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PubMed2003

Thrombolysis in the management of lower limb peripheral arterial occlusion--a consensus document.

The aim of this paper is to develop an intercontinental consensus on the use of thrombolytic therapy in occlusive peripheral arterial disease affecting lower limbs. A working party of self-designated angiologists, hematologists, interventional radiologists, and vascular surgeons of Europe and North America convened at 4 closed meetings. All published data known to any of the participants was entered into discussion. The working party discussed the topics outlined in this paper and a first draft was prepared in segments by members of the working party, discussed, and further revised into an interim report. It was then circulated to a number of Societies for their input. A final meeting of the Working Party together with delegates of the Societies collaborated on the definitive version of the text. The Party appreciates that in many areas the scientific evidence is not yet available. Nevertheless, it was felt that enough practical and scientific data were available to establish recommendations for clinical practice as well as for reporting results of thrombolytic therapy, which could be updated as later evidence became available. The guidelines apply only to drugs currently available for clinical use. The data are also considered to be sufficiently cogent that regulatory agencies should move to approve thrombolytic agents for intra-arterial therapy of acute lower extremity ischemia.

Consensus Statement↗

PubMed1998

Thrombolysis in the management of lower limb peripheral arterial occlusion--a consensus document. Working Party on Thrombolysis in the Management of Limb Ischemia.

Arterial Occlusive Diseases↗

PubMed2005

Neurobehavioral science in hazard identification and risk assessment of neurotoxic agents--what are the requirements for further development?

OBJECTIVES: Modern neurobehavioral methods find useful application in research into the early effects of exposure to neurotoxic agents in the environment. This paper briefly describes the history and evolution of neurobehavioral toxicology, reviews some current trends in research in this specific discipline and identifies the most important needs and challenges to be addressed in future studies. METHODS: All published literature was considered, including ad hoc meeting reports. Further information was obtained directly from experts in the field. RESULTS: The number of studies (including those in occupational, environmental and pediatric exposure) using neurobehavioral evaluation is constantly increasing. Regulatory agencies are using scientific data obtained through neurobehavioral assessment, which includes other areas such as neurosensory toxicology. However, further development of this discipline is facing a number of problems and issues. Three major areas that deserve further attention have been identified: (1) specific technical issues regarding testing development, (2) epidemiological issues regarding the study design, including the need for meta-analysis/multi-center studies and for longitudinal observation, and statistical issues regarding the most adequate models for the analysis and treatment of complex neurobehavioral datasets, and (3) the need for scientific consensus on the significance of adverse effects identified with neurobehavioral methods. CONCLUSIONS: The importance of neurobehavioral toxicology in the evaluation of mechanisms of action and for preventive purposes is progressively growing. Further development is needed for the advancement of this discipline through collaboration between experts from different fields.

Environmental Exposure↗

PubMed1991

[Is assessment of complications following intra- and extracapsular cataract extraction with lens implantation biased?].

Extracapsular Cataract extraction with implantation of a posterior chamber lens has become the standard procedure in cataract surgery. Excellent results are accomplished with this method. It is remarkable, however, that there are scarcely any data about the rate of complications, e.g. capsular fibrosis with the necessity of YAG-laser-capsulotomy and its sequelae. Similarly, data on decentration of the lens, its consequences and correction are rare. The arguments against ICCE with implantation of a Choyce-Mark-IX anterior chamber lens like higher rate of retinal detachment, cystoid macular edema and corneal decompensation can not be confirmed by us on the basis of prospective clinical studies. With an appropriate operation technique equivalent results can be obtained as in ECCE. The debates about cataract surgery are carried out more on the basis of clinical impressions than on the basis of thorough scientific data. Surgery should not be a matter of "trends".

Bias↗

PubMed1997

Creatine supplementation as an ergogenic aid for sports performance in highly trained athletes: a critical review.

Creatine supplementation has become a common practice among competition athletes participating in different sports over the last few years. The mechanism by which supplementary creatine could have potential ergogenic effects would be an increased muscle creatine and phosphocreatine concentration, leading to a higher rate of ATP resynthesis, a delay in the onset of muscular fatigue and a facilitated recovery during repeated bouts of high-intensity exercise. A critical review of the literature reveals that these ergogenic effects, when found, have been generally shown in untrained subjects performing several exercise bouts under laboratory conditions. The limited body of scientific data available concerning highly trained athletes performing single competition-like exercise tasks indicates that this type of population does not benefit from creatine supplementation. Therefore, the widespread use of creatine ingestion to improve competition performance does not seem to be justified. The potential interest of creatine supplementation for elite athletes could be related to an increased ability to perform repeated high-intensity exercise bouts, either during training or during competition in sports in which repeated efforts are required (e.g. soccer, basketball), but this possibility needs scientific confirmation.

