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PubMed2004

The nanny state meets the inner lawyer: overregulating while underprotecting human participants in research.

Without any systematic data or evidence of a problem, or even a thoughtful analysis of costs and benefits, the application of the human participant review system within universities is overreaching at the same time that some risky experimentation on humans outside of universities is unregulated. This article questions the purpose, feasibility, and effectiveness of current IRB approaches to most "2 people talking" situations and proposes scaling back the regulatory system to increase respect accorded it by researchers and its ability to protect human participants of research from real versus imagined harms. In too many cases, the focus is on form over ethical substance: counting what can be counted, rather than focusing instead on what counts. Some disciplines--oral history and journalism, for example--simply do not belong within the scope of institutional review board jurisdiction. Others, such as survey research, informational interviews, and informal interactions, call for a shift from centralized review to more departmentally based (i.e., rooted in disciplinary ethics) oversight, and clearer guidelines on what requires advance review as opposed to provision of post hoc complaint systems.

Behavioral Research↗

PubMed2006

A systematic review of evidence about extended roles for allied health professionals.

OBJECTIVE: Extending the role of allied health professionals has been promoted as a key component of developing a flexible health workforce. This review aimed to synthesize the evidence about the impact of these roles. METHODS: A systematic review of extended scope of practice in five groups: paramedics, physiotherapists, occupational therapists, radiographers, and speech and language therapists. The nature and effect of these roles on patients, health professionals and health services were examined. An inclusive approach to searching was used to maximize potential sources of interest including multiple databases, 'grey' literature and subject area experts. An expanded Cochrane Collaboration method was used in view of the anticipated lack of randomized controlled trials and heterogeneity of designs. Papers were only excluded after the search stage for lack of relevance. RESULTS: A total of 355 papers was identified as meeting relevance criteria and 21 studies progressed to full review and data extraction. The primary reason for exclusion from data extraction was that the study included neither qualitative nor quantitative data or because methodological flaws compromised data quality. It was not possible to evaluate any pooled effects as patient health outcomes were rarely considered. CONCLUSIONS: A range of extended practice roles for allied health professionals have been promoted and are being undertaken, but their health outcomes have rarely been evaluated. There is also little evidence as to how best to introduce such roles, or how best to educate, support and mentor these practitioners.

Allied Health Personnel↗

PubMed1993

Understanding flux patterns in membrane processing of protein solutions and suspensions.

Membrane microfiltration is one of the most effective ways of separating proteins from materials of larger size, such as microbial cells and cell debris. Ultrafiltration is the most effective means of concentrating protein solutions. This review describes the scope and operating patterns of these processes. A major goal for membrane technologists is the development of predictive descriptions of membrane processes, based on a rigorous understanding of the underlying physico-chemical phenomena. The emphasis is placed on quantitative analysis of the interfacial aspects and microhydrodynamics of membrane processes. From existing knowledge, it is already possible to define a number of guidelines for successful filtration process operation.

Membranes, Artificial↗

PubMed2003

The evolution of clinical audit as a tool for quality improvement.

Clinical auditing practices are recognized universally as a useful tool in evaluating and improving the quality of care provided by a health service. External auditing is a regular activity for mental health services in Australia but internal auditing activities are conducted at the discretion of each service. This paper evaluates the effectiveness of 6 years of internal auditing activities in a mental health service. A review of the scope, audit tools, purpose, sampling and design of the internal audits and identification of the recommendations from six consecutive annual audit reports was completed. Audit recommendations were examined, as well as levels of implementation and reasons for success or failure. Fifty-seven recommendations were identified, with 35% without action, 28% implemented and 33.3% still pending or in progress. The recommendations were more likely to be implemented if they relied on activity, planning and action across a selection of service areas rather than being restricted to individual departments within a service, if they did not involve non-mental health service departments and if they were not reliant on attitudinal change. Tools used, scope and reporting formats have become more sophisticated as part of the evolutionary nature of the auditing process. Internal auditing in the Barwon Health Mental Health Service has been effective in producing change in the quality of care across the organization. A number of evolutionary changes in the audit process have improved the efficiency and effectiveness of the audit.

