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At least 163 records · Page 9Linked to original sources
PubMed1995

Pneumococcal vaccine and HIV infection: report of a vaccine failure and reappraisal of its value in clinical practice.

A clinical failure of pneumococcal vaccine is reported. A 22 year old African woman was given 23-valent pneumococcal vaccine at her initial presentation with HIV infection. She was asymptomatic and had a CD4+ lymphocyte count above 500 cells/mm3. Eighteen months later she died of meningitis and septicaemia due to Streptococcus pneumoniae type 9 (an antigen included in the 23-valent vaccine). Pneumococcal antibody levels performed on stored blood demonstrated no serological response to the vaccine. This is the first reported case of clinical failure of pneumococcal vaccine in an HIV infected patient who received vaccine whilst at the asymptomatic stage of HIV infection and with relatively intact immune function. The literature pertaining to pneumococcal vaccination in the context of HIV infection was reviewed. Pneumococcal vaccination is recommended for HIV positive patients in the UK by the Departments of Health. It is likely that many physicians are not aware of these recommendations or are concerned about the poor efficacy of the vaccine, and it may consequently be underused in clinical practice. But the potential gain to the HIV positive patient is such that the vaccine should be offered to all HIV positive patients as soon as they present for medical care, irrespective of the stage of HIV disease. Physicians and patients should be aware that the vaccine is not fully protective and that episodes of sepsis, pneumonia and meningitis could still be pneumococcal in origin and should be treated appropriately. Awareness of the substantial risks of pneumococcal disease in HIV infected patients with prompt diagnosis and effective treatment is the most important strategy to decrease morbidity and mortality.

Adult↗
PubMed1984

A new viscoelastometer for studying the rheological properties of bronchial mucus in clinical practice.

In clinical practice, a wide variety of drugs are given to modify the rheological properties of bronchial mucus but they are frequently not correctly chosen because there is not a simple apparatus available for the routine measurement of the mucus viscoelasticity. We designed a new viscoelastometer which is easy to operate and permit accurate measurement of the viscoelastic properties of mucus. The system has a Couette geometry and requires a sample of 1 ml. The outer cylinder is thermostated and rotates at a constant rate. The resulting torque is measured on the inner cylinder using a microdisplacement transducer. The inner cylinder is suspended by a special wire system which maintains a constant 0.75 mm gap between the two cylinders. The apparent viscosity is calculated up to 100 Pa.s. at a low shear rate (0.4 s-1) and the elasticity is analyzed by a stress relaxation method. The characteristics of the apparatus and the typical viscoelasticity behaviour of several sputum samples are reported.

Bronchi↗
PubMed2001

[Sources of error in clinical practice].

The clinical setting is everything that contact us with the patient's reality, including physical, instrumental and laboratory exploration, and we use it for diagnostic and treatment purposes. Diagnosis is the synthesis by which physicians conclude an elaborated analysis of subjective and objective data, obtained by physical exam and technology. This procedure involves data collection about the patient and his disease, the results of various tests and laboratory findings, the interpretation of the data and a diagnostic summary. Medical errors may be derived from insufficiency in any of these phases. It is evident that technology will never replace the intellectual data recollection, analysis and reasoning that is the physician's art. This contribution underlines some of the defects frequently observed in clinical practice that may cause medical errors.

Humans↗
PubMedDate not supplied

[Clinical aspects of celiac disease. Comparison of 2 periods: before and after the introduction of antigliadin antibody determination in clinical practice].

The clinical aspects of coeliac disease before and after anti-gliadin antibodies (AGA) assessment in clinical practice, referring to personal experience (107 cases in the period 1976-1988) are described. AGA determination has executed by two different ELISA methods. The diagnosis of coeliac disease in the period 1976-1986 has been made according to ESPGAN criteria, while in the last two years following the recent SIP advice. After 1987 with the introduction of AGA assay, the number of diagnosis/year of coeliac disease has increased three times in respect of the period 1976-1986. We have observed a more marked increase of the late beginning forms (from 2.8 to 10 diagnosis/year) in respect of the early beginning ones (from 3.7 to 7.5 diagnosis/year) and of the atypical forms (from 0.7 to 9 diagnosis/year) in respect of the typical ones (from 5.8 to 8.5 diagnosis/year). According to these data we think that prevalence of coeliac disease in our country is probably underestimated. AGA determination is at time most effective mean to make a screening of coeliac disease in the population. According to us the largest employment of this method in the next years could take a most exact estimate of the coeliac disease prevalence in our country.

Adolescent↗
PubMedDate not supplied

[Rational for the use of human immunoglobulins in clinical practice].

