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PubMed2002

Future improvements and implementation of animal care practices within the animal testing regulatory environment.

Animal welfare is an increasingly important concern when considering biomedical experimentation. Many of the emerging regulations and guidelines specifically address animal welfare in laboratory animal care and use. The current revision of the appendix of the European Convention, ETS123 (Council of Europe), updates and improves on the current animal care standardization in Europe. New guidelines from the Organisation for Economic Co-operation and Development and the European Federation of Pharmaceutical Industries Association focus specifically on safety testing. These guidelines will affect the way toxicity studies are conducted and therefore the global drug development process. With the 3Rs principles taken into account, consideration regarding animal welfare will demand changes in animal care practices in regulatory safety testing. The most significant future improvements in animal care and use practices are likely to be environmental enrichment, management of animal pain and distress, and improved application of the humane endpoints. Our challenge is to implement respective guidelines based on scientific data and animal welfare, through a complex interplay of regulatory objective and public opinion. The current goal is to work toward solutions that continue to provide relevant animal models for risk assessment in drug development and that are science based. In this way, future improvements in animal care and use practices can be founded on facts, scientific results, and analysis. Some of these improvements become common practice in some countries. International harmonization can facilitate the development and practical application of "best scientific practices" by the consensus development process that harmonization requires. Since the implementation of good laboratory practices (GLP) standards in safety testing, these new regulations and recommendations represent a new way forward for animal safety studies.

Animal Husbandry↗

PubMed1978

Experience with modern inert IUDs to date: a review and comments.

A review of data from various large-scale studies reveals as much variation between studies as between devices. Many factors clearly unrelated to the IUD design undoubtedly influence their efficacy and continued use. Thus, the conclusions of the 1968 FDA report on effectiveness and utility still appear valid at this time. They are: A. "The Committee finds adequate scientific data attesting to the effectiveness and utility of the intrauterine devices." B. "The intrauterine devices are highly effective in preventing pregnancy, although they are not quite as reliable as the hormonal contraceptives if the latter are taken according to instructions." C. "The rate of continuation of use is similar to that of the oral contraceptives and is far higher than that of traditional methods, at least among the socially and economically deprived."

Animals↗

PubMed2006

The resistance to changing guidelines--what are the challenges and how to meet them.

Bridging the gap between scientific evidence and its practical application is of the utmost importance in improving the quality of care and increasing patient safety. Guidelines based on evidenced-based medicine (EBM) have led to improved performances and better outcomes. However, even though scientific data are available, resistance to adopting evidence-based guidelines is still enormous. Significant barriers hinder the introduction of best medical practice into the daily clinical routine. The barriers to implementing change are complex, multifunctional, and influenced on many levels by various interests both inside and outside the health-care system. Political, organizational, financial, cultural and scientific interests are regarded as being as important as the perception of patients and health workers. Strategies need to be planned which take account of the multidimensional character of quality of care and incorporate it at the various levels. The conclusion, therefore, is that we need to combine methods and tools to tailor our interventions to the patient's needs.

Evidence-Based Medicine↗

PubMed2004

Pharmacological treatment of adolescent major depression.

Antidepressant agents are widely prescribed for adolescents, although specific data regarding their efficacy in this age range are limited. The aims of the present article are to review research findings regarding the use of antidepressant drugs for adolescent depression and to discuss the main results in light of our clinical experience. Only 13 controlled trials on the use of antidepressant drugs for adolescent major depression are available in the literature. Six studies evaluated the efficacy of tricyclic antidepressants, yet they only included 196 adolescents altogether. Seven studies, including a total of 1,403 patients, evaluated the efficacy of three specific serotonin reuptake inhibitors: fluoxetine, paroxetine, and sertraline. Based on published data, serotonin reuptake inhibitors appear to be the first-line psychopharmacologic treatment for adolescent depression, as three compounds (fluoxetine, paroxetine, and sertraline) appeared to be effective in this indication. Conversely, all published studies failed to demonstrate that the tricyclic antidepressants were superior to placebo. Several questions remain open and are discussed: How should we use available scientific data in clinical practice? Are there nonspecific factors implicated in treatment response? Is there a serotonin hypothesis for juvenile depression? What are the priorities for future research?

