Technology Assessment, Biomedical: Evaluation of biomedical technology in relation to cost, efficacy, utilization, etc., and its future impact on social, ethical, and legal systems.Biomedical Technology: The application of technology to the solution of medical problems.United States Office of Technology Assessment: An office established to help Congress participate and plan for the consequences of uses of technology. It provided information on both the beneficial and adverse effects of technological applications. The Office of Technology Assessment closed on September 29, 1995.Cost-Benefit Analysis: A method of comparing the cost of a program with its expected benefits in dollars (or other currency). The benefit-to-cost ratio is a measure of total return expected per unit of money spent. This analysis generally excludes consideration of factors that are not measured ultimately in economic terms. Cost effectiveness compares alternative ways to achieve a specific set of results.Equipment and Supplies: Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures.Quality-Adjusted Life Years: A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)Expert Testimony: Presentation of pertinent data by one with special skill or knowledge representing mastery of a particular subject.Decision Making, Organizational: The process by which decisions are made in an institution or other organization.Great BritainEvidence-Based Medicine: An approach of practicing medicine with the goal to improve and evaluate patient care. It requires the judicious integration of best research evidence with the patient's values to make decisions about medical care. This method is to help physicians make proper diagnosis, devise best testing plan, choose best treatment and methods of disease prevention, as well as develop guidelines for large groups of patients with the same disease. (from JAMA 296 (9), 2006)Models, Economic: Statistical models of the production, distribution, and consumption of goods and services, as well as of financial considerations. For the application of statistics to the testing and quantifying of economic theories MODELS, ECONOMETRIC is available.Biomedical Research: Research that involves the application of the natural sciences, especially biology and physiology, to medicine.Review Literature as Topic: Published materials which provide an examination of recent or current literature. Review articles can cover a wide range of subject matter at various levels of completeness and comprehensiveness based on analyses of literature that may include research findings. The review may reflect the state of the art. It also includes reviews as a literary form.Hospital Shared Services: Cooperation among hospitals for the purpose of sharing various departmental services, e.g., pharmacy, laundry, data processing, etc.Health Policy: Decisions, usually developed by government policymakers, for determining present and future objectives pertaining to the health care system.Device Approval: Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.Research Report: Detailed account or statement or formal record of data resulting from empirical inquiry.State Medicine: A system of medical care regulated, controlled and financed by the government, in which the government assumes responsibility for the health needs of the population.Decision Support Techniques: Mathematical or statistical procedures used as aids in making a decision. They are frequently used in medical decision-making.United States Food and Drug Administration: An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.Randomized Controlled Trials as Topic: Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.Costs and Cost Analysis: Absolute, comparative, or differential costs pertaining to services, institutions, resources, etc., or the analysis and study of these costs.Equipment Safety: Freedom of equipment from actual or potential hazards.Outcome Assessment (Health Care): Research aimed at assessing the quality and effectiveness of health care as measured by the attainment of a specified end result or outcome. Measures include parameters such as improved health, lowered morbidity or mortality, and improvement of abnormal states (such as elevated blood pressure).Databases, Bibliographic: Extensive collections, reputedly complete, of references and citations to books, articles, publications, etc., generally on a single subject or specialized subject area. Databases can operate through automated files, libraries, or computer disks. The concept should be differentiated from DATABASES, FACTUAL which is used for collections of data and facts apart from bibliographic references to them.Comparative Effectiveness Research: Conduct and synthesis of systematic research comparing interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The purpose of this research is to inform patients, providers, and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. ( accessed 6/12/2009)United StatesTechnology: The application of scientific knowledge to practical purposes in any field. It includes methods, techniques, and instrumentation.Guidelines as Topic: A systematic statement of policy rules or principles. Guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by convening expert panels. The text may be cursive or in outline form but is generally a comprehensive guide to problems and approaches in any field of activity. For guidelines in the field of health care and clinical medicine, PRACTICE GUIDELINES AS TOPIC is available.Health Priorities: Preferentially rated health-related activities or functions to be used in establishing health planning goals. This may refer specifically to PL93-641.Risk Assessment: The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988)Policy Making: The decision process by which individuals, groups or institutions establish policies pertaining to plans, programs or procedures.Meta-Analysis as Topic: A quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc., with application chiefly in the areas of research and medicine.Reproducibility of Results: The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.Research Design: A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly.Biomedical Engineering: Application of principles and practices of engineering science to biomedical