The Clinic for Rheumatology and Clinical Immunology of the Military Medical Academy, with the participation of the hosts and experts from eminent Yugoslav institutions, in April 1997 organized the symposium on two current and trendy subjects from clinical immunology: "Antiphospholipid syndrome" and "The use of polyvalent intravenous immunoglobulins in the clinical praxis". This paper summarizes the contemporary knowledge about the structure and biological activity of immunoglobulins, methods for their production, different pharmacokinetic and pharmacodynamic characteristics of two types (5S and 7S) IVIG preparations, etc. We pointed out three basic groups of indications for IVIG clinical use: 1) substitutional therapy in the primary and secondary immunodeficiencies; 2) adjuvant therapy for severe infections; 3) immunomodulation in autoimmune diseases. Particular emphasis was put on currently known mechanisms of immunosuppressive action of IVIG in autoimmune diseases. Except for presently accepted indications for their use (idiopathic thrombocytopenic purpura and Kawasaki syndrome) we mentioned about 40 different diseases in hematology, neurology, rheumatology and other branches of medicine, from neonatology to transplantology, in which IVIG had shown some efficacy. Possibilities of different therapeutic modalities and the choice of diverse pharmacokinetic and pharmacodynamic effects, benefit the very wide spectrum of diseases, while minimal incidence of adverse effects suggested them to be the therapy of the future in the clinical practice.

Humans↗
PubMed2003

Promoting good clinical practices in the conduct of clinical trials: experiences in the Department of Veterans Affairs Cooperative Studies Program.

The ever-increasing concern for the welfare of volunteers participating in clinical trials and for the integrity of the data derived from those trials has generated the concept of Good Clinical Practice (GCP). The Veterans Affairs Cooperative Studies Program, in anticipation of the need to comply with GCP guidelines, developed a Site Monitoring and Review Team (SMART), which consists of a Good Clinical Practice Monitoring Group and a Good Clinical Practice Review Group. The review group conducted 335 site reviews from fiscal years (FY) 1999 through 2001 to assess and encourage adherence to GCP. Data from reviews were compared for two time periods, a 2-year implementation period (FYs 1999/2000, n=204) and a continuing follow-up period (FY 2001, n=131). Overall, high GCP adherence was exhibited by 11.3% (n=23) of study sites in FY 1999/2000 versus 20.6% (n=27) in FY 2001, average to good adherence was exhibited by 84.3% (n=172) in FY 1999/2000 versus 77.0% (n=101) in FY 2001, and below average adherence was exhibited by 4.4% (n=9) versus 1.5% (n=3) in these two periods. These changes were statistically significant by chi square analysis (p=0.029). Moreover, GCP adherence was assessed within eight GCP focus areas: patient informed consent, protocol adherence, safety monitoring, institutional review board interactions, regulatory document management, patient records in investigator file, drug/device accountability, and general site operations. Median assessment scores for all 62 GCP review elements improved from 0.82 to 0.89 (p<0.001). Median assessment scores for the 14 selected critical GCP items improved from 0.78 to 0.89 (p<0.001). Median scores for five of the eight GCP focus areas improved significantly (p<0.001) between the two time periods. These data suggest that the site-oriented activities of SMART combined with centralized quality assurance activities of the coordinating centers represent an integrated, versatile program to promote and assure GCP adherence and data integrity in Cooperative Studies Program trials.

Clinical Trials as Topic↗
PubMed2005

The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research.

Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice (GMP) conditions. This review aims to give an overview of the basic principles and guidelines for the preparation of radiopharmaceuticals. Special attention is given to the production area environment and personnel, the two basic requirements for GMP productions. Especially for the production area, two philosophies have to be combined: the cascade system of over-pressure for the production of pharmaceuticals and the under pressure system for the manufacturing of radioisotopes. Personnel should be selected based on education and regularly given special training for the handling of radioactive material. Compared to pharmaceuticals, radiopharmaceuticals have their own labels, taking into account their specific nature. Besides the standard quality control, other items for quality control of radiopharmaceuticals are also discussed in this article.

Biomedical Research↗
PubMed2004

Lessons learned in implementing SCI clinical practice guidelines.

While clinical practice guidelines (CPGs) were designed as a tool to improve patient outcomes, decrease practice variation, and optimize resource utilization, providers often encounter significant barriers to integrating these into clinical practice. A study was conducted at six spinal cord injury (SCI) centers in the Department of Veterans Affairs (VA) to improve provider adherence and patient outcomes of two CPGs: Prevention of Thromboembolism in Spinal Cord Injury and Neurogenic Bowel Management in Adults With Spinal Cord Injury. To design effective implementation strategies, focus groups were conducted to identify provider-perceived barriers and facilitators to implementing recommendations for each of the SCI guidelines. Based on this information, four guideline implementation strategies were designed: (a) use of local opinion leaders ("clinical champions"), (b) patient-mediated interventions, (c) standardized documentation template/standing orders, and (d) social marketing/outreach visits. These strategies were implemented at each site. This article identifies "lessons learned" during the process of trying to get these CPGs embedded into clinical practice.

