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PubMedDate not supplied

Investigations on the efficacy of two schemes of standard gammaglobulin administration in the prevention of viral hepatitis.

Prophylactic administration of standard gammaglobulin (G) to over 5,000 children led to a more than 6-fold decrease in the incidence of icteric viral hepatitis (V.H.) as compared with the control group and to the disappearance of the autumn--winter epidemic peak. A 3-fold decrease in the incidence of subclinical forms was also achieved. In another group of 5,000 children G was only given to contacts in epidemic foci; the incidence of icteric V. H. was similar to that recorded in controls, while subclinical forms were 2 times more frequent in children having received G after the infectant contact.

Adolescent↗
PubMed1998

[An analysis of the reliability of a data-gathering form. An interobserver concordance study].

OBJECTIVES: To measure the reliability of a data-gathering from by analysing the concordance between observers, and to check the efficacy of the corrective measures applied to improve it. DESIGN: A pre-test/post-test design, without a control. SETTING: Urban Health Centre. PATIENTS AND OTHER PARTICIPANTS: Random selection of 50 clinical records from the list of Type 2 diabetics in the centre's computerised files. INTERVENTIONS: Alterations in the data-gathering form in order to improve concordance between two independent observers, measured by means of the Kappa index for qualitative variables and absolute concordance for quantitative ones. The quality criteria defined by the Diabetes in Primary Health Care Study Group were applied. MEASUREMENTS AND MAIN RESULTS: The Kappa index average improved after the intervention from 0.71 to 0.89 (p = 0.019). There were no significant changes in concordance for quantitative variables (6 out of 8 items with 100% concordance at start and finish). CONCLUSIONS: It is important to verify the reliability of the measuring instruments. Our results justify this concern: two independent observers do not always obtain the same reading from the same source. Concordance improved significantly when the form was altered, so guaranteeing greater data-gathering reliability and improving the overall quality of the research.

Data Collection↗
PubMed2004

Work of the European Haemovigilance Network (EHN).

Haemovigilance has become a crucial part of the blood safety concept. In the Member States of the European Union, national haemovigilance systems are already in place or are developing. With the coming into force of the European Blood Directive 2002/98/EC, Community haemovigilance has become a priority: cooperation between the national haemovigilance systems will be of vital interest. The process of collaboration has already been initiated some years ago by the European Haemovigilance Network (EHN) with the following objectives: to favour the exchange of valid information between its members, to increase rapid alert/early warning between the members, to encourage joint activities between the members and to undertake educational activities relating to haemovigilance. This has been achieved by the EHN by developing and maintaining a website [http://www.ehn-org.net], by establishing a system for rapid alert and early warning (RAS), by discussing on all kinds of definitions relevant to haemovigilance, initiating standardisation of processes and forms (developing a common "mother matrix"), by starting with the compilation and analysis of European data (generated by the national haemovigilance systems in Europe) and by organising annual European Haemovigilance Seminars, where all these items are discussed. As in the past, the EHN will continue in the future to play a major role in promoting European haemovigilance.

Blood Banks↗
PubMed2003

Recommendations for conducting the in vivo alkaline Comet assay. 4th International Comet Assay Workshop.

The in vivo alkaline single cell gel electrophoresis assay, hereafter the Comet assay, can be used to investigate the genotoxicity of industrial chemicals, biocides, agrochemicals and pharmaceuticals. The major advantages of this assay include the relative ease of application to any tissue of interest, the detection of multiple classes of DNA damage and the generation of data at the level of the single cell. These features give the Comet assay potential advantages over other in vivo test methods, which are limited largely to proliferating cells and/or a single tissue. The Comet assay has demonstrated its reliability in many testing circumstances and is, in general, considered to be acceptable for regulatory purposes. However, despite the considerable data published on the in vivo Comet assay and the general agreement within the international scientific community over many protocol-related issues, it was felt that a document giving detailed practical guidance on the protocol required for regulatory acceptance of the assay was required. In a recent meeting held in conjunction with the 4th International Comet Assay Workshop (Ulm, Germany, 22-25 July 2001) an expert panel reviewed existing data and recent developments of the Comet assay with a view to developing such a document. This paper is intended to act as an update to the more general guidelines which were published as a result of the International Workshop on Genotoxicity Test Procedures. The recommendations are also seen as a major step towards gaining more formal regulatory acceptance of the Comet assay.

Animals↗
PubMed2002

AICPA allows low-cost options for compiled financial statements.

The AICPA Accounting and Review Services Committee's (ARSC) SSARS No. 8, Amendment to Statement on Standards for Accounting and Review Services No. 1, Compilation and Review of Financial Statements, issued in October 2000, allows financial managers to provide plain-paper, compiled financial statements for the exclusive use of management. Such financial statements were disallowed in 1979 when the AICPA issued SSARS No. 1, Compilation and Review of Financial Statements. With the issuance of SSARS No. 8, financial managers can prepare plain-paper, compiled financial statements when third parties are not expected to rely on the financial statements, management acknowledges such restrictions in writing, and management acknowledges its primary responsibility for the adequacy of the financial statements.

Accounting↗
PubMed1991

Practical aspects of internal quality assurance.

The final analytical quality of a result is influenced by external and internal factors. The quality of external elements is influenced by the individual laboratory through its choice of method and supply; such elements are, e.g. reference materials, calibrators, control materials, reagents, reagent kits, instruments and disposables. The internal elements can be described through rules for good laboratory practice (GLP), and include all aspects of internal quality assurance. In this paper, GLP is used to describe the proper milieau in which the optimally selected method is working. The control system for acceptance or rejection of any particular batch of analysis, as well as the long-term control, are also described separately.

Bias↗
PubMedDate not supplied

Occupation and lung cancer risk in Leningrad Province, Russia.

To investigate the association between occupation and lung cancer risk in Leningrad Province, Russia, we identified 540 pathologically diagnosed lung cancer cases (474 males and 66 females) and 582 controls (453 males and 129 females) from the 1993-1998 autopsy records of the 88 state hospitals of the Province. Lifetime occupational histories were obtained from personal records coded according to the standard Russian occupational classification system. Lung cancer risk was increased in workers in the manufacturing industry, particularly in the food industry and wholesale/retail trade and in the miscellaneous manufacturing industry. An increased risk was also found in subjects employed in chemical and metal production for 10 years or more. When we considered the association between specific occupations and lung cancer, waste incineration operators and loaders exhibited an excess risk that increased with employment duration. The present study, which is the first to evaluate the risk of lung cancer by occupation in Russia, suggests the presence in Leningrad Province of exposure in the workplace to lung carcinogens that require further characterization to develop targeted and effective preventive measures.

Administrative Personnel↗