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The great escape? Prospects for regulating access to technology through health technology assessment.

OBJECTIVE: Health technology assessment (HTA) can be used both to promote access to safe, efficacious, and cost-effective technologies, and to discourage access to undesirable ones. Yet HTA has had less success than might be hoped in pursuing the latter goal. This paper examines the scope of HTA as currently practiced to contribute to regulation of access to undesirable technologies. DESIGN: The study design is a critical analysis of HTA's methods, based on an exposition of the normative issues involved in restriction of access to health technologies. The paper classifies technologies that might figure as potential candidates for exclusion into five categories and underscores the key social and ethical dilemmas associated with limiting their use. RESULTS: For four of the five categories of technology outlined, limitation of access necessarily involves denial of benefit. Limitation of access thus inevitably raises difficult normative issues. We show that these are ill-addressed by the range of "evidence" typically considered in technology assessments, which centers predominantly on clinical and technical features such as efficacy, safety, and costs. CONCLUSIONS: If HTA is to enhance our ability to make reasonable decisions concerning the use and diffusion of health technologies, it must better integrate consideration of the social, political, and ethical dimensions of health technologies into the process of technology assessment. We suggest a framework within which to approach this goal.

Canada↗

Effects of collimator size of a dental X-ray unit on image contrast.

OBJECTIVES: To examine the effect of collimator size on image contrast in dental radiography. METHODS: Two conventional collimators, one circular (53 mm in diameter) and one rectangular (35x45 mm2), were compared with a small rectangular collimator (26x39 mm2). Low-contrast and high-contrast resolution was assessed with the aid of contrast-detail and line-pair phantoms. RESULTS: Shallower holes were observed with the small rectangular collimator. Two-thirds of 17 observers assessing high-contrast resolution considered the small collimator to result in a clearer image than the conventional collimators. The same effect was demonstrated with the line-pair phantom and by microdensitometry. With the small collimator the energy imparted is estimated to be reduced by 54 and 36% compared with the conventional circular and rectangular collimators respectively. CONCLUSIONS: Decrease of the collimator size to fit the film size used for children will result in improved low-contrast and, under some conditions, improved high-contrast resolution. This improvement might have implications for caries diagnosis and monitoring.

Absorptiometry, Photon↗

Physical evaluation of a system for direct digital intra-oral radiography based on a charge-coupled device.

OBJECTIVES: To determine technical properties of a direct digital intra-oral radiographic system, the Dixel(R) (J Morita Corporation, Kyoto, Japan). METHODS: A dose response function and the dark current were calculated from two series of exposures to a homogeneous radiation field. The line spread function (LSF) and the modulation transfer function (MTF) were determined from radiographs of an edge. The noise power spectrum (NPS) was determined at three exposures from radiographs exposed to homogeneous radiation fields. Noise equivalent quanta (NEQ) were calculated from the one-dimensional NPS and the MTF. The detective quantum efficiency (DQE) was determined from the NEQ and a representative value of the photon fluence. Signal-to-noise ratios (SNR) were calculated from the NEQs and different signal contrasts. RESULTS: The dose response function demonstrated a slight curvature. There was no effect of the dark current. NPS ranged from 10-5 - 10-7 mm2 depending on exposure and frequency. At a peak of about 2 cycles/mm the DQE is on an average about 30 per cent. SNRs are favorable. CONCLUSION: The technical properties found in this study indicate that the Dixel(R) system is suitable for intra-oral dental radiography.

Artifacts↗

[Rapid assessments"--quick evaluation of medical technology].

Assessing the clinical, economical and other consequences of medical technologies (health technology assessment, HTA) is an important instrument to support decisions in many health care systems. A comprehensive HTA, however, is time-consuming and costly while, on the other hand, decisions have to be made quickly. A number of international HTA programmes established rapid assessment tracks although they are variable in scope and methods. In the first part of this paper, these programmes were compared with respect to scope, methods and time to complete assessments. It can be shown from this comparison that there is no common definition of "rapid assessments". In the second part of the paper, a model for processing rapid assessment in the German context is introduced and discussed. The model aims at rapid assessments serving the needs of German decision-makers and ensuring high scientific quality at the same time. The model consists of a modular system that is tailored to the actual demand of the decision-maker. Modules are obligatory (such as a systematic literature search) or optional (such as meta-analysis). All modules are subject to standardisation as far as possible. However, it should be kept in mind that a close collaboration between commissioners and executives of an HTA is necessary to focus on the question and work out the HTA accordingly.

Cost-Benefit Analysis↗

Medical technology -- a different view of the contentious debate over costs.

There is a growing conviction that medical technologies are major contributors to escalating costs, and regulating them is generally viewed as the least contentious way to control expenses in the 1980's. Five forms of technology control are being discussed or developed. All aim to reduce costs by controlling big, expensive technologies in the class of computed tomographic (CT) scanning. We present evidence that technologies such as the CT scanner account for far less of the growth in medical expenditures than do the collective expenses of thousands of small tests and procedures. Furthermore, we suggest that each strategy for controlling large technology involves substantial practical and conceptual problems that would severely limit its effectiveness. We thus suggest a shift away from attempts to harness the big technologies, and toward incentives to encourage the more discerning use of all technologies. To this end, we propose changes in physician reimbursement and education and expanded insurance incentives to encourage physicians and hospitals to be more selective in the use of technology.