Adenosine Triphosphate↗

PubMed1996

Current trends in guideline development: a cause for concern.

Although the development and use of practice-related guidelines as educational aids has a long history in the health professions, scientific assessment indicates that they have had limited success in changing practice patterns. This is principally due to the exclusion of practitioners from the development process, and the lack of a credible scientific basis for many guidelines. Past failures have led to new methods of guideline development based on a critical analysis of scientific data. These methods, which involve legitimate professional organizations at all stages of the development process, are clearly a step in the right direction. Unfortunately, there are signs that current guideline developers still fail to recognize the critical nature of the new methods or the need for an open and inclusive development process. It is even more disquieting that the objective of some guideline developers, such as licensing bodies, is the formulation of standards or review criteria, particularly when there are very few therapeutic practices with a sufficient scientific basis to justify such a designation. National and provincial societies, as well as dental educators, need to assume a leadership role to ensure that if guidelines are required, they will be developed as credible aids for the improvement of patient care. In this paper, the authors recount why the "traditional process" of guideline development resulted in guidelines that were mistrusted by the profession and, as a result, ineffective. They also outline the widely-documented current methodology, which should be followed if guidelines are to be accepted by the profession. Finally, they discuss the critical issue of who should develop guidelines, and examine their role in dental practice and education.

Canada↗

PubMed2004

How long does it take to perform an operative vaginal delivery?

We set out to see how long it takes to achieve an operative vaginal delivery in normal practice. This was a prospective survey, conducted in a major and well-staffed British maternity unit over 1 month. Sixty-two assisted vaginal deliveries occurred in the month of the study. Thirteen data collection sheets were spoiled or could not be confirmed and were discarded before analysis. Therefore the remaining data are based on 49 deliveries. The main outcome measure was the time interval between the decision to assist the vaginal delivery and the delivery. Fifty per cent of babies were delivered within 18 minutes once the decision to act had been made (range 6-85 minutes). If the primary indication for delivery was an abnormal CTG the median time was 16 minutes (mean 20 minutes). Any legal claim based on the assumption that a reasonably competent obstetrician should deliver a baby within 15 minutes cannot be supported by scientific data.

Delivery Rooms↗

PubMed1998

Creutzfeldt-Jakob disease and blood transfusion.

Experimental data suggest that blood components from patients with CJD may carry infectivity. However, most of the studies have been made on the classic form of CJD. Further studies are needed to discern whether infectivity levels in blood from patients with the nvCJD differ from those with the classic form. Possibility of transmission of CJD by blood or blood products can not be excluded and therefore adequate surveillance should be implemented. People who have been exposed to contaminated blood should be followed, while recommendations are being adapted according to new scientific data on infectivity.

Creutzfeldt-Jakob Syndrome↗

PubMedDate not supplied

Intrinsa fails to impress FDA advisory panel.

Female sexual dysfunction (FSD) as a discipline of medicine is not fully recognized by many authorities. Definitions are controversial and data are lacking, yet the public clamors for treatment. The lay press has capitalized on this provocative women's issue, seizing on the public's insatiable desire for new, potentially 'sexy' therapeutic options in this area. Thus, the time was ripe for a potential FSD drug. The sexual medicine community watched with interest as the Food and Drug Administration (FDA) considered the Proctor & Gamble new drug application for Intrinsa (a testosterone patch for hypoactive sexual desire disorder for women who had undergone surgical castration via bilateral oophorectomy). In spite of quality scientific data, Intrinsa was not approved. With this issue of IJIR, a new column, entitled, 'perspective' is provided to the readership. Perspective is an invited opinion or viewpoint that aims to advise and update the medical community on a pertinent or current topic in sexual medicine. Dr Richard Spark, a noted endocrinologist, presents the first of three invited 'perspectives' on Intrinsa and the FDA decision. Dr Spark has authored several manuscripts on the topic of FSD.

Administration, Cutaneous↗

PubMed2006

Oral health status in individuals with dementia living in special facilities.