Adolescent↗

PubMed2000

[Duration of antibiotic treatment in intensive care: current data].

OBJECTIVE: To review the current data on the duration of an antibiotic treatment. METHODS: Analysis of recent and older articles on criteria of discontinuation of an antibiotic treatment in intensive care patients. SYNTHESIS: In intensive care patients the initiation of an antibiotic therapy is more or less codified, in spite of numerous existing problems. The duration of its maintenance, although based on scientific data depends mainly on a multitude of variables. The first step is to assess the therapeutic efficiency in considering the regression of clinical manifestations, the normalization of the acute phase reactants, the sterility of bacteriological samples and the absence of relapse at therapy discontinuation. An assessment after 48 hours is essential, in order to decide the maintenance or the modification of therapy. Finally the indication of bitherapy is considered. The theoretical duration of antibiotic therapy is determined in taking into account the involved microbial agent(s), the centre of infection, the bacterial inoculum, the patient, the presence of foreign material, and the administered antibiotic.

Anti-Bacterial Agents↗

PubMed1997

Torsade de pointes as a complication of subarachnoid hemorrhage: a critical reappraisal.

Subarachnoid hemorrhage is widely accepted as a potential cause of torsade de pointes (TdP), yet this putative etiologic relationship has never been systematically evaluated. We therefore undertook a MEDLINE search from 1966 through 1993, with relevant back referencing, and identified 20 cases of TdP in the setting of subarachnoid hemorrhage. It was impossible in any of these cases (usually because of insufficient data) to completely exclude one or more alternative explanations for TdP, including congenital long QT syndrome, hypokalemia, hypomagnesemia, or drug-induced QT prolongation. Furthermore, of a total of 1,139 patients in 16 prospective series of subarachnoid hemorrhage with electrographic analyses, there were only five reported cases of TdP, all in patients with hypokalemia. Thus, extremely limited scientific data exist to support the notion that subarachnoid hemorrhage can be a distinct cause of TdP. Until more definitive evidence is available, the development of TdP in patients with subarachnoid hemorrhage is probably better characterized as a multifactorial phenomenon occurring in an acute, typically intensive care, setting.

Electrocardiography↗

PubMed2003

Intradiscal electrothermal therapy: a treatment option in patients with internal disc disruption.

STUDY DESIGN: A literature review was conducted. OBJECTIVES: To review the anatomy, pathophysiology, diagnosis, procedure, and clinical results of intradiscal electrothermal therapy (IDET). SUMMARY OF BACKGROUND DATA: Low back pain is a major physical and socioeconomic entity. A significant percentage of low back pain is attributable to internal disc disruption. The management of internal disc disruption has traditionally been limited to either conservative treatment or spinal fusion. IDET has been performed as an alternative to these therapies. METHODS: The available literature was reviewed. RESULTS: Scientific data regarding the pathophysiology, biologic effects, and clinical results are relatively scarce. Early biomechanical and histologic investigations into the effects of IDET are conflicting. However, in early prospective human trials, IDET seems to provide some benefit with little risk. CONCLUSIONS: IDET is potentially beneficial treatment for internal disc disruption in carefully selected patients as an alternative to spinal fusion. More basic science and clinical research with long-term follow-up evaluation is necessary.

Clinical Trials as Topic↗

PubMed2001

The use and evaluation of primary data in 29 trichloroethylene carcinogen risk assessments.

This paper reports the results from a detailed study on how risk assessments of chemicals are actually made. The study is performed by comparing 29 cancer risk assessments made of one and the same chemical substance, namely, trichloroethylene. In this paper, the conclusions that are drawn in these risk assessment documents are described, and differences between the conclusions are explored. This is made within the framework of a proposed cancer risk assessment index. The selection of scientific data for risk assessment purposes is analyzed and the different risk assessors' interpretations and evaluations of individual primary data are compared. It is concluded that the data sets utilized by the trichloroethylene risk assessors are surprisingly incomplete and that biased data selection may have influenced some of the risk assessors' conclusions. Different risk assessors often interpret and evaluate one and the same study in different ways. There are also indications of both interpretation bias and evaluation bias for some of the risk assessors.