Australia↗

PubMed1989

Long-term complications of conventional immunosuppressive treatment.

Recent progress in understanding of the pathophysiologic mechanisms of an increasing number of diseases involving immunologic effector mechanisms and the broadening of indications for allograft transplantation have considerably expanded the use of immunosuppressive drugs in clinical medicine. A new therapeutic situation has thus been created that reproduces various aspects of pathologic conditions such as primary and secondary immunodeficiency disorders. This increasing use of immunosuppressive drugs raises the issue of careful evaluation of the risks involved balanced against the expected benefits. The present review will evaluate, through the literature, the long-term side effects of immunosuppressive drugs commonly used in clinical practice, including cyclophosphamide, azathioprine, and, more recently, cyclosporine A, which has increased the spectrum of allograft transplants, in particular, cardiac and hepatic. Other immunosuppressive drugs have been used less extensively. Their side effects are less well known or are analogous to those of the conventional immunosuppressive drugs just mentioned, in particular, chlorambucil, whose mode of action follows a pathway similar to that of cyclophosphamide. New developments in the spectrum of immunosuppressive drugs in clinical practice, such as those of monoclonal antibodies, await future evaluation. Their use is only recent, and a discussion of their side effects is beyond the scope of this review.

Autoimmune Diseases↗

PubMed1983

Electromechanical and physicochemical properties of connective tissue.

This review has dealt primarily with the electromechanical and transport properties of the extracellular matrix, which generally contains ionized charged groups under physiological conditions. Connective tissues are not electrically "active" in the sense of nerve or muscle; that is, electrical signals do not propagate as waves within the tissue. However, we have attempted to show the importance of "passive" electromechanical coupling and the coupling of passive transport mechanisms to the functional health of connective tissues. The effect of mechanical and electrical stresses on cell growth and biosynthesis is a relatively new and exciting area of research that should provide important clues concerning the interactions between cells and the extracellular matrix. While the role of cells in connective tissues is beyond the scope of this review, it is well known that environmental stresses have a direct effect on the structure and composition of connective tissues. Studies have shown that changes in the chemical and mechanical environment of cells can significantly alter cell synthesis of polysaccharide and protein components of the matrix. For example, Gillard et al. studied the glycosaminoglycan and collagen composition of the flexor digitorium profundus tendon of the rabbit. In regions where the tendon is subject to tensile forces, the tissue GAG content is approximately 0.2% of the dry weight, a value not unlike other tendons. However, in the small sesamoid region where the tendon hooks around the heel bone, the tendon is subjected to high compressional stresses. In this region, the GAG concentration is 15 to 20 times higher and the GAG composition is similar to that of articular cartilage. Gillard et al. found that manipulation of the tendon so as to release the compressional forces lead to a decrease in GAG content by more than 60%. Subsequent replacement of the tendon to its original position caused a concomitant increase in the GAG content. These results can be interpreted to be directly linked to the influence of mechanical forces on cell synthesis. The recent finding that cell synthesis is also affected by imposed electrical fields may suggest that electrical, mechanical and chemical signals are somehow interpreted by the cells along common pathways. The fact that electrical potentials are naturally produced near cells by deformation of the extracellular matrix provides additional support for such hypotheses.

Animals↗

PubMed2004

Criminalization of HIV transmission: can doctors be liable for the onward transmission of HIV?

The English Court of Appeal has recently confirmed that the reckless transmission of HIV can amount to a criminal offence, following on from a similar development in Scotland in 2001. This development has led to some concern as to whether doctors could, in certain circumstances, themselves be liable for the onward transmission of HIV by a patient. This article reviews the current scope of the criminal law, before considering the law on liability for onward transmission in the UK. It concludes that civil liability (liability in damages) for onward transmission will be imposed only in unusual cases, and probably only where a doctor has failed to discharge his or her duty of care towards one of his or her own patients. Criminal liability is perhaps theoretically possible but exceptionally unlikely.

Confidentiality↗

PubMed1999

Immunisation coverage in Australian children: a systematic review 1990-1998.

