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At least 1,099 records · Page 61Linked to original sources
PubMed2003

Asthma-like symptoms assessment through ECRHS screening questionnaire scoring.

The definition of asthma has always been a matter of discussion. The European Community Respiratory Health Survey (ECRHS) is a multinational survey designed to compare the prevalence of asthma in subjects aged 20 to 44 years throughout European countries. In each center a representative sample completed a self-administered screening questionnaire composed of nine dichotomous items. We propose a method for constructing a score for the ECRHS screening questionnaire and we validate the method with reference to the clinical diagnosis available for the Italian centers. Clinical diagnosis was made by a group of medical experts after examining the responses to a standardized clinical interview, respiratory function tests, and allergy tests. Before constructing a summary score, the number of latent factors/dimensions explaining correlations among the observed items was recognized. We identified only one factor/dimension underlying the screening questionnaire, so a summary score was determined by the Homogeneity Analysis by Alternating Least Square (HOMALS). Using best Receiver Operating Characteristic (ROC) threshold the diagnostic test of the score had sensitivity and specificity of 75.1 and 80.1%, respectively. The method of scoring is easily reproducible, and has the advantage of optimizing information recoded by the questionnaire.

Adult↗
PubMed1996

An analysis of decisions by European general practitioners to admit to hospital patients with lower respiratory tract infections. The European Study Group of Community Acquired Pneumonia (ESOCAP) of the European Respiratory Society.

BACKGROUND: The purpose of this study was to identify factors on which European general practitioners (GPs) base their decisions to admit to hospital patients with lower respiratory tract infections (LRTI). METHODS: A survey was carried out from December 1993 to January 1994 to identify factors that affect GPs' decisions to admit to hospital patients with LRTI by collecting data on 2056 patients from 605 GPs in France, Germany, Italy, Spain, and the UK. RESULTS: Only 93 (4.5%) of the patients included in the study were admitted to hospital. Univariate analysis showed that age > 60 years, institutionalisation of the patient, concomitant diseases, cardiac insufficiency, asthma, a diagnosis of pneumonia, and clinical signs such as chest pain, cyanosis, tachypnoea and hypotension significantly (odds ratio (OR) > 2.0, p < 0.002) influenced the decision to admit to hospital. No influence could be shown for sex, smoking habits, history of bronchiectasis or chronic bronchitis, the presence of fever, chills, myalgia, cough or purulent sputum, and the diagnoses of acute bronchitis, influenza or exacerbation of chronic bronchitis. In the multivariate analysis only the presence of chest pain (OR 2.3, 95% confidence interval (CI) 1.5 to 3.5), cyanosis (OR 4.1, 95% CI 2.4 to 7.1), dyspnoea (OR 4.9, 95% CI 3.1 to 7.9), and hypotension (OR 2.9, 95% CI 1.6 to 5.2), as well as a diagnosis of pneumonia (OR 6.6, 95% CI 4.3 to 10) (all p < 0.00001) remained as factors that significantly affected the decision to admit to hospital. CONCLUSIONS: Clinical signs of severe infection and a diagnosis of pneumonia are the main factors that induce GPs to admit patients with LRTI to hospital in Europe.

Europe↗
PubMed2002

[Recent initiatives of the European Union on the field of drug use and trafficking].

Moving from the general framework offered by the Treaties of the European Union and European Community, the paper presents the more recent specific initiatives of the Union in the field of fight against drugs and in particular on the European Union Plan of Action, adopted by the European Council in June 2000, and on the need for a global and balanced approach which it proposes as the main focus of the action of the European institutions. The paper then examines separately the initiatives taken both at the level of the reduction of the demand, mainly at the preventive and sanitary level, and of the supply reduction, of a mainly repressive character. Conclusively, the main initiatives in the field of international co-operation among the European Union and third Countries.

Commerce↗
PubMed1996

[EDMUS--a new European databank for multiple sclerosis. A brief introduction of ongoing and planned multicenter studies within the scope of the "European Concentrated Action for Multiple Sclerosis"].

EDMUS, the European Database for Multiple Sclerosis (MS), was established on the occasion of the first European Concerted Action for MS under the auspices of the European Community. The system is user-friendly and makes it possible to record and retrieve data relevant to MS. Within the framework of another European Concerted Action, several international multicenter trials are currently in progress. EVALUED, a validation of the EDMUS system, assesses the interrater variability; PRIMS examines the influence of pregnancy and the post-partum period on the course of MS; and PRESTIMUS investigates predictive factors in suspected MS. Further, planned studies include ERAZMUS (early azathioprine and interferon-beta treatment in MS) and AZASTOP, which is designed to evaluate the effect of stopping azathioprine treatment.

