The legal acknowledgement of the electronic signature: a key for a secure direct access of patients to their computerised medical record.
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Computer Security↗
Biomedical subjects
F A Allaert
Publications and source records attributed to F A Allaert.
Assessment of cetirizine, an antihistamine, to prevent cutaneous reactions to nevirapine therapy: results of the viramune-zyrtec double-blind, placebo-controlled trial.
We conducted a 12-week, multicenter, randomized, double-blind, placebo-controlled trial of cetirizine to assess the ability of antihistamines to prevent nevirapine-associated rash in patients infected with human immunodeficiency virus type 1. Patients initiating treatment with nevirapine were randomized to receive either cetirizine, 10 mg q.d. (104 patients), or placebo (96 patients) during the first 6 weeks of therapy. Rash occurred in 22 (11%) of 200 patients; 10 (9.6%) were in the cetirizine group and 12 (12.5%) were in the placebo group (odds ratio [OR], 0.75; 95% confidence interval [CI], 0.31-1.81; P=.5). Five of 22 rashes were cases of hypersensitivity syndrome. The rate of nevirapine discontinuation due to rash was similar in the 2 groups (7.7% and 6.25% in the cetirizine and placebo groups, respectively; P=.4). Multivariate analysis showed no treatment-group effect but indicated that age >40 years (OR, 3.83; 95% CI, 1.4-10.46; P=.008) was associated with an increased risk of rash. Cetirizine has no preventive effect on nevirapine-associated rash.
Adult↗
Primary osteoarthritis and occupations: a national cross sectional survey of 10 412 symptomatic patients.
AIMS: To describe the age standardised prevalence of symptomatic osteoarthritis (OA) in a nationwide cross sectional survey of 10 412 patients in France, and their functional and work limitations. METHODS: Cases in the survey were compared with their expected counterpart by age, gender, and occupational groupings using data from the 1998 French National Survey on Health Impairment and Disability. RESULTS: Women represented 66.2% of the sample; mean age was 66.2 years. One third of patients had OA of the knee, 16% of the hip, and 12% of the hand; a third had multiple joint OA. Peak prevalence of symptomatic OA was in the 60-69 year category in women and in the 70-79 year category in men. Agricultural workers showed a significant excess prevalence of OA, with an observed to expected (O/E) ratio of 1.7 in women and 2.3 in men. Linear trends in prevalences between white collar, "mixed" collar, and blue collar workers were also significant, with odds ratios respectively of 1.0, 2.9, and 2.6 in women and 1.0, 1.2, and 1.7 in men. Specific excess prevalence was found in women among housekeepers (O/E 4.4), and in men among unskilled labour workers (O/E 10.3) and truck drivers (O/E 6.7). Total work disability was highest among blue collar workers and partial disability among agricultural workers. CONCLUSION: Results contribute to the mounting evidence that OA is potentially aetiologically linked to occupation in a sizeable segment of the population and that OA can no longer be considered an inevitable disease of ageing.
Adult↗
Law and standards faced to market rules in health information security.
This paper presents the main differences existing in the elaboration process of law and standard and analyses their potential conflicts. It also describes the respective force of law and standards in three main areas: legal threat versus financial threat, conflict versus cooperation and finally their respective position faced to oligarchic power.
Compensation and Redress↗
[Acne in adult women: data from a national study on the relationship between type of acne and markers of clinical hyperandrogenism].