Attitude of Health Personnel↗
PubMed2003

European guidelines on cardiovascular disease prevention in clinical practice: third joint task force of European and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of eight societies and by invited experts).

Guidelines aim to present all the relevant evidence on a particular issue in order to help physicians to weigh the benefits and risks of a particular diagnostic or therapeutic procedure. They should be helpful in everyday clinical decision-making. A great number of guidelines have been issued in recent years by different organisations--European Society of Cardiology (ESC), American Heart Association (AHA), American College of Cardiology (ACC), and other related societies. By means of links to web sites of National Societies several hundred guidelines are available. This profusion can put at stake the authority and validity of guidelines, which can only be guaranteed if they have been developed by an unquestionable decision-making process. This is one of the reasons why the ESC and others have issued recommendations for formulating and issuing guidelines. In spite of the fact that standards for issuing good quality guidelines are well defined, recent surveys of guidelines published in peer-reviewed journals between 1985 and 1998 have shown that methodological standards were not complied with in the vast majority of cases. It is therefore of great importance that guidelines and recommendations are presented in formats that are easily interpreted. Subsequently, their implementation programmes must also be well conducted. Attempts have been made to determine whether guidelines improve the quality of clinical practice and the utilisation of health resources. In addition, the legal implications of medical guidelines have been discussed and examined, resulting in position documents, which have been published by a specific task force. The ESC Committee for practice guidelines (CPG) supervises and coordinates the preparation of new guidelines and expert consensus documents produced by task forces, expert groups or consensus panels. The Committee is also responsible for the endorsement of these guidelines or statements.

Adult↗
PubMed2005

A composite disease activity scale for clinical practice, observational studies, and clinical trials: the patient activity scale (PAS/PAS-II).

OBJECTIVE: To develop and validate a composite patient self-report disease activity scale for use in clinical practice and in observational studies and clinical trials. METHODS: A total of 9078 patients with rheumatoid arthritis completed detailed questionnaires that included measure of quality of life in the form of utilities. We evaluated several disease activity scales by measuring their agreement with the utility scales, and also their assessed ability to predict mortality and prescription for anti-tumor necrosis factor therapy. RESULTS: A composite index composed of a visual analog scale (VAS) for pain, a patient global VAS, and the Health Assessment Questionnaire (HAQ) or the HAQ II formed the Patient Activity Scale (PAS) and PAS-II. These scales performed as well as or better than longer, more complex scales. CONCLUSION: A simple, useful clinical scale, the PAS or PAS-II, can be formed by the use of common clinical variables. It is well correlated with and relevant to a wide range of clinical variables. This scale should be useful for comparative studies, clinical care, and regulatory documentation.

Aged↗
PubMed2003

[The ideal curriculum for undergraduate clinical practice training in clinical laboratory medical education].

A model core curriculum for medical education is proposed to serve as an essential basis of material to be mastered. The fundamental laboratory techniques specified by this curriculum are the following five items. 1. Ability to appropriately record a 12-lead EKG. 2. Ability to perform urinalysis. 3. Ability to prepare and examine blood smear samples. 4. Ability to select and preserve microbiological samples for analysis, and to perform Gram staining analysis. 5. Ability to perform and evaluate pregnancy test. However, many other laboratory skill items are permitted in the model curriculum, as emphasized by the individual university. Therefore, reforms require appropriate changes in the educational programs for laboratory practice on the undergraduate level. In the Toyama Medical and Pharmaceutical University, all students must study compulsory fundamental laboratory technique in the first semester of the 5th year and, in addition, 6th graders in the last two months may choose an advanced clinical training course including genetic examinations. An important feature of our clinical training program is to introduce problem-based learning(PBL) tutorial education, which utilizes reversed CPC(R-CPC). An additional elective curriculum in clinical laboratory practice will be required, providing unique training programs based on student needs, the educational principles of each university and the specialties of the instructors.

Clinical Laboratory Techniques↗
PubMed2000

A clinical practice guideline for treating tobacco use and dependence: A US Public Health Service report. The Tobacco Use and Dependence Clinical Practice Guideline Panel, Staff, and Consortium Representatives.

