International Journal of Risk & Safety in Medicine - Volume 10, issue 1
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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 present thesis, which is based on a review and 12 published articles, concerns clinical epidemiological methods [176–187]. The Nordic countries have for many years established numerous registries. The establishment in Denmark of the National Population Registry in 1924 and the personal registration number (the CPR number) in 1968 allowed person-identification of remarkable quality, and made it possible to gather information on the same person in several registries. This situation is unique to the Nordic countries. The administrative registries were not primarily established for research purposes but have often proved a valuable tool in research. Despite the extensive…use of registries in research, the methodological literature on this subject is limited. The purpose of the present thesis was: 1) to analyse strengths and limitations in using regional administrative registries in research, 2) to develop a framework for evaluation of existing registries for use in clinical epidemiological research, 3) to develop methods for evaluation of the data quality in regional registries, and 4) to evaluate four regional Danish administrative health registries for use in clinical epidemiological research. The analyses of strengths, limitations and data quality were based on studies of data from the regional hospital information systems, health service registries, and public health officers' surveillance system for strong analgesics and notifiable diseases. Against the background of the studies, the many advantages of using registries in research are discussed. The most important advantage is that data already exist and time consumption is thus considerably reduced, compared with studies based on collection of primary data. Costs are also considerably reduced. Other advantages included the generally large sample sizes, which provide great precision in estimates and which allow the study of rare exposures, diseases and other effects. Typically, the registries are complete as far as the persons in the target population are concerned; this ensures representativeness. Collection of registry data has been done independently of the present study, and this often reduces various types of bias such as recall, non-response, and influence on the diagnostic process determined by the study. A number of health problems manifest themselves many years after the exposure, and existing registries are thus especially valuable when studying diseases with a long period between exposure and disease manifestation. The limitations in the use of registries are considerable and often ignored. The most significant problems are related to data selection and data quality because the data collection method is determined by the registry. The studies have varied in quality, which is often evaluated at regional level, since the same information is usually stored in several registries. This allows for comparison with respect to the completeness and validity of the data. The use of discharge diagnoses from hospital registries involves considerable data quality problems, while data from the health service registries, and from the public health officers' surveillance system for strong analgesics and notifiable diseases are of satisfactory quality. Misclassification of data exists, however, in all data sources; this can only be revealed by comprehensive studies of the validity of the data quality.
Abstract: Angiotensin Converting Enzyme Inhibitors (ACE-I) have been very effective in treating hypertension. Adverse conditions in the fetus with the use of ACE-I, such as oligohydramnios, intra-uterine growth restriction (IUGR), hypocalvaria, persistent ductus arteriosus with fetal and neonatal death have been rerported. Though the pathophysiology was thought to be a problem with renal hypoperfusion in the fetus, it remained unclear whether the first trimester exposure to these drugs produced a similar pattern. We participated in a collaborative trial initiated by the Organization of Teratology Information Services (OTIS) in the United States to examine whether first trimester exposure to ACE-I was of…concern. Eight women from our High Risk Pregnancy Unit who delivered in our hospital were enrolled in the trial. All were treated with either Enalapril or Captopril in the first trimester due to various reasons, mainly chronic hypertension and diabetic nephropathy. No major malformations were detected in the nine newborns studied (one pair of twins). Two cases of IUGR were diagnosed, one of them ended in an intra-uterine death, but this was attributed to maternal severe disease and probably not to drug effect. We are definitely not suggesting that women should stay on ACE-I until the second trimester, but it seems that renal blood flow and its associated problems with glomerular filtration are not affected in the first trimester.
Keywords: Drugs in pregnancy, ACE inhibitors, teratogenesis
Abstract: Benign familial leukopenia (BFL) has been described in various ethnic groups around the world; in Israel it is found among Yemenites and Ethiopians. Neuroleptics infrequently cause acute leukopenia. We described nine Ethiopian subjects who were treated with conventional antipsychotics for four weeks. In three subjects probable BFL was demonstrated prior to treatment. By the end of four weeks of treatment 6/9 subjects developed leukopenia with neutropenia. Reduction in mean WBC counts and neutrophil counts was significant (p=0.014 and p=0.001, respectively). None of the subjects developed an acute illness or an infection during the studied period. We tentatively suggest that…in subjects belonging to ethnic groups where BFL is common antipsychotics may induce its expression without significant clinical symptomatology.
Abstract: Congenital malformations are important public health issues since malformations are expensive conditions to treat. Congenital heart disease and neural tube defects are some of the commonest congenital anomalies. Advances in the diagnosis and treatment of these conditions should be reflected in declining specific mortality rates. The Maltese mortality statistics listing congenital heart disease and neural tube defects as the primary cause of death on death certificates were analysed for evidence of such trends. This study has shown that since 1950, there has been a significant fall in mortality from congenital heart disease in Malta (r=−0.84, p<0.0001) which has not yet…levelled off. There was no such trend for neural tube defects (r=−0.27, p<0.83). In spite of these advances, about a third of infants born with congenital malformations still die from the disorder, mainly during the perinatal period.
Abstract: A consecutive series of intertrochanteric fractures treated with sliding screw and plate fixation were radiographically evaluated for the optimal position of the screw. An optimal position was determined. It was characterized by four position indexes in the head-neck region.
Keywords: Intertrochanteric hip fractures, screw position
Abstract: Mutilation was a common punishment in Byzantium, which in all probability was introduced from the East. In legislation it was first featured in the “Eclogi” collection of laws of the Emperor Leo Isavrus III (717–741 A.D.). There are, however, indications that this punishment was already established and widespread in the time of Justinian I (527–565 A.D.), because some chroniclers of that era state that this was used for gamblers using dice and for homosexuals. The collection of laws of Leo VI the Wise (886–912 A.D.), the well-known “Hexabiblos”, applied this punishment to a variety of offences such as theft, incest,…adultery, attempted murder, sacrilege and the like. This punishment, furthermore, was the main penalty used against rebels and against Byzantine emperors and members of the royal family when they were removed from the throne after a successful insurrection. The basis of the latter punishment was that a mutilated person was excluded from the throne of Byzantium because the emperor was expected to fulfil the customary ideal presupposition of “perfection”. No matter how curious it sounds, this barbaric penalty was imposed for reasons of leniency, i.e., to avert the heavier death penalty.