INTRODUCTION: The role of hyperandrogenism in acne occurring or persisting in adult women is controversial. Studies reported have often been carried out in hospital settings. The aim of this nationwide prospective and descriptive study was to evaluate the frequency of clinical hyperandrogenism in a large number of adult acneic women visiting dermatologists in a non-hospital setting. PATIENTS AND METHODS: Three hundred and fifteen dermatologists completed clinical questionnaires concerning the next five female patients with acne at their private practices. These patients had to be between 25 and 45 years of age. The questionnaire covered patients' demographic characteristics, medical history, gynaecological status and acne history. Patients' acne, seborrhea and cycle disorders were described, as well as other signs suggesting hyperandrogenism, such as hirsutism and alopecia. RESULTS: A total of 1 135 questionnaires were analyzed. Nearly 50 p. 100 of the patients had major scalp or facial seborrhea, 18.4 p. 100 hirsutism, 7 p. 100 alopecia and 32.2 p. 100 menstrual cycle abnormalities. When these signs were present, acne was more often retentional, with more scarring and more widespread. CONCLUSION: This prospective study in a large number of patients in a non-hospital setting shows that acne in adult women is frequently associated with clinical hyperandrogenism.
Acne Vulgaris↗
Pharmaco-epidemiology of the treatment of chronic venous insufficiency in general medicine.
BACKGROUND: A report is presented of a multicenter pharmaco-epidemiological study on chronic venous insufficiency conducted in France on 5043 patients. METHODS: It was based on a questionnaire that included the demographic characteristics of the patients, their risk factors for venous disease, history of venous insufficiency, physical and functional symptoms, and clinical stage according to the CEAP classification, as well as modalities of treatment and professional practice of the participating doctors. The various treatment modalities (phlebotonics, compression stockings, sclerotherapy and surgery) were related to the stage of the venous insufficiency and to the satisfaction expressed by the patients. RESULTS: The results of the study showed a minimum annual sick leave rate of 7.2%. CONCLUSIONS: In conclusion, this study brings to the fore the change in treatment modalities for venous insufficiency according to its severity stage, principally as regards medico-economics.
Adult↗
Body fluid osmolality and tonicity in preterm infants.
In adult patients, a recent physiological approach for the osmoregulatory system based on body fluid tonicity (the so-called effective osmolality) seems to provide better information on water movements than does the classical body fluid osmolality. To evaluate whether plasma or urinary tonicities could give a better assessment of osmoregulation than plasma and urine osmolalities in sick preterm infants cared for in a NICU. A prospective study was conducted in 30 preterm infants (BW=1284+/-377 g; GA=28.8+/-1.7 weeks). Fifteen consecutive 8-h urine collections were performed for each infant from the 8th h of life (450 periods). A plasma sample was obtained at the end of each urine collection. Sodium, potassium, creatinine, osmolality and tonicity were measured or calculated in urine and blood samples as often as possible. Hypernatremia (PNa=146-149 mmol/l) was observed in seven infants (23.3%) and in 5.9% of the periods. Fifty-three percent of the infants and 20.4% of the periods presented with plasma hyperosmolality (>300 mosmol/kg H2O). The relationship between Posm and PNa was significant, but the clinical relevance was weak (r(2)=0.411; P<0.001). Plasma osmolality (Posm) positively correlated with urine osmolality (Uosm), but did not correlate significantly with CH2O/100 ml GFR. Plasma tonicity (2x(PNa+PK)) positively correlated with both urine tonicity (2x(UNa+UK)) and effective water clearance (EWC/100 ml GFR). On an individual basis, the linear relationship between urine and plasma osmolalities was significantly weaker than the relationship between urine and plasma tonicities. This study suggests that the calculation of plasma and urine tonicities allows a better assessment of water movements in body fluid compartments than plasma and urine osmolalities.
Blood↗
An approach for integrating heterogeneous information sources in a medical data warehouse.
In recent years, medical professionals are witnessing an explosive growth in data collected by various organizations and institutions. At the same time, the ongoing developments of networking technologies provide doctor with the capability to access these data across the boundaries of interconnected computers. In this paper we present a medical data warehousing methodology that aims to use data semantics to regroup and merge patients' medical data from different health information systems, which may be autonomous and heterogeneous. The proposed solution takes into account European laws concerning the security and anonymity of personal data.
Database Management Systems↗
[Frequency and detection rate of silent myocardial ischemia by Holter monitoring in patients with stable coronary insufficiency under treatment. Study of 95,725 recorded hours].
