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At least 289 records · Page 16Linked to original sources
PubMed1999

Classification of medicines according to their influence on driving ability.

Within the scope of an information campaign of the Belgian Institute for Road Safety an attempt was made to classify 179 medicinal drugs from 9 therapeutic groups, listed in the Belgian "Commented Repertory of Drugs--1997", according to their effect on driving performance. The categorisation was based on literature data from about 500 references and used the system proposed by Wolschrijn et al [1]: 7 classes ranging from no effect (I) over minor and moderate (II.1,II.2) to severe effects (III), completed with the respective* categories (I*,II*,III*) for presumed classes with insufficient scientific data. Forty-two drugs (24%) were considered having severe effects (III/III*). Only 28/179 molecules (16%) were classed in I/I*: no hypnotics-sedatives (33), anticonvulsants (10), antidepressants (25), neuroleptics (29), nor narcotic analgesics and antitussives (18) were listed in this no-effect category, while for 7/24 antihistamines (5/20 H1 and 2/4 H2), 12/20 beta blockers and 9/10 central stimulants the effect was considered negligible. Antidiabetics were not classified, as the danger lies in the risk of hypoglycemia due to inadequate use. The classification of the molecules proved to be problematic due to the lack of study data (42% of molecules in presumed categories) and the diversity in the study protocols. The effect on driving ability is dose-dependent and time-related, which makes the use of a single category inadequate; the effect further depends on co-ingestion of other medicines or alcohol, the development of tolerance and the condition of the subject. Physicians and pharmacists can use the proposed categorisation as a scientific base for guiding their patients, but should take into account the factors involved for each patient when estimating the driving ability.

Automobile Driving↗
PubMed1984

FDA's priority-based assessment of food additives. I. Preliminary results.

The principles outlined in the Bureau of Foods' recently published Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food (the Redbook) have been systematically applied to a Bureau of Foods food additive data base comprising nearly 1600 food and color additives and synthetic flavoring substances. The present publication is the first of several papers reviewing and analyzing the results of this work. This paper describes the content and organization of the scientific data base that the Bureau has compiled, and presents some preliminary general conclusions regarding the processing of these data according to Redbook principles.

Animals↗
PubMed2004

The use of nebulized opioids in the management of dyspnea: evidence synthesis.

PURPOSE/OBJECTIVES: To analyze the evidence about the use of nebulized opioids to treat dyspnea using the Priority Symptom Management (PRISM) level-of-evidence framework and to make a practice recommendation. DATA SOURCES: Computerized database and manual search for articles and abstracts that included experimental trials, chart reviews, and case studies. DATA SYNTHESIS: 20 articles with evaluable evidence were identified. Analysis was complex because of heterogeneous variables and outcome measures. A major limitation is small sample sizes. The majority of PRISM level I and II studies indicated unfavorable evidence. CONCLUSIONS: Scientific data supporting the use of nebulized opioids to treat dyspnea in patients with chronic pulmonary disease, including malignancy, are lacking. IMPLICATIONS FOR NURSING: Insufficient data identify a need for further research with random crossover designs involving larger samples that are stratified according to prior opioid use. Consistency of study variables should be emphasized.

Administration, Inhalation↗
PubMed2005

MRI changes associated with partial status epilepticus.

Neurological disorders of different etiology may cause identical clinical symptoms requiring additional diagnostic procedures for a precise differential diagnosis. Focal epileptic seizures have been shown to cause increased signal intensities in T2 and diffusion-weighted magnetic resonance images (MRI), mimicking other neurological disorders or diseases such as viral encephalitis. In some cases even the combination of neuroimaging and cerebrospinal fluid (CSF) analysis is not sufficient to obtain the final diagnosis, since epileptic seizures may cause pleocytosis as well. Some epilepsy centers presented cases of focal status epilepticus with severe but reversible MRI changes. These cases indicate that MRI-changes following focal seizures are reversible over a different time window compared to MRI changes associated with other etiologies, such as viral infection. This data further suggest that in cases where focal seizures can not be ruled out, a follow-up MRI scan within a few days following the onset of symptoms significantly improves the precision of the differential diagnosis. Recently new scientific data were reported in this review.

Animals↗
PubMed2002

Characterisation of infant food modifications in the European Union.