AIM: The aim of this review was to retrieve data describing the oral health status of individuals with dementia living in special facilities. MATERIALS AND METHODS: A literature search on the MEDLINE database (Entrez PubMed) was performed. The literature search yielded 208 papers, of which seven publications were selected for evaluation. RESULTS: From the available studies poorer oral hygiene, decreased saliva flow rates and a higher caries incidence were reported in individuals with dementia living in special facilities when compared with healthy individuals. Oral health problems were more pronounced in the severe stage of the disease. CONCLUSIONS: There is limited scientific data describing the oral health status of individuals with dementia living in special facilities. However, available data indicate that individuals with dementia living in special facilities have more oral health problems than individuals without dementia.

Aged↗

PubMed2002

[Ototoxicity-related vertigo].

Many substances may be the source of dizziness or transient equilibrium disturbances due to dysfunction of the CNS or to an impairment of visual or proprioceptive informations. Other agents are responsible for drop of arterial pressure by changing position, including antihypertensive drugs, alpha-blocking agents used in urology, antipsychotics, cyclic antidepressants, vasodilators and nitrates, dopaminergic antiparkinson drugs, sedatives, etc. Only drug with true ototoxic properties will be discussed here, namely substances that are able to damage the inner ear (cochlear or vestibular damage) or the VIIIth cranial nerve, causing impairment of equilibrium and/or (most often) hearing. No relevant data report the actual incidence of ototoxic problems, but more than 130 products have been classified as potentially dangerous. Individual susceptibility seems highly variable, but some predisposing factors have been identified: renal failure, age, combination of ototoxic drugs, familial sensitivity to ototoxic effects or previous neurosensorial deficit. We will first discuss the ototoxic medications that have certainly been extensively studied and among which we find several antibiotics (especially aminoglycosides and macrolides), the loop diuretics, and some antimalarial or chemotherapeutic agents. Environmental toxins and drug of abuse will then be discussed briefly because scientific data are much less significant. Early recognition of subjects who are at risk of developing ototoxicity, use of therapeutic monitoring and close observation of cochleovestibular functions in high risk situations (often not easy in critical patients) are the best way to prevent severe complications that have occasionally disastrous consequences on the quality of further life.

Anti-Bacterial Agents↗

PubMed2004

[Ototoxicity-related dysequilibrium].

Many substances may be the source of dizziness or transient equilibrium disturbances due to dysfunction of the CNS or to an impairment of visual or proprioceptive informations. Other agents are responsible for drop of arterial pressure by changing position, including antihypertensive drugs, alpha-blocking agents used in urology, antipsychotics, cyclic antidepressants, vasodilators and nitrates, dopaminergic antiparkinson drugs, sedatives, etc. Only drug with true ototoxic properties will be discussed here, namely substances that are able to damage the inner ear (cochlear or vestibular damage) or the VIIIth cranial nerve, causing impairment of equilibrium and/or (most often) hearing. No relevant data report the actual incidence of ototoxic problems, but more than 130 products have been classified as potentially dangerous. Individual susceptibiity seems highly variable, but some predisposing factors have been identified: renal failure, age, combination of ototoxic drugs, familial sensitivity to ototoxic effects or previous neurosensorial deficit. We will first discuss the ototoxic medications that have certainly been extensively studied and among which we find several antibiotics (especially aminoglycosides and macrolides), the loop diuretics, and some antimalarial or chemotherapeutic agents. Environmental toxins and drug of abuse will then be discussed briefly because scientific data are much less significant. Early recognition of subjects who are at risk of developing ototoxicity, use of therapeutic monitoring and close observation of cochleo-vestibular functions in high risk situations (often not easy in critical patients) are the best way to prevent severe complications that have occasionally disastrous consequences on the quality of further life.

Anti-Bacterial Agents↗

PubMed2002

Statins in acute coronary syndromes.

The development of 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors (statins) has been a very significant development in the management of coronary artery disease. Large prospective clinical trials have provided unequivocal evidence that cholesterol lowering therapy with statins reduces all-cause mortality in patients with coronary artery disease. There is now accumulating data indicating that statin treatment should be initiated early after an acute coronary syndrome. This body of evidence is based on large databases in which investigators compared outcomes among patients taking statins with those patients who were not prescribed cholesterol lowering therapy. Prospective, randomized, clinical trials also indicate that early statin therapy reduces recurrent ischemia. Finally, studies examining long-term compliance with statin therapy suggest increased adherence to therapy when statins are prescribed during the initial hospitalization for an acute coronary syndrome. In tandem with these clinical observations, there is a large body of scientific data that highlights many important cellular and molecular mechanisms through which statins may confer early benefit. These effects involve relatively rapid improvement in endothelial function, antiischemic, antithrombotic and antiinflammatory actions of statins.