Azathioprine↗
PubMed2002

The comparability of community outcomes for European and non-European survivors of stroke in New Zealand.

AIMS: To measure community outcomes for stroke comparing European and non-European survivors. METHODS: This was a prospective, hospital-based study of consecutive patients admitted to three general hospitals in Wellington with acute stroke. Patients were assessed using a range of instruments for prestroke function, function while in hospital, and then followed for twelve months post-hospital discharge. Ethnicity was decided by self-report and Maori, Pacific people and Asians were grouped together as "non-Europeans" for analysis. RESULTS: 181 people with stroke were enrolled of whom 171 (94.5%) were followed up to death or twelve months post hospital discharge. 33 (18%) were non-European with 13 (7%) Maori, 14 (8%) Pacific people and 6 (3%) Asians. Non-European survivors at twelve months post hospital discharge were more likely to be dependent (corrected OR 21.0, 95% CI 3.1, 141), have significantly lower Functional Independence Measure scores, lower London Handicap Scores and lower scores on the Short Form 36 domains of physical functioning and vitality and Physical Component Summary score. CONCLUSIONS: Community outcomes for survivors of stroke may be worse for non-Europeans although this should be confirmed in a larger study.

Activities of Daily Living↗
PubMed1991

Syst-Eur. A multicentre trial on the treatment of isolated systolic hypertension in the elderly: objectives, protocol, and organization.

The Syst-Eur Trial is a concerted action of the European Community's Medical and Health Research Programme. The trial is carried out in consultation with the World Health Organization, the International Society of Hypertension, the European Society of Hypertension and the World Hypertension League. This article describes the objectives and the protocol of Syst-Eur, a multicentre trial designed by the European Working Party on High Blood Pressure in the Elderly (EWPHE), to test the hypothesis that antihypertensive treatment of elderly patients with isolated systolic hypertension results in a significant change in stroke morbidity and mortality. Secondary endpoints include cardiovascular events, such as myocardial infarction and congestive heart failure. To be eligible patients must be at least 60 years old and have a systolic blood pressure averaging 160-219 mmHg with a diastolic pressure less than 95 mmHg. Patients must give their informed consent and be free of major cardiovascular and non-cardiovascular diseases at entry. The patients are randomized to active treatment or placebo. Active treatment consists of nitrendipine (10-40 mg/day), combined with enalapril (5-20 mg/day) and hydrochlorothiazide (12.5-25 mg/day), as necessary. The patients of the control group receive matching placebos. The drugs (or matching placebos) are stepwise titrated and combined in order to reduce systolic blood pressure by 20 mmHg at least to a level below 150 mmHg. Morbidity and mortality are monitored to enable an intention-to-treat and per-protocol comparison of the outcome in the 2 treatment groups. A one-year pilot trial (1989) showed that the protocol is practicable. The Ethics Committee therefore decided to start the definite study (1990), in which randomized patients will be followed for 5 years. Recruitment of new centres and of the required 3,000 patients will last 3 years (until 1993).

Aged↗
PubMed2006

Regulatory aspects of radiation protection.

The paper introduces the projects launched by the European Community to foster prospects in dosimetry, radiation protection and best use of equipment in the medical field. These projects are put in perspective with the European legal framework for radiation protection, in particular, the Basic Safety Standards Directive, the Medical Exposures Directive and the Directive on High-Activity Sealed Sources. A summary is given of the overall mission statements of the commission services in the field of radiation protection, including the field of research, and how they relate to other actions in the overall health policy of the EU. In conclusion, a number of priority areas for future work in the medical field are highlighted.

European Union↗
PubMed1993

[Blood replacement in elective surgery: results of the Sanguis Study].

The aim of the Sanguis study, a project sponsored by the European Community, is to assess the use of blood and blood components including the use of programs for autologous blood transfusion in 43 hospitals in 10 European countries. The study was inaugurated by Prof. G. Sirchia, Milan, who formed a study group of experts from 10 countries. The study group defined the study design, identified the centers, and followed the progress of the project. From October 1990 until September 1991 data were collected in the 43 hospitals from patients undergoing one of six elective surgical procedures. The results obtained from interim analysis (70% of expected data) of patients with total hip replacement revealed differences in the frequency of homologous blood transfusion between hospitals and also regional differences between different countries. There was great variation in the use of alternative programs for reduction or even avoidance of homologous blood transfusion between hospitals. For total hip replacement, the calculated probability to receive homologous blood varied between 0 and 100% in different hospitals. This observational study will provide a data base concerning the transfusion practice in 6 elective surgical procedures in 10 European countries. According to the findings of this study, recommendations for improving the transfusion practice shall be elaborated and indications for alternative programs identified. In a subsequent study (Sanguis 2), these recommendations are to be validated.