research and health care.National Health Programs: Components of a national health care system which administer specific services, e.g., national health insurance.Insurance Coverage: Generally refers to the amount of protection available and the kind of loss which would be paid for under an insurance contract with an insurer. (Slee & Slee, Health Care Terms, 2d ed)Sensitivity and Specificity: Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)Decision Making: The process of making a selective intellectual judgment when presented with several complex alternatives consisting of several variables, and usually defining a course of action or an idea.Practice Guidelines as Topic: Directions or principles presenting current or future rules of policy for assisting health care practitioners in patient care decisions regarding diagnosis, therapy, or related clinical circumstances. The guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by the convening of expert panels. The guidelines form a basis for the evaluation of all aspects of health care and delivery.Treatment Outcome: Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.EuropeHealth Care Costs: The actual costs of providing services related to the delivery of health care, including the costs of procedures, therapies, and medications. It is differentiated from HEALTH EXPENDITURES, which refers to the amount of money paid for the services, and from fees, which refers to the amount charged, regardless of cost.Natural Language Processing: Computer processing of a language with rules that reflect and describe current usage rather than prescribed usage.Quality of Life: A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.Information Storage and Retrieval: Organized activities related to the storage, location, search, and retrieval of information.Health Services Research: The integration of epidemiologic, sociological, economic, and other analytic sciences in the study of health services. Health services research is usually concerned with relationships between need, demand, supply, use, and outcome of health services. The aim of the research is evaluation, particularly in terms of structure, process, output, and outcome. (From Last, Dictionary of Epidemiology, 2d ed)Education, Medical, Continuing: Educational programs designed to inform physicians of recent advances in their field.Questionnaires: Predetermined sets of questions used to collect data - clinical data, social status, occupational group, etc. The term is often applied to a self-completed survey instrument.Vocabulary, Controlled: A specified list of terms with a fixed and unalterable meaning, and from which a selection is made when CATALOGING; ABSTRACTING AND INDEXING; or searching BOOKS; JOURNALS AS TOPIC; and other documents. The control is intended to avoid the scattering of related subjects under different headings (SUBJECT HEADINGS). The list may be altered or extended only by the publisher or issuing agency. (From Harrod's Librarians' Glossary, 7th ed, p163)Medical Informatics: The field of information science concerned with the analysis and dissemination of medical data through the application of computers to various aspects of health care and medicine.MEDLINE: The premier bibliographic database of the NATIONAL LIBRARY OF MEDICINE. MEDLINE® (MEDLARS Online) is the primary subset of PUBMED and can be searched on NLM's Web site in PubMed or the NLM Gateway. MEDLINE references are indexed with MEDICAL SUBJECT HEADINGS (MeSH).Abstracting and Indexing as Topic: Activities performed to identify concepts and aspects of published information and research reports.Data Mining: Use of sophisticated analysis tools to sort through, organize, examine, and combine large sets of information.Technology Transfer: Spread and adoption of inventions and techniques from one geographic area to another, from one discipline to another, or from one sector of the economy to another. For example, improvements in medical equipment may be transferred from industrial countries to developing countries, advances arising from aerospace engineering may be applied to equipment for persons with disabilities, and innovations in science arising from government research are made available to private enterprise.Biomedical Enhancement: The use of technology-based interventions to improve functional capacities rather than to treat disease.Neoplasms: New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.Terminology as Topic: The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.PubMed: A bibliographic database that includes MEDLINE as its primary subset. It is produced by the National Center for Biotechnology Information (NCBI), part of the NATIONAL LIBRARY OF MEDICINE. PubMed, which is searchable through NLM's Web site, also includes access to additional citations to selected life sciences journals not in MEDLINE, and links to other resources such as the full-text of articles at participating publishers' Web sites, NCBI's molecular biology databases, and PubMed Central.Periodicals as Topic: A publication issued at stated, more or less regular, intervals.Unified Medical Language System: A research and development program initiated by the NATIONAL LIBRARY OF MEDICINE to build knowledge sources for the purpose of aiding the development of systems that help health professionals retrieve and integrate biomedical information. The knowledge sources can be used to link disparate information systems to overcome retrieval problems caused by differences in terminology and the scattering of relevant information across many databases. The three knowledge sources are the Metathesaurus, the Semantic Network, and the Specialist Lexicon.Algorithms: A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task.Software: Sequential operating programs and data which instruct the functioning of a digital computer.Internet: A loose confederation of computer communication networks around the world. The networks that make up the Internet are connected through several backbone networks. The Internet grew out of the US Government ARPAnet project and was designed to facilitate information exchange.Database Management Systems: Software designed to store, manipulate, manage, and control data for specific uses.Semantics: The relationships between symbols and their meanings.