The Australian Childhood Immunisation Register (ACIR) commenced operation in January 1996 and provides a comprehensive database of children's immunisations in Australia. The ACIR enables implementation of an immunisation recall and reminder system and improved surveillance and reporting of immunisation coverage. Before the introduction of the ACIR, the methods used in assessing coverage varied widely in design and quality, with few studies measuring coverage at national or statewide level. This is a systematic review of the scope and reliability of estimates of immunisation coverage available in Australia from 1990 to 1998. A total of 108 studies were identified of which 51 were classified as higher quality based on a range of criteria including whether they had a response rate of 50% or better.

Adolescent↗

PubMedDate not supplied

Three decades of research on computer applications in health care: medical informatics support at the Agency for Healthcare Research and Quality.

The Agency for Healthcare Research and Quality and its predecessor organizations-collectively referred to here as AHRQ-have a productive history of funding research and development in the field of medical informatics, with grant investments since 1968 totaling $107 million. Many computerized interventions that are commonplace today, such as drug interaction alerts, had their genesis in early AHRQ initiatives. This review provides a historical perspective on AHRQ investment in medical informatics research. It shows that grants provided by AHRQ resulted in achievements that include advancing automation in the clinical laboratory and radiology, assisting in technology development (computer languages, software, and hardware), evaluating the effectiveness of computer-based medical information systems, facilitating the evolution of computer-aided decision making, promoting computer-initiated quality assurance programs, backing the formation and application of comprehensive data banks, enhancing the management of specific conditions such as HIV infection, and supporting health data coding and standards initiatives. Other federal agencies and private organizations have also supported research in medical informatics, some earlier and to a greater degree than AHRQ. The results and relative roles of these related efforts are beyond the scope of this review.

Databases, Factual↗

PubMed2003

The problem of decompensated heart failure: nomenclature, classification, and risk stratification.

Despite its high prevalence and significant rates of associated morbidity and mortality, the syndrome of decompensated heart failure remains poorly defined and vastly understudied. Few high-quality epidemiologic studies, randomized controlled trials, or published guidelines are available to guide the management of this complex disease. In addition, there is no consensus definition of the clinical problem that it presents, no agreed upon nomenclature to describe its clinical features, and no recognized classification scheme for its patient population; all of which has contributed to the lack of therapeutic development in this critical arena of cardiovascular disease. This review outlines the scope of the problem and proposes a system of nomenclature and classification sufficiently simple for general acceptance among clinicians while still encompassing the heterogeneity of the patient population. It also defines the current understanding of strategies for risk stratification in the setting of decompensated heart failure.

Acute Disease↗

PubMed1990

A review of fine needle aspiration cytology and its scope in Papua New Guinea.

Fine needle aspiration cytology has become a very popular investigative procedure in many parts of the world for the diagnosis and management of primary neoplasms. Nevertheless the technique is still not very familiar to most clinicians in Papua New Guinea. Hence this paper provides a brief review of fine needle aspiration biopsy with special emphasis on its methodology, applications and usefulness in a Papua New Guinean setting and on its limitations. It is hoped that such a simple procedure will be used more often in future for tumour diagnosis.

Biopsy, Needle↗

PubMed1988

Policy principles for utilizing science in decision-making on chronic health issues.

Scientific advances will continue to contribute to our understanding of latent chronic diseases related to chemical exposure. Regulatory agencies must deal with a complex matrix of emerging scientific information, a diversity of potential risk situations, and a variety of statutory prescriptions for protecting public health. Seven policy principles are proposed for facilitating integration of the latest scientific thought into the administrative decision-making process. The principles relate to distinguishing between risk assessment and risk management, analysis of all relevant information in developing a risk assessment, consideration of weight-of-the-evidence and more probable than not criterion on key assumptions, scientific peer review of assessments, scoping scientific input appropriately with the nature of a specific regulatory activity, emphasizing research which enhances the basis of risk assessment, and education and communication on risk matters. The policy principles are interdependent; collectively they need endorsement and promotion by the scientific and regulatory communities and by policy leaders in federal and state governments in the interest of establishing a framework for further improving the basis of critical decisions for protecting public health.

Chronic Disease↗

PubMed1997

Influence of race or ethnicity on pharmacokinetics of drugs.

