International Journal of Risk & Safety in Medicine - Volume 6, issue 2
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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: A project implemented within the framework of the International Clearinghouse for Birth Defect Monitoring Systems is named MADRE: MAlformation DRug Exposure surveillance. The idea is to survey the simultaneous occurrence of malformations and first-trimester drug exposures. In a 2-year period 1990–91, this has yielded 1448 infants known to have been exposed to drugs and that are known to have malformations. Cases have been reported by eight programs: Australia, Central-East France, Israel, Italy IPIMC, Italy IMER, Japan Red Cross Hospitals, Japan Maternal Health and Welfare, and South America. By searching this databank for associations between drugs and malformations, specific relationships can…be detected. The 9th revision of the WHO International Classification of Diseases, adapted by the British Paediatric Association, known as ICD9/BPA is used for coding malformations. This is a hierarchical system with 5 digits as the maximum level of specification of each malformation. The ATC (Anatomical Therapeutic Chemical) classifications system is used for coding drugs. This is a multiple level, hierarchical classification with up to 7 digits for specifying each drug. Up to five drugs and malformations are coded for each case using ATC and ICD9/BPA classifications, and all observed drug-malformation pairs form the basis for the analysis. For each drug-malformation combination where three or more cases are observed, a set of 2×2 tables is formed and analyzed as in case-control studies. The odds ratio for the pair, stratified for program, gives the relative risk for the malformation in question, comparing use of the specific drug with all other drugs. Well known or controversial associations were tested in the collected material, and at this stage only one new association is suggested, that is between cardiac defects and maternal treatment with thyroid hormones. This finding has to be further explored with new data.
Keywords: Surveillance, Malformation, Birth defect registry, Drug exposure, Teratogen, Case-control study
Abstract: Alterations of the cerebral function caused by anesthetics or due to potentially harmful situations are reflected in the electroencephalogram (EEG). Nevertheless, the EEG has not become a routine monitoring device so far because of the complicated and time-consuming recording procedure. Furthermore, interpretation of the EEG requires special knowledge. In order to facilitate the use of the EEG in the theatre and the intensive care unit a new monitoring device the Narkograph, was developed. To our knowledge, the Narkograph is the first monitor for day-to-day use which performs an automatic classification of drug-induced changes of the EEG in real-time. Staging into…different levels of anesthesia is performed according to proposals made by Kugler (1981). By means of several case reports the use of the Narkograph and the benefits of routinely conducted EEG monitoring are presented. As, due to the on-line interpretation of EEG data, information on the current functional status of the brain can easily be obtained, the Narkograph is considered an essential contribution to the patients' security.
Abstract: Study objectives: Recent research has brought into question patients willingness to accept immediate treatment risk for the possibility of increased 5-year survival. This study was designed to assess whether patients are able to identify the probability of initial mortality they would be willing to accept in order to increase their chance of long-term survival. Design: Cross-sectional structured interviews with continuity clinic patients. Setting: A university-based Department of Veterans Affairs Medical Center general medicine clinic. Participants: 128 consecutive patients (mean age = 65.4 years (s.d. = 11.27, range of ages = 30–83)), seen in the second half of…1992. Measurements and results: In a hypothetical setting, patients were presented with a pair of curves representing expected survival over a 5-year period for I two alternative treatments. The disease and treatments were not identified. In one curve, there was a 10% peri treatment mortality rate and a 37% 5-year survival; in the second curve, there was a 0% peritreatment mortality rate and a 22% 5-year survival. Once patients selected the treatment they preferred based on the curve pair, they were asked whether they were willing to accept an initial risk higher than the one they had selected. Of the 128 patients, 26.6% (34/128) selected the treatment with a 0% mortality in the peritreatment period. For these 34 patients, their mean initial acceptable probability of death was 3.75% (s.d. = 2.32, range 0–9). Of the 94 study patients who selected the 5-year curve with 10% mortality in the peritreatment period, the mean initial risk they were willing to accept was 14.73% (s.d. = 9.12, range = 10–70). Older patients were less willing than younger patients to accept probabilities at higher than the given immediate peritreatment risks for both treatments (chi square = 4.330, d.f. = 1, P < 0.04). Conclusions: Patients are not as uncomfortable at taking immediate risks of death for a 5-year survival benefit. Patients report a willingness to accept risk of immediate death for 5-year survival benefits.
Abstract: In 1991, Denmark established a Patient Insurance Scheme. The Scheme entered into force on 1 July 1992 and the first experiences with the Scheme have now been gained. Even though it is still too early to draw a clear picture of the significance of the Scheme, it is already safe to conclude that the Scheme provides a much more extensive coverage than did the hitherto prevailing negligence-based liability system. Furthermore, it is safe to conclude that the Scheme works much faster than the fault liability system where it might take years before the courts reached a decision.
Keywords: Patient Insurance Act, Medical injury, Denmark