*  Cost-Effectiveness Analyses of Targeted Oral Anti-Cancer Drugs: A Systematic Review | SpringerLink

Commercializing successful biomedical technologies. New York, NY: Cambridge University Press; 2008.CrossRefGoogle Scholar ... A literature search in PubMed, The Cochrane Library, and the Health Technology Assessment (HTA) reports published by the ... Glanville J, Paisley S. Identifying economic evaluations for health technology assessment. Int J Technol Assess Health Care. ... Whyte S, Pandor A, Stevenson M. Bevacizumab for metastatic colorectal cancer: a NICE single technology appraisal. ...

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*  U.S. GAO - Human Fetal Tissue: Acquisition for Federally Funded Biomedical Research

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Health-Care Technology Development and Assessment: Integrating Research and Undergraduate Education in Biomedical Engineering ... Health-Care Technology Development and Assessment: Integrating Research and Undergraduate Education in Biomedical Engineering ... Tiny Technologies and Regenerative Medicine Massachusetts Institute of Technology Cambridge, MA Michael Elowitz, PhD ... California Institute of Technology Pasadena, CA Loren Frank, PhD Investigator Neural Circuits Underlying Learning, Remembering ...[0]=17828

*  The'utility'of the visual analog scale in medical decision making and technology assessment : Is it an alternative to the time...

Mots-cl s Pascal anglais : Visual Analogue Scale Crichton, Evaluation scale, Health, Technology, Biomedical equipment, ... INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE, vol. 12, n 2, 1996, pages 291-298, 17 r f., ISSN 0266-4623, GBR ... The'utility'of the visual analog scale in medical decision making and technology assessment : Is it an alternative to the time ...

*  Multiple Sclerosis - Abstracts 05a-2g1

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*  Giuliano Mariani

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*  2015-2019 Europe Clinical Chemistry and Immunodiagnostic Markets: Supplier Shares, Country Forecasts, Innovative Technologies,...

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*  2017 Belgium Virology and Bacteriology Testing Market: Volume and Sales Forecasts for 100 Tests, Competitive Strategies,...

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*  Analysis of Targeted Viral Protein Nanoparticles Delivered to HER2+ Tumors | Protocol

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*  Evaluation measures for models assessment over imbalanced data sets

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*  Those Who Have the Gold Make the Evidence: How the Pharmaceutical Industry Biases the Outcomes of Clinical Trials of...