OBJECTIVE: To summarize the recently published US Public Health Service report Treating Tobacco Use and Dependence: A Clinical Practice Guideline, which provides recommendations for brief clinical interventions, intensive clinical interventions, and system changes to promote the treatment of tobacco dependence. PARTICIPANTS: An independent panel of 18 scientists, clinicians, consumers, and methodologists selected by the US Agency for Healthcare Research and Quality. A consortium of 7 governmental and nonprofit organizations sponsored the update. EVIDENCE: Approximately 6000 English-language, peer-reviewed articles and abstracts, published between 1975 and 1999, were reviewed for data that addressed assessment and treatment of tobacco dependence. This literature served as the basis for more than 50 meta-analyses. CONSENSUS PROCESS: One panel meeting and numerous conference calls and staff meetings were held to evaluate meta-analytic and other results, to synthesize the results, and to develop recommendations. The updated guideline was then externally reviewed by more than 70 experts and revised. CONCLUSIONS: This evidence-based, updated guideline provides specific recommendations regarding brief and intensive tobacco cessation interventions as well as system-level changes designed to promote the assessment and treatment of tobacco use. Brief clinical approaches for patients willing and unwilling to quit are described. Major conclusions and recommendations include: (1) Tobacco dependence is a chronic condition that warrants repeated treatment until long-term or permanent abstinence is achieved. (2) Effective treatments for tobacco dependence exist and all tobacco users should be offered those treatments. (3) Clinicians and health care delivery systems must institutionalize the consistent identification, documentation, and treatment of every tobacco user at every visit. (4) Brief tobacco dependence treatment is effective, and every tobacco user should be offered at least brief treatment. (5) There is a strong dose-response relationship between the intensity of tobacco dependence counseling and its effectiveness. (6) Three types of counseling were found to be especially effective-practical counseling, social support as part of treatment, and social support arranged outside of treatment. (7) Five first-line pharmacotherapies for tobacco dependence-sustained-release bupropion hydrochloride, nicotine gum, nicotine inhaler, nicotine nasal spray, and nicotine patch-are effective, and at least 1 of these medications should be prescribed in the absence of contraindications. (8) Tobacco dependence treatments are cost-effective relative to other medical and disease prevention interventions; as such, all health insurance plans should include as a reimbursed benefit the counseling and pharmacotherapeutic treatments identified as effective in the updated guideline. JAMA. 2000;283:3244-3254

Cost-Benefit Analysis↗
PubMed1985

Definition of clinical pharmacy as a specialty in clinical practice. Committee on Clinical Pharmacy as a Specialty. American Pharmacy Association.

Specialty credentialing has been discussed extensively and debated within pharmacy for more than ten years. Within the profession, there now appears to be a consensus on the need for and appropriateness of acknowledging professional practice areas as unique, defined entities. However, there remain substantive differences on how the definition of specialty practice should be constructed. One approach is to identify practice areas by functional activity (e.g., nuclear pharmacy, drug information) and/or therapeutic focus (e.g., psychopharmacy, clinical pharmacokinetics). A second approach is to define clinical pharmacy as a specialty practice that would, at least initially, coalesce clinical practitioners with the common denominator of an active role in the therapeutic decision-making process. The following document was developed by the Committee on Clinical Pharmacy as a Specialty (CCPS). The CCPS is independent of any formal organizational affiliations. It will serve as the preface to a petition that will be submitted to the Board of Pharmaceutical Specialties requesting recognition of clinical pharmacy as a specialty. The intention of the committee is to resolve the question of specialty status for clinical pharmacy through the Board of Pharmaceutical Specialties' review process. It is then hoped that pharmacy can move forward on the important issue of specialty credentialing.

Certification↗
PubMed1995

Clinical practice should reflect clinical science.

The Cochrane Collaboration was set up in 1992 as a world-wide network for creating and disseminating systematic reviews of randomised controlled trials (RCTs) in healthcare. Systematic reviewing of RCTs is an essential stage, prior to the creation and dissemination of clinical guidelines, in the practice of evidence-based medicine. This paper is intended to provide the health telematics community with an introduction to the motives, aims and activities of the Cochrane Collaboration.

Computer Communication Networks↗
PubMed2006

Evidence-based practice: a framework for clinical practice and research design.

The evidence-based practice (EBP) framework emerged in the early 1970s as a means of improving clinical practice. This shift towards EBP allowed health professionals to move from a culture of delivering care based on tradition, intuition and authority, to a situation where decisions were guided and justified by the best available evidence. Despite the many advantages of EBP, many practitioners remain cautious about embracing the model. Part of this opposition is due to a misunderstanding of EBP, which this paper aims to address.

Evidence-Based Medicine↗