Acute Disease↗

PubMed2025

Impact of laboratory-driven proactive reanalysis: Reclassification to positive in 5% of initially negative or uncertain exome sequencing cases.

PURPOSE: Reanalysis of exome sequencing (ES) data increases diagnostic utility; however, there is no consensus on when and under what circumstances reanalysis should occur. Requesting and performing ES reanalysis burdens both clinical and laboratory workflows. Maximizing the potential for reclassification is essential. Here, we describe the impact of a laboratory-driven proactive reanalysis process that triggers reanalysis when new evidence is identified. METHODS: We reviewed reanalysis outcomes of an ES cohort. Reanalysis events were categorized based on initiating factors (laboratory-driven proactive, family studies, and clinician-initiated). Laboratory-driven proactive reclassifications are prompted by systematic review of new scientific data. Outcomes were evaluated by initiating factors, reclassification types, evidence used, and time since original report. RESULTS: Overall, 23% of cases underwent at least 1 reanalysis, with 35% of reanalyses resulting in reclassification. There was a 4% increase in diagnostic yield, including 5% of initially unsolved ES receiving diagnostic reports. Diagnostic reclassifications rates were significantly higher for laboratory-driven proactive reanalyses (54%; P < .0001) than family studies (18%) and clinician-initiated reanalyses (4%). New gene-disease relationships were the most efficacious evidence source. Laboratory-driven proactive reclassifications occurred steadily over time. CONCLUSION: Laboratory-driven proactive reanalysis effectively provides more diagnostic reclassifications compared with clinician-initiated reanalysis. Laboratories should curate and integrate emerging evidence into ES reanalysis.

Humans↗

PubMedDate not supplied

[The toxicology and prevention of the risks of occupational exposure to aromatic polycyclic hydrocarbons. I. Guide lines for the prevention of the risks of occupational exposure to aromatic polycyclic hydrocarbons. Società Italiana Valori di Riferimento and Cattedra di Medicina del Lavoro, Università di Brescia].

These guidelines mainly deal with prevention of carcinogenic effects following occupational exposure to polycyclic aromatic hydrocarbons (PAH). After some toxicological remarks, the guidelines define a possible method to demonstrate and evaluate occupational exposure to PAH. In particular, it is illustrated the strategy of environmental monitoring and indicated which PAH should be measured, with suggestion about the most appropriate analytical techniques. As regards biological monitoring, the 1-OH-pyreneseems to be currently the most useful indicator since it reflects the recent and global exposure to PAH. The guidelines also give elements to interpret monitoring data, taking into account environmental and biological reference and limit values suggested by some authors, Associations, or current regulations. The most important health effects are carcinogenic and excess risks have been described mainly for lung, bladder and skin cancer in some PAH exposed workers. The studies on cytogenetic effects showed contradictory results. On the basis of such information and current regulations, the guidelines show how to perform health surveillance in preventive and periodical examinations and how to proceed for the information and formation of exposed workers. It is not advisable, on the basis of the current scientific data, to screen asymptomatic PAH exposed workers for early diagnosis of lung or bladder cancer, nor it is opportune the use of tumor markers for health surveillance nor is genetic screening applicable for individual susceptibility evaluation outside research programs.

Carcinogens↗

PubMedDate not supplied

National campaign against hepatitis C in France (1999-2002).

Since 1988, several measures have been applied in France to control HCV infection. HCV seroprevalence in the adult population is estimated at 1.1% (500,000 to 650,000 persons) and the number of chronically infected at 400,000 to 500,000 persons. In 1994, most of them might not be aware of their infection. Blood products administration and injecting-drug use are identified as the main transmission routes. The national hepatitis C plan (1999-2002) was based on scientific data and developed after a consensus conference and several expert consultations. It involves six programs and quantified objectives: prevention of new infections, enforcement of screening access; improvement of care management; implementation of a surveillance system, clinical research and evaluation. Specific financial supports were attributed for the implementation of the plan. The 2001 progress report confirmed a major increase in national and regional actions. In 2000, considering the high proportion of persons still unaware of their infection (at least one third) and the increase of treatment efficacy, the target population of the screening strategy was considerably extended after scientific analysis. A national consciousness-raising campaign directed at general practitioners was launched in June 2000. In 2001, a media campaign directed to the general population was developed, in newspapers and on radio stations. Since the end of 1999, a national toll free phone number provides information to the public. In order to improve access to screening, a new regulation added HCV testing to the missions of anonymous and free HIV testing centres, as well as of family planning centres. The hepatitis C prevention strategy is still included in a national public health program and improved in view of its renewal.