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Incremental cost-effectiveness ratio: The incremental cost-effectiveness ratio (ICER) is a statistic used in cost-effectiveness analysis to summarise the cost-effectiveness of a health care intervention. It is defined by the difference in cost between two possible interventions, divided by the difference in their effect.Biological resistanceDisease burden: Disease burden is the impact of a health problem as measured by financial cost, mortality, morbidity, or other indicators. It is often quantified in terms of quality-adjusted life years (QALYs) or disability-adjusted life years (DALYs), both of which quantify the number of years lost due to disease (YLDs).Expert elicitation: In science, engineering, and research, expert elicitation is the synthesis of opinions of authorities of a subject where there is uncertainty due to insufficient data or when such data is unattainable because of physical constraints or lack of resources. Expert elicitation is essentially a scientific consensus methodology.National Cancer Research Institute: The National Cancer Research Institute (NCRI) is a UK-wide partnership between cancer research funders, which promotes collaboration in cancer research. Its member organizations work together to maximize the value and benefit of cancer research for the benefit of patients and the public.Bestbets: BestBETS (Best Evidence Topic Reports) is a system designed by emergency physicians at Manchester Royal Infirmary, UK. It was conceived as a way of allowing busy clinicians to solve real clinical problems using published evidence.Penalized present value: The Penalized Present Value (PPV) is a method of Capital Budgeting under risk developed by Fernando Gómez-Bezares in the 1980s.Systematic Protein Investigative Research EnvironmentCircuit rider (water/wastewater): Rural water circuit riders are roving technical experts employed by State Rural Water Associations to provide training and assistance to rural and small water utilities within their state.Health policy: Health policy can be defined as the "decisions, plans, and actions that are undertaken to achieve specific health care goals within a society."World Health Organization.Food and Drug Administration Modernization Act of 1997William M. Laffan: William MacKay Laffan (1848–1909) was the publisher and editor of the New York Sun in the final years of the 19th century and the first years of the 20th,Comment on his death in the New York Times, November 20, 1909. Accessed 29 March 2010.Value of control: The value of control is a quantitative measure of the value of controlling the outcome of an uncertainty variable. Decision analysis provides a means for calculating the value of both perfect and imperfect control.IontocaineAIP Conference Proceedings: AIP Conference Proceedings is a serial published by the American Institute of Physics since 1970. It publishes the proceedings from various conferences of physics societies.Pavement life-cycle cost analysis: In September 1998, the United States Department of Transportation (DoT) introduced risk analysis, a probabilistic approach to account for the uncertainty of the inputs of the cost/benefit evaluation of pavement projects, into its decision-making policies. The traditional (deterministic) approach did not consider the variability of inputs.Medical device: A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).Summarised from the FDA's definition.List of Parliamentary constituencies in Kent: The ceremonial county of Kent,Medical sign: A medical sign is an objective indication of some medical fact or characteristic that may be detected by a physician during a physical examination of a patient. For example, whereas paresthesia is a symptom (only the person experiencing it can directly observe their own tingling feeling), erythema is a sign (anyone can confirm that the skin is redder than usual).Aging (scheduling): In Operating systems, Aging is a scheduling technique used to avoid starvation. Fixed priority scheduling is a scheduling discipline, in which tasks queued for utilizing a system resource are assigned a priority each.Global Risks Report: The Global Risks Report is an annual study published by the World Economic Forum ahead of the Forum’s Annual Meeting in Davos, Switzerland. Based on the work of the Global Risk Network, the report describes changes occurring in the global risks landscape from year to year and identifies the global risks that could play a critical role in the upcoming year.Chronic care: Chronic care refers to medical care which addresses pre-existing or long term illness, as opposed to acute care which is concerned with short term or severe illness of brief duration. Chronic medical conditions include asthma, diabetes, emphysema, chronic bronchitis, congestive heart disease, cirrhosis of the liver, hypertension and depression.Generalizability theory: Generalizability theory, or G Theory, is a statistical framework for conceptualizing, investigating, and designing reliable observations. It is used to determine the reliability (i.Institute of Biomaterials and Biomedical Engineering: The Institute of Biomaterials and Biomedical Engineering (IBBME) was founded in 1962 at the University of Toronto (U of T). IBBME is home to the common research and teaching interests of the faculties of Applied Science and Engineering, Dentistry, and Medicine at the U of T.Assay sensitivity: Assay sensitivity is a property of a clinical trial defined as the ability of a trial to distinguish an effective treatment from a less effective or ineffective intervention. Without assay sensitivity, a trial is not internally valid and is not capable of comparing the efficacy of two interventions.The Final Decision: The Final Decision is an episode from season 1 of the animated TV series X-Men Animated Series.National Clinical Guideline CentreGA²LENDragomir R. Radev: Dragomir R. Radev is a University of Michigan computer science professor and Columbia University computer science adjunct professor working on natural language processing and information retrieval.Time-trade-off: Time-Trade-Off (TTO) is a tool used in health economics to help determine the quality of life of a patient or group. The individual will be presented with a set of directions such as:Conference and Labs of the Evaluation Forum: The Conference and Labs of the Evaluation Forum (formerly Cross-Language Evaluation Forum), or CLEF, is an organization promoting research in multilingual information access (currently focusing on European languages). Its specific functions are to maintain an underlying framework for testing information retrieval systems and to create repositories of data for researchers to use in developing comparable standards.Closed-ended question: A closed-ended question is a question format that limits respondents with a list of answer choices from which they must choose to answer the question.Dillman D.Semantic translation: Semantic translation is the process of using semantic information to aid in the translation of data in one representation or data model to another representation or data model. Semantic translation takes advantage of semantics that associate meaning with individual data elements in one dictionary to create an equivalent meaning in a second system.Translational bioinformatics: Translational Bioinformatics (TBI) is an emerging field in the study of health informatics, focused on the convergence of molecular bioinformatics, biostatistics, statistical genetics, and clinical informatics. Its focus is on applying informatics methodology to the increasing amount of biomedical and genomic data to formulate knowledge and medical tools, which can be utilized by scientists, clinicians, and patients.Process mining: Process mining is a process management technique that allows for the analysis of business processes based on event logs. The basic idea is to extract knowledge from event logs recorded by an information system.Wisconsin Alumni Research Foundation: The Wisconsin Alumni Research Foundation is the independent nonprofit technology transfer organization serving the University of Wisconsin–Madison and Morgridge Institute for Research. It provides significant research support, granting tens of millions of dollars to the university each year and contributing to the university's "margin of excellence.Boss CoffeeInternational Committee on Aeronautical Fatigue and Structural IntegrityBritish Journal of Diabetes and Vascular Disease: The British Journal of Diabetes and Vascular Disease is a peer-reviewed academic journal that publishes papers six times a year in the field of Cardiovascular medicine. The journal's editors are Clifford J Bailey (Aston University), Ian Campbell (Victoria Hospital) and Christoph Schindler (Dresden University of Technology).Statutory auditor: Statutory auditor is a title used in various countries to refer to a person or entity with an auditing role, whose appointment is mandated by the terms of a statute.Clonal Selection Algorithm: In artificial immune systems, Clonal selection algorithms are a class of algorithms inspired by the clonal selection theory of acquired immunity that explains how B and T lymphocytes improve their response to antigens over time called affinity maturation. These algorithms focus on the Darwinian attributes of the theory where selection is inspired by the affinity of antigen-antibody interactions, reproduction is inspired by cell division, and variation is inspired by somatic hypermutation.Mac OS X Server 1.0Internet organizations: This is a list of Internet organizations, or organizations that play or played a key role in the evolution of the Internet by developing recommendations, standards, and technology; deploying infrastructure and services; and addressing other major issues.SciDBConcurrency semantics: In computer science, concurrency semantics is a way to give meaning to concurrent systems in a mathematically rigorous way. Concurrency semantics is often based on mathematical theories of concurrency such as various process calculi, the actor model, or Petri nets.