Review of the current literature on racial differences in pharmacokinetics of drugs supports the premise that only pharmacokinetic processes which are biologically or biochemically mediated have the potential to exhibit differences between racial or ethnic groups. Thus, the pharmacokinetic factors which can be expected to potentially exhibit racial differences are (1) bioavailability for drugs which undergo gut or hepatic first-pass metabolism, (2) protein binding, (3) volume of distribution, (4) hepatic metabolism, and (5) renal tubular secretion. Absorption (unless active), filtration at the glomerulus, and passive tubular reabsorption would not be expected to exhibit racial differences. As is evident from this review, there are relatively few drugs for which there is information on ethnic or racial differences in pharmacokinetics. Thus it is often necessary to try to predict whether such differences might exist. Taking into consideration the above factors and evaluation of the pharmacokinetic characteristics of the drug, it should be possible to identify those drugs most likely to exhibit differences in their pharmacokinetics. For example, a drug which is eliminated entirely by the kidneys through filtration and reabsorption and is not highly bound to plasma proteins (or is bound to albumin) is highly unlikely to exhibit racial differences in its kinetics. Conversely, a drug which undergoes significant gut and/or hepatic first-pass metabolism and is highly bound to AGP is much more likely to exhibit kinetic differences between racial groups. A discussion of the impact of racial differences in kinetics on drug response or racial differences in drug efficacy, toxicity, or pharmacodynamics (concentration-response relationship) is beyond the scope of this review. However, a number of the papers described above also evaluated differences in pharmacodynamics or response. Among the comparisons of Chinese and Caucasians, these include the papers on propranolol, morphine, nifedipine, triazolam, diazepam, and omeprazole. For those studies comparing differences in blacks and Caucasians, responses or pharmacodynamics were also determined in the studies of propranolol, trimazosin, and methylprednisolone. Interested readers are also referred to the review by Wood and a more recent review by Kitler for additional discussion of ethnic/racial differences in pharmacodynamics/drug response.

Biological Availability↗

PubMed2004

Recent advances in prion biology.

PURPOSE OF REVIEW: Prion diseases continue to present a diagnostic and therapeutic challenge to clinicians and researchers worldwide. Many important aspects of prion biology remain unclear, and we still do not understand the nature of the infectious agent, the mechanisms leading to central nervous system damage, and the physiological function of the cellular prion protein. The current diagnostic tools for prion infections are breathtakingly insensitive when compared with those of other infectious diseases. Finally, there are hardly any therapeutic strategies. However, not all is gloomy, and many recent developments have advanced our basic understanding of prion diseases. RECENT FINDINGS: In most prion infections, the portal of entry is extraneural. Although we still do not understand all details, several molecules and cell types have been identified as key players in prion neuroinvasion. These include lymphotoxins and their receptors, follicular dendritic cells, and the autonomic nervous system. These advances in knowledge are spurring the exploration of strategies for postexposure prophylaxis. SUMMARY: The prion phenomenon is, at the same time, the cause of horrible diseases, and a fascinating biological enigma. The scope of this review is to discuss a selection of novel findings in prion research.

Animals↗

PubMed1995

Perspectives for the control of tuberculosis.

The control of tuberculosis has become more elusive with the increased incidence of HIV, and the continued selection of multidrug-resistant organisms. The intracellular pathogenesis of, and host-response to Mycobacterium tuberculosis present challenges to both classical chemotherapeutic and vaccination approaches, with the organism able to replicate in an unrestricted manner in lung but not other tissues. Adequate control of this pathogen, that has evolved so successfully for its symbiotic exploitation of man, will require complex approaches including additional chemotherapeutics of more acceptable toxicity and efficacy, vaccination and commitment to public health measures. In this review, the worldwide scope of the disease is outlined, and its direct and indirect costs considered. The organism enjoys the protective advantages of a slow replication and of a specialized phagolysosomal intracellular niche, requiring a host-response capable of breaching these cellular barriers. The challenges of current vaccine approaches, including live vaccines, target antigen selection and the antigen delivery and adjuventation necessary to elicit adequate pulmonary responses are discussed. Our current understanding is inadequate to control TB and the rekindling of fundamental experimental approaches to the organism, and the host response it evokes, are essential to generate the preventative and therapeutic means necessary for its worldwide control.