Improvements in the understanding of human milk composition, in dietetic effects on physiological outcomes in infants, and in food technology have lead to modifications in infant formulas and other dietetic products for infants. In Europe, new ingredients may be added to infant formula and follow-on formulas if their suitability for particular use by infants from birth has been established by generally accepted scientific data. However, there is uncertainty as to the nature of the evaluation needed to evaluate whether modifications in dietetic products for infants can be regarded as suitable and safe. Moreover, there is no agreement on the nature of evidence required to justify the scientific validity of potential effects on infant health and well-being, which might provide the basis for the communication of such effects to health professionals and consumers. Therefore, a scientific workshop was held under the auspices of the Child Health Foundation, Munich, Germany, and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition to discuss issues arising in this area among participants representing academia, infant food industry, consumer organisations, the European Commission, and food regulatory bodies of some European Union member states. This article summarises the outcomes of this workshop. The participants agreed on general concepts of evaluation of innovations and on establishing evidence for benefits, but felt that further discussion would be necessary on the principles and practicalities involved in setting up a central register of clinical trials and of a central repository of trial data.

Clinical Trials as Topic↗
PubMed2001

What judges and lawyers think about the testimony of mental health experts: a survey of the courts and bar.

The testimony of mental health experts is often important evidence considered by criminal courts in determining issues arising throughout the adjudicative process, but not all evidence provided by experts is equally valid or probative. Using a hypothetical insanity defense case, we compared the preferences of Virginia judges, prosecutors, and defense attorneys for different types of forensic mental health evidence, including descriptive and diagnostic testimony, testimony about relevant research and actuarial data, and ultimate issue testimony. In addition, we determined their preferences for different types of mental health professionals. Four key findings emerged. First, many participants preferred that psychiatrists, rather than psychologists or other mental health professionals, conduct forensic evaluations for the court. Second, while participants were interested in most types of mental health evidence, they were primarily interested in clinical diagnosis, followed by an analysis of whether the condition met the relevant legal threshold, and an ultimate opinion on the legal issue. Third, participants were less interested in research or actuarial evidence. Fourth, participants differed in their evidentiary preferences in ways that reflect their respective roles in the adversary system. The findings suggest that while courts and attorneys find traditional clinical testimony useful in criminal cases, they also favor ultimate issue testimony, and view research data or statistically based information as less helpful. Mental health professionals should consider how to educate the courts and bar about the dangers inherent in over-reliance on the conclusory legal testimony of mental health experts, the utility of scientific data as such information becomes more routinely introduced as evidence at trial, and the expertise available from various mental health professionals.

Analysis of Variance↗
PubMed1990

Economic appraisal of new technology in the absence of survival data--the case of total hip replacement.

The development of total hip replacement has reached a level at which little further improvement in pain relief or quality of life can be expected from the introduction of new prosthetic technology. Rather, it is reasonable to expect longer trouble-free prosthetic life. This paper develops a mathematical model for a comparative economic appraisal of two types of prostheses, the conventional cemented one and the new cementless one. The lack of reliable survivorship data precludes reaching definite conclusions. However, by extensive sensitivity analysis with respect to a number of cost parameters the model can be used to derive conditions under which the cementless prosthesis is more cost effective. Expert medical judgement can then be used to gage whether these conditions are likely to be satisfied. The paper highlights the importance of collecting statistically valid performance data on any new medical technology from its first introduction. Without these, its full-scale adoption will be based largely on subjective grounds rather than a proper cost benefit analysis. It finally shows how both aspects--economic modeling and scientific data collection--form part of an integrated management programme for the economic evaluation of new medical technology.

Acrylates↗
PubMed2003

[Childhood circumcision: review of the evidence].

Circumcision is one of the most frequent surgical procedures in children. Because of greater immigration to Spain, health professionals need to know how to interpret new health demands. One of the most important of these is ritual circumcision. Moreover, in the last few years scientific data showing the potential health benefits of circumcision have been published. The aim of this study was to identify the therapeutic indications of this procedure, to clarify the origins of its cultural and religious bases and, finally, to review the scientific evidence to date on its possible benefits.

Circumcision, Male↗
PubMed2005

Digital biology: an emerging and promising discipline.

This article examines the role of computation and quantitative methods in modern biomedical research to identify emerging scientific, technical, policy and organizational trends. It identifies common concerns and practices in the emerging community of computationally-oriented bio-scientists by reviewing a national symposium, Digital Biology: the Emerging Paradigm, held at the National Institutes of Health in Bethesda, Maryland, November 6th and 7th 2003. This meeting showed how biomedical computing promises scientific breakthroughs that will yield significant health benefits. Three key areas that define the emerging discipline of digital biology are: scientific data integration, multi-scale modeling and networked science. Each area faces unique technical challenges and information policy issues that must be addressed as the field matures. Here we summarize the emergent challenges and offer suggestions to academia, industry and government on how best to expand the role of computation in their scientific activities.

Computational Biology↗
PubMed1991

Plasma glucose and insulin response to macronutrients in nondiabetic and NIDDM subjects.