(1/533) 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.  (+info)

(2/533) The cost-effectiveness of ibutilide versus electrical cardioversion in the conversion of atrial fibrillation and flutter to normal rhythm.

Atrial fibrillation and atrial flutter are cardiac rhythm disorders that are often symptomatic and may interfere with the heart's function, limiting its effectiveness. These arrhythmias are responsible for a large number of hospitalizations at a significant cost to the healthcare system. Electrical cardioversion (EC) is the most common nonpharmacologic intervention used to convert atrial fibrillation and atrial flutter to normal rhythm. Electrical cardioversion is highly successful in converting patients to normal rhythm; however, it is more traumatic and resource intensive than pharmacologic treatment. Recently, a new rapid-acting drug, ibutilide, was approved for the conversion of atrial fibrillation and atrial flutter. Ibutilide is administered through intravenous infusion and does not require anesthetization of the patient, as is required for EC. A decision-tree model was developed to estimate the cost-effectiveness of ibutilide therapy compared with EC therapy. Clinical outcomes were based on a phase III trial of ibutilide, and resource use was based on the literature and physician clinical judgment. A stepped conversion regimen of first-line ibutilide followed by EC for patients who fail to convert is less expensive and has a higher conversion rate than first-line EC. Sensitivity analysis shows that our results are robust to changes in cost and effectiveness estimates.  (+info)

(3/533) Technology assessment, coverage decisions, and conflict: the role of guidelines.