Cost-Benefit Analysis↗

PubMed2002

[Medical ethics, a counter-weight to the logics of the Perruche decree].

FROM A CONTRACTUAL LOGIC TO A PROBABILISTIC APPROACH: Since 1936, reflections on the relationship between the physician and the patient have progressed within the context of a contractual legal concept. Its contents have been based more on jurisprudence than on the physicians' reflections with regard to their practice. Associated with this contractual logic, some confusion exists between a lesion, a medical concept, and a handicap, which is the social consequence of one's status of health. This has been reinforced by the scientific progress made in medicine, which privileges a probabilistic approach based on scientific data, rather than the uncertainty, inscribed in the dialogue and singularity of the encounter. REGARDING THE PERRUCHE DECREE: We analyzed the reports submitted to the court of cessation regarding the Perruche affair, together with the first chapter of the law concerning the rights of the patients and the quality of health system, by studying the extent to which this decision was inscribed or not in the continuity of past legal decisions, and whether the characteristics described above were present. In this decree, the predominating contractual logic is that the notion of handicap is not analyzed, and the scientific and probabilistic conception of medical practice is involved in the debate. THE NECESSITY FOR REFLECTION: Our discussion insists on the necessity of constructing a reflection on the medical presentation; society cannot accept that this be reduced to the strict respect of the elements of the contract, defined by legal decisions. It should be carefully thought out by health professionals, and in collaboration with human science.

Persons with Disabilities↗

PubMed1999

From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection.

OBJECTIVES: To review the scientific data on the role of sexually transmitted diseases (STDs) in sexual transmission of HIV infection and discuss the implications of these findings for HIV and STD prevention policy and practice. METHODS: Articles were selected from a review of Medline, accessed with the OVID search engine. The search covered articles from January 1987 to September 1998 and yielded 2101 articles. Methods used to uncover articles which might have been missed included searching for related articles by author, and combing literature reviews. In addition, all abstracts under the category "sexually transmitted diseases" from the XI and XII International Conferences on AIDS (Vancouver 1996 and Geneva 1998) and other relevant scientific meetings were reviewed. Efforts were made to locate journal articles which resulted from the research reported in the identified abstracts. All original journal articles and abstracts which met one of the following criteria were included: (1) studies of the biological plausibility or mechanism of facilitation of HIV infectiousness or susceptibility by STDs, (2) prospective cohort studies (longitudinal or nested case-control) which estimate the risk of HIV infection associated with specific STDs or STD syndromes, or (3) intervention studies which quantitate the effect which STD treatment can have on HIV incidence. RESULTS: Strong evidence indicates that both ulcerative and non-ulcerative STDs promote HIV transmission by augmenting HIV infectiousness and HIV susceptibility via a variety of biological mechanisms. These effects are reflected in the risk estimates found in numerous prospective studies from four continents which range from 2.0 to 23.5, with most clustering between 2 and 5. The relative importance of ulcerative and non-ulcerative STDs appears to be complex. Owing to the greater frequency of non-ulcerative STDs in many populations, these infections may be responsible for more HIV transmission than genital ulcers. However, the limited reciprocal impact of HIV infection on non-ulcerative STDs and the evidence that non-ulcerative STDs may increase risk primarily for the receptive partner (rather than bidirectionally) may modulate the impact of these diseases. The results of two community level randomised, controlled intervention trials conducted in Africa suggest that timely provision of STD services can substantially reduce HIV incidence, but raise additional questions about the optimal way to target and implement these services to achieve the greatest effect on HIV transmission. CONCLUSIONS: Available data leave little doubt that other STDs facilitate HIV transmission through direct, biological mechanisms and that early STD treatment should be part of a high quality, comprehensive HIV prevention strategy. Policy makers, HIV prevention programme managers, and providers should focus initial implementation efforts on three key areas: (i) improving access to and quality of STD clinical services; (ii) promoting early and effective STD related healthcare behaviours; and (iii) establishing surveillance systems to monitor STD and HIV trends and their interrelations.

Disease Susceptibility↗