Information on the metabolic response in people with non-insulin-dependent diabetes mellitus (NIDDM) to ingested individual macronutrients is limited. Available information is reviewed herein. The major absorbed products of carbohydrate-containing foods are glucose, fructose, and galactose. The quantitative effect of these on the plasma glucose and insulin response is different for each. In addition, available data indicate that the glucose and particularly the insulin response is different from that in nondiabetic people. The quantitative effect of dietary proteins and fats on the circulating glucose and insulin concentrations in nondiabetic and NIDDM subjects also has been reviewed. Neither has a significant effect on the glucose concentration. Protein stimulates insulin secretion, and this is relatively more prominent in people with NIDDM. A strong synergistic interaction with glucose on insulin secretion is present, but this is absent in nondiabetic people. Ingested fat does not independently stimulate insulin secretion. However, when ingested with carbohydrate, it may have a considerable effect on the plasma glucose and/or insulin response to that carbohydrate, and the responses are different in nondiabetic and NIDDM subjects. This is probably not due to altered carbohydrate absorption. Intestinal hormones undoubtedly are playing a large role in the insulin secretory response in all of these studies, but this remains to be completely elucidated. Overall, the data indicate that the metabolic response to various foods determined in people with NIDDM may be different than that in nondiabetic people. In our opinion, much more information is required before dietary recommendations for NIDDM subjects can be made based on solid scientific data.

Blood Glucose↗
PubMedDate not supplied

Screening protocols for diseases in women: a review of screening principles and examination of practices.

Screening for disease prior to the manifestation of clinical symptoms is a secondary method of disease prevention. Its use in clinical laboratory testing is based on disease prevalence, etiology, and physiology and on characteristics of the screening tests, including sensitivity, specificity, and positive and negative predictive values. An overview of the principles of screening is presented. Analytic evaluation methods, such as cost-effectiveness analysis, use data relevant to screening programs to examine new protocols. Results of studies reported in the literature are included in the discussion of screening with clinical laboratory tests for three diseases affecting women. Development of effective and appropriate screening protocols for specific diseases incorporate scientific data from randomized controlled trials and economic analytical evaluation methods in conjunction with societal perspectives and desires.

Bias↗
PubMed1988

Bilateral renal agenesis in two litters of Shetland sheepdogs.

Two cases of bilateral renal agenesis (1 pup from each of 2 related bitches) were observed in a purebred Shetland sheepdog breeding colony. Gross postmortem and histopathologic examinations confirmed a diagnosis of bilateral renal agenesis as the cause of death. Limited available data strongly suggests an inherited etiology for bilateral renal agenesis. (Editor's Note: This report is published as an example of a situation where circumstantial evidence suggested a cause-and-effect relationship between the change in heartworm medication and the anomalies. Careful scientific data collection and review avoided falling into that trap and identified the genetic basis for the observed defects.

Animals↗
PubMed2003

Medicinal properties of Echinacea: a critical review.

Preparations from Echinacea purpurea are among the most widely used herbal medicines. Most uses of E. purpurea are based on the reported immunological properties. A series of experiments have demonstrated that E. purpurea extracts do indeed demonstrate significant immunomodulatory activities. Among the many pharmacological properties reported, macrophage activation has been demonstrated most convincingly. Phagocytotic indices and macrophage-derived cytokine concentrations have been shown to be Echinacea-responsive in a variety of assays. Activation of polymorphonuclear leukocytes and natural killer cells has also been reasonably demonstrated. Changes in the numbers and activities of T- and B-cell leukocytes have been reported, but are less certain. Despite this cellular evidence of immunostimulation, pathways leading to enhanced resistance to infectious disease have not been described adequately. Several dozen human experiments--including a number of blind randomized trials--have reported health benefits. The most robust data come from trials testing E. purpurea extracts in the treatment for acute upper respiratory infection. Although suggestive of modest benefit, these trials are limited both in size and in methodological quality. Hence, while there is a great deal of moderately good-quality scientific data regarding E. purpurea, effectiveness in treating illness or in enhancing human health has not yet been proven beyond a reasonable doubt.

Adjuvants, Immunologic↗
PubMed1998

Effective regulatory approval process for food ingredient technologies.

Most sciences and technologies related to food safety have advanced exponentially over the 40 years since passage in the U.S. of the Food Additive Amendment of 1958 to the Federal Food, Drug and Cosmetic (FD&C) Act. Effective regulatory decision making places a high premium on competent professional and administrative judgement applied to sound scientific data. This review discusses changes and lessons learned in the food safety sciences over the last 4 decades. Other segments of the safety and compliance infrastructure necessary to assure that the public receives safe and wholesome foods have not kept pace with the new scientific knowledge. The quality of foods in our marketplace can be improved only after the regulatory and legislative segments of the infrastructure, discussed in a companion symposium paper, are brought into better synchrony with the sciences.