As pressure grows for health plans to be accountable for increasing quality of care within a cost-control environment, coverage of new technologies becomes a particularly challenging issue. For a number of reasons, health plans have adopted evidence-based methods for guiding technology decisions. The implementation of these methods has not been free of controversy, and conflicts have arisen between plans and proponents of technologies who often use the political and legal arena in an attempt to secure coverage. Unless these conflicts are resolved, the healthcare system may have difficulty meeting cost and quality objectives. Technology assessment and coverage process guidelines and flexible coverage approaches may be possible ways of resolving these conflicts.  (+info)

(4/533) Technology assessment of medical devices at the Center for Devices and Radiological Health.

We reviewed the Food and Drug Administration's regulatory process for medical devices and described the issues that arise in assessing device safety and effectiveness during the postmarket period. The Center for Devices and Radiological Health (CDRH), an organization within the Food and Drug Administration, has the legal authority and responsibility for ensuring that medical devices marketed in the United States are both reasonably safe and effective for their intended use. This is an enormous challenge given the diversity of medical devices and the large number of different types of devices on the market. Many scientific and regulatory activities are necessary to ensure device safety and effectiveness, including technology assessment, albeit in a manner quite different from that of conventional technology assessment. The basic approach taken at the CDRH to ensure device safety and effectiveness is to develop an understanding of the way in which a medical device works and how it will perform in clinical situations.  (+info)

(5/533) Role of technology assessment in health benefits coverage for medical devices.

With the profusion of new medical technology, managed care organizations are faced with the challenge of determining which medical devices and services warrant health benefits coverage. To aid in this decision-making process, managed care companies turn to technology assessment, a process that differs from the Food and Drug Administration's review of medical devices. Health plans typically use a structured approach to implementing coverage requirements in employer group benefits contracts and use technology assessment to evaluate the scientific evidence of effectiveness to support coverage decisions. Also important is the societal context for decisions regarding coverage for new technologies and the options being considered by policy makers for accountability in technology assessment by private insurers and health plans.  (+info)

(6/533) Transmyocardial laser revascularization: a qualitative systematic review.

OBJECTIVE: To evaluate the status of transmyocardial laser revascularization (TMLR) from an evidence-based perspective to help hospitals make resource management decisions. STUDY DESIGN: Qualitative systematic review of the clinical literature. METHODS: We searched the reference databases MEDLINE, BIOSIS, EMBASE, SciSearch, and Current Contents to identify all articles related to TMLR published between January 1985 and March 1997. We collected, analyzed, and summarized clinical studies in evidence tables. RESULTS: The cumulative evidence available in the medical literature regarding the safety and effectiveness of TMLR encompasses approximately 2000 patients treated worldwide, primarily those with medically refractory angina. Preliminary data suggest that TMLR has an acceptable survival rate and effectively relieves angina in approximately 75% of patients. Data showing improved myocardial perfusion, cardiac function, or prognosis are inconclusive. The mechanism by which TMLR relieves angina is not yet known. CONCLUSIONS: Early evidence regarding TMLR suggests it will be useful for treating patients with end-stage coronary artery disease. Definitive recommendations await critical analysis of the results of ongoing randomized clinical trials, post-market surveillance studies, and third-party payer acceptance.  (+info)

(7/533) The limited state of technology assessment for medical devices: facing the issues.

Medical devices are an integral part of clinical practice and account for a substantial proportion of the national health budget. Clinical testing and regulation of medical devices, however, is vastly different from and inferior to the testing and regulation of drugs. As managed care organizations begin to exert controls on device use, providers are being caught between the policies of their organizations and the demands of device manufacturers and patients, who want wider access to devices. We outline several reasons for the poor state of medical device evaluations and the dangers of using devices without adequate information, and include the recently developed device assessment and reporting guidelines created by the Task Force on Technology Assessment of Medical Devices.  (+info)

(8/533) Healthcare technology assessment: methods, framework, and role in policy making.