Clinical Laboratory Techniques↗

Role of ergonomics in the transfer of technology to industrially developing countries.

Technological development has contributed to economic growth and social progress as well as a reduction of many sources of occupational accidents, injuries and stresses. However, advanced technology has also brought new sources of work stress and injuries. Industrially developing countries (IDC) have tended to try to achieve economic growth and development by importing technology designed for IDC. However, because of several complex technical, cultural and socio-economic factors, this policy has not been always successful. Inappropriate technology transfer has led to many work environment and productivity problems. Consideration of ergonomics in the choice and utilization of the transferred technology can help to create a good fit between technology, technology users and the operating environment. Application of ergonomics is, however, not widely spread in most IDC. Ergonomics input will create the appropriate working environment in which people are safe and motivated to participate and can better utilize company resources for increasing system productivity, reliability and availability.

Developing Countries↗

Outcomes measurement: health state preferences and economic evaluation.

A major health care policy issue in this era of accountability is controlling the introduction and utilization of increasingly sophisticated and expensive health care technologies. Data are needed about both the effectiveness and the costs of assistive technologies before making decisions without relying on "that's what we did last time," "gut feelings," or even "educated guesses." Services, such as assistive technology, fall in the category where rigorous scientific evidence about cost-effectiveness is virtually nonexistent. The field of medical technology assessment has been studying cost-effectiveness for decades and offers many methodological ideas to related fields such as assistive technology. Based on the experiences of medical technology assessment, the measurement of health state preferences and its use to estimate quality-adjusted life years is discussed in this paper. Economic evaluation can be defined as the comparative analysis of alternative courses of action in terms of both costs and consequences. Information from economic evaluation studies, including the use of quality-adjusted life years as an outcome measure, helps us to determine which health care services we can afford to incorporate into routine clinical practice. The major forms of economic evaluation for health care described in this paper are cost-benefit, cost-effectiveness, and a special form of cost-effectiveness, cost-utility. Important national and state health care policies are being considered and implemented on the basis of economic evaluation data and these are bound to have major implications for assistive technology. The assistive technology field needs to be aware of these methods both to understand how large scale health-related policy decisions are impacted by economic evaluations and to become participants in and contributors to this process.

Cost-Benefit Analysis↗

Future AAC technology needs: consumer perspectives.

This article suggests the need for rethinking the role that consumer perspectives will play (and ought to play) in the design and development of future augmentative and alternative communication (AAC) technologies. After carefully defining what they mean by "AAC consumers," "consumer perspectives," and "AAC technologies," the authors consider the extent to which current research has illuminated our understanding of (1) how consumers view AAC technologies and (2) how consumers themselves would define future technology needs. It's not a pretty picture. While it is clear that there already exist specific constructs and methods that could enable researchers and developers to learn more about consumer perspectives, it is equally clear that few, if any, researchers make much use of these constructs and methods. The authors focus specifically on ways that consumer perspective can helpfully infuse participatory action research, technology transfer processes, and ergonomics. In addition, the authors consider how research that investigates the ways in which assistive technologies impact the daily lives of individuals with severe communication impairment also influences public policy issues, which can in turn affect future definitions of AAC technology needs. Throughout the article, the authors advocate for a paradigm shift in the quantity and quality of the collaborations that occur between AAC consumers and AAC researchers, manufacturers, and developers. Augmented communicators and their families have a major stake in all types of research that can affect the design and development of AAC devices and accessories, and the results of this research, in turn, can affect public policy decisions about AAC technologies. This makes it all the more important that AAC consumers be involved at each step of the research and development process.

Communication Devices for People with Disabilities↗

Actor-network theory: a tool to support ethical analysis of commercial genetic testing.

Social, ethical and policy analysis of the issues arising from gene patenting and commercial genetic testing is enhanced by the application of science and technology studies, and Actor-Network Theory (ANT) in particular. We suggest the potential for transferring ANT's flexible nature to an applied heuristic methodology for gathering empirical information and for analysing the complex networks involved in the development of genetic technologies. Three concepts are explored in this paper--actor-networks, translation, and drift--and applied to the case of Myriad Genetics and their commercial BRACAnalysis genetic susceptibility test for hereditary breast cancer. Treating this test as an active participant in socio-technical networks clarifies the extent to which it interacts with, shapes and is shaped by people, other technologies, and institutions. Such an understanding enables more sophisticated and nuanced technology assessment, academic analysis, as well as public debate about the social, ethical and policy implications of the commercialization of new genetic technologies.

Breast Neoplasms↗

Clinical and economic evaluation of health care technologies: a joint and sequential approach.

Promising new technologies have to be carefully analyzed before their integration into clinical practice. Moreover, the existing technologies need to be confronted with the new ones in terms of effectiveness and efficiency. Logical guidelines for both clinical and economic evaluation are described in the present review paper which mainly deals with diagnostic technology. All the proposed steps are not instrumental for each technology assessment but they provide a more rational approach to the acceptance and diffusion of technology.

