International Journal of Risk & Safety in Medicine - Volume 2, issue 5
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The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: The International Clearinghouse for Birth Defects Monitoring Systems (ICBDMS), founded in 1974, is an organization devoted to the prevention of birth defects. A major activity of member programs is the monitoring of rates of birth defects, searching for changes that might herald the introduction of a new teratogen into the environment. The primary purpose of the ICBDMS is to provide a forum for member programs to share information. This sharing is done through regular quarterly and annual reports of data, at annual meetings, and through informal contacts of the staff of member programs. In 1988, the ICBDMS established an International…Centre for Birth Defects (ICBD) at the University of Bergen, generous financial support is being provided by the Norwegian government. The Centre is to function as a “headquarters” for the Clearinghouse, promoting and facilitating its activities. It will establish a focus for collaborative epidemiologic research on birth defects, promote improvements in birth defects monitoring, and provide a setting for training.
Keywords: Epidemiology, Birth defects, International cooperation
Abstract: The International Clearinghouse for Birth Defects Monitoring Systems (Clearinghouse) was created as a monitoring network aimed at exchanging epidemiological data on malformations in newborns. After several years of experience, directors of two programs participating in this network describe some rather unknown aspects of this membership. Firstly, a short description is given of these two different programs: one located in France (Rhone-Alpes/Auvergne) which is regional and population-based and collects information on birth defects, and one located in Spain which is nation-wide, hospital-based and collects iuformation on birth defects and controls. The Clearinghouse membership gives the possibility to utilize a data base…more effectively by receiving external material with which to compare local data, being given advice from experts in case of clusters, and conducting international collaborative studies, examples of these activities are given. The international contacts established through the Clearinghouse are looked upon as educational, and may actually increase the possibility of detecting risk factors for birth defects and eventually preventing them.
Keywords: Epidemiology, Birth defects, International cooperation, Methodology
Abstract: Multimalformed infants (MMI) without a diagnosis of a specific syndrome have often been successfully used by alert clinicians to prompt studies which have led to the definition of new teratogens. However, usually they are not analyzed in any specific way in the routine monitoring by birth defects registries. In 1980 the International Clearinghouse for Birth Defects Monitoring Systems (ICBDMS) decided to try to develop new methodologies to use MMI in the larger and more systematic context of birth defects monitoring. Before starting the following issues had to be addressed: (a) definitions of “single defect” and of “multimalformed infant”, (b) transmission…of information, and (c) coding. Only those registries able to give detailed descriptions of defects could take part. Between January 1983 and December 1987, out of more than 6.5 million births from 19 registries, 3,534 infants with at least three unrelated defects of any type were centrally registered and coded by a single person. Three main monitoring procedures were used: (a) statistical analysis of the frequency of 58 types of defects observed among the MMI, (b) computer aided search for “similar cases”, and (c) identification of “non random associations” and comparison with appropriate baseline material. This last procedure can also be used in cumulated material to study some well-known associations such as “VATER”. These monitoring activities did not identify any “alarm” situation, however, many simulations have shown the efficiency of the procedures, as well as the possibilities and limits of this collaborative monitoring activity.
Abstract: Medical authorities in developing countries are primarily interested in nutritional and infectious diseases. Therefore, activities directed to the prevention and control of low priority illnesses, such as birth defects, need to be particularly effective, simple, and economical. Monitoring of congenital anomalies is one of the preventive activities which can be efficiently performed at very low cost. Guidelines for this are given, and their application exemplified by the case of Uruguay. Uruguay has recently attained an infant mortality rate of 20/1,000, with the congenital anomalies ranking as its second cause. The government of Uruguay, through the Pan American Health Organisation/World Health…Organisation (PARO/WHO) called the Estudio Colaborativo Latino Americano de Malformaciones Congenitas (ECLAMC) for advice in order to plan a program for the prevention of birth defects. The recommendations given were based on conclusions drawn from the analysis of data the ECLAMC program has been accumulating, from Uruguay and other Latin-American countries, since 1967. The case of Uruguay clearly indicates that sensible guidelines for birth defects prevention can be provided, after working with this “low priority and uninteresting” group of illnesses for more than twenty years.
Abstract: Statistical methods for surveillance are reviewed for use with both hospital-based systems and central registries. In the hospital-based system the surveillance methods are applied as each new case occurs and the methods focus on the number of unaffected births between each case. In centralized systems, it is usually more convenient to observe the number of cases in time intervals of fixed length. Methods for calculating exact confidence limits about the number of cases, the proportion of malformed cases and the observed-to-expected ratio are reviewed, as are methods allowing evidence to accumulate over several time periods. Examples are given to illustrate…the use of the different methods.