Animals↗

PubMed2005

A multi-criteria approach to Great Barrier Reef catchment (Queensland, Australia) diffuse-source pollution problem.

This paper presents a multi-criteria based tool for assessing the relative impact of diffuse-source pollution to the Great Barrier Reef (GBR) from the river basins draining into the GBR lagoon. The assessment integrates biophysical and ecological data of water quality and pollutant concentrations with socio-economic information pertaining to non-point source pollution and (potential) pollutant impact. The tool generates scores for each river basin against four criteria, thus profiling the basins and enabling prioritization of management alternatives between and within basins. The results support policy development for pollution control through community participation, scientific data integration and expert knowledge contributed by people from across the catchment. The results specifically provided support for the Reef Water Quality Protection Plan, released in October 2003. The aim of the plan is to provide a framework for reducing discharge of sediment, nutrient and other diffuse-source loads and (potential) impact of that discharge and for prioritising management actions both between and within river basins.

Agriculture↗

PubMedDate not supplied

Data quality assurance for thermophysical property databases--applications to the TRC SOURCE data system.

To a significant degree processes of database development are based upon human activities, which are susceptible to various errors. Propagation of errors in the processing leads to a decrease in the value of original data as well as that of any database products. Data quality is a critical issue that every database producer must handle as an inseparable part of the database management. Within the Thermodynamics Research Center (TRC), a systematic approach to implement database integrity rules was established through the use of modern database technology, statistical methods, and thermodynamic principles. The four major functions of the system--error prevention, database integrity enforcement, scientific data integrity protection, and database traceability--are detailed in this paper.

Journal Article↗

PubMed2005

[A role for combination therapy in pulmonary arterial hypertension].

For patients with pulmonary arterial hypertension (PAH) two first line therapies - iloprost inhalation (Ventavis) and bosentan (Tracleer) -- are available in Germany. A third substance, sildenafil, is already approved in the US and will be approved for this indication in the European Union soon. Patients with PAH can be stabilized or improved with a specific mono-therapy for a limited period of time only. Therefore, the question arises when and how to initiate treatment escalation. The available data from controlled clinical trials are insufficient to give a definite answer to these questions. Moreover, it is still unclear which combination of the above mentioned substances may be superior in the treatment of PAH. On the other hand, combination therapy is already reality in clinical practice. Based on this background experts from specialized centers dealing with PAH discussed the scientific basis of the role of combination therapy in PAH patients during a workshop held on April 22/23. 2005 in Wiesbaden. The goal of this workshop was to formulate a common position with regard to combination therapy of PAH on the basis of the available scientific data and clinical experience.

Administration, Inhalation↗

PubMedDate not supplied

Evaluating the quality of clinical practice guidelines.

OBJECTIVE: To review and identify established methods for evaluating the quality of practice guidelines and to use a selected assessment tool to assess 2 chiropractic practice guideline documents. METHODS: A search of the medical literature was performed to identify current methods and procedures for practice guideline evaluation. Two chiropractic practice guideline documents, Vertebral Subluxation in Chiropractic Practice (CCP) and Guidelines for Chiropractic Quality Assurance and Practice Parameters (Mercy) were then independently evaluated for validity by 10 appraisers using the identified appraisal tool. The appraisal scores were tabulated, and consensus appraisals were generated for the CCP and Mercy guideline documents. RESULTS: The "Appraisal Instrument for Clinical Guidelines" (Cluzeau instrument) was identified as a reliable and valid method of guideline evaluation. The result of the application of this appraisal tool in the assessment of the CCP and Mercy guideline documents was that the former scored notably lower than the latter. On the basis of the results of the guideline appraisals, the CCP document is not recommended, and its guidelines are not considered suitable for application in chiropractic practice. The Mercy guidelines are recommended for application in chiropractic practice, with the proviso that new scientific data should be considered. CONCLUSIONS: The literature reviewed suggests that professional organizations or groups should undertake a critical review of guidelines using available critical guideline appraisal tools. Guideline validity appraisal should be done before acceptance by the chiropractic profession. To avoid unwarranted utilization of poorly constructed guidelines, it is strongly recommended that all future guidelines be reviewed for validity and scientific accuracy with the findings published in a medically indexed journal before they are adopted by the chiropractic community.