Animals↗

PubMedDate not supplied

Development of nurse specialists/advanced practitioners in Ireland.

An Bord Altranais (Irish Nursing Board) published "Report of the Commission on Nursing: A Blueprint for the Future" in 1998. This report was the result of collaborative work among those involved in nursing in Ireland. It recommended the establishment of clinical career pathways, which would allow a nurse with extensive experience and advanced expertise, as well as an appropriate course, to be recognized as a clinical nurse specialist. Further advancement along this pathway could possibly enable the nurse to progress to an advanced practitioner grade. The report acknowledged that there are "various and differing interpretations" of the title "practitioner". This article explores the growth and development of the roles of the clinical nurse specialist and advanced nurse practitioners in Ireland over the past number of years. The literature reflects elements of confusion that exist in some areas about the role of a clinical nurse specialist and an advanced nurse practitioner. The "Review of the Scope of Nursing and Midwifery Practice" (An Board Altranais, 2000) recognized a lack of clear differentiation between the role of the clinical nurse specialist and the advanced nurse practitioner. Overall, some clear roles are identified for the nurse who advances or wishes to advance along clinical career pathways in nursing. However, there still appears to be a certain degree of confusion about the use of titles such as "nurse specialist" and/or "nurse practitioner". The guidelines about the level of practice and education/training required for the nurse moving along the pathways of clinical nurse specialism and/or advanced nursing practice is somewhat obscure and is interpreted in different ways in the literature.

Career Mobility↗

PubMedDate not supplied

Internet Medline providers.

Each database in this review has features that will appeal to some users. Each provides a credible interface to information available within the Medline database. The major differences are pricing and interface design. In this context, features that cost more and might seem trivial to the occasional searcher may actually save time and money when used by the professional. Internet Grateful Med is free, but Ms. Coady and I agree the availability of only three ANDable search fields is a major functional limitation. PubMed is also free but much more powerful. The command line interface that permits very sophisticated searches requires a commitment that casual users will find intimidating. Ms. Coady did not believe the feedback currently provided during a search was sufficient for sustained professional use. Paper Chase and Knowledge Finder are mature, modestly priced Medline search services. Paper Chase provides a menu-driven interface that is very easy to use, yet permits the user to search virtually all of Medline's data fields. Knowledge Finder emphasizes the use of natural language queries but fully supports more traditional search strategies. The impact of the tradeoff between fuzzy and Boolean strategies offered by Knowledge Finder is unclear and beyond the scope of this review. Additional software must be downloaded to use all of Knowledge Finders' features. Other providers required no software beyond the basic Internet browser, and this requirement prevented Ms. Coady from evaluating Knowledge Finder. Ovid and Silver Platter offer well-designed interfaces that simplify the construction of complex queries. These are clearly services designed for professional users. While pricing eliminates these for casual use, it should be emphasized that Medline citation access is only a portion of the service provided by these high-end vendors. Finally, we should comment that each of the vendors and government-sponsored services provided prompt and useful feedback to e-mail questions about usage. In conclusion, we would suggest you try the various services, determine which interface suits your style and budget, then perform simple searches until you learn the strengths and weaknesses of the service you select.

Humans↗

PubMed2005

Medical applications of electronic nose technology.

Electronic nose technology has been developed over the past 15 years in the field of chemistry as an electronic equivalent of the biologic mechanism of smell. Since its inception, it has been well recognized that there is great potential in applying this technology to the field of medicine. This review discusses those areas of medicine in which electronic nose technology has been applied. For each area, this review addresses the scope of the medical problem that has been studied, how the electronic nose technology may help address the medical problem, and the results of such studies to date. Next generation electronic noses will be refined to better analyze specific disease states. This will require further evaluation of the specific volatiles to be tested. This information may then be brought to bear on refinement of the chemistry of the electronic nose sensors, making them more sensitive and specific for the particular disease of interest. The ultimate goal of work in this arena is to make an electronic nose that is portable, fast, inexpensive and, therefore, suitable for use in the examination room or at the bedside, making it facile as a diagnostic tool.

Biomimetics↗