Aged↗
PubMed1997

[The Chernobyl incident: emergency management in Italy and other European countries].

Several measures were adopted by European countries in the aftermath of the Chernobyl accident. In this paper these measures are reviewed and the European Communities initiatives for food marketing and exports are analyzed, together with the reference levels for radioactive concentration in the main food matrices chosen in different European countries in the very few days after the accident. A particular attention has been devoted to the emergency management in Italy, outlining exhaustively the laws enforced at the time of the accident and explaining how the reference levels for food contamination were chosen. Finally, a tentative balance about emergency management in Italy is struck and some questions are raised about the commitments undertaken or to be undertaken by international institutions.

Animals↗
PubMed2004

ECCO peer review--development since 1996 and future prospects.

Plant protection products have to be evaluated and authorized in the EC-Member States since 1993 in accordance with Directive 91/414/EEC. The programme for evaluating existing active substances (which were on the market before July 1993) involves several steps and stages, stretching over a period of up to formerly 10, and now 15 years. The programme is co-ordinated by the European Commission, with the assistance of the European Community Co-Ordination (ECCO)-Team since 1996. The ECCO-Team consists of two groups; one is situated at the Pesticides Safety Directorate in York (United Kingdom) and the other at the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit-BVL (Federal Office for Consumer Protection and Food Safety) in Braunschweig (Germany). They provide technical and administrative support to the programme for the evaluation of active substances on behalf of the European Commission, and are responsible for the ECCO peer review programme in particular. The programme has been extremely successful, with over 160 active substances having been peer reviewed, facilitating over 100 decisions on the acceptability of those actives at Community level.

Animals↗
PubMed1995

Ethnic differences in the perception of a video developed for a multiethnic diabetes prevention programme in south Auckland, New Zealand.

Videos were developed to help increase diabetes awareness among local Maori, Pacific Islands and European communities. The Maori and Pacific Islands versions incorporated modifications to the basic content to make them more appropriate for the target audience. Lay audiences, comprising 108 Europeans, 94 Maori and 90 Pacific Islands people in 12 different sites, viewed the version of the video tailored to their ethnic group. The Maori version was also viewed by 32 Diabetes Nurse Specialists. Likert scale ratings and open-ended questions were used to evaluate the video. The video was rated highly by all audiences and most subjects were able to repeat the main messages of the video. Compared with Maori and Pacific Islands subjects, Europeans found the video the easiest to understand but gained the least information. Maori and Pacific Islands subjects would have preferred a longer video ( > 17 minutes). Different viewing sites revealed evidence of within-ethnic-group heterogeneity. Pacific Islands subjects particularly appreciated the educational components, while Maori and Europeans were more likely to comment on presentation. Audio-visual material is perceived differently by different ethnic groups, such differences need to be addressed when embarking on diabetes awareness campaigns.

Adult↗
PubMed2004

[Diagnostic kits in parasitology: which controls?].