Agriculture↗
PubMed2006

Evidence-based practice of oral pathology and oral medicine.

Oral pathology is the specialty area of dentistry that deals with the diagnosis and management of oral diseases and more specifically, diseases other than dental caries, periodontal disease, restorative dentistry, and orthodontic therapy. Oral medicine represents the clinical arm of oral pathology and deals with diagnosis and treatment of soft-tissue lesions, whereas oral histopathology is the specialty area that focuses on the microscopic diagnosis of soft- and hard-tissue lesions of the head and neck area. The diagnosis and treatment of oral pathologic conditions is often based on empirical decision-making and many approaches to treatment have not been well-supported by clinicopathologic studies. The need for evidence-based, scientifically documented approaches to both diagnosis and treatment is eminent. Specific diagnostic criteria are lacking for many oral diseases, and therapeutic strategies have not been assessed by the gold standard of placebo-controlled, double-blind trials. Additionally, there are scientific data in the published literature that continue to be ignored by dental practitioners who manage patients with oral pathologic conditions. In this article, specific disease entities that are commonly managed by oral pathologists and oral medicine practitioners will be discussed with recommendations for future scientific studies that can serve as a framework for evidence-based diagnostic and therapeutic approaches.

Epithelium↗
PubMed1985

Community care for the chronically mentally ill.

This article has presented the background, history, examples, and analyses of community care programs for the chronically mentally ill. From these data, it is concluded that such programs are as if not more effective an cost-efficient than conventional inpatient programs plus conventional follow-up for this population. The future, however, may depend much more on current political and economic trends than the scientific data available.

Chronic Disease↗
PubMed2003

Hormone use and abuse: what is the difference between hormones as fountain of youth and doping in sports?

GH can induce changes in body composition that are considered to be advantageous to aging subjects especially. However, there are no results indicating that the use of GH during aging should be advocated, because of the lack of any proven efficacy for whatever parameter. Also, data indicate that calorie restriction can extend life spans by altering the rate of decline in reserve capacity as well as by reducing the cumulative exposure to GH. Moreover, animal data suggest that lower GH actions are positively correlated with longevity. The abuse of GH by sportsmen is based on the belief that it has potent anabolic effects, while it is difficult to detect the abuse. Again, this supposed efficacy cannot be supported by any scientific data.

Adult↗
PubMed2006

Evolving European guidance on the medical management of neovascular age related macular degeneration.

BACKGROUND: Until recently, only two options were available for the treatment of choroidal neovascularisation (CNV) associated with age related macular degeneration (AMD)-thermal laser photocoagulation and photodynamic therapy with verteporfin (PDT-V). However, new treatments for CNV are in development, and data from phase III clinical trials of some of these pharmacological interventions are now available. In light of these new data, expert guidance is required to enable retina specialists with expertise in the management of AMD to select and use the most appropriate therapies for the treatment of neovascular AMD. METHODS: Consensus from a round table of European retina specialists was obtained based on best available scientific data. Data rated at evidence levels 1 and 2 were evaluated for laser photocoagulation, PDT-V, pegaptanib sodium, and ranibizumab. Other treatments discussed are anecortave acetate, triamcinolone acetonide, bevacizumab, rostaporfin (SnET2), squalamine, and transpupillary thermotherapy. RESULTS: PDT-V is currently recommended for subfoveal lesions with predominantly classic CNV, or with occult with no classic CNV with evidence of recent disease progression and a lesion size <or=4 Macular Photocoagulation Study (MPS) disc areas (DA). The new classes of anti-angiogenic agents-namely, pegaptanib sodium and ranibizumab (the latter when peer reviewed phase III data become available) are recommended for subfoveal lesions with any proportion of classic CNV or occult with no classic CNV. For juxtafoveal classic CNV, PDT-V or anti-angiogenic therapy should be considered if the new vessels are so close to the fovea that laser photocoagulation would almost certainly extend under the centre of the foveal avascular zone. For all other well demarcated juxtafoveal lesions and for extrafoveal classic lesions, laser photocoagulation remains the standard treatment. Therapy should be undertaken within 1 week of the fluorescein angiogram on which the clinical decision to treat is based. At each follow up, fluorescein angiography should be performed and best corrected visual acuity measured as a minimum requirement. CONCLUSIONS: These recommendations provide evidence based guidance for the choice and use of non-surgical therapies for the management of neovascular AMD. Revisions of the recommendations may be required as new data become available.

Antibodies, Monoclonal↗