AIM OF THE STUDY: To determine in standard living conditions the circadian variation of the symptomatic and silent electrocardiographic ischaemia in patients with chronic stable coronary insufficiency. To evaluate the influence of the past history of the patients on the circadian variations of the symptomatic and silent ischaemic events. METHODS: The patients included in the study presented with stable angina pectoris and have undergone a 96 hours Ambulatory ECG (AECG) monitoring with a low-weight and compact material which did not modify their daily activities (R-test). The system records the trace that the patient has initiated it himself following the onset of symptoms and makes possible to distinguish between silent and symptomatic ischaemia. The same experienced cardiologist validated all the AECG records. RESULTS: 1,022 patients aged 64.6 +/- 11.0 years suffering of coronary insufficiency from 5.8 +/- 6.0 years have undergone an electrocardiographic record by an R-test for a total duration of 95,725 hours. Of the 1,022 records, 3,258 ischaemic events have been validated: 295 (9.1%) were symptomatic and 2,963 (90.9%) were silent which correspond to a ratio of 1 versus 9 while this ratio is usually described as 1 versus 4. By 26.5% (n = 271) of the patients, ischaemia have been detected and among them more than a half (54.6%, n = 148) were presenting only silent ischaemia. Of these patients who present silent ischaemia, it was recorded during the first 24 hours by only 63.7% of them which is the usual duration of an ambulatory ECG monitoring. This percentage increases to 83.1% after 48 hours and to 94.1% after 72 hours. CONCLUSION: By more than one third (36.3%) of the patients with stable coronary insufficiency, an ambulatory ECG monitoring recorded during only 24 hours is insufficient to detect a silent ischaemia which will happen later. A record duration of 48 hours reduces this risk to 20% of the patients and of 72 hours to less than 5%.
Activities of Daily Living↗
A virtual intranet and data-warehousing for healthcare co-operation.
As patient's medical data is disseminated in different health structures, developing a medical or epidemiological patient-oriented data warehouse has some specific requirements compared to intra healthcare structure data-warehousing projects. The difference is that the healthcare structures implicated in a patient-oriented data warehouse project require some considerations about the confidentiality of the patient data and of the activities of healthcare structures. Building a data-warehousing system at a regional level, for example in cancerology, requires the participation of all concerned health structures, as well as different health professionals. The heterogeneity of sources medical data of has to be taken into account for choosing between several organizational configurations of the data warehousing system. In top of data warehousing, we propose a concept of Virtual Intranet, which provides a solution to the problem of medical information security arising from heterogeneous sources.
Computer Communication Networks↗
Info-vigilance or safety in health information systems.
The paper examines the issues of security and safety in Health Information Systems and focuses the need for the development of appropriate Guidelines for the effective use of IEC 61508 standard.
Computer Security↗
The Swiss solution for anonymously chaining patient files.
Being able to link the successive hospitalizations of a given patient for epidemiological surveys together by preserving patient anonymity requires a specific procedure. For its medical hospital statistics, Switzerland has adopted anonymous record linkage procedure, ensuring an irreversible transformation of identity and allowing the linkage of anonymous files. Concepts, algorithms and organization have been developed by the Federal Statistical Office. Algorithms are closed to those developed in Dijon University Hospital.
Algorithms↗
Law and standards.
A comparison is made between the widely different processes of creating legislation and that of developing standards. Despite their very different origins, in practical terms standards can influence the development of legislation as well as demonstrating compliance with legislative requirements.
Handwriting↗
Comparison of in-vivo antibacterial activity of two skin disinfection procedures for insertion of peripheral catheters: povidone iodine versus chlorhexidine.