The development of new diagnostic tools particularly for some parasitic "neglected diseases", is slowed or even hindered by limited resources assigned for basic and applied research in public institution and private sector. Even if the time-line and costs needed for developing a new In Vitro Diagnostic (IVD) test are generally lower compared to vaccines or new drugs, industry is poorly engaged in investing resources due to the perception of limited markets. To accelerate the development of diagnostics for the world's most deadly diseases, the World Health Organization's (WHO) Special Programme for Research and Training in Tropical Diseases (TDR), the United Nations Development Programme, the World Bank and the Gates Foundation, last year launched a new initiative, FIND (Foundation for Innovative New Diagnostics, www.finddiagnostics.org). The aim is to "apply the latest biotechnology innovations to develop and validate affordable diagnostic tests for diseases of the developing world". Ideally, a new diagnostic test should be accurately evaluated prior to use in medical practice. The first step would be a pre-clinical evaluation, an analytic study to determine its laboratory performance. A crucial point in this phase is the calibration of reagents (antigens, antibodies, DNA probes, etc.) against a standard reference preparation. WHO, through the WHO International Laboratories for Biological Standards, "provides International Biological Reference Preparations which serve as reference sources of defined biological activity expressed in an internationally agreed unit" (www.who.int/biologicals/IBRP/index.htm). Standardization allows "comparison of biological measurements worldwide" and ensures the reliability of diagnostic procedures. These preparations are generally intended for use in the characterization of the activity of secondary reference preparations (regional, national or in-house working standards). Unfortunately, international reference standards for parasitic diseases are not available at present, except for Toxoplasma antibodies. The first international standard reagent for Anti-Toxoplasma Serum was established in 1968 and at present, an international standard reference serum, Anti-toxoplasma serum, human TOXM is available at the National Institute for Biological Standards and Control (NIBSC) in UK. Several collaborative, multicenter studies were carried out to assess the performance of different methods and commercial tests for the diagnosis of toxoplasmosis, by providing to participating laboratories a panel of well-defined sera to be tested. A four-phase process following well-accepted methodological standards for the development of diagnostics, analogous to those internationally accepted for drugs and vaccines was recently proposed. The pre-clinical evaluation, the analytic study to assess sensitivity, specificity, predictive values in laboratory (phase I), should be followed by a proof of principle study to distinguish diseased from healthy persons in easily accessible populations (phase II). The evaluation of test performance in populations of intended use (phase III), and finally the delineation of cost-effectiveness and societal impact of new tests in comparison with existing tools (phase IV) should complete the validation procedure. In this context, national regulatory agencies play a major role in pre-market approval and post-market surveillance of IVDs. The European Community in 1998 approved a directive (Directive 98/79/EC) which rules the marketing of IVD medical devices, in order to harmonise the performance levels and standards in European countries. But, among IVDs for parasitic diseases, only those to detect congenital toxoplasmosis are submitted to defined procedures to provide the verification of products before their placing on the market and the surveillance after their marketing by a notified body, which perform appropriate examinations, tests and inspections to production facilities to verify if the device meets the requirements of the directive. In U.S.A., the Food and Drug Administration (FDA), through the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), provides a comprehensive and regulatory activity for IVDs through pre-market evaluation and post-market surveillance. In developing countries, the scarcity of resources limits the procedures through which the national control authority can assure safety, quality and efficacy of products marketed, both imported and locally manufactured.

Animals↗
PubMed1993

[Standardization, control and approval of surgical implants in Europe].

The "new approach" policy limits the European Community legislative harmonization to adopting essential safety requirements which medical devices brought on the market will have to meet, and thereafter obtaining free trade in the European market. A set of harmonized standards will explain in detail what the essential requirements mean in practice. Therefore, the work being done on standards for surgical implants by the European Committee for Standardization (CEN) is indispensable. The impact of the "New Approach" on the Norwegian legislation is discussed, and it is concluded that the Committee for Single-Use Medical Devices, which registers all surgical implants prior to marketing in Norway, will have to close down in 1995.

Biocompatible Materials↗
PubMed2005

Toxicokinetic study of dioxins and furans in laying chickens.

Since foodstuffs from animal origin and particularly poultry products have been pointed out several times as reservoir of dioxins and related compounds, notably in Belgium few years ago, food chain safety issues appeared. Although food chain contamination incidents occurred many times through contaminated feedstuffs consumption in commercial chicken farms, very few studies have been carried out on transfer of dioxins and related compounds from commercial feed to hens. The present work continues a preliminary study on dioxin transfer in laying chickens carried out in our lab and available on-line on November 2004 in Environment International. In this work, absorption of dioxins were not preferential for 2,3,7,8-substituted congeners, increase with increasing number of chlorines, and was not linearly dependent of the octanol/water partition. Only 2,3,7,8-congeners were found in all organs studied, and these latter showed the same congener profile and similar lipid-normalized concentration, except for the liver. Abdominal fat and liver seemed to be the major storage sites and the liver preferentially retained highly chlorinated congeners. Unfortunately in this previous trial, laying process stopped very early for unknown reason leading to a considerable lost of information. In the present toxicokinetic study, more complete gastrointestinal absorption, excretion in eggs and bioaccumulation of dioxins in different tissues were investigated in chickens fed for 14 weeks with a 9 ng TEQ/kg contaminated feed. Stable levels were reached after 7 weeks in excreta and 9 weeks in eggs. During the whole trial, gastrointestinal absorption ranged between 41% and 91% depending on the congener. At steady state conditions, excretion of 1,2,3,4,6,7,8-HpCDD, OCDD, 1,2,3,4,6,7,8-HpCDF and OCDF exceeded 100% demonstrating excretion from tissues of these congeners which were also the most abundant in feed. 1,2,3,7,8-PeCDD, 1,2,3,7,8-PeCDF, 2,3,4,7,8-PeCDF, 1,2,3,6,7,8-HxCDF, 1,2,3,7,8,9-HxCDF and 2,3,4,6,7,8-HxCDF seemed to be metabolized more efficiently. Lipid adjusted concentrations and pattern were unexpectedly similar in the abdominal fat and the liver. On the contrary, eggs and breast muscles showed different pattern with higher level for high chlorinated congeners. When extrapolating our results, we found that a feed containing 0.750 ng TEQ/kg of dioxins (European norm for feedstuff) would cause a level lower than the maximum threshold level of 3 pg TEQ/g fat for chicken eggs fixed by European Communities. Nevertheless, a concentration lower than 0.6 ng TEQ/kg in feed would be needed to produce breast muscles less contaminated than 2 pg TEQ/g fat authorized in European.