Chiropractic↗

PubMed2006

Improving street food vending in South Africa: achievements and lessons learned.

Until the late 1990s there were limited scientific data on the microbiological quality and safety of street-vended foods in South Africa, while information was already available in other developing countries, including those within the African region. At that time street-vended foods were perceived as unsafe and street food vending in South Africa was regarded as a practice, which should be outlawed. The first comprehensively documented scientific research into the safety of street-vended foods in South Africa was carried out through university-based research. This research found that street food vendors in South Africa were capable of producing relatively safe foods, with low bacterial counts, although there was still a need for proper hygiene conditions and access to basic sanitary facilities. The Department of Health of South Africa, when coordinating an FAO Technical Cooperation Programme (TCP) project on Improving Street Foods in South Africa, drew similar conclusions. This article provides information of the efforts by universities and health authorities in South Africa towards improving the safety and promoting the sale of street-vended foods. It is shown that a successful transition from street food vending being perceived as a nuisance by health authorities can be made to these authorities promoting and improving street food vending instead.

Commerce↗

PubMed2002

Managing the risk of nosocomial transmission of prion diseases.

PURPOSE OF REVIEW: Prion diseases such as Creutzfeldt-Jakob disease represent a unique infection control problem because prions exhibit an unusual resistance to conventional chemical and physical decontamination methods. This paper reviews the recent literature and provides recommendations for the prevention of nosocomial transmission of prion agents. RECENT FINDINGS: Recommendations to prevent the cross-transmission of infection from medical devices potentially contaminated with prions have been based primarily on prion inactivation studies. Newer recommendations consider inactivation data, but also use epidemiological studies of prion transmission, the infectivity of human tissues, and the efficacy of removing microbes by cleaning. Prion-specific disinfection/sterilization is required in only limited settings. Healthcare workers are not at risk of acquiring transmissible spongiform encephalopathies. Blood or blood products have not been demonstrated to be vehicles for transmission. SUMMARY: On the basis of scientific data, only critical (e.g. surgical instruments) and semicritical devices contaminated with high-risk tissue (i.e. brain, spinal cord, eye) from high-risk patients (e.g. with known or suspected Creutzfeldt-Jakob disease) require special treatment.

Creutzfeldt-Jakob Syndrome↗

PubMed2005

Treatment of osteoporosis in chronic kidney disease and end-stage renal disease.

As glomerular filtration rate (GFR) declines from age-related bone loss or disease that specifically induces a decline in GFR, there are a number of metabolic bone conditions that may accompany the decline in GFR. These metabolic bone conditions span a spectrum from mild-to-severe secondary hyperparathyroidism in early stages of chronic kidney disease (CKD) to the development of additional heterogeneous forms of bone diseases each with its distinctly quantitative bone histomorphometric characteristics. Osteoporosis can also develop in patients with CKD and ESRD for many reasons beyond age-related bone loss and postmenopausal bone loss. The diagnosis of osteoporosis in patients with severe CKD or end-stage renal disease (ESRD) is not as easy to do as it is in patients with postmenopausal osteoporosis (PMO)--neither fragility fractures nor The World Health Organization bone mineral density criteria can be used to diagnose osteoporosis in this population since all forms of renal bone disease may fracture or have low "T scores". The diagnosis of osteoporosis in patients with CKD/ESRD must be done by first the exclusion of the other forms of renal osteodystrophy, by biochemical profiling or by double tetracycline-labeled bone biopsy; and the finding of low trabecular bone volume. In such patients, preliminary data would suggest that oral bisphosphonates seem to be safe and effective down to GFR levels of 15 mL/min. In patients with stage 5 CKD who are fracturing because of osteoporosis or who are on chronic glucocorticoids, reducing the oral bisphosphonate dosage to half of its usual prescribed dosing for PMO seems reasonable from known bisphosphonate pharmacokinetics, though we do need better scientific data to fully understand bisphosphonate usage in this population.

Bone Density↗

PubMedDate not supplied

Risk assessment of mixtures and standard setting: working towards practical compromises.