Cost-Benefit Analysis↗

Label-free cell-based assays with optical biosensors in drug discovery.

Once viewed solely as a tool for low throughput and kinetic analysis of biomolecular interactions, optical biosensors are gaining widespread uses in drug discovery because of recent advances in instrumentation and experimental design. These advances have expanded the capabilities of optical biosensors to meet the needs at many points in the drug discovery process. Concurrent shifts in drug discovery paradigms have seen the growing use of whole cell systems for drug screens, thus creating both a need in drug discovery and a solution in optical biosensors. This article reviews important advances in optical biosensor instrumentation, and highlights the potential of optical biosensors for drug discovery with an emphasis on whole cell sensing in both high throughput and high content fashions.

Biological Assay↗

Dynamic and label-free cell-based assays using the real-time cell electronic sensing system.

Cell-based assays have become an integral part of the preclinical drug development process. Recently, noninvasive label-free cell-based assay technologies have taken center stage, offering important and distinct advantages over and in addition to traditional label-based endpoint assays. Dynamic monitoring of live cells, the preclusion of label, and kinetics are some of the fundamental features of cell-based label-free technologies. In this article we will discuss the real-time cell electronic sensing (RT-CES, ACEA Biosciences Inc., San Diego, CA) system and some of its key applications for cell-based assays such as cell proliferation and cytotoxicity, functional assays for receptor-ligand analysis, cell adhesion and spreading assays, dynamic monitoring of endothelial barrier function, and dynamic monitoring of cell migration and invasion. Also, where appropriate we will briefly discuss other label-free technologies in an application-specific manner.

Biological Assay↗

Cellular dielectric spectroscopy: a label-free comprehensive platform for functional evaluation of endogenous receptors.

The CellKey (MDS Sciex, South San Francisco, CA) system enables comprehensive pharmacological evaluation of cell surface receptors, including G-protein coupled receptors (GPCRs) and tyrosine kinase receptors, using adherent and suspension cell lines and primary cells. A unique application enabled by the ability of the CellKey system to reliably quantify activation of endogenous receptors is receptor panning. This application allows investigators to easily screen disease-relevant cell types for functionally active target receptors by treating cells with a panel of receptor-specific ligands. Receptor panning of multiple cell types including Chinese hamster ovary, human embryonic kidney 293, HeLa, U-937, U-2 OS, and TE671 cells resulted in the identification of many functionally active, differently coupled endogenous GPCRs, some of which have not been previously documented in the literature. Upon detecting GPCR activation in live cells, unique cellular dielectric spectroscopy (CDS) response profiles are generated within minutes that reflect the signaling pathways utilized and have been shown to be characteristic of Gs, Gq, and Gi GPCRs. The fact that the CDS response profiles are predictive of the G-protein coupling mechanism of the receptor was demonstrated by using examples of subtype-selective agonists/antagonists to identify the subtypes of the endogenous histamine and beta-adrenergic receptors expressed in U-2 OS cells. A direct correlation is shown between receptor subtype G-protein coupling and CDS response profile. In addition, complex pharmacology, including detection of partial agonism and Schild analysis for endogenous receptors, is presented. The CellKey system allows investigators to conduct studies using endogenously expressed receptors to generate data that are physiologically relevant and in disease context.

Biological Assay↗

Principles of cost effectiveness analysis for the assessment of current and new therapies.

Economic issues have a prominent place in the debate about reforming the U.S. health care system. If more rational allocations of health care resources are to occur, the principles of decision analysis and clinical economics will need to be understood and used to assess current and new technologies. This requires an explicit assessment of the costs and benefits of a health care intervention, defining the current standard intervention, and clarifying the perspective of the assessment (societal, patient, payer, or provider). Detailed cost accounting of resources is optimal in contrast to costs or charges. These principles were included in 1992 proposed Canadian guidelines for using economic evaluations for adoption of new technologies. Such guidelines provide further impetus for the economic assessment of phase III clinical trials. When applied to peripheral blood progenitor cells, future studies should assess the incremental benefits of the strategy using the progenitor cells, not just the cost savings compared to traditional autologous bone marrow transplantation.

Canada↗

Medical technology and inequity in health care: the case of Korea.

There has been a rapid influx of high cost medical technologies into the Korean hospital market. This has raised concerns about the changes it will bring for the Korean health care sector. Some have questioned whether this diffusion will necessarily have positive effects on the health of the overall population. Some perverse effects of uncontrolled diffusion of technologies have been hinted in recent literature. For example, there is a problem of increasing inequity with the adoption of expensive technologies. Utilization of most of the expensive high technology services is not covered by national health insurance schemes; examples of such technologies are Ultra Sonic, CT Scanner, MRI, Radiotherapy, EKG, and Lithotripter. As a result, the rich can afford expensive high technology services while the poor cannot. This produces a gradual evolution of classes in health service utilization. This study examines how health service utilization among different income groups is affected by the import of high technologies. It discusses changes made within the health care system, and explains the circumstances under which the rapid and excessive diffusion of medical technologies occurred in the hospital sector.

Cost-Benefit Analysis↗