This activity is designed for healthcare organization managers and clinicians, particularly those involved in technology-related decisions, including coverage decisions, technology acquisition, practice guideline development, and evidence-based medicine. GOAL: To provide a basic understanding of the principles, methods, and systematic framework of healthcare technology assessment. OBJECTIVES: 1. Understand the role of healthcare technology assessment in policy making and the technical properties and impact assessed. 2. Become familiar with the categories and basic attributes of methods used in healthcare technology assessment. 3. Comprehend the ten-step framework for conducting a healthcare technology assessment.  (+info)

emerging market entrants

  • Strategic assessments of major suppliers and emerging market entrants, including their sales, product portfolios, marketing tactics, and new products in R&D. (


  • Abbott will supply Bigfoot with next generation glucose sensing technology for clinical and comm. (


  • Biotechnology, Pharma and Biopharma News - Research - Science - Lifescience ://Biotech-Biopharma-Pharma: Biomedical Engineer I ., Description Hello, We are currently seeking a Biomed. (


  • Polarization light spectroscopy imaging for assessment of RBC concentration in the skin microvasculature is a robust and accessible technique for the clinical setting. (
  • Additionally, the technique has pre-clinical research applications for investigation of the spatial and temporal aspects of skin erythema and blanching as well as a potential role in drug development, skin care product development and skin toxicological assessment. (
  • Biomedical informatics is an emerging field of healthcare that aims to translate the laboratory observation into clinical practi. (
  • Combining Induced Pluripotent Stem Cells and Genome Editing Technologies for Clinical Applications. (
  • Although for some infections the etiology is still a mystery, while for others the causative microorganisms are present in minute concentrations long before the occurrence of first clinical symptoms, recent advances in genetic engineering and detection technologies are creating exciting opportunities for highly sensitive, specific and cost-effective products. (


  • Rats were the first mammalian species domesticated for scientific purposes, and they soon became the most widely used animal model in biomedical sciences, including cardiovascular research and behavio. (
  • Here the synergy between different fields (technological, natural, exact, social and health sciences) is created and new ideas are born. (


  • Biomedical engineering has long been a driver of advances in healthcare. (
  • Tallinn University of Technology, the only technological university in Estonia, is the flagship of Estonian engineering and technology education. (
  • Exponent provides the highest quality engineering, regulatory, safety assessment, epidemiological, and health economics services to assist our clients with matters related to combination products. (


  • NewsAbbott and Bigfoot Biomedical announce collaboration to develop breakthrough diabetes technologies. (
  • The research scientists of the Institute of Geology at Tallinn University of Technology in collaboration with their colleagues have attempted to find an answer to this question. (


  • From new technologies to diagnose and treat some of the most complex disease to advances that improve quality of life for every. (
  • The past decade has witnessed great advances in biomedical informatics. (


  • In addition to our testing and results, this Evaluation includes an overview of AI/DS technology. (


  • HHMI is a science philanthropy whose mission is to advance basic biomedical research and science education for the benefit of humanity. (
  • Comeback of the Rat in Biomedical Research. (


  • Review of current instrumentation technologies, and a feature comparison of high-, medium-, and low-volume/POC analyzers. (


  • The aim of this study is to present and evaluate a new, portable and easy-to-use imaging technology for investigation of the red blood cell (RBC) concentration in the skin microvasculature based on the method of polarization light spectroscopy using modified standard digital camera technology. (


  • PARIS and LONDON, March 6, 2012 /PRNewswire/ -- Biospace Lab S.A. and the Centre for Advanced Biomedical Imaging at University College London will collaborate on the development of novel real-time in. (


  • Assessment of current and emerging technologies, and their potential market applications. (


  • Comprehensive lists of companies developing or marketing new technologies and products by test. (


  • Assessment of molecular diagnostic, monoclonal antibody, immunoassay, and other technologies and their potential applications for infectious disease testing. (


  • We used multivariate logistic-regression analysis to assess the effects of the race and sex of the patients on treatment recommendations, while controlling for the physicians' assessment of the probability of coronary artery disease as well as for the age of the patient, the level of coronary risk, the type of chest pain, and the results of an exercise stress test. (


  • Biomedical synthetic biology is an emerging field in which cells are engineered at the genetic level to carry out novel functions with relevance to biomedical and industrial applications. (