3 for total dust. If a reduction in dust levels could prevent byssinosis, it would likely also control the risk factor for developing bronchitis.

Byssinosis↗

PubMed1984

Spontaneous abortions among laboratory workers; a follow up study.

An investigation was conducted among all female laboratory workers in the county of Funen to test the hypothesis that work in laboratories during pregnancy increases the risk of spontaneous abortion. Laboratory workers from hospital, university, and other public laboratories and from laboratories in industry were investigated. A socially comparable reference group less exposed to chemicals at work included office workers, technical assistants and designers, physiotherapists, and occupational therapists. Information was obtained through a postal questionnaire study in May 1980 and from hospital records. Neither the occupation in any single category of laboratory nor the alleged exposure to any single chemical during pregnancy showed a significant increase in the odds ratio for spontaneous abortion. A selection bias was found among the non-respondents with respect to both occupation and outcome of pregnancy, but the influence on the results was slight, owing to the small number of non-respondents. The higher rates of hospital admission for spontaneous abortion among the cases compared with the controls indicates that register data are not more valid than self reported data. This leads to several methodological problems that ought to be studied in further detail.

Abortion, Spontaneous↗

PubMed1996

Anthrax: memorandum from a WHO meeting.

The risk of anthrax can be reduced through international collaboration in health education and training, promotion of research, and provision of scientific and technical advice. These issues were discussed by a WHO Working Group on Anthrax in September 1995, and this Memorandum presents their priority concerns and recommendations in several areas: surveillance, epidemiology, diagnosis in humans and in animals, prevention and control, and international cooperation.

Animals↗

PubMed2004

Hand hygiene among physicians: performance, beliefs, and perceptions.

BACKGROUND: Physician adherence to hand hygiene remains low in most hospitals. OBJECTIVES: To identify risk factors for nonadherence and assess beliefs and perceptions associated with hand hygiene among physicians. DESIGN: Cross-sectional survey of physician practices, beliefs, and attitudes toward hand hygiene. SETTING: Large university hospital. PARTICIPANTS: 163 physicians. MEASUREMENTS: Individual observation of physician hand hygiene practices during routine patient care with documentation of relevant risk factors; self-report questionnaire to measure beliefs and perceptions. Logistic regression identified variables independently associated with adherence. RESULTS: Adherence averaged 57% and varied markedly across medical specialties. In multivariate analysis, adherence was associated with the awareness of being observed, the belief of being a role model for other colleagues, a positive attitude toward hand hygiene after patient contact, and easy access to hand-rub solution. Conversely, high workload, activities associated with a high risk for cross-transmission, and certain technical medical specialties (surgery, anesthesiology, emergency medicine, and intensive care medicine) were risk factors for nonadherence. LIMITATIONS: Direct observation of physicians may have influenced both adherence to hand hygiene and responses to the self-report questionnaire. Generalizability of study results requires additional testing in other health care settings and physician populations. CONCLUSION: Physician adherence to hand hygiene is associated with work and system constraints, as well as knowledge and cognitive factors. At the individual level, strengthening a positive attitude toward hand hygiene and reinforcing the conviction that each individual can influence the group behavior may improve adherence among physicians. Physicians who work in technical specialties should also be targeted for improvement.

Adult↗

PubMed1995

[Disposable versus reusable instruments in laparoscopic surgery--a controlled study].

The instruments for laparoscopic surgery are usually available in a disposable and in a reusable type. We performed a prospective, randomized study, based on the most frequent laparoscopic operation, the cholecystectomy, in order to directly quantify and compare the advantages and disadvantages of both types of instruments. 158 patients, who planned to undergo a cholecystectomy, were randomly distributed into two groups. 80 patients (group A) underwent surgery with reusable instruments and 78 patients (group B) with disposable instruments. We investigated the following parameters and compared them for both groups: length of operation, complications, conversion rate to open surgery, subjective postoperative pain, length of inability to work, technical problems during operation, postoperative hospitalization time, satisfaction of operating room personnel. The analysis of the results demonstrates no difference in the postoperative hospitalization time, in the postoperative complication rate, subjective pain sensation and postoperative inability to work. Differences in favour for the group of patients, operated with disposable instruments, were found in the conversion rate, in the length of operation and, statistically significant, in the amount of intraoperative problems, caused by instrument-technical reasons. Even if considering the greater expenses in time and personnel costs, operations with reusable instruments are in average 1015 DM cheaper.

Adolescent↗

PubMed2006

Future prospects for fMRI in the clinic.

Functional MRI (fMRI) has tremendous clinical potential that is as yet unrealized. There are tremendous unmet medical needs that fMRI could address with significant benefit to human health. However, both medical and technical barriers prevent this benefit from accruing today. Technical barriers may be the reflexive focus of the current practitioners of fMRI, a technically savvy group. However, the real challenge lies in the medical realm, and this will require multidisciplinary and interdisciplinary work since the technical aspects of fMRI are ahead of the medical aspects. This can be seen in a range of diseases from Alzheimer's disease to schizophrenia to ischemic stroke: in each case our ability to image changes with fMRI outstrips our ability to do anything useful for the patient with them. Diagnostic imaging will always be linked in the clinic to therapeutic choices, and therefore the most powerful approach to link fMRI more directly to the clinic will be to tie fMRI to therapy development and implementation.

Brain Mapping↗