Absorption↗
PubMed1998

Assessing the progress of the M.Sc. course in health informatics under the ERASMUS programme.

Health informatics is an emerging and important multi-disciplinary field that involves, informatics but also medicine, nursing, engineering, biology and other-related subjects. A co-ordination of this field at a postgraduate level becomes important now in Europe where other European Community programs such as the 'Telematics for Health Care' will require at the Fourth Framework Programme (94-99) adequate human resources of higher potential and knowledge. This European M.Sc. course meets all the above objectives. The Curriculum was developed according to the results of the ERASMUS Workshop, which was held in Athens on 13-15 September 1990 under the ERASMUS Contract number ICP-90-G-0009/12. The implementation now runs under the contract ICP-95-G-1038/12. The 6-year evaluation of the course based both on staff and student evaluation proved that the M.Sc. course in health informatics has been successful.

Curriculum↗
PubMed1999

Effect of current and forthcoming European legislation and standardization on the setting of quality specifications by laboratories.

A network of national and international guidelines and directives developed in the last few decades by various bodies will lead to a new concept of total quality for medical laboratory services comprising legislative regulations on national and international levels, standardizations backed up by legislation and recommendations of professional societies. One example is the IVD Directive of the European Community. It will not only stimulate accreditation in the field of laboratory medicine, but also necessitate numerous standardization activities which are presently co-ordinated by the European Committee for Standardization (CEN). Another standardization example is the development of quality management systems, mainly by ISO. The ISO 9000 series has become the most successful family of standards world-wide. Meanwhile, specific standards for the needs of laboratories (ISO 17025), and in particular of medical laboratories (ISO 15189), are being worked out. A new trend to develop quality management systems towards total quality management systems can be observed including additional aspects such as economic and quality interests of society, customers and owners of laboratories. The goal of all activities is to create a network of confidence which provides some guarantee to the clients, i.e. the physicians and their patients, that they will receive a high-quality medical laboratory service.

Clinical Laboratory Techniques↗
PubMed1997

Prevalence of Sjögren's syndrome in a closed rural community.

OBJECTIVE: To define the prevalence of Sjögren's syndrome (SS) through an epidemiological survey in a closed rural community. The classification of SS is based on the validated criteria reported by a multicentre study performed in Europe and supported by the Epidemiology Committee of the European Community (EEC-COMAC Epidemiology). METHODS: The population under study consisted of 837 women aged 18 years or older, residing in the Astakos community of Aitoloakarnania, Greece. The study protocol was subdivided in two parts. In part I, an exhaustive epidemiological survey of these women was conducted in July and August of 1992. The validated questionnaire used in the survey assesses both ocular and oral involvement. In part II, 45 of the women reporting symptoms of both dry eye and dry mouth were approached for a full examination based on the validated set of classification criteria of SS. The full complement of the diagnostic tests was performed on 35 of these women. A subject is classified as a definite primary SS case if at least four of six items of the subject's test items are positive. If three of six items are positive the subject is classified as a probable primary SS case. RESULTS: The classification criteria for definite primary SS were satisfied by five women. This number corresponds to an estimated prevalence of 0.60% (exact 95% CI 0.19%, 1.39%). Probable primary SS was diagnosed for 25 women (prevalence = 2.99%). CONCLUSION: Because of the loss of follow up (10 of 45) and the use of slightly stricter criteria for inclusion of possible SS cases in part II of the study, we consider our estimate of the prevalence of SS to be conservative. This study concurring with other recent reports, suggests that SS is more prevalent than previously thought.

Adolescent↗
PubMed1997

The regulatory situation in central and eastern Europe.

The countries of central and eastern Europe, as part of their integration into the European Community, are required to adopt Community regulatory systems for medical devices. This article discusses the challenges faced by these countries during the transition, and support the Community itself can provide to assist their integration. The views expressed in this article are those of the author and do not necessarily represent those of the European Commission.

Equipment and Supplies↗