Basic concepts of 'dose/concentration additivity' and 'response addition/independence' may be applied to evaluate chemical mixtures in human toxicology, as well as in ecotoxicology. In the case of compounds that cause the same toxicological effect by the same mechanism, 'dose addition' is a more plausible form of joint action than 'response addition'. Data on the effects of halogenated hydrocarbons on the kidney, the effects of organic solvents on the central nervous system, and the effects of organophosphates on cholinesterase, are the basis of this assumption. For such compounds, response addition will generally underestimate risk. None the less, both dose addition and response addition are 'non-interactive' forms of joint action. As such, neither additivity assumption will accurately predict risk for compounds that exhibit toxicological interactions regardless of the primary mechanism(s) of toxicity. More often, the additivity approach overestimates the risk of a combination of chemicals. From a public health perspective, such results over-protect the public; hence this approach can be used for standard setting. The introduction of a special safety factor of 10 for the standard setting for mixtures in addition to those normally used for deriving acceptable daily intakes, reference doses or minimal risk levels is not supported by data. Instead, each exposure scenario should be considered on a case-by-case basis. Furthermore, considerations of multiple endpoints, including multiple organs, multiple effects, multiple mechanisms and potential interactions between such mechanisms, are very desirable for overall toxicity and risk assessment of chemical mixtures. In conclusion, additivity could be used to estimate potential risks for a combination of chemicals: only if scientific data support independence of effects can response independence be used as an alternative for standard setting.

Dose-Response Relationship, Drug↗

PubMed1991

Integrated displays and the perception of graphical data.

Three experiments are presented that apply a principle of compatibility of proximity to the perception of graphical data. These experiments demonstrate that the merits and costs of integral displays relative to separable displays depend in part on the task being performed. Experiment 1 employs a data extrapolation task in which information must be integrated. Here an integral display is found to be superior to a separable display. Experiment 2 employed a data perception task that requires focused attention. This reveals superior performance with separable displays. Experiment 3 employed a multiple cue judgement task in which information integration could be manipulated. Data from Experiment 3 were analysed using the Brunswick lens procedures, and indicated that knowledge of the task structure was influenced by the display type. When selective attention was required, knowledge of the task was superior with separable displays. The results are discussed with reference to the principle of compatibility of proximity, and the implications of the results for the perception of scientific data are noted.

Adult↗

PubMed2002

Depression and epilepsy: how closely related are they?

Article abstract Depressive disorders (DDs) are the most common type of psychiatric co-morbidity in patients with epilepsy. They are more likely to occur in patients with partial seizure disorders of temporal and frontal lobe origin and are more frequent among patients with poorly controlled seizures. Despite their relatively high prevalence, DDs remain unrecognized and untreated in a large proportion of patients. This article highlights the evidence of a close association between DDs and epilepsy, beginning with the bi-directional relationship between the two disorders. Not only are patients with epilepsy more likely to experience a DD, but a history of DD preceding the onset of the seizure disorder is more likely to be identified in patients with epilepsy than in a control group. In support of these observations, we review data from animal models of epilepsy showing that decreased activity of serotonin, norepinephrine, dopamine, and GABA facilitate the kindling process of seizure foci, worsen seizure frequency and severity, and are reversed or blocked by antidepressant drugs. Decreased activity of these neurotransmitters is a pivotal pathogenic mechanism of DDs and forms the basis of their pharmacotherapy. Thus, DDs and epilepsy may share common pathogenic mechanisms that facilitate the occurrence of one in the presence of the other. Contrary to long-held beliefs by patients and clinicians alike, in the sense that DDs are a "normal reaction" to the obstacles posed by epilepsy, we review evidence that points to their biologic or endogenous nature. We find a genetic predisposition to DDs, as evidenced by the frequent family history of mood disorders in these patients. Neuroimaging and neuropsychological data support a frontal lobe dysfunction in DDs, and a recent study documents concomitant dysfunction of mesial temporal structures. Depressive disorders have various clinical presentations, some typical of the different types of mood disorders in non-epileptic patients, others constituting rather frequent atypical presentations that can easily go unrecognized. A review of the pharmacologic treatment of DDs in epilepsy highlights the lack of scientific data and points to the empirical form in which these patients have been treated up to the present time. Contrary to clinicians' fears, most antidepressant drugs are safe in patients with epilepsy.

Comorbidity↗