Skin disinfection is a key step in the prevention of nosocomial infections especially prior to invasive procedures such as the insertion of peripheral catheters. Alcohol-based antiseptics improve bactericidal activity and decrease the time needed for skin disinfection in emergencies. A randomized study was performed in two groups of 22 volunteers to compare the in vivo bactericidal effect of two rapid disinfection procedures using povidone iodine (PVP-I) in scrub formulation followed by alcoholic PVP-I, or chlorhexidine in scrub formulation followed by alcoholic chlorhexidine. Bacteria were recovered using the cylinder scrub method. Comparison of reductions in the aerobic and anaerobic flora from baseline levels to each of the three sampling times (30 sec, 3 min, 2 h) showed no significant difference between the two procedures Log(10)reduction after 30 seconds was around 1.5 for the aerobic flora and 1.1 for the anaerobic flora. After 3 minutes the corresponding values were 2.1 and 1.8, and after 2 hours 2.0 and 1.3. The products were well tolerated in both groups. The two procedures had comparable rapid bactericidal activity in vivo.
Adult↗
[Security services: an overview of the French legislation on cryptography].
This paper deals with the main security services of data protection: integrity, authentication, nonrepudiation and confidentiality. It describes the different tools which may be used to achieve these security objectives: encryption, digital signature, access controls, integrity control, audit and certification. The French legislation concerning encryption has been recently updated in order to simplify the use of encryption techniques for personal data security. This legislation describes different authorization or reporting procedures according to the type of the request (application, equipment, import or export of encryption techniques) and the security level required.
Algorithms↗
[Security of healthcare data networks used for epidemiological studies].
Record linkage, for compiling sameperson records from various source files, can improve the feasibility of epidemiological research using populationbased studies. The question is comply with the European legislation on data privacy and data security. For example, a computerized record hash coding and linkage procedure is described to link medical information within the framework of epidemiological followup. Before their extraction, files are rendered anonymous using a oneway hash coding based on the standard hash algorithm (SHA) function. Once rendered anonymous using the software ANONYMAT, the linkage of patient information can be accomplished by means of a mixture model, taking into account several identification variables. An application of this anonymous record linkage procedure was carried out in order to link medical files on cancer, from 3 hospitals of the French RhôneAlpes region. This application stresses how the use of the ANONYMAT software allows compliance with the legislation on data confidentiality without entailing problems on data availability.
Computer Communication Networks↗
Anonymous statistical methods versus cryptographic methods in epidemiology.
Sensitive data are most often indirectly identifiable and so need to be rendered anonymous in order to ensure privacy. Statistical methods to provide anonymity require data perturbation and so generate data processing difficulties. Encryption methods, while preserving confidentiality, do not require data modification.
Computer Security↗
[Frequency of silent and painful ischemia in patients with treated stable coronary insufficiency].
The present study was aimed at determining the frequency and circadian variations in symptomatic or silent myocardial ischemia in ambulatory patients with stable coronary disease. A comparative analysis was then made of the recordings on symptomatic and asymptomatic patients according to their medical history. Three hundred and twenty-one cardiologists recruited a total of 1,088 patients who were monitored for 4 days with a new type of electrocardiographic recorder. The patients were able to voluntarily start up the recorder in the case of cardiac discomfort or pain. The results showed that over a total recording period of 95,725 hours, the following data, which were validated by an experienced cardiologist, were obtained: 3,258 ischemic episodes, 2,963 (or 91%) of which were cases of silent ischemia, and 295 (or 9%) which were symptomatic. All the ischemic episodes involved a limited number of subjects, i.e., 271 patients. Of these, 148 (54.6%) were completely asymptomatic; only 63% of these patients with silent ischemia would have been detected if the recording had just lasted 24 hours. Moreover, the medical history showed a correlation between certain factors (such as poorly managed arterial hypertension, cardiac insufficiency, renal failure, arteritis of the lower limbs, and a waist-hip relation of over one in men) and an increase in the number of cases of silent ischemia. However, no single factor was found to be linked more to silent ischemia than to symptomatic ischemia. This investigation therefore shows the significant numeric incidence of silent ischemia. It raises the question of the need to prescribe treatment in at-risk subjects which includes recordings of long duration, so that silent ischemia, which may increase the risk of mortality, can be more readily detected.
Aged↗